IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2021-02-12

DGFT Committee Minutes

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_ ; Office of Directorate General of Foreign Trade a New Delhi -0 Y ae FD ey Pet ~», Para.4.07 Decision Pe a cue Pe a Minutes of the Norns Committee — 3 Meeting ‘No. NC/3/MEET/Jaw/202021/4 dated 12.02.2021 ae ‘ (PART -~1j (actually held on 26.02.2021, 12.03.2021 and 12.05.2021) for considering the Cases/issues under wv Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy, 2015-20 pertaining to Chemical and Allied Products falling under Chapter 29 and 30, held under the Chairmanship of Shri Vijay Kumar, Add]. DGFT ; (Online Meeting dated 12.05.2021) and Shri Rajbir Sharma, Jt. DGFT (Meeting dated 26.02.2021, 12.03.2021 : in Room No.4 and 11, Udyog Bhawan, New Delhi) | . Following members were present in the Meeting: oo |Sl.No. [Name & Designation _ : ; [LTIn attendanceShri Shaish Kumar Technical — 1} | Consultant "J 7 [2 Shi DN. Mathur, Technical — 2 | Consultant “J 4 ; . i Shri AjayKumar, Deputy Director [DGFT 2, The Norms Committee has taken decision only with respect to technical aspect/ wastage norms, While PTP/HBPtedeeming the application, RAs should check that the applicant has fulfilled all requirements as prescribed in policy/procedurefor issuai nc eluding ofAdvancethose Authorizat onin policy c i rculars and regularizationissued from time of theto case, time - or any other provisions under . (actually' The heldcommittee on 04.12.2020,went through 16.12.2020the andminutes 24,12.2020),of earlier meeting— No, . 1/82-ALC4/2020 dated 04.12.2020 :

. ONLINE CASES riCase No.:56/7/82-AL C4019" Party Names Lt| | CALCIUMLIMITED PRIVATEGLOBAL ~~ 112.02,2021iNC/3/MEET/Jan/20202Nee’ No/Baies Statues1/4 Deferred | [SQ Hie PRA File eee15314.[| |:01/82/050/0055 1/AM20/ £07/24/040/00107/AN30 121.08.2019 , it Decision: ‘The Commie considered the ease eset aasnie in the presence of technical experts and it / Was decided to call for following information.from the firm: . 7 ; Some i | molar basis. | (i) Complete and balanced chemical reaction, molecular weight and % yield on : poi. (ii) Justification for tow yield. - | i i (iii) Production — Consumption data duly certified by GST. ' :

. | ; iamnineteennineteen AB 10 ANC I I OT “eanmarnanrsamivymse “eanmarnanrsamivymse mma scrmssems fems f f iStatus: an/202021/4 |Approved |Approved cenammnrerenncancnrmi seenmstencnranasonsninssmstencnranasonsninss : No/Date:3410045650 r[[ decided][ to]][[ to]][[Tolify]][[norms]] [[under]][[Para]] . aan|| .

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----- Start of picture text ----- cc enntnmnannntts tt ee AS eceneyme sana iamnineteennineteen AB 10 ANC I I OT “eanmarnanrsamivymse “eanmarnanrsamivymse mma scrmssems fems f f oon decent | iCase No.:31/13/82- PartyName:DEEPAK [MeetNo/Date: iStatus: | |ALC4/2019 PHENOLICS LIMITED INC/3/MEET/Jan/202021/4 |Approved |Approved j earner en nein oe cenammnrerenncancnrmi seenmstencnranasonsninssmstencnranasonsninss : | [HQ File RLA File | [Lic No/Date:3410045650 r |.01/82/050/00874/AM20/ :34/24/040/00223/AM20/ (27 11.2019 [[norms]] \ [[under]] [[Para]] . aan|| it [was][[ decided][ to]][[ to]] [[Tolify]] . | Decision: “=the Committee considered Tie case as per agendaand ‘— Qty ? |14.07 ofExport ProductHBP Vol. 1 as per details givenQtybelow| orSk. as applied by the firm, whichever is less: } No. . | NE iste | IRA concerned may take further necessary action as per above decision ofNC. . 7(Gave Nos32it3i@- SayNameDEEPAK MocNoDae: Status: | jALC4/2019 PHENOLICS“12.02.2021 LIMITED INCISIMEET an/202021/4 |Approved ba . . ) Fie No/Date:3410045651 rn | [HQ = ol ‘Rikie : 1:01/82/050/00875/AM20/ :34/24/040/00205/AM20/ . {27.11.2019 od and itcided to rally norms under Para | Dosons The Commies considered case as poragenda Qty 3 407 ofHBP Vol. Las per details given below or asapplied by the firm, whichever is less: | Qty Sl. Export Product No. 7 . | brexorE ume] | IRA concerned may take further necessary action asperabove decision ofNC. | VicciNoibates Status: mo [iCase. [Noe][artyNameBALAIT] 12.02.2021 | —, . +] \ALC4/2019 [AMINES LIMITED NC/3/MEET/San/202021/4 Approved Noipate3110067616 | — | [IRLA][aig] Fe . fiQFile - | /,01/82/050/00887/AM20/ |.31/83/040/00117/AM20/ _ (02.12.2019 . ‘by the firm, whichever is }ess: | : aoe a Sanne cits Be 9 A norms under | . 4 Para 4.07 of HBP Vol. Las per details given below or as applied [mportitems pe | | | ‘T Export product | 0-160 ks | WMETHYE-2-PYRROLIDONE: | ikg METHANOLAMMONIA ANHYDROUS posTOke [|] ; GAMMA BUTYROLACTONE 0.885 kg | 7 or | : . . . | RA may take approptiate action. as per the decision of Norms Committee. 4 . . ----- End of picture text -----

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----- Start of picture text ----- | [Case No.:104/13/82- —~—~—*(PartyName:MENTHA ALC4/2019 & (Meet Nolbaien Isa _ {ALLIED PRODUCTS NC/3/MEET/Jan/202021/4 |Deferred | jPRIVATE LIMITED 12.02.2021. f. TQFie REA Bile ©[Lic.No/Date:0510413159. [ | was decided to call for following information from the firm: 15 Decision: The Committee considered the case as per agenda in the presence of technical experts and it (iD Complete chemical name structural formula. | (ii) COA of import item from foreign supplier. i. (iii) COA of Export Product from’ manufacturer. | (iv) Last two years Production / Consumption data duly certified by GST. |[CaseNo.:112/13/82-‘Party Name:TOIO VIKAS [Meet | NolDates [Siang 1ALC4/2019 INTERNATIONAL _ NC/3/MEET/Jan/202021/4 |Approved |AQF|:01/82/050/00955/AM20/REAPRIVATE:05/24/040/006File LIMITED1 6/AM20/ Nate03.01.202012.02.2021 s 10d 18108 ‘6 Decision: The Committeeconsideredthe case as per agenda and itwas decided to ratify norms under i |Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Export Product Qty Sl. | ‘Import Items Qty — | No. [ag] | [SOLARFOLIDE [i [T)ScraRboL] RA concerned may take further necessary action as per above decision of NC, |pf||ALC4/2019[Case No.:140/13/82- ‘(Party. PHENOLICSName:DEEPAKLIMITED [MeetNC/3/MEET/Jan/20202No/Dates1/4 [Seana|Approved ' || (HQ8.08 ee Fileeen ee EA mn rt nnn a er EMMA MOL ~ aC A IREAee a ee ley enFile Be Es ABBE OP Os fo ema 4 EO an mre ape eh" 8 Seatenetaiendiaaaiaaetidtel\Lie:No/Date:341004576912.02.2021la adieheelahdeteeale Ueteiniatataeeiteainnced. Cocoa | ':01/82/050/00983/AM20/ |:34/24/040/00267/AM20/ 07.01.2020 . _ | |Decision: . The Committee considered the case as per agenda and‘it was decided to ratify norms under| (7 (Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Export Product Qty | Sl. | Import Items : Qty | | {RA concerned may take further necessary action as per above decision ofNC. | ----- End of picture text -----

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[Case No:141/13/82- Party Name:DEEPAK Meet No/Date: States | | jALC4/2019 (PHENOLICS LIMITED NC/3/MEET/Jan/202021/4 |Approved ig IRA Fite TeNo MDates 3410045770Tk | " [Decision: “The Committee considered the case as per agenda and it was decided to ratify norms under 8 Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: | Export Product Qty Sl. | Import Items Qty | ; No. ; ACETONE ] BENZENE 0.522 kg

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RA concerned may take further necessary action as per above decision of NC.

(Case No176/13/82.~*(PartyName:DEEPAK Meet No/Date: —~—~=«(Status: = i = |ALC4/2019 _ |PHENOLICS LIMITED NC/3/MEET/Jan/202021/4 Approved | | 12.02.2021 ot HQ Filecme RIA File Lic.No/Date:3410045794 | | 1:01/82/050/01019/AM20/ 1:34/24/040/00304/AM20/ 17.01.2020 Decision: TheCommittee considered the case[as][ per][ agenda][and][it][ was][decided][to][ratify][ norms][under] r Para 4.07 of HBP Vol. Las per details given below or as applied by the firm, whichever isless: - Export Product Qty Sl. | Import Items Qty | ; No. | [RENOL Te [ 1 BENZENE 07) |RA concerned may take further necessary action as per above decision of NC. |

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----- Start of picture text ----- | (Case No.:189/13/82- ~~" PartyName:GLOBAL “(Meet No/Date: —~—~—SStatus: i jALC4/2019 ICALCIUM PRIVATE NC/3/MEET/Jan/202021/4 |Approved | (0)| -|(LIMITED1) — [Lie.No/Date:0710116038.12.02.2021 || Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in | the light of earlier decision taken by NC in its Meeting No, 7/82-ALC4/2019, dated 06.09.2019 against | Advance Authorization No. 0710113895 dated 25.09.2018, it was decided to ratify the ad-hoc input output . | norms under para 4.7 ofHBP Vol. I as per details below or as applied by firm whichever is lower: | Sl. | Export product Qty. | Sl. | Import items Qty. | INo. No. f°) Tr CALCIUM LACTATE] 1 kg LACTIC ACID - ANY GRADE | 0560 kg |} oe LUCONATE . CALCIUMCALCIUM CARBONATE GLUCONATE 0.3100,686 kg kg ~ | FERROUS LACTATE LACTIC ACID - ANY.GRADE | 1,028 kg | MAGNESIUM LACTATE LACTIC ACID - ANY GRADE | 1.19 kg | | [4[2INCLACTATE7 [ike [1 [LACTICACID- ANY GRADE [0.990 ke 5 |MAGNESIUM LACTATE lke LACTIC ACID - ANY GRADE | 0,390 kg | LUCONATE GLUCONO DELTA LACTONE [| 0.617 kg i CALCIUM LACTATE 1 kg LACTIC ACIDCALCIUM CARBONATE ~ ANY GRADE | 0.9220.50 kg kg lea concerned may take further necessaty may take further necessaty take further necessaty further necessaty necessaty action as per above decision of as per above decision of per above decision of above decision of decision of of NC, ----- End of picture text -----

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----- Start of picture text ----- lea concerned may take further necessaty may take further necessaty take further necessaty further necessaty necessaty action as per above decision of as per above decision of per above decision of above decision of decision of of NC, . | [CaseNo.:3/2/82-ALC4/2020 [PartyCHEMICALSName:ETERNISLIMITED,FINE [MeetNC/3/MEET/Jan/20202No/Dates Stata _ 12.02.2021 1/4 (Deferred (QF IR aBleeaten ogsdaae | :01/82/050/01037/AM20/ :03/94/040/00715/AM20/ 20,01.2020 i i Decision: The Committee considered the case as per agenda in the presence of technical experts and it | was decided fo call for following information.from the firm: , . (i) Exact chemical name of export product. I (ii) Past production consumption of raw material for two years duly certified by| - ----- End of picture text -----

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----- Start of picture text ----- OTt (Case| No.9//82-ALC42020 PartyName:LACTOSE(INDIA) LTD., [[Meet] NC/3/MEET/Jan/202021/4 [No/Date:][ ~—~—~‘(Status:—=—] (Deferred =| | [HQFieREA File [Lie.][ No/Date:0310834414] [—] (01/82/050/01043/AM20/ :03/95/040/01033/AM20/ 23.01.2020 12 [ecision: ‘The Committee considered the case as per agenda in the presence of technical expertsand it was decided to call for following information from the firm: | (i) Specific item of import and export. : (ii) COA of export product. Lot a) COA of import item from foreign suppnierl ["[Gase No.:27/2/82-ALC4/2020 [PartyName:KLI——=~SSMeetNovDate: (Status: ‘PLASTICIZERS LIMITED. — |NC/3/MEET/Jan/202021/4 |Approved i 12.02.2021 _ [BQREA File LicNo/Date:0510413496 |” i :01/82/050/01061/AM20/ 1:05/23/040/004 17/AM20/ 31.01.2020 Decision: The Committee ‘consideredthe case as per agenda and it was decided to ratify 1normsunder [|] | Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: . Export Product Qty Sl. | Import Items Qty No. ; TRI ETHYL CITRATE lkg CITRIC ACID 0.726 kg 8 (TEC) DENATURED ETHYL 0.526 kg | (PACKED IN 400 NOS. OF ALCOHOL HM-HDPE DRUMS MADE 3 HDPE GRANULES Relevant as | (3,400,000 KGS, WITHOUT KGS.) policy | ‘| | SHALLWASTAGE)) (EACH WEIGHT 8.5 KG DRUM mo, | AND STORAGE CAPACITY ; . | 250.000 KGS.) ; , | RA. concerned may take further necessary action as per above decision of NC. , ----- End of picture text -----

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----- Start of picture text ----- _ | |Case No.:84/2/82- Party Name:PIRAMAL Meet No/Date: (Status: , . i ALC4/2020 ENTERPRISES LIMITED NC/3/MEET/Jan/202021/4 |Approved , US a | 12.02.2021 | | |HQFie ~IRLA File ) __[Lic.No/Date:0310835077 | ~| hE ae den Sane ey © :01/82/050/01118/AM20) © 105795/040/0T1217AM207 “" 2B:0220B0 i Decision: | The Committee considered the case as per agenda in the presence of Technical Experts and it | was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol, Las per details below or as | applied by firm whichever is lower: . No. Export; Product : Qty. | 1 Atorvastatin Calcium Tablets USP 10mg (Pack Size 90 tabs) | 1 Number | (Net wt. of Import Sr. No. 1 is 629.53kgs, Sr. No; 2 is 3486.56kg, Sr. No. 3 is | Tablet 990.08kg, Sr. No. 4 is 634680 Nos., Sr. No. 8 is 634680 Nos.)" . | 2 Atorvastatin Calcium Tablets USP 10mg (Pack Size 1000 - tabs) | 1 Number | (Net wt. of Import Sr. No. 1 is 157,38kgs, Sr. No, 2 is 871.62kg, Sr. No. 3 is | Tablet i 247.52kg, Sr, No. 5 is 14280 Nos,, Sr. No. 9 is 14280 Nos,)" | 3 Atorvastatin Calcium Tablets USP 20mg (Pack Size 90 tabs) | 1 Number | P| (Net wt. ofImport Sr. No, 1 is 787.01kgs, St. No. 2 is 4374.12kg, Sr, No. 3 is | Tablet | 1241,46kg, Sr. No. 4 is 396720 Nos., Sr. No. 8 is 396720 Nos.)" | i Atorvastatin Calcium Tablets USP 40mg (Pack Size 90 tabs) | 1 Number | (Net wt. of Import Sr. No. 1 is 1836.07kgs, Sr. No. 2 is 10169.5 lkg, Sr. No. 3 is | Tablet 5 2887.80kg, Sr. No. 4 is 462770 Nos,, Sr. No. 8 is 462770 Nos.)" ‘Atorvastatin Calcium Tablets USP 80mg (Pack Size 90 tabs) | 1 Number , (Net wt. of Import Sr. No, 1 is 1049.18kgs, Sr. No. 2 is 5839,10kg, Sr. No. 3 is | Tablet | 1656.89kg, Sr. No. 6 is 132220 Nos., Sr. No. 8 is 132220 Nos.) Atorvastatin Calcium Tablets USP 80mg (Pack Size 1000 tabs) | 1 Number 14 1242.69kg, Sr. No. 7 is 8925 Nos., Sr. No. 10 is 8925 Nos.)" | (Net wt. of Import Sr. No. 1 is 786.90kgs, Sr. No. 2 is 4379.40kg, Sr. No. 3 is | Tablet | No,Sl. | Import Item For(All export Qty. in of mg). 1 Number Tablet | USP, : PH 102) , : ! a5, 250cc(Plastic RndBottlesWhite.250CC53/400whiteHdpeHDPESclairRound58a Relevant as per; packing policy. . a 7 | 1500cc(Plastic RoundBottles Extrusion1500CC white89/400HDPENeck RoundWhite ‘ | | ce |i fe Caps/ClosuresCR38400APJT865 PP 383MM-400BLUE PP465 Blue CR)1400 (Plastics | - : ; ' Bs| bog Blue(Plastics53mmCaps/ClosuresPp Cap Lp-EPP 53MM-400& TrisealBlue PP)F217hy . | |. 10 | CC8940AFS837(Plastics Caps/ClosuresWHITEP P P5S5189MM-400CT 89 400SPWhite . , . . h Plain) : . RA concerned may take further necessary action as per above decision ofNC, | : ----- End of picture text -----

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----- Start of picture text ----- | Case No.:135/2/82- Party Name:MANGALAM_ {Meet No/Date: Status: | | ALC4/2020 DRUGS AND ORGANICS = [NC/3/MEET/Jan/202021/4 !Approved | | HQ File RLA File Lic.No/Date:0310835580 : | :01/82/050/01169/AM20/ :03/95/040/01164/AM20/ 20.03.2020 | | Decision: | The Committee considered the case as per agenda and it was decided to ratify norms under Ls Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: ‘ Export Product Qty Sl. | ImportItems © Qty No, ; (DIBUTYLAMINO) METHYL -9H- . FLUORENE-4-METHANOL (DBA) i | RA concerned may take further necessary action as per above decision of NC. i ALC4/2020 ENTERPRISES LIMITED —_|NC/3/MEET/Jan/202021/4 |Approved | atc No.:141/2/82- |‘Party Name:PIRAMAL re12.02.2021 No/Date: Status: | - | THQ File RLA File Lic. No/Date:03 10835591 , | :01/82/050/01175/AM21/ :03/95/040/01215/AM20/ [i104 2020 | Decision: |The Committee considered the case as per agenda in the presence of Technical Experts and it | was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as per details below or as | applied by firm whichever is lower: | . \ No. , . 1 | Atorvastatin Calcium Tablets USP 10mg (Pack Size 90° tabs) | 1 Number (Net wt. of Import Sr. No. 1 is 406.67kgs, Sr. No. 2 is 2252.30kg, Sr.No. 3 | Tablet | is 639.59kg, Sr. No. 4 is 410000 Nos., Sr. No. 8 is 410000 Nos.) i; “2 Atorvastatin Calcium Tablets USP 10mg (Pack Size 1000 tabs) | 1 Number No, 3 is 4298.58kg, Sr. No. 5 is 248000 Nos., Sr. No. 9 is 248000 Nos.)" ; Poo 3 Atorvastatin Calcium .Tablets .USP:. 20mg (Pack Size. 90, tabs) | 1 Number. | — ; reo | (Net wt. of Lmport Sr. No,| is 1031.57kgs, Sr. No. 2 is $733.37kg, Sr.No. | Tablet ° ; ’ | 3 is 1627.24kg, Sr. No. 4 is 520000 Nos., Sr. No. 8 is 520000 Nos.)’ . | 4 Atorvastatin Calcium Tablets USP 40mg (Pack: Size 90 tabs) | 1 Number . Ft (Net wt. of Import Sr. No. 1 is 3967.56kgs, Sr. No. 2 is 21975.30kg, Sr. | Tablet 7 ane No. 3 is 6240.24Kg, Sr, No. 4 is 1000000 Nos,, Sr. No. 8.is 1000000 Nos;). eee oe | 4 4s Atorvastatin Calcium Tablets USP 80mg (Pack Size 90 tabs) | 1 Number 7 4 || No.(Net3 wt.is 3859.65kg, of Import Sr.Sr. No. No. 6| isis 308000 2444.02kgs, Nos., Sr.Sr. No. No, 82 isis 30800013601.90kg, Nos.) Sr. | Tablet |: . i | 6 Atorvastatin Calcium Tablets USP 80mg (Pack Size 1000 tabs) | 1 Number , (Net wt. of Import Sr. No. 1 is 793.51kgs, Sr. No. 2 is 4416.20kg, Sr. No, 3 | Tablet is 1253,13kg, Sr. No. 7 is 9000 Nos., Sr. No. 10 is 9000 Nos.)" J i ----- End of picture text -----

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RA concerned may take further necessary action as‘per above decision of NC.

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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|10|.|
|||{Case No.:171/2/82-|(Party Name:ADCOCK|Meet No/Date:|Status:|
||||ALC4/2020,|0|INGRAM LTD,|NC/3/MEET/Jan/202021/4||Approved|
|i|12.02.2021|
|TG Fe|REA|Fle|LieNo/Date:0710116359 J|.|
||||Decision:|||The Committee|considered|the case as per agenda in the presence of Technical|Experts|and in||
|||the|light|of|earlier|decision|taken|by|NC|in|its|Meeting|No.|15/82-ALC4/2018|
|,|||,|dated|22.03.2019|against|Advance|Authorization|No.|0710113282|dated|15.05.2018,|it|was|decided|to,|'|
|i|ratify the|ad-hoc|input|output norms|under para 4.7|of|HBP|Vol.|I|as per|details|below|or|as|applied by|firm}|
|;|||whichever is lower:|;|;|
|,|No.|,|No.|,|
|||1.|| SYNDOL|TABLETS|~-|(Paracetamo! ||1|million|
|.|i|450mg|+|Caffeine|30mg|+|||tablets|IH|.|
|Doxylamine|Succinate|5mg|+|Codeine|4.|CodienePhsophate|10.2 kg|i|
|i|Phosphate|10mg|Colour|Yellow|BP/EP/USP/PH.EUR|
|_|||14037-1,632mg)|(Parasite|
|6750.000+Caff|-450,000+|—Doxy-|
|75.000+Codeine|-|150,000|Colour|
|:|Yellow|14037-24.480|KGS)|(No.|of|
|||Tablets|15000000)|.|
|||BP/EP/USP/PH.EUR|
|2|ADCO DOL TABLETS|-(Paracetamol|||1|million|||2.|Colour Quinoline|4.56|kg|.|
|i|450mg+Codeine|Phosphate ||tablets|Yellow WS|
|{17|+Doxylamine10mg+Caffeine|Succinate|S5mg+Colour45mg|4,|(spectracol)CODIENE|10,2|kg|L|
|Yellow|Lake-4.56mg+|Colour|Yellow|PHOSPHATE BP/|||
|||WS-2,43mg)(Para-|EP|/ USP|/ PH.EUR|
|||42750.000+Codeine-|950.000+Caff-|
|4275.000+Doxy-475.000|Colour|
|||Yellow|Lake-433.200|Colour|Yellow|
|||WS-230.850|KGS)(No.|of|Tablets|
|_|| 95000000)BP/EP/USP/PH.EUR|,|
|;|3|BETAPYN|TABLETS|-(Paracetamol|||1|million|||1.|Colour Yellow 14037|| Donot|:|
|||+450mg Doxylamine+|SuccinateCaffeine Smg +|Colour50mg ||tablets|'|IH|matchMBF|with|
|||.|Yellow|14037-1.848mg+Codeine||,|;|
|||Phosphate|10mg.|Tablets)|(Para|-|;|4.|CodienePhsophate|10.2 kg|
|||1|2.12|5|0.|0|+Colour00+|CaffYellow-125.00014037-4.620Doxy-|_|| BP/EP/USP/PH.EUR|||
|.||).|||Codeine|-25.00|KGS.|(No,|of|Tablets|oe|_|||os.|po|
|pool|‘||2500000) BP/|EP|/|USP|/ PH.EUR|jo|
|}|450mg|+|Caffeine|45mg|+|/|tablets|- BP/EP/USP/PH.EUR|
|,|||4.-||PYNSTOP TABLETS|- (Paracetamol||‘1 million ||4.|CodienePhsophate|10.2|kg|||.|
|Poot|Doxylamine|Succinate|5mg|+|Codeine|:|
|-.,|||||"||Phosphate|10mg|-Tablets|(Para|-|-|a|aa|
|hod||12.500+Colour1125.000+|CaffYellow-112.50014037-4.620Doxy-|.|||
|i|Codeine|-25.00|KGS|(No.|of|Tablets|||;|
|,||||2500000) BP / EP/USP / PH.EUR|||,|
|||IRA concerned may take further|necessary action|as per above decision of NC.|>|.|||

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|:|11|‘|:|
|||Case No.:172/2/82-|Party|Name:ADCOCK|Meet No/Date:|Status:|||
|||jancaranzo|INGRAM LTD,|NC/3/MEET/Jan/202021/4||Approved|
|TAQ||File|_|RLA File.|[Lic.No/Date:071011636012.02.2021|||||
|:|||(Decision:|The Committee|considered the case as per agenda in the presence of|Technical|Experts and in|
|||jthe|light|of|earlier|decision|taken|by|NC|in_|its|Meeting|No.|15/82-ALC4/2018|
||||,|dated|22.03.2019.|against|Advance|Authorization|No.|0710113282|dated|15.05.2018,|it|was|decided|to|.|
|||{ratify the ad-hoc|input|output norms under para 4.7 of|HBP|Vol.|I|as per|details below|or|as|applied by firm|
|||whichever is lower:|
|ese|Export product|Qty.|Sl.|||Import items|Qty.|
|||No,|No.|
|||1||450mgSYNDOL|+TABLETSCaffeine-|(Paracetamol30mg|+||||tablets1 million|ColourIH|Yellow 14037 ||1.632 kg|.|
|i|i|Doxylamine|Succinate 5mg + Codeine|4.|CodienePhsophate|10.2 kg|
|||Phosphate|10mg|Colour|Yellow|BP/EP/USP/PH.EUR|||
|||||14037-1.632mg)|(Para|-|
|i|||||||6750,000+Caff|-450.000+|— Doxy-|
|||||75,000+Codeine|-|150,000|Colour|||
|||||YellowTablets|14037-24.480|KGS)15000000)(No.|of|
|Good|BP/EP/USP/PH.EUR|
|.|||2|| ADCO DOL TABLETS|-(Paracetamol|||1|million|| 2.|| Colour Quinoline|A56kg|-|vo:|
|ol|450mg+Codeine10mg+Caffeine|Phosphate45mg ||tablets|Yellow(spectracol) WS|
|[18|i|
|ftFo|Yellow+DoxylamineLake-4.56mg+SuccinateColourSmg+ColourYellow|4,|PHOSPHATECODIENE|BP/|10.2 kg|
|i|||WS-2.43mg)(Para-|EP / USP / PH.EUR|
|||42750.000+Codeine-|—950.000+Caff-|
|4275.000+Doxy-475.000|Colour|
|||WS-230.850Yellow|Lake-433.200KGS)(No.Colourof|TabletsYellow|||
|i|||95000000)BP/EP/USP/PH.EUR|||.|
|"|i"|||3|BETAPYN|TABLETS|-(Paracetamol ||1 million|||1.|"||Colour|Yellow|14037|| Donot|
|{450mg|+|Caffeine|50mg||tablets|IH|match with|
|:|,||||||+Yellow Doxylamine14037-1.848mg+Codeine Succinate 5mg + Colour|.|MBF|.|
|||||Phosphate|10mg|Tablets)|(Para|-|4,|| CodienePhsophate|10.2 kg|
|:|i|||1125.000+|Caff|~125.000|Doxy-||’|BP/EP/USP/PH.EUR|
|-|fo;|||Codeine12.500+Colour-25.00|KGSYellow(No.14037-4.620of|Tablets|:|fo|;|al||
|*|||2500000)BP/|EP/|USP|PH.EUR|en|fj|
|||||450mg|+|Caffeine|45mg|+|||tablets|.|BP/EP/USP/PH.EUR|
|.|P|_|4|PYNSTOPDoxylamine TABLETSSuccinate|Smg- (Paracetamol+|Codeine|||1 million|| 4.|||CodienePhsophate|10.2 kg.|;|||oo|,|
|oe|pd|Phosphate|10mg|Tablets|(Para|- |.|ft|Co|
|po|1125.000+|Caff|-112.500|Doxy-|,|
|P|||||Codeine12.500+Colour-25.00|KGSYellow(No.14037-4.620of|Tablets|||
|2500000)|BP/|EP|/|USP /PH.EUR|°|:|
|;|||‘|
|||RA concerned|may take further necessary action as per above decision of NC,|||

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----- Start of picture text ----- . [~~ [€ase No.:187/2/82- ~~—~(Parly Name:STERILE INDIA [MeetNo/Date: Status: 1 |ALC4/2020 (PRIVATE LIMITED NC/3/MEET/Jan/202021/4 iDeferred 12.02.2021 FQ FI IRA File FieNo/Date:0510414084 [| , | Decision: | The Committee considered the case as per agenda in the presence of technical experts and it | was decided to call for following information from the firm: (i) Complete technical details as per Appendix 4E. ----- End of picture text -----

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----- Start of picture text ----- "(Case No:201/2/82-~~. ~~*‘(PartyName:ALPHAMED 4 ALC4/2020 FORMULATIONS PRIVATE(Meet§ (NC/3/MEET/Jan/202021/4No/Date:(Status:|Approved | . LIMITED 12.02.2021 . | [HQ Fe IRA File icNo/Date:0910068698 [ :01/82/050/01235/AM21/ :09/24/040/00049/AM21/ 29,04,.2020 || [Decision: The Comamittee considered the [case] as per agenda in the presence of Technical Experts and in| [ jthe, datedlight13.11.2020— of earlieragainst Advancedecision Authorizationtaken by No.NC0910067834in its datedMeeting25.07.2019,No. it6/82-ALC4/2020|was decided to ratify the ad-hoc input output norms under ppara 4.7 of HBP Vol. I as per details below or as applied by firm | whichever is lower: | |20 Export product : Qty. No.Sl. | Import items inQty. mg/tablet Allowed | [BOLT ENERGY | T Number 51,00 | EFFERVESCENT Ascorbic Acid (Crystalline) 306.0 | TABLETS Caffeine Anhydrous 51.00 mg (Each . Tablet Contains - Sodium Polyphosphate | Glucuronolactone 50 Sodium Hydrogen Carbonate 950.0 mg,Ascorbic Acid 6 Gin Fizz Micron Flavour 300mg,Caffeine 50mg) 7 | Macrogol 6000 135.00 mg | | | 8 Monosodium Fumarate | 2000000, | RA concerned may take further necessary action as per above decision of NC. ----- End of picture text -----

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----- Start of picture text ----- [Case No.204/2/82- ~~ YParty Name:DEEPAK ~~ /Mesi No/Date: (Status: | oo ALC4/2020- - PHENOLICS LIMITED — | /NC/3/MEET/Jan/202021/4 ‘Approved _ in 12.02.2021 “| | | (HQRie REA File Lic.No/Date:3410046035 | :01/82/050/01238/AM21/ :34/24/040/00396/AM20/ 30.04.2020 _21 [Decision: _ The Committee considered the caseas peragendaand it wasdecidedto ratify norms under , - 4.07 ofHBP Vol. 1 as per details given below or as applied by the firm, whichever is less: | Export Product Qty SI. | Import Items . Qty _ ‘ No. ‘ :IRA concernedPHENOL may take further necessary action as perBENZENE above decision of NC. 0.87 kg ----- End of picture text -----

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----- Start of picture text ----- :. , ie Case No.:232/2/82- [Party Name:ADCOCK Meet No/Date: Status: | jALC4/2020 INGRAM LTD, - NC/3/MEET/Jan/202021/4 Approved | 12.02.2021 . OS | THQFile : IRLA File — ILic.No/Date:0710116421. | See Decision: | The Committee considered the case as per agenda in the presence of Technical Experts and : | jthe light of earlier decision taken by. NC in its Meeting No. 15/82-ALC4/2018 | » dated 22.03.2019 against Advance Authorization No. 0710113282 dated 15.05.2018, it was decided to | ratifywhichever the ad-hocis lower: input output norms under para 4.7 ofHBP Vol. I as per details below or as applied by firm | No. ' No. ‘ |i 1 450mg.SYNDOL +TABLETSCaffeine- (Paracetamol |30mg + | tablets1 million |Pf1. Colourpy YellowYellow 1408714037 || 1.6521.632 ke kg | i Doxylamine Succinate 5mg + Codeine 4. CodienePhsophate 10.2 kg I Phosphate 10mg Colour Yellow BP/EP/USP/PH.EUR | 6750.000+Caff14037-1.632mg) —-450.000+(Para — Doxy-oc | | 75.000+Codeine - 150,000 Colour Yellow 14037-24.480 KGS) (No. of | Tablets 15000000) BP/EP/USP/PH.EUR | 2 ADCO DOL TABLETS -(Paracetamol | 1 million | 2, Colour Quineline 4.56 kg ° , | 450mg+Codeine Phosphate | tablets Yellow WS \22 10mg+Caffeine 45mg (spectracol) i Yellow+DoxylamineWS-2.43mg)(Para-Lake-4.56mg+SuccinateColour5mg+ColourYellow 4, PHOSPHATECODIENE BP/ 10.2 kg ! 42750.000+Codeine- 950.000-+Caff- EP / USP / PH.EUR 4275,000+Doxy-475.000 Colour . Yellow Lake-433.200 Colour Yellow i WS-230.850 KGS)(No. of Tablets 7 95000000) BP/EP/USP/PH.EUR , a 3 BETAPYN TABLETS -(Paracetamol | 1 million | 1., | Colour Yellow 14037 | Do not -| 450mg ‘+ ° Caffeine 50mg | tablets IH "| match with | + Doxylamine Succinate Smg + Colour MBF } _ Yellow 14037-1.848mg+Codeine . Phosphate 10mg Tablets) (Para - 4, CodienePhsophate ‘| 10.2 kg i 1 2,12 5 0. 0 +Colour00+ Caff’Yellow-125.00014037-4.620Doxy- BP/EP/USP/PH.EUR; ‘ ‘ fod Codeine -25.00 KGS (No. of Tablets ' | 2500000) BP/EP/USP/PH.EUR +» | °° | 7 ; fi.|| ys . 4 PYNSTOP TABLETS- (Paracetamol | 1 million | 4. CodienePhsophate 10.2 kg | . , | 450mg + Caffeine 45mg + | tablets BP/EP/USP/PH.EUR | |. Doxylamine Succinate 5mg + Codeine 7 , P| Phosphate 10mg= Tablets (Para. ° - of . . i ‘ Po 1125.000+ Catf -112.500 Doxy-| , i P| Codeine -25.00 KGS (No. of Tablets | | 12.500+Colour Yellow 14037-4.620 . | . |i hea| concerned2500000) mayBP take /EP further/ USP necessary/ PH.EUR action as per above: decision of NC. , |i| ----- End of picture text -----

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----- Start of picture text ----- . 14 ; Case No.:278/2/82- [Party Name:KOPRAN [Meet No/Date: ~~ |Status: || ALC4/2020os RESEARCHLABORATORIES LTD. f12.02.2021NC/3/MEET/Jan/202021/4 |Approved SIG Fie Raite ieNoDates0319836269 Fn - Decision: The Committee considered the case as per agenda and it was decided to ratify norms under : |93 (Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Export Product Qty Sl. | Import Items Qty | ; No. ; | ~ | CEFOTAXIME 18500.000 1 CEFOTAXIME ACID NON- | 18296.50 kg 7 | SODIUM STERILE kg STERILE | | RA concerned may take further necessary action as per above decision of NC. |("IGaseNo2279/2/82.—SSSC(iBartyALC4/2020 (PHARMACEUTICALSName:GLENMARK LTD[MeetNC/3/MEET/Jan/202021/4No/Date:Status:|Approved | [HOFile ~~ CRA File "Lic. No/Date:0310836283 | | | :01/82/050/01313/AM21/ 1:03/94/040/00082/AM21/ 20.05.2020 |. [Decision: TheCommiticeconsidered Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: - | the case as per agenda and it was decided to’ratify norms under | No.Sl. | Export Product Qty. 1 Clotrimazole & Betamethasone Dipropionate Cream USP 1%/0.05% (Pack | 900000.000 | Size 15gm) (0.643 mg Betamethasone Dipro equi to Betamethasone | Packs 0.5mg) (Net Wt. of Betamethasone Dipro micr USP is 9.106Kgs & Clotrimazole USP is 135.00 Kgs) | 2 Clotrimazole & Betamethasone Dipropionate Cream USP 1%/0.05% (Pack | 850000.000 Size 45gm) (0.643 mg Betamethasone Dipro equi to Betamethasone | Packs , F 0.5mg) (Net Wt. of Betamethasone Dipro micr USP is 25.800 Kgs & , ; : | ’ | Clotrimazole USP is 382.500 Kgs) mo 94 3 Betamethasone Dip Augm. Cream 0.05% (Pack Size 15gm) (0,643 mg | 400000.000 | Betamethasone | Dipro. equi. to Betamethasone 05mg) | Packs | ‘ Net Wt. of Betamethasone Dipropionate micr. USP is 3.858 Kgs ) | 4 Betamethasone Dip Augm. Cream 0.05% (Pack Size 50gm) (0.643 mg | 360000.000 : 1 Betamethasone Dipro. equi. to Betamethasone 0,5mg) | Packs : i _. {Net Wt. of Betamethasone Dipropionate micr, USP is 11.574 Kgs.) L. boo. 1. 7 | 5 Clotrimazole. Cream USP “1% (Pack Size 15 Grams) (Net Wt. of | 500000,000 * ; 7 ; | ‘Clotrimazole USP is 75.00 Kgs.) . , Packs . ; : 6 Clotrimazole Cream USP 1% (Pack Size 30 Grams) ( Net Wt. of | 500000.000 _ | Clotrimazole USP is 150.00 Kgs.) . Packs Po LT. Clotrimazole Cream -USP 1% (Pack Size 45 Grams) { Net Wt. of,} 400000.000 ~ | | Clotrimazole USP is 180.00 Kgs.) Packs fo | - | SL "| Import ltems ‘ Qty | No. ; , : Clotrimazole USP ; 940.95 kg ’ BETAMETHASONE DIPROP. MICRONIZED USP 51.35 kg - , : | RA concerned may take further necessary action as per above decision of NC. : 7 alarmstsnaindennnnnenaunrnnnietininitintennienntnininisintnn giancnaninmnenrtnnniniicsnnmetntntiinaineteneinninnineinatine ----- End of picture text -----

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.:: ; . [ Case No.:290/2/82- — Party Name:NOVEL Meet No/Date: — Status: i |ALC4/2020 NUTRIENTS PVT LTD INC/3/MEET/Jan/202021/4 Deferred . | 412,02,2021 THQ Fite REAFile eoatesO[TOTES] | Decision: | The Committee considered the case as per agenda in the presence of technical experts and it | _ |was decided to call for following information from the firm: | (i) Copy of Approval from Food & Drugs Administration (FDA) for the export product. (ii) COA for import item from foreign supplier.

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----- Start of picture text ----- |” |CaseNo.:294/2/82- ~—~—~‘(Party Name:NEW [Meet NoDaten TT IStamer . ALC4/2020 ALLIANCE DYE CHEM NC/3/MEET/Jan/202021/4 |Approved PVT LTD 12.02.2021 | [HQ File REA Bile grated ORSEISE | |:01/82/050/01328/AM21/ :03/95/040/00081/AM21/ 26.05.2020 || |Decision: “The Committee considered the [case] as per agenda in thepresonesof Technical Experts and in i the light of earlier decision taken by NC in its Meeting No. 10/82-ALC4/2019 | » dated 29.11.2019 against Advance Authorization No. 0310832837 dated 18.11.2019, it was decided to whichever is lower: °° ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as per details below. or as; applied by firm | DISODIUM EDTA ZINC [ZN|/1ke |1. | ETHYLENE DIAMINE| 0.685 kg CONTENT 15% (+/- 0.5%)] TETRA ACETIC ACID | ; (EDTA) | |RA concerned may take further necessary action as per above decision of NC. [ ALC4/2020Case [No.:291/2/82-] ‘(Party Name:VERVE (Mee NolDatesStara - |HUMAN CARE {NC/3/MEET/Jan/202021/4 iApproved | : |LABORATORIES j12.02.2021 . | [AQFileRLAFile——SSSS«ic, NovDate:0510414258 | | :01/82/050/01325/AM21/ |:05/24/040/00028/AM21/_ \27.05,.2020 . Decision: The‘Committee considered the case as per agenda and it was decided to ratify norms under | . i Para 4.07 of HBP Vol. J as per details given below or as applied io7 |. by the firm, whichever is léss! ” rn | . Export Product Oty Sl. | Import Items ; Qty | | |. | 2mgInj. Norepinephrineeq. to NorepinephrineBitartrate1 || 1135000.000Number | 1 Noradrenaline Bitartrate | 9.988 kg i | mg/ml, 4 ml Ampoule , IRA concerned may take further necessary action as per above decision of NC. . . | ----- End of picture text -----

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----- Start of picture text ----- [|Case No.:297/2/82- PattyName:VERVE[Meet No/Daie. ——S*«~sS [tats;] ALC4/2020 , HUMAN CARE NC/3/MEET/Jan/202021/ Approved | LABORATORIES 4 12.02.2021. GESIRAFile Tie NoMDate:0510414268 Decision: The Committee considered the case as per agenda and it was decided to ratify norms under | Para 4,07 of HBP Vol. Las per details given below or as applied by the firm, whichever is less: | SI. Export Product Qty Sl. | Import Items Qty ; | No. ; No. 1 Tab. Terpine Hydrate | 40797800.000 | 1 Codeine Phosphate | 416.138 kg i 100mg+ Codeine Phosphate |Number i ‘ (28 , 10mg ‘ [ Tab. Terpine Hydrate . | 100mg+ Codeine Phosphate . | 10mg | 2 Tab. Codeine Phosphate 30 | 1000000.000 | 1 Codeine Phosphate 30.6 kg mg Number . Tab. Codeine Phosphate 30 | mg | 3 Tab. Codeine Phosphate 30 } 700000.000 1 Codeine Phosphate 21.42 kg | mg + Paracetamol 325 mg | Number | Tab. Codeine Phosphate 30 , . i mg + Paracetamol 325 mg : | | RA concerned may take further necessary action asper above decision ofNC. | ----- End of picture text -----

[~~[Case No.:298/2/82PartyNameGLAND [MeetNo/Date:—~=«(Status:= | \ALC4/2020 PHARMA LIMITED NC/3/MEET/Jan/202021/4 |Approved | 12.02.2021 | fo —~«*iLie No/Datez0910068809| | fAQFile RLAFile I :01/82/050/01332/AM21/ :09/24/040/00066/AM21/ 27.05.2020. re (Decision: The Commiltee considered the case as per agenda and it wasdecided to ratifynorms under ‘Para 4,07 of HBP Vol. Las per details given below or as applied by the firm, whichever is less: ‘ 29 ‘SL. Export Product ° Qty: Si. | Import Items Qty ; an No. “+ | No, —_ 1 Timolol Maleate Ophthalmic | 20400.000 1 -Timolol Maleate 353.736 | i Gel Forming Solution 0.25%, ; Number Gram \ ee | | SmbBottel “Le ' : i . | 27 Timolol Maleate Ophthalmic | 132800.000 | 1 Timolol Maleate 4605.504 | Gel Forming Solution 0.5%, | Number ; Gram | 5ml Bottel | : RA concerned may take further necessary action as per above decision of NC. . |

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----- Start of picture text ----- [ | |ALC4/2020Case No.:308/2/82- Party Name:PIRAMAL Meet No/Date: Status: i | ENTERPRISES LIMITED NC/3/MEET/Jan/2020212.02.2021 1/4 |Approved ; | TRI Fie IRA Fite Re Noiatesdsi0seAeT| BS HOI7S2/OSO/OTSAD/ AMET/* ~ 720379S/040/0007S/AMIIF —0108.3020° i Decision: | The Committee considered the case as per agenda in the presence of Technical Experts and it twas decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as per details below or as . | applied by firm whichever is lower: . ; . : , | 1 Atorvastatin’ Calcium Tablets USP 10mg (Pack Size 90 tabs) | 1 Number | is(Net3587.93kg, wt. of ImportSr. No. Sr.4 No,is 23000001 is 2281.35kgs, Nos., Sr. No.Sr. No.8 is 2 2300000 is 12634.87kg, Nos.)" Sr. No. 3 | Tablet ' . i 2 Atorvastatin Calcium Tablets USP 10mg (Pack. Size 1000 tabs) { 1 Number : | (Net wt. of Import Sr. No. 1 is 440.84kgs, Sr, No. 2 is 2441,52kg, Sr. No. 3 is | Tablet 3 693.32kg, Sr. No. 5 is 40000 Nos., Sr. No, 9 is 40000 Nos.)" | (NetAtorvastatinwt. of ImportCalciumSr. No. Tablets1 is 1031.57kgs,USP Sr.20mgNo, 2 (Packis 5733.37kg,Size Sr.90No.tabs)3 is || Tablet1 Number 1627.24kg, Sr. No. 4 is 520000 Nos., Sr. No. 8 is 520000 Nos.)" 4 Atorvastatin Calcium Tablets USP 40mg (Pack Size 90 tabs) | 1 Number : | is(Net 4992.19kg, wt. of ImportSr. No.Sr. 4 No.is 8000001 is 3174.05kgs, Nos., Sr. No.Sr. No.8 is 2800000 is 17580.24kg, Nos.}" Sr. No. 3 | Tablet . 4 5 Atorvastatin Calcium -Tablets USP 80mg (Pack Size 90 tabs) | 1 Number : (Net wt. of Import Sr. No. 1 is 396.76kgs, Sr. No. 2 is 2208.10kg, Sr. No. 3 is | Tablet 30 626.57kg, Sr. No. 6 is 50000 Nos., Sr. No. 8 is 50000 Nos.)" | Atorvastatin Calcium Tablets USP 80mg (Pack Size 1000 tabs) | 1 Number. (Net wt. of Import Sr. No, 1 is 3526.72kgs, Sr. No. 2 is 19627.56kg, Sr. No. 3 | Tablet ; is 5569.48kg, Sr. No. 7 is 40000 Nos., Sr. No. 10 is 40000 Nos.)" | No.St. | Import Item For(All exportQty. in of mg)1 Number Tablet USP: ' | 102) ; | Relevant as per packing policy . Lo | Bottles 250CC white HDPE Round 38mm) ; 7 a Plastic Bottles 120CC white HDPE Round 38mm Lat a | ; . 7 7 1500cc Round Extrusion 89/400 Neck White |’ ‘ | . 38mm) “| (Plastic’ Bottles 1500CC white HDPE Round mo | ' cpae | Caps/ClosuresCR38400APJT865PP 38MM-400BLUE PP465 Blue CR).1400 (Plastics|-* me yi;oh, | Blue 53mm Pp Cap Lp-E & Triseal F217hy (Plastics Caps/Closures PP 53MM-400 Blue PP) . i 10 CE8940AFS837 WHITE PP551 GT. 89 400SP ' . |i | Plain)(Plastics Caps/Closures. PP 89MM-400 White . : ; RAconcerned may take further necessary action as per above decision of NC. . ----- End of picture text -----

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----- Start of picture text ----- i[~~ {CaseALC4/2020No.:306/2/82-————«([PartyName:ALPAiLABORATORIES LTD., [Meet No/Date:INC/3/MEET/Jan/202021/4 Status:|Approved || eC | [AQFileREAP Lic.No/bate:5610005886| :01/82/050/01340/AM21/ 1:56/24/040/00004/AM21/ 03.06.2020 | (Decision: ‘The Committee considered the case as peragea n d itdawas decided | Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whicheverto isratifyless: norms under Sl Export Product Qty No.Sl. | Import Items Qty © Ciprofloxacin Hydrochloride | 3000000.000 | 1 CIPROFLOXACIN 1665.00 kg i Tablets BP 500 mg, | Tablets HYDROCHLORIDE : (EACH FILM COATED TABLET IP/BP/USP , | CONTAINS:CIPROFLOXACIN HYDROCHLORIDE BP EQ. TO | CIPROFLOXACIN 500 MG.) ----- End of picture text -----

| RA concerned may take further necessary action as per above decision of NC.

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||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|,|i Case No.:318/2/82-|[Party Name:ADCOCK|Meet No/Date:|IStatus:|
|.|||(ALC4/2020|©|INGRAM LTD,|_|{NC/3/MEET/Jan/202021/4 |Approved|
|||12.02.2021|||
|.|||THQ File|RTA|File|)|_|Lic.No/Date:0710116553||.|ot|.|
|Be|1201/82050/01352/AM21/|~~ |:07/24/040/00000/AM2H|+"|04:08:2020|5" SE|
|,|||Decision:|||The Committee|considered the case as per agenda in the presence|of|Technical Experts and in|-|
|||the|light|of|earlier|decision|taken|by|NC|in|its|Meeting|No.|15/82-ALC4/2018|
|||,|dated|22.03.2019|against.Advance|Authorization.|No.|0710113282|dated|15.05.2018,|it|was|decided|to|
|whichever|is|lower:|
|||ratify the ad-hoc input output norms under para 4.7 ofHBP Vol.|I as per details below or as applied by firm|
|Export product|Sl.|||Import|items|Qty.|
|;|||iLNo,|No.|;|
|i||.|{| 1|||450mgSYNDOL -TABLETS+|Caffeine -|(Paracetamol30mg|+||||tablets1 million|fi|| ColourTH|Yellow 14037|||1.632 kg|
|i|Doxylamine|Succinate|5mg +|Codeine|4,|CodienePhsophate|10.2 kg|
|Phosphate|i0mg|Colour|Yellow|:|BP/EP/USP/PH.EUR|
|||14037-1.632mg)|(Para|-|
|6750.000+Caff|-450,000+|Doxy-|;|
|75.000+Codeine|-|150,000|Colour|
|||Yellow|14037-24.480|KGS)|(No.|of|
|||~|||Tablets|_|15000000)|
|||BP/EP/USP/PH.EUR|:|)|
|||2|ADCO DOL TABLETS|-(Paracetamol|||1|million|||2.|Colour Quinoline|4.56|kg|
|_|450mg+Codeine|Phosphate ||tablets|Yellow WS|
|139°|10mg+Caffeine|45mg|‘||(spectracol}|||
|||+Doxylamine|Succinate|Smgt+Colour|4.|CODIENE|10.2 kg|;|
||||Yellow|Lake-4,56mg+|Colour|Yellow|PHOSPHATE BP/|
|||42750.000+Codeine-WS-2.43mg)(Para-|—950.000+Caff-|,|EP / USP / PH.EUR|
|Yellow|Lake-433,200|Colour|Yellow|
|||4275.000+Doxy-475.000|Colour|
|!|WS-230.850|KGS)(No.|of|Tablets|
|i|95000000)BP/EP/USP/PH.EUR|;|
|||3|BETAPYN|TABLETS|-(Paracetamol|||1|million|||1.|Colour Yellow|14037|| Do not|
|||450mg|+|Caffeine|+|50mg ||tablets|IH|match with|.|:|
|,|+ Doxylamine|Succinate 5mg +|Colour|MBF|;|
|||Yellow|14037-1.848mg+Codeine|
|||Phosphate1125,000+|10mgCaff|Tablets)-125,000°(ParaDoxy--|||4,|BP/EP/USP/PH.EURCodienePhsophate|10,2 kg|:|
|,|_*|wed|||12.500+Colour.|Yellow|14037-4.620|a|po|
|||Codeine|-25.00|KGS|(No.|of|Tablets|||.|‘|jo|’|
|.||.|2500000) BP/EP/USP/PH.EUR|.|.|,|
|||4|PYNSTOP|TABLETS|-|(Paracetamol|||1|million|||4.|CodienePhsophate|10.2 kg|sO|
|‘|;|||450mg|+|Caffeine|45mg|+|||tablets|BP/EP/USP/PH.EUR|||
|bl|Doxylamine|Succinate|5mg +|Codeine|jlo.|oe|
|||||Phosphate|10mg|Tablets|(Para|-|||
|;|1125.000+|Caff|-112.500°|Doxy-|.|||
|||12,500+Colour|Yellow|14037-4.620|i|
|||2500000)Codeine|-25.00BP|/ EPKGS/ USP(No./ PH.EURof Tablets|.|i|
|||i" concerned may|take further necessary action as per above decision.|of NC.|||

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| jiALC4/2020 (PHARMA LIMITED NC/3/MEET/Jan/202021/4 |Approved - | 12.02.2021 . | iene [PartyName:GLAND SCihe ta ap | FQ Fe RTA File TLieNo/Date:09100g8850 FO Decision: The Committee considered thecaseas per agenda andit was decided to[ratify][norms][under}] | Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less;

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----- Start of picture text ----- | Case No.:323/2/82- , Party Name:AUROBINDO _ [Meet No/Date: Status: | |ALC4/2020 ~ |{PHARMA LIMITED NC/3/MEET/Jan/2020212.02.2021 1/4 |Approved . | HQ File RA ~ [Lie.No/Date;0910068853 | mm yi $OL/82/050/01387/AM21) °° :09;247040/0013 1YAM21/~ (08106.2020 EB Decision: The Committee considered the case as per agenda and it was decided to ratify norms under | | Para 4.07 of HBP Vol. Las per details given below or as applied by the firm, whichever is less: | Export Product Qty Sl. | Import Items Qty i No. i" Clavamox Drops 62.50 mg/ml - | 1 Number ‘ 15ml 2 Clavulanate Potassium | 455.66 mg , [Relevant Bulk Drug content in +Syloid’ / Clavulanate 1 the Export Product . Potassium Diluted with Amoxycillin Trihydrate is 1134 syle’ (Silicon Dioxide) kgs and Potassium Clavulante (1:1) | 283.50silicon KgADioxideJ syloid.| (:1) is RA concerned may take further necessary action as per above decision of NC. ; | scoCase No.:324/2/82- ProinerieasParty Name:GLENMARK. LTD[MeetResaietinaianNo/Date: 1/4 AroStatus: | 12.02.2021 :01/82/050/01358/AM21/ :03/94/040/00120/AM21/ 08.06.2020 | fae File REA File Lio NfDeter031089 6566 | | Decision: The Committee considered the case as per agenda and it was decided to ratify norms under Para 4.07 ofHBP Vol. | as per details given below or as applied by the firm, whichever is less: | *| SL» | Export Product ' ' Qty, |} , ' Mometasone Furoate Ointment 0.10% (Pack 10gms) | ' (Net Wt. ofMometasone Furoate Micronized 0.200 Kgs.) ‘Packs S35 Mometasone Furoate Ointment 0.10% (Pack: 15gms) | 70000.000 | nr | Mometasone Furoate Ointment 0.10% /Momate Ointment 0.10% (Pack 20gms) pone.000 | | MometasoneWet Wt..of Mometasone— Furoate Miéronized ‘0.400 Kgs.) __-| Packs ty | (Net Wt. of MometasoneFuroate Furoate MicronizedOintment 3.0000.10% Kgs.) (Pack 30gms). | Packs100000.000 | 5 Mometasone ~ Furoate Ointment 0.10% (pack 45gms) | 100000.000 |! ; ; | so Mometasone —— Furoate Ointment 0.10% ° (Pack SOgms) : | (Net Wt. of Mometasone Furoate Micronized 1.00-Kgs.) Packs . b Eb ]T Mometasone Furoate Ointment 0,10% (pack 60gms) ; 30000.000 | | Mometasone Furoate Ointment 0.10% (pack 100gms) | 20000.000 ; (Net Wt. of Mometasone Furoate Micronized 2.000 Kgs.) Packs | 9 (NetMometasone Wt. of MometasoneFuroate Tropical Furoate MicronizedSolution USP 0.9000.1% Kgs.) (Lotion) (Pack 30ml) Packs30000.000 ----- End of picture text -----

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----- Start of picture text ----- | Mometasone Furoate Tropical Solution USP 0.1% (Lotion) (Pack 60ml) . ’ (Net Wt. of Mometasone Furoate Micronized 1.800 Kgs.) Packs | (Net Wt. of Mometasone Furoate Micronized 0.300 Kgs.) Packs | (Net Wt. of Mometasone Furoate Micronized 1.050 Kgs.) Packs i ee | ee(Net Wt. ofoe Mometasoneto +. Furoate: Furoate0: -CreathMicronized© ¢ 1.00< ON%@ 7 Kgs.) oA (Packt. > 20gms)-!. °50000:000-Packs : Worms | (Net Wt. of Mometasone Furoate Micronized 2.40 Kgs.) Packs | (Net Wt. of Mometasone Furoate Micronized 1.800 Kgs.) Packs | (Net Wt. of Mometasone Furoate Micronized 3.000 Kgs.) Packs | | (Net Wt. of Mometasone Furoate Micronized 4.800 Kgs.) Packs . (Net Wt. of Mometasone Furoate Micronized 28.700 Kgs.) Packs - | . SI. | Import Items Qty | | No. | i [1 | Womeiasone Furie Mioronzed «SGT i RA concerned may take further necessary action as per above decision of NC. | ; | Case No.:325/2/82- [Party Name:GLENMARK Meet No/Date: Status: . | | jALC4/2020 ‘LIFE SCIENCES LIMITED = }NC/3/MEET/Jan/202021/4 |Approved , | . | /12.02.2021 ns:01/82/050/01359/AM21/ File :03/94/040/00135/AM21/IRLA File caspases08.06.2020 0836569 | Decision: The Committee considered case as per agenda in the presence of the technical experts and it | was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as applied by firm whichever is lower: ; | : No. ; ‘ 36 ROSUVASTATIN | 1 kg] 1. | Tert-Butyl(E)-(6-(2-(4-(4-fluorophenyl)-6- 1.30 kg ; | CALCIUM . Isopropyl-2-(Methyl(Methyi Sulfonyl)Amino | . ; | . TePy r imidin-5-yl)t-Butyl(E)-(6-(2-(4-(4-fluorophenyl)-6-Vinyl)(4R,68)-2,2.... ‘ . oe oo a Pyrimidin-5-yl)Isopropyl-2-(Methyl(MethylVinyl)(4R,6S)-2,2-. SulfonylJAtnino ° fe| oe , | Dimethyl(1,3)Dioxane-4-yl) Acetate. ba concerned may take further necessary action as per above decision ofNC. | ----- End of picture text -----

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----- Start of picture text ----- [ Case No.:333/2/82- Party Name:STENORA /Meet No/Date: Status | {|ALC4/2020 | PHARMA PRIVATE iNC/3/MEET/Jan/202021/4 Approved | LIMITED [12.02.2021 | TAQ File REA File ieNomDate:0310836808 | (Decision: The Committee consideredthecaseas per agendaand it was decidedto ratify_norms under:pS : | Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: i Export Product Qty Sl. | Import Items Qty 37 INJECTION (FRUCTON ) (D- 1] 1- 1 (D-Fructose 1,6- 5.50 gins | FT r uctoseisodium Salt 1,6-Diphosphatefor Injection) |Number Diphosphate Trisodiumfor Injection) Salt | Each Combipack contain: Each) | . vial Contains:- D-Fructose 1,6- , Diphosphate Trisodium Hydrate | | Diphosphoric(Eq. to 3.75gAcidFructose5g) Each1,6- , | Solvent Contains Water for , | injection USP 50ml ot RA concerned may take further necessary action as per above decisionof NC, . ; - Case No.:334/2/82- ‘Party Name:CADILA Meet No/Date: /Status: . | ; | ALC4/2020 (HEALTHCARE LIMITED —|NC/3/MEET/Jan/202021/4 Approved | | 12.02.2021 | | |HQFile:01/82/050/01368/AM21/ “IRLAFile|:08/24/040/00049/AM21/ “|Lic.No/Date:0810147921.09.06.2020 [| | Decision: : The Committee considered the case as per agenda and it was decided to ratify norms under . | Para 4.07 ofHBP Vol. I as per details given below or as applied by the firm, whichever is less: : k No, : . | Jf 1 NYSTATIN OINTMENT USP 1S, GRAM| 186632.000 | (EACH GRAM CONTAINS 100000 UNITS OF NYSTATIN USP | Number | EQUIVALENT TO 0.0182 GRAM OF NYSTATIN USP) (ACTIVE ] INGREDIENT: NYSTATIN USP - NET WEIGHT 50.951 KGS. & ‘ 88) | | RELEVENT PACKING MATERIAL IN FINISHED FORM - NET NOS. | 2 NYSTATIN OINTMENT USP 30 . GRAM | 239960,000 , ie| | EQUIVALENT(EACH GRAM TOCONTAINS0.0182 GRAM100000OFUNITSNYSTATINOF NYSTATINUSP) (ACTIVEUSP | Number || : Pood: INGREDIENT: NYSTATIN USP - NET WEIGHT 131.018 KGS. & i RELEVENT PACKING MATERIAL IN FINISHED FORM - NET NOS. | 239960) . . | 3 NYSTATIN & TRIAMCINOLONE ACETONIDE OINTMENT USP 15 | 53330.000 | | GRAM . ‘ Number i 7 7i EQUIVALENT(EACH GRAM‘TOCONTAINS0.0182 GRAM.OF100000 UNITSNYSTATINOF NYU S P)TATIN(ACTIVEUSP : | . | INGREDIENT: NYSTATIN USP - NET WEIGHT 14.559 KGS. & an . RELEVENT PACKING MATERIAL IN FINISHED FORM - NET NOS. | | 53330) . ; | ----- End of picture text -----

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----- Start of picture text ----- 4 NYSTATIN & TRIAMCINOLONE ACETONIDE OINTMENT USP 30 | 46654.000 GRAM . Number . | (EACH GRAM CONTAINS 100000 UNITS OF NYSTATIN USP ; EQUIVALENT TO 0.0182 GRAM OF NYSTATIN USP) (ACTIVE | INGREDIENT: NYSTATIN USP - NET WEIGHT 25.473 KGS. & RELEVENT PACKING MATERIAL IN FINISHED FORM - NET NOS. | lL. 5 NYSTATIN & TRIAMCINOLONE ACETONIDE OINTMENT USP 60 | 13330.000 GRAM Number (EACH GRAM CONTAINS 100000 UNITS OF NYSTATIN USP EQUIVALENT TO 0.0182 GRAM OF NYSTATIN USP) (ACTIVE | INGREDIENT: NYSTATIN USP - NET WEIGHT 14.556 KGS. & i RELEVENT PACKING. MATERIAL IN FINISHED FORM - NET NOS. . | 13330) : | | No. - . : . | Sl. | Import Items Qty | 1 NYSTATIN USP (Potency 6230 U/mg) | 212.806 kg | (THIS LICENCE IS ISSUED AS PER POLICY CIRCULAR NO. 9 i DATED 30.06.2003 AND POLICY CIRCULAR NO, 15 DATED | 17.09.2003 AND AS PER PARA 4.07 OF HBP 2015-20 SUBJECT TO FIXATION OF NORMS BY ALC, NEW DELHI) - | 2 ALUMINIUM ‘TUBES FOR : NYSTATIN OINTMENT USP 15 | Relevant as per | GRAM (AS PER GENERAL NOTE FOR CHEMICAL AND| packing policy 4 ALLIED PRODUCTS POINT NO. 5, WASTAGE ALLOWED @ | 1%) ; : i 3 ALUMINIUM TUBES FOR : NYSTATIN OINTMENT USP 30 | Relevant as per GRAM (AS PER GENERAL NOTE FOR CHEMICAL AND| packing policy ALLIED ‘PRODUCTS POINT NO. 5, WASTAGE ALLOWED @ . | | 1%) | | 4 ALUMINIUM TUBES FOR : NYSTATIN & TRIAMCINOLONE| Relevant as - per (AS PER GENERAL NOTE FOR CHEMICAL AND ALLIED PRODUCTS POINT NO. 5, WASTAGE ALLOWED @ 1%) 5 ALUMINIUM TUBES FOR : NYSTATIN & TRIAMCINOLONE | Relevant as per | - | ‘| (AS PER GENERAL NOTE FOR CHEMICAL AND ALLIED| . fob | PRODUCTS POINT NO. 5, WASTAGE ALLOWED @ 1%) | ALUMINIUM TUBES FOR : NYSTATIN & TRIAMCINOLONE| Relevant as per (AS PER GENERAL NOTE FOR CHEMICAL AND ALLIED . | PRODUCTS. POINT NO. 5, WASTAGE ALLOWED @ 1%) , : ta - RA concerned may take further nécessary action as per abovedecision [of] [NC.] ° - ; ----- End of picture text -----

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----- Start of picture text ----- Case No.:335/2/82- —~—~=SPartyName:GLAND ‘(Meet No/Date:. ~—~S*SStatus:—S | {ALC4/2020 (PHARMA LIMITED INC/3/MEET/J an/202021/4 |Approved | HQ File ees, REAP Iie [Eic.No/Date:0910068857 OO | :01/82/050/01369/AM21/ 1:09/24/040/00044/AM21/ 109.06.2020 | |Decision: ‘The Committee considered the case as per agenda and it was decided to ratify norms.under | Para 4.07 ofHBP Vol. I as per details given below or as applied by the firm, whichever is less: Sl. | Export Product Qty.. | No. 1 Esmolol Hydrochloride in Sodium Chloride Injection 2000 mg per 100ml | 15000.000 139 (20mg per ml) single dose bags _ . Number i {2 Esmolol Hydrochloride in Sodium Chloride Injection 2500 mg per 250ml | 19000.000 | (10mg per ml) single dose bags Number SI]. Import Items Qty . | No. i Esmolol Hydrochloride 81.375 kg Flexible Bags Net to Net with Accountability clause Twist off Port Stoppers. - Net to Net with Accountability clause . | RA concerned may take further necessary action as per above decision ofNC, ----- End of picture text -----

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----- Start of picture text ----- [Case No.:337/2/82- Party Name:J.B. [Meet No/Date: Status: - ALC4/2020 CHEMICALS& | iNC/3/MEET/Jan/202021/4 jApproved i PHARMACEUTICALS 12,02,2021 | LIMITED | | Be ee HQ File REA File * 3 + he iG-No/Date‘0310836623 © fs | {o1/sz/oso/o137 /AM21/ |.03/94/040/00143/AM21/ |10.06.2020 | | Decision: | The Committee considered the case as per agenda and it was decided to ratify norms under | Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: | No. |' No. ‘ 1 Life Brand Sore Throat & Nasal | 800000.000 Congestion Relief Extra Strength | Number 2 | Isomalt ST-M 2056.80 kg (Flavours —-Cherry/Honey & | Lemon/Other flavours) Sugar . : | Free Lozenges. Each Lozenge Contains : Bezocaine 15 mg & Isomalt ST-M . 2571 Mg. Net Content Benzocaine 12 i 2 Kgs. And Isomalt ST-M - 2056.80 Kgs, | ' | Personne!lle Oral Anesthetic Sore | 755552.000 i _ | Throat Lozenges Extra Strenght Sugar |Number 4 Tsomalt ST-M 1942.52ke | | Lemon/OtherFree (Flavours Cherry/Honeyflavours) I Each Lozenge Contains Bezocaine 15 . | i] + | mg & Isomalt ST-M 2571 Mg. Net . } Content Benzocaine 11.333 Kgs. and | | Isomalt ST-M - 1942.524 Kgs '49-{| 3 Option+Oral Lozenges Sore Throat & | 755552.000 | Nas(Fl a voursl CongestionCherry/HoneyRelief ExtraLemon Strenght/Other | Number Isomalt ST-M 1942.52 kg | flavours), Each Lozenge Contains Bezocaine 15 mg & Isomalt ST-M 2571 Mg. Net | Content Benzocaine 11.333 Kgs. and | Isomalt ST-M - 1942.524 Kgs, 4 | BIOMEDIC ST & NC RELEX | 755552.000 : , Lozenges -(Flavours Cherry / Honey | Number’ Isomalt > ST-M | 1942.52 kg i Lemon/ Other flavours) Each Lozenge Items at S].Nos.1,3,5,7 , Contains Bezocaine 15 mg & 9 are drugs and will & Isomalt ST-M 2571 Mg.-Net Content be covered . under . | Benzocaine 11.333 Kgs. and Isomalt |. conditions of Policy . ST-M - 1942.524 Kgs. Circular No.9, ; | dt:30.06.2003 read with . ; ifoot : re Policy17.09:2003.Circular. 15,dt: aei . . | 5 Atoma Sore Throat & Nasal | 755552.000/9 |BenzocaineSs ‘11.45ke __|- i + Congestion Relief -Extra Strength | Number 10 -| Isomalt ST-M | 1942.52 kg Po, Lozenges Cherry/Honey & Lemon Items at S1.Nos.1,3,5,7 : P| Flavour. Eagh Lozenge ‘Contains & 9 are drugs and is, : i Bezocaine 15 mg & Isomalt ST-M covered under i | . 2700 Mg. Net Content Benzocaine conditions of the Policy ; | { 11.333 Kgs. and Isomalt ST-M - Cir.No.9,dt:30,06.2003 | P 4 , 1942,524 Kgs. . readCircular with ‘Policy . |Po . : : | RA concerned may take further necessary action as per above decision. No, of 15,dt:17.09.2003.NC. | ----- End of picture text -----

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----- Start of picture text ----- , oo, i Case No.:347/2/82- ‘[PartyName:INDOCO [Meet No/Date: ~|Status: _ ALC4/2020 REMEDIES LIMITED NC/3/MEET/Jan/20202 1/4 |Approved ; | 12.02.2021 | TAQ Fig IRAFile«Lic No/Date:0310836601 . Decision: The Committee consideredthe case as per agenda and it was decided to ratify norms under . {Para 4.07 of HBP Vol. Las per details given below or as applied by the firm, whichever is less: | Export Product Qty Sl. | Import Items Qty | ;| | 7Ciprofloxacin and 1600000.000 No. Ciprofloxacin HCL 41.40 kg | Dexamethasone Suspension USP. | Number 12.60 kg 41 (0.3% - 0.1% ) 7.5ml Bottle, 3 Bottle Relevant as | (Each ml . per packing | Contains:CIPROFLOXACIN | policy ; HYDROCHLORIDE 4 Cap Relevant as | EQUIVALENT TO : per _ packing | perCIPROFLOXACIN bottle of 7,5ml) BASE(Each 75 3mg) ml : 5 Dropper policyRelevant as | andContains: DexamethasoneCiprofloxacin7.5 22.5mgmg) Net perpolicy packing |. wt.is: (1) ctprofloxacin HCL 36 . ° : | kgs (2) Dexamethasone 12 kgs. - . | RA concerned may take further necessary action as per above decision of NC. || [CaseALC4/2020No.:348/2/82- ——~—([PartyName:KOPRANRESEARCHLABORATORIES LIMITED‘(MeetNC/3/MEET/Jan/20202/12.02.2021No/Date: ~~—~—~(Status:1/4 Deferred . | [BQ Fie IR Fife No Matec0310830602 PO , (2 :01/82/050/01382/AM21/ :03/94/04.0/00156/AM21/ 15.06.2020 | [Decision:~ The Committee considered the caseas per agenda in the presence of technical experts and | was decided to call for following information from the firm: it .. | | er () Complete technical details as per Appendix 4E. : | . ----- End of picture text -----

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----- Start of picture text ----- , [Case No.:350/2/82- —~—=-(PartyName:FDCLTD ——‘([Meet No/Date: Status: | jALC4/2020 INC/3/MEET/Jan/202021/4 |Approved 12.02.2021 —| (HO FIeTRA File TesNo/Date:0310836606. pe eS 2201/82/050/01384V/AM21/* “403/94 040/00160/AM21/ ~~ 415.06.20200 0 © | Decision: The Committee considered the case as per‘agenda and it was decided to ratify norms under i Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: 43 Export Product Qty . | SL. | Import Items Qty . No. . | CHLORAMPHENICOL EYE | 1 1 Chloramphenicol 51.00 mg . | DROPS 0.5% w/v of 10 ML | Number | (Micronized) | (Chlorafast Eye Drops 10 ML & . | Clorogen Eye Drops 10 ML) . RA concerned may take further necessary action as per above decision of NC. D| |ALC4/2020CaseNo.:351/2/82-——S~PartyPHARMACEUTICALS Name:GLENMARK LTD Meet|NC/3/MEET/Jan/202021/4No/Date: — fStatus:|Approved ~ 12.02.2021 . | |:01/82/050/01385/AM21/ ':03/94/040/00167/AM21/ 17.06.2020 | | (Decision: The Committee considered the case as per agenda and it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: | Sl. | Export Product Qty. | No. | 1 FLUCORT N SKIN CREAM 0.025% (Pack Size 15 gms) | | 2 (NetFLUCORT Wt.of FLUOCINOLONE ACETONIDESKIN CREAM 0.025% BP(Pack is 1.210 Kgs.)Size 15 gms) 322660.000 Packs | (Net Wt.of FLUOCINOLONE ACETONIDE BP is 1.210 Kgs.) | 322660.000 Packs 3 FLUCORT. SKIN ‘CREAM 0.025% (Pack Size 10 gms) , | ( Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.605 Kgs.) - 242000.000 Packs | 4° | FLUCGORT SKIN CREAM 0.025% (Pack Size 5 * gis) laa (Net Wt.of FLUOCINOLONE ACETONIDE BP js 1.210 Kgs.) - | 2©8000.000 Packs , 5 FLUOCINOLONE CREAM (TDR) ET 0.025% (Pack Size 10 gms) | g¢eq9 099 packs | ___ | (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.) ; || fo (NetCYNOZETWt.of FEUOCINOLONECREAM 0.025%ACETONIDE(PackBPis= 0.242Size Kgs.)95 ~~ gms) |, 193600.000 Packs: ‘ | 7 ‘| CYNOZET CREAM 0.025% ‘(Pack Size 15 gms) SUPRICORT CREAM 0.025% (Pack Size 5 ‘gms) | : (Net Wt.ofFLUOCINOLONE ACETONIDE BP is 0.242 Kgs.) ___| 04932000 Packs , . / | | ( Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.726 Kgs.) 580800.000 Packs | | 4 19 SUPRICORT CREAM: 0.025% (Pack = Size * 15 gims) |- oa, ; | | 10| (NetSUPRICORT Wt.of FLUOCINOLONECREAM 0.025% ACETONIDE(Pack BP is 0.726Size Kgs.)250 gms) 193596.000 Packs Ji ( Net Wt.of FLUOCINOLONE ACETONIDE BP is.0.242 Kgs.) 3873.000 Packs | 1 11 SUPRICORT N CREAM 0.025% (Pack Size 5 gms) | (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.242 Kgs. ) 193600.000 Packs | | _ oo 12. | SUPRICORT N CREAM 0.025% (Pack Size 15 gms) . / . | (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.) 64532.000 Packs | . | 13 Flucortt C Cream 0.01% (Pack Size 15 — gms). . (Net Wt.of FLUOCINOLONE ACETONIDE BBP is 0.095 Kgs) 63332.000 Packs ----- End of picture text -----

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psec 1 teers ss ttonnannnnrislapnonennnninnninnnemnnen) ’ | 14 | FLUCORT C OINTMENT 0.025% (Pack Size 15° gms) | ( Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.605 Kgs.) 161330.000 Packs | 15 GLENCORT GEL 0.025% (Pack Size 5 gms) | (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.452 Kgs.) 361600.000 Packs i | ie GLENCORT(Net Wt.of FLUOCINOLONEGEL 0.025% ACETONIDE(Pack BP is 0.484 Kgs,Size 30 gms) 64535.000 Packs | ef AT SECUCQRT oMZ. SKIN OINTMENT 0.019 ,(Pack. Size: 15” emis) lj.78. ooo packs “| (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.145 Kgs.) or | Sl. | Import Items : Qty | No. FLUOCINOLONE ACETONIDE BP 9.10 kg RA concerned may take further necessary action as per above decision of NC. | | [Case No.:353/2/82-——~—~(Party Name:BIOLOGICAL E [MeetNo/Daie: ——~—~S=«S Status: | ALC4/2020 iLTD INC/3/MEET/Jan/202021/4 [Approved a | 12.02.2021 7 | | |HQFile ~—”—”—SRLA | :01/82/050/01387/AM21/ [:09/24/040/00637/AM20/File t—CSsS |17.06.2020[Lic.No/Date:0910068881[ Decision: The Committee considered the case as per agenda and it was decided to ratify norms under af Para 4.07 of HBP Vol. I as per details given below or as appliedby the firm, whichever is less: i 5 Export Product Qty Sl. | Import Items Qty | = No. | DAPTOMYCIN FOR INJECTION | 510000.000 1 DAPTOMYCIN | 280.500 kg | | - 500 MG PER VIAL (IN 10ML VIAL) | Vials (The relevent Bulk drug content in the export product is Daptomycin 255 kgs) RA concerned may take further necessary action as per above decision of NC. | [Case No.:354/2/82- ——SParty[Name:MAKCUR] ‘(Meet No/Date:.—~—~=S Status: | |ALC4/2020 ’ iLABORATORIES LTD. INC/3/MEET/Jan/20202 | : 12.02.2021 ‘ 1/4 Deferred |” HQ File ~ RLAFIe [Hic.No/Date:0810147963 | a 46 §:01/82/050/01388/AM21/ 1:08/24/040/00062/AM21/ 17.06.2020. os i |i |Decision:{was decided—toThecall Committeefor following informationconsidered tiie fromcase theas per.agendafirm: in thepresence, of technical0experts andit} | i . (i Copy of DML slowing Approved Composition of Export Product. oa

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----- Start of picture text ----- F [CaseALC4/2020 [No.:355/2/82-] ‘HUMAN CARE [—~—«(PartyName:VERVE] ‘(MeetINC/3/MEET/Jan/202021/4 No/Date:. ——_—(Status:|Approved|| | (HQFie RLAFile = Lic. No/Date:05.10414412 |” :01/82/050/01389/AM21/ :05/24/040/00027/AM21/ 17.06.2020 i| (Decision: The Committee considered-thecase as per agenda and it was decided to ratify norms under} — 47 Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: ' No. | Inj. Norepinephrine Bitartrate 2mg | 1 Number | 1 Norepinephrine Bitartrate | 8.80 mg " | eq. to Norepinephrine img/ml , 4 ml Ampoule . » | RA concerned may take further necessary action as per above decision ofNC. | ----- End of picture text -----

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----- Start of picture text ----- [Case No.:356/2/82-———=—«(PartyName:VERVE ————(MeetNovDate: =SSs(Status: | ALC4/2020 _ [HUMAN CARE - - INC/3/MEET/Jan/202021/4 [Approved | LABORATORIES 12.02.2021 | (|HQFile ~ ~——~—~—SIRLAFile :01/82/050/01390/AM21/ :05/24/040/00098/AM21/~~————~O—«(LLitc_ 17 . 06.2020NoDatte:0510414419 | . | Decision: The Committee considered the case as per agenda and it [was][ decided] [to] [ratify] [norms] [under}] 48 {Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: | Export Product Qty Sl. | Import Items Qty | No. | Tab. Phenobarbital 100 mg} 1Number | 1 Phenobarbitone 102.00 mg . | Tab. Phenobarbital 100 mg | (Phenobarbital) | RA concerned may take further necessary action as per above decision of NC. | ----- End of picture text -----

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----- Start of picture text ----- ; . 31 ; : [ ~ [Case No.:358/2/82- ~—~—‘(Party NameJ.B. "(Meet No/Date: ~~S«Status: SSS | ‘ |. jALC4/2020 CHEMICALS & NC/3/MEET/Jan/202021/4 |Approved : | PHARMACEUTICALS 12.02.2021 . LIMITED | | a - | boi/sziso/o1392/aM2i/ — |:03/94/040/00097/AM21/. {17.06.2000 it _ | [Deeision: ~~ The Committee considered the case as per agenda and it was decided to ratify norms under | Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: . . |Sl. | Export Product Qty. | No. : : | 1 NifedipineEach tablet Extended-Releasecontains (i) Sentry TabPo l etsyox 30mg. WSR Coagulant NF - 56.80 mg (ii) Number7306350.000 . Eastman (TM Cellulose Acetate (CA.398-10NF/EP)- 33.12 mg (iii) ; SENTRY POLYOX WSR N80 FP NF - 118.40 mg. Net content (i) 415 Kgs “ | (ii) 241.99 Kgs (iii) 865.07 Kgs 149 2 Nifedipine Extended-Release Tablets 60mg. 1716540.000 Each tablet contains (i) Sentry Polyox WSR Coagulant NF - 113.60 mg (ii) Number Eastman (TM Cellulose Acetate (CA 398-10NF/EP)- 42.32 mg (iii) | . SENTRY POLYOX WSR N80 FP NF - 236.80 mg. Net content (i) 195 Kgs | (ii) 72.64 Kgs (iii) 406.48 Kgs : | | Sl. Import Items , Qty . | . SENTRY POLYOX WSR COAGULANT NF ) 415.000 kg | EASTMAN (TM) CELLULOSE ACETATE (CA 398-10NF/EP) 241.990 kg | SENTRY POLYOX WSR N80 FP NF 865.070 kg SENTRY POLYOX WSR COAGULANT NF 195.000 kg | EASTMAN (TM) CELLULOSE ACETATE (CA 398-10NF/EP) 72.640 kg | |6 | SENTRY POLYOX WSR N80 FP NF 406,480 kg i . RA concerned may take further necessary action as per above decision of NC. a | ; [Case No.:361/2/82-—~—~—«(PartyName:AURORELIFE |MeetNo/Date: | |ALC4/2020 ‘SCIENCES PRIVATE iNC/3/MEET/Jan/202021/4—(Status:|Approved = a i . LIMITED 12.02.2021 | [HQ File “IREAFile———S~S™SC~CO [CLL] [ic.] No/Date:0910068890 ; So . . - :01/82/050/01395/AM21/ 109/24/040/00628/AM20/ -. 18.06.2020. . ae : . Doe |50 Decision: — TheCommittee considered the case as per agenda and it was decided [to][ratify] [norms] [under]] = . Para 4.07 of HBP Vol. | as per details given below or as applied by the firm, whichever is less: . . | Export Product Qty SL. | Import Items ~ | Qty i ; | . |‘RA concernedPinnaverium may Bromidetake further necessary action as per above decisionDihydroof Nopol NC. ~ | 0.60: kg ‘ | ----- End of picture text -----

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| Case|ALC4/2020 No.:362/2/82&Party PHARMACEUTICALS Name:J.B. CHEMICALS MestNC/3/MEET/Jan/202021/4Approved——|-—--—-—---—No/Date Status: | | HQ File RLA File Lic.No/Date:03 10836729 | ; :01/82/050/01396/AM21/ :03/94/040/00172/AM21/ 18.06.2020 | Decision:the light |Theof Commearl i ertteedecicon si onderedtaken the caseby as perNC agendain in theits presenceMeeting of TechnicalNo. 7/82-ALC4/2020Experts and in | , dated 04.12.2020 against Advance Authorization No. 0310837889 dated 26.08.2020, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as per details below or as applied by firm | whichever is lower: | No. : No. | 1 (FlavoursRinza sip Orange/with VitaminLemon/C | Sachet1 Number 1 PowderCaffeine Anhydrous | 30.35 gm mg/ sachet Black Currant/ Other flavours) | Lemo& Ri n /za Sip (Flavours Orange/ , 51 BlackHoney Lemon/currant/Other— Cranberry/flavours). | - | EachCaffeinesachetAnhydrousof 5gm containsPowder . , | 30mg. Net content of Caffeine | Anhydrous Powder 154.55 Kgs : | 2 | Rinza Tablets. Each tablet | 1 Number Contains Caffeine Anhydrous | Tablet Powder 30 mg tablet Powder 30 mg and Paracetamol 3 Paracetamol BP 510 mg/ BP 500 mg. 500 mg tablet Net Content of Caffeine | Anhydrous Powder - 667.32 i Kgs and Paracetamol BP- 11122 4 Kgs f , || 3 (FlavoursRinza SipRaspberry/for Childrenother || Sachet1 Number 4 Paracetamol BP ° 282.803 gm sachet mg/ |} | flavours) ; ob Each’ sachet of 3gm contains , i Paracetamol BP - 280mg. Net content- 485.44 Kgs. . . | |RA concerned may take further necessary action 4s per above decision of NC, , oy -

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----- Start of picture text ----- nnn COCCI | Case No.:367/2/82-TTT? 4 emma [PartyPere Name:ORTINene TT {Meet No/Date: Status: . | jALC4/2020 | LABORATORIES LTD NC/3/MEET/Jan/202021/4 {Approved | 12.02.2021 IQ File REA FileSSCLic No/Date:0910068802. [ Decision: The Committee considered the case as per agendaandit was decided to ratify norms under} — - 52 Para 4.07 ofHBP Vol. I as per details given below or as applied by the firm, whichever is less: i ‘No. “| ((5-Thiazolyl)-(4- Lkg 1 2-Chloro-5- 1.50 kg nitrophenyl)carbonate, (NCT)} (Chloromethyl) thiazole RA concerned may take further necessary action as per above decision of NC. | [Case No.:368/2/82- —~—~—~*<([Party Name:CIPLA LIMITED. | . |ALC4/2020 (MeetINC/3/MEET/JNo/D a n/20202te:1/4 |Approved(Status: | 12.02.2021 | HQFile ~~—SY(REAFile.~——~CO—[L-ice.No/Date:0310836755 |SSS :01/82/050/01402/AM21/ :03/94/040/00166/AM21/ 419.06.2020 | [Decision: ~The Committee considered the case as per agenda in thepresenceof TechnicalExperts ; “}was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as per details belowandor itas | japplied by firm whichever is lower: | No,SL Export product | Qty. No.Sl. | Import items Qty. | 1 Telmisartan and Amlodipine | 1 Number 1 Telmisartan 68.034 mg | Tablets 40/10mg / Granules 3 Each uncoated tablets contains : 2 Amlodipine Besilate | 10.20 mg yo. Telmisartan 40 mg Telmisartan | 40 mg equivalent to Telmisartan ‘ | , | granules 67.36mg Amlodipine : ; Besilate equivalent to Amlodipine USP 10mg : | 2 || Telmisartan and. Amlodipine | 1 Number 1 Telmisartan 68.034 mg | Tablets 40/5mg / Granules i Each uncoated tablets contains : 2 | Amlodipine Besilate | 5,10 mg | Telmisartan 40 mg Telmisartan : Poof. 40 mg equivalent to Telmisartan i | granules 67.36mg Amlodipine | - - |. . : yjbo, Besilate equivalent to : ; Amlodipine USP 5mg : ; -RA concerned may take further necessary action as-per above decision.of NC, ce 7 ----- End of picture text -----

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----- Start of picture text ----- "Case No.:369/2/82- [Party Name:CIPLA Meet No/Date: Status: | |ALC4/2020 iLIMITED. NC/3/MEET/Jan/202021/4 Approved ce ge THQ File REA File Lie.No/Date:0310836757_FO he 901/827030/01403/AMZI/~ 203794 040/00 176/AM21/" 19.00.2020 | Decision: The Committee considered the case as per agenda and it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: ‘ | No. , | 1 PotassiumER Caps USP Chloride750mgExtended(Pack Size Release100 CapsulesCapsulesEach) 750mg/ Potassium Chlor | 9600000.000Number , . Each extended Release Capsule contains: Potassium Chloride USP 750mg | 2 Potassium Chloride Extended Release Capsules 750mg / Potassium Chlor | 2080000.000 . ER Caps USP 750mg (Pack Size 500 Capsules Each) Each extended Number ; 5 Release Capsule contains: Potassium Chloride USP 750mg | 3 Potassium Chloride Extended Release Capsules 600mg/ Potassium Chlor | 8000000.000 | | ER Caps USP 600mg MICRO-K Extencaps 600mg (Pack Size 100 Number Capsules Each) Each extended Release Capsule contains: Potassium Chloride USP 600mg 54 : Sl. Import Items Qty ‘ | No. . : :. DIBUTYL SEBACATE NF HG | ETHANOL USP 99.9% | 5 100CC WHITE HDPE BOTTLE WITH 38MM NECK DB-02 Relevant as per | | | TRIVENI PLASTIC packing policy 38/400 FG, CRC HAVING UNIPAC SG-75M LINER PTD. WITH Relevant as per | SFYP IN BLACK (REXAM CLOSURES) packing policy Jt TF (90950 C ountC WHITE-HDPE) (100 Count)BOTTLE 750mg / WITH (100 count) 53MM 600mg NECK DB-22 Relevant. as per (500 Count) 750mg ; | 53/400 LSC, SCREW CAP HAVING UNIPAC SG-75M LINER PTD, |-Relevant as per : | | WITH SFYP IN BLACK (REXAM CLOSURES) . packing policy ; | (100 Count) (500 Count) 750mg ; “ RA concerned thay take further-necessary. action asper above decision of NC. Se ----- End of picture text -----

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----- Start of picture text ----- . 35 . a pa Case No.:370/2/82- (Party Name: VERVE Meet No/Date: iStatus: .| jALC4/2020 . HUMAN CARE NC/3/MEET/Jan/202021/4 |Approved THQ. | File RA(LABORATORIESFile,| (Lic.No/Date:0Si0giaast12.02.2021 Decision: The Committee considered the case as per agenda andit was decided to ratify norms under | Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Sl. | Export Product Qty. 1 No. ‘ | 1 Inj. Pethidine HCL 50mg/ml, [ml ’ 400000.000 Number : | 2 Inj. Pethidine HCL 50mg/ml, 2m] ' 1106500.000 55 Number . 3 Inj. Pethidine HCL ’75mg/1.5ml . 430000.000_ Number i 4 Tab. Pethidine HCL 50mg 40000.000 Number | Sl. | Import Items , Qty | No. . | . 1 | Pethidine Hydrochloride . 181.23 kg Pethidine Hydrochloride No objection Certificate (NOC) is required from i Narotics Commissioner, Gwalior, before import of the item in terms of | — Notification No.39/2015-2020 dt,3,10,2018. RA concerned may take further necessary action as per above decision of NC. ----- End of picture text -----

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----- Start of picture text ----- . . ||CaseNo.:385/2/82-—~—~—~«(PartyName:UPLLTD. (MeetNo/Date:~—~—(Status:—SS | ALC4/2020 iNC/3/MEET/Jan/202021/4 |Approved an 412.02.2021 . | , | AQ [File] IRL File ,_. [Lic,No/Date:0310836829. | :01/82/050/01419/AM21/ :03/95/040/00134/AM21/ 23.06.2020 | |Decision: The Committee considered the case as per agenda and it was decided to ratify normsunder : Para 4.07 of HBP Vol. Las per details given below or as applied by the firm, whichever is less:  ' 156 ! fk Export Product . Qty SI. | Import Items Qty |} | Diethyl -P-Toluene — Sulfonyloxy | V'kg =] 1 "| Paratoluene sulphonyl +] 0.635 kg - | - 4 Methy! Phosphonate (DESMP) .| chloride (PTSCI) . 2 Phosphorus Acid 0.108 kg Crystals ‘RA concerned may take further necessary action as per-above deédision of NC. ~ , ----- End of picture text -----

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----- Start of picture text ----- , [| 1CaseALC4/2020 No.:389/2/82- HEALTHCAREParty Name:CADILA LIMITED iNC/3/MEET/Jan/202021/4|Meet No/Date: Status:Approved | ; :12,02,2021 | | THO File ~ ~~ IRLA File, ov TLic.No/Date:0810147995 | Decision: |The Committee considered the case as per agenda in the presence of Technical Experts and in | | the light of earlier decision taken by NC in its Meeting No, 4/82-ALC4/2020 | , dated 18.09.2020 against Advance Authorization No. 0810143413 dated 07.09.2018, it was decided. to} ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as per details below or as applied by firm | | whichever is lower: ; , ; | | No. Tablet , | PROMETHAZINE 1 “11 PROMETHAZINE 12.75 25.50mg | 51.0mg | | HYDROCHLORIDE | Number HYDROCHLORIDE | mg 97 | | TABLETS USP 12.5 | Tablet USP . | MG / 25 MG / 50 NEW DELHI) MG Tablet 2 HYDROXY 2.00 mg | 4.00mg | 8.00 mg | ; PROPYL i CELLULOSE (LOW _ SUBSTITUTE) 3 |HYDROXYPROPYL| 4.00 mg | 8.00mg | 16.00 mg | . CELLULOSE NF . ; (KLUCEL LF) | . MONOHYDRATE mg mg mg NF/PH.EU 5 MAGNESIUM - | 0.50 mg | 1.00 mg 2.00 mg STEARATE PH.E/NE/IP | i Ira concerned may take further necessary action as per above decision ofNC. | / ----- End of picture text -----

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----- Start of picture text ----- | [Case No.:390/2/82- Party Name:CIPLA {Meet No/Date: Status: . ALC4/2020 LIMITED, NC/3/MEET/Jan/202021/4 jApproved | 112.02.2021 | | TAQ File IRLA File [Lic.No/Date:0310836876 | oo — |Decision:- ~The Committee-considered-thecase-as per-agenda-im the presence of [Technical-Experts-and:in}—--—] the light of earlier decision taken by NC in its Meeting No. 3/AM21 , dated 02.09.2020 against Advance Authorization No. 0310805844 dated 30.06.2016, it was decided to. | ratifyfirm whicheverthe ad-hocis inputlower: output_ norms under para 4.7 of HBP Vol. I as per details below or as applied by Export Product | No. | 1. Amoxicillin and.Clavulanate Potassium for Oral Suspension USP 250mg / 29586.000 i 62,5mg (Pack Size 75ml) Number | Each 5ml contains: Amoxycillin Trihydrate USP equivalent to Amoxicillin I 250mg, Clavulanate Potassium USP equivalent to Clavulanic Acid 62.50mg |' 2 Amoxicillin and Clavulanate Potassium for Oral Suspension USP 250mg/ 102660.00 | Each62.5mg 5ml (Packcontains: Size Amoxycillin100ml) Trihydrate USP Soequivalent to Amoxicillin 0 Number | 250mg, Clavulanate Potassium USP equivalent to Clavulanic Acid 62.50mg i 3 Amoxicillin and Clavulanate Potassium for Oral Suspension USP 250mg / 34470,000 | 62.5mg (Pack Size 150ml) . Number 5 8 Each 5ml contains: Amoxycillin Trihydrate USP equivalent to Amoxicillin | Rode 250mg, Clavulanate Potassium USP equivalent to Clavulanic Acid 62.50mg | Sl. | Import Item For export of Amoxicillin and Clavulanate ‘No. Potassium for oral suspension USP 250 mg / 62.5 mg size size size | , SILICON DIOXIDE 1:1 , | 4. 115CC HDPE BOTTLES 75 ML * Relevant , as per packing policy | (250/62.5) ; | (250/62.5) . & | 225 CC HDPE BOTTLES 150 ML | PRINTED FSM-1 . fe CapINDUCTION 28/400 WHTSEALING CRC W/FS M-I WITH . : lea concerned may take further necessary action as per above decision ofNC. | ----- End of picture text -----

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----- Start of picture text ----- . 38 [Case No,:391/2/82- [Party Name:GLAND [Meet No/Date: (Status: ——+---——— Boe gee ede a AC472020600 6 0 es PHARMA LIMITER. 000. NC/S4MEETJan/202021/4 Approved. 0 es . Lo | . |12.02,2021 | a . | (HQ File LA File [Lic. No/Date:0910068902 . | :01/82/050/01425/AM21/ |:09/24/040/00138/AM21/ 25.06.2020 ; . | Decision: | The Committee considered the case as per agenda and it was decided to ratify norms under |59 {Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: | | : No, 4 : | lkg 1 Rocuronium Bromide Diol 1.05 kg i Condition: Customs should verify ITC HS : | Codes of the items at the time of export and . | import of products RA concerned may take further necessary action as per above decision of NC. | Case No.:276/1/82- Party Name:PIRAMAL Meet No/Date: Status: ALC4/2019 JENTERPRISES LIMITED NC/3/MEET/Jan/202021/4 |Approved | 12,02,2021 . | HQ File ~ RLA File Lic.No/Date:03 10829108 | : | j:01/82/050/00182/AM20/ :03/95/040/00143/AM20/ 17.05.2019 - | |Decision: | The Committee considered the case as per agenda in the presence of Technical Experts and it | |was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as per details below or as : i japplied by firm whichever is lower: f | No. : (Net wt. of Import Sr. No. 1 is 2856.64kgs, Sr. No. 2 is 19730.30kg, Sr. No. 3 is 5500.22 kg, Sr, | Number . No. 4 is 2880000 Nos., Sr. No. 6 is 2880000 Nos.} Tablet . 4] 2 Atorvastatin ; Calcium Tablets * USP 20mg | t ; | No.(Net4 wt.is 1600000of ImportNosSr . No., Sr. No.| is 3174.05kgs,6 is 1600000 Nos.)Sr. No. 2 is 21777.12kg, Sr. No, 3 is 6072.48kg, Sr. |NumberTablet (Net wt. of Inport Sr, No. 1 is 3967.56kgs, Sr. No, 2 is 27683.10kg, Sr. No. 3 is 7719.30kg, Sr. | Number . | ; No. 4 is 1000000 Nos., Sr. No, 6 is 1000000 Nos,) - | Tablet : ! 4 Atorvastatin Calcium Tablets USP - 80mg | 1 . i i (Net wt. of Import Sr. No. 1 is 793.5tkgs, Sr. No, 2 is 5389.02kg, Sr. No. 3 is 1502.82kg, Sr. | Number | | : . : : on No. 4 is 100000 Nos., Sr. No. 6 is [O0000.Nos:)_ + - . ; ; Tablet: | | rn) i 5 Atorvastatin, Calcium Tablets USP ' 80mg | 1 ‘ 7 | (Net wt. of Import Sr, No. 1 is.4408.40kgs, Sr. No, 2 is 29939.00kg, Sr. No. 3 is 8349.00kg, Sr. | Number . ; | No. 5 is 50000 Nos., Sr. No. 6 is 50000 Nos.) Tablet |° | All Qty. in mg) ' | [2 | Microcrystalline Cellulose (MCC) NF (Avicel PH 102) 61,038 _ BOT 75CC WHT HDPE RND 38MM MEDIPLAST Relevant as per packing policy | RA concerned may take further necessary action as per above decision of NC. : ----- End of picture text -----

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----- Start of picture text ----- -— Case No.:171/10/82- ~ Party Name:GLENMARK [Meet No/Date: —_—(Status: | 7 | |ALC4/2019 LIFE SCIENCES LIMITED |NC/3/MEET/Jan/202021/4 ‘Approved : | of [12.02.2021 | HQ Fie IRLA FileTic. No/Date:0310832312[| BS O1/82/0S0/007457 AMZ0/ ~ * ":03/94/040/00566/AM20/ US LOLBOPG TR oe ee , | (Decision: The Committee consideredthe case as | Para 4.07 of HBP Vol. I as per details given below or ‘peras applied agenda andby theitfirm, was decidedwhichever tois ratifyless: norms under , , | No. ROSUVASTATIN CALCIUM | 1400.000 kg | 1 Tert-Butyl(E)-(6-(2-(4-(4- 1820 kg | fluoropheny!)-6-Isopropy!-2- | 61 ; (Methy(MethylSulfonyl)Amino Pyrimidin- | 5 ; Tert-Butyl(E)-(6-(2-(4-(4-5-yl) Vinyl)(4R,6S)-2,2-.. | fluorophenyl)-6-Isopropyl-2- | (Methyl(Methyl Sulfonyl)Amino Pyrimidin- | ; 5-yl) Vinyl)(4R,68)-2,2- , Dimethyl(1,3)Dioxane-4-yl) Acetate. ACETONITRILE 943.6 kg . ‘ METHANOL 2623.6kg | | i TOLUENE 1080.8 kg : | _ {RA concerned may take further necessary action as per above decision of NC. . (Case No.:424/13/82-—~—~—~=«(PartyName:DEEPAK | 'ALC4/2018 NITRITE LIMITED {MeetINC/3/MEET/Jan/20202 No/Date:—~—~(Status: ~~ i | 12.02.2021 1/4 |Deferred | (HQFile RLAFile - [Lie.No/Date:3410044635 | ; \62 :01/82/050/01402/AM19/ :34/24/040/00144/AM19/ (25,10.2018 | Decision: The Committee considered | {was decided to call for following informationthe casefrom theas perfirm: agenda in the presence of technical experts, and it | me) Production / Consumption data for imported inputs from,GST for licensing hod. period. . . | CaseNo.:426/13/82-—~—~—~—«(PartyName:DEEPAK. | JALC4/2018 - {NITRITE LIMITED ‘([MectNo/Date:NC/3/MEET/Jan/202021/4°~(Status:(Deferred = iol 112.902.2021 | - | JHQFile ss S”~“<s«é<S@RLA Flee =—S~S~~*~<CS~S~SS:CL ieNoDDate:3410044036=— 63 |:01/82/050/01404/AM19/ |:34/24/040/00208/AM19/ [25.10.2018 | (Decision: The Committee considered the case as per agenda in thepresence of technical experts and it . iwas decided to call for following information from the firm: . ; : | | (7) Production / Consumption data for certified by GST for licensing period. | ----- End of picture text -----

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----- Start of picture text ----- || [Case No.:2/15/82-ALC4/2018(PartyName:DEEPAK “(Meet No/Date: (Status: | . |iNITRITE LIMITED NC/3/MEET/Jan/202021/412.02.2021 Deferred | THQ File 0 RLAFile 0 [Lic.NofDate:3410044710 | co | _ |Decision: The Committee considered the case as per agenda in the presence of technical experts and it was decided to call for following information from the firm: ----- End of picture text -----

(i) Production / Consumption data for certified by GST for licensing period. |

P"lCase No.:85/15/82-~~ PartyName:DEEPAK ALC4/2018 NITRITE LIMITED NC/3/MEET/Jan/202021/4 (Deferred | ——~—s|'MeetNo/Date: =—Ss«dStatus: = | (12.02.2021 | [HQ File ~~ TREAFile———~S~™C™ CS Lic.No/Datte:3410044711 165 1:01/82/050/01542/AM19/ 134/24/040/00255/AM19/ 20.11.2018 | (Decision: The Committee considered the case as per agenda in the presence of technical experts and it | iwas decided to call for following information from the firm: | ,

(i) Production / Consumption data for certified by GST for licensing period.

| [CaseALC4/2018No.:86/15/82-~—~«(PartyName:DEEPAK\NITRITE LIMITED ‘(MeetNC/3/MEET/Jan/20202 No/Date: —*(Status:1/4 Deferred = | ; 12.02.2021 : | (HQ FileRAFile~~~ {Lic.No/Date:3410044712 — (66 |:01/82/050/01543/AM19/ |:34/24/040/00256/AM19/ 20.11.2018 | [Decision: The Committee considered the case as per agenda in the presence of technical experts | jiwas decided to call for following information from the firm: and it | i (i) Production / Consumption data for certified by GST for licensing period. |

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----- Start of picture text ----- I~~ Case No.59/4/82-ALC4/2020a [Party(LIMITED Name:ANUH- PHARMA NC/3/MEET/Jan/20202|MeetNo/Date: —~—SStatus: | ; | 12.02.2021 1/4 [Deferred, 1| |:01/82/050/01560/AM21/HQ File * ov 1:03/94/040/00361/AM21/BAFile osevanay) Lac(19.08.2020NopDate:0310837761 : | ——. : &7 (Decision: ‘The Committee consideredthe case as per agendain thepresence of technical experts P= decided to call for following information from the firm: ‘ and it,| : i (i) | Detailed Chemistry, Structural Formula of import and export, molecular Bo , -weight, % yield. . , ;/ it (ii) Stoichiometric balance between import and export. — | ----- End of picture text -----

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Case No.1101/4/82~ Party Name:TINA ORGANICS(Meet No/Date: Status: j|ALC4/2020 PRIVATE LIMITED NC/3/MEET/Jan/202021/4 (Deferred 12.02.2021 | TAQFile REA File SSC LicNo/Date:0510415052, | | Decision: The Committee considered the case as per agenda in the presence of technical experts and it | was decided to call for following information from the firm: i (i) Chemistry, molecular weight from stating raw material of import ie.

(i) Chemistry, molecular weight from stating raw material of import ie. Phosphorus Yellow. ;

p Case No.:15/7/82-ALC4/2020_ Party Name:CLEAN (Meet No/Date: —~—~—~«s(Status: SCIENCE AND NC/3/MEET/Jan/202021/4 \Deferred ' . LIMITED | TECHNOLOGY PRIVATE 12.02.2021 : | [HQFile 169 |:01/82/050/01807/AM21/~~ ————”—~«*SRLA-:31/83/040/00087/AM21/ File=S—S—~S™~SC Lic02.11.2020No/DDatez3110067912 | | Decision: The Committee considered the case as peragendain the presenceof technical experts and it | was decided to call for following information from the firm: ; ()) Quantity and value of By-Product i.e. Mixed Mono Cresols & Acetic Acid i against 1 Tonne of Expojst.

|| [Case1ALC4/2019No.:253/10/82-~~» (PartyName:VINS.——S(MeetBIOPRODUCTS LTD’ No/Date:6/82-.ALC4/2020 (Status:Deferred , 13.11.2020 | (HQFile ~~ (RELA File.~———S~S~S~S~S*~*~:C:S LicNov/Daates0910008189 | | :01/82/050/00827/AM20/ :09/24/040/004 10/AM20/ 15.11.2019 '79| (Decision:{decided to callTheforCommittee followingconsideredinformationthefromcase theas firm:per agenda in the presenceoftechnical expertsand it; was | ; (i) DML. | (ii) Justification for process loss. i | * (iii) QA approved Batch manufacturing record. , oO i (iv) - Process flow diagram. :

_ || [Case No.:623/15/82-—~~—«(PartyName:VINS “|MeetNo/Date: "Status:| | |ALC4/2018‘ © (BIOPRODUCTS LTD NC/3/MEET/Jan/202021/412.02.2021" Deferred/ | iHQPile - IRLA File © SSS «SLi. 1[¢01/82/050/02080/AM19/] 1:09/24/040/00363/AM 19/ (14.11.2018.NovDate:0910066851ne) : | [Decisioniwas decided toThe call Committeefor followingconsideredinformationthe from case theas per firm:agenda, in the presence of technical experts and i

, {i) Details of 12% processing wastage which supported by QA approved batch . manufacturing record : .

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----- Start of picture text ----- [Case No.:220/6/82-ALC4/2019 [Party Name:BHARAT(Meet No/Date: (Status: . SERUMS & VACCINES LTD |NC/3/MEET/Jan/202021/4 (Deferred || TQ FieRa Fie. 12.02.2021hie NovDate-03 10830891 |72| twasDecision:decided toThecall forCommittee followingconsidered informationthe fromcase theas perfirm:agenda in the presence of technical expertsand it | (i) Details of processing wastage which should be supported by QA approved batch | manufacturing record, . ; (ii) CA/ Chartered Engineer Certificate for production and consumption may also be} _ provided. . | [ [CaseNo.:84/4/82-ALC4/2020 [PartyName:BIOLOGICAL E [MeetNo/Date; Status:| i LTD NC/3/MEET/Jan/202021/4 |Deferred | | . 12.02.2021 | 1H File RLA File _ [Lic.No/Date:0910069107 | :01/82/050/01585/AM21/ :09/24/040/00253/AM21/ 27.08.2020 |" (Decision: The lwas decided to callCommitteefor following conside info r mationed the casefrom theas‘per firm: agenda in the presence of technical experts and it | | } +, ‘ Hi fy (i) Details of 12% processing wastage which should be supported by QA approved | | batch manufacturing record. 1 | (ii) CA/Chartered Engineer Certificate for production and consumption. | [Case Now179/10/82- Party Name:PANACEA” (MeetNo/Date. —~—SStatus: | ;ALC4/2019 BIOTEC LTD,, INC/3/MEET/Jan/202021/4 Deferred ; | [12.02.2021 ||. [HQFile:01/82/050/00753/AM20/~— ——”—~<CS~SRLA_|:05/24/040/00410/AM20/le SSCs Lic,21.10.2019ND ates0510412195. | - | |Decision: The Committee considered the case as peragendain the presence of technical experts and it . |74 iwas decided to call for following information from the firm: . | od (i) Clarification on 36.5 % wastage on the following items: ' - ot (a) Diptheria bulk Do ~ (b) Tetanus toxoid bulk | . | , (ii) _ Potency of import inputs in terms of IU as mentioned in the drug license. | ----- End of picture text -----

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----- Start of picture text ----- . 43 . | Case No.:7/2/82-ALC4/2020 [Party Name:PANACEA Meet No/Date: Status: - ‘BIOTEC LTD., NC/3/MEET/Jan/202021/4 Deferred 12.02.2021 | /HQFile ~ IRLAFile Lic.No/Date:0510413419 | | OLAS2OSO/OFOFLT/AM20/ ~ * ”:05/24/040/00683/AM20/ > -j2201.2020° °F pe | Decision: | The Committee considered the case as per agenda in the presence of technical experts and it} — jwas decided to call for following information from the firm: : (i) A copy of 4,07 application. | (ii) Clarification on 36.5 % wastage on the following items: : | (a) Diptheria bulk ' (b) Tetanus toxoid bulk (c) Pertussisbulk . | (iii) Potency of import inputs in terms of IU as mentioned in the drug license. [ Case No.:40/6/82-ALC4/2020 (Party Name:GLAND [Meet No/Date: [Status: . i aPHARMA LIMITED . : — 12.02.2021|NC/3/MEET/Jan/202021/4 [Approved . | HQ File IRLA File Lic.No/Date:0910061513 | :01/82/050/01649/AM21/ 1:09/24/040/00563/AM15/ 08.01.2015 , | Decision: | The Committee considered case as per agenda in the presence of the technical experts and it | was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as applied by firm whichever is lower: | No. No. | Injection 40mg Pre filled Number . . | Powder ; = | Injectable Glass * 76 ; . | Rubber ; ; : Rubber ‘| : : 7 AntiKits FactorXa~ Test Kits | Consurnables,Accessories, etc. ae . “policy. Z Kits Accessories, etc. i | ; . Anti Factorlla Test Kits | Consumables,not allowed under || i . , Kits _ | Accessories, ete. not allowed under | : policy ----- End of picture text -----

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----- Start of picture text ----- ; . . 44 . | ; Columns _ Accessories, ° ete. : . Kits not allowed under : | policy . | ll PaperMedical Grade Paper Accessories,Consumables, . etc. i not allowed under Oo 7 i , , 12 | Tubing Consumables, | 4 | ' | Plastic notAccessories,allowed underete. ' . polic : | 13 Anti FactorXa Consumables, Kits Accessories, etc. a not. allowed under i , polic | | Kits Accessories, etc, | . not, allowed under : of ; olic: ff 15 N.M.LR. Standard Consumables, | || _ | Kits Accessories,not allowed underetc. | policy | 16- | Mol. Wt.StandardKits Accessories,Consumables, etc, : not allowed under . . polic . Injection 60mg Pre filled Number Powder | - Injectable Glass . Rubber i , Rubber | Plastic : a [* eSPlastic ° |' . 7 KitsAnti FactorXa Test Kits | Consumables,Accessories, ete. . . ; | ‘ 5 ; policynot allowed_ under , , | , Anti FactorlIa Test Kits | Consumables, | ' Kits ‘| Accessories, ete. | | : Df, . ae a not allowed under : ‘ Pj ; , - 7 policy i. ' i . i , . 19 Analytical Columns Consumables; . { . . -| Kits Accessories, ete. . not allowed under | - ‘ “110 | Analytical Guard © Consumables, i oe i , Columns - | Accessories, etc. | i Kits | not allowed under | ; ; P| , ' . is Medical Grade Paper | policyConsumables, . i . : . : . Paper : Accessoties, ete. | . ' . notpolic allowed under ; . . ‘ . . . . ‘ Accessories ete. . ----- End of picture text -----

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|||||||||
|---|---|---|---|---|---|---|---|
|:|13|Anti|FactorXa|Consumables,|
|i|Kits|Accessories,|etc.|
|||not|allowed|under|
|||policy|
|i|Kits|_|Accessories,|ete.|||||.|
|||not|allowed|under|||
|||polic|
|||15|N.M.R.|Standard|Consumables,|.|
|i|Kits|Accessories,|etc.|
|not|allowed|under|
|t|polic|‘|
|||16|Mol.|Wt.Standard|Consumables,|
|Kits|Accessories,|ete,|,|
|i|not|allowed|under|
|||;|olic|
|||RA concerned may take further necessary action as per above decision ofNC.|||

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----- Start of picture text ----- ; 46 . | Case No.:39/6/82- [Party Name:MEDREICH Meet No/Date: ‘Status: | ALC4/2020 LIMITED NC/3/MEET/Jan/202021/4 |Approved | 12.02.2021 | woe ow (AQ Fie IRL File oo ‘Lic.No/Date:0710112322 | cee bow a Decision: |The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as applied by firm whichever is lower: . | : 1 TabletsAmoxicillin &625mg[420000Potassium ClavulanateNo.] || 420000No. 1 » TRINYDRATEAMOXICILLIN 245.602 kg : i [Each tablet contains Amox. Trihydrate BP | Tablets BP/PH.EUR COMP ; i as Amoxicillin 500mg Pot. Clavulanate BP EXT.DRY : i (as dil. Pot. Clayulanate BP) equivalent to 2 POTASSIUM 127,461 kg | Clav. Acid 125mg] CLALVULANATE + | [ 240.786+124.962=365.748AdhocNorms : Case S.No.276Kgs]- AVICELCOs [1:1] NON | W/1312/27.11.15]01/82/50/01357/AM-15/DES- CLALVULANATE[POTASSIUM + i MCC BLEND [1:1] | NON COS | 2 Amoxicillin & Potassium Clavulanate | 3680000 : . | Tablets 1125mg —- [3680000 = No] | No. . TRISYDRATE | i [Each tablet contains Amox. Trihydrate BP | Tablets BP/PH.EUR COMP 7 as Amoxicillin 1000mg Pot. Clavulanate BP EXT.DRY |177 (as[4219.488+1094.903=53Clavulanicdil. Pot. ClayulanateAcid14,391BP) equivalent Kgs] 125mg]to 2 - | CLALVULANATEPOTASSIUMAVICEL [1:1] NON + 1116,801 kg . . :: | 01/82/50/01357/AM-15/DES-[AdhocNorms:Case #.276- cos[POTASSIUM , | TH/13 12/27.11,15] CLALVULANATE + | MCC BLEND [1:1] | NON COS] 3 | Amoxicillin & Potassium Clavulanate [ 700000 | 1000mg ‘tablets[700000 No] | No. TRIHYDRATE | . | [Each tablet contains Amox, Trihydrate BP | Tablets BP/PH.EUR COMP as Amoxicillin 875mg Pot. Clavulanate BP EXT.DRY Pook, (asClavudi l .anicPot. ClavulanateAcidBP) equivalent125mg]to 2 POTASSIUMCLALVULANATE + | 212.435> kg i _ | [AdhocNorms:Case[702,293-+-208,.270=910.563Kgs] #.276- cosAVICEL [1:1] NON | , | 01/82/50/01357/AM-15/DES- : [POTASSIUM ~ . _ 11/1312/27,11.15] . CLALVULANATE+ | | || . NON COS] i 4 Amoxicillin & Potassium Clavulanate | 320000 1 AMOXICILLIN _ | 187.125kg ; 562.5mg Tablets [320000 No] | No. TRIHYDRATE - ' [Each tablet contains Amox. Trihydrate BP | Tablets BP/PH.EUR COMP . i : a ‘as Amoxicillin 500mg Pot. Clavulanate BP -EXT.DRY-’ ae : : i (as dil, Pot. Clavulanate BP) equivalent to 2 POTASSIUM 48.557 kg i . | i| Clavulanic[183.456+47.604=231.06Kgs]}Acid 62.5mg] : CLALVULANATEAVICEL [1:1] NON + | . . i i [AdhocNorms:Case : #.276- : COS ; : 01/82750/01357/AM-15/DES- . [POTASSIUM .” . TII/1312/27,11.15] . CLALVULANATE + . . | . . MCC BLEND [1:1] . . . | : NON COS] , ----- End of picture text -----

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----- Start of picture text ----- so, | 5 Amoxicillin & Potassium Clavulanate | 200000 1 AMOXICILLIN 58.447 kg ‘ ’ OO, i 375mg Tablets [200000 No.] | No. TRIHYDRATE ' ; ; [Each tablet contains Amox. Trihydrate BP | Tablets BP/PH:EUR COMP , l° as Amoxicillin 250mg Pot. Clavulanate BP EXT.DRY . . {as dil. Pot. Clavulanate BP) equivalent to 2 POTASSIUM 36.417 kg | Clavulanic Acid 75mg] CLALVULANATE + ; oe [57.330+35.703=93,033Kgs] ot AVICEL [1:1] NON | ; : | . | 01/82/50/01357/AM-15/DES- [POTASSIUM | : | T1/1312/27.11.15] CLALVULANATE + | ° | | MCC BLEND [1:1] . . . NON COS] : . | RA concerned may take further necessary action as per above decision of NC, ; | Case No.:853/15/82- Party Name:ALPHAMED Meet No/Date: Status: i ALC4/2018 FORMULATIONS PLTD. |NC/3/MEET/Jan/202021/4 jApproved . 12.02.2021 : | HQ File RLA File Lic.No/Date:0910067120 | :101/82/050/02310/AM19/ —_|:09/24/040/00511/AM19/ 31.01.2019 : | Decision: |The Committee considered case as per agenda in the presence of the technical experts and it as applied by firm whichever is lower: : | was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or- . Sl. | Export Product Qty. e SL. Import items Qty. ve i No. : No. | Tablet)@er , | 1 XycamDisperisble Tablets 20mg | 1 Number 1 Piroxicam (Assay - 98%) | 204mg : | (Each Tablet Contains - 20 Mg of (Pre-import Condition is . - | Piroxicam) imposed as per Appendix 4]). | EO Should be completed within 12 months from the date of | import of Each Consignment) 2 Xycam Capsules 20mg | 1 Number t Piroxicam (Assay - 98%) | 20.4 mg | (Each Tablet Contains - 20 Mg of (Pre-import Condition _ is | : Piroxicam) imposed as per Appendix 4J). ; . 78 ] ’ , ; EO Should be completed within . ; i 12 months from the date of . . | * |import of Each Consignment) | ‘ \ 3 Ulsanic 1g Effervescent Tablets | 1 Number 2 Sucralfate (Assay - 98%) | 1.02 gms . | (Each Tablet Contains - 1 gramof | ~ (Pre-import Condition — is ‘ i Sucralfate) ‘ imposed as per Appendix 4J). : ‘ : | : * | EO Should be completed. within ; Pa dS ee: -- + + 12import,months of Each:Consignment)from the date of : !Do | 4 Nafasol’ EC 500mg Tablets | 1 Number 3 Naproxen (Assay - 98%) | 510.0 mg | (Each Tablet Contains - 500mg of “| @re-import Condition is | i Naproxen} . imposed as per. Appendix 4J), . : ; PoE ; ae oy .EO Should.be completed within |. . i 12 months from the date of i ; | : import of Each Consignment) : | ' ‘ : (5 Nafasol EC 250mg Tablets | | Number 3 Naproxen (Assay: - 98%) 255.0mg | } ‘ , (Each Tablet Contains - 250mg of . (Pre-import Condition is : Naproxen). imposed as per Appendix 4J).. | ” . yo EO Should be completed within | . : | . 12 months from the date of ; | ; import of Each Consignment) ----- End of picture text -----

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, : . : 7 i: : -

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----- Start of picture text ----- | Betanoid 0.5mg Tablets | 1 Number 4 Betamethasone (Assay‘- 98%) | 0.51 mg | | -(Each Tablet Contains - 0.5mg of (Pre-import Condition is | Betamethasone) imposed as per Appendix 4J). i EO Should be completed within : P, 12 months from the date of i import ofEach Consignment) | STEe TE og i ee| I T Teohlor(Each Tablet Containseo- 100mgpablets of ybNuniber 9° S° *]-Ateriolél’(Pre-import. “(AssayCondition“7° 98%)is ) 1020 mg. | - . Atenolol & Chlorthalidone 25mg) imposed as per Appendix 4J). i EO Should be completed within 12 months from the date of | import of Each Consignment) | Chlorthalidone (Assay 98%) | 25.50mg | | ! . (Pre-import Condition _ is i imposed as per Appendix 4]). | ; EO Should b¢ completed. within ‘ import of Each Consignment | 12 months from the date of | Tenchlor HS Tablets | 1 Number | 5 Atenolol (Assay 98%) | 51.0 mg : (Each Tablet Contains - 50mg of (Pre-import Condition is i Atenolol & — Chlorthalidone imposed as per Appendix 4J). 12.5mg) EO Should be completed within 12 months from the date of 1 import of Each Consignment | Chlorthalidone (Assay 98%) | 12.75 mg | (Pre-import Condition _is i ’ . imposed as per Appendix 4J). . oe EO Should be completed within 12 months from the date of import of Each Consignment | : Lenditro(Each Tablet Contains5mg - 5mgTabletsof | 1 Number 7 98%)Oxybutynin Chloride (Assay- | 5.10 mg Oxybutynin chloride) (Pre-import Condition is imposed as per Appendix 4J). i EO Should be completed within . 12 months from the date of | import of Each Consignment RA concerned may take further necessary action as per above decision of NC, | ----- End of picture text -----

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oo, [~ Case No.:855/15/82Party Name:SMS . Meet No/Date: Status: ~ | ALC4/2018 a LIFESCIENCES INDIA NC/3/MEET/Jan/202021/4 |Approved LIMITED 12.02.2021 | ‘/01/82/050/02312/AM19/ |:09/24/040/00542/AM19/ [31.01.2019 | | Decision: The Committee considered the case as per agenda and it was decided to ratify norms under Para | 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: . 7 | Export Product Qty No.Sl. | Import Items ) . | Qty 79 EZETIMIBE - IV Lkg (S)-4-PHENYL-OXAZOLIDIN-2-ONE | 0.45 kg | | | INTERMEDIATE TIMMCALA-T2-150 (ENZYME) 9.066 kg METHYLENE DICHLORIDE | 6.00 kg . N-HEPTANEMETHANOL 4.403.20 kgkg _ [6 | TOLUENE 7.80 kg POTASSIUM HYDROXIDE FLAKES | 0.90 kg : | |8 | ISO PROPYL ALCOHOL 3.00 kg 9 | DIMETHYL FORMAMIDE 0.40 kg RA concerned may take further nécessary action as per above decision of NC. : , nee nennninmnennetnnnntneetstnesi t iveninennntaannan mnentettetttienent Retin t e ntnnrnnnnet@tct tnsntinneninnei . -[CaseALC4/2018No.:863/15/82Party Name:JAY ANT[AGRO][ [Meet] No/Date: ‘Status: — 12.02.2021 | | ORGANICS LTD., NC/3/MEET/Jan/202021/4 |Approved | |HQFile (RLAFile ~~ {Lic.No/Date:0310826798 |” :01/82/050/02320/AM19/ ———|:03/94/040/00948/AM19/ 04.02.2019 | (Decision: The Committee considered the case as per agenda and it was decided to ratify norms under iso Para 4.07 of HBP Vol. I as per details given. below or as applied by the firm, whichever is less: . | Export Product Qty | Sl. | Import Items Oty | "| No. . | ~ | | DICAPRYL ADIPATE [| 1 kg ADIPIC ACID 0.411 kg (JAGROPLAST-DCA): 2-OCTANOL 0.737 kg a ‘RA concerned may take further necessary action as per above decision of NC. oo fo

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"(Case No.:881/15/82- —-([PartyName:SHILPA—S|MeetNo/Date: =—(Status: | jALC4/2018 MEDICARE LIMITED INC/3/MEET/Jan/202021/4 ;Approved | ; 12.02.2021 hy FAQ File REA File Tic.[Ng/Date:0710114519][ FO] Decision: | The Committee considered the case as per agenda and it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

RA concerned may take further necessary action as per above decision of NC.

;

|| [Case{ALC4/2018[No.:894/15/82-] SsPartyName:DEEPAKPHENOLICS LIMITED= [MeetiNC/3/MEET/Jan/202021/4 No/Date: = ‘[Status:|Approved || (HQFie= ———~<“—s~sti‘“s«~RLA deSSS—S—*~SCS LicN/DDates3410044883| t 1:21 {:01/82/050/02351/AM19/ONEROUS OOOO BSIUSADOELSLIE LOUGHEED|:34/24/040/00328/AM19/AOSOOILAAANPOLONOU LURE COPPA AOA EOI ANOLA SAUNA EIEN112.02,2019EEA EOIN NEELNEE EEL | |Decision: The Committee considered the case as per agenda and it was decided to ratify norms under Para! | g2 (4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: | Export Product Qty Sl. | Import Items Qty No. | ACETONE BENZENE 0522kg

L RA concerned may take further necessary action as per above decision ofNC.

["ICase No.:936/15/82-.—~—~—«(Party | {ALC4/2018 PVT LTDName: VISION DRUGS |MéetNC/3/MEET/Jan/202021/4 No/Date:—«(Status:‘Approved | |:01/82/050/02393/AM19/ ——|:09/24/040/00575/AM19/* ‘25.02.2019 fo | (Decision: ‘The Committee considered the case as peragendaand it was[decided] | 4.07 of HBP Vol. | as per details given below or as applied by the firm, whichever tois less:ratify norms under Para) “hos - Export Product -~" - ” - Oty - ] SL | Impoftltéms' _ | Qty ee . 3,4-Dimethoxyphenethylamine(HVA) . . lkg Sodium Cyanide 0.501.44 kgkg ' . | . 1.40 kg : | RA concerned may take further necessary action as per above decision of NC.

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|||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|54|;|
|||[Case No.:1039/15/82-|Party|Name:GLAND|‘Meet No/Date:|(Status:|
|a|i|=|ALC4/2018|PHARMA LIMITED|‘NC/3/MEET/Jan/202021/4|[Approved|
|||.|.|12.02.2021|
|||HQ|File|—|IRLA File|Lic.No/Date:0910067225|||_|
|Decision:|| The|Committee|considered|case|as per|agenda|in|the presence|of the|technical|experts|and|it|
|was|decided|to|ratify|the|ad-hoc|input|output|norms|under|para|4.07|of HBP|Vol.|J|as|per|details|below|or|
|||as applied by firm whichever is lower:|.|
|!|
|:|No.|No.|
|||1|Enoxaparin|Sodium|||1 Number|1|Heparin|Sodium ||59.6 mg|
|||Injection|30mg/0.3ml,|Pre-|The|firm|should|complete|
|;|.|filled|=|-|Syringes|within|12|months|from|the|
|ae|a|The|firm|should|complete|.|date|of|Import|of|each|.|
|||within|12|months|from|the|consignment|of|Input|at|
|||date|of|Import|of|each|SLNo.1|and|SILNo.7|of|
|consignment|of|Input|at|Import|List|as|per|Policy|
|||SLNo.1|and|SI.No.7_|of|Circular|No.|9|dated|
|||Import|List|as|per|Policy|30.6.2003|read|with|
|1|Circular|No.|9|dated|Appendix|4J|of|FTP|[2015-|
|||30,6.2003|read|with|20]|
|sa|fy|||70h|||
|.|shielding|System|
||||2|1|Enoxaparin|Sodium|||1 Number||Tete7|Heparin|SodiumPP||198.664 mg|;|
|Injection|100mg/1.0ml|Pre-|The|firm|should|complete|i|
|||filled|Syringes|within|12|months|from|the|||
|||withinThe|firm12|monthsshould|fromcompletethe|consignmentdate|of|Importof|Inputof|eachat|||_|
|i|date|of|Import|of|each|SLNo.1|and|SI.No.7|of|.|
|||*|"||consignment|of|Input|at|Import|List|as|per|Policy|
|||SLNo.t|and|SINo.7|of|Circular|No.|9|dated|
|Import|List|as|per|Policy|;|30.6.2003|read|with|
|||Circular|No.|9|dated|Appendix|4]|of FTP|[2015-|
|||*|||30,6.2003|read|with|20]|,|
|I|Appendix|AY|of FTP|[2015-|Pe|[imi Barrel Syringes|||[NettoNet__]|
|’|Pd|;|-|||shielding|System|.|
|.|||RA concerned may take further necessary action as per abave decision of|NC.|||

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_ Case No.:143/1/82~ Party Name:TINA [Meet No/Date: Status: ° | |ALC4/2019 - JORGANICS PRIVATE INC/3/MEET/Jan/202021/4 jApproved | . . LIMITED 12.02.2021 (HQ File REAFile [Lic.No/Date:0510409855[| | Decision: The Committee considered the case as per agenda and it was decided to ratify norms under | Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: [85| Export Product Qty | Sl. | Import Items Qty . TRI XYLENYL| 1 kg ‘MIXED XYLENOL LIQUID 0.939 kg — | PHOSPHATE 2 PHOSPHOPROUS YELLOW SOLID 0.087 kg | ADDITIVE FOR : | . | LUBRICATIING OIL . | RA concerned may take further necessary action as per above decision ofNC. |

a

| [Case Noi204/1/82-—~—~—~«(iParty Name:DEEPAK Meet No/Date: ~~ [Status: ] ; {ALC4/2019 PHENOLICS LIMITED 4NC/3/MEET/Jan/202021/4 {Approved . | . 12.02.2021 . JHQFile| :01/82/050/02599/AM19/~~ sSREAFile|-34/24/040/00353/AM19/=. ~——~CS~S=C*«CdL 14.03.2019YeNDaates3410044969 | , . | [Decision: The Committee considered the case (86[|4.07][of][ HBP][Vol.][I][as][ per][details][given][ below][or][as] as[applied] per agenda[ by][ the] and[firm,] it was[whichever] decided to[is] ratify[less:] norms under Para | Export Product Qty Sl. | Import Items Qty No. | ACETONE BENZENE 0,522 kg

;

|jRA concerned may take further necessary action as per above decision of NC.

|(Case[No.:133/6/82-ALC4/2019] [PartyName:ORIENTAL[Meet No/Date: Status: ' AROMATICS LTD |NC/3/MEBT/J an/202021/4 ‘Approved . 12.02.2021 1| [HQ1:01/82/050/00359/AM20/ File — £:03/95/040/01320/AM19/[REA File soO/AMI! 118.03.2019'Lic.No/Date:03 10827769 i| oe | (Decision: “ The Committee considered the case as peragendaand itwas decided to ratify norms under Para, ig 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: . __| [Ally Heptoate (ABIS073) Heptoate (ABIS073) (ABIS073) 080K) Ally Alcohol 0.380 kg

__| [Ally Heptoate (ABIS073) Heptoate (ABIS073) (ABIS073) Ally Alcohol IRA concerned may take further necessary action as per above decision of NC.

| | |

53 ;

: ,

: :

‘

;

| [Case No.:187/1/82PartyName:OPTRIX ‘(Meet No/Date: Status: , ALC4/2019 | LABORATORIES PRIVATE |NC/3/MEET/Jan/202021/4 Approved | LIMITED 12.02.2021 FQFH REA File CL. No/Date:0910067207, Decision: The Committee consideredthe case as per agenda and it was decided to ratify norms under gg Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: No. | Export Product | Qty | Sl. | Import Ttems Qty FLIBANSERIN — | 1 kg 1-(2-chloroethyl)-1H-benzo[d]imidazol-2(3H)-one 0.62 kg ; | 1-(3-(trifluoromethy!)phenyl) piperazine hydrochloride | 0.84 kg

| RA concerned may take further necessary action as per above decision of NC.

[ [CaseNo.:214/1/82-~—~—~*‘(iPartyNName:DEEPAK | ALC4/2019 PHENOLICS LIMITED ‘(MeetNC/3/MEET/Jan/202021/4 No/Date: ~~ Status:iApproved | HQFile (RLAFile ~~. {Lic.No/Date:341004499012.02.2021 | 4 {:01/82/050/02609/AM19/ 134/24/040/00327/AM 19/ 20.03.2019 "bey Decision: The Committee considered the case as per agehda 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: | and it was decided to ratify norms underPara - ACETONE No. BENZENE 0,522 kg RA concerned may take further necessary action as per above decision of NC.

("Case No.:14/1/82-ALC4/2019 [Party Name:CLEAN SCIENCE[Meet No/Date: —————‘[Status: , AND TECHNOLOGY INC/3/MEET/Jan/202021/4 |Approved | . PVT.LTD. _ 12.02.2021 . | [HQFile RLAFile Lie.[No/Date:3110067371] | | :01/82/050/00014/AM20/ 1:3 1/83/040/00299/AM19/ 104.04.2019 , _ || (Decision: The Committee considered the case as per[agenda] and it was decided to ratify norms under Para 99.4.07 ofHBPae Vol, I as per detailsce given below or as applied_ by thea firm, whichever is less: i: | | | Export Product Qty | SL | Import Items - ‘ Qty is || | Resi Anioi Te 08056 Kg : 3 Acetic Anhydride PURITY 99% 0.755 kg | !RA concerned may take further necessary action as per above decision ofNC. 4

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| | [Case No.:67/1/82-ALC4/2019 |Party Name:AUROBINDO[Meet No/Date: —~—=S{Status:=— 112,02.2021 | PHARMA LIMITED iINC/3/MEET/Jan/202021/4 |Approved ee a AQ File IRL File Lie No/Date:0910067414 [| | Decision: The Committee considered the case as per agenda and itwas decided to ratify norms under. — | Para 4.07 of HBP Vol. J as per details given below or as applied by the firm, whichever is less: Export Product Qty Sl. | Import Items Qty i ; No. ; °! CEFUROXIME AXETIL | 1kg 7-Amino Cephalosporanic Acid (7-ACA) 0.544kg |i | | |POVIDONEcontaining NLTMIXTURE70% Activated Carbon (Carbon Enoanticromos) | 05 . 910686 kg kg Cefuroxime Axetil . Chlorosulfonyl Isocyanate (CSI) 0.374 kg | Di Isopropyl Ether (or) Iso Propyl Ether 0.41 kg i | 6 | Methanol (Methyl Alcohol) 0.88 kg | a Methylenechloride (MDC) 0.94 kg | | . | 8 | N,N-Dimethyl Acetamide 1.66 kg || | Acid(Z)-2-Methoxy, Ammonium_Imino(Furyl-2-YL)Salt (SMIA) Acetic | 0.438kg ‘ ; | RA concerned may take.further necessary action as per above decision of NC. .

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["\Case No.:97/1/82-ALC4/2019{Party Name:CLEAN SCIENCE [MeetNo/Date: -~—~(Status:—— | ANDPVT.LTD. TECHNOLOGY (12.02.2021NC/3/MEET/Jan/202021/4 |Approved | (HQFile = ——~CS~:«SRLA Fle ~{Lie,No/Date:3110067404 a | §:01/82/050/00097/AM20/ :31/83/040/00013/AM20/ (01.05.2019 Decision:The Committee considered the case as per agenda and it was decided to ratify norms under Para 4.07 of HBP Vol. Las per details given below or as applied by the firm, whichever is less: 92 . | | Export Product Qty | Sl | Import Items Qty . Reeiyranisoe [Te ROSES | | | @ Methoxy Acetophenone) . 12 0.276 kg ‘ 3" | Acetic Anhydride PURITY 99% 0.755 kg mS ° (RA concerted may take further necessary action as per above decisfon of NC. , |

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----- Start of picture text ----- | ALC4/2019 CHEMICALS LIMITED, | |NC/3/MEET/Jan/202021/4 jApproved [ ate No.:194/6/82- ce Name:ETERNIS. FINE =12.02.2021 No/Date: ai . | {HQ File . IRLAFile ~~~ Lic.No/Date:0310828815. {| > , Decision: The Committee considered the case as per agenda and it was decided to ratify norms under , | Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: |93 Export Product : Qty Sl. | Import Items Qty . | No. | ALPHA HEXYL CINNAMALDEHYDE| 1kg | AND OR HEXYL CINNAMIC 2 BENZALDEHYDE 0.584 kg | "|RA concerned may take further necessary action as per above decision of NC. , 7 |[ cALC4/2019ase No.:251/1/82- P artyHARMA Name:GLAND LIMITED. NC/3/MEET/Jan/202021/4Meet No/Date: [Status|Approved | oe 12.02.2021 | | HQ:01/82/050/00137/AM20/ File RLA:09/2.4/04.0/00043/AM20/ File Lic.No/Date:091006751914,05,2019 ; | . (Decision: The Committee considered the case as per agenda and it was decided to ratify norms under - : | [Pare 4.07 ofHBP Vol. I as per details given below or as applied by the firm, whichever is less: | SL Export Product Qty Sl. ; Import Items Qty 1 | | No. No. | b i 1 Enoxaparin Sodium |1Number | 1 Heparin Sodium | 39.733 mg i filled Syringes thisconditionis Unregisteredis imposedandinexportcase | Injection 20mg Pre- *Condition: Pre —_— import | | , obligation should be completed , i , within 12 months from the date | of Import of each consignment 4 | . . . ; as[2015-20].per Appendix 4] of FTP . , i : System . |: | {o Preventis. Needle Shielding | i 12 -Enoxaparin Sodium |1Number | 1 Heparin . Sodium | 59.6 mg ! Injection 30mg Prey 2] *Condition: Pre import | filled Syringes condition is imposed in case | 4 this is Unregistered and export a obligation should be completed | | fo ‘ within 12 months from the date ‘ | | , of Import of each consignment , as per Appendix 4J of FTP | fo : [2015-20], ; ----- End of picture text -----

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|oo|oo|||||||||||||||||System||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|ee<br>ee<br>te <br>rs<br>i<br>|<br>fo||||||3<br> Jo.|||||Enoxapatin<br>Sodium| 1Number | 1<br>Heparin<br>Sodium| <br> Injection<br>40mg Pree |.<br>|, Condition:<br>Pre<br>import|<br>‘filled Syringes.Sa ee" Condition“is'imposed invcasé<br>this is Unregistered and export<br>obligation should be completed||||||79.466mg<br>{7°<br>7|mg<br>ce||Lee<br>ae fay<br>tena<br>ye||||
|||||<br>;||:|||||;|||||within 12 months from the date<br>of Import of each consignment||||||||
||||bodys||||||||||||as per Appendix 4J of FIP<br>[2015-20].||||||||
|:|||7<br>|<br>i<br>i<br>i<br>||||4||||Enoxaparin<br>Sodium | 1Number <br>Injection 60mg<br>Pre-<br>filled Syringes<br>:|||ee<br>=Sle<br>System<br> | 1<br>Heparin<br>Sodium| 119.187mg<br>*Condition:<br>=<br>Pre<br>import<br>condition is imposed in case<br>this is Unregistered and export|||||||||.|.|
||||i<br>i||<br>i<br>||,|||||.|.||||obligation should be completed<br>within 12months fromthe date<br>|,<br>of Import ofeach consignment<br>as per Appendix 4J of FTP||.||||||
||||||||||||||||[2015-20].||||||||
|||||||||||||||||||||||.|
||||;|||||||||||||Preventis<br>Needle<br>Shielding|||||||:|
|||||||||||||||||System.||||||||
|||,|1<br>|<br>|||<br>i<br>|||5|||<br>;||Enoxaparin<br>Sodium | 1 Number <br> Injection<br>80mg<br>Pre-<br>filledSyringes<br>.<br>:|||||1|Heparin<br>Sodium | <br>: | *Condition:<br>Pre<br>|<br>import<br>condition is imposed in case<br>this is Unregistered and export<br>obligation should be completed|158.93 mg.<br>,<br>:||||||’|
|||||||||||.|,|,|||within 12 months from the date||||||,||
||||L||||||||.<br>,|||||of Import of each consignment<br>as per Appendix 4] of FTP|.||||||||
||||;|of||||||Enoxaparin|Sodium | 1 Number||||1|System<br>°<br>Heparin.<br>Sodium ||198.664mg|||<br>|}||||-|
|‘|||<br>|<br>,<br>i<br>|<br>po||||||||filledSyringes||:|||condition is imposed in case}<br>this is Unregistered and export<br>obligation should be completed<br>within 12 months from the date|||||.|||
|,|.|;|;||<br>||||||||;||;<br>;||_of Import of each consignment<br>as_perAppendix4JofFTP||.||||;|,|

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----- Start of picture text ----- L | et taereeg vf acre ‘ spiel _to yd bony Prevents.System / Needle. .° Shielding| | Net to-NetyeCo | | |7 Enoxaparin Sodium | 1Number | 1 Heparin Sodium | 238.40 mg > Injection 120mg Pre- *Condition: Pre import | . filled Syringes condition is imposed in case ob this is Unregistered and export ho withinobligation12. monthsshould frombe completedthe date | | of Import of each consignment i ' as per Appendix 4] of FTP bof. 2015-20). 7i nePreventis Needle Shielding | Net to Net . | Enoxaparin Sodium | 1 Number | i Heparin Sodium | 298.00 mg a Injection 150mg Pre- *Condition: Pre import ef filled Syringes condition is imposed in case | ° | this is Unregistered and export | obligation should be completed | | ofwithinImport12 months fromof each consignment the date i | as per Appendix 4J of FTP | | [2015-20]. | | i System | IRA concerned may take further necessary action as per above decision ofNC, i [Case No.:1/6/82-ALC4/2019 [Party Name:MALLADI ~~ (Meet No/Date: __, Status: —| - SO DRUGS & _ INC/3/MEET/Jan/202021/4 |Approved | Ey ‘PHARMACEUTICALS {12.02.2021 ee “| ° | [HQ File IRLA File [Lie No/Date:0410165665° [ . | :01/82/050/00227/AM20/ . — ;:04/24/040/00048/AM20/' > —‘/31,05.2019 . , : 195 Hor‘Decision: ofHBP Vol.The Committee I as per detailsconsidered given belowthe case or asas appliedper agenda by the and firm,it was whichever decided is to less: ratify norms under Para|| i 4 ‘Export Product Qty Si. { Import Items: _ , , Qty. _ | , No. - | {RA concerned may take further necessary action as per above decision of NC. : ----- End of picture text -----

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----- Start of picture text ----- [~\Ease No.:30/6/82-ALC4/2019|Party Name‘TIDE ~~(MeetNo/Date: =———(Status: . INDUSTRIES INC/3/MEET/Jan/202021/4 Approved . FRG ie REA. /12.02.2021 Fie Tie NoDate'3410045200 | So (Decision: |The Committee considered the case as per agenda and it was decided to ratify norms under Para | 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: - 196 : Export Product Qty | Sl. | Import Items Qty , ; | No. ; | Gamma Nonalactone or | 1 kg Hexyl Alcohol or N-Hexanol 0.900 kg ; | Aldehyde C18 Acrylic Acid 0.66 kg | Di-tert Buty! Peroxide 0.229 kg RA concerned may take further necessary action as per above decision ofNC. | , | [CaseNo.:33/6/82-ALC4/2019. [PartySCIENCEName:ASHISH PVT.LTD. LIFEINC/3/MEET/Jan/202021/4MeetNo/Date: —([Status:|Approved | J /|12,02,2021 | fHQFile “REA File ——S—~S~SLic Neate: 0310829569 | . | 101/82/050/00259/AM20/ |:03/94/040/00197/AM20/ (12.06.2019 , a . Decision: |The Committee considered the case as per agenda and itwas decided to ratify norms under Para | 14,07 of HBP Vol. Las per details given below or as applied by the firm, whichever is less: i No, TYLOSIN TARTRATE POWDER 100%-100GM | 1500.000 TYLOSIN 2579.28 kg i SACHET (EACH GRAM CONTAINS TYLOSIN | Number TARTRATE 1 TARTRATE 100%) (net content of exempt material is (RAW | 150 kgs) MATERIAL) | 2 TYLOSIN TARTRATE POWDER 100% ~-500GM | 300.000 | SACHET (EACH GRAM CONTAINS TYLOSIN | Number , ; | TARTRATE 100%) (net content of exempt material is ; . , | 150 kgs | 3 * | TYLOSIN TARTRATE POWDER 100% -1KG JAR | 150.000 . ‘ 97 (EACH GRAM CONTAINS TYLOSIN TARTRATE | Number ; 100%) (net content of exempt material is 150 kgs ‘ ‘| 4 TYLOSIN TARTRATE POWDER 99% -100GM | 1500.000 ‘ . : . SACHET (EACH GRAM CONTAINS TYLOSIN | Number * : oe: TARTRATE 99%) ! tog (11et content of exempt material is 148:5 kgs) ee . “I ‘ LI 5 | TYLOSIN TARTRATE POWDER 99% -500GM | 300.000 i ‘| TS A RTRATECHET (EACH99%) (netGRAMcontentCONTAINSof exempt materialTYLOSINis | Number . ‘ ‘ . i 148.5kes) . . i] 6 TYLOSIN TARTRATE POWDER 99% -1KG JAR | 150.000 ' - 7 i | (EACH GRAM CONTAINS TYLOSIN TARTRATE | Number i , | ~ | 99%) (net content of exempt material is 148-5kgs) | . 7 TYLOSIN TARTRATE POWDER 20% -100GM | 5000.000 , . i : EQ.(EACHTO TYLOSINGRAM CONTAINS 20%) (net contentTYLOSINof exemptTARTRATEmaterial | Number , i : is 100 kgs) . . TYLOSIN TARTRATE POWDER 20% -500GM | 2000,000 > . | (EACH GRAM CONTAINS TYLOSIN TARTRATE | Number . i EQ. TO TYLOSIN 20%) (net content of exempt material ; i is 200 kgs) : ; : . ----- End of picture text -----

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----- Start of picture text ----- | {ToT TYEOSIN TARTRATE POWDER 20%-iKG JAR |2000.000 | _ a , | (EACH GRAM CONTAINS TYLOSIN TARTRATE | Number . | -EQ. TO TYLOSIN 20%) | net content of exempt material is 400 kgs |. 10 | TYLOSIN’ BOLUS 200MG (EACH BOLUS | 100000.000 | CONTAINS TYLOSIN 200MG) (nett content of exempt | Number . Pog | material is 20 kgs) _ _ ee ne pe Me PT TEOSIN INJECTION: © 5%-30- ME (EACH™ ME 7 -75000,000 ~ ae a |° CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN | Number ; : || -1[42: _| | FYLOSINkgs)BASE 50MG)INJECTION(net; content ;5%-50of exempt.MLmaterial(EACH:is 112.5ML | 50000,000; | CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN ; Number ; BASE 50MG) (net content of exempt material is 125 | ; | 13 TYLOSIN INJECTION 5%-100 ML (EACH ML | 10000,000 . | ; CONTAINS TYLOSIN TARTRATE EQ. TQ TYLOSIN | Number i BASE 50MG) (net content of exempt material is 50kgs) ' | 14 | TYLOSIN TARTRATE INJECTION 20%-30 ML| 10000,000 . ‘ | (EACH ML CONTAINS TYLOSIN TARTRATE EQ. | Number . i TO TYLOSIN 200MG) (net content of exempt material i is 60 kgs) | 15 TYLOSIN TARTRATE INJECTION 20%-50 ML | 25000.000 (EACH ML CONTAINS TYLOSIN TARTRATE EQ. | Number TO TYLOSIN 200MG) (net content of exempt material is 250 kgs) i 16 | TYLOSIN TARTRATE INJECTION 20%-100 ML | 15250.000 (EACH ML CONTAINS TYLOSIN TARTRATE EQ. | Number oo] . TO TYLOSIN 200MG) (net content of exempt material | . . | is 305kgs) . ; | RA concerned may take further necessary action as per above decision of NC. , "(Casepod No.:50/6/82.ALC4/2019 [Party Name:VISIONDRUGS [MectNo/Date: —~S<{Status:— ob | PRIVATE LIMITED NC/3/MEET/Jan/202021/4 |Approved 12.02.2021 | (HQFile mnIRLA File. SS*~*~SCSCS Lic. NDate2 0910067669 | — | }:01/82/050/00276/AM20/ :09/24/040/0012 1/AM20/ 14.06.2019 , . Decision: The Committee considered the case as per agendaand [was] it [decided][ to][ratify][ norms][ under][ Para] |, 14.07 ofHBP Vol. | as per details given below or as applied by the fizm, whichever is less: : | * Export Product . Qty | SL | Import Items Qty 1 | 3,4-Dimethoxyphenethylamine (HVA) 1kg 144kg ; | Pye Sodium Cyanide. , .|.0.50kg 000) “ }RA concemed may take further necessary action as per above decision of NC. ----- End of picture text -----

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~ | Case No.:60/6/82-——~—~—~=«SPartyNName:TIDE~(MeetNo/Date: ~=~—~—SStatus: || ALC4/2019 INDUSTRIES NC/3/MEET/Jan/2020212.02.2021 1/4 |Approved HQ File File IREA Bile Mie No/Date:3410045217 | (Decision: | The Committee considered the case as per agenda and itwas decided to ratify norms under 99 _ |Para 4.07 of HBP Vol. Las per details given below or as applied by the firm, whichever is less:

cng HQ File File

I |Export Product Qty Sl. | Import Items Qty . i ae No, ; Rose Oxide (Tetrahydro-4-Methy! -2lkg 1 Citral Synthetic 3,454 kg - | (2-Methy! Propenyl) 2 H Pyron | | {RA concerned may take further necessary action as per above decision of NC. .

| {Case No.:75/6/82-ALC4/2019 |Party Name:NAARI—s(Meet No/Date:~——S~S*«~SStnts:s | PHARMA PRIVATE NC/3/MEET/Jan/202021/4 |Approved L . {LIMITED —-412,02.2021 | HQ File “IRLAFile———~—S~SCS LicNoDates0510411026 [CS | |:01/82/050/00301/AM20/ :05/24/040/00172/AM20/ 24.06.2019 ‘ : | [Decision: The Committee considered the case as per agenda and it was decided to ratify norms under 190 [Pata 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: | Export Product _ Qty Si. | Import Items : | Qty | No. | Nandrolone Decanoate 1kg 19-Norandrostenedione 0.982 kg | Decanoyl Chloride 0.45 kg | RA concerned may take further necessary action as per above decision of NC. | , . | (Case No.:154/6/82--[Party Name:INDO AMINES [Meet No/Date:—S*(Status: | . ALC4/2019a LIMITED , . NC/3/MEET/Jan/202021/412.02.2021 , jApproved . ; | |HOFile ‘RLAFile~~~ {Lic.No/Date:0310830244. [OC . :01/82/050/00380/AM20/ ‘|:03/94/040/00122/AM20/ 12.07.2019 | Decision: The Committee considered the case as per agenda and it was decided to ratify norms under} . , OL iPara 4.07 of HBP Vol. | as per details given below or.as applied by the firm, whichever is less: - | : . . | | Export Product . Qty. | SL‘No. Import Items ) - Qty | i | , - | | INDO-COAT CLY 12 OR DI-ISO- | Lkg DI-ISOBUTYL KETONE | -(1.048 kg | . | BUTYL CARBINOL NECATALYST 0.001kg | RA concerned may take further neceSsary action as per above decision of NC, , ; i

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----- Start of picture text ----- "TC ase No.:248/6/82-~—~—~—~=«*(Party Name:HUBERGROUP(Meet No/Date:—~—~(Status: , ALC4/2019 INDIA PRIVATE LIMITED. |NC/3/MEET/Jan/202021/4 |Approved . hd . 12.02.2021 | | JH File REA File LieNo/Date:0310830713FP : Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: | Decision: |§ The Committee considered the case as per agenda and it was decided to ratify norms under | Export Product Oty Sl. | Import Items Qty No. . a2 Polyester Acrylate | 100000.000 kg Tetrachlorophthalic Anhydride | 12830.000 kg | (53% Resin Content In Adipic Acid 1520.000 kg Trimethylolpropane | 3. | Iso Phthalic Acid 26330.000 kg || | Ethoxy Triacrylate) | 4 | TertiaryQuinone(TBHQ) Butyl Hydroxy 120.000 kg | Neo Pentyl Glycol 19850.000 kg | 6 . | Propylene Glycol 4650.000 kg , Phthalic Anhydride 1580.000 kg | Trimethylolpropane Ethoxy } 38350.000 kg | Triacrylate : . | JRA concerned may take further necessary action as per above decision of NC. ; ‘ . ----- End of picture text -----

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----- Start of picture text ----- |[Case [No.:44/7/82-ALC4/2019][ {PartyName:SWATI] | . MENTHOL & ALLIED ~~ MeetNo/Date:NC/3/MEET/Jan/20202—=—S—S=«S1/4 |ApprovedStatus: (CHEMICALS LTD., 12.02.2021 | HQ File - , : IRLA File —_ Tie.No/Date:2910025423 | | | :01/82/050/00539/AM20/ 4:29/24/040/0001 1/AM20/ 19.08.2019 Decision: The Committee considered the case as per agenda and in the light of earlier decision taken in Meeting no. 10/82-ALC4/2019dated29,11.2019 against Advance Authorization No. 0510412433 dated 103 08.11.2019, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as : | applied by the firm, whichever is less: , . | Terpineol Extra Pure Alpha Pinene . | 100kg   RA concerned may take further necessary action as per above-ilecision of NC. - . : oe ----- End of picture text -----

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----- Start of picture text ----- . | [CaseNo.:48/7/82-—~—~—=S[PartyName:SRINI.—SMeeetNo/Date. =——S Status: ALC4/2019 PHARMACEUTICALS INC/3/MEET/Jan/202021/4 [Approved | PRIVATE LIMITED )12,02.2021 eepeg | JHQFile REA File" LieNo/Date:0910067906FE, ee 101/82/050/003543/AM20/ ~~ }:09/24/040/00269/AM20/°~ “)20.08.2019 °° . | (Decision:The Committee considered the case as per agenda and itwasdecided | Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whicheverto ratifyis less: norms under . | Export Product Qty | Sl. | Import Items Qty 104) | METHYLa ALPHA-|ikg 11No. | 4,5,6,7- ; 0.74 kg (4,5,6,7-TETRAHY DRA- TETRAHYDROTHIENO(3,2,C)PY RIDINE 5-THIENO(,2- HYDROCHLORIDE (CPG-10) _' | C)PYRIDYL)2- METHYL ISO BUTYL KETONE (MIBK) | 1.092 kg : / | | CHLORO- 3 DI CHLORO ETHANE / ETHYLENE DI 0.70 kg || | PHENYL)ACETATE CHLORIDE (EDC) : HYDROCHLORIDE . | (CPG-20) | | .| |RA concerned may take further necessary action as per above decision ofNC. _ | Case No.:32/10/82-~«(PartyName:DEEPAK [Meet No/Date: (Status: | ALC4/2019 NITRITE LIMITED {NC/3/MEET/Jan/202021/4 |Approved | ; j — {42.02.2021 | |HQFile ~—~~~*(RLAFile ~ “[Lie.No/Date:3410045437 :01/82/050/00606/AM20/ 134/24/040/00111/AM20/ 09.09.2019 | Decision: The Committee considered the case as per agendaand it was decided to ratify norms under | Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: (to be| . | check) . ; Export Product Qty | SL {| Import Items Qty . Po ‘ No. | 3-TRIFLUOROMETHYL’ | 1 kg Benzo Trifluoride 1,260 kg . : | ACETO PHENONE 2 Sodium Nitrite Not allowed as ‘ | , ‘ shown domestic ‘ N95} | : 0.150ks ee hood]aft of 2: [4 | CausticSoda Lye [0.50kg. | 7 we ; 5 Acetaldoxime 50% Min ‘Solution | 0.951 kg ‘ bo ; : in Water : ‘ Copper Sulphate , Not allowed as al ‘ . 7 Acetic-Acid |. a wn. |. Not-allowedas|shown domestic -joc e | | . ’ shown domestic | | |. . Sulphuric Acid Not allowed as} | . ; : shown domestic i , . . | , 9| Soda Ash 0.005 kg .||. 10°| Nitric Acid .= - . Notshownalloweddomesticas ° ----- End of picture text -----

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----- Start of picture text ----- pe . 11 Catalyst “| Not allowed as | . . no details provided . . | 12 | Hydrogen Not allowed as . na nn chew bf sn ewe te fone del. Hydrochloric Acid. 00.0 rs. | Not. allowed. asf bel {RA concerned may take further necessary action as per above decision of NC, | ALC4/2019 NITRITE LIMITED NC/3/MEET/Jan/202021/4 Approved . i . [ atc No:186/10/82-a Name:DEEPAK xe No/Date: Status: ~ {Lic.No/Date:3410045560 | | ; 12.02.2021 | HO:01/82/050/00760/AM20/Fit OOTetVAMO 1:34/24/040/00173/AM20/IRLA Fil [e] Io 10.2019 | Decision:The Committee considered the case as per agenda and it wasdecided 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: (to be | check) , = Export Product Qty | Sl. | Import Items to ratifyQty norms under . ACETO PHENONE Min . 2 Sodium Nitrite Not allowed | - since shown as | indigenous Water . ‘ 6 | Copper Sulphate ‘ Not allowed since shown as | ‘ indigenous . : 7 Acetic Acid . Not allowed . . since shown as 4 : indigenous nl 8 |Sulphamic Acid — a Not allowed | | on . ‘ since -shown’ as | | * . i , 7 , indigenous - “WEP rE IE R IEAEPRSYEHEENRIEY concerned PCEAREEHIM YASS ‘may MHA RAHAMAS takerd fe corfurtherPRY FEE necessaryOPP EOPPPEUEY EWC APPEA action AYLI EPRI BAPRAUELYn as per AUhPi above eer d e eecisioneret eh He PYE ofer PEPPYNC. FPP PPP7.PHRRPPEYEMI WPF EAP MPLA SPRAY ALniAtionatrnoerelve oO ----- End of picture text -----

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----- Start of picture text ----- |” [CaseNo.:194/10/82- PartyName:NATURALAND [MeetNo/Date: Status: | jALC4/2019 . {ESSENTIAL OILS PVT LTD |NC/3/MEET/Jan/202021/4 jApproved 12.02.2021 | BQ Fie IRA FileLic.No/Dates0710115596 | Decision:Para 4.07 of HBPThe Vol.CommitteeI as per considereddetails giventhe belowcase oras asperappliedagenda byand theitfirm, was whicheverdecidedto isratifyless: norms under 1107 : | SI. Export Product Qty | Sl. { Import Items Qty No. No, CaffeineP owder 9000.000kg | 1° | Crude Caffeine | 16825.000 kg - (decaffeination from green 2 Coffee ExtractsPowder {| 5500.000 kg ‘coffee) Purity | 47,76%Powder i RA concerned may take further necessary action as per above decision ofNC. [~~[Gase No:239/10/82-~~—~(PartyNameINDOCO—(MeetNo/Date: —=—=—~S~S«~Stats: | ALC4/2019 REMEDIES LIMITED NC/3/MEET/Jan/202021/4 |Approved ff —— {12,02,2021 i | |HQFile ~ RLAFile ~~~“ (Lic.No/Date:0310832731| | :01/82/050/008 13/AM20/ :03/94/040/00587/AM20/ 13,11.2019 | | Decision:The Committee considered the case as per agenda and it was decided to ratify norms under | Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Export Product Qty Sl. Import Items Qty 1108 No. | Ciprofloxacin and Dexamethasone |.1 Number Ciprofloxacin HCL | 25.875 mg | Suspension USP (0.3% / 0.1% 7.875 mg i )7.5ml Bottle 3 Bottle Relevant as per | | (Each ml Cont:Ciprofloxacin HCL packing policy | equal to Ciprofloxacin Base .3mg 4 Cap Relevant as per | mye per btle of 7.5ml)(Each 7.5mi ‘ packing policy | | | cont:Ciprofloxacin 225mg & 5 Dropper - Relevant as per || ke concernedDexamethasone may take7.5mg further necessary action as per above decision ofNC. ; packing policy . ----- End of picture text -----

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----- Start of picture text ----- . 65 . wy, | Case No.:26/13/82- Party Name:GLAND [Meet No/Date: ~ Status: co. DM. LIMITED. [Noe12.02.2021 an/202021/4 . Some | IQ FIREA File LieNo/Date:0910008227 — Decision: | The Committee considered the case as per agenda and it was decided to ratify norms under Para 4.07 of HBP Vol. J as per details given below or as applied by the firm, whichever is less: ; | Sl. Export Product Qty SL Import Items Qty : 1 Heparin Sodium Injection USP, | 1 Number 1 Heparin Sodium | 175.00 mg / | _ ; ’ | _ | 1000IU/ml, 30ml Vial Pre-import condition is | vial . | USPaccount* forCondition: 377.462The Kgs firm should of input at ’ impose?‘A Saitional Condi4 tionaor , Sl No.1 and 2180600 Nos cach of . 3 Glass Vials Relevant as . || list in the resultant product which : | input at SI No.2,3,4 of the import pie should . . policy | be reflected in SBs. 3 Rubber Stoppers Relevant as : | , . i p olicyer packing 4 Flip off Seals Relevant as . ‘ , . ° policy : . 2 Heparin Sodium Injection USP, | 1 Number 1 Heparin Sodium | 291.67 mg / “= | 5000TU/ml, 10ml Vial Pre-import condition is | vial , 109 “| USP * Condition: The firm should . imposed a onier . account for 1.789 Kgs of input at Sl itional Condition No.1 and 6200 Nos each of input at 3 Glass Vials Relevant as . Sl No.2,3,4 of the import list in the | resultant product which should be ; perpolicypacking reflected in SBs. 3 Rubber Stoppers Relevant as . per packing : | ; : policy , ‘ | , | 4 Flip off Seals Relevant as , . per packing ‘ || 3 Heparin Sodium Injection USP, | 1 Number Heparin Sodium | policy116.67 mg/ - i 200001U/ml, Iml Vial Pre-import condition is | vial USP * Condition: The firm should’ “imposed = ase . : account for 6.462 Kgs of input at Sl ; L Appendix AJ _ under : * hook ja : . L, . Additional Condition - }- . Poa ; 4 : No.1 and 56000 Nos each of input |. ap Glass Vials Relevant as | | ’ i - | at SI No.2,3,4 ofthe import list in . . : i . the resultant product which: should ‘ per : ‘packing : . be reflected in SBs. ° 3 Rubber Stoppers _ Relevant as| > ~ - cp . , ae , per packing | | ~ . . . policy | . 4 Flip off Seats Relevant as | | | . : ; policy , | [RA concerned may take further nevessary action as per above decision of NC. , —— ----- End of picture text -----

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----- Start of picture text ----- | ALC4/2019 NITRITE LIMITED NC/3/MEET/Jan/202021/4 |Approved 12.02.2021 iz atc No.:33/13/82-iene~ . No/Date: aoe . BL HO Fle IRL Fig Tic NovDate:3410045652 FO po ees | *}:01/82/050/00876/AM20/ ©” }:34/24/040/00240/AM20/ °" 27-11.2019 rn . Besision:’” The Commilice considered ihe case as por agenda and it was decided to Tally norms under | | {Para 4.07 ofHBP Vol. I as per details given below or as applied by the firm, whichever is less: | Export Product Qty SL Import Items Qty i . | : ACETO PHENONE ' 2 Sodium Nitrite Not allowed as | Solution in Water 110 Copper Sulphate Not allowed = as . 7 Acetic Acid Not allowed as , | . eeSulphuric Acid Not allowed ‘as | , 10 Nitric Acid Not allowed as details provided 12 Hydrogen Not allowed as 4 , 13 Hydrochloric Acid Not allowed as . RA concerned may take further necessary action as per above decision of NC. ; iZ ----- End of picture text -----

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----- Start of picture text ----- i . {ALC4/2019 NITRITE LIMITED NC/3/MEET/Jan/202021/4 |Approved . . || |[Case No.:34/13/82- |sn Name:DEEPAK Rcanieth12.02.2021 oe FQ FileIRA File Iie.No/ipate:3410045653 | al |. [Deeision: | Para 4.07 of HBP‘The CV o l.mmitteeI as per considered thdetails giv e casen belowas peror asagendaappliedandbyit wasthe decidedfirm, whichever to ratifyis normsless: (to*be | check) . . | Export Product Qty Sl. | Import Items Qty - | ACETO PHENONE 2 Sodium Nitrite Not allowed since , | CopperSolutionSulphate in Water — Not allowed since 7 Acetic Acid Not allowed since Sulphuric Acid Not allowed since | ;RA concerned may take further necessary action as per above decision of NC. ‘||a acALC4/2019- No.:43/13/82- - EntLeLIMITED seises SCIENCES PRIVATEare fe412.02.2021|NC/3/MEET/Jan/202021/4 No/Date:' . ame{Approveda, : . em:01/82/050/00886/AM20/oo RLAFile:09724/040/00425/aM201SScr02.12.2019aaa , ; | Para 4.07 of HBP Vol. 1 as per details given below or as applied by the firm, whichever is less: . [ . ot, Poor Committee considered the case as per agenda and it was decided to ratify norms under No. , . ~ | No, (mg/Tablet) | | ; 7 1 600mgGabapentin| Tablets USP - | 1 Number Hydroxxy Propyl | , ‘ Dog Cellulose (LH-21) | . Cellulose (Klucel EF) . | _ . ‘ ‘| 100SD) an ; i . Micro 127) ----- End of picture text -----

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----- Start of picture text ----- | Cellulose ( LH-21) Cellulose (Klucel EF) | | Gabapentin Tablets USP ~-| 1 Number | 1 Low Substituted | 15.00 mg Se feted a ets fee tt oe ade ge oyphen pOOSD) Aten ae fy |e | : 630) , Micro 127) ’ _ JRA concerned may take further necessary action as per above decision of NC. ; . | sicALC4/2019° No.:67/13/82- CirestevetDLIFECARE PVT. LTD. N[M12.02.2021 e etNo/Date:aMEETAan/20202 1/4 Approved(Status:| : HHO:01/82/050/009 Fie OOSIO10/ AM 20/IO LAT:52/24/040/00ec 0 46/s/ A M20/M20 (12.12.2019[ie nofDates210043259 |[t—~S a . | 113 Decision: ‘The Committee consideredthe case as peragendaand it was decided to ratify norms under | Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: | Export Product Qty Sl. | Import Items Qty : | RA concerned may take further necessary action as per above decision ofNC. | ALC4/2019 PLASTICIZERS LIMITED. = {NC/3/MEET/Jan/202021/4 Approved |[season -mustaunre. NESMEE tine oe | 12.02.2021 | Ha:01/82/050/00919/AM20/Fite - oo RUA:05/23/040/00363/AM20/Ti oscvamaor ,. hanopaens19.12.2019 10412972fo , Para 4.07 of HBP Vol. J as per détails given below or as applied by the firm, whichever is less: . pot: “The Committee considered the case as per agenda and it was decided to ratify norms under | | i Export Product Qty SL | Import Items. Qty | : se ta)| 7|(PACKEDDLOCTYL(OS) INSEBACATE477eeNOS. | 100000,000ae. kg |Hr1 2-ETHYLSeale HEXANOL ac - 64200.00050000.000ke: kg |,’; OF HM-HDPE DRUMS| . 3 HDPE GRANULES| Relevant as per | ;MADE OF — HDPE . 4,257,225oe KGS.)CHT = | packing policy | i,| + | GRANULES — (4,054.500 . . . KGS. WITHOUT | WASTAGEB)) (EACH | » | |DRUM SHALL WEIGHT of 7 ' | | | 85 KG AND STORAGE Tt . f CAPACITY. 210.000 . : | RA concerned may take further necessary action as per above decision of NC. _ ; . ----- End of picture text -----

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----- Start of picture text ----- . | CaseNo.:119/13/82- —~—=«(PartyName:STYRAXLIFE|MeetNo/Date: —«*(Status:—— . | ALC4/2019 SCIENCES PRIVATE NC/3/MEET/Jan/20202 1/4 [Approved | LIMITED | 12.02.2021 | eee eh HQ File IRLAFile = TLicNo/Date:2610012891 [| - . | Decision:Para 4.07 of HBPTheVol. CommitteeI as per considereddetails giventhe belowcase oras asperappliedagenda byand theitfirm,was whicheverdecided to ratifyis less: norms under} | Export Product Qty | Sl. | Import Items. Qty i115 No | (iR,28,5R)-METHYL-5R- Lkg GLYOXALIC ACID 50% 0.72 kg | HYDROXY-1,3-OXATHIOLANE- 2,5-DIHYDROXY-1,4-DIATHINE | 0.30 kg 2R-CARBOXYLATE OR CME-I | ME 5 CMENTHOL- (FRESH O735E£20 KB . | | | ORF a RECOVERY) Pe | | TRI ETHYL AMINE (TEA) 0.015 kg | RA concerned may take further necessary action as per above decision of NC. || [Case [No.:133/13/82-] [Party NameINTAS[Meet No/Date:.Status: || |(HQFileALC4/2019: | ~~ RLAFilePHARMACEUTICALS~~—~~—~—_[Lic.No/Date:0810146922,| LTD. |NC/3/MEET/Jan/202021/412.02.2021 iApproved | ———| | :01/82/050/00976/AM20/ :08/24/040/00321/AM20/ 103:01,2020 | | |Decision: The Committee considered the case as peragendaand in the light of earlierdecision | Meeting no. 7/82-ALC4/2020 dated 04.12.2019 against Advance Authorization No. 0810149014takendated in 06.11.2020, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: : Sl. | Export Product Oty. Sl. | Import items ; Qty. | . No. No. 1 | PACLITAXEL” | 2306436.000 TAXUS BACCATA 52000.014 kg , , INJECTION USP | Number 2 1,5-BIS[DI ISOPROPYL-(+)- 4- | 58.130 kg - | - 6 MG/ML, S5ML PHENYL-2-AZETIDINONE-3-, ; 116 VIAL HYDROXY-SILYL]PENTANE . | EACH ML | |. | CONTAINS: ~ ov a3. -] KOLLIPHORELP.. 2230.548kg -| | PACLITAXEL ° ' | PH.EUR. 6 MG : 4 |'5/16.7/50(AS PER GENERAL NOTEML GLASS VIALS FOR | pR e levant’r ‘packingas F : - CHEMICALS & ALLIED | policy Qty rn an : _| PRODUCTS) | , | 5 |13 MM/20 MM RUBBER | a | : . FOR(AS PACKINGPER GENERALMATERIAL)POLICY . . ° 13 MM/20 MM FLIP OF SEAL . . (AS PER GENERAL POLICY | : FOR PACKING MATERIAL) Sy ----- End of picture text -----

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|||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|;|50|;|
|7|||| 2|7 PACLITAXEL|—|||716550.000|
|.||:|6|MG/ML,|PHENYL-2-AZETIDINONE-3-|,|
|||16.7ML|VIAL|;|HYDROXY-SILYL]PENTANE|
|||EACH|ML|
|CONTAINS:|4|5/16.7/50|ML|GLASS|VIALS|||Relevant|as|||||
|oo|||PH.EUR.|6 MG|||CHEMICALS|&|~|ALLIED|||policy.|
|.|||PRODUCTS)|
|po|5|| 13|MM/20|MM|RUBBER|
|—_|STOPPERS|°-|
|||(AS|PER|GENERAL|POLICY|
|.|FOR PACKING MATERIAL)|
|i|13|MM/20|MM|FLIP|OF|SEAL|
|7]|eeeFOR PACKING MATERIAL)|||
|||8|||PACLITAXEL _ ||240799.000|||
|“||INJECTION|USP|| Number-|2|1,5-BIS[DI|ISOPROPYL-(+)-|4-|| 58.130 ke|
|:|6|MG/ML,|PHENYL-2-AZETIDINONE-3-|
|||50ML|VIAL|HYDROXY-SILYLJPENTANE|
|EACH|ML|
|.|||CONTAINS:|4|||5/16.7/50|ML|GLASS|VIALS|||Relevant|as|
|io|PACLITAXELPH.EUR.|6 MG|.|(ASCHEMICALSPER GENERAL&|NOTEALLIEDFOR |||p|olicyer|packing|
|PRODUCTS)|||
|.|:|.|5|13.|MM/20|MM|.RUBBER|
|||STOPPERS|
|i|(AS|PER|GENERAL|POLICY|
|FOR PACKING|MATERIAL)|
|:|6|°||13|MM/20|MM|FLIP|OF|SEAL|
|||(AS|PER|GENERAL|POLICY|
|||FOR PACKING MATERIAL)|
|||
|||RA|concerned may take|further|necessary|action|as per|above|decision of|NC.|||
|||Case No.:173/13/82-|‘Party|Name:|VHB|Meet No/Date:|Status:|
|||(ALC4/2019|MEDISCIENCES|LTD.|NC/3/MEET/Jan/20202|1/4|[Approved|
|.||||LaLa[HQ|File ROso/oto16/ANaa|-{RLA:03/95/040/01016/AM20/ File|Lic.16.01.2020No/Date:03 10834259.|||
|oo|||Decision:|The|Committee|considered|the|case|as|per|agenda|and|it was|decided|to|ratify norms|under:|||
|;|:|es 4.07 of HBP|Vol.|i as per details given below or as|applied by the firm,|whichever is|less:|*|,|
|i|173|Export, Product|Qty|SL.|| Import Items|:|Qty|||
|;|||||| Colistmethate|~|Sodium:|for|||17000.000-||1|Colistimethate|Sodium|Sterile|[1334.38|gms|||||
|||injection|BP|COLISIN-RD | Number|EP|-|||
|||1MIU|(Net|content|of|Import|||
|iz|»|||item =|1310.00 gm)|,|'|=e|
|:|ij|pa concerned may take further necessary action as per above decision ofNC,|||.|

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|; [Case No.:188/13/82—~—~(PartyName:DEEPAK‘(Meet No/Date:. —~—~—~—~«(Status: SS _ ALC4/2019. 7 PHENOLICS LIMITED {12.02.2021INC/3/MEET/Jan/202021/4 |Approved IRQ Re REAge oats 4100875 | (Decision: ‘The Committee considered the case as peragendaandit wasdecided 18 [Para 4.07 of HBP Vol. Las per details given below or as applied by the firm, whichever is less: : to ratify normsunder | Export Product Qty Sl. | Import Items Qty . No, a | PHENOL BENZENE 0.87 kg ‘ | RA concerned may take further necessary action as perabove decision of NC. i| [CaseALC4/2019No.:191/13/82-: ———~—«(PartyName:AUROBINDOPHARMA LIMITED [MeetINC/3/MEET/Jan/20202No/Date: 1/4 |Approved —~—~‘(Status: | |HQFie = ————~«<RKLA Fle Lic.No/Date:0910068384 |” | :01/82/050/01034/AM20/ |:09/24/040/00527/AM20/ 20.01.2020 | | (Decision: The Committee considered the[case] as per agenda and it[was][decided] to ratify norms under : | * {Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: ly 19 Export Product Qty Sl. | Import Items Qty Clindamycin Palmitate | 1 kg Clindamycin Hydrochloride 1,059 kg | Hydrochloride Sulfolane Anhydrous 0.31 kg | 210 | 5.00 kgkg | Methylene Chloride (MDC) 2.06 kg RA concerned may take further necessary action as per above decision of NC. me

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----- Start of picture text ----- |"Case No.:1/2/82-ALC4/2020[PartyName:ARCH(Meet No/Date: Status; | | , . PHARMALABS LTD NC/3/MEET/Jan/202021/412.02.2021 i|Approved | IQ Fig IRA File, Tic,No/Date:0310834332 So| 101/82050/01035/AM20/[Deeision: The Committee ~” 1:03/94/040/00888/AM20/considered the case as per agenda—j20.01.2020°°and it was decided to ratify norms under | a Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Export Product Qty Sl. | Import Items Qty . | _ | No. URSODEOXYCHOLIOC | 1kg CHOLIC ACID 1.40 kg (120 ACID , 2 |HYDRAZINESOLUTION) HYDRATE (80% | 1.487kg ° , IEP OX 239 SPRAY DRIED ENZYME| 0.030 kg | . POWDER . | IEP OX 235 SPRAY DRIED ENZYME| 0.035 kg } | POWDER 5 TEP OX 152 SPRAY DRIED ENZYME| 0.066 kg POWDER . . ; IEP SP 41 SPRAY DRIED ENZYME| 0.035 kg POWDER 7 | IEP OX 243 SPRAY DRIED ENZYME| 0.036 kg POWDER * “|| . Le | DINUCLEOTIDE((B-NAD)B-NICOTINAMIDE-ADENINECOENZYME-1) 0.014 kg « ‘ RA concerned may take further necessary action as per above decision of NC. | {CaseNo.:5/2/82-ALC4/2020 [Party [Name:ARCH][ Meet][ No/Date:] [ ~—~—*(Status:—] : i PHARMALABS LTD NC/3/MEET/Jan/202021/4 iApproved f | 12.02.2021 . i | [HQFileREA FileSC LicNovDate:0310834354 ~ | {:01/82/050/01039/AM20/ :03/94/040/00889/AM20/ 21.01.2020 : , ; | (Decision: The Committeeconsidered, the case as per agenda ;and [it] wasdecided to ratify norms under , ; | Pare 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: | ; , | Export Product Qty Sl. | ImportItems . . | Qty | ; . . | | | GR-CIs)-1-1- | 1kg ETHYL-4-CHLORO ACEO ACETATE 1.06 kg, Ho | | DIMETHYL-6- LITHIUM METAL 0.10 kg - | G@YANOMETHYL-2-2°00 | TERT BUTYL ACETATE ‘°° 24ike | ’ |. | | DIMETHYL-1,3 4 | LYOPHILISED ENZYME POWDER CDX- | 0.0031 kg : . | | DIOXANE-4-ACETATE 403 . | | | (ATS-8) 5 | LYOPHILISED ENZYME POWDER CDX- | 0.019kg | | be | , |__| 041 . ; : i : - 6 | LYOPHILISED ENZYME POWDER CDX-'| 0,0055kg | | | 7 | (B-NAD) — B-NICOTINAMIDE-ADENINE | 0.0005 kg | | - |DINUCLEOTIDE (COENZYME-1) | . . a | 8 | 2,2-DIMETHOXY PROPANE 0.95kg° | | | | 9 | LYOPHILISED ENZYME POWDER CDx: | 0.015 kg . | i | ; 014 ; . IRA concerned may take further necessary action as per above decision ofNC. ‘ ----- End of picture text -----

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----- Start of picture text ----- , Case No.315/2/82-ALC4/2020 |Party Name:SWAASA " |Meet No/Date: ‘Status: | PHARMA LIMITED iNC/3/MEET/Jan/202021/4 |Approved 112,02.2021 TQ File IRLA File ~~ (Lie.No/Date:2610012902. [SC , 7 ParaDecision: 4.07 of|HBPThe CommitteVol. | as p e r cons deta i lsderedgiven the below case as or peras applied agenda by and the it wasfirm, decidedwhichever to ratifyis less: norms at | 122 Export Product Qty | SL. Import Items Qty ; No. ; 5-Fluoro-1-1(2R,58)- | Lkg | 1 (2R58-5 (4 Amino 5 fluoro 2 oxo 2| 1.726kg |. 2(hydroxymethyl) 1,3- hpyrimidin1 yl)[1,3]oxathiolane2carboxylic | | oxathiolan-5-yl cytosine ‘ acid,28-isopropylSRmethyliR cyclohexyl | , | or (Emtricitabine crude) , 5 ester 046k | | RA concerned may take further necessary action as per above decision of NC. [ Case No.:26/2/82-ALC4/2020 |Party Name:GLAND Meet No/Date: Status: PHARMA LIMITED NC/3/MEET/Jan/202021/4 |Approved ‘ | , 12.02.2021 4. | HQ File RLA File Lic.No/Date:09 10068434 :01/82/050/01060/AM20/ :09/24/040/00545/AM20/ 31.01.2020 | Decision: |The Committee considered case as per agenda in the presence of the technical experts and it | was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as applied by firm whichever is lower: 1 Acetylceysteine Solution | 1 Number | 1 Acetyleysteine USP 408.00 mg/vial | No. No. ' USP 100mg/ml (10%), 4m] | Condition: Pre Import | | Vial condition is imposed fod. oo ; as per Appendix 4J in i Additional Condition i , packing policy : packing policy 2 Acetyleysteine Solution | 1 Number .| 1 Acetylcysteine USP 1020.00 mg/vial . | USP 100mg/ml (10%), ; Condition: Pre Import packing. policy | , ; ne 10m Vial ; condition is imposed a as per Appendix 4J in “| | . : 2 GlassAddition Vi al s Condition Relevant. as; per | ‘ 7 Rubber Stoppers Relevant as per | ‘ , ‘| packing policy 4 Flip off Seals _ | Relevant as per , a , packing policy ----- End of picture text -----

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----- Start of picture text ----- | 7A | 3 | Acetyleysteine * Solution | 1 Number | 1 Acetylcysteine USP | 3060.00 mg/vial USP 100mg/ml (10%), Condition: Pre Import ' , 30m! Vial condition is imposed ; | _ | as per Appendix 4J in Additional Condition (fb Beagles aide seeders Pe ee be deca ea Seto) packing'pélicy 2 , | packing policy | ; | packing policy po. 4 AcetylcysteineUSP: 200mg/ml (20%),Solution4ml | 1 Number | 1 AcetylcysteinCondition: Pr e USPImport | -816.00 mg/vial | Vial condition is imposed | ; as per Appendix 4J in ; : i Additional Condition 4 packing policy | packing policy packing policy , | 5 Acetylcysteine Solution | 1 Number | 1 Acetyleysteine USP 2040.00 mg/vial | USP 200mg/ml (20%), Condition: Pre | 10ml Vial Importcondition is : | . ° , imposed as per . ° ‘ | Appendix 4J in | Additional Condition | packing policy - | 3 Rubber Stoppers packing policy i packing policy : fo 4 6 . USPAcetylcysteine200mg/ml Solution(20%), || 1 Number | 1 AcetylcysteineCondition: Pre Import USP 6120.00 mg/viat . 30ml Vial condition is imposed ; i as per Appendix 4J in j , Additional Condition ’ i . 2 | Glass Vials . | packing policy | packing policy . ; ; * “| packing policy ‘ , | 7 Acetylcysteine Injection | 1 Number | 1 Acetylcysteine USP 6300.00 mg/vial , USP 200mg/ml, 30m! Vial ° Condition: Pre Import ; Fg . ; condition is imposed : poe ' fee as per Appendix 4J in ' i | Additional Condition po ; : ; packing policy : 3 Rubber Stoppers ~ Relevant as per - —_ . packing policy . ff. |4 | Flip off Seals Relevant as per | - ; ‘ packing policy . ; RA concerned may take further necessary action as per above decision ofNC. | * ----- End of picture text -----

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----- Start of picture text ----- |(CaseNo.:28/2/82-ALC4/2020 [Party Name:SMS.~—~—~(MeetNo/Date: ~—«*(Status:—S i LIFESCIENCES INDIA NC/3/MEET/Jan/202021/4 |Approved . | LIMITED 12.02.2021 1Fie IRACe File Fie NovDates0910068451SC WUT TOP Cee TreponFO |; {Para(Decision: 4.07 of —HBPTheVol.CommitteeI as per considereddetails giventhe belowcaseoras asperappliedagenda byand the it wasfirm, decidwhich e dver to ratifyis less: norms under : | _| Export Product Qty SL | Import Items ; Qty EZETIMIBE, , lkg No. (S)-4-PHENY L-OXAZOLIDIN-2-; 0.45 kg INTERMEDIATE IV - ETZ- ONE i Iv (OR) (S)-3-((S)-5- IMMCALA-T2-150 (ENZYME) 0,063 kg | BENZYLOXY)-5-(4- METHYLENE DICHLORIDE 6.00 kg | FLUOROPHENYL) 4 SODIIUM BOROHYDRIDE 0.345 kg | PENTANOYL)-4- | PHENYLOXAZOLIDIN-2- ONE ----- End of picture text -----

RA concerned may take further necessary action as per above decision ofNC.

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----- Start of picture text ----- | [Case No.:36/2/82-ALC4/2020|Party Name:AURORELIFE (MeetNo/Date:(Status: _ + SCIENCES PRIVATE NC/3/MEET/Jan/202021/4 Approved | |[HQFile ~<ALIMITEDile SSSSSS~SSS*«diC{12.02.2021 | | :01/82/050/01070/AM20/ te No atesOLS | :09/24/040/00459/AM20/ (06.02.2020 | | |Decision: ~The Committee considered the case as per agenda and it was decided to ratify normsunder | Para 4.07 of HBP Vol. | as per details given below or as applied by the firm, whichever is less: i125 Export Product Qty | SL Import Items Qty | ~ | No. ; , Amlodipine Base Base | 1kg Ethyl-4-chloro aceto acetate 0.993 kg , Ortho chloroBenzyldehyde 0.775 ke | Methyl Aceto Acetate ; 146kg ' . 2.40 kg ----- End of picture text -----

RA concerned may take further necessary action as per above decision of NC.

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----- Start of picture text ----- [CaseALC4/2020 No.:37/2/82- [eryDERMACEUTICALS NemesALEOR MeeNC/3/MEET/Jan/202021/4 No/Date: ‘Status:iApproved | . L HOF:01/82/050/01071/AM20/Coonan eine:34/24/040/00339/AM20/nossoianno pecamae06.02.2020 0045849 | ~ |Decision:~ The Committee considered the case as per agenda and it was decided to ratify norms under . | Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: : SL Export Product Qty Sl. | Import Items Qty } 1 CLOBETASOL PROPIONATE | 12000.000 | 1 CLOBETASOL 153.0 gms {126 TOPICAL SOLUTION USP | Number PROPIONATE 7 0.05% 25 “mil * | USP | (Net content of active ingredients (MICRONIZED) 150 gm) 2 CLOBETASOL PROPIONATE | 78000.000 | 1 CLOBETASOL 1989.0 gins TOPICAL SOLUTION USP| Number PROPIONATE . 0.05% 50 ml USP (Net content of active ingredients (MICRONIZED) : | - *| 1950 gm) ; : . | IRA concerned may take further necessary action as per above decision of NC. | | ALC4/2020 DERMACEUTICALS NC/3/MEET/Jan/202021/4 Approved |[ ~ |[Case No.:38/2/82- omLIMITEDName:ALEOR | Rc12.02.2021No/Date. ion| | HO:01/82/050/01072/AM2 Fi otorziaMz 0 /) Ra| :34/24/040/00342/AM20/onsaaaM2or LieNoDete:341—_|06.02,2020 0045850”fo |.| [Decision:Para 4.07 of HBP‘The Vol.CommitteeI as per considdetails giventhe belowcase oras asp e appliedr agendared byand theitfirm,was whicheverdecidedto ratifyis less: norms under} | . Sl. Export Product Qty . SL. | Import Items > | Qty . | | 1 DESONIDE LOTION | 5352.000 Bottles -| 1 DESONIDE USP 161.042 127 | 0.05% - 2 fl oz Bottle ( MICRONIZED) Grams | | : (net .conetent of active |” . rn cn , ingredients. = 157.884 . . . . . 2 ‘1 0.05%DESONIDE- 4 fl ozLOTIONBottle ||. 9912.000Bottles . 1 DESONIDE(MICRONIZED) USP - 596,50Grams . | || i( n etgredieco nt sent - of584,808active : | ha concemed may take further necessary action as per above decision ofNC. . | ----- End of picture text -----

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----- Start of picture text ----- | [CaseNo.:40/2/82-ALC4/2020|PartyName:MAKSON | netaLIMITEDCARE PRIVATE (MeetNo/Date.Rinna12.02.2021 ~—~—~—~SStatus:——SArm a FAQFite IRDA Fle ie NoMBakest 110028682 | |Decision: The Committee considered the case as per [agenda] and it wasdecidedto ratify norms under : | Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: | Vicks Vaporub in Packs ( (1) 5 Gm. | 100 kg ; || | @)50Gm,Flats (2)10 Gm.Jans (5)100Flats (3) Gm, 25gm Jars) Jars RA concerned may take further necessary action as per above decision of NC. . pop| HEALTHLIMITED CARE PRIVATE. — |NC/3/MEET/Jan/202021/412.02.2021 | |Approved | ee:01/82/050/01075/AM20/otorsaao’ (iA1:1 1/24/040/00009/A eSvoccos/a M 20/ao — 10.02.2020aNobe ttt0028683 | |Decision: ‘The Committee considered the case as per agenda and it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: | Export Product Qty Sl. Import Items Qty | [VICKS VAPORUBIN' 100% |_| | Packs (1) $0 Gm, | | | sans @ 806m. Tubes | | | @) 100 em Jars | 5 White Petrolatum (White soft 82.30 kg | : 6 : | . 7 50 gms Labels (Nos.) " Relevant as per ; 3 . _ | packing policy with | | : | pf ce" . ‘ : Accountability =| | 7 ; 100 gms Labels (Nos.)} Relevant as per - . | , : packing policy with | i . Accountability 7 oo 9 80 gms Tube & cap (Nos,) Relevant as per 7 | | ; Accountability : . 10 Direction folders (Nos.) , ~ | Relevant as per . packing policy with | |. RA concerned may take further necessary action as per above decision of NC. . 7 ; ----- End of picture text -----

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["[Case No.:46/2/82-ALC4/2020 [PartyName:SRINI—~—=«(MeetNo/Date: «Status: | . PHARMACEUTICALS NC/3/MEET/Jan/202021/4 |Approved i PRIVATE LIMITED 12,02.2021 | SQFTvamavanetoemeacentesternttomececcrinebcmcbecewirenneren irecteclati!tajen! essotab|an|IRAsnrsabcANQeS4OSINAN) YAANINAASAAIAIRIERALLANLPIAAIBLORRIOS File IA JARSARDOGOE ROSES ESOLSAUASHERSSISCE OYBOPASE ROYHOYANAEGTie ANG No/Date:0910068471eee lhe BANANAaman Faen eter cetera, | [Deeision: The Committee considered the case as per agenda and it was decided to ratify norms under | Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is tess: i . . 1130 Export Product Qty Sl. | Import Items Qty | No, : . . | | |LEVOFLOXACIN lkg | 1 © | 9,10-DIFLUORO-2,3-DIHYDRO-30.8571 kg | | |HEMIHYDRATE METHYL-7-OX0-(38)-7H-PYRIDO[1,2,3. | ‘DE]-1,4-BENZOXAZINE-6-CARBOXYLIC , | ACID(LVF 40) | | HEXAMETHYLDISILOXANE - | 0,500 kg . | (HMDSO) RA concerned may take further necessary action as per above decision ofNC.. [~~ [€aseNo.:53/2/82-ALC4/2020 [PartyName:GLENMARK [MectNo/Date:(Status:| | fo . LIFE SCIENCES LIMITED — |NC/3/MEET/Jan/202021/4 Approved | ; (12.02.2021 . | ; . | HQRile RLAFile——~—~—~—S~™S*«& Lie,No/Daate.0310834854 | :01/82/050/01087/AM20/ :03/94/040/00940/AM20/ (13,02,.2020 | | (Decision: ‘The Committeconsidered the cas e as per agenda and it was decided to ratify norms under) Para 4.07 of HBP Vol. | as per details given below or as applied by the firm, whichever is less: Export Product Qty SL. | Import Items Qty | No. 131, |TOFACITINIB tke [1 | @R,4R)-1-BENZYL-N,42.60 kg eo". | CITRATE DIMETHYLPIPERIDIN-3-AMINE | DIHYDROCHLORIDE ; . i 2 2,4-DICHLORO-7H-PYRROLO-[2,3-D]- | 1.54 kg . | PYRIMIDINE I. METHYLENE CHLORIDE (MDC) T120kg | | , ACETONITRILE 464kg | | . | ; TETRA HYDRO FURAN (THF) 4.00 kg |. | (| . METHANOL 6.84 kg . | i Z ; DIMETHYL FORMAMIDE (DMF) 450kg |. ‘ | IRA concerned may take further necessary action as per above decision ofNC. |

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|||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|,|[|Case No.:58/2/82-ALC4/2020||Party Name:GLENMARK|Meet No/Date:|‘Status:|
|||||(PHARMACEUTICALS|LTD|[NC/3/MEET/Jan/202021/4||Approved|
|||cane|
|FAQ File|RLA File|‘{Lic.No/Date:0310834878|FF|
|-|||Decision;|| The|Committee|considered|the|case|as|per agenda and|it was|decided|to|ratify norms under|
|{Para 4.07|of HBP|Vol.|I|as per|details|given below|or|as|applied by the|firm,|whichever|is|less:|
|||SL|Export Product|Qty|SL.|Import Items|;|Qty|
|i|1|Potassium|Chloride|ER ||1|Number|1|Potassium Chloride USP|||765|mg/|
|i|Tablets|USP|10|mEq|K|(750 ||Tablet|750 mg Tablet|
|||mg)|(Per’|Pack|90|Tabs.)|'|
|(Net|Wt.|of|Potassium|:|
||.|||Chloride USP|is 67.50 Kgs)|
|||2|Potassium|Chloride|ER ||1|Number|1|Potassium Chloride USP|765|mg/|,|
|||Tablets|USP|10|mEq|K.|(750 ||Tablet|750 mg Tablet|
|||mg)|(Per|Pack|100|Tabs.)|:|
|||(Net|Wt.|of|Potassium|,|
|:|Chloride USP|is|75.00 Kgs)|:|
|||3|Potassium|Chloride|ER||1Number|||1|Potassium|Chloride USP|765|mg/|
|||Tabletsmg)|(Per USPPack10 mEq1000 KTabs.)(750|} Tablet.|750 mg Tablet|*|
|1133|;|(Net|Wt.|of|Potassium|:|
|Chloride USP|is|750.00|Kgs)|
|i.|4|Potassium|Chloride|ER ||1|Number|1|Potassium Chloride USP|1530|mg/|1500|
|.|
|||Tablets|USP|20|mEq K|(1500 ||Tablet|"mg Tablet|
|mg)|(Per|Pack|90|Tabs.)|
|(Net|Wt.|of|Potassium|
|Chloride USP|is|675.00|Kgs)|
|||5|Potassium|Chloride|ER ||1 Number|1|Potassium Chloride USP|1530|mg/ 1500|
|a|Tabletsmg)|(Per USPPack20 mEq100 K (1500Tabs.) } Tablet|mg Tablet|
|,|(Net|Wt.|of|Potassium|:|an|:|
|Chloride USP|is|750.000|Kgs)|mo|
|||.|Potassium|Chloride|ER-||{|Number|1|Potassium Chloride USP|1530|mg/ 1500|.|
|a|Tablets USP|20 mEq K (1500 ||Tablet|mg Tablet|;|
|i|mg)|(Per|Pack|500|Tabs.)|
|||(Net|Wt.|of|‘Potassium|:|
|Chloride USP|is 3750.00 Kgs)|‘|
|,|||P||7|Potassium|Chloride|ER||.)|Number.|-|Potassium|Chloride|USP|.|1530|mg/|1500||;|
|.|||Tablets|USP|20 mEq K|(1500|} Tablet’|,|.|mg Tablet|a|
|:|mg)|(Per|Pack|1000|Tabs.)|‘|
|:|(Net|Wt.|of|Potassium|||.|
|a|Chloride USP|is 7500.00 Kgs)|.|;|
|||IRA concerned may take further necessary action|as per above decision of|NC.|||

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----- Start of picture text ----- a | [CaseNo.:74/2/82-ALC4/2020 Party Name-RECKITT (Meet No/Date: Status: | . wa po BENCKISER (INDIA) NC/3/MEET/Jan/202021/4 ‘Approved | Ma aoe PRIWASTESIMITED (8 9 12,02, 2024 ote ete pit rete cs ee oo ear ste : | {HQ File — RLAFile~~~ {Lic.No/Date:0510413690 | . | :01/82/050/01108/AM20/ :05/24/040/0073 1/AM20/ 24.02.2020 | Decision: The Committee considered the case as per agenda and in the light of earlier decision taken in { Meeting no. 7/82-ALC4/2019 dated 06.09.2019 against Advance Authorization No. 0510409279 dated | 09.01.2019, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: : | . Sl. | Export product Qty. SL. Import items ' Qty. z No. : No. (mg/tablet) a 1 | DISPRIN CARDIOCARE 1 Number SACCHARIN BASE | 0,300 | 4 34 (ASPIRIN BP 100MG) 550x ACETYL SALICYLIC ACID | GLYCINE EP 44.30 100 mg Tablet (ASPIRIN) TALC EP oe | 2 | DSPRN,ZA,EXTRA 20X52 | 1 Number SACCHARIN BASE , | _ | (28) (ASPIRIN PH.EUR 55Ox 500MG) ACETYL TALC EP 10.00 | SALICYLIC ACID 500 mg CITIRIC ACID 50.00 | oe 5 CALCIUM 150.00 | , ° CARBONATE EP 6 Aluminium Foil Relevant as i | | ; ‘| perpolicypacking ; RA concerned may take further necessary action as per above decision of NC, ----- End of picture text -----

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----- Start of picture text ----- *-F""|Gase No.:81/2/82-ALC4/2020 [PartyName:DEEPAK (MeetNo/Date:~~ (Status: . PHENOLICS LIMITED NC/3/MEET/Jan/202021/4 :Approved 12.02.2021 || (HQFile:01/82/050/01115/AM20/~~"REA——__‘|:34/24/040/00359/AM20/File S™~™””:S™S 25.02.2020icNDate:3410045910[ ; |. Decision:— The Committee considered the case as per agenda and it wasdecidedtoratifynorms under | ~ 135 Para 4.07 of HBP Vol, I-as per details giver below or-as applied by.the firm, whichever is less; 7 O , | Export Product Qty ‘| SL | Import Items , Qty , | : No. : ||) PHENOL” lkg BENZENE : 0.87 kg _ IRA concerned may take further necessary action as per above decision ofNC. | ----- End of picture text -----

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----- Start of picture text ----- |[Case No.:82/2/82-ALC4/2020 (PartyName:DEEPAK | PHENOLICS LIMITED ~(MeetNo/Date:NC/3/MEET/Jan/202021/4 —=(Status:‘Approved = | . 12.02.2021 . | HQ FileIRAFile MieNo/Date:3410045911Fn, | (Decision: The Committee considered the case as per agenda and it was decided to ratify norms under |136 |Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: - | Export Product Qty SL. | Import Items. . Qty | No, . | PHENOL BENZENE 0.87 kg | {RA concerned may take further necessary action as per above decisionof NC. [~~ [CaseNo.:83/2/82-ALC4/2020 [PartyESSENTIALName:NATURAL OILS PVT LTDAND |MeetNo/Date:—(Status:|NC/3/MEET/Jan/202021/4 ‘Approved’|| | [HQ File RLA File “[Lie.No/Date:0710116169 | :0.1/82/050/01117/AM20/ :07/24/040/00288/AM20/ 25.02.2020 | Decision:The Committee considered the case as peragenda and it was decided to ratify norms under. : | Para 4.07 of HBP Vol. J as per details given below or as applied by the firm, whichever is less: S1. Export Product Qty Sl. Import Items Qty No. : No |. ; 137 1 Caffeine 8800.000 kg | 1 (decaffeinationCrude NaturalfromCaffeinegreen | 5600.000 kg : | coffee)Purity 47.38% 2 Coffee Extracts 6250,000 kg | 1 Crude Natural Caffeine | 12000.000 kg (decaffeination from green : i coff fe e)Puritye)Purity 47.38%47.38% 3 Caffeine 9000.000 kg | 2 Crude Natural Caffeine | 5600.000 kg | , ; . ’ ({decaffeinationcoffee)Purity 48.98%from green . , 4 Coffée Extracts 6000.000 kg | 2 Crude Natural Caffeine |°12000.000 kg | . , (decaffeination from green : ; | ; ; coffee)Purity 48.98% . - | RA concerned may take further necessary action as per above decision of NC. , 7 ----- End of picture text -----

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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|||(Case|No.:86/2/82-|——S«PartyName:SRINI|
|||ALC4/2020|{PHARMACEUTICALS=|NC/3/MEET/Jan/202021/4[MeetNo/Date:(Status:|Approved =|
|;|||PRIVATE LIMITED|12.02.2021|
|fe|THQ File|REAFile[Lic.No/Date:0910068522J|
|||[Decision:|—|The|Committee|considered|the|case|as|per|agenda|and|it|was|decided|to|ratify|norms|under|
|||Para 4.07|of|HBP|Vol.|I|as per|details given below or|as|applied by the firm,|whichever is|less:|
|Export Product|Qty|Sl.|||Import Items|Qty|,|
|:|138|METHYL ALPHA-|lkg|1|4,5,6,7-TETRAHYDROTHIENO(3,2,-|0.74 kg|
|||(4,5,6,7-|C)PYRIDINE HYDROCHLORIDE (CPG|
||||||TETRAHYDRA-S5-|10)|
|||THIENO(,2-|METHYL ISO BUTYL KETONE (MIBK)|||1.092 kg|
|||C)PYRIDYL)(2-|~|13|onCHLORO ETHANE /|ETHYLENE DI|0.70 kg|
|||CHLORO-|
|||PHENYL)ACETATE|
|||HYDROCHLORIDE|
|||||||(CPG 20)|oS|.|
|||
|[RA concerned may take|further necessary|action as per above|decision of|NC.|i|
||||CaseNo.:87/2/82-ALC4/2020||Party Name:AURORELIFE|(MeetNo/Date: —~*|(Status:—|oo|
|||.|SCIENCES PRIVATE|INC/3/MEET/Jan/202021/4|[Approved|;|:|
|LIMITED|12.02.2021|
||||HQFile ~~——*S(RLAFile~——~SO——|
|||:01/82/050/01121/AM20/|:09/24/040/00596/AM20/|[Lic{02.03.2020NoMDate0910008530||SSCS|
|||(Decision:|‘The|Committee|considered|the|case|as|per|agenda|and|it|was|decided|to|ratify|norms under|.|
|1139|Para 4.07|of|HBP|Vol.|I|as per|details given below|or as applied by the|firm,|whichever|is less:|
|,|||.|Export Product|Qty.|||SL|||Import Items|,|,|~|| Qty|—|.|
|||No.|
|TRA concerned may take further necessary action|as per above decision of|NC.|.|;|

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. 84 ; [! [ase|ALC4/2020Notoyait2Party(LIMITED. NameiCiPLA [MeetINC/3/MEET/Jan/202021/4No/Date: aStatus:Approved | — | THQ File RLA File Lic.No/Date:03 10835171 |:01/82/050/01 123/AM20/ :03/94/040/0099 1/AM20/ 03.03.2020 | Decision: | The Committee considered the case as per agenda and it was decided to ratify norms under Para 4.07 ofHBP Vol. I as per details given below or as applied by the firm, whichever is less: | Export Product Qty - | SL | Import Items Qty | No. Azelastine 1000000.000 | 1 Azelastine Hydrochloride 16440.000 1140 Hydrochloride and Number Gram | | Fluticasone Propionate 2 Fluticasone Propionate 6000.000 | ; | Nasal Spray / Dyrista Gram | | Nasal Spray (Pack 3 140 mcl pumps. Relevant | | 120MD) Each Spray Net + 1% delivers: ~ 4 25ml USP type | amber glass vial Relevant | | ‘Azelastine Net + 1% | | | Hydrochloride BP 5 Nasal actuator Relevant ‘ | “{ | 137meg Fluticasone ; , : Net + 1% . | | Propionate 50meg |RA concerned may take further necessary action as per above decision of NC, ; ; | [Case | ALC4/2020No.:93/2/82-——=—~—~=«SPartyName:BDRPHARMACEUTICALS——~—~S(MeetNC/3/MEET/Jan/202021/4 No/Date:——s—~~«Stats:Approved — INTERNATIONAL PVT. 12.02.2021 ;| FHQFiie| = ——=—<~SS~<S~SRLA LTD. FileS*~S~SC*S LicNo/Dattes00310835222 fp| | j:01/82/050/01 127/AM20/ ——j:03/94/040/01012/AM20/ {04.03.2020 | [Deeision: “The Committee considered the case as per agendaand it was decided to ratify norms under 141 » Para 4.07 of HBP Vol. 1 as per details given below or as applied by the firm, whichever is less: - | | Export Product Qty — Sl. | Import Items . Qty . _ | LEFLUNOMIDE 1333%DCG || 200.000kg] 1 [LEFLUNOMIDE ~ | 20.926ke |), | | Net content ofinput/lkg=134.633gm ’ a | | lea concerned may take further necessary action as per above decision of NC. .|

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----- Start of picture text ----- . —_ |\ALC4/2020(CaseNo. :101/2/82- Pest Name:SENTISSPHARMA PVT.LTD. INC/3/MEET/Jan/202021/4[Meet NovDate:a Seta:[Approved | | Ror voussiamay RSA :LieNofDatens 10413849_ | | (Decision::01/82/050/01135/AM20/The Committee considered:05/24/040/00758/AM20/the case as per agenda12.03.2020and it was decided to ratify norms under | Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: [142 SL. Export Product : Qty Sl. | Import Items Qty : | |1 BromfenacBroxinac Eye Eye Drops Drops0.09% 0.09%1.7 1.7ml ml/ Wal1 Vial 1 Bromfenacguide |e1,235 mg , | eo2 BroxinacBromfenac Eye Eye Drops Drops0.09% 0.09%2.5 2.5ml ml/ iver1 Vial TT1 enmariydateBromfenac ~ [oe2.639 mg ° | RA concerned may take further necessary action as per above decision of NC. | ALC4/2020 LABORATORIES P LTD = jNC/3/MEET/Jan/202021/4 jApproved , ‘ - easems Name:WEXFORD [12.02.2021Choma [pe | HO:01/82/050/01144/AM20/File otlavaMa._ —_4:07/24/040/00302/AM20/RRLA File os0/AM20/ {16.03.2020[Lic.No/Date:0710116263 fo. | Decision: The Committee considered thecase [as] [per] [agenda] [and] [it] [was] [decided] [to] [ratify] [norms][ under] | Para 4.07 of HBP Vol. J as per details given below or as applied by the firm, whichever is less: No. No. 1 CEFADROXIL CAPSULES USP | 1 Number |} 1 CEFADROXIL 510 mg/ | 500MG (46 KG) ' |MONOHYDRATE | 500 mg ; '143| | 2 | CEFADROXIL CAPSULES USP | 1Number [2 | CEFADROXIL 510 mg/ , 4 500MG (46 KG) . . MONOHYDRATE| 500 mg : 3 CEFADROXIL CAPSULES USP | 1 Number | 3 CEFADROXIL 510 mg / 500MG (46KG) MONOHYDRATE| 500 mg | : : 4 CEFADROXIL CAPSULES USP’ | 1 Number | 4. | CEFADROXIL 510 mg/ | j 500MG - CETRALON: (92KG) . - USPMONOHYDRATE| capsules500 mg 7 _ 135° | GEFADROXIL FORORAL | INumber [5 | CEFADROXIL ~ | 5248.50mg | | | | SUSPENSION USP 250MG/5ML - MONOHYDRATE| / 100 ml. | i CETRALON, 100 ML (46 KG) | USP bottle , IRA concerned may take further necessary action as per above decision of NC, | ----- End of picture text -----

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| RA concerned may take further necessary action as per above decision ofNC.

| [Case No.:117/2/82PartyName:KOPRAN [Meet No/Date: “[Status: | ALC4/2020 {RESEARCH NC/3/MEET/Jan/202021/4 |Approved | LABORATORIES LIMITED {12.02.2021 _ | |HQ File ~ (RLAFile ~*~: SLi. No/Daatte10310835448 a | :01/82/050/01151/AM20/ |:03/94/040/01052/AM20/ 17.03.2020 Decision: The Committee considered the case as per agenda and it was decided to ratify norms under 145 Para 4.07 of HBP Vol. | as per details given below or as applied by the firm, whichever is less:

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----- Start of picture text ----- | j|ALC4/2020 LABORATORIES PVT.LTD., NC/3/MEET/Jan/202021/4 [Approved , . . | ac. No.:118/2/82-' 8. Name:LEBEN~~‘-/|12.02.2021MeetNo/Date: ‘ ce JHQ File REA File Tic No/Daie:0310835458 [ . . | Decision:Para The Committee considered the case as per agendaandit wasdecidedto ratify norms under 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: | Sl. | Export Product Qty SL. | Import Items Qty | 1 | AMOXICILLIN. TABLET 125MG| 1 1 | AMOXICILLIN | 146.319 MOXILEB KID TABLET | Number TRIHYDRATE | mg | (EACH TABLET CONTAINING BP ; | EQUIVALENTAMOXICILLIN TO 125MGTRIHYDRATE= OF (COMPACTED) AMOXICILLIN). NET CONTENT OF : IMPORT/EXEMPT MATERIAL USED IN | . EXPORTTRIHYDRATEPRODUCTBP 1) (COMPACTED)-AMOXICILLIN | 157.795KGS (EXCL 2% WASTAGE) 2 | AMOXICILLIN TABLET 250MG. | 1 2 | AMOXICILLIN | 292.638 . MOXILEB-250DT Number TRIHYDRATE | mg’ | (EACH TABLET CONTAINING (COMPACTED) | | AMOXICILLIN TRIHYDRATE 146 . | AMOXICIEQUIVA L LIN).ENT NETTO CONTENT250MG OF | - . IMPORT/EXEMPT MATERIAL USED IN | EXPORT PRODUCT 1)AMOXICILLIN | TRIHYDRATE BP (COMPACTED)- | 157.795KGS (EXCL 2% WASTAGE) 3. | AMOXICILLIN CAPSULES 250MG. | 1 3 | AMOXICILLIN | 292.638 . | MOXILEB-250 CAPSULE. | Number TRIHYDRATE | mg (EACH CAPSULE ~—-CONTAINING BP AMOXICILLIN TRIHY DRATE (COMPACTED) 7 EQUIVALENT TO (250MG OF AMOXICILLIN) NET CONTENT OF | "| IMPORT/EXEMPT MATERIAL USED IN : , oo, = _ | EXPORT PRODUCT. 1)AMOXICILLIN . , L.. : ot TRIHYDRATE BP ~° (COMPACTED)- . ; i- | 1966.216KGS (EXCL 2% WASTAGE) | 4 | AMOXICILLIN CAPSULES 500MG. | 1 4 | AMOXICILLIN | 585.282 | |} |” | MOXILEB-500 _ + CAPSULE, }| Number “TRIHYDRATE | ing jo a i (EACH CAPSULE — CONTAINING BP , | | | *| AMOXICILLIN —°—s TRIHYDRATE (COMPACTED) | | EQUIVALENT TO SO0OMG OF]. ; =e | -| AMOXICILLIN). NET CONTENT OF . | | IMPORT/EXEMPT MATERIAL USED IN ; . i EXPORT PRODUCT 1)AMOXICILLIN : . TRIHY DRATE BP(COMPACTED)- . . . 215.177KGS(EXCL 2% WASTAGE) ; a ----- End of picture text -----

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. [ [CaseNo.:144/2/82-~—~—~—~«(Party Name:SENTISS [MeetNo/Date: —«(Status: i ALC4/2020 PHARMA PVT.LTD. NC/3/MEET/Jan/202021/4 !Approved | a to 12.02.2021 | THQ Fie IRLAFile TLie.No/Date:0510413989 | whet ane oS 0F/82/0S07011 78/AM217 ** (205/24/040/007917AM20/° }13.04:20200 © | 149 |ParaDecision: 4.07 of HBPTheVol.Committee1 as per considereddetails giventhe below case or asas per applied agenda and by the itfirm,was whichever decided to ratifyis less: norms under : ; | Export Product Qty Sl. | Import Items Qty J ode No. |. | Kombinil -Duo Eye/Ear Drops 5ml 1 Pack | 1 ‘Dexamethasone Micronised | 5.10 mg f Vial PH EUR USP JP . | RA concerned may take further necessary action as per above decision of NC. Case No.:145/2/82-—~—~—~—~«(PartyName:SENTISS | ALC4/2020 PHARMA PVT.LTD. —[MeetINC/3/MEET/Jan/202021/4 No/Date: ——Ss« Status::Approved , 12.02.2021 : | HQ File “IRLAFile ~——SSSCLic. Nov/DDate0510413990 [ :01/82/050/01179/AM21/ :05/24/040/00792/AM20/ 13.04.2020 . Decision:[of][ HBP][Vol.][I][as][ per][details][given][ below][or][as][applied][ by][ the][firm,][whichever][is][less:] 150[Para][ 4.07] The Committee considered the case as per -agenda and it was decided to ratify norms under fo | . | Export Product Qty _| SL | Import Items Qty ; | No, Cyclomed Eye Drops 1% 5ml Cyclopentolate HCL 51.00 mg | RA concerned may take further necessary action as per above decision of NC. Case[No.:152/2/82-~—~—~«(Party] Name:STERILEINDIA [MeetNo/Date: —(Status: =| | ALC4/2020 PRIVATE LIMITED NC/3/MEET/Jan/202021/4 |Approved oa ; 12.02.2021 . |. (HQFile ———S—~<“—s~«‘«zSRA FideS™S~~SCSCSCS Lie,Nco/Date20510414006. |— :0.1/82/050/01186/AM21/ (05/24/040/00004/AM21/ 16.04.2020 ; : ‘ [Peciston:° "The Commitee considered the case as per agenda and it was decided to ratify norms under ; 151 iPara 4.07 of HBP Vol. las per details given below or as applied by the firm, whichever is less: _ i ‘ | . Export Produ ct _Qty SL Import Items Qty : . No, . : CEFEPIME FOR INJECTION 4050.000 kg.| 1 CEFEPIME HCL 2588.78 kg . ae Oo 7 (NON STERILE) ; : lea concerned may take further necessary action as per above decision ofNC. | :

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----- Start of picture text ----- . 90 . . . . : ° ~ [accin CaseprnnnstetetnninnnneeennnncianNo.:153/2/82- pnenmetnetnnnnamentntiainieParty Name:STERILEietsmnnatnnnnieINDIA {Meetpaaciaeinnnmecinnniananuntanttennetia No/Date: jrnmmanmaentetneStatus: neal , ALC4/2020 . PRIVATE LIMITED NC/3/MEET/Jan/202021/4 |Approved 12.02.2021 oe |) THQ File IRA File MieNo/Date:0510414007 Fe _ | Decision: 152 [Para] [4.07] [of] ~~ [HBP] The [Vol.] Committee [I] [as][ per] considered [details] [given] the case [below] as [or][ as] per [applied] agenda [ by] and [ the] it [firm,] was decided [whichever] to ratify [is] [less:] norms under | Export Product Qty Sl. | Import Items Qty , | Vancomycin Hydrochloride | lkg | 1 Vancomycin HCL (Non Sterile) | 1.01 kg ; (Sterile) ; ; . | RA concerned may take further necessary action as per above decision of NC, . |” (CaseNo.:156/2/82-ALC4/2020 | |Party1& PHARMACEUTICALS Name:J.B. CHEMICALS NC/3/MEET[MeetNo / Jan/202021/4Date: «Status:|Approved | - {LIMITED — 412,02,.2021 | {HQ File ~~ IRLA File ~~ (Lic. No/Date:0310835634 :01/82/050/01190/AM21/ :03/94/040/01088/AM20/ 18.04.2020 . , | Decision: | The Committee consideredthe case as per agenda and in the light of ¢earlier decision takenin . : | {Meeting no. 7/82-ALC4/2020 dated 04.12.2020 against Advance Authorization No, 0310837889 dated | 26.08.2020, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as | applied by the firm, whichever is less:, - . SL. Export product Qty. Sl, Import items Qty. | No. No. 1 Rinza sip with Vitamin C (Flavours | ] Number | 1 Caffeine Anhydrous 30.3 mg/ | Orange/ Lemon/ Black Currant/ Other | Sachet Powder 5 gm sachet . flavours) &Rinza Sip (Flavours Orange/ | ’ | Lemon/ : : . , ‘ 53 Black currant/ Cranberry/ Honey Lemon/ | ° ' : ’ i, Other flavours). Each sachet of 5gm . | contains Caffeine Anhydrous Powder , | 30mg. Net content of Caffeine ‘ , Anhydrous Powder 209.17 Kgs. | ‘ 2 Rinza Tablets. Each tablet Contains | ] Number | 2 | Caffeine Anhydrous 30,60 mg/ ‘ : Caffeine Anhydrous, Powder 30.mg and | Tablet Powder ‘| 30mg tablet | | . ’ | Paracetamol BP 500. mg. : : . , - | Net Content of Caffeine Anhydrous ‘ 3 Paracetamol BP >10 mg /500 |. Powder - 696.09 Kgs and Paracetamol mg tablet | BP- 1160.57 Kgs. . he : 2 | 3 “| Rinza Sip for Children (Flavours |. | Number | 4 | Paracetamol BP... 282,80 mg /. : ; r Raspberry/ other flavours). | Sachet . 3 gm sachet | | , i || Each sachet of 3gm contains Paracetamol | , lea [concerned] BP - 280mg. may [ take] Net [further] content- [ necessary] 116.51 Kgs. [action] [as][ per] . [above] [decision] [of][ NC.] _ . |- , ----- End of picture text -----

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----- Start of picture text ----- [IGaseNo:159/2/82-~—~(PartyName:INDOCO—‘([MeetNo/Date: —=(Status:— . | ALC4/2020 REMEDIES LIMITED NC/3/MEET/Jan/202021/4 |Approved | 12.02.2021 | IRQFie REAFile Tie. [No/Date:0310835745] | toe - | ‘Decision: The Committee considered the case as per agenda and it was decided to ratify norms under | Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: (to be : check from licence amendment sheet) . . | Export Product Qty Sl. Import Items Qty co No. i- l154 Ciprofloxacin and Dexamethasone | 1 Number Ciprofloxacin HCL | 25.875 mg | Suspension USP ( 0.3% - 0.1% ) 7.5rhl | Bottle 7.875 mg ’ . | Bottle. 3 Bottle Relevant as , | (Each ml Contains: . - | per packing . CIPROFLOXACINHYDROCHLORIDE policy EQUIVALENT TO CIPROFLOXACIN 4 Cap Relevant as BASE 3mg) per bottle of 7.5ml) (Each 7.5 per packing fo mi Contains: Ciprofloxacin 22.5mg and . ; policy Dexamethasone 7,5 mg) Net wtis: (1) 5 Dropper Relevant as | ‘ciprofloxacin. HCL 27 kgs (2) per packing ; i Dexamethasone 9 kgs, olic: | policy  'RA concerned may take further necessary action as per above decision of NC. [[Gase No.:167/2/82- ~~(PartyName:USV PRIVATE [MeetNo/Date: —=/Status: i ALC4/2020 {LIMITED NC/3/MEET/Jan/202021/4 Approved 12.02.2021 | | GORI BER Hie nn ijeNo/Dates0310838770 | ssn | :01/82/050/01201/AM21/ :03/95/040/01193/AM20/ 121.04.2020 || ParaDecision: 4.07 of HBP:The Vol.CommitteeI as per considereddetails giventhe belowcase oras peras appliedagenda byand theitfirm,was decidwhich e verd to ratifyis less: norms under . | SL. Export product Qty. Sh Import items Qty. | No. No. | | ' | 1 ‘Doxycycline Tablets, USP 100 MG | 1 Number 1 Doxycycline USP 103.40 mg [/] [100] : : 3508 . . (Monohydrate) mgtablet 1155 ( 84,000 Bottles x 50 Per Bottles = : boone . | 42,00,000 Tablets), (Net Content. : . . . :fee . ‘ i . , | : 2 WeightDoxycycline = 420.000 Kgs) Tablets, USP 100_* MG | 1 Number 2 Doxycycline USP | 103.40 mg / 100 . 7 | 5008 « | (Monohydrate) mg tablet ( 14,000 Bottles x 500 Per Bottles . : ; Pod = 70,00,000 Tablets) ( Net Content ; . a oo i ; i Weight = 746.200 Kgs) : | 3 Doxycycline308 Tablets, USP 150 MG | | Number 3 Doxycycline(Monohydrate) USP mg155,10 tabletmg / 150 : ' (5,000 Bottles x 30 Per Bottles = : . : i 1,50,000 Tablets) ( Net Content . 7 i Weight = 22.500 Kes RA concerned may take further necessary action as per above decision of NC. ----- End of picture text -----

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----- Start of picture text ----- : |[CaseNo.:170/2/82-[Party [Name:GLENMARK] [[Meet] [No/Date:] ———SS=*(Status: | ALC4/2020 {PHARMACEUTICALS LTD |NC/3/MEET/Jan/202021/4 |Approved , | 12.02.2021 ee HQ File IRAFile Tie. No/Date:0310835803 | Decision: The Committee considered the case as per agenda and it was decided to ratify norms under | Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: /156 Export Product Qty No.Sl. Import Items . Qty Colesevelam HCL for oral 24500.000 Packs | 1 Colesevelam 2894.06 kg suspension 3.75 GM (Pack size Hydrochloride . | 30s) | | ColesevelamHydrochloride [Wet.] [Content] [of] is ; . 2756.250 kgs) | RA concerned may take further necessary action as per above decision ofNC, [~~[CaseNo.:175/2/82-—~—~=~«(PartyName:ORTIN‘(Meet No/Date: —~—~—~—~—=«S(Status: ‘ 4 ALC4/2020 : LABORATORIES LTD NC/3/MEET/Jan/202021/4 - |Approved | . : 12.02.2021 iO Hie inner IRA FileNN TFETSRTae :01/82/050/01209/AM21/ (:09/24/040/00028/AM21/ 24.04.2020 | | |Decision: The Committee considered the case as per agenda and itwasdecidedto ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Export Product Qty SL. | Import Items Qty | No. | [28,38,58]-5-t- Lkg 1,2-dimethoxy — ethane(1,2- | 4.74 kg [157 butyloxycarbonylamino-2-Amino-3- DME) __. ; hydroxy-1,6-diphenylhexane | SODIUM BORO HYDRIDE | 0.45 kg | succinate(BDH. Succinic Acid RIT) | * METHANE SULPHONIC | 1.50 kg | a L-PHENYLALANINE 0.342 kg | . | ; 5 N,N-DIMETHYL ; 0.80 kg fo ACETAMIDE | , es rs ‘ oo 16 | Di-Tert-Butyl- Di- Carbonate | 0.60kg | - . . [7 [5% Palladium Carbon (Wet)’ | 0.010 kg. | | ; . rs | ISOPROPYL ALCOHOL 2.90 kg io RA concerned may take further necessary action as pet above decision of NC. : ----- End of picture text -----

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oe | (CaseALC4/2020No.:177/2/82-SS PartyName:SHILPAMEDICARE LIMITED [MeetNC/3/MEET/Jan/20202No/Date:1/4 Seatas:[Approved | | [HQRile ——SIRLAFileSS *C[Lic.No/Date:0710116370 | | Decision::01/82/050/01211/AM21/— The Committee considered:07/24/040/00019/AM21/the case as peragenda124.04.2020and it wasdecidedtoratify | Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: norms under 52 Export Product Qty Sl. | Import Items Qty | No. GEMCITABINE HCL lkg | 1 2-DEOXY-2,2-DIFLUORO-D"| 5.70 kg RIBOFURANOSE-3, 5-DIBENZOATE-1. METHANESULFONATE . CYTOSINE 4.38 kg HEXAMETHYLDISILAZANE 14.25 kg an | RA concerned may take further necessary action as per above decision of NC. porn popenenpeennni 7" [Case No.:178/2/82Party Name:KOPRAN Meet No/Date: Status: | ; | |ALC4/2020 RESEARCH NC/3/MEET/Jan/20202 1/4 |Approved | LABORATORIES LIMITED |12.02.2021 jo HQ File ~~ IRLA File “ ~~ [Lic.No/Date:03 10835866 , — I: |:01/82/050/01212/AM21/ :03/94/040/00017/AM21/ 25.04.2020 — 4] | |Decision: The Committee considered the case as per agenda and it was decided to ratify norms under nl59 Para 4.07 of HBP Vol. Las per details given below or as applied by the firm, whichever is less: | | | Export Product Qty Sl. | Import Items Qty | No. AZITHROMYCIN DIHYDRATE | ; | AZITHROMYCIN AMINE | 1.00 kg . : | oo e ACETONE 0.90 kg jRA concerned may take further necessary action as per above decision ofNC. ;

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|||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|ALC4/2020|‘PHARMACEUTICALS LTD||NC/3/MEET/Jan/202021/4||Approved|.|
|||||—|412.02.2021|
|——atc|No.:183/2/82-|~~~ Party|Name:GLENMARK|re|No/Date:|~~ca|
|IQ Fie|RTA Hie|LicNo/Date-0310835013|
|oo|ene eee|21/82/050/0121|VAM21/ ~|*/03/94/040/00013/AM21/|~°j25.04.2020|=|i|
|||[Decision:|‘The|Committee|considered|the case|as per|agenda|and|it|was|decided|to|ratify|norms|under|
||||Para 4.07 of|HBP Vol.|| as per details given below or as applied by the firm, whichever|is less:|
|||SL.|Export Product|Qty|_|||SL.|||Import|Items|Qty|
|‘||1|Potassium|Chloride ER Tablets USP|||1 Number|||1|Potassium|765 mg/|
|Hood.|10 mEq K (750 mg)|(Per Pack 90|Pack|Chloride USP|Tablet|
|||Tabs.)|
|||(Net Wt.|of Potassium|Chioride|.|
|||USP|is 337.50|Kgs)|
|2|Potassium Chloride ER Tablets USP|||1 Number|||1|Potassium|765 mg|/|
|||10 mEq K (750 mg) (Per Pack|100|||Pack|Chloride USP|Tablet|
||||Tabs.)(Net Wt.|of|Potassium|Chloride|
|||USP|is 375.00 Kgs)|
|3|Potassium Chloride ER Tablets USP|}|1|Number|||1|Potassium|765 mg|/|
|-|||10 mEq K (750|mg)|(Per Pack|1000|| Pack.|Chioride USP|||Tablet|
|Tabs.)|
|161|(Net Wt.|of Potassium Chloride|
|||USP|is 3750.00 Kgs)|.|.|
|4|Potassium|Chloride ER Tablets USP|||1 Number|||1|Potassium|1530 mg /|
|||Tabs.)20 mEq K (1500 mg) (Per Pack 90|| Pack|Chloride USP|Tablet|.|.|
|(Net Wt.|of Potassium|Chloride|
|||USP|is 675.00 Kgs)|
|||5|Potassium.Chloride ER Tablets USP|||1 Number|||1|Potassium|1530 mg /|
|fod||.|20 mEq K (1500 mg)|(Per Pack|100|| Pack|||Chloride USP|Tablet|
|||Tabs.)|.|
|(Net|Wt.|of Potassium|Chloride|
|4d|USP|is 750.000|Kgs)|
|Potassium Chloride ER Tablets USP|||1 Number|||1|Potassium|1530|mg|/|
|20 mEq K (1500 mg)|(Per Pack 500|| Pack|°|Chloride USP|Tablet|
|,|\|(Net Wt.|of Potassium|Chloride|“i|.|,|
|.||[|||7|USPPotassium is 3750.00Chloride Kgs) ER Tablets USP|||1 Number|||1|Potassium|1530mg/|||||
|||,|| 20 mEq K (1500. mg)|(Per Pack|Pack|Chloride USP|Tablet|
|;||||(Net1000 Wt. Tabs.) of|Potassium Chloridenl|"|.|||
|||USP|is 7500.00 Kgs)|||
|:|ka concerned may take further necessary action as per above decision ofNC.|||

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----- Start of picture text ----- _ |_ |ALC4/2020(Case Nos1842/82- ‘CHEMICALS[PartyName:S PVT LTD KANT [Meet—_—sINC/3/MEET/Jan/202021/4NovDate: ota Seatus:[Approved | i i . i : i i : | {HQ File : RLA File Lic.No/Date:0310835937 | :01/82/050/01218/AM21/ :03/95/040/00024/AM21/ —|26.04,2020 : ‘146 (Decision: — TheCommitteeconsidered the case as per agenda and it was decided | Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whicheverto ratifyis less: norms under : Export Product Qty - | SL | Import Items Qty | No. ACYCLOVIR 3400.000 kg DIACETYL ACYCLOVIR | 4851.80 kg . | RA concerned may take further necessary action as per above decision of NC. . . i"Case No.:185/2/82-~—~—~(Party Name:GLENMARK(Meet No/Date: ~—~—~—(Status:~—| | ALC4/2020—. PHARMACEUTICALS LTD |NC/3/MEET/Jan/202021/412.02.2021 {Approved | |HQFie ~+~{RLAFile =~~—~—~—__[Lic.No/Date:0310835970 | , . :01/82/050/01219/AM21/ :03/94/040/00028/AM21/ 26.04.2020 - | Decision: The Committee considth e caseredas per agenda‘andit was decided to ratify norms under | Para 4.07 ofHBP Vol. I as per details given below or as applied by the firm, whichever is less: | Sl. Export Product Qty Sl. | Import Items Qty i 163 No. No. | | 1 Gms)Ciclopirox(Net wt.Gelof Ciclopirox0.77% (PackUSP30;is 1 Number | 1 Ciclopirox USP | 235.62pack mg/ | 23.10 Kgs.) 2 Ciclopirox Gel 0.77% (Pack 45 | | Number | 1 Ciclopirox USP | 352.967 mg an ' | Gis)34.65 (NetKgs.) wt. of Ciclopirox USP is uo , /pack . | 3 Ciclopirox Gel 0.77% (Pack 100 | 1 Number | 1 Ciclopirox USP | 785.00 mg/ | ; . | ; Gms) (Net wt. of Ciclopirox USP is , : pack - ; 77,00 Kgs.) : : iRA concerned may take further necessary action as per above decision of NC. | ----- End of picture text -----

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----- Start of picture text ----- so [Case No.:188/2/82-ALC4/2020 —~—=«(PartyName:STYRAX[PHARMA PRIVATE [MeetINC/3/MEET/Jan/202021/4NovDate: eile Stator{Approved || | (HQFile ——~—————sS(RLA File [Lic.No/Date:0910068675 :01/82/050/01222/AM21/ :09/24/040/0002 1/AM21/ 27.04.2020 : Decision:The Committeeconsidered | Para 4.07 of HBP Vol. Las per details giventhe case below as.or peras applie agen d a andby theitfirm, was decidedwhichever to ratifyis less: norms under j | Export Product Qty Sl. | Import Items Qty , | No. ‘ - 1164 1-(2,2-dimethoxyethy])-5- 1 kg | 1 | methyl-4-methoxy acetoacetate | 0.725 kg f methoxy-6-(methoxycarbonyl) 4- | dimethyl formamide dimethyl | 0.65 kg . oxo-1,4-dihydropyridine-3- acetal (dmf-dma) \ carboxylic acid or DSS 2-chloro acetaldehyde dimethyl | 1.24 kg fooF dimethylacetal oxalate 1.17 kg | , 2.60 kg | , | 6 | methylene di chloride (MDC) 3.00 kg i lithium hydroxide monohydrate | 0.30 kg : | “IRA concerned may take further necessary action as per above decision ofNC. , ----- End of picture text -----

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----- Start of picture text ----- [ [Gase [No.:196/2/82-~«(‘PartyName:AUROBINDO] [(MeetNo/Date:] —~—~—~*(Status:— ALC4/2020 PHARMA LIMITED NC/3/MEET/Jan/202021/4 |Approved 12.02.2021 | WHQFile ~~ RLAFile ~~——_ Lic. [No/Date:0910068686] ~ :01/82/050/01230/AM21/ :09/24/040/00017/AM21/ — {28.04.2020 | Decision: The Committee considered the case as per agenda and it was decided to ratify norms under | Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: , | SL. Export Product Qty Jl. | Import Items Qty | . No. No. | | 1 Penicillin V Potassium 500mg 34000000000 | 1 Penicillin V 17340.00 kg | Tablets Number Potassium ~ 165 [ The relevant Bulk Drug content (Phenoxymethyl = po | .in:the: total Export“portQuanaityY of yo P enicillinotassium a) :i | the Export Product is ; 17000 . _ J Kgs of Penicilin V Potassium | . i (2 Penicillin V Potassium 250mg 5000000.000 | 1 -) Penicillin V 1275.00kg _| | : Tablets. .- | Number _ | Potassium [ The relevant Bulk Drug content | @henoxymethyl | i : . i : Penicillin : i in the total Export Quanaity.of. Potassium. } i i the Export Product is : 1250 Kgs . . | | | of Penicilin V Potassium ] : | | iRA concerned may take further necessary action as per above decision of NC. . — ----- End of picture text -----

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----- Start of picture text ----- | . |© [Case No.:197/2/82-—~—~—~«(PartyNName:MEDREICH [(Meet] [No/Date:][—=‘(Status:] | 1ALC4/2020 LIMITED NC/3/MEET/Jan/202021/4 {Approved= . | | 12.02.2021 eSoo OT/8ZIOSO/OIZ3/AM2I/TRQ Fie REA| :07/24/040/00023/AM21/File Lic.28004-20207No/Date:0710116385FO . | Decision: ~The Committee considered the case as per agenda and it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: 1166 Export Preduct . Qty Sl. | Import Items Qty ; No, . GENTAMYCIN “EYE/EAR | 1 Number 1 GENTAMYCIN 0.03675 gms | DROPS BP 0.3% , W/V 10ML| Bottle SULPHATE BP ; | 56.5495mg[Export Qty:per40000010ml, BottlesBottle =x . ; | | | 22.620 KG] a a concerned may take further necessary action as per above decision ofNC. a iets ontennneacrenantanAmapenenrNrnenenns\thtn Me lat MeLIe ASM AMRENRERARRARARTTANE {ne RAL AReITE NRE IRA MARA WARREN AATOREA Aum A MRRCON ASA AON AA cvptunicniann-winsictnmntuneaeininanane set memnnnamininnnnmensanmnpa nacre f | Case No.:199/2/82- Party Name:NEULAND Meet No/Date: Status: | ALC4/2020 LABORATORIES LTD NC/3/MEET/Jan/202021/4 |Approved | [HQ File ) RLAFile ———Lie.No/Date:0910068697 a | — :01/82/050/01233/AM21/ 4:09/24/040/00045/AM21/ (29.04.2020 ! Decision: | The Committee considered the case as per agenda and it was decided to ratify norms under 167 Para 4.07 ofHBP Vol. I as per details given below or as applied by the firm, whichever is less: | Export Product Qty Sl. | Import Items Qty | No. | | IBREXAFUNGERP CITRATE ENFUMAFUNGIN __ | 4.55 kg , {RA concerned may take further necessary action as per above decision of NC. ("ICase No.:222/2/82-—~—~—~«(PartyName:SWAASA (MeetNo/Date:—~—~—(Status: ; > |(ALC4/2020 PHARMA LIMITED NC/3/MEET/Jan/202021/4 ‘Approved ' | HQFile~~FileSSS Lic. No/Date:2610012909 FO : ‘ }:01/82/050/01256/AM21/ (:26/24/040/00001/AM2I1/'~ — j29.04.2020 js | . . | (Decision: The Committee considered the case as pet agenda and it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: , , 168 -Export Product - . | Qty Sl. | Import Items.” : Qty , i 5-Fluoro- 1-1(2R,55)- lkg 1 (2R58-5 (4 Amino 5 fluoro 2 oxo 2 | 1.726 kg | ; _ | No, . — «| 2¢hydroxymethy!)1,3-oxathiolan-5-yl hpyrimidin - — lyl) (1,3) ; 3 isopropy methy . | cytosine or’ (Emtricitabine . oxathiolane carboxylicpaid, se | . . crude)or(EMO1) : cyclohexyl ester . : : . Sodium Borohydride - 0.46 kg | , RA concerned may take further necessary action as per above decision of NC. | ----- End of picture text -----

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: r"TGaseNo.:202/2/82- ~—~«(PartyName:DEEPAK ——‘[MeetNo/Date:| —S(Status: = - | JALC4/2020 PHENOLICS LIMITED _ INC/3/MEET/Jan/202021/4 Approved 4 | 12.02.2021 THQ Fe REA File Tic NovDate:3410046032 | [Decision: ‘The Committee considered the case as per agenda and it was decided to ratify norms under 169 Para 4.07 ofHBP Vol. J as per details given below or as applied by the firm, whichever is less: | Export Product Qty Sl. | Import Items Qty i « No. ‘ | PHENOL BENZENE “| 0.87 kg | RA concerned may take further necessary action as per above decision of NC. ‘ : || [CaseALC4/2020No.:203/2/82-~«(PartyName:DPHENOLICS LIMIT E DEPAK© ~—(MeetNo/Date.NC/3/MEET/Jan/202021/4 Status:|Approved | f | 12.02.2021 | | a | |HQFile —~——sSCRLA Fille ~The. No/Date:3410046034 | :01/82/050/01237/AM21/ 1:34/24/040/00386/AM20/ [30.04.2020 Decision: TheCommittee considered the case as‘per agenda and it was decided to ratify norms under ‘ /170 |Para 4.07 of HBP Vol. | as per details given bélow or as applied by the firm, whichever is less: , , | Export Product Qty Sl. | Import Items Qty PHENOL BENZENE O87ks || | IRA concerned may take further necessary action as per above decision ofNC. | . (~~ [CaseNo.:214/2/82-~‘(PartyName:SUVEN[ —S(Meet][No/Date:][=——Ss«(] Status: . | . |ALC4/2020 PHARMACEUTICALS _ NC/3/MEET/Jan/202021/4 |Approved | “LIMITED 12.02.2021 oO | |HQFile —SS~~~SREA leSSS~S~S~«wLicNo/Dates0910008714 [ , | :01/82/050/01248/AM21/ — :09/24/040/00052/AM21/ 01.05.2020 : ’ : Decision: The Committee considered the case as per agenda andit was decided to ratify norms under | Para 4.07 of HBP Vol. Las per details given below or as applied by the firm, whichever is less: . . ; ‘ nate “171 | Export Product’ ~ | Othe “Si. | Import ltems Qty | 0G . (28)-(1-TETRAHYDROPYRAMID-2- | 1 kg L-VALINE 1.04 kg : : ao bo | ONE)-3-METHYLBUTANOICye ACID a 2 CHLOROFORMATEMETHYL . 0.84 kg a 3. | ISO PROPYL ALCOHOL| 1.50 kg | : (IPA) ‘ , , IRA concerned may take further necessary action as per above decision of Nc. - | .

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----- Start of picture text ----- . 100 , [ [Case Now216/2/82- PartyName:FDCLTD—~MeetNo/Date: =——s(Status: | ALC4/2020 NC/3/MEET/Jan/202021/4 |Approved | | 12,02.2021 ee HQFe , IRA File TieNo/Date:0310836053 a Decision: The Committee considered the case as per agenda and it was decided to ratify norms under Para 4.07 of HBP Vol. Las per details given below or as applied by the firm, whichever is less: | J | SL Export Product Qty - Sl. | Import Items Qty 172 | | No. ‘No | | ‘L Gentamicin Ear/Eye Drops 5 ML 295209.00 | 1 GENTAMICIN 5.42 kg | _ | (Bactigen Eat/Eye Drops 5 ML), 0 vials SULPHATE } 0.3% w/v 2 Gentamicin Ear/Eye Drops 10 ML 896207.00 | 2 GENTAMICIN | | 32.94 kg | (Bactigen0.3% wiv Ear/Eye Drops 10 ML), 0 vials . SULPHATE | _ |RA concerned may take further necessary action as per above decision of NC. Case No.:218/2/82-~—~—~«(PartyName:CIPLA—~—~—~—SALC4/2020 a ‘ LIMITED, (MeetNC/3/MEET/Jan/202021/4No/Date. Status:|Approved - . | |HQFile SRA FileSSCS. Lic12.02.2021No/Date 0310836063 | | | :01/82/050/01252/AM21/ |:03/94/040/00036/AM21/ 01.05.2020 | Decision: The Committee considered the case as per agenda and it was decided to ratify norms under | Para 4,07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: | Export Product Qty Sl. | Import Items Qty 173 No, | Amoxicillin and Clavulanate | 1 Number | 1 AMOXICILLIN - 585.0 mg \ Potassium Tablets USP Novaclav , TRIHYDRATE : | 625 ’ Tab 2 POTASSIUM ° ‘ 303.6 mg | Each film coated tablet contains: CLAVULANATE WITH : : Amoxycillin Trihydrate USP AVICEL 1:1 . equivalent to Amoxicillin 500mg, ; ; | Clavulanate Potassium USP | ° . | : equivalent to Clavulanic Acid 125mg ; . ° : | {RA coticerned may take further necessary dction as per above decision,of NC. | . , ----- End of picture text -----

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----- Start of picture text ----- . a 101 . [Case No.:223/2/82-~—«(PartyName:PHAROSE | ALC4/2020 REMEDIES LIMITED —([MeetNo/Date:NC/3/MEET/Jan/202021/4——[Status:|Approved ; , | 12.02.2021 | (Decision: The Committee considered the caseasperagenda | Para 4.07 of HBP Vol. I as per details given below or as applied byandtheit firm,was whicheverdecided to isratifyless:norms under 1174 . . | Export Product Qty Sl. |. Import Items Qty . L No. |, | : Alpha Ketoanalogue + Essential 1 Number | 1 L-HISTIDINE 38.76 mg | _ | Amino Acids Film-Coated Tablet BULK DRUG - MEDICINE : RA concerned may take further necessary action as per above decision ofNC. , ("Case No.:224/2/82- ~—~—~—~«(PartyName:SUVEN —'(MeetNo/Date: Status; | i ALC4/2020 PHARMACEUTICALS NC/3/MEET/Jan/202021/4 |Approved - | LIMITED 12.02.2021 || (HQFile:01/82/050/01258/AM21/=————~«SRLAC:09/24/040/00056/AM21/ File’[Lie04.05.2020 No/Date:0910068721_ . | Decision: The Committee considered the case as per agenda and it was decided to ratify norms under | -{Para-4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: 175 “Export Product Qty SL. Import Items Qty No. iz | |METHYLCHLOROMETHY (E)-2-(2- LPHENYL)-3- Lkg ACIDORTHO TOLYL ACETIC | 1.56 kg | METHOXYACRYLATE SODIUM METHOXIDE | 0.4i6kg | | | POTASSIUMIODIDE _| 0.008 kg ; | THIONYL CHLORIDE | 1.24kg RA concerned may take further necessary action as per above decision of NC. : . | |ALC4/2020[Case Now22erag2- PartyIPHARMAName:SENTISS PVT.LTD. ——[MeetINC/3/MEET/Jan/20202 No/Date: = 1/4 fstatus:|Approved | oo | . a So 912,02,20212 oe ; | [HQFiieREA File Lie.No/Date:0510414103-| | :01/82/050/01262/AM21/ :05/24/040/00021/AM21/ 04.05.2020 4 oe - | (Decision:— The Committee considered the case as per agenda and it wasdecided 116 [‘Para] [4,07] [of][ HBP.] [Vol.] [I] [as:per] [details] [given] [below] [or] [as] [applied] [by] [the] [firm,] [whichever] toisratifyless: norms under: | : | | Export Product Qty Sl. | Import Items Qty | Sf | No. . ‘| Brinex / Brinex-M / Brinarga / Brinera 1Pack | 1 | Brinzolamide - 51.00 mg : | (Brinzolamide Opthalmic Suspension 1%) 5m!" , | RA concerned may take further necessary action as per above decision ofNC. oo ----- End of picture text -----

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----- Start of picture text ----- . 102 - |" ICaseNo.:229/2/82-~—~—~«(PartyName:SENTISS —‘([MeetNo/Date. Status: | | |ALC4/2020 . ‘PHARMA PVT.LTD. NC/3/MEET/Jan/202021/4 ;Approved i _112,02.2021 i ee (6) OC | (Decision: The Committee considered the case as per agenda and it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: . 77 Sl. Export Product Qty Sl. | Import Items Qty , Lo No. ; No. , | i Broxinac Eye Drops 0.09% 1.7 ml [/] 1 Vial 1 Bromfenac 1.235 mg ; | Bromfenac Eye Drops 0.09% 1.7ml Sodium Hydrate 2. | Broxinac Eye Drops 0.09% 2.5 ml/ 1 Vial 1 Bromfenac 2.639 mg . | Bromfenac Eye Drops 0.09% 2.5ml . Sodium Hydrate . | {RA concerned may take further necessary action as per above decision of NC. ----- End of picture text -----

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----- Start of picture text ----- "Case No.:235/2/82-ALC4/2020 (Party Name:J.B. CHEMICALS [MeetNo/Date: Status: ie (LIMITED& PHARMACEUTICALS— NC/3/MEET/Jan/2020212.02.2021 1/4 |Approved | THQ File IRA | :01/82/050/01269/AM21/ _ $:03/94/040/00038/AM21/File ic No/Datte:031083609905.05.2020 | (Decision: The Committee considered the cases as per agenda and in thelight of earlier decision taken in Meeting No. 10/82-ALC4/2019 dated 29.11.2019 against Advance Authorization No. 0310832727 dated | 13.11.2019, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as | applied by the firm, whichever is less: 7 Export Product | | : i Export Product i No. i 1 GLIPIZIDE EXTENDED RELEASE TABLETS 10 MG. Each tablet contains (i) Glipizide | 1 Number | USP- 10 mg (ii) Eastman _ (™ Cellulose | ; ‘ | Acetate (CA 398-10NF/EP)- 29.70 mg (iii) Sentry Polyox WSR N80 FP NF- 178.10 mg . (iv) Sentry Polyox WSR 303 NF- 100 mg. Net content (i) 200 Kgs (ii) 594 Kgs (iii) 3562 1178 Kgs (iv) 2000 Kegs. ‘ 2 GLIPIZIDE EXTENDED RELEASE TABLETS 5 MG, Each tablet contains (i) Glipizide | 1 Number | — | USP- 5 - mg (ii) Eastinan (TM - Cellulose Acetate | - . (CA 398-LONF/EP)- 20.40 mg (iif) Sentry.Polyox WSR N80 FP NF- 89.05 mg (iv) Sentry i Polyox WSR 303 NF- 50 mg. Net content (i) 175.65 Kgs (ii) 716.66 Kgs (iii) 3128.37 Kgs ! . i i|3 ° | GLIPIZIDE EXTENDED RELEASE TABLETS 2.5 MG, Each tablet contains (i) | 1 Number on Glipizide USP- +» 2.5 mg (ii) Eastman (TM Cellulose : i - | Acetate (CA 398-10NF/EP)- 20.40 mg (iii) Sentry Polyox WSR N80 FP NF- 89.05 mg (iy) | Sentry Polyox WSR 303 NF- 50 mg, Net content (i) 63.72 Kgs (ii) 519.93 Kgs (iii) i a 2269.59 Kgs (iv) 1274.34 Kgs. ae a 2 EASTMAN (TM) CELLULOSE ACETATE (CA 398- 10NF/EP) . SENTRY POLYOX WSR N80 FP NF 89.05 me . SENTRY POLYOX WSR 303 NF 50.00 mg | 50.00 mg i RA concerned may take further necessary action as per above decision ofNC... ----- End of picture text -----

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103

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----- Start of picture text ----- [ [Case No.:236/2/82- Party Name:GLENMARK. Meet No/Date: Status: i jALC4/2020 . LIFE SCIENCES LIMITED |NC/3/MEET/Jan/202021/4 |Approved a FO | 12.02.2021 | . a - HO File "“IREAAfile. File ““HioNo/Date0310830118 corres ae | Decision: "The Committee considered the case as per agenda and it was decided to ratify norms under Para 4.07 of HBP Vol. Las per details given below or as applied by the firm, whichever is less: | | Export Product _ | Qty {SL | Import Items Qty | ROSUVASTATIN CALCIUM Lkg | t. Tert-Butyl(E)-(6-(2-(4-(4- 1.30 kg | J: fluorophenyl)-6-Isopropyl-2- ' | ' (Methyl(Methy! 179 Sulfonyl)Amino Pyrimidin-5- . , Po . yl) Vinyl)(4R, 68)... fluorophenyl)-6-Isopropyl-2- | Tert-Butyl(E)-(6-(2-(4-(4- 1 | (Methyl(Methyl | Sulfonyl)Amino. Pyrimidin-5- ; 1 Lo yl) Vinyl)(4R,68)-2,2- | Dimethyl(1,3)Dioxane-4-yl) | Acetate _ ACETONITRILE a IRA concerned may take further necessary action as per above decision of NC, , [ (Case ‘No.:227/2/82- Party Name:SUVEN Meet No/Date: Status: | ALC4/2020 PHARMACEUTICALS NC/3/MEET/Jan/202021/4 |Approved | | LIMITED 12.02.2021 , || Ko:01/82/050/01261/AM21/ File RRL:09/24/04.0/00065/AM21/ File PsNopDate091006873106.05.2020 | |* |Decision: The Committee considered the case as per agenda and it was decided to ratify norms under , | Para 4.07 of HBP Vol. | as per details given below or as applied by the firm, whichever isless: —. || 180 Export Product —- Qty | No,Sl. | Import Items Qty | | RCHLORO THIOXANTHONE” [Te | / | ern | : oak |) | istkg | | 3517Kg IRA concerned may take further necessary action as per above decision of NC. | ----- End of picture text -----

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||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
||Poof[OaseNos230/2162-ALCa/2020 [PartyName:RECKITTIBENCKISER HEALTHCARE|—(MeetNo/Dater|NC/3/MEET/Jan/202021/4 Status:|Approved|||
|"|1HQ|File|RLA|File|Lic.No/Date:0510414108|
|||:01/82/050/01264/AM21/|:05/24/040/00025/AM21/|{06.05.2020|
|||(Decision:|—|The|Committee|considered|the|case|as|per|agenda|and|in the|light|of|earlier|decision taken|
|||Meeting|No.|1/82-ALC4/2019|dated03.06.2019|against|Advance|Authorization|No.|0510407915|datedin||
|27.09.2018,|it|was|decided|to|ratify norms|under|Para|4.07|of HBP|Vol.|I|as|per|details|given|below|or|as|
|applied by the|firm,|whicheveris|less:|;|
||||
||Cepacol|Extra|Strength|||1|Number|||1|ISOMALT|ST-M|1822.00|
|||Lozenges|Cherry|Tablet|mg|
|[81|(Lozenges)|[>|LYCASIN|80/55 (MALTOTOL)|456.00/ Tablet mg|
|||/|Tablet|
|||-|:|3|D&C redno.33|0.055 mg/|
|||oe|Tablet|
|||FD&C Red no. 40|As applied|||||
|||.|5|*|||Benzocaine USP|15.30mg/||)|
|||Tablet|
|||6|Wild Cherry Flavour TAK 040489|12.71 mg/|
|||:|‘Tablet|
|||7|Cherry Bark FL NAT TAK 054757|||4.90 mg/|
|Tablet|
|8|||Intensate Cool Flavour TAK052848|||As applied|
|||RA concerned may take|further necessary action|as per above decision of|NC.|

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||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|—|7" IGase|No.:23 1/2/82-A1.C4/2020|Party|[Name:RECKITT]|
|L|-|IBENCKISER HEALTHCARE‘(MeetNo/Date:__||NC/3/MEET/Jan/202021/4—«([Status:[Approved|.|
|INDIA PRIVATE LIMITED|12.02.2021|
|IQ BIRLA File|TLieNo/Date:0510414109 [7|
|||(Decision:|
|||Meeting|No.The6/82-ALC4/2019 Committee considereddated|16.08.2019 the case asagainst per|agendaAdvance and inAuthorization the light of earlierNo.|0510411091decision|takendated in|
|||(28.06.2019,|it|was|decided|to|ratify|norms|under|Para 4.07|of HBP|Vol.|I|as|per|details|given below|or|as|
|||lapplied by|the|firm,|whichever|is less:|
||||.|||Cepacol Extra|TNumber|||1|ISOMALT ST-M|2313.35 mg|
|||_|||Strength Lozenges-|/Tablet|
|1182|Honey Lemon|2|D&C YELLOW NO.|10|0.44 mg|/|
|||||FD&C YELLOW NO. 6|TabletAs applied|
|:|4|BENZOCAINE|USP|15.30 mg|/|
|||Tablet|
|:|||:|-|"45|’||HONEY|&|LEMON|FLAVOUR|||6.444 mg/|,|:|
|||TAK 042202|Tablet|||
|oo|INTENSATE|COOL|FLAV|TAK||4.69 mg/|
|||vs|:|052848|:|Tablet|
|7|MOUTHFEEL|ENHANCER|TAK ||2.30 mg/|
|;|053628|;|Tablet|
|RA concerned may take further necessary action as per above decision ofNC.|||
|[TGase No.:240/2/82-~~|~‘(PartyName:SENTISS|‘(MeetNo/Date:——~—(Status:||
|.|||ALC4/2020|PHARMA PVT.LTD.|INC/3/MEET/Jan/20202 1/4|;Approved|.|
|12.02.2021|
|‘||||HQFile:01/82/050/01274/AM21/~~~ (REAFile~———~O™—~—C—:05/24/040/00029/AM21/|~|SLi.108.05,2020NoDates0510414133|||;|
||i|[Decision:i|The|Committee|considered|the|case|as|pper|agenda andit|wasdecidedto|ratify|norms|under|||
|at|Para 4.07|of HBP|Vol:|as|per details given|below|oras|applied|by-the firm,|whichever|is less:|4|an|
|:|1183|-|7|SL|Export Product|Oty|-|Sl.|||Import Items|Qty|:|
|‘|||No.|.|No.|:|,|
|.|1|Visallergol|Eye|Drops|0.2%|||1|Number Vial|| 1|Olopatadine HCL|||5.61|mg|||;|:|
|||||2|Oftahist|(Olopatadine|Eye|||| Number Vial|1|Olopatadine HCL|||5.61 mg|||.|
|||Solution 0.1%|in Sml|Vial)|;|;|
|Ra concerned may|take further necessary|action as per above decision ofNC,|||7|

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----- Start of picture text ----- , 106 | ALC4/2020 — CHEMICALS & NC/3/MEET/Jan/202021/4 |Approved | PHARMACEUTICALS 12.02.2021 bo ate| No.:242/2/82- [LIMITEDa Name:J.B. = No/Date: i | /.01/82/050/01276/AM21/ -03/94/040/01058/AM20/ [11.05.2020 | | [Decision: ‘The Committee considered the case as per agenda and it was decided to ratify norms under | Para 4.07 of HBP Vol. 1 as per details given below or as applied by the firm, whichever is less: | SL. Export Product Qty | SL | Import Items Qty 1 |' CetylpyridiniumBenzydamine HydrochlorideChloride,and | 1 Number  | Pholcodine Lozenges Sugar Free Hydrochloride | Blackcurrant/ Pineapple & Lime/ : | Honey, Lemon & Ginger/Other oride ann (i)PholcodineFlavours. Each Lozenge.contains5.50mg 4 Isomalt ST-M 2583.0 mg (i)Benzydamine Hydrochloride 1.50mg (iii)Cetylpyridinium (184 Chloride 1,33 mg (iv)Isomalt | | ST-M 2583 mg. Net Content . , : (i)87.719kgs . | (ii)23.923kgs(ili)21.212kgs(iv)4 fo. 1196.164kgs . | 2 | Pholcodine and Cetylpyridinium | 1 Number | OrangeChloride /LozL e ngesmon Sugarand OthFr e re S| C hlorideebipyridinium 1.357 mg | Flavours. Each Lozenge contains 7 Isomalt ST-M | 2579.0 mg } (i) Pholcodinetae: 5.50 : mg (ii) ImportSLNos.1,2,3,5,6Items areat | Cetylpyridiniumse Chloride 1.33 drugs& and will | | mg (iii) Isomalt ST-M 2579 mg. ' abide by - the Net Content (i) Pholcodine- conditions of the ; | 48.176 kg (i) Cetylpyridinium Policy Circular | Chloride-11.65 kg (iii) Isomalt No.9,dt:30,06,2003, | ST-M-22590.245 kg. . read with Policy: | . Circular . | No.15,dt:17.09.200 | RA concemed may take further necessary action as per above decision ofNC. . ----- End of picture text -----

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||<br>CaseNo.:243/2/82-<br>[PartyName:GLENMARK<br>MeetNo/Date:<br>Status:<br>—<br>|<br>.<br>ALC4/2020<br>PHARMACEUTICALSLTD |NC/3/MEET/Jan/202021/4 |Approved<br>|<br>:<br>|<br>12.02.2021<br>TAQFig<br>TRUAFie<br>‘Lie. No/Date:0310836158<br>|<br>re<br>I ~:01/82/0S0/01277AM21/ — :03/94040/000435/AM217°<br>“F1.05.20200<br>'re<br>|<br>Decision:<br>The Committee consideredthe case as per agenda and it was decided to ratify norms under;||<br>CaseNo.:243/2/82-<br>[PartyName:GLENMARK<br>MeetNo/Date:<br>Status:<br>—<br>|<br>.<br>ALC4/2020<br>PHARMACEUTICALSLTD |NC/3/MEET/Jan/202021/4 |Approved<br>|<br>:<br>|<br>12.02.2021<br>TAQFig<br>TRUAFie<br>‘Lie. No/Date:0310836158<br>|<br>re<br>I ~:01/82/0S0/01277AM21/ — :03/94040/000435/AM217°<br>“F1.05.20200<br>'re<br>|<br>Decision:<br>The Committee consideredthe case as per agenda and it was decided to ratify norms under;||<br>CaseNo.:243/2/82-<br>[PartyName:GLENMARK<br>MeetNo/Date:<br>Status:<br>—<br>|<br>.<br>ALC4/2020<br>PHARMACEUTICALSLTD |NC/3/MEET/Jan/202021/4 |Approved<br>|<br>:<br>|<br>12.02.2021<br>TAQFig<br>TRUAFie<br>‘Lie. No/Date:0310836158<br>|<br>re<br>I ~:01/82/0S0/01277AM21/ — :03/94040/000435/AM217°<br>“F1.05.20200<br>'re<br>|<br>Decision:<br>The Committee consideredthe case as per agenda and it was decided to ratify norms under;||<br>CaseNo.:243/2/82-<br>[PartyName:GLENMARK<br>MeetNo/Date:<br>Status:<br>—<br>|<br>.<br>ALC4/2020<br>PHARMACEUTICALSLTD |NC/3/MEET/Jan/202021/4 |Approved<br>|<br>:<br>|<br>12.02.2021<br>TAQFig<br>TRUAFie<br>‘Lie. No/Date:0310836158<br>|<br>re<br>I ~:01/82/0S0/01277AM21/ — :03/94040/000435/AM217°<br>“F1.05.20200<br>'re<br>|<br>Decision:<br>The Committee consideredthe case as per agenda and it was decided to ratify norms under;||<br>CaseNo.:243/2/82-<br>[PartyName:GLENMARK<br>MeetNo/Date:<br>Status:<br>—<br>|<br>.<br>ALC4/2020<br>PHARMACEUTICALSLTD |NC/3/MEET/Jan/202021/4 |Approved<br>|<br>:<br>|<br>12.02.2021<br>TAQFig<br>TRUAFie<br>‘Lie. No/Date:0310836158<br>|<br>re<br>I ~:01/82/0S0/01277AM21/ — :03/94040/000435/AM217°<br>“F1.05.20200<br>'re<br>|<br>Decision:<br>The Committee consideredthe case as per agenda and it was decided to ratify norms under;||<br>CaseNo.:243/2/82-<br>[PartyName:GLENMARK<br>MeetNo/Date:<br>Status:<br>—<br>|<br>.<br>ALC4/2020<br>PHARMACEUTICALSLTD |NC/3/MEET/Jan/202021/4 |Approved<br>|<br>:<br>|<br>12.02.2021<br>TAQFig<br>TRUAFie<br>‘Lie. No/Date:0310836158<br>|<br>re<br>I ~:01/82/0S0/01277AM21/ — :03/94040/000435/AM217°<br>“F1.05.20200<br>'re<br>|<br>Decision:<br>The Committee consideredthe case as per agenda and it was decided to ratify norms under;||<br>CaseNo.:243/2/82-<br>[PartyName:GLENMARK<br>MeetNo/Date:<br>Status:<br>—<br>|<br>.<br>ALC4/2020<br>PHARMACEUTICALSLTD |NC/3/MEET/Jan/202021/4 |Approved<br>|<br>:<br>|<br>12.02.2021<br>TAQFig<br>TRUAFie<br>‘Lie. No/Date:0310836158<br>|<br>re<br>I ~:01/82/0S0/01277AM21/ — :03/94040/000435/AM217°<br>“F1.05.20200<br>'re<br>|<br>Decision:<br>The Committee consideredthe case as per agenda and it was decided to ratify norms under;||<br>CaseNo.:243/2/82-<br>[PartyName:GLENMARK<br>MeetNo/Date:<br>Status:<br>—<br>|<br>.<br>ALC4/2020<br>PHARMACEUTICALSLTD |NC/3/MEET/Jan/202021/4 |Approved<br>|<br>:<br>|<br>12.02.2021<br>TAQFig<br>TRUAFie<br>‘Lie. No/Date:0310836158<br>|<br>re<br>I ~:01/82/0S0/01277AM21/ — :03/94040/000435/AM217°<br>“F1.05.20200<br>'re<br>|<br>Decision:<br>The Committee consideredthe case as per agenda and it was decided to ratify norms under;||<br>CaseNo.:243/2/82-<br>[PartyName:GLENMARK<br>MeetNo/Date:<br>Status:<br>—<br>|<br>.<br>ALC4/2020<br>PHARMACEUTICALSLTD |NC/3/MEET/Jan/202021/4 |Approved<br>|<br>:<br>|<br>12.02.2021<br>TAQFig<br>TRUAFie<br>‘Lie. No/Date:0310836158<br>|<br>re<br>I ~:01/82/0S0/01277AM21/ — :03/94040/000435/AM217°<br>“F1.05.20200<br>'re<br>|<br>Decision:<br>The Committee consideredthe case as per agenda and it was decided to ratify norms under;||<br>CaseNo.:243/2/82-<br>[PartyName:GLENMARK<br>MeetNo/Date:<br>Status:<br>—<br>|<br>.<br>ALC4/2020<br>PHARMACEUTICALSLTD |NC/3/MEET/Jan/202021/4 |Approved<br>|<br>:<br>|<br>12.02.2021<br>TAQFig<br>TRUAFie<br>‘Lie. No/Date:0310836158<br>|<br>re<br>I ~:01/82/0S0/01277AM21/ — :03/94040/000435/AM217°<br>“F1.05.20200<br>'re<br>|<br>Decision:<br>The Committee consideredthe case as per agenda and it was decided to ratify norms under;||<br>CaseNo.:243/2/82-<br>[PartyName:GLENMARK<br>MeetNo/Date:<br>Status:<br>—<br>|<br>.<br>ALC4/2020<br>PHARMACEUTICALSLTD |NC/3/MEET/Jan/202021/4 |Approved<br>|<br>:<br>|<br>12.02.2021<br>TAQFig<br>TRUAFie<br>‘Lie. No/Date:0310836158<br>|<br>re<br>I ~:01/82/0S0/01277AM21/ — :03/94040/000435/AM217°<br>“F1.05.20200<br>'re<br>|<br>Decision:<br>The Committee consideredthe case as per agenda and it was decided to ratify norms under;||<br>CaseNo.:243/2/82-<br>[PartyName:GLENMARK<br>MeetNo/Date:<br>Status:<br>—<br>|<br>.<br>ALC4/2020<br>PHARMACEUTICALSLTD |NC/3/MEET/Jan/202021/4 |Approved<br>|<br>:<br>|<br>12.02.2021<br>TAQFig<br>TRUAFie<br>‘Lie. No/Date:0310836158<br>|<br>re<br>I ~:01/82/0S0/01277AM21/ — :03/94040/000435/AM217°<br>“F1.05.20200<br>'re<br>|<br>Decision:<br>The Committee consideredthe case as per agenda and it was decided to ratify norms under;||<br>CaseNo.:243/2/82-<br>[PartyName:GLENMARK<br>MeetNo/Date:<br>Status:<br>—<br>|<br>.<br>ALC4/2020<br>PHARMACEUTICALSLTD |NC/3/MEET/Jan/202021/4 |Approved<br>|<br>:<br>|<br>12.02.2021<br>TAQFig<br>TRUAFie<br>‘Lie. No/Date:0310836158<br>|<br>re<br>I ~:01/82/0S0/01277AM21/ — :03/94040/000435/AM217°<br>“F1.05.20200<br>'re<br>|<br>Decision:<br>The Committee consideredthe case as per agenda and it was decided to ratify norms under;||<br>CaseNo.:243/2/82-<br>[PartyName:GLENMARK<br>MeetNo/Date:<br>Status:<br>—<br>|<br>.<br>ALC4/2020<br>PHARMACEUTICALSLTD |NC/3/MEET/Jan/202021/4 |Approved<br>|<br>:<br>|<br>12.02.2021<br>TAQFig<br>TRUAFie<br>‘Lie. No/Date:0310836158<br>|<br>re<br>I ~:01/82/0S0/01277AM21/ — :03/94040/000435/AM217°<br>“F1.05.20200<br>'re<br>|<br>Decision:<br>The Committee consideredthe case as per agenda and it was decided to ratify norms under;||<br>CaseNo.:243/2/82-<br>[PartyName:GLENMARK<br>MeetNo/Date:<br>Status:<br>—<br>|<br>.<br>ALC4/2020<br>PHARMACEUTICALSLTD |NC/3/MEET/Jan/202021/4 |Approved<br>|<br>:<br>|<br>12.02.2021<br>TAQFig<br>TRUAFie<br>‘Lie. No/Date:0310836158<br>|<br>re<br>I ~:01/82/0S0/01277AM21/ — :03/94040/000435/AM217°<br>“F1.05.20200<br>'re<br>|<br>Decision:<br>The Committee consideredthe case as per agenda and it was decided to ratify norms under;||<br>CaseNo.:243/2/82-<br>[PartyName:GLENMARK<br>MeetNo/Date:<br>Status:<br>—<br>|<br>.<br>ALC4/2020<br>PHARMACEUTICALSLTD |NC/3/MEET/Jan/202021/4 |Approved<br>|<br>:<br>|<br>12.02.2021<br>TAQFig<br>TRUAFie<br>‘Lie. No/Date:0310836158<br>|<br>re<br>I ~:01/82/0S0/01277AM21/ — :03/94040/000435/AM217°<br>“F1.05.20200<br>'re<br>|<br>Decision:<br>The Committee consideredthe case as per agenda and it was decided to ratify norms under;||<br>CaseNo.:243/2/82-<br>[PartyName:GLENMARK<br>MeetNo/Date:<br>Status:<br>—<br>|<br>.<br>ALC4/2020<br>PHARMACEUTICALSLTD |NC/3/MEET/Jan/202021/4 |Approved<br>|<br>:<br>|<br>12.02.2021<br>TAQFig<br>TRUAFie<br>‘Lie. No/Date:0310836158<br>|<br>re<br>I ~:01/82/0S0/01277AM21/ — :03/94040/000435/AM217°<br>“F1.05.20200<br>'re<br>|<br>Decision:<br>The Committee consideredthe case as per agenda and it was decided to ratify norms under;||<br>CaseNo.:243/2/82-<br>[PartyName:GLENMARK<br>MeetNo/Date:<br>Status:<br>—<br>|<br>.<br>ALC4/2020<br>PHARMACEUTICALSLTD |NC/3/MEET/Jan/202021/4 |Approved<br>|<br>:<br>|<br>12.02.2021<br>TAQFig<br>TRUAFie<br>‘Lie. No/Date:0310836158<br>|<br>re<br>I ~:01/82/0S0/01277AM21/ — :03/94040/000435/AM217°<br>“F1.05.20200<br>'re<br>|<br>Decision:<br>The Committee consideredthe case as per agenda and it was decided to ratify norms under;||<br>CaseNo.:243/2/82-<br>[PartyName:GLENMARK<br>MeetNo/Date:<br>Status:<br>—<br>|<br>.<br>ALC4/2020<br>PHARMACEUTICALSLTD |NC/3/MEET/Jan/202021/4 |Approved<br>|<br>:<br>|<br>12.02.2021<br>TAQFig<br>TRUAFie<br>‘Lie. No/Date:0310836158<br>|<br>re<br>I ~:01/82/0S0/01277AM21/ — :03/94040/000435/AM217°<br>“F1.05.20200<br>'re<br>|<br>Decision:<br>The Committee consideredthe case as per agenda and it was decided to ratify norms under;||<br>CaseNo.:243/2/82-<br>[PartyName:GLENMARK<br>MeetNo/Date:<br>Status:<br>—<br>|<br>.<br>ALC4/2020<br>PHARMACEUTICALSLTD |NC/3/MEET/Jan/202021/4 |Approved<br>|<br>:<br>|<br>12.02.2021<br>TAQFig<br>TRUAFie<br>‘Lie. No/Date:0310836158<br>|<br>re<br>I ~:01/82/0S0/01277AM21/ — :03/94040/000435/AM217°<br>“F1.05.20200<br>'re<br>|<br>Decision:<br>The Committee consideredthe case as per agenda and it was decided to ratify norms under;|.<br>|<br>re||<br>:|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|.||||Para4.07 ofHBP Vol. I asperdetails||||given below or asappliedbythe firm,||||whichever is less:||||||||||
|||| .<br>|||Sl.<br>No.|||ExportProduct|Qty||Sl.<br>No.|| ImportItems|Items|||Qty|||||||
|||i<br>:<br>i<br>||1.<br>;<br>L||||Calcipotrene OintmentUSP |60000.000<br>0.005%<br>(Calcitrene<br>Ointment<br>USP .0.005%)<br>(Pack<br>Size<br>60gm)<br>(Net Wt. of Calcipotriene|60000.000Number||1|CALCIPOTRIENE | <br>(CALCIPOTRIOL)<br>,<br>.||||3753.60gms||gms|||||
|.||1|||||(Calcipotriol)<br>is<br>180.00|.||||||||||||:||
||:||<br>|||2|||Gms,<br>Calcipotrene Ointment USP | <br>0.005%<br>(Calcitrene|100000.000Number|||||||||||||;|
|||r|||||Ointment<br>USP<br>0.005%)<br>(Pack<br>Size<br>5gm)_||||||||||||.|||
|||\<br>||||||(Net Wt. of Calcipotriene<br>(Calcipotriol)<br>is<br>25.00||||||||||||||.|
||‘||<br>lo<br>|<br>|<br>|<br>|<br>|185||3|||Gms.<br>Calcipotrene OintmentUSP | <br>0,005%<br>(Calcitrene<br>Ointment<br>USP<br>0.005%)<br>(Pack<br>Size<br>—-:120gm)<br>(Net Wt, of Calcipotriene<br>(Calcipotriol)<br>is<br>600.00|100000.000Number<br>:|,||;|||‘||:||||.||
||||||||Gms.)|||||||||||||||
|||||4|||Calcipotrene OintmentUSP ||100000,000Number||||||||||||||
||||||||0.005%<br>(Calcitrene|||||||||||||||
||||||||Ointment<br>USP<br>0.005%)|||||||||||||||
|||i|||||(Pack<br>Size<br>15gm)|||||||||||||||
||||<br>i|||||(Net Wt. of Calcipotriene<br>(Calcipotriol)<br>is.<br>75,00||||||||||:||||;|
|.||<br>|<br>i<br>a<br>||||5<br>,|||Calcipotrene OintmentUSP | <br>0.005%<br>*<br>— (Calcitrene<br>Ointment<br>USP,<br>0.005%)<br>(Pack<br>Size<br>459m)<br>(Net Wt. of Calcipotriene ||100000.000Number<br>:|||:||||.|:||||:||
||||||||(Calcipotriol)<br>is<br>225.00|||:||||:||||||||
||~|i*<br>|<br>|<br>|}<br>i|||{6||*|Gms.)<br> | CalcipotreneOintment’USP: }+100000.000Number ~<br>| 0.005%<br>(Calcitrene<br>Ointment USP 0.005%)<br>:<br>(Pack<br>Size<br>30gm)}<br>(Net Wt. of Calcipotriene<br>(Calcipotrio!)<br>_ is<br>"150.00<br>.<br>a.||||<br>.|:|.|,|oe<br>‘<br>'||||‘|i<br>aa<br>|<br>!|Oe||
|.|,||<br>|<br>:<br>i<br>i|||7|<br>*|| CalcipotreneOintmentUSP| <br>| 0.005%<br>(Calcitrene<br>Ointment<br>USP<br>0.005%)<br>(Pack<br>Size<br>90gm)<br>(Net Wt. of Calcipotriene-||100000.000Number<br>.<br>,||:||'||||||||<br>:<br>3|.||
|,|||||||(Calcipotriol}<br>is<br>450.00|.||||||||||||.||

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||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|,|108|‘|
|:|||‘|Calcipotrene|Ointment USP|||100000.000 Number|;|
|rt|0.005%|(Calcitrene|a|.|
|i|Ointment|USP|0.005%)|
|(Pack|Size|—|100gm)|;|
|(Net|Wt.|of|Calcipotriene|.|
|(Calcipotriol)|is|500.00|:|
|ng|ed re ST|Calcipottisiié|Crean”)|L00000:000|Nuriiber|©|2]|6|0|oteeg|Qe|Ba|ae|eB|et|
|0.005%|(Calcitrene|Cream||.|.|.|:|
|1|USP|0.005%)|(Pack|Size|||°|
|||5gm)|
|i|(Net|Wt.|of|Calcipotriene|.|
|i|(Calcipotriol}|is|25,00|
|‘|i|Calcipotriene|Cream|||100000.000 Number|.|
|;|0.005%|(Calcitrene|Cream|
|.|||USP|0.005%)|(Pack|Size|;|.|
||i|30am)(Net|Wt.|of|Calcipotriene|,|
|7|(Calcipotrio!)|is|150.00|.|
|i|Gms.)|
|11|Calcipotriene|Cream|}|100000,000 Number|
|;|i|0,005%|(Calcitrene|Cream|;|;|
|||USP|0.005%)|(Pack|Size|
|i|45gm)|,|
|||(Net|Wt.|of|Calcipotriene|i|
|||(Calcipotrio!l}|is|225.00|
|Gms.|
|||»|||12|Calcipotriene|Cream|||50000.000 Number|:|.|
|.|||0.005%|(Calcitrene|Cream|.|.|
|i|USP|0.005%)|(Pack|Size|
|60gm)|
|.|||(Net|Wt.|of|Calcipotriene|.|;|‘|.|:|
|||(Calcipotriol)|is|150,00|-|:|
|||13|CalcipotrieneGms.|Cream ||100000.000 Number|
|0.005%|(Calcitrene|Cream|
|i|USP|0.005%)|(Pack|Size|
|||100gm)|:|
|(Net|Wt.|of|Calcipotriene|‘|
|(Calcipotriol)|is|500.00||.|.|.|
|,|||14|Calcipotriene|Cream||}|50000.000 Number|
|'|»|||0.005%|(Calcitrene|Cream|:|,|:|
|USP|0.005%)|(Pack|Size|
|:|
|’|||(Net|Wt.|of|Calcipotriene|.|.|
|:|i|.|(Calcipotriol)|is|300.00|,|“|.|
|||||Gms.)|{|
|;|
|.|||:|15.|||Calcipotrene|Qintment|USP.)|50000.000|Number|.|.|y|oo|*|i|:|
|*|"||0.005%|(Calcitrene|:|:|i|:|
|7|Ointment|USP|0,005%)|‘|||
|i|«|||(Pack|Size|50gm)|:|
|-|i|||(Net|Wt.|of|Calcipotriene|.|||;|
|Pod|_|||(Caleipotriol)|is|125,00|ot|i|
|||a concemed may take further necessary action as per above decision of|NC,|||

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==> picture [22 x 68] intentionally omitted <==

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----- Start of picture text ----- . 1409 . | |CaseNo.:244/2/82- |ALC4/2020 === (PartyLIMITED.Name:CIPLA—S(MeetNo/Date:NC/3/MEET/Jan/202021/4.————S—«SSttatus:|Approved = : 12.02.2021 | FAQ File REA File =, HLic.No/Date:0310836159 fe | |Decision:The Committee considered the caseas per [agenda] and it was decided to ratify norms under . Para 4.07 of HBP Vol. J as per details given below or as applied by the firm, whichever is less: | | Export Product Qty Sl. | Import Items Qty | Potassium Chloride Extended | 1 Number | 1. POTASSIUM CHLORIDE 765.00 | | | ‘ReleasePotassium CapsulesChlor ER Caps750mgUSP/ USPCITRIC ACID mgs10,00 mgs a | | | 750mg (Pack Size 100 Capsules . (MONOHYDRATE USP) . | | | Each) ; DIBUTYL SEBACATE NF 12.00 mgs |. 1196 | Each extended Release Capsule ETHANOL USP 99.9% 2.62 mi i | | USPcontains: 750mgPotassium Chloride 5 BOTTLE100CC WHITEWITH 38MMHDPE [|] | [as] Relevantper : || | NECKPLASTIC~~ DB-02 TRIVENI policypacking; ;; | 38/400 FG, CRC HAVING | Relevant 1| |if. ; UNIPACPTD. WITHSG-75MSFYPLINERIN| packingas per ; | ; BLACKCLOSURES) (REXAM| py (90 Count ) (100 Count) a| 750mg/ (100 count) 600mg HAVING UNIPAC SG-75M| ag per | 7 53/400 LSC, SCREW CAP| Relevant fo LINER PTD. WITH SFYP IN | packing fo BLACK (REXAM | 1 CLOSURES) poly (100 Count) 750mg | _ [RA concerned may take further necessary action as per above decision of NC. : (Case No:247/2/82-ALC4/2020 PasiySCIENCESName:AMILIFEPRIVATE MeetINC/3/MEET/Jan/202021/4No/Date: Status:|Approved |i : | {HQFie = ~—SIREAFile~—S~S*~S~S~S*«~dC ic Ne/DDate 3410046053 | , i [01/82/0500 1281/AM21/ 134/24/040/00015/AM21/ 11.05.2020 | (Decision: The Committee considered the case as per agenda and it was decided to rati fy norms under | : , 187 Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: ; | Export Product Qty SL. Import Items Qty | , |. | |TADALAFIL 1 D-TRYPTOPHAN L0l4kg |i - | RA concerned may take further necessary action as per above decision ofNC. " . | ----- End of picture text -----

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||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|:|oe|110|
|[Case No.:255/2/82-—~—~=«(PartyName:SWISS.—~—«([Meet|No/Date:———~*~*«~SStatsz;—|
|ALC4/2020|PARENTERALS|LTD|NC/3/MEET/Jan/202021/4||Approved|
|12.02.2021|
|:|||FAQ File|REA|File|Lic.|No/Date:0810147772|||bo|
|eS|191/82/050/01289/AM21/|| :08/24/040/00025/AM21/°|*|15.05.2020-|
|||{Deeision:|||The|Committee|considered|the|case|as|per|agenda|and|it|was|decided|to|ratify norms under|
|||Para 4,07 of|HBP Vol.|I as per details given below or as applied by the firm, whichever|is less:|,|
|||SL|Export Product|Qty|Sl.|||Import Items|Qty.|
|||No.|an|No.|;|
|1|MEROPENEM|‘FOR }|255000.000|1|MEROPENEM|320.02|kg|
|INJECTION|1GM | Number|;|TRIHYDRATE|
|.|USP/BP/IP/CEP/EP/ChP|USP/BP/IP/CEP/EP/|
|EACH|VIAL|CONTAINS|:|(Net|
|MEROPENEM|TRIHYDRATE|,|
|||»-Sterile)|.|
|(188||.|MEROPENEMEQUIVALENT|ANHYDROUSTO|||
|1000MG|SODIUM|
|||’|||CARBONATE|EQUIVALENT|
|i|TO SODIUM 90,.2MG|
|2|MEROPENEM|FOR|||177000.000|| 2|MEROPENEM|111.07 kg|
|‘|of|INJECTION|.|500MG ||Number|TRIHYDRATE|.|
|USP/BP/IP/CEP/EP/ChP|reneCEP/EP/|.|
|EACH|VIAL|CONTAINS|:|ChP(Non-Sterile)|
|MEROPENEM|TRIHYDRATE|,|:|
|||EQUIVALENT|TO|
|MEROPENEM|ANHYDROUS|
|500MG|SODIUM|
|i|CARBONATE|EQUIVALENT|
|TO|SODIUM|45.1|MG|
|;|||_|{RA|concerned may take further necessary action|as per above|decision|of|NC.|+|;|
|F"(Case No.:256/2/82-~—~—~«*(PartyName:SWISS—~~—«[Meet No/Date.|——~S|Status:|||
|‘|ALC4/2020|PARENTERALS LTD|_.|INC/3/MEET/Tan/202021/4|jApproved|
|:|a|[12.02.2021|po|
|.|2.)|JHQFieIREFile|S~SS~:~SSCLieNoo/Date:0810147773,|
|-|*4:01/82/050/01290/AM21/|—_*||:08/24/040/00024/AM21/|{15.05.2020|ee|
|.|,|i|ParaDecision: 4.07|of HBPTheVol.CommitteeI|as per|considereddetails|giventhe belowcase|oras peras appliedagenda by and the itfirm,was decidedwhicheverto|isratifyless:|norms|under|
|mo|Po|‘Export|Product:|Qty|«||SL|||Import|Items|-|Oty|.|||
|;|||||||CEFOTAXIME|.|FOR ||3708000.000|||;|No.1|CEFOTAXIME|4000,930.|kg||||||
|||INJECTION|_|1GM | Number|SODIUM|—-|STERILE|Dot|
|||USP/BP/IP/CEP/EP/ChP|USP/BP/CEP/IP/EP/ChP|
|a concerned may take further necessary action asper above decision ofNC.|a|

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— — F"TGase No.:262/2/82oo | . |ALC4/2020 ——=—=S=SPartyName:UKAROMATICS & —~CSN MeetNC/3/MEET/Jan/202021/4No/Date: ——S~S«~SSétatujApprovedss a |\CHEMICALS 12.02.2021 | (HQFile ~~———~<C*~SRAFile’—~CSs~SsCS Lic NDate0310836217| | (Decision: The Committee considered the case as per agenda and it was decided to ratify norms under | i ‘\Para 4.07 ofHBP Vol. I as per details given below or as applied by the firm, whichever is less: | | Sl. Export Product Qty | SL. | Import Items | Qty . 1190 No. No. | 1 N AMYL SALICYLATE lkg N AMYL ALCOHOL 0.47 kg SALICYLIC ACID 0.737 kg 2 N AMYL BUTYRATE Lkg N AMYL ALCOHOL 0.619 kg N BUTYRIC ACID 0.619 kg N AMYL ACETATE N AMYL ALCOHOL 0.153 kg ISO AMYL BUTYRATE N BUTYRIC ACID 0.655 kg | BENZYL BUTYRATE N BUTYRIC ACID 0.581 kg | RA concerned may take further necessary action as per above decision ofNC. [ [CaseNo.:263/2/82-——=—[PartyName:ZIM_Ss[Meet NovDate: =—SsStatus: , | ALC4/2020 . LABORATORIES LIMITED |NC/3/MEET/Jan/202021/4 |Approved , : 12.02.2021 | {HQFile ~~ IRLA File LicNo/Date:0310836218| | :01/82/050/01297/AM21/ :03/95/040/00078/AM21/ 15.05.2020 . | (Decision: The Committee considered the case as per agenda and it was decided[Vol.][Las][ per][details][given][ below][or][ as][applied][ by][ the][firm,][whichever][is][less:] 191[Para][ 4.07][ of][HBP] to ratify norms under | Export Product Qty Sl. Import Items Qty No. Acitretin Pellets 10.87% 227.690 kg Acitretin Micro USP/ EP | 25.000 kg | RA concerned may take further necessary action as per above decision ofNC. , : [Case No.:264/2/82-[Party[Name:FDCLTD] —([Meet No/Date:=———Ss«(Status: . | ALC4/2020 . . INC/3/MEET/Jan/20202 1/4. |Approved . | 12.02.2021 | | | os iO Fie” wn omnes “idenaaebs 10836003 f nnn ; 01 /82/050/01298/AM21/ :03/94/040/00067/AM21/ 15.05.2020, i ’ . | Decision: The Committee considered the case as per agenda andit was decided to ratify ‘norms under ; Para 4.07 of HBP-Vol. Las per details given below or as applied by the firm, whichever is less: i | Export Product Qty SL. Import Items Qty | i : | CHLORAMPHENICOL «EYE | | Number Vial 1. | Chloramphenicol | 5.10mg + | | DROPS 0.05% w/v of 10 ML] - (Micronized) * (Chlorafast Eye Drops 10° ML | &Clorogen Eye Drops 10 ML) , ee | RA concerned may take further necessary action as per above decision of NC, |

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----- Start of picture text ----- | | | : 112 | : . : . oN : [Case No.:265/2/82-~—~~—~(PartyName!NIFTYLABS {MeetNo/Date: —~—~—~(Status: : ALC4/2020 PVT LTD., INC/3/MEET/Jan/202021/4 |Approved _ | 12.02.2021 ; | FAQ File RTA File (Lic. [No/Date:0910068761] . | [Decision:Para 4,07 of HBPTheVol.Committee1 as per detailsconsideredgiventhe belowcaseorasasperappliedagenda byandthe itfirm,waswhicheverdecidedto isratifyless: norms under ; : Export Product Qty SL. Import Items Qty | : : No. 4 | Dibenzo [b,f] [1,4] thiazepin - | 1 kg Thiophenol 0.59 kg , | 11(10H) — one HydrazienHydrate 80% 0.688 kg ; Poly Phosphoric Acid 84% | 4.03 kg . , RA concerned may take further necessary action as per above decision of NC. , |© [Case Nowi270/2/82- PartyName:KOPRAN [Meet No/Date: —~—~—~=<(Status:——| i ALC4/2020 RESEARCH - NC/3/MEET/Jan/202021/4 [Approved | | | _ LABORATORIESLTD. ‘12.02.2021 | || (AQFile“REA FileS™~~CSS™«SL-ic.No/Dates0310836264 5 | Decision::01/82/050/01304/AM21/| The Committee — considered|:03/94/040/00071/AM21/the‘case as per agenda/20,05.2020and it was decided. to. ratify| norms, under ; | Para 4.07 of HBP Vol. Las per details given below or as applied by the firm, whichever is less: Export Product Qty Sl. | Import Items Qty : No. (194) | CEFEPIME FOR| 3000,000 kg CEFEPIME HCL (NON- 1907.10 kg INJECTION STERILE) | ; ACETONE 5448.000 kg | L-ARGININE 1110.000 kg . Lo ‘ , [45 || ISOPROPYLPacking Materials- ALCOHOL __| Relevant1176.000 as kg . , Aluminium Bottle Anodized | . Aluminium Canister (10kg)/ || perpolicy packing ° ; : | ——|2M . RA concerned may take further necessary action as per above decision of NC, , ----- End of picture text -----

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----- Start of picture text ----- | | 113 | || (CaseALC4/2020No.:281/2/82- ~—~—~—~(PartyName:OPESHEALTHCARE PRIVATE LIMITED =|MeetNo/Date:|NC/3/MEET/Jan/202021/4—{Status:|Approved= . | . 12.02.2021 _ : | Decision:Para 4.07 of HBPTheVol.CommitteeI as per considereddetails giventhe belowcase oras asperapplied agenda by and the itfirm, was decidedwhichever to ratifyis tess: norms under} | , | ‘No.Sl. | Export Product Qty No.Sl. | Import|- Items Qty | 1 Metamizaole Magnesium 300 mg and | 1 Number | 1 Metamizole | 1.575 gm/ 1195 "| Pargeverine Hydrochloride 6mg per ML | Bottle Magnesium | § ml bottle | ; Oral Drop — of 5 ML. ; , | NET CONTENTS OF METAMIZOLE | | MAGNESIUM IS 324 KGS. | 2 Metamizaole Magnesium 300 mg and | 1Number | 1 Metamizole | 4.725 gm/ | Pargeverine Hydrochloride 6mg per ML | Bottle Magnesium } 15 ml bottle Oral Drops of 15° ML. . | NET CONTENTS OF METAMIZOLE | MAGNESIUM IS 5076 KGS. | RA concerned may take further necessary action as per above decision of NC, "Case No.:283/2/82-—=—=—~—=«(PartyName:ADCOCK——‘(MeetNo/Date: —[Status: ; ALC4/2020 INGRAM LTD, NC/3/MEET/Jan/2020212.02.2021 1/4 |Approved | JHQFile | JREAFile~~ ~~—~—~——__{Lic.No/Date:0710116485 . a :01/82/050/01317/AM21/ :07/24/040/00048/AM21/ 22.05.2020 | (Decision: The Committee considered the case as per agenda and it was decided to ratify norms under | Para 4.07 of HBP Vol. | as per details given below or as applied by the firm, whichever is less: Export Product ; Qty Sl. | Import Items Qty , | | [ACURATE TABLETS - [7 Number DOXYLAMINE SUCCINATE | (Paracetamol USP /Ph. Eur Grade | 5.10 mgs . “196. | 450mg+Doxylamine © a 3 CAFFEINE = ANHYDROUS } 30.60mgs- |... | Succinate 5mg+Caffeine BP2010/USP/eP/PH.BUR/BP ; i , 30me+Codeine Phosphate’ 3. | CODEINE PHOSPHATE | 10.20 mgs . | e Spm BP/USP/EP/PH.EUR . L 10mg+Colour — Quinoline 4 | COLOUR QUINOLINE | 2.00 mgs » | | Yellow 2Mg) (Para - | YELLOW Cl 47005. | - | | | 36000.000+Doxy- . (SPECTRACOL) poo | | | 400.000+Caffeine- - | 1 | | 2400,000+Codeine- : _. | | 800.000+Colour- 160.000Kgs)(No. of Tablets . | 80000000) . ; . | RA concerned may take further necessary action as per above decision of NC. : : ----- End of picture text -----

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----- Start of picture text ----- . [Case No.:284/2/82- “Party [Name:ADCOCK] [MeetNo/Date: ‘|Status: ALC4/2020 : INGRAM LTD, NC/3/MEET/Jan/202021/4'|Approved | 12,02,2021 . Oo HQ File eau [RLA File aciaaiy [Lic.No/Date:0710116486 | cea apn |p ROMB2/050/01318/AM21 07/24/04 0/00049/AM21 22.05.2020 |) Becision: ~The Committee considered the case as per agenda and it was decided to ratify norms under | : i Para 4.07 of HBP Vol. | as per details given below or as applied by the firm, whichever is less: | 7 |. Export Product Qty Sl. | Import Items Qty . | ACURATE TABLETS -|1Number | 1 DOXYLAMINE 5.10 mgs "4 || (Paracetamol SUCCINATE USP /Ph, Eur ‘ 197|| S0mg#. Doxy/aminean : 2 CATFEINE ANHYDROUS| 30.60.60 mgs ~ | sraane ae ain aa BP2010/USP/EP/PH.EUR/BP 30:60 mgs | | mg*Codeine Phosphate 3 CODEINE PHOSPHATE | 10.20 mgs 10mg+Colour = Quinoline BP/USP/EP/PH.EUR ; | | Yellow 2Mg) (Para - 4 COLOUR QUINOLINE | 2.00 mgs . | 36000.000+Doxy- _| YELLOW Cl 47005 , | 400.000+Caffeine- (SPECTRACOL) | 2400,000+Codeine- ) i . | 800.000+Colour- | 160.000Kgs)(No. of Tablets . + | 80000000) ' . ‘ | | ta concerned may take further necessary action as per above decision ofNC. ----- End of picture text -----

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----- Start of picture text ----- ("Case No.:307/2/82--~—~—~=«(PartyName:PHAROSE | ALC4/2020 REMEDIES LIMITED —s (MeetNC/3/MEET/Jan/202021/4No/Date: ~——~=«S |ApprovedStatus: 12.02.2021 J| 101/82/050/01341/AM21/(HQFie|. —(RLAFile|:18/24/040/00002/AM21/~~ [Lic.No/Date:181000435103.06.2020 | CS” ’ | Decision: , The Committee considered the case as per agenda and it was decided to ratify normsunder | Para 4.07 of HBP Vol. | as per details given below or as applied by the firm, whichever is less: | 198 . Export Product; . Qty SL ; Import Items . Qty . | | Alpha Ketoanalogue + Essential | 1 Number 1 | L-HISTIDINE 38.76 mg | | Amino -Acids ‘ Film-Coated Tablet | . BULK DRUG. ‘ i . | | - MEDICINE - . . | jRA concerned may take further necessary action as-per above decision of NC, ; : ----- End of picture text -----

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----- Start of picture text ----- | [CaseNo.:349/2/82-—~—~—~SPartyName:TIDE ~—~—‘(MeetNo/Date. | ALC4/2020 . . INDUSTRIES , _ INC/3/MEET/Jan/202021/4= —(Status:|Approved = 7 12.02.2021 oo | HQ RieREA File Lie. NovDate:3410046153 | |Decision: j199 Para 4.07 of HBPTheVol. Committee [I] as per considereddetails giventhe below case as peror as applied agenda by andthe it wasfirm, decidwhich e dverto ratify [is] less: norms under _ | Export Product Qty SL. Import Items Qty : Alpha Amyl Cinamic Aldehyde Benzaldehyde 0,583 kg i ‘ | RA concerned may take further necessary action as per above decision of NC. | [CaseNo.:357/2/82- ~—s|iParty.=—=Ss=é<“<«~‘é‘;*CMeet WNdatew:|— SS [Seatuss | ALC4/2020 Name:CON VERGENCE INC/3/MEET/Jan/202021/4 |Approved , | CHEMICALS PRIVATE 12.02.2021 | | oo LIMITED | | | |HQFie ~~ ~(RLAFile =~~~ {Lic.No/Date:3410046157 |” :01/82/050/01391/AM21/ :34/24/040/00047/AM21/ 17.06.2020 . | * (Decision: The Committee consideredthe case as per agendaand [of][ HBP] [Vol.] [I] [as][ per] [details] [given][ below] [or] [as] [applied][ by] [the] [firm,] [whichever] [is] [less:] 000 [Para][ 4.07] it was decided to ratify norms under | Export Product - | Qty ; Sl. | Import Items Qty - HEXAFLUORO 500,00 MT 1 PRICAT 62-3M METAL| 5.0 MT ISOPROPYL METHYL CATALYST (Molybdenum | ETHER(HFMOP) Cadmiam based) | RA concerned may take further necessary action as per above decision of NC, ----- End of picture text -----

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----- Start of picture text ----- || ALC4/20200Cas No.:373/2/82- ~ ENTERPRISESPasty Name:PIRAMAL LIMITED INC/3/MEET/Jan/202021/4[Meet No/Date: Approved‘Status: || fo FoF:01/82/050/01407/AM21/MOANA oan:03/95/040/00153/AM21/vooisvamay — 22.06.2020bxagbaeostonerss Ao[ | [Decision: The Committee considered the case as per agenda and it wasdecidedto ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: | No. No. | it Clopidogrel Tablets USP 75mg | 1 Number 1 Clopidogrel Bisulfate | 99.8325 ‘ | (Pack Size 90 _ Tabs.) | Tablet USP mg / . (Each Tablet contains Clopidogrel : tablet Bisulfate 97.875 mg equivalent to 2 Plastic Bottles 75CC | Relevant : clopidogrel base 75mg) (Net wt. of _ | OPQ’ white HDPE| as per | Import Sr. No. 1 is 5285.25 kgs, Sr. Round 38mm packing | ; No. 2 is 600000 Nos, Sr. No. 4 is ; oe policy | | 600000 Nos.) 4 | CR38400APJT865BLUE PP465 1400]| asperRelevant |!|i . i201 ; . . (Plastics i Caps/Closures PP lic | 38MM-400 Blue CR) | P°"°Y . 2 Clopidogrel Tablets USP 75mg | 1 Number 1 Clopidogrel Bisulfate | 99.8325 | (Pack Size ° 1000 ~ Tabs.) | Tablet USP mg / (Each Tablet contains Clopidogrel tablet i Bisulfate 97.875 mg equivalent to 3 CC8940AFS837 | Relevant clopidogrel base 75mg) (Net wt. of WHITE PP551 CT 89 | as per Import Sr. No. 1 is 9,79 kgs, Sr. Plast PsTSR Wie packing | |1 Nos)“ is. 100 Nos, Sr. No, 5 is: 100 . 400CCHDPEasticRoundOPQ 53mm)whiteottles policy' |i 5 Blue 53mm Pp Cap | Relevant |)’ . | . Lp-E &Triseal | as per , | , F217hy Part ID packing ; | | AC53400-BLP(Plastics p o licly . | ° Caps/Closures PP Pod ee _l , _ | 53MM-400 Blue PP) | | . lea concerned may take further necessary action as per above decision ofNC. | ----- End of picture text -----

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----- Start of picture text ----- |[ [CaseALC4/2020No:386/2/82-. PartyjAROMATICS Names) & [MeetNo/Date:INC/3/MEET/Jan/20202 1/4 [ApprovedStatus: | | (HQFile “IRLAFile————~—~—~SCS No/Date:0310836830Lic | | :01/82/050/01420/AM21/ :03/95/040/00181/AM21/ 23.06.2020 | Decision:The Committee considered the case as per agenda and it was decided toratify norms under |- | Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: . |202 SL. Export Product Qty | SL. | Import Items Qty. | No. No. HEXYL ACETATE ° N HEXANOL 0.782 kg: | 2 | HEXYL SALICYLATE Lkg N HEXANOL 0.438 kg . : SALICYLIC ACID 0,654 kg ISO AMYL SALICYLATE SALICYLIC ACID 0.737 kg RA concerned may take further necessary action as per above decision of NC. ri ~ [Case No.:8/9/82-AL.C4/2020 — PartyPHARMAName:NAARI PRIVATE ‘(MeetNC/3/MEET/Jan/202021/4No/Date:. —~—~—~=S Status:Approved ft . {LIMITED * 12.02.2021 , | [AQ File REA File Lic.No/Date:0510414507 | | :01/82/050/01435/AM21/ 1:05/24/040/00143/AM21/ 30.06.2020 | |Decision: The Committee considered the case as per agenda and it was decided to ratify norms under |203 Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: | | Export Product Qty SL Import Items Qty . | No. Nandrolone Decanoate 19-Norandrostenedione (NAD) | 0.982 kg RA concerned may take further necessary action as per above decision of NC. . ----- End of picture text -----

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----- Start of picture text ----- . . , |[ |Case No.:23/3/82-ALC4/2020oo FoorLTD|Party Name:SAISONS & INDUSTRY PVT CantinaMeet12.02.2021 No/Date:. BrooStatus: ase FHQ File REA FileIieNo/Date: 0310837035Py 01/82/050/01450/AM21/'+~ :03/95/040/0020VAM2i7* 06.07.20200 0 , | Decision: | The Committee considered the case as per agenda and it was decided to ratify norms under | {Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: | Export Product Qty | Sl. | Import Items Qty | ; . No. _ | (for export of "| 1 Number PFS) |_| [uRsopzoxycHori0c Tig | | SOLUTION) | 23 [iameroweeIEP OX 239 SPRAY DRIED | 0.030kg 4 IEP OX 235 SPRAY DRIED | 0.035 kg , |I: | °ENzMe5 |IEP OX poworR152 SPRAY DRIED| . , ENZYME POWDER . ' | Sxyerowee || | ENZYME POWDER || |RA concerned may take further necessary action asADENINE( COENZYME-1) per aboveDINUCLEOTIDE decision ofNC. , | ----- End of picture text -----

: {Case No.:35/3/82-ALC4/2020 |Party Name:GLAND Meet No/Date: Status: . © NC/3/MEET/Jan/202021/4 |Approved . | | po PHARMA LIMITED 12.02.2021 re | ; le:01/82/050/01462/AM21/ File :09/24/040/00070/AM21/IRLA File [ienoate:091006894207.07.2020 : . || peeDecision; 4.07 ofHBPThe Vol.Committee I as per detailsconsidered giventhe belowcase oras asper appliedagenda byand the it firm,was whichever decided to ratify is less: norms under| He tg , | Sl. | -Export Product . Qty |. SL. | Limport. Items Qty. | , No. | ' . a No. , . i. , 1005 1 Enoxaparin Sodium _ | L Number | ‘ ; Syringes | {o° Plunger Stoppers | 5 Preventis Needle Net to Net | , 2 | Enoxaparin Sodium. 1Number | 1 |HeparinSodium> 7 Injection 120mg Precfled | 238.40mg sf.

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----- Start of picture text ----- |) EeeTT [Shielding][ System] . | 3 | Enoxaparin Sodium 1 Number Heparin Sodium = _—«(|: 298.0 mg Injection 150mg Pre-filled — Barrel Syringes Net to Net oan Syringes 7 Plunger Stoppers Net to Net J - Plunger Rods Net to Net te ek ee en ceed ke. cd. S....] Preventis Needle. +], NettoNet. 9 fe io ‘ on Shielding System | * of | RA concerned may take further necessary action as per above decision ofNC. | = Case [No.:45/3/82-~~(PartyName:AUROBINDO] [[Meet] No/Date:) ——=—S~S~«~SStattus:— | ALC4/2020 PHARMA LIMITED NC/3/MEET/Jan/202021/4 jApproved | i _ 12.02.2021 F | {HQFile RLAFile Lic.No/Date:0910068952 - Lo :01/82/050/01472/AM21/ —|:09/24/040/00144/AM21/, 10.07.2020 + | Decision: TheCommittee consideredthe case as per agenda‘and it was decided | Para 4,07 of HBP Vol. I as per details given below or asp applied by the firm, whicheverto ratifyis less: norms under | | SL. Export Product Qty Sl. | Import Items Qty | | | No. No, oe LO | | 1 Penicillin V Potassium 500mg | 34000000.000 | 1 Phenoxymethyl 17340 kg ae Tablets Number _ | Penicillin Potassium ; Pott. (Each Tablet contains 500mg (Penicillin Vie 206 | relevantPencillin BulkV Potassium)Drug content[ Thein Potassium ) the total Export Quanaity of the a _ Export Product is ; 17000 Kgs ‘| of Penicilin V Potassium ] | 2 Penicillin V Potassium 250mg | 5000000.000 | 1 | Phenoxymethyl 1275 kg | Tablets(Each Tablet contains 250mg Number Penicil(Penici l linin Potassium Vv | Penicillin V Potassium) [ The Potassium) | relevant Bulk Drug content in | the total Export Quanaity of the , Export.Product is : 1250 Kgs of | - ‘ , ; , . : | Penicilin V Potassium | : . ;RA concerned may take further necessary action as per above decision ofNC. : ee ----- End of picture text -----

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|||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|||(Case No.:42/3/82-ALC4/2020||Party|Name:INTAS|Meet No/Date:|Status:|
|||PHARMACEUTICALS|LTD.||NC/3/MEET/Jan/202021/4|‘Approved|.|
|12.02.2021|
|File|””CSRA|Fife|'Lic.No/Date:0810148124 ||
|Decision:||The|Committee|considered|the|case|as|per|agenda|and|in|the|light|of|earlier|decision|taken|in|
|||Meeting|no.|7/82-ALC4/2020|dated|04.12.2020|against|Advance|Authorization|No.|0810149014|dated|
|:|i|(06.11.2020,|it|was|decided|to|ratify norms|under|Para 4.07|of HBP|Vol.|I|as|per|details|given|below|or|as|
|applied by the|firm,|whichever|is|less:|
|||INo.|No.|
|;|[.|1|| PACLITAXEL|2306436.000|
|.|i||INJECTION6|MG/ML,|USPSML:|| Number|72|PHENYL-2-AZETIDINONE-3-1,5-BIS[DI|JSOPROPYL-(+)-|4-|||58,130kg|
|EACH|ML|
|||VIAL|HYDROXY-SILYL]PENTANE|
|||CONTAINS:|4|5/16.7/50|ML|GLASS|VIALS||Relevantas|
|:|PACLITAXEL|(AS|PER|GENERAL|NOTE|FOR||per packing|
|:|||PH.EUR.|6 MG|CHEMICALS & ALLIED PRODUCTS)|policy|
|||(AS|PER|GENERAL|POLICY|FOR|
|||PACKING MATERIAL|
|13.|MM/20|MM|FLIP|OF|SEAL|
|:|.|;|.|:|(AS|PER|GENERAL|POLICY|FOR:|
|i|PACKING MATERIAL)|
|log|||2|| PACLITAXEL|||716550.000|
|.|||6|MG/ML,|16.7ML|PHENYL-2-AZETIDINONE-3-|
|VIAL|HYDROXY-SILYL]PENTANE|
|EACH|ML|
|i|CONTAINS:|4|5/16.7/50|ML|GLASS|VIALS|||Relevant|as|
|I|PACLITAXEL|(AS|PER|GENERAL|NOTE|FOR||per packing|
|||PHLEUR.|6 MG|CHEMICALS & ALLIED PRODUCTS) _||policy|
|||5|13|MM/20|MM|RUBBER|STOPPERS|
|;|fo||||.|.|:|6|PACKING13.|MM/20 MATERIAL)MM|FLIP|OF|SEAL|;|
|;|PACKING MATERIAL|
|||.||B|| PACLITAXEL|||240799.000|
|||_|||INJECTION|USP:|||Number|2|1,5-BIS[DI|ISOPROPYL-G)-|—4-|||58.130kg|
|i|6|MG/ML,|50ML|PHENYL-2-AZETIDINONE-3-|
|VIAL|HYDROXY-SILYL]PENTANE|
|Fo||.|| EACH|ML|3|||[KOLLIPHORELP]|| 2230.554kg|
|‘|ni|CONTAINS:|4|5/16.7/50|ML|GLASS|~~|VIALS|||Relevant a8|||||
|||PH.EUR.|6 MG|CHEMICALS & ALLIED PRODUCTS) _}|policy|
|!|5|13|MM/20|MM|RUBBER|STOPPERS|
|:|
|‘|:|‘|‘|‘|.|PACKING|MATERIAL)|+|:|ty|
|;|(AS|PER|GENERAL|POLICY|FOR|
|aof|aPACKING MATERIAL)|
|;|||lea concerned may take further necessary action as per above decision ofNC.|||

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. - 121 : . ~~" [GaseNo.:49/3/82-ALC4/2020 [PartyName:NEOGEN ‘([MeetNo/Date: (Status: | _ {CHEMICALS LIMITED NC/3/MEET/Jan/202021/4 |Approved | | 12.02.2021 SIE IRCFile Jie[NovDate:0310837205][ FT] | (Decision: The Committee considered the case as per agenda and it was decided to ratify normsunder i Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Pos | Export Product Qty SL. Import Items Qty oo | , No. , | 1,4 DIBROMOBUTANE lkg TETRAHY DROFURAN 0.412 kg | LIQUID BROMINE 0.912 kg . | RA concerned may take further necessary action as per above decision of NC,

[ [Case No.:55/3/82-~«“iPartyNName:STYRAXLIFE (MeetNo/Date: (Status: | ALC4/2020 SCIENCES PRIVATE INC/3/MEET/Jan/20202 1/4 ‘Approved | , LIMITED 112,02.2021 , | [HQFile ~~ RLAFile—~—~—~—_[Lic.No/Date:0910068904 | | :01/82/050/01482/AM21/ :09/24/040/00166/AM21/ 17.07.2020 | Decision: The Committeeconsideredthe case as per agenda and it was decided to ratify norms under i Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: 1209 | 1 _ Export Product : Qty . | SL Import Items Qty ; | . No. L-MENTHYL GLYOXYLATE | ikg ‘GLYOXALIC ACID 50% | 0.752 kg HYDRATE (MGH) CYCLOHEXANE 1.41 kg | RA concerned may take further necessary action as per above decision of NC. |” (CaseNo.:68/3/82-ALC4/2020‘ [PartyName:STYRAX MectNo/Date: | Status: PHARMA PRIVATE INC/3/MEET/J.[an/202021/4][|Approved] . ’ LIMITED » (12.02.2021 > . (HQRie REA FileSSSSSCSCLicNov/Date:0910008986 | | :01/82/050/01495/AM21/ :09/24/040/00208/AM21/ (21.07.2020 | (DecisiThe C o mmitteen: consideredthe case as per agenda and it was decided to ratify norms under i Para 4.07 of HBP Vol. Las per details given below or as applied by the firm, whichever is less: i 210 . | Export Product Qty | SL Import Items : Qty “4 | L-MENTHYL ~— GLYOXYLATE | 1 kg GLYOXALIC ACID 50%. ‘|: 0.752: kg | HYDRATE (MGH) CYCLOHEXANE 1.41 kg | ’ {RA concerned may take further necessary action as per above decision of NC. : :

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----- Start of picture text ----- . . a 122 [Case No.:64/3/82- —~—~—~—«SParty Name:USV PRIVATE |MeetNo/Date: —~*(Status:—— | ALC4/2020 . LIMITED INC/3/MEET/Tan/20202.1/4 Approved : (12.02.2021 ee . ~ | © 401/82/050A14917AM21/ :03/95/040/00236/AM21/ . (22.07.2020 ns oe ne i | Decision: The Committee considered the caseas peragenan d itawasdecided | Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whicheverto ratifyis less: norms under | SL. Export Product ; Qty SL Import Items | Qty i211 1 Doxycycline Tablets, USP 50 MG 100 S (| 1 1 Doxycycline 51.70 mg [/] a 32,400 Bottles x 100 Per Bottles = 32,40,000 | Number USP 50 mg Tablet . . | Kgs)Tablets) ( Net Content Weight =, 162.000 (Monohydrate) ; - ; | 2 Doxycycline Tablets, USP 100 MG 50 S (| 1 1 Doxycycline 103.40 mg / } . | H 84,000 Bottles x 50 Per Bottles = 42,00,000 | Number USP 100 mg Tablet ‘ i Tablets) ( Net Content Weight = 420.000 (Monohydrate) :i; Kgs) 3. | Doxycycline Tablets, USP 100 MG 500 S$ ¢ | 1 Doxycycline 103.40 mg / 22,400 Bottles x 500. Per Bottles = | Number USP 100 mg Tablet 1,12,00,000 Tablets) ( Net Content Weight = (Monohydrate) | ‘| 1120.000 Kgs) ‘ ; ; {RA concerned may take further necessary action as per above decision of NC. J ["[Case No.:71/3/82-—~—~=*PartyName:DEEPAK‘(MeetNo/Date: | ALC4/2020 ; = ~—~—~—~S Status: == || HQFile| SRA|NITRITE File LIMITED——S—~™~S~SCS——— LicINC/3/MEET/Jan/202021/4|12.02,2021No/Dates3410046248 [Approved[| :. :01/82/050/01498/AM21/ 134/24/040/00404/AM20/ [24.07.2020 | | | |Decision: | The Committee considered the case as per agenda and it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:(to be check) : | | ; , No. . os || | SIRIRLUOROMETAYE [Tie Joo | ACETO PHENONE , [282 , : . | : Solution in Water on re oo, : 7 “Nat-allowed asshoivn domestic | ; y ‘ 8 Not allowed as shown domestic | ' . | : (9 [SofaAsh «OS [eC] : i . Il Catalyst ; Not allowed as no details ‘ i ‘ : a ; ‘ ‘ . provided os , i ; Hydrogen Not allowed as shown domestic | Hydrochloric Acid Not allowed as shown domestic | . IRA concerned may take further necessary action as per above decision of NC. . | ----- End of picture text -----

oe oc :

. : :

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----- Start of picture text ----- T°" ICaseNo.:48/6/82-—~—~—~—~—=«(iParty Name:KOPRAN‘(Meet No/Date: ————S—s(Status: ALC4/2020 RESEARCH NC/3/MEET/Jan/202021/4 jiApproved |LABORATORIES LIMITED /12.02.2021 | | [Decision: The Committee considered the case as peragenda andit wasdecidedto ratify norms under Para 4.07 of HBP Vol. | as per details given below or as applied by the firm, whichever is less: No. 213 Export Product | Qty | Sl. | Import Items Qty DORIPENEM Lkg | 1 MAP(METHYL VINYL PHOSPHATE:CAS 2,50kg | STERILE NO.189177-38-3)(4R-58-68-3-DIPHENY LOXY-6- | "| IR-HYDROXYETHYL-4-METHYL-7-OX0O-1 ‘ . | 2 DORIPENEM SIDE CHAIN(4-NITROBENZYL(28- | 2.463 kg | * | 48)-4-ACETYLTHIO-2-(N-SULFAMOYL-N-(TERT-BUTOXYCARBONOYL)AMINO)PYRRROLIDINE- “ | z | | {RA concerned may take further necessary action as per above decision of NC, | ----- End of picture text -----

==> picture [435 x 177] intentionally omitted <==

----- Start of picture text ----- / [CaseNo.:51/6/82-——=—~—~S~=* Party Name:FINE ORGANIC [MeetNo/Date: «Status: | jALC4/2020 - INDUSTRIES LIMITED ‘ |NC/3/MEET/Jan/202021/4 [Approved | | 12.02.2021 | | swrurunaneiiaeraimunmrneignmeraneraiaarareiaynmerqrunywmununeiay perma eneeivinseeininr vin inieerntinitisidsttsintuiiionine perounvanaieun win menemaniliecninnmeenvieteeunmutetel felcesktiaotihsbientnituitttiit | (HQFile . RLA File Lic.No/Date:0310838277 | :01/82/050/01660/AM21/ :03/94/040/00426/AM21/ 15.09.2020 ; | (Decision:The Committee considered the case as per agenda and it was decided 1214 [|Para] [4.07] [of][ HBP] [Vol.] [Las][ per] [details] [given][ below] [or] [as] [applied][ by][ the] [firm,] [whichever] to ratify [is] [less:] norms under | | Export Product Qty SL. Import Items Qty | GLYCERYL DI BEHENATE | 1 kg No. BEHENIC ACID 0,941 kg _ Lo. GLYCERINE 0.152kg |} _ [|RA][ concerned][ may][ take][ further][ necessary] [action][ as][ per][ above][ decision][ of] [NC.] ----- End of picture text -----

424

) . ; .

|:<br>|<br>.<br>|<br>7<br>re |<br>se"|:<br>|<br>.<br>|<br>7<br>re |<br>se"|:<br>|<br>.<br>|<br>7<br>re |<br>se"|:<br>|<br>.<br>|<br>7<br>re |<br>se"|[Case No.:70/6/82-<br>[PartyName:BIOLOGICALE[Meet No/Date:<br>aoe<br>|ALC4/2020<br>LTD<br>_ INC/3/MEET/Jan/202021/4<br>Approved<br>|<br>_<br>|<br>112.02.2021<br>.<br>THO File _ UREA File<br>_.__<br>Lic.No/Date:0910069236.<br>if<br>01/82/050/01679/AM21/<br>+|209/24/040/00303/AM214 > 22.09.2020<br>en<br>\Decision:<br>|The Committee considered the case as per agenda and it was decided to ratifynorms under|[Case No.:70/6/82-<br>[PartyName:BIOLOGICALE[Meet No/Date:<br>aoe<br>|ALC4/2020<br>LTD<br>_ INC/3/MEET/Jan/202021/4<br>Approved<br>|<br>_<br>|<br>112.02.2021<br>.<br>THO File _ UREA File<br>_.__<br>Lic.No/Date:0910069236.<br>if<br>01/82/050/01679/AM21/<br>+|209/24/040/00303/AM214 > 22.09.2020<br>en<br>\Decision:<br>|The Committee considered the case as per agenda and it was decided to ratifynorms under|[Case No.:70/6/82-<br>[PartyName:BIOLOGICALE[Meet No/Date:<br>aoe<br>|ALC4/2020<br>LTD<br>_ INC/3/MEET/Jan/202021/4<br>Approved<br>|<br>_<br>|<br>112.02.2021<br>.<br>THO File _ UREA File<br>_.__<br>Lic.No/Date:0910069236.<br>if<br>01/82/050/01679/AM21/<br>+|209/24/040/00303/AM214 > 22.09.2020<br>en<br>\Decision:<br>|The Committee considered the case as per agenda and it was decided to ratifynorms under|[Case No.:70/6/82-<br>[PartyName:BIOLOGICALE[Meet No/Date:<br>aoe<br>|ALC4/2020<br>LTD<br>_ INC/3/MEET/Jan/202021/4<br>Approved<br>|<br>_<br>|<br>112.02.2021<br>.<br>THO File _ UREA File<br>_.__<br>Lic.No/Date:0910069236.<br>if<br>01/82/050/01679/AM21/<br>+|209/24/040/00303/AM214 > 22.09.2020<br>en<br>\Decision:<br>|The Committee considered the case as per agenda and it was decided to ratifynorms under|[Case No.:70/6/82-<br>[PartyName:BIOLOGICALE[Meet No/Date:<br>aoe<br>|ALC4/2020<br>LTD<br>_ INC/3/MEET/Jan/202021/4<br>Approved<br>|<br>_<br>|<br>112.02.2021<br>.<br>THO File _ UREA File<br>_.__<br>Lic.No/Date:0910069236.<br>if<br>01/82/050/01679/AM21/<br>+|209/24/040/00303/AM214 > 22.09.2020<br>en<br>\Decision:<br>|The Committee considered the case as per agenda and it was decided to ratifynorms under|[Case No.:70/6/82-<br>[PartyName:BIOLOGICALE[Meet No/Date:<br>aoe<br>|ALC4/2020<br>LTD<br>_ INC/3/MEET/Jan/202021/4<br>Approved<br>|<br>_<br>|<br>112.02.2021<br>.<br>THO File _ UREA File<br>_.__<br>Lic.No/Date:0910069236.<br>if<br>01/82/050/01679/AM21/<br>+|209/24/040/00303/AM214 > 22.09.2020<br>en<br>\Decision:<br>|The Committee considered the case as per agenda and it was decided to ratifynorms under|[Case No.:70/6/82-<br>[PartyName:BIOLOGICALE[Meet No/Date:<br>aoe<br>|ALC4/2020<br>LTD<br>_ INC/3/MEET/Jan/202021/4<br>Approved<br>|<br>_<br>|<br>112.02.2021<br>.<br>THO File _ UREA File<br>_.__<br>Lic.No/Date:0910069236.<br>if<br>01/82/050/01679/AM21/<br>+|209/24/040/00303/AM214 > 22.09.2020<br>en<br>\Decision:<br>|The Committee considered the case as per agenda and it was decided to ratifynorms under|[Case No.:70/6/82-<br>[PartyName:BIOLOGICALE[Meet No/Date:<br>aoe<br>|ALC4/2020<br>LTD<br>_ INC/3/MEET/Jan/202021/4<br>Approved<br>|<br>_<br>|<br>112.02.2021<br>.<br>THO File _ UREA File<br>_.__<br>Lic.No/Date:0910069236.<br>if<br>01/82/050/01679/AM21/<br>+|209/24/040/00303/AM214 > 22.09.2020<br>en<br>\Decision:<br>|The Committee considered the case as per agenda and it was decided to ratifynorms under|[Case No.:70/6/82-<br>[PartyName:BIOLOGICALE[Meet No/Date:<br>aoe<br>|ALC4/2020<br>LTD<br>_ INC/3/MEET/Jan/202021/4<br>Approved<br>|<br>_<br>|<br>112.02.2021<br>.<br>THO File _ UREA File<br>_.__<br>Lic.No/Date:0910069236.<br>if<br>01/82/050/01679/AM21/<br>+|209/24/040/00303/AM214 > 22.09.2020<br>en<br>\Decision:<br>|The Committee considered the case as per agenda and it was decided to ratifynorms under|pe||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
||||||Para4.07 ofHBP Vol. I asper details givenbelow or as applied bythe firm, whichever is less:||||||||||
|||||||||No. <br>{1||<br>|ENOXAPARIN|85000.000|No.||||||
||||||||INJECTION:|||(POLYPROPYENE)|Number||||
||:||||||||5|ML(CHLOROBUTYL)<br>|05ML<br>CLEAR<br>GLASS||Number<br> 85000.000||||
|||||||||SODIUM|Number|||Gram||||
|||||||||40MG/0.4MLPRE|||(POLYPROPYENE)|Number||.||
|||7|||||(PFS)||||Number||||
||||al5!<br>a||||||5|ML(CHLOROBUTYL).<br>|05ML<br>CLEAR<br>GLASS||Number<br> 1147500.000||||
||||||||SODIUM<br>.-|Number|||Gram||||
|||||||||60MG/0.6MLPRE||||Number||||
|,|||||||(PFS)|,|7|(POLYPROPLYNE)<br>|PLUNGER STOPPER 1 ML| <br>(CHLOROBUTYL)|Number<br> 425000.000<br>Number||.<br>’||
||ne|,|ee||<br>|<br>|nl|ee||i|1.0ML<br>LONG| <br>7 GRADUATION 0.025 ML|Number<br>CLEAR GLASS<br>.||425000.000<br>Number<br>:||:<br>.<br>po|||
|||i|||||SODIUM|Number||_Gram|||.||
||||||||INJECTION 80||3|BD PREVENTIS|||||
|.||ft<br>/<br>||||||MG/0.8 MLPRE<br>FILLEDSYRINGE<br>(PFS)||’||:<br>PLUNGER<br>ROD<br>IML<br>(POLYPROPLYNE)<br>- |Number|Number<br>Number|||.||
|.|4<br>|||||,|,|oo<br>,|:|(CHLOROBUTYL)<br>_ |Number<br>71.0ML<br>LONG|212500.000<br>GRADUATION’ 0.025 ML |Number<br>CLEARGLASS<br>~||Number<br>212500.000<br>Number||||.|

: : .

==> picture [551 x 417] intentionally omitted <==

----- Start of picture text -----

||||||||
|---|---|---|---|---|---|---|
|125|.|
|1|SODIUM|Number|Gram|
||||MG/1|ML PRE|,|Number|0|
|(PFS)|(POLYPROPLYNE)|Number|||
|||eee ||ee|
|(CHLOROBUTYL)|_||Number|-|
|7|:|’|oooCLEAR1.0ML|GLASS|LONG|||170000.000.|
|||6»|| ENOXAPARIN|106250.000|
|||INJECTION|120|Number|
|||okFILLED|SYRINGE|Ee(POLY PROPLYNE)|Number|
|||||
|;|{|.|(CHLOROBUTYL)|.|Number|
|||1.0ML|LONG||106250.000|
|egGLASS|
|CLEAR|ot ee|
|||SODIUM|Number|||Gram|eo|
|MG/1ML PRE|Number|
|||(PFS)|(POLYPROPLYNE)|Number|
|;|(CHLOROBUTYL)|Number|
|||Poon|1.0ML|.|LONG||85000.000|
|GRADUATION|0.025|ML | Number|
|||CLEAR GLASS|
|||iRA concerned may take further necessary action as per above decision of|NC.|-|||

----- End of picture text -----

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----- Start of picture text -----

|||||||||||
|---|---|---|---|---|---|---|---|---|---|
|||ALC4/2020|(ORGANIC INDUSTRIES|=|{NC/3/MEET/Jan/202021/4||Approved|—|
|,|||ac No.:82/6/82-|,|(LIMITED)[Party|Name:FINE|‘|[Meet12.02.2021 No/Date:|,||Rome|
|:|iw:01/82/050/01691/AM21/File|—_}:03/94/040/00451/AM21/fae|24.09.2020iLic.No/Date:03 10838429|||'|
|Decision:|The Committee|considered the case as per agenda and|it was decided to ratify norms under|
|L1G|‘Para 4.07 of HBP Vol.|||as per details|given below|or as|applied|by the|firm, whicheveris|less;|
||||.|[RAPVACDESTER|[Te|rz|
|be concerned may|take further necessary action as per above decision ofNC.|||

----- End of picture text -----

126

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----- Start of picture text ----- |[Case No.:88/6/82- —~—~=«*(PartyName:SRIAMLABS [MeetNo/Date: SSStatus: i ALC4/2020 PRIVATE LIMITED NC/3/MEET/Jan/202021/4 |Approved . | 12.02.2021 a | ‘Decision: The Committee considered the case as per agenda and it was decided to ratify norms wader Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: a (217. Export Product Qty SL.| Import Items Qty |. . No. ; | (18, 4R)-Cis-4- Lkg | 1 2-Azabicylo [2.2.1] ‘hept-5-en-3-one (Vince | 1.337 kg || | | Amino-2-cyclopentene-1- lactam)Sodium borohydride 0.214 kg | methanol L(+) Tartaric acid | 0.90 kg tartrate(CAP-I1) D() Tartaric acid Tartaric acid acid 0.742 kg kg | | {RA concerned may take further necessary action as may take further necessary action as take further necessary action as further necessary action as necessary action as action as per above decision ofNC. above decision ofNC. decision ofNC. ofNC.NC. | ----- End of picture text -----

==> picture [514 x 240] intentionally omitted <==

----- Start of picture text ----- tartrate(CAP-I1) D() Tartaric acid Tartaric acid acid 0.742 kg kg | | : _ {RA concerned may take further necessary action as may take further necessary action as take further necessary action as further necessary action as necessary action as action as per above decision ofNC. above decision ofNC. decision ofNC. ofNC.NC. | || {Case:ALC4/2020No.:108/6/82-——=—S«(PartyName:ASTECLIFESCIENCES LTD [MeetNC/3/MEET/Jan/202021/4No/Date:Status:jApproved . Jt | : | . [12,02,2021 . | 101/82/050/01717/AM21/HO Tile TITIAMDY) oad1:03/94/040/00425/AM21/oosssiamon (oe{05.10,2020NoDate0310838661 ) | [Decision: ~The Committee considered the case as per agenda and it was decided to ratify norms wide (2 [18] }‘Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: | | Export Product Qty Sl. | Import Items Qty . | No, || | Dextrinol i" CROTONIC ACID 0.849 kg bo Ts BUTADIENE 0.629 kg IRA concerned may take further necessary action as per above decision of NC. | ----- End of picture text -----

. . . . ; - | | oe

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==> picture [495 x 618] intentionally omitted <==

----- Start of picture text ----- | jALC4/2020 . (PHARMA LIMITED NC/3/MEET/Jan/202021/4 |Approved |ee PartyName;GLAND| Semel12.02.2021 | |, TQ FieREAFile TLje.No/Date:0910069305 | [Decision: The Committee considered the case as per agenda and it was decided to ratify normsunder | Para 4.07 of HBP Vol. | as per details given below or as applied by the firm, whichever is less: I. . . | SL Export Product Qty Sl. | Import Items Qty ae No. No] . (For export of ‘ | PPT GewMotecutar Weight [1 Number 1 No. PFS) | Heaprin Enoxaparin Sodium . | Injection USP 20mg in | 0.2m Prefilled Syringe b19 2 Low Molecular Weight | 1 Number | Heaprin Enoxaparin Sodium | Injection USP 40mg. in | 0.4ml Pre-filled Syringe ‘ 3. | Low Molecular Weight |.1 Number | _ | Heaprin Enoxaparin Sodium | |< | nection USP 6omg. in 3__| Plunger Stoppes | NettoNet__| | | | 6m Presfited syringe : 4 | Low Molecular Weight | 1 Number Heaprin Enoxaparin Sodium | Injection USP 80mg_ in | 0.8m Pre-filled Syringe | RA concerned may take further necessary action as per above decision of NC,  [~~(Case No.:151/6/82-—~—~—(Party Name:NEOGEN [Meet No/Date:_ (Status: | ; ; ‘ALC4/2020_ ‘CHEMICALS LIMITED. INC/3/MEET/Jan/202021/4 ‘Approved [7| [a:01/82/050/01760/AM21/ |:03/95/040/00053/AM21/SO 19.10.2020: 220 Para 4.07 of HBP Vol: Las per details given below or'as applied by the firm, whichever is less: | Export Product Qty SI. | Import Items ) Qty | ||_| [SOBUTYCBROMIDEC:aROMO2 METHYL PROPANE) |=ikg [2 —/HouiDaROMRE [pe || : |RA concernedmay take further necessary action as per above decision of NC. | ----- End of picture text -----

128

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----- Start of picture text ----- Case No.:163/6/82- [Party Name:NEOGEN (Meet No/Date: Status: ALC4/2020 }CHEMICALS LIMITED |INC/3/MEET/Jan/202021/4 |Approved | | }12.02.2021 | THQFileREA File Lic. No/Date:0310839070 [SS , |221| (Decision:|Para 4.07 of| HBP The CommitteeVol. I as per considereddetails given the below case as peror as applied agenda and by the it firm, was decidedwhichever to ratifyis less: norms sn| Export Product . Qty SL Import Items Qty ]. | ; ; No. | | [EBROMO-CFLUGROBENZENE [Tig [1 |FLUOROBENZENE[O80kg | _ IRA concerned may take further necessary action as per above decision ofNC. | ; Case No.:182/6/82- [Party Name:ASHISH LIFE [Meet No/Date: — (Status: — |. |ALC4/2020 ISCIENCE PRIVATE NC/3/MEET/Jan/202021/4 |Approved a . LIMITED 12.02.2021. | | [BeHQ File’ 179 VAMOU/ R LAe Fileee STO/AM2U [ieNorDaLic.No/Date:03 10839193 | _ |Decision: The Committee considered the case as per agenda and it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: . No. | 1 TYLOSIN TARTRATE POWDER 100%-100GM | 1500.000 TYLOSIN 2579.28 kg | SACHET (EACH GRAM CONTAINS TYLOSIN | Number TARTRATE | TARTRATE150 kgs) 100%) (net content of exempt material is MATERIAL)(RAW 2 TYLOSIN TARTRATE POWDER 100% -500GM | 300.000 SACHET (EACH GRAM CONTAINS TYLOSIN | Number TARTRATE 100%) (net content of exempt material is . | 150 kgs) oo, . (EACH GRAM CONTAINS TYLOSIN TARTRATE Number | . 100%) (net content of exempt material is 150 kgs) , . | 4 TYLOSIN TARTRATE POWDER 99% -100GM } 1500.000 . . SACHET (EACH GRAM CONTAINS TYLOSIN | Number , | TARTRATE 99%) (net content of exempt material is | I. 5 | TYLOSIN TARTRATE POWDER 99% -500GM | 300.000 . | |. TS148.5kgs) A RTRATECHET (EACH99%) (netGRAMcontent, CONTAINSof exempt materialTYLOSINis | Number | . | TYLOSIN TARTRATE POWDER 99% -1KG JAR | 150.000 j (EACH GRAM CONTAINS TYLOSIN TARTRATE | Number I 99%) (net content of exempt material is 148.5kgs) 7 | | 7 TYLOSIN TARTRATE POWDER 20% -100GM | 5000.000 . . (EACH GRAM, CONTAINS TYLOSIN TARTRATE | Number - EQ. TO TYLOSIN 20%) | _ | {net content of exempt material is 100 kgs) ; : ‘ ----- End of picture text -----

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----- Start of picture text -----

|||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
|||TYLOSIN|TARTRATE|POWDER|20%|-500GM ||2000.00|
|.|(EACH|GRAM|CONTAINS|TYLOSIN|TARTRATE ||Number|’|
|i|EQ.|TO|TYLOSIN|20%)|
|||(net|content|of exempt material|is 200|kgs)|.|
|:|9|TYLOSIN|TARTRATE|POWDER|20%|-1KG|JAR ||2000.000|
|||(EACH|GRAM|CONTAINS|TYLOSIN|TARTRATE|||Number|||.|
|||(net content of|exempt material is 400 kgs)|;|oO|
|;|||10|TYLOSIN|BOLUS|200MG|(EACH|BOLUS ||100000,000|‘|
|:|i|exempt material|is 20|kgs)|,|
|||11|TYLOSIN|INJECTION|5%-30|ML|(EACH|ML||75000,000|
|i|CONTAINS|TYLOSIN|: TARTRATE|EQ.|TO ||Number|q|
|TYLOSIN|BASE|50MG)|
|(net|content|of exempt material js|112.5|kgs)|:|
|;|12|TYLOSIN|INJECTION|5%-50|ML|(EACH|ML ||50000.000|;|
|.|CONTAINS|TYLOSIN|TARTRATE|EQ.|TO ||Number|.|
|||TYLOSIN|BASE|50MG)|
|||(net|content of exempt material|is|125|kgs)|
|||13|TYLOSIN|INJECTION|5%-100|ML|(EACH|ML|||10000.000.|
|CONTAINS|TYLOSIN|TARTRATE|EQ.|TO ||Number|
|||(nettTYLOSINcontent of|exemptBASEmaterial|is|50kgs)|50MG)|
|||14|TYLOSIN|TARTRATE|INJECTION|20%-30|ML ||10000.000|
|,|7|||TO(EACH ML CONTAINS TYLOSINTYLOSIN|TARTRATE"200MG) EQ. |||Number|,|
|;|(net|content of exempt material|is|60|kgs)|
|||15|TYLOSIN|TARTRATE|INJECTION|20%-50|MI ||25000.000|
|.|| (BACH ML CONTAINS TYLOSIN TARTRATE|EQ. | Number|a,|
|||~|| TO|TYLOSIN|200MG)|
|||:|(net content of|exempt material is 250 kgs)|
|||16|TYLOSIN|TARTRATE|INJECTION|20%-100|ML ||15250.000|.|
|||(EACH ML CONTAINS|TYLOSIN TARTRATE|EQ.||.|Number|
|||TO|TYLOSIN|200MG)|
|||(net|content of exempt material|is 305kgs)|:|;|
|:|RA concerned may take further necessary|action|as|per above|decision of|NC.|,|,|-|
|.|.||||ateALC4/2018 No.:830/15/82-|.|_|.(SOMANAHALLD Name:R CHEM PVT.LTD,|CantaMeet12.02.2021 No/Date:|anDeferred|||.|.|
|A|HOFile|“URLA|File|ee|Teic:No/Date:0910067074|||||.|
|.||||:01/82/050/02287/AM19/|/:09/24/040/00516/AM19/|18.01.2019|||.|
|:|||223 Decision:|Te‘Committee consideredthe|case|as|per agenda|in|the|presence|of technical|experts andit|
|jwas decided to call|for following information|from the firm:|.|i|
|i|(i)|Molecular weight of Export|Product.|||
|.|||||(ii)(iii)|Copy% yiéld of on Technical molar basisLiterature for eachin step. support of yields|envisaged.||a|

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. [ CaseNo.:851/15/82Party Name:SI GROUP - Meet No/Date. Status: “| ALC4/2018 INDIA PRIVATE LIMITED | -{NC/3/MEET/Jan/202021/4 ‘Deferred —_ . 12.02.2021 eb HQ File IRLAF le Lic. No/Date:0310826724 Foe . SF *:01/82/050/02308/AM19/ $'03/95/040/01108/AM19/ ~ ° (30.01.2019 ~ fp ge . (224 Decision: The Committee considth e caseredas per agenda in the presence of technical experts andit ‘twas decided to call for following information from the firm: | . (i) Complete chemical reaction from raw material, acetone to 3,3,5TRIMETHYLCYCLOHEXANONE showing molecular weights of each i component with percentage yield on molar basis at each step of the reaction.

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----- Start of picture text ----- [\Case No.:891/15/82- —~—~—«(PartyName:GELTEC.—~‘(MeetNo/Date: ———S—S(Status: || (HQFileALC4/2018 REAPRIVATE File LIMITED.SSCS:- NC/3/MEET/Jan/20202{12.02.2021ic No/Daate:0310826970 1/4 [Deferred(| ;. | :01/82/050/02348/AM19/ :03/94/040/00970/AM19/ - 11.02.2019 | ?25 Decision:was decided ~Theto callCommitteefor followingconsideinfo r edmation the casefrom as the perfirm: agenda inthe presence of technical experts and it | (i) Copy of Master Batch Formula for both medicament and shall showing net | . content of inputs in export item. . 1 mrs sereuymeorert meuarsudan mary x9 88s #9088 Ame E109 wR NN A YAR BRA) A AAMAS ARN OLA A OA Ae AA RSA ON ARAL AR Fe ORS LN UR Rn a non aa ok |” [Case No.:924/15/82- ALC4/2018 —~=«(Party Name:INDO{LIMITED AMINES (MeetNC/3/MEET/Jan/20202No/Date: ——=([Status: 1/4 \Deferred 12.02.2021 | | {HQFile —~———”——SRLA File.—————~™CO—CSLicNo/Date:0310827206 [| | :01/82/050/0238 1/AM19/ :03/94/040/00984/AM19/ —s {21.02.2019 : 726 Decision: ‘The Committee considered the case as per [agenda] in the presence of technical experts and it was decided to call for following information from the firm: : | | Amine@® COA of entire import quantity from supplier indicating % purity ofcoc ----- End of picture text -----

131

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| [Case No.:934/15/82~—~‘(PartyName:ASTRAL[Meet No/Date: [Stans TALCA/2018 - _ |STERITECH PVT. LTD. INC/3/MEET/Jan/202021/4 ‘Deferred 7 | QRie IRA File [Lic.No/Date:3410044929 | —_ :01/82/050/02391/AM19/ :34/24/040/00356/AM19/ 22,02.2019 27 Decision: ‘The Corhmittee considered ‘the case as per agenda in the presence of technical experts and it was decided to call for following information from the firm:

(i) Please indicate whether the injections for export is 1 gm,2 gm or 10 gm dose per

[Case No.:935/15/82——~—~*‘(PartyName:ASTRAL ———_—(|[ MeetNo/Date:Status: | | [HQALC4/2018 Rg - ERESTERITECHFile PVT.Tie LTD. No/Date:3410044930INC/3/MEET/Jan/202021/412.02.2021 |Deferred| | | :01/82/050/02392/AM19/ :34/2.4/040/00355/AM19/ 22.02.2019 |228 Decision: The Committee considered the‘case as per agenda in the presence of technical experts and it | was decided to call for following information from the firm: . , ‘

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----- Start of picture text ----- (i) Please indicate whether the export item is 20 ml or 30 ml as both are given ----- End of picture text -----

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----- Start of picture text ----- ["[Gase No1033/15/82-——~—*(PartyName:SRIAMLABS [MeetNo/Date: (Status: | ALC4/2018 PRIVATE LIMITED NC/3/MEET/Jan/202021/4 jDeferred 2 | QIREAod File Lic12.02.2021 [No/Date:0910067219] | 209 :01/82/050/02490/AM19/ :09/24/040/0059 1/AM19/ 26.02.2019 | Decision: The Committee considered the case as per agenda -in the presence of technical experts and it |; jwas decided to call. for following information from the firm: : . . | , (i) Complete technical details as per Appendix 4E,_. . ----- End of picture text -----

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| |-_[CaseFALCAROI9No167/1/82a—PPartyISCIENCES Neme:AUROREPRIVATE LIFE——s [MestNovDates|NC/3/MEETJan/202021/4 Status:(Deferred || :01/82/050/02562/AM19/ —-}:09/24/040/00612/AM19/ 13.03.2019 . [230 Decision: The Committee considered the caseas peragenda | was decided to call for following information from the firm: in the presence of technical experts and it | , i Specific names of import item No. 3, 4 and 5 alongwith their catalogues. | ; (ii) Specific purpose for utilization of 4 types of Enzymes in a single step. | (iii) Justification for quantitative requirement of all Enzymes shown in the process, | their recovery and wastage claimed.

MIME iinCasetintind i tirtnenenttreee renner PPA RNEREY HERI UUCER RT OEEARREPEIHEPEENUPCCETHCLAN CHEHCHRAOUECHAHCRY EATONAMSO LOL E GAYA MG DASA PRAY ARON AARON Sch teemteiercterpcten orca ecverecnenscccnannE | ALC4/2019No.:200/1/82INDUSTRIES{Party Name:AETHERLIMITED INC/3/MEET/Jan/202021/4Meet No/Date: {DeferredStatus: 1 . Lo 12.02.2021 || THQ:01/82/050/02595/AM19/ File ~IRTA:52/24/040/00085/AM File 19/~~"19.03.2019 Lie,No/Date:5210043000 : b31 Decision: — The Committee considered the case as per agenda in the presence of technical experts and[it] was decided to call for following information from the firm: , | re) Step-wise manufacturing process, | (ii) Complete chemical reactions with molecular and structural formula and | molecular weights alongwith stage wise % yields on molar basis. 4 (iii) Material balance (Stoichiometric balance details) for the entire manufacturing process, —

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----- Start of picture text ----- |foo?(CaseNo.:39/1/82-ALC4/2019 [Party Name:TIDE ——(Meet No/Date: —Ss(Status: a ok INDUSTRIES NC/3/MEET/Jan/202021/412.02.2021 . |Approved =| | JHQFile . . (RLAFie~~~ (Lic.No/Date:3410045044 | | :01/82/050/00039/AM20/ :34/24/040/00009/AM20/ 11.04.2019 ; |. . | [Decision:Para 4.07 of HBP‘The CommitteeVol. I as per considerdetails giventhe belowcas e ordasasperappliedagendabyandtheitfirm,was deciwhichd e verd to ratifyis less: norms under| Export Product * Qty Ts. Import Items Qty - No. oo | S| L-Rose Oxide(4-Methyl-2-(2-Methy|prop- | -enyljoxane lke_. | 1 ‘ ;L-Citronellol 3,269_— kg . lea concerned may take further necessary action as per above decision of NC. | ----- End of picture text -----

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. = Case No.:140/1/82Party Name:MALWA_ [Meet No/Date: (Status; | — {ALC4/2019 OXYGEN & INDUSTRIAL INC/3/MEET/Jan/202021/4 ‘Deferred nn GASES PVT.LTD., 12.02.2021 | | FQ FIT REAFile LieNo/Date:5610005605Fn . 1233 Decision: The Committee considered the case as per agenda in the presence of technical expertsand[it] | was decided to call for following information from the firm: . | (i) Justification for low yield of 33%. . . | ood. (ii) Authentic technical literature / catalogue in support of % yield claimed. | (iii) Last 2 years Production / corresponding Consumption of raw material duly | oo, certified by GST. [~[Case No.:203/6/82~—~(PartyName:SONGWON[MeetNo/Date: | ALC4/2019 SPECIALTY CHEMICALS — {NC/3/MEET/Jan/202021/4(Status:(Deferred =| | - NDIA PVT.LTD. - 12.02.2021 | {HQFile STRELA File SS—=~~~S«w Lc Note:3410045298 ~~ | :01/82/050/00429/AM20/ . — }:34/24/040/00069/AM20/ 18.07.2019 234 Decision: The Committee considered the case as per agenda in the presence of technical experts and it i — jwas decided to call for following information from the firm: , | @ % yield at every stage of manufacturing. i (ii) Calculation Sheet to arrive at the quantity of raw material asked per kg of export on the basis of Stoichiometric balance and % of yield. ase No.:4/7/82-ALC4/2019 } . [PartyFRAGRANCES Name:KEVAPRIVATE(MeetNC/3/MEET/Jan/20202No/Date:1/4 Status:|Deferred {LIMITED 12.02.2021 | HQFile ~~ ~~~~—<RLAFile.~~——~—~—~S*SC:CSS«S Lic.[N/Date0310830887][|] | :0.1/82/050/00499/AM20/ ——_—_j:03/94/040/00373/AM20/ 07.08.2019 , . \235 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was decided'to call for following information from the firm: : | . . (i) Exact chemical name of import and export. . ; . (ii) COAcomposition.of import from foreign supplier indicating weight wise % Do (iii). COA of Export item. 8, an

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134

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----- Start of picture text ----- / (Case No.:28/7/82-ALC4/2019 |Party Name:UPL LTD. Meet No/Date: ~~ (Status: | . NC/3/MEET/Jan/202021/412.02.2021 (Deferred ote FQFile IRA File LieNo/Date:0310830995 Fo , Ot | §:01/82/050/00523/AM20/ | :03/95/040/01337/AM19/ * j14.08.2019 oy - [236 (Decision:© The Committee considered the case as per agenda in the presence of technical experts and it was decided to call for following information from the firm: ----- End of picture text -----

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(i) Complete and balanced chemical reaction from basic stage of Phenol and | Phosphorus showjng molecular weight and % yield on molar basis. (ii) C.A. Certificate showing past production of each intermediate (TPPI and i TMP) vis-a-vis actual consumption of raw material,

ened tet st ernmetcennetinpmanernbtteetnnsstnisenstssernsneatnamniniatbt pestendste ers tutmetensoratntnssenbenstmtstatoreheetuinnaenstind seems mmm races stmmny is fimtA ern th RA Ah hn mm 4HEN | Case No.:33/7/82-ALC4/2019 Party Name:AETHER Meet No/Date: Status: Co i i 12.02.2021 | || (HQFile—RLAFileINDUSTRIESLic. LIMITED| No/Date:5210043146.NC/3/MEET/Jan/20202 1/4 |‘Deferred | :01/82/050/00528/AM20/ |:52/21/040/00085/AM20/ /14.08.2019 | 237 [Decision: ~The Committee considered the case as per agenda in the presence of technical experts and it | was decided to call for following information from the firm: . (i) % composition of both the components in export product. | (ii) % recovery of solvent i.e. Tetrahydrofuran (TFH). | (iii) _ Production / Consumption data duly certified by GST for last two years. |

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----- Start of picture text ----- [Case No.:34/7/82-ALC4/2019 [PartyName:AETHER | INDUSTRIES LIMITED —(MeetNo/Date:NC/3/MEET/Jan/202021/4—~—~—~S{Status:—Deferred | 12.02.2021 | THOFile RL /:01/82/050/00529/AM20/. :52/21/040/00086/AM20/FileSS™~SCSCSCS Lic14.08.2019 No/Doate 5210043147 | : |'238” Decision:twas decided toThecall Committeefor following consideredinformationthe casefrom theas perfirm: agenda in the. presence of technical experts and ity . | me) Stoichiometric balance for the entire reaction. ; i (ii) Requirement and recovery of solvents. (iii) Justification for low yield. | ----- End of picture text -----

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, 135 ‘ | . 7 [CaseNo.:35/7/82-ALC4/2019[Party[Name:AETHER] (MeetNo/Date: (Status: , INDUSTRIES LIMITED NC/3/MEET/Jan/202021/4 {Deferred Mh BQ RAG TESTE ee FRET TTT nie12,02.2021NODE STORSTET POT | |:01/82/050/00530/AM20/ 152/21/040/0006 1/AM20/ {14.08.2019 | | (Decision: ‘The Committee considered the case as per agenda in the presenceof technical expertsand it . 1239 lwas decided to call for following information from the firm: | . (i) Complete chemical reaction with molecular and structural formula and net) | molecular weight. fo (ii) Stiochiometric material balance for each step. : (iii) Justification for low yield. {oo | (iv) Recovery of solvents. | (v) Production / Consumption data duly certified by GST for last two years. | . 7 [EaseNo.:84/7/82-ALC4/2019[PartyName:LYRUS . SCIENCES PVT LTD NC/3/MEET/Jan/202021/4 |Deferred | LIFE [MeetNo/Date: (Status: 12.02.2021 | [HQ File —_ “IREAFile Lic.No/Date:0710115309 | ; (240 |:01/82/050/00549/AM20/ :07/24/040/0009 1/AM20/ 20.08.2019 | Decision: The Committee considered was decided to call for following information from the firm: | the case as per agenda in the presence of technical experts and it | ™ (i) Copy of DML for export item showing composition. . : ["Gase No3/13/82-~~~«(iPartyNName:SRFLIMITED (MeetNo/Date:—~|(Status: ALC4/2019 NC/3/MEET/Jan/202021/4 |Deferred | : 12.02.2021 | | lHQFile ——~—~—~™”:CSRA FleSS*~S~S Lie. Nev ates[0510412564][[] , ' aq :01/82/050/00846/AM20/ :05/24/040/00445/AM20/ {21.11.2019 | a . | Decision: The Committee considered the case as per agenda in the presence oftechnical experts and it 1, {was decided to call for following information from the firm: : . , | . oo | nt) Complete technical details as per Appendix 4E having chemistry, molecular | ; weight, yield of reaction, stiochiometric balance of chemical reaction. ‘ . | [Case[No.:4/13/82-] | ALC4/2019 SS «(Party Name:SRF LIMITED [MeetINC/3/MEET/Jan/202021/4No/Date: [Deferred—~([Status:—| | | HQ Fie REA File [Lic NovDate:0510412505 | | lo42 :01/82/050/00847/AM20/ :05/24/040/0047 1/AM20/ [21.11.2019 me ~ Decision: ‘The Committee considered the case as per agenda in the presence of technical experts and it, . | |was decided to call for following information from the firm: | . (i) ’ weight,Complete % technicalyield, stiochiometricdetails as perbalance Appendixof chemical 4E havingreaction.chemistry; molecular*

136

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----- Start of picture text ----- oe [~~[CaseJALC42019No.:11/13/82-~~ JORGAParty N ame:ICS MANGALAM” LIMITED, [MeetNC/3/MEET/Jan/202021/4 No/Date: (Status:'Deferred ,| |(243 |:01/82/050/00854/AM20/(HQFile= ===———<“—t~s:t‘“‘“C«s«SREA|:03/95/040/00790/AM20/Fle=——~<CS~st~SCSCS Lic21.11.2019NoDate20310832931 |. | Decision: The Committee considered the case as per agenda in the presence of technical experts and it | was decided to call for following information from the firm: ‘ (i) Quantity and commercial value of By-Product Dipentene and Dipentene a fo | residue. | [Case No.:12/13/82-——=—S«Party | ALC4/2019 CHEMName:LINKLIMITED PHARMA ’ [Meet (NC/3/MEET/Jan/202021/4No/Date: \Deferred(Status: | 12.02.2021 | | (HQFile lo4a [:01/82/050/00855/AM20/] ~~ ——~<“<i~‘zRA:34/24/040/00256/AM20/Wile SSSS™~S~SCL 21.11.2019ic No/D ates3410045034 | ‘ | [Decisionwas decided toThecall Committeefor following info conside r edmationthe case from as the perfirm: agenda in the presence of technical. experts and it | (i) Recovery of dromium sulphate per kg export item and its sale-value. . (ii) Recovery of sodium sulphate per kg export item and its sale-value. ----- End of picture text -----

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----- Start of picture text ----- [~~ (Case No.:40/13/82- —~~~—~(Party NameJ.B. CHEMICALS [Meet No/Date: ——~S*«*Status: ALC4/2019 & PHARMACEUTICALS INC/3/MEET/Ian/202021/4 |Deferred | LIMITED /12,02,2021 | |HQFile (RLAFile ~~ Lic. [No/Date:0310833120] a _ |245 }:01/82/050/00883/AM20/ ,_ :03/94/040/00677/AM20/ (02.12.2019 ; | |Decision: The Committee considered the case as per agenda in the presence of technical experts and it was decided to call for following information from the firm: (i) Copy of Master Batch Formula for each export item. | ----- End of picture text -----

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----- Start of picture text ----- SO | |CaseNo.:54/13/82--—~—~—~«|Party Name:US AMINO ——SMeet No/Date: SSCS ‘Status:=,| ALC4/2019 PRIVATE LIMITED’ iNC/3/MEET/Jan/202021/4 |Deferred . . (12.02.2021 | JHQFile—~<—~Ssti‘“‘—s~s~iRLA Fle—™—~~S*~*~SCS«SLi.No/Dattes0310833244| , | :01/82/050/00897/AM20/ ,:03/95/040/008 16/AM20/ (05.12.2019 i 1246 [ecision: The Committee considered the case as per. agenda in the presence of technical experts and il ' _ |was decided to call-for following information from the firm: oo ot (i) Technical literature on Feed Grade import item with standard specifications. : . . _ (iii)Gi) COACOA ofof export import item.item from foreign supplier. . ; : ; | (iv) Process details with wastage. ----- End of picture text -----

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_ Case No.:59/13/82“Party Name:M/S “—""";Meet No/Date. —~—~—~S«wStatus: ok | ALC4/2019 HIMALAYAN PRODUCTS § |NC/3/MEET/Jan/202021/4 |Deferred | & INDUSTRIES CORPN., 12.02.2021 _ | IP.LTD . | | |247 £01/82/050/00902/AM20/ |.05/24/040/00483/AM20/ | 12.12.2019 | | Decision: The Committee considered the case as per agenda in thepresence of technical experts and it | was decided to call for following information from the firm: . | (i). % content of a.i. in imported extract. . (ii) COA of import item from foreign supplier. : (iii) Complete technical details as per Appendix 4E. [~~ [EaseNo.:66/13/82- ~—~—~—(PartyName:AETHER | ALC4/2019 INDUSTRIES LIMITED ‘(MeetiNC/3/MEET/Jan/202021/4No/Date: Status:|Deferred | |12,02,2021 | (HQFile RLAFile ~~ (Lic.No/Date:5210043258 | :01/82/050/00909/AM20/ :52/24/040/00044/AM20/ ° 12.12.2019 \248 Decision:The Committee consideredthe case as per agenda in the presence of technical experts and it | was decided to call for following information from the firm: | , (i) Complete technical details as per Appendix 4E. , | wee (ii) Complete chemical reaction with molecular and structural formula and | molecular weight alongwith stage wise.% yield on molar basis. | _ (iii) Recovery of solvent. ["TGase No.:65/13/82-~—~—~—«~(Party Name:ASHISHLIFE (Meet[No/Date:] | ALC4/2019 SCIENCE PRIVATE |NC/3/MEET/Jan/202021/4SS |Deferred‘[Status: LIMITED {12.02.2021 _ (HQFile ——SIREAFile—S—S~S~S~SCSSCL'ic, ND atc:0310833391 [ : [249 :01/82/050/00908/AM20/ ° :03/94/040/00662/AM20/ (13.12.2019 , ‘ Decision: The Committee consideted the case as per agenda in the presence of technical experts and it ° jwas decided to call for followitig information from the firm: . . . | — (i) Copy of Mater-Batch Formula showing net content of inputs and Batch records.

138

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||||||||||
|---|---|---|---|---|---|---|---|---|
|a|||ALC4/2019|||BIOTEC LTD.,|NC/3/MEET/Jan/20202|1/4|Deferred|,|
|||(12.02.2021|
||||HQFile-|~~~(RLAFile|~~~|(Lic.|[No/Date:0510412934]|[|]|
|250|:01/82/050/009 13/AM20/|:05/24/040/00566/AM20/|(17.12.2019|
|||Decision:|| The Committee|considered the case as per agenda|in the presence of technical|experts|and|it|
|||was|decided|to call|for|following|information from the firm:|
|||‘|()|Copy|of DML showing the composition|as|indicated|in export description.|
|||.|(ii)|COA|of import|item from foreign|supplier.|.|
|"(Case No.:92/13/82-—~—~—~—*(PartyName:TADIMETY|
|||ALC4/2019|_||AROMATICS|PVT,|LTD|(MeetNC/3/MEET/Jan/202021/4No/Date.—~—~—~<(Status:—=SS‘Deferred|
|||ae|12.02.2021|
|||0|Filontes fem|
||251|{:01/82/050/00935/AM20/|:07/24/040/00229/AM20/|27,12.2019|
|“Decision:|The Committee|considered|the case as|per|online agenda|in the presence|of technical|experts|
|and|it was decided to|call|for following|information from the firm:|
|.|@)|Chemistry and|material|balance|(Stiochiometric),|__|

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BOCase No:95/13/82[Party Name:PHALANX feet NovDate:oo | _ JALC4/2019 ‘LABS PRIVATE LIMITED — [NC/3/MEET/Jan/202021/4 Deferred | | HQ File ~ (REA File ~- \Li¢.No/Date:2610012888 (252 }:01/82/050/00938/AM20/ ———|:26/24/040/00013/AM20/ 27.12.2019 | [Devision: ~ The Committee considered the case as per online agenda im the presence of technical experts : | and it was decided to call for following information from the firm: | bot Complete technical details as per Appendix[4B.]

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----- Start of picture text ----- t| [Case No.:107/13/82- PartyName:SRIAMLABS [(MeetNo/Date.] ~~*(Statuss STC | ALC4/2019 PRIVATE LIMITED NC/3/MEET/Jan/202021/ |Approved FQ Ra | Bde Gates4 12.02.2021 0068310 :01/82/050/00950/AM20/ |:09/24/040/00477/AM20/ {01.01.2020 | |Decision: ~The Committee considered the case as per [agenda] | Para 4.07 of HBP Vol. I as per details given below or as applied byandtheitfirm,was whicheverdecided to ratifyis less:norms under | . 253 Export Product Qty | Sl. | ImportItems ' - | Oty | No. | (1S, 4R)-Cis-4- Lkg 2-Azabicylo [2.2.1] . hept-5-en-3-one (Vince | 1,337 kg cyclopentene-1- Sodium borohydride 0.214 kg | methanol L(G) Tartaric acid 0.90 kg tartrate(CAP-HI) D(-) Tartaric acid 0.742 kg i | RA concerned may take further necessary action as per above decision ofNC. | || [Case No.:108/13/82-~—~—~—~~PartyName:PANACEA[Meet No/Date. .~—~S Status | ALC4/2019- BIOTEC LTD., INC/3/MEET/Jan/202021/4 ‘Deferred | 12,02:2021 ! HQ File RLAFile ——SSC(Lic.No/Date:0510413189 [ 54 :01/82/050/00951/AM20/ :05/24/040/00619/AM20/ 02.01.2020 , ‘ | Decision: The Committee consideredthe case as per online agenda in the presence of technical experts | and, it was decided to call for following information from the’firm: ; (0)(ii) CopyCOAofof importDML showing item fromthe compositionforeign supplier. as given in export description.. | ----- End of picture text -----

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----- Start of picture text ----- [CaseALC4/2019 No.:118/13/82- “Party Name:AURORE LIFE_‘Meet No/Date: “lStatus: . SCIENCES PRIVATE |NC/3/MEET/Jan/202021/4 Deferred : | _ [LIMITED 12.02.2021 | ee* QTE REAFile (Lic, No/Date:0910068340Fe | }:01/82/050/00961/AM20/ —— |:09/24/040/00496/AM20/ * \06.01.2020 es es \255 Decision: The Committee considered the case as per online agenda in the presence of technical experts | and it was decided to call for following information from the firm: ° | (i) Complete and balanced chemical reaction showing molecular weight and molar , .. |i (ii) requirement.% yield on molar basis. .° : (iii) Complete material balance. [[Gase No:150/13/82-~~~*(PartyName-TINA~—~—~—~<(MeetNo/Date. —~—~—~—~S«~SStatus:— | ALC4/2019 ORGANICS PRIVATE iINC/3/MEET/Jan/202021/4 (Deferred LIMITED 412.02.2021 | nanrsanatanunsinuivnnunuivanseanenntuentnnnrnneeneesnstynnenenininsamuunuite yaunsenneunssmtnaninunanunnanennaninunnnirnecernnemnnnuninitaninhins jinhssnannannnnnntwentestin rthethhnhannnnnnnnnnAniane suurnmwnqantannnstinaratantntintih | HQ File RLA File ‘Lic.No/Date:0510413266 256 :01/82/050/00993/AM20/ :05/24/040/00633/AM20/ (09.01.2020 . | [Peciston: The Committe considered the case as per online agenda in the presence of technical experts | pnd it was decided to call for following information from the firm: | (i) Manufacturing process, chemistry material balance from starting raw material as IPA and Phosphorus. | [ase No.:175/13/82-—~—~—~«(PartyName:RENOWN —(MeetNo/Date: (Status: |. ALC4/2019 PHARMACEUTICALS (NC/3/MEET/Jan/202021/4 |Deferred | PRIVATE LIMITED _ 12.02.2021 QF REA File Lic.No/Date:3410045792 :01/82/050/0 1018/AM20/ :34/24/040/00326/AM20/ 17.01.2020 _ ; ; . | Decision: The Committee considered the case as per online | jand: it was decided to call for following information from the firm:‘agenda in. the presence of technical’ experts . | , (i) Export product description is not complete and not matching with DML . (257 _ furnished. Each export product may be separately described as per DML ; | alongwith number of capsules to be exported, ; | (ii) Copy of Master-Batch Formula for each export product duly authenticated by [|] . : : ... Q.C..Incharge indicating net content of each input: both for shell and » ‘ | medicament. . . ’ | ' (iii) Net weight of Soft Gelatine Capsules shell and medicament for each export | . product, : . : | (iv) Copy of Batch-Log Sheet for latest three consecutive batches. foo . i (vy) Technical catalogue for Encapsulation machine with Guaranteed Wastage | Po norms. ; i (vi) Detailed working for calculation of import requirement and norms applied. ----- End of picture text -----

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----- Start of picture text ----- , 141 poo pe pte | Case No.:179/13/82- Party Name:SUN iMeet No/Date: Status: | ALC4/2019 PHARMACEUTICAL INC/3/MEET/Jan/202021/4 (Deferred | | , INDUSTRIES LTD. (12.02.2021 ; eeSO HQ RileREAFile Lig NoiDatesO810813373FO - 258 }:01/82/050/01022/AM20/ :05/24/040/00669/AM20/ (17.01.2020 “ i | | {Decision: ‘The Commitee considered the case as per onlineagenda | and it was decided to call for following information from the firm: in the presence of technical experts (i) Complete technical details as per Appendix 4E. ----- End of picture text -----

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----- Start of picture text ----- ac| [CaseNo.:11/2/82-ALC4/2020[Party Name:AURA[MeetNo/Dates Status; | 4ILIFECARE PRIVATE NC/3/MEET/Jan/202021/4 [Deferred i LIMITED. 12.02.2021 | THQFile REA File YF NoDate-34 10048804 7 - i :01/82/050/01045/AM20/ :34/24/040/00323/AM20/ 23.01.2020 1259i Pre tnttsntmenannaremiennneinnnaianenizmannainenang ntine ittnenanttineniiiiiaiasnennnen tintiannetnciitintitinnnenmaeemmatiemammmnnenmamedseistninsnttuninnuinmeee | |Decision: The Committee considered the case as per online agenda in the presence of technical experts | r it was decided(i) to callCopy for following informationof DML for export item from No. the5. firm: | (ii) Copy of B.P. to show whether Glucose BP and Dextrose BP are exactly same : hos compound / Isomers. . | (iii) Copy of Master Batch Formula for all export products. . || [Case No.:12/2/82-ALC4/2020 [PartyName:GLENMARK[Meet Nolbaie)Statues | PHARMACEUTICALS| LTD {NC/3/MEET/Jan/202021/412.02.2021 : |Deferred | |HQFie~~”EREAFile. ~———SCSO Lies NoDates03 10834474 0 :01/82/050/01046/AM20/ :03/94/040/00906/AM20/ 24.01.2020 Decision: ‘The Committee considered the case as per online agendain thepresence of technical experts; , ; | and it was decided to call for following information from the firm: ' ‘ (i) Density of Export item No. 1, 2 and 3." : | : (ii) Filled yolume and weight of medicament in each export item per unit of! [ packing. ; ----- End of picture text -----

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----- Start of picture text ----- | (Case No.:42/2/82-ALC4/2020 (Party Name:PHALANX Meet No/Date) "Status i . . LABS PRIVATE LIMITED — |NC/3/MEET/Jan/202021/4 !Deferred ‘| . 12.02.2021 . IHQFile ~IRTAFie ~~ {Lic.No/Date:2610012904 ‘| — —_ 261 :01/82/050/01076/AM20/ /:26/24/040/00019/AM20/ :10.02.2020° i | (Decision:and The Committee ‘considered the case as per online agenda in the presence of technical expers| it was decided to call for following information from the firm: | 7 | | (i) Complete technical details as per Appendix 4E. | ----- End of picture text -----

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FIG ase No.:95/2/82-ALC4/2020 [Party Name:MANGALAM [MeetNo/Date: ——=s(Status: [ . FORMERLYORGANICS LIMITED DUJODWALA 12.02.2021|NC/3/MEET/Jan/202021/4 |Deferred Sr ey Ce 2 eeerint satin aati mee acre aaa on Be ‘262 |201/82/050/01129/AM20/ |03/95/040/01078/AM20/ 106.03.2020 | | [Decision: The Committee considered the case as per agendain the presence of technical experts and | fit was decided to call for following information from the firm: . | (i) Manufacturing process in detail indicating chemistry and material balance. i (ii) Quantity and value of By-Product obtained, if any. [Case No.:96/2/82-ALC4/2020 [PartyINDUSTRIES Name:AETHERLIMITED (MeetiNC/3/MEET/Jan/202021/4No/Date: \DeferredStatus: || | 12.02.2021 | [HO RIeRA File Lic No/Date:5210043358 [| | :01/82/050/01130/AM20/ :52/24/040/00068/AM20/ 106.03.2020 _ 263 Decision: ‘The Committee considered the case as per agenda in the presence of[technical][ experts][and] | it was decided to call for following information from the firm: ‘ ; (i) . Specific name of export product, : a (ii) Product/Consumption data for last two years duly certified by GST. (iii) Justification for low yield. [~~|CaseNo.:102/2/82-——S«(PartyName‘SUN [MeetNo/Date: ~—‘(Status:[|] | |ALC4/2020 PHARMACEUTICAL INC/3/MEET/Jan/202021/4 \Deferred i INDUSTRIES LTD. (12.02.2021 | (HQ FeREA FileLie. No/Date:0510413850 ~~ 264 j:01/82/050/01136/AM20/ /:05/24/040/00749/AM20/ 112.03,2020 7 Decision: | The Committee considered the case[as][ per][online][agenda][in][ thé][ presence][of][technical][experts] . | land it was decided to call for following information from the firm: : | - fi) Complete, technical details as per Appendix 4E. . . "aseNo103/2/82-—~—~~S~SPartyName:KEVA [MeetNo/Date: Status: ‘ | j{ALC4/2020 ' iFRAGRANCES PRIVATE — |NC/3/MEET/Jan/202021/4 [Deferred i : . LIMITED |12.02.2021. ‘ | (HQ FileIRCA Fe SSSSS~S*L He No/Dates0310835375| ; © :01/82/050/01137/AM20/ 1103/94/040/01017/AM20/ 12.03.2020 7 : 265| (Decision: The Committee considth e caseredas peragendain the presenceof technicalexperts and it} was decided to call for following information from the firm: ‘ | i (i) : Complete technical details as per Appendix4E. ; "| : 7 | (ii) Specific chemical naime of import and export. | ~ Gid COA of import item from foreign supplier. ; | | (iv) COA of export product. : ee

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: _ | [Case No.:106/2/82—~—~—«(Party Name:SALICYLATES[Meet No/Date: ——~—~*(Statust | . ALC4/2020 & CHEMICALS PRIVATE . |NC/3/MEET/Jan/202021/4 \Deferred : ae LIMITED 12.02.2021 ee FAQRite IRAFile ie NovDatesoi006ss7e : ||266 wasDecision: decided— toThe Committeecall for following consideredinformation the case from as the perfirm: agenda in the presence of technical experts and i |‘i -@(ii), CompleteComplete technicalchemical detailsreactions as perwith Appendixmolecular 4E.weight and structural formula | z : and molecular weight alongwith % yield on molar basis. : |

)

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----- Start of picture text ----- | [Case No.:107/2/82-.—~—~(Party Name:SALICYLATES (MeetNo/Date: (Status ALC4/2020 & CHEMICALS PRIVATE = /NC/3/MEET/Jan/202021/4 |Deferred : |an(HQFile REA FileLIMITED Ee112.02.2021 [No/Date:0910068575] . °7 :01/82/050/01141/AM20/ :09/24/040/00614/AM20/ /13.03.2020 Decision: ‘The Committee considered the case as per agenda in the presence oftechnical experis andit was decided to call_fi) for followingComplete informationtechnical fromdetailsthe firm:as per Appendix 4E. . : | | (ii) Complete chemical reactions with molecular weight and structural formula and molecular weight alongwith % yield on molar basis. | [CaseNo.:127/2/82-—~—~=«(PartyNName:M/S.—~—~S~S*~SSWMeat Novae: ~——SdStatuss | ALC4/2020 HIMALAYAN PRODUCTS — |NC/3/MEET/Jan/202021/4 !Deferred & INDUSTRIES CORPN., 12.02.2021 ' P.LTD | HQFile REA [File][ TeNoDates0810413034-] i068 :01/82/050/01161/AM20/ :05/24/040/00774/4M20/ 19.03.2020 | Decision: The Committee considered the case as per agenda in the presence of technical experts and | was decided to call for following information from the firm: it . | (ii)(i) COA% content ofof import a.i. item in imported from foreign extract.supplier. : (iii) Complete technical details as per Appendix 4E. . | (Case No.:142/2/82-~—~—~—~«(Party Name:RECKITT [MeetNo/Date. ———(Status: | PodALC4/2020 BENCKISER HEALTHCARE NC/3/MEET/Jan/202021/4 |Deferred | | . INDIA PRIVATE LIMITED 12.02.2021 a lo69 (HQFile:01/82/050/01176/AM21/REA:05/24/040/00007/AM21/ File ie(13.04.2020 NowDate:0510413971 | / | Decision: The Committee considered the case as per agenda in the presence oftechnical expertsand it, was decided to cali for following inforrnation from the firm: {7 . : . @ Copy of DML for export item No. 2. ' (ii) Copy of Master Batch Formula for export item No. 2. ----- End of picture text -----

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. [~~ [GaseNo.162/2/82-~«(PartyName:SUN—~—~—~—~—<(MeetNo/Date:. ~——SS«( Status:| | ALC4/2020 IPHARMACEUTICAL INC/3/MEET/Jan/202021/4 |Deferred : RQ FI. IREFileINDUSTRIES LTD. Le{12.02.2021 No/Date:05 10414035. J| “ OT 270 j:01/82/050/01196/AM21/ 1:05/24/040/00013/AM21/ {20.04.2020 or , i “os . | (Decision: The Committee considered the case as per agenda in the presence of technical experts and it was decided to call for following information from the firm: (i) Composition of export item alongwith COA. - ; - (ii) COA of import item from foreign supplier. . _ "(Case No.:179/2/82- Party Name:GLENMARK [Meet No/Date: Status: L | ALC4/2020 PHARMACEUTICALS LTD iNC/3/MEET/Jan/20202 1/4 Deferred . | j12.02.2021 | THQ File 7[:01/82/050/01213/AM21/] , RLAFile:03/94/040/00022/AM21/ 125.04.2020[Lic.No/Date:0310835878 . | Decision: The Committee considered the case as per agenda inthe presence of technical experts and it | | was decided to call for following information from the firm: , | | @ Specific gravity of each export item.. — | . (ii) ° Detailed calculation sheet as the DML given is on w/w basis. * . pone pntnnn Penne niin neon | iCase No,:219/2/82Party Name:SUN ‘Meet No/Date: Status: : ALC4/2020 PHARMACEUTICAL INC/3/MEET/Jan/202021/4 |Deferred | INDUSTRIES LTD. (12.02.2021 | [BQFile ~~ REA FileSSSSSCSLieN/Date:0510414098 [oO 272 :01/82/050/01253/AM21/ :05/24/040/00022/AM21/ '04.05.2020 | Decision: ‘The Committee considered the case as per agenda -[in][the][presence][of][ technical][experts][ and][it] : | was decided to call for following information from the firm: . | (i) Composition of export item alongwith COA. | (ii) COA of import item from foreign supplier. : [Case No.:238/2/82- "(Party Name:S.KANT Meet No/Date: Status: . |. JALC4/2020 ~ HEALTHCARE LTD. NC/3/MEET/Jan/202021/4 Deferred . | HQ FileREA File ic.No/Date:0310836133 | ; (273 }:01/82/050/01272/AM21/ -|:03/95/040/00715/AM20/ 107.05.2020 jand it was decided to call for following information from the firm: | | (id) Complete technical details as per Appendix 4E for cach export item. | ;

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: [Case No.:289/2/82~ |PartyName:NATURAL & (Meet No/Date: ~~" (Status: i ALC4/2020 ESSENTIAL OILS PVT.LTD., |NC/3/MEET/Jan/202021/4 |Deferred 112.02.2021 THQ Bite IRA File ic No/Dates0710116493 FO re 274 j:01/82/050/01323/AM21/ © :07/24/040/000S1/AM21/ 26.05.2020 + —— pee | [Decision: The Committee considered the case as per online agenda in thepresence | and it was decided to call for following information from the firm: of technical experts | (i) % purity of all the four export products.

[~~[€ase No.:309/2/82- SSS Party Name:CLARIANT -[Meet No/Date: Status: : ALC4/2020 INDIA LIMITED |NC/3/MEET/Jan/202021/4 Deferred _ )12.02.2021 | {HQ File —IREAFileSSS™S™S~CSS Lic No /Dates0310830469 [ | :01/82/050/01343/AM21/ :03/94/040/00110/AM21/ (01.06.2020 (275 Decision:— The Committee considered the case as per online agenda in the presence of technical experts | and it was decided to call for following information from the firm: | di)@ Calculation% yield at everySheet stage ofto arrive reaction.at the quantity of raw material asked on the basis || ,(iid) ofRecovery molecular weightof Methanol andQuantity % of yield.and its commercial value.‘ | [Case No.:312/2/82-‘(Party Name:VEERAL [Meet No/Date:. | SS Status | LIMITED 112.02.2021 | ALC4/2020 JADDITIVES PRIVATE NC/3/MEET/Jan/202021/4 |Deferred | HQFie— -*S(REAFile ~~~ -~*S (Lic.No/Date0310830487 | :01/82/050/01346/AM21/ :03/95/040/00113/AM21/ 04.06.2020 lo76 Decision: — The Committee considered the case as per agenda in the presence of technical experts and it | 7 was decided to call for following information from the firm: , ; . | (i) ° Weight of export product. . | | ; (ii) Material Balance (Stoichiometric Balance details) for entire manufacturing | . (iii), Commercialprocess. value; of By-Product Methanol. . . | (iv) Production-Consumption data for two years duly certified by GST.

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[ Case No.:329/2/82~~" [Party Name:AETHER [Meet No/Date: (Status: | ALC4/2020 . INDUSTRIES LIMITED iNC/3/MEET/Jan/202021/4 |Deferred | (12.02.2021 SQFT IREAFile, Lc.[No/Date:5210043426] Fn oo oo r - {:01/82/050/01363/AM21/——_|:52/24/040/00004/AM21/ 08.06.2020 - 10 277 Decision: The Committee considered the case as per agenda in the presenceof technical experts ; twas decided to call for following information from the firm: and it (i) Specific name of Export Product. ; | (ii) Justification for low yield. , ; i (iii) Technical literature / catalogue in support of yield. a | _ fiv) Production / Consumption data for last two years duly certified by GST. ["(Gase Nou331/2/82.~~S:«WdiP arty Name@cAETHER (MeetNo/Date: ——~—~—«(Status: | ALC4/2020 INDUSTRIES LIMITED INC/3/MEET/Jan/202021/4 (Deferred | | i (12.02.2021 . | {HQ File TO RIAFile——SSSSS~S*«Lic.No/Dates5210043427 | | :01/82/050/01365/AM21/ _ :52/24/040/00003/AM21/ 109.06.2020 : |278 (Decision: ‘The Committee considered the case as per agenda in the presence of technical experts and it | was decided to call for following information from the firm: , | ro) Step-wise manufacturing process. : so did Complete chemical reactions with molecular and structural formula and po molecular weights alongwith stage wise % yields on molar basis. . | (iii) Material balance (Stoichiometric balance details) for the entire manufacturing ° process. ; ("TGase| No.:352/2/82- —~—~SS*«~di arty[Name:AETHER] — [MeetNovDate: (Status: | ALC4/2020 INDUSTRIES LIMITED [12.02.2021|NC/3/MEET/Jan/202021/4 Deferred 6 HQ File REA File SSS NoDates5210043441 [0 | :01/82/050/01386/AM2 1/ :52/24/040/00017/AM21/ 116.06,2020 _ 279 (Decision: The Committee considered the case as peragendain thepresenceof technical experts was decided to call for following information from the firm: ; | and it , ) (i) Step-wise manufacturing process. , , i (ii). . , Complete chemical reactions with-molecular and structural formula and . ' . ; , | : molecular weights alongwith stage wise % yields on molar basis. | ‘ | (iii) Justification for low yield alongwith any published literature. : | . (iv) Past Production / Consumption data for last two years duly certified by GST. |

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ppppte Case No.:371/2/82Party Name:AETHER ‘Meet No/Date: Status: | jALC4/2020 7 INDUSTRIES LIMITED INC/3/MEET/Jan/202021/4 Deferred oo 112.02.2021 | THQ File REA File Lic No/Date:5210043443° - so © :01/82/050/01405/AM217 —j:52/24/040/00016/AM217 (19.06.2020 | Decision: The Committee considered thecaseas per agendain the presence of technical experts and it was decided to call for following information from the firm: i780 (i) Step-wise manufacturing process. ; . i (ii) Complete chemical reactions with molecular and structural formula and ; | molecular weights alongwith stage wise % yields on molar basis. | (iii) Material balance (Stoichiometric balance details) for the entire manufacturing ' | process. . S| (iv) Justification for low yield alongwith any published literature. . | (y) Past Production / Consumption data for last two years duly certified by GST. | (vi) Authentic Technical Literature / Catalogue in support of % yield claimed in the entire manufacturing process.

;

[Case ALC4/2020No.:375/2/82-~—~—~=«(Party Name:AETHER~~ ([MeetNo/Daie. SS[Status: INDUSTRIES LIMITED NC/3/MEET/Jan/202021/4 Deferred 12.02.2021 | || |HQFile ~~ REAFiléSS™”*«w De No/Dates5210043446 |[281 Decision:|was:01/82/050/01409/AM21/decided toThecall forCommittee followingconsidered information:52/24/040/00018/AM21/the fromcase theas perfirm:agendain[23.06.2020thepresencof technical |exp e rts andit | | | (i i)) CompletStep-wis e manufacturingchemical reactions process.with molecular and structural formula and | molecular weights alongwith stage wise % yields on molar basis. . | | (iii) Stoichiometric balance details for entire manufacturing process. |

[ [Case No:113/U/82-«Party Name:AURORE LIFE | ALC4/2019 {SCIENCES PRIVATE [MeetNC/3/MEETNo / Jan/202021/4Date: [Statuss!Deferred | ’ - {LIMITED : 12.02.2021 | |t AQFile:01/82/050/001RTA 13/AM20/ }:09/24/040/000 FileSS1 1/AM20/ (Bie09.05.2019NoDate:0910067466 - , 282; Decision: The Committee considered the caseas per agenda in the[presence] of technical experts and it wes decided to call for following information from the firm: a . | (i) Specific names of import item No. 3, 4 and 5 alongwith their catalogues, | ae :| ; (iii).(ii) _ JustificationSpecific purposefor forquantitative utilization ofrequirement4 types of Enzymesof all inEnzymes a singleshown step. in- the.: ff process, their recovery and wastage claimed. |

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~TGase No:109/1/82-~~SCPartyName:SAURAV (Meet No/Date: (Status: . ALC4/2019 CHEMICALS LIMITED NC/3/MEET/Jan/202021/4 \Deferred i | . | 12,02.2021 FRO FiteREA FileLieNo/Date:2210016146Fe, re (283 ):01/82/050/00109/AM20/ |:22/24/040700011/AM20/ 10.05.2019 | i co | Decision: The Committee considered the case as per agenda in the presence of technical experts and it | was decided to call for following information from the firm: foi yield on molar basisforeach step withsupporting literature, ("Case No305/1/82.~ ~~(PartyNameRUMIT‘(Meet No/Date: ——~—~=<(Status:—* ; ALC4/2019 CHEMISYNTH PRIVATE NC/3/MEET/Jan/202021/4 Deferred | , -|LIMITED . 12.02.2021 | . | |HQFile ”—~—”:CSRAFleSS*~S~S«S Lc, Neo/Datez 0310829292 | loga :01/82/050/00211/AM20/ :03/95/040/00196/AM20/ 28.05.2019 || (Decision:was decided The to call forCommittee followingconsidered informationthe fromcase theas perfirm:agenda in the presence of technical experts and it | . (i) Complete chemistry, molecular weight, % yield, material balance and stoichiometric balance. | [Case No.:36/6/82-ALC4/2019[PartyName:NOVEL , NUTRIENTS PVT LTD NC/3/MEET/Jan/202021/4 Deferred | (Meet No/Date: Status: | —412.02,2021 | (AQ File REA FileLic. No/Date:0710115041 | | :01/82/050/00262/AM20/ :07/24/040/00056/AM20/ 11.06.2019 85 Decision: ‘The Committee considered the case as per agenda in the presence oftechnical experts and it was decided to call for following information from the firm: | " (i) °% content of a.i. in imported extract. a , Z (ii)(iii) COACompleteof import technicalitem details from foreign as per Appendixsupplier. 4E. | , [Case No.:34/6/82-ALC4/2019- [Party Name:DIPSs [Meet No/Date: Status: | - . ; : ‘BIOSCIENCE PVT.LTD. : 'NC/3/MEET/Jan/20202 1/4 ‘Deferred : FY - | ‘(12.02.2021 jo: | . | fHOFile ~~ RLAFile”~ ~~~ Lic.No/Date:0310829573 | |286 |:01/82/050/00260/AM20/ :03/94/040/00199/AM20/ 12,06.2019 | , , | ywas decided to cail for following information from the firm: | | (i) Copy of DML for each export product item showing Approved composition, |

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, re CaseNo.:49/6/82-ALC4/2019[(Party] Name:DHANUKA I. LABORATORIES LTD ~~~ [MeetNC/3/MEET/Jan/202021/4No/Date: Status:|Deferred oo —-#12,02.2021 TQ Fite REA File Lie No/Date:0510410949 FO BS s ~4:01/82/050/00275/AM20/ 4:03/23/040/00104/AM20/ = * (14.06.2019 © | oe a 287 Decision: The Committee considered the case as per agenda in the presence of technical experts and it | was decided to call for following information from the firm: | (i). The firm has shown molar yields of 100%, 84% and 90%. However, norms | _ applicable for import item No. 1 do not match with the given yields. Technical ‘justification with correct c.c, may be furnished. |

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----- Start of picture text ----- P Case No.:61/6/82-ALC4/2019 Party Name:ASTRAL ™ Meet No/Date: ee Status: ~ STERITECH PVT. LTD. NC/3/MEET/Jan/202021/4 {Deferred | |12,02.2021 | (HQFile ~~ FileS—S~~~SCS Lic ND atez3410045218| 1288 :01/82/050/00287/AM20/ 4:34/24/040/00102/AM20/ 19.06.2019 , Decision: The Committee considered the case as per agenda in the presence of technical experts and it 7 | was decided to call for following information from the firm: ; | (i) . Dose of the export item whether 1 gm injection or others. ; fo i (id) Copy of relevant DML. [ [Case No.:67/6/82-ALC4/2019|PartySTERITECH [Name:ASTRAL] PVT. LTD.——(MeetINC/3/MEET/Jan/202021/4 No/Date: —————=(Status:(Deferred 12.02.2021 | JHQFile “REA File ~~ [Lic.No/Date:3410045222 lagg :01/82/050/00293/AM20/ :34/24/040/00100/AM20/ 20.06.2019 | (Decision: — The Committee considered the caseas per agenda in the presence of technical expertsand it . | was decided to call for following information from the firm: . . , ; | (i) Dose of the export item whether 1 gm injection or others. | ; (ii) Copy, of relevant DML. . ; _ ["TGase No:127/6/82-—~—~«PartyName:APNAR(Meet No/Date:.—~—~S~=SStatus: | ALC4/2019 : LIMITEDiPHARMA PRIVATE. ~ 12.02.2021INC/3/MEBT/Jan/202021/4 DeferredsO | | FQFile RLAFile [Lic No/Date:341 [0045258][ |] 1:01/82/050/00353/AM20/ :34/24/040/00098/AM20/ :05,07,2019 . i 290 Decision: The Committee considered the caseas peragendain thepresenceof technical expertsand | . | Pe [decided][ to][ call][ for][ following information][ from][ the][ firm:] it) | (i) : Export’ quantity to be given in number of Tablets/Capsules. : , (ii) Detailed working of inputs applied. | ; . (iii) Master Batch Formula for each export product. ~ : ----- End of picture text -----

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p Case No.:160/6/82~~ Party ![Name:ORIENTAL] (Meet[No/Date:][_] Status: i ALC4/2019 AROMATICS LTD NC/3/MEET/Jan/202021/4 Deferred | 12.02.2021 | bg THQ FIe RTA File Tie, No/Date:0310830298 ~ 291 04/82/050/00386/AM20/ ~—-|:03/95/040/00363/AM20/ = j15.07.2019 ty op | Decision: . The Committee considered the case as per agenda in the presence of technical experts | was decided to call for following information from the firm: and it | (i) Complete chemistry, molecular weight and % yield. ; ; . (ii) Stoichiometric balance. . [CaseNo.:216/6/82- ~—~—~—~*(PartyName:ORIENTAL (MeetNo/Date:——~S=«(Status: . 4 ALC4/2019 AROMATICS LTD NC/3/MEET/Jan/202021/4 (Deferred || [HQFilea REAFile- [Lie No/Date:031083054712.02.2021 lo99| A:01/82/050/00442/AM20/A 049 PA a FARR NPS FF RENE ANR Y SR:03/95/040/00413/AM20/OR N N R t ua yL 24.07.2019aed LaedA dAAAOYARP A AA RAYA Hm na ad| nan naan an mrad adi Decision: | The Committee considered the case as per agenda in the presence of technical experts and it | was decided to call for following information from the firm: ()) Complete chemistry, material balance, % yield and molecular weight. . (ii) ‘Exact chemical name of Export Product. . . | [~~ [GaseNo.:268/6/82-~—~~(Party Name:CHEMIESYNTH[MectNovDste: Status: ALC4/2019 (VAPILTD., NC/3/MEET/Jan/202021/4 jDeferred | | / /12,02.2021 | (HQFile 993[-01/82/050/00494/AM20/] ——SRLAFile:03/94/040/00363/AM20/~————~S~SCSC 05.08.2019LicNoDates0310830809 [| | Decision: ‘The Committee considered | was decided to call for following informationthe case fromasthe perfirm: agenda in the presence of technical experts and it | @ Exact chemical name of Export Product with molecular weight. (ii) Coniplete chemistry, molecular weight, material balance and % yield. ° | [ [Case No.:19/10/82[PartyName:MEHK [MeetNo/Date: Status:—| | IALC4/2019 JCHEMICALS PVT.LTD, . *NC/3/MEET/Jan/202021/4 ‘Deferred i | |HQFile 294[:01/82/050/00593/AM20/] = ~—~—~—~—SRLAFile.———~—~S™«Liic.No/Date:0310831392“1:03/95/040/00555/AM20/ 06.09.2019 © ’ || | ;wasDecision: ~The Committee considered the case as per agenda in the presenceof technical experts andit decided to call for following information from the firm: : | (i) Complete chemistry, molecular weight, % yield and material balance. '

==> picture [594 x 447] intentionally omitted <==

----- Start of picture text ----- Po.| |” [Case No.:33/10/82-—~—~—~*(Parly Name:NISARG ‘(MeetNo/Dates.SS [Stata : ALC4/2019 BIOSCIENCES PVT LTD NC/3/MEET/Jan/202021/4 \Deferred ; | i 12.02.2021 | a . 2 THO FIle REA Filethie. No/Date:0910067984 FO | ©. :01/82/050/00607/AM20/ © :09/24/040/00309/AM20/ 11.09.2019 - po |295 Decision: — The Committee considered the case as per agenda in the presence of technical experts and it) | was decided to call for following information from the firm: ——fi)" % yield at each stage of manufacturing. ;: (ii) Calculation Sheet for requirement of quantity asked | on the basis of % yield and ; molecular weight. , ; | ; [~ [GateALC4/2019Necaasriors2. Party [Name:SUVEN] LIFE {MeetNo/Date:(Status: fo | SCIENCES LIMITED NC/3/MEET/Jan/2020212.02.2021 1/4 Deferred | HQ File REAFile No Datesooiooest76 [296 :01/82/050/00809/AM20/ :09/24/040/00407/AM20/ 13.11.2019 | Decision:was decided toThe callCommitteefor followingconsidered informationthe casefrom theas perfirm:agendain the; presence of technical experts and it ; | ; (i: Complete chemical name of export product. . : | (ii) Stepwise complete and balanced chemical reactions showing molecular weight tf and % yield on molar basis. (iii) Technical justification for the yields at various steps. | (CaseNo.:263/10/82-—~—~—~(iParty Name:STERLING [MeetNo/bates Status: | . ALC4/2019 . AUXILIARIES PVT LTD NC/3/MEET/Jan/202021/4 (Deferred | |HQ 12.02.2021 | FileRECA File Ngater03 10832853 aaa , 297 :01/82/050/00837/AM20/ :03/95/040/008 12/AM20/ 19.11.2019 | , , | Decision:was decided~Theto call Committeefot following information considered the fromcase astheperfirm:agenda in thepresenceoftechnical: experts and it | . Exact+ specification and blend ratio of Export Product No. 1 and 2. » |f ; - ----- End of picture text -----

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||||<br>CaseNo.:40/3/82-ALC4/2020 PastyName:TIDE<br>food<br>.<br>_.<br>INDUSTRIES<br>—_||<br>CaseNo.:40/3/82-ALC4/2020 PastyName:TIDE<br>food<br>.<br>_.<br>INDUSTRIES<br>—_||<br>CaseNo.:40/3/82-ALC4/2020 PastyName:TIDE<br>food<br>.<br>_.<br>INDUSTRIES<br>—_||<br>CaseNo.:40/3/82-ALC4/2020 PastyName:TIDE<br>food<br>.<br>_.<br>INDUSTRIES<br>—_||<br>CaseNo.:40/3/82-ALC4/2020 PastyName:TIDE<br>food<br>.<br>_.<br>INDUSTRIES<br>—_||<br>CaseNo.:40/3/82-ALC4/2020 PastyName:TIDE<br>food<br>.<br>_.<br>INDUSTRIES<br>—_||MeetNo/Date:<br>(Status:<br>INC/3/MEET/Jan/202021/4 Deferred|MeetNo/Date:<br>(Status:<br>INC/3/MEET/Jan/202021/4 Deferred|MeetNo/Date:<br>(Status:<br>INC/3/MEET/Jan/202021/4 Deferred|MeetNo/Date:<br>(Status:<br>INC/3/MEET/Jan/202021/4 Deferred|||<br>|||||;|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
||||<br>1298|.01/82/050/01467/AM2<br>;|THQFile<br>RLAFile<br>Lic.No/Date:3410046210<br>|<br>|.01/82/050/01467/AM2 V/<br>:34/24/040/00086/AM21/<br>{13.07.2020<br>ae<br>Decision:<br>TheCommittee consideredthecase asperagenda inthepresence oftechnical expertsand <br>wasdecidedto cal} for followinginformationfromthe firm:||||||||||it||||||
||||<br>|||(i)<br>ExactchemicalnameofexportproductwithStructural formula.<br>(ii)<br>Chemistry and material balance (Stoichiometric).|||||||||||||||
||||||||||,||||||||||
|||Following caseswere deferred:|||||||||||||||||
|||SI.No.||HQFileNo.<br>;||RA FileNo.|Authorization<br>No.||Date of<br>Authorization<br>Issued||PartyName<br>—<br>'||||||||
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154

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|‘|||||29.|JHQRNORMAPPLY|~|[05AA04022853||]0511000697||08/01/2021||ZEELABORATORIES|||||
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|||||||00058317||AM2i|||||||||.|
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155

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| 167

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|od<br>- ||297,<br>Fl <br> 298,||[018205000819<br> vezo|<br>(018205000829<br>AM20|-|||992404000414<br>laAM20<br>092404000421<br>AM20|[0910008184<br>114711/2019 _ <br>|<br>8 <br>0910068191<br>}15/11/2019||||ISUVENLIFE<br> SCIENCESLIMITED<br>[PORUS<br>LABORATORIES||||||
|.|||||,||||:||.||PRIVATE LIMITED|||||
||399,||1018205000885|||“092404000374||0910008241|||102/12/2019||IVIVIMEDLIFE|:||||
||||AM20|||-||AM20||||||SCIENCES PRIVATE|||||
||||||||||||||LIMITED<br>||||||
||||||||||||||||.|||
||300, <br>:||1018205001710<br>AM21||||092404000362<br>AM21|[0910069287|||[30/09/2020<br>.||[AURORE LIFE<br>SCIENCES PRIVATE<br>LIMITED°|||||
|"397,|||1018205001773||||092404000356|0910060364||.|[22/10/2020||[JODAS EXPOIM|||||
|7|||lama||||AM21.||||||PRIVATELIMITED|||||

| - a

==> picture [19 x 16] intentionally omitted <==

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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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|oe<br>|||pe.|[3Q4.70T8205001803<br>AM21||-—-*|||1092404000371<br>AM21|||[0910009415 <br>|||}29/10/2020°|INCHEM: ©"<br>LABORATORIES<br>PRIVATE LIMITED||||||
||||305,||018205001976<br>AMID|||||1092404000288<br>AMI19||[0910066679||18/09/2018||[SUVENLIFE<br>SCIENCES LIMITED|||||
||||306, <br>307.|018205002062:<br>AMI19<br> 018205002155<br>AM19||*|||‘(1092404000354<br>AM19<br>{092404000412<br>AM19||0910066781<br>0910066949||[26/10/2018 <br>06/12/2018|~~ |SUVENLiFE<br>SCIENCES LIMITED<br>~~ |VISION DRUGS<br>PRIVATE LIMITED|||||
||||308,|[018205001202<br>AM21|||||992404000027<br>AM21||[0910068657||[21/04/2020||JODAS EXPOIM<br>PRIVATELIMITED|||||
||||309,|[018205001210|||||092404000036||[0910068668||[24/04/2020|[ALPHAMED|||||
|||||AM21<br>—|||||AM21|||||FORMULATIONS|||||
|||||||||||||.|||PRIVATE LIMITED|||||
||||310,|[018205001286|||||092404000077||0910068744||[12/05/2020|[JODASEXPOIM|||||
|||||AM21|||||AM21||||||PRIVATE LIMITED|||||
||||311,|[018205001483|||||092404000008||[0910066148||[17/04/2018|[GLANDCHEMICALS|||||
|||||AMi9<br>—|||||AM19|||||PVT LTD|||||
||||312.|[018205001494<br>AM21|||||092404000209<br>AM21||0910068983||[21/07/2020|[AUROBINDO<br>PHARMALTD|||||
||||313.<br>314,|[018205001532<br>AM21<br>[018205001572<br>AM21|||||092404000197<br>AM21<br>092404000250<br>AM21||[0910069018<br>0910069090||05/08/2020<br>[24/08/2020|[ORTIN<br>LABORATORIES LTD<br> |THERAPIVA<br>PRIVATELIMITED|||||
|:|||315,|(018205001614<br>AM21|||,||082404000395<br>AM20|||0810148478||[03/09/2020|[CONCORD BIOTECH<br>LTD<br>,<br>‘|||||
||||316,|[018205000475|||||092404000232|||0910067851||[30/07/2019||AUROBINDO|||||
|||||_ |AM20||||_||Am20|;|||_|[PHARMA LTD.|||||
|||||317,||018205001228|||||992404000275||[0910058223|||13/11/2013.||ATGCBIOTECH|=||||
|||||AM14_-|||||AMI14<br>:|||||PRIVATE LIMITED||||.|
|||:|318,|:}018205001394<br>AM21—°||||-.|{092404000169<br>JAM2i|||09100683§6.||18/06/2020|RACHEMPHARMA<br>LIMITED|||.|||
||<br>)|||319,||018205001483<br>AM21_|||||092404000174<br>AM21||0910068965||[20/07/2020||INNOVARELABS<br>PRIVATELIMITED|©||||
||||320,|{018205000343|||||092404000172||0910067749||[03/07/2019||SYNTHO CHIRALS|||||
|||||AM20<br>||||||AM20||™|||PRIVATELIMITED|||||
||||321,|}018205000566|||||092404000275|||0910067938||27/08/2019|SYNTHOCHIRALS|||||
|||||AM20_||||*||AM20|||'|,|PRIVATE LIMITED|||.||
||||322,|4018205001229|||||092404000039||[0910068685||28/04/2020|AURORE LIFE|||||
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==> picture [481 x 617] intentionally omitted <==

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|323,|[018205001249|—-|1092404000059|[0910068716|01/05/2020|JOPTRIX|
|AM21|.|AM21|LABORATORIES|
|PRIVATE|LIMITED|
|324,|[018205001378|092404000127|10910068863|[12/06/2020||VANDANA|LIFE|
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|AM21|.|AM21|PRIVATE LIMITED|
|326,|[018205001743|.|092404000272|0910069335||15/10/2020||OPTRIX|.|
|AM21|AM21|LABORATORIES|
|PRIVATE|LIMITED|
|327,|[018205002574|082404000430|[0810144782|[18/03/2019|_|SHANKUS|
|AMI9_,|AMI19|PHARMACEUTICALS|
|328,||018205000488|092404000244|10910067866|[05/08/2019||SUVEN|LIFE|
|,|AM20|-|AM20|.|SCIENCES|LIMITED|
|329,|1018205001062|092404000251|[0910066620|[03/09/2018||SRINI|
|AM19|AM19|PHARMACEUTICALS|
|PRIVATE|LIMITED|.|
|330,||018205001380|092404000129|[0910068864|112/06/2020||3AK CHEMIE|
|~||AM21|AM21|:|PRIVATE LIMITED|
|33],|[018205001447|092404000143|[0910068917|[30/06/2020||SRINI|
|AM21|_|AM21|PHARMACEUTICALS|||
|‘/PRIVATE|LIMITED|
|332,|[018205001508|092404000160|10910068998|[28/07/2020|_|[ALPHAMED|
|JAm21|AM21|_||FORMULATIONS|
|.|PRIVATE|LIMITED|
|333,|]018205001524|092404000239|[0910069013|13/07/2020|_||DR.REDDY'S|
|AM21|AM21|LABORATORIES|LTD|
|334,|{018205001575|092404000047|[0910069097|25/08/2020||OPTRIX|.|
|AM21|AM21|LABORATORIES|
|.|PRIVATE|LIMITED|.|
|335,|[018205001744|092404000273|[0910069336|(15/10/2020||OPTRIX|
|AM21|AM21|LABORATORIES|—|-|
|.|
|.|PRIVATE|LIMITED|
|336,|[018205001905|092404000200|[0910066511|[24/07/2018|_|AUROBINDO|
|AM19|AM19|-|IPHARMALTD|—|-|
|337,|1018205001259|092404000061.|10910068725|104/05/2020|_.||JODAS EXPOIM|
|1-338.|1018205001300AM21|AM21092404000072|0910068763|[18/05/2020|‘|PRIVATE/INNOVARELABS LIMITED|||
|339,||018205001509AM21|-|[992404000167AM21|[0910069002|-|[28/07/2020_||PRIVATE/STYRAX LIFELIMITED|,|
|AM21|AM21|.|__||SCIENCES|PRIVATE|
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|AM21|LABORATORIES|
|;|PRIVATE LIMITED|

----- End of picture text -----

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==> picture [66 x 15] intentionally omitted <==

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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
||||||||||||||||||||LIMITED|||||
|oo<br>oo|a<br>oo,||342,<br>oe<br>**e**n<br>1343"|||[018205001172<br>AM21<br>7<br>ee<br>_<br> 1018205001568<br>AM21||~~|a||||||082404000417<br>AM20<br>«(1092404000262 <br>AM21||[0810147573<br>;<br>—<br> |0910009046°||03/04/2020<br>:<br>.<br>ssLIMITED<br> [17/08/2020||BHAGWATI<br>INDUSTRIESPRIVATE<br>LIMITED<br> JOPTRIX = =<br>LABORATORIES<br>PRIVATE LIMITED||*|,||
||||||344,|1018205000329||||||||||092404000146||0910067735||02/07/2019© |SMILAX||||||
|||||||AM20||||||||||AM20|||LABORATORIES|||||
||||||ae|||||||||||||.|LIMITED|||||
||||||345,|[018205001471|||||~|||||[092404000159|[0910068951||10/07/2020||ALPHAMED|||||
||||||*|TAM21||||||||||AM21||,|FORMULATIONS|||||
||||||||||||||||||||PRIVATE LIMITED|||||
||||||346,|1018205001569<br>AM21||||||||||092404000263<br>AM21|[0910069049|{18/08/2020||INNOVARELABS<br>PRIVATELIMITED|||||
|||||||347,|1018205001959||||||||||092404000260|[0910066621||03/09/2018||SUVEN LIFE|||||
|||||||AM19||||||||||AM19|||SCIENCES LIMITED|||||
||||||||||||||||||||||||.|
||||||348.||018205002059||||||||||092404000229||0910066775||26/10/2018||GLANDPHARMA|||||
|||||||AM19||||||||||AM19|||LIMITED|||||
|||||_||349,|[018205000965<br>AM15||||||||||092404000039<br>AM15|[0910059887|28/04/2014||VIVIMED LABS<br>LIMITED|||||
|||;|||350,|1018205001285<br>AM21||||||||||092404000064<br>AM21||0910068743<br>,||12/05/2020||OPTRIX<br>LABORATORIES<br>PRIVATE LIMITED|||||
||||||351,|]018205001503||||||||||092404000181|[0910066442|[11/07/2018||AUROBINDO|||||
|||||||AM19||||||||||AM19|||PHARMALTD|||||
||||||352,|1018205001571<br>AM21||||||;||||092404000264<br>AM21|0910069070|20/08/2020||AURORE LIFE<br>SCIENCESPRIVATE<br>LIMITED|||||
||||||||||||||||||||||)|||
||||||353,||018205001604<br>AM21<br>.||||||||||092404000274<br>AM21|[0910069187|[15/09/2020||SUVEN<br>PHARMACEUTICALS|||||
|||||||||||.|||||||||LIMITED,|||||
||||||354,|}018205000592||||||||||082404000175|[0810146100||05/09/2019||CADILA|||||
||||;|||AM20<br>.||||||||||AM20|||PHARMACEUTICALS|||||
||||||||||||||.||||.|.|LIMITED|||||
|||||*)|355.|1018205000832<br>AM20||||||||'|1673404000178<br>|AM20||[0710115700||18/11/2019|. [WEXFORD<br>LABORATORIES PVT|||||
||||||||||||||||||||LTD|||||
||||||356,|1018205001782|||||||||~|1082404000249|[0810148893||26/10/2020-||MAKCUR|||||
|||||||AM21||||||||||AM21|||LABORATORIES|||||
||||,|||.||||||||||||:|LIMITED|||||
||||_|||357,|1618205001787<br>AM21<br>,||||||||||072404000209<br>AM21|10710117187|.|27/10/2020||R.L.FINECHEM<br>PRIVATELIMITED|||||
||.||||358.|[018205001813||||||||||072404000217|10710117219|03/11/2020||ADCOCKINGRAM|«||||
|.||||||AM21|.|||||||||AM21|;||LIMITED|||||

171

|.|||||||359,|1018205002209||082404000303|[0810144142|21/12/2018||[ATULLIMITED|||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
||||||||.|{AM19||AM19||;|||||||||
|.|||||||360.|[018205000812||082404000258|10810146544||13/11/2019|||ATUL LIMITED|||||||
|||||||||AM20||AM20|||||.||||||
||||||||36].|[018205001464||072404000102|[0710116730|[10/07/2020||[GLOBALCALCIUM|||||||
|ee|||||||TAM||fama<br>eo|||Ln||JPRIVATE LIMITED.|0||||||oo.|
|||||||||362,|{018205001605|~|1082404000157|10810148453|{01/09/2020|||CADILA|||||||
||||||||”|1AM21||AM21||||HEALTHCARE|||||||
|||||||||||||||LIMITED|||||||
|||.|||||363,|[018205001667<br>AM21||072404000158<br>AM21||0710117023|17/09/2020|||VPLCHEMICALS<br>PRIVATE LIMITED|||||||
||||||||364.|(018205001712||082404000207|[0810148710|[01/10/2020|||CADILA<br>-|||||||
|||||;||||AM21||AM21||||HEALTHCARE|||||||
|||||||||||||||LIMITED|||||||
||.||||||||||||||||||||
||||*||||||||||||||||||
||||||||1365,|1018205000371||082404000114||0810145666|[09/07/2019|||MAHARSHIPHARMA||||:||||
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|||||||||||||||||||||||
||||||||366,|[018205000860|~|1082404000272|10810146634|[22/11/2019|||GOVIND||||||_|
|||||||||AM20|_||AM20||||LABORATORIES PVT||||||.|
|||||||||||||||LTD|||||||
||||||||367,|1018205001466||072404000105||0710116735||13/07/2020|||GLOBAL CALCIUM|||||||
|||||||||AM2i|—|[AM21<br>.|;||*||PRIVATE LIMITED|||||||
||||||||368, <br>—”|[018205001982<br>|AMI9||072404000164<br>AM19.|[0710113890||25/09/2018<br>:||[SHILPA MEDICARE<br>LIMITED|.||||||
||||||||369.|1018205000216<br>AM14||082404000081<br>AM14||0810121432|27/05/2013|||HESTER<br>BIOSCIENCES||||||,|
|||||||||||||||LIMITED|||||||
||||||||||.||||||||||||
||||||||370,|1018205000661||082404000202|[0810146231|25/09/2019||OPES HEALTH CARE|||||||
|||||||||AM20||AM20||||PRIVATE LIMITED|||||||
||||||||371,|[018205001431||072404000092|[0710116675||29/06/2020|||GLOBAL CALCIUM|||||||
|||||||||~°|JAMa21||_|AM21<br>°||ae||PRIVATELIMITED|||||||
||||||||372,|1018205001486||082404000095|[0810148200|(21/07/2020||[ADVANCE||||||.|
|||||||||AM21||AM21||||PETROCHEMICALS<br>LIMITED|||||a|.|
||||||||373.|[018205001846<br>AM19||082404000030<br>AM19||0810142955|[04/07/2018||[ATUL LIMITED|||||||
|,|||||||374,<br>*|1018205003125°<br>1AM19<br>;||082404000264<br>AMI9 -|[0810143988|[29/11/2018|||CADILA~<br>HEALTHCARE|a|||||.|
|||||||||.||||||LIMITED|||||||
|"|||||||||||||||||||||
||||||||375,|1018205000106.<br>AM20||082404000003<br>AM20|[0810145205|[08/05/2019<br>:|||PRACHEM<br>|LABORATORIES||||||:|
||||||||376,|[018205000348<br>AM17||072404000115<br>AM17|0710110184<br>:||29/07/2016|_ |ACEBRIGHT (INDIA)<br>PHARMA PRIVATE|||||||:|
|||||||||.||||||LIMITED|||||||
|.|||||||377,|1018205000376<br>AM20|_|[082404000116 <br>AM20,|[0810145668|[09/07/2019|_ MAHARSHIPHARMA<br>CHEMPRIVATE|||||.|i||
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|---|---|---|---|---|---|---|---|---|---|---|---|
||379,||018205000762<br>AM14||072404000233<br>AM14||[0710099060|[18/10/2013|||SOMUSOLVENTS<br>PVT.LTD|||
|af|380,|]018205001468<br>FAM2D|[082404000075<br>PRMD|||[0810148122<br>epee||14/07/2020<br>DO<br>ee||= ATUL LIMITED|||
||381,|[018205001526||072404000129||[0710116853||10/08/2020||—_[R.L.FINECHEM|||
|||AM21||AM21<br>»|||||PRIVATE LIMITED|||
||382.||018205001588<br>AM21||072404000146<br>AM21||[0710116939||28/08/2020||{GLOBAL CALCIUM<br>PRIVATELIMITED|||
|sO|383.||018205001620||072404000154||[0710116964|[07/09/2020|||TADIMETY|||
|||AM21||AM21|||||AROMATICS|||
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||384,|[018205000319<br>AM20|-|082404000101<br>|AM20|:|[0810145581|27/06/2019|+ |CONCORDBIOTECH<br>LID||||
||||||||.|||||
||385,|[018205000377<br>AM20||082404000117<br>AM20||0810145669|[09/07/2019||[MAHARSHIPHARMA<br>CHEMPRIVATE<br>LIMITED|||
||386,|[018205000604||072404000141||[0710115523|[03/10/2019||[TADIMETY|||
|||AM20||AM20|||||AROMATICS PRIVATE|||
||||||||||LIMITED|||
|* ||387,|[018205001095<br>AM20||072404000276<br>AM20|||0710116142|-|18/02/2020|||TADIMETY<br>AROMATICS<br>PRIVATE LIMITED||LO|
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||389,|{018205001501<br>AM21||072404000118<br>AM21||[0710116798|[27/07/2020|||GLOBALCALCIUM<br>PRIVATELIMITED|||
||390,|[018205001680||082404000186||[0810148644||23/09/2020||[MAHARSHIPHARMA|||
|||AM21|,|{AM21|||||||CHEM PRIVATE|||
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||391.|[018205000086||082404000005||0810145144|01/05/2019|||ASCENTFINECHEM|||
|;|*||AM20|-||AM20|||||PRIVATE LIMITED|||
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||397,|[018205001663<br>AM21|_<br>oo,|1072404000163<br>AM21||[0710117014|[15/09/2020<br>*|||VIBRANT<br>PHARMACHEM<br>|PVT.LTD,,|||

==> picture [1 x 1] intentionally omitted <==

----- Start of picture text ----- } ----- End of picture text -----

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|404,|[018205001516<br>AM21|-|082404000110<br>[AM21|0810148274|04/08/2020||[CADILA<br>HEALTHCARE||||
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|405, <br>~|[018205001532<br>LAMIS||072404000535<br>AM13||0710096312|[28/06/2013<br>_|||WRIGLEY INDIA PVT<br>{LTD||||
|406.||018205001812<br>AM21||072404000218<br>AM21|[0710117218|[03/11/2020||[ADCOCK INGRAM<br>LIMITED||||
|“T4097,|[018205002096<br>AMI9||682404000187<br>AM19|[0810143923|/20/11/2018|||CADILA<br>HEALTHCARE|°||.|
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|408,|[018205002340||1082404000374|[0810144562||08/02/2019|||MAHESHRAJ<br>_||||
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|AQ9,|(018205000113<br>AMI14||072404000020<br>AMI4|[0710095227|[06/05/2013||[MICRO LABS<br>LIMITED||||
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|AJ,|{018205001563<br>AM21|.|052404000225<br>AM21|10510414951|20/08/2020||(SRF LIMITED<br>.||||
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|414,|[018205001445|AM21|[052404000149|10510414531|[01/07/2020|||TOJOVIKAS||||
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|.||||__|:<br>—_|||PRIVATE LIMITED||||
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||||:||||INDUSTRIES||||
|||||-|||LIMITED||||
|416,|(018205001617||052404000248|0510415116|[04/09/2020|||VENOR PHARMA||||
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174

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|||||||||||||||INDUSTRIES CORPN.,||||
|||||||||||||||P.LTD||||
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|.||||||||||||||INDUSTRIES CORPN.,||||
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||||~||AM21|||||AM21|||.||PRIVATE LIMITED||||
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|||||.|||||||||__|HINDUSTRIES||||
|||||||||||||||LIMITED||||
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==> picture [10 x 13] intentionally omitted <==

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|||||||AM20||AM19|||||INDUSTRIES||||
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||521.|[018205000524||052304000185|||10510361498||01/08/2013|||INDOPHYTOCHEM|||||||||
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||||||||||.||LIMITED|||||||||
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181

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==> picture [531 x 652] intentionally omitted <==

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==> picture [2 x 3] intentionally omitted <==

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==> picture [437 x 638] intentionally omitted <==

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==> picture [30 x 12] intentionally omitted <==

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|---|---|---|---|---|---|---|---|---|---|---|---|---|
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||||||||||||LIMITED||
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||||||||||||LIMITED||
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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||||||||||||||||||LIMITED||||
|||||||618205000618||||||039504000477||[0310831537||113/09/2019|[RELIANCE||||
|||||||AM20|||||AM20<br>mf|||.||.|INDUSTRIES||||
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||||||||||||||||||LIMITED||||
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|||||673,||018205000849<br>JAM18|||||||039504000503<br>AM18|[0310817005||||13/11/2017 _ [RELIANCE<br>INDUSTRIES LIMITED|||||
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188

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==> picture [468 x 622] intentionally omitted <==

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----- End of picture text -----

189

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==> picture [459 x 627] intentionally omitted <==

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----- End of picture text -----

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|||F9ay,||[018205000443|||039504000387||0310830566|(25/07/2019||[RELIANCE||||||
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192

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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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||||||||750,||018205000687<br>AM19|||~|039504000116<br>|AMI9||[0310821813||[21/06/2018|RELIANCE<br>INDUSTRIES<br>-<br>LIMITED|||
|||||||||||||||||.||||
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||||||||||||||||||LIMITED|||
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||||||||752,|[018205001398<br>AM21||||039504000137<br>AM21||[0310836741||(18/06/2020|[VERGO PHARMA<br>RESEARCH<br>LABORATORIES<br>PRIVATE LIMITED|||
||||||||753,|[018205001433<br>AM21||||039504000196<br>AM21||[0310836944||[30/06/2020|[SHIRDICHEMICALS<br>PRIVATELIMITED|||
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||||||||755,||018205001589<br>AM19<br>.||||039504000355<br>AMI9||[0310825690||[17/12/2018|/RELIANCE<br>INDUSTRIES<br>LIMITED||yoo.|
|.|||||||756.|[018205001735<br>AM21|||039504000361<br>AM21|||0310836514||(28/09/2020|[ZENITH<br>DYEINTERMEDIATES<br>LIMITED|||
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||||.|||.|(758.|[018205000619<br>AM20||~|-|[039504000325<br>|[AM20|'|0310831538<br>7||./13/09/2019||RELIANCE<br>~~<br>INDUSTRIES LIMITED|||
|:|||||||759,|1018205000687<br>AM20<br>,|||“1039504000340<br>.<br>|AM20<br>.|||10310831915<br>.||[30/09/2019<br>,||STERLING<br>=<br>*<br>AUXILIARIESPVT<br>LTD<br>°|||
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|||:||||762,|1018205000841<br>AMI8||||039504000395<br>AMI8|[0310816996|||13/11/2017<br>-|[RELIANCE<br>|INDUSTRIES||||
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194

| =. : .

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----- Start of picture text ----- | ----- End of picture text -----

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195

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==> picture [505 x 655] intentionally omitted <==

----- Start of picture text -----

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----- End of picture text -----

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197

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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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==> picture [2 x 1] intentionally omitted <==

----- Start of picture text -----

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|54,||1018205000677<br>AM20||939404000404<br>AM20|10310831806<br>)||27/09/2019||AVIK<br>PHARMACEUTICAL||;|||
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||||;||||||||||INDUSTRIES LTD.||||
|||874,||018205000696<br>AM20|||039404000514<br>AM20|||0310832013||[04/10/2019|||7BCHEMICALS<br>AND<br>PHARMACEUTICALS||||
|||||;||an|||||||LIMITED|||.|
|||875,|{018205000818<br>AM20|||= 039404000636|||[0310832767||114/11/2019||IGLENMARK||||
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|||876.|1018205000828<br>AM20|||039404000628<br>AM20||||0310832799||{15/11/2019<br>_’|LIMITED<br>- |GLENMARK LIFE<br>|SCIENCES LIMITED||;|||
|||877,||018205001383|||039404000568|||0310824072|||28/09/2018|||ARCHPHARMALABS||||
||||AM19|||AM19|||;||||LIMITED||||
|||878,|1018205001673|||039404000430|||(0310838379|||21/09/2020|||GLENMARKLIFE||||
||||AM21|||AM21|||||||SCIENCES LIMITED||||
|||879,||018205001704|||039404000467|||{0310838594|||30/09/2020|||KAIRAV<br>.||||
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||||||||||||||LIMITED||||
|||881.||018205001748<br>AM21|||039404000514<br>AM21<br>,|||/0310838947<br>‘|||16/10/2020|||[BENZO,CHEM<br>INDUSTRIES PVT||||
|.||||||||||.|||LTD||||
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||"|889.|1018205001756<br>AM21|-||039404000825<br>AM20||||0310838959<br>;||[16/10/2020||AARTI DRUGS<br>LIMITED|||||
|||883,|{018205001764|||039404000414|||[0310838998||[20/10/2020|||ANUHPHARMA||||
||||AM21|||AM21|||||...,||LIMITED.<br>—||||
|;||884,|[018205001811<br>AM21|||039404000500<br>AM21||||0310839257.||02/11/2020||||ENCUBE ETHICALS<br>PVTLTD||||
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|||887,|[018205001765<br>AM21|.|.|039404000415<br>AM21|||{0310838999||[20/10/2020|||ANUHPHARMA<br>LIMITED<br>°||||

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|||||||.<br>[osT0838058<br>:|PHARMACEUTICALS<br>LIMITED<br>[osT0838058<br>16/10/2020[AARTIDRUGS<br>‘<br>[LIMITED||PHARMACEUTICALS<br>.<br>DRUGS<br>,|
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933, |018205001724 022404000087 10210210144 06/10/2020 HALDIA AM21 . |AM21 PETROCHEMICALSLIMITED
. 934, 018205001400AM21 022404000028 |0210209929 18/06/2020 HALDIA : : a AM21 : ” |[PETROCHEMICALS] LIMITED
-, LIMITED

The Committee has also taken following decisions:

@ While considering the cases of M/s Deepak Phenolics Limited, it was decided to ’ ; - issue(a) PhenolStandardand Input(b) Acetone.Output Norms (SIONs)}, with‘ respect to Export products namely (ii), The Committee also considered the pending cases of M/s Reliance Industries Ltd. for ° ; | ; fixation of adhoc norms and it was decided to refer all the pending cases of M/s Reliance Industries Ltd. to D/o C&PC for its comments. . wre : ; a | LO Meeting ended with thanks-to Chair.and participants OO, ; .

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