IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2018-08-24

DGFT Committee Minutes

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Office of Directorate General of Foreign Trade New Delhi -

Para 4.7 Decision

07/82/2018 of 2018-19 dated 24.08.2018 (actually held on 28.08.2018 and 29.08.2018) considered the cases/issues under 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 J.V. Patil, Addl. DGFT in Room No.11, Udyog Bhawan, New Delhi.

Following members were present:-

Shri Nirmal Kumar, Dy. Director General of Foreign Trade Consultant, Technical Expert Pharmaceuticals Consultant, Technical Expert Chemicals

MEETING NUMBER

: 7/82-ALC4/2018 MEETING DATE: 24.08.2018

_ Case No.:148/6/82-ALC4/2017 Party Name: VENUS REMEDIES (Meet No/Date:7/82-—«*(Status: [| LTD., ALC4/2018 Approved (24.08.2018 i HQ File :01/82/050/00718/AM18/ RLAFile Lic.No/Date:2210014909 :22/24/040/00016/AM15/ 23.05.2014 | | Decision: The Committee considered the case as per agenda and in the presence of the technical experts, it was | decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm | whichever is lower: | Export product Exp. Qty. Sl. Import items Qty. No. 1 CEFTRIAXONE/ 1000 No Vials SULBACTAM SODIUM | 604.44 grams _ | | SULBACTAM 1.5 GM/ VIAL STERILE | POWDER FOR SOLUTION i | FOR INJECTION/ INFUSION | EACH VIAL CONTAINS: 2 CEFTRIAXONE 1160.00 grams | CEFTRIAXONE — SODIUM SODIUM STERILE EQV. TO 1 | CEFTRIAXONE.....1000 MG, | SULBACTAM SODIUM EQV. TO SULBACTAM.........500 | | MG, DISODIUM | | EDETATE......37 MG. _ RA may take appropriate action as per the decision of Norms Committee. | Case No.:65/15/82-ALC4/2014 PartyName:ABEERS ~ Meet No/Date:7/82——S—S=«SStatus: | PHARMACEUTICALS PVT —ALC4/2018 Approved 1 LTD (24.08.2018 2HQFie == ~~ RLAFile =~=——S_Lic.No/Date:0510392011. | :01/82/050/01352/AM15/ :05/23/040/00360/AM 15/ (14.11.2014 Decision: The Committee considered the case as per agenda and in the presence of the technical experts, it was _ decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm

_ whichever is lower: | |

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----- Start of picture text ----- | No. allowed | |__| SUPPORT CAPSULES mg/capsule | _ | (MEDICAMENTS OF 2 Tinospora cordifloia (herbal extract 102.0 | 3 Glycyrrhiza glabra (herbal extract 102.0 | | A powder) mg/capsule powder) | powder) | powder) | RA may take appropriate action as per the decision of Norms Committee. _ Case No.:82/18/82-ALC4/2014 |Party Name:ABEERS ‘Meet No/Date:7/82- ‘Status: | | | [PHARMACEUTICALS PVT (ALC4/2018 Approved | | | LTD 24.08.2018 | | HQ File :01/82/050/01448/AM15/ |RLA File ‘Lic.No/Date:0510392368 | | | ':05/23/040/00413/AM15/ 10.12.2014 | | | |Decision: | The Committee considered the case as per agenda and in the presence of the technical experts, it was | decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: | Export product Exp. Sl. Import items Qty. | Qty. No. | | | ABEERS LIPID CARE CAPSULES Number Arjun (Terminalia 102.0 mg/ | | (MEDICAMENTS OF AYURVEDIC 1 arjuna) herbal extract capsule | / | | SYSTEM ) powder | 3 Fenugreek (Trigonella 102.0 mg/ | | | foenum graecum) herbal | capsule | i | extract powder | | 3 Turmeric (Curuma 102.0 mg/ | oo powder | 4 Gymnema (Gymenma 102.0 mg/ | || | oa5 BlackpowderPepper (Piper 102.0 mg/ || i | powder | | | Long pepper (Piper 102.0 mg/ | powder RA may take appropriate action as per the decision of Norms Committee. う ----- End of picture text -----

(Case No.:72/4/82-ALC4/2015 Party Name:LANTECH Meet No/Date:7/82‘Status: | | i ‘PHARMACEUTICALS LTD \ALC4/2018 Approved | | 24.08.2018 | HQ File :01/82/050/00111/AM16/ RLAFile ‘Lic.No/Date:09 10061664 | | | :09/24/040/00647/AM15/ (04.03.2015 | | Decision: The Committee considered the case as per agenda and in the presence of the technical experts, it was | decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: 4 | | (1S,48,5S)-4-Bromo-61 kg 3-Cyclohexene-|-Carboxylic acid 1.773 kg | | | oxabicyclo [3.2.1] octan-7R(+)-Pheny] ethylamine 1.353 kg | | | | one Methylene Dichloride 3.00 kg | | Ethyl Acetate 6.30 kg | Flexible Containers | | |RA may take appropriate action as per the decision of Norms Committee | / |Case No.:65/4/82-ALC4/2015 PartyName:MYLAN ——S Meet No/Date:7/82-. Status: } | ‘LABORATORIES LIMITED /ALC4/2018 Rejected | | | 24.08.2018 5|HQ File :01/82/050/00104/AM16/:09/24/040/00662/AM15/RLA File - Lic.No/Date:0910061843[31.03.2015 | | | Decision: The Committee observed that the firm still not submit the reply to the D/L No. 35011/240/2015-P1 | (Norms) dated 09.09.2015 issued by D/o Pharmaceutical, hence the Committee decided to reject the case. |

| \Case No.:73/4/82-ALC4/2015 ‘Party Name:VIVIMED LABS _ Meet No/Date:7/82. ‘Status: - | | ‘LIMITED ‘ALC4/2018 ‘Approved | } | | 24.08.2018 | | |HQFile :01/82/050/00112/AM16/|RLAFile = | | :09/24/040/00700/AM15/= ~=~~—~—_Lic.No/Date:091006182131.03.2015 | Decision: The Committee considered the case as per agenda and in the presence of the technical experts, it was | decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm. whichever is lower: 6 | Export product Qty. | Sl. | Import items Qty. | | No. | | TRICLOSAN OR TRICLOSAN USP OR| 1 kg 2,4 DICHLORO PHENOL 1.50 kg | et bien PERCHLORO EHTYLENE 2.50 kg | | SODIUM NITRITE 0.50 kg | | HEXANE 2.00 kg | | 5 | ACTIVATED 0.100kg | | | CARBON(CARBOPAL Gn-A II) | | RA may take appropriate action as per the decision of Norms Committee.

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----- Start of picture text ----- 5 ; | Z METHYLENE 1.38 kg | | DICHLORIDE | | METHANOL 219k | || ISOPROPYL ALCOHOL | 0.555kg__ | | | SODIUM BOROHYDRIDE | 0.06 kg | | }6 | DEBUTYLAMINE 0.50kg | || DIMETHYL FORMAMIDE. | 0.555kg |. || P- 0.3476 kg | | CHLOROBENZALDEHYDE || }9 | N-HEPTANE 0.757kg | | 10 ACTIVATED CARBON 0.011 kg | | (CECA ENO PC) | | HEXANE 0.832 kg | RA may take appropriate action as per the decision of Norms Committee | | \Case No.:116/13/82-ALC4/2016 [PartyName:SOFTGEL ~—(Meet No/Date:7/82- —SStatus: | | (HEALTH CARE PVT. LTD., ALC4/20 18 Deferred | ‘10 Ho File RLA File Lic.No/Date:0410161132 Defer Date: | ::01/82/050/00744/AM17/ ':04/24/040/00143/AM16/ 20.10.2015 | | Decision: Deferred forcomment ofTE. tt ath ee ae a a | |i CaseNo.:2/1/82-ALC1/2016 ‘Party Name:UNIJULESLIFE Meet No/Date:7/82-. Status: | ‘SCIENCES LTD. ALC4/2018 Approved ; HQ File :01/82/050/01776/AM16/ RLA File Lic.No/Date:03 10800416 | | 03/95/040/00632/AM16/ 26.11.2015 | Decision: The Committee considered thecaseas per agenda and in the presenceof the technical experts,itwas | idecided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm | Fi , Whichever is lower: || | | | NOVATRIZOATEMeglumine and Diatrizoate76 %(DiatrizoateSodium 1 Vial DIATRIZOIC ACID 627.168mg/ ml | | Injection USP 760mg/ml) 2000.00Kgs | | RA may take appropriate action as per the decision of Norms Committee. | | [Case No.:2/17/82-ALC4/2015 |'PartyName:ARENELIFE Meet No/Date:7/82-. Status: SCIENCES LIMITED. ALC4/2018 Approved — | HQ File:01/82/050/01462/AM16/ RLA File _ ‘Lic.No/Date:0910063114 | | | :09/24/040/00571/AM16/ 08.01.2016 | lo ‘Decision: The Committee considered the case as per agenda and in the presence of the technical experts, it was. '~ decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm | whichever is lower: | |LUMEFANTRINE 1 kg (28,3S)-1,2-EPOXY-3- 0.647 kg | | BOC-AMINO)-4- つ ----- End of picture text -----

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----- Start of picture text ----- 6 i a = - a enero sstnsrseeesnmnernevenennee rm renee erence en enecerttetecrseenesnot eee —— — sr en | “* | | 2 (3S,4aS,8aS)-3-N-tert 0.598 kg | | | Butylcarboxamido | | | decahydro isoquinoline | Methylene Dichloride 6.24 kg | _ | RA may take appropriate action as per the decision of Norms Committee. | | Case No.:17/10/82-ALC4/2016 Party Name:IND-SWIFT "Meet No/Date:7/82- Status: i LABORATORIES LTD., ALC4/2018 ‘Approved | ||HQ File :01/82/050/00363/AM17/RLA File - ‘Lic.No/Date:2210015407 | ‘:22/24/040/00104/AM16/ (01.02.2016 | | | ‘Decision: |The Committee considered the case as per agenda and in the presence of the technical experts, it was | | decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm | whichever is lower: | | Export product Qty. Sl. Import items Qty. | Rosuvastatin Calcium 1 kg 1 Z-8 [4-(4-Fluorophenyl)-6- 1.338 kg | | | Isopropyl-5-Formyl-2Methyl-N- (N- | ; | Methanesulfonylamino) i Pyrimidine] | 113 | 2 Methyl Tert. Butyl Ether 10.00 kg | (MTBE) | ; | 4 J-6 [Methyl (3R)-3-Tert- 1.80 kg | | Butyldimethylsilyloxy)-5- | i | Oxo-6- | i Triphenylphosphoranylidene | i | Hexanoate] | | | 5 Diethylmethoxy Borane It was observed that the | firm did not provide | || anymaterial, detailshence of thisthe raw | | || | toCommitteeallow thisdecidedimport not |.| | | item. | | 6 | Sodium Borohydride 0.28 kg | | RA may take appropriate action as per the decision of Norms Committee. | Case No.:69/1/82-ALC1/2016 PartyName:ENCUBE —(Meet No/Date:7/82-. «Status: | | ETHICALS PVT LTD ALC4/2018 ‘Approved | HQ File :01/82/050/01843/AM16/ |RLA File ~ |Lie.No/Date:0310802291 | hall ':03/94/040/00922/AM16/ 08.02.2016 | | | ‘Decision: The committee considered the caseasper agenda and in the light of earlier decision taken by NC in its | 8/82 meeting dated 11.07.2013, it was decided to ratify norms for the following export product: | | | 1. | Secura Protective Cream 40 Gms. | _ | 2. Secura Protective Cream 50 Gms. | Ｄ７つ ----- End of picture text -----

3 i| 4. — reSecura ProtectivereeOintment 159ronGms. Sn ene eee | | 5. | Secura Moisturizing Cream 85 Gms. | 6. Secura Moisturizing Cream 184 Gms. | | 7. Secura Extra Protective Cream/ Secura Extra Protective Cream Z 30 92 Gms. ; ot 8. Secura Extra Protective Cream 219.7 Gms | 9, Secura AF Greaseless 57 Gms. | | 10. Secura Antifungal Extra Thick 92 Gms. | ; | 11. Secura Moisturizing Lotion 236 MI. (238.36 Gms. as SG is 1.01) _
| | 1 32 . UnicareSecura Moisturizing LotionMoisturizing Lotion 60236 MI.MI. (60.6(238.36 Gms.Gm a s SG. as isSG1.01)is 1.01) |

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Unicare Moisturizing Lotion 60 MI. (60.6 Gms. as SG is 1.01)

/ | 1S. Uni Derm Moisturizing Cream 85 Gms. | | 16. Uni Derm Moisturizing Cream 80 Gms. | 17. Secura Extra Protective Cream 90 Gms.

|| 18. Secura Protective Cream /Secura Protective Z 10 78 Gms. | 19. Solosite Wound Gel 85 Gms | under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

| S. No. 1,2 &18 SECURA Protective cream 40gms., 50gms., & 78gms.

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----- Start of picture text ----- | S.No. Name of ingredients Qty.(Kg.) allowed per kg of | any other | bearing brand/trade name emulgadeF or any other つ ----- End of picture text -----

'S. No. 3& 4 SECURA Protective ointment 70 gms & 159 gms.

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LQ-(SG)(SORBITAN SESQUIOLEATE/CRILL 43) or any other

S. No. 7,8 & 17 SECURA Protective Cream 92 gms, 219.7 gms & 90 gms

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|||||||
|---|---|---|---|---|---|
|||export|product|with|2%|wastage|
|Karaya Gum|0.0728|||
|Diazolidiny]|Urea|0.00204|i|

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S. No. 9 Secura Antifungal greaseless 57 gms

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||||||||||
|---|---|---|---|---|---|---|---|---|
|||export|product|with 2% wastage|||
|||2|Petroleum|Jelly yellow/white|bearing|Brand/ Trade|0.1530|kg|
|i|||or|any|other|
|14|Mixture|of Stearyl|Alcohol|with|nonionic|Emulsfer|0.0714|kg|
|||2.5-DIOXO-4-IMIDAZOLLIDINYL|UREA|bearing|0.00204|kg|||
|||57|grams|i|
|_|S.No.|10 Secura Antifungal|extra thick 92 gms|||
|[|S.No.|Name of ingredients|Qty.(Kg.) allowed per kg of|||
|name|Petroleum|or|White|Fonoline|any|other|
|||trade name GLUCATE ™|DO EMULSIFIER|or any|||
|other|
|or|any|other|
|or|any|other|
|to|||AKUCELL|AF|2781W|or|any|other|
|KARAYA GUM|SUPERFINE MK|200 FCC|or any|||
||||e|||Karaya Gum bearing brand/ trade name PWD|0.0714 kg|||
|—|Lonza Guard|or any|other|||

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----- Start of picture text ----- | |S. No. 15&16 Uniderm moisturizing cream 85 & 80 gms | [SNe | export product with 2% wastage | 1 White Mineral Oil bearing brand/.trade name Kaydol or «73 Petroleum Jelly yellow/white bearing brand name Super | | (SG)(SORBITAN SESQUIOLEATE/CRILL 43)or any | other 5 Benzethonium Chloride USP Bearing |S. No. 19 Solosite wound gel 85 gms | | export product with 2% 2% wastage つ ----- End of picture text -----

export product with 2% 2% wastage

| [1 _| Akucell sw 3009 |2| Allantoin (2-5 dioxo-4-imidazollidinylx 181 Carboxy methylurea) 0.0 0511785kg kg || RA may take appropriate action as per the decision of Norms Committee. | Case No.:79/7/82-ALC4/2016 Party Name:OPTIMUS DRUGS Meet No/Date:7/82-. Status: PRIVATE LIMITED ALC4/2018 ‘Approved | | | | 24.08.2018 | HQ File :01/82/050/00253/AMI7/ RLAFile = =~ ~—~—|Lic.No/Date:0910063240 | :09/24/040/00586/AM 16/ '10.02.2016 | | | Decision: ~ TheCommittee considered the case as per agenda and in the presence of the technical experts, it was | ‘decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever | is lower: | | | Simeprevir 1 kg (2R,3aR, 10Z,11aS,12aR,14aR)1.03 kg | | Sodium 2,3,3a,4,5,6,7,8,9,| 1a,12,13,14,14a-Tetradecahydro-2-[[7| quinoliny]]oxy]-5-methyl-4,methoxy-8-methyl-2-[4-(1-methylethyl)-2-thiazoly]]-4- 14|| | dioxocyclopenta[c]cyclopropa[g][1,6]diazacyclotetradecine| 12a(1H)-carboxylic acid _ RA may take appropriate action as per the decision of Norms Committee. || | (Case No.:13/10/82-ALC4/2016 [PartyName:IND-SWIFT Meet No/Date:7/82-. (Status: LABORATORIES LTD., 'ALC4/2018 Approved | | | | 24.08.2018 | | HQ = aaa RLeae aes aieT 7 | | :01/82/050/00359/AM17/ :22/24/040/00109/AM16/ (17.02.2016 | | from‘Decision: — The Committee considered case as peragendain the presence of the technical experts and takingcue | No. 2210015847its earlier decisiondated 18.01.2018,taken in Meetingdecided No.to4/82-ALC4/2018,ratify the ad-hoc inputdatedoutput19.06.2018normsagainstunder paraAdvance4.7 ofAuthorization HBP as per| details below or as applied by firm whichever is lower: | 16. ; || Ropinirole Hydrochloride Ikg | No.1 N-(2-Methy]-3-Nitrophenethyl)-N2.146 kg || | Propylpropan-1-Amine Hydrochloride | | 981kg | | £76k | RA may take appropriate action as per the decision of Norms Committee. | "(Case No.:82/7/82-ALC4/2016 Party Name:OPTIMUSPRIVATE LIMITED DRUGS [MeetALC4/2018No/Date:7/82- —*(Status:‘Approved =O | 24.08.2018 | | HQ File :01/82/050/00256/AM17/RLA File = = =~=~=~—~—~—_Lic.No/Date:0910063357 | | | :09/24/040/00721/AM 16/ 03.03.2016 | | ‘'7 Decision: The Committee considered the case as per agenda and in the presence of the technical ‘experts, it was. decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm | whichever is lower: |

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----- Start of picture text ----- on, ee nr rnraonennictesnsnieneneci screceenennts acetatettn einem cect irene — — — enero menmnmemnacnnmnica ~ ve | Daclatasvir Dihydrochloride 1 kg 4,4-Bis(Chloromethyl)Bipheny] 1.00 kg | | 2 BOC-L-Proline (OR) N-BOC- 1.15 kg | | PROLINE | | 3 N-(Methoxycarbonyl)-L-valine (OR) | 0.55 kg | | | Moc-l-valine | | RA may take appropriate action as per the decision of Norms Committee | | (Case No.:67/4/82-ALC4/2016 Party Name:STRIDES SHASUN Meet No/Date:7/82- Status: | | LIMITED ALC4/2018 Approved — | (HQ File :01/82/050/00130/AM17/ RLAFile === ~=~=~—~—Lic.No/Date:0410161684 | | :04/24/040/00256/AM 16/ 04.03.2016 | ‘Decision: The Committee considered the case as per agenda and in the presence of the technical experts, “it was [|] | decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm | | jwhichever is lower: | | | GABAPENTIN TABLETS USP 600 Number | 612.00 mg _— GABAPENTIN USP | | 2 Mannitol (Pearlitol 100 91.5 18 | SD) USP/NF mg/tablet | | 3 Copovidone/Plasdone S- | 30.0 mg | | 630 USP/NF/Ph.Eur. /tablet | | | 4 Poloxamer (Lutrol M 127) | 1.00 | | | NF. meg/tablet / | | n) Magnesium Stearate VEG. | 2-00 } | EP/USP / NF mg/tablet Hydroxy Propyl Cellulose | 30.00 ; | NF.Ph.Eur(Klucel-EF PH) | mg/tablet | | 7 Low-substituted 10.00 | | | Hydroxypropyl cellulose mg/tablet | | | USP/NF,JP (LHPC LH- | | | RA may take appropriate action as per the decision of Norms Committee [Case No.:55/4/82-ALC4/2016 |Party Name:ENCUBE —Meet No/Date:7/82-. Status: Rejected | | ETHICALS PVT LTD “ALC4/2018 | | | | 24.08.2018 | lig HQ Fileee RLA File Lic.No/Date:03 10803171 | | | ~ (:01/82/050/00118/AM17/ :03/94/040/01044/AM16/ 09.03.2016  Decision: — TheCommittee observed that the firm still not submit the reply to the information as asked for vide | (Minutes of the Meeting No. 3/82/ALC-4/2018, dated 05.06.2018 (actually held on 27.06.2018, 28.06.2018 and | 05.07.2018) , hence the Committee decided to reject the case. つ ----- End of picture text -----

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----- Start of picture text ----- [Case No.:186/10/82- —-—~—=Party Name: VOVANTIS —— Meet No/Date:7/82-. Status: | _ ALC4/2016 ‘LABORATORIES PVT LTD —_ALC4/2018 Rejected 20hQFie ~~ ~RLAFile = ~~—~—~—_Lic.No/Date:3410042021 | | :01/82/050/00532/AM17/ ':34/24/040/00290/AM16/ 30.03.2016 ‘Decision: | The Committee observed that the firm still not submit the reply to the information as asked for vide. ----- End of picture text -----

||12||
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|||ame|
||<br>Minutes of the Meeting No.3/82/ALC-4/2018, dated 05.06.2018 (actually held on27.06.2018, 28.06.2018 and_<br>05.07.2018) , hence the Committee decided to rejectthe case.|||
|}<br>||‘CaseNo.:43/4/82-ALC4/2016<br>|PartyName:AARTI<br>Meet No/Date:7/82-<br>(Status:<br>|<br>INDUSTRIESLIMITED<br>ALC4/2018<br>Approved<br>|<br>|<br>24.08.2018<br>|<br>|||
|||HQFile :01/82/050/00106/AMI17/ RLA File<br>==—————S—SCL<br>ic.NcDaate0310803663<br>|<br>|<br>:03/94/040/01108/AM16/<br>31.03.2016<br>|<br>Decision:<br>|The Committee consideredthecase asperagendaand inthepresenceofthetechnical experts, itwas.||
|**_**|decided to ratify the ad-hoc input output norms under para 4.7 ofHBP as per details below or as applied by firm<br>|||
|**__**|whichever is lower:<br>|||
|つ<br>__[G,S,S)-2-Azabicyclo-[3,3,0]Octane-3- | 1kg 1<br>|Lserine<br>1.50kg<br>|<br>|<br>| oa:neBenzylEster<br>BenzylAlcohol<br>2.128kg<br>|<br>;<br>|<br>rochloride<br>:<br>|<br>; yy<br>3<br>5%Palladiumon Carbon<br>0.050kg<br>|<br>Catalyst<br>||||
||RA may take appropriate action as per the decision ofNorms Committee||
|つ<br>つ<br>/<br>CaseNo.:123/7/82-ALC4/2016 PartyName:AARTI<br>~ MeetNo/Date:7/82-<br>Status:<br>}<br>INDUSTRIES LIMITED<br>ALC4/2018<br>‘Approved<br>;<br>|<br>|<br>24.08.2018<br>|<br>|<br>HQ File :01/82/050/00297/AM17/ 'RLA File<br>-<br>" Lic.No/Date:0310803819<br>|<br>;<br>|<br>:03/94/040/01038/AM 16/<br>06.04.2016<br>|<br>Decision:<br>TheCommitteeconsideredthecaseasperagenda and“inthepresenceofthetechnical experts, itwas |<br>|<br>decided to ratify the ad-hoc input output norms under para 4.7 ofHBP as per details below or as applied by firm|<br>27 whichever is lower:|||
||<br>;<br>_|つ<br>|<br>|AZABICYCLO(3.3.0)OCTANE-3-<br>2<br>|<br>|_|<br>CARBOXYLICACIDBENZYL<br>a ;<br>|<br>|<br>ESTERHCL<br>3<br>% Palladium on<br>Carbon<br>0.050kg<br>|<br>|<br>Catalyst<br>|<br>RA may take appropriate action as perthe decision ofNorms Committee<br>|||
|CaseNo.:181/10/82-<br>‘PartyName:ALEMBIC<br>M**e**t<br>No/Date:7/82-ALC4/2018<br>|Status:<br>ALC4/2016<br>PHARMACEUTICALS LTD<br>24.08.2018<br>‘Deferred|||
|23 <br>~—<br>||HQ File<br>RLA File<br>~—<br>|Lic.No/Date:3410042142<br>‘Defer Date:<br>01/82/050/00527/AM17/<br>:34/24/040/00021/AM17/<br>(05.05.2016<br>|<br>|<br>Decision:<br>Raply reocivelfonthei TT<br>“|||
|CaseNo.:86/11/82-ALC4/2016<br>PartyName:ALMELO<br>—_|Meet No/Date:7/82-ALC4/2018 Status:<br>PRIVATELIMITED<br>24.08.2018<br>Rejected|||
||<br>(24 <br>_|HQFile<br>RLA File<br>‘Lic.No/Date:09 10063626<br>|<br>|<br> ':01/82/050/00620/AM17/<br>:09/24/040/00056/AM17/<br>(17.05.2016<br>|<br>|<br>Decision:<br>_The Committee observed that thefirm still notsubmit<br>the reply to theinformation<br>asasked for vide.<br>‘Minutes of the Meeting No. 3/82/ALC-4/2018, dated 05.06.2018 (actually held on 27.06.2018, 28.06.2018 and |<br>05.07.2018),hencetheCommitteedecidedtorejectthecase.||

/ (Case No.:134/7/82-ALC4/2016 |PartyName:ORBIT LIFE —|' Meet No/Date:7/82-. Status: | | ‘SCIENCE PVT. LTD. ‘ALC4/2018 ‘Approved || | 24.08.2018 | | HQ File :01/82/050/00308/AM17/ RLAFile = =—~—_Lic.No/Date:0310804944 | | ':03/95/040/00069/AM17/ 24.05.2016 | ‘Decision: The Committee considered the case as per agenda and in the presence of the technical experts, ‘it was” | decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm. whichever| } is lower: | || | IMIPENEM (STERILE/TECHNICAL) | 1 kg ACETONE 6.03 kg | | ACTIVATED CARBON 0.100kg | | | 3 P-NITROBENXL-6-(11.872 kg i HYDROXYETHYL)-1| | | AZBICYCLO(3.2.)HEPTANE| | 3, 7-DIONE-2| | CARBOXYLATE/BCK | | | 4 CYSTEAMINE 0.672 kg | | | HYDROCHLORIDE | | 5 DI PHENYL 1.596 kg | | CHLOROPHOSPHATE | | (DPCP) 25 }6 | ISO PROPYL ALCOHOL 20.51 kg | | | 7 METHYLENE DI CHLORIDE| 17.20 kg | | (MDC) | /8 | METHANOL 2.54 kg | | | /9 | TETRAHYDRO FURAN 0.97 kg | | 10 2.5% PALADIUM ON 0.002 kg i CARBON | | ACETIC ACID 0.60 kg | || ACETIC ANHYDRIDE 0.51 kg | || BENZOYL CHLORIDE 1.20 kg | | | BENZYL ALCOHOL 0.90 kg | | 15 DI ISOPROPYLE 1.86 kg | | ETHYLAMINE (DIPEA) | | 16 DI METHYL AMINO 0.0232 kg | | PYRIDINE (DMAP) | | | 17 DIMETHYL FORMAMIDE 0.35 kg | | (DMF) | | | HYFLOW 0.410 kg | || N METHYL MORPHOLINE | 1.65 kg i | N METHYL PYRILIDONE | 2-50 kg | | | RA may take appropriate action as per the decision of Norms Committee (Case No.:121/10/82-ALC4/2016 Party Name:OPTIMUS DRUGS Meet No/Date:7/82-. Status: | | PRIVATE LIMITED ALC4/2018 Approved | | 24.08.2018 26 |HQ File:01/82/050/00467/AM17/ RLAFile = ~~ ~—~—_Lic.No/Date:0910063765 || ':09/24/040/00032/AM17/ 08.06.2016 | | ‘Decision: ~The Committee considered the case as per agenda and in the presence of the technical experts, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm

||14||
|---|---|---|
|||whichever is lower:<br>-<br>7<br>:<br>i<br>/|||
||<br>:|Daclatasvir Dihydrochloride<br>1 kg<br>1<br>4,4-<br>1.00 kg<br>Bis(Chloromethyl)Bipheny1<br>|<br>2<br>BOC-L-Proline<br>1.15 kg||<br>|<br>||
||||<br>(OR)N-BOC-PROLINE<br>|<br>3<br>N-(Methoxycarbonyl)-L-<br>0.55 kg<br>|<br>valine||<br>||
||Cor ) Moc-l-valine||
|||4<br>1-(3-Dimethylaminopropy])-<br>0.60kg<br>|<br>3-ethylcarbodiimide||<br>||
||hydrochloride(EDC-HCL)||
||<br>|<br>||orEDC-HCLORN-(3-<br>|<br>Dimethylaminopropyl)-N-<br>|<br>ethylcarbodiimide||<br>||
||hydrochloride (EDC)|||
||RA may take appropriate action as perthe decision ofNorms Committee||
|||||
||CaseNo.:61/11/82-ALC4/2016 |PartyName:KEKULE<br>—'MeetNo/Date:7/82-.——Ss«SStatus:<br>|<br>PHARMALTD<br>ALC4/2018<br>‘Rejected||
|7‘HQ<br>|<br>||‘HQFile<br>i<br>a<br>RLAFile<br>Lic.No/Date:0910063781<br>|<br>:01/82/050/00595/AM17/<br>:09/24/040/00017/AM17/<br>09.06.2016<br>|<br>|<br>Decision:— TheCommittee<br>observed that the firm stillnotsubmit thereply tothe information asasked forvide<br>Minutes of the Meeting No. 3/82/ALC-4/2018, dated 05.06.2018 (actually held on 27.06.2018, 28.06.2018 and<br>05.07.2018) ,hencetheCommitteedecided to rejectthecase.<br>|||
|CaseNo.:23/10/82-ALC4/2016 PartyName:RECKITT<br>‘(MeetNo/Date:7/82-<br>__[Status: Rejected<br>BENCKISER ( INDIA)<br>ALC4/2018||||
|P|<br>‘PRIVATELIMITED,<br>24.08.2018<br>|<br>|<br>7 ont<br>aoa<br>aterenretease R7<br>enRTC oral<br>|<br>“**~**<br>:01/82/050/00369/AM17/<br>':05/24/040/00128/AM17/<br>16.06.2016<br>|<br>|<br>Decision:<br>The Committee observed that thefirm still notsubmitthereplyto the information asasked forvide<br>‘Minutes of the Meeting No. 3/82/ALC-4/2018, dated 05.06.2018 (actually held on 27.06.2018, 28.06.2018 and |<br>05.07.2018) , hence the Committee decided to reject the case.<br>||||
|/|CaseNo.:109/10/82-<br>“Party Name:DSMSINOCHEM[MeetNo/Date:7/82-_|Status: Deferred<br>ALC4/2016<br>PHARMACEUTICALS INDIA<br>ALC4/2018<br>||||
|HQ File<br>RLAFile=————S—S—SCLiie. No/Datte:2210015511<br>[Defer Date:<br>29 :01/82/050/00455/AM17/<br>:22/24/040/00022/AM17/<br>23.06.2016||||
|_<br>**_**_<br>|<br>_|Decision:<br>TheCommittee observed that the firm neither attended the PHnor submit thedetailsas asked for.<br>vide Minutes of the MeetingNo. 3/82/ALC-4/2018, dated 05.06.2018 (actually held on 27.06.2018, 28.06.2018 and|<br>05.07.2018) ,hence theCommittee decided togive lastopportunity to firm to attendPHandsubmit its reply, failing<br>|<br>which, its case will be rejected.||
|_<br>Case No.:10/11/82-ALC4/2016 |Party Name:MATRIXFINE<br>[MeetNo/Date:7/82-ALC4/2018‘Status;<br>SCIENCESPVT.LTD.,<br>24.08.2018<br>Rejected<br>|<br>HQFile<br>RLAFile =<br>Lic. No/Date:0310806238<br>|<br>30 :01/82/050/00544/AM17/<br>':03/95/040/00304/AM17/<br>(14.07.2016<br>|<br>|<br>Decision:<br>The Committee observed that the firm still<br>notsubmit<br>the reply to the information asaskedforvide.<br>**_**<br>Minutes of the Meeting No. 3/82/ALC-4/2018, dated 05.06.2018 (actually held on 27.06.2018, 28.06.2018 and_<br>05.07.2018),hencetheCommitteedecidedtorejectthecase.|||

==> picture [493 x 666] intentionally omitted <==

----- Start of picture text ----- | CaseNo.:9/14/82-ALC4/2016 Party Name:ALEMBIC ——( Meet No/Date:7/82-. Status: | PHARMACEUTICALS LTD ALC4/2018 ‘Approved | | | 24.08.2018 | | HQ File :01/82/050/00807/AM17/ RLA File ‘Lic.No/Date:3410042403 _ | | ; | :34/24/040/00133/AM17/ 04.08.2016 | | | Decision: The Committee considered the case as per agenda and in the presence of the technical experts, it was | | whicheverdecided to ratifyis lower:the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm | OLMESARTAN MEDOXOMIL 1 kg TRITYL OLMESARTAN 1.70 kg fo MEDOXOMIL ||t| DICHLOROMETHANE 2.70 kg | | ACETONE 1.58 kg | RA may take appropriate action as per the decision of Norms Committee | | [Case No.:19/13/82-ALC4/2016 Party Name:FRESENIUS KABI Meet No/Date:7/82-. Status: | | ONCOLOGY LIMITED ALC4/2018 Approved | |HQ File:01/82/050/00647/AMI17/ RLA File = =~=——Lic,.No/Date:0510399492 | ':05/23/040/00234/AM17/ 19.08.2016 | | Dd eci sion:ded to ~ratify ThetheCommitteead-hoc consideredinput output thenorm ca s e asunder per agendapara 4.7 andof HBP‘in theas prp e sencer details of thb e techniclow or a sl appliedexperts,byit was.firm | whichever is lower: | | Export product Qty. Sl. Import items Qty. | No. | PACLITAXEL SEMI SYNTHETIC lkg 1 2-(PMP)-N-Bz-Ph- 1.12 kg 132 | Oxazolidine Carbox Acid. | ft White to off white crystalline | | powder with Assay NLT 98%. | | | 2 Silica Gel. 20.00 kg | | White ctystalline solid with | | moisture content not more | | than 95%. | | | 3 Cerrous Chloride Anhydrous. | 0.100 kg i White to greenish blue | | | hygroscopic powder with | | Assay NLT 95%. | | 4 Taxus Baccitta Leaves. 1722.00kg | | | Greenish leaves powder with | i | D/L ratio NLT 0.1 _| RA may take appropriate action as per the decision of Norms Committee. || |CaseNo.:150/13/82-ALC4/2016 [PartyName:SUN—S Meet No/Date:7/82-. Status: | 33 | PHARMACEUTICALINDUSTRIES LTD., ALC4/24.08. 201 88 ‘Approved| | | HQ File:01/82/050/00778/AM17/ RLAFile=== ~—_Lic.No/Date:0510399507 | | | ':05/24/040/00201/AM17/ (19.08.2016 う ― ----- End of picture text -----

~ Decision: Committee considered case as per agenda and deliberated onthe matter in the presence of the technical. experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as_ | applied by firm whichever is lower: | | | Export Product | Clarithromycin Carbomer Granules 43.5% / 43.75% / 44% --- 1 kg | | 1 Clarithromycin 0.4394 kg | | Or its raw material as per SION A-2263 on [2___| pro-rata basis | Carbopol 974P 0.370 kg | RA may take appropriate action as per the decision of Norms Committee | Case No.:164/13/82‘Party Name: HETERO LABS Meet No/Date:7/82‘Status: Deferred | PoALC4/2016 LIMITED (ALC4/2018 | AO | (24.08.2018 | | 34 = a RRR ee TTT Defer ae | :01/82/050/00792/AM17/ :09/24/040/00311/AM17/ 01.09.2016 | Decision: The Committee observed that the firm neither attended the PH nor submit the details as asked for vide| Minutes ofthe Meeting No. 3/82/ALC-4/2018, dated 05.06.2018 (actually held on 27.06.2018, 28.06.2018 and _|which,05.07.2018), hence the Committee decided to give last opportunity to firm to attend PH and submit its reply, failing| its case will be rejected. | | Case No.:168/13/82Party Name:HETERO LABS Meet No/Date:7/82-.[Status: Deferred _ ALC4/2016 ‘LIMITED ALC4/2018 | | |35. joi:01/82/050/00796/AM17/ LA':09/24/040/00301/AM17/File $<(01.09.2016ate:0910064085 [Defer Date|

Decision: The Committee observed that the firm neither attended the PH nor submit the details as asked for. vide Minutes of the Meeting No. 3/82/ALC-4/2018, dated 05.06.2018 (actually held on 27.06.2018, 28.06.2018 and 05.07.2018) , hence the Committee decided to give last opportunity to firm to attend PH and submit its reply, failing | | which, its case will be rejected. |

(Case No.:105/13/82-ALC4/2016 Party Name:AARTI DRUGS [Meet No/Date:7/82‘Status: LIMITED ALC4/2018 ‘Approved | | HQ File :01/82/050/00733/AMI7/ RLAFile ====——S—S Lic. No/Date:0310807836. | | | | :03/94/040/00487/AM17/ 16.09.2016 | _ Decision:meeting Committee considered case as per agenda andIn the light of earlier decision taken by NC in its 3/82, applied by05.06.2018,the firm, whicheverit was decidis l e ss:d to ratify norms under Para 4.7 of HBP v1 as per details given below or as.

==> picture [486 x 95] intentionally omitted <==

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||||||||||
|---|---|---|---|---|---|---|---|---|
|36|||
|||Item of Export|Quantity|||SI.|Item of Import|Quantity allowed|
|||No.|in kg|
|||Norfloxacin|kg|1.|2,4|Dichloro-5-Fluoro|||0.877|||
|Acetophenone(DCFA)|||
|Dimethyl|Carbonate|0.789|
|i|Sodium Hydride|0.289|||

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

==> picture [17 x 14] intentionally omitted <==

----- Start of picture text ----- i ----- End of picture text -----

17 i | 6. Dimethyl] Sulphate 0.670 Dimethyl Formamide 0.385 | | 8 | Mono Ethyl Amine(70%) 0.439 | |; | [9 Caustic Flakes 0.410 10 Not importabl | | item | 0.150 | RA may take appropriate action as per the decision of Norms Committee. || (Case| No.:90/16/82-ALC4/2016 Party‘SCIENCES Name:MAHIMAPVT.LTD. LIFE Meet(ALC4/2018 No/Date:7/82‘DeferredStatus: | 137 HQ File RLA File ‘Lic.No/Date:0510399749 Defer Date: ~ © :01/82/050/00907/AM17/ :05/24/040/00229/AM17/ 16.09.2016 | Decision: The Committee observed that the firm did not attend the PH as asked for vide Minutes of[the][ Meeting] ' No. 3/82/ALC-4/2018, dated 05.06.2018 (actually held on 27.06.2018, 28.06.2018 and 05.07.2018), hence the, | (Committee decided to give last opportunity to firm to attend PH, failing which, its case will be rejected. BeeTrafamea Rica Nabe777 7 SCIENCES PVT.LTD. ALC4/2018 Deferred | | | 24.08.2018 | 3g HQ File RLAFile = ~~—~—~—_Lic.No/Date:0510399750 Defer Date: © :01/82/050/0091 1/AM17/ :05/24/040/00230/AM17/ 16.09.2016 | ‘Decision: The Committee observed that the firm did not attend the PH as asked for vide Minutes ofthe Meeting | No. 3/82/ALC-4/2018, dated 05.06.2018 (actually held on 27.06.2018, 28.06.2018 and 05.07.2018) , hence the | Committee decided to give last opportunity to firm to attend PH, failing which, its case will be rejected. | | |Case No.:95/16/82-ALC4/2016 |Party Name:MAHIMA LIFE Meet No/Date:7/82Status: | | ‘SCIENCES PVT.LTD. ‘ALC4/2018 ‘Deferred | | 24.08.2018 39 HQ File (RLAFile = ~~~—~—~—_Lic.No/Date:0510399746 Defer Date: ~ :01/82/050/00912/AM17/ :05/24/040/00222/AM17/ (16.09.2016 | Decision: The Committee observed that the firm did not attend the PH as asked for vide Minutes of the Meeting | No. 3/82/ALC-4/2018, dated 05.06.2018 (actually held on 27.06.2018, 28.06.2018 and 05.07.2018) , hence the _ Committee decided to give last opportunity to firm to attend PH, failing which, its case will be rejected.

| |Case No.:97/16/82-ALC4/2016 |PartySCIENCES Name:MAHIMAPVT.LTD.LIFE MeetALC4/2018 No/Date:7/82-. Status:Deferred ho HQFie SSa 7. anPSI CMe ee /~ |:01/82/050/009 14/AM17/ 05/24/040/00261/AM17/ 16.09.2016 | | 'Decision: The Committee observed that the firm did not attend the PH as asked for vide Minutes ofthe Meeting | | No. 3/82/ALC-4/2018, dated 05.06.2018 (actually held on 27.06.2018, 28.06.2018 and 05.07.2018) , hence the | Committee decided to give last opportunity to firm to attend PH, failing which, its case will be rejected. "(Case| No.:6/20/82-ALC4/2016 Party Name:MAHIMALIFEMeet No/Date:7/82-. Status: i || ‘SCIENCES| PVT.LTD. ‘ALC4/201824.08.2018 Deferred | 41HQFile = (RLAFile === ~——~——_Lic.No/Date:0510399744 Defer Date: | ':01/82/050/01183/AM17/ ':05/24/040/00221/AM17/ 16.09.2016 | | ‘Decision: The Committee observed that the firm did not attend the PH as asked for vide Minutes of[the][Meeting] __ |No. 3/82/ALC-4/2018, dated 05.06.2018 (actually held on 27.06.2018, 28.06.2018 and 05.07.2018) , hence the.

ovnsnvneeoae semrsaencsntraonsnsnencnncnnnenseneinsietnsints sven steer etereCe Cen CCenCenretnttettCPCR CtICCCCCCettettiett st CCC tet cOCCCCCeeCtAtTCeAeLCtteteteTerttCtCttCettCCCteCenectNbCCes-cttettteTtTenCCCtCtsTCTeCCte Cent CCR tut tTetAtTCetetCteettteteCtCntnetetetCetICCtCtrCCeneveleCentCttncte!tttietIetCAteTtetieCenTGCtCetNOPCTIetEA/CerTCCCICCOnCCeUAte OGLE:CTReICCet TtCentC QOS CCTtG$tt60 RACETERECCTCONCOOCOCOLHeTCseCHNCCRCINTTTeANCNtCenCCsTeCteetre ao, | (Committee decided to give last opportunity to firm to attend PH, failing which, its case will be rejected.

‘Case No.:72/16/82-ALC4/2016 Party Name:ASIATIC DRUGS [Meet No/Date:7/82-. Status: | &PHARMACEUTICALS PVT. ALC4/2018 ‘Approved | LTD. 24.08.2018 | | | HQ File :01/82/050/00889/AM17/ RLA File Lic.No/Date:0510399816 | 05/23/040/002 14/AM17/ 22.09.2016 | | | Decision: ‘The Committee considered the case as per agenda and in the presence of the technical experts, it was. decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm | whichever is lower: | 42 | | | Ampicillin anhydrous lkg 6-Amino penicillanic acid(6-APA) 0.715 kg | D-(-)-Alpha phenyl glycine base(PG base) 0.50 kg | | Immobilized amidase (HIT-ABC) | | | Isopropyl alcohol 1.20 kg | RA may take appropriate action as per the decision of Norms Committee.

(Case No.:113/13/82-ALC4/2016 Party Name:HETERO LABS Meet No/Date:7/82-. Status: = ‘(LIMITED ALC4/2018 Deferred | HQFile == RLAFile = Lie.No/Date:0910064191 [Defer Date: 43 :01/82/050/00741/AM17/ :09/24/040/00342/AM17/ 27.09.2016 | Decision: The Committee observed that the firm neither attended the PH nor submit the details as asked for | | vide Minutes of the Meeting No. 3/82/ALC-4/2018, dated 05.06.2018 (actually held on 27.06.2018, 28.06.2018 and 05.07.2018) , hence the Committee decided to give last opportunity to firm to attend PH and submit its reply, failing | | which, its case will be rejected. |

==> picture [487 x 286] intentionally omitted <==

----- Start of picture text ----- (Case| | No.:114/13/82-ALC4/2016 PartyLIMITEDName:HETERO LABS — Meet‘ALC4/2018 No/Date:7/82- (Status:Deferred=| - HQFile — 9 — RLAFile ==——S—SSsCLLic.No/Date:0910064192 [Defer Date: 44 :01/82/050/00742/AM17/ ::09/24/040/00341/AM17/ 27.09.2016 | | Decision: The Committee observed that the firm neither attended the PH nor submit the details as asked for vide Minutes of the Meeting No. 3/82/ALC-4/2018, dated 05.06.2018 (actually held on 27.06.2018, 28.06.2018 and | 05.07.2018) , hence the Committee decided to give last opportunity to firm to attend PH and submit its reply, failing which, its case will be rejected. | _ Case No.:90/13/82-ALC4/2016 Party Name:AMIORGANICS [Meet No/Date:7/82-.—*{Status: ‘PVT LTD. ‘ALC4/2018 Deferred “9 [HQ File :01/82/050/00718/AMI7/ [RLAFile ~~~——S ‘Lic.No/Date:5210042032 [Defer Date: :52/24/040/00042/AM17/ 30.09.2016 | | | ‘esisions Deferred fox Sianinrn ele ~ Case No.:11/17/82-ALC4/2016 |Party Name:CIPLA LIMITED. {Meet No/Date:7/82-. ‘Status: | 46 | ALC4/2018 Deferred | 24.08.2018 | | ‘HQ File :01/82/050/00972/AM17/ RLA File Lie. No/Date:0310808312 [Defer Date: ----- End of picture text -----

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----- Start of picture text ----- | Decision: The Committee considered case as per agenda in the presence of the technical experts | to call the following information / documents from the firm: and it wasdecided| | | i) Copy of DML for each export product | ii) Master Batch Formula for each export product | ili) NOC from Ministry of Environment Forest and Climate Change | /|CaseNo.:15/17/82-ALC4/2016 PartyName:HARMONY ——sMeet No/Date:7/82-. Status: | | (LIFESCIENCE PRIVATE ALC4/2018 Approved | | LIMITED (24.08.2018 | | HQ File :01/82/050/00976/AM17/ RLA File OB ‘Lic.No/Date:03 10808773 | | | | :03/94/040/00672/AM17/ 26.10.2016 | Decision: The Committee considered the case as per agenda and in the presence of the technical experts, it was | decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm | whichever is lower: | Flecainide Acetate lkg 1 2, 5-Bis (2, 2, 2- 1.084 kg | | trifuoroethoxy) Benzoic acid | | Methylene dichloride 5.00 kg | | N,N Dimethyl Acetamide 1.523 kg / | | 4 | j Indigenously | | | Triethyl Amine ; | procured | ; | 5 Indigenous! ;i || a Pivaloyl Chloride procured | | fo | 2 - Aminomethy] Pyridine 0.39 kg | 7 ; Indigenously | | | | Sodium carbonate 47 procured | | | ; . Indigenously ; | Sodium Chloride procured i | . . Indigenously | | a Hydrochloric Acid (CP) | | procured | | 10 Indigenous ; | Nitrogen Cylinder = u | | procured | | 12 Glacial Acetic Acid Indigenous|= a: | procured | | | 13 10% palladium charcoal (50% | 0.008 kg | | 14 d Cylind Indigenously | | | | Hydrogen Cylinder epee’ i 16 Indigenousl | a EDTA disodium salt . yy | | | procured | | 17 Indigenous| | Caustic soda flakes = , procured | | 18 Indigenously fo] Cyclohexane / | | procured | | [19 [Iso PROPYL ALCOHOL _| 627 kg | つ ----- End of picture text -----

20 ~~ i.| ee =< — piste Tinteaony | | |4 Hyflow Super Cell procured | | RA may take appropriate action as per the decision of Norms Committee. | | Case No.:152/20/82-ALC4/2016 Party Name:BIOLOGICALE Meet No/Date:7/82- Status: | LTD ALC4/2018 ‘Approved | | 24.08.2018 | | HQ File :01/82/050/01329/AMI7/RLA File - ‘Lic.No/Date:0910064300 | 48 :09/24/040/00220/AM17/ (26.10.2016 | Decision: Committee considered the case as per agenda and it was decided to ratify the ad-hoc input output norms| as applied by the firm under para 4.7 of HBP one time basis only no repeat licence allowed. ‘RA may take appropriate action as per the decision of Norms Committee. | | Case No.:25/20/82-ALC4/2016 Party Name:ALKALOIDS Meet No/Date:7/82-. Status: } | \CORPORATION ‘ALC4/201 8 ‘Approved | | HQ| File :01/82/050/01202/AM17/RLA:02/24/040/00145/AM17/ File =—————S—S~S~S=«<iLic.NcDaate:0210207123(07.11.2016 || Decision: |The Committee considered the case as per agenda and in the presence of the technical experts, it was | 49 decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: | __ | Papaverine Hydrochloride BP plke}l | Papaverine Crude Content 95% 1.05 kg RA may take appropriate action as per the decision of Norms Committee. | (Case No.:101/17/82S| PartyNName:JUBILANT —'Meet No/Date:7/82-.—Ss|Status: = | ALC4/2016 GENERICS LTD ‘ALC4/2018 ‘Approved | | (24.08.2018 | HQ File RLAFile =~=~——Lic.No/Date:0510400404 | | :01/82/050/01062/AM17/ ':05/23/040/00372/AM17/ (11.11.2016 | | | Decision: The Committee considered case as per agenda in the presence of the technical experts and taking cue. | from its earlier decision taken in Meeting No. 6/82-ALC4/2016, dated 14.06.2016 against Advance Authorization | No. 0510397645 dated 18.02.2016 decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per. _ details below or as applied by firm whichever is lower: | | | Export Product Is0 Atorvastatin Tablets Smg and 10 mg _ | S.NO. | Import Items For export of 1 No. Tablet (Qty. In mg) | [1 | Atorvastatin Calcium SC 10.84 | _ [2 __| Microcrystalline Cellulose (PH-101) 28.00 34.00 | [3 | Lactose Monohydrate JP 14.88 13.81 | | ||6[Croscarmellose] Precipitated calcium Sodium carbonate[ JP] 18.70 | [7 _ | Polysorbate 80 JP | [8___| Magnesium Stearate JP |

| (RAmay take appropriate take appropriate appropriate action as per the decision per the decision the decision decision ofNorms Committee.Norms Committee. Committee.

==> picture [490 x 698] intentionally omitted <==

----- Start of picture text ----- | (RAmay take appropriate take appropriate appropriate action as per the decision per the decision the decision decision ofNorms Committee.Norms Committee. Committee. | | [Case No.:92/1/82-ALC4/2017Party [Name:HARMONY] [——sMeeet][ No/Date:7/82-] Status: | | | LIFESCIENCE PRIVATE ALC4/2018 Approved | | ‘LIMITED 24.08.2018 | | | HQ File — IRLAFile = Lic. No/Date:0310809129 | :01/82/050/01446/AM17/ ':03/94/040/00701/AM17/ 11.11.2016 | ‘Decision: The Committee considered the case as per agenda and in the presence of the technical experts, it was | decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm | whichever is lower: | || | IMIPENEM 1 kg ACETONE 6.03 kg | ||| (STERILE/TECHNICAL/N- AATEED GAREOE 0.100 ke || | FORMIMIDOYL/THIENAMYCIN | | yeLy 3 P-NITROBENXL-6-(1- 1.872 kg | | | HYDROXYETHYL)-1- | | AZBICYCLO(3.2.)HEPTANE- | | 3, 7-DIONE-2- | | CARBOXYLATE/BCK | i 4 CYSTEAMINE 0.672 kg | | HYDROCHLORIDE | | 5 DI PHENYL 1,596 ke i CHLOROPHOSPHATE | | (DPCP) | | /6 | ISO PROPYL ALCOHOL 20.51 kg | || 7 METHYLENE(MDC) DI CHLORIDE| 17.20 kg || st /8 | METHANOL g | | [9 | TETRAHYDRO FURAN 0.97 kg | | 10 2.5% PALADIUM ON 0.002 kg | | CARBON | | | ACETIC ACID 0.60 kg | | | ACETIC ANHYDRIDE 0.51 kg | | | BENZOYL CHLORIDE 1.20 kg | | BENZYL ALCOHOL 0.90 kg || 15 DI ISOPROPYLE 1.86 kg | | ETHYLAMINE (DIPEA) | | | 16 DI METHYL AMINO 0.0232kg | | | | PYRIDINE (DMAP) | | 17 DIMETHYL FORMAMIDE _ | 0.35 kg | | (DMF) | | | HYFLOW 0.410 kg | | | N METHYL MORPHOLINE_ | 1.65 kg | | | N METHYL PYRILIDONE | 2-50 kg | || N METHYL MORPHOLINE __| It was i | that these | | NMP (N-methyl pyrilidone) | items are | | | 24 t | | | SODIUM HYDROSULFITE | "= | | material. || RA may take appropriate action as per the decision of Norms Committee. ７８２ ｍ Ｍｅｅ つ つ つ う ----- End of picture text -----

|~ Case| No.:120/20/82-ALC4/2016 P artyHARMACEUTICALS Name:RAKSHITLTD ‘MeetALC4/2018 No/Date:7/82Status:Approved | | | | (24.08.2018 | | _ HQ File :01/82/050/01297/AM17/ |RLA File Lic.No/Date:0910064379 | | ':09/24/040/00421/AM17/ (15.11.2016 | | Decision: |The Committee considered the case as per agenda and in the presence of the technical experts, it was | _ decidedwhicheverto isratifylower: the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm || | || | Citicoline Sodium 1 kg 1 Cytidine-5-MonoPhosphate(CMP) 1.25 kg || | | 2 CalciumChloride Phosphoryl(CPCC) Choline | 2.25 kg || | | 3 N,N-Dicyclohexyl 1.30 kg | } Carbodiimide(DCC) | | _ RA may take appropriate action as per the decision of Norms Committee |

/ | Case No.:124/20/82‘Party Name:SUVEN LIFE Meet No/Date:7/82-ALC4/2018 |Status: ALC4/2016 SCIENCES LIMITED 24.08.2018 ‘Approved HQ File 'RLA File ‘Lic.No/Date:09 10064382 | _ :01/82/050/01301/AM17/ ::09/24/040/00432/AM17/ 15.11.2016 | Decision: The Committee considered the case as per agenda and in the presence ofthe technical experts, it was | decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm | whichever is lower: | _ | 62/0- 3-FLUORO-2-(METHYL1 kg 2-FLUORO ANILINE 2.50 kg | | Sen(a AMINO)2 2-METHYL TETRA HYDRO| 4.8 kg | 3 PROPYL 0.75 kg | | CHLOROFORMATE | _ RA may take appropriate action as per the decision of Norms Committee |

| "SisGiemanbis ala apethedsdsbashitasOsaaties

|23<br>~,<br>| "SisGiemanbis alaGiemanbis alaalaapethedsdsbashitasOsaaties|23<br>~,<br>| "SisGiemanbis alaGiemanbis alaalaapethedsdsbashitasOsaaties||||||
|---|---|---|---|---|---|---|
|/<br>CaseNo.:121/20/82-ALC4/2016<br>PartyName:HETEROLABSMeetNo/Date:7/82-||Status:|||||
||LIMITED<br>ALC4/2018|‘Deferred|||||
||__|<br>24.08.2018<br>>> [HQ File :01/82/050/01298/AMI7/ [RLAFile ~~ Lic.No/Date:0910064401<br>|<br>:09/24/040/00461/AM17/<br>18.11.2016||_Defer Date:||||||
||||Decision: Deferred forcomments ofTE. Oe|.|||||
|||[Case No.:127/20/82-ALC4/2016 |PartyName:AKTINOSPHARMAMeetNo/Date:7/82-|Status:|||||
||||<br>PVTLTD,<br>‘ALC4/2018|Deferred|||||
||||<br>|<br>24.08.2018||||||
|pe <br>||HQ File :01/82/050/01304/AM17/ [RLAFile===———SCL<br>ic.No/Date:0910064397<br>|<br>'09/24/040/00459/AM17/<br>18.11.2016|DeferDate:|||||
||SO|—|||||
|||Decision: Deferred forcomments ofTE.||||||
||<br>|<br>||[CaseNo.:128/20/82-ALC4/2016 PartyName:HETERO<br>LABS —_—MeetNo/Date:7/82-<br>|<br>LIMITED<br>ALC4/2018<br>|<br>|<br>24.08.2018|Status:<br>Deferred<br>|||||||
|P7 <br>|<br>||HQFile :01/82/050/01305/AMI7/ RLAFile<br>==——— Lic.No/Date:0910064400<br>|<br>09/24/040/00436/AM17/<br>18.11.2016<br>(Geciions Deferredforcommentsof<br>_|DeferDate:|||||
|| (CaseNo.:66/17/82-ALC4/2016<br>|PartyName:MEGHMANI—_—MeettNo/Date:7/82-<br>|<br>INDUSTRIES LTD,<br>‘ALC4/2018||Status:<br>Deferred<br>||||||
||||<br>|<br>24.08.2018|||||||
|||:01/82/050/01027/AM17/<br>:08/24/040/00293/AM17/<br>22.11.2016||||||
|-<br>(Case No.:120/17/82-ALC4/2016<br>PartyName:ZIM<br>==~—~—SMeetNo/Date:7/82-||Status:|||||
||||<br>LABORATORIES LTD.<br>ALC4/2018|Deferred|||||
||<br>>?||<br>|<br>24.08.2018<br> IQFile:01/82/050/01081/AMI17/ RLAFile<br>~—~—~—_Lic,.No/Date:0310809205||<br>_Defer Date:|||||
||||<br>:03/95/040/00602/AM17/<br>22.11.2016||||||
|||Decision: DeferredforcommentsofTE.<br>_||||||
||(CaseNo.:138/17/82-ALC4/2016 PartyName:MAPLECROSS<br>_—_—( MeetNo/Date:7/82-<br>|<br>REMEDIESPRIVATELIMITED ALC4/2018<br>||<br>|<br>24.08.2018<br>(60 HQFile:01/82/050/01099/AM17/RLAFile<br>‘Lic.No/Date:0310809210<br>|<br>|<br>':03/95/040/00624/AM17/<br>22.11.2016||Status:<br>Deferred<br>|<br>Defer Date:|||||<br>||
|||(Decision: Deferred forcommentsofTE.=|||||||
||\CaseNo.:99/17/82-ALC4/2016<br>|PartyName:SAURAV.—SMeeet No/Date:7/82-.||Status:||||||
||||<br>(CHEMICALS LTD,<br>‘ALC4/2018|‘Deferred|||||
|l61||<br>|<br>24.08.2018|||||||
|[HQ<br>||File:01/82/050/01060/AMI7/ [RLA File<br>~<br>[Lie.No/Date:2210015598<br>|<br>:22/24/040/00073/AM17/<br>23.11.2016|Defer Date:|||||

enn iodofiz

| ne | | (CaseNo.:87/17/82-ALC4/2016 Party Name:ASIATIC DRUGS” ‘Meet No/Date:7/82Status; f | ‘&PHARMACEUTICALS PVT. ALC4/2018 ‘Approved _ | HQ File :01/82/050/01048/AM17/ RLA File Lic.No/Date:05 10400453 | | ':05/23/040/00365/AM17/ (24.11.2016 | | | Decision: The Committee considered the caseas per agenda and in the presence of the technical experts, it was. _ decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm | | whichever is lower: | i Export product Qty. Sl. Import items Qty. | | | No. | Ampicillin Trihydrate 1 kg pl 6-Amino penicillanic acid(6-APA) 0.596 kg | | | Vitor GAIA Route) D-(-)-Alpha phenyl glycine base(PG base) 0.417 kg | RA (HIT-ABC)-Immobilized amidase 0.0027 kg may take appropriate action as per the decision of Norms Committee. _ CaseNo.:86/17/82-ALC4/2016 |Party Name:ALCHEM. [Meet No/Date:7/82‘Status: = INTERNATIONAL PVT. LTD. ALC4/2018 ‘Rejected _ 24.08.2018 | 63 HQFile :01/82/050/01047/AM17/ RLA File ~=~=~—~—S Lic.No/Date:0510400474. | | i :05/23/040/00358/AM17/ (25.11.2016 | ‘Decision: The Committee observed that the firm did not attend the PH as called for vide Minutes of the Meeting | | No. 3/82-ALC4/2018, dated 05.06.2018, hence the Committee decided to reject the case. | | (Case No.:180/17/82-ALC4/2016 [Party Name:ENCUBE ‘Meet No/Date:7/82Status: ; | ETHICALS PVT LTD 'ALC4/2018 ‘Approved f | | 24.08.2018 | | _ HQ File :01/82/050/01141/AM17/ |RLA File ) ~ Lic.No/Date:0310809370 | | ':03/94/040/00689/AM17/ 28.11.2016 | | Decision: The committee condiered the casaeas peragenda 8/82 and in the light of earlier decision taken by NC in its. meeting dated 11.07.2013, it was decided to ratify norms for the following export product | 1. Secura Protective Cream 50 Gms Tubes 2. Secura Protective Cream 2.75 OZ 78Gms Tubes Protective Cream 2.75 OZ 78Gms Tubes Cream 2.75 OZ 78Gms Tubes 2.75 OZ 78Gms Tubes OZ 78Gms Tubes 78Gms Tubes Tubes / Secura Protective Cream Z Secura Protective Cream Z Protective Cream Z Cream Z Z 10 78 Gms Tube 78 Gms Tube Gms Tube Tube (3. Secura Protective Cream 70 Gm Gm Tube 4. Secura Protective Cream 40 Gm Gm |64 5. Secura Protective Ointment 70Gm Tube Protective Ointment 70Gm Tube Ointment 70Gm Tube 70Gm Tube Tube 6. Secura Protective Protective Ointment 159 Gms Tube Gms Tube Tube | 7. Secura Moisturizing Cream Moisturizing Cream Cream 85 Gms Tube Gms Tube Tube | 8. Secura Moisturizing Cream 184 Gm Gm Tube 10. |9. |9. Secura Secura ExtraExtra ProtectiveProtective CreamCream Z90 30Gms 92Gms Secura ExtraExtra ProtectiveProtective CreamCream Z90 30Gms 92Gms ExtraExtra ProtectiveProtective CreamCream Z90 30Gms 92GmsExtra ProtectiveProtective CreamCream Z90 30Gms 92Gms ProtectiveProtective CreamCream Z90 30Gms 92GmsProtective CreamCream Z90 30Gms 92Gms CreamCream Z90 30Gms 92GmsCream Z90 30Gms 92Gms Z90 30Gms 92Gms90 30Gms 92Gms 30Gms 92GmsGms 92Gms 92Gms / Secura Secura Extra Protective Cream 92 Gms Tube Cream 92 Gms Tube 92 Gms Tube Gms Tube Tube | 11. Secura Extra Extra Protective Cream 219.70 Gms Tube 219.70 Gms Tube Gms Tube Tube | 12. Secura AF GREASELESS AF GREASELESS GREASELESS 57 Gm Gm Tube 13. Secura Antifungal Extra Thick Thick 92 Gms Tube Gms Tube Tube 14. Solosite Wound Gel 85 Gms Tube | under Para 4.7 of HBP v1 Para 4.7 of HBP v1 4.7 of HBP v1 of HBP v1 HBP v1 v1 as per details given per details given details given given below or as applied or as applied as applied applied by the the firm, whichever whichever is less: | S.No. 1,3 &4 SECURA Protective cream &4 SECURA Protective cream SECURA Protective cream Protective cream cream 50gms., & 70gms. 40gms., & 70gms. 40gms., 70gms. 40gms., 40gms., |

Secura Protective Cream 50 Gms Tubes

_ 2. Secura Protective Cream 2.75 OZ 78Gms Tubes Protective Cream 2.75 OZ 78Gms Tubes Cream 2.75 OZ 78Gms Tubes 2.75 OZ 78Gms Tubes OZ 78Gms Tubes 78Gms Tubes Tubes / Secura Protective Cream Z Secura Protective Cream Z Protective Cream Z Cream Z Z 10 78 Gms Tube 78 Gms Tube Gms Tube Tube (3. Secura Protective Cream 70 Gm Gm Tube 4. Secura Protective Cream 40 Gm Gm

|64 5. Secura Protective Ointment 70Gm Tube Protective Ointment 70Gm Tube Ointment 70Gm Tube 70Gm Tube Tube 6. Secura Protective Protective Ointment 159 Gms Tube Gms Tube Tube

Secura Moisturizing Cream Moisturizing Cream Cream 85 Gms Tube Gms Tube Tube _ 8. Secura Moisturizing Cream 184 Gm Gm Tube __ 10. |9. |9. Secura Secura ExtraExtra ProtectiveProtective CreamCream Z90 30Gms 92Gms Secura ExtraExtra ProtectiveProtective CreamCream Z90 30Gms 92Gms ExtraExtra ProtectiveProtective CreamCream Z90 30Gms 92GmsExtra ProtectiveProtective CreamCream Z90 30Gms 92Gms ProtectiveProtective CreamCream Z90 30Gms 92GmsProtective CreamCream Z90 30Gms 92Gms CreamCream Z90 30Gms 92GmsCream Z90 30Gms 92Gms Z90 30Gms 92Gms90 30Gms 92Gms 30Gms 92GmsGms 92Gms 92Gms / Secura Secura Extra Protective Cream 92 Gms Tube Cream 92 Gms Tube 92 Gms Tube Gms Tube Tube | 11. Secura Extra Extra Protective Cream 219.70 Gms Tube 219.70 Gms Tube Gms Tube Tube | 12. Secura AF GREASELESS AF GREASELESS GREASELESS 57 Gm Gm Tube 13. Secura Antifungal Extra Thick Thick 92 Gms Tube Gms Tube Tube 14. Solosite Wound Gel 85 Gms Tube

| under Para 4.7 of HBP v1 Para 4.7 of HBP v1 4.7 of HBP v1 of HBP v1 HBP v1 v1 as per details given per details given details given given below or as applied or as applied as applied applied by the the firm, whichever whichever is less: S.No. 1,3 &4 SECURA Protective cream &4 SECURA Protective cream SECURA Protective cream Protective cream cream 50gms., & 70gms. 40gms., & 70gms. 40gms., 70gms. 40gms., 40gms.,

| |

| export product with 2% wastage ; | any other | | bearing brand/trade name emulgade F or any other

'S. No. 2 SECURA Protective cream 78gms.

;

==> picture [448 x 126] intentionally omitted <==

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

|||||||||||
|---|---|---|---|---|---|---|---|---|---|
|||export|product|with|2%|wastage|
|i|||any|other|
|13|Mixture|of stearyl|alcohol|with|non-|ionic|emulsifier|0.0714|kg|
|[7|| Clovebudoilcloveoil|0.00204 kg|

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

| S. No. 5& 6 SECURA Protective ointment 70 gms & 159 gms.

==> picture [460 x 264] intentionally omitted <==

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

|||||||||||
|---|---|---|---|---|---|---|---|---|---|
|a|iexport|product|with 2%|wastage|
|i|||petrolatum|white|Fonoline|or|any|other|
||||S.|No. 7&|8 Secura|moisturizing|cream|85 gms &|184 gms|
|||export|product|with 2%|wastage|
|||Wi|Petroleum|jelly|yellow/White|bearing|brand/trade|name|
|||2|White|Mineral|oil|Bearing|Brand/tradename|Super|
|||||3|Sorbitan|Sesquioleate|bearing|brand name|SPAN83-|0.0306|kg|
|||||LQ-(SG)(SORBITAN|SESQUIOLEATE/CRILL|43)|or|
||__||[srtiresiteccntte|]|TTS|

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

==> picture [2 x 11] intentionally omitted <==

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

| 'S. No. 9, 10 &11 SECURA Protective Cream 90 gms, 92 gms & 219.7 gms

||||||export productwith2% wastage|||
|---|---|---|---|---|---|
||||||KarayaGum|0.0728|||
||||<br>a <br>[9||Diazolidinyl Urea<br>0.00204<br>|<br> ira<br>bc<br>|Zincoxide08|||

| §. Np. 12 Secura Antifungal greaseless 57 gms

||i||export product with2%wastage||||
|---|---|---|---|---|---|
|||name superWhite Protopet or any<br>other|||||
|||<br>|<br>or any<br>other<br>4<br>Mixture ofStearyl Alcohol with nonionic Emulsfer<br>0.0714 kg<br>|" | ingiisanctimigaiereranyane [Tf<br>[5<br>Wickenol63<br>00K<br>|<br>2.5-DIOXO-4-IMIDAZOLLIDINYL UREA bearing<br>0.00204 kg|||||<br>|<br>||
|||57 grams||||
|||S. No.|13Secura Antifungal extra thick92gms|||||
||i||export productwith2%wastage||||
|i|||name Petroleum orWhite Fonoline any other|||||
|_||trade nomeGLUCATE™DO EMULSIFIER orany|||||
|||||other||||
||||||||
|f|||or any<br>other||||
|—||orany other||―<br>|||
||||AKUCELL AF 2781W<br>orany other|||||
||||KARAYAGUMSUPERFINEMK200FCC orany<br>other||||<br>||
||i|Lonza Guard or any<br>other|||||
||||DIAZOLIDINYLUREA Bearing brand /trade name|0.00204 kg||||
||i|92grams|||||

| S. No. 14 Solosite wound gel 85 gms | | export product with 2% wastage | | RA may take appropriate action as per the decision of Norms Committee | (Case No.:128/1/82-ALC4/2017 Party Name:STRIDES SHASUN Meet No/Date:7/82‘Status: | (LIMITED ‘ALC4/2018 Approved HQ File RLA File ‘Lic.No/Date:0410162536 | (:01/82/050/01482/AM17/ :04/24/040/00145/AM17/ 02.12.2016 Decision: | The Committee considered case as per agenda in the presence of the technical experts and taking cue | from its earlier decision taken in Meeting No. 5/82-ALC4/2018, dated 25.07.2018 against Advance Authorization| _ No. 0410163748 dated 29.11.2017, decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per. | details below or as applied by firm whichever is lower: | | [| Export Product Qty. Sl. Import items Quantity | | | No. allowed in | | tablet | 65 | GABAPANTIN 1 No. | | |MG USP/NF | | | USP/NF/Ph.Eur. | ; | EP/USP/NF | | NF/Ph.Eur (KLUCEL EF Ph.) | | PROPYL CELLULOSE USP/NF/JP | [RARE / | |RA concerned may take further necessary action as per above decision of NC. | (Case No.:79/17/82-ALC4/2016 Party Name:ABEERS ‘Meet No/Date:7/82‘Status: | | PHARMACEUTICALS PVT —-ALC4/2018 Approved | | LTD 24.08.2018 HQ File RLA File Lic.No/Date:05 10400659 | :01/82/050/01040/AM17/ ':05/23/040/00426/AM17/ 07.12.2016 | | Decision: | The Committee considered case as per agenda in the presence of the technical experts and taking cue | 'from its earlier decision taken in Meeting No. 3/82-ALC4/2018, dated 05.06.2018 against Advance Authorization[|] | No. 0510395773 dated 30.09.2015, decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per 66 details below or as applied by firm whichever is lower: | | | Export Product Qty. SI.No. | Import items | | | allowedcapsule) (Per || [ABEERSLIPIDCARE [1Number [1 |(Terminaliaarjuna)Arjun | 102.0mg_| | || |MEDICAMENTS OF foenum graecum)

28 ~ || |AYURVEDICSYSTEM)| =~ ~—«([3___| Turmeric (Curumalonga) [1020mg | | | 4 Gymnema (Gymenma 102.0 mg | sylvestre) 6 LongBlack pepper Pepper(Piper (Piper nigrum)longum) | 102.0 mg | | (RA concerned may take further necessary action as per above decision of NC. | | Case No.:80/17/82-ALC4/2016 Party Name:ABEERS Meet No/Date:7/82-. Status: i | PHARMACEUTICALS PVT ALC4/2018 ‘Deferred | i | LTD (24.08.2018 | | 67HQFile = = = == RLAFile =——————~S~SCLicNo/Daate:0510400658 Defer Date: | :01/82/050/01041/AM17/ 05/23/040/00424/AM17/ (07.12.2016 | | Decision: It was decided to call the firm for personal hearing along with all technical details to explain its _ case before the committee. | |i (Case No.:142/20/82-ALC4/2016Party Name:HINDYS LAB PVT Meet No/Date:7/82-.SsStatus: | LTD ‘ALC4/2018 Deferred 68 11Q File :01/82/050/01319/AM17/ RLAFile ~ Lic.No/Date:0910064449 Defer Date: | | ':09/24/040/00492/AM17/ 07.12.2016 | | _| (Case No.:22/20/82-ALC4/2016 PartyName:JUBILANT Meet No/Date:7/82- (Status: | | GENERICS LTD /ALC4/2018 Deferred © | | 24.08.2018 | | HQ File :01/82/050/01199/AM17/ RLAFile SS ‘Lic.No/Date:0510400686Defer Date: ; | :05/23/040/00404/AM17/ (08.12.2016 | (2 ith | CC : fo a ; |~ (Case No.:37/20/82-ALC4/2016 [Party Name:IOL CHEMICALS [Meet No/Date:7/82-. (Status: | AND PHARMACEUTICALS ALC4/2018 ‘Approved | ‘LIMITED 24.08.2018 | | | HQ File :01/82/050/01214/AM17/ RLA File = ~ ~—~—_Lic.No/Date:3010103898 [ a | i | | (:30/24/040/00026/AM17/ 09.12.2016 | | Decision: The Committee considered the case as peragenda and in the presenceof the technical experi t s,was | _ whicheverdecided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm| is lower: | Export product Qty. | SLNo. | Import items Qty. Allowed | 70 inkg | IBUPROFEN lkg /} 1 ACETONE 0.076 | ; || LIQUIDDrug Allowed- withsubjectconditionto Registrationthat Import of i| Procedure. | | 2 ISO PROPYL ALCOHOL (IPA) 0.50 | | LIQUID | 3 HEXANE 0.257 | , | 4 LIQUIDSODIUM DI CHROMATE 0.643 | | | 5 SODIUM METAL 0.235 || SOLID |

29 a || TRICHLOROETHYLENE (TCE) 0145 |. } | LIQUID | 7 TOLUENE 0.738 | | LIQUID | | METHANOL 0.020 | | LIQUID | | POTASSIUM CARBONATE 0.076 | | | (GRANULAR POWDER) | | | SOLID | | RA may take appropriate action as per the decision of Norms Committee. | Case No.:118/20/82-ALC4/2016 |Party Name:SUVEN LIFE Meet No/Date:7/82-. Status: | | ‘SCIENCES LIMITED ‘ALC4/2018 ‘Approved | | | 24.08.2018 | | HQ File 7 i RLA File Oe |Lic.No/Date:09 10064464 [a :01/82/050/01295/AM17/ :09/24/040/00472/AM17/ (09.12.2016 | Decision: The Committee considered case as per agenda in the presence of the technical experts and taking cue ‘from its earlier decision taken in Meeting No. 11/82-ALC4/2012, dated 19.06.2012 against Advance Authorization | No. 0910050304 dated 20.12.2011, decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: | Export product Exp. Qty. Import items Qty. allowed | | PENICILLAMINE 1 Kg. ISO BUTYRALDEHYDE 8.36 kg/kg | | RA concerned may take further necessary action as per above decision of NC. |

"Case No.:143/17/82-ALC4/2016 [Party Name:JINDAL DRUGS [Meet No/Date:7/82-. Status: || PRIVATE LIMITED ALC4/2018 ‘Approved | HQ File:01/82/050/01104/AM17/ RLAFile == =~ ~—~—_Lic.No/Date:0310809758 | :03/94/040/00819/AM17/ 13.12.2016 | ‘Decision: ~ The Committee considered the case as per agenda and in the presence of the technical experts, it was | decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm i ‘whichever is lower: | | Export product Qty. SI. Import items Qty. | | | No. | | | PURE CINEOLE EUCALYPTOL OIL 1.05 kg | | | RA may take appropriate action as per the decision of Norms Committee. |

ee

|||||||30||||
|---|---|---|---|---|---|---|---|---|---|
||||||||||a,|
|CaseNo.:7/20/82-ALC4/2016<br>|<br>|||||PartyName:BIOTECH<br>MeetNo/Date:7/82-<br>OPHTHALMICS PVTLTD<br>ALC4/2018|||‘Status:<br>‘Approved||<br>|||
|||||||24.08.2018|||||
||HQ File :01/82/050/01184/AM17/||||RLA|File<br>‘Lic.No/Date:0810139274|||||
||<br>|||<br>Decision:||':08/24/040/00348/AM17/<br>(13.12.2016<br>|<br>|TheCommittee considered the case asperagendaand in the presence ofthe technical experts,<br>itwas||||||||
|||decided to <br>whichever||ratify the ad-hoc input output norms under para 4.7 ofHBP as per details below or as applied by firm<br> is lower:||||||||
||**_**|| Exportproduct|product|Qty.||Ｓ<br>‐<br>Sl.<br>Import items|Qty.||||
|||||BIOHYALURPLUS||90000.000|||.||||
|||OPHTHALMICSOLUTION)||||2<br>BARRELS(HYPAKSCF2.25MLRF|90000.000Nos.|||
|||||||PRTC FM 27)|||||
||<br>|<br>|<br>|<br>||<br>|<br>|||||||(COMPONENT FORPREFILLED<br>SYRINGE)(HEIGHT 73.30MM,<br>DIAMETER(EXTERNAL) 10.85MM<br>DIAMETER(INTERNAL) 8.65MM (+/-<br>10%))<br>3<br>PLUNGERROD(HYPAKPR 2.25 ML PP_ | 90000.000 Nos.|||<br>|<br>|<br>|<br>|<br>|||
||<br>73<br>po||<br>|<br>|<br>|<br>||||||)<br>(COMPONENTFORPREFILLED<br>SYRINGE)(LENGTH 58.52MMTO60.10<br>MM, WIDTH 11.99MMTO 12.75 MM (+/-<br>10%))<br>4<br>PLUNGERSTOPPER(HYPAK BSCF 1-3 _| 90000.000Nos.|||<br>|<br>|<br>|||
||||||||MLPHML PH 701/50C BLK SI 1000<br>WWD)|||<br>|||
||<br>|<br>[|<br>;||||||(COMPONENT FORPREFILLED<br>SYRINGEHEIGHT 7.7MM,OUTER<br>DIAMETER 9.15 MM,INNER|||<br>|<br>|||
|||||||DIAMETER 6.25MM (+/- 10%))|||||
|||||||5<br>BACK STOP (BACK STOP 1-3 ML PP<br>CLEAR)|90000.000 Nos.||<br>|||
|||||||(COMPONENT FOR PREFILLED||||
|[|<br>i||<br>**|**<br>||||||SYRINGE)(LENG**T**H24.2MM, WIDTH<br>16.50MM, HEIGH<br>5.1 MM (+/- 10%))<br>oo BLISTER(PPBLISTER2.25ML/3.0ML)|90000.000<br>(PACKINGMATERIAL FORPREFILLED<br>SYRINGE)|90000.000Nos.||<br>|<br>**|**<br>|||
||||||||7<br>CANNULA|90000.000 Nos.||||
|||||||(COMPONENT FOR PREFILLED||||
||<br>}||<br>|<br>|<br>|<br>_|RAmaytakeappropriateaction|||SYRINGE)(OUTERDIAMETER 0.40MM<br>TO 0.63MM (+/- 10%))<br>TYVEK LID<br>-(PACKINGMATERIAL FORPREFILLED<br>SYRINGE (LENGTH 144MM, WIDTH 50<br>MM (+/- 10%))<br>asperthedecisionofNormsCommittee.||90000.000 Nos.||<br>|<br>|<br>|<br>|||

| (Case No.:9/20/82-ALC4/2016 Party Name:BIO TECH ‘Meet No/Date:7/82‘Status: | \OPHTHALMICS PVT LTD ‘ALC4/2018 ‘Approved | | | 24.08.2018 | | HQ File 'RLA File Lic.No/Date:08 10139275 | ——:01/82/050/01186/AM17/ ':08/24/040/00355/AM17/ 13.12.2016 | | Decision: The Committee considered the case as per agenda and in the presence of the technical experts, it was | decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm | whichever is lower: | | | Export product Qty. SL Import items Qty. | | OPTIFLEX HA 1000.00 | | SHISEIDO SODIUM HYALURONATE 14.7mg/1 ml | | |||_| | (SODIUM14MG/ML PFS Nos. 2 BARRELSSZE GRADE (HYPAK EP SCF 2.25 ML RF vial10000.000 || ' | |HYALURONATE PRTC FM 27) (COMPONENT FOR Nos | | | OPHTHALMIC PREFILLED SYRINGE)(HEIGHT 73.30 | | SOLUTION) MM, DIAMETER (EXTERNAL) 10.85MM DIAMETER (INTERNAL) 8.65MM (+/| 10%)) 3 PLUNGER ROD (HYPAK PR 2.25 ML PP__| !0000.000 ; | ) Nos | | (COMPONENT FOR PREFILLED lv | SYRINGE)(LENGTH 58.52 MM TO 60.10 | | MM, WIDTH 11.99 MM TO 12.75 MM (+/| || | 10%)) | 4 PLUNGER STOPPER (HYPAK BSCF 1-3 10000.000 | | ML PH ML PH 701/50C BLK SI 1000 Nos | | WWD) (COMPONENT FOR PREFILLED | | SYRINGE HEIGHT 7.7 MM, OUTER | | DIAMETER 9.15 MM, INNER | | DIAMETER 6.25 MM (+/- 10%)) | | 5 BACK STOP (BACK STOP 1-3 ML PP 10000.000 | | CLEAR) ( COMPONENT FOR Nos | PREFILLED SYRINGE) (LENGTH 24.2 | | | MM, WIDTH 16.50 MM, HEIGHT 5.1 MM | | (+/- 10%)) | | BLISTER (PP BLISTER 2.25ML / 3.0 ML) | 10000.000 (PACKINGMATERIAL FOR PREFILLED | Nos | SYRINGE) | 7 CANNULA 10000.000 | | (COMPONENT FOR PREFILLED Nos | | SYRINGE) (OUTER DIAMETER 0.40 MM | | TO 0.63 MM (+/- 10%)) | | TYVEK LID 10000.000 | | SYRINGE (LENGTH 144 MM, WIDTH 50 | | | MM (+/- 10%)) | | RA may take appropriate action as per the decision of Norms Committee. | (Case No.:19/1/82-ALC4/2017 Party Name:IND-SWIFT ‘Meet No/Date:7/82‘Status: | | ‘LABORATORIES LTD., ALC4/2018 Deferred || 24.08.2018 | |’ HQ File :01/82/050/01373/AM17/ RLA File Lic.No/Date:22 10015609 ‘Defer Date: | | /:22/24/040/00081/AM17/ 13.12.2016 | | | Decision: Deferred for comments of TE.

32 ~ Case No.:53/20/82-ALC4/2016 Party Name:TORIN ORGANICS Meet No/Date:7/82-. Status: | ‘PVT LTD ‘ALC4/2018 Approved — |; HQ File :01/82/050/01230/AM17/ [RLAFile -Lic.No/Date:35 10045081 | | | :35/24/040/00011/AM17/ 21.12.2016 | | Decision: The Committee consideredthe case as peragenda and in the presence ofthe technical experts,[it] was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm| whichever is lower: | | Export product Qty. SL. Import items Qty. | |ETHAMBUTOL HCL | 1 kg DL-2- AMINOBUTANOL 1.60 kg | | | | BRAUSP MONOSODIUM GLUTAMATE 0.90 kg | || ISOPROPANOL ALCOHOL 1.00 kg | || TOLUENE 0.90 kg | | RA may take appropriate action as per the decision of Norms Committee. ‘Case No.:124/1/82-ALC4/2017 Party Name:TORIN ORGANICS Meet No/Date:7/82—|Status: PVT LTD ALC4/2018 ‘Approved | | | 24.08.2018 | | HQFile:01/82/050/01478/AMI7/ RLAFile = ==~=~—~—_Lic.No/Date:3510045080 | (:35/24/040/00070/AM 16/ 21.12.2016 | Decision: |The Committee considered the case as per agenda and in the presence of the technical experts, it was | decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: | 77 | | | Export product Qty. SI. Import items Qty. | | | No. | _ |g) | ETHAMBUTOLBur HCL 1kg pl DL-2-MONOSODIUM AMINOBUTANOL GLUTAMATE | 0.90kg1.60 kg | ISOPROPANOL ALCOHOL 1.00 kg | | TOLUENE 0.90 kg | RA may take appropriate action as per the decision of Norms Committee. | Case No.:54/20/82-ALC4/2016 Party Name:CADILA. Meet No/Date:7/82Status: HEALTHCARE LTD ALC4/2018 ‘Approved HQ File :01/82/050/01231/AM17/ RLA File Oe ~ |Lic.No/Date:0810139351 [ - | | ':08/24/040/00320/AM17/ 22.12.2016 | Decision: In the light of earlier decision taken by NC in its 4/82 dated 19.06.2018, ‘it was decided to ratify the ad- hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: | 78 | | Export Product Export S. Import Product Quantity | i || Quantity | No. /1000Allowedtabletin gm | | HYDROXYCHLOROQUINE | Number | 1. 4,7 DICHLOROQUINOLINE 147.492 | | SULFATE TABLETS USP | | 200 MG HYDROXY NOVALDIAMINE 136.884 | CORN STARCH NF |

33 Pr a NE | 4 MAGNESIUM STEARATE 4.50 | | PH.E/NF/JP | | 5 DIBASIC CALCIUM PHOSPHATE | 106.50 | DIHYDRATE USP | | | Relevant as per packing policy | RA may take appropriate action as per the decision of Norms Committee. || [Case No.:50/1/82-ALC4/2017 PartyName:CLARIANTINDIA Meet No/Date:7/82-. Status: | || ‘LIMITED| 24.08.2018ALC4/2018 Approved | | HQ File :01/82/050/01404/AM17/ RLA File Lie, No/Date:03 10810099 | _ :03/94/040/0088 1/AM17/ (23.12.2016 || fromDecision:its earlierThedecision Committeetaken consideredin MeetingcaseNo.as4/82-ALC4/2011, per agenda in the prdat e senced 26.04.2011 of the technaga i nstcal Advanceexperts andAuthor tak i ngzation cue _ No. 0910046390 dated 13.04.2011, decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per. | details below or as applied by firm whichever is lower: i No. _ | VIVINOL OR 4-N-BUTYL 1 kg RESORCINOL 2.42 kg | |_| RESORCINOL OR 4-N-BUTYL4 (N) BUTYRIC ACID 2.54 kg | | 1,3-DIHYDROXY BENZENE ZINC CHLORIDE ANHYDROUS 1.00 kg | | TOLUENE 1.00 kg | | | HEXANE 1.00 kg | | | |6 | ISO PROPYL ALCOHOL 1.00 kg | RA may take appropriate action as per the decision of Norms Committee. ~ [Case No.:125/1/82-ALC4/2017 Party Name:TORINORGANICS MeetNo/Date:7/82-. Status: | | PVT LTD ALC4/2018 Approved | | 24.08.2018 | | |HQFile :01/82/050/01479/AMI7/ RLAFile = ~~~—~—~—Lic.No/Date:3510045085 | | | :35/24/040/00045/AM17/ 23.12.2016 | ‘Decision: ~ The Committee consideredthe case as per agenda and in the presence of the technical experts, it was | | decidwhich e dverto isratifylower: the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm || | | Export product Qty. SI. Import items Qty. ; | No. | | | ETHAMBUTOL HCL BP/USP | 1 kg pl | DL-2- AMINOBUTANOL 1.60 kg | | | MONOSODIUM GLUTAMATE | 0.90 kg | | ISOPROPANOL ALCOHOL 1.00 kg | | | TOLUENE 0.90 kg | | RA may take appropriate action as per the decision of Norms Committee. | [Case No.:6/1/82-ALC4/2017 |Party Name:INFINITY ———S MeetNo/Date:7/82-. ss Status: | | LABORATORIES PVT.LTD., ‘ALC4/2018 ‘Deferred | | 24.08.2018 | ‘81 1Q File :01/82/050/01360/AM17/ [RLA File ‘Lic.No/Date:2210015625 Defer Date: | | ':22/24/040/00083/AM17/ 29.12.2016 | Decision: Deferred for comments of TE. |

/| Case No.:32/1/82-ALC4/2017PartyName:ALEMBIC M e t No/Date:7/82-. Status: | PHARMACEUTICALS LTD ALC4/2018 ‘Approved | HQ File:01/82/050/01386/AMI7/ RLAFile ==——————[Lic.No/Date:3410042818 | | | | ':34/24/040/00268/AM17/ (04.01.2017 | | _ Decision:The Committee consideredthe case as per agenda and in the presence ofthe[technical][experts,] it was _ decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm | whichever is lower: | i Lithium Capsule USP 150 mg (Net Number LITHIUM CARBONATE 153.0 mg/ 150 mg _ | content of active ingredients 90 kgs ) USP capsule | Lithium Capsule USP 300 mg (Net Number LITHIUM CARBONATE 306.0 mg / 300 mg | | content of active ingredients 450 kgs ) USP capsule | | | Lithium Capsule USP 600 mg (Net Number LITHIUM CARBONATE 612.0 mg / 600 mg | content of active ingredients 225 kgs ) USP capsule | | RA may take appropriate action as per the decision of Norms Committee | ~ CaseNo.:32/20/82-ALC4/2016 PartyName:FRESENIUS ONCOLOGY LIMITED KABI \ALC4/2018(Meet No/Date:7/82‘Status;‘Deferred | | (24.08.2018 | | 01/82/050/01209/AM17/ 05/23/040/00474/AM17/ (05.01.2017 | | Decision: DeferredforcommentsofTE. Oo | "\Case No.:22/1/82-ALC4/2017PartyName:ASCENT ——S(Meet No/Date:7/82-. —=(Status: | FINECHEM PVT. LTD., ‘ALC4/2018 |Approved HQ File :01/82/050/01376/AM17/ RLA File ‘Lic.No/Date:0810139477 | | :08/24/040/00388/AM17/ 05.01.2017 | | | Decision:decided — The Committee considered the case as peragendaand in the presence of the technical experts,it was to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever[is][lower:] || 84 | _ | Export product Qty. SI. Import items Qty. | | No. N-(3-AMINOPROPYL) 1 kg IMIDAZOLE (white off white 0.68 kg | __ | IMIDAZOLE (Clear Colorless to crsytals) / IMIDAZOLE | i Pale Yellow liquid) / N-(32 SODIUM METHOXIDE (White 1.00 kg | | AMINOPROPYL) IMIDAZOLE - Powder) / SODIUM | IPA METHOXIDE | ACRYLONITRILE 0.466 kg | | | RA may take appropriate action as per the decision of Norms Committee. |

~ Case No.:54/1/82-ALC4/2017

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| Decision:— The Committee considered the case asperagenda and in thepresence of thetechnicalexperts, it was whichever is lower: | | decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm | HITEC 3089 (N-Methy! Aniline) kg ANILINE 0.965 kg | | | METHANOL 0.322 kg | | _ RA may take appropriate action as per the decision of Norms Committee. 7 (Case No28/1/82-ALC42017 Party N<oCADILA ‘Meet No/Date:7/—— Satur = | i HEALTHCARE LTD ‘ALC4/2018 ‘Approved | | | 24.08.2018 | HQ = RLAee ~ Lie No/Date:08 CTT in iin | :01/82/050/01382/AM17/ :08/24/040/00430/AM17/ (13.01.2017 | |_ hocDecision:input outputIn the normslight ofunder earlier paradecision 4.7 of takenHBP byas perNC detailsin its below5/82 dated or as applied25.07.2018, by firmit waswhicheverdecidedistolower:ratifythe ad-

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----- Start of picture text ----- | EXPORT PRODUCT : OCTREOTIDE ACETATE INJECTION 50 MCG/ML (1 ML VIAL), 100 MCG/ML ie ML VIAL), 200 MCG/ML (5 ML VIAL), 500 MCG/ML (1 ML VIAL) and 1000 MCG/ML (1 ML VIAL) | | | Qty. Allowed per ML 86 im Imort Items on 50 100 200 500 megmt | 1000 | i| | : y: mcg/ml55 | mcg/ml110 |} 220mcg/ml 550 mcg/ml1100 | Vila | eeerare MCG |MCGper|MCGper |MCGper | MCG per | | | Vials | per ML | ML ML ML ML i RS CB 13MM RFS j j ; | 2 EFCOAT Relevant as per packing policy | | 3 [RSCB 20MM RFS | | | EFCOAT | RA may take appropriate action as per the decision ofNorms Committee | [Case| | No.:25/1/82-ALC4/2017 PartyPHARMA Name:AUROBINDO LIMITED — MeetALC4/2018No/Date:7/82-. Status:Approved — | {HQ File:01/82/050/01379/AMI17/ RLAFile ==———S—SCLiic.No/Datte:0910064590 | :09/24/040/00550/AM17/ 16.01.2017 | Decision: The Committee considered the caseas per agenda and in the presence of the technical experts, [it] was | decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm 87 whichever is lower: ．Ｓ ----- End of picture text -----

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||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
|||||Export product|Qty.|Sl.|Import items|Qty.|||
|||||Amoxycillin and Potassium|lkg|AMOXYCILLIN TRIHYDRATE|||585.28 mg|
|i|Clavulanate|625 mg Tablets|2|Potassium|Clavulanate|with|303.773 mg|||
||||||[The Relevant Bulk Drug content|in|Microcrystalline Cellulose|(1:1)|/|
|_||_||the|Export|Product|is|: Amoxycillin|Clavulanate|Potassium|+Avicel|||

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----- Start of picture text ----- a | | _ —— a and Gnd 0 Oe — | | Potassium is 125mg in each | _ _ | Tablet](i.e. Amoxycillin Trihydrate | | | 21000 Kgs and Clavulanate | Potassium 5250 Kgs containing in | Total Licence Qty) | RA may take appropriate action as per the decision of Norms Committee. Case No.:86/20/82-ALC4/2016 Party Name:RUSAN PHARMA Meet No/Date:7/82-. ——=SStatus: | LTD. ALC4/2018 ‘Deferred | 88 11Q File:01/82/050/01263/AM17/ RLAFile===~—~—Lic.No/Date:0310810600 Defer Date: | ; | 03/95/040/00823/AM17/ 18.01.2017 | | Decision: Deferred for comments of TE. |  CaseNo.:3/1/82-ALC4/2017 ‘(Party Name:DHANUKA ‘Meet No/Date:7/82- Status: LABORATORIES LTD. ALC4/2018 Approved | | | 24.08.2018 | | HQ File :01/82/050/01357/AM17/ RLA File Lic.No/Date:0510401381 | ho ':05/23/040/00507/AM17/ 25.01.2017 | | | Decision: ~The Committee considered the case as per agenda and in the presence ofthe technical experts, it was | | decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm | whichever is lower: | | CEFIXIME METHYL ESTER 1 kg 1 7-Phenylacetamideo -3- | 1.4219 kg | USP/BP/IP/EP Chloromethyl | | POWDER Cephalosporanic Acid Para ; | Methoxy Benzyl Ester f | (GCLE) | |leo | ACETONETRIPHENYL PHOSPHINE | 0.7756kg0.806 kg || | 4 N,N DIMETHYL 2.736 kg | FORMAMIDE (DMF) | i; | 5 Dichloromethane 3.393 kg | 1 | (METHYLENE CHLORIDE/ | || MDC) | | /6 | TRIETHYLAMINE 0.2268kg | | | PHENOL 0.3808kg | i /8 | METHANOL 4.222 kg | | | [9 | ACTIVATED CARBON 0.050 kg | | | MICA ESTER 0.82 kg | | | 11 TETRA HYDROFURAN 1.644 kg | _ | (THF) | | RA may take appropriate action as per the decision of Norms Committee. | | (Case No.:2/1/82-ALC4/2017 |Party Name:ALKALOIDS. Meet No/Date:7/82- (Status: | logs ‘CORPORATION ALC4/2018 ‘Approved HQ File :01/82/050/01356/AM17/ RLA File === LicNo/Date0210207287 | つ ----- End of picture text -----

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----- Start of picture text ----- ‘Decision: | The Committee considered the case as per agenda and in the presence of the technical experts, it was __ decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm. _ _ whichever is lower: | | | Export product Qty. SI. Import items Qty. | | No. | | | RA may take appropriate action as per the decision of Norms Committee. | [CaseNo.:113/1/82-ALC4/2017PartyName:CORONA ——SMeeet No/Datte:7/82-. Status: | ‘REMEDIES PRIVATE LIMITED ALC4/2018 ‘Deferred | 9! THQ File :01/82/050/01467/AM17/ RLAFile SS ‘Lic.No/Date:0810139606 DeferDate: | | ':08/24/040/00387/AM17/ 30.01.2017 | Decision: Deferred for comments of TE. OS OB  - |Case No.:105/20/82- ~~: PartyName:SAIMIRRA ——Meeet No/Date:7/82-ALC4/2018 _ Status: | |ALC4/2016 INNOPHARM PVT LTD 24.08.2018 Approved | HQ File RLA File | Lie. No/Date:0410162758 | | :01/82/050/01282/AM17/ :04/24/040/00186/AM17/ 31.01.2017 | 92 ‘Decision: | The Committee considered the case as per agenda and in the presence of the technical experts, it was | |decided to ratify the ad-hoc input output norms as applied for by the firm under para 4.7 of HBP for one time basis ‘only and no repeat licence allowed. | | RA may take appropriate action as per the decision of Norms Committee " |Case No.:13/1/82-ALC4/2017 Party Name:MEDICAMEN ——(Meet No/Date:7/82-. Status: ; | (BIOTECH LIMITED ALC4/2018 ‘Approved | |HQ File :01/82/050/01367/AM17/ RLA File Lic.No/Date:05 10401421 | | | :05/24/040/00543/AM17/ 31.01.2017 | ‘Decision: The Committee considered thecase as per agenda and in the presence of the technical experts, it was | decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm | | whichever is lower: | | Export product Qty. Sl. Import items Qty. allowed || No. | |93| [TABLETS Number | 1 PHENOXYMETHYLPENICILLIN | 565.0 | || | PHENOXYMETHYLPENICILLIN POTASSIUM BP 2014 mg/tablet || | B.P.EACH SO0MG. TABLET CONTAINS : | | | PHENOXYMETHYLPENICILLIN | | | | POTASSIUM BP eq. TO | | PHENOXYMETHYLPENICILLIN | | 500MG. NET WEIGHT: 2800 || LKGS. | | TABLET CONTAINS : Number PHENOXYMETHYLPENICILLIN | 565.0 | | | | PHENOXYMETHYLPENICILLIN POTASSIUM BP 2014 mg/tablet _| | POTASSIUM B.P. eq. TO | || | PHENOXYMETHYLPENICILLIN | ｎ ----- End of picture text -----

| | TABLETS Number | 1 PHENOXYMETHYLPENICILLIN | 565.0 | PHENOXYMETHYLPENICILLIN POTASSIUM BP 2014 mg/tablet | | | B.P. SOOMG. | _ | | EACH TABLET CONTAINS : | _ | | PHENOXYMETHYLPENICILLIN | POTASSIUM BP eq. TO _ | PHENOXYMETHYLPENICILLIN | / | KGS.500MG. NET WEIGHT: 545.00 | | | | TABLETS Number | 1 PHENOXYMETHYLPENICILLIN | 595.04 | | |PHENOXYMETHYLPENICILLIN POTASSIUM (GRANULES) BP mg/tablet | | B.P. SOOMG. 2014 | EACH TABLET CONTAINS : | PHENOXYMETHYLPENICILLIN | | POTASSIUM BP eq. TO | _ | PHENOXYMETHYLPENICILLIN 500MG. NET WEIGHT: 575.00 || _ | RA may take appropriate action as per the decision of Norms Committee. | — (Case No.:105/1/82——PartyName:CADILA—S=« MeetNoDaate:7/82Status: ALC4/2017 HEALTHCARE LTD ALC4/2018 ‘Approved | | HQFile = RA File:08/24/040/00451/AM17/ [Lic.No/Date:0810139644 | | :01/82/050/01459/AM17/ (02.02.2017 | Decision: |The Committee considered the case as per agenda and in the presence ofthe technical experts, ‘it was **** decidwhich e dverto isratifylower:the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm | 94 | | || 'TRIMEBUTINE TABLETS 100 MG Number TRIMEBUTINE MALEATE | 102.0 | _ | | TABLETS)(TRIMEBUTINE ZYDUS 100 MG mg/tablet | || RA may take appropriate action as per the decision of Norms Committee | ~ Case No.:108/1/82-ALC4/2017 Party Name:CADILA (Meet No/Date:7/82- s Status: || HEALTHCARE LTD ALC4/2018 ‘Approved | | 24.08.2018 | | HQ File :01/82/050/01462/AM17/ |RLA File ) ~|Lic.No/Date:0810139643 | | :08/24/040/00450/AM17/ (02.02.2017 | | _ Decision: |The Committee considered the case as per agenda and in the presence of the technical experts, it was | a decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm | whichever is lower: _ | CELIPROLOL TABLETS 200 MG | Number 1 CELIPROLOL 204.00 | | (CELIPROLOL ZYDUS 200 MG HYDROCHLORIDE PH. mg/Tablet | TABLETS) EUR.) | RA may take appropriate action as per the decision of Norms Committee. |

|i |CaseNo.:10/1/82-ALC4/2017|Party Name:JODAS EXPOIM ‘Meet No/Date:7/82Status: ~~ | | PVT.LTD.,| ‘ALC4/201824.08.2018 |‘Approved | HQ File :01/82/050/01364/AMI17/ RLAFile =~ ~—Lic.No/Date:0510401481 | :05/23/040/00521/AM17/ 03.02.2017 | Decision: ~The Committee considered the case as peragenda decided[to][ratify][the][ad-hoc][input][output][norms][under][para][4.7] and in[of][ HBP] the[as] presence[per][details] of the[below] technical[or][as] experts,[applied][by] it[firm,] was **** _ whichever is lower: | | | CEFEPIME FOR INJECTION Number 1 STERILE CEFEPIME WITH | 1.8975 gram | || | USP IGRAM TOTAL NET ARGININE / vial | | | | WEIGHT 97.561kg. | RA may take appropriate action as per the decision of Norms Committee. | | [CaseNo.:117/1/82-ALC4/2017PartyName:CADILA ——S Meet No/Date:7/82-. Status: | | HEALTHCARE LTD ALC4/2018 Approved — | HQ File :01/82/050/01471/AMI17/ 'RLA File ‘Lic.No/Date:0810139654 | | :08/24/040/00452/AM17/ 06.02.2017 | ‘Decision: | The Committee considered the case as per agenda and in the presence of the technical experts, it was | | decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm | | whichever is lower: | | | BISOPROLOL FUMARATE AND | Number | BISOPROLOL 2.51 mg/Tablet | | |HYDROCHLOROTHIAZIDE TABLETS 2.5 FUMARATE | _ | | BISOPROLOL FUMARATE AND | Number 5.1 mg/Tablet 97 |HYDROCHLOROTHIAZIDE TABLETS 5 none | | | BISOPROLOL FUMARATE AND | Number 10.2 mg/Tablet | | HYDROCHLOROTHIAZIDE TABLETS — 10 Sven | | | BISOPROLOL TABLETS 1.25 MG | Number |BISOPROLOL 1.275 mg/Tablet || | (BISOPROLOL ZYDUS 1.25 MG TABLETS) FUMARATE || | BISOPROLOL TABLETS 2.5 MG | Number |BISOPROLOL 2.51 mg/Tablet | | | | (BISOPROBISOPRO LOL ZYDUSTABLETS2.5 MG TABLETS)5 MG | Number | BISOPROLOLFUMARATE 5.1 mg/Tablet | (BISOPROLOL ZYDUS 5 MG_ TABLETS) FUMARATE | RA may take appropriate action as per the decision of Norms Committee

40 | Case No.:3/20/82-ALC4/2016 PartyName:INCHEMSs Meet No/Date:7/82-. ‘Status: | | | LABORATORIES PRIVATE ‘ALC4/2018 ‘Deferred 78 | ‘LIMITED 24.08.2018 | | HQ File :01/82/050/01180/AM17/ |RLA File. —~—~—~—~—~—~—S~S~SCWLic, NoDaate0910064656 Defer Date: | :09/24/040/00497/AM17/ 07.02.2017 | | Decision: Deferred forcommentofTE. = - | | Case No.:161/20/82-ALC4/2016 Party Name:ARVEE — Meet No/Date:7/82-. Status: LABORATORIES INDIA ALC4/2018 ‘Approved | | PRIVATE LIMITED 24.08.2018 | HQ| File :01/82/050/01338/AMI17/ RLAFile = == ~—~—~—Lic.No/Date:0810139667 i :08/24/040/003 15/AM16/ 07.02.2017 | Decision: The Committee consideredthe caseas per agenda and in the presence of the technical experts, it was | **** _ decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm | 99 Whichever is lower: | _ | Dimethyl 5-Nitroisophthalate lkg | Isophthalic Acid 0.771 kg | _ RA may take appropriate action as per the decision of Norms Committee. | (Case No.:41/1/82-ALC4/2017__ [PartyName:GODAVARI ——_—sMeeet No/Date:7/82‘Status: f DRUGS LTD ALC4/2018 ‘Deferred ; | | 24.08.2018 | | 100 HQ File :01/82/050/01395/AMI7/ |RLAFile= ~=~—~—~—~—Lic.No/Date:0910064654 Defer Date: | :09/24/040/00607/AM17/ 07.02.2017 | | Decision:details as per appendix|The Committee4E fromconsideredthe firm.the case as per agenda andit was decidedto call for the complete technical | Case No.:116/1/82-ALC4/2017PartyName:CADILA —S Meet No/Date:7/82-. —=(Status: | HEALTHCARE LTD /ALC4/2018 ‘Approved | | | | 24.08.2018 | HQ File :01/82/050/01470/AM17/ |RLA File — |Lie.No/Date:0810139668 | | | ':08/24/040/00453/AM17/ (07.02.2017 | | Decision: The Committee considered the case as per agenda and in the presence of the technical ~ experts, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by _ firm whichever is lower: | 101 | ETOMIDATE INJECTION USP 1 Number | ETOMIDATE USP 22 mg/ 10 ml | | 2MG/ML (10 ML) vial | | | VIAL 10 ML CLR SUL. TRE. Relevant as per | ho VIAL 20 ML CLR SUL. TRE. | Relevant as per | ; KAISHACHCV20CIP03 packing policy | _ RS BLT 20MMRFSFLURTC | Relevant as per |. } | (ART 1243 4110/40) packing policy | | | ETOMIDATE INJECTION USP 1 Number | ETOMIDATE USP 42 mg/20 ml | 2MG/ML (20 ML) vial

i | VIAL 10 ML CLR SUL. TRE. Relevant as per | | KAISHACHCV10CIP04 packing policy |. | | VIAL 20 ML CLR SUL. TRE. Relevant as per |. | | KAISHACHCV20CIP03 packing policy , | RS BLT 20 MMRFSFLURTC | Relevant as_ per | | | RA may take appropriate action as per the decision of Norms Committee. | | (Case No.:11/1/82-ALC4/2017PartyName:SUNMeet No/Date:7/82Status: ; | PHARMACEUTICAL ALC4/2018 Approved | | | INDUSTRIES LTD. 24.08.2018 | -HQFile — RLAFile ~_Lic.No/Date:0510401582 | — :01/82/050/01365/AM17/ :05/24/040/00557/AM17/ 08.02.2017 | Decision:from its earlierThe Committeedecision taken considin Me e redting caseNo. as3/82-ALC4/2018, per agenda in theprdat e senced 05.06.2018 of thetechnicalagainst Advanceexperts andAuthor tak i zationng cue | | (No. 0510399649 dated 08.09.2016 decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per. details below or as applied by firm whichever is lower: 102, | | Export product Qty. Sl. Import items Qty. No. || | Dorzolamide and Timolol Ophthalmic | 1 No vial DORZOLAMIDE 116.80 | || Solution, 2.0%w/v + 0.5%w/v, Sml HYDROCHLORIDE mg/vial | | (TIMODOL _ Sterile Eye — Drops) 2 TIMOLOL MALEATE _ | 35.88 | | | (LOFTEMIDE) mg/vial | RA may take appropriate action as per the decision of Norms Committee. / [Case No.:121/1/82-ALC4/2017 Party Name:CLEAN SCIENCE Meet No/Date:7/82Status: | | AND TECHNOLOGY ALC4/2018 Approved | PVT.LTD. 24.08.2018 | HQFile == —————~C*«<SRLA Fle Lic.No/Date:3110066608 | | :01/82/050/01475/AM17/ :31/83/040/00168/AM17/ (02.03.2017 ‘Decision: The Committee considered the case as per agenda and in the presence of the technical experts, it | was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by | firm whichever is lower: | _ | Guaiacol 99% PURITY 1 kg 1 Phenoxy methane / Anisole PURITY 117kg | | | 93% MAXIMUM | | | 2 Hydrogen Peroxide (60%) PURITY 0.687 kg | | | Acetone (Solvent) 0.14 kg | | RA may take appropriate action as per the decision of Norms Committee. (Case No.:27/6/82-ALC4/2017 |Party Name:CLEAN SCIENCE Meet No/Date:7/82-. Status: | | ‘AND TECHNOLOGY PVT.LTD. ALC4/2018 Approved | | | 24.08.2018 (104 11Q File :01/82/050/00597/AM18/ RLA File ~'Lic.No/Date:3110066777 | | :31/83/040/00035/AM 18/ 09.06.2017 | | | ‘Decision: The Committee considered the case as per agenda and in the presence of the technical experts, it

42 A, | was decidedto ratify the ad-hoc input output norms under para4.7 of HBP as per details below or as applied by ‘firm whichever is lower: | | Guaiacol [kg |1 | Phenol PURITY 99% AND ABOVE | 1.108 kg | | 2 Dimethyl! Sulphate PURITY 99% 0.847 kg || AND ABOVE | | | 3 Caustic Lye PURITY 40% AND 0.35kg |, ABOVE (100% basis) | 4 Hydrogen Peroxide (60%) PURITY 0.687 kg |, | | 60% | | Acetone (Solvent) 0.14 kg | RA may take appropriate action as per the decision of Norms Committee. | | Case No.:1/6/82-ALC4/2017___Party Name:DSM SINOCHEM — Meet No/Date:7/82-. (Status: ; | PHARMACEUTICALS INDIA —ALC4/2018 Deferred | | PVT.LTD. 24.08.2018 | | 05 HQ| File :01/82/0S0/00571/AMI8/ RLAFile:22/24/040/00094/AM17/————«Lic.No/Date:221001573823.06.2017 |Defer Date: | | Decision: Deferredfor comments of TE. | | Case No.:40/6/82-ALC4/2017 |Party Name:CIPLA LIMITED. Meet No/Date:7/82Status: ; | ‘ALC4/2018 ‘Deferred | | HQFile = ss RLA File =——=~*~SCSL ic No/Daate:0310814908 [Defer Date: | |:01/82/050/00610/AM18/ ':03/94/040/00295/AM18/ (31.07.2017 | | (106 Decision: |The Committee considered case as per agenda inthe presence of the technical experts and taking cue | No.from0310808312its earlier decisiondated 06.10.2016,taken in MeetingdecidedNo.to 3/82-ALC4/2018,call for following informationdated 05.06.2018/ documents:against Advance Authorization|| | | iv) Copy of DML for each export product | — vy) Master Batch Formula for each export product | vi) NOC from Ministry of Environment Forest and Climate Change | (Case No.:23/6/82-ALC4/2017__Party Name:SHARP MINT LTD. MeetNo/Date:7/82-—=(Status: | ; | | ALC4/2018 ‘Approved | 24.08.2018 | HQ File :01/82/050/00593/AM18/|RLA File . Lic.No/Date:0510403559 | ':05/24/040/00194/AM18/ (01.08.2017 | | | Decision: | The Committee considered the caseas per agenda and in the presence of the technical “experts, it _ was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by | firm whichever is lower: | 107, | i **** | Export product Qty. SI. Import items Qty. | | No. | || Iso Propyl Alcohol As per Appendix 4E, | | 33 | Vinyl- Acetate allare these rawindigenouslymaterials | |, 4 procured. Hence, not || _ RA may take appropriate action as per the decision of Norms Committee. |

‘

CaseNo.:94/6/82-ALC4/2017[PartyName:KOPRAN —s( Meet No/Datte:7/82Status; | RESEARCH LABORATORIES |ALC4/2018 ‘Approved | | ‘LTD. 24.08.2018 | HQ File :01/82/050/00664/AM18/ RLAFile = ~—~—Lic.No/Date:0310815019 | ':03/94/040/00385/AM18/ 04.08.2017 i ‘Decision: The Committee considered the case as peragendaand in the presence of the technical experts, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: | | Export product Qty. Sl. | Import items Qty. | | No. | | | CLARITHROMYCIN GRANULES kg CLARITHROMYCIN _ | 0.2778 kg | 108) | 27.5% ACETONE 1.00 kg | || [CLARITHROMYCIN GRANULES 1 kg pl | CLARITHROMYCIN 0.333 kg _ | | 3% ACETONE 1.00 kg || CLARITHROMYCIN GRANULES 1 kg CLARITHROMYCIN 0.404 kg | | / 0, | | | |%% ACETONE 1.00 kg || | CLARITHROMYCIN GRANULES lkg CLARITHROMYCIN 0.4242 kg | |} | |e ACETONE 1.00 kg | _ | CLARITHROMYCIN GRANULES kg i CLARITHROMYCIN _ | 0.4343 kg ) | {8% ACETONE 1.00 kg | | | RA may take appropriate action as per the decision of Norms Committee | Case No.:95/6/82-ALC4/2017PartyName:KOPRAN ——s(Meet No/Date:7/82-. Status: | | RESEARCH LABORATORIES =(ALC4/2018 ‘Approved — | | ‘LTD. 24.08.2018 [HQ File :01/82/050/00665/AM18/ |RLA File == ~—~—Lic.No/Date:0310815033 | | | ':03/94/040/00383/AM 1 8/ (04.08.2017 | | | ‘Decision: The Committee considered the case as per agenda and in the presence of the technical experts, it | was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: | || PREGABALIN Lkg ISOVALERALDEHYDE 4.08kg | | | CYANOACETAMIDE 5.42 kg || | 3 R(+)-METHYLOR (R)-1-PHENYLETHYLAMINE)BENZYL AMINE 0.114 kg | | | ISO PROPYL ALCOHOL (IPA) 1.96 kg | | CHLOROFORM 2.50 kg | RA may take appropriate action as per the decision of Norms Committee | / [Case No.:137/6/82-ALC4/2017 |Party Name:P.K. PHARMATECH Meet No/Date:7/82= Status: ; | PVT LTD. ‘ALC4/2018 Deferred | | | 24.08.2018 | |‘110 FQ File:01/82/050/00707/AMI18/ [RLAFile ——sLLiic.No/Date:0310815140 Defer Date: | ':03/95/040/00036/AM 18/ 11.08.2017 | ‘Decision: Deferred for comments of TE. |

(Case No.:108/6/82-ALC4/2017 Party Name:USV PRIVATE Meet No/Date:7/82-. Status: ‘LIMITED (FORMERLY USV | ALC4/2018 \Deferred LIMITED) (24.08.2018 | | TIT iQ File :01/82/050/00678/AMI18/ |RLA File . ‘Lic.No/Date:0310815158 Defer Date: || :03/95/040/00393/AM 18/ 16.08.2017 | | | Decision: Deferred forcommentsofTE | | Case No.:16/6/82-ALC4/2017PartyName:SUN_ SMe No/Date:7/82-. Status: ‘(PHARMACEUTICAL ALC4/2018 ‘Deferred 1 INDUSTRIES LTD., 24.08.2018 | | HQ File :01/82/050/00586/AMI18/ [RLAFile ——«CLie.No/Date:0510403733 [Defer Date: | ':05/24/040/00219/AM18/ 18.08.2017 | | | Decision: Deferred forcommentsofTE = | | Case No.:149/6/82-ALC4/2017 Party Name:THEON SS Meet No/Date:7/82-. Status: ‘PHARMACEUTICALS LTD., =|ALC4/2018 ‘Approved | HQ File:01/82/050/00719/AMI8/ RLAFile =i. No/Date:221001575224.08.2018 | || | |:22/24/040/00030/AM18/ /18.08.2017 | | Ble Decision: The Committee considered the case as per agenda and in the presence of the technical experts, it was decided to ratify the ad-hoc input output norms as applied for by the firm under para 4.7 of HBP for one time | | basis only and no repeat licence allowed. | | ‘RA may take appropriate action as per the decision of Norms Committee | | Case No.:106/6/82-ALC4/2017 |Party Name:SPAK ORGOCHEM |MeetNo/Date:7/82- Status: | (INDIA) PVT. LTD. ALC4/2018 ‘Approved | HQ File :01/82/050/00676/AM18/ |RLA File ~ |Lic.No/Date:0310815299 | | | ':03/95/040/01038/AM17/ 22.08.2017 | | FFfirm 4 WasDecision:decidedwhichever|toTheratifyis lower:Committeethe ad-hocconsideredinput outputthe casenorms as perunder agenda andpara 4.7 ofin HBP the presence ofas per details thebelow technicalor as exap p erts,lied byit,|| || | Sorbitan Mono Oleate 1 kg 1 | Sorbitol 70% Solution 0.46kg |. | Oleic Acid 0.77 kg _ RA may take appropriate action as per the decision of Norms Committee. | _ Case No.:107/6/82-ALC4/2017 |Party Name:ROYAL PHARMA (Meet No/Date:7/82-.——=Status: | | | ‘ALC4/2018 Approved HQ File :01/82/050/00677/AM18/ 'RLA File = =~=~~~—~—_Lic.No/Date:0310815337 ':03/95/040/00424/AM18/ 23.08.2017 | 115 Decision:from its earlier| Thedecision Committeetaken consideredin MeetingcaseNo.as4/82-ALC4/2018, per agenda in thedated presence19.06.2018ofthe technicalagainst Advanceexperts andAuthorization taking cue | No. 0310817585 dated 07.12.2017, decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: | [fermen TR dren

| [BICALUTAMIDE SULFIDE ]1kg. | 1. | N-[4-CYANO-3-(TRIFLUORO__‘| 0.709kg_)_ | | CHEMICAL NAME: N-[4METHYL) PHENYL] | CYANO-3-(TRIFLUORO METHACRYLAMIDE | FLUOROPHENYL THIO)] -2 M.F. :C6HSF5 M. Wt.: 128 | | | HYDROXY-2-METHYL || PROPIONALIDE [RA may take appropriate action as per the decision of Norms Committee. | | (CaseNo.:109/6/82-ALC4/2017 Party Name:RUSAN PHARMA Meet No/Date:7/82Status: — ; 4 (LTD. ALC4/2018 ‘Deferred | | 24.08.2018 HS HQ File :01/82/050/00679/AM18/ RLAFile = ‘Lic.No/Date:0310815403 Defer Date: | :03/95/040/0043 1/AM18/ (28.08.2017 | Decision: Deferred forcommentsofTE | (Case No.:123/6/82-ALC4/2017 Party Name:SHREE LIFE ——Meet No/Date:7/82Status: | ‘SCIENCES PVT LTD ALC4/2018 Deferred pad HQ File :01/82/050/00693/AM18/ |RLA File Lie. 24.08.2018No/Date:0310815404 Defer Date: | :03/95/040/00437/AM 18/ 28.08.2017 | | Decision: Deferred for comments of TE | [CaseNo.:30/6/82-ALC4/2017__Party Name:CAPLIN POINT Meet No/Date:7/82Status: | ‘LABORATORIES LTD., ALC4/2018 ‘Approved | HQFile:01/82/050/00600/AMI8/ RLAFile = =~ ~—Lic.No/Date:0410163473 | ':04/24/040/001 10/AM18/ 30.08.2017 / | Decision: The Committee considered case as per agenda in the presence of the technical experts and taking cue | ‘from its earlier decision taken in Meeting No. 3/82-ALC4/2018, dated 05.06.2018 against Advance Authorization '118 No. 0410162034 dated 10.06.2018, decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per | details below or as applied by firm whichever is lower: | Export product Qty. SI. Import items Qty. | | No. | Lincomycin Injection USP | 51704.000 | 1. Lincomycin Hydrochloride USP | 31.785 BOU | | 600mg/2ml - 2 ml Vials Lincomycin Hydrochloride | ‘RA may take appropriate action as per the decision of Norms Committee. | [CaseNo.:68/6/82-ALC4/2017_(PartyName:NECTAR ——s Meet No/Datte:7/82- Status: | | ‘LIFESCIENCES LIMITED ‘ALC4/2018 Approved | | [HQ File :01/82/050/00638/AM18/ RLA File Lic.No/Date:2210015762 ; | :22/24/040/00009/AM1 8/ 30.08.2017 i! 0 ‘Decision:from its earlier ~ ThedecisionCommitteetakenconsideredin Meeting caseNo.as6/82-ALC4/2014, per agenda in the presencedated 29.08.2014 of the technicalagainst Advanceexperts andAuthorization taking cue | ‘No. 0910060798 dated 04.08.2014, decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per, | details below or as applied by firm whichever is lower: | Ceftriaxone Sodium Sterile Ceftriaxone Sodium (Non 1.04 kg

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----- Start of picture text ----- ; moreT call a +5aSe | | | Kes each Aluminium”. Bottle ae | ee 3 Aluminium Bottle Relevant as |. _ | Anodized with Tear of alu & . . . | | Anodized with Tear off alu cap per _ packing | | | Chlorobutyl Plug & chlorobuty! plug policy | | RA may take appropriate action as per the decision of Norms Committee. ~ Case No.:150/6/82-ALC4/2017 Party Name:NECTAR _ Meet No/Date:7/82- (Status: | ‘LIFESCIENCES LIMITED ‘ALC4/2018 ‘Approved | | 24.08.2018 | | HQ File :01/82/050/00720/AMI18/ RLAFile = = =~=~—~—_Lic.No/Date:2210015760 | :22/24/040/00032/AM18/ 30.08.2017 | | | Decision: In the light of earlier decision taken by NC in its 7/82 meeting dated 11.09.2014, it was decided to ratify | | ‘norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: | kg/kg | | Cefixime Trihydrate 1kg GCLE 1.507 | | | Sodium bromide 0.3628 | | | Tri Phenyl Phosphine 0.820 | 120. Methylene Chloride 1.546 }6 Formaldehyde 1.118 | aa Butyl Acetate 0.302 | | | MICA Ester 0.820 | | Triethylamine (TEA) 0.2717 RA may take appropriate action as per the decision of Norms Committee. | Case No.:143/6/82-ALC4/2017 |Party Name:SHIVA ~|Meet No/Date:7/82- Status: | PPHARMACHEM LTD ALC4/2018 Rejected | | 24.08.2018 | | 191 HQ File RLA File ‘|Lic.No/Date:3410043429 | :01/82/050/00713/AM18/ 134/24/040/00121/AM18/ (31.08.2017 | | Decision: The Committee considered the case as per agenda in the presence of thetechnical experts, wherein it! was observed that in the 4.7 application, there are two different raw material with no bifurcated. Hence, the | Committee decided to reject the case. | う ----- End of picture text -----

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----- Start of picture text ----- | ‘Case No.:151/6/82-ALC4/2017 Party Name:NECTAR ‘Meet No/Date:7/82- Status: | ‘LIFESCIENCES LIMITED |ALC4/2018 Approved | | HQ File :01/82/050/00721/AM18/ RLA File ==~—~—|Lic.No/Date:2210015767 | fo | :22/24/040/00034/AM 1 8/ (31.08.2017 | Decision: The Committee considered case as per agenda in the presence of thetechnical experts and taking cue. || fromNo. 0910060798its earlier decisiondated 04.08.2014,taken in MeetingdecidedNo.to 6/82-ALC4/2014,ratify the ad-hoc inputdatedoutput29.08.2014normsagainstunder Advancepara 4.7 ofAuthorization HBP as per.| | details below or as applied by firm whichever is lower: | || | Export product Qty. | SI. Import items Qty. | i No. | | | Ceftriaxone Sodium Sterile | 1 kg pl Ceftriaxone Sodium (Non Sterile) 1.04 kg | 3 Aluminium Bottle | Relevant as per | ; | chlorobuty]Anodized withplug Tear off alu cap & packing policy | | | RA may take appropriate action as per the decision of Norms Committee. |Case No.:83/6/82-ALC4/2017 PartyName:FRESENIUSKABI (Meet No/Date:7/82-. Status: | ONCOLOGY LIMITED ALC4/2018 ‘Approved | HQ File :01/82/050/00653/AM18/ RLA File —Lie.No/Date:0510403920 | | | ':05/23/040/00218/AM18/ 04.09.2017 | | | Decision: The Committee consideredcase as per agenda in the presence of the technical experts and taking cue | from its earlier decision taken in Meeting No. 1/82-ALC4/2018, dated 01.05.2018 against Advance Authorization | ‘No. 0510402049 dated 23.03.2017 decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per | details below or as applied by firm whichever is lower: a No. | ho3 | Vinorelbine 1 Number Vinorelbine Tartrate IP/USP. 15.239 mg/ vial "| Injections IP/USP | | | 10mg/Iml. 2 Rubber Stoppers for Pharmaceutical | Relevant as per packing | | Article Use R/S 13mm Daikyo policy | | | Fluorotec S2-F451W D777-1. | Rubber Stoppers 13mm dia coated. | | | Vinorelbine 1 Number Vinorelbine Tartrate IP/USP. 76.195mg/ vial | Injections IP/USP | | | SOREttl 2 Rubber Stoppers for Pharmaceutical | Relevant as per packing i | Article Use R/S 20mm Fluorotec policy ; | 1242-1888 WSTR. | | Rubber Stoppers 20mm dia coated. | RA concerned may take further necessary action as per above decision of NC. / |CaseNo.:78/6/82-ALC4/2017_'PartyName:JUBILANT —-Meet No/Date:7/82- Status: | | '(GENERICS LTD ‘ALC4/2018 ‘Deferred ; | 24.08.2018 '124 TQ File:01/82/050/00648/AMI18/ RLA File Lie. No/Date:0510403934 [Defer Date: } | ':05/23/040/00217/AM18/ 05.09.2017 | | Decision: Deferred for comments of TE つ Ｓ‐ つ ----- End of picture text -----

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----- Start of picture text ----- Case No.:76/6/82-ALC4/2017 Party Name:JODAS EXPOIM Meet No/Date:7/82-. Status: PVT.LTD ALC4/2018 ‘Deferred 125 11Q File :01/82/050/00646/AM18/ [RLA File ‘Lic.No/Date:0510403960 Defer Date: ; | 05/23/040/00227/AM 18/ (07.09.2017 | | ‘Decision: Deferredfor commentsof TE | _ (Case No.:79/6/82-ALC4/2017 Party Name:JODAS EXPOIM —-Meet No/Date:7/82- Status: | | PVT.LTD ALC4/2018 ‘Deferred | | | 24.08.2018 126 11Q File :01/82/050/00649/AM18/ RLAFile ——~—LLic.No/Date:0510403959 [Defer Date: 105/23/040/00226/AM 18/ 07.09.2017 | Decision: Deferred for commentsofTE | | Case No.:72/6/82-ALC4/2017 |Party Name:STRIDES‘LIMITED SHASUN /Meet No/Date:7/82- Status: a | 24.08.2018ALC4/201 8 ‘Approved| | | HQ File :01/82/050/00642/AM18/ RLA File ~ Lic.No/Date:0410163499 | | ; | ':04/24/040/00112/AM18/ 08.09.2017 | | Decision: |The Committee considered case as per agenda in the presence of the technical experts and taking cue | from its earlier decision taken in Meeting No. 4/82-ALC4/2018, dated 19.06.2018 against Advance Authorization| | ‘No. 0410163776 dated 06.12.2017 decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per| details below or as applied by firm whichever is lower: | | | Export Product Export S. Import Product Quantity Allowed | Quantity | No | | 127 |POEX T ASSIUMENDED CITRATE- RELEASE Number 550.8 mg/ 5 mEq /tablet || [API] [CONT:572.400MG] | [NET] TABLETS USP SmEq - 540MG/ Chath ne. || PER TABLETS INCL WASTAGE | | POTASSIUM CITRATE Number | 2 1101.6 mg/ 10 mEq /tablet | EXTENDED RELEASE | || TABLETS USP 10mEq - 1080MG Otattoep. | | NET API CONT: 1144.8MG / PER | | | TABLETPOTASSIUMINCL CITRATE WASTAGE. Number | 3 1652.4 mg/ 15 mEq /tablet || | | EXTENDED RELEASE TRIPOTASSIUM | | TABLETS USP 15mEq - 1620MG CITRATE | |_| NET API CONT:1717.200MG/ | | | PER TABLET INCL WASTAGE | IRA may take appropriate action as per the decision of Norms Committee. | ~ Case No.:120/6/82-ALC4/2017 PartyName:YASHO—S(Meeet No/Date:7/82-. —=(Status:= INDUSTRIES PVT.LTD. ALC4/2018 ‘Approved | | 24.08.2018 | HQ File :01/82/050/00690/AMI18/ RLAFile = ~—~—Lic.No/Date:0310815731 | i | ':03/95/040/00481/AM18/ 13.09.2017 | | 128 Decision: | The Committee considered case as per agenda in the presence of the technical experts and taking cue |  _ |fromNo. its earlier decision taken in Meeting No. 2/82-ALC4/2018, dated 16.05.2018 against Advance Authorization| details0310810430below or asdatedapplied10.01.2017by firm whicheverdecided toisratifylower:the ad-hoc input output norms under para 4.7 of HBP as per|| | | Export product Exp. SI. Import items Qty. | a Qty. No. Allowed | Ｓ ----- End of picture text -----

||_| (BHA)(FLAKES/POWDER’FF)<br>TERTIARYBUTANOL| 0.839 kg||_| (BHA)(FLAKES/POWDER’FF)<br>TERTIARYBUTANOL| 0.839 kg||||
|---|---|---|---|
||<br>|<br>PHOSPHORIC ACID|||||
||<br>|<br>(4 [HEXANE|||||
|_<br>RAmaytake appropriate action as perthe decision ofNormsCommittee|||||
||(Case No.:131/6/82-ALC4/2017PartyName:YASHO.—SMeet No/Date:7/82-.|Status:|||
||<br>INDUSTRIES PVT.LTD.<br>ALC4/2018|‘Deferred|||
||<br>|<br>|<br>24.08.2018<br>‘129HQFile:01/82/050/00701/AM18/ |RLA File<br>~<br>Lic.No/Date:0310815729|DeferDate:|||
||<br>':03/95/040/00480/AM 18/<br>(13.09.2017||||||
||<br>(Decision: eee<br>eeee<br>|||||
||<br>(CaseNo.:90/6/82-ALC4/2017 PartyName:PCL<br>OIL&<br>MeetNo/Date:7/82-<br>Status:<br>|<br>|<br>‘SOLVENTS LTD.<br>‘ALC4/2018<br>‘Approved<br>|<br>|<br>|<br>24.08.2018<br>|<br>|<br>HQFile<br>RLAFile<br>= ~~<br>~—~—_Lic.No/Date:0510404051<br>130':01/82/050/00660/AM 18/<br>::05/24/040/00259/AM18/<br>20.09.2017<br>|<br>|<br>Decision:<br>TheCommittee consideredthecase as peragendaand<br>in thepresenceofthe technical experts, ‘itwas.<br>|<br>decided to ratify the ad-hoc input output norms as applied forby the firm under para 4.7 ofHBP forone time basis<br>|||||
||<br>onlyandno repeat licence allowed.||||
|L JRAmaya<br>Aa2 Le||||
||<br>(CaseNo.:75/6/82-ALC4/2017<br>PartyName:STRIDESSHASUN MeetNo/Date:7/82-<br>|<br>|<br>‘LIMITED<br>‘ALC4/2018|Status:<br>Deferred|||
||<br>|<br>24.08.2018<br>131 11Q File:01/82/050/00645/AMI18/ [RLAFile<br>~~~—~—~—_Lic.No/Date:0410163547<br>/<br>|<br>|:04/24/040/00124/AM18/<br>(21.09.2017|DeferDate:|||
||<br>GaUGn<br>Deemed Gicomneeel|||||
|CaseNo.:87/6/82-ALC4/2017 |PartyName:MEGHMANI—Meet No/Date:7/82-. Status:<br>|<br>|<br>INDUSTRIESLTD,<br>ALC4/2018<br>Deferred<br>|<br>|<br>|<br>24.08.2018<br>|<br>‘192TQFile:01/82/050/00657/AM18/RLAFile<br>SSCL<br>icNo/Daate:0810140981<br>DeferDate:<br>;<br>|<br>':08/24/040/00099/AM18/<br>21.09.2017<br>|||||
||<br>Decision:<br>Deferred for comments of TE<br>_|||||
|[Case No.:119/6/82-ALC4/2017PartyName:UPL<br>—~—SMeetNo/Date:7/82-.<br>|<br>|<br>LTD(FORMERLYUNITED<br>—ALC4/2018<br>|<br>|<br>‘PHOSPHORUS LTD.)<br>24.08.2018<br>|133 iQFile:01/82/050/00689/AM18/ RLAFile<br>‘Lic.No/Date:0310815884<br>':03/95/040/00482/AM18/<br>21.09.2017|Status:<br>Deferred<br>|<br>|<br>DeferDate:<br>||||
||<br>Decision: Deferred forcomments ofTE|||||
||<br>Case No.:125/6/82-ALC4/2017 |PartyName:USVPRIVATE<br>MeetNo/Date:7/82-.<br>|<br>|<br>\LIMITED(FORMERLY USV<br>ALC4/2018<br>|<br>|<br>LIMITED)<br>24.08.2018<br>134FQ File<br>:01/82/050/00695/AMI18/[RLA File<br>Lic.No/Date:0310815872<br>|<br>|<br>':03/95/040/00460/AM18/<br>(21.09.2017|Status:<br>Deferred<br>|<br>|<br>DeferDate:||||

50 ‘Case| ALC4/2017No.:86/6/82~~~ PartyName:CADILAHEALTHCARE LTD —sMeett 24.08.2018No/Datte:7/82-ALC4/2018 Status: Deferred | 5 | HQ File ‘RLA File Lic.No/Date:08 10140994 ‘Defer Date: | ':01/82/050/00656/AM18/ —_:08/24/040/00151/AM18/ 22.09.2017 | | | Decision: Deferred for comments of TE. | Case No.:118/6/82-ALC4/2017 Party Name:METROPOLITAN Meet No/Date:7/82-. (Status: ; | EXIMCHEM PRIVATELTD. —_ALC4/2018 Deferred 136 | | 24.08.2018 | | | HQ File :01/82/050/00688/AMI18/ RLAFile ==—=——_Lic. No/Date:0310815895 Defer Date: | ':03/95/040/00446/AM18/ [22.09.2017 | Decision: Deferredfor comments of TE | | Case No.:122/6/82-ALC4/2017[PartyName:RELIANCE ——s‘ Meet No/Date:7/82-- Status: a INDUSTRIES LTD. ALC4/2018 Deferred | | 24.08.2018 | | HQ File :01/82/050/00692/AMI18/ [RLAFile = = =~=~—~—~—_Lic.No/Date:0310815890 ‘Defer Date: i :03/95/040/00246/AM 18/ 22.09.2017 | [IS 7 Decision: The Committee examined the reply furnished by the firm and it was observed that the firm has only | | indicated the process parameters to be maintained in the plant and not furnished the guaranteed norms of| | ‘consumption from Ethane to Ethylene. | | Hence, the Committee decided to call for guaranteed norms of consumption from Ethane to Ethylene from the| ||(Case No.:129/6/82-ALC4/2017|PartyName:RELIANCE ——s'Meet No/Date:7/82-. —=«[Status:= INDUSTRIES LTD. ALC4/2018 Deferred | HQ File RLAFile =i. No/Date:0310815896 [Defer Date: ''38 :01/82/050/00699/AM 18/ ':03/95/040/00371/AM18/ 22.09.2017 | | indicated‘Decision: theThe processCommitteeparametersexaminedto thebe replymaintained furnishedin theby theplantfirmandandnotit wasfurnishedobservedthethatguaranteedthe firm hasnormsonlyof, consumption from Ethane to Ethylene. | Hence, the Committee decided to call for guaranteed norms of consumption from Ethane to Ethylene from the | "Case No.:70/6/82-ALC4/2017 Party Name:CAPLIN POINT (Meet No/Date:7/82-. —~Status: ; | LABORATORIES LTD., ‘ALC4/2018 ‘Deferred 139 iQ File :01/82/050/00640/AM18/ [RLA File ‘Lic.No/Date:0410163550 ‘Defer Date: ; | |:04/24/040/00128/AM18/ (25.09.2017 | | | Deiim iwi ee | (Case No.:3/7/82-ALC4/2017 [Party Name:CLEAN SCIENCE [MeetNo/Date:7/82- —~*(Status:—S L‘140; || AND TECHNOLOGY PVT.LTD. ALC4/201824.08.2018 Deferred| | FQ File :01/82/050/00725/AMI18/ RLAFile. ——~—~—~—~—~—~—~«WLie-No/Date:3110066880 Defer Date: | :3 1/83/040/00080/AM18/ (25.09.2017 | | | sDeckion Debresl brane te Se a ea eae aot neem mn —|

| | (CHEMICALS PVT. LTD. ‘ALC4/2018 ‘Deferred 141 |HQ File :01/82/050/00685/AM18/ |[RLA File —— 24.08.2018|Li¢.No/Date:0310815952 |Defer Date: | | :03/95/040/00500/AM18/ 26.09.2017 | | | Decision: Deferred forcommentsofTE _ —_ Oe | | CaseNo.:152/6/82-ALC4/2017 |Party Name:SCOTT-EDIL ———Meet No/Date:7/82Status: | ADVANCE RESEARCH LAB. —ALC4/2018 Deferred | | AND EDUCATION LTD 24.08.2018 | 42 HQ File :01/82/050/00722/AM18/ RLAFile ==———LLiic. No/Date:2210015780 Defer Date: | |:22/24/040/00038/AM18/ (27.09.2017 | Se a _ (Case No.:1/7/82-ALC4/2017 Party Name:CLEAN SCIENCE Meet No/Date:7/82Status: | | ‘AND TECHNOLOGY PVT.LTD. ALC4/2018 Approved | | 24.08.2018 | | HQ File :01/82/050/00723/AM18/ RLAFile = = ~=~~—~—Lic.No/Date:3110066885 | | ':3 1/83/040/00082/AM 18/ 03.10.2017 | | | Decision: The Committee considered the case as per agenda and _ in the presence of the technical experts, it. was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by. **** _ firm whichever is lower: | | | Guaiacol kg Phenol PURITY 99% AND ABOVE | !.108kg | | | 2 Dimethyl Sulphate PURITY 99% 0.847 kg | | | AND ABOVE | | | 3 Caustic Lye PURITY 40% AND 0.35kg | | | ABOVE (100% basis) | | | 4 Hydrogen Peroxide (60%) PURITY 0.687 kg |, | | 60% | | | Acetone (Solvent) O.14kg | | | RA may take appropriate action as per the decision of Norms Committee.

Manual Agenda of NC Meeting No. 7/2018 Scheduled to be held on 24.08.2018

Case No. B- | M/s. Dsm Sinochem Pharmaceuticals India Pvt., Ltd. M.No.7/AM-18 File No. 01/82/50/01788/AM16/DES-II] Date 24.08.2018 RLA No. 22/24/040/00085/AM16 Adv.Auth. No. 2210015363 Dated:09.12.2015

Decision: Committee considered case as per agenda and in consultation with technical expert present in the meeting, it was decided to amend/correct the description of import item SI. No. 2 to be read as “Formidase (Enzyme)” instead of “Elcolase Enzyme”. Rest of minutes would remain same.

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

| 52

“a

Case No. B- 2 M/s. RAY CHEMICALS PRIVATE LIMITED, M.No.7/AM-18 File No. 01/82/050/01217/AM13 Date 24.08.2018 RLA No. 07/24/040/00398/AM13 Adv.Auth. No. 0710092831 dated 01.01.2013

Decision: Committee considered case as per agenda and in consultation with technical expert present in the meeting, it was decided to amend the quantity of import item at SI. No. | to be read as “1 BROMO 3 CHLORO PROPANE - 0.92” kg instead of “1 BROMO 3 CHLORO PROPANE - 0.092 kg”. Rest of minutes would remain same. Case No. B- 3 M/s. INDO AMINES LIMITED M.No.7/AM-18 File No. 01/82/050/00181/AM15 Date 24.08.2018 RLA No. 03/94/040/00958/AM14 Gea Decision : 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 4.7 of HBP as per details below or as applied by firm whichever is lower:

Export product Import items Qty. No. COCO AMINE DISTILLED COCONUT FATTY

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

Case No. B- 4 M/s. INDO AMINES LIMITED M.No.7/AM-18 File No. 01/82/050/00417/AM16 Date 24.08.2018 RLA No. 03/94/040/01024/AM15 Adv.Auth. No. 0310794134 Dated 25.02.2015

Decision : Committee considered case as per agenda and as per earlier decision taken by NC in its meeting dated 2/AM19 dated 16.05.2018 it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Qty. CY ANOETHANE 1 Kg. PROPIONITRILE 98% | 1.02 kg (osRA concerned may take further necessary| action|ROPONTRLEas per above decision ofSeeNC. [ig

Case No. B- 5 M/s. MICRO LABS LTD M.No.7/AM-18 File No. 01/82/50/01047/AM18/DES-III RLA No. 07/24/040/00372/AM16 Adv.Auth. No. 0710109368 dated 04.02.2016

Decision: Committee considered case as per agenda and deliberated on the matter in the presence of the technical experts and it was decided to revise the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Import items AMOXICILLIN 125 1 No. | AMOXICILLIN 3012.83 / bottle MG+FLUCLOXACILLIN 125 fete | TRIHYDRATE mg

==> picture [447 x 172] intentionally omitted <==

----- Start of picture text ----- 53 100 ML BOTTLES BP/EP/USP/IP mg / bottle FLUCLOXACILLIN 250 MG Capsules TRIHYDRATE mg/capsule CAPSULES BP/EP/USP/IP BP/EP/USP/IP ( 4750 KG ) 2 FLUCLOXACILLIN SODIUM | 277.47 BP/EP/USP/IP mg/capsule RA concerned may take further necessary action as per above decision of NC つ つ ----- End of picture text -----

Case No. B- 6 M/s. Asiatic Drugs &Pharmaceuticals Pvt. Ltd M.No.7/AM-18 File No01/82/050/00612/AM17/DES-III Date 24.08.2018 RLA No. 05/23/040/00123/AM17 Adv.Auth. No. 0510399239 Dated 27.07.2016

Decision: Committee considered the case as per agenda and in consultation with technical expert present in the meeting, it was decided to amend the description of Export product from “ Amoxcillin Trihydrate ” to “ Ampicillin Trihydrate (From 6-APA Route) ” and amendment in the description of import item SI. No. 2 from “D-(-)-para-hydroxy phenyl glycine base(p-HPG base)” to “ D-(-)-Alpha phenyl glycine base(PG base) ” . Rest of minutes would remain same. RA concerned may take further necessary action as per above decision of NC

Case No. B- 7 M/s. DIVIS LABORATORIES LTD M.No.7/AM-18 File No. 01/82/050/01788/AM16

Adv.Auth. No. 0910063414 dated 15.03.2016

meeting, it was decided to amend the description of import item SI. No. 1 may be corrected and to be read as “2-(2-OXO-PYRROLIDIN-1-YL) BUTANOIC ACID” instead of “2-(2-OXO-Pyrrolidin-1YL)”. Rest of minutes would remain same. RA concerned may take further necessary action as per above decision of NC

Case No. B- 8 M/s. DIVIS LABORATORIES LTD Date 24.08.2018 RLA No. 09/24/040/00658/AM14 Adv.Auth. No. 0910059678 dated 28.03.2014 Decision : Committee considered case as per agenda and in consultation with technical expert present in the meeting, it was decided to revise to revise the input output norms in line with the Central Excise Certificate submitted by the firm as under para 4.7 of HBP as per details below or as applied by firm whichever is lower :-

==> picture [469 x 124] intentionally omitted <==

----- Start of picture text ----- Export product Exp. Sl. | Import items Qty. Qty. No. allowed in kg DICHLOROPHENYL)-2- CARBONATE ae(GUANIDINOIMINO) = eee fe ACETONITRILE 3 2,3-DICHLORO BENZOYL 1.19 RA concerned may take further necessary actionPeras per a bove decisionOOof NC. Ｏ ----- End of picture text -----

Case No. B- 9 M/s. DIVIS LABORATORIES LTD M.No.7/AM-18 File No. 01/82/050/00491/AM15 Date 24.08.2018 RLA No. 09/24/040/00150/AM15 Pe ewer

Decision : Committee considered case as per agenda and in consultation with technical expert present in the meeting, it was decided to revise to pease the input output norms in line with the Central Excise Certificate and the details submitted by the firm as under para 4.7 of HBP as per details below or as applied by firm whichever is lower :-

==> picture [441 x 199] intentionally omitted <==

----- Start of picture text ----- Export product Exp. Qty. | SI. No. | Import items Qty. allowed in kg TELMISARTAN Ikg. a1. 2-CYANO-4-METHYL s 4 MeANOD Ee [900 2-N-PROPYL-4-METHYL-6- | 0.79 aeBENZIMIDAZOLE 5 N-METHYL ORTHO 0.71 DIHYDRO CHLORIDE ae PHENYLENE DIAMINE clin p [ramoae] PHOSPHOROUS 1.50 ξ ----- End of picture text -----

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

Case No. B- 10 M/s. DIVIS LABORATORIES LTD M.No.7/AM-18 File No. 01/82/50/00820/AM17 Date 24.08.2018 RLA No. 09/24/040/00346/AM17 ES a ee Decision : Committee considered case as per agenda and in consultation with technical expert present in the meeting and noted that the firm has submitted Certificate of Analysis (COA) shows that the export item VALACYCLOVIR HCL of Anhydrous grade and in line with the Central Excise Certificate and it was decided to revise the input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:-

==> picture [449 x 171] intentionally omitted <==

----- Start of picture text ----- Export product Exp. | Sl. | Import items Qty. allowed in VALACYCLOVIRHCL | Tks. [1._[acycLovik 082 (Valacyclovir Hcl Anhydrous) P2. [eaesopinipeN,N DI CYCLO HEXYL |1.15 ee gievarNe. pea RA concerned may take further necessary action as per above decision of NC. つ ----- End of picture text -----

ham

Case No. B- 11 M/s. DIVIS LABORATORIES LTD M.No.7/AM-18 File No. 01/82/050/00161/AM18 Date 24.08.2018 RLA No. 09/24/040/00567/AM17 Adv.Auth. No. 0910064650 dated 07.02.2017 Decision : Committee considered case as per agenda and in consultation with technical expert present in the meeting, it was decided to revise the input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:-

Export product Exp. Qty. | SI. No. | Import items Qty. allowed in kg IOPAMIDOL kg. ATIPA DI CHLORIDE 2: 2-ACETOXY PROPIONYL 0.49 CHLORIDE DI METHYL FORMAMIDE ISO PROPYL ALCOHOL METHANOL N,N-DIMETHYL 1.46 ACETAMIDE NITRO METHANE (8 [TOLUENE RA concerned may take further necessary action as per above decision of NC. Case No. B- 12 M/s. DIVIS LABORATORIES LTD M.No.7/AM-18 File No. 01/82/050/01077/AM18 Date 24.08.2018 RLA No. 09/24/040/00283/AM18 Adv.Auth. No. 0910065442 dated 08.09.2017 Decision : Committee considered case as per agenda and in consultation with technical expert present in the meeting and noted that firm has claimed overall yield 33.25% in four steps process and considering the justification given by the firm i.e. stepwise yield of 80% x 60% x 90% x 90% or 39% overall yield and it was decided by the committee to revise the input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:NABUMETONE Ikg. 1. 2-ACETYL-6-METHOXY 2.25 kg NAPHTHALENE METHANOL 6.54 kg RA concerned may take further necessary action as per above decision of NC. Case No. B- 13 M/s. DIVIS LABORATORIES LTD M.No.7/AM-18 File No. 01/82/050/00653/AM17 Date 24.08.2018 RLA No. 09/24/040/00254/AM17 Adv.Auth. No. 0910064042 dated 16.08.2016

Decision : Committee considered case as per agenda and in consultation with technical expert present in the meeting, it was decided to revise the input output norms in line with the Central Excise Certificate and the details submitted by the firm as under para 4.7 of HBP as per details below or as applied by firm whichever is lower :- Export product Exp. Qty. | Sl.No. | Import items Qty. allowed in kg ATOVAQUONE lkg. 2-CHLORO-1,41.74 NAPHTHOQUINONE ACETONITRILE 4-CPCCA

|[4||TOLUENE<br>600|
|---|---|
|(6||MetianoL__—~d<br>0<br>SS—*S|

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

Case No. B- 14 M/s. GLENMARK PHARMACEUTICALS LTD M.No.7/AM-18 File No. 01/82/050/00276/AM18/DES-III Date 24.08.2018 File No. 01/82/050/00/616/AM18/DES-III RLA No. 03/94/040/00070/AM18 RLA No. 03/94/040/00322/AM18 Adv.Auth. No. 0310812668 dated 21.04.2017 Adv.Auth. No. 0310814681 dated 19.07.2017

Decision: Committee considered case as per agenda and in consultation with technical expert present in the meeting, it was decided to amend the description of import item Sl. No. 1 to be read as “ Trans-4-(4-chlorophenyl) Cyclohexane Carboxylic Acid ” instead of “ 4-(4-chlorophenyl) Cyclohexane Carboxylic Acid”. Rest of minutes would remain same.

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

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