IN FORCE Advance Authorisation

DGFT Minutes

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Office of Directorate General of Foreign Trade New Delhi -0 ;

Para, 4.07 Decision

Minutes of the Norms Committee — 3'Meeting No. 7/82-ALC4/2020 dated 04.12.2020 (actually held on 04.12.2020, 16.12.2020 and 24.12.2020) for considering the cases/issues under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy, 2015-20 pertaining to Chemic a ndl Allied products falling under Chapter 29 and 30, held under the Chairmanship of Shri Rajbir Sharma, Jt. DGFT in Room No.4 and 11, Udyog Bhawan, New Delhi,

Following members were present in the Meeting:

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----- Start of picture text ----- Sl.No. |Name & Designation Department - _ 1 _| [Shri] [Shaish] [Kumar,] [Technical][ —] [1] Consultant | 2 Shri D.N. Mathur, Technical — 2 Consultant _In attendance __ _ l __| Shri Munish Kumar, Dy, DGFT _,| DGFT 2 __| Shri Ajay [Kumar,] [Assistant][ Director] _/ | DGFT ----- End of picture text -----

The Norms Committee has taken decision only with respect to technical aspect/ wastage norms. While redeeming the application, RAs should check that the applicant has fulfilled all requirements as prescribed in policy/procedure including those in policy circulars issued from time to time or any other provisions under FTP/HBP for issuance of Advance Authorization and regularization of the case.

‘The committee went through the minutes of earlier meeting No. 6/82-ALC4/2020 dated 13.11.2020 (actualy held on 18.11.2020 and 25.11.2020).

f Advance Authorization and regularization of the case.

‘The committee went through the minutes of earlier meeting No. 6/82-ALC4/2020 dated 13.11.2020 (actualy held on 18.11.2020 and 25.11.2020).

, ONLINE CASES ° Case No.:60/4/82-ALC4/2020 Party Name: HETEROLABS Meet No/Date:7/82Status; ‘LTD. ALC4/2020 ,Withdrawn | 04.12.2020 i HQ File . RLA File Lic.No/Date:0910038262 a :01/82/050/01561/AM21/ ::09/24/040/00092/AM 10/ 17.06.2009 | Decision: The firm vide e-mail dated 04.12.2020 has enclosed a copy of Redemption Letter dated | 02.04.2012 issued by RA, Hyderabad and has stated that since they had fulfilled 100% Export Obligation| and also RA, Hyderabad had issued EODC, hence they do not require fixation of norms of subject Advance Authorization. : In view of above, the Committee decided to withdraw the case. |

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Case No.:56/4/82Party Name:CORAL DRUGS Meet No/Date:7/82‘Status: i ALC4/2020 PVT. LTD., ALC4/2020 ‘Approved 04.12.2020 : HQFile . ,RLA File Lic.No/Date:0510287831 :01/82/050/01557/AM21/ :05/23/040/00006/AM12/ . 08.04.2011 | Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in| meeting no. 15/AM 13 dated 09.08.2012 against advance authorization No. 0510226234 dated 26.08.2008 and[|][dated][26.11.2007,][it][was][decided][to][ratify][norms][under][Para][4.07][of][ HBP][Vol.][I][as][per][details:] >[0510212483] given below or as applied by the firm, whichever is less: |[!]

.11.2007,][it][was][decided][to][ratify][norms][under][Para][4.07][of][ HBP][Vol.][I][as][per][details:] >[0510212483] given below or as applied by the firm, whichever is less: |[!]

|Export Product Qty. Import items FLUTAMIDE USP tke | 1 4-NTRO-3-TRIFLUOROMETHYLANILINE 1.04 kg Note: The above norms are only for closure purpose of subject Advance Authorization. Hence, no repeat norms will be allowed on the basis of the above decision. RA concerned may take further necessary action as per above decision of NC. Case No.:969/15/82Party Name:SOMU Meet No/Date:7/82Status: ALC4/26018 iSOLVENTS PVT. LTD ‘“ALC4/2020 Rejected | 04.12.2020 HQ File "ORLA File ‘Lic.No/Date:0710108673 :0.1/82/050/02426/AM 19/ °:07/24/040/00175/AM16/ 02.09.2015 : + Decision: The Committee considered the case as per agenda in the presence of technical experts and it. was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. : 12/82-ALC4/2019 dated 17.01.2020, followed by Reminder on 07.08.2020 and Final Reminder on: 16.10.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019. Hence, the Committee decided to reject the case. : | RA concerned may take further necessary action as per above decision of NC. i

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15.05.2019. Hence, the Committee decided to reject the case. : | RA concerned may take further necessary action as per above decision of NC. i

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----- Start of picture text ----- Case No.:265/15/82- Party Name:ATUL ‘Meet No/Date:7/82- Status: ALC4/2018 LIMITED, ‘ALC4/2020 ‘Approved : 04.12.2020 HQ File RLA File | Lic. [No/Date:0810139395] -01/82/050/01722/AM19/ ':08/24/040/00374/AM17/ 28.12.2016 Decision: |The Committee considered case as per agenda in the presence of the technical experts and it was . decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as [|] A applied by firm whichever is lower: : / Export Product Qty. Import items Oty. | Amine Chain Extender (3,3 — Diethyl | lkg | | Methanol Not allowed, 4,4 —Diamino Diphenyl Methane) since not shown in the process RASC concerned may take further necessary actionpo as per2 above_ OrthodecisionEthylofAnilineNC. 1.058 kg ----- End of picture text -----

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her necessary actionpo as per2 above_ OrthodecisionEthylofAnilineNC. 1.058 kg ----- End of picture text -----

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----- Start of picture text ----- {| |Case No.:276/15/82- Party Name:JODAS EXPOIM = |Meet No/Date:7/82- Status: ALC4/2018 , PVT.LTD., ALC4/2020 Deferred | 04.12.2020 5 |HQ File RLA File Lic.No/Date:0510401758 | (:01/82/050/01733/AM19/ :05/23/040/00561/AM17/ 22.02.2017 Decision: |The Committee considered the case as per agenda and it was observed that the firm was issued Show Cause Notice vide letter dated 10.10.2019. Case No.:55/4/82- Party Name:J.B. Meet No/Date:7/82-ALC4/2020 ‘Status: ALC4/2020 CHEMICALS & 04.12.2020 Approved PHARMACEUTICALS LIMITED | THO:01/82/050/01556/AM21/ File RLA1:03/94/040/01066/AM17/ File |23.02.2017Lic.No/Date:03 10811424 Decision: The Committee considered case as per agenda in the presence of the technical experts and it was | decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as: | lapplied by firm whichever is lower: | | SL | Import Items Qty. Sl. | Import Items Qty. for 100 | | No. No.

input output norms under para 4.07 of HBP Vol. I as per details below or as: | lapplied by firm whichever is lower: | | SL | Import Items Qty. Sl. | Import Items Qty. for 100 | | No. No. recommended ; | Lozenges ; | Flavours Raspberry/Eucaluptus & | Number Hydrochloride i | Menthol/Honey&Lemon/Orange. an Chloride : 6) 3 358-460 gram_| 2 | Difflam Mint Fresh Sugar Free | 100 4 Benzydamine 0.306 gram Lozenges Number Hydrochloride Lozenges in Black Current/ Honey | Number Hydrochloride & Lemon/ Eucalptus& Menthol 7 Isomalt ST-M 257.00 gram Flavours. 4 | Andolex -C Lozenges Sugar Free | Number100 fo BenzydamineHydrochloride 0.306 gram { leanneChloride i | | 5 | Septolete “Extra Lozenges | 100 | || Contains,Cetylpyridinium-Each Lozenges | Number 12 | Isomalt ST-M 249,526 gram | | MChloride2578.840mg.EP 1.00mg/ Isomalt ST- | IRA concerned may take further necessary action as per above decision ofNC. ----- End of picture text -----

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malt ST- | IRA concerned may take further necessary action as per above decision ofNC. ----- End of picture text -----

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----- Start of picture text ----- TGase No.294/15/82-*(PartyName:SUPREET [Meet No/Date:7/82- (Status: | |ALC4/2018 CHEMICALS PVT.LTD. ALC4/2020 Approved 04.12.2020 | |1 1:01/82/050/0175[HQ [File] | 1/AM19/~ [RA:52/24/040/00006/AM18/File ~~ [Lic.No/Date:521004224902.05.2017 —— Decision: The Committeeconsidered case as per agenda in the presence of the technical experts and it [was] 7 \decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. | as per details below or as applied by firm whichever is lower: ----- End of picture text -----

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----- Start of picture text ----- No. ----- End of picture text -----

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----- Start of picture text ----- 5 nitro 2 amino phenol 0.864 kg ----- End of picture text -----

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

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amino phenol 0.864 kg ----- End of picture text -----

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

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----- Start of picture text ----- [Case No.:311/15/82- PartyName:ASSOCIATED [Meet No/Date:7/82- —[Status: ALC4/2018 DYESTUFF PVT. LTD ALC4/2020 Rejected 04.12.2020 | HQ File oo ARLA File —— ~~ fCic.No/Date:0810140725 | :01/82/050/01768/AM1 9/ :08/24/040/00123/AM18/ 26.07.2017 g (Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 12/82-ALC4/2019 dated 17.01.2020, followed by Reminder on 07.08.2020 and Final Reminder on 16.10.2020 as per Policy Circular No, 23/2015-20, dated 15.05.2019. : ----- End of picture text -----

RAHence, concerned the Committeemay takedecided furtherto necessaryreject the actioncase. as per above decision of NC.

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~"\Gase Now327/15/82.~-‘(Party NamesJODAS EXPOIM (Meet[No/Date:7/82-][(Status:] ALC4/2018 PVT.LTD., ALC4/2020 Deferred 04.12.2020 9 figFile~~ ~(RLAFile~~ ~—~—~—~—*(Lic.No/Date:0510404290 | :01/82/050/01784/AM19/ :05/23/040/00268/AM18/ 13.10.2017 Decision: The[Committee][considered][ the][case] as per agendaand it wasobserved thatthe firmwas issued Show Cause Notice vide letter dated 10.10.2019.

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0268/AM18/ 13.10.2017 Decision: The[Committee][considered][ the][case] as per agendaand it wasobserved thatthe firmwas issued Show Cause Notice vide letter dated 10.10.2019.

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| [CaseALC4/2018No.:328/15/82-—~—«Party Name:JODAS EXPOIM [MeetNo/Date:7/82- (Status: PVT.LTD., ALC4/2020 Deferred 04.12.2020 Ho|HQFile ==~=~=~=~=~—~—S({RLAFile ~=————~C~S~SCS Lic No attes0510404285 | | -|:01/82/050/01785/AM19/|Decision: The Committee considered:05/23/040/00266/AM18/the caseas per agenda and13.10.2017it was observed thata the firm was issued | |Show Cause Notice vide letter dated 10.10.2019. [CaseALC4/2018No.:329/15/82—~—~—«(PartyPVT.LTD.,Name:JODASEXPOIM(MeetALC4/2020No/Date:7/82-—‘(Status:Deferred — 04.12.2020 H{HQFile:01/82/050/01786/AM19/= ~—~—~—S (RLAFFile{:05/23/040/00267/AMoe1 8/ ~ (13.10.2017fEsNo‘Date:05 10404287 [ | Decision:Show Cause Notice|TheCommitteevide letter considereddated 10.10.2019. the case as per agenda anda it was observed that the firm was issued [[Case No.:550/15/82- ‘(PartyName:TADIMETY |ALC4/2018 AROMATICS PVT. LTD [MeetALC4/2020No/Date:7/82-—([Status:ApprovedSS | | | (04.12.2020 [HQFile _[RLAFile a “[Lic.No/Date:0710112366 o[ : | :01/82/050/02007/AM19/ _ |:07/24/040/00202/AM18/ — [08.11.2017 | 12 (Decision:iwas decided—~ toTheratifyCommittee the ad-hoc consideredinput output case norms as per agendaunder para in the 4.07 presence of HBP of Vol.theItechnicalas per details experts below and orit las applied by firm whichever is lower: | ISO NONYL ACETATE lkg No.

put output case norms as per agendaunder para in the 4.07 presence of HBP of Vol.theItechnicalas per details experts below and orit las applied by firm whichever is lower: | ISO NONYL ACETATE lkg No. NONANOL (ISONONYL 0.815 kg | RA concerned may take further necessary action as per aboveALCHOHOL)decision ofNC. {CaseALC4/2018No.:1021/15/82- —*{PartyName:ANLON—_—([MeetNo/Date:7/82‘Status: HEALTHCARE ALC4/2020 Approved | (PRIVATELIMITED 04.12.2020 | HQFie ~—~—~—~—S(RLAFile—~—SCS [Lic No/Date:2410042334 2 [:01/82/050/02478/AM 19/ |-24/24/040/00039/AM1 8/ 12.01.2018 Decision: —The Committee consideredcase as per agendain the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. 1 as per details below or as 3 applied by firm whichever is lower: No, LOXOPROFEN ; Chemical Name: 2-(4- | 1 kg | 1 Methyl 2-oxocyclo | 0,784 kg ((oxocyclopentyl)methyl)phenylpropanoicacid. Case No:68767-14-6 pentanecarboxylate,10472-24-9 CASE - 2 2-Phenyl Propionic acid - | 1.276kg Case No.492-37-5 RA concerned may take further necessary action as per above decision of NC. |

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[7 [Gase No.:165/10/82. —~—~~*(PartyName:AURORELIFE [MeetNo/Date:7/82- (Status: —_—| | |ALC4/2018 SCIENCES PRIVATE JALC4/2020 [Deferred . LIMITED 04.12.2020 | [HQ File ~IREAFie Lic. No/Date:0910065915 - .
| 4:01/82/050/00452/AM19/ :09/24/040/00438/AM18/ 20.01.2018 i s twasDecision:decided toThecall Committeefor followingconsideredinformation the casefrom asthe perfirm: agenda in the presence of technical experts andit

/AM19/ :09/24/040/00438/AM18/ 20.01.2018 i s twasDecision:decided toThecall Committeefor followingconsideredinformation the casefrom asthe perfirm: agenda in the presence of technical experts andit

(i) Molecular weight of Step [TV compound and Hexafluoro Compound are different in chemical reactions and material balance / yield calculations. (ii) Use of Methyl] Ethyl Pyridine is not found in the entire process. (iii) AuthoritiesProduction may/ Consumption also be furnished.Data certified by Central Taxes and GST | Case No.1132/10/82-.~~—~«*{Party Name:AURORLIF E (Meet[No/Date:7/82-][ (Status:] jALC4/2018 SCIENCES PRIVATE ALC4/2020 Approved LIMITED 04.12.2020 HQFie|. LA File~~ """TLic.No/Date:0910065954 | - :01/82/050/00419/AM19/ 1:09/24/040/005 16/AM18/ 01.02.2018 | Decision: The Committee considered case as per agenda in the presence of the technical experts and it : was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. 1 as per details below or as applied by firm whichever is lower: 15 Export Product Qty. | No.SI. | Import items Qty. DL-Homocysteine ThiolactoneHCl |1kg | 1 | DL-Methionine 2.81 kg 3 Acetic Acid Not recommended, | Hydrobromic Acid 1.50 kg recovered in the | asprocessit is fully 1 | 0.25 kg Iso Propyl Alcohol 0.25 kg RA concerned may take further necessary action as per above decision ofNC. |

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is fully 1 | 0.25 kg Iso Propyl Alcohol 0.25 kg RA concerned may take further necessary action as per above decision ofNC. |

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----- Start of picture text ----- [Case No.:140/10/82- [Party =—s—<i«é‘ét™~~(MeetNolDate:7/82-= (Status: | jALC4/2018 -(Name:ORTINLABORATORIES.|ALC4/2020 Approved | LTD 04.12.2020 [HQFile IRLA File aie, ~~ |Lic.No/Date:0910065968 :01/82/050/00427/AM19/ — |:09/24/040/00527/AM18/ 06.02.2018 Decision: | The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4,07 of HBP Vol. I as per details below or as applied by firm whichever is lower: ----- End of picture text -----

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----- Start of picture text ----- Export Product Qty. | SL | Import items | Qty. 16 No. (S,Z0-5-AMINO-2- tkg L-PHENYLALANINE 0.4465 kg (DIBENZYLAMINO)-1,6- BENZYL CHLORIDE 1.032 kg DIPHENYLHEX-4-en-3-ONE(DAH-IDI n- HEPTANE 0.450 kg TETRAHYDROFURAN | 1.00 kg SODIUM AMIDE 0.357 kg |6|ACETONITRILE 0.400 kg 7 POTTASIUM 1.075 kg CARBONATE ea concerned may take further necessary action as per.8 above|decision CITRIC ACIDof NC. 1.00 kg: ----- End of picture text -----

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r>ea concerned may take further necessary action as per.8 above|decision CITRIC ACIDof NC. 1.00 kg: ----- End of picture text -----

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----- Start of picture text ----- | iCaseNo.:819/15/82- [PartyName:DHANUKA= [MeetNo/Date:7/82-‘[Status: | | l04,12.2020 | |ALC4/2018 LABORATORIES LTD |ALC4/2020 Rejected | |HQFile ~IRLA File ~ |Lic.No/Date:0510405609 [ | (:01/82/050/02276/AM19/ |:05/23/040/00440/AM 18/ (09.02.201 8 47 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 12/82-ALC4/2019 dated 17.01.2020, followed by Reminder on 07.08.2020 and Final Reminder on 16.10.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019. ----- End of picture text -----

Hence, the Committee decided to reject the case. RA concerned may take further necessary action as per above decision ofNC.

| (Case No.s1009/15/82-—~[Party Name:TADIMETY {Meet No/Date:7/82- —‘[Status: | |ALC4/2018 AROMATICS PVT.LTD — |ALC4/2020 Approved , 04.12.2020 | (HOFieho + ~'(RLAFile= ~—~—~—~—«*(Lic.No/Date0710112820 [| == :01/82/050/02466/AM19/ :07/24/040/00305/AM18/ 13.02.2018

Decision: TheCommittee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 5/82-ALC4/2020 dated 09.10.2020 against advance authorization No. 0710115940 dated | 18 |27.12.2019, it was decided to ratify norms under Para 4.07 of HBP Vol. 1 as per details given below or as applied by the firm, whichever is less:

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----- Start of picture text ----- No. ISO NONYL ACETATE lkg $1 3,5,5, TRIMETHYL HEXANOL | 0,774 kg _| (NONANOL) ----- End of picture text -----

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

CaseNo.:93/10/82-ALC4/2018 (Party Name:YASHO —~—~—*(Meet No/Date:7/82-(Status: INDUSTRIES PVT.LTD. ALC4/2020 Deferred 04.12.2020 119 HQ File ~ IRLAFile ~~ Lie.No/Date:0310819263 [ |:01/82/050/00380/AM19/ (:03/95/040/01007/AM18/ 20.02.2018 | [Decision: The Committee considered the case as per agendain the presence of technical expertsand it ‘Iwas decided to call for following information from the firm:

(i) Molecular weight of Export Product.

\GaseNo.:186/13/82-—~—~—~«*(PartyName:SONGWON—__[Meet No/Date:7/82- (Status: ALC4/2018 SPECIALTY CHEMICALS ALC4/2020 Deferred INDIA PVT. LTD. (04.12.2020 | HQ File ORLA File SSC Lic. No/Date3410043908 | :01/82/050/01164/AM19/ |:34/24/040/00341/AM18/ [22.02.2018

20 |Decision: “The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. 4/82-ALC4/2020 dated 18.09.2020, followed by Reminder on 16.10.2020:

(i) % yield on molar basis at every stage.

Reply awaited from the firm,

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----- Start of picture text ----- [Case No.:286/4/82-ALC4/2018 —~—*[Party Name:SURVIVAL[MeetNo/Date:7/82. ‘Status: SS TECHNOLOGIES |ALC4/2020 Approved PVT.LTD. 04.12.2020 HQ File ~ (REAFile OS™ Lic.No/Date:03_ 10819412 . theDecision::01/82/050/00286/AM19/| The Committee—_}:03/95/040/00993/AM18/considered caseas per agenda in26.02.2018the presence of thetechnical experts and on basis of technical details and GST Certificate provided by the firm, it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as applied by firm whichever is lower: Export Product Qty.

provided by the firm, it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as applied by firm whichever is lower: Export Product Qty. | SL | Import items Qty. 31 No. 3-CYANO PHENLY HYDRAZINE | 1 kg 3-NITROBENZONITRILE | 7.819 kg HYDROCHLORIDE 2 N-HEXANE Not allowed, since it is shown indigenous 3 ACETONITRILE Not allowed, since it is shown indigenous Note: Since, it is a new product, the Committee allowed the above norms on one time basis only for this advance authorization. No repeat norms will be allowed on the basis of the above decision. ----- End of picture text -----

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

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----- Start of picture text ----- [CaseALC4/2018No.r1014/15/82- _‘[PartyName:TADIMETY [[Meet][No/Date:7/82-.~~—~(Status:.] SS | AROMATICS PVT. LTD ALC4/2020 (Approved HQFile|:01/82/050/0247 ~S(RLAFile 1/AM19/ :07/24/040/00361/AM ~~ ~~~:18/ (Lic.04.12.202010.04.2018No/Date-0710113089 || a Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no, 5/82-ALC4/2020 dated 09.10.2020 against advance authorization No. 0710115940 dated D9 27.12.2019, it was decided to ratify norms under Para 4.07 of HBP Vol.

arlier decision taken in meeting no, 5/82-ALC4/2020 dated 09.10.2020 against advance authorization No. 0710115940 dated D9 27.12.2019, it was decided to ratify norms under Para 4.07 of HBP Vol. I as_per details given below or as applied by the firm, whichever is less: No. ISO NONYL ACETATE lkg 3,5,5, TRIMETHYL HEXANOL | 0.774 kg (NONANOL) ----- End of picture text -----

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

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[7IGase[Noz261/12/82.S”SCWParty] Name:AKTINOS [Meet No/Date:7/82-—[Status: {ALC4/2018 HEALTHCARE PRIVATE ALC4/2020 Deferred LIMITED 04.12.2020 | [AQFile “——“REAFile——~~™~C Lc.No/Date:0910066131 | :01/82/050/00888/AM19/ :09/24/040/00668/AM18/ 11.04.2018 Decision: The Committee consideredthe case as per online agenda in the presence of technical experts F? 53 and it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. 4/82-ALC4/2020 dated 18.09.2020, followed by Reminder on 16.10.2020:

(i) Whether export item is physical blending of two compounds as mentioned in export description. If no, please give the chemical name of the export item. | (ii) Molecular weight of export item and its chemical structure. (iii) Use of D-(-) Threo compound in the final step.

Reply awaited from the firm.

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olecular weight of export item and its chemical structure. (iii) Use of D-(-) Threo compound in the final step.

Reply awaited from the firm.

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----- Start of picture text ----- Case Noi26/15/82-ALC4/2018 [Party Name:GLAND[Meet No/Date:7/82- (Status: CHEMICALS PVT LTD ALC4/2020 Deferred ,lOFile SOSO~C~:~:~C~C:C RL File [=S*~~~S~SCSCS] 04.12.2020icNoDates0910066148 | a 24 |.01/82/050/01483/AM1 9/ :09/24/040/00008/AM19/ 17.04.2018 | (Decision: The Committee considered the case as per agenda in the presence of technical experts and it rs decided to call for following information from the firm: | (i)Gi) Stage-wiseComplete chemicalmaterial balance.reaction, molecular weight and % yield on molar basis. [CaseNo.:107/13/82- ParlyNameOPTRIX [MeetNo/Date:7/82- (Status: |ALC4/2018 [PRIVATELABORATORIES LIMITED ALC4/202004.12.2020 Approved fiQFile—””—SIRLAFile—~—~—~S~SS*~S~SC LicNoDaate:0910066210 | :01/82/050/01085/AM19/ |:09/24/040/00006/AM 19/ 09.05.2018 Decision: |The Committee considered case as per agenda inthe presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 ofHBP Vol. I as per details below or as 95 applied by firm whichever is lower: ----- End of picture text -----

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ms under para 4.07 ofHBP Vol. I as per details below or as 95 applied by firm whichever is lower: ----- End of picture text -----

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----- Start of picture text ----- No. FLIBANSERIN lkg | 1 1-(2-chioroethy])-1H- 0.62 kg benzo[d]imidazol-2(3H)-one 2 1-(3-(trifluoromethyl)phenyl) 0.84 kg piperazine hydrochloride ----- End of picture text -----

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----- Start of picture text ----- RA concerned may take further necessary action as per above decision ofNC. ----- End of picture text -----

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----- Start of picture text ----- | [Case No.:250/10/82- —PartyName:AETHER ‘(Meet No/Date:7/82- (Status: ALC4/2018 |INDUSTRIES LIMITED 04.12.2020ALC4/2020 Deferred | |HQFile ———<“<s~s~‘s~‘:‘CRLA QFle ~SSS~~S~~*=S«@i No Dates5210042038 | |:01/82/050/00537/AM19/Decision: The Committee considered:52/24/040/00016/AM19/ the case as per online agenda10.05.2018in the presence— of technical experts and it was noted that the firm still has not furnished the following information asked for by NC-3 in its 26 |Meeting No. 4/82-ALC4/2020 dated 18.09.2020, followed by Reminder on 16.10.2020: . (i) Molecular weight of each raw material and finished product. (ii) Use of import item No. 2 (Sodium Tert Butoxide) in reaction and import item No.

20, followed by Reminder on 16.10.2020: . (i) Molecular weight of each raw material and finished product. (ii) Use of import item No. 2 (Sodium Tert Butoxide) in reaction and import item No. 5 (Tetrahydrofuran). | (iii) “% yield of reaction with stoichiometric balance. | (iv) ReplyRecoveryawaited o f rs o lvents.m the firm. [- (Case No.:18/13/82- (Party Name:SMS_——S—=((MeetNo/Date:7/82- —~—S‘(Status:.SSCS ALC4/2018 LIFESCIENCES INDIA ALC4/2020 Approved _ HQ [File] {LIMITED (04.12.2020 oy :01/82/050/00996/AM19/REA:09/24/040/00067/AM19/File [Pie{18.05.2018 No‘Date:091 0066242 [ | |Decision: —The Committee considered case as per agenda in the presenceof the technical expertsand it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as applied by firm whichever is lower: , 1 | Export Product Qty. Sl. | Import items Qty. 27 | No. | EZETIMIBE (ETZ-IV) Lkg METHYLENE DICHLORIDE 6.00 kg METHANOL 4,40 kg N-HEPTANE 3,20 kg TOLUENE 7.80 kg . POTASSIUM HYDROXIDE FLAKES | 0.90 kg ISO PROPYL ALCOHOL 3.00 kg | |8 DIMETHYL FORMAMIDE 0.40 kg !9 | IMMCALA T2-150 (ENZYME) 0,066 kg | | (S)-4-PHENYL-OXAZOLIDIN-2-ONE | 0.45 kg | [RA concerned may take further necessary action as per above decision of NC. ----- End of picture text -----

| ;

, :

066 kg | | (S)-4-PHENYL-OXAZOLIDIN-2-ONE | 0.45 kg | [RA concerned may take further necessary action as per above decision of NC. ----- End of picture text -----

| ;

, :

"TGase No:168/12/82-~~~(Party Name:MANGALAM [Meet[ No/Date:7/82-.—[Status:] | |ALC4/2018 ORGANICS LIMITED ALC4/2020 Deferred FORMERLY DUJODWALA _ 04.12.2020 PRODU | IHQFiie- ~ ———~”:CSRKTA Fite ~—S—S~S~S~*~S~«~diLie NoDDates0310821107 [ 28 |:01/82/050/00795/AM19/ :03/95/040/01140/AM18/ 21.05.2018 || ‘twas[Decision:decided toThecallCommitteefor followingconsidered informationthe fromcase theas perfirm:agenda in the presence ‘of technical experts and it | (i) COA of import item No. 1 from supplier indicating % Alpha — Pinene content [| in import.

““IGase No.373/15/82-~—~‘(PartyName:TADIMETY[MeetNo/Date:7/82-—|Status: ALC4/2018 AROMATICS PVT. LTD ALC4/2020 Deferred 04.12.2020 21HQFile |~(RLAFile ~ ~~—~——~—«(Lic.No/Date0710113330 | |:01/82/050/01830/AM19/ :07/24/040/00046/AM19/ 25.05.2018 | (Decision: The Committee considered the case as per agenda in the presence of technical expertsand Iwas[noted][ that][the][firm][vide][e-mail][dated][16.11.2019][has][furnished][its][reply.][Deferred][for][ comments][ of][ TE.] it ~(Case No.:378/15/82-~~—~—~(Party Name:JODAS EXPOIM [Meet No/Date:7/82- Status: | | JALC4/2018 PVT.LTD ALC4/2020 Deferred 04.12.2020 30HOFile ~~ {RLAFile~=~—S~S~~~~~*~C”:CSLe No/Daate- 0510400733 | :01/82/050/01835/AM19/ :05/23/040/00080/AM19/ 05.06.2018 | Decision: |The Committee considered the case as per agenda and itwas observed that the firm was is

~~~~~~C”:CSLe No/Daate- 0510400733 | :01/82/050/01835/AM19/ :05/23/040/00080/AM19/ 05.06.2018 | Decision: |The Committee considered the case as per agenda and itwas observed that the firm was issued Show Cause Notice vide letter dated 10.10.2019. TEase No.:379/15/82-—~—~—~—*(Party Name.JODAS EXPOIM [Meet No/Date:7/82Status: ALC4/2018 PVT.LTD ALC4/2020 Deferred (04.12.2020 31 [HQ File IRA File [Lic.No/Date:0510406734 | :01/82/050/01836/AM19/ |:05/23/040/00070/AM 19/ 105.06.2018 Decision: The Committee considered the case as per agenda[and] it was observedthat the firm was issued Show Cause Notice vide letter dated 10.10.2019. .

{Case No.380/15/82-—~—~—~«SParty Name:JODASEXPOIM [Meet No/Date:7/82- —|Status: ALC4/2018 PVT.LTD \ALC4/2020 Deferred (04.12.2020 32/HQFile —~S—t “(REA File ~~~ {Lic.No/Date:0510406736 | :01/82/050/01837/AM19/ 1:05/23/040/00022/AM19/ 05.06.2018 Decision: The Committee considered the case as per agenda anditwas observed that the firm wasissued Show Cause Notice vide letter dated 10.10.2019.

oe me

==> picture [456 x 596] intentionally omitted <==

idered the case as per agenda anditwas observed that the firm wasissued Show Cause Notice vide letter dated 10.10.2019.

oe me

==> picture [456 x 596] intentionally omitted <==

----- Start of picture text ----- | [Case No.:60/15/82- -——~—~(Party [Name:ALPHAMED][[Meet][No/Date:7/82-] [(Status:] - | |ALC4/2018 FORMULATIONS PLTD. jALC4/2020 Approved 04.12.2020 HQFile ——<“—s~sé‘s*~‘SRLA QRile~SSS*~~~S*~*~ST:S LeNeDates0910060310 | :01/82/050/01517/AM19/ ———|:09/24/040/00075/AM19/ 08.06.2018 | |Decision: The Committee considered case as per agenda in the presence of the technical experts and it | was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol.! as per details below or as japplied by firm whichever is lower: Sl. | Export Product Qty. Import items Qty. 1 0. No. MAGNESIA DE PHILLIPS | 22000000.000 Magnesium Hydroxide | 3430,900 kg CHEWABLE — TABLETS, | Number HD 5 33.

irm whichever is lower: Sl. | Export Product Qty. Import items Qty. 1 0. No. MAGNESIA DE PHILLIPS | 22000000.000 Magnesium Hydroxide | 3430,900 kg CHEWABLE — TABLETS, | Number HD 5 33. 1.5 gram (MINT FLAVOUR) GalaenIQ 720 (Isomalt) | 6511.120 kg Povidone (Kollidon 30) | 2200.000 kg 4 Mannitol (Pearlitol 3747 480 kg | 200SD 594.000 ke | 264,000 kg 2 MAGNESIA DE PHILLIPS | 22000000.000 | 1 Magnesium Hydroxide | 3430.900 kg CHEWABLE TABLETS, ; Number HD 5 1.5 gram (STRAWBERRY GalaenIQ 720 (Isomalt) | 6071.120 kg FLAVOUR) Povidone (Kollidon 30) | 2200.000 kg 4 Mannitol (Pearlito} 3747480 kg | 200SD) 594.000 kg |. | Strawberry Flavour $72.000 kg IRA concerned may take further necessary action as per above decision of NC. | |\CaseALC4/2018 [No.:383/15/82-] ——~—~(Party Name:JODAS EXPOIM [MeetNo/Date:7/82- ‘Status. 34|HQFile =——s—<—s~é‘;‘CRWLAQRile’”=~=~=~=~™~~~~~~, PVT.LTD (04.12.2020@(Lic.No/Datecos10400800ALC4/2020 Deferred( :01/82/050/01840/AM19/ :05/23/040/00121/AM19/ {08.06.2018 Decision: The Committee considth e caseredas per [agenda] and itwas observed that the firm was Show issued Cause Notice vide letter dated 10.10.2019. [Case No.:385/15/82-——~—*([Party Name:JODAS EXPOIM [Meet No/Date:7/82.

th e caseredas per [agenda] and itwas observed that the firm was Show issued Cause Notice vide letter dated 10.10.2019. [Case No.:385/15/82-——~—([Party Name:JODAS EXPOIM [Meet No/Date:7/82. (Status: ALC4/2018 PVT.LTD ALC4/2020 Deferred | 04.12.2020 3S|HQFile ==—S—=<“<ss*‘;RLA‘QRidle”~SS~S=<é‘~~~«WL eNotes LOGOS | :01/82/050/01842/AM19/ :05/23/040/00501/AM18/ 08.06.2018 Decision: The Committee considered the‘case as per agendaand it wasobserved that thefirm wasissued Show Cause Notice vide letter dated 10.10.2019. ----- End of picture text -----

“ot

([Gise Now12/15/82. ~~ [PartyName:AURORELIFE (MeetNo/Date:7/82- (Status: | jALC4/2018 SCIENCES PRIVATE ALC4/2020 Approved [LIMITED 04.12.2020 HOFie ~~~” IRLA File ——~—~~SCSCSC& Lic.No/Date:0910066403 | :01/82/050/01469/AM19/ :09/24/040/00113/AM19/ 28.06.2018 (Decision: — The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as 36 |applied by firm whichever is lower: No. MARBOFLOXACIN | 1kg 6,8-Difluoro-1-(formy! methyl amino)-7-(4- | 2.083 kg , methyl _piperazine~1-yl)-1,4-dihydroquinoline3-carboxylic acid ethyl ester

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

-1-(formy! methyl amino)-7-(4- | 2.083 kg , methyl _piperazine~1-yl)-1,4-dihydroquinoline3-carboxylic acid ethyl ester

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

"(Case Nowi2i/12/82. (Party Name:IOL CHEMICALS [Meet No/Date:7/82-(Status: ALC4/2018 AND PHARMACEUTICALS — |ALC4/2020 Approved LIMITED 04.12.2020 HOFile {RLAFie Lic No/Date:301 0104375,i oo :01/82/050/00848/AM19/ 1:30/24/040/00017/AM19/ [29.06.2018 | | Decision: The Committee considered case as per agenda in the presence of the technical experts and it 37 |was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as applied by firm whichever is lower:

==> picture [397 x 25] intentionally omitted <==

----- Start of picture text ----- No. METAISOBUTYLETOLUENE [Ike |1 [ |METAXYLENE] | 0.8745kg ----- End of picture text -----

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

—“IGase NoadI7/15/82.SS (PartyName:JODASEXPOIM [Meet No/Date:7/82-(Status: ALC4/2018 PVT.LTD ALC4/2020 Deferred . 04.12.2020 38(HQFile:01/82/050/01874/AM19/t—~S ~ ( :05/23/040/00167/AM19/RLAIIe Tee Lic.No/Date:051040706904.07.2018 | Decision; The Committee considered the case as per agenda and it was observed that the firm was issued Show Cause Notice vide letter dated 10.10.2019.

Lic.No/Date:051040706904.07.2018 | Decision; The Committee considered the case as per agenda and it was observed that the firm was issued Show Cause Notice vide letter dated 10.10.2019.

| [CaseNo.:418/15/82--—~—*([Party Name:JODAS EXPOIM [MeetNo/Date-7/82-(Status: \ALC4/2018 PVT.LTD ALC4/2020 Deferred 04.12.2020 . (39 HOFile TRLA File oS Lic.No/Date:05 10407077 _ :01/82/050/01875/AM19/ |:05/23/040/00163/AM19/ 04.07.2018 Decision: The Committee considered the case as per agenda and it was observed that the firm was issued Show Cause Notice vide letter dated 10. 10.2019,

[Case No.:419/15/82-——~——~([Party Name:JODAS EXPOIM _ (MeetNo/Date:7/82- (Status: ALC4/2018 PVT.LTD ALC4/2020 Deferred — loa. 12.2020 40(HQFile =—S—<—~*=‘;CS;SRLA@Q (Lic NomDates05 10407078 | SOS :01/82/050/0 1876/AM19/ :05/23/040/00164/AM19/ 04.07.2018 Decision: The Committee considered the case as per agenda and itwas observed that the firm was issued Show Cause Notice vide letter dated 10.10.2019.

| [CaseNo.:389/15/82- ——~—*[Party Name:ATUL LIMITED, [Meet No/Date:7/82. —‘(Status: |'ALC4/2018 | ALC4/2020 Deferred [HQ[File] ae |[RLA File : - Lic.No/Date:081014295504.12.2020 _ oe | +l Decision:was[:01/82/050/01846/AM19/ decided toThe callCommittee for following informationconsidered1:08/24/040/00030/AM19/the fromcase theas firm:peragenda—-in the{04.07.2018 presence of technical experts and. it (i) “ composition of different amines in Export Product. (ii) Manufacturing process for each amine alongwith chemistry, molecular weight, stoichiometric Balance and yield.

technical experts and. it (i) “ composition of different amines in Export Product. (ii) Manufacturing process for each amine alongwith chemistry, molecular weight, stoichiometric Balance and yield.

~ |CaseNo.:617/15/82-—~—~(Party Name:JODAS EXPOIM[Meet[No/Date:7/82.] ‘Status: ALC4/2018 PVT.LTD ALC4/2020 Deferred | _ \04.12.2020 42 [HQ File RLA File [Lic.No/Date:0510407070 [ :01/82/050/02074/AM19/ :05/23/040/00166/AM19/ 04.07.2018 Decision: The Committee considered the case as per agenda and it was observed that the firm was issued Show Cause Notice vide letter dated 10.10.2019.

;

eS No 0G/IIMLALCA/2018 [Party[NameSTERLING][[Meet][No/Date:7/82-][ Status:] AUXILIARIES PVT LTD ALC4/2020 Deferred 04.12.2020 43 HQFile|:01/82/050/00723/AM19/ “CREAFe:03/95/040/00332/AM19/ [Lie(11.07.2018 NoPDate:03 10822247 | Decision: |The Committee considered the case as per agenda in the presence of technical experts and it was observed that for Export Product No. 1, it is stated that it is blend, however in the manufacturing {process provided , it is shown as water of reaction, which is not possible. If it is chemical reaction, then the firm may provide Molecular weight of import and export.

Ciso No46/15/820ALC4/2018 [PartyPHARMAName:AUROBINDO LIMITED [Meet No/Date:7/82-ALC4/2020 Status:Deferred . . (04.12.2020 | 440iOFile~=—SOC~=C~“s~S~~~s*~“C~s~SRWLAC‘QRd [Lic No/Date:0910066442[[] | |Decision:|:01/82/050/01503/AM19/ Deferredforcomments:09/24/040/00181/AM19/of TE. ee \1 1.07.2018

red . . (04.12.2020 | 440iOFile~=—SOC~=C~“s~S~~~s*~“C~s~SRWLAC‘QRd [Lic No/Date:0910066442[[] | |Decision:|:01/82/050/01503/AM19/ Deferredforcomments:09/24/040/00181/AM19/of TE. ee \1 1.07.2018

{Gaze Noui89/i3/82.—~SCS”SCWiarty Name: YASH RASAYAN[MeetNo/Date:7/82- Status: ALC4/2018 & CHEMICALS ALC4/2020 Deferred [HQ Hie . TTR A File SS™S~~™CSC[ Lic04.12.2020No/Daate:3.410044333 | . - j:01/82/050/01 167/AM19/ :34/24/040/001 14/AM19/ 16.07.2018 45 (Decision:The Committee considered the case as peragendain the presence of technical experts and it tH e nce,s observedit was decidedthat thetoreplycall forfurnished following by the informationfirm is samefrom theas alfi r eadym: been given in the 4.07 application. | (i) Completestoichiometric4E reactionwith allandtechnical% of yielddetailsat everychemistry,stage. molecular weight,

Te No asa/isi8.SS arly Name:JODAS EXPOIM [MeetNo/Date:7/82- (Status:ALC4/2018 PVT.LTD ALC4/2020 Deferred i 04,12.2020 4oligFile ~—~—SO*~CS*«~‘“«~MRWLANC‘QW ‘fieNo/Date:0510407217 | :01/82/050/01889/AM19/ :05/23/040/00183/AM19/ 17.07.2018 ; Decision: ‘The Committee considered the ease as per agenda and it was observed that the firm was issued Show Cause Notice vide letter dated 10.10.2019.

;

05/23/040/00183/AM19/ 17.07.2018 ; Decision: ‘The Committee considered the ease as per agenda and it was observed that the firm was issued Show Cause Notice vide letter dated 10.10.2019.

;

|CaseNo.:448/15/82- ‘PartyName:AUROBINDO [MeetNo/Date:7/82-—‘{Status: JALC4/2018 PHARMA LIMITED ALC4/2020 Deferred | 04.12.2020 HQ File REA File ~~ (Lic.No/Date:0910066511 [ :01/82/050/01905/AM19/ :09/24/040/00200/AM19/ 24.07.2018 47 (Decision: TheCommittee considered the case as per agenda in the presence of technical experts and it es decided to call for following information from the firm: (13) Standard composition of Export Item. (ii) Copy of relevant DML. (iii) COA of Export Item.

~~ |CaseALC4/2018No.:239/13/82| PPartyName:KEVAFRAGRANCES PRIVATE MeetALC4/2020No/Date:7/82- (Status:Deferred . ~—S«RLAFile.———S—~S~™ {Leite No/Date0310822723 lH|:01/82/050/01217/AM19/[File] . [LIMITED:03/94/040/00390/AM19/ 0431 . 1207 .20 2018 48 Decision:iwas decided~[The] to call[ Committee] for following[considered] information[ the] from[case][as] the[per] firm:[|][agenda][in][ the][presence][of][ technical][experts][and][it] | |(i) Complete chemistry with molecular weight and % yield. : (ii) Stoichiometric Balance. . (iii) Commercial value of By-Product 2 — Nonanone. (iv) COA of import item from foreign supplier indicating % purity. ; ; * (y) CA hascertified production from April 2017 to Jane 2018, however Chartered 4 Engineer has certified no production. Please clarify it. CaseALC4/2018No.:172/13/82-[Party Name:TIDE [Meet No/Date:7/82-—‘([Status: | INDUSTRIES| ALC4/04.12.

il 2017 to Jane 2018, however Chartered 4 Engineer has certified no production. Please clarify it. CaseALC4/2018No.:172/13/82-[Party Name:TIDE [Meet No/Date:7/82-—‘([Status: | INDUSTRIES| ALC4/04.12. 20 2020 Deferred HQFile ~—~—~—S«(RLAFFile~—SS—~<CS~sSs~SsSS Lc NoDeates 3410044309 | 49 :01/82/050/01150/AM19/ :34/24/040/00094/AM 19/ \08.08.201 8 Decision: | The Committee considered the case as peragenda in the presence of technical experts and it : was decided to call for following information from the firm: : (id) Complete chemistry, material balance, molecular weight, % yield for Citronellol to Rose Oxide.

ICase No.:134/13/82- —~—«(PartyName:YASHO.———S(MeetNo/Date:7/82- —=«‘|Status: | {|ALC4/2018 INDUSTRIES LIMITED ALC4/2020 Deferred to . 04.12.2020 JHQ File RLAFile ~~ {Lic.No/Date:0310822942 [| } — {:01/82/050/01112/AM19/ :03/95/040/00445/AM19/ 09.08.2018 50 Decision: The Committee considered the case as per agenda in the presence of technical experts ¢[and][after] going through the reply of firm dated 16.10.2020, it was observed that the firm still has not furnished the requisite reply. Hence, it was decided to again call for following information from the firm:

(i) Chemica! reaction, structural formula and stoichiometric balance.

irm still has not furnished the requisite reply. Hence, it was decided to again call for following information from the firm:

(i) Chemica! reaction, structural formula and stoichiometric balance.

~[CaseALC4/2018No.:326/13/82PartyAMINESName:BALAIILIMITED “(Meet No/Date:7/82-—~S«Status:ALC4/2020 ApprovedSS | 04.12.2020 HQ File RLA File Lic.No/Date:3110067147 | :01/82/050/01304/AM19/ :31/83/040/00082/AM19/ 20.08.2018 | _ Decision: The Committee considered case as per agenda in the presence of the technical experts and it 5] lwas decided to ratify the ad-hoc input output norms under para 4.07 ofHBP Vol. I as per details below or as applied by firm whichever is lower: No. 2- PYRROLIDONE lkg AMMONIA ANHYDROUS 0,222 kg | GAMMA BUTYROLACTONE | - 1.124 kg RA concerned may take further necessary action as per above decision of NC. ~ [CaseALC4/2018No.:470/15/82- «PartyName:JODASPVT.LTD EXPOIM [MeetALC4/2020No/Date:7/82- (Status:Deferred 04.12.2020 S2\HQFile (RLAFile Lic.No/Date:0510407550 7 |” :01/82/050/01927/AM19/ :05/23/040/00232/AM19/ 20.08.2018 , Decision:Show Cause TheNoticeCommitteevide letterconsidereddated 10.10.2019.the case as per[agenda] and it wasobservedthat the firmwas issued.

82/050/01927/AM19/ :05/23/040/00232/AM19/ 20.08.2018 , Decision:Show Cause TheNoticeCommitteevide letterconsidereddated 10.10.2019.the case as per[agenda] and it wasobservedthat the firmwas issued.

“|Case No.:471/15/82-—~~«[Party[Name:JODAS][ EXPOIM] [Meet[No/Date:7/82-][ (Status:] ALC4/2018 PVT.LTD ALC4/2020 Deferred 04.12.2020 S3IHQFile | (RLAFile ~~~ {Lic.No/Date:0510407551 |CS :01/82/050/01928/AM19/ :05/23/040/0023 1/AM19/ 20.08.2018 Decision: |The Committee considered the case as per agenda and it was observed that the firmwasissued Show Cause Notice vide letter dated 10.10.2019.

||||||[CaseNo.:368/13/82-<br>-—~—*([PartyName:DANOPHARM[MeetNo/Date:7/82-(Status:<br>ALC4/2018<br>CHEMICALS PRIVATE LTD.<br>|ALC4/2020<br>Deferred|
|---|---|---|---|---|
|.||||i<br>04.12.2020|
||||S4/HQFile=<br>~~~ ~*(IRLAFile~~~~~—~—~—~—~—~—-*«(Lic.<br>No/Date:0310823354<br>.||
||||||||:01/82/050/01346/AM19/<br>:03/94/040/00340/AM19/<br>28.08.2018<br>Decision:<br>The Committee considered<br>the case as per agenda in thepresence oftechnical experts and it<br>[was noted that the firm vide e-mail dated 28.11.2019 has furnished its reply. Deferred forcomments ofTE.|
||||~[CaseNo.:369/13/82-<br>—~—~*(PartyName:DANOPHARM[MeetNo/Date:7/82-(Status:<br>ALC4/2018<br>CHEMICALS PRIVATE LTD.<br>|ALC4/2020<br>Deferred||
||||SSIHQFile|104,12,2020<br>=====~ ~~ RLAFile.~~~~~_{Lie.No/Date:0310823358|S<br>:01/82/050/01347/AM19/<br>:03/94/040/00413/AM19/<br>[28.08.2018|

CALS PRIVATE LTD. |ALC4/2020 Deferred|| ||||SSIHQFile|104,12,2020 =====~ ~~ RLAFile.~~~~~_{Lie.No/Date:0310823358|S :01/82/050/01347/AM19/ :03/94/040/00413/AM19/ [28.08.2018|




Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm vide e-mail dated 28.11.2019 has furnished its reply. Deferred for comments of TE. 

```text
||||~~”[CaseNo.:84/13/82-ALC4/2018[PartyNameSRINI.—~—*‘[Meet No/Daie:7/82.—~S*«~dStats<br>PHARMACEUTICALS<br>|ALC4/2020<br>Deferred|
|---|---|---|---|
|||PRIVATELIMITED<br>(04.12.2020<br>°6<br>[HQFile| —RLAFile—SSS™~™S~*S(LLicNo/Datte20910066620<br>7<br>|<br>1:0.1/82/050/01062/AM19/<br>|:09/24/040/00251/AM19/<br>03.09.2018<br>a<br>|<br>|Decision: Deferred forcommentsofTE. ~~<br>SS OO||
||||—[Case Now502/15/82-<br>—~—«*{PartyName:SUVENLIFE<br>[M**e**tNo/Date:7/82-—~*‘(Status:<br>ALC4/2018<br>SCIENCESLIMITED<br>ALC4/2**02**0<br>Deferred<br>|<br>04.12.2<br>0<br>THQFieSSS SRE<br>File”<br>STiNoDatesooi006sea1|
|||||:01/82/050/01959/AM19/<br>:09/24/040/00260/AM19/<br>03.09.2018<br>[Decision: “DeferredforcommentsofTE.<br>**=** =<br>~ ~~SSCSCS<T;«<C;<7;<S:<br>;S;TT|
|||[CaseNo.:435/13/82-—~—~—«*(Party<br>Name:DCM SHRIRAM<br>[MeetNo/Date:7/82.(Status:||
||||ALC4/2018<br>INDUSTRIES LTD,<br>ALC4/2020<br>Deferred|
||||04.12.2020|
|||||,<br>°8 HQ File<br>|<br>~~ (RLAFie<br>Lic.No/Date:0510407689<br>|S<br>:01/82/050/01413/AM19/<br>|:05/23/040/00242/AM19/<br>05.09.2018<br>1<br>(Decision:<br>DeferredforcommentsofTE.<br>eee|

HQ File | ~~ (RLAFie Lic.No/Date:0510407689 |S :01/82/050/01413/AM19/ |:05/23/040/00242/AM19/ 05.09.2018 1 (Decision: DeferredforcommentsofTE. eee|






| 

20 

“\Gase No:44/15/82-——~—*‘{(Party Name:DISCOVERY [Meet No/Date:7/82Status:| | JALC4/2018 LABORATORIES ALC4/2020 Approved , PRIVATE LIMITED 04.12.2020 | lHQRie CREA File —S*~*~*~*~C:CSLic NovDaates0910006631 [ {:0 1/82/050/01501/AM19/ :09/24/040/00283/AM19/ 06.09.2018 | |Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in. \s9 meeting no. 4/82-ALC4/2020 dated 18.09.2020 against advance authorization No. 0910065252 dated |07.07.2017, it was decided to ratify norms under Para 4.07 of HBP Vol. 1 as per details given below or as applied by the firm, whichever is less: No. DIPHENYLAMINOHEXANE(AH ID) L-phenylalanine 0.4465 kg RA concerned may take further necessary action as per above decision of NC. | 

“Case Noi7/7/82-———~—=«Party Name:GLOBAL MeetNo/Date:7/82. ~—~=«*(Status:—SC ALcanol9|[HQ File ~~ IRLA{LIMITEDCALCIUM File PRIVATE: “{Lie.No/Date:0710113843ALC4/204.12.2 **020** Approved| - :01/82/050/00512/AM20/ :07/24/040/00144/AM19/ [12.09.2018 Decision: The Committee considered the cases as per agenda and in thelight of earlier decision taken in meeting no. 8/82-ALC4/2014 dated 25.09.2014 against advance authorization No. 0710103209 dated 26.03.2014, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as \60 lapplied by the firm, whichever is less: | No.

advance authorization No. 0710103209 dated 26.03.2014, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as \60 lapplied by the firm, whichever is less: | No. ; CALCIUM OROTATE OROTIC ACID 1.059 kg | POTASSIUMMAGNESIUM OROTATE OROTATE OROTICOROTIC ACID ACID 1.020kg1.104 kg ZINC OROTATE OROTIC ACID 0.980 kg FERROUS OROTATE OROTIC ACID 0.976 kg IRA concerned may take further necessary action as per above decision ofNC. 

. 

Case Nou400/13/82.~~-*(Party NamesJ.B.CHEMICALS [MeetNo/Date:7/82- (Status: ALC4/2018 & PHARMACEUTICALS ALC4/2020 Deferred | LIMITED . 04.12.2020 | SliggFile ~~ ~—S«(RLAFile Lic.No/Date:0310823779 | [Decision::01/82/050/01378/AM19/Deferred forcomments{:03/94/040/00504/AM19/of[TE.] 17.09.2018 |- ) 



21 

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> [‘(Status] - {CaseNo.:519/15/82—~—«(Party Name:SUVEN LIFE (Meet[No/Date:7/82-] |ALC4/2018 SCIENCES LIMITED , ALC4/2020 Deferred © j 04.12.2020 fiQfile :01/82/050/01976/AM19/= ~~~ ~~*(RLA File~~~SCSCSCSCSTSie NoDaves0910086670°[ (Decision: Deferred for comments_|:09/24/040/00288/AM19/of TE. a {18.09.2018_ 

‘CaseNo.:525/18/82- —~—=*(PartyName:SHILPA ———‘[MeetNo/Date:7/82-. (Status. | {ALC4/2018 - MEDICARE LIMITED ALC4/2020 Deferred 63 | 04.12.2020 HQ File oo “|RLAFile SO Lic.No/Date:0710113890 :01/82/050/01982/AM19/ :07/24/040/00164/AM19/ 25.09.2018 _ |Decision: Deferredfor comments of[TE.] -

DICARE LIMITED ALC4/2020 Deferred 63 | 04.12.2020 HQ File oo “|RLAFile SO Lic.No/Date:0710113890 :01/82/050/01982/AM19/ :07/24/040/00164/AM19/ 25.09.2018 _ |Decision: Deferredfor comments of[TE.] - 

"(Case No.:176/13/82-——=—=—=«*(Party Name:[VOVANTIS][[Meet][No/Date:7/82.][ (Status.] ALC4/2018 LABORATORIES PRIVATE jALC4/2020 Deferred LIMITED 04.12.2020 64 HQ Fie [RLA File Lie.No/Date:3410044518 :01/82/050/01154/AM19/ [Decision: ~The Committee— considered2:34/24/040/00145/AM19/the caseas per agendain(26.09.2018the[presence] of technical expertsand it | {was noted that the firm vide e-mail dated 03.04.2020 has furnished its reply. Deferred for comments of TE. 

> |(Case No.:534/15/82-—~—~—‘(Party Name: YASHRASAYAN ALC4/2018 & CHEMICALS (MeetALC4/2020No/Date:7/82. Status:Deferred | HQFile 04.12.2020 | 65 |:01/82/050/0199 1/AM19/ "(RLA1:34/24/040/00184/AM19/ Fileoo 26.09.2018Lic.No/Date:3410044523. [| (Decision: " The Committee considered the case as per agenda. in the presence oftechnical experts and it “ decided to call for following information from the firm: (i) Complete technical details as per Appendix 4E including complete chemistry, molecular weight, % yield, Stoichiometric Balance, Structural formula.

to call for following information from the firm: (i) Complete technical details as per Appendix 4E including complete chemistry, molecular weight, % yield, Stoichiometric Balance, Structural formula. ~ {CaseALC4/2018 No.:536/15/82[Party Name:YASH RASAYAN [MeetNo/Date:7/82- (Status: i& CHEMICALS ALC4/2020 Deferred 04.12.2020 HQFile RLA File ~~ [Li¢.No/Date:3410044524[SS :01/82/050/01993/AM19/ 1:34/24/040/00185/AM19/ — 66 (26.09.2018 | Decision:was |The Committee considered the case as per agenda in‘the presenceof technical experts ;and it decided to call for following information from the firm: ; (i) Molecular weight of import and export. (ii) % yield of reaction. | (iii) % recovery of Dimethyl Formamide (DMF) with justification of requirement. 



22 

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“(CaseNo.1112/13/82-———~—=«PartyName:VARAHI MeetNo/Date:7/82- (Status: ‘|ALC4/2018 PHARMA PRIVATE LIMITED |ALC4/2020 Deferred Lon: 04.12.2020 197 [HQ File ~RLA File "Lig No/Date:6610000013 | :01/82/050/01090/AM19/ |:66/24/040/00004/AM19/ 03.10.2018 [Decision: Deferred for comments of TEE ee Ghee Nou612/15/8 SSC PartyName:MANGALAM[MeetNo/Date:7/82- (Status: ALC4/2018 ORGANICS LIMITED ALC4/2020 Deferred (FORMERLY DUJODWALA [04.12.2020 “Iie No/Date:0310824148 [| 68 :01/82/050/02069/AM19/HOFiie ~~ ~*'(RLAFile:03/95/040/00560/AM19/ 03.10.2018 | [Decision: The Committee considered the case as per agenda in the presence of technical experts and it | -lwas observed that the reply furnished by the firm is incomplete. Hence, it was decided to call for following information from the firm:

as per agenda in the presence of technical experts and it | -lwas observed that the reply furnished by the firm is incomplete. Hence, it was decided to call for following information from the firm: 

(i) Complete chemistry, molecular weight, yield of reaction, stoichiometric balance. 

lage NowS67/15/8 ~~” (PartyName:VERVEHUMAN [Meet No/Date:7/82- (Status:~~ ALC4/2018 CARE LABORATORIES ALC4/2020 Deferred slioFie : ~'(RLAFIea [ie(04.12.2020 No(Date:6110001546 ; | :01/82/050/02024/AM19/ :61/24/040/00009/AM19/ (04.10.2018 | . . Decision: ‘The Committee considered the case as peragenda in the presenceof technical experts and it was noted that the firm vide e-mail dated 09.08.2019 has furnished its reply. Deferred for comments of TE. 

“1GaceNouS60/15/82. SS (Party NamesJODAS EXPOIM [MeetNo/Date:7/82-[Status: ALC4/2018 PVT.LTD ALC4/2020 Deferred 04.12.2020 | wliQFiie (RLAFIe LicNo/Date:0510408024 | :01/82/050/02026/AM19/ }:05/23/040/00297/AM19/ 08.10.2018 Decision: The Committee consideredthe caseas peragenda and it was observed that the firm was issued Show Cause Notice vide letter dated 10.10.2019. 

- Case NowS70A5/82. Party Name:JODAS EXPOIM [Meet[No/Date:7/82-][ (Status:] ALC4/2018 PVT.LTD ALC4/2020 Deferred (04.12.2020 

- {HoFie ~~ (RLAFie Lic.No/Date:0510408025 - :01/82/050/02027/AM19/ :05/23/040/00295/AM19/ 08.10.2018 DecisiThe C **o** mmitteen: consideredthe case as per agendaand itwasobserved that the firm was issued Show Cause Notice vide letter dated 10.10.2019. 

. . : ; : 



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deredthe case as per agendaand itwasobserved that the firm was issued Show Cause Notice vide letter dated 10.10.2019. 

. . : ; : 



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~[CaseALC4/2018 No.:224/13/82- ——~—~—«(Party Name:ASTRALSTERITECH PVT. LTD. ~~‘[MeetALC4/2020 No/Date:7/82-‘Status:Deferred<br>04.12.2020<br>| Pg|:01/82/050/01202/AM19/ File wotzovamie uate(:34/24/040/00225/AM19/~ “ig.No/Date:341004457310.10.2018 —<br>Decision; Deferred for comments ofTE. )<br>~~[CaseNo.:582/15/82- —~—«(Party.~=—~S*=C*<“i*~S*‘“S*«~Meet Neate 7/80-Stats<br>| jALC4/2018 Name:MACSONPRODUCTS jALC4/2020 Deferred<br>04.12.2020<br>®iQFileIRA File {Lic.No/Date:5210042796 .<br>:01/82/050/02039/AM19/ :52/24/040/00039/AM19/ ‘11.10.2018<br>| [Decision: - Deferred for comments of TE. : )<br>CaseNo.:590/15/82-.——{Party Name: VERVEHUMAN |MectNo/Date:7/82. ‘Status:<br>ALC4/2018 CARE LABORATORIES ALC4/2020 Deferred<br>04.12.2020<br>m4 HQFile  =———s—~<CS*é«*RCLA ide ~~ [Lic.No/Date:61 10001553 a<br>|:01/82/050/02047/AM19/ :61/24/040/00011/AM19/ 11.10.2018<br>[Decision: Deferredforcommentsof TE.

LC4/2020 Deferred<br>04.12.2020<br>m4 HQFile  =———s—~<CS*é«*RCLA ide ~~ [Lic.No/Date:61 10001553 a<br>|:01/82/050/02047/AM19/ :61/24/040/00011/AM19/ 11.10.2018<br>[Decision: Deferredforcommentsof TE. == ==~~~~~<br>~~<br>| "\CaseNo.:801/15/82- (PartyName:DEEPAK[Meet<br>| No/Date:7/82-—~—*‘(Statuss.SS<br>04.12.2020<br>| ALC4/2018 \PHENOLICS LIMITED ALC4/2020 Approved<br>| |HQFile IRL File SSS*~*~*~SCS:SLicN/Dates3.4 1004580<br>(:01/82/050/02258/AM19/ — |:34/24/040/00230/AM19/ 11.10.2018<br>IDecision: The Committee considered case as per agenda in the presence of the technical experts and<br>75 lafter taking cue from SION A — 1461, it was decided to ratify norms under Para 4.07 of HBP Vol. I as<br>re details given below or as applied by the firm, whichever is less:<br>Sl. | Export product Qty. SL | Import items Qty.<br>No. No,<br>2464.790 kg 1 Cumene 3500.090kg | |<br>1478.870 kg<br>RA concerned may take further necessary action as per above decision of NC,<br>-<br>**----- End of picture text -----**<br>


~~ [Case No.:169/13/82-—~—~—~*(Party Name:SPCLIFE [Meet No/Date-7/@. ‘Status: ALC4/2018 SCIENCES PVT, LTD. ALC4/2020 Deferred iQ [04.12.2020 Pile IRA File ~— [Lie.No/Date:3410044586 | a :01/82/050/01147/AM19/ :34/24/040/00211/AM19/ (12.10.2018 |Decision: Deferred forcommentsofTE. ~~~ 



24 

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LTD. ALC4/2020 Deferred iQ [04.12.2020 Pile IRA File ~— [Lie.No/Date:3410044586 | a :01/82/050/01147/AM19/ :34/24/040/00211/AM19/ (12.10.2018 |Decision: Deferred forcommentsofTE. ~~~ 



24 

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[|Gase Nous92/15/82. jALC4/2018 SS PartyPRIVATEName:SRIAMLABS LIMITED [Meet No/Date:7/82-ALC4/2020 Status:Deferred ie 04.12.2020 | iofie =~ SCOC*~<C~=‘“‘=~“~s*~‘“‘<sRSWLAC@QR Lic.No/Date:0910066753 | :01/82/050/02049/AM19/ :09/24/040/00338/AM19/ 16.10.2018 [Decision: Deferred for commentsof TE. rs [Gage Nowl60/15/82.—~~S*~*WiRarty Name:WOCKHARDT [Meet No/Date:7/82- (Status: ALC4/2018 LIMITED |ALC4/2020 [Deferred 78 THQ| File - - |RLAFile JLicNo/Date:031082465104.12.2020 [| |:01/82/050/01626/AM19/ :03/95/040/00755/AM19/ 24.10.2018 (Decision: Deferred for comments of TE. Fe 

CaseNosdvaii38SSCS [PartyName‘DEEPAK‘(Meet No/Date:7/82- (Status: | |ALC4/2018 JNITRITE LIMITED ALC4/202004.12.2020 Deferred 7[iQFie| ~~ ~(RLAFie Lic.No/bate3410044635| :01/82/050/01402/AM19/ :34/24/040/00144/AM19/ 25.10.2018 | IDecision? The Comunitiee considered the case as per agendain the presence of technical experts and it was noted that the firm vide e-mail dated 13.08.2020 has furnished its reply. Deferred for comments of TE.

he Comunitiee considered the case as per agendain the presence of technical experts and it was noted that the firm vide e-mail dated 13.08.2020 has furnished its reply. Deferred for comments of TE. 

aso Nowg3/82. SCS PartyNamesDEEPAK (Meet No/Date:7/82-. (Status: ALC4/2018 NITRITE LIMITED JALC4/2020 Deferred 04.12.2020 soliohile + \(RLAFie Lic.No/Date:3410044636 [ :01/82/050/01404/AM19/ :34/24/040/00208/AM19/ 125.10.2018 Decision: — The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm vide e-mail dated 13.08.2020 has furnished its reply. Deferred for comments of TE. 

“Tease Now597/15/82.—~—S*CiParty Name:AUROBINDO [MeetNo/Date:7/82(Status: ALC4/2018 PHARMA LIMITED ALC4/2020 Deferred 04.12.2020 , 8liiorie~~ ~~——~CSRLA le Lic.No/Date:0910066762 | :01/82/050/02054/AM19/ |:09/24/040/00345/AM19/ 25.10.2018 ; (Decision: Deferred forcomments ofTE. ee 

. 



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c.No/Date:0910066762 | :01/82/050/02054/AM19/ |:09/24/040/00345/AM19/ 25.10.2018 ; (Decision: Deferred forcomments ofTE. ee 

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```text
|||||||||
|---|---|---|---|---|---|---|---|
|[~|GaseNo.:602/15/82-SSS|[PartyName:;GLAND|[MeetNo/Date:7/82- ‘(Status|
|:|ALC4/2018|PHARMA LIMITED|ALC4/2020|Deferred|
|82|||||04.12.2020|
|HQFile ~~*SIRLAFile.|~~|~~~|(Lie|Novbateoo 10066776 ||
|}:01/82/050/02059/AM19/|09/24/040/00229/AM19/|26.10.2018|:|
|Decision:|Deferred for comments of TE,|ees|~~|||
|||[CaseNo.:605/15/82-~~~*(PartyName:SUVENLIFE{Meet|No/bate-7/82.|Status:|
|ALC4/2018|SCIENCES|LIMITED|ALC4/2020|Deferred|
|oe|
|S3ifoFile.|~~|IRLA File|Lic.No/Date:091006678104.12.2020||_|
|:01/82/050/02062/AM19/|:09/24/040/00354/AM19/|[26.10.2018|||
|Decision:|-|Deferred|for comments of|TE.|—_|
|-|
||CaseALC4/2018No.:608/15/82-|~—~—~*(Party|Name:|[MACSON]|[MeetNo/Date-7/82.Status|
|PRODUCTS|ALC4/2020|Deferred|
|84 HQ File||RTA File|~"ie.No/Date:5210042821||04.12.2020|||||—_|
|||':01/82/050/02065/AM19/||:52/24/040/00058/AM19/|26.10.2018|
|[Decision:|DeferredforcommentsofTE.|SS|ee|
|~|[CaseNo.:183/13/82-—~—~—~S|iPartyName:PHAROSE|Meet No/Date:7/82-|(Status:|
||||ALC4/2018|REMEDIES|LTD.|JALC4/2020|Deferred|
|04.12.2020|
|8S|HOFile|~|(RLAFile|~~|———~—S~S™~C:*S|Lic,No/Date:3010104a85||.|
|:01/82/050/01161/AM19/||:30/24/040/00032/AM19/|31.10.2018|
|(Decision:|Deferredforcomments|[TE.]|of|[ ~=~~SOSCtC~CS]|.|
|~[Case Nos11/15/82-|OSS[Party Name:PUNJAB|[Meet No/Date:7/82-|Status:|

85||.|
|:01/82/050/01161/AM19/||:30/24/040/00032/AM19/|31.10.2018|
|(Decision:|Deferredforcomments|[TE.]|of|[ ~=~~SOSCtC~CS]|.|
|~[Case Nos11/15/82-|OSS[Party Name:PUNJAB|[Meet No/Date:7/82-|Status:|
|ALcano18|CHEMICALS AND CROP||ALC4/2020|Deferred|
|86|||PROTECTION LTD|[04.12.2020|.|
|TO:01/82/050/01568/AM19/File|[RLA|:03/95/040/00709/AM19/ File|:|Lic.12.11.2018 No/Date:0310824946||—|
||Decision: Deferredfor commentsof TE.~~eeeoO|

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----- Start of picture text ----- |ALC4/2018 Name:DEEPAKNITRITE jALC4/2020 Approved LIMITED 04.12.2020 | HOFie ~~ ~~S<RLAFile LicNo/bate:3410044685 | : :01/82/050/01544/AM19/ :34/24/040/00267/AM19/ 13.11.2018 | |Decision: |The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol.

11.2018 | |Decision: |The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. 1 as per details below or as | lapplied by firm whichever is lower: No. 3-TRIFLUOROMETHYL lkg |1 3-Amino Benzo Trifluoride | 1.26 kg ACETO PHENONE 99.5% Min [2 |SodiumNiwite| 0.50kg 87, | [3 [Toluene | SO Caustic Soda Lye 47% 0.50 kg 5 Acetaldoxime 50% Min | 0.951 kg Solution in Water Copper Sulphate Not allowed, since it is shown indigenous 7 Acetic Acid Not allowed, since it is shown : indigenous Sulphamic Acid Not allowed, as it is not used | 9 _| Soda Ash 0.005 kg ----- End of picture text -----

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

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----- Start of picture text ----- ~IGase Now623/15/82.~~ (PartyName:VINS MeetNo/Date:7/82-—«(Status: ALC4/2018 BIOPRODUCTS LTD" ALC4/2020 Deferred 04.12.2020 88 HQ File a TIRLA File oo hic.No/Date:091 0066851 |” :0.1/82/050/02080/AM1 9/ :09/24/040/00363/AM19/ 14.11.2018 Decision: A copy ‘of 4.07 application alongwith reply received from the firm has been forwarded to- Department ofBiotechnology on 19.10.2020 for obtaining its comments. Deferred for comments of DBT. ----- End of picture text -----

reply received from the firm has been forwarded to- Department ofBiotechnology on 19.10.2020 for obtaining its comments. Deferred for comments of DBT. ----- End of picture text -----

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----- Start of picture text ----- “(Gage Noi@27/15/82.~—~~STSS«C@Pavty Name:AUROBINDO [MeetNo/bate:7/82-—=«(Status: ALC4/2018 PHARMA LIMITED ALC4/2020 Deferred 04.12.2020 8oFle ~——dS(REAFile TT. No/Dates0910066853 [ :0:1/82/050/02084/AM19/ |:09/24/040/00382/AM19/ 15.11.2018 (Decision:Deferred for comments of TE.ee ----- End of picture text -----

|[CaseALC4/2018[No.:630/15/82-—~—~(Party][Name:][ VIVINDRUGS] & [MeetNo/Date:7/82.—(Status: PHARMACEUTICALS ALC4/2020 Deferred , 7 (LIMITED 04.12.2020 OfQFile =~ ~~~~”-«IRLATile”~=~S~CS:*« Lie Note 0910066856 :0.1/82/050/02087/AM19/ :09/24/040/00391/AM19/ 15.11.2018 Decision: Deferred forcomments ofTE. — —_ ) —

[ [CaseNo.:2/15/82-ALC4/2018 [PartyName:DEEPAK [MeetNo/Date:7/82- (Status: NITRITE LIMITED ALC4/2020 Deferred 04.12.2020 jl [HQFile ————<—s~sé‘—‘;SCRRA We SSSS~S~S~S«diL ie NoDatc3.4100447110 :01/82/050/01459/AM19/ :34/24/040/00254/AM19/ 20.11.2018 Decision: | The Committee considered the caseas per agenda in the presence of technical experts and it | _ |was noted that the firm vide e-mail dated 13.08.2020 has furnished its reply. Deferred for comments of TE.

ommittee considered the caseas per agenda in the presence of technical experts and it | _ |was noted that the firm vide e-mail dated 13.08.2020 has furnished its reply. Deferred for comments of TE.

(Case No.:85/15/82-ALC4/2018 [PartyName:DEEPAK [Meet No/Date:7/82- ~—‘(Status:. {NITRITE LIMITED ALC4/2020 Deferred 04.12.2020 |:01/82/050/01542/AM19/ :34/24/040/00255/AM19/ 20.11.2018 ||92/HQFile{wasDecision:noted that— The the firmCommitteevide~—[RLAe-mailconsidereddated File13.08.2020the case as hasperfurnishedagenda inILie.No/Date:3410044711itsthe reply.presence Deferredof technicalfor commentsexperts of TE.andit: | |CaseNo.:86/15/82-ALC4/2018 | NITRITE|Party Name:DEEPAK LIMITED [MeetALC4/2020 No/Date:7/82- ‘Status:Deferred | | 04.12.2020 93(HQFile:01/82/050/01543/AM19/= ~~ ~(RLAFile:34/24/040/00256/AM19/ ~~”~*(Lic.No/Date341004471220.11.2018 |, StS Decision:}was noted that~ Thethe firmCommitteevide e-mailconsidereddated 13.08.2020the case as perhas agendafurnished‘initsthereply. presenceDeferredof[‘technical] for comments[experts] ofTE.[and][it]

(CaseALC4/2018No.:638/:[5/82-][-—~—([Party][ Name:AUROBINDO] [Meet No/Date:7/82- (Status: | PHARMA LIMITED ALC4/2020 Deferred 74 (04.12.2020 iQ File —_ ‘(RLAFile — ———S—S«SLic.No/Date:0910066874 —_ :01/82/050/02095/AM19/ |:09/24/040/003 86/AM19/ (20. 11.2018 [Decision: Deferred for commentsofTE. eee

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11.2018 [Decision: Deferred for commentsofTE. eee

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i[Case Nou630/15/82. SS”(PartyName:CADILA——‘([Meet No/Date:7/82- Status: jALC4/2018 HEALTHCARE LTD ALC4/2020 Deferred | 04.12.2020 SiioFie ~~ ~~—S”~”~CS RL Pile=SSS*~*~SC«L ieNo/Daate:0810143 93 {Oe | |Decision::01/82/050/02096/AM19/“Deferred for comments:08/24/040/00187/AM19/ of TE. ) 20.11.2018

— [Case No.:463/13/82[Party Name:INDI[[A][GLYCOLS][~][[M][eet][No/Date:7/82-] Statu[so] |ALC4/2018 iLTD.,| j04.12.2020jALC4/2020 |[Deferred Hone ~~~-*Y(RLAFile—SS™S~S~S~S~SCSCL te NoDates0511[0408634][|] 96 :01/82/050/01441/AM19/ :05/23/040/00359/AM19/ 26.11.2018 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was decided to call for following information from the firm: (i) Production / Consumption Data for consumption of Silver Catalyst of 29-30% I | Activity from GST for the period of production.

I IGaieNoed9/15/82.°—~SCSC@Party Name:GLOBE ———~—*(Meet No/Date:7/82- (Status: ALC4/2018 TROTTERS PVT LTD ALC4/2020 Deferred 04.12.2020 Ore IRLAFIe [Lic.No/Date:03 10825212 a :01/82/050/02 106/AM19/ :03/94/040/007 13/AM19/ (26.11.2018 | Decision: Deferred for comments of TE.ee

LC4/2018 TROTTERS PVT LTD ALC4/2020 Deferred 04.12.2020 Ore IRLAFIe [Lic.No/Date:03 10825212 a :01/82/050/02 106/AM19/ :03/94/040/007 13/AM19/ (26.11.2018 | Decision: Deferred for comments of TE.ee

“‘\Gase Noi6S9/15/8% ~~”(PartyName:AUROBINDO[MeetNo/Date:7/82- (Status: ALC4/2018 PHARMA LIMITED ALC4/2020 Deferred 04.12.2020 | %onie CSR ile”=—S*~~S«S Lie[NoDaate:0910060905][[] :01/82/050/021 16/AM19/ :09/24/040/00410/AM19/ 28.11.2018 (Decision: — DefaredforcommentsofTE. SSS— “Tease Now664/15/82. (PartyName:——~SSS~~~*«~Meet No Date: 7/82(Status: = ALC4/2018 SMILAX[MITED LABORATORIES LI |ALC4/202004.12.2020 Deferred 9 THQ File “IRLAFile —~—S Lic.No/Date:0910066915, [ Decision::01/82/050/02121/AM19/DeferredforcommentsofTE.|:09/24/040/00358/AM19/ 28.11.2018ee

; ,

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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|[Case|No.:669/15/82-ALC4/2018|[Party|Name: VERVE HUMAN|[Meet|No/Date:7/82- (Status:|
|iCARE LABORATORIES|ALC4/2020|Deferred|
|04.12.2020|
|100[HQFile:01/82/050/02126/AM19/ ~~~—~—S({RLAFFile’:6 1/24/040/00012/AM19/~=~———~S™SCSSLi28.11.2018Nov/Dates6110001560.|po.|
|Decision:|||The|Committee|considered|the|case|as|per|agenda|in|the presence|of technical|experts|and|it|
|was|noted that the|firm|vide|e-mail|dated|09.08.2019|has|furnished|its|reply.|Deferred|for|comments|of TE.|

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```text
||||||
|---|---|---|---|---|
|"Case No.:670/15/82-ALC4/2018|—~—*‘{PartyCARE|Name:LABORATORIESVERVE|HUMAN|[MeetALC4/2020 No/Date:7/82-—*[Status:Deferred|
|04.12.2020|
|lliiQFile ~~~|(RLAFile ~~~~~-*‘(LieNo/Dateoilooolsol|||
|:01/82/050/02127/AM19/|:61/24/040/00013/AM19/|28.11.2018|
|Decision:|DeferredforcommentsofTE.|

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||||||||||
|---|---|---|---|---|---|---|---|---|
|Y|CaseNo.:671/15/82-—~—~—~*(Party|Name: VERVE|HUMAN|[Meet|[No/Date:7/82-.]|[(Status:]|
|ALC4/2018|CARE LABORATORIES|ALC4/2020|Deferred|
|102|.|04.12.2020|
|IHQFile(:01/82/050/02|~~|(RLAFile~=—~™——[LicNo/Date6110001562 ||
|||Decision;DeferredforcommentsofTE.128/AM19/||:61/24/040/00014/AM 19/|28.11.2018|||
|~~ [CaseNo.:672/15/82-—~—~—~*(Party|Name:|VERVE|HUMAN|(MeetNo/Date:7/82-_—*(Status:|
|ALC4/2018|CARE|LABORATORIES|ALC4/2020|Deferred|
|03|QFiie|==~~=~~~~~S*C*S@RLA|FleS*S*S*S*Sd_|04.12.2020Lie|No|Dates|110001503|[18.09.2020|
|:01/82/050/02129/AM19/|:61/24/040/00015/AM19/|28.11.2018|
|(Decision: “DeferredforcommentsofTE.|eee|_|
|~|[CaseNo.:673/15/82-——~—«(Party|Name: VERVE|HUMAN|[Meet|[No/Date:7/82-]|[(Status:]|
|ALC4/2018|CARE|LABORATORIES|ALC4/2020|Deferred|
|04,12,2020|

.2018|
|(Decision: “DeferredforcommentsofTE.|eee|_|
|~|[CaseNo.:673/15/82-——~—«(Party|Name: VERVE|HUMAN|[Meet|[No/Date:7/82-]|[(Status:]|
|ALC4/2018|CARE|LABORATORIES|ALC4/2020|Deferred|
|04,12,2020|
|\04GiQFile|~~|~~«<IRLAFile.~~—~—~S::””SSa|Lies|NoDateso10001564 ||
|||:01/82/050/02130/AM19/||:61/24/040/00018/AM19/|28.11.2018|||
|Decision:|Deferred for comments of|TE.|_|)|.|—|

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"(Ease No674/15/82-—(Party Name: VERVE HUMAN [Meet No/Date:7/82- (Status: | |ALC4/2018 CARE LABORATORIES —_|ALC4/2020 Deferred | 04.12.2020 l05tiOFile ~”””—COSIRLA File ——S~~~S«LicNoDaatez6110001565 | || [Decision:|:01/82/050/02131/AM19/Deferred for[comments] -61/24/040/00017/AM19/of TE. re28.11.2018 )

[7[Gase No:675/15/82-~—~—~(Party Name: VERVEHUMAN[Meet[No/Date:7/82-][ (Status:] |ALC4/2018 |CARE LABORATORIES — |ALC4/2020 Deferred 04.12.2020 106 HQFile ——TTREAFile—~~S~S™~C [LeicNo/Date:6110001566 | | :01/82/050/02132/AM19/ __|:61/24/040/00016/AM19/ 28.11.2018 [Decision: Deferred forcommentsofTE. | CaseNo.:668/15/82-~~(PartyName:CADILA—~—«([Meet No/Date:7/82-. (Status: ALC4/2018 HEALTHCARE LTD ALC4/2020 Deferred 04.12.2020 | 107 11Q File RLAFile Lic.No/Date:0810143988 | | |:01/82/050/02125/AM19/ |:08/24/040/00264/AM19/ 29.11.2018 | | Decision: DeferredforcommentsofTE.Ssts—<CS~S~si‘“‘=~™™™S:S:SS”S”SS™*:CSC

; :

ee

|ieNo.:689/15/82-<br>PartyName:AUROBINDO= <br>:<br>ALC4/2018<br>PHARMALIMITED<br>||ieNo.:689/15/82-<br>PartyName:AUROBINDO= <br>:<br>ALC4/2018<br>PHARMALIMITED<br>||ieNo.:689/15/82-<br>PartyName:AUROBINDO= <br>:<br>ALC4/2018<br>PHARMALIMITED<br>||ieNo.:689/15/82-<br>PartyName:AUROBINDO= <br>:<br>ALC4/2018<br>PHARMALIMITED<br>||ieNo.:689/15/82-<br>PartyName:AUROBINDO= <br>:<br>ALC4/2018<br>PHARMALIMITED<br>||/MeetNo/Date:7/82-<br>ALC4/2020<br>04.12.2020|Status:<br>Approved||
|---|---|---|---|---|---|---|---|
|||||HQFile<br>IRLAFile<br>:01/82/050/02146/AM19/<br>|:09/24/040/00421/AM19/|||Lie. No/Date0910066921<br>[29.11.2018|||
|||Decision:<br>|The Committee considered|case as per agenda||in the presence ofthe technical experts and||it|
||{was decided to ratify the ad-hoc input output norms underpara 4.07 ofHBP Vol. I as per|||||details below or||
|:||as applied by firm whichever is lower:||||||
|||Si. | ExportProduct|Qty.|Sl,|| Importitems|Qty.||
|||0.||No,|_|| (for 1||
|||||||Number||
|;<br>4108|||AMOXYCILLIN<br>CAPSULES<br>250 mg<br>(Each<br>capsule<br>containing<br>Amoxycllin<br>Trthydrate<br>equivalent<br>to 250 mg of<br>Amoxycillin)|1Number|3|Methyl<br>d-{-)-4-hydroxy- <br>phenylglycinate OR D-(-)-<br>4-hydroxyphenylglycine<br>methyl! ester [PHPG Ester]|Capsule)<br> | 140.93mg {|.|
|t||<br>||[The<br>relevant<br>bulk<br>drug<br>contentintotalexportProduct<br>is 625 Kgs of Amoxycillin<br>Trihydratre}||4|Penicillin<br>G<br>Amidase <br>(Particle size 250 - 500<br>micron,<br>Creamish<br>to<br>Brown<br>regularly<br>shaped|| 0.50mg||

entintotalexportProduct<br>is 625 Kgs of Amoxycillin<br>Trihydratre}||4|Penicillin<br>G<br>Amidase <br>(Particle size 250 - 500<br>micron,<br>Creamish<br>to<br>Brown<br>regularly<br>shaped|| 0.50mg||
||<br>|||<br>|<br>|<br>|<br>|<br>|<br>|<br>||2 |AMOXYCILLIN<br>CAPSULES<br>500 mg<br>(Each<br>..... |.capsule<br>..<br>containing<br>**Amoxy**el**l**in<br>Trihydrate<br>equivalent to 500 mg of<br>ci lin)<br>[The<br>relevant<br>bulk<br>**d**rug<br>content in total exportPro uct<br>is 63000 Kgs of Amoxycillin<br>Trihydratre]|1Number<br>.|beads)<br>3.---|.Methyl<br>-d-(-)-4-hydroxy---|-281:86mg<br>/phenylglycinateORD-(-)-<br>4-hydroxyphenylglycine<br>methy! ester [PHPG Ester]<br>4<br>Penic**i**l**l**in<br>G<br>Amidase | 1.00mg<br>(Part c e<br>size 250<br>- 500<br>micron,<br>Creamish<br>to<br>Brown<br>regularly<br>shaped<br>beads)|||-}~:|

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

. ;

"TGase No.:684/15/82-~—~—~S*(PartyName:GLAND ~—~—S|[Meet No/Date:7/82-(Status: ALC4/2018 PHARMA LIMITED ALC4/2020 Deferred 04.12.2020 HQ File - RLA File ~“{Lic.No/Date:0910066930 [ tS 109 :01/82/050/02141/AM19/ :09/24/040/004 19/AM19/ 03.12.2018 (Decision: The Committee consideredthe case as per agenda in the presence of technical experts :[and][to][call][for][following][information][from][ the][firm:] hwas[decided] it

(i) Conversion ratio between Enoxaparin Sodium and Heparin Sodium. (ii) DML.

in the presence of technical experts :[and][to][call][for][following][information][from][ the][firm:] hwas[decided] it

(i) Conversion ratio between Enoxaparin Sodium and Heparin Sodium. (ii) DML.

~TCase No.:685/15/82-.~—~—~«(PartyName:GLAND ——<[Meet No/Date:7/82(Status: ALC4/2018 PHARMA LIMITED ALC4/2020 ‘Deferred | 04.12.2020 HQFie ~~ ~~~~~'(RLAFile ~~ ~—~—~—~S:*«S LicN/Dates0910060931| 110 :01/82/050/02142/AM19/ ———j:09/2.4/040/00420/AM19/ 03.12.2018 (Decision: — “The Committee considered the case as per agenda in the presence of technical experts and it was decided to call for following information from the firm:

(i) Conversion ratio between Enoxaparin Sodium and Heparin Sodium. . Gi) DML. | ~~ IGase No2688/15/82-—~-(Party Name:JODAS EXPOIM [Meet No/Date:7/82-(Status:| ALC4/2018 PVT.LTD ALC4/2020 Deferred 04.12.2020 | 111 [HQ File TT IRLA File. SS*~*~™~:C:«C LicNo/Dates0510408748 | |:01/82/050/02145/AM19/ :05/23/040/00385/AM19/ 04.12.2018 | Decision: The Committee considered the case as per agenda and it was observed that the firm was issued Show Cause Notice vide letter dated 10.10.2019.

2145/AM19/ :05/23/040/00385/AM19/ 04.12.2018 | Decision: The Committee considered the case as per agenda and it was observed that the firm was issued Show Cause Notice vide letter dated 10.10.2019.

~~ [GaseNo.:103/15/82-~—~*‘(Party Name:STERLING {Meet No/Date:7/82- (Status: ALC4/2018 AUXILIARIES PVT LTD ALC4/2020 Deferred (04.12.2020 WwW IHQFile[|:01/82/050/01560/AM19/] RLA:03/95/040/0085 File 1/AM19/ los.ILic.No/Date:03 12.2018 10825462 _ [Decision: The Committee consideredthe case as per agendain the presence of technical experts and it was decided to call for following information from the firm: (i) Justification for wastage more than 2% in Export products, where wastage is i claimed more.

~[Case No.:696/15/82-[PartyName:AUROBINDO[Meet ALC4/2018 No/Date:7/82- (Status: PHARMA LIMITED ALC4/2020 Deferred
1I3/HQFile ==——é<“<«s~“‘;‘WRLAa@Ridle=~SS~~<C~~~S™”:« 04.12.2020LcNaat0910000044 :01/82/050/02153/AM19/ :09/24/040/00436/AM19/ 05.12.2018
Decision: The Committee considered the case as per agenda in the presence of technical ‘experts and it was noted that the firm vide e-mail dated 19.10.2019 has furnished its reply. Deferred for comments of TE.
|[CaseNo.:773/15/82-——~—~—~*(Party Name:LUPIN LIMITED [MeetNo/Date:7/82-‘Status: ALC4/2018 ALC4/2020 |Withdrawn 04.12.2020
HQ File —— RLA File = ~~ __|Lic.No/Date:0310825460 a :01/82/050/02230/AM19/ _ :03/95/040/00902/AM19/ {05.12.2018

PIN LIMITED [MeetNo/Date:7/82-‘Status: ALC4/2018 ALC4/2020 |Withdrawn 04.12.2020

HQ File —— RLA File = ~~ __|Lic.No/Date:0310825460 a :01/82/050/02230/AM19/ _ :03/95/040/00902/AM19/ {05.12.2018

114 (Decision: _ The firm vide e-mail dated 07.08.2020 has informed that its application for subject Advance Authorization falls under under para 4.18 of HBP Vol. | (Non-Infringing Process) and hence they should be exempted from approval ofNC. | In view of above, the Committee decided to withdraw the case. \procedures. RA concerned may verify the same and take further necessary action as per policy /

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----- Start of picture text ----- | [Case No.:466/13/82- ——~—~([Party Name:DCM SHRIRAM [MeetNo/Date:7/82. (Status \ALC4/2018 INDUSTRIES LTD, ALC4/2020 Deferred "SQ File REA File es NoDates03 10408800 [OT ,01782/050/01444/AM19/ :05/23/040/00376/AM19/ (06.12.2018 (Decision: , Deferred for comments ofTE. / ee - : .. oo ----- End of picture text -----

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----- Start of picture text ----- — [Case No.:698/15/82- Party Name: VISION DRUGS [MeetNo/Date:7/82- —‘(Status:. ALC4/2018 PVT LTD ALC4/2020 Deferred | 04.12.2020 116 0 Fite IRLA File Lic. No/Date:09 10066949 :01/82/050/02 155/AM19/ ':09/24/040/004 12/AM19/ 06.12.2018 Decision: Deferred forcommentsofTE.~~ SOSeee ----- End of picture text -----

ile Lic. No/Date:09 10066949 :01/82/050/02 155/AM19/ ':09/24/040/004 12/AM19/ 06.12.2018 Decision: Deferred forcommentsofTE.~~ SOSeee ----- End of picture text -----

“(ase No.700/15/82-~—(PartyName:J.B.——=( Meet ALC4/2018 CHEMICALS & ALC4/2020No/Date:7/82-Status:Approved_ | LIMITEDPHARMACEUTICALS |04.12.2020 HOFie IRLAFile =——~—~—~——[Lic.No/Dates0310825472, | : :01/82/050/02157/AM19/ :03/94/040/00748/AM19/ — 06.12.2018 | Decision: The Committee consideredthe cases as per agenda and in the light of earlier decision taken in meeting no. 2/82-ALC4/2020 dated 10.07.2020 against advance authorization No. 03 10826640 dated 25.01.2019, it was decided to ratify norms under Para 4.07 of HBP Vol. 1 as per details given below or as applied by the firm, whichever is Sess:

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----- Start of picture text ----- 117) (S}.”] Export product Qty. Sl. | Import items Qty. No. No. 1 Bupivacaine with Adrenaline | 1 Number Bupivacaine 111.67 mg Injection 10 x 20ml Ampoules. Each |Ampoule Hydrochloride ml contains Bupivacaine Hydrochloride 5.3175 mg 2 Bupivacaine Hydrochloride and | 1 Number | 1 Bupivacaine 23.40 mg Dextrose Injection 10x4ml, Each m! |Ampoule Hydrochloride contains Bupivacaine Hydrochloride 5.3175 mg ----- End of picture text -----

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

==> picture [459 x 225] intentionally omitted <==

hloride 5.3175 mg ----- End of picture text -----

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

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----- Start of picture text ----- -"IGase Noi8s/is/82.~~SCParty NamesYASHO ‘(MeetNo/Date-7/82- ——~=*SStatus:| ALC4/2018 INDUSTRIES LIMITED ALC4/2020 Approved | 04.12.2020 HQ File 7 RLA File Lie. No/Date:0310825514. [| |:01/82/050/01642/AM19/ :03/95/040/00925/AM19/ —- [07.12.2018 | Decision: The Commitice [considered] the cases as peragea n d dain the lightof earlier decision taken in . meeting no. 2/82-ALC4/2013 dated 18.04.2013 against advance authorization No. 0310717237 dated 14.12.2012, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as 118 lapplied by the firm, whichever is less: . No. YANTQ 3030 B ( 30% SOLUTION | 1kg [1 | HYDROQUINONE 0.423 kg OF TERTIARY BUTYL TERTIARY BUTANOL 0,312 kg | |HYDROQUINONE) in Propylene 3. |PROPYLENE GLYCOL 0.700 kg Glycol RA concerned may take further necessary action as per above decision of NC. ----- End of picture text -----

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|[CaseNo.:88/15/82-ALC4/2018 [Party Name:J.B.CHEMICALS(Meet[No/Date:7/82-][—‘(Status:] & PHARMACEUTICALS ALC4/2020 Deferred 9 LIMITED 04.12.2020 TiQFiie —~=~—SS””~C:”:””CSRRLAC :01/82/050/01545/AM19/ FileSSS Ye No Dates10825550 | :03/94/040/00774/AM 19/ 10.12,2018 |Decision:Deferred forcommentsofTE. ==== = SStSCtCSTS | [~~[CaseNo.:715/15/82-~—~—~—~«(Party Name:MALLADI[MeetNo/Date:7/82. «(Status ~ |ALC4/2018 DRUGS & ALC4/2020 Deferred PHARMACEUTICALS 104.12.2020 1201. LIMITED HQFile ~~—~*SY(RLAFile ~~ [Lic.No/Date:0410164962a :01/82/050/02172/AM19/ :04/24/040/00143/AM19/ 10.12.2018 Decision:DeferredforcommentsofTE. ==== StS

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||||||||
|---|---|---|---|---|---|---|
|"(Case|No.:139/15/82-—~=«SParty|
||ALC4/2018|RESEARCHName:RUBICONPRIVATE|MeetALC4/2020No/Date:7/82-|‘DeferredStatus:|
||?|||LIMITED|(04.12.2020|
|QFile|
|~~|~=—=—~SSCS”C”:CS”SCSCSCRLA|Files|~SSSSS|We|NoDate-0810828587|—_|
|:01/82/050/01596/AM19/|:03/95/040/00889/AM19/|11.12.2018|
|(Decision:Deferred|for commentsofTE.. =|~~~|

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SCRLA|Files|~SSSSS|We|NoDate-0810828587|—_| |:01/82/050/01596/AM19/|:03/95/040/00889/AM19/|11.12.2018| |(Decision:Deferred|for commentsofTE.. =|~~~|


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- 

| [Case No.:711/15/82-——S—«(Party Name:SUVENLIFE [Meet No/Date:7/82Status: |ALC4/2018 SCIENCES LIMITED ALC4/2020 Deferred 2 . (04.12.2020 iQPile ~~~~~~~”~S«RLA ile’~~S*S*CS™S:CST deo Dates0910080080 [ :01/82/050/02 168/AM19/ :09/24/040/00441/AM19/ 11.12.2018 |Decision: Deferred forcommentsofTE. == = = = ~~~ ~SS~CS;«T;]<;37; 3}FTSFS 

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```text
||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|"(Case|No.:106/15/82-|—~—~—«(Party|Name:SONGWON [MeetNo/Date:7/82-(Status:|
|ALC4/2018|SPECIALTY|CHEMICALS|ALC4/2020|Deferred.|
|INDIA PVT.|LTD.|04.12.2020|
|~~~-*SRLAFile.~—~—S—S™~C*~*:”:”™|Lic|Noo|[ate-3410044.750]|
|[HQ|[File]|.|
|123|(0 1/82/050/01563/AM19/|1:34/24/040/00294/AM19/|12.12.2018|
|Decision:|The|Committee considered|the|case|as per agenda|in|the|presence|of|technical|experts|andit|
|was|decided|to|call|for|following|information|from|the|firm:|

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| (i) % yield at every stage of reaction. | (ii) Quantity of MIBK used (without recovery) in each stage of reaction.

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hout recovery) in each stage of reaction.

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~~ |Case No.:726/15/82-~—~—~—«<(Party Name: NATCO PHARMA [MeetNo/Date:7/82-—s(Status: | |ALc4/2018 LIMITED ALC4/2020 ‘Deferred ie | 04.12.2020 | eSOFile (RLAFile~~~{LicNo/Date0910060973 |S [Decision:-01/82/050/02183/AM19/DeferredforcommentsofTE.:09/24/040/00417/AM19/= = = {18.12.2018| ||

([Case No.:727/15/82-~~~“ (Party Name:AUROBINDO [Meet No/Date:7/82-—~*(Status: | |ALc42018 PHARMA LIMITED JALC4/2020 Deferred {126 10 File RLA File ~ “ ILic.No/Date:0910066974 [ : | |:01/82/050/02184/AM19/ -09/24/040/00443/AM19/ 18.12.2018 | | [Decision: Deferred forcommentsofTE. ee

; . ~

==> picture [519 x 585] intentionally omitted <==

.No/Date:0910066974 [ : | |:01/82/050/02184/AM19/ -09/24/040/00443/AM19/ 18.12.2018 | | [Decision: Deferred forcommentsofTE. ee

; . ~

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----- Start of picture text ----- ~~ [Case No.:735/15/82-—~«(Party Name:CIPLA [Meet No/Date:7/82.—~—~«(Status: SOS ALC4/2018 LIMITED, ALC4/2020 Approved 04.12.2020 | [HQ File — RLAFile———s—~~*~SCS Lie No/Datte0310825758. [SS. :01/82/050/02 192/AM19/ :03/94/040/00753/AM19/ 18.12.2018 (Decision: The Committee considered the cases as per agenda and in the light of [earlier] [decision] [taken][ in] meeting no. 3/82-ALC4/2020 dated 07.08.2020 against advance authorization No. 0310830527 dated 24.07.2019, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: No. ‘ Efavirenz 600mg, Lamivudine | 1Number | 1 [Efavirenz ————S—S=*dS«C 12.0 mg 300mg, TenofovirDisoproxil | Tablet 306.0 mg 127| | Fumarate 300mg Tablets 3 TenofovirDisoproxil 306.0 mg Each Tablet contains: Efavirenz Fumarate 600mg, TenofovirDisoproxil 4 | Croscarmellose Sodium | 123.0 mg Fumarate 300mg, Lamivudine (AC-DI-SOL) NF | | 300mg Tablets 5 | Microcrystalline Cellulose | 297.6 mg NF (Avicel PH 101) Magnesium.

enofovirDisoproxil 4 | Croscarmellose Sodium | 123.0 mg Fumarate 300mg, Lamivudine (AC-DI-SOL) NF | | 300mg Tablets 5 | Microcrystalline Cellulose | 297.6 mg NF (Avicel PH 101) Magnesium. Stearate NF | 17.0mg (Vegetable Grade) \ 7 Hydroxy Propyl Cellulose | 38.4 mg NF (Klucel LF) Lactose for DC (Tablettose | 199.60 mg 80/Super Tab) BP/PH Eur | 9 Silica Gel bags 3 GM| Notan see eee as | eee nt ~ vob oe StripaxsR/F oe ingredient” |----}°" | Ika concerned may take further necessary action as per above decision ofNC. ; ~[CaseNo.:736/15/82-—~—~—«(Party Name:AMI ORGANICS [MeetNo/Date:7/82-—‘(Stamus: 128 jALcanors|[HQFile - LIMITEDIRLAFile—SS~™~™SCSS 04.12.ALC4/LicN/Dates5210042870 20 2020 [Deferred. 1:01/82/050/02193/AM 19/ :52/24/040/00068/AM19/ 18.12.2018 7 Decision: DeferredforcommentsofTE.= ~~~ ~ [CaseNo,:99/15/82-ALC4/2018[Party Name:SUN~~~[MeetNo/Date:7/82-—‘(Status: PHARMACEUTICAL ALC4/2020 Deferred INDUSTRIES LTD. 04,12,2020 9THQFile =~ ~~~~S*&<YiRWLA File.~~SS~CS«~ te Nate 10408088 | 1:01/82/050/01556/AM19/ :05/24/040/00503/AM19/ 19.12.2018 Decision: Deferred forcommentsofTE. = = ~~ ~~~~~~~~~SS~CS;«T; <;37;7 CTS ----- End of picture text -----

10408088 | 1:01/82/050/01556/AM19/ :05/24/040/00503/AM19/ 19.12.2018 Decision: Deferred forcommentsofTE. = = ~~ ~~~~~~~~~SS~CS;«T; <;37;7 CTS ----- End of picture text -----

[Case No.:738/15/82-—~—~—~*(Party Name:VIVIMEDLABS {MeetNo/Date:7/82- (Status: ALC4/2018 LIMITED ALC4/2020 Deferred 04.12.2020 B0nOFiea IRLAFile ~~~ {Lic.No/Date:0910066983 | :01/82/050/02195/AM19/ :09/24/040/00460/AM19/ | 19.12.2018 [~~[Case[No.:1025/15/82-—‘[PartyName:ANLON] [MeetNo/Date:7/82-——s([Status: ALC4/2018 HEALTHCARE ALC4/2020 Approved HQ File[a] 7 - IRLAPRIVATELIMITED File —— ~ — |Lic.No/Date:2410042604-(04,12,2020 | oo :01/82/050/02482/AM19/ |.24/24/040/00044/AM19/ 19.12.2018 Decision: |The Committee considered case as per agenda in the presence of the technical experts and it 131 was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. 1 as per details below or . Jas applied by firm whichever is lower: No. 2-(4-((2-oxocyclopentyl)methyl)pheny1) l kg 1 2-Phenyl Propionic Acid - | 1.276 kg propanoic acid Case No.68767-14-6 Case no.492-37-5 RA concerned may take further necessary action as per above decision of NC. ~~ TGase No.:742/15/82-—~—~—~«(Party Name:BEST ALC4/2018 CHEM PVT. LTD. VALUE [Meet|ALC4/2020 No/Date:7/82-.—[Status:Deferred loa, 12.2020 132 HQFile ~IRLAFile ~~ ———~—~SCSLic.No/Datte:34] 0044774 | ~ |:01/82/050/02199/AM19/ :34/24/040/00295/AM19/ |20.12.2018 | . Decision: RLA, Vadodara vide e-mail dated 20.10.2020 has been requested to check and verify whether the advance authorization No.

74 | ~ |:01/82/050/02199/AM19/ :34/24/040/00295/AM19/ |20.12.2018 | . Decision: RLA, Vadodara vide e-mail dated 20.10.2020 has been requested to check and verify whether the advance authorization No. 3410044774 dated 20.12.2018 was issued under para 4.07A of HBP Vol. I— Self ratification scheme and whether they should be exempted from the approval of NC, Reply awaited lfrom RLA, Vadodara. [Case No.743/15/82-~—~—~—~«<(Party Name:SHUBHLAXMI [Meet No/Date:7/82- [Status: ALC4/2018 INDUSTRIES |ALC4/2020}04.12.2020 |Rejected HQFile ” ~IRLAFile -_ [Lic.No/Date:0810 144119 ) ) j:01/82/050/02200/AM 19/ |-08/24/040/00267/AM19/ (20.12.2018 133 Decision: The Committee considered the caseas per[agenda][in][ the] presenceof technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 13/82-ALC4/2019 dated 31.01.2020, followed by Reminder on 07.08.2020 and Final Reminder on 16.10.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019. Hence, the Committee decided to reject the case. RA concerned may take further necessary action as per above decision of NC.

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.2019. Hence, the Committee decided to reject the case. RA concerned may take further necessary action as per above decision of NC.

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----- Start of picture text ----- . [Case Nox752/15/82-‘(PartyNameATUL Meet [No/Date:7/82-][ [statusy] a : | ALC4/2018 LIMITED,| ALC4/2020 Deferred HQ : 04.12.2020 134 File RA Big 'Lic.No/Date:0810144149 [7 |:01/82/050/02209/AM19/ :08/24/040/00303/AM19/ b 1.12.2018 Decision: The Committee considered the case as per agenda in the | presence of technical experts andit was decided to call for following information from the firm: | | (i) Exact chemical name of Export Product. | [Case No.:935/715/82- ‘(PartyName:OPTRIX Meet No/Date:7/82- [Status ALC4/2018 LABORATORIES ALC4/2020 |Approved HQFile ; PRIVATE LIMITED 04.12.2020 | a IRLAFile Lic.No/Date:0910066998 :01/82/050/02382/AM19/ | —_ |:09/24/040/00470/AM19/ —i24.] 2.2018 iwasDecision: The Committee considered caseas per agenda in the presence of the technical experts; and it 135 [as] [applied] decided [by] to [firm] ratify [whichever] the ad-hoc [is] [lower:] input output norms under para 4.07 of HBP Vol, I as per details below or FLIBANSERIN No. —°; || lkg benzofd]imidazol-2(3H1-(2-chloroethy|)-1H- -one 0.62 kg | [|] 2 [-G-(trifluoromethyl)phenyl) | 0.84 kg | piperazine hydrochloride IRA concerned may take further necessary action as per above decisionofNC. — a ----- End of picture text -----

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0.84 kg | piperazine hydrochloride IRA concerned may take further necessary action as per above decisionofNC. — a ----- End of picture text -----

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----- Start of picture text ----- ; Case No.:772/15/82- Party Name: AUROBINDO Meet No/Date:7/82- Status: ALC4/2018 PHARMA LIMITED ALC4/202004.12.2020 Approved | {HQ File IRLA File [ienorbaeor008700° :01/82/050/02229/AM1 9/ |,09/24/040/00445/AM19/ 31.12.2018 | Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. 1 as per details below or as applied by firm whichever is lower: No. ee ae a ae Amoxycillin Tablets 875 mg | 1 Number 1 6-APA 581.77 mg (Each Tablet containing | Tablet (Pre import condition as 1136 Amoxycliin Trihydrate per Appendix 4} of FIP equivalent to 875 mg of 15-20 read with PN Amoxycillin) 62/24.03.2018 is imposed) [The relevant bulk drug content aT Methanol 37 5m in total export Product is 78750 3 Methyl d-(-)-4-hydroxy- 510.17 mg Kgs of Amoxycillin phenylglycinate OR D-(-)- Trihydratre].ZO should be 4-hydroxyphenylglycine fulfilled within 12 months from methyl ester [PHPG Ester] the date of clearance of each 4 \ Penicillin G Amidase | 2.25 mg | | consignment of 6-APA if (Particle size 250 - 500 imported from unregistered micron,Brown regularlyCreamishshapedfo 1| |laasource,concerned may take further ne

icillin G Amidase | 2.25 mg | | consignment of 6-APA if (Particle size 250 - 500 imported from unregistered micron,Brown regularlyCreamishshapedfo 1| |laasource,concerned may take further necessary action as pet above decisionbeads) ofNC. | ----- End of picture text -----

Case No.:775/15/82(Party Name:SUVEN LIFE Meet No/Date:7/82Status: ALC4/2018 ISCIENCES LIMITED ALC4/2020 Deferred | '04.12.2020 | 137 i[HQ File~ eeymanenim cE tata TN ee eM fanRLA File eae(Lic.No/Date:0910067014nee TT CLT Te ie[samaaiense aescautnninecmetn, -0:1/82/050/02232/AM19/ Fa/040/00482/AM19/ \3 41.12.2018 | (Decision: Deferred for comments of TE.

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----- Start of picture text ----- : ||Case No.:788/15/82-—~—~—~*‘(PartyName-MANKIND MeetNo/Date:7/82-(Status: ALC4/2018 PHARMA LTD ALC4/2020 Approved HQFile | (04.12.2020 IRA File SSS iL eso ates S 10409140 |:01/82/050/02245/AM19/ :05/24/040/00552/AM19/ _ 02.01.2019 - , Decision: TheCommittee considered the cases as per agenda and in the light of earlier decision taken in , meeting no. 3/82-ALC4/2020 dated 07.08.2020 against advance authorization No. 0510410328 dated (23.04.2019, it was decided to ratify norms under Para 4.07 of HBP Vol. ] as per details given below or as applied by the firm, whichever is less: 138) Sl. | Export Product Qty. Sl.

28 dated (23.04.2019, it was decided to ratify norms under Para 4.07 of HBP Vol. ] as per details given below or as applied by the firm, whichever is less: 138) Sl. | Export Product Qty. Sl. | Import Items Qty. | | No, No. HCL CAPSULES, USP USP 25 mg capsule | 1 25CLOMIPRAMINEMG 1 Number CLOMIPRAMINE — HCL| 25.50 mg/ 2 CLOMIPRAMINE 1 Number | 1 CLOMIPRAMINE — HCL| 51.00 mg/ HCL CAPSULES, USP USP 50 mg capsule 50 MG 3 CLOMIPRAMINE 1 Number | 1 CLOMIPRAMINE — HCL| 76.50 mg/ 75 MG | HCL CAPSULES, USP USP 75 mg capsule [RA concerned may take further necessary action as per above decision of NC. - ----- End of picture text -----

[[CaseNo.:1072/15/82Party Name:MALLADI MeetNo/Date:7/82- (Status: | |ALC4/2018 DRUGS & — JALC4/2020. [Deferred _ 139 | iLIMITED | HQFile REA File ~S*™C~S:CT SY NoDato] | :01/82/050/02529/AM19/ 1806s |:04/24/040/00218/AM19/ 104.01.2019 Decision:[.][Deferred] forcommentsof TE. BT .

/ [CaseNo.:123/15/82Party Name:REYAANSH [Meet No/Date:7/82- ‘(Status ALC4/2018 ;HEALTHCARE ALC4/2020 Deferred | {04.12.2020 140 [HQ File ~ (RLA File Tig: No/Date-03 10836282 PT 1:0.1/82/050/01580/AM19/ :03/95/040/01019/AM19/ 10.01.2019 | Decision:was — The Committee considered thecaseas peragenda in the presence of technical experts and . it noted that the firm vide e-mail dated 25 -03.2020 has furnished its reply. Deferred for comments ofTE.

: .

onsidered thecaseas peragenda in the presence of technical experts and . it noted that the firm vide e-mail dated 25 -03.2020 has furnished its reply. Deferred for comments ofTE.

: .

(lGise Nowsi1/1si82. (Party Name:ATUL MeetNo/Date:7/82.—«*(Status: = ALC4/2018 LIMITED, ALC4/2020 Approved 04.12.2020 / | - {Lic HQ File RLA File No/Date:08 10144290 : :01/82/050/02268/AM19/ :08/24/040/00328/AM19/ {10.01.2019 Decision: The Committeeconsidered case as per agenda in the presence ofthe technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as applied by firm whichever is lower: 141 No. Amino Methyl Alcohol | 500000.000 kg | 1 2-amino-2-methyl - | 473500.000 kg (Formulated, containing min. 1-propanol | AMP94.7% 2 Amino-2 Methyl-1 | 95 Propanol RA concerned may take further necessary action as per above decision ofNC.

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taining min. 1-propanol | AMP94.7% 2 Amino-2 Methyl-1 | 95 Propanol RA concerned may take further necessary action as per above decision ofNC.

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----- Start of picture text ----- Tee NowB12/I5/82.~~ (PartyName:BALAJL ——_[Meet No/bate:7/82- ~—~=«(Status: = ALC4/2018 AMINES LIMITED ALC4/2020 Approved 04.12.2020 . . HOFile RLA File mn Nolbate3110067279 | :01/82/050/02269/AM19/ |:31/83/040/00158/AM19/ 10.01.2019 Decision: ‘The Committee considered case as per agenda in the presence of the technical experts and on the basis of GST Certificate provided by the firm, it was decided to ratify the ad-hoc input output norms under para 4.07 ofHBP Vol. ] as per details below or as applied by firm whichever is lower: 142 No, DIMETHYL FORMAMIDE | Lkg [i|METHANOL 0.644 kg 2 AMMONIA ANHYDROUS Not allowed, since it is not consumed 3 CALCINATED PETROLEUM| 0.200 kg COKE (CPC) Note: The import of CALCINATED PETROLEUM COKE (CPC) is subject to Public Notice No. 04/2015-20 dated 17.04.2020 issued regarding allocation of quota for import of Calcinated Pet Coke (CPC). _ RA concerned may take concerned may take may take take further necessary necessary action as per above decision of per above decision of above decision of decision of of NC. ----- End of picture text -----

ke concerned may take may take take further necessary necessary action as per above decision of per above decision of above decision of decision of of NC. ----- End of picture text -----

| RA concerned may take concerned may take may take take further necessary necessary action as per above decision of per above decision of above decision of decision of of NC. (Caco NoSd7/15/82.~SS~*«~arty Name@sLJRICON [Meet No/Date:7/82Status: | ALC4/2018 TRADING |ALC4/2020 Deferred | | j04.12.2020 | mn No/Date:0310826053 | 143 [HQ:01/82/050/02304/AM19/File ~ : ‘IRLA-03/95/040/01055/AM19/File 25.01.2019 | ! Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm vide e-mail dated 06.11.2020 has furnished its reply. Deferred for comments of TE. ]

;

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----- Start of picture text ----- ~~[Case No.:53/7/82-.—~-(Party Name-SANMAR Meet No/Date:7/82- (Status: _ j|ALC4/2020 SPECIALITY ALC4/2020 Approved CHEMICALS LIMITED, 04.12.2020 HQFile ———S~~~*«RLA' Fle Lic.No/Date:0410165628- [ :01/82/050/01845/AM21/ :04/24/040/00277/AM19/ 18.05.2019 Decision: _ The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol.

8.05.2019 Decision: _ The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or [applied][ by] [firm] [whichever] [is] [lower:] 144 [as] No. | | AE Phenol [4-(2-Amino-ethyl)-2- | 1 kg Vanillin [4-hydroxy-3-methoxy- | 1.07 kg : | methoxy-phenol] benzaldehyde] | Sodium Cyanide 0,38 kg | Methy! Tetr Butyl Ether 0.115 kg ----- End of picture text -----

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----- Start of picture text ----- [RA concerned may take further necessary action as per above decision of NC. reereretenanen menuecrue 4 eestoryan arnt annie pny pane TT mmeenarenrmare occasion t=—nemttiinininerith aan tsarem erie iennnnnnin’ arena | [Case No.:51/4/82- ~ [Party Name:SIRMAXO Meet | No/Date:7/82-.——‘|Status: 1 |ALC4/2020 CHEMICALS PVT LTD ALC4/2020 \Approved | 04.12.2020 | HQ File IRLFile SSS (esNodDates0310820002° | |Decision:(:01/82/050/01552/AM21/The Committee considered:03/95/040/00252/AM20/the cases [25.06.2019 ee as per agenda and in the light of earlier decision lakenin| i meeting. no:~-1/82-ALC4/2019- dated 03.06.2019 ‘against advance authorization No. 0310807807 dated We '15.09.2016, it was decided to ratify norms under Para 4.07 ofHBP Vol.

decision lakenin| i meeting. no:~-1/82-ALC4/2019- dated 03.06.2019 ‘against advance authorization No. 0310807807 dated We '15.09.2016, it was decided to ratify norms under Para 4.07 ofHBP Vol. 1 as per details given below or as lapplied by the firm, whichever is less: Povidone No. ve Iodine Topical Solution USP | 1 kg Povidone Iodine 0.098 kg 10% (Available Iodine NLT 1% w/v) | IRA concerned may take further necessary action as per above decision ofNC, ----- End of picture text -----

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----- Start of picture text ----- "lence Nou80/4/82.~—~S~*«*Party Name:SPANSULES IMectNo/Date:7/82-—==~=«*Status: : ALC4/2020 |FORMULATIONS {ALC4/2020 Approved ) RLABIe TT Lie04.12.2020 No/Date:0910067792,| | , | [HQ File -01/82/050/01590/AM21/ :09/24/040/00202/AM20/ 17.07.2019 Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 1/82-ALC4/2018 dated 01.05.2018 against advance authorization No. 0910064884 dated 146107,04.2017, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as. applied by the firm, whichever is less: ----- End of picture text -----

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----- Start of picture text ----- ORLISTAT 50% WW PELLETS . ----- End of picture text -----

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intentionally omitted <==**

----- Start of picture text ----- ORLISTAT 50% WW PELLETS . ----- End of picture text -----

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----- Start of picture text ----- No. ORLISTAT USP 0.50 kg ----- End of picture text -----

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

“Gaze Now96/4/82.ALC4/2020 [PartlyName:SRINI Meet No/Date:7/82-—=—«(Status: , PHARMACEUTICALSPRIVATE LIMITED JALC4/2020(04.12.2020 Deferred . figfiie ~~—~—~S~C*«*RLAC Fle mom Noraies0910067796 | 147 |:01/82/050/01597/AM21/ :09/24/040/00642/AM19/ (19.07.2019 | Decision: | The Committee consideredthe case ‘as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 4/82-ALC4/2020 dated 18.09.2020, followed by Reminder to firm on 16.10.2020 for furnishing a copy of 4,07 application as per policy circular no 23/2015-20 dated 15.05.2019. Hence, the case is deferred.

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[(Status:]

(CaseNowi40/4/82-AL.C4/2020[Party Name:S}GROUPMest[No/Date-7/82-] INDIA PRIVATE LIMITED = |ALC4/2020 Deferred | . 04.12.2020 “Bragg TT bie No/Date:0310830654 | _

text -----**

[(Status:]

(CaseNowi40/4/82-AL.C4/2020[Party Name:S}GROUPMest[No/Date-7/82-] INDIA PRIVATE LIMITED = |ALC4/2020 Deferred | . 04.12.2020 “Bragg TT bie No/Date:0310830654 | _

HQFile:0.1/82/050/01550/AM21/ :03/95/040/00390/AM20/ \29.07.2019 Decision: The Committee considered the case as ‘per agenda in the presence of technical ‘experts and it 148 \was decided to call for following information from the firm: )

(i)(ii) CompleteStepwise manufacturingchemical reactionprocess.with molecular and structural formula and molecular weight. (iii) Stagewise % yield on molar basis. (iv) Material balance, stoichiometric balance details. (v) - Recovery of solvent, etc.

: : , !

—

[Case{ALC4/2020 No.:91/4/82-[PartyName:AURORELIFE Meet No/Date:7/82-_‘(Status:. SCIENCES PRIVATE ALC4/2020 |Approved LIMITED 04.12.2020 | {HQFile RUA File ~~ |Lic.No/Date:0910068021 | |:01/82/050/01592/AM21/ |:09/24/040/00328/AM20/ 23.09.2019 | [Decision: ~The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or[applied][by][firm][whichever][is][lower:] 149[as] 2,6-Dihydroxy No. Acetophenone lke |i | ResorcinolMethyl ——SSSSTTI Aceto Acetate | 1.86kg | IRA [4 [Toulene —« 13g | concerned may take further necessary action as per above decision of NC.

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lMethyl ——SSSSTTI Aceto Acetate | 1.86kg | IRA [4 [Toulene —« 13g | concerned may take further necessary action as per above decision of NC.

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----- Start of picture text ----- | [CaseALC4/2020No.:47/4/82-[PartyNameCIBLA Meet No/Date:7/82- ~~ *(Status:. | | LIMITED, ALC4/2020 Approved | | {04.12.2020 | |HQFile 9 (RLAFile |Lic.No/Date:0310832045 [7 |:01/82/050/01348/AM21/ |:03/94/040/00528/AM20/ {07.10.2019 | (Decision: ~The Committee considered case as per : agenda in the presence of the technical experts and ia , ie {was decided-to-ratify-the ad-hoc input outpat noiims under para 4.07 of HBP Vol. [_ as per details below or 1as applied by firm whichever is lower: 150 Export Product Qty. Qty, Azelastine No. | Hydrochloride and 1000000.000 | 1 Azelastine Hydrochloride 16440.00 | Fluticasone Propionate Nasal |Number Gram Spray / Dymista Nasal Spray 2 Fluticasone Propionate 6000.000 (Pack 120MD) Gram Each Spray delivers: Azelastine |3__|140melpumps Relevant Hydrochlor ide BP 137meg 4 25ml USP type 1 amber as per Fluticasone Propionate 50mcg glass vial packing | | IRA concerned may take further necessary action as per above decision ofNC. ----- End of picture text -----

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br>| IRA concerned may take further necessary action as per above decision ofNC. ----- End of picture text -----

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----- Start of picture text ----- Case No.:48/4/82- Party Name:CIPLA Meet No/Date:7/82- Status: ALC4/2020 LIMITED. ALC4/2020 Approved 04.12.2020 HQ File RLA File [sic NovDate:0310892572 [ :01/82/050/01549/AM21/ :03/94/040/0059 1/AM20/ (04.11.2019 Decision: |The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 4/82-ALC4/2019 dated 19.07.2019 against advance authorization No. 0310822521 dated | |93.07,2018, it was decided to ratify norms under Para 4.07 of HBP Vol. 1 as per details given below or as applied by the firm, whichever is less: Sl. | Export Product Qty. Sl. | Import Items Quantity No. No, allowedme/tablet in 1 Telmisartan and Amlodipine | 1 Number Tablets 40/10mg / Each uncoated 2 Amlodipine Besilate 10,20 tablets contains : Telmisartan 40 mg ; Telmisartan 40 mg equivalent to Telmisartan granules 67.36mg Amlodipine Besilate equivalent to Amlodipine USP 10mg 2 Telmisartan and Amlodipine | 1 Number | Tablets 80/10mg / Each uncoated 2 Amlodipine Besilate 10.20 151) tablets contains : Telmisartan 80 | mg Telmisartan 80 mg equivalent to Telmisartan granules 134.72mg : : Amlodipine Besilate equivalent to Amlodipine USP 10mg 3 Telmisartan and Amlodipine | 1 Number Tablets 40/5mg / Each uncoated 2 Amlodipine Besilate 5.10 table

an granules 134.72mg : : Amlodipine Besilate equivalent to Amlodipine USP 10mg 3 Telmisartan and Amlodipine | 1 Number Tablets 40/5mg / Each uncoated 2 Amlodipine Besilate 5.10 tablets contains : Telmisartan 40 mg Telmisartan 40 mg equivalent to Telmisartan granules 67.36mg Amlodipine Besilate equivalent to Amlodipine USP 5mg 4 Telmisartan and Amlodipine | 1 Number | Tablets 80/5mg / Each uncoated 2 Amlodipine Besilate 5.10 mg | tablets contains : Telmisartan 80 | | Telmisartan 80 mg equivalent to Telmisartan granules 134.72mg Amlodipine Besilate equivalent to Amlodipine USP 5mg IRA concerned may take further necessary action as per above decision ofNC. ----- End of picture text -----

| : ;

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| [Case No.:92/4/82-ALC4/2020 [Party LABORATORIESNameORTIN”[MeetNo/Date:7/82- (Status: LTD ALC4/2020 Deferred 04.12.2020 tgp HQ File REA Bile IS Novarwog 0068271 [SS |,01/82/050/01593/AM21/ :09/24/040/00449/AM20/ {10.12.2019 (Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019,

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as per Policy Circular No. 23/2015-20, dated 15.05.2019,

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[Case No.:93/4/82-ALC4/2020 [PartyPHARMACEUTICALSName:SREEPATHI[Meet No/Date:7/82. (Status: | LTD jALC4/2020 Deferred 3 (04.12.2020 HQFieIRCA Be |Lic.No/Date:0910068349 | 1:01/82/050/01594/AM21/ :09/24/040/00502/AM20/ 09.01.2020 (Decision: | Deferred for comments ofTE. _

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----- Start of picture text ----- |[CaseALC4/2020No.:94/4/82-«PartyName:DIVIS.~~“ (Mieet NoDales7/@02 Status: LABORATORIES LTD ALC4/2020 Approved . 04.12.2020 HQFile:01/82/050/01595/AM21/SCS (BLA|:09/24/040/00509/AM20/ File —————~—~——S«WULic.—- No/Date-0910068355[09.01.2020 [Decision The Committeeconsidered case as per agenda in the presenceof the technical experts and it ~ |was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol..I. as per details below-or/.—.. oes" Tasapplied by firm whichever is lower: : 154 | No, . DEXTROMETHORPHAN I kg N-FORMYL OCTABASE 1,55 kg BASE PHOSPHORUS PENTOXIDE | 1.20kg | | |4}3__ || [METHANOL] «dSTOLUENE SS=«d *T.(0.82409 Kg keg | |5__ |«=ACETONE 0.420 IRA concerned may take further necessary action as per above decision of NC. ----- End of picture text -----

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br>IRA concerned may take further necessary action as per above decision of NC. ----- End of picture text -----

| . |

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----- Start of picture text ----- [77 lease Now99/4/820ST [PartyName:MICROLABS [MeetNo/Date:7/82- SS ‘(Status: |ALC4/2020 LTD ALC4/2020 Approved 04.12.2020 fo ~~ IRLA File LicNo/Date0710116065. {| | {HQFile :0.1/82/050/01600/AM21/ :07/24/040/00254/AM20/ = |24.01.2020 Decision: The Committee ‘consideredthe cases as per agenda and in the light of earlier decision taken in meeting no. 12/82-ALC4/2017 dated 20.03.2018 against advance authorization No. 0710109032 dated 12.11.2015, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or 1155 |as applied by the firm, whichever is less: No. DICLOXACILLIN 1 Number DICLOXACILLIN 535.0 mg ALTERNOVA 500 MG SODIUM / capsule CAPSULES BP/EP/USP/IP BP/EP/USP/IP 1380 KG . RA concerned may take further necessary action as per above decision of NC, ----- End of picture text -----

0 MG SODIUM / capsule CAPSULES BP/EP/USP/IP BP/EP/USP/IP 1380 KG . RA concerned may take further necessary action as per above decision of NC, ----- End of picture text -----

eH gIBILALCA/2020 [PartyName:MAGNOLIA[Meet[No/Date:7/82-][ (Status:] LIMITED. |ALC4/2020 Deferred |04.12.2020 156 HQ File . - “RLAFile Lic. No/Date:0310834718 :01/82/050/01551/AM21/ :03/95/040/01071/AM20/ |07.02.2020 | Decision? The Committee noted that the 4.07 application of[subject][Advance][Authorization][is.][wal] available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization | | directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019. | [ence Novog/al82/ALC4/2020 [Party Name:SUN ‘(Meet[No/Date:7/82-][ (Status:] PHARMACEUTICAL ALC4/2020 Deferred IN DUSTRIES LTD. (04.12.2020 157 HQ File eTREAFIGbie NorDate:0510413763 :01/82/050/01599/AM21/ :05/24/040/00742/AM20/ (02.03.2020 * | Decision: The Committee noted“that the 4.07 application of subject Advance Authorization is not. available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019.

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application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019.

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----- Start of picture text ----- [ {Case [No.:54/4/82-ALC4/2020] [Party [Name:ZENITH][ ‘(Meet][No/Date:7/82-—‘(Status:] fo DYEINTERMEDIATES ALC4/2020 Approved LIMITED 04.12.2020 : THQFile =———<—t~i‘™SC‘@dRLA QRile ~=—SS~~~~™S«SLeicNc/Dates0310835403 | :01/82/050/01555/AM21/ :03/95/040/01130/AM20/ 16.03.2020 Decision: The Committee considered thecasesas per agenda and in the light of earlier decision taken in meeting no. 5/82-ALC4/2019 dated 02.08.2019 against advance authorization No. 0310828945 dated ' 1158 |10.05.2019, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: , No. : NAS-S (2-DIAZO-1-NAPTHOL-5-SULFONIC | 1 kg TOBIAS ACID 1.618 kg ACID, SODIUM SALT) PURITY MIN, 97% RA concerned may take further necessary action as per above decision of NC. ----- End of picture text -----

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ALT) PURITY MIN, 97% RA concerned may take further necessary action as per above decision of NC. ----- End of picture text -----

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----- Start of picture text ----- | |Case NesSATRL-ALCAI2O PartyPRIVATE LIMITED ALC4/2020 Deferred | Name:SRIAMLABS {Meet No/Date:7/82- Status: ~— 199 f04.12.2020 | HQ File — RLAFile——SS—™~~SCS«S LicNov/Daate:0910068584 [ | Decision:':01/82/050/01846/AM21/ ‘This case appeared for:09/24/040/00633/AM20/the first time before Norms Committee.18.03.2020Deferred for comments of TE. “omnes "| Casé No.255/7/82-ALC4/2020 [PartyName:FRESENIUS[Meet No/Date-7/82- (Status: | KABI ONCOLOGY LIMITED |ALC4/2020 Deferred 04.12.2020 160 HQFile ~~—~—S(RLA File. ——S—~~S~SCSSS LicNo/Dates0510414380 | . - |:01/82/050/01847/AM21/ :05/23/040/00050/AM21/ 12.06.2020 { 4.07Decision: This case appeared for the first time before Norms Committee. TheCommittee noted that the application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019. ; ----- End of picture text -----

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e authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019. ; ----- End of picture text -----

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----- Start of picture text ----- ~~ [Case No.:1/4/82-ALC4/2020 [PartyName:PHAROSE [Meet No/Date:7/82- (Status: | REMEDIES LIMITED |ALC4/2020 Deferred lO lo4.12.2020 | HQOBIFile E RA RLA FilBl e TTT Lic.No/Date:1810004355Goa glogogaeec ho :01/82/050/01502/AM21/ :18/24/040/00004/AM21/ [24.07 2020 Decision: |DeferredforcommentsofTE. = = —S ----- End of picture text -----

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||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|[Case No6/4/82.ALC4/2020|[PartyName:SYNNAT|(Meet|No/Date:7/82-(Status:|
|PHARMA PRIVATE|ALC4/2020|Approved|
|LIMITED|04.12.2020|
|HOFiie|~~~ '(RLAFile=~=—~—~S*S*S*~*~*S~*«*MCLcNoMDatez0210210010|||
|:01/82/050/01507/AM21/||:02/24/040/00050/AM21/|(27.07.2020|
|Decision:|The Committee Committee|considered the cases the cases cases|as per agenda and per agenda and agenda and and|in the the|light of earlier decision taken of earlier decision taken earlier decision taken decision taken|in|
|meeting|no.|6/82-ALC4/2018|dated|26.07.2018|against|advance|authorization|No.|0210207903|dated.|
|162||24.10.2017,|it was was|decided|to ratify norms ratify norms norms|under|Para|4.07|of HBP HBP|Vol.|I|as|per|details|given below below|or|as|

|against|advance|authorization|No.|0210207903|dated.|
|162||24.10.2017,|it was was|decided|to ratify norms ratify norms norms|under|Para|4.07|of HBP HBP|Vol.|I|as|per|details|given below below|or|as|
|applied by the by the the|firm,|whichever|is|less:|
|No.|
|Noscapine|BP|USP|Ph.Eur|JP|CP|/|Noscapine|||1kg|||1|Noscapine|Crude|||1.10 kg|
|Hydrochloride|BP Ph.Eur|Content 95%|
|RA concerned may take|further necessary|action|as per above|decision of|NC.|

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Decision: The Committee Committee considered the cases the cases cases as per agenda and per agenda and agenda and and in the the light of earlier decision taken of earlier decision taken earlier decision taken decision taken in meeting no. 6/82-ALC4/2018 dated 26.07.2018 against advance authorization No. 0210207903 dated. 162 |24.10.2017, it was was decided to ratify norms ratify norms norms under Para 4.07 of HBP HBP Vol. I as per details given below below or as applied by the by the the firm, whichever is less:

d. 162 |24.10.2017, it was was decided to ratify norms ratify norms norms under Para 4.07 of HBP HBP Vol. I as per details given below below or as applied by the by the the firm, whichever is less:

[7 [Gase No.:2/4/82-ALC4/2020 [Party Name:USV PRIVATE [Meet No/Date:7/82- (Status: LIMITED (FORMERLY ALC4/2020 Approved ; USV LIMITED) (04.12.2020 HQ File oe TRLA File ~~ ie.No/Date:0310837435. [| :01/82/050/01503/AM21/ |.03/95/040/00235/AM21/ 28.07.2020 | [Decision: — The Committee consideredcase as per agendain the presenceof the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or jas applied by firm whichever is lower: 163 No. Desipramine Hydrochloride | 1 Number | 1 Desipramine HCL 153.0 mg / Tablet Tablets, USP 150 MG 508 (4,200 Bottles x 50 Per Bottles = 2,10,000 Tablets) ( Net Content Weight = 31.500 Kgs) RA concerned may take further necessary action as per above decision of NC. “IGase No3/4/82.ALC4/2020 [Party Name:SAFECON [Meet No/Date:7/82- (Status: LIFESCIENCES ALC4/2020 Deferred 04,12.2020 HQ File momee—n—RLAFile———~—~—~SCSO CS Lic.[No/Daate0610039560][|] 164 |:01/82/050/01504/AM21/ :06/24/040/00092/AM20/ 28.07.2020 Decision: The Committeeconsideredthe case as peragenda in the presenceof technical experts andit was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 4/82-ALC4/2020 dated 18.09.2020, followed by Reminder to firm on 16.10.2020 for furnishing a copy of 4.07 application as per policy circular no 23/2015-20 dated 15.05.2019.

by NC-3 in its Meeting No. 4/82-ALC4/2020 dated 18.09.2020, followed by Reminder to firm on 16.10.2020 for furnishing a copy of 4.07 application as per policy circular no 23/2015-20 dated 15.05.2019. Hence, the case is deferred. |

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----- Start of picture text ----- ! | [CaseNo.:4/4/82-ALC4/2020[PartyName:STERILE [MeetNo/Date-7/82- ~~*(Status:. | INDIA PRIVATE LIMITED |ALC4/2020 Approved : 04.12.2020 HQ File ~~ {RLA File - Lic.No/Date:0510414761 :01/82/050/01505/AM21/ :05/24/040/00196/AM21/ —- 28.07.2020 |Decision: The Committee considered case as per agenda in the presence of the technical experts and it 165 jwas decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or Jas applied by firm whichever is lower: No. Piperacillin and Tazobactum Sodium | 1 kg PIPERACILLIN ACID — | 0.890 kg Sterile (8:1) TAZOBACTAM ACID | 0.1078 kg ----- End of picture text -----

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

eee

~~ [Case No.:5/4/82-ALC4/2020[PartyPRIVATEName:S.M.LIMITEDHERBALS (MeetALC4/2020No/Date:7/82- (Status:Deferred | 166 HQFile =——s—<“—~‘“‘;‘SRRdes=SSS~*~S~S« 04.12.2020LieNeDates 0510414764i — |:01/82/050/01506/AM21/ }:05/24/040/00146/AM21/ 28.07.2020 [Decision: ~ The Committee considered the case as per agenda in the presence of technical experts- and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 4/82-ALC4/2020 dated 18.09.2020, followed by Reminder to firm on 16.10.2020 for furnishing a copy of . ...14.07-application-as per policy circular no 23/2015-20.dated -15.05,2019.-Hence, the case-is deferred: ope

| |CaseNoe; 7/4/82-ALC4/2020[PartyFORMULATIONSName:ALPHAMEDP LTD. [MeetALC4/2020No/Date:7/82- ‘Status:Deferred | 04.12.2020 167 |:01/82/050/01508/AM21/HQFile+ (RLAFile:09/24/040/00160/AM21/ [bie(28.07.2020NovDate:091 0068998 f [Decision: —The Committee considered the case as per agenda in thepresence of technical experts andit was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 4/82-ALC4/2020 dated 18.09.2020, followed by Reminder to firm on 16.10.2020 for furnishing a copy of 4.07 application as per policy circular no 23/2015-20 dated 15.05.2019, Hence, the case is deferred.

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irm on 16.10.2020 for furnishing a copy of 4.07 application as per policy circular no 23/2015-20 dated 15.05.2019, Hence, the case is deferred.

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----- Start of picture text ----- "Case No.:8/4/82-ALC4/2020 [Party [Name:STYRAX] LIFE (Meet No/Date:7/82- (Status: SCIENCES PRIVATE ALC4/2020 Deferred LIMITED 04.12.2020 8 iiQFie === ~~~”~S«(RLAFile.~=~SSS*~CS*~SL No DD ates0910060002 [ :01/82/050/01509/AM2 1/ :09/24/040/00167/AM21/ 28.07.2020 Decision:DeferredforcommentsofTE. = = = SSCS ----- End of picture text -----

| |

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----- Start of picture text ----- Case No.:9/4/82-ALC4/2020 |Party Name:GLENMARK [Meet No/Date:7/82- Status: HQ File . |PHARMACEUTICALSRLA File LTD = [04.12.2020|ALC4/2020Lic,No/Date:03 10837490 Approved :01/82/050/01510/AM21/ :03/94/040/00301/AM21/ 29.07.2020 Decision: |The Committee considered the cases as per agendaand in the light of earlier decision taken in meeting no. 7/82-ALC4/2019 dated 06.09.2019 against advance authorization No. 0310831065 dated 19.08.2019, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: 0. No. i Lithium Carbonate capsule USP 1 Number | 1 Lithium Carbonate USP | 153 mg/ 150mg (Pack Size 100 Tabs.) 150 mg ( Net Wt.

ven below or as applied by the firm, whichever is less: 0. No. i Lithium Carbonate capsule USP 1 Number | 1 Lithium Carbonate USP | 153 mg/ 150mg (Pack Size 100 Tabs.) 150 mg ( Net Wt. of Lithium Carbonate Tablet USP is 750.000 Kgs) ; 2 | Lithium Carbonate capsule USP 1 Number | 1 Lithium Carbonate USP | 306 mg/ 300mg (Pack Size 100 Tabs.) 300 mg (Net Wt. of Lithium Carbonate USP Tablet is 1500.000 Kgs) 169 3 | Lithium Carbonate capsule USP 1 Number | 1 Lithium Carbonate USP | 306 mg [/] 300mg (Pack Size 1000 Tabs.) 300 mg (Net Wt. of Lithium Carbonate USP Tablet is 15000.000 Kgs) 4 Lithium Carbonate capsule USP 1 Number | 1 Lithium Carbonate USP | 612 mg/ 600mg (Pack Size 100 Tabs.) 600 mg (Net Wt. of Lithium Carbonate USP Tablet is 3000.000 Kgs) 5 Lithium Carbonate ER Tab USP 1 Number | 1 Lithium Carbonate USP | 306 mg/ 300mg (Pack Size 100 Tabs.) 300 mg (Net Wt. of Lithium Carbonate USP Tablet is 1800.000 Kgs) Lithium Cabronate ER Tab USP 1 Number | 1 Lithium Carbonate USP | 459 mg/ 450MG (Pack Size 100 Tabs.) 450 mg (Net Wt. of Lithium Carbonate USP Tablet is 2475.000 Kgs) 7 Lithium Cabronate ER Tab USP 1 Number | 1 Lithium Carbonate USP | 306 mg/ 300MG (Pack Size 1000 Tabs.) 300 mg (Net Wt. of Lithium Carbonate USP Tablet is 600.000 Kgs) RA concerned may take further necessary action as per above decision ofNC. | ----- End of picture text -----

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Kgs) RA concerned may take further necessary action as per above decision ofNC. | ----- End of picture text -----

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----- Start of picture text ----- [ [CaseNo.:10/4/82-ALC4/2020[Party [Name:KUSUMA][[Meet][No/Date:7/82-.][ (Status:] , PHARMA ALC4/2020 Approved to Oe 04.12.2020 [HQ File ~~ ~—SRLAFile. ~——~C™—_{Luie.No/Date:0310837404 |S (:01/82/050/01511/AM21/ :03/94/040/00198/AM21/ 29.07.2020 Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 2/82-ALC4/2018 dated 16.05.2018 against advance authorization No. 0310814626 dated 179 |14.07.2017, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Export product Qty. | SL Import items Qty. | No. SODIUM SACCHARIN lkg SODIUM SACCHARIN 1.01 kg (PURE DENTAL GRADE) (NON-DENTAL GRADE) RA concerned may take further necessary action as per above decision ofNC. ~[CaseNo.:11/4/82-ALC4/2020 [Party Name:TIDE —«([Meet No/Date:7/82-——‘(Status: INDUSTRIES (ALC4/2020 Deferred lo4.12.2020 IHQFile =—S—s—<C~S*sé‘;‘XRLAC@Rle”~= «LicNo/Dater3410046259 | 1:01/82/050/01512/AM21/ :34/24/040/00111/AM21/ [29.07.2020 171 (Decision: The Committee considered the caseas per agenda in. decided to call for following information from the firm: was the presence of technical‘experts and it | rr ()) ‘Exact chemical name of Export Product and % | | (ii) Complete

er agenda in. decided to call for following information from the firm: was the presence of technical‘experts and it | rr ()) ‘Exact chemical name of Export Product and % | | (ii) Complete chemistry, molecular weight, % yield,purity. stoichiometric balance.rr | | (iii)(iv) QuantiProduc t yion and/ Consumption commercial valuedata ofcertificateLow boilersby GST and Highfor lastboilers. two years. "(Case No.:12/4/82-ALC4/2020 [Party Name:MATRIX FINE[Meet [No/Date:7/82-—‘(Status:] SCIENCES PVT.LTD., ALC4/2020 Deferred 172 [HQFile=. RLAFileSSCL04.12.2020ic No /Date0310837496 [ j:01/82/050/01513/AM21/ |.03/95/040/00239/AM21/ (30.07.2020 Decision: The Committee considered the case as per agenda in the presence of technical experts andit was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 4/82-ALC4/2020 dated 18.09.2020, followed by Reminder to firm on 16.10.2020 for furnishing a copy of 4.07 application as per policy circular no 23/2015-20 dated 15.05.2019. Hence, the case is deferred. ----- End of picture text -----

; 7 :

.2020 for furnishing a copy of 4.07 application as per policy circular no 23/2015-20 dated 15.05.2019. Hence, the case is deferred. ----- End of picture text -----

; 7 :

N11 3/4/82,ALC4/2020[Party Name:DEEPAK [Meet No/Date:7/82(Status: PHENOLICS LIMITED ALC4/2020 Approved }04.12.2020 HOfie ~~~ *'(RLAFile=———S~S~S~=C&@iCL ieNoDaate 3410046263 | :01/82/050/01514/AM21/ :34/24/040/00106/AM21/ 30.07.2020 Decision: The Committee considered case as per agenda in the presence of the technical experts and 173 taking cue from SION A — 1461, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per | details given below or as applied by the firm, whichever is less: : Export product Qty. Import items No. No. | | (1 [Phenol4859.000kg | 1 | Cumene 6900.00 kg RA concerned may take further necessary action as per above decision of NC. |

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----- Start of picture text ----- [Se Nois33/4/82-ALC4/2020 [Party Name:VIVIN DRUGS [MeetNo/Date:7/82- (Status: & PHARMACEUTICALS ALC4/2020 Approved LIMITED 04.12.2020 He|:01/82/050/01523/AM21/ Rie TTR:09/24/040/0023 File 1/AM21/SSS*~S*”CC 31.07.2020LieNoDate-0910069010a fF | Decision: The Commitice consideredthe case as peragenda andin the light of earlier [decision][ taken][in] meeting no. 7/82-ALC4/2019 dated 06.09.2019 against advance authorization No. 0910066857 dated '15.11.2018, it was decided to ratify norms under Para 4.07 of HBP Vol.

ier [decision][ taken][in] meeting no. 7/82-ALC4/2019 dated 06.09.2019 against advance authorization No. 0910066857 dated '15.11.2018, it was decided to ratify norms under Para 4.07 of HBP Vol. 1 as per details given below or as peptied by the firm, whichever is less: No. 174| |4-AMINO-2-OXO PYRIMIDINYL | 1 kg GLYOXYLIC ACID 50% | 0.743 kg OXATHIOLANE-2- 2 2,5 DI HYDROXY 1,4 0.325 kg CARBOXYLIC ACID DITHIANE ISO PROPYL METHYL CYCLO [3 | CYTOSINE —————s*d[ 0.428 kg HEXYL ESTER (CEI-IT) 4 |HEXAMETHYL 0.509 kg | DISILAZANE , Ps [TRIETHYLAMINE [0.034 kg '6 | METHYLENE CHLORIDE | 2.63 kg L-MENTHOL 0.751 kg (8|9 ||TRIPHOSGENEDIMETHYL FORMAMIDE|| (0.400.316 kg kg RA concerned may take further necessary action as per above decision of NC. ----- End of picture text -----

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----- Start of picture text ----- |” [CaseNo.:23/4/82-ALC4/2020 [Party Name:DR. REDDYS [MeetNo/Date:7/82- Status: LABORATORIES LIMITED jALC4/2020 Deferred 04.12.2020. 175 FQ File ETAFie. {Lic.No/Date:0910069013| |.01/82/050/0 1524/AM21/ :09/24/040/00239/AM21/ 31.07.2020 | [Decision: Deferred forcommentsOfte, ----- End of picture text -----

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/24/040/00239/AM21/ 31.07.2020 | [Decision: Deferred forcommentsOfte, ----- End of picture text -----

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----- Start of picture text ----- (léaseNowi4/482.~—~SC*~«~dRarty,=S=~~<~“‘««~MeetNDates 7/82- Status: = ALC4/2020 |Name:DANASHMAND ALC4/2020 Approved jORGANIC PVT.LTD. 04.12.2020 HO File oe IRLAFile—t—~—S Lic.No/Date:03 10837537, —_ :01/82/050/01515/AM21/ :03/94/040/00268/AM21/ 03.08.2020 Decision: The Committee considered case as per agenda in the presence of the technical experts and it 176 was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or Jas applied by firm whichever is lower: No. BENFO THIAMINE ikg j1 THIAMINE HYDROCHLORIDE| 0.922 kg (VIT.B1 HCL) IRA concerned may take further necessary action as per above decision of NC. [Case No.:15/4/82-ALC4/2020 [PartyHEALTHCAREName:CADILA LIMITEDvp MetALC4/2020 No/Date-182- (Status:Deferred | (04.12.2020 aa QFile ———«(RLAFile Lic. No/Date:0810148274 [ | :01/82/050/01516/AM21/ {:08/24/040/00110/AM21/ 04.08.2020 | [Decision: Deferredfor commentsof TE.

-182- (Status:Deferred | (04.12.2020 aa QFile ———«*(RLAFile Lic. No/Date:0810148274 [ | :01/82/050/01516/AM21/ {:08/24/040/00110/AM21/ 04.08.2020 | [Decision: Deferredfor commentsof TE. OO - - fe [~~ [ease No.s30/ag2- "Party Name:ViSION Mest No/Date:7/82- Status: | | ALC4/2020 |IDRUGS PVT LTD loa.ALC4/2020 12.2020 Approved Hofie (RLAFile ~~~ [Lic.No/Date0910069017 [| :01/82/050/01531/AM21/ :09/24/040/00168/AM21/ 04.08.2020 Decision: The Committee considered case as per agenda in the presence of the technical experts and it 178 was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or |as applied by firm whichever is lower: No. Homo Veratronitrile(HVN) tke |i | Veratrole si ‘1.231 kg Paraformaldehyde (37%) 0.423 kg RA concerned may take further necessary action as per above decision of NC. ----- End of picture text -----

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----- Start of picture text ----- ~[Case Nowst/4/s2-ALC42020 PartyLABORATORIES Name:ORTIN LTD [MeetALC4/2020 No/Date:7/82- (Status:Deferred | [04.12.2020 MO QFie RLA File [Lic.No/Date:09 1006901 8 _ :01/82/050/01532/AM21/ |:09/24/040/00197/AM21/ 105.08.2020 . Decision: Deferred forcommentsofTE. ----- End of picture text -----

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/ |:09/24/040/00197/AM21/ 105.08.2020 . Decision: Deferred forcommentsofTE. ----- End of picture text -----

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[CaseALC4/2020No.s32/4/82-~~ [PartyName:ORTIN.LABORATORIES LTD[MeetALC4/2020 No/Date:7/82-(Status:Approved | | 04.12.2020 HQFie ~~ ~*IRLAFile ~~ ~~—~—~—__[Lic.No/Date0910069019 [| :01/82/050/01533/AM21/ :09/24/040/00176/AM21/ —- {05.08.2020 Decision: | The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. 1 as per details below or as applied by firm whichever is lower: 180 No. [2S,38,58]-5-t- 1kg 1,2-dimethoxy ethane(1,2-DME) | 4.74 ke : butyloxycarbonylamino-2- SODIUM BORO HYDRIDE 0.45 kg . Amino-3-hydroxy-1,6- METHANE SULPHONIC ACID | 1.50 kg | | | diphenylhexane succinate 4LePHENYLALANINE 0.342 ke ( uecinic Acid RIT) Di-Tert-Butyl- Di- Carbonate 0.60 kg , 5% Palladium Carbon (wet) 0.010 kg 18| ISOPROPYL ALCOHOL 2.90 kg [9_|TETRA HYDRO FURAN 1.30 kg ----- End of picture text -----

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|ALC4/2020 Deferred 04.12.2020 HQFie ~~ ‘(RLAFile -_ “(Lie No/Date:0910069049 [ 1208 |:01/82/050/01569/AM21/ :09/24/040/00263/AM21/ 18.08.2020

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----- Start of picture text ----- Decision: | The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 4/82-ALC4/2020 dated 18.09.2020, followed by Reminder to firm on 16.10.2020 for furnishing a copy of l4.07 application as per policy circular no 23/2015-20 dated 15.05.2019. Hence, the case is deferred. [[Case Now88/482-~—~—~*(Party Name:SANDHYA [Meet No/Date:7/82- ercue: - | |ALC4/2020 ORGANIC CHEMICALS = j|ALC4/2020 [Approved | | (PRIVATE LIMITED 04.12.2020 | | HOFie ~(RLA File {Lic.No/Date:0310837751 | | |:01/82/050/01559/AM21/ — 403/95/040/00286/AM21/ 19.08,2020 | considered the cases as per agendaand in the lightof earlier decision taken in}~~ (Decision: “ahsGommittee imeeting no. 5/82-ALC4/2019 dated 02.08.2019 against advance authorization No.

| considered the cases as per agendaand in the lightof earlier decision taken in}~~~~ (Decision: “ahsGommittee imeeting no. 5/82-ALC4/2019 dated 02.08.2019 against advance authorization No. 0310828995 dated 14.05.2019, it was decided to ratify norms under Para 4.07 of HBP VoL 1 as per details given below or as 209 applied by the firm, whichever is less: No. DIPHENYLISODECYL PHOSPHITE |ikg {1 [PHENOL —_—s=d|:‘0.557kg (DPDP) [SODECYL ALCOHOL 0.386 ke YELLOW PHOSPHORUS 0.087 kg RA concerned may take further necessary action as per above decision of NC. ~ [Gase No.:59/4/82-ALC4/2020 [Party Name:ANUH PHARMA [MeetNo/Date:7/82- Status: | LIMITED ALC4/2020 Deferred 04.12.2020 — HQFile TO REAFile “[Lic.No/Date:0310837761 {[ {:01/82/050/01560/AM21/ :03/94/040/00361/AM21/ {19.08.2020 . 210 [Decision:was decided ~Theto callCommitteefor following consideredinformationthe case asfrom the perfirm: agenda in the presence of technical experts and it @ Detailed Chemistry, Structural Formula of import and export, molecular weight, % yield. (ii) Stoichiometric baJance between import and export. ----- End of picture text -----

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led Chemistry, Structural Formula of import and export, molecular weight, % yield. (ii) Stoichiometric baJance between import and export. ----- End of picture text -----

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[Case No.:69/4/82-ALC4/2020 [PartyName:OPTRIX ‘(Meet No/Date:7/82-.(Status: LABORATORIES PRIVATE {ALC4/2020 Approved LIMITED 04.12.2020 HQFile ~—S*(RLAFile~=~———S~S~S~*~:~:C—S LicNv/Datez0910069068 | :01/82/050/01570/AM21/ :09/2.4/040/00261/AM21/ 19.08.2020 meetingDecision:no. The4/82-ALC4/2020Committee considereddated 18.09.2020the cases asagainstper agenda andadvance inauthorization the light of earlierNo. 0910066086decision takendatedin 26.03.2018, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as 211 japplied by the firm, whichever is less:

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No. EMPAGLIFLOZIN-IH lkg} 1 (4S)-1 5-Anhydro-1-C-[4-chloro —-3-[[4- | 1.525 kg [[(3S)-tetrahydro-3furanyljoxy]pheny!]methyl]phenyl]-Dglucitol tetraacetate RA concerned may take further necessary action as per above decision of NC.

)-1 5-Anhydro-1-C-[4-chloro —-3-[[4- | 1.525 kg [[(3S)-tetrahydro-3furanyljoxy]pheny!]methyl]phenyl]-Dglucitol tetraacetate RA concerned may take further necessary action as per above decision of NC. ~ [Case No.:62/4/82-ALC4/2020|Party Name:SRF LIMITED [Meet No/Date:7/82- (Status: ALC4/2020 Deferred 212 HQFile ~—SIRLAFile~=——~CO—_LricNoDatte:0510414951: 04.12.2020 i oo :01/82/050/01563/AM21/ :05/24/040/00225/AM21/ 20.08.2020 | Decision: — The Committee considered the case as peragendain the presence of[technical][ experts] andit was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 4/82-ALC4/2020 dated 18.09.2020, followed by Reminder to firm on 16.10.2020 for furnishing a copy of 4.07 application as per policy circular no 23/2015-20 dated 15.05.2019. Hence, the case is deferred.

Case No.:63/4/82-~—~—~—«{PartyName:SUN.—~—~—«s(Meet No/Date:7/82-.—~—«(Status:== ALC4/2020 PHARMACEUTICAL ALC4/2020 Approved INDUSTRIES LTD. 04.12.2020 HQFile ~—S(RLAFile~——~S™:—~C Sic. Nov/DDates0510414952 [ 3 3 :01/82/050/01564/AM21/ :05/24/040/0023 1/AM21/ 20.08.2020 | | |Decision: ~The Committee considered case as per agenda in thepresenceof the technical expertsandit was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. | as per details below or[applied][ by][ firm][whichever][is][lower:] : 313[as] 0. No.

nceof the technical expertsandit was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. | as per details below or[applied][ by][ firm][whichever][is][lower:] : 313[as] 0. No. 1 | Clarithromycin Carbomer | 15000.000 kg Carbopol 974 P Granules 27.5%/ 28% 4165,500 kg | (2 | Clarithromycin Carbomer | 15000.000 kg 5550.000 kg Granules 43.75% / 44% Clarithromycin RA concerned may take further necessary action as per above decision of NC.

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----- Start of picture text ----- |”|CaseNo.:64/4/82-ALC4/2020 [PartyName:PIRAMAL(Meet [No/Date:7/82-._—=[Status:] ENTERPRISES LIMITED ALC4/2020 Deferred P14 :01/82/050/01565/AM21/_HQ File OO |:03/95/040/00288/AM2IRLa File ~~1/ [Lic.No/Date:0320.08.202004.12.2020 _ 10837797 - | [Deeision: Deferredfor comments ofTE. a ~~[CaseNo.:66/4/82-ALC4/2020 [PartyName:FDCLTD[Meet No/Date:7/82-—(Status: ALC4/2020 Deferred gis HQFile. = SRA File[Lic- 04.12.2020No/Dater0310837815 [ :01/82/050/01567/AM21/ :03/94/040/00362/AM2 1/ 20.08.2020 Decision: | The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019. ----- End of picture text -----

all for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019. ----- End of picture text -----

)[Case No.:70/4/82-ALC4/2020 [PartySCIENCES[Name:AURORE] LIFE __[Moet NovDater7/82Status: PRIVATE jALC4/2020 Deferred | LIMITED (04.12.2020 :01/82/050/01571/AM21/ ':09/24/040/00264/AM21/ {20.08.2020 . |167iQHile ~~~~~~Sd(RLAFile SSS ‘Lic.No/Date:0910069070 | | (Decision: Deferred forcommentsofTE. == s—<“<i=<‘<‘(C;7C;OS”!” ~|CaseNo.:71/4/82-ALC4/2020[PartyName:THERAPIVA[Meet No/Date:7/82- (Status: HQFile ~~ ~—~——S({RLAFile.——~SO™—™——_{LicNoo/Date:0910069090PRIVATE. LIMITED loa,12.2020ALC4/2020 |DeferredSS| 217 }:01/82/050/01572/AM21/ :09/24/040/00250/AM21/ 24.08.2020 Decision: The Committee considered the caseas per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 4/82-ALC4/2020 dated 18.09.2020, followed by Reminder to firm on 16.10.2020 for furnishing a copy of \4.07 application as per policy circular no 23/2015-20 dated 15.05.2019. Hence, the case is deferred.

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rm on 16.10.2020 for furnishing a copy of \4.07 application as per policy circular no 23/2015-20 dated 15.05.2019. Hence, the case is deferred.

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----- Start of picture text ----- ~ [Case No.:72/4/82-ALC4/2020 [Party Name:HIKAL LIMITED [Meet No/Date:7/82- (Status: ALC4/2020 Deferred 218 (04.12.2020 QFile ~~ (RLAFile ~~~ [LieNo/Date-0310837840 [SS :01/82/050/01573/AM21/ :03/94/040/00344/AM21/ 24.08.2020 [Decision: DeferredforcommentsofTE. ee ----- End of picture text -----

{Case No.73/4/82-ALC4/2020 [PartyName:BRAWN[Meet No/Date:7/82- —[Status: : LABORATORIES LTD ALC4/2020 Deferred 04.12.2020 219 . FQ File ; ~~IRLA| File ee TLic.No/Date:0510414997 [ :01/82/050/01574/AM21/ :05/23/040/00115/AM21/ [25.08.2020 (Decision: DeferredforcommentsofTE. == sss—s—SsSSSC‘Ci‘CS "(Case No.:74/4/82-ALC4/2020(PartyName:OPTRIX [Meet No/Date:7/82-. (Status: LABORATORIES PRIVATE |ALC4/2020 Deferred LIMITED 04.12.2020 HQFile | (RLAFile~ ee fLic-No/Date:0910069097 | 220 |:01/82/050/01575/AM21/ :09/24/040/00047/AM21/ [25.08.2020 Decision: The Committee consideredthe case as per agendain the presenceof technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 4/82-ALC4/2020 dated 18.09.2020, followed by Reminder to firm on 16.10.2020 for furnishing a copy of _ |4.07 application as per policy circular no 23/2015-20 dated 15.05.2019. Hence, the case is deferred.

ALC4/2020 dated 18.09.2020, followed by Reminder to firm on 16.10.2020 for furnishing a copy of _ |4.07 application as per policy circular no 23/2015-20 dated 15.05.2019. Hence, the case is deferred. CaseNo.:75/4/82-ALC4/2020 |Party[Name:OPTRIX] {LABORATORIES[PRIVATE] (Meet|ALC4/2020 No/Date:7/82-.—‘[Status:Deferred LIMITED 04.12.2020 THQFile IRLA File “ILic.No/Date:0910069098 | 22.1 1:01/82/050/01576/AM21/ :09/24/040/00042/AM21/ [25.08.2020 | Decision: ‘The Committee considered the caseas per agendain the presence of technical expertsand it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. : 4/82-ALC4/2020 dated 18.09.2020, followed by Reminder to firm on 16.10.2020 for furnishing a copy of 4.07 application as per policy circular no 23/2015-20 dated 15.05.2019. Hence, the case is deferred. | ~“|Gase No.:76/4/82-—~—(Party Name:AUROBINDO_ [MeetNo/Date:7/82-ALC4/2020 |Status:| ALC4/2020 PHARMA LIMITED 04.12.2020 Approved HQFie (RLAFile~~~‘ {Lic.No/Date0910009100 | :01/82/050/01577/AM21/ :09/24/040/00258/AM21/ 25.08.2020 Decision: The Committee considered case as per agenda in the presence ofthe technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as applied by firm whichever is lower: No.

nda in the presence ofthe technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as applied by firm whichever is lower: No. 222 | [ZIPRASIDONE ike |1 | Piperzine Derivative (or) 3-(1- | 0.848 kg HYDROCHLORIDE Piperazinyl)-1,2-benzisothiazole MONOHYDRATE hydrochloride 2 Chloroxindole (or) 6-Chloro-5-(2- | 0.726 kg Chloroethy})-1,3-dihydro-2H-indole-2one Isopropyl Alcohol (IPA) Tetrahydrofuran 14.05 kg Methanol (Methyl Alcohol) RA concerned may take further necessary action as per above decision of NC.

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! : 3

Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 4/82-ALC4/2020 dated 18.09.2020, followed by Reminder to firm on 16.10.2020 for furnishing a copy of ie application as per policy circular no 23/2015-20 dated 15.05.2019. Hence, the case is deferred.

82-ALC4/2020 dated 18.09.2020, followed by Reminder to firm on 16.10.2020 for furnishing a copy of ie application as per policy circular no 23/2015-20 dated 15.05.2019. Hence, the case is deferred.

Case No.:78/4/82-ALC4/2020 [Party Name:J.B. CHEMICALS [Meet No/Date:7/82Status: LIMITED& PHARMACEUTICALS ALC4/202004.12.2020 Approved HO File RLA File (Lic. No/Date:03 10837889 :01/82/050/01579/AM21/ :03/94/040/00366/AM21/ [26.08.2020

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----- Start of picture text ----- Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 10/82-ALC4/2019 dated 29.11.2019 against advance authorization No. 0310832084 dated 09.10.2019, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: | No.i Rinza sip with Vitamin C j}1 Number No. Caffeine Anhydrous | 30.3 mg/ | (Flavours Orange/ Lemon/ } Sachet Powder 5 gm sachet an ie | ~~ ~--l-OtherBlack ~flavour's) ~ &--RinzaCurrant/ Sip |—--- s- seen mens amma Sie | ae ; | (Flavours Orange/ Lemon/ Black currant/. = Cranberry/ 224 Honey Lemorn/ Other : flavours).Each sachet of 5gm contains Caffeine Anhydrous Powder 30mg. Net content of 923.64 Kgs. | Caffeine Anhydrous Powder | | 2 | Rinza Tablets. | 1 Number Each tablet Contains Caffeine | Tablet Powder 30 mg tablet Anhydrous Powder 30 mg and 3 Paracetamol BP 510 mg [/] Paracetamol BP 500 mg.

Anhydrous Powder | | 2 | Rinza Tablets. | 1 Number Each tablet Contains Caffeine | Tablet Powder 30 mg tablet Anhydrous Powder 30 mg and 3 Paracetamol BP 510 mg [/] Paracetamol BP 500 mg. Net 500 mg tablet Content of Caffeine Anhydrous Powder - 960.00 Kgs and Paracetamol BP- 16000.00 Kgs 3 Rinza Sip for Children | 1 Number | 4 Paracetamol BP 282.80 mg [/] (Flavours Raspberry/ other | Sachet 3 gm sachet flavours), Each sachet of 3gm contains Paracetamol BP - 280mg. Net content- 582.53 Kgs. ea concerned may take further necessary action as per above decision ofNC. ----- End of picture text -----

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----- Start of picture text ----- . Case No.:80/4/82- Party Name:AUROBINDO {Meet No/Date:7/82- (Status: JALC4/2020 PHARMA LIMITED ALC4/2020 |Approved 04.12.2020 i HQ File IRLA File Lic.No/Date:0910069103 :01/82/050/01581/AM21/ —_|:09/24/040/00210/AM21/ 26.08.2020 Decision: | The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or ‘las applied by firm whichever is lower: Sl. | Export Product Qty. Si.

xperts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or ‘las applied by firm whichever is lower: Sl. | Export Product Qty. Si. | Import items Qty. Tablet c= 1 | Amoxycillin Capsules | 1 Number Ee | 500mg Penicillanic Acid) (Each Capsule containing 2 Methy!} d-(-)-4- | 281.86 mg Amoxycillin Trihydrate hydroxy- equivalent to 500mg of phenylglycinate OR Amoxycillin) D-(-)-4- hydroxyphenylglycin e methy! ester [PHPG ‘ Ester] 225 3 Penicillin G Amidase | 1.00 mg (Particle size 250 - 500 micron, Creamish to Brown , regularly shaped beads) 2 Amoxycillin Capsules | 1 Number 250mg Penicillanic Acid) (Each Capsule containing 2 Methy! d-(-)-4- | 140.93 mg Amoxycillin Trihydrate hydroxy- equivalent to 250mg of phenylglycinate OR Amoxycillin) D-(-)-4- hydroxyphenylglycin e methy] ester [PHPG Ester] 3 Penicillin G Amidase | 0.500 mg (Particle size 250 - 500 micron, Creamish to Brown regularly shaped beads) RA concerned may take further necessary action as per above decision of NC. ----- End of picture text -----

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cture text -----**

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|||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|Case|No.:83/4/82-ALC4/2020||Party|Name:VEKO|CARE|[Meet|No/Date:7/82-|(Status:|
|PRIVATE|LIMITED|ALC4/2020|Deferred|
|||04.12.2020|
||||HOFile| (RLAFile|([Lic.No/Date:3110067835 ||
|228||:01/82/050/01584/AM21/|:31/83/040/00048/AM21/|27.08,2020|
|||Decision:|The Committee|considered|the|case|as|per agenda|in|the|presence of technical|experts|and|it|
|was|noted|that|the|firm|still|has|not|furnished|the|4.07|application|asked|for|by|NC-3|in|its|Meeting|No.|
|4/82-ALC4/2020|dated|18.09.2020,|followed by|Reminder|to|firm|on|16.10.2020|for|furnishing|a|copy|of|
|4.07|application|as per|policy|circular no|23/2015-20|dated|15.05.2019.|Hence,|the|case|is|deferred.|
|[Case No.:84/4/82-ALC4/2020[PartyName:BIOLOGICALE|{Meet|No/Date:7/82- ——‘|Status:|
|LTD|ALC4/2020|Deferred|
|.|04.12.2020|
|7|
|229[HQFile|
|+|(RLAFile~~~ Lic.No/Date.0910069107|[||
|:01/82/050/01585/AM21/|:09/24/040/00253/AM21/|[27.08.2020|
|[Decision:|It|was|decided|toforward|a|copy of 4.07 application of subject|Advance|Authorization|to|
|Department ofBiotechnology (DBT) for obtaining|its comments.|Case|is deferred.|
|||TCaseNo.:85/4/82-ALC4/2020|[PartyDRUGSName:MANGALAM & ORGANICS|[MeetiALC4/2020No/Date:7/82-|(Status:Deferred|
|LIMITED|(04.12.2020|

otechnology (DBT) for obtaining|its comments.|Case|is deferred.|
|||TCaseNo.:85/4/82-ALC4/2020|[PartyDRUGSName:MANGALAM & ORGANICS|[MeetiALC4/2020No/Date:7/82-|(Status:Deferred|
|LIMITED|(04.12.2020|
|230|i:0.1/82/050/01586/AM21/File~~*|(RLAFile1:03/95/040/00299/AM21/~~——~—SCLic.No/Date.0310837947{28.08.2020|||
|[Decision:DeferredforcommentsofTE.|
|““ICaseALC4/2020No.:86/4/82-|—=—=—~=«(PartyIPHARMA|[Name:KUSUMA]|[MeetALC4/2020No/Date:7/82-(Status:|Approved|
|||04.12.2020|
|HQFile|IRLAFile (Lic.|No/Daté0310837963 ||
||.01/82/050/01587/AM21/|:03/94/040/00356/AM21/|—|{28.08.2020|||
|Decision:|The|Committee considerthe cas|e|s|das per agenda andin|the|light of earlier|decision|taken|in||
|meeting|no.|2/82-ALC4/2018|dated|16.05.2018|against|advance|authorization|No.|0310814626|dated|
|231|14.07.2017,|it was|decided|to|ratify|norms under Para 4.07|of HBP|Vol.|I|as|per details|given below|or as|
|applied by|the|firm,|whichever|is|less:|
|Export product|Qty.|||SI.|Import|items|Qty.|
|No.|
|SODIUM|SACCHARIN|kg|1|SODIUM|SACCHARIN|1.01|kg|
||||(PURE|DENTAL GRADE)|(NON-DENTAL GRADE)|
|he concerned may take further necessary action as per above decision ofNC.|

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~ |CaseNo.:87/4/82-ALC4/2020[PartyCALCIUMName:GLOBAL PRIVATE (MeetALC4/2020 No/Date:7/82--‘(Status:Deferred LIMITED 04.12.2020 4232| [HQFile SRA File —SS~~~S*~S~S:S Lie NoDate-0710110939 [

|:01/82/050/01588/AM21/ :07/24/040/00146/AM21/ 28.08.2020 ) (Decision: The Committee considered the case as per agenda in the presence of {was technical experts andit noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 4/82-ALC4/2020 dated 18.09.2020, followed by Reminder to firm on 16.10.2020 for furnishing a copy of 4.07 application as per policy circular no 23/2015-20 dated 15.05.2019. Hence, the case is deferred. [ ~|CaseNo.:88/4/82-ALC4/2020|PartyCALCIUM[Name:GLOBAL] PRIVATE [MeetALC4/2020No/Date:7/82- ‘(StatusDeferred LIMITED 04.12.2020 [HQFile —~—<“—~s~sé‘;™CSRLA@ide”~=SSSSS™S™S™~™~*C«w LicNo/DaatesO710110940 | 233 |:01/82/050/01589/AM21/ |:07/24/040/00145/AM21/ 28.08.2020 | Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. |4/82-ALC4/2020 dated 18.09.2020, followed by Reminder to firm on 16.10.2020 for furnishing a copy of 4.07 application as per policy circular no 23/2015-20 dated 15.05.2019. Hence, the case is deferred,

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rm on 16.10.2020 for furnishing a copy of 4.07 application as per policy circular no 23/2015-20 dated 15.05.2019. Hence, the case is deferred,

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----- Start of picture text ----- | [Case No.:100/4/82- ——[PartyName:SHREE [Meet No/Date:7/82-ALC4/2020 |Status: |ALC4/2020 iBANKEY BEHARI LAL 04.12.2020 Approved | uavors re IHQ File ~ ~(RLAFile———~—~S~SOCSLitc. No/Daate:0510415050 ~ |:01/82/050/01601/AM21/Decision: . |:05/24/040/00253/AM21/ 31.08.2020 7 meeting no. The12/82-ALC4/2018 Committee ‘considereddated 12.12.2018 the case as peragainst agendaadvance and inauthorization the light of earlierNo. 0510406602 decision takendatedin 234 |24.05.2018, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: | No. THYMOL 99% PURE & ABOVE lkg 1 META98.5% PURE- CRESOL ABOVE| 0.785 kg RA concerned may take further necessary action as per above decision of NC. ----- End of picture text -----

. : : |

~~! GaseNo.:101/4/82-ALC4/2020 [Party Name:TINA ORGANICS {Meet No/Date:7/82(Status: PRIVATE LIMITED ALC4/2020 Deferred to. (04.12.2020 | |HQFie IRLAFile ~~—~—~—~——‘*{Lic.No/Date:0510415052 f loa5 :01/82/050/01602/AM21/ :05/24/040/00252/AM21/ 31.08.2020 Decision: | The Committee considered the case as per agenda in the presence of technical experts and it was decided to call for following information from the firm:

05/24/040/00252/AM21/ 31.08.2020 Decision: | The Committee considered the case as per agenda in the presence of technical experts and it was decided to call for following information from the firm:

(i) Chemistry, molecular weight from stating raw material of import Le. 1 of 7 _ Phosphorus Yellow.

{Case No.:102/4/82-ALC4/2020 [Party Name:ASTEC—~—~—~*[Meet No/Date:7/82- (Status: . LIFESCIENCES LTD ALC4/202004.12.2020 Deferred HOFile~~ (RLAFile~~~ {Lic.No/Date:0310838005 |tC }236 |:01/82/050/01603/AM21/ -1:03/94/040/00388/AM21/ 31.08.2020 (Decision: The Committee considered the case noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. |4/82-ALC4/2020we dated 18.09.2020, followed by Reminderas per agendato firmin‘theon presence16,10.2020 offortechnical expertsfurnishing a copy and itof 14.07 application as per policy circular no 23/2015-20 dated 15.05.2019. Hence, the case is deferred.

~~ [Case No.:103/4/82-ALC4/2020 |PartyLABORATORIESName:DHANUKALTD [MeetALC4/2020 No/Date:7/82Status:Deferred 237QFie ~~| ~~~ (RLAFile=~=~————~—~S~SCSCSLc.No/Datex0510415006104.12.2020 [ :01/82/050/01604/AM21/ {:05/23/040/00157/AM21/ 13.08.2020 Decision: “Deferred for comments of TE. . -_ _ a -_

CaseNo.:104/4/82-ALC4/2020 |PartyName:CADILA ~~ (Meet[No/Date:7/82-][ (Status:] HEALTHCARE LIMITED ALC4/2020 Deferred 04.12.2020 38HQFile ~~ ~'(RLAFie ~~~ {Lie.No/Date:0810148453 [| :01/82/050/01605/AM21/ :08/24/040/00157/AM21/ 101.09.2020 [Decision: DeferredforcommentsofTE.= = = =

E LIMITED ALC4/2020 Deferred 04.12.2020 38HQFile ~~ ~'(RLAFie ~~~ {Lie.No/Date:0810148453 [| :01/82/050/01605/AM21/ :08/24/040/00157/AM21/ 101.09.2020 [Decision: DeferredforcommentsofTE.= = = =

; , : ‘

[ 7 GaseNo.t108/4/82-ALC4/2020 [Party Name:SHARP MINT [Meet No/Date:7/82- (Status: LTD. ALC4/2020 Deferred : 04.12.2020 HQFile ———"REAFile. ~~ ——~S~S~C~CO_ {LieNo/Date:0510415091 [ |242 |:01/82/050/01609/AM21/ :05/24/040/00265/AM21/ 02.09.2020 | Decision: | The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 4/82-ALC4/2020 dated 18.09.2020, followed by Reminder to firm on 16.10.2020 for furnishing a copy of | |4.07 application as per policy circular no 23/2015-20 dated 15.05.2019, Hence, the case is deferred. —"TGase Noi86/7/82-ALC4/2020[PartyName‘SRIAMLABS[Meet No/Date:7/82-. Status: PRIVATE LIMITED ALC4/2020 Deferred 04.12.2020 43 OFile ~~~ IRLAFile ie. No/Date:0910069251 | |:01/82/050/01848/AM21/ :09/24/040/00346/AM21/ [23.09.2020 (Decision: This caseappeared for the first time before Norms Committee. Deferredfor comments of TE.


```text
|~~ GaseNo.:58/7/82-ALC4/2020 [PartyName:;GLENMARK[Meet No/Date:7/82-<br>(Status:<br>|<br>PHARMACEUTICALS LTD<br>= jALC4/2020<br>Deferred<br>|<br>[04.12.2020<br>|<br>“4nofile<br>[RLA FileLig.<br>No/Date:0310839024 \-<br>:01/82/050/01850/AM21/<br>{:03/94/040/00550/AM2.1/<br>10.10.2020<br>_ [Deeision:<br>This case appeared forthefirsttime before Norms Committee. Deferred forcommentsofTE.|
|---|
|—~TGase NoiI8LALC4/2020<br>[PartyName:MAHIMALIFE [MeetNo/Date:7/82-(Status:<br>|<br>SCIENCESPRIVATE<br>ALC4/2020<br>Deferred<br>LIMITED<br>(04.12.2020|
|Hoe<br>~~<br>(RLAFile———S*S*~*~*~S~S~SCSCS:C<br>icNo/Date20510415667 a<br>245 |:01/82/050/01793/AM21/<br>:05/24/040/00372/AM21/<br>28.10.2020<br>|<br>Decision: This case appeared forthe firsttime before Norms Committee. TheCommittee notedthatthe<br>4,07 applicationofsubjectAdvance Authorization isnot available. Hence, itwas decided to call for acopy<br>of4.07 application ofthe subject advance authorization directly from the firm as per Policy Circular No.|
|23/2015-20,dated15.05.2019.<br>.|
```





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, itwas decided to call for acopy<br>of4.07 application ofthe subject advance authorization directly from the firm as per Policy Circular No.|
|23/2015-20,dated15.05.2019.<br>.|
```





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~~ Case No.:2/7/82-ALC4/2020 {Party Name:RAJASTHAN [MeetNo/Date:7/82-(Status: ANTIBIOTICS LTD ALC4/2020 Deferred 04.12.2020 | HQFile ~~ ——~——~S™:CRLA Fle) =—SS™*~=<CS~S~*sS~S«i icN/Dates0510415685- | |246.|:01/82/050/01794/AM21/ :05/24/040/00385/AM21/28.10.2020 , a Decision: This case appeared for the first time before Norms Committee. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019. ; . a 

~~"[Gase[No.:3/7/82-ALC4/2020] [PartyName:AUROBINDO [MeetNo/Date:7/82-.(Status: |PHARMA LIMITED ae2020 Deferred (04.12.2020 HQFie ~~*'(RLAFile~~—~—S*~*~*~CSC:CSLicNc/Daate-0910069400 | 247 Decision:|:01/82/050/01795/AM21/This case appeared for:09/24/040/00372/AM21/ the first time before Norms Committee.—(28.10.2020The Committee noted that the 4,07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019.

n is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019. 

- [Case No.:6/7/82-ALC4/2020 PartyName:SATYADEVA (Meet No/Date:7/82- (Status: |PHARMACEUTICALS PVT = |ALC4/2020 Deferred ; | LTD 04.12.2020 a a} HQ File == TRAFile = -[ Lies No/Date:091 0069398. re rr 248 |:01/82/050/01798/AM21/ |:09/24/040/00429/AM21/ 28.10.2020 Decision: This case appeared for the first time before Norms Committee. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019, 

7[Case No.:9/7/82-ALC4/2020 [Party Name:ALEOR [Meet No/Date:7/82Status: | DERMACEUTICALS ALC4/2020 Deferred | LIMITED (04.12.2020 ae HQFile | [RLA File ~ (Eig. No/Date:3410046497[[] - 249 |:01/82/050/01801/AM21/ (:34/24/040/00205/AM21/ 28.10.2020 Decision: This case appearedfor the first time before NormsCommittThe Committe **e** notede.that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy | **l** of23/2 4. **0** 15-20,7 applicd **at** ioned 15.05.2019.of the subject advance authorization directly from the firm as per Policy| Circular No. 



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*0** 15-20,7 applicd **at** ioned 15.05.2019.of the subject advance authorization directly from the firm as per Policy| Circular No. 



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**----- Start of picture text -----**<br>
```text
||||||||||
|---|---|---|---|---|---|---|---|---|
|~[Case No.:4/7/82-ALC4/2020 |PartyName:NEULANDILABORATORIES|LTD|‘(MeetALC4/2020 No/Date:7/82-.—«|Status:‘Deferred|
|04.12.2020|
|20|QFile|RTA File|{Lie|No/Date:0910069406|
|:01/82/050/01796/AM21/|:09/24/040/00413/AM21/|(29.10.2020|
|Decision:|This|case|appeared for the|first time before Norms|Committee.|Deferred|for comments|of TE.|
```

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|[CaseNo.:5/7/82-ALC4/2020 [Party Name:HETERODRUGS [MeetNo/Date:7/82- (Status:<br>yo LIMITED |ALC4/2020 Deferred<br>| 104. 12.2020<br>251 HQFie|:01/82/050/01797/AM21/ = ————~*«SRLA|:09/24/040/00417/AM21/Pile ~~ {Lic.No/Date:0910069407i29.10.2020 |<br>**----- End of picture text -----**<br>


|Decision: This case appeared for the first time before Norms Committee. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019.

n is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019. 

| [Case[No.:7/7/82-ALC4/2020] [PartyPHARMACEUTICALSName:SUVEN MeetALC4/2020No/Date:7/82statu:Deferred 252 i LIMITED 104,12,2020 . . . . 1Q File. / IRLAFile = ~~——~—~—_[Lic.No/Date:0910069403 | / —_ |:01/82/050/01799/AM21/ |.09/24/040/00430/AM21/ 29.10.2020 | | |DeciThi **s** caseion:appeared forthefirst time before Norms Committee. Deferred for comments ofTE. 

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```text
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|---|---|---|---|---|---|---|
|CaseNo.:8/7/82-ALC4/2020|[Party|Name:BALAJI|AMINES|[Meet|[No/Date:7/82-]|[(Status:]|
|LIMITED||ALC4/2020|Deferred|
|}(04.12.2020|
|253|HQFie|:01/82/050/01 800/AM2|1/|RLAFie:31/83/040/00089/AM21/|[Lic.No/Date:3(29.10.2020|10067907|
```

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Decision: This case appeared for thefirst time before Norms Committee. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4,07 application of the subject advance authorization directly from the firm as per Policy Circular No, 23/2015-20, dated 15.05.2019. 



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07 application of the subject advance authorization directly from the firm as per Policy Circular No, 23/2015-20, dated 15.05.2019. 



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[Ease No.:10/7/82- ~~ Party Name: VIVIN DRUGS [Meet No/Date:7/82- ——s‘[Status:<br>JALC4/2020 & PHARMACEUTICALS = |ALC4/2020 Approved<br>| LIMITED 04.12.2020<br>HQFile ~*(RLAFile ~==~——~—_[Lic.No/Date:0910069414 a<br>:01/82/050/01802/AM21/ :09/24/040/00423/AM21/ [29.10.2020 '<br>| (Decision: The Committee considered the cases as per agenda ¢ [and] [in][ the] [light][ of][ earlier] [decision] [taken] [in]<br>meeting no. 7/82-ALC4/2019 dated 06.09.2019 against advance authorization No. 0910066857 dated<br>15.11.2018, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as<br>applied by the firm, whichever is less:<br>No.<br>2541 4-AMINO-2-OXO PYRIMIDINYL| 1 kg GLYOXYLIC ACID 50% __| 0.743 kg<br>|OXATHIOLANE-2- 2 2,5 DI HYDROXY 1,4 | 0.325kg<br>CARBOXYLIC ACID | DITHIANE<br>ISO PROPYL METHYL CYCLO CYTOSINE 0.428 kg<br>HEXYL ESTER (CEI-ID 4 HEXAMETHYL 0.509 kg<br>DISILAZANE<br>TRIETHYLAMINE 0.034 kg<br>, 6 METHYLENE 2.63 kg<br>|| CHLORIDEL-MENTHOL 0.751 kg .<br>DIMETHYL 0.316 kg<br>FORMAMIDE<br>. '9 | TRIPHOSGENE 0.40 kg<br>en oe IRA concerned_may.take. further. necessary action.as. per above decision OF NC. once ce e ce eeeeef ee<br>**----- End of picture text -----**<br>


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concerned_may.take. further. necessary action.as. per above decision OF NC. once ce e ce eeeeef ee<br>**----- End of picture text -----**<br>


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**----- Start of picture text -----**<br>
"(Case No.11/7/82-ALC4/2020 [PartyName:INCHEM<br>LABORATORIES PRIVATE‘(Meet |ALC4/2020No/Date:7/82-.—|Status:Deferred<br>| LIMITED 04.12.2020<br>PSO File. ~~ ~~ ~~—””—SIRLAFile~——~S~SO:”:”””—™S Lic.<br>[Decision::01/82/050/01803/AM21/This case appeared for:09/24/040/00371/AM21/ the first time before Norms—  Committee.29.10.2020NevDaates0940009415Deferred for comments[|  of [TE.]<br>| [Case No,112/7/82-ALC4/2020 - (Party Name:OPTIMUS [MeetNo/Date:7/82- (Status:<br>| DRUGS PRIVATE LIMITED (04.12.2020jALC4/2020 |Deferred<br>HQ File “IRLAFile [Lic.No/Date:0910009417 |<br>256 |:01/82/050/01804/AM2<br>1/ :09/24/040/00388/AM21/ 29.10.2020 . .<br>Decision:This case appeared for the first time before NormsCommittee, TheCommittee noted that the<br>4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy<br>of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No.<br>23/2015-20, dated 15.05.2019.<br>**----- End of picture text -----**<br>




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.07 application of the subject advance authorization directly from the firm as per Policy Circular No.<br>23/2015-20, dated 15.05.2019.<br>**----- End of picture text -----**<br>




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{Case No.:13/7/82-ALC4/2020|PartyName:OPTIMUS ‘(MeetNo/Date:7/82-. —s|Status: {DRUGS PRIVATE LIMITED |ALC4/2020 Deferred . [04.12.2020 | | {HQFile ~(RLAFile ~~ Lie.No/Date:0910069418 | 257 |:01/82/050/01805/AM21/ :09/24/040/00389/AM21/ 29.10.2020 Decision: This case appeared for the first time before Norms Committee. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4,07 application of the subject advance authorization directly from the firm as per Policy Circular No. |23/2015-20, dated 15.05.2019. 

| {CaseNo.114/7/82-ALC4/2020[PartyName:VEKO PRIVATE LIMITEDCARE [MeetALC4/2020No/Date:7/82——‘|Status:‘Deferred Le,HQFile | |(|RLAFile” ee Lic.04.12.2020No/Date:3110067911 [| 258 |:01/82/050/01806/AM21/ :31/83/040/00085/AM21/ 29.10.2020 | | ‘Decision: This case appeared for the first time before Norms Committee. The Committee noted that the (4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy lof 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. [23/2015-20, dated 15.05.2019. .

is not available. Hence, it was decided to call for a copy lof 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. [23/2015-20, dated 15.05.2019. . “[Case No.:15/7/82-ALC4/2020 [Party Name:CLEAN SCIENCE [Meet ALC4/2020 {Deferred | |AND[TECHNOLOGY] No/Date:7/82-—|Status: ~| [PRIVATE LIMITED 04.12.2020 | {HQFie (RLAFie {Lic.No/Date:3110067912| 02.11.2020 | 959 }:01/82/050/0 1807/AM21/ :31/83/040/00087/AM2[1/] [Decision: The Committee considered the case as per agenda in. the presence of technical experts and it jwas decided to call for following information from the firm: 

(i) Quantity and value of By-Product i.e. Mixed Mono Cresols & Acetic Acid against 1 Tonne of Export. _ (Case No.:16/7/82-ALC4/2020 Party Name:GLAND—~—S/ MeetNo/Date:7/82-. (Status: PHARMA LIMITED jALC4/2020 Deferred | 04.12.2020 - | 200QFie "(BLA File Lic.No/Date:0910069419 | |:01/82/050/01808/AM21/ 1:09/24/040/00428/AM21/ lo2.11.2020 [DeciThi **s** caseion:appeared for the first time before Norms Committee. Deferredfor comments of TE. 

[Ease No.17/7/82-ALC4/2020 (Party Name:SRIAMLABS (MeetNo/Date:7/82- (Status:| IPRIVATE LIMITED ALC4/2020 Deferred | 04.12.2020 olgFile ~~~ IRLAFileSCS ~~ [Lic.No/Date:0910069426 - :01/82/050/01809/AM21/ :09/24/040/00432/AM21/ (02.11.2020 |Decision: ~ This case appeared for the first time before Norms Committee. Deferred for comments of TE. 



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. Deferred for comments of TE. 



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Case No.:18/7/82Party Name:CIPLA Meet No/Date:7/82Status: ALC4/2020 ‘LIMITED. ‘ALC4/2020 ‘Approved : HQ File RLA File 7 ‘Lic.No/Date:03 10839254 a -:01/82/050/01810/AM21/ -03/94/040/00593/AM21/ 02.11.2020 Decision; The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 6/82-ALC4/2018 dated 26.07 2018 against advance authorization No, 03 10813433 dated | 22.05.2017, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as | applied by the firm, whichever is less: | Export Product Qty. Sl. | Import Items Qty. No. Triamist Nasal Spray (120 MD) j | Number ] Triamcinolone Acetonide 6.732 mg[/] / Triamcinolone Acetonide | Pack a : pack 55mcg Nasal Spray (120 MD) 2 PUMP VP3/100 FCS 20MM| Relevant as | Each Spray delivers: 3 20ML WHITE OPAQUE | per packing | | Triamcinolone Acetonide HDPE VIAL WITH 20MM policy | 55mcg NECK FINISH 4 NASAL ACTUATOR ; ~ RA concerned may take further necessary action as per above desision of NC. Case No.:19/7/82-ALC4/2020 ‘Party Name:ENCUBE Meet No/Date:7/82-. Status: | ETHICALS PVT LTD -ALC4/2020 ‘Deferred | 04.12.2020 HO File monn eerennennnncnamng igs iat face ce menamnenmennnnnnnns on mde Ng Pate: 031083 9257 wesc hn 263 :01/82/050/0181 1/AM21/ :03/94/040/00500/AM2 1/ 02.11.2020 : Decision: This case appeared for the first time before Norms Committee.

ace ce menamnenmennnnnnnns on mde Ng Pate: 031083 9257 wesc hn 263 :01/82/050/0181 1/AM21/ :03/94/040/00500/AM2 1/ 02.11.2020 : Decision: This case appeared for the first time before Norms Committee. The Committee noted that the 4.07 application of[subject][ Advance][Authorization][is][not][available.][Hence,][it][ was][decided][to][call][for][a][copy] | of 4,07 application of the subject advance authorization directly from the firm as per Policy Circular No. ; 23/2015-20, dated 15.05.2019. ' 

262 

Case No.:26/7/82-ALC4/2020 Party Name:ADCOCK Meet No/Date:7/82‘Status: INGRAM LTD, ALC4/2020 ‘Deferred ‘04.12.2020 HQ File RLAFile Lic.No/Date:0710117218 | / 264 :01/82/050/01 812/AM21/ :07/24/040/00218/AM21/ 03.11.2020 ; Decision: ‘This case appeared for the first time before Norms Comm ittee. The Committee noted that the , 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy” of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019. 



84 

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| : 

oo . ; , ; 

, ; 

.

to call for a copy” of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019. 



84 

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| : 

oo . ; , ; 

, ; 

. 

Case No.:21/7/82-ALC4/2020 Party Name: ADCOCK. Meet No/Date:7/82Status; INGRAM LTD, ALC4/2020 Deferred — : : . 04.12.2020 HQ File -RLA File ‘Lic.No/Date:0710117219 ; 265 :01/82/050/01813/AM21/ 07/24/040/00217/AM21/ 03.11.2020 : | Decision: This case appeared for the first time before Norms Committee. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call fora copy , of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019. 

. 

| 

. 

Case No.:22/7/82-ALC4/2020 Party Name:M/S Meet No/Date:7/82Status: | ‘HIMALAYAN PRODUCTS & jALC4/2020 ‘Deferred; INDUSTRIES CORPN., P.LTD 04.12.2020 ‘HQ File RLA File Lic,No/Date:0510415723 - 266 :01/82/050/01814/AM21/ 105/24/040/00396/AM21/ 03.11.2020 , i Decision: This case appeared for the first time before Norms Committee. The Committee noted that the : 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. | 23/2015-20, dated 15.05.2019.

n is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. | 23/2015-20, dated 15.05.2019. | Case No,:23/7/82-ALC4/2020 Party Name:STERILE INDIA Meet No/Date:7/82‘Status: PRIVATE LIMITED ALC4/2020 Approved 04.12.2020 HQ File _ RLA File Lic.No/Date:0510415732 | | :01/82/050/01815/AM21/ '05/24/040/00397/AM21/ ‘03.11.2020 _ meetingDecision:no. |The4/82-ALC4/2018 Committee considereddated 19.06.2018the cases asagainstper agendaadvance and authorizationin the light of earlierNo. 0510405492decision takendatedin|| 267 02.02.2018, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Export Product “Oty. SI. Import Items Qty. : | No. : CEFEPIME FOR I kg | CEFEPIME HCL (NON STERILE) | 0.655 kg INJECTION _ _ jo 


Case No.:24/7/82-ALC4/2020 Party Name: ALPHAMED ‘Meet No/Date:7/82Status: | ‘FORMULATIONS P LTD. ALC4/2020 ‘Deferred : 04.12.2020 268 HQ:01/82/050/01816/AM21/File £09/24/040/004RLA File 10/AM2 1/ Lic.No/Date:091006942903.11.2020 : 

Decision: This case appeared for the first time before Norms Committee. The Committee noted that the 4.07 application of subject Advance Authorization is not available, Hence, it was decided to call for a copy : of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. : 23/2015-20, dated 15.05.2019, 



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cation of the subject advance authorization directly from the firm as per Policy Circular No. : 23/2015-20, dated 15.05.2019, 



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~[Case No.:25/7/82-ALC4/2020 |PartyLIMITED [Name:HONOUR] LAB [MeetNo/Date:7/82-ALC4/2020 - Deferred(Status:<br>04.12.2020<br>| |HQFilea  ~—~—~—~—S*{RLAFile=——~C~*~S~SCSa Lic.No/Dates0910009433 |.<br>269 |:01/82/050/01817/AM21/ | :09/24/040/00404/AM21/ 03.11.2020<br>Decision: This case appeared for the first time before Norms Committee. The Committee noted that the<br>4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy<br>of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No.<br>23/2015-20, dated 15.05.2019.<br>**----- End of picture text -----**<br>


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[<br>[Case No.:26/7/82-ALC4/2020 {Party No.:26/7/82-ALC4/2020 {Party {Party Name:AARTI DRUGS [Meet No/Date:7/82- ‘Status:<br>LIMITED ALC4/2020 Deferred<br>04.12.2020<br>{270 HQ File ~~ IRL File a Lic,No/Date:0310839307 | _<br>|:01/82/050/01818/AM21/ :03/94/040/01085/AM20/ 04.11.2020<br>Decision: This case appeared for the first time before Norms Committee, The Committee noted that the<br>| | ‘|4.07lof 4.07applicationapplicationof subjectof the subjectAdvanceadvanceAuthorizationauthorizationis not available.directly fromHence,the itfirmwasasdecidedper Policyto callCircularfor a copyNo.<br>|23/2015-20, dated 15.05.2019.<br>**----- End of picture text -----**<br>


. 

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,the itfirmwasasdecidedper Policyto callCircularfor a copyNo.<br>|23/2015-20, dated 15.05.2019.<br>**----- End of picture text -----**<br>


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[| "|Case No.:27/7/82- -—_—‘[Party Name: ASHISH LIFE. [MeetNo/Date:7/82-ALC4/2020 (Status:<br>|[ALC4/2020 SCIENCE PRIVATE 04.12.2020 Approved<br>| LIMITED<br>we JQ File IRA File [Lie No/Date:0310839310....0 0<br>|:01/82/050/01819/AM21/ —_|:03/94/040/00589/AM21/ [04.11.2020<br>Decision: |The Committee considered case as per agenda in the presence of the technical experts and it.<br>was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. 1 as per details below or<br>as applied by firm whichever is lower:<br>271 No.<br>| BENZYL PENICILLIN FOR | 893600.000 | 1 BENZYL PENICILLIN | 2948.90 kg<br>| INJECTION 5 MEGA (EACH | Number SODIUM<br>VIAL CONTAINS BENZYL RAW MATERIAL<br>PENICILLIN SODIUM<br>3.00GM EQ. TO 5000000<br>UNITS)<br>(3000MG)(NET CONTENT<br>OF EXEMPTED MATERIAL<br>IS 2680.800 KGS)<br>RA concerned may take further necessary action as per above decision of NC.<br>**----- End of picture text -----**<br>




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.800 KGS)<br>RA concerned may take further necessary action as per above decision of NC.<br>**----- End of picture text -----**<br>




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[CaseNo.:28/7/82-ALC4/2020 [PartyName:SREEPATHI [MeetNo/Date:7/82- —-|Status:<br>PHARMACEUTICALS LTD — |ALC4/2020 Deferred<br>:P72 HO File ; ~~ IRLA File a {Lic,04.12.2020No/Date:09 10069435<br>|:01/82/050/01820/AM21/ :09/24/040/00442/AM21/ (04.11.2020<br>|Decision: This case appeared for the first time before Norms Committee. Deferred | [for][ comments] [of][ TE.]<br>[Ease No29/7/82-~—~—~~*(Party Name:USV PRIVATE [Meet No/Date:7/82-—Ss([Status:<br>ALC4/2020 LIMITED ALC4/2020 [Approved<br>. 04.12.2020 |<br>HQ File<br>—— (RLA File ~ Lic.No/Date:0310839333. [|<br>:0.1/82/050/01821/AM21/ :03/95/040/00496/AM21/ 04.11.2020<br>Decision: The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or<br>as applied by firm whichever is lower:<br>Sl. | Export Product Si. | Import items Qty.<br>273| No.

ded to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or<br>as applied by firm whichever is lower:<br>Sl. | Export Product Si. | Import items Qty.<br>273| No. No.<br>1 Perphenazine Tablets USP 4 mg | 1164000,.000 Perphenazine USP 23.68 kg<br>100 $ Tablets<br>(11,640 Bottles x 100 Per Bottle<br>= 11,64,000 Tablets) (Net<br>Content Weight = 4.656 kg)<br>2 Perphenazine Tablets USP 8 mg | 2320000.000<br>1008 Tablets<br>( 23,200 Bottles x 100 Per Bottle<br>= 23,20,000 Tablets) (Net<br>Content Weight = 18.560 kg)<br>RA concerned may take further necessary action as per above decision of NC,<br>~ "Case [No.:30/7/82-ALC4/2020]<br>|Party Name:AMI ORGANICS — [Meet NofDate:7/82- (Status: |<br>LIMITED jALC4/2020 Approved<br>(04.12.2020<br>HQFie |RLAFie ~~{Lic.No/Date:52 10043588<br>:01/82/050/01822/AM21/ :52/24/040/00064/AM2 1/ 04.1 1.2020<br>Decision:The Committee considered the casesasper agendaand in the light of earlier decision taken in.<br>meeting no. 10/82-ALC4/2019 dated 29.11.2019 against advance authorization No. 5210043197 cate<br>274 09.10.2019, it was decided to ratify norms under Para 4.07 of HBP Vol. 1 as per details given below or as<br>applied by the firm, whichever is less:<br>No.<br>TERT- BUTYL 1-PIPERAZINE Lkg 1 DI - TERT BUTYL | 1.94 kg<br>CARBOXYLATE (1-BOC DICARBONATE<br>PIPERAZINE) PIPERAZINE ANHYDROUS<br>**----- End of picture text -----**<br>


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-"TGase No.i31/7/82-ALC4/2020[PartyName:SUVEN ALC4/2020 Deferred PHARMACEUTICALS [MeetNo/Date:7/82- (Status: J. |LIMITED 04.12.2020 275OFile ~~~ ~~ '(IRLA#ile~~——S~S~SCSCSC*S LicNo/Dates0910069441 —_ :01/82/050/01823/AM21/ :09/24/040/00445/AM21/ 04.11.2020 |Decision: ‘This case appeared for the first time before Norms Committee, Deferred for comments ofTE. 

r"\Gase No.:32/7/82-ALC4/2020[PartyName:BHARAT[MeetNo/Date:7/82-(Status: SERUMS AND VACCINES — |ALC4/2020 Deferred LIMITED 04.12.2020 276 HQFile|:01/82/050/01824/AM21/ “TIRLAFile|:03/94/040/00594/AM21/ [Lie.No/Date:03}05.11.2020 10839355 t - Decision:This case appearedfor the first time before Norms Committee. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019. [77 |Gase No.:33/7/82~~—~”~«(Party[Name:ENALTEC][[Meet][ No/Date:7/82-][(Status:] ALC4/2020 LABS PRIVATE LIMITED j|ALC4/2020 Approved 04.12.2020 HQ File ~~ TRLA File - Lic.

2015-20, dated 15.05.2019. [77 |Gase No.:33/7/82~~—~”~«(Party[Name:ENALTEC][[Meet][ No/Date:7/82-][(Status:] ALC4/2020 LABS PRIVATE LIMITED j|ALC4/2020 Approved 04.12.2020 HQ File ~~ TRLA File - Lic. No/Date:03 10839357 | :01/82/050/01825/AM21/ :03/94/040/00600/AM2 1/ 05.11.2020 (Decision: The Committee considered case as per agenda inthe presenceof the technical experts and it P iwas decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or 277 P applied by firm whichever is lower: Product caS| [Inport — _—| [Export Product | No. items capa Febuxostat lkg 1 2-[3-Cyano-4-(2-Methylpropoxy) Phenyl]-4- | 1.512 kg Methyl-5-Thiazolecarboxylic Acid Ethyl Ester IRA concerned may take further necessary action as per above decision of NC. ‘|Case No.:34/7/82-ALC4/2020 Party Name:AARTI DRUGS [MeetNo/Date:7/82- (Status: | |LIMITED ALC4/204.12.2 **02** 00 Deferred. HQFile ~—~——«&[RLA File : Lic.No/Date:03 10839361 | 278 |:01/82/050/01826/AM21/ |:03/94/040/00596/AM21/ 05.11.2020 (Decision: This caseappearedfor the first time[‘before][Norms][ Committee.] The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No.. 153/2015-20, dated 15.05.2019. . 



88 

, ;

e. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No.. 153/2015-20, dated 15.05.2019. . 



88 

, ; 

~~" {CaseNo.:35/7/82-ALC4/2020 [Party Name:AARTIDRUGS [Meet No/Date:7/82(Status: LIMITED ALC4/2020 Deferred 04.12.2020 | HQFie (RLAFile [Lic.No/Date:03 1[0839362][ [] 279 |:01/82/050/01827/AM21/ :03/94/040/00597/AM21/ (05.11.2020 

Decision: This case appeared for the first time before Norms Committee. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. (23/2015-20, dated 15.05.2019, 

~~ CaseNo.:42/7/82-ALC4/2020 [PartyName:DEEPAK ——‘([Meet No/Date:7/82- (Status: Jo ‘PHENOLICS LIMITED ALC4/2020 Deferred 7 104,12.2020 HQ File 280 |:01/82/050/01834/AM21/OO [Rta:34/24/040/00202/AM21/ File **~** |Lic.No/Date:3410046526(05.11.2020 | Decision: This case appeared for the first time before Norms Committee. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4,07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019.

n is not available. Hence, it was decided to call for a copy of 4,07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019. 

~~” [Case No.:43/7/82-ALC4/2020|PartyName:TIDE ~—~—~—«([Meet No/Date:7/82- —S[Status: INDUSTRIES ALC4/2020 Deferred (04.12.2020 281 HQFile [RLA File (Lic. No/Date:3410046524 a }:01/82/050/01835/AM21/ :34/24/040/00204/AM21/ j05.11.2020 | Decision:This case appearedfor the first time before Norms Committee. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy jof 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. (23/2015-20, dated 15.05.2019. 



89 

/ 

CaseNo.:36/7/82-ALC4/2020 |PartyAUXILIARIESName:STERLINGPVT LTD [Mest No/Dete:7/82-ALC4/2020 DeferredStatus: 04.12.2020 HQFile ~~ (RLAFile ~~~ [Lic.No/Date:0310839386 [| 282 |:01/82/050/01828/AM21/ :03/95/040/00492/AM21/ 06.11.2020 , . Decision: This case appeared for the first time beforeNorms Committee. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. _ {23/2015-20, dated 15.05.2019.

s not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. _ {23/2015-20, dated 15.05.2019. 

© [Case Nowi37/1/82-ALC4/2020 Party Name:EAST AFRICAN [Meet No/Date:7/82- ‘Status: 04.12.2020 | (INDIA) OVERSEAS ALC4/2020 Deferred HQFile |RLAFile ~ {Li¢.No/Date:0510415769 - 283 |:01/82/050/01829/AM21/ :05/23/040/00263/AM21/ 06.11.2020 Decision:This case appeared for the {first time before Norms Committee. The[Committee][noted][that][the] 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy | jof 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. {23/2015-20, dated 15.05.2019, . - | 

| [Case fos38/782-AL.CAz020 Party Name: VERVE HUMAN [Most No‘Dats 7/82 Status: i | i (04.12.2020 | | (HQFie (RLAFile ~ |Lic.No/Date:0510415764 | 284 |:01/82/050/01830/AM21/ :05/24/040/00390/AM21/ 06.11.2020 [Decision: ~ This case appeared for the first time before Norms Committee. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019. a | | 



90 

.

e. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019. a | | 



90 

. 

["|Case No.:39/7/82-ALC4/2020 Party Name:VERVE HUMAN |Meet No/Date:7/82- (Status; CARE LABORATORIES ALC4/2020 Deferred loa, 12,2020 | |HQFile {285 ~~——~<CS~S:*SRLA Fle = S—S™S~SCSC Lic. N/Datez0510415763 [ |:01/82/050/0183 1/AM21/ 05/24/040/00391/AM21/ (06.11.2020 pO Decision: This caseappearedfor the first time before Norms Committee. The Committeenoted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy jof 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019. 

```text
|~~ “[CaseNo.:40/7/82-ALC4/2020|[PartyName:SUN—~—S*([MeetNo/Date:7/82-(Status:|(Status:|
|---|---|---|
||PHARMACEUTICAL<br>ALC4/2020|Deferred|
||INDUSTRIES LTD.<br>04.12.2020||
|HQFile<br>~<br>286 |:01/82/050/01832/AM21/|IRLA File<br>~~[Lic.No/Date:0510415761<br>:05/24/040/00405/AM2 1/<br>|06.11.2020|-|
|Decision: “Thiscaseappeared for thefirsttimebefore NormsCommittee. TheCommitteenotedthatthe<br>'4.07 application ofsubjectAdvance Authorization is notavailable. Hence, it was decided to call fora copy|||
|of4.07 application ofthe subject advance authorization directly from the firm as per Policy||Circular No.|
|23/2015-20,dated15.05.2019.|||
```



, 



91 

- 

. | : 

| 

**==> picture [509 x 636] intentionally omitted <==**

ject advance authorization directly from the firm as per Policy||Circular No.|
|23/2015-20,dated15.05.2019.|||
```



, 



91 

- 

. | : 

| 

**==> picture [509 x 636] intentionally omitted <==**

**----- Start of picture text -----**<br>
```text
|||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|||[Case No.:41/7/82-|Party Name:INTAS|Meet No/Date:7/82-|Status:|
||ALC4/2020|PHARMACEUTICALSLTD.|ALC4/04.12.|20|2020|Approved|
|JHQ|File|RLA|File|Lic.No/Date:0810149014|
|:01/82/050/01833/AM21/|:08/24/040/00192/AM21/|06.11.2020|
|Decision:|| The The|Committee|considered|case|as|per|agenda|in|the|presence|of the the|technical|experts|and|
|was|decided|to|ratify|the|ad-hoc|input|output|norms|under|para 4.07 4.07|of HBP HBP|Vol.|I|as|per|details|below|
|as|applied by by|firm|whichever|is|lower:|
|i|0.|No,|
|1|| PACLITAXEL|2306436.000|
|INJECTION|USP|:|| Number|1,5-BIS{[DI|ISOPROPYL-(+)-|4-|
|6|MG/ML,|5ML|PHENYL-2-AZETIDINONE-3-|
|VIAL|HYDROXY-SILYL]PENTANE|
|NET|CONTENTS|
|OF|PACLITAXEL|4|5/16.7/50|ML|GLASS|VIALS|||Relevant|as|
|PH.EUR.|—|69,193|(AS|PER|GENERAL|NOTE|FOR||per|_|packing|
|KGS.|CHEMICALS|&|ALLIED ||policy|
|PRODUCTS)|
|5|13|MM/20|MM|RUBBER|STOPPERS|
|||PACKING13.|MM/20 MATERIAL)MM|FLIP|OF|SEAL|
|P(e Seer|
|fo|PACKING(AS|PER|MATERIAL)GENERAL|POLICY|FOR|
|if|PACLITAXEL|716550,000|
|||||INJECTION|USP|:|| Number|2|1,5-BIS[DI|ISOPROPYL-(+)-|4-|||58,130 kg|
|oo(287|||ae6 MG/ML,|16.7ML|7|PHENYL-2-AZETIDINONE-3-yr oxy-SILYLIPENTANE ||
|i|NET|CONTENTS|
|OF|PACLITAXEL|4|5/16.7/50|ML|GLASS|VIALS ||Relevant|as|

mber|2|1,5-BIS[DI|ISOPROPYL-(+)-|4-|||58,130 kg|
|oo(287|||ae6 MG/ML,|16.7ML|7|PHENYL-2-AZETIDINONE-3-yr oxy-SILYLIPENTANE ||
|i|NET|CONTENTS|
|OF|PACLITAXEL|4|5/16.7/50|ML|GLASS|VIALS ||Relevant|as|
|KGS.|CHEMICALS|&|ALLIED||policy|
|PH.EUR.|— 71.798|-|PRODUCTS)(AS|PER|GENERAL|NOTE|FOR||per|_ packing|
|5|13|MM/20|MM|RUBBER|STOPPERS|
|PACKING|MATERIAL)|
|7|[Seer]|Ee|
|(AS|PER|GENERAL|POLICY|FOR|
|aaPACKING MATERIAL)|
|B|||PACLITAXELINJECTION|240799.000|[1||TAXUSBACCATA| 52000,147 kg ||
|6VIAL|USP|:|||Number||2|HYDROXY-SILYL]PENTANE1,5-BIS[DI_|ISOPROPYL-(+)-|—4-|| 58.130 kg|
|||NETMG/ML,CONTENTS50ML|PHENYL-2-AZETIDINONE-3-|
|||OF|PACLITAXEL|4|5/16.7/50|ML|GLASS|VIALS ||Relevant.|as|
|PH.EUR.|72,24|(AS|PER|GENERAL|NOTE|FOR||per|packing|
|KGS|CHEMICALS|&|ALLIED||policy|
|PRODUCTS)|
|(AS|PER|GENERAL|POLICY|FOR|
|PACKING|MATERIAL)|
|[aes13.|MM/20|MM|FLIP|OF|SEAL|
|IRA|concerned|may|take|further|necessary|action|as|perPACKINGabove|decision MATERIAL)of|NC.|
```

**----- End of picture text -----**<br>


Decision: | The The Committee considered case as per agenda in the presence of the the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 4.07 of HBP HBP Vol. I as per details below or as applied by by firm whichever is lower: 



92

the the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 4.07 of HBP HBP Vol. I as per details below or as applied by by firm whichever is lower: 



92 

```text
||~~|GaseNo.:44/7/82-ALC4/2020|[Party Name:SRF LIMITED<br>[MeetNo/Date:7/82-(Status:<br>ALC4/2020|(Status:<br>Deferred|
|---|---|---|---|
|||-<br>(04.12.2020<br>'||
|||[HQ File<br>~~<br>288 |:01/82/050/01836/AM21/<br>Decision:<br>This case appeared|IRLAFile<br>~<br>[Lic.No/Date:0510415782<br>oo<br>:05/24/040/00395/AM21/<br>09.11.2020<br> for the firsttimebeforeNormsCommittee. TheCommittee noted thatthe||
||4,07 application ofsubject Advance Authorization is not available. Hence, it was decided to cail for acopy|||
||of4.07 application ofthe subject advance authorization directly from the firm as per Policy||Circular No.|
||23/2015-20,dated15.05.2019.|+||
```



**==> picture [454 x 118] intentionally omitted <==**

**----- Start of picture text -----**<br>
TCase No:45/7/82-~~—~«S(iPartyName:FDCLYD [Meet No/Date:7/82-(Status: =<br>ALC4/2020 |ALC4/2020 |Approved<br>oe 04.12.2020 |<br>HQFile | (RLAFile |Lic.No/Date:0310839409 |<br>:01/82/050/01837/AM21/ :03/94/040/00614/AM21/ (09.11.2020<br>Decision: The Committee considered thecasesas per agenda and in the light of earlier decision taken in<br>meeting no. 10/82-ALC4/2019 dated 29.11.2019 against advance authorization No. 0310831779 dated<br>289 |25.09.2019, it was decided to ratify norms under Para 4.07 of HBP Vol.

ier decision taken in<br>meeting no. 10/82-ALC4/2019 dated 29.11.2019 against advance authorization No. 0310831779 dated<br>289 |25.09.2019, it was decided to ratify norms under Para 4.07 of HBP Vol. 1 as per details given below or as<br>applied by the firm, whichever is less:<br>**----- End of picture text -----**<br>


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**----- Start of picture text -----**<br>
No.<br>| |BRIMONIDINE TARTRATE EYE | 1Number | 1 BRIMONIDINE — L- | 0.0102<br>DROPS 0.2% W/V S5ML TARTRATE gm/vial<br>**----- End of picture text -----**<br>



**==> picture [455 x 178] intentionally omitted <==**

**----- Start of picture text -----**<br>
~~ CaseNo.:46/7/82-ALC4/2020 Party NameALTA Meet No/Date:7/82- ~|Status:<br>|LABORATORIES LIMITED j04.12.2020 jALC4/2020 |Approved<br>HQFie ~~ ~'(RLAFile ~~—~——-—*(Lic.No/Date:0310839428 [<br>:01/82/050/01838/AM21/ :03/94/040/00622/AM21/ 09.11.2020 |<br>Decision: The Committee considered the case as per agenda in the presence of technical experts and it<br>290 \was decided to ratify norms under Para 4.07 of HBP Vol. 1 as per details given below or as applied by the.<br>firm, whichever is less: .<br>No.<br>.<br>he concernedSODIUM SALICYLATE may take further necessaryfikgaction  |1 as per above[| SALICYLICdecision of NC. ACID 0.80kg |<br>**----- End of picture text -----**<br>




| 

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urther necessaryfikgaction  |1 as per above[| SALICYLICdecision of NC. ACID 0.80kg |<br>**----- End of picture text -----**<br>




| 

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**----- Start of picture text -----**<br>
~ [Case No.:47/7/82-ALC4/2020 |PartyName:AUROBINDO{Meet [No/Date:7/82-][ (Status:]<br>IPHARMA LIMITED |ALC4/2020(04.12.2020 Deferred<br>291 [HQFile}:01/82/050/01839/AM21/~———s—<“—s~s*é‘;™*C‘*SRAQRle~SS”S*S*~*~S*S*«wL:09/24/040/00455/AM2I/ 09.11.2020ie NoDaate 0910009458 | -<br>Decision: This case appeared for the first time before Norms Committee. The Committee noted that the<br>4,07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy<br>of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No.<br>23/2015-20, dated 15.05.2019.<br>||Case [No.:48/7/82-ALC4/2020] (PartyName:AETHER (Meet No/Date:7/82. ‘(Status<br>INDUSTRIES LIMITED ALC4/2020 ‘Deferred<br>04,12,2020<br>HQFie “(RLAFile = ————~—~—~—~—~—~—«S[ Lic.No/Date:5210043591.  | -<br>292 Decision:|:01/82/050/01840/AM2t/ :52/24/040/00060/AM21/ 09.11.2020 |<br>4.07 This case appeared for the first time before Norms Committee.The Committee noted that the<br>, application of subject Advance Authorization is not available.

2/24/040/00060/AM21/ 09.11.2020 |<br>4.07 This case appeared for the first time before Norms Committee.The Committee noted that the<br>, application of subject Advance Authorization is not available. Hence, it was decided to call for a copy<br>of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No.<br>23/2015-20, dated 15.05.2019,<br>|| [Case No.:51/7/82-ALC4/2020 [PartyPHARMAName:SYNNAT PRIVATE MeetALC4/2020No/Date:7/82- (Status:Approved<br>| | (LIMITED 04.12.2020<br>——-} [HQ1:0.1/82/050/01843/AM21/File— RE:02/24/040/00099/AM21/Bile gate109.1 1.2020  02 T02 10004 [on<br>(Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>793 meeting no. 6/82-ALC4/2019 dated 16.08.2019 against advance authorization No. 0210209260 dated<br>17,06.2019, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as<br>applied by the firm, whichever is less:<br>No,<br>Noscapine BP USP Ph.Eur JP CP /| | ke 1 Noscapine Crude Content 95% 110kg |<br>Noscapine Hydrochloride BP Ph.Eur<br>RA concerned may take further necessary action as per above decision of NC.<br>**----- End of picture text -----**<br>




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ide BP Ph.Eur<br>RA concerned may take further necessary action as per above decision of NC.<br>**----- End of picture text -----**<br>




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“TESS Noi49/7/82.ALC4/2020 [PartyName:SUN—~—~—~*(Meet No/Date:7/82-. (Status:<br>PHARMACEUTICAL ALC4/2020 Approved<br>INDUSTRIES LTD. 04.12.2020<br>HQFie ‘(RLAFile —_ [Lic.No/Date:0510415816<br>:01/82/050/0184 1/AM21/ :05/24/040/004 12/AM21/ (10.11.2020<br>Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>Imeeting no. 10/82-ALC4/2019 dated 29.11.2019 against advance authorization No. 0510412089 dated<br>11.10.2019, it was decided to ratify norms under Para 4.07 of HBP Vol. 1 as per details given below or as<br>, applied by the firm, whichever is less:<br>| Export product Qty. Si. | Import items Qty. per 5 ml<br>No, vial<br>294|Dorzolamide and Timolol|1Number |1 |DORZOLAMIDE 117,095 mg<br>|<br>| Ophthalmic Solution, 2.0%w/v + HYDROCHLORIDE<br>0.5%w/V, 5ml 2 TIMOLOL MALEATE 35.70 mg<br>. (TIMODOL Sterile Eye Drops)<br>(LOFTEMIDE) (Each ml contains<br>Dorzolamide Hydrochloride<br>equivalent to Dorzolamide 20 mg<br>(Equivalent to 1.300 Kg of Bulk<br>Drug), and Timolol Maleate<br>equivalent to Timolo! 5.0 mg<br>(Equivalent to 0.325 Kg, of Bulk<br>Drug<br>| [RA] [concerned][ may] [take][ further] [necessary] [action] [as] [per][ above] [decision] [of][ NC.]<br>ee NoIS0/7/82. (Party Name:SUN—~—~*(MeetNo/Date:7/82-.

alent to 0.325 Kg, of Bulk<br>Drug<br>| [RA] [concerned][ may] [take][ further] [necessary] [action] [as] [per][ above] [decision] [of][ NC.]<br>ee NoIS0/7/82. (Party Name:SUN—~—~*(MeetNo/Date:7/82-. —s(Status: |<br>|ALC4/2020 PHARMACEUTICAL ALC4/2020 Approved<br>INDUSTRIES LTD. 04.12.2020<br>HQFie|01/82/050/01842/AM21/ FRA|:05/24/040/00413/AM21/ Fie _ “WLicNo/Date:051041581710.11.2020  |<br>Decision: |The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4,07 of HBP Vol. I as per details below or<br>as applied by firm whichever is lower:<br>295<br>No.<br>Nepafenac Ophthalmic Suspension, 0.1% | 15000.000 | 1 Nepafenac 76.5 Gram<br>w/v NEPALACT Sterile Eye Drops, Sml) |Number<br>Nepafenac 1.0 mg (Equivalent to 75.000<br>| (PRANAYAM) (Each ml contains<br>baGram [concerned]  ofBulk [ may]  Drug) [ take] [further][ necessary] [action] [as][ per][ above][ decision] [of][NC.]<br>**----- End of picture text -----**<br>




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