IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2019-01-14

DGFT Committee Minutes

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Office of Directorate General of Foreign Trade New Delhi -0

Para 4.7 Decision

Minutes of the Meeting No. 13/82-ALC4/2018 dated 14.01.2019 (actually held on 22.01.2019, 23.01.2019 and 07.02.2019) for considering the cases/issues under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy, 2015-20 pertaining to Chemical and Allied products falling under Chapter 29 and 30, held under the Chairmanship of Shri Satyan Sharda, Addl. DGFT in Room No.11, Udyog Bhawan, New Delhi.

Following members were present:-

Shri Nirmal Kumar, Dy. Director General of Foreign Trade Shri S.K. Pangrahi, Economic Officer Consultant, Technical Expert Pharmaceuticals Consultant, Technical Expert Chemicals

The committee went through the minutes of earlier meeting No. 12/82-ALC4/2018 MEETING DATE : 12.12.2018 (actually held on 13.12.2018, 14.12.2018 and 04.01.2019)and approved the same.

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----- Start of picture text ----- MEETING NUMBER : 13/82-ALC4/2018 MEETING DATE: 14.01.2019 (actually held on 22.01.2019, 23.01.2019 and 07.02.2019) Case No.:167/13/82- Party Name:VIVEK Meet No/Date:13/82- Status: ALC4/2018 PHARMACHEM (INDIA) ‘ALC4/2018 Approved LED. 14.01.2019 HQ File RLA File Lic.No/Date: 13 10043417 :01/82/050/01145/AM19/ :13/24/040/00031/AM12/ 19.06.2013 Decision: The Committee considered case as per agenda and in the presence of the technical experts, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: 1 Export product Qty. Sl. | Import items Qty. No. HYDROCORTISONE 1 Number HYDROCORTISONE 110 mg / vial SODIUM SUCCINATE FOR SODIUM SUCCINATE INJECTION USP 100mg STERILE BUFFERED (Blend of Hydrocortisone Sodium Succinate USP & 2 VIALSSterile Sodium Carbonate) | Relevant__ as per | | 7 packing policy ----- End of picture text -----

RA may take appropriate action as per the decision of Norms Committee.

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----- Start of picture text ----- Case No.:434/13/82- Party Name: MOREPEN Meet No/Date:13/82- Status; ALC4/2018 LABORATORIES LTD., ALC4/2018 ‘Approved 14.01.2019 HQ File RLA File . Lic. No/Date:05 10360081 | :01/82/050/01412/AM19/ :05/24/040/00120/AM 14/ 17.07.2013 ----- End of picture text -----

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2 Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 5/82-ALC4/2015, dated 25.06.2015, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:

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----- Start of picture text ----- | | Export product Qty. Sl. Import items — Qty. | ----- End of picture text -----

(622 Ge | er e | | Rosuvastatin lkg Tert-Butyl-2-((4R,6S)-6-((E)-2-(4(-(4-fluorophenyl)1.425 kg | | | | Calcium 6-isopropyl-2-[N-methy] (methylsulphonyl)amino] | Sal pyrimidin-5-yl) viny])-2,2-dimethyl-1 ,3-dioxane-4| | l)acetate | | 2.53 kg_ | | | Tert-butyl methyl ether (MTBE) 0.79 kg | || RA may take appropriate action as per the decision of Norms Committee. Case No.:430/13/82Party Name:MOREPEN Meet No/Date:13/82Status: | ALC4/2018 LABORATORIES LTD., ALC4/2018 Approved | 3 14.01.2019 | HQ File RLA File ‘Lic.No/Date:05 10387695 | | |:01/82/050/01408/AM19/ :05/24/040/00087/AM15/ (29.05.2014 Decision: The Committee considered the case as per agenda in the presence ofTechnical Experts and in| | ithe light of earlier decision taken by NC in its Meeting No. 5/82-ALC4/2015, dated 25.06.2015, it was | decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: | 3 | | tH No. | Rosuvastatin lkg Tert-Butyl-2-((4R,6S)-6-((E)-2-(4(-(4-fluoropheny])1.425 kg Calcium 6-isopropyl-2-[N-methy] (methylsulphonyl)amino] = pyrimidin-S-yl) vinyl)-2,2-dimethyl-1,3-dioxane-4= l)acetate | ———SSCSCS~«S | | | [2 [ Methanol | | Tert-butyl methyl ether (MTBE) 0.79 kg |

RA may take appropriate action as per the decision of Norms Committee.

"(Case No.:198/6/82-ALC4/2014 (Party Name:-MOREPEN Meet No/Date:13/82-. Status: I i LABORATORIES LTD., ALC4/2018 Approved 1 | 14.01.2019 | | Ia@Fie |. © IRLA File a ‘Lic.No/Date:0510389652 -|:01/82/050/00600/AM15/ ':05/24/040/00145/AM15/ (11.07.2014 | | | Decision:‘the light of earlierThe Committeedecision consideredtaken by NC thein caseits asMeeting per agendaNo. in5/82-ALC4/2015, the presence ofdatedTechnical25.06.2015, Experts andit was in[|] | decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by | ‘firm whichever is lower: 4 | Export product Import items No. | | Rosuvastatin lkg Tert-Butyl-2-((4R,6S)-6-((E)-2-(4(-(4-fluorophenyl)1.425 kg | / | Calcium 6-isopropyl-2-[N-methy] (methylsulphonyl)amino] | ro pyrimidin-5-yl) vinyl)-2,2-dimethyl-1,3-dioxane-4| } | ljacetate | —SSOS~—S~«S SY ra] Methanol | Tert-butyl methyl ether (MTBE) || || RA may take may take take appropriate action as per the per the the decision of Norms Norms Committee. , |

|| RA may take may take take appropriate action as per the per the the decision of Norms Norms Committee.

/ Case No.:477/13/82Party Name:ENVEE DRUGS Meet No/Date:13/82(Status: ALC4/2018 PVT LTD ALC4/2018 ‘Approved 14.01.2019 | HQFile “RLAFile ==——_Lic.No/Date:3410041070 | | :01/82/050/01455/AM19/ :34/24/040/00340/AM15/ 20.03.2015 Decision: |The Committee considered the case as per agenda in the presence of Technical Experts and it 5 was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied | | by firm whichever is lower: No. Clobetasole Propionate BP/USP Betamethasone BP/USP/IP 1.00kg |) RA may take appropriate action as per the decision of Norms Committee. Case No.:470/13/82—~—sParty Name:FINE CURE ‘Meet No/Date:13/82‘Status: | \ALC4/2018 PHARMACEUTICALS LTD. |ALC4/2018 Approved (14.01.2019 HQ File RLA File Lic.No/Date:0810135044. | :01/82/050/01448/AM19/ :08/24/040/00467/AM15/ 16.04.2015 Decision: The Committee considered case as per agenda and deliberated on the matter in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per _ details below or as applied by firm whichever is lower:

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----- Start of picture text ----- Sl. Export product Qty. Sl. | Import items Qty. No. No. allowed CO-AMOXICLAV 5000000.000 AMOXICILLIN 585.24 TABLETS BP 625 MG OR Tablets TRIHYDRATE mg/Tablet AMOXICILLIN WITH IP/USP/BP CLAVULANATE 2 POTASSIUM 303.773 POTASSIUM TABLETS CLAVULANATE mg/Tablet 625 MG IP/USP DILUTED IP/BP WITH 6 MICROCRYSTALLINE CELLULOSE (1:1) 3 ALUMINIUM Relevant as |. LAMINATED FOIL | per packing PRINTED polic a ALU ALU BOTTOM Relevant as FOIL FOR BLISTER per packing |) PACK polic 2 CO-AMOXICLAV FOR 100000.000 AMOXICILLIN 4200 mg | ORAL SUSPENSION BP Bottles TRIHYDRATE 228.5 DRY SYRUP IP/USP/BP (100ML) 2 POTASSIUM 1414.193 | CLAVULANATE mg DILUTED IP/BP WITH MICROCRYSTALLINE CELLULOSE (1:1 | (RA concerned may take further necessary action as per above decision of NC. 銚針 ----- End of picture text -----

~«~ A ease No.:469/13/82Party Name:FINE CURE ‘Meet No/Date:13/82Status: ALC4/2018 ‘PHARMACEUTICALS LTD. '‘ALC4/201 8 Approved | | | 14.01.2019 HQ File RLA File Lic.No/Date:0810135720 | | | :01/82/050/01447/AM19/ :08/24/040/00116/AM16/ 22.07.2015 | | Decision: The Committee considered case as per agenda and deliberated on the matter in the presence of | | thedetails technical below experts or as applied and it by wasfirm decided whichever to ratifyis thelower: ad-hoc input output norms under para 4.7 of HBP as per | || || LNo. No. | | CO- AMOXICLAV TABLETS 10000000.000 AMOXICILLIN 585.28 | | | BP 625 MG OR AMOXICILLIN | Tablets TRIHYDRATE mg/tablet | = WITH CLAVULANATE IP/USP/BP | POTASSIUM TABLETS 625 (IMPORTED), 1.16 Kg oe MG IP/BP/ equivalent to 1 Kg LH USP Amoxicillin 2 POTASSIUM 303.773 | ta CLAVULANATE mg/tablet | | a DILUTED IP/BP WITH | | | MICROCRYSTALLINE | | | CELLULOSE (1:1) The Potassium Clavulanic diluted IP/ | Poa BP with Microcrystalline | | Cellulose (1:1), 2.40 kg ial equivalent of 1 kg active | = of Clavulanic Acid | 7 | 3 |ALUMINIUM Relevant |, | | LAMINATED FOIL as per Y PRINTED packing |, Pq polic 4 ALU ALU BOTTOM Relevant oF FOIL FOR BLISTER as per | | PACK packing | miae: CO-AMOXICLAV TABLETS 200000.000 5 AMOXICILLIN 46.82 | BP 50 MG OR AMOXICILLIN Tablets TRIHYDRATE mg/tablet | | i 4 WITH CLAVULANATE IP/USP/BP i POTASSIUM TABLETS 50 MG (IMPORTED), 1.16 Kg Pil IP/BP/ equivalent to 1 Kg | | USP Amoxicillin Yi POTASSIUM 24.30 | | CLAVULANATE mg/tablet | | | DILUTED IP/BP WITH | MICROCRYSTALLINE | ; | CELLULOSE (1:1) The | Potassium Clavulanic | | | diluted IP/ BP with Microcrystalline Cellulose (1:1), 2.40 kg 4 equivalent of | kg active | a of Clavulanic Acid | 3 CO-AMOXICLAV TABLETS 200000.000 7 AMOXICILLIN 234.11 | BP 250 MG OR AMOXICILLIN | Tablets TRIHYDRATE mg/tablet | Zz WITH CLAVULANATE IP/USP/BP | | POTASSIUM TABLETS 250 (IMPORTED), 1.16 Kg | | | MG IP/BP/ equivalent to 1 Kg

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----- Start of picture text ----- | USP | |AmoxicillinPOTASSIUM | 121.50 CLAVULANATE mg/tablet | | DILUTED IP/BP WITH MICROCRYSTALLINE | CELLULOSE (1:1) The | | Potassium Clavulanic diluted IP/ BP with Microcrystalline Cellulose (1:1), 2.40 kg equivalent of | kg active of Clavulanic Acid 4 CO-AMOXICLAV TABLETS 200000.000 AMOXICILLIN 468.22 | BP 500 MG OR AMOXICILLIN | Tablets TRIHYDRATE mg/tablet | WITH CLAVULANATE IP/USP/BP | POTASSIUM TABLETS 500 (IMPORTED), 1.16 Kg MG IP/ BP/ equivalent to 1 Kg USP Amoxicillin POTASSIUM 243.02 CLAVULANATE mg/tablet DILUTED IP/BP WITH MICROCRYSTALLINE CELLULOSE (1:1) The | Potassium Clavulanic . diluted IP/ BP with Microcrystalline | Cellulose (1:1), 2.40 kg equivalent of | kg active | of Clavulanic Acid RA concerned may take further necessary action as per above decision of NC. Case No.:191/13/82- Party Name:NATURAL & Meet No/Date:13/82- Status: _ ALC4/2018 ESSENTIAL OILS PVT.LTD., |ALC4/2018 Deferred — 14.01.2019 8 HQFile RLA File \Lic.No/Date:0710108878 :01/82/050/01169/AM19/ :07/24/040/00226/AM 1 6/ 13.10.2015 | _ Decision: |The Committee considered the case as per agenda and it was decided to refer the case to Coffee Board for its comments and also call the firm for personal hearing to explain the case. | | (Case No.:112/20/82- ‘Party Name:SUPREET Meet No/Date:13/82- Status: _ ALC4/2015 (CHEMICALS PVT.LTD. ALC4/2018 ‘Deferred 14.01.2019 | | HQ File RLA File Lic.No/Date:03 10800620 9 |:01/82/050/01695/AM16/ :03/95/040/00646/AM 1 6/ 03.12.2015 _ 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 | from RLA, Mumbai with complete technical details as per Appendix 4E along with Chemical reaction, stage | | _wise yield of production and molecular weight from the firm. 」 ----- End of picture text -----

‘Case No.:468/13/82Party Name:FINE CURE \Meet No/Date: 13/82Status: | ALC4/2018 PHARMACEUTICALS LTD. |ALC4/2018 Approved [10 14.01.2019 HQ File RLA File ‘Lic.No/Date:08 10136646

| |:01/82/050/01446/AM19/ —_—:08/24/040/00300/AM16/. «04.12.2015 sti(‘(ia;t;O;;‘i;:;é™ | Decision: The Committee considered case as per agenda and deliberated on the matter in the presence of | ithe technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per | details below or as applied by firm whichever is lower:

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----- Start of picture text ----- | No. No. allowed a CO-AMOXICLAV 5000000.000 AMOXICILLIN 585.24 4 TABLETS BP 625 MG OR| Tablets TRIHYDRATE mg/Tablet AMOXICILLIN WITH IP/USP/BP ba POTASSIUMCLAVULANATETABLETS 2 | POTASSIUMCLAVULANATE mg/Tablet303.773 | | 625 MG IP/USP DILUTEDMICROCRYSTALLINE IP/BP WITH CELLULOSE (1:1) | eB | | | 3 | ALUMINIUM we. ™ yl LAMINATED — FOIL | yingi EB — polic | | 4 | atu atusotrom | Relevant | Pa FOIL FOR BLISTER = P = PACK —s | | | polic | 2 CO-AMOXICLAV FOR 100000.000 AMOXICILLIN 4200 mg | ORAL SUSPENSION BP Bottles TRIHYDRATE PH 228.5 DRY SYRUP IP/USP/BP | | | (100ML) 2 POTASSIUM 1414.193 | | CLAVULANATE mg | DILUTED IP/BP WITH | MICROCRYSTALLINE i] CELLULOSE (1:1) | | RA concerned may take further necessary action as per above decision of NC. ed ‘Case No.:473/13/82- Pa Party Name:SWISS — _ Meet No/Date:13/82- Status:i _ ALC4/2018 PARENTERALS PVT.LTD. =(ALC4/2018 Approved 14.01.2019 2 —(RLAFile Lic.No/Date:0810136715 | | :01/82/050/01451/AM19/ :08/24/040/00285/AM 16/ 11.12.2015 Decision: ~The Committee considered case as per agenda and deliberated on the matter in the presence of | the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per re details below or as applied by firm whichever is lower: | | | O. | | _ |TABLETS/CAPSULES | 380000.000 RELEVANT BULK DRUG| 510 mg/Tablet | | | |CLARITHROMYCIN Number CLARITHROMYCIN _ | LTABLETS 500MG USP/BP/IP | RA concerned may take further necessary action as per above decision of NC. | ~~ \CaseNo.:3/13/82-ALC4/2018 [PartyName:TATVA ~~ Meet No/Date:13/82- (Status: 112 CHINTAN PHARMA CHEM "= ALC4/2018 Approved | PVT LTD 14.01.2019 訛 ----- End of picture text -----

HQ File RLAFile Lic.No/Date:34 10042076 — | |Decision:':01/82/050/0098| The1/AM19/Committee considered':34/24/040/00344/AMthe case as per1 agenda 6/ in 15.04.2016the presence of Technical— Experts— and in | ‘the light of earlier decision taken by NC in its Meeting No. 5/82-ALC4/2018, dated 25.07.2018, it was | decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by | firm whichever is lower: | | METHYL TRIBUTYL TRIBUTYL AMINE 0.619 kg | | AMMONIUM = CHLORIDE | | Z ACETONITRILE 0.125 kg

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

|_|CaseNo.:478/13/82-<br>ALC4/2018|~~ PartyName:ENVEEDRUGS<br>PVTLTD|Meet No/Date:13/82-.<br>ALC4/2018|Status:<br>Approved||
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||||14.01.2019|||
||HQ File|IRLAFile ~~~|Lic.No/Date:3410042181||||
||:01/82/050/01456/AM19/|:34/24/040/00036/AM17/|19.05.2016|||

Decision: | The Committee considered case as per agenda and deliberated on the matter in the presence of 13 the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:

No. CLOBETASOL 1.00 kg BETAMETHASONE 1.00 kg PROPIONATE BP/USP BP/EP/IP/USP RA concerned may take further necessary action as per above decision of NC.

Case No.:1/13/82-ALC4/2018 Party Name:SOMU ORGANO Meet No/Date:13/82(Status: CHEM PVT.LTD., ALC4/2018 Approved 14.01.2019 HQ File RLAFile = =—~—_Lic.No/Date:0710110874 | itt~«~CS*S | :01/82/050/00979/AM19/ :07/24/040/00320/AM17/ (30.12.2016 | Decision: The Committee considered case as per agenda and deliberated on the matter in the presence of the 14 technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: | No. 1,3-CYCLOHEXANEDIONE |1kg[1 | RESORCINOL 1.196 kg | | RA concerned may take further necessary action as per above decision of NC. | CaseNo.:5/13/82-ALC4/2018 Party Name:TATVA —S-Meet No/Date:13/82- (Status: | CHINTAN PHARMA CHEM §|ALC4/2018 Approved 15 PVT LTD 14.01.2019 HQ File RLA File Lic.No/Date:34 10042874 ':01/82/050/00983/AM19/ :34/24/040/00269/AM17/ 20.01.2017 ;

| decidedtheDecision:light of earlierThe Committeedecision consideredtaken by NCthein caseits asMeeting per agendaNo. 2/82-ALC4/2018,in the presence ofdatedTechnical16.05.2018,Experts andit was|in. to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by | firm whichever is lower: | i |i No. _ | TCPC - CAT - 18 (METHYL| 1 kg ALAMINE336 OR TRI0.845 kg | TRIOCTYL AMMONIUM OCTYL/DECYL AMINE | CHLORIDE) TRI (C-8, C-10) ALKYL | METHYL TRI (C-8, C-10) ALKYL AMINE | |_| AMMONIUM CHLORIDE CAS |_No.63393-96-4 ASSAY 88 - 92%

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

" \Case No.:20/13/82-ALC4/2018 PartyName:RECKITT {Meet No/Date:13/82Status: | i 'BENCKISER HEALTHCARE ALC4/2018 Deferred | INDIA PRIVATE LIMITED 14.01.2019 = HQ File RLA File Lic.No/Date:0510401413 a | :01/82/050/00998/AM19/ :05/24/040/00535/AM17/ (30.01.2017 | | Decision: Deferred for comments of TE. | (CaseNo.:479/13/82Party Name:ENVEEDRUGS MeetNo/Date:13/82‘Status: ALC4/2018 PVT LTD ALC4/2018 Approved BS 14.01.2019 HQ File RLA File Lic.No/Date:34 10042949 | | |:01/82/050/01457/AM19/ :34/24/040/00338/AM17/ 17.02.2017 | Decision: |The Committee considered case as per agenda and deliberated on the matter in the presence of | _ |the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per [17 details below or as applied by firm whichever is lower: || | | No. CLOBETASOL 1 kg BETAMETHASONE 1.00 kg _ | PROPIONATE BP/USP IP/BP/USP/EP | | RA concerned may take further necessary action as per above decision of NC.

| (Case No.:159/13/82—|PartyName:VDHCHEM —_—Meet No/Date:13/82- Status: /ALC4/2018 TECH PVT. LTD. ALC4/2018 Approved | | (14.01.2019 | HQ File —IRLA File . Lic.No/Date:05 10401857 | :01/82/050/01137/AM19/ :05/24/040/00611/AM17/ 06.03.2017 | | 18 Decision: The Committee considered the case as per agenda in the presence of Technical Experts and it | | byge firm decided whichever to ratifyis thelower: ad-hoc input output norms under para 4.7 of HBP as per details below or as applied || O.

a Sie eel; oe.SODIUM 45.1MG |

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' \Case No.:391/4/82-ALC4/2017 Party Name:FINE ORGANIC Meet No/Date:13/82Status: INDUSTRIES, ALC4/2018 Approved | (14.01.2019 | HQ File RLA File Lic.No/Date:0310813432 | :01/82/050/00399/AM18/ :03/94/040/00155/AM18/ \22.05.2017 | Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the. | light of earlier decision taken by NC in its Meeting No. 1/82-ALC4/2018, dated 01.05.2018, it was decided | ‘to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm[|] | _ |\whichever is lower: | 21 el | | ‘Bags No. | |NEUTRALIZED AMIDE ESTER/ 1 kg STEARIC ACID 1.06 kg | (ETHANOL AMIDE STEARATE) | | MONO ETHANOL AMINE | 1148 | RA concerned may take further necessary action as per above decision of NC. ~ CaseNo.:206/13/82~—~—~»~PartyName:NATURAL ——«(Mcet No/Date:13/82-. Status: ALC4/2018 /REMEDIES PVT.LTD., \ALC4/2018 Deferred = | 14.01.2019 | | 2 =e RLAFile Lic.No/Date:0710111893 | |:01/82/050/01184/AM19/ :07/24/040/00307/AM17/ 20.07.2017 [22 Decision: The Committee considered the case as per agenda and it was decided to call for following | information: (i) Complete set of application. | (ii) Copy of DML / approved composition from Competent Authority. | 4 (iii) Complete technical details as per Appendix 4E | Case No.:199/13/82Party Name:NATURAL AND Meet No/Date:13/82- _ ‘Status: ALC4/2018 ESSENTIAL OILS PVT LTD ~=ALC4/2018 Deferred | =f (14.01.2019 23 HQ File IRLA File ‘Lic.No/Date:0710112040 :01/82/050/01177/AM19/ :07/24/040/00148/AM18/ 21.08.2017 | | (Decision: The Committee considered the case as per agenda and it was decided to refer the case to Coffee | Board for its comments and also call the firm for personal hearing to explain its case. _ Case No.:195/13/82Party Name:NATURAL & ‘Meet No/Date:13/82Status: | ALC4/2018 ESSENTIAL OILS PVT.LTD., ALC4/2018 Deferred | be | 14.01.2019 24 HQ File RLA File Lic.No/Date:07 10112050 | | |:01/82/050/01173/AM19/ :07/24/040/00150/AM18/ 23.08.2017 | Decision: The Committee considered the case as per agenda and it was decided to refer the case to Coffee Board for its comments and also call the firm for personal hearing to explain its case.

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----- Start of picture text ----- Case No.:29/13/82- Party Name:PCL OIL & Meet No/Date:13/82- Status: _ | (ALC4/2018 SOLVENTS LTD. ALC4/2018 ‘Approved HQFile (RLA File Lie. No/Date:051040464714.01.2019 | | :01/82/050/01007/AM19/ :05/24/040/00357/AM18/ 20.11.2017 | theDecision: |The Committee considered case as per agenda and deliberated on the matter in the presencea of 25 detailstechnicalbelow expertsor as applied and it wasby firm decidedwhicheverto ratifyis thelower: ad-hoc input output norms under para 4.7 of HBP as per | No. (DINP)PLASTICIZER (PVC) lkg |1| PhthalateIso Nonyl AnhydrideAlcohol 0. 726355 kg | ， ｄ 訛 ----- End of picture text -----

Case No.:28/13/82-ALC4/2018 Party Name:PCL OIL & Meet No/Date:13/82Status: | SOLVENTS LTD. ALC4/2018 Approved /14.01.2019 HQ File RLA File -Lic.No/Date:0510404985 | :01/82/050/01006/AM19/ :05/24/040/00413/AM18/ 19.12.2017

Decision: | The Committee considered case as per agenda and deliberated on the matter in the presence of 26 the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: No. | PLASTICIZER (PVC) 1kg |1| Phthalate Anhydride 0.355 kg | L@INP) Iso Nony! Alcohol 0.726 kg

~ Case No.:2/13/82-ALC4/2018 Party Name:SOMU ORGANO (Meet No/Date:13/82(Status: | CHEM PVT.LTD., ‘ALC4/2018 Approved 14.01.2019 HQ File RLA File Lic.No/Date:0710112571 | _ :01/82/050/00980/AM 19/ :07/21/040/00577/AM18/ (20.12.2017 27 theDecision:technical expertsThe Committee and it wasconsidereddecided tocaseratify as theper ad-hocagenda andinput deliberatedoutput normson underthe matterpara 4.7 in the ofpresenceHBP as per. of | details below or as applied by firm whichever is lower: 1 i No. | || [1,3-CYCLOHEXANEDIONE |1kg[1 | RESORCINOL 1.196 kg _ RA concerned may take further necessary action as per above decision of NC. |

Case No.:471/13/82Party Name:SWISS _ Meet No/Date:13/82Status: 28 ALC4/2018 PARENTERALS LTD ALC4/2018 Deferred 14.01.2019

“~a“

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|||銚<br>|<br>|<br>No.<br>|<br>}<br>|<br>| METHYL<br>TRIBUTYL|<br>1 kg<br>TRIBUTYLAMINE<br>0.619kg<br>| AMMONIUM — CHLORIDE<br>|<br>ACETONITRILE<br>0.125 kg<br>||||||<br>|<br>||
|||||RA concerned may take further necessary action as perabove decision ofNC.||||
|||||Case No.:46/13/82-ALC4/2018 PartyName:OPTRIX<br>‘Meet No/Date:13/82-<br>‘Status:||||
||||LABORATORIESPRIVATE<br>|ALC4/2018<br>Approved|||||
||||LIMITED<br>14.01.2019||||
|||—|-HQFile<br>-<br>RLAFile<br>=—————S—S—sCLic.No/Date:0910065982||||
|||_|:01/82/050/01024/AM19/<br>:09/24/040/00584/AM18/<br>13.02.2018<br>|||||
||||Decision:<br>—§TheCommittee consideredcase as peragendaand deliberatedonthematter in thepresenceof <br>the technical experts and it was decided to ratifythe ad-hoc input outputnorms underpara4.7 ofHBP asper<br>detailsbeloworasappliedbyfirmwhichever is lower:||||<br>||
|||||||||
|||針<br>つ<br>No.<br>32<br>|VELPATASVIR-<br>kg<br>(28,4S)-tert-butyl<br>__2-(5-(2-((2S,5S)-1- | 0.75kg<br>COPOVIDONE ~—IH<br>((S)-2-<br>((methoxycarbony])amino)-3-<br>|<br>|<br>methylbutanoyl)-5-<br>|<br>|<br>methylpyrrolidin-2-yl)-1,11-<br>|<br>|<br>dihydroisochromeno[4,3:6,7<br>]naphtho[ 1,2-<br>}<br>|<br>djimidazol-9-yl)-1H-imidazol-2-<br>__yl)-4-|||||<br>|<br>||
||||(methoxymethy])pyrrolidine-1-||||
||||carboxylate||||
|||||<br>2<br>(2R)-[(methoxycarbonyl)amino](phenyl) | 0.31 kg<br>ethanoic acid||||
||||RAconcernedmaytake furthernecessary actionasperabove decisionofNC.|||||
|||||CaseNo.:48/13/82-ALC4/2018PartyName:OPTIMUS<br>(MeetNo/Date:13/82-___ Status:<br>DRUGSPRIVATE LIMITED<br>|ALC4/2018<br>Approved||||
||||14.01.2019||||
|||HQFile<br>RLAFile<br>Lic.No/Date:0910065980 |<br>|:01/82/050/01026/AM19/<br>:09/24/040/00589/AM 18/<br>(13.02.2018|||||
|||_<br>|<br>|||Decision:<br>TheCommittee consideredthecase asperagenda in the presenceofTechnical Expertsand in<br>the light of earlier decision taken by NC in its Meeting No. 4/82-ALC4/2018, dated 19.06.2018, it was.<br>decided to ratifythe ad-hoc input outputnormsunderpara4.7ofHBP asperdetails below oras appliedby<br>|<br>firm whichever is lower:||||
|||||||||
|||33|| Exportproduct<br>Qty. | SI.<br>Importitems<br>Qty.<br>No.|||<br>|||
||||| LedipasvirCopovidone<br>lkg<br>(1R,3S,4S)-3-(6-Bromo-1H-<br>0.85 kg<br>(LedipasvirAmorphous)<br>benzimidazol-2-yl)-2-a-zabicyclo|||||
||||(2.2.1)heptane2-carboxylic<br>acid||||
||||1,1-dimethylethy]<br>ester||||
|||||2<br>(6s)-6-(5-(7-bromo-9,9-difluoro-<br>0.85kg<br>|<br>9H-fluoren-2-yl)-1 H-imidazol-2-yl-|||||
||||5-azaspiro(2,4||||
|}|||Bis(Pinacolato)Diboron<br>0.85kg<br>|<br>Dichlorobis(di-tert-<br>0.0516kg|||||

| | |__| ri | _|RA may take appropriate action as per the decision of Norms Committee.

|__| butylphenylphosphine)palladium(II

Case No.:49/13/82-ALC4/2018 Party[Name:OPTIMUS] Meet No/Date:13/82Status: | | DRUGS PRIVATE LIMITED ALC4/2018 Approved | 7 14.01.2019 | HQSeeFile RLA File Lic.No/Date:0910065981 | |:01/82/050/01027/AM19/ ':09/24/040/00588/AM18/ 13.02.2018 | Decision: The Committee considered the case as per agenda in the presence of Technical Expertsand in | the light of earlier decision taken by NC in its Meeting No. 8/82-ALC4/2018, dated 31.08.2018, it was | \decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by | | firm whichever is lower: | 34 | |

34 | Pad No. _ | SOFOSBUVIR-IH lkg 2-deoxy-2-fluoro-2-C-methyluridine 0.90 kg ii or) (2R)-2-Deoxy-2-Fluoro-2-Methyluridine PH 2 N-[(S)-(2,3,4,5,6-Pentafluorophenoxy) 1.60 kg | phenoxyphosphiny]]-L-alanine 1-methylethyl | ester | || (OR)phenoxy)phosphory] propan-2-yl(2S)-2-amino}{[(pentafluorophenoxy)propanoate

| ‘RA may take appropriate action as per the decision of Norms Committee.

' |CaseNo.:420/13/82~~ Party Name:ENVEE DRUGS Meet No/Date:13/82Status: ALC4/2018 PVT LTD ALC4/2018 Approved | 14.01.2019 | | |HQ File RLA File Lic.No/Date:3410043896 | :01/82/050/01398/AM19/ :34/24/040/00337/AM18/ 19.02.2018 | Decision: |The Committee considered the case as per agenda in the presence of Technical Experts and in | ‘the light of earlier decision taken by NC in its Meeting No. 4/82-ALC4/2018, dated 19.06.2018, it was_ 35 decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied Iby[firm][whichever][is][lower:] | ; | | | _ |Betamethasone Dipropionate eT | Betamethasone EP/BP/IP/USP| 0.868 kg | |RA may take appropriate action as per the decision of Norms Committee. |

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|||||||
|---|---|---|---|---|---|
|Case No.:47/13/82-ALC4/2018|Party Name:ORTIN|‘Meet No/Date:13/82-|Status:|
|||LABORATORIES|LTD|ALC4/2018|Deferred|
|||||(14.01.2019|||
|36 HQ File|RLA File|Lic.No/Date:0910066003|||
||||:01/82/050/01025/AM19/|::09/24/040/00587/AM|18/|20.02.2018|||
|Decision:|Deferred|for comments|of TE.|
|137|Case No.:186/13/82-|Party|Name:SONGWON|Meet No/Date:13/82-.|Status:|
|~*|ALC4/2018|SPECIALTY CHEMICALS|ALC4/2018|Deferred|

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----- Start of picture text ----- Oo -INDIAPVT.LTD. =—=*/14.01.2019 | = | HQFile = ~ ~ RLAFile Lic.No/Date:3410043908 | — :01/82/050/01164/AM19/ :34/24/040/00341/AM18/ (22.02.2018 | Decision:technical detailsThe Committeeas per Appendixconsidered4E alongthe casewithasChemicalper agendareaction,and it molecularwas decidedweightto callandforpercentagecomplete| | of yield on molar basis from the firm. | ‘Case No.:50/13/82-ALC4/2018 Party Name:VIVIMED LIFE Meet No/Date:13/82- (Status: SCIENCES PRIVATE ALC4/2018 Approved | LIMITED 14.01.2019 | | HQFile RLAFile Lic.No/Date:09 10066027 | :01/82/050/01028/AM19/ :09/24/040/00594/AM18/ (01.03.2018 | | Decision: The Committee considered thecase as per agenda in the presence of Technical Experts and in. the light of earlier decision taken by NC in its Meeting No. 8/82-ALC4/2018, dated 31.08.2018, it was| decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by| firm whichever is lower: ----- End of picture text -----

|Export product

Losartan Potassium Tablets USP (Losartan) 25 Mg, 50 Mg, 100 Mg

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----- Start of picture text ----- || | || SI. Import items Norms Recommended for one Tablet 38 | No. 25Mg Tablet | 50 Mg Tablet 100 Mg Tablet Losartan Potassium (or) Losartan 25.5 mg 51 mg 102 mg Potasium USP | Mannitol (Pearlitol 160C) 101.9 mg 203.8 mg 407.6 mg | | Microcrystalline Cellulose (Avicel PH | 40.5 mg 81.0 mg 162 mg | 102) | Croscarmellose Sodium (Ac Di Sol) 7ASmg 14.38 mg 28.76 mg | Povidone(PLASDONE K-29/32) 20) 08 neem vevimg | | | Magnesium Stearate (Mallinckrodt 1.8 mg 3.6 mg 7.2 mg 2257) . 訛 ----- End of picture text -----

| |RA may take appropriate action as per the decision of Norms Committee.

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----- Start of picture text ----- |— Case No.:125/13/82- === PartyName:ORTIN. —S(Meeet No/Datte:13/82-—(Status:| | ALC4/2018 LABORATORIES LTD ALC4/2018 Deferred | 39 ~ 14.01.2019 | THQ File RLA File [Lie.No/Date:0910066054 | / :01/82/050/01103/AM19/ :09/24/040/00611/AM18/ 12.03.2018 | Decision: Deferred for comments of TE. ; - | Case No.:33/13/82-ALC4/2018 PartyName:VISWAAT ‘(Meet No/Date:13/82-‘Status: 40 (CHEMICALS LIMITED 14.01.ALC4/ 201 98 Deferred | HQ File RLA File ; Lic.No/Date:0310819857 | | :01/82/050/01011/AM19/ :03/95/040/01027/AM18/ 16.03.2018 ----- End of picture text -----

ES eee

Decision: Deferred for comments of TE.

E ‘Case No.:127/13/82Party Name:SPANSULES Meet No/Date:13/82Status: | /ALC4/2018 FORMULATIONS |ALC4/2018 Deferred 14.01.2019 41 HQ File RLA File ‘Lic.No/Date:09 10066066 | :01/82/050/01105/AM19/ :09/24/040/00619/AM18/ 20.03.2018 | | |Decision: The Committee considered the case as per agenda and it was decided to call for a copy of DML for each export product from the firm. "(Case No.:74/13/82-ALC4/2018 Party Name:PORUS —-Meet No/Date:13/82-. Status: = LABORATORIES PRIVATE ALC4/2018 Approved © cS. LIMITED 14.01.2019 | | | HQ File RLA File ‘Lic.No/Date:0910066090 | : ':01/82/050/01052/AM19/ 09/24/040/00598/AM18/ 26.03.2018 | Decision: | The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 1/82-ALC4/2018, dated 01.05.2018, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by | firm whichever is lower: | 42 | | | | 2-Phenyl-3,3-bis(4-hydroxy | 1 kg PTHALIC ANHYDRIDE 0.927 kg | | phenyl)phthalimide (PPP-BP) ea Ds CT a a [3 |[ZINCCHLORIDE] | (0.104 kg B [4 [ANILINE (0.596 kg | | [Ss |METHANOL (0.715 kg 4 16[_][ |][ ACTIVATED][ CARBON] 0.200 kg a CAUSTIC SODA LYE 2.31 kg | a ||RA concerned may take further necessary action as per above decision of NC. (Case No.:126/13/82Party Name:OPTRIX Meet No/Date: 13/82Status; ALC4/2018 LABORATORIES PRIVATE ALC4/2018 Deferred LIMITED 14.01.2019 | (43 HO File ~_IRLA File : Lic.No/Date:09 10066086 |:01/82/050/01104/AM19/ :09/24/040/00639/AM18/ 26.03.2018 Decision: Deferred for comments of TE. [~\Gase No188/13/82.. +~«(iPartyName:SHIVA —(Meet No/Date:13/82-. (Status: ALC4/2018 PHARMACHEM LTD ALC4/2018 Approved | | | (14.01.2019 | | (HQFile ~ IRLA File ‘Lic.No/Date:3410044013 | | |:01/82/050/01166/AM19/ :34/24/040/00384/AM18/ 28.03.2018 44 Decision: The Committee considered case as per agenda and deliberated on the matter in the presence of | ‘the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per | details below or as applied by firm whichever is lower: | | No.

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----- Start of picture text ----- L7 A“, = = =" aaa || _ [2METHOXY ETHYL CHLORIDE | | kg 2 METHOXY ETHANOL| 0.89 kg | | CLEAR COLOURLESS LIQUID CLEAR COLOURLESS LIQUID | 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 ----- __| ----- End of picture text -----

| Case No.:200/13/82Party Name:NATURAL & Meet No/Date: 13/82‘Status: ALC4/2018 ESSENTIAL OILS PVT.LTD., |ALC4/2018 Deferred | 14.01.2019 45 HQFile RLAFile = Li.No/Date:0710113036 | | :01/82/050/01178/AM19/ :07/24/040/00370/AM 1 8/ 03.04.2018 | (Decision: The Committee considered the case as per agenda and it was decided to refer the case to Coffee Board for its comments and also call the firm for personal hearing to explain its case. Case No.:70/13/82-ALC4/2018Party Name:VIRCHOW (Meet No/Date:13/82(Status: PETROCHEMICAL PVT LTD. |ALC4/2018 Rejected 14.01.2019 | 46 HQ File -RLA File Lic.No/Date:0910066144 _ :01/82/050/01048/AM19/| :09/24/040/0051 1/AM18/ 12.04.2018 butDecision: The Committee observed that firm was called for PH before the committee for similar cases, | the firm neither attended the PH nor submit its reply. Hence the Committee decided to reject the case. "Case No.:72/13/82-ALC4/2018 Party Name:VIRCHOW —[Meet No/Date:13/82-. Status: PETROCHEMICAL PVT LTD. ALC4/2018 Rejected 14.01.2019 | 47 HQ File RLAFile ‘Lic.No/Date:0910066143 | — | :01/82/050/01050/AM19/ :09/24/040/00480/AM 18/ 12.04.2018 | Decision: |The Committee observed that firm was called for PH before the committee for similar cases, 7 _ but the firm neither attended the PH nor submit its reply. Hence the Committee decided to reject the case. Case No.:73/13/82-ALC4/2018 Party Name:VIRCHOW _ Meet No/Date: 13/82Status: | PETROCHEMICAL PVT LTD. |ALC4/2018 Rejected 14.01.2019 ~— 48 HQ File -RLA File -— Lic.No/Date:0910066145 :01/82/050/01051/AM19/ :09/24/040/00608/AM 1 8/ 12.04.2018 | |Decision: |The Committee observed that firm was called for PH before the committee for similar cases, but the firm neither attended the PH nor submit its reply. Hence the Committee decided to reject the case. | CaseNo.:156/13/82—(PartyName:SMS-——=~S=«wMeet NoDate :13/82Status: | ALC4/2018 LIFESCIENCES INDIA ALC4/2018 Deferred | LIMITED 14.01.2019 | | | |HQ File RLA File Lic.No/Date:0910066137 49 :01/82/050/01134/AM19/ :09/24/040/00654/AM 1 8/ 12.04.2018 Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for hard copy of 4.07 application of the subject advance | | authorization from RLA, Hyderabad with complete technical details as per Appendix 4E along with | Chemical reaction, stage wise yield of production and molecular weight from the firm.

| |CaseNo.:318/13/82Party Name:GULBRANDSEN - MeetNo/Date:13/82- (Status: | |ALC4/2018 CHEMICALS PVT LTD /ALC4/2018 Approved — 14.01.2019 |HO File RLA File Lic.No/Date:34 10044038 | | |:01/82/050/01296/AM19/ :34/24/040/00005/AM19/ 16.04.2018 | Decision: |The Committee considered case as per agenda and deliberated on the matterin the presence of 50 the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per[as][applied][by][firm][whichever][is][lower:] details[below][ or] | bol No. | [Ti Bthy! Aluminium (TEAL Aluminium Grit/Granules 0.248MT__| |

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

[Case No.:320/13/82-~—~-Party Name:GULBRANDSEN Meet No/Date:13/82Status: ‘ALC4/2018 (CHEMICALS PVT LTD ALC4/2018 ‘Deferred | ni | 14.01.2019 | |= HQ File RLA File ‘Lic.No/Date:34 10044039 . ~~ |:01/82/050/01298/AM19/ :34/24/040/00006/AM19/ 16.04.2018 Decision: The Committee considered the case as per agenda and it was decided to call for complete | | technical details as per Appendix 4E along with Chemical reaction, molecular weight and percentage _ of yield on molar basis from the firm. | Case No.:122/13/82== PartyName:SUVENLIFE Meet ‘SCIENCES LIMITED ‘ALC4/2018 Deferred ‘ALC4/2018 No/Date:13/82- Status: | by 14.01.2019 pA HQFie ||| |RLAFile Lic.No/Date:0910066156 | |:01/82/050/01100/AM19/ ':09/24/040/00024/AM 19/ (18.04.2018 Decision: Deferred for comments of TE. "Case No.:312/13/82- -~|PartyName:KUTCH ——_—Meet No/Date:13/82-. Status: | | ALC4/2018 (CHEMICALLTD INDUSTRIES ALC4/201814.01.2019 Approved | |HQFile nd RLA File Lic.No/Date:3410044060 _ | |:01/82/050/01290/AM19/ :34/24/040/00018/AM19/ 18.04.2018 | Decision: The Committee considered case as per agenda and deliberated on the matter in the presence of | the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per ‘details below or as applied by firm whichever is lower: 53. | No. | | | 2 ETHYL HEXYL NITRATE lkg |1 | 2ETHYLHEXANOL 0.764 kg | } | 2 CONCENTRATED NITRIC Not | ACID 98% importable, | 3 | SULPHURIC ACID 98% sae te] allowed | | ‘RA concerned may take further necessary action as per above decision of NC. |

~

==> picture [459 x 678] intentionally omitted <==

----- Start of picture text ----- "Case No.:421/13/82- —~—~—=-Party Name:LUPIN LIMITED [Meet No/Date:13/82- Status: | ALC4/2018 ALC4/2018 Approved — 14.01.2019 HQFile - RLAFile == —Lic.No/Date:0310820552 | | Decision::01/82/050/01399/AM19/| The Committee considered:03/95/040/01104/AM18/case as per agenda and deliberated19.04.2018on the matter in the presence of || ‘the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: | | No : | ETHAMBUTOL HCL 1kg |1 | DL2 AMINOBUTANOL 1.6014 kg TARTARIC ACID 0.153 kg | METHANOL 0.4172 kg | ISOPROPYL ALCOHOL 0.187 kg ETHYLENE DICHLORIDE 0.4663 kg | RA concerned may take further necessary action as per above decision of NC. Case No.:67/13/82-ALC4/2018 Party Name:STYRAX —Meet No/Date:13/82- — Status: PHARMA PRIVATE ALC4/2018 Approved | | LIMITED 14.01.2019 | HQ File RLA File Lic.No/Date:09 10066167 | | 101/82/050/01045/AM19/ :09/24/040/00032/AM 19/ 23.04.2018 Decision: | The Committee considered the case as per agenda in the presence of Technical Experts and it) was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied | \by firm whichever is lower: | -~ | No. | 1-(2,2-DIMETHOXYETHYL)- | 1 kg METHYL-4-METHOXY ACETO| 0.750 kg | | | S-METHOXY-6- ACETATE | | | |(METHOXYCARBONYL)-4- 2 DIMETHYL FORMAMIDE 0.735kg | | — | OXO-1,4- DIMETHYL ACETAL | | DIHYDROPYRIDINE-3- DIMETHYL OXALATE 1.515 kg CARBOXYLIC ACID METHANOL 3.094 kg (DOLUTEGRAVIR SODIUM) 5 METHYLENE DICHLORIDE| 3.375 kg MDC) | RA concerned may take further necessary action as per above decision of NC. Case No.:17/13/82- - PartyName:SYNTHO ——CMeeet No/Date:13/82- ‘Status: — | ALC4/2018 CHIRALS PRIVATE ALC4/2018 Approved LIMITED 14.01.2019 | | | HQ File RLA File Lic.No/Date:0910066173 | :01/82/050/00995/AM19/ :09/24/040/00027/AM 19/ 25.04.2018 | 56 Decision: The Committee considered case as per agenda and deliberated on the matter in the presence of the | | technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per| details below or as applied by firm whichever is lower: | | | No. | ----- End of picture text -----

-~ || | Sodium(S)-4-0x0-4,6,7,8————SSs« kg] 1]2,5-Norbomadiene | 173g) | | || || carboxylatetetrahydropyrrolo[1,2-a]pyrimidine-6| RA concerned may take further necessary action as per above decision of NC. | "Case No.:190/13/82- - ~ |Party Name:ONEIRO Meet No/Date: 13/82Status: | ALC4/2018 CHEMICALS PVT LTD ALC4/2018 ‘Approved — 14.01.2019 HQ File RLA File Lic.No/Date:3410044080 | | |:01/82/050/01168/AM19/ ':34/24/040/00033/AM19/ 26.04.2018 | | ‘theDecision:light of earlierThe Committeedecision taken consideredby NC thein caseits Meeting as per agendaNo. in4/82-ALC4/2018, the presence ofdatedTechnical19.06..2018, Experts andit was in| | firmdecided whichever to ratifyis thelower: ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by |S7 | | | | 4,7-Dichloro Quinoline l kg flNo. Di Ethyl Ethoxy Methylene Malonate 1.65 kg | Meta Chloro Aniline 0.97 kg e Light Liquid Parafin 0.97 kg iy [4 |C=*dCRBTolune Kg | | [6 |sidPhosphorous OxychlorideMethanol 0.97 kg | RA concerned may take further necessary action as per above decision of NC. |\Case No.:319/13/82= PartyName:AMILIFE ——s(MeetNo/Date:13/82Status: | ALC4/2018 SCIENCES PRIVATE ‘ALC4/2018 Deferred | ee ‘LIMITED 14.01.2019 | i HQ File -IRLAFile——S*~~~*:S LicNo/Date=34100441221 | | :01/82/050/01297/AM19/ :34/24/040/00019/AM19/ (01.05.2018 | Decision: Deferred for comments of TE. 4 cos No.:30/13/82-ALC4/2018 Party Name:SHREEJAYA [Meet No/Date:13/82Status: | | LABORATORIES PVT LTD. ALC4/2018 ‘Approved | | 14.01.2019 | | HQFile RLAFile =———CLic, No/Date:0910066185 | | ':01/82/050/01008/AM19/ :09/24/040/00023/AM19/ 02.05.2018 Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in | 59 the light of earlier decision taken by NCin its Meeting No. 3/82-ALC4/2018, dated 05.06..2018, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by, _ firm whichever is lower:[ACETONITRIL] 0.17 kg | | | 5-DIFLUOROMETHOXYlkg |1[|] |_| | 2MERCAPTO-1HCHLOROFORM 0.18 kg | | | BENZIMIDAZOLE SODA ASH 3.03 kg | | | PARACETMOL 1.435 kg

7; ~ 75|CARBONDISULFIDE[0.70kg | | |6 | FREUON GAS 0.715 kg _ RA concerned may take may take take further necessary action as per above above decision of NC. NC. . | ‘Case No.:68/13/82-ALC4/2018 Party Name:NASENSE LABS (Meet No/Date:13/82‘Status: PVT LTD ALC4/2018 Deferred | | 14.01.2019 | | 60 HQFile — RLAFile = ~—_Lic.No/Date:0910066196

~~ |:01/82/050/01046/AM19/ :09/24/040/00018/AM19/ 04.05.2018 | | Decision: The Committee considered the case as per agenda and it was decided to call for complete technical details as per Appendix 4E along with Chemical reaction, molecular weight and percentage| of yield on molar basis from the firm.

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

==> picture [461 x 297] intentionally omitted <==

----- Start of picture text ----- Case No.:121/13/82- Party Name:VIVIMED LABS Meet No/Date:13/82- ‘Status: ALC4/2018 LIMITED ALC4/2018 Deferred | 14.01.2019 | | 61 HQ File . RLA File ~_Lie.No/Date:0910066198 :01/82/050/01099/AM 19/ :09/24/040/00044/AM19/ 04.05.2018 Decision: Deferred for commentsof TE. = a eT Case No.:124/13/82- Party Name:VIVIMED LABS Meet No/Date:13/82- Status: | \ALC4/2018 LIMITED ALC4/2018 Approved | | | (14.01.2019 | HQ File RLA File Lic.No/Date:0910066201  |:01/82/050/01102/AM19/ :09/24/040/00042/AM 19/ (07.05.2018 | | Decision: | The Committee considered case as per agenda and deliberated on the matter in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per | i details below or as applied by firm whichever is lower: | No. NITRO BLUE / JAROCOL BLUE-12 | 1 kg VIOLET 1,4 D (OR) JAROCOL 1.70kg | | VIOLET 1,4 D ( N,N-BIS(2- | HYDROXYETHYL)-2-NITRO-P- | PHENYLENEDIAMINE 趾 ― ----- End of picture text -----

}

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

Case No.:228/13/82~—PartyName:GUJARAT ~—S(Meet No/Date:13/82-__Status: | ALC4/2018 (ORGANICS LIMITED ALC4/2018 |Approved | | 14.01.2019 | | HQ File RLAFile Lic.No/Date:03 10820800 | :01/82/050/01206/AM19/ :03/94/040/00070/AM 19/ (07.05.2018 | 63 Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in | the light of earlier decision taken by NC in its Meeting No. 6/82-ALC4/2018, dated 26.07.2018, it was| | decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:

| |

;

f a = —_— > — a = . < “ be eo | LPropyl Paraben flkgN[1 | Para Hydroxy B e nzoic Acid 0.850 kg e |

| |CaseNo.:9/13/82-ALC4/2018 |Party Name:OPTRIX ——~(Meet No/Date:13/82-—*Status: SS ia POBORATORIES PRIVATE |ALC4/2018 Approved | . | LIMITED '14.01.2019 | |HQ File RLA File ‘Lic.No/Date:0910066209 q | |:01/82/050/00987/AM19/ :09/24/040/00005/AM19/ (09.05.2018 | _ ldecidded|theDecision:lighttoofratify|earlier Thethe Committeedecisionad-hoc inputtakenconsideredoutputby NC thenormsin caseitsunder asMeeting perpara agenda4.7No. of in1/82-ALC4/2018, HBP the presenceas per details of datedTechnicalbelow01.05.2018,or Expertsas applied andit was in,by| 64 firm whichever is lower: bas No. | | | LINEZOLID 1 kg 3,4-Difluoro nitrobenzene | 0.80 kg | 2 (s)-EpichlorohydrinOR 3,4 Di fluoro nitrobenzene 0.80 kg tov OR) (s)-(+)-2-(chloromethy])oxirane | se concerned may take further necessary action as per above decision of NC.

Case No.:12/13/82-ALC4/2018 Party Name:OPTRIX Meet No/Date:13/82‘Status: | LABORATORIES PRIVATE |ALC4/2018 Deferred | | |] LIMITED '14.01.2019 es HQ File RLA File Lic.No/Date:0910066208 — |:01/82/050/00990/AM19/ :09/24/040/00004/AM19/ 09.05.2018 | _ Decision: Deferred for comments of TE. | [CaseNo.:107/13/82~—*‘(PartyName:OPTRIX ——<(Meet No/Date:13/82-. ‘Status: |ALC4/2018 LABORATORIES PRIVATE ALC4/2018 Deferred Li LIMITED 14.01.2019 | (Cloris ~~ ~~SCSRLA Fille ~ [Lic.No/Date:0910066210 | |:01/82/050/01085/AM19/ 09/24/040/00006/AM 19/ 09.05.2018 | | Decision: Deferred for comments of TE. / |Case No.:123/13/82-—-(PartyName:OPTIMUS ——_—(Meet No/Date:13/82(Status: —| | ALC4/2018 DRUGS PRIVATE LIMITED ALC4/2018 Approved | 4 14.01.2019 HQ File RLA File a Lic.No/Date:0910066218 | :01/82/050/01101/AM19/ :09/24/040/00003/AM19/ 10.05.2018 |67 Decision: The Committee considered the case as per agenda in the presence of Technical Experts and | in the light of earlier decision taken by NC in its Meeting No. 8/82-ALC4/2018, dated 31.08.2018, it was | decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied | 'by firm whichever is lower: ie. | | || [Export product | Qty. | Sl.No. [Importitems —s—“—é‘“~dr «Cid | |SOFOSBUVIR-IH 2-deoxy-2-fluoro-2-C-methyluridine 0.90 kg |

-«,

| | ; ae ct Tale=i (or)) (2R))-2-Deoxy-2-Fluoro-2-Methyluridine-2-Fluoro-2-Methyluridine a| | 2 N-[(S)-(2,3,4,5,6-Pentafluorophenoxy) 1.60 kg phenoxyphosphinyl]-L-alanine 1- | methylethyl ester (OR) propan-2-yl(2S)-2{[(pentafluorophenoxy) | phenoxy)phosphory] amino} propanoate | RA concerned may take further necessary action as per above decision of NC. | CaseNo.:6/13/82-ALC4/2018 Party Name: VINDHYA "'Meet No/Date:13/82Status: ORGANICS PVT LTD ALC4/2018 Approved | | 14.01.2019 | HQFile — RLAFile Lic.No/Date:09 10066229 :01/82/050/00984/AM 19/ ':09/24/040/00062/AM19/ /11.05.2018 | Decision: | The Committee considered the case as per agenda in the presence of Technical Experts and in | the light of earlier decision taken by NC in its Meeting No. 4/82-ALC4/2018, dated 19.06.2018, it was | ‘decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by | firm whichever is lower: | 68, _ | AFC ABACAVIR (ABV) I lkg 2-AZABICYCLO (2.2.1) HEPT-5- | 1.14kg | EN-3-ONE; (VINCELACTAM | 2 N-(2-AMINO-4, 6-DICHLORO-5- | 0.764 kg |. PYRIMIDINYL) FORMAMIDE | 3 POWDERSODIUM BOROHYDRIDE 0.226 kg ||| D(-) TARTARIC ACID 0.780 kg | L + TARTARIC ACID 1.23 kg | ee RAeeeemaen concernedia may take- further~—ns necessary2 ee actionaeas per abovenn decision—— of NC. = Serraino tar[Ame] | No.:7/13/82-ALC4/2018 Party Name:PORUS _ ~ ‘Meet No/Date:13/82_—[Status: | | LABORATORIES PRIVATE §|ALC4/2018 Approved LIMITED 14.01.2019 HQ File RLA File Lic.No/Date:09 10066235 __ :01/82/050/00985/AM19/ :09/24/040/00001/AM19/ 15.05.2018 |Decision: | The Committee considered the case as per agenda in the presence of Technical Experts and in | | (thedecidedlighttoofratifyearlierthedecisionad-hoc inputtakenoutputby NCnormsin itsunderMeetingpara No.4.7 of1/82-ALC4/2018, HBP as per detailsdatedbelow01.05.2018,or as appliedit wasby| firm whichever is lower: 69 | | Export Product | Qty. | SLNo. | Importitems Qty. || | pheny])phthalimide2-Phenyl-3,3-bis(4-hydroxy(PPP-BP) lkg |1.| P THALICHENOL ANHYDRIDE 0.9271.145 kg | | | ZINC CHLORIDE 0.104 kg ANILINE 0.596 kg | METHANOL 0.715 kg | | 16‘| ACTIVATED CARBON 0.200 kg | CAUSTIC SODA LYE 2.31 kg | RA concerned may take further necessary action as per above decision of NC.

24 - Case No.:69/13/82-ALC4/2018 Party Name:PORUS Meet No/Date: 1 3/82Status: | LABORATORIES PRIVATE ALC4/2018 Deferred ; | LIMITED (14.01.2019 | “79 HQ|:01/82/050/01047/AM19/ File :09/24/040/00002/AM19/RLA File Lic.No/Date:0910066234.15.05.2018 | | Decision:‘technical detailsThe Committeeas per Appendixconsidered4E showingthe caseStoichiometryas per agendabalance,and itmolecularwas decidedweightto andcall percentagefor completeof|| yield at every stage from the firm. | |CaseNo.:120/13/82——PartyName:ORTIN. —[Meet No/Date:13/82Status: || ALC4/2018| LABORATORIES| LTD \ALC4/201814.01.2019 Deferred| || AQ File RLA File Lic.No/Date:09 10066236 | :01/82/050/01098/AM19/ :09/24/040/00614/AM18/ 15.05.2018 Decision: Deferred for comments of TE. | Case No.:155/13/82~—*'PartyName:PRASOL =—S Meet No/Date:13/82-. Status: ALC4/2018 CHEMICALS PRIVATE ALC4/2018 ‘Approved — i LIMITED 14.01.2019 | | HQ File RLA File Lic.No/Date:0310821018 | | | :01/82/050/01133/AM19/ ':03/95/040/00134/AM19/ (16.05.2018 Decision: | The Committee considered the case as per agenda in the presence of Technical Experts and in| 72 the[decided] light[to] of[ratify] earlier[the] decision[ad-hoc] taken[input][output] by NC[norms] in its[under] Meeting[para] No.[4.7] 4/82-ALC4/2018,[of][ HBP][as][per][details] dated[below] 19.06.2018,[or][as][applied] it was[ by][|] | |firm whichever is lower: | | | Export product Qty. SL. Import items Qty. | | MESITYL OXIDE fikg [1 | ACETONE 1.902 kg eS RA concerned may take further necessary action as per above decision of NC. / (Case No.:187/13/82Party Name: TIDE Meet No/Date:13/82Status: | ALC4/2018 INDUSTRIES ALC4/2018 Approved — to (14.01.2019 | [HQFile | RLA File Lic. No/Date:34 10044152 | :01/82/050/01165/AM19/ :34/24/040/00054/AM19/ 17.05.2018 | | Decision: | The Committee considered the case as per agenda in the presence of Technical Experts and in| | |the light of earlier decision taken by NC in its Meeting No. 6/82-ALC4/2018, dated 26.07.2018, it was 73 decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by | |firm whichever is lower: | Export product Qty. Sl. Import items Qty. | | | No. | |RA concerned may take further necessary action as per above decision of NC.

==> picture [460 x 679] intentionally omitted <==

----- Start of picture text ----- Case No.:194/13/82- Party Name:NATURAL AND [Meet No/Date:13/82- (Status: _ ALC4/2018 ESSENTIAL OILS PVT LTD = |ALC4/2018 (Deferred 14.01.2019 | 74 HQ File RLA File Lic.No/Date:0710113301 | |:01/82/050/01172/AM19/ :07/24/040/00042/AM19/ 17.05.2018 | Decision: The Committee considered the case as per agenda and it was decided to refer the case to Coffee | Board for its comments and also call the firm for personal hearing to explain its case. ‘Case No.:8/13/82-ALC4/2018 Party Name:SRINI ‘Meet No/Date:13/82- ‘Status: | PHARMACEUTICALS ALC4/2018 Approved PRIVATE LIMITED 14.01.2019 | | | HQ File RLA File | Lic.No/Date:0910066244 :01/82/050/00986/AM 19/ :09/24/040/00036/AM19/ /18.05.2018 | Decision: | The Committee considered case as per agenda and deliberated on the matter in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: | No. VALACYCLOVIR 1 kg CARBOBENZYLOXY [-] [L-] 1.1824kg | | HYDROCHLORIDE VALINE (CBZ-L-VALINE MONOHYDRATE 2 N,N-DICYCLOHEXYL 1.061 kg CARBODIIMIDE (DCC }| || 3 4-DIMETHYLAMINOPYRIDINE (DMAP 0.028 kg || ACYCLOVIR 0.758 kg | RA concerned may take further necessary action as per above decision of NC. ‘Case No.:10/13/82-ALC4/2018 Party Name:SPANSULES Meet No/Date:13/82- ‘Status: FORMULATIONS ALC4/2018 Approved 14.01.2019 | | HQ File RLA File Lic.No/Date:0910066243 | 0 1/82/050/00988/AM 19/ ':09/24/040/00063/AM19/ /18.05.2018 | | ‘Decision: | The Committee considered the case as per agenda in the presence of Technical Experts and in| the light of earlier decision taken by NC in its Meeting No. 1/82-ALC4/2018, dated 01.05.2018, it was 76 \decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by | | | firm whichever is lower: | ORLISTAT 50% WW 1 Kg. ORLISTAT USP 0. 50 kg | PELLETS | RA concerned may take further necessary action as per above decision of NC. | ~ (Case No.:18/13/82-ALC4/2018 Party Name:SMS ‘Meet No/Date:13/82- Status: =. 77 LIMITEDLIFESCIENCES INDIA 14.01.2019ALC4/2018 |Deferred | | {HQFile (RLAFile Lic.No/Date:0910066242 | ----- End of picture text -----

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----- Start of picture text ----- —™ | :01/82/050/00996/AM19/ ——:09/24/040/00067/AM19/.—«*(18.05.2018 =Sté<CS~StC<CS | | Decision: Deferred for comments of TE. | | (Case No.:154/13/82- ———(Party Name:UNITECH | Meet No/Date:13/82- (Status: | |ALC4/2018 INTERNATIONAL LIMITED |ALC4/201814.01.2019 ‘Approved | || |HQ:01/82/050/01132/AM19/ File —RLA:03/95/040/0003 File 1/AM19/ Lic.No/Date:03(18.05.2018 10821095 | | | theDecision:technical| Thexp e rts Committeeand it was considered decided to caseratify as the per ad-hoc agendainput and deliberatedoutput norms on theunder matter para 4.7in the of presenceHBP as per of | details [below] [or][ as] [applied][ by] [firm] [whichever] [is] [lower:] | 78] a r : | > if 0. | | || | RegeneratedEsters of MethacrylicMethyl MethacrylateAcid -| 1 kg PiecesAcrylic andPlastic OffcutsStrips and and Cut Mix Lot 1.10 kg | || | NetMonomerContent(PurityPer Kg.:LessAcrylicthan Plastic99%) ofThereofAcrylic Sheets and Cut || | Strips and Cut Pieces and Offcuts and |_ || | ThereofMix Lot- of1.63Acrylic Kgs. Sheets and Cut RA concerned may take further necessary action as per above decision of NC. | Case No.:41/13/82-ALC4/2018 Party Name: VIJAYASRI Meet No/Date:13/82- |Status: Bi ORGANICS LTD ‘ALC4/2018 ‘Approved | | | 14.01.2019 | | HQ File IRLAFile ‘Lic.No/Date:09 10066263 | |  |:01/82/050/01019/AM19/ :09/24/040/00435/AM18/ 22.05.2018 | | | Decision: |The Committee considered case as per agenda and deliberated on the matter in the presence of | thedetails technicalbelowexpertsor as applied and it wasby firm decidedwhichever to ratifyis thelower: ad-hoc input output norms under para 4.7 of HBP as per | 79 No. || || |4-FLUORO-a-2-METHYL-1-OXOPROPYL)-g-OXO-N-B- 1 kg ACETATEMETHYL ISO(MIBA) BUTYRYL 0.76 kg | |DIPHENYL BENZENE TEI ETHYL AMINE (TEA) 0.25 kg ||_| |BUTANEAMIDE (DIKETONE - ANILINE OIL 0.47 kg | INTERMEDIATE FOR 4 | METHYLENE CHLORIDE 1.50 kg | | MDC | | FLUOROBENZENE 0.52 kg |a |6|ACETONE 0.50 kg 7 | ISO PROPYL ALCOHOL 0.50 kg RA concerned may take further necessary action as per above decision of NC. 「 ― 趾 銚 ----- End of picture text -----

==> picture [465 x 499] intentionally omitted <==

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|||||||||||
|---|---|---|---|---|---|---|---|---|---|
|‘Case No.:42/13/82-ALC4/2018|Party Name:VIJAYASRI|Meet No/Date:|3/82-|Status:|
|ORGANICS LTD|ALC4/2018|Approved|||
|||/14.01.2019|||
|HQ File|RLA File|‘Lic.No/Date:0910066264|||
|':01/82/050/01020/AM19/|:09/24/040/00034/AM19/|(22.05.2018|||
|||Decision:|||The Committee considered|case as per agenda and deliberated on the matter in thepresence of|||
|||the technical experts and|it was decided to ratify the ad-hoc input output norms under para 4.7 of|HBP as per|||
|||details below or as applied by firm whichever|is lower:|||
|||No.|
|80|[4-FLUORO-a-2-METHYL-1-|lkg|METHYL ISO BUTYRYL|0.76 kg|
|OXOPROPYL)-g-OXO-N-B-|ACETATE|(MIBA|
|DIPHENYL|BENZENE|[2||TEIETHYLAMINE|(TEA)|_||0.25 kg|
||||BUTANEAMIDE|(DIKETONE|-|[3|||[ANILINEOIL]|[(47]|[kg]|||
|||INTERMEDIATE FOR|4||METHYLENE CHLORIDE|1.50 kg|||
|MDC|
|||FLUOROBENZENE|0.52|kg|
|||
|||7|ISO PROPYL ALCOHOL|0.50 kg|
|||
|IPA|||
|RA concerned may take|further necessary|action|as per above|decision|of|NC.|
|~~|
|Meet No/Date:13/82-|Status:|
|~~||Case No.:14/13/82-ALC4/2018|Party Name:OPTRIX|
|LABORATORIES|PRIVATE|ALC4/2018|Approved|
|LIMITED|14.01.2019|
|HQ File|RLA File|Lic.No/Date:09 10066270|
|—||:01/82/050/00992/AM19/|:09/24/040/0007 1/AM19/|(24.05.2018|||
|||Decision:|“The Committee|considered|the case|as per agenda in the presence of Technical Experts and it|
|81|was decided to ratify the ad-hoc input output norms under para 4.7 of|HBP as per details below or as applied|||
|by firm whichever is lower:|||
|}|||||
|||
|RA concerned may take|further necessary|action as per above decision of|NC.|

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~ "Case No.:105/13/82party Name:NAGARJUNA [Meet No/Date:13/82Status: _ ALC4/2018 AGRICHEM LTD \ALC4/2018 Deferred — (14.01.2019 | ~~ RLAFile” ~—— [Lie.No/Date:0910066269 | HOFie | :01/82/050/01083/AM19/ ':09/24/040/00085/AM 19/ (24.05.2018 | | (82 Decision: The ‘Committee considered the case as per agenda and it was decided to call for following | documents / information from the firm: ; (i) complete technical details as per Appendix 4E showing Stoichiometry balance, molecular | | weight and percentage of yield at every stage and | (ii) Use of import item No. 2, 3 and 4 are not indicated in the manufacturing process

[Case No.:106/13/82Party Name:PORUS ‘Meet No/Date: 13/82Status: ALC4/2018 LABORATORIES PVT LTD ALC4/2018 ‘Deferred |6. ae:| \ eee Lic.No/Date:09(14.01.2019 10066268 | :01/82/050/01084/AM19/ :09/24/040/00089/AM19/ 24.05.2018 |a3 doDe c ision:uments /Theinformation ‘Committeefromconsideredthe firm: the case as per agenda and it was decided to call for following || | (i) Percentage of yield. || (ii) Calculation sheet showing quantity of Sulphuric Acid and Nitrate Acid. CaseNo.:13/13/82-ALC4/2018 [Party Name:OPTIMUS [Meet No/Date:13/82. Status: i DRUGS PRIVATE LIMITED ALC4/2018 ‘Approved | | | | 14.01.2019 || |HQFile RLA File Lic.No/Date:09 10066271 | || | :01/82/050/00991/AM19/ ':09/24/040/00069/AM19/ \25.05.2018 | Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in | ithe light of earlier decision taken by NC in its Meeting No. 4/82-ALC4/2018, dated 19.06.2018, it was | || decided to ratify the ad-hoc inputP outputi norms under para 4.7 ofHBP as per details below or as applied by jfirm whichever is lower:

84 | Export product Qty. Sl. Import items Qty. | | No. | Rosuvastatin Calcium lkg (4R-Cis)-6-((Acetyloxy)1.80 kg a Methyl)-2,2-Dimethyl-1,3| Dioxane-4-Acetic Acid-1,1| = Dimethylethyl Ester || 2 4-(4-Fluorophenyl)-61.338 kg 4 Isopropyl-2-[(N-Methyl-NPo Methylsulphony!) ra Amino]Pyrimidine-5-YL|aye| Methanol RA concerned may take further necessary action as per above decision of NC. a | (Case No.:143/13/82Party Name:UNITECH [Meet No/Date:13/82. Status: | | |ALC4/2018 INTERNATIONAL LIMITED ‘ALC4/2018 Approved | | | 14.01.2019 | |HQ File RLA File Lic.No/Date:0310821282 | | :01/82/050/01121/AM19/ :03/95/040/00155/AM19/ 29.05.2018 |Decision: The Committee considered case as per agenda and deliberated on the matter in the presence of »[details] the technical experts[ below][ or][ as][ applied] and it[ by] was[ firm] decided[ whichever] to ratify[is] the[lower:] ad-hoc input output norms under para 4.7 ofHBP as per | || | Export product Qty. | SI. Qty. | | | No. | ||| | Esters of Methacrylic Acid - Crude lkg Acrylic Plastic Strips and Cut 1.10 kg | | Methyl Methacrylate © Monomer Pieces | Net Content Per M.T. : Acrylic Plastic | | Strips and Cut Pieces - 1.33 M.T. | | RA concerned may take further necessary action as per above decision of NC. |

"(Case No.:229/13/82-—~—~«SPartyName:GUJARAT ——«(Meet No/Date:13/82‘Status: ALC4/2018 ORGANICS LIMITED ‘ALC4/2018 Approved 14.01.2019 HQ File RLA File ‘Lic.No/Date:0310821292. | | |:01/82/050/01207/AM19/ :03/94/040/00179/AM19/ '29.05.2018 | | Decision: | The Committee considered case as per agenda and deliberated on the matter in the presence of g6 the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: | | No. | _ | PARA ANISIC ACID Para Hydroxy Benzoic Acid 1.12 kg

[Case No.:259/13/82- === PartyName:AVA_————S*«<wMeett No/Daate:13/82Status: _ ALC4/2018 (CHEMICALS PVT.LTD, \ALC4/2018 Approved | | (14.01.2019 | HQ File RLAFile ~—~—_|Lic.No/Date:0310821336 | :01/82/050/01237/AM19/ :03/94/040/00151/AM19/ 30.05.2018 | Decision: | The Committee considered case as per agenda and deliberated on the matter in the presence of | (87 thedetails technical below experts or as applied and it by wasfirm decided whichever to ratifyis thelower: ad-hoc input output norms under para 4.7 of HBP as per) No. _ | DISODIUM ZINC EDTA Content | 1 kg ETHYLENE DIAMINE| 0.685 kg | | 15% (+/- 0.5%) TETRA ACETIC ACID

RA concerned may take further necessary action as per above decision of NC. | [Case No.:19/13/82-ALC4/2018 PartyName:SMS ——- Meet No/Date:13/82-. Status: | | PHARMACEUTICALS LTD =ALC4/201814.01.2019 Approved || HQ File RLA File Lic.No/Date:0910066288 | |:01/82/050/00997/AM 19/ :09/24/040/00095/AM19/ 31.05.2018 | : seein ——<—<—<—<——<$<——$_——— a R E S nf | |Decision: | The Committee considered case as per agenda and deliberated on the matter in the presence of | the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per) | details below or as applied by firm whichever is lower: | No. | | | EFAVIRENZ lkg | 1 4-CHLORO-2-TRIFLUORO 1.05 kg | } | ACETYLANILINE HYDROCHLORIDE | | MONOHYDRATE (E2 | | | CYCLO PROPYL ACETYLENE 0.26 kg [4 |[TRIPHOSGENE] 2, 2,CITRIC 2-TRI ACID FLUORO MONOHYDRATE ETHANOL| 0.21kg0.788AD k gg|| | _ | RA concerned may take further necessary action as per above decision of NC. |

Case No.:39/13/82-ALC4/2018 Party Name:ORTINMeet No/Date:13/82Status: Be LABORATORIES LTD ALC4/2018 Deferred | 14.01.2019 heme ~ (RLAFile Lic. No/Date:09 10066291 _ |:01/82/050/01017/AM19/ :09/24/040/00082/AM19/ 01.06.2018 | Decision: Deferred for comments of TE. eae | (Case No.:40/13/82-ALC4/2018 PartyName:ORTIN ——([Meet No/Date:13/82-—Status: LABORATORIES LTD ALC4/2018 Deferred | 14.01.2019 °O HQ File RLA File Lic. No/Date:09 10066292 | |:01/82/050/01018/AM19/ :09/24/040/00083/AM19/ (01.06.2018 | Decision: Deferred for comments of TE. | (Case No.:184/13/82"Party Name:STERMONE —Meet No/Date:13/82-_—(Status: || ||ALC4/2018 (CHEMICALS PVT LTD |ALC4/201814.01.2019 Approved| | | [HQFile = (RLAFFile . Lic.No/Date:3410044195 | |:01/82/050/01162/AM19/ :34/24/040/00011/AM19/ (01.06.2018 91 Decision: "The Committee considered case as per agenda and deliberated on the matter in the presence of | detailsthe technicalbelow expertsor as applied and it wasby firm decidedwhichever to ratifyis thelower: ad-hoc input output norms under para 4.7 of HBP as per | | | [Hydrocortisone Acetate | kg [1No.| Hydrocortisone _——*«t~«a.OO Kp | RA concerned may take further necessary action as per above decision of NC.

| Case No.:196/13/82—-Party Name:NATURAL AND [Meet No/Date:13/82.—*(Status: | _ ALC4/2018 ESSENTIAL OILS PVT LTD ALC4/2018 Deferred | | | 14.01.2019 92 HQ File RLA File Lic.No/Date:0710113399 | | |:01/82/050/01174/AM19/ :07/24/040/00059/AM19/ (06.06.2018 | Decision: The Committee considered the case as per agenda and it was decided to refer the case to Coffee | Board for its comments and also call the firm for personal hearing to explain its case. (Case No.:197/13/82‘Party Name:NATURAL AND [Meet No/Date:13/82Status: _ |ALC4/2018 ESSENTIAL OILS PVT LTD —ALC4/2018 Deferred | | (14.01.2019 93 HQ File RLA File Lic.No/Date:0710113400 | |:01/82/050/01175/AM19/ :07/24/040/00060/AM19/ 06.06.2018 | Decision: | The Committee considered the case as per agenda and it was decidedto refer the case to Coffee | Board for its comments and also call the firm for personal hearing to explain its case.

| |Case No.:216/13/82—_—‘[Party Name: BALAJI AMINES [Meet No/Date:13/82. Status: _ ALC4/2018 LIMITED ALC4/2018 ‘Approved 94 14.01.2019 | HQ File RLA File Lic.No/Date:3 | 1 10067070 “4 |:01/82/050/01194/AM19/ :31/83/040/00033/AM19/ 07.06.2018 |

~“~

‘Case No.:58/13/82-ALC4/2018 Party Name:SUVEN LIFE (Meet No/Date:13/82Status: SCIENCES LIMITED ALC4/2018 Approved | | | 14.01.2019 HQ File RLA File Lic.No/Date:0910066298 | | |:01/82/050/01036/AM19/ :09/24/040/00096/AM19/ (08.06.2018 Decision: | The Committee considered the case as per agenda in the presence of Technical Experts and in | the light of earlier decision taken by NC in its Meeting No. 1/82-ALC4/2018, dated 01.05.2018, it was| 95 decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by | firm whichever is lower: 1-BROMO-2lkg | 1. | 2-BROMOANILINE 1.086 kg IODOBENZENE POTASSIUM IODIDE _| 0.733 kg CYCLOHEXANE 2.75 kg |

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

"(Case No.:119/13/82Party Name:SUVEN LIFE [Meet No/Date:13/82Status: ALC4/2018 SCIENCES LIMITED (ALC4/2018 Approved 14.01.2019 HQ File RLA File _ Lic.No/Date:09 10066297 | ':01/82/050/01097/AM19/ :09/24/040/00092/AM 19/ 08.06.2018 | (Decision: | The Committee considered case as per agenda and deliberated on the matter in the presence of | the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per | | details below or as applied by firm whichever is lower: | 96 | _ | |METHYLCHLOROMETHYLPHENYL)-3-(E)-2-(2| 1 kg ft ORTHOACID TOLYL ACETIC 1.56 kg || _ | METHOXYACRYLATE SODIUM METHOXIDE 0.416kg |. | | POTASSIUM IODIDE 0.008 kg | | THIONYL CHLORIDE 1.24 kg | |RA concerned may take further necessary action as per above decision of NC. _ |

| \Case No.:166/13/82Party Name:S;ONGWON Meet No/Date:13/82‘Status: | ALC4/2018 SPECIALTY CHEMICALS —ALC4/2018 Approved INDIA PVT. LTD. (14.01.2019 | [HQFile = |RLAFile Lic.No/Date:34 10044223 | | | |:01/82/050/01144/AM19/ :34/24/040/00024/AM19/ 08.06.2018 Decision: The Committee considered case as per agenda and deliberated on the matter in the presence of; the | details below or as applied by firm whichever is lower: | technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per | No. | lo7 EDOT (3,4 - Ethylenedioxythiophene) | 1 kg | 1 | Dimethyl 2,2-thiobisacetate | 0.566 kg | | | (Other Organo-Sulphur Compnds) Dimethyl! Oxalate 1.30 kg lw 3 Sodium Methoxide Solution | 4.39 kg 30% (Sodium Methylate | | Dimethylformamide 0.329 kg ti 1,2- Dichloroethane 1.76 kg | | 6 | Sulfolane 0.4186 kg | 7 Sodium Sulphide Not shown in | | the process, hence not = allowed. | | en concerned may take further necessary action as per above decision ofNC. | |CaseNo.:44/13/82-ALC4/2018 Party Name:VIRCHOW ‘Meet = No/Date:13/82Status: | [PETROCHEMICAL PVT LTD. |ALC4/2018 ‘Rejected 98 | 14.01.2019 | _ HQ File RLA File Lic.No/Date:0910066322 |:01/82/050/01022/AM19/ :09/24/040/00649/AM18/ 11.06.2018 | Decision: The Committee observed that firm was called for PH before the committee for similar cases, | |but the firm neither attended the PH nor submit its reply. Hence the Committee decided to reject the case. | Case No.:59/13/82-ALC4/2018 Party Name:VIVIMED LABS [Meet No/Date:13/82(Status: | | LIMITED ALC4/2018 Deferred 14.01.2019 ‘99 HQ File RLA File ‘Lic.No/Date:09 10066318 :01/82/050/01037/AM19/ :09/24/040/00106/AM19/ 11.06.2018 technicalDecision: The Committee considered the case as per agenda andit was decidedto call for complete _ of yield ondetailsmolar asbasis per Appendixfrom the firm. 4E along with Chemical reaction, molecular weight and percentage |_ (Case| No.:62/13/82-ALC4/2018(Party Name:SATYA ‘MeetNo/Date:13/82Status: | DEEPTHA ‘ALC4/2018 Deferred — 100.| PHARMACEUTICALSLIMITED 14.01.2019 | HQ File RLA File /— Lie.No/Date:0910066325 |_ :01/82/050/01040/AM19/Decision: Deferred for comments:09/24/040/00110/AM19/of TE. 11.06.2018i | |

“~

“~

| (Case No.:64/13/82‘Party Name: VIVIMED LABS [Meet No/Date:13/89. Status: | | |ALC4/2018 ‘LIMITED ALC4/2018 Approved fo] | 14.01.2019 | [HQ File RLA File Lic.No/Date:0910066319| SS | |:01/82/050/01042/AM19/ :09/24/040/00100/AM19/ 11.06.2018 | Decision: The Committee considered the case as per agenda in the presence ofTechnical Experts and in. | the light of earlier decision taken by NC in its Meeting No. 2/82-ALC4/2018, dated 16.05.2018, it was | | decidedfirm whichever to ratifyis thelower: ad-hoc input output norms under para 4.7 ofHBP as per details below or as applied by) 1102 | || | | Export product Qty. | No.SI. Qty. | | SODIUM PAS GRANULES kg SODIUM PARA AMINO 0.808 kg | | | 80%(W/W) OR SODIUM SALICYLATE POWDER OR AMINO | PAS GRANULES SALICYLATE SODIUM BP Ed 2. HYDROXY PROPYL METHYL 0.05 kg | CELLULOSE PHTHALATE | ISOPROYL ALCOHOL 11.00kg| | | EUDRAGITL 100 |[0.05kg] | RA | concerned may take further necessary action as per above decision of NC. | (Case No.:65/13/82-ALC4/2018 Party Name: VIRCHOW Meet No/Date:13/82(Status: | | PETROCHEMICAL PVT LTD. ALC4/2018 ‘Rejected 103/HQFile 14.01.2019 | | =———s—s—=~~~S«wRE Ale Lic.No/Date:09 10066323 | | |:01/82/050/01043/AM19/ ':09/24/040/00623/AM18/ 11.06.2018 | |Decision: "The Committee observed that firm was called for PHbefore the committee for similar cases, ‘but the firm neither attended the PH nor submit its reply. Hence the Committee decided to reject the case. | (Case No.:75/13/82-ALC4/2018 |Party Name:SATYA _ (Meet No/Date:13/82(Status: DEEPTHA \ALC4/2018 ‘Approved | PHARMACEUTICALS 14.01.2019 LIMITED ... =a ae Lic.No/Date:0910066324 | :01/82/050/01053/AM19/ :09/24/040/00109/AM19/ 11.06.2018 | Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in | F the light of earlier decision taken by NC in its Meeting No. 4/82-ALC4/2018, dated 19.06.2018, it was firm04 decidedwhichever to ratifyis thelower: ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by | | | | Export product Qty. | SL. Qty. | No. | | | AFC ABACAVIR (ABV) I lkg 2-AZABICYCLO (2.2.1) HEPT-51.14kg |} | | EN-3-ONE; (VINCELACTAM | | 2 N-(2-AMINO-4, 6-DICHLORO-5- | 0.764 kg | PYRIMIDINYL) FORMAMIDE | 4 SODIUM BOROHYDRIDE 0.226 kg |.

|||i<br>1 =<br>|[POWDER.——“‘s;CCdrCCOC~d@™rd’|i<br>1 =<br>|[POWDER.——“‘s;CCdrCCOC~d@™rd’|i<br>1 =<br>|[POWDER.——“‘s;CCdrCCOC~d@™rd’|
|---|---|---|---|
||D(-) TARTARIC ACID|0.780 kg|||
||L +TARTARICACID|1.23 kg_||||
|―|RA concerned may take furthernecessary action as perabove decision ofNC.|||
|・||||
||CaseNo.:314/13/82-<br>‘PartyName:JNPPRODUCTS MeetNo/Date:13/82-|Status:||
||ALC4/2018<br>ALC4/2018|Approved||
|||<br>14.01.2019|||
|||HQFile<br>~<br>IRLAFile<br>==<br>—~—_Lic.No/Date:3410044232<br>:01/82/050/01292/AM19/<br>:34/24/040/00081/AM19/<br>11.06.2018<br>Decision: | TheCommittee consideredcaseas peragenda anddeliberated onthe matter inthepresence <br>ofthe technical experts and itwas decided to ratify the ad-hoc input output norms underpara 4.7 ofHBP|||<br> ||
|105|asper details belowor as applied by firmwhichever is lower:||||
||Exportproduct<br>Qty.<br>| Sl. | Import items<br>No.<br>ParaAminoPhenol<br>1kg |1 | ParaNitroChloroBenzene|1.222kg|||
||Caustic Soda Lye|0.764 kg||
||RA concerned may take further necessary action as perabove decision ofNC.||||
|CaseNo.:118/13/82-<br>PartyName:OPTIMUS<br>Meet No/Date:13/82- _—Status:|||||
||ALC4/2018<br>DRUGS PRIVATELIMITED<br>ALC4/2018|Approved||
||14.01.2019|||
||HQFile<br>RLA File<br>Lic.No/Date:0910066332|||
||:01/82/050/01096/AM19/<br>:09/24/040/00066/AM19/<br>12.06.2018||||
|||Decision:<br>|TheCommittee consideredthecase asperagenda inthepresence ofTechnical Expertsandin,|||
||the light of earlier decision taken by NC in its Meeting No. 8/82-ALC4/2018, dated 31.08.2018, it was|||
||decided to ratify the ad-hoc input output norms under para 4.7 ofHBP as per details below or as applied by|||
||firmwhicheverislower:|||

==> picture [464 x 240] intentionally omitted <==

----- Start of picture text ----- | No. | SOFOSBUVIR-IH 2-deoxy-2-fluoro-2-C-methyluridine 0.90 kg | or) (2R)-2-Deoxy-2-Fluoro-2-Methyluridine | 2 N-[(S)-(2,3,4,5,6-Pentafluorophenoxy) 1.60 kg phenoxyphosphinyl]-L-alanine 1-methylethyl ester (OR) propan-2-yl(2S)-2- | {[(pentafluorophenoxy) | phenoxy)phosphory] Jamino} propanoate RA may take appropriate action as per the decision of Norms Committee. | Case No.:16/13/82- | ‘Party Name:PERKIN ‘Meet No/Date:13/82- Status: a | | ALC4/2018 LABORATORIES |ALC4/2018 ‘Approved | (14.01.2019 | 107 HQ File (RLAFile ‘Lic. No/Date:09 10066350. | :01/82/050/00994/AM19/ :09/24/040/00627/AM 1 8/ 19.06.2018 | | Decision: | The Committee considered case as per agenda and deliberated on the matter in the presence of ― ----- End of picture text -----

==> picture [493 x 692] intentionally omitted <==

----- Start of picture text ----- 36 ~, the technical experts and it was decided to ratify the ad-hoc inputoutput norms under para 4.7 of HBP as | | ed details below or as applied by firm whichever is lower: O. | | | Bromo Ketorolac 750.000kg [1 | Pyrrole ——*Y|:-592.500 kg |__| (OR) 5-Benzoyl, 3bromo-2,3- 675.000 kg | | _ | Dihydro,1-H pyrrolizine-1- Dimethyl sulphoxide | 1282.500 kg | | | carboxylic acid 1147.500 kg | | 3120.000 kg | | RA| concerned may take further necessary action as per6 above| Di-ethyldecision malonate of NC. 1717.500 kg | | (Case No.:43/13/82- -——|PartyName:SMILAX (Meet No/Date:13/82-—‘(Status: | _ |ALC4/2018 LABORATORIES LIMITED ALC4/2018 Approved HQ | 14.01.2019 | File RLA File ‘Lic.No/Date:0910066351/ :01/82/050/01021/AM19/ :09/24/040/00128/AM19/ 19.06.2018 | Decision: | The Committee considered case as per agenda and deliberated on the matter in the presence of | the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as_ 108 per details below or as applied by firm whichever is lower: | | No. | | PANTOP OLE BASE lkg MALTOL 0.728 kg | | | 4H-PYRAN-4-ONE(3-HYDROXY-2-METHYL- | | | ‘RA concerned may take further necessary action as per above decision of NC. /|Case No.:101/13/82- =——(PartyName:STYRAX ———s_Meet No/Date:13/82-.— Status: | ALC4/2018 PHARMA PRIVATE \ALC4/2018 Approved | | LIMITED ‘14.01.2019 | | |< RO File: =~ -RLA File Lic.No/Date:0910066365 | | | :01/82/050/01079/AM19/ :09/24/040/00141/AM19/ 20.06.2018 Decision: The Committee considered case as per agenda and deliberated on the matter in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as | per details below or as applied by firm whichever is lower: | TENOFOVIR DISOPROXIL | | kg No. 9-(2-Phosphony! methoxy) 0.769 kg | |FUMARATE propyl) adenine } 2 chloromethyl-2-isopropyl 1.3527 kg | carbonate | | N-Methyl-2-pyrrolidone 1.4878 kg | | 0.4477 kg | | | Methylene Dichloride (MDC) | 4.32 kg | | | }i | ‘RA concerned may take further necessary action as per above decision of NC. | ´ ハ 訛 ― ・ ― ----- End of picture text -----

'110 (Case No.:66/13/82|Party Name:SRIAMLABS Meet No/Date:13/82Status:

ALC4/2018 PRIVATE LIMITED — ‘ALC4/2018 =—S Approved | 14.01.2019 | HQ File RLA File Lic.No/Date:0910066366 :01/82/050/01044/AM19/ :09/24/040/00147/AM19/ 21.06.2018 | | ‘Decision: |The Committee considered case as peragenda and deliberated on the matter in the presence of. the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBPas | per details below or as applied by firm whichever is lower: | | No. Hydroxychloroquine or Hydroxy | 1 kg 11__|[4,7-dichloroquinoline] 0.934 kg Chloroquine Base or 2-[[4-[(72 Hydroxynovaldiamine 0.866 kg | | Chloro-4quinoyl) amino] pentyl] ethylamine] ethanol

==> picture [2 x 24] intentionally omitted <==

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

~~ (Case No.:35/13/82-ALC4/2018 Party Name:VIVIMED LABS Meet No/Date:13/82Status: (LIMITED ALC4/2018 Deferred | 14.01.2019 | | HQ File RLAFile ~~—~—~—_Lic.No/Date:0910066375 | :01/82/050/01013/AM19/ :09/24/040/00136/AM19/ 22.06.2018 111 Decision: The Committee considered the case as per agenda and it was decided to call for following documents / information from the firm: | | (i) Exact chemical name of Import Item No. 3 - VANISPERSE with catalogue & its use in export | | product; and (ii) Recovery of METHANOL in the production process. |

"Case No.:36/13/82-—=—PartyName:UNIMAX ———_—Meet No/Date:13/82Status: _ | | ALC4/2018 ‘LABORATORIES PVT.LTD ALC4/2018 ‘Approved | | 14.01.2019 HQ File . RLAFile Lic.No/Date:03 10821888 :01/82/050/01014/AM19/ :03/95/040/00256/AM19/ 22.06.2018 | Decision: The Committee considered case as per agenda and deliberated on the matter in the presence | | of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as | per details below or as applied by firm whichever is lower: |

|| Prednisolone Sodium Phosphate | 1 kg |

|} | }

==> picture [245 x 97] intentionally omitted <==

----- Start of picture text ----- No. Prednisolone (Prednisolone 0.839 kg || Base ). | Tech Spec. : Pharmacoepial Grade. Prednisolone is used as an intermediate in manufacture of Prednisolone Sodium | Phosphate | ----- End of picture text -----

[* ‘Case }No.:71/13/82-ALC4/2018 Party Name: VIVIMED LABS Meet No/Date:13/82- i Status: =o ‘LIMITED ALC4/2018 Deferred 13 14.01.2019 _ HQFile = -IRLAFile Lic.No/Date:09 10066374 | | ~ :01/82/050/01049/AM19/ ':09/24/040/00134/AM19/ 22.06.2018 Decision: The Committee considered the case as per agenda and it was decided to call for complete ‘technical details as per Appendix 4E indicating use of raw material in the export product along with ‘Chemical reaction, molecular weight and percentage of yield on molar basis and from the firm. | Case No.:76/13/82-ALC4/2018 |Party Name: VIVIMED LABS Meet No/Date:13/82Status: = LIMITED ‘ALC4/2018 Deferred 114 14.01.2019 | HQ File RLA File Lic.No/Date:09 10066376 | |:01/82/050/01054/AM19/ :09/24/040/00135/AM19/ 22.06.2018 Decision: The Committee considered the case as per agenda and it was decided to call for recovery of. Import Item No. 2, 3 and 4 in the production process from the firm.

Case No.:214/13/82‘Party Name:FOURRTS Meet No/Date:13/82[Status: | LoALC4/2018 (INDIA) LABORATORIES P ALC4/2018 Deferred LTD 14.01.2019 | [115 | | fa File RLA File ae Lic.No/Date:0410164438 | |:01/82/050/01192/AM19/ ':04/24/040/00036/AM19/ 22.06.2018 Decision: Deferred for comments of TE. “ue E | (Case No.:185/13/82[PartyName:SPCLIFE [Meet No/Date:13/82(Status: | =ALC4/2018 SCIENCES PVT. LTD. ALC4/2018 Deferred (118 | 14.01.2019 | TQ File RLA File oe Lic.No/Date:3410044282 | | :01/82/050/01163/AM19/ :34/24/040/00109/AM19/ 26.06.2018 Decision: Deferred for comments of TE. i | (CaseNo.:117/13/82|PartyName:ORTIN. ‘MeetNo/Date:13/82(Status: | |ALC4/2018 SSSALABORATORIES LTD ALC4/201814.01.2019 ‘Deferred Peis | ile SS cn :01/82/050/01095/AM19/ ea :09/24/040/00150/AM19/ 27.06.2018 Decision: Deferred for comments ofa 7 ee eee, | [Case No.:15/13/82-ALC4/2018[Party Name: VIRCHOW MeetNo/Date:13/82Status: PETROCHEMICAL PVT LTD. ALC4/2018 Rejected | | 14.01.2019 118 HQ File RLA File Lic.No/Date:09 10066398 :01/82/050/00993/AM19/ :09/24/040/00137/AM19/ 28.06.2018 Decision: The Committee observed that firm was called for PH before the committee for similar cases, ‘but the firm neither attended the PH nor submit its reply. Hence the Committee decided to reject the case. | Liye ‘Case No.:260/13/82a, Party Name:GLENMARK E Meet No/Date: 13/821 Status: ALC4/2018 PHARMACEUTICALS LTD., ALC4/2018 Deferred

| eZ a 14.01.2019 fo | HQ File RLA File Lic.No/Date:0310822054 | | :01/82/050/01238/AM19/‘Decision: Deferred for comments':03/94/040/00271/AM19/ fcr — 29.06.2018Oe — os opt aed See Uaseasagpaaaaeioeaeeon a a oa etii Sl

a a oa etii Sl

Case No.:308/13/82Party Name:AMI LIFE —- Meet[No/Date:13/82-] ‘Status: ALC4/2018 SCIENCES PRIVATE ALC4/2018 Approved LIMITED 14.01.2019 | ~~ [Lic.No/Date:3410044289, HQ File RLA File | :01/82/050/01286/AM19/ :34/24/040/00113/AM19/ 29.06.2018 | Decision: The Committee considered case as per agenda and deliberated on thematter in the presence of 129 the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as_ per details below or as applied by firm whichever is lower: No. [Benfotiamine| kg [1 __| Thiamine Hydrochloride 0.0922 kg

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

"(Case No.:313/13/82~~ |Party Name:AMILIFE _—<(Meet No/Date:13/82(Status: ALC4/2018 SCIENCES PRIVATE /ALC4/2018 Approved LIMITED 14.01.2019 HQ File RLA File Lic.No/Date:3410044292 | :01/82/050/01291/AM19/ :34/24/040/00112/AM19/ 29.06.2018 | | ‘Decision: The Committee considered case as per agenda and deliberated on the matter in the presence of | the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as} 121 per details below or as applied by firm whichever is lower: |[|] No. | kg | SS | |

No. | kg SS | RA concerned may take further necessary action as per above decision of NC. "(Case No.:315/13/82-. -—Party Name:AMI LIFE Meet No/Date:13/82(Status: ALC4/2018 SCIENCES PRIVATE ALC4/2018 Approved LIMITED 14.01.2019 — HQFile ~— RLA File P :01/82/050/01293/AM19/ ':34/24/040/001 10/AM19/ 29.06.2018Lic.No/Date:3410044293 | | | Decision: The Committee considered case as per agenda and deliberated on the matter in the presence of | | the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBPas | 122 per details below or as applied by firm whichever is lower: | No. ke = ee |

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

| (Case No.:316/13/82- —_—(Party Name:AMI LIFE _ Meet No/Date:13/82‘Status: | ALC4/2018 SCIENCES PRIVATE ALC4/2018 ‘Approved | | | LIMITED 14.01.2019 | | | (HOFie ~~ TIRE File Lic.No/Date:3410044288 —:01/82/050/01294/AM19/ :34/24/040/00111/AM19/ 29.06.2018 _| | Decision:the The Committee considered case as per agenda and deliberated on the matter in the presence of | (123 per dt e tailschnicalbelow experts or as andappliedit was by decided firm whicheverto ratify theis lower: ad-hoc input output norms under para 4.7 of HBP as

No.

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

==> picture [463 x 475] intentionally omitted <==

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

|||||||||||
|---|---|---|---|---|---|---|---|---|---|
|||(Case|No.:325/13/82-|-—(PartyName:AMILIFE|_|Meet No/Date:13/82-__|Status:|||
|||/ALC4/2018|SCIENCES PRIVATE|‘ALC4/2018|Approved|
|;|||LIMITED|14.01.2019|
||||HQ|File|iia)|RLA File|Lic.No/Date:34 10044290|||
||||:01/82/050/01303/AM19/|':34/24/040/00099/AM19/|29.06.2018|||||
|||Decision:|The Committee considered case|as per agenda and deliberated|on|the matter|in the presence of|
|||the technical|experts and|it was decided to ratify the ad-hoc|input output norms|under para 4.7 of|HBP au|
|||per details below or as applied by firm whichever|is|lower:|
|124.|
|No.|
|_|||DOXOFYLLINE.|WHITE|lkg|ANHYDROUS|0.80 kg|
||||||||LOD:NMTCRYSTALLINE POWDER.|CRYSTALLINETHEOPHYLLINE. WHITEPOWDER|LOD|||
|||||||1.0% W/W ASSAY BY HPLC|NIT|
||||||BETWEEN 98% TO|101.00%|0.5%|W/W|ASSAY.|BETWEEN|
|||||W/W|(ON DRIED BASIS|98.0% TO 101.0%|
|||RA concerned may take|further necessary action as per above decision of|NC.|||
|| \Case|No.:327/13/82-|-—=*[PartyName:AMILIFE|‘(MeetNo/Date:13/82-|Status:|
|a:ALC4/2018|SCIENCES PRIVATE|‘ALC4/2018|Approved|||
|(LIMITED|14.01.2019|||
|||HQ File|RLA|File|~||Lic.No/Date:3410044291|||
|||':01/82/050/01305/AM19/|:34/24/040/00108/AM19/|29.06.2018|||
|||‘Decision:|The Committee considered case as per agenda and|deliberated|
|the|on|the matter in|the|presence|of|||
|per|technicaldetails|belowexpertsor|as andappliedit was by decidedfirm|whicheverto ratify theis|lower: ad-hoc|input output norms|under para 4.7 of|HBP|as_|
|1125|
|No.|
|||DOXOFYLLINE.|WHITE|lkg|ANHYDROUS|0.80 kg|
|CRYSTALLINE POWDER.|THEOPHYLLINE. WHITE|
|_|||LOD:NMT|CRYSTALLINE|POWDER|LOD|||
|_|||1.0% W/W ASSAY BY HPLC|NIT|||
||||BETWEEN 98% TO|101.00%|0.5%|W/W|ASSAY.|BETWEEN|
|||||||W/W|(ON DRIED BASIS|98.0% TO|101.0%|||

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

==> picture [460 x 341] intentionally omitted <==

----- Start of picture text ----- Bb het SS OC LS Se | HQ File RLA File Lic.No/Date:03 10822074 | | ':01/82/050/01239/AM19/ ':03/94/040/00275/AM19/ (02.07.2018 theDecision: |The Committee considered case as per agenda and deliberated on the matter in the presence of| technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as details below or as applied by firm whichever is lower: | it | | [SL] Export product Qty. | Sl. | Import items Qty. | | | No. No. ; Mupirocin Ointment USP 2% (Pack | 1 pack Mupirocin USP 0.4488 | USP is 154.000 Kgs.) pack | | Size 22gms) ( Net Wt.of Mupirocin gm/22 gm | 2 Supiroban 15gm Ointment ZA 1 pack Mupirocin USP 0.306 gm/15 |, | Mupirocin(Pack Size USP 15gms)is 27.000 ( Net Wt.of Kgs.) gm pack | 3 Supiroban 14gm zulu Ointment 1 pack Mupirocin USP 0.2856 (Pack Size 14gms) ( Net Wt.of mg/14 gm | | | Mupirocin USP is 25.000 Kgs.) pack | |4 Supiroban 50gm Ointment (Pack 1 pack Mupirocin USP 0.51 gm/50 | Size 50gms) ( Net Wt.of Mupirocin gm pack USP is 55.000 Kgs.) | | RA concerned may take further necessary action as per above decision of NC. | [|] Ｆ 訛 ----- End of picture text -----

==> picture [458 x 286] intentionally omitted <==

----- Start of picture text ----- [- ‘Case No.:298/13/82- = Party Name:GLENMARK Meet No/Date:13/82- Status: | ALC4/2018 PHARMACEUTICALS LTD., ALC4/2018 Deferred aS: 14.01.2019 otis .- WREA File Lic.No/Date:0310822084 | | ':01/82/050/01276/AM19/ ':03/94/040/00274/AM19/ 02.07.2018 | Decision: Deferred for comments of TE. | (Case No.:302/13/82- -—|PartyName:AJANTA ——{Meet No/Date:13/82- Status: | |ALC4/2018 PHARMA LTD., ALC4/2018 Approved | } | 14.01.2019 | 01/82/050/01280/AMHQ File 19/ RLA:03/94/040/00165/AM19/ File Lic.No/Date:0310822121(04.07.2018 | | Decision: | The Committee considered case as per agenda and deliberated on the matter in the presence of | | the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as | per details below or as applied by firm whichever is lower: 131 | ; | No. || Indoflam Eye Drops 2000000.000 Indometacin EP (Micronized 10.000 kg _ | bottle contains Smg | | | 0.1% FA, 5 ml (Each Sm! |Number DMF Grade) Indometacin EP) ｄ Ｓｔａｔ ----- End of picture text -----

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

| ‘Case No.:241/13/82'Party Name:CLARIANT —_—s Meet No/Date:13/82Status: | ALC4/2018 ‘(CHEMICALS [INDIA] LTD. |(ALC4/2018 ‘Deferred | | 14.01.2019 | HQ File RLA File Lie. No/Date:0310822143 | | :01/82/050/01219/AM19/ :03/94/040/0029 1/AM19/ 05.07.2018 | 132 Decision: The Committee considered the case as per agenda and it was decided to call for following | documents / information from the firm: | (i) Complete chemical reaction showing molecular weight ; and | (ii) Percentage of yield on molar basis.

/ (Case No.:99/13/82-ALC4/2018 [Party Name:VIRCHOW (Meet No/Date:13/82Status: PETROCHEMICAL PVT LTD. |ALC4/2018 ‘Rejected | 14.01.2019 | - |RLAFile Lic.No/Date:0910066425 | 1133 HQ File :01/82/050/01077/AM19/ ':09/24/040/00065/AM19/ 06.07.2018 | | Decision: The Committee observed that firm was called for PH before the committee for similar cases, || ‘but the firm neither attended the PH nor submit its reply. Hence the Committee decided to reject the case. _ (Case No.:249/13/82~~ |Party Name:J.B. CHEMICALS Meet No/Date:13/82Status: | ALC4/2018 & PHARMACEUTICALS ALC4/2018 Deferred — \LIMITED 14.01.2019 | I4OQFie — IRLA File Lic.No/Date:0310822175 | | | :01/82/050/01227/AM19/ |:03/94/040/00298/AM19/ 06.07.2018 | Decision: Deferred for comments of TE. |

[ Case No.:251/13/82Party Name:GLENMARK ‘Meet No/Date:13/82Status: |ALC4/2018| | PHARMACEUTICALS LTD., ALC4/201814.01.2019 aang || | HQ File = RLAFile Lic.No/Date:0310822155 | | | ':01/82/050/01229/AM19/ |:03/94/040/00272/AM19/ (06.07.2018 | | Decision: |The Committee considered case as per agenda and deliberated on the matter in the presence | | perthe technical details belowexperts or as and appliedit was by decided firm whichever to ratify the is lower: ad-hoc input output norms under para 4.7 of HBP as| | [SL] Export product Qty. Import items eae ete | | No. Ursodiol Tablets USP 250mg | 1 pack No. Ursodiol USP 255 mg/250mg | | (Pack Size 100 Tabs.) tablet | ( Net. wt. of Ursodiol USP is | | || 1500.000 Kgs.) | oa | | | 2 Ursodiol Tablets USP 500mg (__| 1 pack Ursodiol USP 510 mg/ 500 mg | | | Pack Size 100 Tabs.) tablet (Net. wt. of Ursodiol USP is 2500.000 Kgs.) | ‘RA concerned may take further necessary action as per above decision of NC. | Case No.:250/13/82==—(PartyName:BDR=—=S Meet No/Datte:13/82- _—Status: | \ALC4/2018 PHARMACEUTICALS ALC4/2018 Deferred ce INTERNATIONAL PVT. LTD. 14.01.2019 136 FQ File RLA File (Lie.No/Date:0310822211 | | |:01/82/050/01228/AM19/ :03/94/040/00285/AM 19/ 10.07.2018 | Decision: Deferred for comments of TE. | (Case No.:161/13/82Party Name:UNITECH ‘Meet No/Date:13/82Status: ALC4/2018 INTERNATIONAL LIMITED |ALC4/2018 Approved — | 14.01.2019 HQ File RLA File Lic.No/Date:03 10822254 | :01/82/050/01139/AM19/ :03/95/040/00236/AM19/ 11.07.2018 | Decision: The Committee considered case as per agenda and deliberated on the matter in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP | as per details below or as applied by firm whichever is lower: ri | || Esters of Methacrylic Acid - Crude No. Acrylic Plastic Strips and Cut 1.10 kg | _ | Methyl Methacrylate © Monomer Pieces | | Net Content Per M.T.: Acrylic Strips | | | Land Cut Pieces - 1.33 M.T. | | ig concerned may take further necessary action as per above decision of NC. ||

Case No.:252/13/82Party Name:KOPRAN Meet No/Date:13/82Status: ALC4/2018 /RESEARCH ALC4/2018 Approved ‘LABORATORIES LTD. 14.01.2019 | HQ File RLA File Lic.No/Date:03 10822228 | ::01/82/050/01230/AM19/ ':03/94/040/00214/AM19/ 11.07.2018 Decision: |The Committee considered the case as per agenda in the presence of Technical Experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as_ applied by firm whichever is lower:

==> picture [461 x 164] intentionally omitted <==

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

|||||||||
|---|---|---|---|---|---|---|---|
|||
|Export product|Qty.|Sl.|Import items|Qty.|||
|138|No.|
||||||PREGABALIN|1|kg|ISOVALERALDEHYDE|2.72 kg|||
|CYANOACETAMIDE|5.33|kg|||
|||3|R(4)-METHYL BENZYL AMINE|||0.114 kg|
|OR|(R)-1-|
|PHENYLETHYLAMINE|||
|ISO PROPYL ALCOHOL (IPA)|||1-74kg_||.|
|CHLOROFORM|2.50kg|||,|
||||||
|RA may take appropriate|action|as per the decision of Norms Committee.|

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

' ~IGase No.:93/13/82-ALC4/2018 [Party Name:PORUS __—‘([Meet No/Date:13/82‘Status: LABORATORIES PVT LTD ALC4/2018 Deferred — | | 14.01.2019 | | |139 HQ File RLA File ‘Lic.No/Date:0910066447 | | :01/82/050/01071/AM19/ :09/24/040/00172/AM19/ 12.07.2018 | Decision: The Committee considered the case as per agenda and it was decided to call for complete technical details as per Appendix 4E along with Chemical reaction, molecular weight and percentage[|] of yield on molar basis from the firm.

"Case No.:253/13/82- in Party Name:ALTA i Meet No/Date:13/82- ; Status: | ALC4/2018 LABORATORIES LTD. ALC4/2018 ‘Approved /14.01.2019 | HQ File RLA File ‘Lic. No/Date:03 10822278 :01/82/050/01231/AM19/ ':03/94/040/00307/AM 19/ 12.07.2018 | Decision: |The Committee considered case as per agenda and deliberated on the matter in the presence of[|] 140 the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as| per details below or as applied by firm whichever is lower: SODIUM SALICYLATE rikg[1No.| SALICYLIC ACID 0.88 kg | |

==> picture [334 x 17] intentionally omitted <==

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

|||||i“,|i“,|
|---|---|---|---|---|---|
|||<br>‘CaseNo.:262/13/82-<br>a<br>‘PartyName:ALTA<br>‘(MeetNo/Date:13/82-<br>Status:<br>ALC4/2018<br>‘LABORATORIES LTD.<br>‘ALC4/2018<br>Approved<br>—<br>14.01.2019<br>HQ<br>File<br>RLAFile<br>- [Lic.No/Date:0310822279<br>|<br>SSS<br>:01/82/050/01240/AM19/<br>:03/94/040/00308/AM19/<br>12.07.2018<br>|<br>Decision:<br>TheCommitteeconsideredcaseasperagendaanddeliberatedonthematterinthepresenceof,<br>**_**,<br>|the technical expertsand itwasdecided to ratifythead-hoc inputoutputnorms underpara4.7ofHBPas)<br>i141 perdetailsbeloworasappliedbyfirmwhicheverislower:<br>|||||||
||||||||
||||||||
|||<br>|||||||
|||<br>No.|||||
|||<br>RAconcernedmaytakefurthernecessaryactionasperabovedecisionofNC.|||||
||Case No.:311/13/82-<br>‘PartyName:GULBRANDSEN MeetNo/Date:13/82-<br>—[Status:<br>_<br>(ALC4/2018<br>‘CHEMICALSPVT LTD<br>ALC4/2018<br>Deferred<br>ae<br>14.01.2019<br>(142TQFile<br>~|RLAFile<br>~ |Lic.No/Date:3410044328<br>|<br>|<br>:01/82/050/01289/AM19/<br>:34/24/040/00139/AM19/<br>12.07.2018<br>Decision: Deferred forcomments ofTE.||||<br>|||
||||||||
||_— CaseNo.:91/13/82-ALC4/2018 [Party Name:SUVENLIFE [MeetNo/Date:13/8.<br>Status:<br>ie<br>SCIENCESLIMITED<br>ALC4/2018<br>‘Deferred<br>bow<br>14.01.2019<br>eHQFile<br>~<br>IRLAFile<br>Lic.No/Date:0910066455<br>|<br>:01/82/050/01069/AM19/<br>:09/24/040/00177/AM19/<br>13.07.2018<br>|<br>|<br>Decision: Deferred forcommentsofTE.|||||||
||pa Case No.:98/13/82-ALC4/2018 PartyName:SUVENLIFE<br>‘Meet No/Date:13/82-<br>Status: ae<br>|<br>SCIENCESLIMITED<br>|ALC4/2018<br>Deferred<br>||<br>|<br>14.01.2019<br>|<br>2ooSeree<br>-<br>Lic.No/Date:0910066454<br>|<br>|<br>_:01/82/050/01076/AM19/<br>:09/24/040/00176/AM19/<br>13.07.2018<br>|<br>Decision:Deferred forcommentsofTE.||<br>||||||
|}<br>||| rmeruian ~<br>——“hety NaockAGit<br>MeetNo/Date:13/82-<br>Status:<br>|<br>(ALC4/2018<br>PHARMALIMITED<br>ALC4/2018<br>Deferred<br>|<br>14.01.2019<br>HQFile<br>RLAFile<br>Lic.No/Date:0910066457<br>|:01/82/050/01078/AM19/<br>:09/24/040/00188/AM19/<br>13.07.2018<br>Decision: IDeferredforcommentsofTE. a<br>oe<br>7||||||
|ｄ<br>Ｓ<br>ｔ<br>ａ<br>ｔ<br>(CaseNo.:102/13/82-<br>SSCSPartyName:SATYA<br>[MeetNo/Date:13/82.<br>Status:<br>'ALC4/2018<br>DEEPTHA<br>ALC4/2018<br>Deferred<br>146<br>PHARMACEUTICALS<br>14.01.2019<br>iH<br>(LIMITED<br>[HQ<br>File<br>RLAFile<br>Lic.No/Date:0910066456<br>ess||||||

==> picture [462 x 722] intentionally omitted <==

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|||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|47|
|:01/82/050/01080/AM19/|':09/24/040/00184/AM19/|13.07.2018|[|||
|Decision:|Deferred|for|comments|of TE.|=¥|an|a|el|
|(Case No.:92/13/82-ALC4/2018 Party|Name:VIVIN|DRUGS & Meet No/Date:13/82-|‘Status:|||
|PHARMACEUTICALS|ALC4/2018|Approved|—|
|‘LIMITED|14.01.2019|||||
|HQ|File|RLA|File|Lic.No/Date:0910066463|||
|:01/82/050/01070/AM19/|:09/24/040/00183/AM19/|16.07.2018|||
|Decision:||The|Committee|considered|case|as|per agenda and|deliberated|on|the|matter|in|the|presence|of|||
|||the|technical|experts|and|it|was|decided|to|ratify|the|ad-hoc|input|output|norms|under|para|4.7|of HBP|as||
|per|details|below|or|as|applied|by|firm|whichever|is|lower:|
|||||||
|No.|
|147|4-AMINO-5-FLURO-1-((2R,5S)-2-|1kg||1|||L-MENTHOL|1.72 kg|
||HYDROXYMETHYL-|GLYOXYLIC ACID|- 50%|||1.92kg|
|||[1,3]|OXATHIOLANE-|3|2,5|DI HYDROXY|1,4|0.82|kg|
|5-YL)-1 H-PYRIMIDIN-2-|DITHIANE|||
|ONE(EMO-I) OR EMO-I OR EMO|/4|||5-FLUORO CYTOSINE|1.20|kg|||
|5|HEXAMETHYL|0.75|kg|
|DISILAZANE|||
|||[6|||METHYLENE CHLORIDE ||6.00 kg|
|||TRIPHOSGENE|0.87 kg|||
|8|SODIUM BOROHYDRIDE ||0.48|kg|
|DIPOTASSIUM|2.07|kg|
|HYDROGEN|PHOSPHATE|
|RA concerned may take|further necessary action as per above decision of|NC.|||
|~|(Case|No.:189/13/82-|-—~—~Party|Name:YASH|RASAYAN|Meet No/Date:13/82-|Status:|
|ALC4/2018|'& CHEMICALS|ALC4/2018|Deferred|||
|||14.01.2019|||
|148|iQ File|RLAFile|~|Lic.No/Date:3410044333|||||
|:01/82/050/01167/AM19/|:34/24/040/00114/AM19/|16.07.2018|
|Decision:|Deferred|for comments of TE.|
|Case|No.:254/13/82-|Party Name:GLENMARK|Meet No/Date:13/82-|‘Status:|
|ALC4/2018|PHARMACEUTICALS|LTD.,|ALC4/2018|Approved|
|HQFile|IRLAFile|=|~~—~—~—_Lic.No/Date:031082231014.01.2019||||||
|:01/82/050/01232/AM19/|:03/94/040/00310/AM19/|16.07.2018|||
|Decision:|The|Committee|considered|case|as per agenda and deliberated|on|the|matter|in|the|presence|of|||
|||the|technical|experts|and|it|was|decided|to|ratify|the|ad-hoc|input|output|norms|under para|4.7|of HBP as|
||149|[per]|[details]|[below][ or][ as][ applied][ by]|[firm][ whichever]|[is]|[lower:]||||
|||
|Sl.|Export product|Qty.|Sl.|||Import|items|
|||No.|No.|
|||iroci|0.4488|
|||Mupirocin Ointment USP 2% (Pack|a|MORAN|gm/22 gm|||
|Size|22gms)|(|Net Wt.of Mupirocin|aie|

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

“

==> picture [458 x 158] intentionally omitted <==

----- Start of picture text ----- bee oe eee oe ae ee ae = a nn as a ie Supiroban 15gm Ointment ZA ] pack Mupirocin USP 0.306 gm/15 |. |; | (PackMupirocinSize USP15gms)is 27.000( Net Wt.ofKgs.) gm pack | | | 3 Supiroban 14gm zulu Ointment l pack | 1 Mupirocin USP 0.2856 | | (PackMupirocin Size 14gms)USP is 25.000( Net Wt.ofKgs.) packmg/14gm | | | 14 Supiroban 50gm Ointment (Pack 1 pack Mupirocin USP 0.51 gm/S0 | Size 50gms) ( Net Wt.of Mupirocin gm pack 4 USP is 55.000 Kgs.) ----- End of picture text -----

| | |

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

| (Case No.:297/13/82- ~ ‘ Party Name:GLENMARK ——Meeet No/Date:13/82Status: _ ALC4/2018 PHARMACEUTICALS LTD., ALC4/2018 Deferred fi aif | 14.01.2019 0 QFile ~ IRI-A Fille ‘Lic.No/Date:03 10822322 | | ':01/82/050/01275/AM19/ '03/94/040/00309/AM 19/ 16.07.2018 | | Decision: Deferred for comments of TE. || |CaseNo.:299/13/82- |Party Name:BENZOCHEM Meet No/Date:13/82-.—‘(Status: | (ALC4/2018| INDUSTRIES‘LIMITED, PRIVATE 14.01.ALC4/ 20 1918 Approved| | | HQ File RLA File Lic.No/Date:0310822333 | | _ |:01/82/050/01277/AM19/ ':03/94/040/00270/AM19/ 17.07.2018 | | Decision: The Committee considered case as per agenda and in the presence of thetechnical experts, it ‘was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as. 151 ae by firm whichever ae by firm whichever by firm whichever firm whichever whichever is lower: lower: |

==> picture [464 x 734] intentionally omitted <==

----- Start of picture text ----- 49 | HQ File —RLA File ~— Lie, No/Date:0310822339 :01/82/050/01281/AM19/ |:03/94/040/00317/AM19/ /17.07.2018 | Decision: The Committee considered case as per agenda and inthe presence of the technical experts, it| ‘was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as|| | applied by firm whichever is lower: | Export product Qty. Sl. | Import items Qty. | No. | | LITHIUM CARBONATE EXTENDED | Number | 1 306 mg/ 300 || RELEASE TABLETS USP 300 MG. mg tablet | | (PACK OF 100) | | EACH EXTENDED RELEASE FILM LITHIUM | COATED TABLET CONTAIN 300 MG CARBONATE USP OF LITHIUM CARBONATE USP. NET CONTENT OF LITHIUM CARBONATE USP 454.560 KGS. LITHIUM CARBONATE EXTENDED 2 459 mg/ 450 || || RELEASE(PACK OF TABLETS 100) USP 450 MG mg tablet | EACH EXTENDED RELEASE FILM Nuaber LITHIUM | | [COATED] OF LITHIUM [ TABLET CONTAIN] CARBONATE USP. [450][ MG] NET CARBONATE USP | CONTENT OF LITHIUM | | CARBONATE USP 442.485 KGS | RA may take appropriate action as per the decision of Norms Committee (Case No.:304/13/82- in Party Name:GLENMARK Meet No/Date:13/82- Status: a _ (ALC4/2018 PHARMACEUTICALS LTD., ALC4/2018 Approved 14.01.2019 HQ File RLA File Lic.No/Date:03 10822335 | | :01/82/050/01282/AM19/ :03/94/040/00303/AM19/ 17.07.2018 | _ Decision: Committee considered case as per agenda and as per earlier decision taken by NC in its 4/82 | | ‘meeting dated 19.06.2018, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as, | __per details below or as applied by firm whichever is lower: | Export Product Import Product Quantity Allowed in kg | No. Qty. Lamotrigine Tablets CD 25mg __| packs 22.50 mg/ 25 mg tablet | (Pack size 100 Tabs.) Net Wt. of —- | 154 Lamotrigine is 54.250 Kgs.) 8 | || Lamotrigine Tablets CD Smg packs 5.10 mg/ 5 mg tablet } | 3 (Pack size 100 Tabs.) Net Wt. of aasenibatien | | Lamotrigine is 10.500 Kgs.) g | | Lamotrigine Tablets USP 100mg | packs 102.0 mg/ 100 mg tablet 3 (Pack size 100 Tabs.) Net Wt. of ——_ Lamotrigine is 10.000 Kgs.) 8 | Lamotrigine Tablets USP 150mg | packs 153.0 mg/ 150 mg tablet } | 4 | (PackLamotrigine size 60is Tabs.) 9.000 Net Kgs.) Wt. of ——8 | | [5 ieee| Lamotrigine—a TabletsSee atemrsey USP 200mgal =e mien wach _ a 204.0a mg/a 200 mg— tabletnl| ----- End of picture text -----

50 ~, | | |@acksize60Tabs)NetWiof | | | | | Lamotrigine is 12.000 Kgs.) } | Lamotrigine Tablets USP 25mg _ | packs 25.50 mg/ 25 mg tablet | . (Pack size 100 Tabs.) Net Wt. of Lamotrigine | | Lamotrigine is 2.500 Kgs.) | | RA may take appropriate action as per the decision of Norms Committee |(Case No.:433/13/82- = PartyName:MOREPEN —(Meet No/Date:13/82-. ‘Status: | ALC4/2018 LABORATORIES LTD., \ALC4/2018 Approved Pl 14.01.2019 | | | [HQFile /RLA File Lic.No/Date:0510407231 | | :01/82/050/01411/AM19/ ':05/24/040/00217/AM19/ (18.07.2018 | Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the | | ‘light of earlier decision taken by NC in its Meeting No. 5/82-ALC4/2015, dated 25.06.2015, it was decided | | __ to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm | 1155 whichever is lower: | | | | | | Export product Qty. | Sl. | Import items Qty. | No. | | ROSUVASTATIN CALCIUM 1 kg tert-Butyl-2-((4R,6S)-6-((E)-2-(4(- | 1.425 kg | (4-fluoropheny])-6-isopropyl-2-[N| methyl (methylsulphonyl)amino] | pyrimidin-5-yl) vinyl)-2,2| | | ed dimethyl-1,3-dioxane-4-yl)acetate rg | | | tert-butyl methyl ether (MTBE) 0.79 kg | RA may take appropriate action as per the decision of Norms Committee. | | (Case No.:87/13/82-ALC4/2018 [Party Name:VIVIMED LIFE [Meet No/Date:13/82(Deferred | =. SCIENCES PRIVATE ALC4/2018 | [196 ‘LIMITED 14.01.2019 | fiQ File RLA File Lic.No/Date:0910066481 Defer | | ':01/82/050/01065/AM19/ |09/24/040/00148/AM 19/ /19.07.2018 | ‘Decision: Deferred for comments of TE - ar | | ae CaseALC4/2018|No.:97/13/82oe PHARMAParty Name:STYRAX PRIVATE ‘ALC4/2018Meet No/Date:13/82ApprovedStatus: ches = LIMITED 14.01.2019 | | | [HQ File RLA File ‘Lic.No/Date:0910066485 | si | | ':01/82/050/01075/AM19/ :09/24/040/00199/AM19/ '19.07.2018 | Decision: Committee considered case as per agenda and in the presence oftechnical experts, it was decided | 157 to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm| whichever is lower: | | | | 4-AMINO-5-FLUORO-11Kg. ||1. Glyoxalic acid 50% 2.234 | [(2R,5S)-22 2,5-Dihydroxy-1,4| | OXATHIOLAN-S-YL]-1,2-(HYDROXYMETHYL)-1,35-Fluoro CytosineDithiane 1.348 | |

“"~

|| | DIHYDROPYRIMIDIN-2| [4 | SodiumBorohydride [050 || | ONE (EMO / EMT) SBH a HexaHMDS Methyl Disilazane Methylene Di Chloride RA concerned may take further necessary action as per above decision of NC (Case No.:255/13/82-~—~—S~Party Name:CIPLA LIMITED. Meet No/Date:13/82Status: ALC4/2018 ALC4/2018 Approved | 14.01.2019 HQ File RLA File - Lic.No/Date:0310822432 | |. :01/82/050/01233/AM19/ ':03/94/040/00321/AM19/ 19.07.2018 | | | {Decision: In the light of earlier decision taken by NC in its 4/82-ALC4/2018 meeting dated 19.06.2018,it| was decided to ratify the norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: | Export Product: Amoxicillin and Clavulanate Potassium for Oral Suspension USP 250mg / 62.5mg | |1.| Amoxycillin Trihydrate 4.200 kg 5.649 kg 8.274 kg | CLAVULANATE POTASSIUM 2.3444kg | 3.126kg 4.6888 kg ‘158 WITH SILICON DIOXIDE 1:1 | 3. SILICONE DIOXIDE(SYLOID 1.50 kg 2.00 kg 3.00 kg 244FP | 4. 115CC HDPE BOTTLES 75 ML Relevant as per packing policy | 250/62.5 3: 185 CC HDPE BOTTLES 100 ML 250/62.5 225 CC HDPE BOTTLES 150 ML | 250/62.5 | | 7 28-400 WHITE CLIC LOC CAP | | | WITH PRINTED FSM-1 | Cap 28/400 WHT CRC W/FS M-I | WITH INDUCTION SEALING **** repeat 70 ml and applied 75 ml RA may take appropriate action as per the decision of Norms Committee. Case No.:317/13/82Party Name:AMILIFE —-Meet No/Date:13/82-. Status: ALC4/2018 SCIENCES PRIVATE ALC4/2018 Approved | |_ HQFile RLAFileLIMITED ~ Lic.No/Date:341004434414.01.2019 | | |:01/82/050/01295/AM19/ ':34/24/040/00131/AM19/ 19.07.2018 | | Decision: TheCommittee considered case as per agenda and in the presence of the technical experts and| 159 i. the light of earlier decision of NC Meeting No. 12/82-ALC4/2018 dated 12.12.2018 it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm) whichever is lower: | | No |

|RA may take appropriate action as per the decision of Norms Committee

||(CaseNo.:263/13/82-<br>-—‘Party Name:J.B. CHEMICALS [MeetNo/Date:13/82-__[Deferred|<br>|<br>(ALC4/2018<br>&PHARMACEUTICALS<br>ALC4/2018<br>‘LIMITED<br>14.01.2019<br>[160FQFile<br>RLAFile<br>Lic.No/Date:0310822486 {Defer<br>|<br>:01/82/050/01241/AM19/<br>:03/94/040/00341/AM19/<br>20.07.2018<br>|<br>Decision:Deferred forcommentsofTE|
|---|
||<br>CaseNo.:238/13/82-<br>-—PartyName:CIPLALIMITED.<br>[MeetNo/Date:13/82-<br>[Deferred<br>|<br>ALC4/2018<br>ALC4/2018<br>|<br>|<br>=<br>|<br>14.01.2019<br>H°\lQFie =<br>(RLAFile<br>[LicNo/Date-0310820521<br>[Dems<br>|<br>|<br>|:01/82/050/01216/AM19/<br>:03/94/040/00330/AM19/<br>'23.07.2018<br>|<br>|<br>Decision: Deferred forcommentsofTE|
|(CaseNo.:248/13/82-<br>———=PartyName:FDCLTD<br>MeetNo/Date:13/82-<br>Deferred<br>-<br>ALC4/2018<br>|<br>ALC4/2018<br>|<br>|<br>fl<br>14.01.2019<br>|<br>|<br>Porc<br>-. .<br>WRAHIe<br>WieNoieeodiogmee lous<br>|<br>':01/82/050/01226/AM19/<br>:03/94/040/00323/AM19/<br>23.07.2018<br>|<br>Decision: Deferred forcommentsofTE|
||<br>CaseNo.:34/13/82-ALC4/2018<br>(PartyName:NITIKA<br>(MeetNo/Date:13/82-_(Deferred “|<br>ES]<br>PHARMACEUTICAL<br>ALC4/2018<br>|<br>|<br>Se<br>SPECIALITIESPVT.LTD.<br>14.01.2019<br>|<br>|<br>|163FQFile<br>- \RLAFile———~—~S~™O<br>[LicNo/Date:5010002462 Defer<br>|<br>|<br>':01/82/050/01012/AM19/<br>':50/24/040/00013/AM19/<br>'24.07.2018|
||<br>Decision: Deferred forcomments ofTE<br>||
|| (CaseNo.:78/13/82-ALC4/2018 [PartyName:SMS_—=SMeetNo/Date:13/82-—*‘(Deferred|<br>LIFESCIENCESINDIA<br>ALC4/2018<br>|<br>|LIMITED<br>14.01.2019<br>|<br>(164TQFile<br>RLAFile<br>Lic.No/Date:0910066505 [Defer<br>|<br>:01/82/050/01056/AM19/<br>:09/24/040/00205/AM19/<br>24.07.2018<br>|<br>||
|Decision: Deferred for comments ofTE<br>||
|| (CaseNo.:80/13/82-<br>-—PartyName:SMS<br>—~—~—«(MeetNo/Date:13/82.<br>Status:|<br>|<br>‘ALC4/2018<br>PHARMACEUTICALSLTD<br>/|ALC4/2018<br>Approved<br>|<br>|<br>|<br>14.01.2019<br>|<br>|<br>|<br>HQFile<br>RLAFile<br>Lic.No/Date:0910066501<br>|<br>|<br>165 :01/82/050/01058/AM19/<br>:09/24/040/00201/AM19/<br>24.07.2018|
|Decision: TheCommittee considered case asperagendaand in the presence ofthetechnical experts, it,<br>|<br>was decided to ratify the ad-hoc input output norms under para 4.7 ofHBP as per details below or as|<br>applied byfirmwhicheverislower:<br>||

las

==> picture [462 x 681] intentionally omitted <==

----- Start of picture text ----- | | | EFAVIRENZ 1 Kg. (S)-5-Chloro-Alpha-Cyclo 0.987 kg Propy! Ethynyl)-2-Amino- Alpha-(Tri Fluoro Methyl) | Benzene Methanol | | TRIPHOSGENE 0.431 | RA concerned may take further necessary action as per above decision of NC / (Case No.:244/13/82- -—«|'Party Name:GLENMARK —-Meet No/Date:13/82-. ‘Status: | ALC4/2018 PHARMACEUTICALS LTD ALC4/2018 Approved | | 14.01.2019 | HQ File RLA File Lic.No/Date:0310822541 | net :01/82/050/01222/AM19/ ':03/94/040/00360/AM19/ 24.07.2018 | | | Decision: The Committee considered case as per agenda and in the presence of the technical experts, al was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as | applied by firm whichever is lower: | [ Sl. Export product Qty. Sl. | Import items Qty. | No.| Estradiol Vaginal Tablet 1|OMCG 1 No. No. Estradiol || (Pack size 4 Tabs.) (Net Wt. of Tablet Hemihydrate USP | ia Estradiol Hemihydrate USP is 12.875 gm.) | | 2 Estradiol Vaginal Tablet 1OMCG | 1 No. Estradiol | = (Pack size 6 Tabs.) (Net Wt. of | Tablet Hemihydrate USP | Estradiol Hemihydrate USP is 10.2 meg/ tablet | 12.875 gm.) | | 3 Estradiol Vaginal Tablet 1OMCG | 1 No. Estradiol | (Pack size 8 Tabs.) (Net Wt. of Tablet Hemihydrate USP || Estradiol12.875 gm.)Hemihydrate USP is | | [4 Estradiol Vaginal Tablet 1OMCG |1No. [1 | Estradiol | | | (Pack size 18 Tabs.) (Net Wt. of Tablet Hemihydrate USP | | Estradiol Hemihydrate USP is | 12.875 gm.) | > Estradiol Vaginal Cream 0.01% 1 No. Estradiol 4.335 mg / tablet | | 42.5 gm (Net Wt. of Estradiol Tablet Hemihydrate USP Hemihydrate USP is 42.500 gm.) | RA may take appropriate action as per the decision of Norms Committee. | ' [Case No.:446/13/82-.-~—~—~=«(Party Name:JUBILANT LIFE McetNo/Date:13/82- Status: | | ALC4/2018 SCIENCES LIMITED ALC4/2018 ‘Approved | | | 14.01.2019 | | | _[HQFile ~IRLAFile ~~ [Lie.No/Date:0510407282 | | 167 -01/82/050/01424/AM19/ :05/23/040/00151/AM19/ 24.07.2018 | | | Decision: Committee considered case as per agenda and as per earlier decision taken by NC in its 12/82, | meeting dated 12.12.2018, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: | 訛 誂 ----- End of picture text -----

| Export product Exp. SI.No. | Import items Qty. Allowed | ||| ‘peePeeseecato Ik. P| Alumino Silicate Catalyst 0.019 k | Ethyl Alcohol (Denatured) | 2.194 ke | Propionaldehyde 0.073 kg | RA may take appropriate action as per the decision of Norms Committee LAr kg | (CaseNo.:245/13/82——(Party Name:GLENMARK _[Meet No/Date:13/82[Deferred | ALC4/2018 PHARMACEUTICALS LTD —ALC4/2018 } | (14.01.2019 “ia .. aa ‘Lic. :01/82/050/01223/AM19/ No/Date:0310822600 [Defer | Decision: Deferred for comments:03/94/040/00361/AM19/ of TE (25.07.2018 | | (Case No.:323/13/82‘Party Name:ALEMBIC Meet No/Date:13/82[Deferred | (ALC4/2018 PHARMACEUTICALS LTD —_ALC4/2018 | | | 14.01.2019 | | 69 iQ File RLA File Lic.No/Date:3410044364 [Defer | ':01/82/050/01301/AM19/ :34/24/040/00140/AM19/ 25.07.2018 | Decision: Deferred for comments of TE | | Case No.:445/13/82[Party Name:JUBILANT LIFE (Meet No/Date:13/82. Status | ALC4/2018 |SCIENCES LIMITED 14.01.2019ALC4/2018 |Approved — _ |HQ File RLA File ~ Lic.No/Date:0510407309 | | :01/82/050/01423/AM19/ |.05/23/040/00185/AM19/ 25.07.2018 | Decision: Committee considered case as per agenda and as per earlier decision taken by NC in its 12/82 | meeting dated 12.12.2018, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:170 | | | i ; in kg | Beta Picoline 1 Kg. pl] Denatured Ethyl Alcohol 1.120 | [2 [Methanol«TCS } | Alumino Silicate Catalyst 0.0065 | | Propionaldehyde 0.057 | RA concerned may take further necessary action as per above decision ofNC | | CaseNo.:103/13/82—~—*[Party Name:ORIENTAL [Meet No/Date:13/82Status: 171 ‘ALC4/2018 AROMATICS LTD ALC4/2018 ‘Approved | | /HQ| File RLA File Lic.No/Date:031082264014.01.2019 | | | _ :01/82/050/01081/AM19/ ':03/95/040/00384/AM19/ 26.07.2018 |

||Ｅ<br>Ｅ<br>D5|
|---|---|
||<br>|<br>||Decision:The Committee considered case as peragenda<br>and inthepresence<br>of the technical experts, it,<br>‘was decided to ratify the ad-hoc input output norms under para 4.7 ofHBP as per details below or as<br>appliedbyfirmwhichever is lower:-<br>||
||<br>||CAMPHOR(EP)<br>ALPHAPINENE<br>1.146kg<br>|<br>RAconcernedmaytake furthernecessary action as perabove decision ofNC<br>||
|(CaseNo.:246/13/82-<br>||No.:246/13/82- -—*|PartyName:GLENMARK<br>——Meet No/Date:13/82-<br>Deferred|<br>ALC4/2018<br>PHARMACEUTICALS LTD.,<br>ALC4/2018<br>|<br>14.01.2019<br>||
|172|FQFile<br>RLAFile<br>‘Lic.No/Date:0310822665<br>[Defer|
|||:01/82/050/01224/AM19/<br>:03/94/040/00380/AM19/<br>27.07.2018|
|||Decision: Deferred forcomments ofTE<br>7<br>r<br>a<br>et|
|"(CaseNo.:247/13/82-<br>|<br>||No.:247/13/82-<br>PartyName:GLENMARKMeetNo/Date:13/82- Status:<br>|<br>ALC4/2018<br>PHARMACEUTICALS LTD., ALC4/2018<br>Approved<br>|<br>14.01.2019|
||<br>||HQFile<br>RLAFile<br>—<br>~<br>Lic.No/Date:0310822664 |<br>|<br>:01/82/050/01225/AM19/<br>:03/94/040/00378/AM19/<br>(27.07.2018<br>|<br>||
||<br>|<br>||Decision: The Committee considered case as per agenda and in the presence ofthe technical experts,<br>it|<br>_was decided to ratify the ad-hoc input output norms under para 4.7 ofHBP as per details below or as,<br>appliedbyfirmwhichever islower:<br>||
|||誂<br>Sl.<br>Exportproduct<br>Qty.<br>Sl. | Import items<br>Qty.|
||Hydrocortisone Valrate OintUSP<br>| 1No. |<br>1<br>Hydrocortisone<br>0.0306gm/pack|
|—<br>0.2% 15g(Net Wt. of<br>pack<br>ValerateUSP<br>Hydrocortisone ValerateUSP is||
||||<br>0.900Kgs.)<br>||
||<br>173|2<br>Hydrocortisone ValrateOintUSP<br>| 1 No. | 2<br>Hydrocortisone<br>0.0918gm/pack<br>|<br>0.2%45g(NetWt. of<br>pack<br>ValerateUSP<br>|<br>Hydrocortisone ValerateUSP is<br>|<br>2.700 Kgs.)<br>**|**|
|**|**<br>|||
|||3<br>Hydrocortisone Valrate OintUSP | 1No. | 3<br>Hydrocortisone<br>0.1224 gm/pack<br>||
||<br>|||<br>0.2% 60g (NetWt. of<br>pack<br>ValerateUSP<br>|<br>|<br>HydrocortisoneValerateUSP is<br>|<br>4.800 Kgs.)|
||<br>||<br>|<br>14<br>Hydrocortisone Valrate Cream<br>1 No. | 4<br>Hydrocortisone<br>0.0306 gm/pack<br>|||
||USP 0.2% 15g (NetWt. of<br>pack<br>Valerate USP<br>Hydrocortisone ValerateUSP is<br>||
||0.750Kgs.)<br>**|**|
|j||<br>5<br>HydrocortisoneValrateCream<br>1No. | 5<br>Hydrocortisone<br>0.0918gm/pack<br>||
|||USP0.2%45g (NetWt. of<br>pack<br>ValerateUSP<br>Hydrocortisone ValerateUSP is<br>||
||1.800Kgs.)<br>||

==> picture [459 x 719] intentionally omitted <==

----- Start of picture text ----- 56 [6 | Hydrocortisone ValrateCream |1No. |6 | Hydrocortisone | 0.1224 gm/pack | | | USP 0.2% 60g (Net Wt. of pack Valerate USP | ; | Hydrocortisone Valerate USP is | 3.600 Kgs.) | RA may take appropriate action as per the decision of Norms Committee. Case No.:283/13/82- Party Name:ARCH Meet No/Date:13/82- Deferred _ ALC4/2018 ‘PHARMALABS LTD ALC4/2018 | | 14.01.2019 | | | |HQFile = RLAFile = Lic.No/Date:0310822656 [Defer | ':01/82/050/01261/AM19/ |:03/94/040/00198/AM19/ (27.07.2018 1174 ‘Decision: The Committee considered the case as per agenda and it was decided to call for following | information / documents from the firm: | (i) Stepwise complete and balanced chemical reaction showing Molecular weight and | Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process. (CaseNo.:284/13/82- = PartyName:ARCH ~=——s-MeetNo/Date:13/82- [Deferred ALC4/2018 PHARMALABS LTD ALC4/2018 = | 14.01.2019 | || Ho:01/82/050/01262/AM19/ File -(RLA:03/94/040/00197/AM File 19/ Lic.No/Date:031082265727.07.2018 [Defer | 175 Decision: The Committee considered the case as per agenda and it was decided to call for following | ‘information / documents from the firm: | (i) Stepwise complete and balanced chemical reaction showing Molecular weight and | | (ii) PR e ra c entagetion and ofRecoveryyield on molar of solvent basisat each stage | i @ Material of balance for the entire process | [ a | | ba —— 7 = Sg a i | (Case [No.:285/13/82-] [=][ PartyName:ARCH] ~=——=SMeet No/Date:13/82-. —Deferred  (ALC4/2018 PHARMALABS LTD ALC4/2018 | 14.01.2019 HQ File RLA File /Lic.No/Date:0310822659 Defer | | :01/82/050/01263/AM19/ :03/94/040/00160/AM19/ 27.07.2018 1176 ‘Decision: The Committee considered the case as per agenda and it was decided | information / documents from the firm: to call for following ; || | | Percentage of yield on molar basis | | (i) Stepwise complete and balanced chemical reaction showing Molecular weight and | | | (ii) Reaction and Recovery of solvent at each stage | | (iii) Material of balance for the entire process (Case No.:286/13/82- -—|Party Name:ARCH Meet No/Date:13/82- ‘Deferred | ALC4/2018 /PHARMALABS LTD ALC4/2018 1177 | 14.01.2019 HQ File IRLA File Lic.No/Date:03 10822660 Defer | |:01/82/050/01264/AM19/ ':03/94/040/00126/AM19/ 27.07.2018 | ｌＮ ＞ ＞ ヽ ----- End of picture text -----

57,

==> picture [462 x 689] intentionally omitted <==

----- Start of picture text ----- Decision: The Committee considered the case as per agenda and it was decided to call for following information / documents from the firm: | | (i) Stepwise complete and balanced chemical reaction showing Molecular weight and | Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process ~ |Case No.:287/13/82-. -—~Party Name:INDO AMINES Meet No/Date:13/82- Status: | ALC4/2018 LIMITED ALC4/2018 Approved — | 14.01.2019 | | | HQFile RLA File ~ Lic.No/Date:0310822662 | :01/82/050/01265/AM19/ ':03/94/040/00336/AM19/ 27.07.2018 Decision: The Committee considered case as per agenda and in the presence of the technical experts, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as_ ‘178 applied by firm whichever is lower:- | | Oty. N METHYL MORPHOLINE| | Kg. 1] 0.391 kg OXIDE 50% OR IAL NMMO MORPHOLINE 50% RA concerned may take further necessary action as per above decision of NC ~ Case No.:288/13/82- ~ \PartyName:ARCH ——~—_—s Meet No/Date:13/82- Deferred — ALC4/2018 PHARMALABS LTD ALC4/2018 | | 14.01.2019 | | HQ File RLA File Lic.No/Date:0310822658 Defer | :01/82/050/01266/AM 19/ :03/94/040/00193/AM19/ 27.07.2018 | 179 Decision: The Committee considered the case as per agenda and it was decided to call for following | | information / documents from the firm: (i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process | ~ |Case No.:324/13/82- ~ |Party Name:GULBRANDSEN Meet No/Date:13/82- ‘Deferred ALC4/2018 '\CHEMICALS PVT LTD ALC4/2018 | 14.01.2019 |180 FQ File - ~ RLAFile ————«CLic.No/Date:3410044367 [Defer | :01/82/050/01302/AM 19/ ':34/24/040/00150/AM19/ 27.07.2018 | Decision: Deferred for comments of TE ‘Case No.:90/13/82-ALC4/2018 Party Name:PORUS Meet No/Date:13/82- Status: [LABORATORIES PVT LTD =ALC4/2018 Approved — 181 14.01.2019 —-HQ File RLA File s Lic.No/Date:09 10066524 :01/82/050/01068/AM19/ :09/24/040/00203/AM19/ 30.07.2018 | ｔ ― ＞ Ｄ ----- End of picture text -----

~ | Decision: Committee considered case | as per agenda and as per earlier decision taken by NC in its 4/82 | ‘asmeeting per detailsdatedbelow19.06.2018, or as appliedit was by decided firm whichever to ratify theis lower: ad-hoc input output norms under para 4.7 ofHBP | } | Export product Exp. | SI. Import items Qty. allowed | |i 2-Phenyl-3,3-bis(4-hydroxy Qty.1kg |[1No. kg | | _ | | PTHALIC ANHYDRIDE 0.927 | phenyl)phthalimide (PPP-BP) [2 [PHENOL 1.145 bod| [4[[ANILINE] | 0.596 | = [5 [METHANOL= 0.715 | 16_| ACTIVATED CARBON 0.200 I] | | CAUSTIC SODA LYE | RA may take appropriate action as per the decision of Norms Committee | | [CaseNo.:153/13/82- —~—‘([PartyNName:YASHO [Meet No/Date-13/82Status: =ALC4/2018 INDUSTRIES LIMITED ALC4/2018 Approved | | | 14.01.2019 | | HQ File RLA File Lic.No/Date:0310822696 | ':01/82/050/01131/AM19/ ':03/95/040/00403/AM19/ '30.07.2018 Decision: The Committee considered case as per agenda and in the presence of the technical experts, it | | '182 was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as | applied by firm whichever is lower:| | Pity: [ZINC ETHYL PHENYL 1Kg. [1 [| _ N-ETHYLANILINE___—*| 0.569kg ‘| | QUREACC ZEPC CARBON DISULPHIDE | | | DITHIOCARBAMATE 2 0.368 kg IRA concerned may take further necessary action as per above decision ofNC | |_ Case No.:237/13/82——(Party Name:GLENMARK ~/Meet No/Date:13/82- ‘Status: | ALC4/2018 PHARMACEUTICALS LTD., ALC4/2018 Approved | | 14.01.2019 | HQ File -_IRLA File Lic.No/Date:03 10822694 | | | ':01/82/050/01215/AM19/ ':03/94/040/00379/AM 19/ 30.07.2018 | Decision: The Committee considered case as per agenda and in the presence of the technical experts, it | | ‘wasapplied decided by firmto whichever ratify the ad-hoc is lower:- input output norms under para 4.7 of HBP as per details below or as)| | ‘183i!| Lidocaine: Ointment USP 5% 451.86 kg | (Pack Size 35.44gms) ( Net LIDOCAINE USP |__| Wtof Lidocaine USP is a | | | 443.000 Kgs.) ice | [Lidocaine Ointment USP 5% 2 561.00kg |. | Wt.of Lidocaine USP is ee | | | (Pack Size 50gms) ( Net LIDOCAINE USP | 550.000 Kgs.) = |

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

“

==> picture [465 x 656] intentionally omitted <==

----- Start of picture text ----- [ ‘Case No.:240/13/82- ‘Party Name:ARCH ~ 'Meet No/Date:13/82- Deferred | ALC4/2018 PHARMALABS LTD ALC4/2018 — 14.01.2019 | -HQFile 7 IRLAFile ===~—~—_Lic.No/Date:0310822704 [Defer | :01/82/050/01218/AM19/ ':03/94/040/00142/AM19/ 30.07.2018 '184 Decision:— The Committee consideredie the caseSereras eisper Se agenda and it was decidedtsito call for followingeae ——} information / documents from the firm: | (i) Stepwise complete and balanced chemical reaction showing Molecular weight and | Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage | (iii) Material of balance for the entire process Case No.:242/13/82- - |Party Name:ARCH Meet No/Date:13/82- Deferred ALC4/2018 PHARMALABS LTD ALC4/2018 14.01.2019 | HQ File RLA File Lic.No/Date:0310822702 [Defer __ :01/82/050/01220/AM19/ :03/94/040/00109/AM19/ 30.07.2018 185 Decision: The Committee considered the case as per agenda and it was decided tocall for following | information / documents from the firm: (i) Stepwise complete and balanced chemical reaction showing Molecular weight and | Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage | (iii) Material of balance for the entire process | Case No.:243/13/82- ==—SPartyName:ARCH '/Meet No/Date:13/82- ‘Deferred ALC4/2018 PHARMALABS LTD ALC4/2018 14.01.2019 | HQ File RLA File _ Lic.No/Date:0310822700 (Defer | :01/82/050/01221/AM19/ ':03/94/040/00196/AM19/ 30.07.2018 186 informationDecision: The Committee considered the case as per agenda andit was decided to call for following | / documents from the firm: | (i) Stepwise complete and balanced chemical reaction showing Molecular weight and | Percentage of yield on molar basis | (ii) Reaction and Recovery of solvent at each stage | (iii) Material of balance for the entire process Case No.:408/13/82- Party Name:MANGALAM Meet No/Date:13/82- Status: | ALC4/2018 DRUGS AND ORGANICS ALC4/2018 Approved — (LIMITED 14.01.2019 | HQFile = RLAFile Lic.No/Date:03 10822706 | :01/82/050/01386/AM19/ ':03/95/040/00399/AM19/ 30.07.2018 | 187 Decision: The Committee considered case as per agenda and in the presence of the technical experts, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as | applied by firm whichever is lower:- Qty. | 冨 ＞ ＞Ｄ ― ----- End of picture text -----

“~ | [ TENOFOVIR DISOPROXIL | 1 Kg. [(R)-9-(2-PHOSPHONYL —*(| 0.769kg—sd;, | | FUMARATE METHOXY PROPYL) | | | ADENINE | | RA concerned may take further necessary action as per above decision ofNC "(CaseNo.:23/13/82-ALC4/2018 Party‘SOLVENTS Name:PCL LTD.OIL & Meet\ALC4/2018No/Date: 13/82(Status:Approved | 4 14.01.2019 | | HQ File RLA File Lic.No/Date:0510407385 | | | ':01/82/050/01001/AM19/ ':05/24/040/00204/AM19/ 3 1.07.2018 Decision: The Committee considered case as per agenda and in the presence of‘the technical experts, it | 188 was‘applieddecided by firmto whicheverratify the ad-hocis lower:-input output norms under para 4.7 of HBP as per details below or as | | || Export product Exp. Sl.No. | Import items Qty. allowed | | | PVCPLASTICIZER (DINP) |1Kg. [1 | PHTHALIC ANHYDRIDE 0.3532 kg | | | ISO NONYL ALCOHOL 0.695kg |, } | on| RA concerned may take further necessary action as per above decision of NC | ~ |Case No.:31/13/82-ALC4/2018 [Party Name:PARAMOUNT Meet No/Date:13/82Status: | ‘LIMITED 14.01.2019 | | | (AROMACHEM PRIVATE —ALC4/2018 Approved — | [HQ File© ~ (RLAFile | -01/82/050/01009/AM19/ ':05/24/040/00257/AM19// (31.07.2018Lic.No/Date:0510407369 | | Decision: The Committee considered case as per agenda and in the presence of the technical experts, it) | ‘was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as) **** applied by firm whichever is lower:| 1189 | | | Oty. | | CARVACROL 1 Kg. D-LIMONENE (LIMONENE, CITRUS | 2.14 kg TERPENE, ORANGE TERPENE, | | | BRAZALIAN CITRUS | TERPENE.STANDARD CITRUS = TERPENE | fl | RA concerned may take further necessary action as per above decision of NC | —s' Meet No/Date:13/82-. Deferred | | Case No.:239/13/82'PartyName:KEVA | ALC4/2018 ‘FRAGRANCES PRIVATE |ALC4/2018 | |_| ‘LIMITED 14.01.2019 | (190 FQ File RLA File | ‘Lic.No/Date:0310822723 [Defer /:01/82/050/01217/AM19/ ':03/94/040/00390/AM19/ 31.07.2018 | Decision: Deferred for comments of TE = Case /PHARMALABS LTD ALC4/2018 191[ALC4/2018] No.:271/13/82(PartyName:ARCH —s MeetNo/Date:13/82-. [Deferred 14.01.2019 | |

| HQ File _ J RLA Filees Lic.No/Date:0310822732 [Defer a | :01/82/050/01249/AM19/ ':03/94/040/00162/AM19/ 31.07.2018 Decision: The Committee considered the case as per agenda and it was decided to call for following information / documents from the firm: (i) Stepwise complete and balanced chemical reaction showing Molecular weight and | (ii) ReactionPercentageandofRecovery yield on molarof solventbasisat each stage || (iii) Material of balance for the entire process | ~ Case No.:272/13/82‘PartyName:ARCH =——sMeet No/Date:13/82-. ‘Deferred ALC4/2018 PHARMALABS LTD ALC4/2018 14.01.2019 192 Decision:HQ:01/82/050/01250/AM19/File The Committee consideredRLA:03/94/040/00192/AM19/theFilecase_ as per agenda and it was31.07.2018Lic.No/Date:0310822731decided to call for following|Defer || | information / documents from the firm: | (i) Stepwise complete and balanced chemical and balanced chemical balanced chemical reaction showing showing Molecular weight and and

(i) Stepwise complete and balanced chemical and balanced chemical balanced chemical reaction showing showing Molecular weight and and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process

Case No.:273/13/82~|PartyName:ARCH =——~— Meet No/Date:13/82-. Deferred ALC4/2018 PHARMALABS LTD ALC4/2018 14.01.2019 | HQ File RLA File i Lic.No/Date:0310822729 Defer :01/82/050/01251/AM19/ :03/94/040/00141/AM19/ 31.07.2018 193 Decision: The Committee considered the case as per agenda and it was decided to call for following | information / documents from the firm: | (i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process | Case No.:274/13/82- = PartyName:IPCA. =—S=<CwMeett Noo Date: 13/82Status: | ALC4/2018 LABORATORIES LIMITED —ALC4/2018 ‘Approved | | 14.01.2019 | | HQFile - RLA File Lie. No/Date:0310822724 | | ::01/82/050/01252/AM19/ ':03/94/040/00376/AM 19/ 31.07.2018 | | Decision: The Committee considered case as per agenda and in the presence of the technical experts, it | ‘was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as | 194,‘applied by firm whichever is lower:| Qty. kg | | PYRANTEL 1 Kg. Thiophene 2 Aldehyde | | PAMOATE - | - | = |

RA concerned may take further necessary action as per above decision ofNC | Ss ‘Case No.:275/13/82-. = PartyName:IPCA———S—S«SMeet Non/Daate:13/82Status: | ALC4/2018 ‘LABORATORIES LIMITED —ALC4/2018 ‘Approved | | 14.01.2019 | HQ File RLAFile Lic. No/Date:0310822725 | | | |:01/82/050/01253/AM19/ ::03/94/040/00377/AM19/ (31.07.2018 | | Decision: The Committee considered case as per agenda and “in the presence «of the technical experts, it) ies decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as| | 195,applied by firm whichever is lower:| | Export product Exp. SI. Import items Qty. allowed in | Oty. No. kg s | | ETODOLAC 1 Kg. paal 7-Ethyl Tryptophol 0.8197 | - | | Methyl -3-Oxopentanoate 0.623 | RA concerned may take further necessary action as per above decision of NC | [Case ALC4/2018 /PHARMALABS LTD |ALC4/2018 || |No.:282/13/82--——|PartyName:ARCH| ———(Meet14.01.2019 No/Date:13/82|Deferred | | {HQFile = (RLAFile - Lie. No/Date:0310822734 [Defer | | :01/82/050/01260/AM19/ ':03/94/040/00158/AM19/ 31.07.2018 | | 196 Decision: The Committee considered the case as per agenda and it was decided to call for following information / documents from the firm: | | (i) Stepwise complete and balanced chemical reaction showing Molecular weight and | Percentage of yield on molar basis | (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process | || (CaseNo.:310/13/82——|PartyName:CHEMCON ——s'Meeet No/Date:13/82-—‘(Status: | |ALC4/2018 SPECIALITYPVT LTD CHEMICALS |14.01.ALC4/ 20 1918 |Approved —| | HQ File - IRLA File | Lic.No/Date:3410044377 | | ':01/82/050/01288/AM19/ |:34/24/040/00143/AM19/ 31.07.2018 | | Decision: The Committee considered case as per agenda and as per earlier decision taken by NC in its | ‘197 10/82 meeting dated 16.10.2018, it was decided to ratify the ad-hoc input output norms under para 4.7 of | |‘HBP as per details below or as applied by firm whichever is lower:| | CHLOROMETHYL 1Qty.Kg. No. METHYL 0.943 kg | | ISOPROPYL CARBONATE CHLOROFORMATE (MCF

RA concerned may take further necessary action as per above decision of NC | "(Case No.:221/13/82-—=«(PartyName:ASTRAL —SMeet No/Date:13/82-. (Deferred ALC4/2018 STERITECH PVT. LTD. ALC4/2018 | 14.01.2019 198 HQ File ~(RLAFile ~ Lic.No/Date:3410044381 [Defer :01/82/050/01199/AM19/ :34/24/040/00115/AM19/ 01.08.2018 | Decision: Deferred for comments ofTE a. ) | | CaseNo.:268/13/82= PartyName:FDCLTD —=—-Meet No/Date:13/82-—|Status: ALC4/2018 | ALC4/2018 ‘Approved — 14.01.2019 | HQ:01/82/050/01246/AM19/File RLAFile == ~~—~—~—Lic.No/Date:0310822763 | Decision: :03/94/040/00374/AM 19/ 01.08.2018 | | The Committee considered case as per agenda and in the presence of the technical experts, it) 199[applied] was decided[ by][ firm] to[ whichever] ratify the ad-hoc[is][ lower:-] input output norms under para 4.7 of HBP as per details below or as || | Export product Sl. Import items Qty. allowed | Qty. No. BRIMONIDINE Packs 0.0105 gm/5 ml pack |. | TARTRATE EYE DROPS ct sl 0.2% W/V SML | RA concerned may take further necessary action as per above decision of NC | Case No.:269/13/82- ~—*PartyName:KRISHNA—S Meet No/Date:13/82-. Status: ALC4/2018 ANTIOXIDANTS PVT. LTD. ALC4/2018 Approved — | | | 14.01.2019 | | HQ File / sat? RLA File = ~~~—~Lic.No/Date:0310822755 - :01/82/050/01247/AM19/ :03/94/040/00289/AM19/ 01.08.2018 | | Decision: The Committee considered case as per agenda and in the presence of the technical experts, it | was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as | 200 applied by firm whichever is lower:} | Qty. No. | | | 2-PHENOXYETHANOL |1Kg. [1| PHENOL 0.681 kg | | ETHYLENE OXIDE 0.329 kg | | RA concerned may take further necessary action as per above decision ofNC | | (Case No.:215/13/82- === PartyName:GLOBAL ——Meet No/Date:13/82-.—(Status: 201 ALC4/2018 PVT/PHARMA LTD HEALTH CARE ALC4/214.01.2 01 98 Approved| | — -HQFile RLAFile Lic.No/Date:0410164549 | | :01/82/050/01193/AM19/ :04/24/040/00084/AM 19/ (02.08.2018 i. S|

~, | Decision: The Committee considered case as per agenda and in the presence of the technical experts, it | | was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as_ | applied by firm whichever is lower:1| | |Export product Exp. Qty. Qty. allowed | | No. HYOSCINE BUTYL| 1 Number HYOSCINE BUTYL 10.2 mg/tablet | | BROMIDE 10MG Tablet BROMIDE IP/BP | | ‘RA concerned may take further necessary action as per above decision of NC | CaseNo.:265/13/82~—*{Party Name:ADISHANK —sMeeett No/Date:13/82-. Deferred _ _ ALC4/2018 CHEMICALS PVT.LTD: ALC4/2018 | a (14.01.2019 202 HQ File BLA File Lic.No/Date:0310822825 Defer :01/82/050/01243/AM19/ ':03/94/040/00178/AM19/ (02.08.2018 | Decision: Committee considered the case as per agenda and it was decided to ask the firm to furnish ; | per ag || | complete technical details as per appendix 4E. [ ‘Case No.:270/13/82- Pe a Party Name: AIMS IMPEX Meet No/Date: 13/82Status: | |ALC4/2018 PVT. LTD., ALC4/2018 ‘Approved | | (14.01.2019 | | HQ File RLA File — ] Lic.No/Date:0310822801 Defer | .01/82/050/01248/AM19/ ':03/94/040/00346/AM19/ 02.08.2018 | Decision: The Committee considered case as per agenda and in the presence of the technical experts, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as_ applied by firm whichever is lower:203 | | | | | Export product Exp. Sl. Import items Qty. allowed | | COUMARIN ft | SALICYLALDEHYDE | 0.92 kg | Yo ACETOC ANHYDRIDE _ | Not allowed | | 4 || | RA concerned may take further necessary action as per above decision of NC | |Case No.:276/13/82= -—-Party Name: ARCH Meet No/Date:13/82Deferred _ ALC4/2018 PHARMALABS LTD ALC4/2018 = | 14.01.2019 | HQ File aay — (RLAFile Lic.No/Date:0310822799 [Defer | | |:01/82/050/01254/AM19/ ':03/94/040/00392/AM 19/ 02.08.2018 | 204 Decision: The Committee considered the case as per agenda and it was decided to call for following information / documents from the firm: | @ Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis | di Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process | 505 Case No.:277/13/82Party Name:ARCH Meet No/Date:13/82Deferred | ALC4/2018 PHARMALABS LTD ALC4/2018

| 7 se iS ee CC ee ae HQ File — RLAFile =———————S—SSSsLLiic.No/Date:0310822798 Defer | | -:01/82/050/01255/AM19/ :03/94/040/00394/AM19/ 02.08.2018 | Decision: The Committee considered the case as per agenda and it was decided to call for following | information / documents from the firm: (i) Stepwise complete and balanced chemical reaction showing Molecular weight and (ii) PercentageReaction and ofRecoveryyield on molarof solvent basisat each stage | (iii) Material of balance for the entire process | Case No.:278/13/82= PartyName:ARCH_ SMe No/Date:13/82(Deferred _ ALC4/2018 /PHARMALABS LTD ALC4/2018 | | | 14.01.2019 | HQ File :01/82/050/01256/AM19/ — ::03/94/040/00391/AM19/(RLA File ~Lic.No/Date:031082279702.08.2018 [Defer 206 Decision: The Committee considered the case as per agenda and it was decided to call for following | information / documents from the firm: | (i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage | of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process | | Case No.:279/13/82——|Party Name:ARCH No/Date:13/82- (Deferred ALC4/2018 /PHARMALABS LTD ALC4/2018 | 14.01.2019 | HQ File RLA File Lic.No/Date:0310822800 [Defer | :01/82/050/01257/AM19/ :03/94/040/00393/AM19/ 02.08.2018 207 Decision: The Committee considered the case as per agenda and it was decided to call for following | information / documents from the firm: | | (i) Stepwise complete and balanced chemical reaction showing Molecular weight and | Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process | Case No.:280/13/82——(Party Name:GLENMARK —_—Meet No/Date:13/82-. ‘Deferred ALC4/2018 PHARMACEUTICALS LTD., ALC4/2018 14.01.2019 208 HQ File RLA File Lic.No/Date:0310822789 [Defer |: :01/82/050/01258/AM19/ ':03/94/040/00368/AM19/ 02.08.2018 | | Decision: Deferred for comments of TE ~ Case No.:281/13/82Party Name:GLENMARK —Meet No/Date:13/82‘Deferred | ALC4/2018 PHARMACEUTICALS LTD., ALC4/2018 14.01.2019 | 209HQFile ~~ +(RLAFile Lic.No/Date:0310822791 ‘Defer | | :01/82/050/01259/AM19/ :03/94/040/00373/AM19/ 02.08.2018 | | Decision: Deferred for comments of TE |

[ (CaseALC4/2018No.:431/13/82_ [PartyName:MAHIMALIFE Meet No/Date:13/82- Status: ; | SCIENCES PVT.LTD. ALC4/2018(14.01.2019 Approved| | | |HQ File RLA File : | :01/82/050/01409/AM19/ ':05/24/040/00254/AM19/ 02.08.2018Lic.No/Date:05 10407414 | Decision: The Committee considered case as per agenda and in the presence ofthe technical experts, it, 210 appliedwas decidedby firmto whicheverratify the isad-hoclower:-input output norms under para 4.7 of HBP as per details below or as | | 4 | | Export product Exp. Sl. Import items Qty. allowed ; f° |if Qty. No. |[DEXAMETHASONE] 1 Kg. DEXAMETHASONE 0.78 kg | SODIUM PHOSPHATE | | RA concerned may take further necessary action as per above decision of NC | (Case No.:432/13/82Party Name:MAHIMA LIFE Meet No/Date:13/82-. ‘Status: | ALC4/2018 |SCIENCES PVT.LTD. ALC4/201814.01.2019 |Approved | || HQ|:01/82/050/01410/AM19/ File RLA|:05/24/040/00253/AM19/ File ‘Lic.No/Date:051040741502.08.2018 | | Decision: The Committee considered case as per agenda and in the presence of the technical experts, it) | was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as| (211 applied by firm whichever is lower:No. } | | Export product Exp. Qty. Qty. allowed | | | BETAMETHASONE 1 Kg. BETAMETHASONE _ | 0.868 kg | DIPROPIONATE | | RA concerned may take further necessary action as per above decision of NC | Case No.:26/13/82-ALC4/2018 Bay Name:PCLOIL & Meet No/Date:13/82Status: | ie SOLVENTS| LTD. ALC4/14.01. 201 98 Approved| | HQ| |:01/82/050/01004/AM19/File ss ':05/24/040/00128/AM19/REA File 03.08.2018Lic.No/Date:0510407430 | || Decision: The Committee considered case as per agenda and in the presence of the technical experts, it) | \was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as_ pia lapplied| by firm whichever is lower:| |[|] | No. | | | Plasticizer (DINP) 1 Kg. PHTHALIC ANHYDRIDE | 0.352 kg | | ISO NONYL ALCOHOL __| 0.695 kg | RA concerned may take further necessary action as per above decision of NC |

~

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----- Start of picture text ----- (Case No.:77/13/82-ALC4/2018 Party Name:ORTIN Meet No/Date:13/82- [Deferred ‘LABORATORIES LTD ALC4/2018 | 14.01.2019 |213 HQ File ~RLAFile ~———SCLic.No/Date:0910066546 (Defer | :01/82/050/01055/AM19/ ::09/24/040/00211/AM19/ 03.08.2018 | Decision: Deferred for comments of TE | | Case No.:141/13/82- Party Name:RELIANCE — Meet No/Date:13/82-. (Deferred ALC4/2018 INDUSTRIES LIMITED (ALC4/2018 | 14.01.2019 214 FQ File ~_ RLA File ~~ [Lic.No/Date:0310822835 [Defer :01/82/050/01119/AM19/ :03/95/040/00342/AM19/ 03.08.2018 | Decision: The Committee decided to refer the case to D/o C&PC for obtaining its comments | Case No.:144/13/82- = PartyName:UPLLTD. Meet No/Date:13/82- (Status: ALC4/2018 | ALC4/2018 ‘Approved | | 14.01.2019 | HQ File - IRLAFile :01/82/050/01122/AM19/ = =————~CS*~S~SCSSCLLic NoDaatte:0310822841 | :03/95/040/00149/AM19/ 03.08.2018 Decision: The Committee considered case as per agenda and in the presence of the technical experts, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as_ 215 applied by firm whichever is lower:- | | Export product Exp. Qty. Qty. allowed | | No. | Phenyl Chloro Formate 1 Kg. |1 | Phenol = == sd 0.5978 kg | Ethylene Dichloride 0.0564 kg | RA concerned may take further necessary action as per above decision of NC Case No.:145/13/82- ‘Party Name:UNIMAX Meet No/Date:13/82-_—|Status: | ALC4/2018 (LABORATORIES PVT.LTD |ALC4/2018 ‘Approved | 14.01.2019 | HQFile RLAFile ~_Lic,No/Date:0310822839 | :01/82/050/01123/AM19/ ':03/95/040/00395/AM19/ 03.08.2018 | ｒ 飢 ----- End of picture text -----

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----- Start of picture text ----- Decision: The Committee considered case as per agenda and in the presence of the technical experts, it) was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as) 216| applied by firm whichever is lower:- | || Export product Exp. Qty. Qty. allowed No. Betamethasone Sodium Phosphate | | Kg. 0.78 kg | USP (Micronised) a ar | Tech. Spec: Pharmacopeial Grade | ‘RA concerned may take further necessary action as per above decision of NC | "(Case No.:266/13/82- —-Party Name:DORF-KETAL Meet No/Date:13/82-_Status:Deferred 217 ALC4/2018 CHEMICALS INDIA ALC4/2018 PVT.ETD. (14.01.2019 誂 ----- End of picture text -----

~~.

| |HQFile == RLAFile = Lic. No/Date:0310822847 [Defer | :01/82/050/01244/AM19/ :03/94/040/00399/AM19/ 03.08.2018 | Decision: Committee considered the case as per agenda and it was decided to ask the firm to furnish | | complete technical details as per appendix 4E. | | |CaseNo.:267/13/82(Party Name:DORF-KETAL — Meet[No/Date:13/82-.][ (Deferred] \ALC4/2018 (CHEMICALS INDIA ALC4/2018 ie PVT.LTD. 14.01.2019 218 |HQ File RLA File ~ |Lic.No/Date:0310822848 Defer ':01/82/050/01245/AM19/ ':03/94/040/00400/AM19/ (03.08.2018 | Decision: Committee consideredthe caseas per agenda and it was decided to ask the firm to furnish ‘complete technical details as per appendix 4E. | "~~ [Case No.:309/13/82-—~—~(Party Name:CLEAN SCIENCE [Meet No/Date:13/82- (Status: | (ALC4/2018 ‘AND TECHNOLOGY ALC4/2018 Approved = PVT.LTD. 14.01.2019 | | | ‘HQ File RLA File Lic.No/Date:3 110067136 | | :01/82/050/01287/AM19/ ':31/83/040/00064/AM19/ 03.08.2018 | Decision: The Committee considered case as per agenda and as per earlier decision taken by NC in ie | 9/82 meeting dated 18.09.2018, it was decided to ratify the ad-hoc input output norms under para 4.7 of |219 ‘HBP as per details below or as applied by firm whichever is lower: | | [Restyl Anisole (@-Methoxy |1kg [1 Phenol _——=*('0.906ke | | | _ Acetophenone) Dimethyl Sulphate 0.693 kg aa Caustic Lye PURITY 40% 0.437 kg | | 4| A ceticND ABOVE Anhydride(100% PURITY 99% Basis | 0.755 kg | | |RA may take appropriate action as per the decision of Norms Committee. Case No.:25/13/82-ALC4/2018 Party Name:SUN Meet No/Date:13/82Deferred | | PHARMACEUTICAL ALC4/20 18 | fl INDUSTRIES LTD. 14.01.2019 | 220 HQ File RLA File Lic.No/Date:0510407451 [Defer | :01/82/050/01003/AM19/ ':05/24/040/00266/AM19/ 06.08.2018 | Decision: Deferred for comments of TE _ |Case No.:264/13/82-—‘[PartyName:KRISHNA Meet No/Date:13/82-. Status: | ALC4/2018 AA OAIDANES PVT.LTD. ALC4/2018 ‘Approved | 14.01.2019 | HQ File RTA File ; Lic.No/Date:03 10822856 | | | :01/82/050/01242/AM19/ ::03/94/040/00363/AM19/ 06.08.2018 | i221 ‘Decision: The Committee considered case as per agenda andin thepresence of the technical experts, it lapplied by firm whichever is lower:| | ‘was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below oras | | | No.

~ | TRIS TRIDECYL PHOSPHITE| | Kg. TRI MEHTYL 0.245 kg | | (PHENOL FREE) PHOSPHITE TRI DECYL 1.003kg | ALCOHOL RA concerned may take further necessary action as per above decision of NC Case No293/13/82--—~—~—=(Party Name:BLISS GVS Meet No/Date:13/82«Status: ALC4/2018 PHARMA LTD. ALC4/2018 Deferred | 14.01.2019 | oe 222 HQ File RLA File LicNo/Date:0310822858 [Defer -01/82/050/01271/AM19/ -03/94/040/004 16/AM19/ 06.08.2018 | | Decision: Committee considered the case as per agenda and itwas decided to ask ‘the firm to furnish | complete Generic name of export product and Drug Manufacturing Licence for each export product. - ~~ \Gase No.:11/13/82-ALC4/2018 Party Name:SRI Meet No/Date:13/82Status: VYJAYANTHI LABS PVT ALC4/2018 Deferred LTD 14.01.2019 | | 223 —— cn ee aa = <r RAK Nef | HQ File RLA File Lic.No/Date:26 10012846 \Defer -0.1/82/050/00989/AM 19/ ':26/24/040/00007/AM19/a 07.08.2018 | | Decision: Deferred for comments of TE

~ [Meet No/Date:13/82‘Status: ~ [Party Name:ARCH CaseALC4/2018No.:289/13/82'PHARMALABS LTD ALC4/2014.01.20 1 98 Deferred | . ~ Lie No/Date:0310822880 Defer | | HQFile RLA File -01/82/050/01267/AM19/ 03/94/040/00404/AM19/ 07.08.2018 | | (224 Decision: The Committee considered the case as per agenda and it was decided to call for following information / documents from the firm: (i) Stepwise complete and balanced chemical reaction showing Molecular weight and | Percentage of yield on molar basis | (ii) Reaction and Recovery of solvent at each stage | (iii) Material of balance for the entire process — ———~ feet No/Date:13/82Status: | -~lGase No.:290/13/82‘Party Name:ARCH ALC4/2018 PHARMALABS LTD ALC4/14.01. 201 98 ‘Deferred | | __ {bic.No/Date:03 10822878 Defer | —— (HQFile ———PrAFile -01/82/050/01268/AM19/ '03/94/040/00401/AM19/ 07.08.2018 225 Decision: The Committee considered the case as per agenda and it was decided to call for following | os formation / documents from the firm: | | (i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process 226 ‘Case No.:291/13/82‘Party Name: ARCH Meet No/Date:13/82Status:

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----- Start of picture text ----- | -« [aucanois PHARMALABSLTD s(Akcasorg aie 9 | HQFile RLA File Lic.No/Date:031082288214.01.2019 ‘Defer | ee :01/82/050/01269/AM19/— Paz = — :03/94/040/00407/AM19/$ 7 7 ~ 2 . ——(07.08.2018 Decision: ee = Psy are eer eee a | ‘information The/ documents Committeefrom consideredthe firm: the case as per agenda and it was decided to call for following | | ;| @ Stepwise complete and balanced chemical reaction showing Molecular weight and | Percentage of yield on molar basis ee)(iii) Reaction and Recovery of solvent at each Stage | Material of balance for the entire process |/— (Case No.:292/13/82. Party Name:GLENMARK Meet No/Date:13/82-SaStatus: | | ALC4/2018 PHARMACEUTICALS LTD., ALC4/2018 ‘Deferred |(227 iQ File —TIREA File . 14.01.2019Lic.No/Date:0310822872 [Defer |:01/82/050/01 270/AM19/ :03/94/040/00411/AM19/ (07.08.2018 Decision: Deferred for comments of TE Riel heise tye | H4= Case No.:295/13/82- ef ‘Party Name:ARCH ~ Meet No/Date: 13/82- Status: | ———ALC4/2018 ——————PHARMALABSee LTD (14.01.2019ALC4/2018 |Deferred ————————|] -| HQ File IRLA File Lic.No/Date:03 10822879 ‘Defer (:01/82/050/01 273/AM19/ :03/94/040/00402/AM19/ (07.08.2018 228 Decision:information The/ documentsCommittee from consideredthe firm: the case as per agenda and it was decided to call for following | | (i) PercentageStepwise complete and of yield on molar balanced chemicalbasis reaction showing Molecular weight and (iii)(ii) Reaction and Recovery of solvent at each stage | Material of balance for the entire process || Case No.:296/13/82- Party Name:ARCH SS Meet No/Date:13/82- [Status | ALC4/2018 PHARMALABS LTD ALC4/2018 Deferred || |HQ File RLA File . Lic.No/Date:031082287714.01.2019 Defer | 229 (:01/82/050/01274/AM19/ ':03/94/040/00101/AM19/ (07.08.2018 8 |‘eatiDecision:information The Committee / documents from considered the firm: the case as per agenda and it was decided to call for followin8 = } | (i) PercentageStepwise c o mplf yi e teld o a n dmolar balanced basis chemical reaction showing Molecular weight and | | (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process | (Case| No.:301/13/82- |‘Party Name:ARCH Meet No/Date:13/82- ‘Status: — || ALC4/2018 /PHARMALABS LTD ALC4/2018 ‘Deferred 230 HQ File RLA File Lic.No/Date:031082287614.01.2019 “(Defer| :01/82/050/01279/AM19/ ':03/94/040/00106/AM19/ 07.08.2018 information / documents from the firm: Decision: The Committee considered the case as per agenda and it was decided to call for following ０ ----- End of picture text -----

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage | (iii) Material of balance for the entire process | “Case No.:132/13/82-.~—~—~—~—SParty Name:USV PRIVATE _ Meet No/Date:13/82Status: | | ALC4/2018 LIMITED (ALC4/2018 ‘Approved | | 14.01.2019 | HQ File RLA File Lic.No/Date:0310822931 | :01/82/050/01110/AM19/ :03/95/040/00443/AM19/ 08.08.2018 Decision: The Committee considered case as per agenda and in the presence of the technical experts, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as_ 231 applied by firm whichever is lower:-

||||||ま<br>Export product<br>Exp. Qty.<br>Qty. allowed<br>No.<br>Bivalirudin for Injection 250 MG |Number<br>ae<br>275 mg/vial<br>(NetContentWeight= 1.813Kgs)<br>Bivalirudin||<br>||||
|---|---|---|---|---|---|---|---|---|
||||||RAconcernedmay take further necessary action asperabove decision ofNC||||
|||||~|ｄ<br>“<br>(Case No.:140/13/82...<br>~~<br>(PartyName:YASHO.—-—~—S<(Meet'No/Date:13/82-<br>(Status:<br>ALC4/2018<br>INDUSTRIES LIMITED<br>ALC4/2018<br>Approved||||
||||||14.01.2019<br>|||||
|||||||HQFile<br>——_IRLAFile<br>Lic.No/Date:0310822925<br>Defer<br>:01/82/050/01118/AM19/<br>:03/95/040/00442/AM19/<br>08.08.2018|||||
|||||||Decision: TheCommitteeconsidered case asperagenda inthepresence ofthe technical experts andtaking|||||
||||||cue from its earlier decision taken in MeetingNo. 7/82-ALC4/2018, dated24.08.2018 decided to ratify the<br>ad-hoc input output norms under para 4.7 ofHBP as per details below or as applied by firm whicheveris||<br> ||||
||||232||lower:|||||
||||||||Exportproduct<br>Exp.<br>Sl.<br>Importitems<br>Qty.<br>Qty.<br>No.<br>Allowed<br>| BUTYLATEDHYDROXYANISOLE<br>tkg |1<br>| HYDROQUINONE<br>1247kg<br>(BHA)(FLAKES/POWDER/FF)<br>TERTIARYBUTANOL| 0.839kg<br>PHOSPHORICACID _| 1.00kg<br>HEXANE<br>1.00kg<br>RAmaytakeappropriate action asperthedecisionofNormsCommittee||<br>**|**||,<br>|<br>|||
||||(CaseNo.:172/13/82-<br>[Party Name:TIDE~<br>MeetNo/Date:13/82-<br>Status:<br>|<br>ALC4/2018<br>INDUSTRIES<br>ALC4/2018<br>‘Deferred<br>14.01.2019|||||||
||||233QFile<br>|<br>RLAFile<br>~~<br>Lie.No/Date:3410044399<br>[Defer<br>:01/82/050/01150/AM19/<br>':34/24/040/00094/AM 19/<br>08.08.2018<br>|<br>_|||||||
||||||Decision:Deferred forcommentsofTE<br>-<br>.<br>-<br>:<br>oe||||
||||'|(CaseNo.:294/13/82-<br>-—=PartyName:KRISHNA<br>MeetNo/Date:13/82-<br>(Status:<br>234 ALC4/2018<br>ANTIOXIDANTSPVT.LTD.<br>ALC4/2018<br>Deferred<br>|<br>14.01.2019<br>|||||||

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----- Start of picture text ----- _ (HQFile == ORLA File = Lie. No/Date:0310822933 [Defer | :01/82/050/01272/AM19/ :03/94/040/00364/AM19/ (08.08.2018 | ‘Decision: ‘The Committee noted that the 4.07 application of subject Advance Authorization is noti | authorization\available. Hence, it was decided to call for hard copy of 4.07 application of the subject advance| from RLA, Hyderabad with complete technical details as per Appendix 4E along with! Chemical reaction, stage wise yield of production and molecular weight from the firm. eB er No.:134/13/82- |Party Name:Y ASHO ‘Meet No/Date:13/82- Status: | |ALC4/2018 INDUSTRIES LIMITED ALC4/2018 Deferred — Lael | 14.01.2019 | | ori... (REAFie Lic.No/Date:0310822942 Defer | ':01/82/050/01112/AM19/ ':03/95/040/00445/AM19/ 09.08.2018 | | | Decision: Deferred for comments of TE | (Case No.:160/13/82- ——PartyName:SURVIVAL _ {Meet No/Date:13/82- ‘Status: ALC4/2018 TECHNOLOGIES PVT.LTD. |ALC4/2018 Approved — HQ File RLA File. Lic.No/Date:031082295214.01.2019 || | | |:01/82/050/01138/AM19/ :03/95/040/00433/AM19/ 09.08.2018 | Decision: The Committee considered case as per agenda in the presence of the technical experts and taking | \cue from its earlier decision taken in Meeting No. 9/82-ALC4/2018, dated 18.09.2018 decided to ratify the | 236 ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is | lower: | | | Export product Qty. | SI. Import items Qty. No. | || | TERT-BUTYL CARBAZATE | 1 kg BOC ANHYDRIDE 1.86kg | } i 2 HYDRAZINE99.0% HYDRATE NLT| 0.95 kg ‘RA 3 METHYLMTBE TERT BUTYL ETHER| 2.0kg may take appropriate action as per the decision of Norms Committee. | Case No.:173/13/82- ———PartyName:SHIVA—~—~<(Meet No/Date:13/82-—*(Status: ALC4/2018 PHARMACHEM LTD ALC4/2018 Deferred — aa 14.01.2019 | |237 HQ File RLA File Lic.No/Date:34 10044409 ‘Defer :01/82/050/01151/AM19/ :34/24/040/00147/AM19/ 09.08.2018 || Decision:complete technicalCommitteedetailsconsideredas per appendixthe case4E.as per agenda and it was decided to ask the firmto furnish. ｄ Ｓｔａｔ 趾 ----- End of picture text -----

(Case No.:234/13/82‘Party Name:LASENOR INDIA (Meet No/Date:13/82_|Status: _ (ALC4/2018 PRIVATE LIMITED ALC4/2018 Deferred a 14.01.2019 193g HQ File RLA File Lic.No/Date:5010002465 [Defer :01/82/050/01212/AM19/ ':50/24/040/00015/AM19/ 09.08.2018 | Decision: Committee considered the case as per agenda and it was decided to ask the firm to furnish’ ‘complete Certificate of Analysis (COA) export and import from foreign supplier along with technical | \details as per appendix 4E.

|73|||
|---|---|---|
|CaseNo.:428/13/82--—~=«*(PartyName:DEEDY |<br>—-MeetNo/Date:13/82-.<br>Status:<br>ALC4/2018<br>(CHEMICALS PRIVATE<br>ALC4/2018<br>Approved|||
||<br>.<br>oe<br>LIMITED<br>14.01.2019<br>|<br>|<br>{HQFile<br>RLAFile<br>Lic.No/Date:0810143228 |<br>:01/82/050/01406/AM19/<br>:08/24/040/00158/AM19/<br>09.08.2018<br>|<br>Decision: TheCommittee consideredcaseasperagendaand inthepresenceofthetechnical experts, it |<br>was decided to ratify the ad-hoc input output norms under para 4.7 ofHBP as per details below or as||||
|239 applied by firm whichever is lower:-|||
|||||
|鏃<br>Exportproduct<br>Exp. Qty.<br>Qty. allowed<br>No.<br>|<br>VALERYLCHLORIDE<br>VALERICACID<br>0.891 kg||||
|||||
|―||||
|RAconcerned maytake further necessary action as perabove decision ofNC|||
|・<br>ｄ<br>．<br>．<br>―<br>"CaseNo.:79/13/82-ALC4/2018 PartyName:SVRDRUGSMeetNo/Date:13/82-<br>‘\Status:<br>PRIVATELIMITED<br>ALC4/2018<br>‘Approved<br>—<br>|<br>|<br>14.01.2019<br>-HQFile<br>RLA File<br>~ [Lic.No/Date:0910066558<br>|<br>:01/82/050/01057/AM19/<br>:09/24/040/00224/AM19/<br>10.08.2018<br>|<br>|<br>Decision: TheCommittee considered case asperagendaand in thepresence ofthetechnical experts,<br>it<br>|<br>‘was decided to ratify the ad-hoc input output norms under para 4.7 ofHBP as per details below oras<br>||||
|240 appliedbyfirmwhichever is lower:-||||
|Exportproduct<br>Exp. Qty.<br>Qty. allowed<br>No.<br>|<br>2-(CHLOROMETHYL)-3,4-<br>1 kg<br>1<br>0.91 kg<br>|<br>DIMETHOXY<br>PYRIDINE<br>ee||||<br>||
||<br>HYDROCHLORIDE|||
|―<br>-<br>RAconcernedmaytake furthernecessary action asperabovedecisionofNC|||
|CaseNo2133/13/82..~—~—~«S(PartyName:RUBICON<br>MeetNo/Date:13/82- Status:<br>ALC4/2018<br>RESEARCHPVT.LID.,<br>ALC4/2018<br>Deferred<br>|<br>14.01.2019<br>|<br>|<br>241 HQ File<br>7<br>—RLAFile<br>~~<br>|Lie,No/Date:0310822983<br>Defer<br>|<br>:01/82/050/01111/AM19/<br>:03/95/040/00417/AM19/<br>10.08.2018<br>|<br>Decision: Committeeconsideredthecaseasperagenda and itwasdecidedtocallformthefirmcopyof<br>|<br>Masterbatch Formula(MBF)dulyauthenticatedbyQuality Control Incharge(QCl)..<br>||||
|師<br>CaseNo.:146/13/82- :<br>7 ‘Party Name:SIDDHARTHMeetNo/Date:13/82-<br>Status: |<br>|<br>ALC4/2018<br>CARBOCHEMPRODUCTS =ALC4/2018<br>Deferred<br>|<br>LTD.<br>14.01.2019<br>|<br>|<br>242OFile~~SC~*~*~*~S~S*S*SRLACQRile’«SSSSSSSSS«LicNovDate:0310823016<br>[Defer<br>:01/82/050/01124/AM19/<br>:03/95/040/00462/AM19/<br>13.08.2018<br>Decision: Deferred forcomments ofTE.<br>7<br>7<br>oo<br>a|||
|CaseNo.:305/13/82-<br>~ [Party Name:J.B.CHEMICALS MeetNo/Date:13/82-<br>Status:<br>243 ALC4/2018<br>&PHARMACEUTICALS<br>ALC4/2018<br>Deferred<br>LIMITED<br>14.01.2019—<br>{||||

| |HQFie ==————“C*“‘«dREA ile ~=S=~=SSS ie Novato 0310803011 Den a | -01/82/050/01283/AM19/Decision: Deferred for comments:03/94/040/00418/AM19/ of TE 13.08.2018 ee en a ae / (CaseNo.:321/13/82‘Party Name:AMITEX AGRO [Meet No/Date:13/82- Status: | i ALC4/2018 PRODUCT PVT LTD ALC4/2018 Approved | | (14.01.2019 | | {HQFile. = = ~~ ~—~—”~—S(RLA File SSCS Lic.No/Date:0310823010 | | | :01/82/050/01299/AM19/ ':03/94/040/00294/AM 19/ 13.08.2018 Eieee Decision: The Committee considered case as per agenda and in the presence of the technical experts, it) aa belowwas decided to ratify the ad-hoc input output norms under para 4.7 of HBP on net to net basis as given | | Export product Exp. Qty. Qty. allowed | oq No. Standard Soya Lecithin Liquid | 158.000 Crude Soya Lecithin 158.000 kg | Net Exempted Material per M.T.: kg Liquid | Crude Soya Lecithin Liquid = 1 MT 4 | RA concerned may take further necessary action as per above decision ofNC (Case No.:412/13/82- SS PartyName:GLENMARK [Meet No/Date:13/82. Status: | /ALC4/2018 PHARMACEUTICALS LTD., ALC4/2018 Approved | | 14.01.2019 | :01/82/050/01390/AM|HQ File 19/ :03/94/040/00423/AM19/RLA File Lic.No/Date:0313.08.2018 10823008 | || Decision: Committee considered case as per agenda and in the presence of the | technical experts, it was | firm whichever is lower:| decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by) — || No. | Export product Exp. Qty. ——" Qty. allowed | (Per Pack 100 Tabs.) (Net wt. of _ | Indomethacin Capsule USP 25mg 1 No. 25.50 mg/25 mg | 1545 | Indomethacin USP is 125.000 Kgs) Indomethacin‘ USP capsule: | |||| (PerIndomethacin Capsule Pack 1000 Tabs.) (Net USP 25mgwt. of 1 No. 25.50 mg/25 mg | | ) Indomethacin USP is 500.000 Kgs) Indomethacin, USP capsule. | |__| (PerIndomethacin Capsule Pack 100 Tabs.) (Net USPwt. 50mgof | 1 No. 51.00 mg/50mg |.| |_| , capsule | ; Indomethacin USP is 35.000 Kgs) Indomethacin USP ' | | Indomethacin= Capsule USP 50mg 1 No. || || Indomethacin@er Pack 500 USP Tabs.) is (Net 400.000 Kgs) wt. of Indomethacin: USP eanieiie51.00 mg/50 mg | || |ee RA concerned may take further necessary action as per above decision of NC

Case No.:128/13/82Party Name:SUNSHIELD Meet No/Date:13/82(Status: ALC4/2018 CHEMICALS LTD. ALC4/2018 Deferred 14.01.2019 | nageHQ File ; _—— RLA File Lic.No/Date:0310823049 Defer :01/82/050/01106/AM19/ :03/95/040/00473/AM- 19/ a 14.08.2018 — Decision: Deferred for comments of TE Case No.:306/13/82‘Party Name:ARCH | [Meet No/Date:13/82- Status: ALC4/2018 /PHARMALABS LTD ALC4/2018 ‘Deferred 14.01.2019 | os | HQ File RLA File Lic.No/Date:0310823058 Defer | :01/82/050/01284/AM19/ :03/94/040/00446/AM19/ 14.08.2018 | 247 Decision: The Committee considered the case as peragenda and it was decided to call for following information / documents from the firm: | (i) Stepwise complete and balanced chemical reaction showing Molecular weight and | Percentage of yield on molar basis | (ii) Reaction and Recovery of solvent at each stage | (iii) Material of balance for the entire process (Case No.:307/13/82‘Party Name:ARCH Meet No/Date:13/82Status: ALC4/2018 PHARMALABS LTD ALC4/2018 Deferred | 14.01.2019 ~ _Lie.No/Date:0310823050 [Defer | HQ File RLAFie :01/82/050/01285/AM19/ ':03/94/040/00439/AM 19/ 14.08.2018 | 248 Decision: The Committee considered the case as per agenda and it was decided to call for following information / documents from the firm: | (i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis | | (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process (Case No.:380/13/82- - Party Name:ARCH Ue: Meet No/Date:13/82. ‘Status: _ ALC4/2018 PHARMALABS LTD ALC4/2018 Deferred | | 14.01.2019 | HQ File REA File Lic.No/Date:0310823052 Defer | :01/82/050/01358/AM 19/ :03/94/040/00440/AM19/ 14.08.2018 249 Decision: The Committee considered the case as per agenda and it was decided to call for following information / documents from the firm: | | (i) Stepwise complete and balanced chemical reaction showing Molecular weight and | Percentage of yield on molar basis | | | (ii) Reaction and Recovery of solvent at each stage | | (iii) Material of balance for the entire process ; | / ‘Meet No/Date: 13/82Status: | "Case No.:381/13/82- a ; Party Name:ARCH - ALC4/2018 PHARMALABS LTD ALC4/2018 Deferred 14.01.2019 250 HQ File RLA File Lic.No/Date:0310823037 Defer | :01/82/050/01359/AM19/ :03/94/040/0043 1/AM19/ 14.08.2018 |e |

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----- Start of picture text ----- Decision:The Committee considered the case asper agenda and it was decided information to call for following | | / documents from the firm: | |nn ()) Stepwise complete and balanced chemical reaction showing. Molecular weightP and / Percentage of yield on molar basis | | (ii) Reaction and Recovery of solvent at each stage iii) Material of balance for the entire process | er eninge (Case No.:382/13/82- Party Name:AVA [Meet No/Date:13/82- (Status: | ALC4/2018 (CHEMICALS PVT.LTD., ALC4/2018 Approved | | | | 14.01.2019 | | |HQFile =————*CSRLEA ile Lic.No/Date:03 10823069 | | :01/82/050/01360/AM19/ ':03/94/040/003 15/AM19/ 14.08.2018 | ‘Decision: The Committee considered case as per agenda and in the presence of the technical experts, it) | |was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as | 251 applied by firm whichever is lower:- | | | | Export product Exp. Qty. Qty. allowed | |if No = | EDTA FERRIC SODIUM Fe| | kg Crude Soya Lecithin 0.730 kg | | content 13% ( +/- 0.5) Liquid | RA concerned may take further necessary action as per above decision of NC (Case No.:383/13/82- PartyName:ARCH ‘(MeetNo/Date:13/82. Status: | |ALC4/2018 PHARMALABS LTD ‘ALC4/2018 Deferred | | | 14.01.2019 | | HQ File RLA File Lic.No/Date:03 10823055 ‘Defer | :01/82/050/01361/AM19/ |:03/94/040/00444/AM19/ 14.08.2018 |2282 Decision:Pasocmosions The/ docu Com m entsitteefr c o mnsidered the firm: the case as per agenda and it was decided to call for following | (i) Stepwise complete and balanced chemical reaction showing Molecular weight and | (ii) Percentage of yield on molar basis e Reaction and Recovery of solvent at each stage eee Material of balance for the entire process [ Case No.:401/13/82- ae ‘Party Name:ARCH — Meet No/Date:13/82- Status: _ ALC4/2018 PHARMALABS LTD ALC4/2018 Deferred Pod (14.01.2019 [HQeee:01/82/050/01379/AM19/ File :03/94/040/00438/AM19/RLA————$<<<<—<$—_ File a oe14.08.2018Lic.No/Date:0310823046 [Defer | 253 Decision: The Committee considered the case as per agenda and it was decided. to call for following ---| ; |information / documents from the firm: ‘eae | @& Stepwise complete and balanced chemical reaction showing Molecular weight and | Percentage of yield on molar basis (ii i)) MaterialReaction and Recoveryof balance for the of entiresolvent process at each stage | 554 Case No.:402/13/82- ‘PartyName:ARCH ‘(Meet No/Dates13/822 Status: ea */ALC4/2018 | — _____ PHARMALABS LTD ALC4/2018 Deferred | ０ 一 針 Ｆ ----- End of picture text -----

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----- Start of picture text ----- | HQ File| a RLA File . (14.01.2019Lic.No/Date:0310823044a Defer :01/82/050/01380/AM19/ :03/94/040/00436/AM19/ 14.08.2018 Decision: The Committee considered the case as per agenda and it was decided to call for following - information / documents from the firm: (i) Stepwise complete and balanced chemical reaction showing Molecular weight and complete and balanced chemical reaction showing Molecular weight and and balanced chemical reaction showing Molecular weight and balanced chemical reaction showing Molecular weight and reaction showing Molecular weight and showing Molecular weight and Molecular weight and weight and and Percentage of yield on yield on on molar basis (ii) Reaction and Recovery of solvent solvent at each stage (iii) Material of balance balance for the entire process process ＞ Ｄ ----- End of picture text -----

==> picture [464 x 605] intentionally omitted <==

----- Start of picture text ----- (i) Stepwise complete and balanced chemical reaction showing Molecular weight and complete and balanced chemical reaction showing Molecular weight and and balanced chemical reaction showing Molecular weight and balanced chemical reaction showing Molecular weight and reaction showing Molecular weight and showing Molecular weight and Molecular weight and weight and and | Percentage of yield on yield on on molar basis (ii) Reaction and Recovery of solvent solvent at each stage (iii) Material of balance balance for the entire process process ' ~~ \Gase No.:403/13/82-.~(PartyName:ARCH ~=—~—~—=«SMcet No/Datte:13/82- (Status: ALC4/2018 PHARMALABS LTD ALC4/2018 Deferred | 14.01.2019 HQ File RLA File Lic.No/Date:0310823045 [Defer | :01/82/050/01381/AM19/ :03/94/040/00437/AM19/ 14.08.2018 | 255 Decision: The Committee considered the case as per agenda and it was decided to call for following information / documents from the firm: | (i) Stepwise complete and balanced chemical reaction showing Molecular weight and | Percentage of yield on molar basis | | (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process '\Gase No:409/13/82... +~«*‘(PartyName:ARCH ~=——«<(Meet No/Date:13/82- Status: ALC4/2018 PHARMALABS LTD ALC4/2018 Deferred 14.01.2019 | HQ File RLA File Lic.No/Date:03 10823062 Defer | |:01/82/050/01387/AM19/ ':03/94/040/00445/AM19/ 14.08.2018 | 256 Decision: The Committee considered the case as per agenda and it was decided to call for following information / documents from the firm: | (i) Stepwise complete and balanced chemical reaction showing Molecular weight and || Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage | (iii) Material of balance for the entire process [ Case No.:410/13/82- ~ Party Name:ARCH - Meet No/Date:13/82- Status: | ALC4/2018 /PHARMALABS LTD ALC4/2018 Deferred 14.01.2019 | HQ File — ~IRLA File 7 Lic.No/Date:0310823066 Defer | :01/82/050/01388/AM19/ :03/94/040/00443/AM 19/ 14.08.2018 | | 1257 Decision: The Committee considered the case as per agenda and it was decided to call for following | information / documents from the firm: | (i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis | (ii) Reaction and Recovery of solvent at each stage | (iii) Material of balance for the entire process Case No.:411/13/82- ~ | Party Name:ARCH Meet No/Date:13/82- ~ \Status: (258 ALC4/2018 /PHARMALABS LTD ALC4/2018 Deferred 14.01.2019 ＞ Ｄ ----- End of picture text -----

~ | |HQFile = = ~~ *(RLAFile = ~—~—_|Lic.No/Date:0310823060 [Defer | | ':01/82/050/01389/AM19/ :03/94/040/00442/AM19/ 14.08.2018 See eee | Decision: The Committee considered the case as per agenda and it was decided to call for following information / documents from the firm: (i) Stepwise complete and balanced chemical reaction showing Molecular weight and | (ii) Percentage of yield on molar basis | | (iii) ReactionMaterial andof balance Recoveryfor the of solvententire process at each stage —| (CaseNo.:413/13/82Ss PartyName:ARCH ——~—s(Meet No/Date:13/82(Status: ALC4/2018 PHARMALABS LTD ALC4/2018 Deferred } 14.01.2019 | |HQFile = + +‘(RLAFile Lic.No/Date:0310823048 Defer | '01/82/050/0139 1/AM19/ ':03/94/040/00441/AM19/ 14.08.2018 259 Decision: The Committee considered the case as per agenda and it was decided to call for following || information / documents from the firm: (0) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis | (ii) Reaction and Recovery of solvent at each stage | (iii) Material of balance for the entire process | (CaseNo.:89/13/82-ALC4/2018 |Party Name:SUVEN LIFE Meet No/Date:13/82. (Status: | SCIENCES LIMITED ALC4/2018 Deferred 260 | 14.01.2019 | FQ File RLA File Lic.No/Date:0910066569 [Defer |:01/82/050/01067/AM19/ :09/24/040/00227/AM19/ 16.08.2018 | Decision: Deferred for commentsofTE = = | Zea:| |Case No.:22/13/82-ALC4/2018|Party Name:SUN [MeetNo/Date:13/82. Status: = PHARMACEUTICAL ALC4/2018 Approved © INDUSTRIES LTD. 14.01.2019 | HQ File RLA File _—__Lie.No/Date:0510407546 | | |:01/82/050/01000/AM19/ :05/24/040/00286/AM19/ '17.08.2018 | | Decision:was The Committee considered case as per agenda andin the presence of the technical experts, it decided to ratify the ad-hoc input Output norms under para 4.7 of HBP as per details below or as| ‘applied by firm whichever is lower:| 61 | Export product Exp. Qty. Qty. allowed || | || OphthalmicTobramycin and Dexamethasonesuspension || Number16000.000 ft Tobramycin: 252.00 gm | | (OBRAMETH) Sml 2 84.00 gm | (Each ml contains Tobramycin 3 | ™s& Dexamethasone img Dexamethasone USP || (Equivalent to 240gm Tobramycin (Micronised) || || DexamethasoneBulk Drug Bulk Drugand 80gm | |RA concerned may take further necessary action as per above decision of NC

Case No.:32/13/82-ALC4/2018 Party Name:SUN Meet No/Date:13/82Status: | PHARMACEUTICAL \ALC4/2018 Approved | INDUSTRIES LTD. 14.01.2019 | | a ; ~ [Lic.No/Date:0510407547 | | |HQ File RLA File :01/82/050/01010/AM19/ ':05/24/040/00287/AM19/ 17.08.2018 | Decision: The Committee considered case as per agenda and in the presence of the technical[~] experts, it, was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as | applied by firm whichever is lower:-

262 Export product Exp. Qty. Qty. allowed | O. | | Ketorolac Tromethamine | 188700.000 | 1 Ketorolac 4.953 kg | Ophthalmic Solution 0.5% w/v 5 | Number Tromethamine ml, | (Each ml contains Ketorolac | Tromethamine 5 mg (Equivalent to 4.718 Kg of Bulk Drug) | (Pharmaceutical Formulations / Standard Grade | RA concerned may take concerned may take may take take further necessary necessary action as per above decision of as per above decision of per above decision of above decision of decision of of NC |

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

~\CaseNo.:198/13/82-.. ~”~«*(Party Name:NATURAL AND [Meet No/Date:13/82Status: | ALC4/2018 ESSENTIAL OILS PVT LTD ALC4/2018 ‘Deferred 14.01.2019 | 263 HQ File RLA File Lic.No/Date:0710113726 (Defer :01/82/050/01176/AM19/ ':07/24/040/00128/AM19/ 17.08.2018 | ‘Decision: Committee considered the case as per agenda and it was decided to call the firm for personal[|] | hearing to appear before the Norms Committee to explain their case.

(Meet No/Date:13/82(Status: | "(Case No.:45/13/82-ALC4/2018 Party NameSOHAN HEALTHCARE PVT. LTD ALC4/2018 ‘Approved | 14.01.2019 | HQ File | ~ RLAFile| ~ |Lie,No/Date:3110067151 | | |:01/82/050/01023/AM19/ ':31/83/040/00075/AM19/ 20.08.2018 | Decision: Committee considered case as per agenda and in the presence of the technical experts, it was | | decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by | firm whichever is lower:-

==> picture [460 x 125] intentionally omitted <==

----- Start of picture text ----- 264 (Export product Exp. Qty. Qiy.allowed ‘ | METFORMIN 1 kg 1 DICYANDIAMIDE 0.567 kg _ | [HYDROCHLORIDE] BP/EP (DCDA) WHITE | WHITE CRYSTLLINE POWDER POWDER. | | | | RA concerned may take further necessary action as per above decision of NC - ee | 誂 ----- End of picture text -----

||80||||
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|||||~|
|||(CaseNo.:151/13/82-. =———|PartyName:STERLING<br>——_—(Meet No/Date:13/82-<br>Status:<br>ALC4/2018<br>(AUXILIARIESPVTLTD<br>ALC4/2018<br>Deferred<br>|<br>|<br>|<br>14.01.2019<br>ey<br>a)<br>ae -\RLAFile<br>- |Lic.No/Date:0310823127 [Defer<br>|<br>':01/82/050/01129/AM19/<br>':03/95/040/00489/AM19/<br>20.08.2018 - <.<br>Poke<br>Toe ee<br>|<br>_Decision: Deferred forcommentsofTE<br>st eeeeeS||||
||onl<br>Sanaa<br>—————<br>-<br>-<br>——- --—_—<br>ae<br>|<br>CaseNo.:217/13/82-<br>PartyName:CLEAN SCIENCE MeetNo/Date:13/82-<br>‘Status:<br>—<br>|ALC4/2018<br>|ANDTECHNOLOGY<br>ALC4/2018<br>‘Approved<br>|<br>}<br>|<br>PVT.LTD.<br>14.01.2019<br>|<br>|<br>—<br>HQFile<br>——IRLAFile<br>Lic.No/Date:3110067150<br>|<br>|<br>':01/82/050/01195/AM19/<br>:31/83/040/00074/AM 19/<br>20.08.2018<br>’<br>—_—<br>Decision:<br>Committeeconsidered caseasperagenda andasperearlierdecisiontakenbyNCtakenbyNC |<br>|in<br>its9/82meeting dated 18.09.2018, itwasdecidedto ratifythead-hocinputoutputnormsunderpara4.7 |<br>|266ofHBPasperdetailsbeloworasapplied byfirmwhichever is lower:||||
|||<br>[Aestyl<br>“Anisole “GMethony<br>|Tke [1 | Phenol<br>__——————~*OO|<br>|_|<br>|Acetophenone)<br>DimethylSulphate<br>0.693kg<br>|<br>(3<br>[Caustictye —————SS—«*dOASTRg]<br>|<br>|<br>AceticAnhydridePURITY99%| 0.755kg<br>|<br>{RAmaytakeappropriate action asperthe decision ofNormsCommittee.||||
|||||||
||ｄ<br>Ｓ<br>ｔ<br>ａ<br>ｔ<br>(CaseNo.:326/13/82-<br>‘PartyName:BALAJIAMINES<br>[MeetNo/Date:13/82-<br>(Status:<br>|<br>‘ALC4/2018<br>(LIMITED<br>ALC4/2018<br>Deferred<br>|<br>|<br>14.01.2019<br>|<br>petHQFile<br>RLAFile<br>Lic.No/Date:3110067147 {Defer<br>|<br>|:01/82/050/01304/AM19/<br>:31/83/040/00082/AM19/<br>20.08.2018<br>|<br>Decision: Deferred forcommentsofTE||||
|||<br>[Case<br>No.:370/13/82-——_—‘|[Party Name:GLENMARK<br>'/Meet No/Date:13/82-<br>(Status:<br>\ALC4/2018<br>PHARMACEUTICALS LTD., ALC4/2018<br>Deferred<br>Leal<br>|<br>14.01.2019<br>|<br>|<br>768FQFile<br>RLAFile<br>7<br>Lic.No/Date:0310823140<br>[Defer<br>|<br>|:01/82/050/01348/AM19/<br>:03/94/040/00448/AM19/<br>20.08.2018<br>Decision:DeferredforcommentsofTE<br>_<br>ee eee ee |||||
||| [Case No.:372/13/82-<br>‘(Party Name:GLENMARK<br>[MeetNo/Date:13/82- (Status:<br>|<br>ALC4/2018<br>PHARMACEUTICALS LTD.,<br>|ALC4/2018<br>‘Approved<br>|<br>14.01.2019||||
|||<br>HQFile<br>RLAFile<br>Lic.No/Date:0310823141<br>|<br>|<br>:01/82/050/01350/AM19/<br>:03/94/040/00449/AM19/<br>20.08.2018<br>aDecision: Committee considered case as peragendaand as perearlier decisiontaken byNCin its4/82<br>|<br>meeting<br>dated 19.06.2018, itwasdecidedtoratifythead-hoc inputoutputnormsunderpara4.7ofHBPas)<br>perdetailsbeloworas appliedby firmwhichever is lower:||||
|||針<br>ExportProduct<br>ImportProduct<br>QuantityAllowed inkg<br>|_No.<br>Qty.||||

==> picture [480 x 735] intentionally omitted <==

----- Start of picture text ----- 81 | Lamotrigine TabletsCD 25mg | packs | ——T37.50mg/25mgtablet i | (Pack size 100 Tabs.) Net Wt. of oe | Lamotrigine is 54.250 Kgs.) Lamotrigine | Lamotrigine Tablets CD S5mg packs 5.10 mg/ 5 mg tablet | 2 (PackLamotrigine size 100is Tabs.) 10.500 Net Kgs.) Wt. of Lamotriginewi | | Lamotrigine Tablets USP 100mg packs 102.0 mg/ 100 mg tablet | 3 (Pack size 100 Tabs.) Net Wt. of La aid | Lamotrigine is 10.000 Kgs.) sail te } | Lamotrigine Tablets USP 150mg packs 153.0 mg/ 150 mg tablet | 4 (Pack size 60 Tabs.) Net Wt. of : . | Lamotrigine is 9.000 Kgs.) amotrigine | Lamotrigine Tablets USP 200mg packs 204.0 mg/ 200 mg tablet | sai ind 5 (Pack size 60 Tabs.) Net Wt. of ti 5 || Lamotrigine is 12.000 Kgs.) | | Lamotrigine Tablets USP 25mg packs 25.50 mg/ 25 mg tablet | (Pack size 100 Tabs.) Net Wt. of Lamotrigine || | Lamotrigine is 2.500 Kgs.) | | RA may take appropriate action as per the decision of Norms Committee [|Party][Name:ORIENTAL] [|] [Meet] [No/Date:13/82-] [(Status:] Case} [No.:110/13/82-ALC4/2018] } | AROMATICS LTD ALC4/2018 Approved | | | 14.01.2019 | | | HQ File RLA File ‘Lic.No/Date:031082316 | '-01/82/050/01088/AM19/ 03/95/040/00295/AM19/ 521.08.2018 || | | Decision: Committee considered case as per agenda and as per earlier decision taken by NC taken by NC in | | its 10/82 meeting dated 16.10.2018, it was decided to ratify the ad-hoc input output norms under para 4.7 | | of HBP as per details below or as applied by firm whichever is lower: | [27 | 0 Export product Exp. | Sl.No. — | Qty. Allowed in |) Qty. kg | _ | BACDANOL TOCO lkg | 1 italpha” 1.47 | | @-Bthyl-4-(2 2 3- | | Trimethylcyclopent-3-en-yl)- but- N-Butyraldehyde [07722 | | ent [secBunt poo | ButoxideBLN Buylamine joo? | | | RA may take appropriate action as per the decision of Norms Committee | -|Case No.:222/13/82- ‘Party Name:JNP PRODUCTS Meet No/Date:13/82- (Status: _ (ALC4/2018 ALC4/2018 Approved 14.01.2019 | | Oo ‘Lic. No/Date:3410044425 | | Pa HQ File— RLA File -0.1/82/050/01200/AM19/ ':34/24/040/001 77/AM19/ 21.08.2018 | | Decision: The Committee considered case as per agenda and deliberated on the matter in the presence of | ″ コ 「 ----- End of picture text -----

==> picture [489 x 711] intentionally omitted <==

----- Start of picture text ----- || Ithe technical experts and itwas decided to ratify the ad-hoc input output norms under para 4.7 of HBP as) per details below or as applied by firm whichever is lower: | | | No. || [Para Amino Phenol! 1 kg Para Nitro Chloro Benzene | 1.222 kg | | Caustic Soda Lye | 0.764 kg | | RA concerned may take further necessary action as per above decision of NC. = | Pod-| |CaseNo.:371/13/82. SS Party Name:GLENMARK ‘Meet No/Date:13/82- Status: ALC4/2018 PHARMACEUTICALS LTD., ALC4/2018 Approved | || {HQ File iy ~ [RLA File ‘Lic.14.01.2019 No/Date:03 1082319] | :01/82/050/01349/AM19/ :03/94/040/00450/AM19/ 21.08.2018 | ‘Decision: The Committee considered ‘case as per agenda and in the presence of the technical experts, it)| appliedwas decidedby firmto whicheverratify the ad-hocis lower:input output norms under para 4.7 of HBP as per details below or as | (272 | Pl| | Export product Qty. SI. No. Qty. | | Norethindrone Acetate Tab. | | 1 ; Norethindrone. Acetate 5.10 mg/tablet | | (USPNet SmgWt. (Packof SizNor e 50thindrone Tabs.) | No. (Norethisterone acetat) | | || || Acetateis 25.00 (Norethisterone Kgs.) acetat) ‘RA may take appropriate action as per the decision of Norms Committee [ - Case No.:24/13/82-ALC4/2018 Party Name:SENTISS [Meet No/Date:13/82- (Status: Py PHARMA PVT.LTD. ALC4/2018 Approved 14.01.2019 | || :01/82/050/01HQFile 002/AM19/ :05/24/040/00300/AM19/RLA File 23.08.2018Lic.No/Date:0510407597 | i: 273 Decision: The Committee considered case as per agenda and in the presence of the technical experts, t| [applied‘was decided by firmto whicheverratify the ad-hocis lower:input Output norms under para 4.7 of HBP as per details below or as | |rf Export product Qty. Sl. Qty. || No. | |PROLATAN EYE DROPS 523833.000 68.753 gram | 0.005% 2.5ML pack Pn] LATANOPROST | RA may take appropriate action as per the decision ofNorms Committee |"(Case No.:152/13/82. Party Name:YASHO ‘Meet No/Date:13/82- Status: |ALC4/2018 INDUSTRIES LIMITED ALC4/2018 Approved See | 14.01.2019 | - HQ File RLA File |Lic.No/Date:03 10823212 a || |:01/82/050/01 130/AM19/ :03/95/040/00501/AM19/ '23.08.2018 Decision: Committee considered case as per agendaand in the light ofearlierdecision taken |by NC in its 趾 ----- End of picture text -----

|||83||
|---|---|---|---|
|||10/AM19meetingdated 16.10.2018, itwasdecidedto ratifythe ad-hoc input output norms underpara47<br>ofHBP asperdetailsbelow orasappliedbyfirmwhichever is lower:<br>|||
|||Exportproduct<br>Exp.| Sl.<br>Importitems<br>Qty.Allowed inkg<br>|||
||__||Qty. | No.<br>OCTYLATED<br>tkg [1 | DIPHENYLAMINE<br>0.405<br>DIPHENYLAMINE(OCD<br>DHISOBUTYLENE<br>[02|<br>___LFLAKES/POWDER)<br>ACTIVATEDCLAY<br>[0.1+d<br>= RAmaytake appropriate action asperthe decisionofNorms Committee<br>||||
||-<br>||~~<br>|CaseNo.:129/13/82-.~‘PartyName:YASHO.—~—S<(MeetNo/Date:13/82-.<br>Status:<br>ALC4/2018<br>INDUSTRIES LIMITED<br>\ALC4/2018<br>Approved<br>14.01.2019<br>|||
||“HQFile<br>RLAFile<br>Lic.No/Date:0310823244<br>|<br>i<br>(sis<br>:01/82/050/01107/AM19/<br>—_:03/95/040/00502/AM19/<br>24.08.2018<br>|<br>Decision: The Committee considered case as per agenda andin thepresence ofthe technical experts,it!|||
|||was decided to ratify the ad-hoc input output norms under para 4.7 ofHBP as per details below or as||
||'275 applied by firm whichever is lower:|||
|||Exportproduct<br>Exp.| Sl.<br>Importitems<br>Qty.Allowedinkg<br>|<br>Qty. |No.|||
|||YAPOXCL<br>1 kg<br>0.579 kg||
|||30/10"HYDROQUINONE BIS"<br>HYDROQUINONE||
||||(2HYDROXY ETHYLETHER)<br>RAmaytake appropriate action asper thedecisionofNormsCommittee||
||-|ｄ<br>(CaseNo.:130/13/82-.—~—~—~—~=«Party Name:PRO-LIFEBIO-<br>MeetNo/Date:13/82-<br>Status: |<br>|<br>ALC4/2018<br>(CHEMICALINDUSTRIES(P) ALC4/2018<br>‘Deferred<br>LTD.<br>14.01.2019<br>|<br>|<br>276 FQFile<br>RLAFile<br>Lic.No/Date:0310823271<br>[Defer<br>:01/82/050/01108/AM19/<br>':03/95/040/00470/AM19/<br>24.08.2018<br>|||
|||Decision:Deferred<br>forcommentsofTE||
|||'<br>[Case No.:142/13/82-<br>~ {PartyName:PALADIN<br>—MeetNo/Date:13/82-<br>(Status:<br>ALC4/2018<br>PAINTSANDCHEMICALS =ALC4/2018<br>Deferred<br>PVT. LTD.,<br>14.01.2019<br>271 HOFile<br>~~~ (RLAFile «=i. NoDate-0310823254 Defer<br>|<br>:01/82/050/01120/AM19/<br>:03/95/040/00456/AM19/<br>24.08.2018<br>|<br>Decision:DeferredforcommentsofTE<br>oe|||
|||—~IGaseNo.:149/13/82.<br>~«*(PartyNName:RELIANCE<br>==—MeeetNo/Date:13/82-<br>‘Status:<br>ALC4/2018<br>INDUSTRIES LTD.<br>ALC4/2018<br>Deferred<br>14.01.2019<br>|<br>278 QFile<br>IRAFile<br>LicNo/Date:0310823249<br>[Defer<br>:01/82/050/01127/AM19/<br>':03/95/040/00423/AM19/<br>24.08.2018<br>|||
|||‘Decision:<br>TheCommitteedecidedto referthecasetoD/oC&PC forobtaining itscomments —<br>-|||
|||(CaseNo.:175/13/82-<br>=~PartyName:TIDE<br>~|Meet No/Date:13/82-<br>(Status:<br>279 ALC4/2018<br>INDUSTRIES<br>ALC4/2018<br>‘Approved<br>|<br>14.01.2019<br>}|■|

—_

| (HQFile = RLAFile ~=—S—=~~S«Le NoDate:3410044435[SS~*™ | :01/82/050/01153/AM19/ :34/24/040/00168/AM19/ 24.08.2018 remanence: = | Decision: Committee considered case as per agenda and in the presence of the technical experts, it was | decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by) | firm whichever is lower: | | | | |} | Export product Exp. | SI. Import items Qty. Allowedinkg | | | Qty. | No. | | | 7 1.92 k | | Aldehyde C-12 MNA 1 kg fh | Seip ina g | ‘RA may take appropriate action as per the decision of Norms Committee |

==> picture [467 x 552] intentionally omitted <==

----- Start of picture text ----- — — - — ‘Case = | No.:209/13/82- |Party Name:DEEPAK Meet No/Date: 13/82- Status: | |ALC4/2018 NOVOCHEM \ALC4/2018 Deferred | ‘TECHNOLOGIES LTD 14.01.2019 | 280 HQ File ORLAFile Lic.No/Date:3110067162 [Defer | ':01/82/050/01187/AM19/ :31/83/040/0008 1/AM19/ (24.08.2018 | Decision: Committee considered the case as per agenda and it has been observed that the chemistry given __ |by the firm is not clear, since stating that the raw material shown as phenol while import is of OCP 50. It. | was decided to ask the firm to furnish exact chemical name of OCP 50 along with manufacturing process _ |and all technical details starting from OCP 50. | | CaseNo.:375/13/82-—~‘(PartyName:IPCA. SS ‘Meet No/Date:13/82- (Status: =| | |ALC4/2018 |LABORATORIES LIMITED 14.01.2019/ALC4/2018 Approved / HQ File RLA File Lic.No/Date:03 10823270 | | _:01/82/050/01353/AM19/ _ :03/94/040/00464/AM19/ (24.08.2018 | | ‘Decision: Committee considered case as per agenda and in the presence of the technical experts, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by | firm whichever is lower: || | | Export product Exp. | SI. Import items Qty. Allowed in kg | 281 | Qty. | No. | LUMEFANTRINE l kg a(Dibutylamine 0.8691 | Methyl)2,7-Dichloro-4- | | Fluoren Methanol [DBA] / | ! 2,7-Dichloro-A- ; (Dibutylamino)Methyl- | 4 9H-Fluorene-4-Methanol P-Chlorobenzyldehyde 0.3476 } | 1 | z | RA may take appropriate action as per the decision of Norms Committee | SS ex RG > pm +. — = 9 ae 7 eects “sy f ees (282 Case No.:86/13/82-ALC4/2018 Party Name:RAKSHIT ‘Meet No/Date:13/82- \Status: | PHARMACEUTICALS LTD —ALC4/2018 Deferred — Ee Ree ees Cn (14.01.2019 | ｄ | Ｓｔａｔ ----- End of picture text -----

“a

HQ File - RLA File ; Lic.No/Date:0910066593 ‘Defer :01/82/050/01064/AM19/ :09/24/040/00239/AM19/ 27.08.2018 | | Decision: Deferred for comments of TE : aw - _ 7 - |

Case No.:104/13/82Party Name:ORIENTAL Meet No/Date:13/82(Status: |— ALC4/2018 AROMATICS LTD ALC4/2018 Approved 14.01.2019 HQ File RLA File Lic.No/Date:0310823304 | :01/82/050/01082/AM19/ |:03/95/040/005[1] 1/AM19/ 27.08.2018 | | Decision: Committee considered case as per agenda and in the light of earlier decisiontaken by NC in its | 12/AM19 meeting dated 12.12.2018, it was decided to ratify the ad-hoc input output norms under para 4.7 | of HBP as per details below or as applied by firm whichever is lower: | 283 Export product Qty. | Sl. | Import items Qty. No. | | SANJINOL TOCO Lkg Alpha Pinene 147kg | (2-Ethyl-4-(2 2 3-Trimethylcyclopent-3N-Butyraldehyde 0.77 kg | oa 0.40kg | Aluminum Tri-sec-Butoxide 0.072kg || Di N Butylamine 0.077 kg RA may take appropriate action as per the decision of Norms Committee. |

|"(CaseNo.:150/13/82-<br>ALC4/2018|———S—~ParrtyName:STERLING<br>AUXILIARIES PVTLTD|MeetNo/Date:13/82-<br>ALC4/2018|Status:<br>Deferred|||
|---|---|---|---|---|
|||14.01.2019|||
||284 fr File<br>7<br>:01/82/050/01128/AM19/|——RIAFile<br>~~<br>:03/95/040/00413/AM19/|Lic.No/Date:0310823301<br>27.08.2018|{Defer|||

Decision: Deferred for comments of TE

||||‘CaseNo.:164/13/82-<br>-~—~—~PartyName:SARNA<br>ALC4/2018<br>\CHEMICALSPVTLTD|MeetNo/Date:13/82-<br>ALC4/2018|Status:<br>‘Deferred|||
|---|---|---|---|---|---|
||||14.01.2019|||
||85|HQFile<br>RLAFile<br>Lie. <br>:01/82/050/01142/AM19/<br>':52/24/040/00044/AM 19/|No/Date:5210042742<br>(27.08.2018|[Defer<br>||||
|||Decision: Deferred forcomments ofTE||||
||CaseNo.:165/13/82-<br>PartyName:SARNA<br>|<br>ALC4/2018<br>‘CHEMICALSPVTLTD||MeetNo/Date:13/82-<br>ALC4/2018<br>14.01.2019|Status:<br>Deferred<br>|||
||286FQ<br>||FQFile<br>IRLAFile<br>SSCL.<br>-:01/82/050/01143/AM19/<br>|:52/24/040/00046/AM19/<br>Decision:Deferred forcomments ofTE|No/Daate:5210042743 <br>27.08.2018|Defer<br>|<br>|||
||“(CaseNo.:27/13/82-ALC4/2018 |PartyName:SHREEBANKEY MeetNo/Date:13/82-<br>+‘(Status:<br>BEHARI LALAROMATICS — ALC4/**20**18<br>287<br>|<br>14.01.<br>19<br>HQFile<br>~IRLAFile”<br>~<br>ILie-No/Date:0510407626|||+‘(Status:<br>‘Approved<br>|<br>||||

| |:01/82/050/01005/AM19/ —|:05/24/040/00313/AM19/ ——_—28.08.2018 ee | Decision: The Committee considered case as per agenda and in the presence of the technical experts, it) 'was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as| applied by firm whichever is lower:

| Export product Qty. | Sl. | Import items Qty. | No. | | CARVACROL lkg D-LIMONENE (LIMONENE CITRUS 1.48 kg i TERPENE, ORANGE TERPENE, BRAZILIAN CITRUS TERPENE, | ORANGE OIL (Not more than 50% strength) | | 2 |HYDROGEN PEROXIDE 1.00 kg ‘RA may take appropriate action as per the decision of Norms Committee. | | (Case No.:131/13/82-. ———(PartyName:UNITECH (M e t No/Date:13/82- (Status: ALC4/2018 INTERNATIONAL LIMITED ‘14.01.20ALC4/20 1 98 |Approved | [HQ File RLA File Lic.No/Date:03 10823340 | (:01/82/050/01109/AM19/ ':03/95/040/00449/AM19/ 28.08.2018 | Decision: The Committee considered case as per agenda and in the presence of the technical experts, it \was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as | applied by firm whichever is lower: | 288 | |_| Export product Qty. | SI. | Import items Qty. | No. | Esters of Methacrylic Acid - Crude | 1 kg Acrylic Strips and Cut | 1.10 kg | Methyl Methacrylate Monomer Pieces Net Content Per M.T.: Acrylic Strips and Cut Pieces - 1.33 M.T. | RA may take appropriate action as per the decision of Norms Committee. Fg Case No.:148/13/82-2 Party Name:RELIANCE Meet No/Date:13/82Status: | ALC4/2018 INDUSTRIES LID: ALC4/2018 Deferred bs | 14.01.2019 | | HQ File RLA File Lic.No/Date:0310823341 Defer | |:01/82/050/01126/AM19/ ':03/95/040/00406/AM 19/ 28.08.2018 Decision: The Committee decided to refer the case to D/o C&PC for obtaining its comments | | (Case No.:210/13/82———Party Name:CLEAN SCIENCE {Meet No/Date:13/82(Status: | _ ALC4/2018 |AND TECHNOLOGY ALC4/2018 Approved — | 4 PVT.LTD. 14.01.2019 | [HQ File RLA File Lic.No/Date:3110067165 | | |:01/82/050/01188/AM19/ 3 1/83/040/00085/AM19/ (28.08.2018 | [290 Decision: The Committee considered the case as per agenda and inthe light of earlier decision taken by| NC in its 7/82 meeting dated 24.08.2018, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: | |

==> picture [1 x 5] intentionally omitted <==

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| Guaiacol lke Phenol PURITY 99% AND _| 1.108kg |, | ABOVE | Dimethyl] Sulphate PURITY 99% 0.847 kg | | AND ABOVE | Hydrogen Peroxide (60%) 0.687 kg | PURITY 60% Acetone (Solvent) 0.14kg |, _ RA may take appropriate action as per the decision of Norms Committee. | ~ \Gase No367/13/82-.~”~S(PartyName:BDR—~C*<SMeetNo /Date13/82Status: ALC4/2018 PHARMACEUTICALS ALC4/2018 Approved INTERNATIONAL PVT. LTD. 14.01.2019 | | HQ File RLA File Lic.No/Date:0310823350 | | :01/82/050/01345/AM19/ :03/94/040/00475/AM19/ 28.08.2018 | Decision: The Committee considered case as per agenda and in the presence ofthe technical experts, ) it| | ‘was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as) 291 applied by firm whichever is lower:

Export product Qty. Sl. Import items Qty. allowed | | No. | Leflunomide 13.33% DCG 100.00 kg 13.4633kg | Leflunomide | | RA may take appropriate action as per the decision of Norms Committee. Case No.:368/13/82.. ~*(PartyName:DANOPHARM [Meet No/Date:13/82Status: ALC4/2018 (CHEMICALS PRIVATE LTD. ALC4/2018 Deferred 14.01.2019 | | | ~~ |Lic.No/Date:0310823354 Defer — HQFile ~ IRLAFile :01/82/050/01346/AM19/ ':03/94/040/00340/AM19/ 28.08.2018 | i Decision: Committee considered the case as per agenda and it was decided to call form the firm following | information:i) End use of the export product | ii) Molecular weight of the final product iii) The yield given is very much on the lower side, in support of yield, furnish the copy of Published Technical Literature. | -~|Gase No:369/13/82..~«(@Party Name:DANOPHARM MeetNo/Date:13/82Status: ALC4/2018 CHEMICALS PRIVATE LTD. ALC4/2018 Deferred | 14.01.2019 | | | 2 Lic.No/Date:0310823358 Defer | | HQFie (RLAFile | :01/82/050/01347/AM19/ ':03/94/040/00413/AM19/ 28.08.2018 | pea Decision:Committee considered the case as per agenda and it was decided to call form the firm following information: | | i)ii) EndMolecular weight ofuse of the exportthe product final product | | | iii) The yield given is very much on the lower side, in support of yield, furnish the copy of | Published Technical Literature.

«A

==> picture [459 x 685] intentionally omitted <==

----- Start of picture text ----- | a | Casea No.:373/13/82-a a Rg ‘Partyee Name:GLENMARK [MeetOg No/Date: riya ae aa 13/82-i ene | ><foeatae: Ee me | | ALC4/2018 PHARMACEUTICALS ‘ALC4/2018 Approved | LTD., 14.01.2019 | |HQFile - (RLAFile =————~~~*~SCSL icNo/Daate:0310823331 | :01/82/050/01351/AM19/ :03/94/040/00471/AM19/ 28.08.2018 | Decision: Committee considered case as per agenda and deliberated on the matter in the presence; of the | technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per poate below or as applied by firm whichever is lower: | }| |SL. Export product Exp. Import items Qty. Allowed | | No. Qty. bd Lithium Carbonate capsule aes | USP 150mg (Pack Size 100 | Lithivan Carbonate = | 153 img/l50 mg || Tabs.) paar USP Tablet | | : Lithium Carbonate capsule Lithium Carbonate 4 USP 300mg (Pack Size 100 _s USP 306 mg/300 mg 294 | Tabs.) P Tablet | 44 | = 62/0- Lithium Carbonate Lithium Carbonate 306 mg/300 mg =| capsule USP 300mg (Pack is USP Tablet | Size 1000 Tabs.) ai | | | 4 Lithium Carbonate capsule | | USP 600mg (Pack Size 100 ~— Lithium Carbonate 612 mg/600 mg | Tabs.) Pa USP Tablet | | 15 Lithium Carbonate ER Tab Lithium Carbonate | } | USP 300mg (Pack Size 100 k USP 306 mg/300 mg PS |4 Tabs.) pe Tablet | | USPLithium Cabronate 45 P ERi Tab 459 mg/45 | Tab | OMG (Pack Size 100 packs Lithium Carbonate hi | s.) USP Tablet RA may take appropriate action as per the decision of Norms Committee ||Case No.:374/13/82- ‘(Party Name:GLENMARK [Meet No/Date-13/82. ‘Status; | ALC4/2018 PHARMACEUTICALS LTD., ALC4/2018 Approved | | 14.01.2019 | HQ File RLA File Lic.No/Date:03 10823339 295 :01/82/050/01352/AM19/ ':03/94/040/00478/AM19/ 28.08.2018 | | Decision: Committee considered case as per agenda anddeliberated on the matter in the | foe experts and it was decided to ratify the ad-hoc input output norms under para 4.7presence of HBP as per|of the. ;| |details below or as applied by firm whichever is lower: | | | [St [Export product Exp. |Importitems| Qty. Allowed | ----- End of picture text -----

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

||||||||||
|---|---|---|---|---|---|---|---|---|
|o“|
|Doiy|
|Carvedilol|Tablets|USP|
|||3.125mg (Pack|Size|100|Carvedilol|3.1875|mg/3.125 mg|
|Tab.) (Net content of|k|Tablet|
|Import Item Sr.no.1|is|packs|||
|37.125|Kgs)|
|}||
|}|92|Carvedilol|Tablets|USP|
||;|||:ab.) 1nee(Net (Packcontent Sizeoa|3.1875 mg/3.125 mg|
|Import Item Sr.no.1|is|packs|Carvedilol|sit|
|||||68.750 Kgs)|||
|3|Carvedilol|Tablets|USP|
|||6.25mg (Pack|Size|100|6.375mg/6.25 mg Tablet|||
|{||Tab.)Import (NetItem contentSr.no.1 ofis|P|ack|s|C|a|rvedilol|||
|||||81.250 Kgs.)|||
|||
|||14|Carvedilol|Tablets|USP|
|6.25mg (Pack|Size|500|Carvedilol|
|Pentaen|[ :][‘]|packs|6.375mg/6.25 mg Tablet|||
|156.250|Kgs.)|
|||[5|||Carvedilol Tablets USP|||
|||||12.50mg (Pack Size|100|||
|||Tab.) (Net content of|k|Carvedilol|12.75 mg/12.50 mg|
|Import Item|Sr.no.1|is|Packs|Tablet|
|62.500|Kgs.)|||
|Carvedilol|Tablets|USP|
|12.50mg|(Pack|Size|500|
|}|||Tab.) (Net content of|ack|12.75 mg/12.50 mg|||
|}|||Import|Item|Sr.no.1|is|nn|Carvedilol|Tablet|
||||250.000 Kgs.)||||
|7|Carvedilol|Tablets|USP|
|25mg|(Pack|Size|100|
|Tab.)|(Net content of|‘|2|5|Tablet|
|Import Item Sr.no.1|is|packs|ee|5.5|mg/25|mg|Table|||
|200.000|Kgs.)|
|7|
|||Carvedilol|Tablets|USP|||
|;|||25mg (Pack Size 500|||
|Tab.)|(Net content of|:|25.5|mp/25|me|Tablet|
|312.500 Kgs.)|||
|||Import Item Sr.no.1|is|i|~~|SoS|BE|||
|||‘RA may take appropriate|action as per the decision of|Norms Committee|||
|-~|Gase No.:436/13/82-.~—~—~*(Party|Name:MAHIMA|LIFE|Meet|No/Date:13/82-.|(Status:|
|ALC4/2018|SCIENCES PVT.LTD.|ALC4/2018|Deferred|_|
|||14.01.2019|||
||296 FO|File|-'RLA File|Lic.No/Date:0510407628|Defer|||
|:01/82/050/01414/AM19/|':05/24/040/00307/AM|19/|28.08.2018|z|
|||Decision:|Deferred|for comments of TE|ee|ee|

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

| (Case No.:85/13/82-ALC4/2018 PartyName:S VLABS PVT Meet No/Date:13/82-. Status: | | LTD (14.01.2019ALC4/2018 Deferred pe"| HQFie::01/82/050/01063/AM19/CO RLAFle':09/24/040/00246/AM19/ Lic.No/Date:0910066602(29.08.2018 [Defer | Decision: Deferred for comments of TE Sd | Case No.:147/13/82—*|Party Name:NAPROD LIFE Meet No/Date:13/82- Status: | ALC4/2018 ‘SCIENCES PVT. LTD. ALC4/2018 Deferred — ll | 14.01.2019 | | PORIc = (REA File Lic.No/Date:0310823401 [Defer | :01/82/050/01125/AM19/ :03/95/040/00537/AM 19/ 29.08.2018 | | Decision: Deferred for comments of TE | Case No.:139/13/82‘Party Name:UPL Meet No/Date:13/82_[Status: | | ALC4/2018 LTD.(FORMERLY UNITED §(ALC4/2018 Approved Ped PHOSPHORUS LTD.) 14.01.2019 | | (HQFile = RLAFile Lic.No/Date:0310823438 | | :01/82/050/01117/AM19/ ::03/95/040/00503/AM19/ 30.08.2018 | | | a The Committee considered case as per agenda and in the presence of the technical experts, it | | was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as | = applied by firm whichever is lower:= No. | Phenyl Chloro Formate 1 Kg 1 | Phenol = sd 0.5978 kg | | Ethylene Dichloride 0.0564 kg | || |RA concerned may take further necessary action as per above decision of NC |

(Case No.:162/13/82|Party Name:SUPREET ‘Meet No/Date:13/82Status: | ALC4/2018 (CHEMICALS PVT.LTD. ALC4/2018 |Approved bey | ‘14.01.2019 | | HQ File RLA File ‘Lic.No/Date:5210042749 [sd | |:01/82/050/01140/AM19/ ':52/24/040/00049/AM 19/ 30.08.2018 | | Decision: The Committee considered case as per agenda and_ in the presence of the technical ‘experts, it, ag was[applied] decided[by][firm] to[whichever] ratify the ad-hoc[is][lower:] input output norms under para 4.7 of HBP as per details below or as | |__| Export product Qty. | Sl. | Import items Qty. | |.|_|4 2-amino phenol4 sulfonic acid / Lkg } No.1 ORTHO AMINO PHENOL OR | 0.66 kg | ortho amino phenol para sulfonic/ OAP OA ACID/ SP-23 | | } iz ‘RA may take appropriate action as per the decision of Norms Committee.

(Case No.:376/13/82Party Name:CIPLA LIMITED. Meet No/Date:13/82Status: ALC4/2018 ALC4/2018 ‘Approved | | (14.01.2019 | eT HQ File re |<"RLA File a: Lic.No/Date:03ae oT 10823444roe ee |al| :01/82/050/01354/AM19/ :03/94/040/00415/AM19/ 30.08.2018 Decision: |The Committee considered case as per agenda and in the presence of the technical ‘experts, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as_ applied by firm whichever is lower: | 301 | Export product Qty. Sl. | Import items Qty. No. | VETPRO - 20 PERCENT| 10000 Amprolium Hydrochloride 202.00 kg |) | POWDER / ROPIODOL 20 | Number | | PERCENT Amprolium 20 Percent | packs Powder (Each Pack 100 Gms) | Each gm contains Amprolium Hydrochloride BP 200mg | RA may take appropriate action as per the decision of Norms Committee. | = Meet No/Date:13/82Status: "(Case No.:21/13/82-ALC4/2018 [Party Name:PAYAL POLSEL SE PRIVATE ALC4/2018 Approved (LIMITED 14.01.2019 “HQ File RLA File Lic.No/Date:0510407655 | :01/82/050/00999/AM——— _ — ————— 19/ — ':05/24/040/00303/AM19/———<$—$—$—$—$—— = - ——— 31.08.2018—— ———<$ ———— | —— —} Decision: The Committee considered case as per agenda and in the presence of the technical experts, it) 302 was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as_ ~ applied by firm whichever is lower: | No. Plasticizer PVC (Di-Octyl Tera | 1 kg pl | Pure Tera Phthalic Acid 0.447kg |. [| Phthalate 2 [DBihylHexno! = 0.680 | RA may take appropriate action as per the decision of Norms Committee. | - [Case No.:83/13/82-ALC4/2018 [Party Name:SUVEN LIFE Meet No/Date:13/82Status: ‘SCIENCES LIMITED ALC4/2018 ‘Approved | | 14.01.2019 | -HoFile ~~ RLAFile ~~ Lie.No/Date:0910066615 | :01/82/050/01061/AM19/ ':09/24/040/00236/AM19/ 31.08.2018 | | Decision: The Committee considered case as per agenda and in the presence of the technical experts, it | 303 Wasapplied decidedby firmto whicheverratify the ad-hocis lower:input output norms under para 4.7 of HBP as per details below or as |

No : | RA may take appropriate action as per the decision of Norms Committee. __|

| (Case No.:366/13/823 ‘PartyName:KOPRAN | Meet No/Date:13/82Status: | | ‘ALC4/2018 RESEARCH ALC4/2018 Approved | LABORATORIES LTD. (14.01.2019 |HOFie”SSCA ile Lic.No/Date:03 1082346 | | :01/82/050/01344/AM19/ :03/94/040/00481/AM19/ 8 | | 31.08.2018 | Decision: The Committee considered case as per agenda and in the presence of the technical experts, | it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: | [304 Export product Qty. Sl. Qty. | | No. | | CEFEPIME FOR INJECTION | | kg | 1 CEFEPIME HCL(NON0.655 kg | STERILE | | 3 [LeARGININE Tork] | ae: ISO PROPYL ALCOHOL 10.392 | kg | | | 5 PACK.MAT.:ALU.CAN.(1OKG) | Relevant as | | | | ALU.BOTL.ANO.2M(20L000T.8 per packing | | || 020XY)(ONE SET CONT.ONE policy ie CAN./ALU.BOTL.ANO.+IN | LID+OUT LID+ | RA may take appropriate action as per the decision of Norms Committee. | (CaseNo.:84/13/82-ALC4/2018 ‘Party Name:SRINI [Meet No/Date:13/82Status: 4 ie PHARMACEUTICALS ALC4/2018 ‘Deferred | 3° PRIVATE LIMITED 14.01.2019 | HQ File ARTA File Lic.No/Date:0910066620 Defer :01/82/050/01062/AM19/ ':09/24/040/00251/AM19/ 03.09.2018 | Decision: Deferred for comments of TE ) | Case No.:88/13/82-ALC4/2018 [PartyName:SATYADEVA [Meet No/Date-] 3/82- (Status: | | PHARMACEUTICALS PVT /ALC4/2018 Deferred | co 306 LTDeee 14.01.2019Ee = Anis ences ae| ed| ~ HQ File 'RLA File Lic.No/Date:0910066623 Defer | :01/82/050/01066/AM19/ ':09/24/040/00247/AM 19/ 03.09.2018 | | | Decision: Deferred for comments of TE perole aa | [Case No.:136/13/82- SOS ‘Party Name:S.KANT [Meet No/Date:13/82-[Status:_ E ALC4/2018 /HEALTHCARE LTD. ALC4/2018 Approved — ee | 14.01.2019 | | /HQ File RLA File __|Lic.No/Date:0310823519 Pee | | ':01/82/050/01114/AM19/ :03/95/040/00045/AM19/ 04.09.2018 | | Decision: The Committee considered case as per agenda and in the presence of the technical ‘experts, it | applied by firm whichever is lower: 307 \was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as | | No. | ‘ea| lkg 2, 7 DICHLORO-A0.8691 kg | (DIBUTYLAMINO) METHYL9H-FLUORENE-4-METHANOL

| [t™t~t—it.CE— |«|fm«BA99%MINay%MIN a| | RA may take appropriate action as per the decision of Norms Committee. | Case No.:137/13/82Party Name:ORIENTAL ~ Meet No/Date:13/82Status: ALC4/2018 AROMATICS LTD ALC4/2018 ‘Approved | | | | 14.01.2019 | | f- = ae ~ SS ee = = a ss —4 i kT | ~~ -——_| HQ File RLA File Lic.No/Date:03 10823487 :01/82/050/01115/AM19/ |:03/95/040/00507/AM19/ (04.09.2018 | | Decision: The Committee considered case as per agenda and ‘in the presence of the technical ‘experts, it, 308 was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: No. CAMPHOR USP pike] 1 | ALPHA PINENE 1.146kg |, RA may take appropriate action as per the decision of Norms Committee. | (Case No.:163/13/82Party Name:VIRDEV~ ‘Meet No/Date:13/82Status: | ALC4/2018 INTERMEDIATES PVT LTD ALC4/2018 Approved 14.01.2019 HQ File RLAFile ~—~—_Lic.No/Date:5210042754 | :01/82/050/01141/AM19/ ':52/24/040/0005 1/AM19/ 04.09.2018 Decision: The Committee considered case as per agenda and in the presence of the technical experts, it 309 was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as | applied by firm whichever is lower: | No. | DIACEREIN |1kg]1| ALOE EMODIN 95% 1.05kg |, | RA may take appropriate action as per the decision of Norms Committee. Case No.:230/13/82"Party Name:KAIRAV ~~ ‘Meet No/Date:13/82— Status: ALC4/2018 (CHEMOFARBE INDUSTRIES ALC4/2018 Deferred 310 HQFile LTD.RLA File” i " 'Lic.No/Date:031082351314.01.2019 |Defer | :01/82/050/01208/AM19/ ':03/94/040/00403/AM19/ 04.09.2018 | | Decision: |The Committee considered the case as per agenda and it was decided to call for complete[|] technical details as per appendix 4E from the firm. (Case No.:231/13/82- Party Name:GLENMARK Meet No/Date:13/82Status: | ALC4/2018 PHARMACEUTICALS LTD |ALC4/2018 Approved — ‘ 14.01.2019 | — HQFile ~ IRLAFile ~ |Lic.No/Date:0310823517 | :01/82/050/01209/AM19/ :03/94/040/00497/AM 19/ 04.09.2018 311 Decision: The Committee considered case as per agenda and in the presence of the technical experts, | it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as[|] applied by firm whichever is lower: No. No. 1 ofDesonide Desonide Cream USP 0.05%Micronised 15gm (Net(Sicor) Wt.is || 75000.000 Packs fe DesonideMicronised (SicorUSP | 10.403 kg

“

| | 2 Desonide Cream 0.05% 60gm (Net Wt. | 75000.000 || 2.250 Kgs) | | ofDesonide USP Micronised (Sicor) is | Packs | } |3 Desonide Lotion 0.05% 59ml (Net Wt. | 75000.000 | || of2.213 DesonideKgs) USP Micronised (Sicor) is | Packs | | i | [4| Wt.Desonideof DesonideLotion 0.05%USP 118mlMicronis(N e dt | 40000.000 | | (Sicor) is 2.360 Kgs) |

| 5 Desonide Ointment 0.05% 15gm (Net | 75000.000 | | | Wt.(Sicor)ofis 0.563Desonide Kgs) USP Micronised | Packs | | Desonide Ointment 0.05% 60gm (Net | 75000.000 Wt. of Desonide USP Micronised | Packs | (Sicor) is 2.250 Kgs) | | \RA may take appropriate action as per the decision of Norms Committee.

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||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|Case No.:377/13/82-|PartyName:CIPLA|Meet No/Date:13/82-|Status;|
|||ALC4/2018|LIMITED.|ALC4/2018|Approved|
|}|||||14.01.2019|||||
|—|HQFile|‘|RLAFile|=|—_Lic.|No/Date:031082350|||||
|||:01/82/050/01355/AM19/|:03/94/040/00429/AM19/|8|
|||04.09.2018|||
|||Decision:|||The Committee|considered|the|case|as|per agenda|in|the|presence|of Technical|Experts|and|
|in|the|light|of earlier|decision|taken|by NC|in|its|Meeting|No.|2/82-ALC4/2018,|dated|16.05.2018,|it was|||
|decided|to|ratify|the|ad-hoc|input|output|norms|under|para|4.7|of HBP|as|per|details|below|or|as|applied||
|||by|firm whichever|is|lower:|
|||Sl.|||Export product|Qty.|Sl.|||Import|items|Qty.|
|||No.|No.|
||||Potassium|Chloride|||1|No.of||1|||POTASSIUM CHLORIDE USP _ ||765.0 mg|
|Extended|__ Release|| Cangule|:|
|Capsules|750mg|/||~°P|2|‘||CITRIC ACID|10.0 mg|
|Potassium|Chlor|ER|(MONOHYDRATE|USP)|
|||Caps|USP|750mg|
|||(Pack|_—|Size|100|||
|Capanice|Each)|3.|| DIBUTYL SEBACATE NF|12.0 mg|||
|||Each|extended Release|
|||Capsule|contains:|
|||Potassium|— Chloride|
|USP|750mg|||
|i|
|_|ETHANOL USP 99.9%|2.62 ml|||
|5|53/400 LSC, SCREW CAP|Relevant,|
|312|HAVING|UNIPAC|SG-75M|as|per|
|LINER PTD. WITH SFYP|IN|packing|
|||BLACK|(REXAM CLOSURES|polic|||
|||38/400 FG, CRC HAVING|——|||
|UNIPAC|SG-75M|LINER|PTD.|
|||WITH|SFYP|IN BLACK|Per-|||
|(REXAM|packing|
|®|
|||CLOSURES)|on|
|||
|||
|}|||Capsulesooo|750mgeae/|||°#P||12||||CITRICPOTASSIUM CHLORIDE ACID|USP|10.0 mgmg||||
|}|||Potassium|Chlor|ER|MONOHYDRATE USP|||
|||||la|DIBUTYL SEBACATE NF|12.0 mg|||
|Each extended Release|La|BEEANOL|Var|m|
|||Capsule|contains:|5|Relevant,|
|||||Potassium|—|Chloride|950CC WHITE HDPE BOTTLE|||as|||
|||ar ae|WITH 53MM NECK DB-22|per|
|TRIVENI|PLASTIC|packing|||
|polic|
|||||53/400 LSC, SCREW CAP|ian|||
|||HAVING UNIPAC SG-75M|er|||
|||||LINER PTD. WITH SFYP IN|eae,|||
|}|
|||BLACK (REXAM CLOSURES)|vn|&|
|||Exiended,|Release|| fp no.7||1|| POTASSIUM CHLORIDE USP|mg|||
|||||Capsules|600mg|/||“?P|2|‘||CITRIC ACID|8.0 mg|||
|||Potassium|Chlor|ER|MONOHYDRATE USP|||
|||||—|Sf|oe|DIBUTYL SEBACATE NF|||

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;

==> picture [486 x 712] intentionally omitted <==

----- Start of picture text ----- ~ Rhee: Se nn. co”. OR 2.62 ml ic | | a a |4 | ETHANOL USP 99.9% |2.62ml__ } | Each extended Release 5 100CC WHITE HDPE BOTTLE | Relevant, | me ee WITH 38MM NECK DB-02 as | ‘otassium oride | USP 600mg TRIVENI PLASTIC packingper — | } | 38/400 FG, CRC HAVING policy | | | UNIPACWITH SFYP SG-75M LINER IN BLACK PTD. | (REXAM CLOSURES) (90 Count ) (100 Count) 750mg/ 100 count) 600mg | || |RA may take appropriate action as per the decision of Norms Committee. ~ \Case No.:475/13/82- —~—«S|;Party Name:MAKSON Meet No/Date:13/82- ‘Status: ALC4/2018 INDUSTRIES PVT. LTD. ALC4/2018 Approved ; | 14.01.2019 | | [HQ File RLA File Lic.No/Date:1110028373 | ':01/82/050/01453/AM19/ ':11/24/040/00018/AM19/ 04.09.2018 | | Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by | {the light of earlier decision taken by NC in its Meeting No. 2/82-ALC4/2018, dated 16.05.2018, it was | ‘aaa whichever|is lower: sts aap Qy.[SLNe | [Importiems ———SS~«d id | Vicks Vaporub DL-Camphor (Synthetic Camphor) 5.365kg |) YY 100 kg Eucalyptus Oil 1.356kg | | | Nutmeg Oil 0.697 kg | | | Turpentine Oil 4.77kg | | Cedarleaf Oil 0.448 kg | | White Petrolatum (White Soft 82.30kg | | Paraffin cries | | RA may take appropriate action as per the decision of Norms Committee. | |Case No.:476/13/82- (PartyName:MAKSON—Meet No/Date:13/82-—[Status: | _ |ALC4/2018 INDUSTRIES PVT. LTD. ALC4/2018 ‘Approved | | | | 14.01.2019 | | | [HQ File RLA File ~——|Lie.No/Date:1110028374 | | | ':01/82/050/01454/AM19/ :11/24/040/00019/AM19/ 04.09.2018 | | | Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in| 314 the light of earlier decision taken by NC in its Meeting No. 2/82-ALC4/2018, dated 16.05.2018, it was | decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by | firm whichever is lower: ; | || No. _ | Vicks Vaporub 100 kg fl. | DL-Camphor (Synthetic Camphor) 5.365 kg || ´ ----- End of picture text -----

97 Eucalyptus Oil 1356kg | | Nutmeg Oil 0.697kg | Turpentine Oil 4.77 kg | fs | WhiteCedPar a rleafffin PetrolatumOil (White Soft | 82.300.448 kg || 0.0918kg | 8.| 50 gms Labels Relevant as_ | '9.| 100 gms Labels per packing | 10.| 80 gms Tube & cap policy | | |11.— | Direction Folders | | | RA may take appropriate action as per the decision of Norms Committee. Case No.:138/13/82~ [Party Name:RELIANCE ——-Meet No/Date:13/82-. Status: ALC4/2018 INDUSTRIES LTD. ALC4/2018 Deferred 14.01.2019 | |315 HQ File RLA File Lic.No/Date:0310823558 [Defer | | :01/82/050/01116/AM19/ ':03/95/040/00515/AM19/ 05.09.2018 | | Decision: The Committee considered case as peragenda and in the presence of the technical experts, it was decided to forward a copy of application to D/o C&PC for obtaining its comments.

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|||||||||
|---|---|---|---|---|---|---|---|
|(Case|No.:435/13/82-|~|[Party|Name:DCM|SHRIRAM|Meet No/Date:13/82-|‘Status:|
|ALC4/2018|INDUSTRIES LTD,|ALC4/2018|Deferred|
|||14.01.2019|
|[316|fiQ|File|.|RLAFile|LicNo/Date:0510407689 [Defer|
|||:01/82/050/01413/AM19/|':05/23/040/00242/AM19/iii|a05.09.2018|)|)|||
|Decision:|Deferred|for|comments|of TE|

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a ‘Case No.:211/13/82F Party Name:GLOBAL Meet[No/Date:13/82-] ‘Status: | ALC4/2018 PHARMA HEALTH CARE ALC4/2018 ‘Approved | ~ || HQ File _ PVTRLA LTDFile (14.01.2019|Lic.No/Date:0410164648 || :01/82/050/01189/AM19/ :04/24/040/00116/AM19/ 06.09.2018 Decision: | The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 4/82-ALC4/2018, dated 19.06.2018, it was 3 17 decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by. / firm whichever is lower: | | [Export Proauct SS ty. | SINo [import Product TQ. HYOSCINE BUTYL BROMIDE 10MG}_ 1 No. HYOSCINE BUTYL | 10.2 mg/tablet ablet BROMIDE IP/BP | RA may take appropriate action as per the decision of Norms Committee. "(Case No.:227/13/82~~ [Party Name:GLENMARK M e t No/Date:13/82Status: }318 ALC4/2018| |PHARMACEUTICALS LTD., ALC4/201814.01.2019 a

==> picture [468 x 696] intentionally omitted <==

----- Start of picture text ----- | [HQFile ==——~C:«SRA'@Ridle—=<S=Sé=<CS«wie NoMDate-0310823048 (Dek | _ :01/82/050/01205/AM19/ ':03/94/040/00518/AM19/ 07.09.2018 Decision: Deferred for comments of TE |ALC4/2018Case No.:429/13/82- ‘Party Name:CADILA_ Meet No/Date:13/82- ‘Status: | |HEALTHCARE LTD ALC4/2018 Deferred — Po | 14.01.2019 | | QFile RLAFile —__[Lie.No/Date:0810143413 Defer | :01/82/050/01407/AM19/ :08/24/040/00131/AM19/ 07.09.2018 Decision:Deferred for comments of TE (Case No.:94/13/82-ALC4/2018 |Party Name:VIVIMED LABS [Meet No/Date:13/82. Status: | ; LIMITED ALC4/2018 Deferred 320/HQFile | 14.01.2019 | = ~~~—RLAFile _ (Lie. No/Date:0910066645 [Defer | |:01/82/050/01072/AM19/ :09/24/040/00273/AM19/ 10.09.2018 | | | ‘Decision:yield at every“ThestageCommittee with stoichiometric considered thebalance case asfrom per agendathe firm. and it was decided to call for percentage of (Case No.:95/13/82-ALC4/2018 (Party Name:OPTIMUS Meet No/Date:13/82- Status: DRUGS PRIVATE LIMITED ALC4/2018 Approved | 14.01.2019 (HQFile = ~~ ~~~(RLAFile ~=~SCSCSS Lic.No/Date:09 10066646 | | :01/82/050/01073/AM19/ ':09/24/040/00241/AM19/ 10.09.2018 | Decision: | The Committee considered the case as per agenda in the presence of Technical Experts and in| _ __ the light of earlier decision taken by NC in its Meeting No. 4/82-ALC4/2018, dated 19.06.2018, it was | decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm | whichever is lower: | | | _ | 321 || Export product Qty. | No.SI. Import items Qty. | Ledipasvir Copovidone (1R,3S,4S)-3-(6-Bromo-1H- 0.85 kg = (Ledipasvir Amorphous) benzimidazol-2-yl)-2-a-zabicyclo = (2.2.1)heptane2-carboxylic acid 1,1- ee dimethylethyl ester | 2. (6s)-6-(5-(7-bromo-9,9-difluoro-9H- 0.85 kg | fluoren-2-yl)-1 H-imidazol-2-yl-5- LF azaspiro(2,4 Bis(Pinacolato) Diboron 0.85 kg 4 4. Dichlorobis(di-tert- 0.0516 kg |) | || butylphenylphosphine)palladium(II | | | RA may take appropriate action as per the decision of Norms Committee. | (CaseNo.:82/13/82-ALC4/2018 [Party Name:ORIENTAL Meet No/Date:13/82- (Status: 322. AROMATICS LTD ALC4/2018 Approved — 14.01.2019 HQ | | File RLA File Lie.No/Date:0310823719 | :01/82/050/01060/AM19/ :03/95/040/00341/AM19/ 12.09.2018 訛 ----- End of picture text -----

CAMPHOR USP USP | RA may may take

Decision: The Committee considered caseas per agenda and in the presence of the technical experts, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as.| applied by firm whichever is lower: No. CAMPHOR USP USP pike} | ALPHA PINENE 1.146kg ||

RA may may take appropriate action as per the decision of Norms Committee.

Case No.:108/13/82~~ |Party Name:SHREE BANKEY [Meet No/Date:13/82_‘|Status: ALC4/2018 /BEHARI LAL FLAVORS ALC4/2018 Deferred | 14.01.2019 HQ File RLA File Lic.No/Date:0510407757 ‘Defer :01/82/050/01086/AM19/ :05/24/040/00324/AM19/ 12.09.2018 323 Decision: | The Committee considered the case as per agenda and it was decided tocall for following information from the firm:

(i) Complete technical details as per Appendix 4E with chemical reaction, stage wise yield of production and molecular weight. (ii) Catalogue of Import Item No. 3- ARROWZYME/LIPASE AMANO IME. (ili) Production Consumption data duly certified by CA / GST. Case No.:180/13/82"Party Name:SARNA ~ ‘Meet No/Date:1 3/82Status: ALC4/2018 (CHEMICALS PVT LTD ALC4/2018 Deferred — | | | 14.01.2019 | 1374 HQ File RLA File Lic.No/Date:5210042764 Defer | :01/82/050/01158/AM19/ :52/24/040/00050/AM19/ 14.09.2018 Decision: |The Committee considered the case as per agenda and it was decided to call for Certificate of Analysis (COA) of import item from the firm: [—~\Gase No.:395/13/82-. ~«'(iPartyName:ARCH +~=~—~—~—~—~<(Meet No/Date:13/82(Status: ALC4/2018 PHARMALABS LTD ALC4/2018 Deferred | | | ~~ 14.01.2019 | | HQ File a ~'RLAFile |Lie,No/Date:0310823783 Defer :01/82/050/01373/AM19/ 03/94/040/00435/AM19/ 17.09.2018 Decision: The Committee considered the case as per agenda and it was decided to call for following | pas information / documents from the firm:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process

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(Case No.:396/13/82~~ [PartyName:AVA —~—sMeet No/Date:13/82- Status: ALC4/2018 ‘CHEMICALS PVT.LTD., ALC4/2018 /Approved | (14.01.2019 | 326HQFile ~~ RLAFile Lic.No/Date:03 10823801 | | :01/82/050/01374/AM19/ ':03/94/040/00507/AM19/ 17.09.2018 | Decision: The Committee considered case as per agenda and in the presence of the technical experts, it| was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as

100

~ | applied by firm whichever islower: ===SsSsS*~<S~S~<SsSCSS | — No. ; | EDTA DIAMMONTIUM Liquid 40% lkg ETHYLENE DIAMINE TETRA | 0.377 kg | _ | ACETIC ACID RA may take appropriate action as per the decision of Norms Committee. [ ‘Case No.:398/13/82Party Name:AVA Meet No/Date:13/82‘Status: | | ALC4/2018 (CHEMICALS PVT.LTD., ALC4/2018 Approved 14.01.2019 | HQFile ~~RLAFile Lie. No/Date:0310823776 oe:01/82/050/01376/AM19/a ——— —:03/94/040/00492/AM19/nr — - Sr 17.09.2018 | ———_____ ——_—— _ — _ nee f _ , , peseien: The Committee considered case as per agenda and in the presence of the technical experts, | 327 |It was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as | | applied by firm whichever is lower: | No. _ | | EDTA Tetra Sodium - Liquid (min 38 | | kg ETHYLENE DIAMINE TETRA | 0.285 kg | | | % ACETIC ACID ‘RA may take appropriate action as per the decision of Norms Committee. | [Case No.:400/13/82[Party NameJ.B. CHEMICALS [Meet No/Date:13/82Status: SlALC4/2018 & PHARMACEUTICALS ALC4/2018 Deferred 328 ‘LIMITED 14.01.2019 HQ File ; IRLAFile | ___|Lic.No/Date:0310823779 [Defer - 4 :01/82/050/01378/AM 19/ :03/94/040/00504/AM19/ 17.09.2018 | Decision: Deferred for comments ofTE as Sn

Case No.:55/13/82-ALC4/2018 Party Name:SUVEN LIFE [Meet No/Date:13/82. Status: i SCIENCES LIMITED ALC4/2018 ‘Approved | | 14.01.2019 | |HQ File RLA File Lic.No/Date:0910066680 [Defer | :01/82/050/01033/AM19/ :09/24/040/00285/AM19/ 18.09.2018 Decision:RE eT The CommitteeSee ‘< consideredSee case— as per agenda and“iarin the presence ofPay the technical experts,|| it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as. applied by firm whichever is lower: 329, ; | No. | | | TETRAHYDROFURAN 0.514kg | | RA may take appropriate action as per the decision of Norms Committee.

101

Case No.:225/13/82-_ Party Name:LUPIN LIMITED Meet No/Date:13/82Status: ALC4/2018 ALC4/2018 Approved | (14.01.2019 | HQFile, REA File Lie. No/Date:0310823818 | | :01/82/050/01203/AM19/ ':03/95/040/00478/AM19/ 18.09.2018 | Decision: The Committee considered case as per agenda and in the presence of the technical experts, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:

}

||||
|---|---|
||針<br>No.|

| No. RA may take appropriate action as per10the|decision[sc2-amnopurvrampence] of Norms Committee. | 0.95ke |

Case No.:397/13/82_ Party Name:INDO AMINES Meet | ALC4/2018 ‘LIMITED ALC4/2018No/Date:13/82‘Approved(Status: | 14.01.2019 | -HQFile RLA File Lic.No/Date:03 10823814 | | | :01/82/050/01375/AM19/ :03/94/040/00414/AM19/ 18.09.2018 | | Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in | the light of earlier decision taken by NC in its Meeting No. 5/82-ALC4/2018, dated 25.07.2018, it was| 331 decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by | firm whichever is lower:

==> picture [424 x 69] intentionally omitted <==

----- Start of picture text ----- No. COCO AMINE DISTILLED| 1 kg COCO AMINE DISTILLED (Purity 98%) | 1.02 kg Purity 99.50% ‘RA may take appropriate action as per the decision of Norms Committee. 趾 ----- End of picture text -----

; ~ Case No.:399/13/82Party Name:AARTI DRUGS — Meet No/Date:13/82(Status: | | ALC4/2018 LIMITED ALC4/2018 Deferred | 14.01.2019 | 332 [iQ File RLAFile Lic.No/Date:0310823810 {Defer :01/82/050/01377/AM19/ :03/94/040/00506/AM19/ 18.09.2018 | | Decision: Deferred for comments of TE

102

| (Case No.:81/13/82-ALC4/2018 PartyName:ORIENTAL ‘Meet No/Date:13/82- Status: | | AROMATICS LTD ALC4/2018 Approved IBS| | 14.01.2019 HQ File RLA File Lic.No/Date:03 10823851 | | :01/82/050/01059/AM19/ |:03/95/040/00335/AM19/ 19.09.2018 | | Decision: | The Committee considered the case as per agenda in the presence of Technical Experts and in | ithe light of earlier decision taken by NC in its Meeting No. 4/82-ALC4/2018, dated 19.06.2018, it was | decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by | firm whichever is lower: | 333° | | | | Export product Qty. | SI. Import items Qty. | No. | | _ [SANJINOL TOCO Ike [1 | Alpha Pinene 47ke | | (2-Ethyl-4-(2 2 3- N-Butyraldehyde 0.777 kg | _ | Hrimehyeytopen3-en-y- bat 040k | _ | | | 2-en-1-ol) AluminumDi N Butylam Tr i -sec-Butoxidene 0.07 27 kg | ‘RA may take appropriate action as per the decision of Norms Committee. | / Case No.:109/13/82-. Party Name:RAJASTHAN Meet No/Date:13/82-Status: | (ALC4/2018 ANTIBIOTICS LTD ALC4/201 8 Approved — | 14.01.2019 | | | [HQ File RLA File Lic.No/Date:05 10407831 | ':01/82/050/01087/AM19/ ::05/24/040/00191/AM19/ | 19.09.2018 | | Decision: The Committee considered case as per agenda and in the presence of the technical experts, 334 jit was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as | applied by firm whichever is lower: | | | = No. | || Meropenem for Injection fikg [1 | Meropenem trihydrate Non Sterile 0.9586 kg | RA may take appropriate action as per the decision of Norms Committee. | (Case No.:452/13/82- -—(Party Name:DSM SINOCHEM Meet No/Date:13/82Status: | ALC4/2018 PHARMACEUTICALS INDIA ALC4/2018 Approved | | PVT.LTD. 14.01.2019 | |HQ File RLA File Lic.No/Date:2210015978 | | |:01/82/050/01430/AM19/ ':22/24/040/00055/AM19/ 19.09.2018 | Decision: The Committee considered case as per agenda and in the presence of the technical experts, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as_ applied by firm whichever is lower: 335 | |No. | Amoxycillin Trihydrate through | 1 kg 1 6-AMINO PENICILLANIC ACID(6- | 0.55 kg || route6 -APA route through enzymatic 2 APA)D(-)P-HYDROXY PHENYL 0.477 kg | | GLYCINE METHYLESTER | | | ELCOLASE (ENZYME) 0.005 kg || | RA may take appropriate action as per the decision of Norms Committee.

103

"(Case No.:387/13/82—~—SPartyName:IPCA.———S*«~Meet NoDaate:13/82- —(Status: | ALC4/2018 ‘LABORATORIES LIMITED —ALC4/2018 Approved | 14.01.2019 | ae iG ra a EE = = = = a irra a ates HQ File RLA File Lic.No/Date:0310823910 | :01/82/050/01365/AM19/ :03/94/040/00545/AM19/ 21.09.2018 | ‘Decision: | The Committee considered the case as per agenda in the presence of Technical Experts and in | | |the light of earlier decision taken by NC in its Meeting No. 3/82-ALC4/2015, dated 20.05.2015, it was| | decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by | firm whichever is lower: 336 | Export product Qty. | Sl. | Import items Qty. | | No. | |__| Morantel Citrate lkg |1 | 3-Methyl Thiophene 0.330 kg || | Dimethyl formamide 0.2700.180 kgkg || | | 0.640 kg | Iso propyl Alcohol 0.225 kg RA may take appropriate action as per the decision of Norms Committee. epee els sete - | (Case No.:364/13/82SS PartyName:AVA_ ~ ‘Meet No/Date:13/82‘Status: (ALC4/2018 (CHEMICALS PVT.LTD., ALC4/2018 ‘Approved 14.01.2019 | HQ File iIRLA File Lic.No/Date:03 10823938 [ :01/82/050/01342/AM19/ ':03/94/040/00544/AM19/ 24.09.2018

Decision: The Committee considered case as per agenda and in the presence of the technical experts, _ 337 appliedit was decidedby firm towhicheverratify theisad-hoclower: input output norms under para 4.7 of HBP as per details below or as_ | | No. | | EDTA DIAMMONIUM Liquid | | kg ETHYLENE DIAMINE _ TETRA| 0.33 kg 40% ACETIC ACID | RA may take appropriate action as per the decision of Norms Committee. | Case No.:226/13/82; Party Name:ENCEE ~—s Meet. No/Date:13/82- ——Status: | ALC4/2018 AROMATICS PVT. LIMITED ALC4/2018 Approved 14.01.2019 | — -HQFile — (RLAFile =e. No/Date:3210078668 | 7 | :01/82/050/01204/AM19/ :32/24/040/00034/AM 19/ 25.09.2018 | | | Decision: | The Committee considered the case as per agenda in the presence of Technical Experts and in| 338 the light of earlier decision taken by NC in its Meeting No. 2/82-ALC4/2018, dated 16.05.2018, it was ~ decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: No. [Secondary Butyl Quinoline | ikg |1.[[Glycerine] | 2.748 kg |

104

_ RA may take appropriateaction as per the decision of Norms Committee. = (Case No.:96/13/82-ALC4/2018 Party Name:PORUS ‘Meet No/Date:13/82Status: | | LABORATORIES PVT LTD |ALC4/2018 ‘Approved | | 14.01.2019 | HQ File RLA File Lic.No/Date:09 10066698 | | ::01/82/050/01074/AM19/ |:09/24/040/00291/AM19/ 26.09.2018 | Decision: The Committee considered case as per agenda and in the presence of the technical experts and | in the light of earlier decision taken in Meeting No. 9/92-ALC4/2018 dated 18.09.2018, it was decided to| | (ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm) | 339 whichever is lower: , No. || BISIMIDE lkg pl BISPHENOL - A As applied | | | 2. |HEXAETHYLGUANIDINIUM As applied |, | CHLORIDE(HegCL(Catalyst | | PHTHALIC ANHYDRIDE As applied | | ! METHANOL 1.00kg | | | TOLUENE 2.00kg | | RA may take appropriate action as per the decision of Norms Committee. |Case No.:113/13/82‘Party Name:PREMIER ‘Meet No/Date:13/82‘Status: ALC4/2018 INDUSTRIES ALC4/2018 Approved =HQ File RLA File 14.01.2019Lic.No/Date:5010002476 || = |ol ':01/82/050/01091/AM19/ ':50/24/040/00018/AM19/ 26.09.2018 | | Decision: |The Committee considered case as per agenda and in the presence of the technical experts, it) 340 was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as, applied by firm whichever is lower: | No. | ‘RA| 2,4 may - Dinitrotake Anilineappropriate action as perikg the decision[1 |ofParaNorms NitroCommittee. Chloro Benzene 0.895kg _ (Case No.:176/13/82-ALC4/2018 = PartyName:VOVANTIS MeetNo/Date:13/82-. Status: } LABORATORIES PRIVATE ALC4/2018 Deferred — ST QFile| LIMITEDRLA File Lic.No/Date:341004451814.01.2019 [Defer| | :01/82/050/01154/AM19/ :34/24/040/00145/AM19/ 26.09.2018 | | Decision: Deferred for comments of TE - _ | ~ |CaseNo.:179/13/82Party Name:SVCHEM [Meet No/Date:13/82|Status: _—| 14.01.2019 | | ALC4/2018 INTERMEDIATES P LTD ALC4/2018 Approved © 342 HQ File RLA File Lic.No/Date:0410164716 ':01/82/050/01157/AM19/ :04/24/040/001 14/AM19/ 26.09.2018 | | | Decision: | TheCommittee considered case as per agenda and in the presence of the technical experts, | ‘it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as|

105

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|||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|oe|:|.|
|-|ail|4|
|applied by firm whichever|is lower:|
|||Export product|Qty.|Sl.|||
|No.|||
|||
|||Carbobenzyloxy-L-Valine|1|kg|0.50 kg|
|||||(CBZ-L-Valine|||
|RA may|take|appropriate|action as per the decision of|Norms Committee.|
|"(Case No.:212/13/82-|~~|(PartyName:DRJ|Meet No/Date:13/82-|(Status:|
|||ALC4/2018|PHARMACHEM PRIVATE|ALC4/2018|Approved|
|LIMITED|14.01.2019|||
|Lie.|No/Date:3110067178|||
|HQ|File|RLA|File|
|||:01/82/050/01190/AM19/|':31/83/040/00099/AM19/|26.09.2018|||||
|||Decision:|The Committee|considered|case as per agenda and|in the presence|of the technical|experts,|
|343|it|was|decided|to|ratify|the|ad-hoc|input|output|norms|under|para|4.7|of HBP|on|net|to|net|basis|as per|[|]|
|details below:|||
|No.|
|||
|||SODIUM|BENZOATE||42372.050 kg|SODIUM BENZOATE|42372.050 kg||.|
|MICRONISED|POWDER|
|||RA may take|appropriate|action|as per the|decision of|Norms Committee.|
|[~|[Case Nos213/13/82.|~~»|'(PartyName:-DEEPAK|—‘([Meet No/Date:13/82-|‘Status:|
|||ALC4/2018|NOVOCHEM|ALC4/2018|Deferred|
|||TECHNOLOGIES LTD|14.01.2019|||
|344|HQ File|RLA File|Lic.No/Date:3110067177|Defer|
|:01/82/050/01191/AM19/|':31/83/040/00094/AM 19/|26.09.2018|
|Decision:|The|Committee|considered|the|case|as|per|agenda|and|it|was|decided|to|call|for|exact|
|chemical name|of the|export product|from the|firm.|
|[Meet|No/Date:13/82-—‘(Status:|
|"(Case|No.:365/13/82-|‘Party|NameELPPE|
|||ALC4/2018|(CHEMICALS PRIVATE|ALC4/2018|‘Deferred|—|
|(LIMITED|14.01.2019|
|345|HQ File|RLA File|Lic.No/Date:0310823993|(Defer|
|:01/82/050/01343/AM19/|':03/94/040/00551/AM19/|26.09.2018|||||
|||Decision:|Deferred|for comments|of TE|
|Case No.:384/13/82-|~~||Party Name:ALTA|—~|Meet No/Date:13/82-|—‘(Status:|
|ALC4/2018|LABORATORIES LTD.|ALC4/2018|‘Approved|||
|14.01.2019|||
|HQ File|RLA|File|Lic.No/Date:0310824013|||
|:01/82/050/01362/AM19/|:03/94/040/00553/AM19/|26.09.2018|||||
|Decision:|The Committee considered|case|as per agenda and|in the presence|of the technical|experts,|
|346|it|was|decided|to|ratify|the|ad-hoc|input|output|norms|under|para|4.7|of HBP|as|per|details|below|or|as|||
|applied|by|firm|whichever|is|lower:|
|No.|
|RA may take appropriate|action as per the decision ofNorms Committee.|||

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

106

n ‘Case No.:385/13/82- ies "Party Name:ALTA : p Meet No/Date: 13/82Status: - ALC4/2018 LABORATORIES LTD. ALC4/2018 ‘Approved | | 14.01.2019 HQ File RLA File Lic.No/Date:0310824012,. SS | :01/82/050/01363/AM19/ :03/94/040/00550/AM19/ 26.09.2018 | | Decision: | The Committee considered case as per agenda and deliberated on the matter in the presence of | 347 ‘the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as_ per details below or as applied by firm whichever is lower: | | No. P|| 1kg [1 | SALICYLIC ACID 10.955 kg ‘RA concerned may take further necessary action as per above decision of NC. | | (Case No.:386/13/82‘[PartyName:ALTA [Meet No/Date. 13/82- Status: | ALC4/2018 LABORATORIES LTD. /ALC4/2018 ‘Approved | | 14.01.2019 || HQ File - ae RLA File [Lie No/Date:0310824011 || || |:01/82/050/01364/AM19/ :03/94/040/00547/AM 19/ 26.09.2018 | Decision: The Committee considered case as per agenda and in 348 the presence ofthe technical experts, | | applied|jit was decided by firm whicheverto ratify theis ad-hoclower: input output norms under para 4.7 of HBP as per details below or as | | Export product Qty. | No.SI. Qty. || RA may take appropriate action as per the decision of Norms Committee. (Case No.:388/13/82Party Name:IPCA Meet No/Date:13/82(Status: | ALC4/2018 LABORATORIES LIMITED 'ALC4/2018 Approved | 14.01.2019 | | jfoFte ‘IRLAFile Lic.No/Date:03 10824010 | | | :01/82/050/01366/AM19/ ':03/94/040/00552/AM19/ 26.09.2018 | Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in | the light of earlier decision taken by NC in its Meeting No. 4/82-ALC4/2018, dated 19.06.2018, it was | | | firmdecidedwhichever to ratifyis thelower: ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by | 349 | | | GLIMEPIRIDE 1 kg 4-[ 2-(3-Ethyl-4-Methyl-2-Carbonyl0.80 kg | | | Pyrrolidonylamino)-Ethyl]-Pheny]Sulfomide [MPR-II ee Trans-4-Methyl Cyclohexylamine 0.39 kg | _ Methylene Di Chloride 2.70kg | ST | | [4 TAccione ‘RA may take appropriate action as per the decision of Norms Committee.

107

"Case No.:389/13/82=== PartyName:IPCA Meet No/Date:13/82- ‘Status: ALC4/2018 LABORATORIES LIMITED —=ALC4/2018 ‘Approved 14.01.2019 HQ File — RLA File ~ Lic.No/Date:03 10824017 :01/82/050/01367/AM19/ ::03/94/040/00546/AM 19/ 26.09.2018 | | | Decision: | The Committee considered the case as per agenda in the presence of Technical Experts and in | | the light of earlier decision taken by NC in its Meeting No. 4/82-ALC4/2018, dated 19.06.2018, it was | decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: |

|350.<br>||Export product|Qty.|||SI.|;<br>Import items|Qty.|||
|---|---|---|---|---|---|---|---|
|||||No.||||
||PAROXETINE|lkg|||(-)Trans-4R-(4-Fluorophenyl)-3S-||0.810kg||)|
||HYDROCHLORIDE<br>HEMIHYDRATE||||Hydroxymethyl-N-Methy]<br>Piperidine|||
||||||DimethylSulfoxide|2.930kg||

|||RAmaytakeappropriate action asperthedecisionofNormsCommittee.<br>ee ||RAmaytakeappropriate action asperthedecisionofNormsCommittee.<br>ee ||RAmaytakeappropriate action asperthedecisionofNormsCommittee.<br>ee ||RAmaytakeappropriate action asperthedecisionofNormsCommittee.<br>ee ||
|---|---|---|---|---|
|CaseNo.:439/13/82-<br>——~PartyName:JUBILANT<br>ALC4/2018<br>(GENERICS LTD|||MeetNo/Date:13/82- Status:<br>ALC4/2018<br>Deferred||
||||14.01.2019<br>|||
|351 iQFile<br>RLAFile<br>_<br>:01/82/050/01417/AM19/<br>:05/23/040/00272/AM19/|||‘Lic.No/Date:0510407887<br>[Defer<br>26.09.2018<br>|||
||_<br>.||)||
||Decision: Deferred for comments ofTE||||
|/<br>||CaseNo.:57/13/82-ALC4/2018 |Party Name:RECKITT<br>—<br>—-<br>———HEALTHCARE<br>INDIA PRIVATE LIMITED||MeetNo/Date:13/82-.Status:<br>ALC4/2**01**8<br>Deferred<br>14.01.2<br>9<br>||||
|352 iQ File<br>RLA File|||Lic.No/Date:0510407915<br>[Defer||
||:01/82/050/01035/AM19/<br>:05/24/040/00359/AM19/||27.09.2018<br>|||
||Decision: Deferred for comments ofTE||||
|ALC4/2018|CaseNo.:390/13/82-<br>PartyName:AVA<br>ALC4/2018<br>(CHEMICALSPVT.LTD.,||MeetNo/Date:13/82-<br>(Status:<br>ALC4/2018<br>‘Approved||<br>—|
||<br>|||<br>|<br>HQFile|<br>—<br>RLAFile<br>:01/82/050/01368/AM19/<br>:03/94/040/00548/AM19/|||<br>14.01.2019<br>Lic.No/Date:0310824039<br>|<br>27.09.2018||<br>|<br>||
||353 Decision:<br>The Committee considered case as per agenda and||in the presence ofthe technical experts,||
||it was decided to ratify the ad-hoc input output norms under|para 4.7 ofHBP as per details below or as||||
||applied by firm whichever is lower:|||||
||||||||||||
|針<br>|<br>No.|||||

108

| [EDTA DIAMMONIUM Liquid 40% ]1kg]1 1 ETHYLENE DIAMINE TETRA | 0.377kg ||| | ACETIC ACID ACID RA may take appropriate may take appropriate take appropriate appropriate action as per the decision as per the decision per the decision the decision decision of Norms Committee. Committee.

||| | ACETIC ACID ACID ||, RA may take appropriate may take appropriate take appropriate appropriate action as per the decision as per the decision per the decision the decision decision of Norms Committee. Committee. | | ALC4/2018Case No.:447/13/82-—~—«(PartyINDUSTRIESName:AETHERLIMITED [MeetALC4/2018 No/Date:13/82. (StatussDeferred || ps4 (14.01.2019 HQ File RLA File : Lic.No/Date:5210042774 [Defer | /:01/82/050/01425/AM19/ ':52/24/040/0003 1/AM19/ 27.09.2018 | Decision: Deferred for comments of TE : (Case No.:450/13/82PartyName:AETHER ———|[Meet No/Date:13/82- Status: | ALC4/2018 INDUSTRIES LIMITED ALC4/2018 Deferred | | | | 14.01.2019 | 995 HQ File RLAFile ~ [LicNo/Date:5210042776 Defer | ':01/82/050/01428/AM19/ :52/24/040/00048/AM19/ 27.09.2018 | Decision: Deferred for comments of TE - ; (Case No.:60/13/82-ALC4/2018 Party Name:PAYAL Meet No/Date:13/82‘Status: ie POLYPLAST PRIVATE ALC4/2018 Approved © LIMITED 14.01.2019 | HQFile = = ———— RLAFile - Lic.No/Date:0510407941 | | |:01/82/050/01038/AM19/ :05/24/040/00364/AM19/ 28.09.2018 | | | Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in | 356 ‘the light of earlier decision taken by NC in its Meeting No. 10/82-ALC4/2018, dated 16.10.2018, it was | firm|decided whichever to ratifyis the lower: ad-hoc input output norms under para 4.7 ofHBP as per details below or as applied by | ; | No. | | Plasticizer PVC (Di-Octyl Tera | 1 kg pl Pure Tera Phthalic Acid 0.447 kg | RAPhthalate [2 |[BihylHexanol] 2 | 0.680 kg] may take appropriate action as per the decision of Norms Committee.

(Case No.:394/13/82|Party Name:ARCH Meet No/Date:13/82Status: ALC4/2018 /PHARMALABS LTD ALC4/2018 Deferred | i | HQ File ant RLA| File Lic.No/Date:031082407314.01.2019 [Defer| | | :01/82/050/01372/AM19/ :03/94/040/00571/AM19/ 28.09.2018 I357 Decision: The Committee considered the case as per agenda and it was decided to call for following . information / documents from the firm: | | | } (i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis | (iii)(ii) MaterialReaction and Recoveryof balance for the of solvententire process at each stage ~ ~ 58 Case No.:404/13/82Party Name:ARCH Meet No/Date:13/82Status: ALC4/2018 /PHARMALABS LTD ALC4/2018 Deferred —

109

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----- Start of picture text ----- | if © (i429 | | _ HQFile:01/82/050/01382/AM19/ RLA':03/94/040/00564/AM19/File 28.09.2018Lic.No/Date:0310824071 \Defer | Decision: The Committee considered the case as per agenda and it was decided to call for following / information / documents from the firm: | | (i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage | (iii) Material of balance for the entire process ~ [Meet No/Date:13/82- (Status: | Case No.:405/13/82- [Party Name:ARCH | ALC4/2018 /PHARMALABS LTD ALC4/2018 Deferred 14.01.2019 | | HQ File IRLA File Lic.No/Date:03 10824072 Defer | :01/82/050/01383/AM19/ ':03/94/040/00568/AM19/ 28.09.2018 [The][ Committee][ considered] [the][ case][ as][ per][ agenda and] [it][ was][ decided][ to][ call] [for][ following] 359 [‘Decision:] information / documents from the firm: (i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis | (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process Case No.:406/13/82- Party Name:ARCH ‘Meet No/Date:13/82- ‘Status: ALC4/2018 PHARMALABS LTD ALC4/2018 Deferred } | 14.01.2019 | / RLAFile Lic.No/Date:0310824068 Defer | HQ File :01/82/050/01384/AM19/ :03/94/040/00569/AM19/ 28.09.2018 | Decision: The Committee considered the case as per agenda and it was decided to call for following |360 information / documents from the firm: (i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis | (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process | Case No.:407/13/82- Party Name:ARCH Meet No/Date:13/82- ‘Status: | ALC4/2018 PHARMALABS LTD ALC4/2018 Deferred 14.01.2019 | | HQFile ts” RLAFile Lic.No/Date:0310824070 Defer :01/82/050/01385/AM19/ ':03/94/040/00567/AM19/ 28.09.2018 | | Decision: The Committee considered the case as per agenda and it was decided to call for following | 361 |;,formation / documents from the firm: | (i) Stepwise complete and balanced chemical reaction showing Molecular weight and | Percentage of yield on molar basis | (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process | ＞ ぅ ＞ Ｄ ０ ０ ----- End of picture text -----

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----- Start of picture text ----- (Case No.:414/13/82- Party Name:ARCH Meet No/Date:13/82- ‘Status: ALC4/2018 PHARMALABS LTD ALC4/2018 Deferred 14.01.2019 HQ File ae File ‘Lic.No/Date:03 10824069 Defer | | 101/82/050/01 392/AM19/ :03/94/040/00565/AM19/ 28.09.201 8 | 362 Decision:information The/ documents Committeefrom considered the firm:the case as per agenda and it was decided to call for following | | (i)| PercentageStepwise completeof yield andon molar balancedbasis chemical reaction showing Molecular weight and | | | (ii) Reaction and Recovery of solvent at each stage | iii) Material of balance for the entire process _ |Case No.:441/13/82- Party Name:FRESENIUS ‘Meet No/Date:13/82- |Status: | — ALC4/2018 KABI ONCOLOGY LIMITED ALC4/2018 Approved — 14.01.2019 | |HQ File RLA File Lic.No/Date:05 10407939 | | ::01/82/050/01419/AM19/ :05/23/040/00279/AM19/ 28.09.2018 | | Decision: | The Committee considered the case as per agenda in the presence of Technical Experts and in| | the light of earlier decision taken by NC in its Meeting No. 3/82-ALC4/2018, dated 05.06.2018, it was | firm whichever is lower: | decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by | | Export Product | | Gemcitabine Injections 200mg | || Gemcitabine Injections 1gm, | |Gemeitabine Injections 1.4gm | | | Gemcitabine Injections 2gm | | | 200 1gm /vial 1.4 gm/ vial | 2 gm/ vial | 363 | mg/vial ; | 2-Deoxy-2,-difluoro-D- 1.08 mg 5.40 mg 7.60 mg 10.80 mg ; | ribofuranose-3,5-dibenzoate- | | || White1-methanesulphonatecrystalline powder. (T-8). | — Assay: NLT 90.0% N-Acetyl cytosine. 0.77 mg 3.84 mg 5.38 mg 7.69 mg } | Whitpowd e r. orAssay: offwhiteNLT crystalline98.0% } | TypeVCDINIOR1 Tubular, 10Glass ml ISOVial Clear20 | Relevant, as per packing policy. | ; | mm crimp neck. | Glass10 ml. Vial , tubular Capacity - | 4 Rubber Stopper for | | || LyotecPharmaceuticals4432- Use S 87 I f 4 50GS3WESTARRSIMPK } 4 SP01 OR 1 oH Rubber Stoppers for | ; | Pharmaceutical Use S 87 J } | 4405-50/GREY EPP RS SIL 1 ＞ ----- End of picture text -----

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----- Start of picture text ----- 3 Glass Bottles Antibiotique 50 ,Clear Glass Type 1 Neck Finish IS083620200. Moulded Glass Bottle 50 ml Capaci VCT050-20CT-S0ml Clear Type 1 Tubular Glass Vial 20 mm crimp neck 68X42.5X1.5MM. | 7 Glass Bottles 01500 30 039 | Antibiotique 100 Clear Glass Type 1 Neck Finish | 1SO836220.0 Pack with 88 | Vials. | RA may take appropriate action as per the decision of Norms Committee. | ~~ (Case No.:328/13/82- —~—~=«PartyName:ARCH ~=——S Meet No/Date:13/82-. Status: ALC4/2018 PHARMALABS LTD ALC4/2018 Deferred 14.01.2019 HQ File RLA File ~~ |Lie.No/Date:0310824112 [Defer :01/82/050/01306/AM19/ :03/94/040/00574/AM 19/ 01.10.2018 | [The][ Committee][ considered][ the][ case][ as][ per][ agenda] [and][ it][ was] [decided] to call for following 364 [Decision:] information / documents from the firm: | | (i) Stepwise complete and balanced chemical reaction showing Molecular weight and | Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process | '\Gase No329/13/82..~«S(iPartyName:ARCH ~=~—~—=<Meet No/Date:13/82-{Status: ALC4/2018 PHARMALABS LTD ALC4/2018 ‘Deferred 14.01.2019 HQ File RLA File ~|Lic.No/Date:0310824092 Defer :01/82/050/01307/AM19/ :03/94/040/00587/AM19/ 01.10.2018 | | Decision: The Committee considered the case as per agenda and it was decided to call for following | 365 information / documents from the firm: | (i) Stepwise complete and balanced chemical reaction showing Molecular weight and | Percentage of yield on molar basis | | (ii) Reaction and Recovery of solvent at each stage | | (iii) | Material of balance for the entire process | [Meet No/Date:13/82- (Status: "(Case No.:330/13/82-. -—~—Party Name:ARCH- | ALC4/2018 PHARMALABS LTD ALC4/2018 Deferred 14.01.2019 Leg HQ File ~RLAFile ~~ |Lic.No/Date:0310824113 Defer | :01/82/050/01308/AM19/ ':03/94/040/0058 1/AM19/ 01.10.2018 | Decision: TheCommittee considered the case as per agenda and it was decided to call for following information / documents from the firm: ― ＞ ＞ Ｄ ----- End of picture text -----

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aie

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----- Start of picture text ----- information / documents from the firm: a Se | (i) Stepwise complete and balanced chemical reaction showing Molecular weight and | Percentage of yield on molar basis | | (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process ~~ (Case No.:352/13/82-—~—~—~=«SPartyName:ARCH =——<Meeet No/Date: | 3/82. (Status: ALC4/2018 PHARMALABS LTD ALC4/2018 Deferred a | 14.01.2019 | | | HQ File RLA File Lic.No/Date:0310824088 Defer :01/82/050/01330/AM19/ ':03/94/040/00603/AM 19/ 01.10.2018 [The][ Committee] [considered] [the][ case] [as][ per][ agenda and] [it][ was][ decided] [to] [call] [for][ following] . | 371 [Decision:] information / documents from the firm: (i) Stepwise complete and balanced chemical reaction showing Molecular weight and | Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process | [ —~\GaseNo353/13/82.. ~~» '(PartyName:ARCH ~=—~—~—~S*«~<SMeetNoDaate13/82- Status: ALC4/2018 PHARMALABS LTD ALC4/2018 Deferred | 14.01.2019 | | HQ File RLA File Lic.No/Date:03 10824101 ‘Defer | :01/82/050/01331/AM19/ :03/94/040/00576/AM19/ 01.10.2018 | | Decision: The Committee considered the case as per:agenda and it was decided to call for following 372 information / documents from the firm: (i) Stepwise complete and balanced chemical reaction showing Molecular weight and | Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage | (iii) Material of balance for the entire process J | ~ (Case No.:354/13/82- -—~—=iParty Name:ARCH Meet No/Date:13/82- Status: | ALC4/2018 PHARMALABS LTD ALC4/2018 Deferred | 14.01.2019 | | - HOFile ~~ RLAFile Lie. No/Date:0310824087 Defer :01/82/050/01332/AM19/ :03/94/040/00592/AM19/ 01.10.2018 | Decision: The Committee considered the case as per agenda and it was decided to call for following | Pee information / documents from the firm: | (i) Stepwise complete and balanced chemical reaction showing Molecular weight and | Percentage of yield on molar basis | (ii) Reaction and Recovery of solvent at each stage | (iii) Material of balance for the entire process [ ‘Case No.:355/13/82- ; Party Name:ARCH > - Meet No/Date:13/82- / Status:i | _ ALC4/2018 PHARMALABS LTD ALC4/2018 Deferred | 374 | : ~~ [Lic.No/Date:031082409714.01.2019 |Defer | | HQ File| 7 ~ (RLA File ----- End of picture text -----

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----- Start of picture text ----- | |:01/82/050/01333/AM19/ |:03/94/040/00602/AM19/ (01.10.2018 Decision: eee information / documents from the firm: | The Committee considered the case as per agenda and it was decided to call for following | | P -@) Stepwise complete and balanced chemical reaction showing Molecular weight and oa Percentage of yield on molar basis (iii) Reaction and Recovery of solvent at each stage Material of balance for the entire process Case No.:391/13/82- |Party Name:ARCH’ _ [Meet No/Date:13/82- Status: — | _ ALC4/2018 /PHARMALABS LTD ALC4/2018 Deferred | | | 14.01.2019 tee... | | tate Lic. No/Date:03 10824121 ‘Defer | :01/82/050/01369/AM19/ ':03/94/040/00583/AM19/ 01.10.2018 | 375 Decision: The Committee considered the case as per agenda and it was decided to call for following ‘information / documents from the firm: | | | (¢)) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process | |Case No.:392/13/82- —~—~—‘[Party Name:ARCH ‘Meet No/Date:13/82- Status: i i ALC4/2018 PHARMALABS LTD ALC4/2018 Deferred — 14.01.2019 | HQ File RLABile - -‘WidaNometcostomalis ‘Defer | :01/82/050/01370/AM19/ :03/94/040/00580/AM19/ (01.10.2018 376 Decision: The Committee considered the case as per agenda and it was decided to call for following — ‘information / documents from the firm: | (i) Stepwise complete and balanced chemical reaction showing Molecular weight and | Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process _ a ‘Case No.:393/13/82- a Party Name:ARCH _ Meet No/Date:13/82- Status: | (ALC4/2018 PHARMALABS LTD ALC4/2018 Deferred HQ 14.01.2019 File RLA File Lic.No/Date:0310824116 (Defer 577 :01/82/050/01371/AM19/ :03/94/040/00573/AM19/ (01.10.2018 Decision: The Committee considered the case as per agenda and it was decided | information / documents from the firm: to call for following | (i) Stepwise complete and balanced chemical reaction showing Molecular weight and (ii) Percentage of yield on molar basis (iii) Reaction and Recovery of solvent at each stage Material of balance for the entire process I57g [Case No.:415/13/82- [Party Name:ARCH ‘Meet No/Date:13/82- (Status: | i ALC4/2018 ___———sS[PHARMAALABSS LTD ALC4/2018 Deferred ０ 「 ｄ Ｓｔａｔ ----- End of picture text -----

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----- Start of picture text ----- ~ ; ~~ (14.01.2019 | | i oe | HQ File RLA File Lie.No/Date:0310824128 [Defer — :01/82/050/01393/AM19/ :03/94/040/00579/AM 19/ 01.10.2018 | | Decision: The Committee considered the case as per agenda and it was decided to call for following information / documents from the firm: ----- End of picture text -----

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----- Start of picture text ----- (i) Stepwise complete and balanced chemical reaction showing Molecular weight and | Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process Case No.:416/13/82- Party Name:ARCH Meet No/Date:13/82- Status: | ALC4/2018 'PHARMALABS LTD ALC4/2018 ‘Deferred | | 14.01.2019 _ ; HQ File RLA File LicNo/Date:0310824108 (Defer | -0.1/82/050/01394/AM19/ '03/94/040/00577/AM19/ 01.10.2018 | 379 [Decision:][ The][ Committee][ considered][ the][ case][ as][ per][ agenda and][ it] [was][ decided][ to][ call][ for][ following][ —] information / documents from the firm: (i) Stepwise complete and balanced chemical reaction showing Molecular weight and | Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process | "Case No.:417/13/82- Party Name:ARCH Meet No/Date:13/82- Status: ALC4/2018 PHARMALABS LTD ALC4/201814.01.2019 ‘Deferred| — HQ File RLA File Lic.No/Date:0310824118 |Defer -0.1/82/050/01395/AM19/ ':03/94/040/00578/AM19/ 01.10.2018 | | 380 Decision: The Committee considered the case as per agenda and it was decided to call for following | 380 information / documents from the firm: | (i) Stepwise complete and balanced chemical reaction showing Molecular weight and | Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process -\Gase No.418/13/82- Carty NameARCH (Meet No/Date: 13/92. «Status: — — ALC4/2018 PHARMALABS LTD ALC4/201814.01.2019 Deferred| | | ~ LieNo/Date:0310824130 Defer HQFile ~—REAFile -0.1/82/050/01396/AM19/ -03/94/040/00586/AM19/ 01.10.2018 Decision: The Committee considered the case as per agenda and it was decided to call for following 381 information / documents from the firm: | (i) Stepwise complete and balanced chemical reaction showing Molecular weight and | Percentage of yield on molar basis | (ii) Reaction and Recovery of solvent at each stage | (iii) Material of balance for the entire process | ０ ０ ０ Ｉ ----- End of picture text -----

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“.

[Case No.:419/13/82. PartyName:ARCH (Meet No/Date:13/82Status: | ALC4/2018 PHARMALABS LTD ALC4/2018 Deferred a | 14.01.2019 HQ — ST —__ Se, pe LS LY ee essinstemnenen | jilan: :01/82/050/01397/AMFile 19/ :03/94/040/00575/AM19/RLA File (01 10.2018Lic . No/Date:03 10824123 Defer | Decision: The Conmitiee ca ee ———— 3[a2][ ‘information] The[/][ documents] Committee[from] considered[ the][ firm:] the case as per agenda and it was decided to call for following | | | @ Stepwise complete and balanced chemical reaction showing Molecular weight and | Percentage of yield on molar basis @ Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process | ais) | Case No.:112/13/82Party Name:VARAHI Meet No/Daie-13/@9Status: - ALC4/2018 es PHARMA PRIVATE ‘ALC4/2018 Deferred ea ‘LIMITED (14.01.2019 | “RLA File Lic.No/Date:6610000013 [Defer | | :01/82/050/01090/AM19/ :66/24/040/00004/AM 19/ 03.10.2018 Decision: Deferred for comments of TE | || [Case No.:332/13/82. ‘Party Name:ANUH PHARMA Meet[No/Date:13/82-_|Statusr] ALC4/2018 ‘LTD. ALC4/2018 ‘Approved | || [HQ File 7 RLAFile ‘Lic.No/Date:03‘14.01.2019 10824185. ae ':01 /82/050/01310/AM19/ 03/94/040/00596/AM 19/ (03.10.2018 384 Decision: The Committee considered case as per agenda andin the presence of the technical “experts, applied by firm whichever is lower: | it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as | ;| Export product Qty. | SI. Qty. | || No. | Mometasone Furoate BP/EP/USP/IP [ke fi] 8 DM/ 16-Alpha Methyl Epoxide | 1.00 kg IRA may take appropriate action as per the decision of Norms Committee. ||Case No.:51/13/82-ALC4/2018 Party Name:STYRAX ‘Meet PHARMA No/Date:13/82. “Status: fie PRIVATE ALC4/2018 Approved | LIMITED 14.01.2019 | [HQ File IRLA File Lic.No/Date:09 10066710 :01/82/050/01 029/AM19/ :09/24/040/00308/AM1 9/ 04.10.2018 Decision: The Committee considered case asper agenda and in the presence of the technical experts, 385 applied by firm whichever is lower: ieit was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as | i No. | } (methoxycarbonyl)-4-oxo-| ,4f | |-(2,2-dimethoxyethyl)-5-methoxy-61]> methyl-4-methoxy= acetoacetate 0.75kg | | | | dihydropyridine-3-carboxylic acid }2 | dimethyl! oxalate | 1515ke | methylene di chloride (mdc) | 3.375 kg ||

117

7 RA may take appropriate action as per the decision of Norms Committee. . ~ (Case No.:52/13/82-ALC4/2018 Party Name:S VLABSPVT Meet No/Date:13/82‘Status: LTD ‘ALC4/2018 Deferred | | hee a | 14.01.2019 | HQ File RLA File Lic.No/Date:09 10066711 Defer :01/82/050/01030/AM19/ :09/24/040/00301/AM19/: —— 04.10.2018 a | Decision: Deferred for comments of TE Case No.:53/13/82-ALC4/2018 Party Name:SATYADEVA "Meet No/Date:13/82‘Status: _ ‘| PHARMACEUTICALS PVT (ALC4/2018 Approved — ‘LTD 14.01.2019 | HQ File RLA File ‘Lic.No/Date:0910066718 | :01/82/050/0103 1/AM19/ ':09/24/040/00297/AM19/ '04.10.2018 | | | Decision: The Committee considered case as per agenda and in the presence of the technical experts, | | it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as 387 applied by firm whichever is lower: No. (4R-Cis)-1,1-Dimethylethyl-6-(21 kg (4R-Cis)-1,1-Dimethylethy|-61.01 kg aminoethyl)-2,2-Dimethyl-1 3 cyanomethyl-2,2-Dimethy]- 1,3Dioxane-4-acetate (OR) Amino ketal dioxane-4-acetate (ATS-8 | RA may take appropriate action as per the decision of Norms Committee. | Case No.:56/13/82-ALC4/2018 Party Name:S MS [Meet No/Date:13/82(Status: | PHARMACEUTICALS LTD ALC4/2018 Deferred | 14.01.2019 | | ~~ Lie No/Date:0910066717 [Defer 388oFile:01/82/050/01034/AM19/ (RLAFile':09/24/040/00321/AM19/ 04.10.2018 | | Decision: Deferred for comments of TE | -\Gase No.:440/13/82———SCs@Paarty NameJUBILANT LIFE [Meet No/Date:13/82«Status: _ ALC4/2018 SCIENCES LIMITED (14.01.20ALC4/20 1 98 ‘Approved| | aT ————— | 2HQ File es IRLAeee File Lic.No/Date:0510407985 | | = a — aa | —-01/82/050/01418/AM19/a a zi -05/23/040/00275/AM19/aaa = Saoeen = 04.10.2018 | | Decision:the light of earlier| The Committeedecision taken considered by NC thein caseits asMeeting per agendaNo. 2/82-ALC4/2018, in the presence ofdatedTechnical16.05.2018, Experts andit was in || decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by | 389 firm whichever is lower: | | Beta Picoline 1 kg Denatured Ethyl Alcohol piizike | Alumino Silicate Catalyst r0.007kg sd, Propionaldehyde [o.0s7kg | {| RA may take appropriate action as per the decision of Norms Committee. _|

118

| [Case| No.:442/13/82- SS ‘Party Name:MOREPEN [Meet No/Date:13/82Status: | ALC4/2018 LABORATORIES LTD., ALC4/2018 ‘Deferred ss 14.01.2019 | | | ne RLAFile ~ Lic.No/Date:0510407973 [Defer :01/82/050/01420/AM19/ :05/24/040/00367/AM19/ 04.10.2018 Decision: Deferred for comments of TE bee. (Case No.:444/13/82- SS Party : ef - Name:MOREPEN (Meet No/Date:13/82- Status: 1 ALC4/2018ace Ry ri ss : LABORATORIES LTD., ‘ALC4/2018 Approved | }'HQy File , Md RLAf| File = frLic.No/Date:051040797414.01.2019ni 7 : ~ss| | = || ':01/82/050/01422/AM19/ ':05/24/040/00363/AM19/ (04.10.2018 | ‘Decision: The Committee considered the case as per agenda and in the Presence of Technical Experts, it. applied by firm whichever is lower: was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as | | | No. :| ROSUVASTATIN CALCIUM tert-Butyl-2-((4R,6S)-6-((E)-2-(4(-(41.425 kg | fluoropheny!)-6-isopropyl-2-[N-methy] ; (methylsulphonyl)amino] | oa Pyrimidin-5-y]) vinyl)-2,2-dimethy]1 ,3-dioxane-4-yl)acetate |} | tert-butyl methyl ether (MTBE) rere RA may take appropriate action as per the decision of Norms Committee. | _ — (Case No.:218/13/82Party Name:CLEAN SCIENCE Meet No/Date:13/82(Status: | (ALC4/2018 AND TECHNOLOGY ALC4/2018 ‘Approved _ | |PVT.LTD. '14.01.2019 | ':01/82/050/01HQ File 196/AM19/ [:3RLA 1/83/040/00100/AM19/ File -[Lic.No/Date:311006718805.10.2018 ees Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 9/82-ALC4/2018, dated 18.09.2018, it was |[is][lower:] '392[firm whichever] decided to ratify the ad-hoc input output norms under para 4.7 ofHBP as per details below or as applied by || [ Reetyl“AnisoleG-Methony [1k aes | ae | ||__|| | Acetophenone) }2 Dimethyl! Sulphate 0.693 kg } [3 [Caustic tye omar [4| Acetic Anhydride PURITY 99% |0.755kg it | x [RA may take appropriate action as per the decision of Norms Committee.

119

Case No.:333/13/82- ~ [Party Name:ETERNIS FINE Meet No/Date:13/82-. Status: ALC4/2018 ‘CHEMICALS LIMITED, ALC4/2018 Approved — : =| 14.01.2019 HQ File RLA File Lic.No/Date:0310824249 | :01/82/050/01311/AM19/ ':03/94/040/00593/AM19/ 05.10.2018 | Decision: | The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 4/82-ALC4/2018, dated 19.06.2018, it was[|] decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by | | firm whichever is lower: 393 Cyclohexy! Acetate and or PHENOL 0.300 kg | OrthoCyclohexylTertiary AcetateButyl Super [3 | ACETICANHYDRIDE | 0.123kg CARBON CATALYST RA may take appropriate action as per the decision of Norms Committee. | [Case No.:334/13/82~ party Name:ETERNIS FINE Meet No/Date:13/82‘Status: ALC4/2018 CHEMICALS LIMITED, ALC4/2018 Approved | 14.01.2019 . | HQ File RLA File Lic.No/Date:0310824248 | | :01/82/050/01312/AM19/ :03/94/040/00582/AM19/ (05.10.2018 | | Decision: | The Committee considered the case as per agenda in the presence of Technical Experts and in| the light of earlier decision taken by NC in its Meeting No. 1/82-ALC4/2018, dated 01.05.2018, it was 394 decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by | firm whichever is lower: | | Export product Qty. Sl. | No. | [eoumarin =i ee [| Saline | RA may take appropriate action as per the decision of Norms Committee. | ~\Case No454/13/82-.~—~—~(iPartyNName:IND-SWIFT —Meeet No/Date:13/82(Status: ALC4/2018 LABORATORIES LTD., ALC4/2018 Deferred | 14.01.2019 | 395 HQ File ~RLAFie Lic.No/Date:2210015989 [Defer | :01/82/050/01432/AM19/ ':22/24/040/00058/AM 19/ * 05.10.2018= - - aa — = — — || . =a man — ae a a = = i | Decision: Deferred for comments of TE | ~~ (Gase No.:174/13/82-.~—~—~SWParty Name:SHANPAR Meet No/Date:13/82- (Status: | ALC4/2018 INDUSTRIES PVT. LTD: ALC4/2018 ‘Approved | | 14.01.2019 | | 306HQFile IRLAFile ~~—~—Lie.No/Date:3410044557 | | :01/82/050/01152/AM19/ :34/24/040/00190/AM19/ (08.10.2018 | | | Sea —— vas — = = = = ——— = - ————— | Decision: The Committee considered case as per agenda and in the presence of the technical experts, | jt was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below oras

121

Case No.:449/13/82-.~(iPartyName:CADILA —*([Meet No/Date:13/82-. ‘Status: ALC4/2018 HEALTHCARE LTD ‘ALC4/2018 Approved | 14.01.2019 aHQ File RLA File Lic.No/Date:08 10143638 | :01/82/050/01427/AM19/ :08/24/040/00227/AM19/ (08.10.2018 | eeDecision: The committeeena es,camerconsidered[eRe] case as per agenda and in consultation with technical authority | | Al iain ER ES Gi | present in meeting decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower: | 400 | Export product Exp. Qty. Qty. allowed No. | HXDROBROMIDE | —_— TABLETS 20 | Number ELETRIPTAN 24.735 mg / 20 mg tablet | | || (ASHYDROBROMIDE) | | ELETRIPTAN TABLETS 40 | Numbe4r | 2 ELETRIPTAN 49.47 mg / 40 mg tablet MG HYDROBROMIDE AS HYDROBROMIDE RA concerned may take further necessary action as per above decision of NC | | —————— i ‘Case No.:54/13/82-ALC4/2018 Party Name: VIJAYASRI Meet No/Date:13/82Status: ORGANICS LTD ALC4/2018 ‘Approved | | 14.01.2019 | " Lic.No/Date:09 10066727 | HQ File ~IRLAFile :01/82/050/01032/AM19/ ':09/24/040/003 17/AM19/ 09.10.2018 | Decision: The committee considered case as per agenda and in consultation with technical authority | | present in meeting decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as _ | | applied by firm whichever is lower: | Qty. in kg 401 | 4-FLUORO-a-2-METHYL-1- | 1 Kg. a METHYL ISO BUTYRYL | OXOPROPYL)-g-OXO-N-BACETATE (MIBA | | DIPHENYL BENZENE TRIETHYL AMINE (TEA) [0.25 |, _ | BUTANEAMIDE ST PANMINEOR «047 | _ | (DIKETONE i 4 METHYLENE CHLORIDE 1.50 | | INTERMEDIATE FOR MDC | | ATORVASTATIN)/DKT-3 FLUOROBENZENE | 7 ISO PROPYL ALCOHOL | | IPA | RA concerned may take further necessary action as per above decision ofNC ee |

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‘Case No.:170/13/82(Party Name:ONEIRO—_[Meet No/Date:13/82Status: |ALC4/2018 CHEMICALS PVT LTD ALC4/2018 Approved — | fHQFile — (RLAFile SCS ‘Lic.14.01.2019No/Date:34 10044567 || | :01/82/050/01148/AM19/ :34/24/040/001 78/AM 19/ 09. 10.201 8 | Decision: The committee considered case as per agenda and in consultation with technical authorityiis | | | appliedPresent inby meetingfirm whichever decided to ratifyis lower: norms on repeat basis under para 4.7 of HBP as per details below or as | 402 | Export product Exp. SI.No. | Import items Qty. allowed | | | Oty. in kg | 4,7 DICHLOROQUINOLINE | 1 Kg. Di Ethyl Ethoxy Methylene 1.65 ae Malonate = Meta Chloro Aniline | | = Light Liquid Parafn Co) | [4 [Tole«iid Phosphorous Oxychloride OS sy | | RA concerned may take further necessary action as per above decision ofNC | |[Case No.:331/13/82- ‘(Party Name:AVA (Meet NoDaisi3/@do Status: | |ALC4/2018 CHEMICALS PVT.LTD., ALC4/2018 Deferred 403 | 14.01.2019 | HQ File RLA File / Lic.No/Date:0310824321 [Defer | | :01/82/050/01309/AM19/ |:03/94/040/00609/AM19/ (09.10.2018 | Decision: Committee considered the case as per agendaand it wasdecided to ask the firm tofurnish complete technical details as per appendix 4E. 4 -(Case No.:443/13/82Party Name:MOREPEN [Meet No/Date:13/@2. ‘Status: | ALC4/2018 LABORATORIES LTD., ALC4/2018 Approved | are| | Ah. 14.01.2019 ReaM amnion e io. | | || ‘HQ File RLA File ‘Lic.No/Date:05 10408040 || :01/82/050/01421/AM19/ :05/24/040/00378/AM19/ 09.10.2018 | Decision: The committee considered case as per agenda and in consultation with technical authority | appliedPresent in by meetingfirm whichever decided to ratifyis lower: norms on repeat basis under para 4.7 of HBP as per details below or as | | Q } | MONTELUKAST SODIUM 1 Kg. (S)-(E)-2-[2-[3-[2-(7-CHLORO- | in1.24kg } | 2-QUINOLINYL)Li| HYDROXYPROPYL)]-ETHENYLPHENYL]-3be PHENYL]-2-PROPANOL | | [2 [METHANOL +2325 | } | 3 N,N0.30 | DIISOPROPYLETHYLAMINE | TETRAHYDROFURAN [3.15

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==> picture [470 x 694] intentionally omitted <==

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|||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|2-[1-(MERCAPTOMETHYL)|0.40|||
|||
|CYCLOPROPYL]|ACETIC|
|ACID/|1,1-CYCLOPROPANE|||
|}}||||DIMETHANOL|
|-_|RA|concerned may take further necessary action as per above decision ofNC|||
|/|(Case No.:455/13/82-|-—~Party Name:DSM SINOCHEM|Meet No/Date:13/82-|_—Status:|
|ALC4/2018|PHARMACEUTICALS INDIA|ALC4/2018|‘Approved|||
|Pot|(PVT.LTD.|14.01.2019|||||
|-HQ File|RLA File|Lic.No/Date:2210015990|||
|:01/82/050/01433/AM19/|:22/24/040/00057/AM19/|09.10.2018|
|||
|Decision:|The|committee|considered|case|as|per|agenda|and|in|consultation|with|technical|authority.|
|present|in|meeting decided|to|ratify norms|on|repeat basis|under para 4.7 of|HBP|as per details|below|or as|
|applied by|firm|whichever|is|lower:|||
|405|
|;|||Qty.|in kg|||
|Amoxycillin|Trihydrate|||1|Kg.|1|6-AMINO PENICILLANIC|0.55|||
|||Through|6-APA|route|through|ACID(6-APA|
|Enzymatic|route|(2|||ELCOLASE|(ENZYME) __||0.005|||
|3|D(-)P-HYDROXY PHENYL|0.477|
|||GLYCINE METHYLESTER|
|RA concerned may take further necessary action as per above decision of|NC|||
|"(Case No.:61/13/82-ALC4/2018 PartyName:RAJASTHAN|Meet|No/Date:13/82-|Status:|
||||ANTIBIOTICS LTD|ALC4/2018|Approved|
|14.01.2019|||||
|HQ File|RLAFile|~~|Lic.No/Date:0510408052|||
|||:01/82/050/01039/AM19/|':05/24/040/00323/AM19/|10.10.2018|||
|Decision:|The|committee|considered|case|as|per|agenda|and|in|consultation|with|technical|authority|[|]|
|||present in meeting decided to|ratify norms on repeat basis under para 4.7 of|HBP as per details below or as|
|406|applied by firm whichever|is lower:|||
||_||Export product|Sl.No.|||Import items|Qty.|allowed|
|Qty|in kg|
|||Piperacillin|Sodium|and|1|Kg.|sl|Tazobactam Acid|(0.109|||
|||Tazobactam|Sodium|Sterile|)|:|—_|-|0.891|
|||RA concerned may take further necessary action as per above decision of|NC|||
|Case|
|No.:157/13/82-—~—~=«SParty|Name:VENUS|Meet No/Date:13/82-|(Status:|
|ALC4/2018|/REMEDIES|LTD.,|ALC4/2018||Approved||—|
|14.01.2019|
|||||
|~|'Lie.|[No/Date:2210015993]|
|HQFile|~IRLAFile|
|407|.91/82/050/01135/AM19/|'-22/24/040/00059/AM19/|10.10.2018|||
|||Decision:|The|committee|considered|case|as|per|agenda|and|in|consultation|with|technical|authority|||
|||present in meeting decided|to|ratify norms on repeat basis under para 4.7 of|HBP as per details below or as_|
|||applied by firm|whichever|is|lower:|

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

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———— — — —— — — - - — ~ — | = —— a ae NE || oH Qty. |_ [AZTREONAM| FOR| vials 1.869 gm/1 | | | INJECTION USP (1.0 AZTREONAM FOR INJECTION | gm injection | | GM)(20ML) USP | | | CONTAINING ( CONTAINING 780 MG OF L- | AZTREONAM FOR ARGENINE PER GM OF | | | || USP(CONTAININGINJECTION 780 MG AZTREONEM) |[OF][L-ARGENINE][PER][GM] | | | OF AZTREONAM | Ro | | | RA concerned may take further necessary action as per above decision of NC | {Case No.:223/13/82[Party Name:ASTRAL ‘Meet No/Date:13/82- _|Status: | | ALC4/2018 ‘STERITECH PVT. LTD. ALC4/2018 Approved | bd | 14.01.2019 | | fHQFile ==—S~*S REA de Lic.No/Date:34 10044574 | (:01/82/050/01201/AM19/ ':34/24/040/00226/AM19/ 10.10.2018 ‘Decision: The committee considered case as per agenda and in consultation with technical authority | present in meeting decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as | applied by firm whichever is lower: | | | | || Export product Exp. Qty. SI. | Import items Qty. | | No. allowed in |, '| | PIPERACILLIN SODIUM| 2100000.000 PIPERACILLIN SODIUM AND kg 408}| AND TAZOBACTAM| Numbers TAZOBACTAM SODIUM(8:1) ( | 9922.50 kg | | SODIUM POWDER OF Sterle Powder) | | INJECTION 4.5gm. PIPERACILLIN SODIUM AND | | PIPERACILLIN SODIUM TAZOBACTAM SODIUM(8:1) ( || AND TAZOBACTAM Sterle Powder | SODIUM POWDER OF 2 Glass Bottles Antibiotic 30ML | | INJECTION 4.5gm Clear Glass Type-1. | | Glass Bottles Antibiotic 30ML As per | | Clear Glass Type-1. relevant se 3 | 20mm Bromo Butyl Serum packing | Stoppers V9025 FM2572 ISAFI policy | RFS ( As Per General Notes) zz 20mm Bromo Butyl Serum | Stoppers V9025 FM2572 ISAFI = RFS (As Per General Notes (RA concerned may take further necessary action as per above decision of NC _| \CaseNo.:224/13/82- SS -PartyName:ASTRAL [Meet No/Date. 13/82(Status: - | ALC4/2018 |STERITECH PVT. LTD, (14.01.2ALC4/2 01 98 Deferred "HQ File RLA File Lic.No/Date:3410044573 [Defer | :01/82/050/01202/AM19/ :34/24/040/00225/AM19/ 10.10.2018 Decision: Deferred for comments ofTE=~~~

125

“~*~

Case No.:448/13/82‘Party Name:BAROQUE Meet No/Date:13/82‘|Status: ALC4/2018 PHARMACEUTICALS PVT. ALC4/2018 ‘Approved | LTD 14.01.2019 | a oe HQ File RLA File LicNo/Date:0810143673. | :01/82/050/01426/AM19/ ':08/24/040/00208/AM19/ 10.10.2018 Decision: The committee considered case as per agenda ‘and in consultation with technical authority. | present in meeting decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as | applied by firm whichever is lower:

Qty. No. CLOXACILLIN SODIUM | Numbers | 1 CLOXACILLIN SODIUM 555.90 | | CAPSULES USP 500MG COMPECTED USP mg/capsule ||, Each hard gelatin capsule CLOXACILLIN SODIUM USP contains Cloxacillin Sodium 573.18MG EQ.TO USP Eq to Cloxacillin 500mg CLOXACILLIN 500 MG.

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

RA concerned may take further necessary concerned may take further necessary may take further necessary take further necessary further necessary necessary action as per above decision of per above decision of above decision of decision of of NC | [Case No:168/13/82.. + ~»-‘(PartyName:SONGWON __—<(Meet No/Date:13/82-{Status: ALC4/2018 SPECIALTY CHEMICALS ALC4/2018 Deferred | INDIA PVT. LTD. 14.01.2019 41luoRie ~~ (RLAFile ~=——SCL ic.NoDate:3410044578 Defer | | :01/82/050/01146/AM19/ :34/24/040/00232/AM19/ 11.10.2018 | Decision: Deferred for comments of TE (Case No.:347/13/82‘Party Name:FDC LTD Meet No/Date:13/82Status: ALC4/2018 | ALC4/2018 ‘Approved — | 14.01.2019 | ie. No/Date:0310824389 | | —_|HQ File ~IRLA File :01/82/050/01325/AM19/ :03/94/040/00607/AM19/ 11.10.2018 | Decision: The committee considered case as per agenda and in consultation with technical authority | present in meeting decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as | applied by firm whichever is lower: 412 | __| Export product Exp. | SI. Qty. allowed — Qty. | No.[vials] BRIMONIDINE L- 0.0102 gn/ vial } | BRIMONIDINE TARTRATE[|] EYE DROPS 0.2% W/V S5ML TARTRATE |

==> picture [461 x 110] intentionally omitted <==

----- Start of picture text ----- | RA concerned may take further necessary action as per above decision of NC _ | Case No.:169/13/82- Party Name:SPC LIFE Meet No/Date: | 3/82- - Status: ; | ALC4/2018 \SCIENCES PVT. LTD. ALC4/201814.01.2019 Deferred| | HQ File ore File Lic.No/Date:3410044586 (Defer | (:01/82/050/01147/AM19/ ::34/24/040/00211/AM19/ aa 12.10.2018 i ell ----- End of picture text -----

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| __Decision: Deferred for comments of TE a. Oe ass eed | Case No.:171/13/82- ———PartyName:TATVA.—_[Meet No/Date:13/82Status: | — |ALC4/2018 (CHINTAN PHARMA CHEM ALC4/2018 ‘Approved | eal PVT LTD 14.01.2019 | |HQ File : IRLAFile Lic.No/Date:3410044583 | fl | |:01/82/050/01149/AM19/ :34/24/040/00240/AM18/ (12.10.2018 ae | ‘Decision: Committee considered case as per agenda and as per earlier decision taken by NC in its 10/82 | _ meeting dated 16.10.2018, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: | Ati Export product Exp. | SI.No. | Import items Qty. allowed | | | Qty. _ | METHOXY METHYL 1kg |1 TRIPHENYL PHOSPHINE | 0.806 kg | | TRIPHENYL PHOSPHONIUM CAS NO: 603-35-0 ASSAY | |Be beens 2 METHYLAL FETRK g Py 4009-98-7 Y NL 7” } — Seger ye ana SU CASNLT NO.99% 109-87-5 ASSAY RA may take appropriate action as per the decision of Norms Committee | [Case No.:177/13/82- -—~—*{Party Name:SONGWON [Meet No/Date:13/82. ‘Status: ALC4/2018 SPECIALTY CHEMICALS ALC4/2018 Deferred #15 INDIA PVT. LTD. 14.01.2019 | TQ File RLA File Lic.No/Date:3410044585 [Defer | :01/82/050/01155/AM19/ ':34/24/040/00169/AM19/ 12.10.2018 | | Decision: Deferred for comments of TE oi | _ \Case No.:178/13/82-———(Party Name:SPC LIFE Meet No/Date:13/82Status: ALC4/2018 SCIENCES PVT. LTD. ALC4/2018 Approved | | 14.01.2019 | |HQ File RLA File Lic.No/Date:3410044587 | | | |:01/82/050/01156/AM19/ :34/24/040/00217/AM19/ 12.10.2018 Decision: The committee considered case as per agenda and in consultation with technical authority | | appliedpresent inby meetingfirm whichever decided istolower: ratify norms on repeat basis under para 4.7 of HBP as per details below or as | a | in kg | || CHLOROHEXAN-2-ONE 1 Kg. PROPANE.1-BROMO 3-CHLORO 2.05 | i CLEAR LIQUID. ; | 2 METHYL ACETO ACETATE. | 1.65 | | CLEAR COLOURLESS TO i LIGHT YELLOW LIQUID | | 3 SODIUM METHOXIDE. 1.25 ; | WHITE POWDER |RA concerned may take further necessary action as per above decision of NC | 417 Case No.:158/13/827 ‘Party Name:UNITECH — Meet No/Date:13/82Status: i]

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----- Start of picture text ----- ALC4/2018 INTERNATIONAL LIMITED |ALC4/2018 ‘Approved ee - | (14.01.2019 | HQ File RLA File ‘Lic.No/Date:0310824473. :01/82/050/01136/AM19/ :03/95/040/00722/AM19/ (16.10.2018 | Decision: The committee considered case as per agenda and in consultation with technical authority| present in meeting decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as | applied by firm whichever is lower: | | Qty. | No. Esters of Methacrylic Acid - Crude Methyl | 1 1 Acrylic Strips and Cut 1.10 kg | Methacrylate Monomer Net Content Per | Kg. Pieces M.T. Acrylic Strips and Cut Pieces - 1.33 | — M.T. | | RA concerned may take further necessary action as per above decision of NC -~IGase No.:338/13/82-. ~«*(PartyName:CLARIANT ——‘(Meet No/Date:13/82- Status: | ALC4/2018 INDIA LIMITED ALC4/2018 Approved — | 14.01.2019 | | + HQ File ~ IRLA File Lie. No/Date:0310824472 | | :01/82/050/01316/AM19/ :03/94/040/00647/AM19/ 16.10.2018 Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the | [|] light of earlier decision taken by NC in its Meeting No. 2/82-ALC4/2018, dated 16.05.2018, it was decided | | to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm | || whichever is lower: || _ | Export product Exp. | SI.No. Qty. Allowed in | | Qty. kg | | PIROCTONE OLAMINE OR lkg 3,3 Dimethylacrylic Acid 0.919 kg | | VIPIROX 418 2 Isononanoy! Chloride or 1.30 | 3,5,5-Trimethy] Haxanyl | | Chloride ; | 3 Hydroxylamine Hel (99% | 0.73 ; | MIN) Or Hydroxylamine Hydro Chloride(99% | faetheMIN OO | 5 Di Chloro Methane | MDC | | EthyleneEDC Di Chloride | | | . Hydro Not shown in | Quinone process | RA may take appropriate action as per the decision of Norms Committee ed [419(Case No.:425/13/82-~(Party Name:JNPPRODUCTS Meet No/Date:13/82- (Status: |  ALC4/2018 ALC4/2018 Approved | 鏃 ― ・ ----- End of picture text -----

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2 oe ne7Cm ao Ee | [HQ File ae — (RLA File . . Lic.No/Date:3410044599 | | |:01/82/050/01403/AM19/ :34/24/040/00237/AM19/ 16.10.2018 Decision: 5 eee Bi athe ande present Thecommittee considered case as per agenda and in consultation with technical authority | applied in[by] meeting[firm][whichever] decided[is] to[lower:] ratify norms on repeat basis under para 4.7 of HBP as per details below or as | | | | Export Product Export | SI. Import items Qty. allowed Qty. No. | Para Amino Phenol l kg a Para Nitro Chloro Benzene 1.222 kg | } | | ee Caustic Soda Lye bon ks | | |RA may take appropriate action as per the decision of Norms Committee | || {Case No.:335/13/82‘[PartyNameAVA Meet No/Date:13/82- Status:_ ALC4/2018 CHEMICALS PVT.LTD., ALC4/2018 Approved |HQFile 14.01.2019 | RLA File Lic.No/Date:0310824511 | | ':01/82/050/01313/AM19/ :03/94/040/00633/AM19/ 17.10.2018 Decision:‘Committee considered _ '420 case as per agenda and deliberated on the matter in the presence of the | td e tailschnicalbelowexperts or as andappliedit was by decided firm whicheverto ratify theis lower: ad-hoc input output norms under para 4.7 of HBP as per| || | pteen Ike ETHYLENE DIAMINE sd | _Content 12.5% (+/- 0.5 TETRA ACETIC ACID || RA concerned may take further necessary action as per above decision of NC }Case| No.:339/13/82Party Name:CIPLA LIMITED. |Meet No/Date:13/82. Status: | _-ALC4/2018 | ALC4/2018 Approved | 14.01.2019 HQ File RLA File Lic.No/Date:0310824507| | |:01/82/050/01317/AM19/ :03/94/040/005 11/AM19/ 17.10.2018 | Decision: Committee considered case as per agenda and deliberated on the matter | in the presence of the | dt e tailschnicalbelowexperts or as and appliedit was by decidedfirm whicheverto ratify theis lower: ad-hoc input output norms under para 4.7 of HBP as per| 421 Export Product Qty. | SI. | Import items Quantity allowed in Telmisartan No. mg/tablet | and Amlodipine Tablets Nos. Telmisartan 68.034 | | | 40/1 Omg Granules | Each uncoated tablets contains : 2 10.20 | _ | Telmisartan 40 mg Telmisartan 40 mg Amlodipi || || equivalent 67.36mg Amlodipine to Telmisartan granules Besilate aesanaes‘pine | |equivalent to Amlodipine USP 10mg | | Telmisartan and Amlodipine Tablets Nos. Telmisartan 136.067 **** | | 80/10mg Granules | Each uncoated tablets contains : 2 Aaslodins 10.20 equivalentTelmisartanto 80Telmisartan mg Telmisartangranules80 mg Sagcasi _—

129

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----- Start of picture text ----- | a a a ss equivalent to Amlodipine USP 10mg Telmisartan and Amlodipine Tablets Nos. 136.067 | 80/Smg Granules Each uncoated tablets contains : 2 5.10 Telmisartan 80 mg Telmisartan 80 mg a equivalent to Telmisartan granules Agate 134.72mg Amlodipine Besilate Besilate equivalent to Amlodipine USP 5mg | Notional Value of Item of Import Nos. Telmisartan TELMISARTAN GRANULES Granules | supplied Free of Cost by Foreign Buyer | RA concerned may take further necessary action as per above decision of NC Case No.:340/13/82- Party Name:J.B. CHEMICALS Meet No/Date:13/82- Status: ALC4/2018 & PHARMACEUTICALS \ALC4/2018 Approved LIMITED 14.01.2019 | ~~ Lie.No/Date:0310824516{ HQ File RLA File :01/82/050/01318/AM19/ :03/94/040/00632/AM19/ 17.10.2018 Decision: Committee considered case as per agenda and deliberated on the matter in the presence of the [|] technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export Product Qty. | Sl. | Import items Quantity allowed in No. mg/tablet TAMBOCOR 50MG TABLET. Each Nos. 51.0 mg /50 mg tablet tablet contains, Flecainide Acetate Flecainide 422 50mg. Acetate | TAMBOCOR 100MG TABLET. Each | Nso. | 2 102.0 mg /100 mg | tablet contains, Flecainide Acetate Flecainide tablet 100mg. Acetate | TAMBOCOR CR 100MG CAPSULE. | Nso. | 3 102.0 mg /100 mg Each Capsule contains, Flecainide Flecainide capsule Acetate 100mg. Acetate | | T-TAMBOCOR CR 200MG CAPSULE. | Nso. | 4 204.0 mg /200 mg | Each Capsule contains, Flecainide Flecainide capsule _ | Acetate 200mg. Acetate | RA concerned may take further necessary action as per above decision of NC | -—~[Gase No:203/13/82-. +©~«*(PartyName:ONEIRO —[Meet.No/Date:13/82- ‘Status: ALC4/2018 \CHEMICALS PVT LTD ALC4/2018 ‘Approved — 14.01.2019 | | Tie No/Date:3410044614 | | | HOFie ~~ (RLAFile —:01/82/050/01181/AM19/ :34/24/040/00239/AM19/ (22.10.2018 7 1 i | 423 Decision: The committee considered case as per agenda and in consultation with technical authority | present in meeting decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower: | Export product Exp. S.No. Qty. allowed | Qty. in kg 針 ----- End of picture text -----

130

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a Light Liquid Parafin Liquid Parafin Parafin 997 Pei Phosphorous Oxychloride Oxychloride ae ‘RA concerned may take further necessary action as per above decision of NC eet od "(Case No.:336/13/82[PartyName:BDR ——(Meet ALC4/2018 No/Date:13/82. (Statuary | PHARMACEUTICALS ALC4/2018 ‘Approved Pod INTERNATIONAL PVT. /14.01.2019 | LTD. | | |HQFile ===—~S*«REAN le Lic.No/Date:0310824550 | | 424 :01/82/050/013 14/AM19/ :03/94/040/00619/AM19/ 22.10.2018 Decision:Committee considered < || | }details|technical belowexperts or as andappliedit wasby decidedfirm whichevercaseto as ratify per agenda theis lower: ad-hoc andinputdeliberated Output on normsthe undermatter parain the 4.7 presence of HBP asof per, the| | | | | Leflunomide 13.33% 300.000 Leflunomide 4.039 kg | | |DCG kg ‘RA concerned may take further necessary action as per above decision of NC | | [Case No.:181/13/82- [Party Name-STERILE INDIA [Meet No/Date:13/82-_[Status: | ALC4/2018 PRIVATE LIMITED ALC4/2018 Approved | Poti (14.01.2019 | (HQ File RLA File Lic.No/Date:3310030488 if | | :01/82/050/01159/AM19/ :33/24/040/00011/AM19/ (23.10.2018 Decision: Committee considered case as per agenda and deliberated on the matter in‘the presence |of the | 425 detailstechnical belowexperts or as and appliedit was by decided firm whicheverto ratify theis lower: ad-hoc input output norms under para 4.7 of HBP as per | Export Product Qty. | SI. Quantity ad No. allowed | STERILE CEFTRIAXONE kg CEFTRIAXONE SODIUM NON| 1.04 kg i | | SODIUM STERILE RA concerned may take further necessary action as per above decision ofNC | Case No.:337/13/82- SS PartyName:IPCA———~—‘(Meet No/Date-13/89(Status: | | |ALC4/2018 LABORATORIES LIMITED ALC4/2018 Approved ; | | 14.01.2019 HQ File RLA File ‘Lic.No/Date:0310824619 | | ”"Deckloar:01/82/050/01315/AM19/ :03/94/040/00657/AM19/ 23.10.2018 | Decision: Thi guides LL en | | The committee considered case as per agenda and in consultation with technical authority | _ applied‘Present by in meeting firm whichever decided tois lower: ratify norms on repeat basis under para 4.7 of HBP as per details below or as

| CILOSTAZOL 1 Kg. a Tetrazole][5-(4-Chlorobutyl)-1-Cyclohexyl-1H-(CBT Cilostazol 0.88 | 6-Hydroxy-3,4-Dihydroquinolinone [ 0.59 HCS Cilostazol | | |iso Propyl Alcohol 290d | | | (RA concerned may take further necessary action as per above decision of NC Case No.:456/13/82"|Party Name:MOREPEN Meet No/Date:13/82Status: ALC4/2018 LABORATORIES LTD., ALC4/2018 Approved | 14.01.2019 | 2 | HQ File RLA File ‘Lic.No/Date:0510408197[|] | -:01/82/050/01434/AM19/ ':05/24/040/00416/AM19/ 23.10.2018 | Decision: The committee considered case as per agenda and in consultation with technical authority present in meeting decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as | applied by firm whichever is lower:

427 | Export product Exp. | SIL. Qty. allowed |. | LINAGLIPTIN Qty.1 Kg. No. 2-(chloromethy!)-4-methylquinazoline in0.785 kg LGO1 | 2 8-bromo-7-(2-butyn-1-yl)-3,7-di hydro-3| methyl-1H-Purine-2, 6-dione(LGSO1) or — 8-bromo-7-(but-2-ynyl)-3-methyl-1H-purine| | 2, 6(3H,7H) - dione (LGSO1 | | (R)-3-(Boc-Amino) piperidine (LGS02) || | RA concerned may take further necessary action as per above decision of NC |

_ Case No.:457/13/82Party Name:JUBILANT LIFE Meet No/Date: 13/82‘Status: | ALC4/2018 SCIENCES LIMITED ALC4/201814.01.2019 Approved| | - REA File ~—~_Lic.No/Date:0510408181 | HQ File | :01/82/050/01435/AM19/ :05/23/040/00247/AM19/ 23.10.2018 |

429 Case No.:111/13/82———_—~Party Name:VARAHI Meet No/Date:13/82Status:

132

|Taconic = =—~CO——” PHARMAPRIVATE —SALC4/2018.S Deferred Yl LIMITED 14.01.2019 e : es | ee --=]REAFie = = Lic.No/Date:6610000017 [Defer | | :01/82/050/01089/AM19/ :66/24/040/00006/AM19/ 24.10.2018 | Decision:The‘committee ‘considered case as per agenda and in consultation with technical authority | presentapplied inby meetingfirm whichever decided to ratifyis lower: norms on repeat basis under para 4.7 of HBP as per details below or as | Export product Exp. | SI. | Import items Qty. allowed in | Qty. | No. kg | CLOPIDOGREL BISULFATE| 1 Kg. DL-2-CHLORO PHENYL } GLYCINE | | | | 2-THIOPHENE ETHANOL 060 L(+)TARTARIC ACID 0.667 a | dl P.T.S. CHLORIDE 1.029 | RA | concerned may take further necessary action as per above decision of NC | “a‘Case> eas ee iPPDreca sentient ee oo a ween ee ee Seat eee orem MT te ee —r1 | No.:192/13/82‘Party Name:NATURAL AND ‘Meet No/Date: 13/82‘Status: 'ALC4/2018 ESSENTIAL OILS PVTLTD /|ALC4/2018 Deferred Pod | 14.01.2019 430/HQFile | | :01/82/050/01170/AM1 |RLA File = Lic.No/Date:0710114044 (Defer | 9/ ':07/24/040/00183/AM19/ (24.10.2018 | Decision:The Committee considered the case as per agenda and it was decided to refer the case to Coffee | Board for its comments and also call the firm for personal hearing to explain its case. ||fCaseNo.:322/13/82[Party NameANLON ‘Meet No/Date:13/82Status: q 'ALC4/2018 \HEALTHCARE ALC4/2018 Deferred | |eee) PRIVATELIMITED 14.01.2019 | 431 HQ File RLAFile = ic.No/Date:2410042548 [Defer | | :01/82/050/01300/AM19/ :24/24/040/00033/AM19/ 24.10.2018 | |Decision: The Committee considered the case as per agenda and ‘complete it was decided to call from the firm | process. chemical reaction, molecular weight and % yield on molar basis for each step of manufacturing| ie Case No.:358/13/82‘Party Name:AARTI ALC4/2018 DRUGS Meet No/Date:13/82[Status: | | ‘LIMITED |ALC4/2018 Approved | 14.01.2019 | |HQFile RLA File __Lie.No/Date:0310824645.) SSS | :01/82/050/01336/AM19/ :03/94/040/00505/AM19/ 24.10.2018 Decision: The committee considered case as per agenda and in consultation with technical authority | = present in meeting decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as | applied by firm whichever is lower: | | Export product Sl. Qty. allowed in | | Q No. kg | Ciprofloxacin Hydrochloride 1 Kg. Ethyl 3 Cyclopropylamino-2(2,4 1.294 ; Dichloro-5 Fluorobenzoy!) | | Acrylate ; | Caustic Soda Flakes ese; | Sulpuric Acid (98%) Not importable J]

133

0.123 | | Anhydrous Piperazine RA concerned may take concerned may take may take take further necessary necessary action as per above as per above per above above decision of of NC Case No.:360/13/82‘|Party Name:FINE ORGANIC Meet No/Date:13/82‘Status: | ALC4/2018 INDUSTRIES LTD ALC4/2018 ‘Approved | 14.01.2019 | | oe HQ File RLA File LicNo/Date:0310824646 | :01/82/050/01338/AM19/ ':03/94/040/00658/AM19/ 24.10.2018

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

Decision: The Committee considered the case as per agenda in the presence of Technical Experts and, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as. applied by firm whichever is lower:

| No. | BEHENYL BEHENATE 1 kg BEHENIC ACID 0.546 kg | 2, 0.524 kg | BEHENYL ALCOHOL

433

RA concerned may take further necessary action as per above decision of NC. | Case No208/13/82~—~—~—+(Party Name:BENZO CHEM [Meet No/Date:13/82-.—‘(Status: | | ALC4/2018 INDUSTRIES PRIVATE ALC4/2018 Approved LIMITED, 14.01.2019 Tie. No/Date:0310824671 | HQ File RLA File | :01/82/050/01186/AM19/ :03/94/040/00626/AM 19/ 25.10.2018 | | ‘Decision: The Committee considered the case as per agenda in the presence of Technical Experts and, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:

==> picture [461 x 123] intentionally omitted <==

==> picture [459 x 75] intentionally omitted <==

----- Start of picture text ----- a Case No.:235/13/82- ‘|Party Name:ALCHYMARS ~ |Meet No/Date:13/82- Status: a ALC4/2018 ICM SM PRIVATE LIMITED ALC4/201 8 Approved 14.01.2019 | 1435 ) Lic.No/Date:0410164810 | HQ:01/82/050/01213/AM19/File IRLA':04/24/040/00168/AM19/File 25.10.2018 : oh aE | ----- End of picture text -----

134

| Decision: The Committee consideredthe case as per agenda in the presence of Technical Experts and, it| applied by firm whichever is lower: | jes decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or “| | No. [aan || | CLINDAMYCIN uk CLINCOMYCIN baz.222 BOUIKgBOU/k | | [HYDROCHLORIDE HYDROCHLORIDE | [INGREDIENT | JACTIVE PHARMACEUTICAL RAW MATERIAL RA concerned may take further necessary action as per above decision of NC. ee | [Case No.:359/13/82__[Party Name:AARTIDRUGS ‘Meet No/Date:13/82_|Status: | ALC4/2018 |LIMITED ALC4/2018 ‘Approved © | 14.01.2019 | HQ)a. — ‘IRLAFile 7 Lic.No/Date:03 10824670 | ':01/82/050/01337/AM19/ .03/94/040/00624/AM 19/ 25.10.2018 | Decision: The‘committee considered case as per agenda and in consultation with technical authority | |present in meeting decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as_ applied by firm whichever is lower: || 436.|Export product Exp. | SI. Qty. allowed in |) || Qty. | No. kg | Ciprofloxacin Hydrochloride | 1 Kg. Ethyl 3 Cyclopropylamino-2(2,4 1.294 | | USP Dichloro-5 Fluorobenzoyl) | ; o4 Acrylate | | Caustic Soda Flakes eae 2 | 4 Sulpuric Acid (98%) | | 4 [Tonersdoes es Anhydrous Piperazine Le Sees RA concerned may take further necessary action as per above decision ofNC 4 | (Case No.:361/13/82‘Party Name:J.B. CHEMICALS (Meet No/Date:13/82. Status: /ALC4/2018 ‘& PHARMACEUTICALS /ALC4/2018 Approved 1437) ‘LIMITED 14.01.2019 [HQ File RLA File Lic. No/Date:0310824695/ SS | |:01/82/050/01339/AM19/ :03/94/040/00666/AM19/ 25.10.2018 Zz decided‘Decision: Committee considered the case as per agenda in the presence of Technical Experts ;and, it was | firm whicheverto ratifyis thelower: ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by | | || No. {LITHIUM CARBONATE Nos. 306 mg/300 mg EXTENDED RELEASE TABLETS LITHIUM CARBONATE || JUSP 300 MG (Pack of 100) USP | tablet | Each tablet contains 300 mg of | [Lithium Carbonate USP. Net content f o Lithium Carbonate USP 454.56 Kgs.

135

~ \Case No.:424/13/82-.~«S“(iPartyName:DEEPAK ——~*(Meet No/Date:13/82(Status: ALC4/2018 NITRITE LIMITED ALC4/2018 Deferred 14.01.2019 = HQ File RLA File Lic.No/Date:3410044635 Defer Decision::01/82/050/01402/AM19/Deferred for comments:34/24/040/00144/AM19/of TE a 25.10.2018 7 a (Case No.:426/13/82‘Party Name:DEEPAK —_—<(Meet No/Date:13/82-. (Status: ALC4/2018 ‘NITRITE LIMITED ALC4/2018 Deferred — 14.01.2019 | 49 HQ File IRLA File Lic.No/Date:3410044636 Defer :01/82/050/01404/AM19/ ':34/24/040/00208/AM19/ 25.10.2018 | | a Decision: Deferred for comments of TE ~~ (CaseNo:453/13/82-. -—~—~=«(Party Name:HESTER = Meet No/Date:13/82(Status: ALC4/2018 [BIOSCIENCES LIMITED ALC4/2018 Deferred | 14.01.2019 ~~~ Lie. No/Date:0810143739 Defer | 440 HQ File —RLAFile | :01/82/050/01431/AM19/ :08/24/040/00231/AM19/ 25.10.2018 Decision: Committee considered the case as per agenda and it was decided to send the copy of application | to Department of Biotechnology for their comments. | ~~ Case No.:357/13/82Party Name:AARTI DRUGS ~~ |Meet No/Date:13/82- (Status: | ALC4/2018 (LIMITED ALC4/2018 ‘Approved | |} | | 14.01.2019 = mone = . —— ee = — = a _ . _ | HQ File IRLA File Lic.No/Date:0310824721 — :01/82/050/01335/AM19/ :03/94/040/00522/AM19/ 26.10.2018 | Decision: The committee considered case as per agenda and in consultation with technical authority | present in meeting decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as | applied by firm whichever is lower: | \441 || Export product Exp. | Sl. | Import items Qty. allowed in | Qty. | No. kg | _ | Ciprofloxacin Hydrochloride 1 Kg. Ethyl 3 Cyclopropylamino-2(2,4 1.294 | Dichloro-5 Fluorobenzoy!) Acrylate | Caustic Soda Flakes [035 3 ; . Not importable |) Sulpuric Acid (98%) : | |

136

||||||136||||
|---|---|---|---|---|---|---|---|---|
|||||||||>|
|||||||<br>i<br>alee<br>eee<br>a| Anhydrous Piperazine||||
|||||||<br>PAconsernedmaytakefurthernecessaryactionasperabovedecisionet<br>decries|cal|||
||||||[CaseNo.:232/13/82-<br>—_—([PartyName:DEEPAK<br>[MeetNo/Date:13/82-<br>‘Status:<br>|<br>ALC4/2018<br>NOVOCHEM<br>ALC4/2018<br>Deferred<br>|<br>4<br>‘TECHNOLOGIESLTD<br>(14.01.2019<br>HQFile<br>RLAFile<br>Lic.No/Date:3110067218 [Defer<br>442<br>:01/82/050/01210/AM19/<br>':31/83/040/00114/AM19/<br>29.10.2018<br>i<br>|<br>Decision: Committee consideredthe caseasperagenda and ithasbeenobservedthatthechemistry given<br>|<br>bythe firm isnot clear, since statingthat therawmaterialshownasphenol whileimport isofOCP50. It<br>|<br>wasdecidedtoaskthefirmto furnishexactchemicalnameofOCP50alongwithmanufacturingprocess<br>**_**<br>jand all technical details starting fromOCP 50.||||
||||||—_||||
|||||||<br>|CaseNo.:356/13/82-<br>——‘{PartyName:AARTIDRUGS<br>(MeetNo/Date:13/82-<br>(Status:<br>|<br>(ALC4/2018<br>‘LIMITED<br>ALC4/2018<br>Deferred<br>Pera<br>14.01.2019<br>|<br>43<br>‘HQ File|NEUE aeRLAFile<br>Lic.No/Date:0310824757 ‘Defer<br>|<br>:01/82/050/01334/AM19/<br>'03/94/040/00217/AM19/<br>29.10.2018<br>|<br>Decision:Deferred forcommentsofTE<br>:|||<br>|||
||||||\CaseNo.:341/13/82-<br>PartyName:GUJARAT<br>_|[MeetNo/Date:13/82.<br>Status:<br>ALC4/2018<br>ORGANICSLIMITED<br>‘ALC4/2018<br>‘Approved<br>|<br>4<br>14.01.2019|||||
||||||HQFile<br>RLAFile<br>Lic.No/Date:0310824781<br>|S<br>|<br>:01/82/050/01319/AM19/<br>':03/94/040/00681/AM19/<br>30.10.2018<br>Decision: TheCommittee considered thecase asperagenda inthepresenceofTechnical Expertsand,it<br>|<br>|<br>|was decided to ratify thead-hoc input outputnormsunderpara 4.7 ofHBP as perdetails below oras<br>i444applied by firm whichever is lower:||||
||||||Sea!||||
|||||||針<br>poe<br>No.<br>|METHYLPARABEN<br>1kg<br>P-HYDROXYBENZOIC<br>0.97kg<br>i<br>ACID||||
||||||RAconcernedmaytake furthernecessaryactionasperabove decisionofNC.||||
|**_**|||| CaseNo.:342/13/82-<br>‘PartyName:GUJARAT<br>MeetNo/Date:13/82-<br>(Status:<br>|<br>jALC4/2018<br>ORGANICSLIMITED<br>ALC4/2018<br>Approved<br>(14.01.2019<br>HQ<br>File<br>RLAFile<br>Lic.No/Date:0310824790 |<br>|<br>|:01/82/050/01320/AM19/<br>':03/94/040/00678/AM19/<br>30.10.2018<br>445Decision: TheCommittee considered the case as per agenda inthepresence of TechnicalExperts and,it<br>was decided to ratify the ad-hoc input output norms under para 4.7 ofHBP as per details below oras|<br>appliedbyfirmwhichever is lower:||||||||
||||||乱<br>|<br>No.||||
|||||||||||

137 1. | P-HYDROXY BENZOIC P-HYDROXY BENZOIC BENZOIC ACID

==> picture [469 x 674] intentionally omitted <==

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|||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|[PROPYL PARABEN|1.|| P-HYDROXY BENZOIC P-HYDROXY BENZOIC BENZOIC|||0.85|kg||||
|ACID|
|RA concerned may take concerned may take may take take|further necessary necessary|action as per above decision of as per above decision of per above decision of above decision of decision of of|NC.|
|"(Case No.:343/13/82-|Party Name:KRISHNA|~~|[Meet No/Date:13/82-|Status:|
|ALC4/2018|‘ANTIOXIDANTS|PVT.|LTD.|ALC4/2018|‘Approved|||
|14.01.2019|
|HQ File|RLA|File|Lic.No/Date:0310824789|||
|:01/82/050/0 1321/AM19/|:03/94/040/00667/AM|1 9/|30.10.2018|
|||Decision:|The|Committee|considered|the|case|as|per agenda|in|the|presence|of Technical|Experts|and, it|||
|was|decided|to|ratify|the|ad-hoc|input|output|norms|under|para|4.7|of HBP|as|per|details|below|or|as|||
|||
|applied|by|firm|whichever|is|lower:|
|446|||
|No.|kg|||
|DI ISODECYL PHENYL|lkg|}||1|YELLOW|0.078|||
||||PHOSPHITE|PHOSPHOROUS|
|||[2|[PHENOL|(02.300|||
|ISODECYL ALCOHOL|0.750|||
|||
|RA concerned may take|further necessary|action|as per above|decision of NC.|
|-|[Case No183/13/82.|~»-‘(iPartyName:PHAROSE|——(Meet No/Date:13/82-|Status:|
|||ALC4/2018|REMEDIES LTD.|ALC4/2018|Deferred|||
|14.01.2019|||||
||447|FQ File|RLA File|LicNo/Date:3010104485|(Defer|
|||:01/82/050/01161/AM19/|':30/24/040/00032/AM19/|31.10.2018|||
|||Decision:|Deferred|for comments|of TE|
|(Case No.:233/13/82-|Party Name:CLEAN SCIENCE|[Meet No/Date:13/82-|(Status:|
|||(ALC4/2018|AND TECHNOLOGY|ALC4/2018|Approved|
|||PVT.LTD.|14.01.2019|||||
|||HQ File|—————raFile.~—~——~—_Lie-No/Date:3110067223|||
|:01/82/050/01211/AM19/|':31/83/040/001 13/AM19/|31.10.2018|||
|Decision:|The|Committee|considered|the|case|as per|agenda|and|in|the|light of earlier|decision|taken by|
|NC|in|its 7/82 meeting dated 24.08.2018,|it was decided to ratify the ad-hoc input output norms under para|||
|4.7|of HBP|as per details below or as applied by firm whichever|is lower:|
|||||
|Guaiacol|1|kg|Phenol PURITY 99% AND|1.108 kg|
|ABOVE|
|2|Dimethyl!|Sulphate PURITY 99%|0.847|kg|||
|AND ABOVE|||
|||4|Hydrogen Peroxide (60%)|0.687 kg||.|
|PURITY|60%|
|Acetone|(Solvent)|0.14kg|||
|RA may take appropriate action as per the decision of|Norms Committee|

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

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

138

_ | (Case No.:236/13/82————[Party Name:CLEAN SCIENCE [Meet No/Date:13/82. Status: || !ALC4/2018—— — — — _ = - PVT.LTD.ANDTECHNOLOGY— _ — e'ALC4/201814.01.2019— = - |Approved | | HQ File RLA File Lic.No/Date:3 110067224[— — — | |:01/82/050/01214/AM19/ ':31/83/040/001 17/AM19/ (31.10.2018 NCDecision: The Committee considered the case as per agenda and in the light —- of earlier decisiontt ==taken by,| 449 in its 9/82 meeting dated 18.09.2018, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: i | | | Acetyl Anisole (4-Methoxy | 1 kg 1 [Phenol s—=—SsS 0.906 kg | _ | Acetophenone) Dimethy! Sulphate 0.693 kg | } | [3 [caustictye ——————SS—*i TR] | RA may take appropriate action as per the decision of NormsAcetic Committee. Anhydride PURITY 99% | 0.755 kg | _(Case No.:344/13/82Party Name:AARTI DRUGS Meet No/Date:13/82Status: =ALC4/2018 LIMITED ALC4/2018 Approved — 14.01.2019 || |HQFile — a ~ {RLA File - Lic.No/Date:0310824838 || | |:01/82/050/01322/AM19/ :03/94/040/00643/AM19/ 31.10.2018 || Decision: The committee considered case as per agenda and in consultation with technical| authority | | __Presentapplied byin meetingfirm whichever decided tois lower: ratify norms on repeat basis under para 4.7 of HBP as per details below or as | | | | Export product SI. Qty. allowed in |450, 2 No. kg | Ciprofloxacin Hydrochloride 1 Kg. Ethyl 3 Cyclopropylamino-2(2,4 1.294 oH Dichloro-5 Fluorobenzoy!) | 4 Acrylate | | Caustic Soda Flakes wae ee od 3 N e | ie Sulpuric Acid (98%) ns || item | (4 [Totvene fos | Anhydrous Piperazine ae ae ‘RA concerned may take further necessary action as per above decision of NC | = / Case No.:345/13/82- “item “Party Name:AARTI DRUGS ~ ‘Meet No/Date:13/82- - Status: — ican LIMITED ALC4/2018 Approved — | State | 14.01.2019 HQ File RLA File Lic.No/Date:0310824837 | 451 :01/82/050/01323/AM19/ :03/94/040/00641/AM19/ 31.10.2018 Decision: The committee considered case as per | agenda. and in consultation with technical resent authority | applied by firm whichever is lower: | in meeting decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as Export product SI. Qty. allowed in |

139

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----- Start of picture text ----- | Ciprofloxacin Hydrochloride ----- End of picture text -----

==> picture [294 x 93] intentionally omitted <==

----- Start of picture text ----- 1 Kg. . a Ethyl 3 Cyclopropylamino-2(2,4 71294” | Dichloro-5 Fluorobenzoy]l) Acrylate | Caustic Soda Flakes (0-123 | [4 | TolSulp u ricene Acid (98%) Not importable Anhydrous Piperazine | ----- End of picture text -----

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

Case No114/13/82-.~«*(PartyName:SYNNAT —|Meet No/Date:13/82- (Status: ALC4/2018 PHARMA PRIVATE ALC4/2018 ‘Approved | Beceem ‘LIMITED 14.01.2019 | | | HQ File RLA File Lic.No/Date:0210208784 | | :01/82/050/01092/AM19/ :02/24/040/001 13/AM19/ 01.11.2018 | Decision: The Committee considered the case as per agenda in the presence of Technical Experts and, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as 452 applied by firm whichever is lower: | No. | ; Noscapine BP USP Ph.Eur JPCP/| lkg | 1. Noscapine Crude Content 1.05 kg | Noscapine Hydrochloride BP 95% || Ph.Eur2 RA concerned may take further necessary action as per above decision of NC. |

[Meet No/Date:13/82Status: ~~ |Gase No.:115/13/82—~—~—S«éParty Name:PAYAL ALC4/2018 POLYPLAST PRIVATE ALC4/2018 Approved LIMITED 14.01.2019 | | HQ File RLA File ; Lic.No/Date:0510408318 :01/82/050/01093/AM19/ ':05/24/040/00392/AM 19/ 02.11.2018 | | Decision: The Committee considered the case as per agenda and in the light of earlier decision taken by | l4s3 NC in its 6/82 meeting dated 26.07.2018, it was decided to ratify the ad-hoc input output norms under para| 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Qty. | Sl.No. | Import items Qty. | allowed PLASTICIZER (DOP) (DI- | 1 kg PHTHALIC ANHYDRIDE 0.3797 kg | OCTYL PHTHALATE) (2 [2ETHYLHEXANOL| 0.700 kg RA may take appropriate action as per the decision of Norms Committee. "Case No.:182/13/82—_—Parrty Name-RAJPIONEER (Meet No/Date:13/82- (Status: | ALC4/2018 LABORATORIES INDIA ALC4/2018 ‘Approved | | PRIVATE LIMITED, 14.01.2019 | | = ~~ ~RLA File | Lic.No/Date:56 10005515 HQFile 454 :01/82/050/01160/AM19/ ':56/24/040/00025/AM19/ 02.11.2018 Decision: The committee considered case as per agenda and in consultation with technical authority present in meeting decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as | applied by firm whichever is lower:

140

~ i:Export[SSS] ees ee ee | product Exp. | SL. Qty. allowed Qty. | No. | | 2,4- DI FLUORO ALPHA- (1 | 1Kg. fT | 1,3 DI FLUOROBENZENE (1,3 | 0.60 kg | | H-1,2,4 TRIAZOLE 1-YL ) DFB i | ACETOPHENONE (D.F.T.A.) 4 AMINO TRIAZOLE 0.42 kg | a 3 METHLENE DI CHLORIDE 1.41 kg ae MDC | 4 . [4 [ACETONITRILE 65k +d | RA concerned may take further necessary action as per above decision of NC | (CaseNo.:116/13/82SS PartyName:SUN. ‘Meet No/Date:13/82cecaStatus:eee ee ALC4/2018 PHARMACEUTICAL ALC4/2018 ‘Approved td INDUSTRIES LTD. 14.01.2019 | |HQFie SRT Re Lic.No/Date:05 10408342 _ | :01/82/050/01094/AM19/ ':05/24/040/00402/AM 19/ (05.11.2018 | | Decision: The Committee considered the case as per agenda and in the light of earlier decision taken by! = |NC in its 4/82 meeting dated 03.07.2014, it was decided to ratify the ad-hoc input Output norms under para | | 4.7 ofHBP as per details below or as applied by firm whichever is lower: | No. | | Volini Gel 30gm (Each tube Nos. | 1. 1.53 gm /30 gm | [contains 1.50gm ofRacementhol) Riana tube | | C equivalentp to 1008.131 Kg of bulk " ; eee |i [RA| concerned may take further necessary action as per above decision of NC. ||| | [Case No.:363/13/82-. ‘Party Name:CIPLA LIMITED. ‘Meet No/Date:13/82(Status: | ;56 Tk.|ALC4/2018 | 'ALC4/201814.01.2019 Deferred | HQ File 'RLA File“oO Lic.No/Date:03 10824906oan ‘Defer | | | ‘Decision:———:01/82/050/01341/AM19/ Deferred<= at fornr comments:03/94/040/00699/AM19/ ofa TE= = == = (05.11.2018= Sn a ee —— a| (Case No.:459/13/82. ST Party Name:JUBILANT LIFE MeetNo/Date:13/82‘Status: oeALC4/2018 SCIENCES LIMITED /ALC4/2018 Approved | 14.01.2019 || |HQ File RLA File -_ |Lie.No/Date:0510408334 sa| | | :01/82/050/01437/AM19/ ':05/23/040/00268/AM19/ (05.11.2018 Decision: Committee considered case as per agenda and as per earlier decision taken by NC in its 2/82 | 457 Meeting dated 16.05.2018, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: | |__| Export product Exp. | SI.No. Qty. Allowed | | _|| Pyridine 98% Min Qty.1k | 0.019 k ‘Soe r < bec Alumino Silicate Catalyst - 2 Ethyl Alcohol (Denatured) | 2.294 kg |

141

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|||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|ra|[Methanol|dT|||
|RA may take|appropriate action|as per the decision of|Norms Committee.|
|Meet No/Date:13/82-|‘Status:|
|“\Case No.:193/13/82-.——~C~C*«#artxY Name:NATURAL|[&]|
|ALC4/2018|ESSENTIAL OILS PVT.LTD.,|ALC4/2018|Deferred|
|||14.01.2019|
|=|:|
|458 HQ File|RLA File|Lic.No/Date:0710114100|Defer|
|||:01/82/050/01171/AM19/|':07/24/040/00197/AM19/|06.11.2018|
|Decision: The Committee considered the case as per agenda and|it was decided to refer the case to Coffee|||
|||Board for its comments and also call the firm for personal hearing to explain the case.|||
|Case No.:258/13/82-|——S—=éaty Name:CLEAN SCIENCE|Meet No/Date:13/82-|Status:|
|ALC4/2018|AND TECHNOLOGY|ALC4/2018|Approved|
|||PVT.LTD.|14.01.2019|||
|HQ File|RLA File|LicNo/Date:3110067227|||
|-01/82/050/01236/AM19/||:3 1/83/040/00122/AM19/|06.11.2018|||||
|Decision:|The Committee|considered|the case|as per agenda|and|in the|light|of earlier|decision|taken by||
|NC in its 7/82 meeting dated 24.08.2018,|it was decided to ratify the ad-hoc input output norms under para|||
|4.7 of|HBP|as per details below or as applied by firm whichever|is lower:|
|||
|Guaiacol|1 kg|PhenolABOVE PURITY 99% AND|1.108 kg|||
|2|Dimethyl|Sulphate PURITY 99%|0.847 kg||||
|AND ABOVE|||
|4|Hydrogen Peroxide (60%)|0.687 kg||,|
|||PURITYAcetone (Solvent) 60%|0.14kg|||||
|RA may take appropriate|action as per the decision ofNorms Committee|||
|~\Gase No.:362/13/82-|——~S—«é@Paarty Name:AARTIDRUGS|Meet No/Date: 13/82.|—*(Status:|
|||ALC4/2018|(LIMITED|ALC4/201814.01.2019|Deferred|||
|460 FQ File|——REAFile||___[LicsNo/Date:0310824929|Deler|||
|||-0.1/82/050/01340/AM19/|-03/94/040/00683/AM19/|06.11.2018|||||
|||Decision: Deferred for comments of|TE|aaa|ed|
|—co—|=e|———|=|————|ee|eee|——|——————|—_——|—_———|————_—|->——|—_—___—||
|||Case No.:458/13/82-|Party|Name:MOREPEN|Meet No/Date:13/82-|Status:|
|ALC4/2018|‘LABORATORIES|LTD.,|ALC4/201814.01.2019|Approved|||
|HQFile|——RIAFile—~—_[Lic.No/Date:0510408362||||
|as|-0.1/82/050/01436/AM19/|'-05/24/040/0043 1/AM19/|06.11.2018|||||
|Decision: The Committee considered the case as per agenda and|in the light of earlier decision taken by|||
|||NC in its 4/82 meeting dated|19.06.2018,|it was decided to ratify the ad-hoc input output norms under para|||
|||4.7 of|HBP as per details below or as applied by firm whichever|is lower:|
|Epon produc|Tap|[Sino [importtems=|alowed _]|

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

142

| | Rosuvastatin Calcium 4-(4-Fluoropheny])-61.338 kg a. isopropyl-2-[(N-methy] ct sulfonyl)amino] pyrimidine| 5-yl-methanol (Z7/RT07 | (4R-cis)-61.80 kg | [(Acetyloxy)methyl]-2,2| dimethy]-1,3-dioxane-4a acetic acid-1, |- fH dimethylethy] ester (DS OR | ee RTS04) / | Tert-Butyl-2-[(4R,6S)-2,2dimethyl-6| [(methylcarbonyloxy) | methyl]-1,3-dioxan-4lJacetate | | RA may take appropriate action as per the decision of Norms Committee acacia en a || (Case No.:351/13/82‘Party Name:AARTI DRUGS [Meet No/Date:13/82Status: ian |ALC4/2018 |‘LIMITED 14.01.2019|ALC4/201 8 |Deferred | | a7eee Lic.No/Date:0310824972 Defer :01/82/050/01329/AM19/ ':03/94/040/00682/AM19/ 12.11.2018 (Decision: Deferred for comments of TE || \CaseNo.:422/13/82‘Party Name:ALEMBIC /Meet No/Date:13/82_|Statusr | ae ‘ALC4/2018 PHARMACEUTICALS LTD 'ALC4/2018 ‘Approved | {HQ:01/82/050/0File 1400/AM19/ ':34/24/040/00266/AM1RLA File 9/ }12 11.2018Lic14.01.2019 . No/Date:34 10044680 i | | ‘Decision: The committee considered case as per agenda and in ‘consultationwith technical authority peptied by firm whichever is lower: | |Present in meeting decided to ratify norms on repeat basis under para 4.7 ofHBP as per details below or as | |_| Export product Exp. Qty. | SI. Qty. allowed | | | TEMAZEPAM CAPSULES USP Number 7.65 mg /7.5 mg tablet | 463 | 7.5MG TEMAZEPAM | kgs.(net content of active ingredients 4.5 USP ||[MG] TEMAZEPAM CAPSULES USP 15 2 15.30 mg/15 mg tablet | TEMAZEPAM | |kgs.| (net content of active ingredients144 | Number USP | 22.5 MG || TEMAZEPAM CAPSULES USP 3 22.95 mg /22.5mg tablet | | i TEMAZEPAM | | (net content of active ingredients Mesnbes USP | 10.10 kgs. ||__| TEMAZEPAM CAPSULES USP 30 4 30.6 mg /30 mg tablet _ | | MG Hisiher TEMAZEPAM || kgs.(net content of active ingredients 324 USP }| |‘RA concerned may take further necessary action as per above decision ofNC

143

| Case No.:423/13/82; Party Name:KUTCH Meet No/Date:13/82Status: ALC4/2018 CHEMICAL INDUSTRIES ALC4/2018 Approved ‘LTD 14.01.2019 |HQ:01/82/050/01401/AM19/ File RLA:34/24/040/00269/AM File 19/ Lic.No/Date:3413.11.2018 10044688 | | ‘Decision:was decidedThetoCommitteeratify the ad-hocconsideredinputtheoutputcase asnormsper agendaunder parain the4.7 presenceof HBPofas Technicalper details Expertsbelow and,or as_it, applied by firm whichever is lower:

464 | No. 2 ETHYL HEXYL NITRATE lkg | 1. | 2 ETHYL HEXANOL 0.764 kg | | 2 CONCENTRATED Not importable NITRIC ACID 98% item SULPHURIC ACID 98% | RA concerned may take further necessary action as per above decision of NC. ~~ (Case No.:204/13/82=== Party Name:RONAK Meet No/Date:13/82Status: | ALC4/2018 '\CHEMICALS ALC4/2018 Deferred 14.01.2019 HQ File RLA File — ‘Lic.No/Date:3410044693 Defer |Decision::01/82/050/01182/AM19/The Committee considered:34/24/040/00262/AM19/the case as per agenda in the14.11.2018presence of Technical Experts| and, it[|] 465 Ws decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: BARBITURIC ACID 1kg[1 | DIETHYL MALONATE 1.46 kg SODIUM METAL 0.179 kg | RA concerned may take further necessary action as per above decision of NC (Case No.:427/13/82Party Name:GULBRANDSEN Meet No/Date:13/82Status: ALC4/2018 \CHEMICALS PVT LTD ALC4/2018 Deferred | 14.01.2019 | 466QFile RLAFile ‘Lic.No/Date:3410044694 [Defer :01/82/050/01405/AM19/ ':34/24/040/00264/AM19/ 14.11.2018 | | Decision: Deferred for comments of TE J -\Gase No:462/13/82.. +~«*‘(PartyName:DHANUKA _—“(Meet No/Date:13/82-. Status: | ALC4/2018 LABORATORIES LTD ALC4/2018 Approved | 14.01.2019 | | | lHQFie | (RLAFile | Lic.No/Date:05 10408444 467 :01/82/050/01440/AM19/ :05/23/040/00337/AM19/ 16.11.2018 a | Decision: The “committee considered case as per agenda and in consultation with technical authority present in meeting decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as | applied by firm whichever is lower: |

144

| Qty. | No. | PowderCEFDINIR USP/BP/IP/JP/EP | 1 Kg. te] 7 AVCA(7AVNA) | | METHYLENE CHLORIDE || | 4 TETRA HYDRO FURAN(THF) 2 [4 [METHANOL [tas e fs [CAEM—S97 | dl |6 | TRIETHYLAMINE 0.155 | | | METHANE SULPHONIC ACID [0.96 ‘| | 8 ot __| ACTIVATED CARBON }0.100| | RA concerned may take further necessary action as per above decision of NC | (Case No.:135/13/82-—{PartyName:PACTLABS (Meet No/Date:13/82. ‘Status: | ALC4/2018 P.LTD. ALC4/2018 Approved oe 14.01.2019 (Teo':01/82/050/01113/AM19/ Rie~ —“(‘éC.&WIA:31/83/040/00126/AM19/i) ~*~ ie19.11.2018ones ioospaaT 7 | Decision: The Committee considered the case as per agenda in the presence of Technical Experts and, it, | was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as gal468 applied by firm whichever is lower: | i | | i 2 FLOURO ANISOLE 1 kg 2 FLUORO PHENOL Purity kg0.935 | |=| 99.5% Min (CAS NO:367-12-4) | |RA concerned may take further necessary action as per above decision of NC ||| | (SS aeeaeses a emt | — ie Bay et at Test mae een as — a ee ee eer Fy - eae ere | (Case No.:460/13/82‘Party Name:JUBILANT LIFE Meet No/Date:13/82Status: | ALC4/2018 \SCIENCES LIMITED ALC4/2018 Approved | { 14.01.2019 | HQ File RLA File . ~ |Lic.No/Date:0510408452 | | ':01/82/050/01438/AM19/ :05/23/040/00358/AM19/ 19.11.2018 Decision: The Committee considered the case as per agenda in the presence of Technical Experts and, it, 469 Was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as | | applied by firm whichever is lower: | = | | Ip| Zinc article PyrithoneSuspension) 50% FPS (Fine | 1 kg Zinc Pyrithionenn Wet Cake 0.50 kg |RA concerned may take further necessary action as per above decision of NC | | [Case No.:461/13/82-——(Party NameJUBILANT Meet No/Date:13/82- (Status: } ALC4/2018 GENERICS LTD ALC4/2018 Deferred — | | | 14.01.2019 | | 70 HQ File RLA File Lic.No/Date:0510408451 Defer ':01/82/050/01439/AM19/ :05/23/040/00353/AM19/ 19.11.2018 | Decision: Deferred for comments ac ° = fe ew

145

Case No.:201/13/82-—_—(Party Name:ONEIRO ~ |Meet[No/Date:13/82-][ Status:] ALC4/2018 CHEMICALS PVT LTD ALC4/2018 Approved | { | | 14.01.2019 HQ File RLA File Lic.No/Date:3410044708 :01/82/050/01179/AM19/ :34/24/040/00270/AM19/ 20.11.2018 - ———$— = ———— ——— Sena —EEEE - —— SS Decision: The committee considered case as per agenda and in consultation with technical authority | | present in meeting decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as | | applied by firm whichever is lower:

Qty. in kg Malonate | 4, 7DICHLOROQUINOLINE | | Kg. La Di Ethyl Ethoxy Methylene 1.65 | Meta Chloro Aniline | Light Liquid Parafn 097d a Phosphorous Oxychloride (0.97 RA concerned may take further necessary action as per above decision of NC Case No.:202/13/82~— [PartyName:ONEIRO.—Meet No/Date:13/82-. Status: ALC4/2018 \CHEMICALS PVT LTD ALC4/2018 Approved 14.01.2019 | HQ File RLAFile = Lic.No/Date:3410044707 | :01/82/050/01180/AM19/ ':34/24/040/00272/AM19/ 20.11.2018 | | | Decision: The committee considered case as per agenda and in consultation with technical authority | | present in meeting decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as | applied by firm whichever is lower: | | 4,7 DICHLOROQUINOLINE | |Qty.Kg. Di Ethyl Ethoxy Methylene in kg | Malonate | Meta Chloro Aniline Light Liquid Parafin 10.97 || Phosphorous Oxychloride oe | | RA concerned may take further necessary action as per above decision of NC | (Case No.:378/13/82-—=—PartyName:BIOMIR‘Meet No/Date:13/82Status: ALC4/2018 VENTURE LLP ALC4/2018 ‘Approved — 14.01.2019 | 473 HQ File” __ RLA File _ Lic.No/Date:31 10067239 :01/82/050/01356/AM19/ ':31/83/040/00098/AM19/ 22.11.2018 | | Decision: The Committee considered the case as per agenda in the presence of Technical Experts and, it) was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as

146

| applied by firm whichever is lower: 7 oy | i 9 i | || Suspension| Florfenicol 20% w/v| Florfenicol 20% w/v Florfenicol 20% w/v 20% w/v w/v 1 litre Florfenicol API API RA concerned may take concerned may take may take take further necessary action as per above decision of necessary action as per above decision of action as per above decision of as per above decision of per above decision of above decision of decision of of NC

. - >

| i 9 i || Suspension| Florfenicol 20% w/v| Florfenicol 20% w/v Florfenicol 20% w/v 20% w/v w/v 1 litre Florfenicol API API 0.20202 kg/litkg/litre | RA concerned may take concerned may take may take take further necessary action as per above decision of necessary action as per above decision of action as per above decision of as per above decision of per above decision of above decision of decision of of NC | [CaseNo.:379/13/82[Party Name-CLEAN SCIENCE |Meet No/Date:13/82‘Status: _ |ALC4/2018 AND TECHNOLOGY ALC4/2018 Approved | | PVT.LTD. 14.01.2019 | | |HQFile = =—~~«C«<RAC les SS Lie.No/Date:3110067240 | | :01/82/050/01357/AM19/ :31/83/040/00128/AM19/ 22.11.2018 | Decision: The Committee considered the case as per agenda and in the light of earlier decision taken by | (NC in its 7/82 meeting dated 24.08.2018, it was decided to ratify the ad-hoc input output norms under para |4.7 of HBP as per details below or as applied by firm whichever is lower: a

| Guaiacol lkg Phenol PURITY 99% AND 1.108 kg |) | ABOVE | | 2 Dimethyl Sulphate PURITY 99% | 0.847 kg | ee AND ABOVE ; | a Hydrogen Peroxide (60%) 0.687 kg | | | PURITY 60% | | Acetone (Solvent) 0.14kg |! | RA may take appropriate action as per the decision of Norms Committee j | (CaseNo.:463/13/82‘Party Name:INDIA GLYCOLS [Meet No/Date:13/82. Status: | ALC4/2018 LTD., ‘ALC4/2018 Deferred | (475 | 14.01.2019 tO File RLA File Lic.No/Date:0510408634 [Defer | :01/82/050/01441/AM19/ :05/23/040/00359/AM19/ 26.11.2018 Decision: Deferred for comments of TE ee ee = zB ‘Case No.:464/13/82‘Party Name:MOREPEN Meet No/Date:13/82_—([Status: | - ALC4/2018 LABORATORIES LTD., ALC4/2018 ‘Approved — 1 | | 14.01.2019 |[HQ File RLA File Lic.No/Date:0510408662 | _|:01/82/050/01442/AM19/ ':05/24/040/00471/AM19/ 28.11.2018 | | Decision: The committee considered case as per agenda and in consultation with technical authority Present in meeting decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as | 476 |applied by firm whichever is lower: | = Export product Exp. SI.No. Qty. allowed | | Qty. in kg || ATORVASTATIN CALCIUM | | Kg. (4R-Cis)-1,1-Dimethylethy]-60.708 ; | } | dioxanecyanomethyl-2,2-dimethyl-1,3--4-Acetate | i] 2 4-Fluoro-alpha-[2-methy]-10.994 | oi oxopropyl]-gamma-oxo-N-betadiphenyl benzene butanamide |

aA,

147 | ss EV Methy] tert-butyl ether (M201)|1.145 1/6 | MT et rahydrofuranhylene chloride 01 . 542414 | Diisopropyl ether 0.754 | RA concerned may take further necessary action as per above decision of NC (Case No.:465/13/82—~—~—sParty Name: MOREPEN Meet No/Date:13/82Status: ALC4/2018 LABORATORIES LTD., ALC4/2018 ‘Approved | 14.01.2019 | HQ File RLA File Lic.No/Date:0510408665 | — :01/82/050/01443/AM19/ :05/24/040/00470/AM19/ 28.11.2018 | Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 5/82-ALC4/2015, dated 25.06.2015, it was decided | to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm | whichever is lower:| Export product Exp. | Sl.No. | Import items Qty. Allowed 477 0 Kp | Rosuvastatin Calcium 1k Tert-butyl-2-((4R,6S)-6-((E)-2-(4 (-(48 fluorophenyl)-6-isopropyl-2-[N-methyl 1.425 (methylsulphonyl) amino] pyrimidin-5| yl) vinyl)-2,2-dimethyl-1,3-dioxane-4-yl) | acetate Tert-butyl methyl ether (MTBE) | |} RA concerned may take further necessary action as per above decision of NC. i| - ~~ \Case No.:205/13/82-.-~—~—~*(Party Name:STERILEINDIA Meet No/Date:13/82- Status:| —| ALC4/2018 PRIVATE LIMITED ALC4/201814.01.2019 |Approved| — HQFile ~ IRLAFile ~~ Lic. No/Date:3310030498 :01/82/050/01183/AM19/ ':33/24/040/00013/AM19/ (03.12.2018 Decision:The Committee considered the case as per agenda in the presence of Technical Experts and, it) _ was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as_ 478 applied by firm whichever is lower: | Vancomycin Hydrochloride 1 Vancomycin HCL (NON | 1.01 kg | Sterile) STERILE) ||

| |

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

148

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----- Start of picture text ----- | ~ (Case No.:207/13/82- a ~ PartyName:FRESENIUS| Meet No/Date:13/82- Status: ' | | (ALC4/2018 KABI| ONCOLOGY LIMITED ALC4/201814.01.2019 ‘Approved | | HQFile =#= | |REAFile ~ \Lic.No/Date:0510408747 | | :01/82/050/01185/AM19/ ':05/23/040/00372/AM19/ 04.12.2018 Decision:technical Committee considered case as per agenda and deliberated on the matter in the presence of the | | experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: ie Export Product ‘Carboplatin Injections 600mg/60ml, 450mg/45ml, 150mg/15ml and 50mg/Sml | | | Ss.No. Import Items For export of 1 No. Injection | (Quantity in gms) | | 600 mg/ 60 ml_| 450 mg/45 ml_[ 150 mg/ 15 ml_[50mg/Sml_| (479) Platinum (Sponge 0.384 0.280 0.098 0.029 | | Purity: 99.9% | Powder) | 2 1,1-Cyclobutane 0.306 0.2295 0.0765 0.0255 | | Dicarboxylic Acid. = Purity: NLT98% e ie Rubber Stoppers for ae Pharmaceutical Use WPS | S10-F451 4432/50G B240 ees: WESTARRS/SP06. = Rubber Stoppers 20mm 4 dia for glass bottles. Relevant as per packing policy | Glass Bottles Antibiotique | Se 100, Clear Glass Type 1, | 4 1SO836220,0.Neck Finish | = Moulded Glass Bottle | 100ml capacity. RA may take appropriate action as per the decision of Norms Committee - |Case No.:467/13/82- ‘Party Name:DHANUKA Meet No/Date:13/82- (Status: _| | |ALC4/2018 LABORATORIES LTD ALC4/201814.01.2019 Approved || HQ File RLA File Lic.No/Date:0510408790|| ‘480 :01/82/050/01445/AM19/ :05/23/040/00387/AM19/ 05.12.2018 | eee: The committee considered case as per agenda and in consultation with technical authority __|present in meeting decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as | applied by firm whichever is lower: ; Qty. inkg ＆ ----- End of picture text -----

149

| Power aminocephalosporanic acid yl) acetic acid ammonium salt | | > lictecnSMIA (| @ [METHANOLPentachloride(PC15 «SOB | | ISOCYANATE (CSI aGUANIDINE | } | DMAC ACETOXYETHYLBROMIDE AEB | omnes | | | RA concerned may take further necessary action as per above decision of NC | Case No.:466/13/82Party Name:DCM SHRIRAM Meet No/Date:13/82‘Status: | ALC4/2018 INDUSTRIES LTD, ALC4/2018 Deferred 14.01.2019 | 481 1Q File RLA File ‘Lic.No/Date:0510408809 Defer | :01/82/050/01444/AM19/ ':05/23/040/00376/AM19/ 06.12.2018 | | Decision: Deferred for comments of TE ‘Case No.:474/13/82Party Name:PAYAL Meet No/Date: 13/82‘Status: | _ ALC4/2018 POLYPLAST PRIVATE /ALC4/2018 Deferred LIMITED 14.01.2019 | | HQ File File Lic.No/Date:0510408987 (Defer | :01/82/050/01452/AM19/ :05/24/040/00511/AM19/ 19.12.2018 | | Decision: The Committee considered the case as per agenda and in the light of earlier decision taken by| | NC in its 6/82 meeting dated 26.07.2018, it was decided to ratify the ad-hoc input output norms under para | 482 4.7 of HBP as per details below or as applied by firm whichever is lower: | Export product Qty. | Sl.No. | Import items Qty. | | allowed | | (DOTP) ACID | RA may take appropriate action as per the decision of Norms Committee

150

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|||||||||
|---|---|---|---|---|---|---|---|
|Manual|cases|
|Case No.|B-|1|M/s.|AMI|Organics|Limited|Ltd|
|M.No.|13/AM19|F.|No.|01/82/050/0041|1/AM19/DES-III|
|Date|14.01.2019|F.|No.|01/82/050/01498/AM16/DES-III|
|F.|No.|01/82/050/00404/AM17/DES-III|
|F.|No.|01/82/050/00589/AM18/DES-III|
|F.|No.|01/82/050/01177/AM18/DES-III|
|RLA|No.|52/24/040/00035/AM16|Adv.Auth.|No.|5210041611|dtd.14.08.2015|
|RLA No.|52/24/040/00064/AM16|Adv.Auth.|No|5210041711|dtd.|15.12.2015|
|RLA No.|52/24/040/00018/AM17|Adv.Auth.|No|5210041937|dtd.|20.06.2016|
|RLA No.|52/24/040/00019/AM18|Adv.Auth. No|5210042319|dtd.|26.07.2017|
|RLA No.|52/24/040/00056/AM18|Adv.Auth.|No|5210042461|dtd.|22.12.2017|

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

||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|Decision:|The|Committee|re-considered|case|as|per|agenda|for|revision|of norms.|The|firm|has|given|copy|of US|
|patent No.|4,|465,|683|in|support|of their|request|for|enhancement|of norms.|The|committee|deliberated|on|the|matter|
|and|inline|with|US|patent,|it|was|decided|to|revise|the|ad-hoc|input|output|norms|in|respect|of above|mentioned|
|advance|authorization|under para 4.7 of HBP|as|under:|
|Export Product|Export|||S.No|Import|Product|Quantity Allowed|
|Quantit|
|a1,2,4|- TRIAZOLO=,|atica|0. (4,3-a) oe|PYRIDIN|-|San2|0|cr|‘ite.|
|1Kg|Tech.|Spec.|:|Powder|
|2-Chloro|Pyridine|
|Tech.spec|:|Liquid|var|ks|
|Mono|Ethylene|Glycol|
|3|Tech|Spec.:|Liquid|1.45|kg|

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RA may take appropriate action as per the decision of Norms Committee.

Case No. B- 2 M/s. AMI Organics Limited Ltd M.No. 13/AM19 F.No.01/82/050/00467/AM 14 Date 14.01.2019 F.No.01/82/050/00954/AM18 F.No.01/82/050/01125/AM14 F.No.01/82/050/00505/AM18 RLA No. 52/24/040/00015/AM14 Adv.Auth. No. 5210040038 dtd. 30.07.2013 RLA No. 52/24/040/00017/AM14 Adv.Auth. No. 5210040150 dtd. 05.09.2013 RLA No. 52/24/040/0003 1/AM14 Adv.Auth. No. 5210040368 dtd. 31.10.2013 RLA No. 52/24/040/00020/AM18 Adv.Auth. No. 5210042320 dtd. 26.07.2017

Decision: The Committee re-considered case as per agenda for revision of norms and in the presence of the technical experts present in the meeting, it is noted that, the firm has given reaction mechanism for solvolysis reaction which is a special type of nucleophillic substitution. Besides the firm has clarified formation of dimer in the reaction thereby reducing the molar yield of 42%. Accordingly, the committee decided to revise the ad-hoc input output norms in respect ofabove mentioned advance authorization under para 4.7 of HBP as under: No. AMINOACETALDEHYDE | ikg CHLOROACETALDEHYDE 2.82 kg DIMETHYL ACETAL DIMETHYL ACETAL 98% MIN. 98% MIN RA may take appropriate action as per the decision of Norms Committee.

151

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----- Start of picture text ----- Case No. B- 3 M/s. AMI Organics Limited Ltd M.No. 13/AM19 F. No. 01/82/050/01035/AM16/DES-III Date 14.01.2019 F. No. 01/82/050/01451/AM17/DES-III RLA No. 52/24/040/00036/AM16 Adv.Auth. No. 5210041615 dtd.21.08.2015 RLA No. 52/24/040/00076/AM17 Adv.Auth. No. 5210042176 Dated:10.02.2017 ----- End of picture text -----

Decision: The Committee re-considered case for revision of norms as per agenda and in the presence of the technical experts, and in line with earlier written comments of Department of C&PC vide U.O.No. 14010/2/2014-Ch.I] dated 21.10.2015 and with 75% recovery of Methylene Chloride (solvent), it was decided to revise the ad-hoc input output norms in respect of above mentioned advance authorization under para 4.7 of HBP as per details below or as applied by firm whichever is lower:

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----- Start of picture text ----- Export Product S. | Import Product Quantity Quantity | No. Allowed VANILLINE- 99.5 % min 1.588 k 3,4 DI HYDROXY 5 NITRO iK Tech.spec: powder ; 8 BENZIL DEHYDE-99% min 8 5 _ | Methylene Chloride aan Tech Spec. : Liquid htt 3 | DIMETHYL FORMAMIDE - 99.5% ahi ae Tech Spec.: Liquid ----- End of picture text -----

RA may take appropriate action as per the decision of Norms Committee.

==> picture [421 x 58] intentionally omitted <==

----- Start of picture text ----- Case No. B- 4 M/s. DEEPAK NOVOCHEM TECHNOLOGIES LTD M.No. 13/AM19 F.No. 01/82/50/00630/AM16/DES-III Date 14.01.2019 RLA F.No. 31/83/040/00144/AM15 Adv. Lic. No. 3110065235 Dated:28.01.2015 ----- End of picture text -----

Decision: Committee considered case as per agenda and as per earlier decision taken by NC in its 2/82 meeting dated 16.05.2018, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: kg TETRA METHYL BISPHENOL F eal 2,6 xylenol 0.986 kg RA concerned may take further necessary action as per above decision of NC

Case No. B-5 M/s. Makson Industries Pvt. Ltd. M.No. 13/AM19 F.No. 01/82/50/451/AM15/DES-III Date 14.01.2019 RLA F.No. 03/95/40/994/AM14 Advance Licence No. 0310776907 dated 03.04.2014 Decision: The Committee re-considered case as per agenda in the presence of the technical experts, and as per written comments of O/o Development Commissioner (MSME) chemical Division vide O.M. No. 23/2/2014Chemical division dated 13.05.2017, it was decided to amend the export product description to be read as “Vicks Vaporub (in packs) 05 GMS Jars, 10 GMS Jars, 25 GMS Jars, 50 GMS Jars, 100 GMS Jars” as the description has been amended by the Jt. DGFT, Mumbai vide amended sheet No. 3. Rest of minutes would remain same. RA concerned may take further necessary action as per above decision of NC

152

Case No. B-6 M/s. KOPRAN LIMITED M.No. 13/AM19 F. No. 01/82/050/01200/AM15/DES-III Date 14.01.2019 F. No. 01/82/050/01199/AM15/DES-III

F.No. 03/94/040/00200/AM15 F.No. 03/94/040/00545/AM15

Adv.Auth. No. 0310789045 dated 11.09.2014 Adv.Auth. No. 0310788934 dated 09.09.2014

|Decision: The Committee|re-considered case as per agenda and in the presence ofthe|re-considered case as per agenda and in the presence ofthe|technical experts,|it was|
|---|---|---|---|---|
|decided to fix the ad-hoc|input output norms in respect ofabove mentioned advance||authorizations under para||
|4.7 ofHBP as per details below or as applied by firm whichever is lower|||||
|Export Product<br>PREGABALIN|Export<br>Quanti<br>a<br>‘|つ<br>ImportProduct<br>/1 | ISOVALERALDEHYDE<br>CYANOACETAMIDE|QuantityAllowed in<br>kg||
|||UREA(TECHNICAL|||
|||CHLOROFORM|||
|||ISOPROPYLALCOHOL<br>5<br>IPA|1.79||
|||R (+)A-METHYL BENZYL|||
|||AMINEOR (R) -1-|0.114||
|||PHENYLETHYLAMINE|||

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

Case No. B-7 M/s. SIDDHARTH M.No. 13/AM19 CARBOCHEM PRODUCTS LTD. Date 14.01.2019 F. No. 01/82/050/00544/AM18/DES-II| F. No. 01/82/050/00893/AM18/DES-III F.No. 03/95/040/00565/AM18 Adv.Auth. No. 0310814958 dated 01.08.2017 F.No. 03/95/040/00362/AM18 Adv.Auth. No. 0310816783 dated 03.11.2017

Decision: Committee re-considered the cases as per agenda. The representative of the firm appeared for personal hearing before the Norms Committee and stated that their item of export is different from other manufacturer, since their export product is Phenol free used for flavor and fragrances. The firm has also given the quantity and value of recoverable import item in manufacturing process. The committee after detailed deliberation on the matter decided to revise the norms in respect of above mentioned two advance authorizations under para 4.7 of HBP as per details below:-

==> picture [445 x 59] intentionally omitted <==

Note: RA Mumbai is requested to check the nil Phenol content in Certificate of Analysis (COA) of applied firm at the time of redemption and take further necessary action as per the above decision of NC. 2. No repeat licence is allowed on above norms

153

Case No. B- 8 M.No. 13/AM19 Date 14.01.2019

M/s Satya Deeptha Pharmaceuticals Ltd., Hyderabad F. No. 01/82/050/00901/AM17/DES-III

Subject: Request of M/s Satya Deeptha Pharmaceuticals Ltd., Hyderabad for revision of adhoc norms for the “(1S, 4R)-4-[(2-AMINO-6-CHLORO-5-FORMAMIDO-4-PYRIMIDINYL)AMINO]-2-CYCLO PENTENE-1METHANOL” in respect of 23 advance authorizations as details given below:-

|[6 | 0910057666 dt.24.09.2013 __| 01/82/S0/289/AM15_| 09/24/40/297/AM14___|
|---|
||8 | 0910058730 dt. 26.12.2013 |O1/82/SO/101/AM15_| 09/24/40/482/AM14___<br>So<br>earner 08 20 pSRRO TIAMIS —_| OS/2SFO/6GS/AMIA__<br>0910060758 dt. 30.07.2014<br>11 | 0910061153 dt.29.10.2014 |01/82/50/1327/AM15_|<br>09/24/40/414/AM1S|
|16 | 0910062527 dt. 21.08.2015 _| 01/82/50/1194/AM16_|09/24/40/232/AM16__|
|18 | 0910063149 dt.22.01.2016 __| 01/82/50/245/AM17_| 09/24/40/626/AM16___<br>19|0910063921dt.14.07.2016__|01/82/S0/901/AM17__|09/24/040/224/AM17_||

Quantit 5-FORMAMIDO-4PYRIMIDINYL) FORMAMIDE PENTENE-1-METHANOL 3-ONE(Vince Lactam SODIUM BOROHYDRIDE Bs 6 Decision: The Committee considered the cases as perfsagenda7 forPorrevision of normss e misin respectnoroof above mention 23 advance authorization. It is noted that RA Hyderabad has forwarded the firm’s request along with certificate from the Central Excise Authority certifying past production consumption data. The committee deliberated on the matter in the presence of technical experts and it was decided to revise / allow the norms as per the production consumption data certified by the Central Excise Authority for relevant export import item mentioned above as per their advance authorization under para 4.7 of HBP. These norms are allowed for redemption purpose and one time basis only. No reapeat licence is allowed. RA may take appropriate action as per the decision of Norms Committee. a RR

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