DGFT Committee Minutes
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Minutes of the Norms Committee (NC-3) Meeting No. 11/82-ALC4/2018 MEETING DATE : 15.11.20189%fctually held on 28.11.2018 and 30.11.2018) 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.1 1, Udyog Bhawan, New Delhi.
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Following members were present:Shri Nirmal Kumar, Dy. Director General of Foreign Trade Consultant, Technica! Expert Pharmaceuticals Consultant,Shri S.K. Pangrahi,Technical EconomicExpert OfficerChemicals
The committee went through the minutes of earlier meeting No. 10/82-ALC4/2018 MEETING DATE : 16.10.2018 (actually held on 05.11.2018 and 13.11.2018) and approved the same
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----- Start of picture text -----<br> MEETING NUMBER; | 1/82-ALC4/2018 MEETING DATE<br>: 15.11.2018<br>I Case No.:491/4/82- Party Name:STERLING Meet No/Date:1 1/82- Status:<br>; ALC4/2017 AUXILIARIES PVT LTD ALC4/2018 Deferred<br>15.11.2018<br>1 HQ File RLA File Lic.No/Date:03 10792906 |Defer<br>:01/82/050/00499/AM 18/ :03/95/040/00847/AM15/ 14.01.2015<br>Decision: —§ The Committee noted that the 4.07 application is still awaited from RLA, Mumbai. Hence, it<br>| |was decided to call for a copy of 4.07 application from RLA, Mumbai for further consideration of the case.<br>Lo Case No.:161/13/82- Party Name:STERLING Meet No/Date:1 1/82- Status:<br>| |ALC4/2015 AUXILIARIES PVT LTD ALC4/2018 Approved<br>15.11.2018<br>HQ File RLA File Lic.No/Date:03 10798374<br>:01/82/050/01124/AM16/ :03/95/040/00274/AM16/ 21.08.2015<br>Decision: |The Committee considered case as per agenda and in the presence of the technical experts, it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied<br>: by firm whichever is lower:<br>: [Si 7 Export product Qty. |S. Qty.<br>‘ | No. No.<br>2 | STERO TAM 250 (Steary! 150000 _|| 1. STEARYL AMINE| 29117kg<br>i Amine Ethoxylate) kg ETHYLENE 120882 kg<br>ai OXIDE<br>at STEROL 1206 150000 LAURYL 83617 kg<br>ai (Laury! Alcohol kg ALCOHOL<br>288 | | Ethoxylate/Lauryl Alcohol 4 ETHYLENE 66382 kg<br>ie: mole Ethoxylate) OXIDE<br>34 | 3. STEROL 1320 150000 TRI DECYL 31647 kg<br>rie | (Iso Tri Decyl Alcohol kg ALCOHOL<br>a i | Ethoxylate/Tri Decyl Alcohol ETHYLENE 118353 kg<br>‘Ts | | 17 moles Ethoxylated) OXIDE<br>149 | STERTEK G 260 75000 GLYCERIN 6507 kg<br>AeeS 22(Glycerin mole Ethoxylated)Ethoxylates/Glycerin | kg Lge OXIDEETHYLENE aeeass<br>----- End of picture text -----<br>
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Pa Case No.:24/21/82-ALC4/2015 |Party Name:BEST VALUE Meet No/Date: CHEM 1 1/82Status: PVT. LTD. ALC4/2018 Withdrawn 15.11.2018 3 [HQ File RLA File Lic.No/Date:3410041832 :01/82/050/01729/AM16/ :34/24/040/00267/AM16/ 28.01.2016
Decision: This case has already withdrawn in NC meeting No. 9/82-ALC4 dated 18.09.2018 as the firm has informed that they had surrendered the subject Advance Authorization to RLA, Vadodara and the same has also been cancelled by RLA, Vadodara.
Case No.:14/21/82Party Name:DHAMPUR Meet No/Date:11/82__[Status: LC4/2015 SUGAR MILLS LTD ALC4/2018 Deferred 4 ——15.11.2018 |HQ File RLA File Lic.No/Date:05 10397521 |Defer :01/82/050/01719/AM16/ :05/23/040/00456/AM 16/ 08.02.2016
Decision: The Committee considered the case as per agenda and it was decided to call the firm for personal hearing to explain its case.
Case No.:137/7/82-ALC4/2016 |Party Name:RELIANCE Meet No/Date:11/82Status: INDUSTRIES LTD. ALC4/2018 Deferred 15.11.2018 5 HQ File RLA File ge: ‘Lic. No/Date:03 10804513 Defer :01/82/050/003 1 1/AM17/ :03/95/040/00763/AM 16/ 10.05.2016
Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the copy of application referred to Department of C&PC for their examination/comments. The comments of Department of C&PC are awaited. The case is deferred.. LESS | center sents hb a
ALC4/2016Case No.:43/10/82SPECIALITIESParty Name:0 C PVT.LTD. — |ALC4/2018Meet No/Date:1 1/82Status: Deferred 15.11.2018 6 |HQ File RLA File Lic.No/Date:03 10805124 |Defer :01/82/050/00389/AM17/ :03/95/040/00169/AM17/ 01.06.2016 Decision: —§ The Committee noted that the 4.07 application is still awaited from RLA, Mumbai. Hence, it was decided to call for a copy of 4.07 application from RLA, Mumbai for further consideration of the case.
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----- Start of picture text -----<br> }<br>ALC4/2016 PHARMACEUTICALS INDIA |ALC4/2018 Approved<br>we No.:109/10/82- mnPVT.LTD. Name:DSM SINOCHEM we15.11.2018 No/Date:11/82- ‘ie<br>:01/82/050/00455/AM17/ :22/24/040/00022/AM17/ 23.06.2016<br>eS Be File = File =o sigan |<br>Decision: The Committee considered case as per agenda and in the presence of the technical experts, it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied<br>by firm whichever is lower:<br>aeeROSUVASTATIN No. |<br>CALCIUM |1. | Thorase Enzyme [1.34<br>eineeee |<br>SSS<br>- CAA 2<br>Sake Da<br>= OS rs 5<br>Carbonate<br>6.| Sodium Cas<br>[7[<br>|8. |Bromine [Acetaldehyde]<br>|9.|[10. BicarbonateSodium |<br>11. | Toluene<br>[12ot | [SulphuricAcid] 2,2,DimethoxyBenzothiazole PropanepialST[0.87Lae*<br>Hydrate<br>cosa [el] el eS<br>19 | N-MethylPyratidon<br>20 _|HydroxideSodium Flakes<br>Fluorophenyl)-6-Isopropyl-<br>2-[(N-Methy]<br>Sulfonyl)amino]pyrimidinyl-<br>5-yl-fomyl<br>=<br>PeaceTHF 30% - 2M solution<br>eeMTBE)<br>a ennht* The firmce vide their letter dash t ed 05.12.2018nani has submitted that they have imported only above 10 raw<br>----- End of picture text -----<br>
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----- Start of picture text -----<br> materials against 23 raw materials. Hence norms is not ratified in respect ofother items. ee ie<br>RA Be:<br> may take appropriate action as per the decision of Norms Committee. $:<br>Case No.:32/11/82-ALC4/2016 |Party Name:STERLING Meet No/Date:1 1/82- Status: : Bi.<br>AUXILIARIES PVT.LTD —_|ALC4/2018 Approved =|),<br>15.11.2018 Bt:<br>HQ File RLA File Lic.No/Date:03 10806544 : Bee<br>:01/82/050/00566/AM17/ :03/95/040/00290/AM 17/ 25.07.2016 isoadri<br>Decision: | The Committee considered case as per agenda and in the presence of the technical experts, it 5 #2<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied} 2:=<br>by firm whichever is lower: th<br>8 Export product Qty. | Sl. | Import items Qty. : i:<br>ofSTERO Piperazine MDEA & Methyl(PIP) - ADi (BlendsEthanol ne MONOAMINE METHYL 0.1369 kg aBik<br>Amine) ETHYLENE OXIDE 0.3886 kg Be:<br>PIPERAZINE 68% 0.4745 kg a:<br>STEROL 161880 — (Cetosteary! CETO STEARYL 0.0957 kg ce<br>Alcohol Poly Glycol ALCOHOL a; :<br>RA Ethoxylated) & ‘<br> may take appropriate action as per the decision of Norms Committee. & :<br>Case No.:164/13/82- Party Name: HETERO LABS = |Meet No/Date:11/82- Status: i :<br>ALC4/2016 LIMITED ALC4/2018 Approved ¥3 ;<br>15.11.2018 Cre<br>HQ File RLA File ‘Lic.No/Date:091006409 1 ee :<br>:01/82/050/00792/AM 17/ :09/24/040/003 1 1/AM17/ |01.09.2016 Mes<br>Decision: |The Committee considered case as per agenda and firm’s letter dated 14.09.2018 in the presence i :<br>of the technical experts, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per| : :<br>details below or as applied by firm whichever is lower: FF }<br>Export product Qty. | SI. Oy. Hi ;<br>Velpatasvir No. : i<br>9) Bs 9-bromo-3-(2-bromoacetyl)-10,15H-dibenzo|c,g|chromen-8(9H)-one 1-dihydro- 3:PA<br>| (28,48)-4-(Methoxymethyl)-1,2- The firm a<br>| pyrrolidinedicarboxylic acid ~—-1-(1,1- | vide their Pa<br>| Ee (58)-N-(Methoxycarbonyl)-L-valyl-5- 14.09.2018 by<br>methyl-L-proline ‘as i iy<br>| Tert-butyl(2S.48)-2-(5-(2-((28,58)-1- > a:<br>| ((methoxycarbony!)-I-valyl)-5- submitted<br>methylpyrrolidin-2-yl) 1, 11- that they g3<br>| (4,3,6,7dihydroisochromenoJnaphtho| 1 ,2-dJimidazole-9-yl)-lh- | haveimported not $3)a !<br>imidazol-2-yl)-4- item at H<br>methoxymethyl)pyrrolidine-1-carboxylate | arial No 3;<br>Say (R)-2-((methoxycarbony!)amino)-2-henylacetic Acid 55 —:A uya:<br>一<br>----- End of picture text -----<br>
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| (6. |[2echloro-d,6-dimethoxy-1.3.Scrazine] | import em | 7. (1-Cyano-2-ethoxy-2-oxoethylidenaminooxy)dimethylaminonumber 1. | morpholino-carbeniumhexafluorophosphate (COMU) | bes benzoquinone)DDQ (2,3-dichloro-5,6-dicyano-1,4-
|RA may take appropriate action as per the decision of Norms Committee.
Case No.:168/13/82Party Name: HETERO LABS _ /|Meet No/Date:11/82Status: ALC4/2016 LIMITED ALC4/2018 Approved . 15.11.2018 *HQ/82/050/00796/AM17/ File RLA:09/24/040/00301/AM17/ File ee01.09.2016 enects
Decision: The Committee considered case as per agenda and firm’s letter dated 14.09.2018 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. 5H-dibenzo[c.g]chromen-8(9H)-one | (2S.4S)-4-(Methoxymethyl)-1,2The firm pyrrolidinedicarboxylic acid 1-(1.1vide their | dimethylethyl) ester letter dated = methyl-L-proline a | 4. Tert-butyl(2S,4S)-2-(5-(2-((2S.5S8)-1? es ((methoxycarbonyl)-I-valyl)-5submitted methylpyrrolidin-2-yl) that they I.11have not dihydroisochromeno(4,3,6,7|naphtho[1,2- | imported dJjimidazole-9-yl)-1h-imidazol-2-yl)-4item at methoxymethyl])pyrrolidine-1-carboxylate Serial No. ; phenylacetic Acid : | a | 6.7. ||2-chloro-4,6-dimethoxy-1,3,5-triazine_|(1-Cyano-2-ethoxy-2numberImport item1. oxoethylidenaminooxy)dimethylaminomorpholino-carbenium } | ie bDDQh e xaflnzoq(2.3-dichloro-5,6-dicyano-1,4- u orophosphateinone) (COMU) ¥, RA may take appropriate action as per the decision of Norms Committee.
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Case No.:192/17/82Party Name:SATYA Meet No/Date:1 1/82Status: ALC4/2016 DEEPTHA ALC4/2018 Approved PHARMACEUTICALS LTD — |15.11.2018 HQ File RLA File Lic.No/Date:09 10064172 :01/82/050/01153/AM17/ :09/24/040/00332/AM17/ 22.09.2016 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. ; TATZANAVIRBOC HYDRIZENE(ATZ) ORI pal 4-BROMOBENZALDEHYDE 1.177 kg Nara,, I 11 | |HYDRAZINE OR 5a TRIETHYL ORTHO 1.88 kg ; : N- (4-PYRIDIN-2-YL; FORMATE EE BENZYL)ee Pn EENECARAap ROR TEM: B1S(DIPHENYLPHOSPHINO3; 2 CHLORIDE : |5. 10% PALLADIUM 0.009 kg ie | CARBON,ISOPROPYL50% ALCOHOLWET 3.72 kg (MDCDICHLORO METHANE 4.73 kg ‘Sie |8.| TOLUENE 5.73 kg ; RA may take appropriate action as per the decision|9.__|ofHEXANE Norms Committee. 2 Case No.:113/13/82Party Name:HETERO LABS _ |Meet No/Date:1 1/82Status: ALC4/2016 LIMITED ALC4/2018 Approved 15.11.2018 IL HQ File RLA File ie.No/Date:0910064191 :01/82/050/0074 1/AM17/ :09/24/040/00342/AM 17/ 27.09.2016 Decision: The Committee considered case as per agenda and _firm’s letter dated 14.09.2018 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 Qty. 12 No. : | Velpatasvir 9-bromo-3-(2-bromoacety!)-10,1 1-dihydro1.00 kg 5H-dibenzo|c,g|chromen-8(9H)-one | 2. - | 7-Hydroxy-1-tetralone The firm | SJ 1-[4-bromo-3-(chloromethy!) vide their | 4. | D-alphapheny! |jethanone phenyl glycine letter14.09.2018 dated has | L-Proline-5-methy!-ethylester-(5S)-4-methy! | submitted benzene sulfonate that they have not
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----- Start of picture text -----<br> item at<br>serial No.<br>2-5.except<br>import<br>item<br>number 1.<br>----- End of picture text -----<br>
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Case No.:114/13/82Party Name:HETERO LABS {Meet No/Date:11/82Status: ALC4/2016 LIMITED ALC4/2018 Approved 15.11.2018 HQ File. RLA File Lic.No/Date:09 10064192 :01/82/050/00742/AM17/ :09/24/040/0034 1/AM17/ 27.09.2016 Decision: The Committee considered case as per agenda and firm’s letter dated 14.09.2018 in the presence of the technical experts, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
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----- Start of picture text -----<br> | Export product Qty. | Sl. | Import items Qty.<br>Velpatasvir No. 9-bromo-3-(2-bromoacetyl)-10,1 I-dihydro- | 1.00 kg<br>5H-dibenzo|c.g¢|chromen-8(9H)-one<br>7-Hydroxy-1-tetralone The firm<br>13 1-[4-bromo-3-(chloromethy!) vide their<br>4. phenyl |ethanone letter dated<br>| D-alpha phenyl glycine 14.09.2018<br>has<br>submitted<br>that they<br>have not<br>L-Proline-5-methyl-ethylessen(58)-4anetinyt | “Ported<br>| benzene sulfonate: serialitem: atNo.<br>2-5 except<br>| importitem<br>number |.<br>RA may take appropriate action as per the decision of Norms Committee.<br>; Case No.:11/17/82- Party Name:CIPLA LIMITED. |Meet No/Date:1 1/82- Status:<br>ALC4/2016 ALC4/2018 Deferred<br>15.11.2018<br>14 |HQ:01/82/050/00972/AM17/File RLA File | Lie.No/Date:03 10808312 [Defer<br>203/94/040/00617/AM17/ 06.10.2016<br>Ｓｌ<br>----- End of picture text -----<br>
Decision: The Committee noted that the 4.07 application is still awaited from RLA, Mumbai. Hence, it was decided to call for a copy of 4.07 application from RLA, Mumbai for further consideration of the case.
Case No.:21/17/82-ALC4/2016 ORGANICS|Party Name:BLUE CIRCLE Meet No/Date:1 1/82Status: PVT. LTD. ALC4/2018 Deferred 3 15.11.2018 15 [HQ:01/82/050/00982/AMFile ~ [RLA File Lic. No/Date:0310808830 17/ :03/94/040/00548/AM17/ 27.10.2016 Decision: The firm was requested to furnish complete technical details as per Appendix 4E along with Chemical reaction, molecular weight and yield on molar basis. Reply received from the firm is under
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. Case No.:121/20/82Party Name:HETERO LABS __ |Meet No/Date:11/82Status: ALC4/2016 LIMITED ALC4/2018 Approved 15.11.2018 HQ File RLA File Lic.No/Date:0910064401 :01/82/050/01298/AM17/ :09/24/040/0046 i/AM17/ 18.11.2016
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----- Start of picture text -----<br> Decision: | The Committee considered case as per agenda and in the presence of the technical experts, it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied<br>by firm whichever is lower:<br>ee ee ee<br>4-AMINO-N-(2R,3S)HYDROXY-4-PHENYL-BUTYL)-N-ISOBUTYLBENZENE_ (3-AMINO-2- 1.2.|| L-PhenylTetrahydrofuranDitert.Butyl alaninedicarbonate |ae1.95kg5.00 kg<br>SULFONAMIDE 4._| Tert.Butyl Chloride 7.20 kg<br>5.<br>Isobutylamine<br>6. | Sodium Borohydride | 20 . 1770 kg<br>1.77 kg<br>RA may take appropriate action as per the decision of Norms Committee.<br>E55 Eo ee BN<br>飢<br>----- End of picture text -----<br>
Case No.:128/20/82Party Name:HETERO LABS __ |Meet No/Date:11/82Status: ALC4/2016 LIMITED ALC4/2018 Approved 15.11.2018 HQ File RLA File Lic.No/Date:0910064400 :01/82/050/01305/AM17/ :09/24/040/00436/AM17/ 18.11.2016
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:
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----- Start of picture text -----<br> 17 Export product : Qty. | SI. Qty.<br>No.<br>3-[3-(4-FLUOROPHENYL)-1-(1-METHYLETHYL)-1H-INDOL-2-YL] = N-Methyl-N-Phenyl-3-Aminoacrolein 0.82 kg<br>-(E)-2-PROPENAL ome 3-(4-Fluorophenyl)-1-(1-Methylethyl)-1H-Indole 1.03 kg<br>: 4 [Toluene «dO<br>; RA may take appropriate action as per the decision of Norms Committee.<br>ｔ<br>ｍ<br>----- End of picture text -----<br>
eA ALC4/2016Case No.:120/17/82LABORATORIESParty Name:ZIM LTD. MeetALC4/2018 No/Date:11/82Status:Deferred aa 15.11.2018 |) . t 18 |HQ:01/82/050/0108File 1/AM17/ RLA:03/95/040/00602/AM17/File 22.11.2016Lic.No/Date:0310809205 [Defer | Decision: |The Committee considered the case as per agenda and it was decided to call for a copy of Drug | j Manufacturing License (DML) showing approved composition of export product from the firm.
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----- Start of picture text -----<br> Case No.:148/17/82- Party Name:STERLING Meet No/Date:1 1/82- Status:<br>ALC4/2016 AUXILIARIES PVT LTD ALC4/2018 Deferred<br>15.11.2018<br>19 HQ File RLA File Lic.No/Date:03 10809708<br>:01/82/050/01109/AM17/ :03/95/040/00703/AM17/ 09.12.2016<br>(Decision: Deferred for comments of TE<br>Case No.:158/17/82- Party Name:STERLING Meet No/Date:11/82-ALC4/2018 |Status:<br>ALC4/2016 AUXILIARIES PVT LTD —|15.11.2018 Deferred<br>20 |HQ File RLA File Lic.No/Date:03 10809727<br>:01/82/050/01119/AM17/ __|:03/95/040/00690/AM 17/ 12.2016<br>‘Decision: Deferred for comments ofTE<br>Case No.:200/4/82- Party Name: MYLAN Meet No/Date:11/82- Status:<br>ALC4/2017 LABORATORIES LIMITED |ALC4/2018 pproved<br>15.11.2018<br>HQ File RLA File Lic.No/Date:09 10064484<br>:01/82/050/00208/AM 18/ :09/24/040/00473/AM 17/ 14.12.2016<br>Decision: | The Committee considered case as per agenda and in the presence of the technical experts, it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied<br>by firm whichever is lower: :<br>Export product Qty. | SL.<br>No.<br>ETORICOXIB lkg 1-{(6-methylpyridine-3-yl)-2-(4- 2.18 kg<br>methylsulphonyl)phenyl }-ethanone<br>21 Ketosulfone)<br>2-Chloro-1.3-bis(dimethylamino)- 2.32 kg<br>trimethinium hexafluorophosphate<br>(Vinamidinium Hexaflurophosphate salt)<br>[3.|SSK n-propionic Acid,<br>r4|Triethylamine ___————~—S~«~i<br>|| [5.|] 6. | n-Heptane [Isopropyl] [alcohol] [(IPA)] [432kg1.10 kg |<br>Toluene 5.65 kg<br>[8ce| 10. |[MethanoliC [een] CrMethanesulfonic acid eee | Kgae<br>RA may take appropriate action as per the decision of Norms Committee.<br>Case No.:55/1/82- Party Name:AARTI DRUGS |Meet No/Date:11/82- Status:<br>ALC4/2017 LIMITED ALC4/2018 Approved<br>a 15.1].2018<br>HQ File RLA File Lic.No/Date:03 10810464<br>:01/82/050/01409/AM17/ :03/94/040/00900/AM 17/ 11.01.2017<br>----- End of picture text -----<br>
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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. Qty. LevofloxacinHemiydrate 1.| 2,3,4,5 Tetrafluorobenzoyl Chloride 1.200 kg . USP (2. | | 3. |N.MethylPiperazinEthyl 3 nn Dimethylamine Acrylat e ——*d;CO0.641 kD g RA 4.| L-Alaninol 0.350 kg may take appropriate action as per the decision ofNorms Committee.
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----- Start of picture text -----<br> Case No.:86/20/82- PartyName:RUSAN —~—sSW(Meeet. No/Date:11/82- (Status:<br>ALC4/2016 PHARMA LTD. \ALC4/2018 Approved<br>}15.11.2018<br>HQ File RLA File Lic.No/Date:03 10810600<br>:01/82/050/01263/AM17/ :03/95/040/00823/AM17/ 18.01.2017<br>----- End of picture text -----<br>
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 23 |by firm whichever is lower:
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----- Start of picture text -----<br> Export product Qty. | SI. | Import items<br>No.<br>APOMORPHINE MORPHINE BASE 3.40 kg<br>HYDROCHLORIDE EP/USP<br>----- End of picture text -----<br>
committee allowed the above norms for one time basis and no repeat norms is allowed. RA may take appropriate action as per the decision of Norms Committee.
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----- Start of picture text -----<br> [ Case No.:41/1/82-ALC4/2017 |Party Name:GODAVARI Meet No/Date:1 1/82- Status:<br>| DRUGS LTD ALC4/2018 Deferred<br>15.11.2018<br>HQ File RLA File Lic.No/Date:0910064654 |Defer<br>24 :01/82/050/01395/AM17/ :09/24/040/00607/AM17/ 07.02.2017<br>----- End of picture text -----<br>
Decision: |The Committee considered case as per agenda and in the presence of the technical experts, it was noted that in Meeting No. 7/82 ALC4/2018, dt. 24.08.2018, the firm was requested to furnish the || complete |from the firm.technicalHence,detailsThe asCommittee per Appendixdecided4E. However,to issue Finalthe requisiteReminderreplyto /firminformationgiving 15is daysstill awaitedtime to submit above information, failing which the case will be rejected
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----- Start of picture text -----<br> (Case No.:58/4/82- Party Name:OMTECH —— [Meet No/Date:11/82- _|Status:<br>ALC4/2017 CHEMICAL INDUSTRIES — |ALC4/2018 Deferred<br>PVT.LTD. 15.11.2018<br>HQ File RLA File Lic.No/Date:03 10811245 |Defer<br>:01/82/050/00066/AM 18/ :03/95/040/00361/AM17/ 15.02.2017<br>----- End of picture text -----<br>
Decision: | The Committee considered case as per agenda and in the presence of the technical experts, it was noted that in Meeting No. 6//82 ALC4/2018, dt. 26.07.2018, the firm was requested to furnish following 25 information:
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(i) Complete chemical reaction molecular weight Structural formula of import and export item showing % yield of every stage of reaction.
(ii) Past production consumption data duly certified by Central Excise / GST (iii) Calculation sheet to arrive at the raw material.
However, the requisite reply / information is still awaited from the firm. Hence, The Committee decided to issue Final Reminder to firm giving 15 days time to submit above information, failing which the case will be rejected
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Case No.:181/4/82Party Name:BRILLIANT BIO |Meet No/Date:11/82Status: LIMITED 15.11.2018 ALC4/2017 PHARMA PRIVATE| ALC4/2018 Deferred 26 |HQ:01/82/050/00189/AM18/File RLA:09/24/040/00561/AM17/File 24.02.2017Lic.No/Date:09 10064725 |Defer Decision: The Committee considered Committee considered considered the case as case as as per agenda and agenda and and it was decided was decided decided to forward a copy copy of 4.07 application of the subject Advance Authorization subject Advance Authorization Advance Authorization Authorization to DBT DBT for obtaining obtaining its comments. comments. CaseALC4/2017No.:37/4/82Party Name:SARNA Meet No/Date:1 1/82Status: 15.11.2018 CHEMICALS PVT.LTD ALC4/2018 Approved HQ File RLA File Lic.No/Date:5210042198 :01/82/050/00045/AM 18/ :52/24/040/00048/AM17/ 01.03.2017 }
Decision: The Committee considered Committee considered considered the case as case as as per agenda and agenda and and it was decided was decided decided to forward a copy copy of 4.07 application of the subject Advance Authorization subject Advance Authorization Advance Authorization Authorization to DBT DBT for obtaining obtaining its comments. comments.
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----- Start of picture text -----<br> Decision: | The Committee considered case as per agenda and in the presence of the technical experts, it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied<br>by firm whichever is lower:<br>27<br>eee3, 2<br>DIMPA5 DIMETHYL/ ORGANICPYRAZOLEDYE/ 3 99%ACETYL ACETONE 1.286 kg<br>INTERMEDIATES SR-122 re HYDRAZINE HYDRATE 0.87 kg<br>RA may take appropriate action as per the decision of Norms Committee.<br>| 80%<br>針<br>----- End of picture text -----<br>
Case No.:76/4/82Party Name:ATHENA DRUG |Meet No/Date:11/82Status: Deferred ALC4/2017 DELIVERY SOLUTIONS ALC4/2018 PRIVATE LIMITED 15.11.2018 HQ File RLA File Lic.No/Date:03 10811511 |Defer :01/82/050/00084/AM 18/ :03/94/040/01078/AM17/ 01.03.2017
Decision: — The Committee considered case as per agenda and in the presence of the technical experts, it 28 wasjinformation: noted that in Meeting No. 6//82 ALC4/2018, dt. 26.07.2018, the firm was requested to furnish following
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i) Copy of Drug Manufacturing licence (DML) ii i)) CopyGeneric of nM a sterme of Batch the imp F or mulat and (MBF)export item. However, the requisite reply / information is still awaited from the firm. Hence, The Committee decided to issue Final Reminder to firm giving 15 days time to submit above information, failing which the case will be rejected
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Case No.:80/4/82Party Name:ATHENA DRUG /|Meet No/Date:1 1/82Status: LC4/2017 DELIVERY SOLUTIONS ALC4/2018 Deferred PRIVATE LIMITED 15.11.2018 HQ File RLA File Lic.No/Date:03 10811513 |Defer :01/82/050/00088/AM 18/ :03/94/040/01072/AM17/ 0 1.03.2017
Decision: | The Committee considered case as per agenda and in the presence of the technical experts, it was noted that in Meeting No. 6/82 ALC4/2018, dt. 26.07.2018, the firm was requested to furnish following 29}. eS information: i i) Copy of Drug Manufacturing licence (DML) | ii) Copy of Master Batch Formula (MBF) iii) Generic name of the import and export item. However, the requisite reply / information is still awaited from the firm. Hence, The Committee decided to issue Final Reminder to firm giving 15 days time to submit above information, failing which the case will be rejected ALC4/2017Case No.:92/4/82SCIENCEParty Name:ORBIT PVT. LTD.LIFE ALC4/2018[Meet No/Date:11/82Status:Approved {154 1.2018 HQ File RLA File ‘Lic.No/Date:03 10812040 :01/82/050/00100/AM 18/ :03/95/040/00995/AM17/ 123.03 2017
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: ee CEFPODOXIMEPROXETIL 2.1.-|| 7-AminoSulfolane Cephalosporanic Acid _(7-ACA) | 0.83780.620 kg kg 0.800 kg 30 r3. | Mathanol 4. |5.|| TriMethylene Ethyl Amine Chloride 40 . 1447 0 kg 2-Mecraptoben Zpthiazoly(z)-2-2(2- | 0.8378 kg Aminothiazole-4-Y L)-2-Methoxyimino Acetate( MAEM) 1-Chloroethy! Isopropyl Carbonate(CEIPC) _ | 0.477 kg fe PAsiee es |aatwee es es 1 ee OS 10.| Ethyl Acetate 120kg |11.| Cyclohexane 1.27 kg | 12.| NN Dimethyl Acetamide (DMAC) 0.240 kg 0350 kg
RA may take appropriate action as per the decision of Norms Committee.
Case No.:114/4/82Party Name:MAHIMA LIFE — |Meet No/Date:11/82Status: ALC4/2017 SCIENCES PVT.LTD. ALC4/2018 Deferred 15.11.2018 31 |HQ File RLA File ‘Lic.No/Date:0510402098 |Defer :01/82/050/00122/AM 18/ :05/24/040/00636/AM17/ 30.03 2017 gafirm. The Committee considered the case as per agenda and it was decided to call for COA from the
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Case No.:119/4/82Party Name:DSM Meet No/Date:1 1/82Status: PHARMACEUTICALS 15.11.2018 INDIA PVT.LTD. ai Se Bae nae _ ia:01/82/050/00127/AM18/ File PS:22/24/040/00114/AM17/ File opr30.03.2017 |
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----- Start of picture text -----<br> Decision: The Committee considered case as per agenda and in the presence of the technical experts, it<br>by [firm] decided [whichever] to ratify [is] the [lower:] ad-hoc input output norms under para 4.7 ofHBP as per details below or as applied<br>| tie 6 104la<br>| eeROSUVASTATIN ee ee<br> CALCIUM | Tkg | 1. | Thorase Enzyme ‘(|<br>aLe13a<br>CAA<br>|<br>Cae ean ae<br>6 |CarbonateSodium<br>8. | [Acetaldehyde]<br>Bicarbonate<br>9.__| Sodium ||<br>ic<br>Ti. [22.DimethoxyPropane [087<br>32 |12. | SulphuricAcid TCS<br>Benzothiazole<br>—Hydrate<br>18. [Methanol<br>19 | N-Methy!<br>Hydroxide<br>20|PyrrolidonSodium Flakes<br>Ez Fluoropheny|)-6-Isopropyl-<br>2-[(N-Methy<br>Sulfony!)amino]pyrimidinyl-<br>5-yl-fomy!<br>THF 30% - 2M solution<br>MTBE<br>; 3 Pong<br>――<br>----- End of picture text -----<br>
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- The firm vide their letter dated 05.12.2018 has submitted that they have imported only above 10 raw materials against 23 raw materials. Hence norms is not ratified in respect of other items.
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----- Start of picture text -----<br> Case No.:277/4/82- Party Name:CIPLA LIMITED. |Meet No/Date:1 1/82- Status:<br>ALC4/2017 ALC4/2018 Deferred<br>15.11.2018<br>33 |HQ File RLA File Lic.No/Date:03 10812323 |Deter 1<br>:01/82/050/00285/AM 18/ :03/94/040/01181/AM17/ 03.04.2017<br>Decision: | The Committee noted that the 4.07 application is still awaited from RLA, Mumbai. Hence, it<br>was decided to call for a copy of 4.07 application from RLA, Mumbai for further consideration of the case.<br>Case No.:320/4/82- Party Name:ALPHAMED Meet No/Date:1 1/82- Status:<br>ALC4/2017 FORMULATIONS P LTD. ALC4/2018 Deferred<br>15.11.2018<br>34 |HQ File RLA File Lic.No/Date:0910064868 |Defer<br>:01/82/050/00328/AM 18/ :09/24/040/00670/AM17/ 06.04.2017<br>Decision: |= The Committee considered the case as per agenda and it was decided to call for a copy of<br>Master Batch Formula duly certified by Q.C. Incharge.<br>Case No.:103/4/82- Party Name:RELIANCE Meet No/Date:1 1/82- Status:<br>ALC4/2017 INDUSTRIES LTD. ALC4/2018 Deferred<br>15.11.2018<br>_ 35 HQ File RLA File Lic.No/Date:03 10812389 |Defer<br>:01/82/050/001 1 1/AM18/ :03/95/040/01013/AM17/ 10.04.2017<br>Decision: The Committee considered the case as per agenda in the presence of technical experts and it was<br>noted that the copy of application referred to Department of C&PC for their examination/comments. The<br>comments of Department of C&PC are awaited. The case is deferred.<br>Case No.:104/4/82- Party Name:RELIANCE aMeet No/Date:1 1/82- Status:<br>ALC4/2017 INDUSTRIES LTD. ALC4/2018 Deferred<br>15.11.2018<br>36 HQ File RLA File Lic.No/Date:0310812391 |Defer<br>:01/82/050/001 12/AM18/ :03/95/040/00947/AM17/ 10.04.2017<br>----- End of picture text -----<br>
Decision The Committee considered the case as per agenda in the presence of technical experts and it was noted that the copy of application referred to Department of C&PC for their examination/comments. The comments of Department of C&PC are awaited. The case is deferred.
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----- Start of picture text -----<br> Fal Case No.:105/4/82- Party Name:RELIANCE [Meet No/Date:11/82- Status:<br>| |ALC4/2017 INDUSTRIES LTD. \ALC4/2018 Deferred<br>|15.11.2018<br>37 HQ File RLA File Lic.No/Date:0310812393 |Defer<br>:01/82/050/00113/AM18/ 703/95/040/01012/AM17/ 10.04.2017<br>----- End of picture text -----<br>
Decision: | The Committee considered the case as per agenda in the presence of technical experts and it was noted that the copy of application referred to Department of C&PC for their examination/comments. The comments of Department of C&PC are awaited. The case is deferred.
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----- Start of picture text -----<br> Case No.:257/4/82- Party Name:MATRIX FINE [Meet No/Date:1 1/82- Status:<br>38 |ALC4/2017 SCIENCES PVT.LTD.. aC15.11.2018si2088 |\Deferred<br>----- End of picture text -----<br>
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ao 17 | | : HQ File RLA File Lic.No/Date:03 10812435 = Date: |Decision: Reply received from the firm. Case is deferred for comments of TE | : :01/82/050/00265/AM18/ __|:03/95/040/00999/AM17/ 11.04.2017 | | ‘ Case No.:340/4/82Party Name:GODAVARI Meet No/Date:1 1/82Status: Deferred Ei ALC4/2017 DRUGS LTD ALC4/201815.11.2018 HQ File RLA File Lic.No/Date:09 10064920 |Defer :01/82/050/00348/AM18/ :09/24/040/00694/AM17/ 13.04.2017 Decision: | The Committee considered case as per agenda and in the presence of the technical experts, it ; was noted that in Meeting No. 6/82 ALC4/2018, dt. 26.07.2018, the firm was requested to furnish following 39 information: seca tera
i) Chemical reaction and manufacturing process, ii) Stepwise chemical reaction and Molecular Weight, technical details as per appendix 4E. iii) Percentage of yield on molar basis and details of solvent reactions along with complete However, the requisite reply / information is still awaited from the firm. Hence, The Committee decided to issue Final Reminder to firm giving 15 days time to submit above information, failing which the case will | {be rejected
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----- Start of picture text -----<br> Case No.:139/4/82- Party Name:RELIANCE Meet No/Date:1 1/82- Status:<br>ALC4/2017 INDUSTRIES LTD. ALC4/2018 Deferred<br>15.11.2018<br>40 HQ File Vs RLA File Lic.No/Date:03 10812568 |Defer<br>:01/82/050/00147/AM18/ :03/95/040/01048/AM17/ 19.04.2017<br>Decision: —§ The Committee considered the case as per agenda in the presence of technical experts and it<br>was noted that the copy of application referred to Department of C&PC for their examination/comments.<br>The comments of Department of C&PC are awaited. The case is deferred.<br>| . Case No.:140/4/82- Party Name:RELIANCE Meet No/Date:1 1/82- Status:<br>ALC4/2017 INDUSTRIES LTD. ALC4/2018 Deferred<br>15.11.2018<br>: 41 HQ File RLA File Lic.No/Date:0310812609 |Defer<br>: :01/82/050/00148/AM18/ :03/95/040/01047/AM17/ 19.04.2017<br>Decision: | The Committee considered the case as per agenda in the presence of technical experts and it<br>was noted that the copy of application referred to Department of C&PC for their examination/comments.<br>The comments of Department of C&PC are awaited. The case is deferred..<br>: } Case No.:341/4/82- Party Name: HONOUR LAB __|Meet No/Date:11/82- Status:<br>Rie ah: ALC4/2017 LIMITED ALC4/2018 Deferred<br>ee “et 15.11.2018<br>+ = 42 HQ File RLA File Lic.No/Date:09 10064954 |Defer<br>Peas a :01/82/050/00349/AM 18/ :09/24/040/00035/AM18/ 24.04.2017<br>‘ re Decision: — The Committee noted that the 4.07 application is still awaited from RLA, Hyderabad. Hence, it<br>: > was decided to call for a copy of 4.07 application from RLA, Hyderabad for further consideration of the<br>----- End of picture text -----<br>
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Case No.:373/4/82Party Name:ENCUBE Meet No/Date:1 1/82-ALC4/2018 |Status: ane ETHICALS PVT LTD 15.11.2018 Approved | — HQ File RLA File Lic.No/Date:03 10812788 i :01/82/050/0038 1/AM18/ :03/94/040/00025/AM18/ 25.04.2017 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 as applied for by the firm and Import Item No. 14 will be in Nos. as per packing policy under para 4.07 of HBP Vol. 1.
aaa ee oe RSS a 43 Import Item (a fut [mento Barbadensis ee es Oia; | . Ean |3___|_ Stearicother Acid Bearing Brand/trade name Emersol 132 oranyother ere296.060 | 4 | Stearyl Alcohol bearing Brand/Trade name Speziol 18 or anyother CE 7LOSO | 5_|Lecithin bearing Brand/Trade name LECITHIN YELKIN DS oranyother | 29.610 6 | Peagrence M744) PERPUME M7746)0 |7_| White Mineral Oil Bearing Brand/trade Name Kaydol oranyother | 45.690 (ailsioBce |[steed] +otherPERMA NERO ne nc nt haeioee a em mee | eaten/ CRILL 43) or | 11__|_BenzethoniumSESQUIOLEATEChloride USP Bearingany brandother /trade name Lonza Guardlaorany other |3.430 SSR RO ee Siemens a! MES 2: a other. Pe re ee
RA may take appropriate action as per the decision of Norms Committee
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CaseALC4/2017No.:380/4/82PartyFINOCHEM Name:DELTA PVT.LTD. Meet No/Date:LC4/2018 1 1/82Status:Approved 15.11.2018 HQ File RLA File Lic.No/Date:03 10812922 :01/82/050/00388/AM 18/ :03/94/040/00030/AM18/ 27.04.2017
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
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----- Start of picture text -----<br> by firm whichever is lower: 7 .<br>No.<br>Dibenzothiazepinone 1.| Thiophenol 0.756 kg<br>2 [CausticSoda =| 0275 kg<br>Phenyl Chloro Formate |10lkg<br>RA may take appropriate action as per the decision ofPolyphosphoricNorms CommitteeAcid 3.36 kg<br>Case No.:205/4/82-ALC4/2017 Party Name: AETHER Meet No/Date:11/82- Status:<br>INDUSTRIES LIMITED ALC4/2018 Deferred<br>15.11.2018<br>45 THQ File RLA File Lic.No/Date:5210042246 [Defer<br>:01/82/050/00213/AM18/ :52/24/040/00004/AM18/ 01.05.2017<br>|Decision: Deferred for comments of TE<br>----- End of picture text -----<br>
Case No.:221/4/82Party Name:BAROQUE Meet No/Date:1 1/82Status: ALC4/2017 PHARMACEUTICALS ALC4/2018 Approved PVT. LTD 15.11.2018 HQ File RLA File Lic.No/Date:0810140185 :01/82/050/00229/AM18/ _|:08/24/040/00536/AM17/ 01.05.2017 Decision: | The Committee considered case as per agenda and in the presence of the technical experts, it decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I, as applied for by the firm:
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----- Start of picture text -----<br> Amoxicillin and 20000000.000<br>Potassium Clavunate | Tablets<br>625 mg Tablets<br>(Each tablet contains<br>Amoxicillin<br>Trihydrate equivalent<br>46 to Amoxicillin 500<br>mg and Potassium AMOXICILLIN TRIHYDRATE 12407.910 kg<br>Clavulanate IP/USP/BP p<br>equivalent to POTASSIUM CLAVULANATE 6591.870 kg<br>Clavulanic acid 125 DILUTED IP/BP kg<br>mg)<br>BENICLAV-375 MG | 1000000.000<br>Tablets Tablets<br>(Each tablet contains<br>Amoxicillin<br>Trihydrate equivalent<br>to Amoxicillin 250<br>mg and Potassium<br>Clavulanate .<br>equivalent to<br>Clavulanic acid 125<br>mg) :<br>ー ―<br>ー<br>ー<br>ー<br>ー<br>ー<br>ー<br>Ｌ<br>Ｆ<br>Ｉ<br>Ｉ<br>‐<br>‐<br>‐<br>‐<br>―<br>―<br>―<br>―<br>―<br>―<br>―<br>―<br>―<br>―<br>―<br>＝<br>----- End of picture text -----<br>
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BENICLAV- 625 | 700000.000 + MG Tablets Tablets (Each tablet contains Amoxicillin Trihydrate equivalent to Amoxicillin 500 mg and Potassium i Clavulanate equivalent to ; Clavulanic acid 125 mg) : : RA may take appropriate action as per the decision of Norms Committee i a a ea ‘! Case No.:206/4/82Party Name: MOREPEN Meet No/Date:11/82Status: ALC4/2017 LABORATORIES LTD., ALC4/2018 pproved 15.11.2018 HQ File RLA File Lic.No/Date:05 10402443 :01/82/050/00214/AM18/ :05/24/040/0004 1/AM18/ (03.05.2017
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----- Start of picture text -----<br> Decision: |The Committee considered case as per agenda and in the presence of the technical experts, it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied<br>by firm whichever is lower:<br>47 Export product Sl. Qty.<br>No.<br>LINAGLIPTIN 2-(chloromethy!)-4-methylquinazoline | 0.785 kg<br>(LGO1)<br>8-bromo-7-(2-butyn- 1-yl)-3,7-di ;<br>hydro-3-methyl-1H-Purine-2, 6-<br>dione(LGSO1) or 8-bromo-7-(but-2-<br>ynyl)-3-methyl-1H-<br>purine-2, 6(3H,7H) - dione (LGSO1<br>3. (R)-3-(Boc-Amino) piperidine | 0.85 kg<br>(LGS02)<br>訛<br>----- End of picture text -----<br>
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----- Start of picture text -----<br> | Case No.:59/9/82- Party Name:AUROBINDO ’ {Meet No/Date:11/82- Status:<br>| |ALC4/2017 PHARMA LIMITED ALC4/2018 Deferred<br>15.11.2018<br>48 HQ File RLA File ‘|Lic.No/Date:0910065008 [Defer<br>:01/82/050/00786/AM 18/ :09/24/040/0002 1/AM18/ 04.05.2017<br>----- End of picture text -----<br>
| |Decision: The Committee noted that the 4.07 application is still awaited from RLA, Hyderabad. Hence, it | case.was decided to call for a copy of 4.07 applications from RLA, Hyderabad for further consideration of the
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----- Start of picture text -----<br> Case No.:1/4/82-ALC4/2017 {Party Name:LEE PHARMA {Meet No/Date:11/82- _[Status:<br>LIMITED ALC4/2018 Deferred<br>15.11.2018<br>----- End of picture text -----<br>
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9 |HQ File RLA File Lic.No/Date:0910065019 |Defer :01/82/050/00009/AM 18/ :09/24/040/00084/AM18/ 11.05.2017
Decision: ‘The Committee noted that the 4.07 application is still awaited from RLA, Hyderabad. Hence, it was decided to call for a copy of 4.07 application from RLA, Hyderabad for further consideration of the
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----- Start of picture text -----<br> ] [2]<br>| [3] Case No.:56/9/82- [Party Name:AUROBINDO __|Meet No/Date:1 1/82- Status:<br>| % ALC4/2017 PHARMA LIMITED ALC4/2018 Approved<br>E "i | 15.11.2018<br>=“8¢ HQ:01/82/050/00783/AM18/ File RLAFile:09/24/040/00086/AM18/ nes11.05.2017<br>kh < ; ‘ Decision: —§ The Committee considered case as per agenda and in the presence of the technical experts, it<br>| ae was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied<br>= ie by firm whichever is lower:<br>i j Export product Qty. | SI. Qty.<br>| ny TENOFOVIR 1.| (R)-PMPA-Pure 0.769 kg<br>Ag1 50| | DISOPROXIL FUMARATE /2.| Chloromethyl Isopropyl Carbonate 1.3527 kg<br>Triethylamine<br>eia3 4.| N-Methyl-2-Pyrrolidone 1.4878 kg<br>"Pot ActivatedEnoanticromos Carbon (Carbon 0.016 kg<br>aoeee | 6. | Isopropyl Acetate | [162kg] |<br>2°35aae |8.| MethyleneIsopropyl Alcohol Chloride (MDC) 4.322.85 kgkg<br>paar |9. |ToweneCd «O2G Kg<br>: Steam/Thermal Coal (Non-Cooking) in | As per<br> i Bulk (Limiting factor is value only, the | relevant fuel<br>ei ie eligible CIF value is 5% of FOB policy<br>aight Value<br>a 4 ; _|RA may take appropriate action as per the decision of Norms Committee.<br>----- End of picture text -----<br>
| Bo Case No.:356/4/82-ALC4/2017 (Party Name:MAHIMA LIFE [Meet No/Date:11/82(Status: Af fs SCIENCES PVT.LTD. ALC4/2018 Deferred ‘Se 15.11.2018 : pa) | 51 HQ File RLA File Lic.No/Date:0510402665 | E ‘ :01/82/050/00364/AM18/ :05/24/040/00045/AM18/ 22.05.2017 ist i Decision: | The Committee as per agenda considered the case. The firm is appeared for norms committee | a5 ae for personal hearing and the committee deleveraged the matter in the presence of technical expert and the rs S firm was advise to submit the technical details to examine the matter. i i- : Case No.:359/4/82Party Name:TRION — . Meet No/Date:11/82Status: : ti ALC4/2017 CHEMICALS PRIVATE ALC4/2018 Approved : { oe LIMITED 15.11.2018 fae HQ File RLA File Lic.No/Date:0810140332 ; A at :01/82/050/00367/AM18/ :08/24/040/00530/AM17/ 23.05.2017 : ae h 52 |Decision: | The Committee considered the case as per agenda in the presence of Technical Experts and in ae Bs the light of earlier decision taken by NC in its Meeting No. 8/82-ALC4/2018, dated 31.08.2018 in respect of i rh M/s Trion Chemicals Private Limited against Advance Authorization No. 0810141799 dated 16.01.2018, it Ei ‘e was decided to ratify the ad-hoc input output norms under para 4.7 ofHBP as per details below or as applied te by firm whichever is lower:
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----- Start of picture text -----<br> Export product Qy TS. Oy. Rees<br>No. ioe :<br>TRICHLORO ISOCYANURIC I kg ya Cyanuric Acid 0.615 kg ; ;<br>ACID(TCCA) (Trichloro Isocyanurate) ie es Caustic Soda Lye 0.573 kg He :<br>F :<br>RA may take appropriate action as per the decision of Norms Committee. es aad<br>Case No.:62/9/82-ALC4/2017 |Party Name: VIRCHOW Meet No/Date:1 1/82- Status: ; tes sie<br>PETROCHEMICAL PVT LTD. ALC4/2018 Rejected ; us<br>15.11.2018 TP eaa Ree<br>53 HQ File RLA File Lic.No/Date:0910065 116 ait<br>:01/82/050/00789/AM 18/ :09/24/040/003 16/AM17/ 31.05.2017<br>Decision: —§ The The Committee observed that in the similar cases the the firm neither attended the PH PH nor submit<br>the details as asked asked for vide Minutes of the the Meeting No. 1/82/ALC-4/2018, dated 01.05.2018 and 8/82/2018 hee:<br>----- End of picture text -----<br>
Decision: —§ The The Committee observed that in the similar cases the the firm neither attended the PH PH nor submit the details as asked asked for vide Minutes of the the Meeting No. 1/82/ALC-4/2018, dated 01.05.2018 and 8/82/2018 Dated 31.08.2018, hence the Committee decided to reject the case.
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----- Start of picture text -----<br> Case No.:71/9/82-ALC4/2017 |Party Name: VIRCHOW Meet No/Date:1 1/82- Status:<br>PETROCHEMICAL PVT LTD. |ALC4/2018 Rejected<br>15.11.2018<br>54 HQ File RLA File Lic.No/Date:09 10065113<br>:01/82/050/00798/AM 18/ :09/24/040/00590/AM 17/ 31.05.2017<br>----- End of picture text -----<br>
Decision: The Committee observed that in the similar cases the firm neither attended the PH nor submit the details as asked for vide Minutes of the Meeting No. 1/82/ALC-4/2018, dated 01.05.2018 and 8/82/2018 Dated 31.08.2018, hence the Committee decided to reject the case.
Case No.:87/9/82-ALC4/2017 |Party Name: VIRCHOW Meet No/Date:1 1/82Status: PETROCHEMICAL PVT LTD. |ALC4/2018 Rejected 15.11.2018 55 HQ File RLA File Lic.No/Date:09 10065115 :01/82/050/008 14/AM18/ :09/24/040/00606/AM17/ 31.05.2017
Decision: The Committee observed that in the similar cases the firm neither attended the PH nor submit the details as asked for vide Minutes of the Mecting No. 1/82/ALC-4/2018, dated 01.05.2018 and 8/82/2018 Dated 31.08.2018, hence the Committee decided to reject the case
Case No.:420/4/82Party Name:RELIANCE Meet No/Date:1 1/82Status: ALC4/2017 INDUSTRIES LTD. ALC4/2018 Deferred 15.11.2018 56 HQ File RLA File Lic.No/Date:03 10813970 |Defer :01/82/050/00428/AM 18/ :03/95/040/00106/AM 18/ 14.06.2017 Decision: | The Committee considered the case as per agenda in the presence of technical experts and it noted that the copy of application referred to Department of C&PC for their examination/comments. The comments of Department of C&PC are awaited. The case is deferred.
.
57 Case No.:452/4/82Party Name:RELIANCE Meet No/Date:1 1/82Status: ALC4/2017 INDUSTRIES LTD. ALC4/2018 Deferred
~ 23 hsaf bye 2 a {15.11.2018 ; - HQ File RLA File Lic.No/Date:03 10814112 |Defer i :01/82/050/00460/AM 18/ :03/95/040/002 15/AM18/ 20.06.2017 i if Decision: — The Committee considered the case as per agenda in the presence of technical experts and it | oek Thewas noted comments that of theDepartment copy of application ofC&PC arereferred awaited.to Department of The case is deferred..C&PC for their examination/comments. ‘3 Case No.:453/4/82Party Name:RELIANCE Meet No/Date:1 1/82Status: Deferred ) in hs ALC4/2017 INDUSTRIES LTD. ALC4/2018 Sie 15.11.2018 hee! 7 4 —— a4 58 HQ File RLA File Lic.No/Date:03 10814111 |Defer ; 2 :01/82/050/00461/AM18/ :03/95/040/002017AM18/ 20.06.2017 ; 3 Decision: | The Committee considered the case as per agenda in the presence of technical experts and it i F was noted that the copy of application referred to Department of C&PC for their examination/comments. ‘oe The comments of Department of C&PC are awaited. The case is deferred.. coe t oe a Case No.:52/9/82-ALC4/2017 |Party Name: VIRCHOW Meet No/Date:11/82—|Status: vies | PETROCHEMICAL PVT LTD. |ALC4/2018 Rejected Psi a ; 15.11.2018 ieAe 59 HQ File RLA File Lic.No/Date:09 10065196 at :01/82/050/00779/AM 18/ :09/24/040/00040/AM18/ 22.06.2017 Decision: The Committee observed that in the similar cases the firm neither attended the PH nor submit the , : details as asked for vide Minutes of the Meeting No. 1/82/ALC-4/2018, dated 01.05.2018 and 8/82/2018 ne Dated 31.08.2018, hence the Committee decided to reject the case. = 5 Case No.:1/6/82-ALC4/2017 |Party Name:DSM SINOCHEM [Meet No/Date:1 1/82Status: : q i PHARMACEUTICALS INDIA |ALC4/2018 Approved ta PVT.LTD. 15.11.2018 i i HQ File RLA File Lic.No/Date:2210015738 : =+e; e Decision::01/82/050/00571/AM18/|The Committee considered:22/24/040/00094/A case as per agenda M17/ and in23.06.2017 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 Pa : by firm whichever is lower: | 12 Export product 2. produc’ SI. Qty. a Be No. 2Fb $ 60 Atorvastatin Calcium “1. |___——_*+|Thorase Enzyme 0.134 kg | Ee | 2. | Chioro Acetal Dehyde 1.735 kg i: SEY Actaldchyde poh Bee CO 2 i ea ae 5.| Sodium Carbonate 1.96 kg oe) Se Ethyl Acetate 1.40 kg fae2aee oFee ae iae |10.9.CE||ae SodiumIso Propyl CyanideAlcohol 0,6293.40 kg kg eei [= e s es (MTBEMethyl Tertiary Buty! Ether 2.17 kg
24
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----- Start of picture text -----<br> 13. | Raney nickel 0.064 kg<br>j14. [Hexane| [2.80][ kg]<br>13.| Pivalic aid<br>|16.|———S~S~«~d DKT3/M4 TO0.994 kg<br>17.[ Methanol<br>|18.||Cyclohexane 200g1.31 kg<br>RA may take appropriate action as per the decision of Norms Committee.<br>----- End of picture text -----<br>
Case No.:51/9/82-ALC4/2017_ |Party Name: VIRCHOW Meet No/Date:1 1/82Status: PETROCHEMICAL PVT LTD. |ALC4/2018 Rejected 15.11.2018 61 HQ File RLA File Lic.No/Date:0910065210 :01/82/050/00778/AM 18/ :09/24/040/00078/A M18/ 23.06.2017
Decision: The Committee observed that in the similar cases the firm neither attended the PH nor submit the details as asked for vide Minutes of the Meeting No. 1/82/ALC-4/2018, dated 01.05.2018 and 8/82/2018) Dated 31.08.2018, hence the Committee decided to reject the case.
Case No.:460/4/82-ALC4/2017 |Party Name: HERBOCHEM Meet No/Date: ALC4/2018 INDUSTRIES 1 1/8215.11.2018 62 |HQ File RLA File Lic.No/Date:0610038656 :01/82/050/00468/AM 18/ :06/24/040/00013/AM18/ 05.07.2017
Deferred” Status:
Decision: The Committee noted that the 4.07 application is still awaited from RLA, Kanpur. Hence, it was decided to call for a copy of 4.07 application from RLA, Kanpur for further consideration of the case.
Case No.:109/12/82Party Name:VIVIMED LABS /Meet No/Date:11/82Status: ALC4/2017 LIMITED ALC4/2018 Deferred 15.11.2018 63 |HQ File RLA File Lic.No/Date:09 10065247 :01/82/050/01064/AM 18/ :09/24/040/00181/AM18/ 06.07.2017 Decision: The Committee considered the case as per agenda and it was decided to call the firm for personal hearing to explain its case.
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----- Start of picture text -----<br> a Case No.:204/12/82- Party Name:DISCOVERY Meet No/Date:1 1/82- Status:<br>ALC4/2017 INTERMEDIATES PVT LTD. |ALC4/2018 Deferred<br>15.11.2018<br>HQ File RLA File Lic.No/Date:09 10065251<br>:01/82/050/01159/AM 18/ :09/24/040/00156/AM18/ 07.07.2017<br>64 |Decision: The Committee considered the case as per agenda and it was decided to call for following<br>information from the firm:<br>----- End of picture text -----<br>
(i) Step-wise complete and balanced chemical reactions showing molecular weight and molar requirements. (ii) Percentage yield on molar basis. — (iii) | Requirement and recovery of solvents.
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----- Start of picture text -----<br> 65 Case No.:541/4/82- Party Name:SUNSHIELD ‘Meet No/Date:1 1/82- Status: Deferred<br>ALC4/2017 CHEMICALS LTD. 'ALC4/2018<br>----- End of picture text -----<br>
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----- Start of picture text -----<br> HQ:01/82/050/00549/AMFile 18/<br>----- End of picture text -----<br>
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----- Start of picture text -----<br> RLA203/95/040/00298/AMFile , 7,18/ (15.11.2018Lic.No/Date:0311.07.2017 10814546ay =<br>----- End of picture text -----<br>
Decision: | The Committee considered case as per agenda and in the presence of the technical experts, it was noted that in Meeting No. 9/82 ALC4/2018, dt. 18.09.2018, the firm was requested to furnish the complete technical details as per Appendix 4E. However, the requisite reply / information is still awaited submitfrom the abovefirm.information,Hence, Thefailing Committee which decidedthe case willto issuebe rejectedFinal Reminder to firm giving 15 days time to
Case No.:544/4/82Party Name:MATRIX FINE _|Meet No/Date:1 1/82Status: 3 ALC4/2017 SCIENCES PYT.LTD., ALC4/2018 Deferred / 15.11.2018 | HQ File RLA File Lic.No/Date:03 10814547 | :01/82/050/00552/AM18/ :03/95/040/00267/AM18/ 11.07.2017 | Decision: —§ The Committee considered case as per agenda and in the presence of the technical experts, it E 66 |S noted that in Meeting No. 9//82 ALC4/2018, dt. 18.09.2018, the firm was requested to furnish following information: (i) Chemistry, Molecular weight & yield and (ii) Production / Consumption Data from Central Excise & Service Tax.
However, the requisite reply / information is still awaited from the firm. Hence, The Committce decided to issue Final Reminder to firm giving 15 days time to submit above information, failing which the case will be rejected
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----- Start of picture text -----<br> Case No.:489/4/82- Party Name:RELIANCE Meet No/Date:1 1/82- Status:<br>ALC4/2017 INDUSTRIES LTD. ALC4/2018 Deferred<br>| 15.11.2018<br>67 {HO File RLA File Lic.No/Date:03 10814608<br>:01/82/050/00497/AM 18/ :03/95/040/00049/AM18/ 13.07.2017<br>Decision: —§ The Committee considered the case as per agenda in the presence of technical experts and it<br>was noted that the copy of application referred to Department of C&PC for their examination/comments.<br>The comments of Department of C&PC are awaited. The case is deferred..<br>| Case No.:490/4/82- Party Name:RELIANCE Meet No/Date:1 1/82- Status:<br>|| uj ALC4/2017 INDUSTRIES LTD. ALC4/201815.11.2018 Deferred<br>| 68 |HQ File RLA File Lic.No/Date:03 10814610<br>:01/82/050/00498/AM18/ :03/95/040/00012/AM18/ 13.07.2017<br>Bt ‘ Decision: | The Committee considered the case as per agenda in the presence of technical experts and it<br>ia 4, was noted that the copy of application referred to Department of C&PC for their examination/comments.<br>ot oe The comments of Department of C&PC are awaited. The case is deferred.<br>ti ‘ ; “ |Case No.:542/4/82- Party Name:RELIANCE Meet No/Date:1 1/82- Status:<br>ae sig ALC4/2017 INDUSTRIES LTD. ALC4/2018 Deferred<br>rh $7 i 15.11.2018<br>Bes yi HQ File RLA File Lic.No/Date:03 10814604<br>:01/82/050/00550/AM18/ :03/95/040/0002 1/AM18/ 13.07.2017<br>: peat Decision: The Committee considered the case as per agenda in the presence of technical experts and it<br>一<br>１<br>６ ７<br>¨<br>----- End of picture text -----<br>
jes} 26 jee | The cn o tedmments that of the Department of copy of applicationC&PC referred are awaited.to TheDepartm cas e nt ofis deferred..C&PC for their examination/comments. | ioeifs ‘; ai ih Case No.:137/12/82Party Name:NASENSE LABS (Meet No/Date:11/82-[Status: Deferred} 2) } ALC4/2017 PVT LTD ALC4/2018 : Ei i } 15.11.2018 i fae ; HQ File RLA File Lic.No/Date:0910065267 ay :01/82/050/01092/AM 18/ :09/24/040/00193/AM 18/ 13.07.2017 Re " <j 70 Daa ‘ (Decision: The Committee considered the case.as per agenda and it was decided to call for following Sti": ‘ information from the firm: Bi i (i) Step-wise complete and balanced chemical reactions showing molecular weight and molar ; t : (ii) Percentage yield on molar basis. re Case No.:33/6/82-ALC4/2017 |Party Name:GODAVARI Meet No/Date:1 1/82Status: DRUGS j a8 . LTD ALC4/2018 Deferred > eS 15.11.2018 be HQ File RLA File a Lic.No/Date:09 10065287 es& al :01/82/050/00603/AM 18/ :09/24/040/00191/AM18/ 19.07.2017 #: Decision: | The Committee considered case as per agenda and in the presence of the technical experts, it ei was noted that in Meeting No. 5/82 ALC4/2018, dt. 25.07.2018, the firm was requested to furnish the S: complete technical details as per Appendix 4E. However, the requisite reply / information is still awaited &: from the firm. Hence, The Committee decided to issue Final Reminder to firm giving 15 days time to = f submit above information, failing which the case will be rejected ie Case No.:103/12/82Party Name:DISCOVERY Meet No/Date:11/82Status: Fi g ALC4/2017 INTERMEDIATES PVT LTD. |ALC4/2018 Deferred Pit 15.11.2018 na HQ File RLA File Lic.No/Date:0910065298 is :01/82/050/01058/AM18/ :09/24/040/00160/AM18/ 21.07.2017 f: 72 |Decision: The Committee considered the case as per agenda and it was decided to call for following } ae information from the firm: es , (i) Step-wise complete and balanced chemical reactions showing molecular weight + and molar requirements. £3 (ii) Percentage yield on molar basis. hs (iii) Requirement and recovery of solvents. ate Case No.:58/6/82Party Name:BLUE CIRCLE —|Meet No/Date:11/82Status: : < ALC4/2017 ORGANICS PVT. LTD. ALC4/2018 Deferred F 15.11.2018 } ae 73 |HQ File RLA File Lic.No/Date:03 10814882 nee :01/82/050/00628/AM 18/ :03/94/040/00324/AM18/ 27.07.2017 ia Decision: | The Committee noted that the 4.07 application is still awaited from RLA, Mumbai. Hence, it it i was decided to call for a copy of 4.07 application from RLA, Mumbai for further consideration of the case. ite ee ee ei i
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Case No.:519/4/82-ALC4/2017 |Party Name:LAKELAND Meet No/Date:11/82Status: HEMICALS (INDIA) LTD. —|ALC4/2018 Deferred 15.11.2018 HQ File RLA File 714[:01/82/050/00527/AM18/] :03/95/040/00018/AM17/_ Penebererm31.07.2017 |
Decision: —§ The Committee considered case as per agenda and in the presence of the technical experts, it was noted that in Meeting No. 9/82 ALC4/2018, dt. 18.09.2018, the firm was requested to furnish the chemical name of export product. However, the requisite reply / information is still awaited from the firm. Hence, The Committee decided to issue Final Reminder to firm giving 15 days time to submit above information, failing which the case will be rejected
Case No.:40/6/82-ALC4/2017 |Party Name:CIPLA LIMITED. {Meet No/Date:11/82Status: ALC4/2018 Deferred 15.11.2018 HQ File RLA File Lic.No/Date:0310814908 :01/82/050/00610/AM18/ :03/94/040/00295/AM 18/ 31.07.2017
Decision: The Committee considered case as per agenda and in the presence of the technical experts, it was 75 noted\information:that in Meeting No. 7/82 ALC4/2018, dt. 24.08.2018, the firm was requested to furnish following (i) Copy of DML for each export product: (ii) Master Batch Formula for each export product and (iii) NOC from Ministry of Environment Forest and Climate Change.
However, the requisite reply / information is still awaited from the firm. Hence, The Committee decided to issue Final Reminder to firm giving 15 days time to submit above information, failing which the case will
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----- Start of picture text -----<br> Case No.:155/12/82- Party Name:SAPTAGIR Meet No/Date:1 1/82- Status:<br>ALC4/2017 CAMPHOR LIMITED ALC4/2018 Approved<br>15.11.2018<br>HQ File RLA File Lic.No/Date:09 10065322<br>:01/82/050/01110/AM18/ :09/24/040/00206/AM18/ 02.08.2017<br>----- End of picture text -----<br>
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----- Start of picture text -----<br> Decision: Committee considered case as per agenda and in the light of earlier decision taken by NC in its<br>% 5/82 meeting dated 25.07.2018 it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP<br>as per details below or as applied by firm whichever is lower:<br>[ Export produc [ Qty. [SNe [Imporitems sd or<br>DIPENTENE part ee Gum Turpentine Oil aed<br>RA may take appropriate action as per the decision of Norms Committee<br>----- End of picture text -----<br>
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----- Start of picture text -----<br> CaseALC4/2017No.:133/6/82- PartyHEMICALS Name:LAKELAND (INDIA) LTD. Meet No/Date:|ALC4/2018 1 1/82- Status:Deferred<br>15.11.2018<br>ra) Ee [:01/82/050/00703/AM] File [18/] as:03/95/040/00223/AM16/ File ' crpoecpancngeaoee04.08.2017 |<br>----- End of picture text -----<br>
Decision: | The Committee considered case as per agenda and in the presence of the technical experts, it was noted that in Meeting No. 9/82 ALC4/2018, dt. 18.09.2018, the firm was requested to furnish the chemical name of export product. However, the requisite reply / information is still awaited from the firm.| Hence, The Committee decided to issue Final Reminder to firm giving 15 days time to submit above information, failing which the case will be rejected
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----- Start of picture text -----<br> Case No.:16/6/82-ALC4/2017 PartyPHARMACEUTICAL Name:SUN ALC4/2018eet No/Date:1 1/82- Status:Approved |<br>INDUSTRIES LTD., 15.11.2018<br>HQ File RLA File Lic.No/Date:05 10403733<br>:01/82/050/00586/AM 18/ :05/24/040/00219/AM18/ 18.08.2017<br>----- End of picture text -----<br>
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:
==> picture [414 x 298] intentionally omitted <==
----- Start of picture text -----<br> | Export product Qty. No.Sl. Qty.<br>Timolol Maleate Long Acting | 36400 Timolol Maleate 2109.75 gm<br>Ophthalmic Solution 0.5%w/v, Sml | Number<br>(TIMATIMSUN)<br>Each ml contains Timolol Maleate USP<br>8mg equivalent to Timolol 5.0 mg<br>(Equivalent to 1456.00Gram of Bulk<br>78 | Drug<br>Latanoprost and Timolol Maleate | 14800<br>Ophthalmic Solution, 0.005% / | Number<br>0.5%w/y, 2.5ml (LATONCURE)<br>| Each ml contains Timolol Maleate USP<br>6.83 mg equivalent to Timolol 5.0 mg<br>(Equivalent to 252.710Gram of Bulk<br>| Drug)<br>| 3 TIMODOL — Sterile Eye Drops | 15000<br>(LOFTEMIDE) (Dorzolamide and | Number<br>Timolol Ophthalmic Solution, 2.0%w/v<br>+ 0.5%w/v, 5ml) Each ml contains<br>Timolol Maleate USP 6.83 mg<br>equivalent to Timolol 5.0 mg<br>(Equivalent to 512.25 Gram of Bulk<br>Drug) Drug Formulation/ Formulation<br>Grade ( Equivalent to Total Bulk Drug<br>Quantity of 2220.96 Gram)<br>RA may take appropriate action as per the decision of Norms Committee.<br>----- End of picture text -----<br>
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Case No.:116/12/82© Party Name: VIVIMED LABS Meet No/Date: C4/2017 LIMITED ALC4/2018 1 1/82Status:Deferred | ex 1.2018 :01/82/050/01071/AM18/ :09/24/040/00234/AM18/ 23.08.2017 79 |HQ File RLA File Lic.No/Date:09 10065373 | Decision: The Committee considered the case as per agenda and it was decided to call the firm for personal hearing to explain its case.
Case No.:134/12/82Party Name:VIVIMED LABS |Meet No/Date:11/82Status: ALC4/2017 LIMITED = ALC4/2018 Deferred 15.11.2018 80 |HQ File RLA File - Lic.No/Date:09 10065372 :01/82/050/01089/AM18/ :09/24/040/00233/AM18/ 23.08.2017
Decision: The Committee considered the case as per agenda and it was decided to call the firm for personal hearing to explain its case.
Case No.:131/12/82Party Name:VIVIMED LABS |Meet No/Date:1 1/82Status: ALC4/2017 LIMITED ALC4/2018 Deferred 15.11.2018 81 |HQ File RLA File Lic.No/Date:0910065396 |Defer :01/82/050/01086/AM18/ :09/24/040/00238/AM18/ 28.08.2017
Decision: The Committee considered the case as per agenda and it was decided to call the firm for personal hearing to explain its case.
Case No.:132/12/82Party Name:VIVIMED LABS |Meet No/Date:1 1/82Status: ALC4/2017 LIMITED ALC4/2018 Deferred 15.11.2018 82 |HQ File RLA File Lic.No/Date:09 10065398 :01/82/050/01087/AM18/ :09/24/040/00235/AM18/ 28.08.2017
Decision: The Committee considered the case as per agenda and it was decided to call the firm for personal hearing to explain its case.
Case No.:141/12/82Party Name: VIVIMED LABS [Meet No/Date:1 1/82Status: ALC4/2017 LIMITED ALC4/2018 Deferred 15.11.2018 83 |HQ File RLA File Lic.No/Date:09 10065397 :01/82/050/01096/AM18/ :09/24/040/00236/AM18/ 28.08.2017 Decision: The Committee considered the case as per agenda and it was decided to call the firm for personal hearing to explain its case.
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Case No.:28/6/82PartyName:SV.——s [Meet No/Date:11/82_[Status: ALC4/2017 PLASTOCHEM PVT.LTD. — |ALC4/2018 Deferred 15.11.2018 HQ File RLA File Lic.No/Date:3110066857 :01/82/050/00598/AM 18/ :31/83/040/00037/AM17/ 31.08.2017 84 (Decision: The Committee considered case as per agenda and in the presence of the technical experts, it was noted that in Meeting No. 9/82 ALC4/2018, dt. 18.09.2018, the firm was requested to furnish the complete technical details as per Appendix 4E along with Chemical reaction, stage wise yield of production and molecular weight from the firm.. However, the requisite reply / information is still awaited from the firm. Hence, The Committee decided to issue Final Reminder to firm giving 15 days time to submit above information, failing which the case will be rejected
Case No.:72/10/82-ALC4/2017 |Party Name:KOPRAN Meet No/Date: RESEARCH ALC4/2018 1 1/82ApprovedStatus: LABORATORIES LTD. 15.11.2018 HQ File RLA File Lic.No/Date:03 10815444 :01/82/050/009 10/AM 18/ :03/94/040/00421/AM18/ 31.08.2017
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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. SI. Qty. No. | PREGABALIN 10000 kg (+/-) -3- (CARBAMOYLMETHYL)-5- | 29400 kg METHYLHEXANOIC ACID | |2.| CHLOROFORM 47500 kg R(+)-METHYL BENZYL AMINE OR 1140 kg (R)-1-PHENYLETHYLAMINE | 4.| ISOPROPYL ALCOHOL RA may take appropriate action as per the decision of Norms Committee.
Case No.:138/12/82Party Name:BRILLIANT BIO |Meet No/Date:11/82Status: ALC4/2017 PHARMA PRIVATE ALC4/2018 Deferred LIMITED 15.1 1.2018 86 |HQ File RLA File Lic.No/Date:09 10065419 :01/82/050/01093/AM 18/ :09/24/040/00267/AM 18/ 31.08.2017
Decision: |The Committee considered the case as per agenda and it was decided to forward a copy of 4.07 application of the subject Advance Authorization to DBT for obtaining its comments.
Case No.:78/6/82-ALC4/2017 |Party Name:JUBILANT Meet No/Date:1 1/82Status: GENERICS LTD ALC4/2018 Approved 15.11.2018 87 HQ File RLA File Lic.No/Date:05 10403934 :01/82/050/00648/AM 18/ :05/23/040/00217/AM18/ 05.09.2017
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 details below or as applied by firm whichever is lower:
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----- Start of picture text -----<br> |=<br>|<br>|Export Product<br>Bupropion XL 300mg Tablet<br>| Bupropion XL 150mg Tablet z<br>“ae (Methacrylic Acid Copolymer Dispersion)<br>RA may take appropriate action as per the decision of Norms Committee.<br>Case No.:76/6/82-ALC4/2017 |Party Name:JODAS EXPOIM_ |Meet No/Date:11/82- Status:<br>PVT.LTD ALC4/2018 Approved<br>15.11.2018<br>HQ:01/82/050/00646/AM18/ File RLA:05/23/040/00227/AM18/ File ene07.09.2017<br>Decision: — The Committee considered case as per agenda and in the presence of the technical experts, it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as applied for by the firm:<br>０<br>----- End of picture text -----<br>
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----- Start of picture text -----<br> No.SI. Export product Qty. No.Sl. | Import items Qty.<br>62/0- Drug | 303030.000 RELEVANT BULK| 1600.000<br>! Formulations, njections,Ampules, Vials |Number DRUG ke<br>above 1OML.Amoxicillin & Potassium AMOXICILLIN<br>Clavulanate for Injection 300mg. SODIUM AND<br>| NET WT. 90.91KG.IMPORT & CLAVULANATE<br>| EXPORT TO BE GOVERNED AS POTASSIUM<br>PER P/C 9 DATED 30.06.2003 STERILE.<br>62/0- Drug 454545.000<br>88 | Formulations, Injections,Ampules, Vials |Number<br>above 1OML. Amoxicillin and<br>Potassium Clavulanate for Injection<br>| 600mg.<br>NET WEIGHT 272.727KG. IMPORT<br>| & EXPORT TO BE GOVERNED AS<br>PER P/C 9 DATED 30.06.2003<br>| 3 62/0- Drug 303030.000<br>Formulations, Injections,Ampules, Vials |Number 5;<br>above 10ML.Amoxicillin and<br>| Potassium Clavulanate for Injection<br>1200mg.<br>NET& EXPORT WEIGHT TO 363.636 BE GOVERNED KG.IMPORT AS<br>PER P/C 9 DATED 30.06.2003<br>62/0- Drug 303030.000<br>| Formulations, Injections,Ampules, Vials |Number<br>above 1OML.Amoxicillin & Potassium<br>Clavulanate for Injection<br>300mg(Combipack)<br>NET WEIGHTwith water for inejction 90.91KG.IMPORT1 Ampule. &<br>eee<br>----- End of picture text -----<br>
;rs Bs a4 E Se bs ‘4 ae 33 ts igi 7 +3 th 3 is | okrs : : ; 4 »: ee ae 4 £3 16 ; #3 ; 3 i “ : a 3 ra a3 a : pe iy. $3 i “ A
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----- Start of picture text -----<br> we PEREXPORT P/C TO9 DATED BE GOVERNED30.06.2003 AS its 57<br>62/0- Drug 454545.000<br>Formulations, Injections,Ampules, Vials |Number<br>above 10ML.Amoxicillin & Potassium<br>Clavulanate for Injection<br>600mg(Combipack)<br>with water for inejction | Ampule.<br>NET WEIGHT 272.727KG.IMPORT<br>& EXPORT TO BE GOVERNED AS<br>PER P/C 9 DATED 30.06.2003<br>62/0- Drug 303030.000<br>Formulations,Injections,Ampules,Vials |Number<br>above LOML.Amoxicillin& Potassium<br>Clavulanate for Injection<br>1200img(Combipack)<br>with water for inejction 1 Ampule.<br>NET WEIGHT 363.636 KG.IMPORT<br>& EXPORT TO BE GOVERNED AS<br>PER P/C 9 DATED 30.06.2003<br>----- End of picture text -----<br>
RA may take appropriate action as per the decision of Norms Committee
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----- Start of picture text -----<br> Case No.:79/6/82-ALC4/2017 |Party Name:JODAS EXPOIM _ |Meet No/Date:11/82- Status:<br>PVT.LTD ALC4/2018 Approved<br>15.11.2018<br>HQ File RLA File Lic.No/Date:05 10403959<br>:01/82/050/00649/AM 18/ :05/23/040/00226/AM 18/ 07.09.2017<br>Decision: | The Committee considered case as per agenda and in the presence of the technical experts, it<br>was decided to ratify the ad-hoc input output norms as applied for by the firm under para 4.07 of HBP Vol. |<br>details as given below:<br>----- End of picture text -----<br>
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----- Start of picture text -----<br> |Sl.No| Export Product Quantity in Numbers<br>DRUG FORMULATIONS, INJECTIONS, AMPULES, VIALS ABOVE<br>\ 10ML. Ampicillin & Sulbactam for Injection 375mg. NETWEIGHT<br>90.91KG. 242424.000<br>IMPORT & EXPORT TO BE GOVERNED AS PER P/C 9 DATED<br>30.06.2003<br>DRUG10ML.Ampicillin FORMULATIONS, & SulbactamINJECTIONS,for Injection AMPULES, 750mg VIALS ABOVE 363636.000<br>| NETAS PER WEIGHTP/C 9 DATED 272.727KG.30.06.2003IMPORT & EXPORT TO BE GOVERNED :<br>DRUG FORMULATIONS, INJECTIONS, AMPULES, VIALS ABOVE<br>1OML.Ampicillin & Sulbactam for Injection 1500mg. 242424.000<br>NET WEIGHT 363.636KG.<br>DRUG FORMULATIONS, INJECTIONS, AMPULES, VIALS ABOVE<br>10ML.Ampicillin & Sulbactam for Injection 3000mg. 60606.000<br>NET WEIGHT 181.817KG. IMPORT & EXPORT TO BE GOVERNED :<br>AS PER P/C 9 DATED 30.06.2003<br>62/0- DRUG FORMULATIONS, INJECTIONS, AMPULES, VIALS<br>| ABOVE 10ML.Ampicillin & Sulbactam for Injection 375mg<br>(Combipack)<br>with water for inejction 1 Ampule. NET WEIGHT 90.91KG. IMPORT&<br>EXPORT TO BE GOVERNED AS PER P/C 9 DATED 30.06.2003<br>DRUG FORMULATIONS, INJECTIONS, AMPULES, VIALS ABOVE<br>10ML.Ampicillin & Sulbactam for Injection 750mg (Combipack) 363636.000<br>: with water for inejction | Ampule. NET WEIGHT 272.727KG. IMPORT :<br>& EXPORTTO BE GOVERNED AS PER P/C 9 DATED 30.06.2003<br>1OML. Ampicillin & Sulbactam for Injection 1500mg (Combipack Soe<br>----- End of picture text -----<br>
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a & EXPORT TO BE GOVERNED AS PER P/C 9 DATED 30.06.2003 DRUG FORMULATIONS, INJECTIONS, AMPULES, VIALS ABOVE j with1OML.water Ampicillinfor inejction & Sulbactam| Ampule. for Injection NET WEIGHT 3000mg181.817KG. (Combipack)IMPORT 60606.000. & EXPORT TO BE GOVERNED AS PER P/C 9 DATED 30.06.2003 | a ‘RELEVANT BULK DRUG AMPICILLIN SODIUM AND I es | SULBACTAMIMPORT & EXPORT SODIUM TO (2:1) BE GOVERNED STERILE AS PER P/C 9 DATED 2000000oe kg 30,06,2003 RA may take appropriate action as per the decision of Norms Committee | : Case No.:84/6/82- No.:84/6/82Party Name: TINA TINA Meet No/Date:11/82- No/Date:11/82(Status: Deferred
Case No.:84/6/82- No.:84/6/82Party Name: TINA TINA Meet No/Date:11/82- No/Date:11/82(Status: Deferred LC4/2017 * |ORGANICS PRIVATE ALC4/2018 LIMITED 15.11.2018 HQ File RLA File Lic.No/Date:05 10403979 :01/82/050/00654/AM 18/ :05/24/040/00256/AM18/ 11.09.2017 90 Decision: —§ The Committee considered case as per agenda and in the presence of the technical experts, it was noted that in Meeting No. 9/82 ALC4/2018, dt. 18.09.2018, the firm was requested to furnish the complete technical details as per Appendix 4E along with Chemical reaction, stage wise yield of production and molecular weight from the firm. However, the requisite reply / information is still awaited from the firm. information, failing which the case will be rejected. Hence, The Committee decided to issue Final Reminder to firm giving 15 days time to submit above
Case No.:126/12/82Party Name:NASENSE LABS /Meet No/Date:11/82Status: 15.11.2018 ALC4/2017 PVT LTD ALC4/2018 Deferred HQ:01/82/050/0108 File 1/AM18/ RLA:09/24/040/00271/AM18/ File Lic.No/Date:091006544811.09.2017 91 Decision: The Committee considered the case as per agenda and it was decided to call for following information from the firm: (i) Step-wise complete and and balanced chemical chemical reactions showing molecular weight weight and molar requirements. (ii) Percentage yield on molar basis. yield on molar basis. on molar basis. basis.
' (i) Step-wise complete and and balanced chemical chemical reactions showing molecular weight weight and molar requirements. | (ii) Percentage yield on molar basis. yield on molar basis. on molar basis. basis. ] shi ; Case No.:177/12/82Party Name:AUROBINDO Meet No/Date:11/82Status: | ALC4/2017 PHARMA LIMITED ALC4/2018 Deferred : * 15.11.2018 | : HQ:01/82/050/01132/AM18/ File RLA:09/24/040/00273/AM File 18/ Lic.No/Date:091006545011.09.2017 | ti ‘Decision: Deferred for comments of TE Bes Be : Case No.:112/12/82Party Name:SATYA Meet No/Date:1 1/82Status: E ALC4/2017 DEEPTHA ALC4/2018 Deferred Hes ' - HARMACEUTICALS LTD |15.11.2018 HQ File RLA File Lic.No/Date:0910065453 | :01/82/050/01067/AM18/ :09/24/040/00303/AM18/ 14.09.2017 | Decision: The Committee considered case as per agenda and in the presence of the technical experts, it
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(ae) ; in Meeting No. No. 8/82 ALC4/2018, dt. 31.08.2018, the firm was was requested to furnish following ; ' 1 ages i) Stepwise complete and balanced chemical reaction showing molecular weights of input ; and output materials. ‘t eS ii) % yield on molar basis for each steps ae iii) Requirement and recovery of each solvent in the process. Bie ti iv) Material balance for each step of manufacturing process. ¥ : requisite reply / information is still awaited from the firm. Hence, The Committee Committee decided to ‘i Reminder to firm giving 15 days time to submit submit above information, failing which the case case will) | ~ in |Party Name:SAPTAGIR Name:SAPTAGIR Meet No/Date:11/82- No/Date:11/82Status: ‘ AMPHOR LIMITED LIMITED ALC4/2018 Deferred iss ; ta} 15.11.2018 m4 RLA File Lic.No/Date:09 10065468 10065468 :09/24/040/00293/AM 18/ 18/ 15.09.2017 Deferred for comments of comments of of TE. |Party Name:STRIDES Name:STRIDES Meet No/Date:1 No/Date:1 1/82Status: SHASUN LIMITED ALC4/2018 Approved : 15.11.2018 it RLA File Lic.No/Date:0410163547 $ 18/ :04/24/040/00124/AM18/ 21.09.2017 3 | The Committee considered Committee considered considered case as per agenda and per agenda and agenda and in the presence of the technical presence of the technical of the technical the technical technical experts, it by to ratify ratify the ad-hoe input output norms under para 4.7 of ad-hoe input output norms under para 4.7 of input output norms under para 4.7 of output norms under para 4.7 of norms under para 4.7 of under para 4.7 of para 4.7 of 4.7 of of HBP as per details as per details per details details below or as applied or as applied as applied applied d is lower: S “ Ba Qty. Sl. Qty. * No. ? 264000. | 1. 1. | METOPROLOL TARTRATE TARTRATE 3366.00 kg kg £ USP|| Packs STEAR © WET (MEGNESIUM|| 196.709 kg kg i 25MG STEARATE/SLS) by =500 AVICEL 102 (MICRO CRYSTALLINE (MICRO CRYSTALLINE CRYSTALLINE 9927.680 kg kg } NET CLEEULOSE NF.PH.EUR.J.P NF.PH.EUR.J.P % Be ACDISOLCARMELLOSE SODIUMSD-711 NF.PH.EUR.J.P)(CROSS |CARMELLOSE SODIUMSD-711 NF.PH.EUR.J.P)(CROSS | SODIUMSD-711 NF.PH.EUR.J.P)(CROSS |SD-711 NF.PH.EUR.J.P)(CROSS | NF.PH.EUR.J.P)(CROSS |(CROSS | | 1573.403 kg 53 oe 5.| LACTOSCLOSUR| LACTOSCLOSUR LACTOSCLOSURCLOSUR E ANHYDROUS38MM38MM CT NF DT(PACKING NF DT(PACKING DT(PACKING(PACKING | 6225.080relevantrelevant kgas|as| | 4 MATERIAL) per packing g policy appropriate action as per the decision of the decision of decision of of Norms Committee. Committee. . Party Name:RELIANCE Name:RELIANCE Meet No/Date:11/82- No/Date:11/82Status: # . INDUSTRIES LTD. LTD. ALC4/201815.11.201815.11.2018 Deferred 3S RLA File Lic.No/Date:03 10815890 10815890 : 18/ :03/95/040/00246/AM18/ 22.09.2017 : ;
was noted that in Meeting No. No. 8/82 ALC4/2018, dt. 31.08.2018, the firm was was requested to furnish following information:
However, the requisite reply / information is still awaited from the firm. Hence, The Committee Committee decided to issue Final Reminder to firm giving 15 days time to submit submit above information, failing which the case case will) be rejected
Case No.:198/4/82-ALC4/2018 |Party Name:SAPTAGIR Name:SAPTAGIR Meet No/Date:11/82- No/Date:11/82Status: AMPHOR LIMITED LIMITED ALC4/2018 Deferred 15.11.2018 as HQ File RLA File Lic.No/Date:09 10065468 10065468 :01/82/050/00198/AM19/ :09/24/040/00293/AM 18/ 18/ 15.09.2017 Decision: Deferred for comments of comments of of TE.
Case No.:75/6/82-ALC4/2017 |Party Name:STRIDES Name:STRIDES Meet No/Date:1 No/Date:1 1/82Status: SHASUN LIMITED ALC4/2018 Approved 15.11.2018 HQ File RLA File Lic.No/Date:0410163547 :01/82/050/00645/AM 18/ :04/24/040/00124/AM18/ 21.09.2017
Decision: | The Committee considered Committee considered considered case as per agenda and per agenda and agenda and in the presence of the technical presence of the technical of the technical the technical technical experts, it was decided to ratify ratify the ad-hoe input output norms under para 4.7 of ad-hoe input output norms under para 4.7 of input output norms under para 4.7 of output norms under para 4.7 of norms under para 4.7 of under para 4.7 of para 4.7 of 4.7 of of HBP as per details as per details per details details below or as applied or as applied as applied applied by firm whichever is lower:
==> picture [430 x 256] intentionally omitted <==
----- Start of picture text -----<br> | Export product Qty. Sl. Qty.<br>95 No.<br>| METOPROLOL 264000. | 1. 1. | METOPROLOL TARTRATE TARTRATE 3366.00 kg kg<br>TARTRATE USP|| Packs STEAR © WET (MEGNESIUM|| 196.709 kg kg<br>TABLETS 25MG STEARATE/SLS)<br>(PACK =500 AVICEL 102 (MICRO CRYSTALLINE (MICRO CRYSTALLINE CRYSTALLINE 9927.680 kg kg<br>TABLETS) NET CLEEULOSE NF.PH.EUR.J.P NF.PH.EUR.J.P<br>| a Be ACDISOLCARMELLOSE SODIUMSD-711 NF.PH.EUR.J.P)(CROSS |CARMELLOSE SODIUMSD-711 NF.PH.EUR.J.P)(CROSS | SODIUMSD-711 NF.PH.EUR.J.P)(CROSS |SD-711 NF.PH.EUR.J.P)(CROSS | NF.PH.EUR.J.P)(CROSS |(CROSS | | 1573.403 kg<br>Coeansyabaeeee oe 5.| LACTOSCLOSUR| LACTOSCLOSUR LACTOSCLOSURCLOSUR E ANHYDROUS38MM38MM CT NF DT(PACKING NF DT(PACKING DT(PACKING(PACKING | 6225.080relevantrelevant kgas|as| |<br>Sie coir MATERIAL) per packing<br>: policy<br>RA may take appropriate action as per the decision of the decision of decision of of Norms Committee. Committee.<br>Case No.:122/6/82- Party Name:RELIANCE Name:RELIANCE Meet No/Date:11/82- No/Date:11/82- Status:<br>96 ALC4/2017 INDUSTRIES LTD. LTD. ALC4/201815.11.201815.11.2018 Deferred<br>HQ File RLA File Lic.No/Date:03 10815890 10815890<br>:01/82/050/00692/AM 18/ :03/95/040/00246/AM18/ 22.09.2017 :<br>----- End of picture text -----<br>
; is | or ae i | : Decision: — The Committee considered the case as per agenda in the presence of technical experts and it was noted that the copy of application referred to Department of C&PC for their examination/comments. The comments of Department of C&PC are awaited. The case is deferred.. | -—| 2 t: Case No.:129/6/82Party Name:RELIANCE Meet No/Date:1 1/82Status: | $3 ALC4/2017 INDUSTRIES LTD. ALC4/15.11. 20 1818 Deferred | Hi 97 HQ File RLA File Lic.No/Date:03 10815896 : :01/82/050/00699/AM 18/ :03/95/040/00371/AM18/ 22.09.2017 | ‘4 Decision: —§ The Committee considered the case as per agenda in the presence of technical experts and it | cH was noted that the copy of application referred to-Department of C&PC for their examination/comments. i | |The comments of Department of C&PC are awaited. The case is deferred. A Case No.:70/6/82-ALC4/2017 |Party Name:CAPLIN POINT __ |Meet No/Date:11/82Status: 4 LABORATORIES LTD.., ALC4/2018 Approved 15.11.2018 : HQ File RLA File Lic.No/Date:04 10163550 :01/82/050/00640/AM 18/ :04/24/040/00128/AM18/ 25.09.2017 gg 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: Ketorolac Tromethamine for 1 Ketorolac 33.0 mg/vial | injection 30mg / ml Number TromethamineUSP Grade API | RA concerned may take further necessary action as per above decision of NC. Bz Case No.:115/6/82Party Name: MEHK Meet No/Date:1 1/82Status: ALC4/2017 CHEMICALS PVT. LTD. ALC4/2018 : Deferred 15.11.2018 | HQ File RLA File Lic.No/Date:03 10815952 | : 99 Decision::01/82/050/00685/AM— The Committee18/ considered:03/95/040/00500/AM18/case as per agenda and26.09.2017in the presence of the technical experts, it was noted that in Meeting No. 9/82 ALC4/2018, dt. 18.09.2018, the firm was requested to furnish the complete technical details as per Appendix 4E along with Chemical reaction, stage wise yield of production and molecular weight from the firm. However, the requisite reply / information is still awaited from the firm. Hence, The Committee decided to issue Final Reminder to firm giving 15 days time to submit above | : information, failing which the case will be rejected | | [Case No.:110/9/82Party Name:SONGWON [Meet No/Date:11/82[Status: i | ALC4/2017 SPECIALTY CHEMICALS |ALC4/2018 Deferred ‘io INDIA PVT. LTD. 15.11.2018 | i HQ File RLA File Lic.No/Date:34 10043505 :01/82/050/00837/AM18/ :34/24/040/00167/AM18/ 27.09.2017 ; ‘Decision: Deferred for comments ofTE . | >
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Case No.:33/10/82-ALC4/2017 |Party Name:ENCUBE Meet No/Date:11/82Status: ETHICALS PVT LTD ALC4/2018 Deferred 15.11.2018 HQ File RLA File Lic.No/Date:03 10816004 :01/82/050/00871/AM18/ :03/94/040/00484/AM 18/ 27.09.2017
Decision: Deferred for comments of TE
ase No.:120/12/82Party Name:PORUS Meet No/Date:11/82Status: ALC4/2017 LABORATORIES PVT LTD = |ALC4/2018 Deferred 15.11.2018 102 |HQ File RLA File Lic.No/Date:0910065521 :01/82/050/01075/AM18/ :09/24/040/003 15/AM18/ 29.09.2017 Decision: | The Committee considered the case as per agenda and it was decided to call for Appendix 4E having all technical details like stage wise yield of production and molecular weight from the firm.
ase No.:125/12/82Party Name:SATYADEVA Meet No/Date:1 1/82Status: ALC4/2017 PHARMACEUTICALS PVT — |ALC4/2018 Deferred LTD 15.11.2018 103 TQ File RLA File LicNo/Date:0910065526 :01/82/050/01080/AM18/ :09/24/040/00328/AM18/ 29.09.2017 |Decision: Deferred for comments of TE Case No.:21/10/82Party Name:CADILA Meet No/Date:1 1/82Status: ALC4/2017 HEALTHCARE LTD ALC4/2018 Deferred 15.11.2018 104 HQ File RLA File Lic.No/Date:081014 1063 :01/82/050/00859/AM18/ :08/24/040/00 152/AM18/ 03.10.2017
Decision: |The Committee noted that the 4.07 application is still awaited from RLA, Ahmedabad. Hence, _ fit was decided to call for a copy of 4.07 application from RLA, Ahmedabad for further consideration of the case.
,
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----- Start of picture text -----<br> Case No.:115/12/82- Party Name:SATY ADEVA [Meet No/Date:11/82- Status:<br>LC4/2017 PHARMACEUTICALS PVT |ALC4/2018 Deferred<br>‘LTD 15.11.2018<br>105 10 File RLA File Lic.No/Date:0910065537<br>:01/82/050/01070/AM18/ :09/24/040/00337/AM18/ 05.10.2017<br>Decision: Deferred for comments of TE<br>----- End of picture text -----<br>
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||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
|Case No.:25/9/82-ALC4/2017|Party Name:JODAS EXPOIM|[Meet No/Date:1|1/82-|Status:|
|PVT.LTD.,|LC4/2018|Deferred|
|me|15.11.2018|
|:01/82/050/00752/AM18/|:05/23/040/00254/AM18/|09.10.2017|
|HQ File|RLA File|Lic.No/Date:0510404221|||
|Decision:|Deferred for comments of|TE|
|Case No.:52/10/82-|Party Name:RELIANCE|Meet No/Date:1 1/82-|Status:|
|LC4/2017|INDUSTRIES LTD»|ALC4/2018|(Deferred|
|15.11.2018|
|107|HQ:01/82/050/00890/AM18/File|i|:03/95/040/0035RLA|File|1/AM18/|oa11.10.2017|
|Decision:|| The Committee considered|the|case as per agenda|in|the|presence of technical|experts and|it|
|was|noted|that|the copy|of application|referred|to|Department|of C&PC|for|their examination/comments.|
|The comments of Department of|C&PC are|awaited.|The case|is|deferred...|
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Case No.:33/9/82-ALC4/2017 |Party Name:STRIDES Meet No/Date:11/82tatus: SHASUN LIMITED ALC4/2018 Approved 15.11.2018 HQ File RLA File Lic.No/Date:04 10163599 :01/82/050/00760/AM18/ :04/24/040/00144/AM18/ 16.10.2017
Decision: — The Committee considered the case as per agenda in the presence of Technical Experts and in ¢ light of earlier decision taken by NC in its Meeting No. 4/82-ALC4/2018, dated 19.06.2018 in respect of M/s Strides Shasun Limited against Advance Authorization No. 0410163776 dated 06.12.2017, 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 -----<br> a<br>108 | POTASSIUM CITRATE TRIPOTASSIUM| 550.8 mg/ 5 mEq /tablet<br>EXTENDED - RELEASE CITRATE USP<br>TABLETS USP SmEq - 540MG<br>NET API CONT:572.400MG /<br>PER TABLETS INCL WASTAGE<br>POTASSIUM CITRATE Number TRIPOTASSIUM| 1101.6 mg/ 10 mEq<br>EXTENDED RELEASE CITRATE USP /tablet<br>TABLETS USP 10mEq - 1080MG<br>NET API CONT: 1144.8MG / PER<br>TABLET INCL WASTAGE.<br>POTASSIUM CITRATE Number | 3 TRIPOTASSIUM| 1652.4 mg/ 15 mEq<br>EXTENDED RELEASE CITRATE /tablet .<br>TABLETS USP 15mEq - 1620MG<br>NET API CONT:1717.200MG /<br>| PER TABLET INCL WASTAGE<br>RA may take appropriate action as per the decision ofNorms Committee.<br>訛<br>----- End of picture text -----<br>
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ase No.:246/4/82-ALC4/2018 |Party Name: VINDHYA Meet No/Date:11/82Status: PHARMA (INDIA)PVT LTD. |ALC4/2018 Approved 15.11.2018 Be:01/82/050/00246/AM File 19/ RLA:09/24/040/00357/AM18/ File Lic.18.10.2017No/Date:0910065564
Decision: | The Committce considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 7/AM15, dated 11.09.2014 in respect of M/s indhya Pharma (India) Pvt. Ltd. against Advance Authorization No. 0910056447 dated 25.06.2013, 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 109 |firm whichever is lower:
Dibenzoyllactol 3,5-Di-O-Benzoy!-2-Deoxy-2,2-Difluro-D1.047 kg ; Erythropentane-1,4-Lactone OR Ethyl 2,2-difluoro-3-hydroxy-3-(2,2dimethyl-1,3 dioxolan-4yl) propionate RA may take appropriate action as per the decision of Norms Committee. Case No.:35/9/82Party Name:AETHER Meet No/Date:11/82Status: LC4/2017 INDUSTRIES LIMITED ALC4/2018 Deferred 15.11.2018 110 }HQ File RLA File Lic.No/Date:5210042414 :01/82/050/00762/AM18/ :52/24/040/00036/AM18/ 23.10.2017 Decision: | The Committee considered the case as per agenda and it was decided to call for Appendix 4E having all technical details like stage wise yield of production and molecular weight from the firm. ase No.:109/10/82Party Name:IND SWIFT Meet No/Date:11/82Status: ALC4/2017 LABORATORIES LIMITED — |ALC4/2018 Approved 15.11.2018 HQ File RLA File Lic.No/Date:22 10015788 :01/82/050/00947/AM18/ :22/24/040/00045/AM 18/ 23.10.2017
Decision: | The Committee considered the case as per agenda in the presence of Technical Experts and in light of earlier decision taken by NC in its Meeting No. 9/82-ALC4/2018, dated 18.09.2018 in respect f M/s Ind-Swift Laboratories Ltd. against Advance Authorization No, 2210015609 dated 13.12.2016, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as AT applied by firm whichever is lower:
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----- Start of picture text -----<br> Export product Qty. Sl. Qty.<br>No.<br>NATEGLINIDE ae] Trans-4-lsopropylcyclohexaneCarboxylic Acid (TPCA) 1.09 kg<br>/2 | N-Hydroxy Succinimide 0.81 ke<br>|4 Triethylamine /2.02kg<br>15 || N.N-DicyclohexylcarbodiimideMethylene Chloride 1.58 kg<br>[6 |AceicAcid 1g<br>■<br>----- End of picture text -----<br>
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----- Start of picture text -----<br> ase No.:247/4/82-ALC4/2018 |Party Name: VIRCHOW Meet No/Date:1 1/82- Status:<br>PETROCHEMICAL PVT ALC4/2018 Rejected<br>LTD. 15.11.2018<br>112 :01/82/050/00247/AM19/HQ File :09/24/040/00205/AMRLA File (= 18/ 27.10.2017Lic.No/Date:0910065611<br>he details as asked for vide Minutes of the Meeting No. 1/82/ALC-4/2018, dated 01.05.2018 and<br>Decision: The Committee observed that in the similar cases the firm neither attended the PH nor submit<br>8/82/2018 Dated 31.08.2018 hence the Committee was decided to reject the case.<br>Case No.:32/9/82-ALC4/2017 SCIENCES|Party Name:JUBILANT LIFE {Meet No/Date:1 1/82- Status:<br> LIMITED ALC4/2018 Approved<br>15.11.2018<br>HQ File RLA File Lic.No/Date:05 10404483<br>:01/82/050/00759/AM18/ :05/23/040/00256/AM 18/ 02.11.2017<br>Decision: | The Committee considered the case as per agenda in the presence of Technical Experts and in<br>the light of earlier decision taken by NC in its Meeting No. 9/82-ALC4/2018, dated 18.09.2018 in respect<br>f M/s Ind-Swift Laboratories Ltd. against Advance Authorization No. 0510403698 dated17.08.2017, it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as<br>113 applied by firm whichever is lower:<br>Export product Qty. No.SI. Qty.<br>Piperidine (Min Purity 99%) | 1 kg Ruthenium Alumina Catalyst 0.00196 kg<br>Ruthenium 5%<br>Alumina Silicate Catalyst 0.019 kg<br>Denatured Ethyl Alcohol 2.242 kg<br>(4 | Propionaldehyde<br>RA 1AdT kg<br> may take appropriate action as per the decision ofNorms Committee.<br>一<br>ヽ<br>----- End of picture text -----<br>
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----- Start of picture text -----<br> Case No.:64/10/82-ALC4/2017 Party Name:MEDISPRAY Meet No/Date:11/82- Status:<br>LABORATORIES PVT. LTD. |ALC4/2018 Deferred<br>a 15.11.2018<br>HQ File RLA File Lic.No/Date:03 10816779<br>:01/82/050/00902/AM18/ :03/95/040/00574/AM 18/ 02.11.2017<br>Decision: Deferred for comments of TE<br>Case No.:79/12/82-ALC4/2017 No.:79/12/82-ALC4/2017 Party Name:CIPLA LIMITED. Name:CIPLA LIMITED. LIMITED. {Meet No/Date:<br>115 | 1/82- Status:<br>ALC4/201815.11.2018 Deferred<br>----- End of picture text -----<br>
Case No.:79/12/82-ALC4/2017 No.:79/12/82-ALC4/2017 Party Name:CIPLA LIMITED. Name:CIPLA LIMITED. LIMITED. 115
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Decision: Deferred for comments of TE
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|ase No.:28/12/82-ALC4/2017||Party Name:PRISM|Meet No/Date:11/82-|(Status:|
|INDUSTRIES|LTD.|ALC4/2018|Deferred|
|15.11.2018|
|“ae|
|HQ|File|RLA|File|Lic.No/Date:3410043610||Defer|»|
|:01/82/050/00983/AM|18/|:34/24/040/00197/AM18/|09.11.2017|
||Decision:|Deferred for comments of|TE|
|ALC4/2017ase|No.:3/10/82-|INDUSTRIESParty Name:RELIANCE LTD.|ALC4/2018Meet No/Date:1|1/82-|Status:Deferred||
|15.11.2018|
|117|HQ File|RLA|File|Lic.No/Date:03 10816996||Defer|
|:01/82/050/0084 1/AM18/|:03/95/040/00395/AM|18/|13.11.2017|
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Decision: | The Committee considered the case as per agenda in the presence of technical experts and it was noted that the copy of application referred to Department of C&PC for their examination/comments. The comments of Department of C&PC are awaited. The case is deferred..
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|Case|No.:10/10/82-|Party Name:RELIANCE|Mect No/Date:11/82-|Status:|
|LC4/2017|INDUSTRIES|LTD.|ALC4/2018|Deferred|
|15.11.2018|
|118|HQ File|RLA|File|Lic.No/Date:03|10816994|Defer|
|:01/82/050/00848/AM18/|:03/95/040/00429/AM 18/|13.11.2017|
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Decision: | The Committee considered the case as per agenda in the presence of technical experts and it was noted that the copy of application referred to Department of C&PC for their examination/comments. he comments of Department of C&PC are awaited. The case is deferred..
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----- Start of picture text -----<br> ~<br>Case No.:11/10/82- Party Name:RELIANCE [Meet No/Date:1 1/82- Status:<br>ALC4/2017 INDUSTRIES LTD. ALC4/2018 Deferred<br>15.11.2018<br>119 HQ File RLA File Lic.No/Date:03 10817005 |Defer<br>:01/82/050/00849/AM18/ :03/95/040/00503/AM 18/ 13.11.2017<br>----- End of picture text -----<br>
Decision: | The Committee considered the case as per agenda in the presence of technical experts and it i was noted that the copy of application referred to Department of C&PC for their examination/comments. | The comments of Department of C&PC are awaited. The case is deferred..
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|Case|No.:12/10/82-|Party Name:RELIANCE|Meet No/Date:1 1/82-|Status:|
|LC4/2017|INDUSTRIES|LTD.|ALC4/2018|Deferred|
|)15.11.2018|
|120|HQ File|RLA File|Lic.No/Date:03|10816995||Defer|
|:01/82/050/00850/AM18/|:03/95/040/00472/AM18/|13.11.2017|
|Decision:|||The Committee|considered|the|case|as|per agenda|in|the presence|of technical|experts|and|it|
|was|noted|that|the|copy|of application|referred|to|Department|of C&PC|for their|examination/comments.|
|comments of Department|of C&PC are awaited.|The|case|is deferred.|
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Case No.:51/12/82Party Name:D. K. PHARMA [Meet No/Date:11/82_[Status: LC4/2017 LAB ALC4/2018 Deferred 15.11.2018 121 |HQ File RLA File Lic.No/Date:03 10816992 me :01/82/050/01006/AM18/ :03/94/040/00603/AM 18/ 13.11.2017 Decision: |The Committee noted that the 4.07 application is still awaited from RLA, Mumbai. Hence. it was decided to call for a copy of 4.07 application from RLA, Mumbai for further consideration of the case. Case No.:215/4/82-ALC4/2018 |Party Name:AUROBINDO Meet No/Date:11/82Status: PHARMALIMIFED ALC4/2018 Deferred sons HQ File RLA File Lic.No/Date:091006567315.11.2018 |Defer :01/82/050/00215/AM19/ :09/24/040/00412/AM18/ 16.11.2017 Decision: Deferred for comments of TE. Case No.:231/4/82Party Name:HETERO LABS |Meet No/Date:11/82-__ Status: ALC4/2018 LIMITED ALC4/2018 pproved 15.11.2018 HQ File RLA File Lic.No/Date:0910065674 :01/82/050/0023 1/AM19/ :09/24/040/00410/AM18/ 16.11.2017 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. 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:
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----- Start of picture text -----<br> | [Export product [ Qty. [ Si.No._| Import tems oy<br>123 (2R-cis)-5-(4-amino- 12- lkg [es Glyoxylic acid 50% 0.743 kg<br>| dihydro-2-oxo- l-pyrimidinyl)- Sodium bisulphite<br>OS See RE 2,5-dihydroxy-1,4-dithiane 0.325 kg<br>: ee ee ee es Ea<br>[S| Triethyl amine | 0034kg<br>: (ae Methane sulfonic acid 0.017 kg<br>| Dimethyl formamide 0.26 kg<br>| [S| Cytosine SS SSCS~*d OAR<br>| : |9 | Hexamethyl disilazane 0.698 kg<br>‘3 | SCYoa Be<br>\ RA may take appropriate action as per the decision of Norms Committee.<br>| i 11] Methylene dichloride 2.63 kg<br>| ase No.:208/12/82- Party Name:ATUL LIMITED, |Meet No/Date:11/82- Status:<br>1s ALC4/2017 ALC4/2018 Deferred<br>Ee 15.11.2018<br>+i fae:01/82/050/01163/AM18/ File :08/24/040/00203/AM18/RLA File 24.11.2017Lic.No/Date:0810141364 Defer<br>} Decision:information fromThethe Committeefirm: considered the case as per agenda and it was decided to call for following<br>----- End of picture text -----<br>
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(i) Molecular weight of product. (ii) Stoichiometric balance. Case No.:234/4/82-ALC4/2018 |Party Name:VIVIMED LIFE — |Meet No/Date:11/82Status: SCIENCES PRIVATE ALC4/2018 Deferred LIMITED 15.11.2018 HQ File RLA File Lic.No/Date:0910065686 |Defer 701/82/050/00234/AM19/ :09/24/040/00396/AM 18/ 24.11.2017 |Decision: Deferred for comments of TE
‘ase No.:236/4/82-ALC4/2018 |Party Name: VIVIMED LABS ect No/Date:11/82Status: LIMITED ALC4/2018 Deferred 15.11.2018 _ HQ File RLA File Lic.No/Date:0910065688 |Defer :01/82/050/00236/AM 19/ :09/24/040/00403/AM18/ 24.11.2017 |Decision: Deferred for comments of TE %
‘|Case No.:243/4/82-ALC4/2018 Party Name:VIVIMED LABS _ |Meet No/Date:11/82Status: “ : LIMITED ALC4/2018 Deferred 15.11.2018 127 FQ File RLA File Lic.No/Date:0910065687 [Defer :01/82/050/00243/AM19/ :09/24/040/00404/AM 18/ 24.11.2017 Decision: Deferred for comments of TE Case No.:98/10/82-ALC4/2017 |Party Name:RELIANCE Meet No/Date:11/82Status: INDUSTRIES LTD. ALC4/2018 Deferred 15.11.2018 128 HQ File RLA File Lic.No/Date:0310817326 |Defer Date: |.91/82/050/00936/AM18/ :03/95/040/00532/AM18/ 27.11.2017 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the copy of application referred to Department of C&PC for their examination/comments. The comments of Department of C&PC are awaited. The case is deferred.
Case No.:229/4/82-ALC4/2018 (Party Name:AURORE LIFE Meet No/Date:11/82Status: SCIENCES PRIVATE ALC4/2018 Deferred LIMITED 15.11.2018 129 TQ File RLA File LicNo/Date:0910065707 (Defer Date: :01/82/050/00229/AM19/ :09/24/040/00346/AM 18/ 28.11.2017 Decision: Deferred for comments of TE.
:
Case No.:13/12/82-ALC4/2017 |Party Name: TRION Meet No/Date:11/82Status: CHEMICALS PRIVATE ALC4/2018 Approved 130 LIMITED 15.11.2018 HQ File RLA File Lic.No/Date:0810141409 :01/82/050/00968/AM18/ :08/24/040/00247/AM18/ 29.11.2017
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Decision: Committee considered case as per agenda and in the presence of the technical experts and as per earlier decision taken by NC in its meeting No. 8/82 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:
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----- Start of picture text -----<br> Export product Qty. SI. Import items Qty.<br>No. Allowed<br>TRICHLORO ISOCYANURIC |1 | Cyanuric Acid 0.615 kg<br>ACID(TCCA) (Trichloro Isocyanurate) |2 | Caustic Soda Lye 0.573 kg<br>RA may take appropriate action as per the decision ofNorms Committee<br>ヽ<br>----- End of picture text -----<br>
- [Case No.:196/12/82Party Name:MATRIX FINE Meet No/Date:11/82Status: ALC4/2017 SCIENCES PVT.LTD., ALC4/2018 Deferred 15.11.2018 HQ File RLA File Lic.No/Date:0310817413 |Defer Date: :01/82/050/01151/AM18/ :03/95/040/0065 1/AM18/ 29.11.2017 131 Decision: The Committee considered case as per agenda and in the presence of the technical experts, it |wasfollowingnotedinformation:that in Meeting No. 8/82-ALC4/2018, dt. 31.08.2018, the firm was requested to furnish
(i) Chemistry, % yield on molar basis (ii) Production / Consumption Data from Central Excise & Service Tax
The requisite information has not been received so far. You are again requested to provide the above information within 15 days, failing which the case will be treated as rejected.
Case No.:76/12/82-ALC4/2017 Party Name:CORAL Meet No/Date: LABORATORIES 1 1/82Status: LTD., ALC4/2018 Rejected 15.11.2018 132 |HQ File RLA File Lic.No/Date:03 10817460 :01/82/050/0103 1/AM18/ :03/94/040/00689/AM18/ 30.11.2017
Decision: The Committee considered the case as per agenda and it has been noted that the requisite information has not been received. Hence, it was decided to reject the case.
S (Case No.:232/4/82-ALC4/2018 {Party Name:SATYA Meet No/Date:11/82__[Status: DEEPTHA ALC4/2018 Deferred PHARMACEUTICALS LTD — /15.11.2018 133 |HQ File RLA File Lic.No/Date:0910065715 [Defer Date: :01/82/050/00232/AM19/ :09/24/040/0042 1/AM18/ 30.11.2017 commentsDecision: ofTheTE Committee considered the case as per agenda and it was decided to deferred the case for
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----- Start of picture text -----<br> Case No.:254/4/82-ALC4/2018 |Party Name:OGENE Meet No/Date:1 1/82- Status:<br>SYSTEMS INDIA LTD. ALC4/2018 Deferred<br>Hse 15.11.2018<br>i: HQ File RLA File Lic.No/Date:0910065713 [Defer Date:<br>----- End of picture text -----<br>
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Decision: The Committee considered the case as per agenda and it was decided to call from the firm plete technical details as per appendix 4E |
No.:38/12/82-ALC4/2017 |Party Name:V.D.H. Meet No/Date:| 1/82Status: : ORGANICS PVT. LTD ALC4/201815.11.2018 Approved | HQ File RLA File Lic.No/Date:05 10404746 :01/82/050/00993/AM18/ 205/24/040/00401/AM18/ 07.12.2017
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 135 [applied by firm whichever is lower:
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----- Start of picture text -----<br> Qty. |<br>lkg BE (M-CRESOLMETA - CRESOL 0.909 kg<br>IPA)<br>呻<br>----- End of picture text -----<br>
RA may take appropriate action as per the decision of Norms Committee
Case No.:85/12/82-ALC4/2017 |Party Name:RELIANCE Meet No/Date:11/82Status: INDUSTRIES LTD. ALC4/2018 Deferred 15.11.2018 136 HQ File RLA File Lic.No/Date:0310817554 |Defer Date: :01/82/050/01040/AM18/ :03/95/040/00399/AM 18/ 07.12.2017
ision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the copy of application referred to Department of C&PC for their examination/comments. comments of Department of C&PC are awaited. The case is deferred.
No.:86/12/82-ALC4/2017 ‘Party Name:RELIANCE Meet No/Date:11/82Status: INDUSTRIES LTD. ALC4/2018 Deferred 15.11.2018 137 HQ File RLA File Lic.No/Date:0310817555_ |Defer Date: :01/82/050/01041/AM18/ :03/95/040/00489/AM 18/ 07.12.2017
Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the copy of application referred to Department of C&PC for their examination/comments. comments of Department of C&PC are awaited. The case is deferred.
;
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----- Start of picture text -----<br> No.:121/12/82- Party Name:RELIANCE Meet No/Date:11/82- Status:<br>ALC4/2017 INDUSTRIES LTD. ALC4/2018 Deferred<br>15.11.2018<br>138 HQ File RLA File Lic.No/Date:0310817606 |Defer Date:<br>:01/82/050/01076/AM18/ :03/95/040/00625/AM 18/ 07.12.2017<br>----- End of picture text -----<br>
Decision: The Committee considered the case as per agenda in the presence of technical experts and it noted that the copy of application referred to Department of C&PC for their examination/comments. comments of Department of C&PC are awaited. The case is deferred.
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é “ | Case No.:140/12/82Party Name:RELIANCE Meet No/Date:1 1/82Status: ALC4/2017 INDUSTRIES LTD. ALC4/2018 Deferred 15.11.2018 | '9°'|:01/82/0S0/0109S/AMI8/HQ File _|:03/95/040/00S88/AMI8)RLA File 4Lic.No/Date:031081760112.2017 ||Defer Date: Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the copy of application referred to Department of C&PC for their examination/comments. © comments of Department of C&PC are awaited. The case is deferred. | ALC4/2017Case No.:159/12/82-Case No.:159/12/82- No.:159/12/82Party Name:RELIANCE Name:RELIANCE Meet No/Date:1 1/82-1 1/82- 1/82Status: INDUSTRIES LTD. ALC4/2018 Deferred 15.11.2018 ) 140 HQ File File RLA File Lic.No/Date:0310817564 |Defer Date: Date:
ALC4/2017Case No.:159/12/82-Case No.:159/12/82- No.:159/12/82Party Name:RELIANCE Name:RELIANCE Meet No/Date:1 1/82-1 1/82- 1/82Status: INDUSTRIES LTD. ALC4/2018 Deferred 15.11.2018 140 HQ File File RLA File Lic.No/Date:0310817564 |Defer Date: Date: :01/82/050/01114/AM18/ :03/95/040/00624/AM18/ 07.12.2017
Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the copy of application referred to Department of C&PC for their examination/comments. © comments of Department of C&PC are awaited. The case is deferred.
‘ ¢ CaseALC4/2017 No.:185/12/82INDUSTRIESParty Name:RELIANCE LTD. ALC4/2018Meet No/Date:1 1/82Status:Deferred 15.11.2018 | 141 HQ File RLA File Lic.No/Date:0310817566 {Defer Date: :01/82/050/01140/AM18/ :03/95/040/00348/AM18/ '7.12.2017 Decision: The Committee considered the case as per agenda in the presence of technical experts and it comments of Department of C&PC are awaited. The case is deferred. | Was noted that the copyofapplication referred to Department ofC&PC for their examination/comments. | Case No.:186/12/82Party Name:USV PRIVATE {Meet No/Date:1 1/82Status: LIMITED) 15.11.2018 | ALC4/2017 LIMITED (FORMERLY USV_ |ALC4/2018 pproved ] HQ File RLA File Lic.No/Date:03 10817664 :01/82/050/01141/AM18/ :03/95/040/00719/AM18/ 11.12.2017 Decision: The Committee considered case as per agenda and and in the presence of the technical experts, _ appliedit was decidedby firm towhicheverratify theis ad-hoclower: input output norms under para 4.7 of HBP as per details below or as Export Product |t .42! |Doxycycline Tablets, USP 50 MG (19,200 Bottles x 100 Per Bonties = 19,20,000 Tablets) Doxycycline Tablets, USP 75 MG ( 4400 Bottles x 100 Per Bottles = 4,40,000 Tablets) ; Doxycycline Tablets, USP 100 MG ( 2.37,600 Bottles x 50 Per Bottles = 1,18,80,000 Tablets) [Doxycycline Tablets, USP 150 MG ( 5,000 Bottles x 30 Per Bottles = 1,50,000 Tablets)
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----- Start of picture text -----<br> 50 mg tablet<br>----- End of picture text -----<br>
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----- Start of picture text -----<br> Norms recommended for mg/tablet<br>tablet<br>100 gmtablet | 150 mg tablet<br>----- End of picture text -----<br>
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----- Start of picture text -----<br> Doxycycline USP 31.7mg —~—sCY|:- 77.55 mg 103.4 mg 155.10 mg<br>(Monohydrate)<br>----- End of picture text -----<br>
Case No.:53/4/82-ALC4/2018 |Party Name:JINDAL DRUGS _ |Meet No/Date:11/82Status; PRIVATE LIMITED ALC4/2018 Deferred 15.11.2018 HQ File RLA File Lic.No/Date:0310817723 Defer Date: :01/82/050/00053/AM19/ :03/94/040/00727/AM 18/ 12.12.2017 Decision: The Committee considered case as per agenda and in the presence of the technical experts, it as noted that in Meeting No. 8/82-ALC4/2018, dt. 31.08.2018, the firm was requested to furnish 143 |following information: i) Fractional Distillation ii) Blending as such following information may be given i) Name of Blending material along with it s quantity ageing 1 kg of export ii) Quantity and value by product obtained during production However, the requisite reply / information is still awaited from the firm. Hence, The Committee decided to issue Final Reminder to firm giving 15 days time to submit above information, failing which the case will be rejected
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----- Start of picture text -----<br> No.:92/4/82-ALC4/2018 |Party Name:MALWA Meet No/Date:11/82- Status:<br>OXYGEN & INDUSTRIAL ALC4/2018 Deferred<br>GASES PVT.LTD.., 15.11.2018<br>HQ File RLA File Lic.No/Date:5610005271 |Defer Date:<br>:01/82/050/00092/AM19/ :56/24/040/00026/AM 18/ 12.12.2017<br>144 |Decision: ‘The Committee considered case as per agenda and in the presence of the technical experts, it<br>was noted that in Meeting No, 8/82-ALC4/2018, dt. 31.08.2018, the firm was requested to furnish complete<br>ical details as per appendix 4E with molecular weight and % of yield at each stage.<br>However, the requisite reply / information is still awaited from the firm. Hence, The Committee decided to<br>issue Final Reminder to firm giving 15 days time to submit above information, failing which the case will<br>be rejected.<br>----- End of picture text -----<br>
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----- Start of picture text -----<br> Case No.:261/4/82-ALC4/2018 |Party Name:VIVIMED LABS Meet No/Date:11/82- Status:<br>LIMITED ALC4/2018 Deferred<br>; 15.11.2018<br>HQ File RLA File Lic.No/Date:0910065727 |Defer Date:<br>:01/82/050/00261/AM19/ :09/24/040/00402/AM 18/ 12.12.2017<br>Decision: The Committee considered case as per agenda and in the presence of the technical experts, it<br>145 |was noted that in Meeting No. 8/82-ALC4/2018, dt. 31.08.2018, the firm was requested to furnish<br>following information:<br>i) Recovery of solvent during production process<br>ii) Production consumption data duly certified by Central Excise / GST<br>However, the requisite reply / information is still awaited from the firm, Hence, The Committee decided<br>----- End of picture text -----<br>
| Se 47 | ! to issue Final Reminder to firm giving 15 days time to submit above information, failing which the case Bw i will be rejected if Case No.:262/4/82-ALC4/2018 |Party Name:VIVIMED LABS |Meet No/Date:1 1/82Status: i LIMITED ALC4/2018 Deferred ei 15.11.2018 ; :01/82/050/00262/AM19/ :09/24/040/00405/AM18/ 12.12.2017 H HQ File RLAFile~—~—~—_{Lic.No/Date:0910065729 pera a Decision: The Committee considered case as per agenda and in the presence of the technical experts, it was i noted that in Meeting No. 8/82-ALC4/2018.dt. 31.08.2018, the firm was requested to furnish following i 146 |information: : i) Recovery of solvent during production process + ii) Production consumption data duly certified by Central Excise / GST However, the requisite reply / information is still awaited from the firm. Hence, The Committee decided ft to issue Final Reminder to firm giving 15 days time to submit above information, failing which the case be will be rejected tf Case No.:215/12/82- No.:215/12/82Party Name:KLJ Name:KLJ Meet No/Date:1 1/82- No/Date:1 1/82- 1/82Status: i: ALC4/2017 PLASTICIZERS LIMITED LIMITED ALC4/2018 Deferred Ps 15.11.2018 as HQ File RLA File Lic.No/Date:0510404915 Defer Date: Date: FE :01/82/050/01170/AM18/ :05/23/040/00334/AM18/ 13.12.2017 2] Decision: The Committee considered Committee considered considered case as per agenda and as per agenda and per agenda and agenda and and in the presence of the presence of presence of of the technical technical experts, it was was iB noted that in Meeting No. No. 8/82-ALC4/2018, dt. 31.08.2018. the firm was requested to furnish following it 147 |information: | a (i) complete technical details as appendix 4E along with technical details as appendix 4E along with details as appendix 4E along with as appendix 4E along with appendix 4E along with 4E along with along with Molecular weight ofexport and import ofexport and importexport and import and import import H (ii) Percentage of yield yield of reaction reaction iii. Material balance Production and consumption data certified 4 by central excise authority or CA. authority or CA. or CA. CA.
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Case No.:215/12/82- No.:215/12/82Party Name:KLJ Name:KLJ Meet No/Date:1 1/82- No/Date:1 1/82- 1/82Status: ALC4/2017 PLASTICIZERS LIMITED LIMITED ALC4/2018 Deferred 15.11.2018 HQ File RLA File Lic.No/Date:0510404915 Defer Date: Date: :01/82/050/01170/AM18/ :05/23/040/00334/AM18/ 13.12.2017 Decision: The Committee considered Committee considered considered case as per agenda and as per agenda and per agenda and agenda and and in the presence of the presence of presence of of the technical technical experts, it was was noted that in Meeting No. No. 8/82-ALC4/2018, dt. 31.08.2018. the firm was requested to furnish following 147 |information: (i) complete technical details as appendix 4E along with technical details as appendix 4E along with details as appendix 4E along with as appendix 4E along with appendix 4E along with 4E along with along with Molecular weight ofexport and import ofexport and importexport and import and import import (ii) Percentage of yield yield of reaction reaction iii. Material balance Production and consumption data certified by central excise authority or CA. authority or CA. or CA. CA. However, the requisite reply / information is still awaited from the firm. Hence, The Committee decided to issue Final Reminder to firm giving 15 days time to submit above information, failing which the case will be rejected
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----- Start of picture text -----<br> Case No.:240/12/82- Party Name:HERBOCHEM Meet No/Date:<br>ALC4/2017 1 1/82- Status:<br>INDUSTRIES ALC4/2018 Deferred<br>15.11.2018<br>|I48 THQ File RLA File Lic.No/Date:0610038759 [Defer Date:<br>:01/82/050/01195/AM18/ :06/24/040/0004 1/AM18/ 14.12.2017<br>Decision: Firm /Ra was requested by email to furnish the copy ofapplication to process the case<br>Case No.:236/12/82- Party Name:FRESENIUS Meet No/Date:1 1/82- Status:<br>ALC4/2017 KABI ONCOLOGY LIMITED |ALC4/2018 Deferred<br>149 15.11.2018<br>HQ File RLA File Lic.No/Date:0510404950 |Defer Date:<br>:01/82/050/01191/AM18/ 205/23/040/00337/AM18/ 15.12.2017<br>け ｍｍ ＝ ｎ ＣｕＩ<br>に<br>”<br>ｍ<br>一<br>一<br>----- End of picture text -----<br>
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Decision: Deferred for comments of TE
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----- Start of picture text -----<br> CaseLC4/2017 No.:201/12/82- INDUSTRIESParty Name:RELIANCELTD. ALC4/2018Meet No/Date:1 1/82- Status:Deferred<br>15.11.2018<br>HQ File File RLA File Lic.No/Date:0310817858 |Defer Date: Date: :<br>:01/82/050/01156/AM18/ :03/95/040/00727/AM 18/ 18.12.2017<br>----- End of picture text -----<br>
150 HQ File File RLA File Lic.No/Date:0310817858 |Defer Date: Date: : :01/82/050/01156/AM18/ :03/95/040/00727/AM 18/ 18.12.2017 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was. noted that the copy of application referred to Department of C&PC for their examination/comments. The comments of Department of Department Department of C&PC C&PC are awaited. The case case is deferred. deferred.
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----- Start of picture text -----<br> comments of Department of Department Department of C&PC C&PC are awaited. The case case is deferred. deferred. f<br>Case No.:205/12/82- Party Name:Y ASHO Meet No/Date:1 1/82- Status:<br>LC4/2017 INDUSTRIES PVT.LTD. ALC4/2018 Deferred é<br>15.11.2018 Poon<br>HQ File RLA File Lic.No/Date:0310817908 [Defer Date: |<br>:01/82/050/01160/AM18/ :03/95/040/00782/AM 18/ 19.12.2017<br>151 Decision: The Committee considered case as per agenda and in the presence of the technical experts, it was<br>|noted that in Meeting No. 8/82-ALC4/2018, dt. 31.08.2018, the firm was requested to furnish the<br>ificate of Analysis (COA) of Clove Leaf Oil and for origin indicating % Engenol Content.<br>However, the requisite reply / information is still awaited from the firm. Hence, The Committee decided to<br>issue Final Reminder to firm giving 15 days time to submit above information, failing which the case will<br>be rejected<br>----- End of picture text -----<br>
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----- Start of picture text -----<br> Case No.:21 1/12/82- Party Name:CADILA [Meet No/Date:1 1/82- Status:<br>ALC4/2017 HEALTHCARE LTD ALC4/2018 Approved<br>(15.11.2018<br>HQ File RLA File Lic.No/Date:0810141577<br>:01/82/050/01166/AM18/ :08/24/040/00274/AM18/ = |20.12.2017<br>Decision: The Committee considered case as per agenda and deliberated on the matter in the presence of<br>the technical experts and as per earlier decision taken by NC in its Meeting No. 8/82-ALC4/2018 dated<br>31.08.2018, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details<br>below with 40% wastage on net content of Estradiol as per DML, the norms allowed is under:<br>EXPORT PRODUCT :<br>152 Estradiol Transdermal System USP (weekly) 0.025 mg/day (Patch Size - 7.5 sq. em)<br>| (Each 7.5 sq. Cm Patch contain 1.888 mg of Estradiol USP)<br>Estradiol Transdermal System USP (weekly) 0.0375 mg/day (Patch Size - 11.25 sq. cm)<br>Each 11.25 sq. cm Patch contain 2.832 mg of Estradiol USP<br>Estradiol Transdermal System USP (weekly) 0.05 mg/day (Patch Size - 15.0 sq. em)<br>Each 15.0 sq. cm Patch contain 3.777 mg of Estradiol USP)<br>Estradiol Transdermal System USP (weekly) 0.06 mg/day (Patch Size - 18.0 sq. em)<br>Each 18.0 sq. cm Patch contain 4.532 mg of Estradiol USP)<br>Estradiol Transdermal System USP (weekly) 0.075 mg/day (Patch Size - 22.5 sq. cm)<br>; EstradiolEach 22.5Transdermalsq: cm PatchSystemcontainUSP5.665 (weekly)mg of Estradiol0.1 mg/dayUSP)(Patch Size - 30.0 sq. cm)<br>Each 30.0 sq. cm Patch contain 7.553 mg of Estradiol USP)<br>Ｉ Ｌ St | tmmort tems Oty. Allowed for11.25em* the export[15cmof 1 No. Patch| 18em*(Quantity __|in22.50 mg em*_] 30cm<br>一<br>----- End of picture text -----<br>
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49 2S BSL"7 Saabs ae = aed epee er: 2.6432 me_| 3.9648 mg | 5.2878 mg | 6.3448 mg | 7.931 mg etg5742 RA may take appropriate actionas per the decision ofNorms Committee Pea Case No.:225/4/82-ALC4/2018 |Party Name: VIRCHOW Meet No/Date:11/82Status: PETROCHEMICAL PVT ALC4/2018 Deferred LTD. 15.11.2018 153 33 HQ:01/82/050/00225/AM19/ File ~_IRLA:09/24/040/00436/AM18/File 20.12.2017Lic.No/Date:0910065771 pee Date:
Decision: The Committee observed that in the similar cases the firm neither attended the PH nor submit the details as asked for vide Minutes of the Meeting No. 1/82/ALC-4/2018, dated 01.05. and 8/82/2018 Dated 31.08.2018, hence the Committee was decided to reject the case
Case No.:106/12/82Party Name:CADILA Meet No/Date:1 i/82Status: ALC4/2017 HEALTHCARE LTD ALC4/2018 Approved 15.11.2018 HQ File RLA File Lic.No/Date:0810141607 :01/82/050/01061/AM18/ :08/24/040/00284/AM18/ 26.12.2017
Decision: The Committee considered the case as per agenda in the presence of the technical experts and 154 as per 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: LS CELIPROLOL TABLETS 200 | Number CELIPROLOL 204.00 MG (CELIPROLOL ZYDUS. ~ HYDROCHLORIDE PH. mg/Tablet 200MG TABLETS) — RA may take appropriate action as per the decision of Norms Committee.
No.:207/12/82Party Name:MAHIMA LIFE Meet No/Date:11/82Status: ALC4/2017 SCIENCES PVT.LTD. ALC4/2018 Deferred ‘a 15.11.2018 HQ File RLA File Lic.No/Date:0510405091 [Defer Date: :01/82/050/01162/AM18/ :05/24/040/00450/AM18/ 26.12.2017 [Decision: Reply received from the firm. The case is deferred for comments ofTE Case No.:221/12/82Party Name:SWISS Meet No/Date:1 1/82Status: ALC4/2017 PARENTERALS LTD ALC4/201815.11.2018 Approved ee File RLA File Lic.No/Date:0810141608 156 |:01/82/050/01176/AM18/ :08/24/040/00279/AM18/ 6.12.2017 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 details below or as applied by firm whichever is lower:
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----- Start of picture text -----<br> No. in gn<br>CEFTRIAXONE SODIUM STERILE USP 1 Vial<br>IGM INJECTION (EACH VIAL CONTAINS<br>CEFTRIAXONE SODIUM STERILE USP CEFTRIAXONE<br>IGM) SODIUM 1.16 gmv/I<br>NET CONTENT OF CEFTRIAXONE STERILE USP | gm vial<br>SODIUM STERILE USP IN EXPORT eae<br>PRODUCTS - 1200 KG<br>CEFTRIAXONE SODIUM STERILE USP 1 Vial<br>500MG EACH VIAL CONTAINS CEFTRIAXONE<br>CEFTRIAXONE SODIUM STERILE 500MG SODIUM mss<br>NET CONTENT OF CEFTRIAXONE STERILE usp _| 87/500 mg<br>SODIUM STERILE USP IN EXPORT vial<br>PRODUCT 275 KG<br>CEFTRIAXONE SODIUM STERILE USP 3<br>250MG (EACH VIAL CONTAINS CEFTRIAXONE | 9 59<br>CEFTRIAXONE SODIUM STERILE 250MG) | , yj; SODIUM mae<br>NET CONTENTS OF CEFTRIAXONE = STERILE USP — ms<br>SODIUM STERILE USP IN EXPORT bis<br>PRODUCT-100 KG<br>----- End of picture text -----<br>
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----- Start of picture text -----<br> No.:29/4/82-ALC4/2018 |Party Name: VAKS PHARMA {Meet No/Date:11/82- Status:<br>PVT.LTD.. ALC4/2018 Deferred<br>15.11.2018<br>157 11Q File RLA File Lic.No/Date:0310818019 Defer Date:<br>:01/82/050/00029/AM19/ :03/95/040/00752/AM18/ 26.12.2017<br>|Decision: Deferred for comments of TE.<br>o/Date:11/82- [Status:<br>Case No.:205/4/82- Party Taste‘Meet No/Date:11/82-<br>ALC4/2018 Name:GULBRANDSEN ‘ALC4/2018 Approved<br>CHEMICALS PVT LTD 15.11.2018<br>HQ File RLA File Lic.No/Date:341004374<br>:01/82/050/00205/AM19/|:34/24/040/00263/AM18/_ 3<br>26.12.2017<br>神 ヽ<br>‐ ―<br>ヽ<br>----- End of picture text -----<br>
Decision: The Committee considered case as per agenda and in light of earlier decision taken in Meeting 158 {No. 10/82 dated 10.01.2018 and also and in consultation with technical authority present in meeting, decided to ratify 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 -----<br> Quanti<br>TriTEAL Ethyl Aluminium oa | Aluminium Grit / Granules<br>RA may take appropriate action as per the decision ofNorms Committec..<br>----- End of picture text -----<br>
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----- Start of picture text -----<br> 0.270 kg<br>----- End of picture text -----<br>
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| ae Case No.:217/12/82Party Name: TITAN Meet No/Date:1 1/82Status: : | ALC4/2017 LABORATORIES PVT. LTD. |ALC4/2018 Deferred ; 15.11.2018 || i‘: HQ:01/82/050/01172/AM18/File RLA:03/95/040/008File 1 1/AM18/ 27.12.2017Lic.No/Date:0310818044 | |Defer Date: : Decision: The Committee considered case as per agenda and in the presence of the technical experts, it i 159 of\was Drug notedManufacturing that in Meeting No. 8/82-ALC4/2018,Formula (DML). dt. 31.08.2018, the firm was requested to furnish a copy | i However, the requisite reply / information is still awaited from the firm. Hence, The Committee decided to % issue Final Reminder to firm giving 15 days time to submit above information, failing which the case will = Case No.:220/12/82Party Name:RELIANCE Meet No/Date:11/82Status: = ALC4/2017 INDUSTRIES LTD. » |ALC4/2018 Deferred A 15.11.2018 £ 160 HQ File RLA File Lic.No/Date:0310818025 |Defer Date: rH :01/82/050/01175/AM18/ :03/95/040/00654/AM18/ 27.12.2017 a Decision: The Committee considered the case as per agenda in the presence of technical experts and it was a noted that the copy of application referred to Department of C&PC for their examination/comments. The * comments of Department of C&PC are awaited. The case is deferred. ii Case No.:105/12/82Party Name:ARBEE Meet No/Date:11/82Status: Fy ALC4/2017 BIOMARINE EXTRACTS ALC4/2018 Deferred = PVT. LTD 15.11.2018 % HQ File RLA File Lic.No/Date:1010059863 |Defer Date: 2 :01/82/050/01060/AM 18/ :10/24/040/00045/AM18/ 01.01.2018 é Decision: The Committee considered case as per agenda and in the presence of the technical experts, it was i 161 noted that in Meeting No. 8/82 ALC4/2018. dt, 31.08.2018, the firm was requested to furnish following ¢ (i) Complete technical details as appendix 4E along with molecular of weight of export and #3 import; percentage of yield of reaction and material balance. ¥ However, the requisite reply / information is still awaited from the firm. Hence, The Committee decided to Bi issue Final Reminder to firm giving 15 days time to submit above information, failing which the case will } be rejected.
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ase No.:219/12/82Party Name:MAHIMA LIFE [Meet No/Date:11/82[Status: ALC4/2017 SCIENCES PVT.LTD. ALC4/2018 Deferred 1‘ 15.11.2018 HQ File RLA File Lic.No/Date:0510405200 |Defer Date: :01/82/050/01174/AM18/ :035/24/040/00490/AM18/ 02.01.2018 Decision: Reply received from the firm. Case is Deferred for comments ofTE. 163= No.:233/12/82Party Name:STRIDES Meet No/Date:11/82_[Status: ALC4/2017 SHASUN LIMITED ALC4/2018 Deferred
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----- Start of picture text -----<br> | (15.1 1.2018 |<br>; ie:01/82/050/01188/AM18/ File RLA:04/24/040/00180/AM File 18/ Lic.No/Date:04101638512.01.2018 |Defer Date:<br>Decision: Deferred for comments of TE ,<br>No.:234/12/82- Party Name:STRIDES Meet No/Date:<br>ALC4/2017 SHASUN LIMITED ALC4/2018 1 1/82- Status:Deferred |<br>15.11.2018<br>ac<br>HQ File _ |RLA File Lic.No/Date:0410163850 |Defer Date: .<br>:01/82/050/01189/AM18/ :04/24/040/00177/AM 18/ 02.01.2018<br>Decision: Deferred for comments of TE<br>Case No.:88/4/82-ALC4/2018 |Party Name:MALWA Meet No/Date:1 1/82- Status:<br>OXYGEN & INDUSTRIAL = |ALC4/2018 Deferred<br>GASES PVT.LTD., 15.11.2018<br>HQ File RLA File Lic.No/Date:5610005293 |Defer Date:<br>:01/82/050/00088/AM19/ :56/24/040/00034/AM 18/ 02.01.2018<br>----- End of picture text -----<br>
Decision: The Committee considered case as per agenda and in the presence of the technical experts, it was 165 noted that in Meeting No. 8//82 ALC4/2018, dt. 31.08.2018, the firm was requested to furnish following information:
(i) Complete technical details as appendix 4E along with molecular weight and percentage of yield at each stage. However, the requisite reply / information is still awaited from the firm. Hence, The Committee decided to issue Final Reminder to firm giving 15 days time to submit above information, failing which the case will be rejected.
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----- Start of picture text -----<br> Case No.:97/4/82-ALC4/2018 |Party Name:HELLO PAINTS _ |Meet No/Date:11/82- Status:<br>(P) LTD ALC4/2018 Deferred<br>15.11.2018<br>166 |HQ File RLA File Lic.No/Date:0510405230 |Defer Date:<br>:01/82/050/00097/AM19/ :05/23/040/00385/AM 18/ 04.01.2018<br>----- End of picture text -----<br>
Decision: The Committee considered the case as per agenda and it was decided to call for complete nical details as per appendix 4E from the firm.
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----- Start of picture text -----<br> Case No.:159/4/82-ALC4/2018 |Party Name:GLOBAL Meet No/Date:1 1/82- Status:<br>CALCIUM PRIVATE ALC4/2018 Deferred<br>LIMITED, 15.11.2018<br>HQ File RLA File Lic.No/Date:0710112636 |Defer Date:<br>:01/82/050/00159/AM19/ :07/24/040/0027 1/AM18/ 04.01.2018<br>167 Decision: The Committee considered case as per agenda and in the presence of the technical experts, it was<br>noted that in Meeting No. 8//82 ALC4/2018, dt. 31.08.2018, the firm was requested to furnish following<br>information:<br>----- End of picture text -----<br>
i) Complete and balanced chemical reactions showing molecular weight, molar requirement ii) Copy of technical literature in support of low yield at different stages.
However, the requisite reply / information is still awaited from the firm. Hence, The Committee decided to
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No.:124/4/82-ALC4/2018 |Party Name:KEVA Meet No/Date:1 1/82Status: FRAGRANCES PRIVATE LC4/2018 Deferred 168 LIMITED 15.11.2018 11Q File RLA File Lic.No/Date:0310818348 [Defer Date: :01/82/050/00124/AM19/ :03/94/040/00762/AM18/ 09.01.2018 |Decision: Deferred for comments ofTE te iS
Case No.:241/12/82Party Name:HERBOCHEM [Meet No/Date:11/82Status: ALC4/2017 INDUSTRIES ALC4/2018 Deferred 169 15.11.2018 iQ File RLA File Lic.No/Date:0610038783 [Defer Date: :01/82/050/01196/AM18/ :06/24/040/00044/AM 18/ 10.01.2018 Decision: Firm /Ra was requested by email to furnish the copy of application to process the case.
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|‘ase No.:30/4/82-ALC4/2018||Party Name:STRIDES|Meet No/Date:1|1/82-|Status:|
|SHASUN LIMITED|ALC4/2018|Deferred|
|170|15.11.2018|
|iQ|File|RLA|File|Lic.No/Date:0410163894|[Defer Date:|
|:01/82/050/00030/AM19/|:04/24/040/00209/AM18/|12.01.2018|
||Decision:|Deferred for|comments ofTE|
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|No.:12/4/82-ALC4/2018||Party|Name:|MELOG|Meet No/Date:1 1/82-|Status:|
|SPECIALITY CHEMICALS|—||ALC4/2018|Deferred|
|PVT.|LTD.|15.11.2018|
|HQ File|RLA|File|Lic.No/Date:0310818490||Defer Date:|
|:01/82/050/00012/AM19/|:03/95/040/008 10/AM18/|15.01.2018|
|Decision:|The Committee|considered|case|as|per agenda and|in|the|presence of the|technical|experts,|it|
|171|was|noted|that|in|Meeting|No.|8//82|ALC4/2018,|dt.|31.08.2018,|the|firm|was|requested|to|furnish|
||following|information:|
|(i)|Complete technical|details as appendix 4E along with Molecular weight of export and|import;|
|percentage of|yield of reaction and|Material|balance.|
|However, the requisite reply / information|is|still awaited from the firm. Hence, The Committee decided to|
|issue|Final|Reminder|to firm giving|15 days time to submit above information,|failing which the case will|
|be|rejected|
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~ ‘ase No.:26/4/82-ALC4/2018 |Party Name:JUBILANT [Meet No/Date:11/82Status: GENERICS LTD ALC4/2018 Approved 15.11.2018 HQ File RLA File Lic.No/Date:05 10405351 :01/82/050/00026/AM 19/ :05/23/040/00396/AM18/ 15.01.2018
Decision: The Committee re-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:
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----- Start of picture text -----<br> Export product Qty. | SI. Qty. allowed<br>= No.<br>Valacyclovir Film Coated Tablet | 1 No. Valacyclovir Hydrochloride USP 600.48 mg<br>500 mg (Valacyclovir HCL USP hydrate)<br>Valacyclovir Film Coated Tablet | 1 No. | 2. Valacyclovir Hydrochloride USP | 1200.96 mg<br>1000 mg (Valacyclovir HCL USP<br>hydrate)<br>％<br>----- End of picture text -----<br>
Note: The firm is advised to mentioned Hydrate / Anhydrous form of import item Valacyclovir HCL USP in future. : RA may take appropriate action as per the decision of Norms Committee.
ase No.:11/4/82-ALC4/2018 |Party Name:REYAANSH Meet No/Date:11/82Status: HEALTHCARE ALC4/2018 Deferred 15.11.2018 173 |HQ File RLA Pile Lic.No/Date:03 10818545 |Defer Date: :01/82/050/00011/AM19/ :03/95/040/00872/AM 18/ 16.01.2018
Decision: The Committee considered the case as per agenda and it was decided to call for the Drug Manufacturing Licence from the firm.
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Case No.:128/4/82-ALC4/2018 |Party Name:ALIVIRA Meet No/Date:11/82Status: ANIMAL HEALTH LIMITED |ALC4/2018 Deferred 15.11.2018 HQ File RLA File Lic.No/Date:0310818544 |Defer Date: :01/82/050/00128/AM19/ :03/94/040/00811/AM18/ 16.01.2018
174 |Decision: The Committee considered case as per agenda and in the presence of the technical experts, it was noted that in Meeting No. 9/82 ALC4/2018, dt. 18.09.2018, the firm was requested to furnish a copy f Drug Manufacturing Licence.
However, the requisite reply / information is still awaited from the firm. Hence, The Committee decided to issue Final Reminder to firm giving 15 days time to submit above information, failing which the case will be rejected.
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Case No,:23/4/82-ALC4/2018 (Party Name:RECKITT Meet No/Date:11/82- ~ ‘ |Status: EMDLABENCKISER PRIVATE HEALTHCARE LIMITED |ALC4/201815.11.2018 Deferred :01/82/050/00023/A M19/ :05/24/040/005 17/AM18/ 19.01.2018 175 FQ File RLA File Lic.No/Date:0510405419 os Date: Decision: Deferred for comments of TE. ; Case No.:24/4/82-ALC4/2018 |Party Name:SUN Meet No/Date:1 1/82Status: PHARMACEUTICAL ALC4/2018 Deferred INDUSTRIES LTD. 15.11.2018 :01/82/050/00024/AM19/ :05/24/040/00525/AM18/ 30.01.2018 176 TQ File RLA File Lic. No/Date:0510405456 | | Decision: Deferred for comments of TE.
— Case No.:76/4/82-ALC4/2018 ReParty Name:RELIANCEae ee ae ene Meet No/Date:11/82Status:. INDUSTRIES LTD. ALC4/2018 Deferred 15.11.2018 177 HQ File RLA File Lic.No/Date:0310818749 |Defer Date: :01/82/050/00076/AM19/ :03/95/040/00833/AM18/ 30.01-2018 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the copy of application referred to Department of C&PC for their examination/comments. The comments of Department of C&PC are awaited. The case is deferred.
Case No.:127/4/82-ALC4/2018 Party Name: CIPLA LIMITED |Meet No/Date:1 1/82Status: ALC4/201815.11.2018 Deferred 178 HQ File RLA File : Lic.No/Date:0310818765 (Defer Date: |:01/82/050/00127/AM19/ :03/94/040/00822/AM18/ 30.01.2018
Decision: The Committee considered the case as per agenda and it was decided to ask the firm to furnish following information: (i) Copy of DML for each export product; (ii) Master Batch Formula for each export product and (iii) OC from Ministry of Environment Forest and Climate Change.
- {Case No.:121/4/82-ALC4/2018 Party Name:GLENMARK Meet No/Date:11/82Status: PHARMACEUTICALS LTD., |ALC4/2018 Deferred 179 15.11.2018 THQ File RLA File Lic.No/Date:0310818971 [Defer Date: :01/82/050/00121/AM19/ :03/94/040/00908/AM 18/ 07.02.2018 |Decision: Deferred for comments of TE s
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----- Start of picture text -----<br> Case No.:142/4/82-ALC4/2018 |Party Name:HERBOCHEM Meet No/Date:11/82- Status:<br>va INDUSTRIES ALC4/2018 Deferred<br>15.11.2018<br>IHQ File IRLA File Lic. No/Date:0610038810 [Defer Date:<br>‐８０<br>一<br>----- End of picture text -----<br>
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[:01/82/050/00142/AM19/ :06/24/040/00047/AM18/ 7.02.2018 Pee, ae poet RA was requested by email to furnish the copy of application to process the!
Case No.:69/4/82-ALC4/2018 |Party Name:RHODIA Meet No/Date:1 1/82Status: SPECIALTY CHEMICALS ALC4/2018 Deferred INDIA PVT. LTD. 15.11.2018 HQ File RLA File Lic.No/Date:0310819042 |Defer Date: :01/82/050/00069/AM19/ :03/95/040/00976/AM 18/ 08.02.2018
181 ision: The Committee considered case as per agenda and in the presence of[the.technical][experts,][it}] noted that in Meeting No. 8/82 ALC4/2018, dt. 31.08.2018, it was decided to call from the firm complete technical details as per appendix 4E and chemical name of “Tolcide PS 70a. However, the requisite reply / information is still awaited from the firm. Hence, The Committee decided to issue Final Reminder to firm giving 15 days time to submit above information, failing which the case will be rejected.
a
Case No.:83/4/82-ALC4/2018 |Party Name:SUN Meet No/Date:11/82Status: PHARMACEUTICAL ALC4/2018 Deferred INDUSTRIES LTD. 15.11.2018 182 11Q File RLA File LicNo/Date:0510405614 [Defer Date: :01/82/050/00083/AM19/ :05/24/040/00558/AM18/ 12.02.2018 Decision: Deferred for comments of TE. : No.:82/4/82-ALC4/2018 |Party Name:V.D.H. Meet No/Date:1 1/82Status: ORGANICS PVT. LTD ALC4/2018 Deferred 15.11.2018 183 |HQ File RLA File Lic.No/Date:05 10405632 |Defer :01/82/050/00082/AM19/ :05/24/040/00563/AM18/ 13.02.2018 Date:31.08.2018 ision: The Committee considered the case as per agenda and it was decided to call for the complete ical details as per appendix 4E from the firm. No.:95/4/82-ALC4/2018 |Party Name: DEEPAK Meet No/Date:[1][1/82-] Status: OVOCHEM ALC4/2018 Approved TECHNOLOGIES LTD 15.11.2018 eee HQ:01/82/050/00095/AM19/File RLA:31/83/040/00129/AM18/File | 13.02.2018Lic.No/Date:3 110066979 Decision: The Committee considered case as per agenda and in light of earlier decision taken in Meeting 184 No.[meeting,] 10/82-ALC4/2018,[it][was][decided] dated[to][ratify] 10.01.2018[norms][under] and also[para] and[4.7][of] in consultation[ HBP][as][per] with[details] technical[below][or] authority[as][applied] present[by][firm] in hichever is lower:Quantit RA may take appropriate action as per the decision of Norms Committee.
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Case No.:103/4/82-ALC4/2018 |Party Name:CONCORD Meet No/Date:1 1/82Status: BIOTECH LTD ALC4/2018 Deferred 15.11.2018 HQ:01/82/050/00103/AM19/ File RLA:08/24/040/00328/AM18/ File 14.02.2018ic.No/Date:0810142000 =x Date:
Decision: The Committee considered case as per agenda and in the presence of the technical experts, it 185 as noted that in Meeting No. 8/82 ALC4/2018, dt. 31.08.2018, the firm was requested to furnish following information: :
i) Pack size of export item and ii) Drug Manufacturing Licence (DML). =
However, the requisite reply / information is still awaited from the firm. Hence, The Committee decided to issue Final Reminder to firm giving 15 days time to submit above information, failing which the case will be rejected
ase No.:139/4/82-ALC4/2018 |Party Name:RELIANCE Meet No/Date:11/82Status: INDUSTRIES LTD. ALC4/2018 Deferred 186 HQ File RLA File Lic.No/Date:0315.11.2018 10819233 |Defer Date: :01/82/050/00139/AM19/ :03/95/040/00834/AM18/ 19.02.2018 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the copy of application referredto Department of C&PC for their examination/comments. The comments of Department of C&PC are awaited. The case is deferred.
ase No.:143/4/82-ALC4/2018 |Party Name:HELLO PAINTS — |Meet No/Date:11/82Status: (P) LTD ALC4/2018 Deferred 15.11.2018 187 |HQ File RLA File Lic.No/Date:0510405684 |Defer Date: :01/82/050/00143/AM19/ :05/23/040/00453/AM18/ 20.02.2018 Decision: The Committee considered the case as per agenda and it was decided to call for complete echnical details as per appendix 4E from the firm.
ase No.:140/4/82-ALC4/2018 |Party Name:RECKITT Meet No/Date:1 1/82Status: BENCKISER (INDIA) ALC4/2018 Deferred 188 PRIVATE LIMITED 15.11.2018 170 File RLA File Lic.No/Date:0510405700 (Defer Date: | Decision::01/82/050/00140/AM19/ Deferred for comments of:05/24/040/00592/AM18/TE 21.02.2018
Case No.:141/4/82-ALC4/2018 |Party Name:STERILE INDIA — {Meet No/Date:1 1/82Status: PRIVATE LIMITED ALC4/2018 Deferred ca 15.11.2018 HQ File RLA File Lic.No/Date:0510405693 |Defer Date: :01/82/050/00141/AM19/ :05/24/040/00577/AM 18/ 21.02.2018 Decision: Deferred for comments of TE a
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----- Start of picture text -----<br> Case No.:286/4/82-ALC4/2018 |Party Name:SURVIVAL Meet No/Date:11/82- Status:<br>TECHNOLOGIES PVT.LTD. |ALC4/2018 Deferred<br>15.11.2018<br>, a HQ File RLA File Lic.No/Date:0310819412 |Defer Date:<br>:01/82/050/00286/AM19/ :03/95/040/00993/AM 18/ 26.02.2018<br>Decision: Deferred for comments of TE.<br>Case No.:6/4/82-ALC4/2018 — |Party Name:SHREE BANKEY [Meet No/Date:11/82- Status:<br>BEHARI LAL FLAVORS ALC4/2018 Deferred<br>15.11.2018<br>191 1Q File RLA File Lic.No/Date:0510405729<br>:01/82/050/00006/AM19/ 705/24/040/00597/AM 18/ 27.02.2018<br>(Decision: Deferred for comments of TE<br>Case No.:145/4/82-ALC4/2018 |Party Name:JUBILANT LIFE |Meet No/Date:1 1/82- Status:<br>SCIENCES LIMITED ALC4/2018 Approved<br>15.11.2018<br>HQ File RLA File Lic.No/Date:05 10405736 :<br>:01/82/050/00145/AM19/ :05/23/040/00430/AM L8/ 27.02.2018<br>Decision: The Committee considered case as per agenda and as per earlier decision taken by NC in its<br>6/82-ALC4/2018 dated 26.07.2018 and 8/82-ALC4/2018 dated 31.08.2018, it was decided to ratify the ad-<br>hoe input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is<br>lower:<br>TQ.<br>sop} [Expotproduct | Qy. [SUNo. | importitems<br>peaceidi i TT ac 0.019 k,<br>/2 | Ethyl Alcohol (Denatured) 2.294 kg<br>Propionaldehyde 0.073 kg<br>3 Cyano Pyridine 2 oe Denatured Ethyl Alcohol Go" aes<br>[6 | Methanol | 405 kg<br>Alumino Silicate Catalyst 0.023kg<br>|8_| Propionaldehyde<br>RA may take appropriate action as per the decision of Norms Committee.<br>Case No.:146/4/82- Party Name:JUBILANT Meet No/Date: 1 1/82- Status:<br>ALC4/2018 LIFE SCIENCES LIMITED |ALC4/2018 Approved<br>15.11.2018<br>HQ File RLA File Lic.No/Date:05 10405723<br>193 |:01/82/050/00146/AM19/ :05/23/040/0038 1/AM 18/ 27.02.2018<br>Decision: The Committee considered case as per agenda and as per earlier decision taken by NC in its<br>6/82-ALC4/2018 dated 26.07.2018 and 8/82-ALC4/2018 dated 31.08.2018, it was decided to ratify the ad-<br>hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is<br>lower:-<br>----- End of picture text -----<br>
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----- Start of picture text -----<br> -<br>Beta Picoline |! | Denatured Ethyl Alcohol 1.120<br>Se<br>oro ee<br>Alumino Silicate Catalyst<br>|S__| [Propionaldehyde] 0.057<br>Pyridine 98% Min ces Alumino Silicate Catalyst 0.019 kg<br>8 | Propionaldehyde 0.073 kg<br>Ethyl Alcohol (Denatured) 2.194 kg<br>Piperidine (Min Purity Ruthenium Alumina Catalyst 0.00196<br>99%) Ruthenium 5 %<br>| 11 | Alumina Silicate Catalyst 0.01896<br>Denatured Ethyl Alcohol 2.242<br>Propionaldehyde<br>RA concerned may take further necessary action as per above decision of NC<br>----- End of picture text -----<br>
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----- Start of picture text -----<br> Case No.:162/4/82-ALC4/2018 |Party Name:GLOBAL Meet No/Date:11/82- Status:<br>CALCIUM PRIVATE ALC4/2018 Approved<br>LIMITED, 15.11.2018<br>:01/82/050/00162/AM19/ :07/24/040/00280/AM18/ 05.03.2018<br>HQ File RLA File Lic.No/Date:0710112927<br>Decision: The Committee considered the case as per agenda and in the light of earlier decision taken in<br>permeeting details no. given 1/82-ALC4/2018below or as applied dated 01.05.2018,by the firm,itwhichever was decidedis toless: ratify norms under Para 4.7 of HBP v1 as<br>kg<br>ALCIUM LACTOBIONATE || 1. CALCIUM CARBONATE 0.172 kg<br>194| (USP/USP FOR INJECTION) ><br>ALCIUM 11. __ | CALCIUM CARBONATE 0.360ke |<br>BROMOLACTOBIONATE [2 [across «1.02 kg<br>HYDROBROMIC ACID 0.510 kg<br>Ike [1.| CALCIUM CARBONATE 0.259kg<br>)<br>ALCIUM GLUBIONATE |2._ {LACTOSE=| 0.829 kp<br>FOR INJECTION) — - 3. CALCIUM GLUCONATE - | 0.430 kg<br>ORAL GRADE<br>LACTOBIONIC ACID (Eur.Ph)tke pe CALCIUM CARBONATE 0.234 kg<br>A may take appropriate action as per the decision of Norms Committee<br>19s Case No.:165/4/82-ALC4/2018 |Party Name:SYNNAT Meet No/Date:11/82- Status:<br>PHARMA PRIVATE ALC4/2018 Deferred<br>●<br>刊<br>----- End of picture text -----<br>
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| LIMITED ry {15.11.2018 | fie101/82/050/00165/AM19/ File :02/24/040/00188/AM18/RLA File Lic.No/Date:02102082607.03.2018 |Defer Date:
Decision: The Committee considered the case as per agenda and it was decided to call for Certificate of Analysis (COA) of the import item from foreign supplier production consumption of Noscapine BP USP Ph.Eur JP CP / Noscapine Hydrochloride BP Ph.Eur separately certified by CA from the firm.
Case No.:177/4/82-ALC4/2018 |Party Name:RELIANCE Meet No/Date:11/82Status: INDUSTRIES LTD. ALC4/2018 Deferred 15.11.2018 196 HQ File RLA File Lic.No/Date:0310819780 |Defer Date: :01/82/050/00177/AM19/ :03/95/040/01001/AM18/ 14.03.2018
Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the copy of application referred to Department of C&PC for their examination/comments. The comments of Department of C&PC are awaited. The case is deferred.
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----- Start of picture text -----<br> Case No.:168/4/82-ALC4/2018 [Party Name:CLEAN SCIENCE {Meet No/Date:1 1/82- Status:<br>AND TECHNOLOGY ALC4/2018 Deferred<br>PVT.LTD. 15.11.2018<br>197 fQ File RLA File LieNo/Date:3110067008 [Defer Date:<br>01/82/050/00168/AM19/ 31/83/040/00165/AM18/ 20.03.2018<br>Decision: Deferred for comments of TE =<br>Case No.:169/4/82-ALC4/2018 [Party Name:CLEAN SCIENCE {Meet No/Date:1 1/82- Status:<br>AND TECHNOLOGY ALC4/2018 Deferred<br>PVT.LTD. 15.11.2018<br>ae HQ File RLA File (Lic.No/Date:3110067007 [Defer Date:<br>:01/82/050/00169/AM19/ :31/83/040/00164/AM18/ '20.03 2018<br>Decision: Deferred for comments of TE<br>Case No.:178/4/82-AL.C4/2018 (Party Name:RELIANCE ——_ [Meet No/Date:11/82- Status:<br>INDUSTRIES LTD. ALC4/2018. Deferred<br>15.11.2018<br>:01/82/050/00178/AM19/ :03/95/040/01042/AM 18/ 22.03.2018<br>199 HQ File RLA File Lic.No/Date:0310820011 |Defer Date:<br>Decision: The Committee considered the case as per agenda in the presence of technical experts and it was<br>noted that the copy of application referred to Department of C&PC for their examination/comments. The<br>comments of Department of C&PC are awaited. The case is deferred.<br>Case No.:166/4/82-ALC4/2018 |Party Name: DEEPAK Meet No/Date:11/82- Status:<br>OVOCHEM ALC4/2018 Approved<br>TECHNOLOGIES LTD 15.11.2018<br>HQ File RLA File Lic.No/Date:3 110067012<br>ca [Decision:] :01/82/050/00166/AM19/ [The][ Committee] [considered] :31/83/040/00156/AM18/ [case] [as] [per][ agenda] [and] [in] [the] 23.03.2018 [presence] [of][ the] [technical] [experts,] [and]<br>per earlier decision taken by NC in its 9/AM19 meeting dated 18.09.2018, it was decided to ratify the<br>ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is<br>lower:<br>----- End of picture text -----<br>
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----- Start of picture text -----<br> |<br>----- End of picture text -----<br>
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: fas | P Poms | :
_ Export product Qty. | SI. No. 2,6 Xylidine Ikg [1 | OrthoCresol
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----- Start of picture text -----<br> Qty.<br>| C27<br>----- End of picture text -----<br>
To be consult with TE
RA may take appropriate action as per the decision of Norms Committee a Rann a irs ack cl emanate a Te eT Oe Case No.:287/4/82-ALC4/2018 |PartyINTERNATIONAL Name:PREGNA Meet No/Date:1 1/82Status: : LTD. LC4/2018 Withdrawn 15.11.2018 Dino hee Lic.No/Date:03 10821409 :01/82/050/00287/AM19/ :03/95/040/0020 1/AM19/ 04.06.2018
underDecision: para It4.7.1 wasHBPdecidedv1. to withdraw the case as advance authorization has been issued on repeat basis
Manual Cases Case No. B-1 M/s. Ami Organics Pvt. Ltd., Surat Meeting No. 11/AM19 dated 15.11.2018 | F. No.01/82/50/576/AM15/DES-II RA F.No. 52/24/40/00010/AM15 Adv. Lic. No.5210041062 dated 23.05.2014 Decision: The Committee considered the case as per agenda and in consultation with technical expert present in the meeting, it was decided to amend the description of export item to be read as 3-4-DI-HYDROXY 5-NITRO BENZALDEHYDE - 99% MIN instead of 3-4- HYDROXY 5-NITRO BENZALDEHYDE - 99% MIN. The rest of the minutes of meeting No.19/AM17 dated 08.03.2017 (at serial B.6) would remain same.
RA concerned may take further necessary action as per above decision ofNC
Case No. B- 2 M/s. Ami Organics Pvt. Ltd., M.No. 11/AMI9 F.No. 01/82/050/00467/AM14 Date 15.11.2018 F.No. 52/24/040/00015/AM14 Decision: Advy.Auth. No. 5210040038 dated 30.07.2013 experts Committee considered case as per agenda and deliberated on the matter in the presence of the technical and, it was decided to ratify the ad-hoe input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: AMINOACETALDEHYDE Ikg CHLOROACETALDEHYDE 2.00 kg DIMETHYL ACETAL 98% MIN. ACETAL 98% MIN. 98% MIN. MIN. DIMETHYL ACETAL 98% MIN
Poms ‘ AMINOACETALDEHYDE Ikg CHLOROACETALDEHYDE | : : DIMETHYL ACETAL 98% MIN. ACETAL 98% MIN. 98% MIN. MIN. |i }‘ RA concerned may take further necessary action as per above decision of NC
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Case No. B- 3 M/s. Ami Organics Pvt. Ltd., M.No. 1/AMI9 F.No. 01/82/050/01125/AM14 Date 15.11.2018 F.No. 52/24/040/00031/AM14 Ady.Auth. No. 5210040368 dated 31.10.2013
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: AMINOACETALDEH YDE CHLOROACETALDEHYDE| 2.00 kg DIMETHYL ACETAL DIMETHYL ACETAL 98% MIN. 98% MIN
RA concerned may take further necessary action as per above decision of NC
Case No. B- 4 M/s. ETERNIS FINE CHEMICALS LIMITED., M.No. IVAMI9 F.No. 01/82/050/00927/AM18/DES-III Date 15.11.2018 F.No. 03/94/040/00545/AM18 Adv.Auth. No. 0310816279 dated 10.10.2017
Decision: The Committee re-considered case as per agenda and in the presence of the technical experts, it was decided to revise the ad-hoe 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: uantit MENTHANOL(4-Isopropy| = se rae 1.350 kg Cyclohexy! Methanol) 1 Kg : 3% RUTHENIUM ON cane : CARBON CATALYST | -"
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----- Start of picture text -----<br> Case No. B- 5 M/s. Jubilant Generics Limited<br>M.No. IV/AMI9 F.No. 01/82/050/00891/AM17/DES-III<br>ae Ta0ig F.No. 01/82/050/00123/AM18/DES-III<br>----- End of picture text -----<br>
F.No. 01/82/050/01423/AM16/DES-III F.No. 01/82/050/00978/AM18/DES-III RLA F.No. 05/23/040/00323/AM17 Advance Licence No. 0510400088 Date 13.10.2016 RLA F.No. 05/23/040/00603/AM17 Advance Licence No. 0510402078 Date 28.03.2017 RLA F.No. 05/23/040/00337/AM16 Advance Licence No. 0510396395 Date 23.11.2015 RLA F.No. 05/23/040/00314/AM18 Advance Licence No. 0510404765 Date 07.12.2017
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----- Start of picture text -----<br> Decision: The Committee re-considered case as per agenda for revision of norms. The representative of the<br>firm appeared before the norms committee in the presence of the technical experts. The firm has furnished<br>COA’s of various import consignment, showing assay and water content in valacyclovir Hel Hydrate USP<br>along with past production consumption certificate issued by Central Tax GST Authorities. It was decided to<br>revise the ad-hoc input output norms in respect of above mentioned advance authorization under para 4.7 of<br>HBP as per details below or as applied by firm whichever is lower:<br>Valacyclovir Film Coated Tablet Valacyclovir Hydrochloride USP 600.48 mg<br>500 mg (Valacyclovir HCL USP hydrate)<br>1000 mg (Valacyclovir HCL USP hydrate)<br>Valacyclovir Film Coated Tablet | 1 No. | 2. — Valacyclovir Hydrochloride USP | 1200.96 mg<br>USPNote:in Thefuture. firm is advised to mentioned Hydrate / Anhydrous form of import item Valacyclovir HCL<br>RA may take appropriate action as per the decision of Norms Committee.<br>----- End of picture text -----<br>
Case No. B- 6 M/s. PRASOL CHEMICALS PRIVATE LIMITED., M.No. I1/AMI9 F.No. 01/82/050/00070/AM19/DES-III Date IS.11.2018 F.No. 03/95/040/00916/AMI18 - Decision: Adv.Auth. No. 0310818880 dated 05.02.2018 the Committee re-considered case as per agenda for revision of norms and deliberated on the matter in be presence of the technical experts, taking into consideration on evaporation loses, lighter / heavier cut cannot extracted in the process and as per production consumption data import item, it was decided to revise the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
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