DGFT Committee Minutes
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Office of Directorate General of Foreign Trade Norms Committee (NC-3)
New Delhi —
Minutes of the Meeting No. 12/82-ALC4/2018 dated 12.12.2018 (actually held on 13.12.2018, 14.12.2018 and 04.01.2019) for considering the cases/issues under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy, 2015-20 pertaining to Chemical and Allied products falling under Chapter 29 and 30, held under the Chairmanship of Shri Satyan Sharda, Addl. DGFT in Room No.1 1, Udyog Bhawan, New Delhi.
Following members were present:-
Shri Nirmal Kumar, Dy. Director General of Foreign Trade Shri S.K. Pangrahi, Economic Officer Consultant, Technical Expert Pharmaceuticals Consultant, Technical Expert Chemicals . \ The committee went through the minutes of earlier meeting No. 1 1/824ALC4/2018 MEETING DATE: 15.11.2018 and approved the same.
Meeting No. 12/82-ALC4/2018 dated 12.12.2018 (actually
held on 13.12.2018, 14.12.2018 and 04.01.2019
Case No.:14/12/82-ALC4/2018 LABORATORIESParty Name:WEXFORD Meet No/Date:1 2/82Status: P LTD ALC4/2018 Rejected : 12.12.2018 1 HQFile RLA File Lic.No/Date:0710101548 :01/82/050/0064 1/AM19/ :07/24/040/00382/AM14/ 23.01.2014 Decision: | The Committee observed that both the export and import item is same. Hence, it was decided to reject the case. Case No.:22/12/82-ALC4/2018 CHEMICALSParty Name:ONEIRO Meet No/Date:1 2/82Status: LTD ALC4/2018 Approved 12.12.2018 HQ File RLA File Lic.No/Date:3410041118 :01/82/050/00649/AM19/ :34/24/040/00347/AM15/ 31.03.2015
Decision: | The Committee considered case as per agenda and in the presence of the technical experts, it 2 wasby firm decidedwhichever to ratifyis thelower: ad-hoc input output norms under para 4.7 of HBP as per details below or as applied Export product ==——s—i<ité‘~™«Qty.:«S;SS.séd| Import items SOSC=CS~S Qty | 4,5,6,7-Tetrahydro(3,2,C) Thiono | | kg |__| Thiophene-2 Ethylamine ———_|:(0.87 kg Pyridine Hydrochloride 2 _| Methanol a a 49 kg : serine eek LS | Meee Cionde Rg RA may take appropriate action as per the decision of Norms Committee. Case No.:332/12/82Party Name:CADILA Mect No/Date:12/82Status: ALC4/2018 HEALTHCARE LTD., ALC4/2018 Approved 12.12.2018 A HQ File RLA File Lic.No/Date:08 10136064 :01/82/050/00959/AM 19/ :08/24/040/00190/AM16/ 16.09.2015 Decision: —§ The Committee considered case as per agenda and in the presence of the technical experts, it
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|wasdecided to ratify thead-hoc|inputoutputnormsunder|underpara4.7ofHBPasperdetailsbeloworasapplied.|underpara4.7ofHBPasperdetailsbeloworasapplied.|underpara4.7ofHBPasperdetailsbeloworasapplied.|underpara4.7ofHBPasperdetailsbeloworasapplied.|
|---|---|---|---|---|---|
|byfirmwhichever islower:|||||||
|Export product<br>Qty.<br>GLOBAC PM SOFTULES<br>12750000.000<br>( IRON - FOLIC ACID SOFT| Nos.<br>GELATIN<br>CAPSULES)<br>(Containing 300 mg of IRON||Sl.<br>No.|Qty.<br>IRON<br>(III)<br>HYDROXIDE| 3824.992<br>POLYMALTOSE COMPLEX| kg<br>(FERRIC<br>HYDROXIDE<br>POLYMALTOSE COMPLEX)|||<br>|<br>|<br>||
|(3)<br>HYDROXIDE||||||
|POLYMALTOSE COMPLEX||||||
|equivalent<br>to<br>Elemental<br>Iron||||||
|100Mg)<br>RA may take appropriate action as per the decision ofNormsCommittee.|||||||
|Case No.:338/12/82-|PartyName:JUBILANT||Meet No/Date:12/82-|Status:||
|ALC4/2018|GENERICSLTD||ALC4/2018|Approved|—|
||||12.12.2018|||
|HQ File|RLA File||Lic.No/Date:0510395790|||
|:01/82/050/00965/AM19/<br>:05/23/040/00270/AM 16/<br>01.10.2015<br>|<br>Decision: |TheCommittee considered case as peragenda and in the presenceofthetechnical experts, it.||||||
|was decided <o ratify the ad-hoc input output norms||under para 4.7ofHBP asperdetails below or as applied|||||
|byfirmwhicheverislower:||||||
4 | SL. Export product Qty. Sl. Qty. No. No. | RA may take appropriate action as per the decision of Norms Committee. |
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----- Start of picture text -----<br> Case No.:331/12/82- Party Name:CADILA Meet No/Date:12/82- Status:<br>ALC4/2018 HEALTHCARE LTD., ALC4/2018 Approved —<br>12.12.2018 |<br>HQ File RLA File Lic.No/Date:0810136389 |<br>:01/82/050/00958/AM19/ :08/24/040/0025 1/AM16/ 29.10.2015 | |<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>Export product Qty. Sl. | Import items Qty.<br>No.<br>ELETRIPTAN 250000.000 Nos. ELETRIPTAN 15.30 kg |<br>HYDROBROMIDE TABLETS HYDROBROMIDE<br>5 |20MG (BETA FORM) |<br>| |<br>ELETRIPTAN 250000.000 Nos. |<br>HYDROBROMIDE TABLETS |<br>40 MG |<br>|<br>RA may take appropriate action as per the decision of Norms Committee.<br>Case No.:330/12/82- Party Name:CADILA Meet No/Date:12/82- Status:<br>ALC4/2018 HEALTHCARE LTD., ALC4/2018 Approved —<br>12.12.2018<br>HQ File RLA File Lic.No/Date:0810136441 |<br>:01/82/050/00957/AM19/ :08/24/040/0027 1/AM16/ 04.11.2015<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>|<br>6 Sl. | Export product Qty. SI. | Import items<br>| No. No. |<br>l Bumetanide Tablets 0.5 mg | 15510200 | BUMETANIDE USP 214625.660 |<br>Number Gram |<br>2 LACTOSE<br>MONOHYDRATE NF 26883.170 kg |<br>(PHARMATOSE 200 M)<br>3 HDPE BOTTLE 40 CC WT | Relevant as<br>33-400 per _ packing |<br>policy<br>4 33PULP MMLINER WHITE PP NCRC |<br>ｐｅ<br>―<br>----- End of picture text -----<br>
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----- Start of picture text -----<br> — ff f | per packing<br>policy<br>2 Bumetanide Tablets 1 mg | 90803100 | 5 300CC WH HDPE |<br>(As per General Policy for elevant wa<br>Packing material - Packing pe peas<br>material in finished form policy |<br>9080 NET NO.) |<br>NCRC WH CAP 45MM Relevant as ||<br>(As per General Policy for policy<br>Packing material - Packing<br>material in finished form<br>9080 NET NO. |<br>3 Bumetanide Tablets 2 mg | 55929600 | 7 60 CC WH HDPE 33-400 Relevant as ||<br>Number per packing |<br>polic<br>750 CC WH HDPE 53-400 | Relevant as |<br>per packing |,<br>policy<br>NCRC WH CAP 53MM Relevant as |)<br>policy<br>RA may take appropriate action as per the decision of Norms Committee. |<br>ｐｅ<br>----- End of picture text -----<br>
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Case No.:13/12/82-ALC4/2018 Party Name:DSM SINOCHEM Meet No/Date:12/82Status: PHARMACEUTICALS INDIA ALC4/2018 Approved \PVT.LTD. 12.12.2018 | | HQ File RLA File Lic.No/Date:2210015406 | :01/82/050/00640/AM 19/ :22/24/040/00099/AM 16/ 01.02.2016 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: Export product Qty. | Sl. | Import items Qty. No. THROUGHAMOXYCILLIN6-APATRIHYDRATEROUTE La 6-AMINOAPA) PENICILLANIC ACID(6- | 0.55kg | | THROUGH: ENZYMATIC 2 GLYCINED(-)P-HYDROXYMETHYLESTER PHENYL| 0.477 kg | ROUTE RA FORMIDASE(ENZY ME) 0.005 ke | | may take appropriate action as per the decision of Norms Committee. |
Case No.:281/12/82Party Name:GLOBAL ——Meet No/Date:12/82-. Status: ALC4/2018 CALCIUM PRIVATE ALC4/2018 Deferred LIMITED, 12.12.2018 . S ss —— oe | HQ File RLA File Lic.No/Date:0710109416 Defer Date: :01/82/050/00908/AM 19/ :07/24/040/00384/AM 16/ 18.02.2016 | 7
Decision: Deferred for comments of TE.
9 Case No.:28/12/82-ALC4/2018 Party Name:MAMTA
Meet No/Date:12/82Status:
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POLYCOATS ALC4/2018 Approved 12.12.2018 | HQ File RLA File Lic.No/Date:34 10042178 :01/82/050/00655/AM19/ :34/24/040/00035/AM17/ 18.05.2016 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: Export product Qty. | SI. Qty. | No. TRIETHYL CITRATE (TEC) — |1kg| 1 _| CITRIC ACID 0.723 kg | | RA may take appropriate action as per the decision of Norms Committee. |
Case No.:328/12/82Party Name:KUSUMA Meet No/Date:12/82(Status: ALC4/2018 PHARMA ALC4/2018 ‘Approved | 12.12.2018 - _ | HQ File RLA File Lic.No/Date:03 10806263 :01/82/050/09955/AM19/ :03/94/040/00306/AM17/ 14.07.2016 Decision: | The Committee considered the case as per agenda in the presence of Technical Experts and in, the light of earlier decision taken by NC in its Meeting No. 2/82 dated 16.05.2018, it was decided to ratify[|] 10 the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is | lower: «did Fxpon prada [ey [impor tems Sodium Saccharin (Pure Dental Grade) eal Sodium Saccharin | | RA may take appropriate action as per the decision of Norms Committee. Case No.:329/12/82Party Name:KUSUMA Meet No/Date:12/82Status:| ALC4/2018 PHARMA ALC4/2018 Approved | 12.12.2018 | HQ File RLA File Lic.No/Date:03 10807243 :01/82/050/00956/AM19/ :03/94/040/00428/AM17/ 22.08.2016 Decision: | The Committee considered the case as per agenda in the presence of Technical Experts and in | the light of earlier decision taken by NC in its Meeting No. 2/82 dated 16.05.2018, it was decided to ratify 11 the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is | lower: | Sodium Saccharin (Pure Dental Grade) Lal Sodium Saccharin lama |
RA may take appropriate action as per the decision of Norms Committee.
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----- Start of picture text -----<br> Case No.:334/12/82- Party Name: MEDREICH Meet No/Date:12/82- Status:<br>ALC4/2018 LIMITED ALC4/2018 Approved<br>12.12.2018 |<br>HQ File RLA File Lic.No/Date:0710110307 |<br>:01/82/050/0096 1/AM19/ :07/24/040/00172/AM17/ 23.08.2016<br>Decision: | The Committee considered case as per agenda and in the presence of thetechnical “experts, |<br>it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below oras |<br>applied by firm whichever is lower:<br>Export product Qty. SI. Qty.<br>No. |<br>12. |AMOXICILLIN & POTASSIUM | | Number AMOXICILLIN — | 585.28 mg/ |<br>CLAVULANATE TRIHYDRATE | tablet<br>| TABLETS625MG 2 POTASSIUM 303.773 mg |<br>[CO-AMOXICLAV 625MG] [Each CLAVULANAT | /tablet<br>film coated tablet contains E+MCC<br>Amoxicillin Trihydrate BP BLEND 1:1 NON |<br>‘valent to Amoxicillin 500 COS GRADE<br>equivalent to Amoxici in mg [CLAVULANAT<br>Pot.Clav BP(as dil.Pot.Clav BP) E POTASSIUM + |<br>equivalent to Clavulanic Acid AVICEL 1:1]<br>125mg]Exp.qty:1874.535+980.391=<br>2854.926Kgs]3260060 No. |<br>RA may take appropriate action as per the decision of Norms Committee.<br>----- End of picture text -----<br>
Case No.:335/12/82Party Name:MEDREICH Meet No/Date:12/82‘Status: ALC4/2018 LIMITED ALC4/2018 Deferred 12.12.2018 'S HQ File ~ RLA File Lic.No/Date:0710110453 Defer Date: | :01/82/050/00962/AM19/ :07/24/040/002 16/AM17/ 23.09.2016 = = =- 7 amenaninean ea | Decision: Deferred for comments of TE.
Case No.:18/12/82-ALC4/2018 Party Name:GULBRANDSEN Meet No/Date:12/82Status: CHEMICALS PVT LTD ALC4/2018 Approved 12.12.2018 HQ File RLA File Lic.No/Date:34 10042634 | :01/82/050/00645/AM19/ :34/24/040/00218/AM17/ 28.10.2016
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. 26/82-ALC4/2012, dated 13.12.2012 in respect| 14 of M/s Gulbrandsen Chemicals Pvt. Ltd. against Advance Authorization No. 3410035538 dated 23.11.2012, 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 |<br>Tri Ethyl Aluminium (TEAI) lanlllli Aluminium Grit / Granules 0.270kg | |<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.:27/12/82-ALC4/2018 Party Name:MAMTA Meet No/Date:12/82Status: POLYCOATS ALC4/2018 ‘Approved HQ 12.12.2018 | | File RLA File Lic.No/Date:34 10042738 | :01/82/050/00654/AM19/ :34/24/040/00235/AM17/ 09.12.2016 | | Decision: |The Committee considered case as per agenda and in the presence ofthe technical experts, it | 15 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. | TRIETHYL CITRATE (TEC) — |Lkg| 1 | CITRIC ACID 0.723 kg | | RA may take appropriate action as per the decision of Norms Committee.
Case No.:322/12/82Party Name:ACEBRIGHT Meet No/Date:12/82Status: ALC4/2018 (INDIA) PHARMA PVT LTD, ALC4/2018 Approved 12.12.2018 HQ File RLA File Lic.No/Date:07101 10862 :01/82/050/00949/AM19/ :07/24/040/00256/AM17/ 29.12.2016 | Decision: | The Committee considered case as per agenda and in the presence of the technical experts, it 16 wasby firmdecided whicheverto ratifyis lower:the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied |
Export product Qty. | SI. Qty. No. | TENOFOVIR DISOPROXIL (R)9-(2-PHOSPHONO 0.69 kg FUMARATE METHOXYPROPYL) ADENINE(PMPA) |
Case No.:282/12/82Party Name:GLOBAL Meet No/Date:12/82Status: ALC4/2018 CALCIUM PRIVATE ALC4/2018 Deferred '7 LIMITED, 12.12.2018 HQ File RLA File Lic.No/Date:0710110965 |Defer Date: :01/82/050/00909/AM19/ :07/24/040/0033 1/AM17/ 13.01.2017 | | Decision: Deferred forcommentsofTE. = = - | Case No.:336/12/82Party Name: MEDREICH Meet No/Date:12/82Status: ALC4/2018 LIMITED ALC4/2018 Approved HQ[File] RLA File Lie. No/Date:071011119012.12.2018 | | :01/82/050/00963/AM19/ :07/24/040/00381/AM17/ |27.02.2017 | r 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: Expon produc ay. [Sk [mportitems ————«
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_ a | Co-Amoxiclav Injection 1200mg | |Number Clavulanate Potassium | 1320 mg/ vial [20ml] [| 1650000 No. of Vials ] Sterile+ Amoxicillin [Co-Amoxiclav Injection BP Sodium —_ Sterile 1:5 | 12g, 238mg of Potassium Sterile[oeneniee+ CravolnsteAmoxicillin clwae| »‘ aaaival = hd Sodium Sterile 1:5 Blend ] 200mg of Clavulanic Acid. | 1060mg of Amoxicillin Sodium | is equivalent to 1000mg of Amoxicillin] RA may take appropriate action as per the decision of Norms Committee.
Case No.:374/4/82-ALC4/2017 Party Name:ETERNIS FINE Meet No/Date:12/82Status: CHEMICALS LIMITED, ALC4/2018 ‘Approved | 12.12.2018 | | HQ File RLA File Lic.No/Date:03 10813006 :01/82/050/00382/AM 18/ :03/94/040/00064/AM18/ 02.05.2017 | Decision: | The Committee considered the case as per agenda in the presence of Technical Experts and in | the light of earlier decision taken by NC in its Meeting No. 4/82-ALC4/2018, dated 19.06.2018 in respect of | M/s Eternis Fine Chemicals Limited against Advance Authorization No. 0310817400 dated 29.11.2017, it) was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied 19 by firm whichever is lower: |
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----- Start of picture text -----<br> Export product Qty. | SI. Qty. |<br>No.<br>HAMBER / HAMBER- BHT/ METHYL ETHYL 0.600 kg<br>HAMBER- Toco (7-Acetyl- KETONE (MEK<br>Tetramethy!1,2,3,4,5,6,7,8-OctahydroNaphthalene 1,1,6,7- idlon MERCENE 1.00 kg |<br>----- End of picture text -----<br>
Case No.:283/12/82Party Name:GLOBAL Meet No/Date:12/82(Status: ALC4/2018 CALCIUM PRIVATE ALC4/2018 Deferred | LIMITED, 12.12.2018 , ‘ = —— — on HQ File RLA File Lic.No/Date:0710111675 Defer Date: :01/82/050/00910/AM19/ :07/24/040/00053/AM18/ 29.05.2017 | | Decision: Deferred for comments ofTE. |
Case No.:389/4/82-ALC4/2017 PartyCHEMICALS Name:ETERNLIMITED,F I NES MeetALC4/2018[No/Date:12/82-] (Status:Approved_ | 12.12.2018 21 HQ File RLA File Lic.No/Date:03 10813672 | -91/82/050/00397/AM18/ :03/94/040/00128/AM18/ 30.05.2017 Decision: | The Committee considered the case as per agenda in the presence of Technical Experts and in | the light of earlier decision taken by NC in its Meeting No. 4/82-ALC4/2018, dated 19.06.2018 in respect of M/s Eternis Fine Chemicals Limited against Advance Authorization No. 0310817400 dated 29.11.2017, it
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was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per detailsbelow oras applied by firm whichever is lower:
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----- Start of picture text -----<br> Export product Qty. | Sl. | Import items Qty.<br>No.<br>HAMBER / HAMBER- BHT/ | kg METHYL ETHYL 0.600 kg<br>HAMBER- Toco (7-Acetyl- KETONE (MEK)<br>Tetramethyl1,2,3,4,5,6,7,8-OctahydroNaphthalene) 1,1,6,7- =a2. age sans | .00Ke |<br>RA may take appropriate action as per the decision of Norms Committee.<br>Case No.:339/12/82- Party Name:MICRO LABS ——-Meet No/Date:12/82- Status:<br>ALC4/2018 LTD ‘ALC4/2018 Approved<br>12.12.2018 |<br>HQ File RLA File Lic.No/Date:0710111682 |<br>:01/82/050/00966/AM 19/ :07/24/040/00065/AM18/ 30.05.2017<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 per details below or as applied |<br>by firm whichever is lower:<br>22 Export product Qty. Sl. | Import items Qty. |<br>No.<br>PREMIX OF NIFUROXAZIDE | 5195 kg NIFUROXAZIDE 2896.316 kg |<br>BP/EP : Each kg of Premix Contains : EP/BP |<br>Nifuroxazide BP/EP 0.552 kg ( for<br>filling Nifuroxazide BP 200 mg /<br>capsule with average weight of 362 mg |<br>/ capsule )<br>----- End of picture text -----<br>
Case No.:323/12/82Party Name:ACEBRIGHT — Meet No/Date:12/82Status: ALC4/2018 (INDIA) PHARMA PVT LTD, ALC4/2018 Approved | 12.12.2018 | HQ:01/82/050/00950/AM19/ File RLAFile:07/24/040/00058/AM18/ ‘Lic.No/Date:071011173208.06.2017 || |
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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, A<br>23 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. Import items Qty.<br>No.<br>TENOFOVIR DISOPROXIL | 1 kg (R)9-(2-PHOSPHONO 0.69 kg<br>FUMARATE METHOXYPROPYL)<br>ADENINE(PMPA) |<br>RA may take appropriate action as per the decision of Norms Committee.<br>oe _<br>Case No.:284/12/82- Party Name:GLOBAL Meet No/Date:12/82- Status: - ~ |<br>i ALC4/2018 CALCIUM PRIVATE ALC4/2018 Approved |<br>LIMITED, 12.12.2018 | |<br>HQ File RLA File Lic.No/Date:0710111905 | |<br>----- End of picture text -----<br>
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|01/82/050/00911/AM19/|:07/24/040/00121/AM18/|21.07.2017|~ 4|||
|Decision:|| The Committee|considered|the case|as|per agenda|in|the|presence of TechnicalExperts|and|in.|
|the|light|of earlier|decision|taken|by NC|in|its|Meeting No.|2/82-ALC4/2018,|dated|16.05.2018|in|respect|of|||
|M/s|Global|Calcium|Private|Limited|against|Advance|Authorization|No.|0710108483|dated|08.07.2015,|it|
|was|decided|to|ratify|the|ad-hoc|input output|norms|under para|4.7|of HBP|as|per|details below|or|as|applied|||
|by firm whichever|is lower:|||
|Export|product|Qty.|Sl.|Qty.|
|No.|
|MAGNESIUM L-ASPARTATE|os|Ee|L-ASPARTIC ACID|||1.02 kg|
|CALCIUM L-ASPARTATE|a|L-ASPARTIC ACID|||0.972 kg|||
|||
|RA|may|take|appropriate|action|as|per the|decision|of Norms|Committee.|
|Case|No.:297/12/82-|Party Name:GLOBAL|Meet No/Date:12/82-|(Status:|
|ALC4/2018|CALCIUM|PRIVATE|ALC4/2018|Deferred|
|LIMITED,|12.12.2018|||
|25|Ss|encaras|——|||
|~~|HQ|File|RLA|File|Lic.No/Date:0710111984||Defer|Date:|||
|:01/82/050/00924/AM19/|:07/24/040/00129/AM|18/|08.08.2017|
|i||
|Decision:|Deferred|for|comments|of TE.|
|=ee||
|Case|No.:307/12/82-|Party Name:EYTAN|LABS|Meet No/Date:12/82-|Status:|
|ALC4/2018|LIMITED|ALC4/2018|Approved|—|
|12.12.2018|
|HQ|File|RLAFile|Lic.No/Date:09 10065333|||
|:01/82/050/00934/AM|19/|:09/24/040/00229/AM|18/|08.08.2017|||
|Decision:|||The|Committee|considered|the|case|as|per agenda|in|the|presence|of Technical|Experts|and|in|
|the|light|of earlier decision|taken by NC|in|its|Meeting|No.|1/82-ALC4/2018,|dated|01.05.2018|in|respect of|
|M/s|Eytan|Labs|Limited|against|Advance|Authorization|No.|0910065152|dated|12.06.2017,|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:|||
|26|||
|Export|product|Qty.|SIL.|Qty.|
|No.|
|4-AMINO-5-FLURO-1-|1|kg|(2R|5S)-5-(4-AMINO-5-FLUORO-2-|||2.075 kg|
|((2R,5S)-2-|OXO-2H-PYRIMIDIN-1-YL)-[1,3]-|
|HYDROXYMETHYL-|OXATHIOLANE-|||
|[1,3)OXATHIOLANE-S-|2-CARBOXYLIC|ACID|2S-|
|YL)-1H-PYRIMIDIN-2-|ISOPROPYL-SR-METHYL-IR-|
|ONE(EMO-I)|OR|EMO-I|OR|CYCLOHEXYL|ESTER(FCE)|
|EMO|SODIUM|BOROHYDRIDE|0.46|ke|
|3|DIPOTASSIUM|HYDROGEN|1.90|kg|
|PHOSPHATE|
|RA may take appropriate|action as per the decision of|Norms Committee.|_||
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----- Start of picture text -----<br> .<br>Case No.:298/12/82- Party Name:AVA<br>ALC4/2018 CHEMICALS PVT.LTD., ALC4/2018Meet No/Date:12/82- Status:Approved |_<br>{12.12.2018 |<br>HQ File RLA File Lic.No/Date:0310815114<br>:01/82/050/00925/AM19/ :03/94/040/00394/AM 18/ 10.08.2017<br>Decision: | |<br>| 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>27 by firm whichever is lower: |<br>Export product Qty. | SL. Qty. |<br>No.<br>DISODIUM MAGNESIUM ETHYLENE DIAMINE TETRA| 0.700kg |<br>EDTA Content 6% (+/- 0.5) as ACETIC ACID<br>RA may take appropriate action as per the decision of Norms Committee.<br>Case No.:15/12/82-ALC4/2018 Party Name:MICRO LABS Meet No/Date:12/82- (Status:<br>LTD ALC4/2018 Approved |<br>12.12.2018<br>HQ File RLA File Lic.No/Date:07 10112020<br>:01/82/050/09642/AM19/ :07/24/040/00134/AM18/ 16.08.2017<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 per details below or as applied |<br>by firm whichever is lower:<br>|<br>Export product Qty. SIL. Qty.<br>No.<br>5g | AmoxicillinClavulanate and375 Potassiummg || Number1000000 Lal BP/EP/IP/USPAMOXICILLIN TRIHYDRATE | 286.95kg |,<br>( Each tablet — Contains 2 DILUTED CLAVULANATE| 303.773 kg<br>Amoxicillin Trihydrate 250 mg POTASSIUM ( LI) |<br>and Potassium: Clavulanate 125 BP/EP/IP/USP<br>mg ) 375 Ke |<br>Amoxicillin and Potassium | 10000000 AMOXICILLIN TRIHYDRATE =| 5739.00 kg |,<br>(ClavulanateEach tablet625 Containsmg | Number 2 BP/EP/IP/USPDILUTED CLAVULANATE| 3037.73 kg |<br>Amoxicillin Trihydrate 500 mg POTASSIUM ( | )<br>and Potassium Clavulanate 125 BP/EP/IP/USP |<br>mg ) 6250 Kg<br>RA may take appropriate action as per the decision of Norms Committee. |<br>Case No.:308/12/82- Party Name:EYTAN LABS Meet No/Date:12/82- Status: |<br>ALC4/2018 LIMITED ALC4/2018 ‘Approved |<br>29 HQ File RLA File ~_Lic.No/Date:091006536112.12.2018 |<br>:01/82/050/00935/AM19/ :09/24/040/00245/AM18/ 22.08.2017<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 per details below or as applied<br>Ｓ‐<br>----- End of picture text -----<br>
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----- Start of picture text -----<br> by firm whichever is lower: - |<br>Export product Qty. | SL. Qty.<br>No.<br>4-AMINO-2-OXO — PYRIMIDINYL 1<br>OXATHIOLANE-2-CARBOXYLIC |GLYOXYLIC2,5 DI HYDROXY ACID1,4 - 50% DITHIANE | 0. 743325 kg | |<br>ACID CYTOSINE 0.428 kg | |<br>ISO. PROPYL METHYL CYCLO .4 | HEXAMETHYL DISILAZANE | 0.698 kg | |<br>HEXYL ESTER (CHE) OR TRIETHYLAMINE 0.034 kg | |<br>CYCLOHEXYL ESTER OR CHE-III Cz METHYLENE CHLORIDE 2.63 kg |<br>L(-) MENTHOL<br>8 ( Fresh/Recovery) | 0.751 kg |<br>|9 | T RIPHOSGENEOLUENE 0415 0kg | ||.<br>RA may take appropriate action as per the decision of Norms Committee.<br>Case No.:309/12/82- Party Name:AURORE LIFE Meet No/Date:12/82- Status; |<br>ALC4/2018 SCIENCESLIMITED PRIVATE ALC4/201812.12.2018 Deferred ||<br>30 HQ File RLA File Lic.No/Date:0910065393 Defer Date:<br>:01/82/050/00936/AM19/ :09/24/040/00132/AM18/ 24.08.2017<br>Decision: Deferred for comments of TE.<br> OS |<br>----- End of picture text -----<br>
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----- Start of picture text -----<br> Case No.:340/12/82- Party Name:MICRO LABS Meet No/Date:12/82- Status: |<br>ALC4/2018 LTD ALC4/2018 Approved |<br>12.12.2018<br>HQ File RLA File Lic.No/Date:0710112103<br>:01/82/050/00967/AM 19/ :07/24/040/00159/AM18/ 06.09.2017 |<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 per details below or as applied |<br>by firm whichever is lower:<br>31 Export product Qty. Sl. | Import items Qty. |<br>No.<br>PREMIX OF NIFUROXAZIDE | 5195 kg NIFUROXAZIDE 2896.316 kg |<br>Each kg of Premix Contains : BP/EP/USP/IP<br>Nifuroxazide BP/EP 0.552 kg ( for |<br>filling Nifuroxazide BP 200 mg /<br>capsule with average weight of 362 mg<br>/ capsule ) |<br>RA may take appropriate action as per the decision of Norms Committee. |<br>Case No.:310/12/82- Party Name:HETERO DRUGS Meet No/Date:12/82- Status: |<br>ALC4/2018 LIMITED ALC4/2018 Approved<br>12.12.2018<br>a2 Pryor r rer aE | |<br>HQ File RLA File Lic.No/Date:09 10065518<br>:01/82/050/00937/AM19/ :09/24/040/00329/AM18/ 28.09.2017<br>----- End of picture text -----<br>
Decision: | The Committee considered case as per agenda and in the presence of the technical experts, it,
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----- Start of picture text -----<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 Qty. |<br>No.<br>Valacyclovir Hydrochloride 2-[(2-Acetamido)-6-0xo0-6,9-dihydro-1H- | 1.083 kg<br>purine-9-YL) methyl] ethyl |<br>acetate/Diacetyl acyclovir/AAEMP)<br>N,N-Dicyclohexy! carbodimide 1.061 kg | |<br>4 — | 4-DimethylN,N-Di Methyl Amin F o rmamidePyridine 20 . 02854kg kg || |<br>SSS<br>© | Methanot 0.603 ks]<br>RA may take appropriate action as per the decision of Norms Committee. 25skg | ||<br>Case No.:285/12/82- Party Name:GLOBAL Meet No/Date:12/82- Status:<br>ALC4/2018 CALCIUM PRIVATE ALC4/2018 ‘Approved<br>LIMITED, 12.12.2018 |<br>HQ File ~ RLAFile Lic.No/Date:0710112292 |<br>:01/82/050/009 12/AM19/ :07/24/040/00193/AM18/ 23.10.2017 }<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 per details below or as applied |<br>°° by firm whichever is lower:<br>----- End of picture text -----<br>
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----- Start of picture text -----<br> Export product Qty. | SL Qty.<br>TIEMONIUM METHYLSULPHATE| | kg 2-ACETYL THIOPHENE 0.75 kg |<br>(TIEMONIUM METHYLSULFATE) |<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> Case No.:300/12/82- Party Name:MALWA Meet No/Date: 12/82- Status;<br>ALC4/2018 OXYGEN & INDUSTRIAL ALC4/2018 Deferred<br>GASES PVT.LTD., 12.12.2018<br>34 HQ File RLA File Lic.No/Date:5610005252 Defer Date: |<br>:01/82/050/00927/AM19/ :56/24/040/00019/AM18/ 26.10.2017<br>Decision: Deferred for comments of TE. ; a Be<br>Case No.:301/12/82- Party Name:SYMBIOTEC Meet No/Date:12/82- Status:<br>ALC4/2018 PHARMALAB PRIVATE ALC4/2018 ‘Approved |<br>LIMITED 12.12.2018 |<br>HQ File RLA File Lic.No/Date:5610005254 |<br>:01/82/050/00928/AM 19/ :56/24/040/00061/AM15/ '26.10.2017<br>35 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 Qty. |<br>No. |<br>----- End of picture text -----<br>
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Hydrocortisone Sodium Succinate for g 1. | Hydrocortisone Hemisuccinate |0.91 kg Injection USP for Manufacturers use IP/BP Organic Chemicals (Hydrocortisone Sodium Succinate Buffered 5% Sterile) RA may take appropriate action as per the decision of Norms Committee. Case No.:302/12/82Party Name:ZENITH Meet No/Date:12/82- (Status: ALC4/2018 DYEINTERMEDIATESLIMITED ALC4/212.12.2 0 1818 Approved | HQ File RLA File Lic.No/Date:03 10816656 | :01/82/050/00929/AM19/ :03/95/040/00534/AM18/ 31.10.2017 Decision: | The Committee considered case as per agenda and in the presence of the technical experts, it | 36 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. ~ 0 | NAS-5 (2-DIAZO-1-NAPHTHOL-S- es TOBIAS ACID | 1.20kg | | SULFONIC ACID, SODIUM SALT) _ iia MIN.97%.) | RA may take appropriate action as per the decision of Norms Committee. Case No.:341/12/82Party Name:MICROLABS Meet No/Date:12/82Status: ALC4/2018 LTD ALC4/2018 ‘Approved | 12.12.2018 | HQ File RLA File Lic.No/Date:0710112360 | :01/82/050/00968/AM19/ :07/24/040/00178/AM18/ 07.11.2017 | wasDecision:decided|Theto ratify Committeethe ad-hoc consideredinput output casenorms as per agenda andunder para 4.7inof the HBP presenceas perofdetails the technicalbelow or Ses,as applied3] 37 by firm whichever is lower: | | | Export product Qty. Sl. Qty. | No. | AMOXICILLIN l GM | 40000000 AMOXICILLIN 45912.00 kg |, DISPERSIBLE TABLETS / | GM | Number TRIHYDRATE | TABLETS BP/IP/EP/USP | BP/IP/EP/USP ( 40000 KG ) | RA may take appropriate action as per the decision of Norms Committee. | Case No.:324/12/82Party Name:ACEBRIGHT Meet No/Date:12/82Status: ALC4/2018 (INDIA) PHARMA PVT LTD, |ALC4/2018 Approved 12.12.2018 HQ File ~—RLA File — Lic.No/Date:0710112461 | 38 Decision::01/82/050/0095|The 1/AM19/Committee considered:07/24/040/00222/AMcase as per agenda 18/ and in(27.11.2017the 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 byExport productfirm whichever is lower: Qty. | SL. Qty. | No. |
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TENOFOVIR DISOPROXIL | 1 kg |1 | (R)9-(2-PHOSPHONO.~——S*¢2=«O02.69kg—sCd FUMARATE METHOXYPROPYL) ADENINE(PMPA
FUMARATE METHOXYPROPYL) | ADENINE(PMPA | i RA may take appropriate action as per the decision of Norms Committee. | | 7 Case No.:303/12/82Party Name:SURVIVAL Meet No/Date:12/82_|Status: | ALC4/2018 TECHNOLOGIES PVT.LTD. ALC4/2018 ‘Approved | | 12.12.2018 | HQ File RLA File Lic.No/Date:0310817453_ | :01/82/050/00930/AM19/ :03/95/040/00708/AM18/ 30.11.2017 | 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: | | SUR-742 ‘1 | HYDRAZINE HYDRATE 99- 100% | 0.707kg | | [1,24] Triazolo —_[1.5-a] METHYLENE DI-CHLORIDE 6.564 kg | pyridine-6-carbonitrile, 8- [ [23- AMINO CROTONONITRILE 1.625 kg | | (dibutylamino) -4-pheny|-5BOC ANHYDRIDE (Ditertbutyl | 1.902 kg | thiazoly]] imino]-2(1Dicarbonate) DI - BOC ethylpenty!) -5,8-dihydro-7TRIFLIC ACID ( Trifluoromethane | 1.425kg | | methyl-5 - Oxo Sulfonic Acid) 6 | TRIFUORO ACETIC ACID 2.85kg | | RA may take appropriate action as per the decision of Norms Committee. | Case No.:304/12/82"Party Name:MALLADI | "Meet No/Date:12/82Status: ALC4/2018 DRUGS & ALC4/2018 Approved | PHARMACEUTICALS 12.12.2018 | LIMITED HQ File RLA File Lic.No/Date:0410163768 Defer Date: :01/82/050/0093 1/AM19/ :04/24/040/00170/AM18/ 04.12.2017 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 applied | by firm whichever is lower: 40 | Export product Qty. | SI. Qty. No. Pyrrolidinyl Nor Ephedrine Base (or) fl | Propiophenone 3.21 kg | ((1828)-Pyrolidny! nor ephedrine) atk | | ee 2.50kg | | Causticsoda Flakes 5.98kg |. (6| L-Glutamic acid 0.89ke | 267s] RA may take appropriate action as per the decision of Norms Committee.
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Case No.:16/12/82-ALC4/2018 Party Name:MICRO LABS Meet No/Date:12/82Status: LTD ALC4/2018 ‘Approved HQ[File] RLA File ‘Lic.No/Date:0712.12.2018 10112576 | :01/82/050/00643/AM19/ :07/24/040/00254/AM18/ 20.12.2017 | Decision: |The Committee considered case as per agenda and in the presence ofthe technical experts, it | was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied | by firm whichever is lower: Export product Qty. Sl. Qty. No. | Amoxicillin and — Potassium | 2375000 | AMOXICILLIN TRIHYDRATE | 681.51 kg 4) | Clavulanate 375 mg Tablets |Number BP/EP/IP/USP | (Each tablet Contains 2 DILUTED CLAVULANATE| 721.46 kg Amoxicillin Trihydrate 250 mg cineca (1.1) | and Potassium Clavulanate 125 mg) BP/EP/IP/USP (890.63 KG ) | 62/0Amoxicillin and | 22342500 AMOXICILLIN TRIHYDRATE | 12822.36 kg | Potassium Clavulanate 625 mg | Number BP/EP/IP/USP | Tablets (Each tablet Contains 2 DILUTED CLAVULANATE| 6787.00 kg | Amoxicillin Trihydrate 500 mg POTASSIUM (1.1) and Potassium Clavulanate 125 BP/EP/IP/USP mg) BP/EP/IP/USP (13964.06 | KG ) | RA may take appropriate action as per the decision of Norms Committee.
Case No.:320/12/82Party Name:AMI LIFE Meet No/Date:12/82Status: | ALC4/2018 SCIENCES PRIVATE ALC4/2018 Approved — LIMITED 12.12.2018 | | HQ File RLA File Lic.No/Date:34 10043763 :01/82/050/00947/AM19/ :34/24/040/00266/AM18/ 28.12.2017 is es ~ = ns = - SN | Decision: | The Committee considered case as per agenda and in the presence of the technical experts, it 42 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. QUERCETINRUTOSIDE TRIHYDRATEDIHYDRATE EP | 73517850kg kg (ASSAYCRUDE BY HPLC NLTRUTIN. 90%) | 21000.001 kg |!| RA may take appropriate action as per the decision of Norms Committee. Case No.:316/12/82Party Name:SARNA Meet No/Date:12/82Status: ALC4/2018 ‘CHEMICALS PVT LTD ALC4/2018 Approved | (12.12.2018 | _ HQ File —RLAFile Lic.No/Date:5210042485 | 43 -01/82/050/00943/AM19/ °§2/24/040/0006 1/AM18/ 11.01.2018 | Decision: | The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 2/82-ALC4/2018, dated 16.05.2018 in respect of | M/s Sarna Chemicals Pvt. Ltd. against Advance Authorization No, 5210039465 dated 14.02.2013, it was
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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. Qty.<br>No.<br>2-(2-AMINO ETHOXY)-2- 2-AMINO ETHOXY 0.800 kg<br>CHLORO DIETHYL ETHANOL<br>SULFONE / ETHERAMINE 2 2- 0.560 kg |<br>MERCAPTOETHANOL |<br>CAUSTIC SODA 0.520 kg |<br>100%) |<br>RA may take appropriate action as per the decision of Norms Committee. _|<br>Case No.:299/12/82- Party Name:Y ASHO Meet No/Date: 12/82- “Status: |<br>ALC4/2018 INDUSTRIES PVT.LTD. ALC4/2018 Approved<br>12.12.2018 |<br>HQ File RLA File Lic.No/Date:03 10818613 |<br>:01/82/050/00926/AM 19/ :03/95/040/00870/AM18/ 18.01.2018<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. 2/82-ALC4/2018, dated 16.05.2018, it was,<br>decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by|<br>44 firm whichever is lower:<br>Export product Exp. | SI. Import items Qty. Allowed<br>Qty. | No.<br>OCTYLATEDDIPHENYLAMINE(OCD 1| DIPHENYLAMINE 0.405 kg<br>FLARES DI-ISOBUTYLENE 0.62 kg |<br>POWDER) ACTIVATEDCLAY | [O.1kg]<br>RA may take appropriate action as per the decision of Norms Committee. _|<br>朝<br>----- End of picture text -----<br>
Case No.:325/12/82Party Name:ACEBRIGHT Meet No/Date:12/82Status: ALC4/2018 (INDIA) PHARMA PVT LTD, ALC4/2018 Approved 12.12.2018 | HQ File RLA File Lic.No/Date:0710112712 :01/82/050/00952/AM19/ :07/24/040/00277/AM18/ 19.01.2018 Decision: |The Committee considered case as per agenda and in the presence of the technical experts, it| was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied | 45 by firm whichever is lower:
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----- Start of picture text -----<br> Export product Qty. | SI. Qty.<br>No. |<br>TENOFOVIR DISOPROXIL (R)9-(2-PHOSPHONO 0.69 kg |<br>FUMARATE METHOXYPROPYL) |<br>ADENINE(PMPA<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> Case No.:321/12/82- Party Name:SWATI —~—sMeet No/Date:12/82- (Status:<br>ALC4/2018 (CHEMICALS‘MENTHOL & ALLIEDLTD., ALC4/201812.12.2018 nie ||<br>HQ File RLAFile Lic.No/Date:2910025325 |<br>:01/82/050/00948/AM19/ :29/24/040/00009/AM18/ 01.02.2018<br>— = —_____———|<br>Decision: | The Committee considered the case as per agenda in the presence of Technical Experts and in|<br>[light] [of] [earlier] [decision] [taken] [by] [NC] [in] [its] [Meeting] [No.] [4/82-ALC4/2018,] [dated] [19.06.2018,] [it] [was][|]<br>46 [the]<br>decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by<br>| firm whichever is lower: |<br>Export product Qty. | SL. Qty. |<br>) No.<br>DIHYDROMYRCENOL /ikg[1 | GUM TURPENTINE OIL 0.195 kg | |<br>RA may take appropriate action as per the decision of Norms Committee. |<br>Case No.:23/12/82-ALC4/2018 Party Name:ONEIRO ——SMeet No/Date:12/82- (Status:<br>CHEMICALS PVT LTD ALC4/2018 Approved<br>12.12.2018 |<br>| HQ File RLA File Lic.No/Date:3410043858 |<br>| Decision::01/82/050/00650/AM19/| The Committee considered:34/24/040/003 case as 14/AM18/ per agenda and in06.02.2018 the presence of the technical| experts, it ||<br>wasby firm decidedwhichever to ratifyis thelower: ad-hoc input output norms under para 4.7 of HBP as per details below or as applied |<br>|<br>47 | Export product Qty. | SI. Qty. |<br>No.<br>4, 7-DICHLORO QUINOLINE 1 | Di Ethyl Ethoxy Methylene Malonate |1.65kg| |<br>Meta Chloro Aniline 0.97kg | |<br>Light Liquid Parafin 0.97 kg<br>4 ||Tolne [8B][ Kg]<br>(6 [[Methanol] Phosphorous Oxychloride 0.97 kg<br>RA may take appropriate action as per the decision of Norms Committee. SSC«d LS<br>e ace SE ETO<br>CaseALC4/2018 No.:278/12/82- PartyLIMITED Name:HETERO LABS —_ [MeetALC4/2018No/Date:12/82- [StatusApproved |<br>HQ 12.12.2018 |<br>File RLA File Lic.No/Date:09 10065975 |<br>:01/82/050/00905/AM 19/ :09/24/040/00580/AM 18/ 08.02.2018<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>4g by firm whichever is lower:<br>Export product Qty. | SI. Qty.<br>No,<br>Cilostazol I kg Fl | 4-Amino Phenol 0.59 kg<br>Dimethy! Sulfoxide 190kg ||<br>4| 5-(4-Chlorobuty!)-1-cyclohexyl-IH-tetrazole_Dimethyl Formamide | 0.88kg2.16 kg | |<br>----- End of picture text -----<br>
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||RAmaytake appropriate action as perthedecision ofNormsCommittee.<br>—<br>ee|||
||Case No.:292/12/82-<br>~~ <br>ALC4/2018|PartyName:ANLON—~—sMeet No/Datte:12/82-__Status:<br>HEALTHCARE<br>ALC4/2018<br>Approved<br>PRIVATELIMITED<br>12.12.2018<br>||||
||HQ File|RLAFile<br>=<br>~—_Lic.No/Date:2410042362|||
|49|:01/82/050/00919/AM19/<br>:24/24/040/00042/AM18/<br>09.02.2018<br>|<br>|<br>Decision:<br>|TheCommittee considered case asperagendaand inthepresenceofthe technical experts, it<br>wasdecidedtoratifythead-hoc inputoutputnormsunderpara4.7ofHBPasperdetailsbelowor as applied<br>|<br>byfirmwhichever islower:<br>|<br>Export product<br>Qty.<br>| SI.<br>Qty.|||
|||No.||
||Tolfenamic Acid<br>(<br>Chemical Name:|<br>| kg<br>3-Chloro 2-Methy] Aniline -Case<br>0.75kg<br>N-(3-chloro-o-toly!)-anthranilic<br>No.87-60-5||||
||acid)<br>Case No: 13710-19-5||||
||RA may take appropriate action|as perthe decision ofNormsCommittee.||
||CaseNo.:25/12/82-ALC4/2018PartyName:REINE<br>—-MeetNo/Date:12/82- _[Status:<br>|<br>‘LIFESCIENCE<br>ALC4/2018<br>Approved<br>\12.12.2018<br>|<br>|<br>HQ File<br>RLA File<br>Lic.No/Date:3410043890<br>:01/82/050/00652/AM19/<br>:34/24/040/00327/AM18/<br>14.02.2018<br>Decision: |TheCommittee considered case as peragenda and inthepresenceofthetechnicalexperts,it|||
|50 <br>~~|Wsdecided to ratify thead-hoc <br>by firm whichever is lower:|inputoutputnorms underpara4.7 ofHBP as perdetailsbelow orasapplied||
||Export product|Qty.<br>SI.<br>Qty.||
||SevelamerHydrochloride<br>Sevelamer Carbonate|No.<br>fikg [lf Allylamine<br>1.012kg<br>ikg || Allylamine<br>1.012kg||<br>||
||RA may take appropriate action|as per the decision ofNormsCommittee.|||
||Case No.:268/12/82-<br>ALC4/2018|PartyName‘NEULAND—_—sMeeet No/Date:12/82-_|Status:<br>LABORATORIES LTD<br>ALC4/2018<br>‘Approved<br>(12.12.2018||<br>||
||HQFile|RLA File<br>Lic.No/Date:0910065984|||
||:01/82/050/00895/AM19/|:09/24/040/00585/AM18/<br>14.02.2018<br>||||
|51|Decision: |TheCommitteeconsidered case asperagendaand in the presence of thetechnical ‘experts, it|<br>wasdecided toratifythead-hoc inputoutputnormsunderpara4.7ofHBPasperdetailsbeloworasapplied |<br>byfirmwhichever islower:<br>|<br>||||
||Export product|Qty. | SL.<br>Qty.|||
||LEVETIRACETAM|No.<br>|1<br>|(S)+2-AMINOBUTYRAMIDEHCL<br>0.95kg |||<br>||
|||4-CHLOROBUTYRYLCHLORIDE<br>1.02kg||.|
|||ACETONITRILE<br>1.028kg<br>4|POTASSIUMCARBONATE<br>0.838kg |<br>METHYLENECHLORIDE<br>0.74kg<br>:<br>—<br>—<br>ae||<br>|<br>|.<br>}|
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~ 20 Sd RA S*d ISOPROPYL ETHER] 050kg | | may take appropriate action as per the decision of Norms Committee. |
Case No.:333/12/82Party Name:CADILA Meet No/Date:12/82Status: | ALC4/2018 HEALTHCARE LTD ALC4/2018 ‘Deferred 12.12.2018 | *2 HQ File -RLAFile————~—~SCLicNo/Date:0810142004 [Defer Date: :01/82/050/00960/AM19/ :08/24/040/00326/AM18/ 14.02.2018 Decision: _ Deferred for comments of TE. |
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----- Start of picture text -----<br> CaseALC4/2018 No.:337/12/82- ‘PartyINDUSTRIES Name:FINEPVT. ORGANICLTD. MeetALC4/2018 No/Date:12/82- ‘ Status:Approved |—<br>12.12.2018 | |<br>HQ File RLA File Lic.No/Date:0310819181<br>:01/82/050/00964/AM19/ :03/94/040/00905/AM18/ 15.02.2018<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. 13/82 dated 17.07.2012, it was decided to ratify|<br>es<br>°° thelower: ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is |<br>Export product Qty. | SL. Qty.<br>No.<br>Sicary] Erucamide [ke [1 |SSS~S~S~EnecicAcd IG | |<br>Stearyl Amine 0.471 kg | |<br>RA may take appropriate action as per the decision of Norms Committee.<br>Case No.:266/12/82- Party Name:PORUS Meet No/Date:12/82-. Status:<br>ALC4/2018 LABORATORIES PRIVATE —=ALC4/2018 Deferred —<br>LIMITED 12.12.2018<br>HQ File RLA File Lic.No/Date:0910065992 Defer Date: |<br>:01/82/050/00893/AM19/ :09/24/040/00564/AM 18/ (16.02.2018<br>4 = SS ee,<br>Decision: The Committee considered the case as per agenda and it was decided to call for following<br>information / documents from the firm:<br>}<br>(i) Molecular weight of export product; |<br>(ii) Percentage of yield and<br>(iii) Stoichiometric balance.<br>Case No.:272/12/82- Party Name:KOPALLE Meet No/Date:12/82- (Status:<br>ALC4/2018 PHARMA CHEMICALS ALC4/2018 Deferred |<br>< PVT.LTD.., 12.12.2018 | |<br>>? HQ File RLA File Lic.No/Date:0910065994 Defer Date:<br>:01/82/050/00899/AM 19/ :09/24/040/00565/AM18/ 16.02.2018<br>Decision: Deferred for comments of TE. |<br>----- End of picture text -----<br>
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Case No.:277/12/82Party Name:NASENSE LABS Meet No/Date:12/82‘Status: | ALC4/2018 PVT LTD ALC4/2018 Deferred 12.12.2018 HQ File RLA File Lic. No/Date:09 10065995 | :01/82/050/00904/AM19/ :09/24/040/00573/AM18/ 16.02.2018 56 Decision: The Committee considered the case as peragenda and it was decided to cal i aowing | information from the firm: |
(i) Step-wise complete and balanced chemical reactions showing molecular weight and molar requirements. (ii) Percentage yield on molar basis | |
Case No.:279/12/82‘Party Name:SRINI. ——=—~—~—=SW Meet No/Date:12/82- Status: | ALC4/2018 PHARMACEUTICALS ALC4/2018 Approved | PRIVATE LIMITED 12.12.2018 | HQ File RLA File Lic.No/Date:09 10066004 | :01/82/050/00906/AM 19/ :09/24/040/00596/AM18/ 20.02.2018 |
Decision: | The Committee considered case as per agenda and in the presence of the technical experts, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied 57 by firm whichever is lower:
|
Export product Qty. | SI. | Import items Qty. No. | MYCOPHENOLATE MOFETIL | 1kg|1 | MYCOPHENOLIC ACID 0.941 kg | | [METHANOL 222 | MORPHOLINOETHANOL L0Skg | |
Case No.:26/12/82-ALC4/2018 Party Name:MAMTA Meet No/Date:12/82- (Status: —| /POLYCOATS ALC4/2018 Approved 12.12.2018 | | HQ File RLA File Lic. No/Date:34 10043906 :01/82/050/00653/AM19/ :34/24/040/00332/AM18/ 22.02.2018 Decision: | The Committee considered case as per agenda and in the presence of the technical experts, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied 58 by firm whichever is lower: |
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----- Start of picture text -----<br> Export product Qty. | SL Import items Qty.<br>No.<br>TRIETHYL CITRATE (TEC) 0.723 kg | |<br>(ESTER OF CITRIC ACID) CITRIC ACID |<br>RA may take appropriate action as per the decision of Norms Committee. |<br>Case No.:263/12/82- Party Name:SUVEN LIFE Meet No/Date: 12/82- a Status: |<br>59 ALC4/2018 SCIENCES LIMITED ALC4/201812.12.2018 Approved |<br>HQ File RLA File Lic. No/Date:09 10066012 |<br>「<br>----- End of picture text -----<br>
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01/82/050/00890/AM19/_-09/24/040/00602/AM18/ 23.02.2018 | Decision: TheCommittee considered case as per agenda and in the presence of the technical ‘experts, it, was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied | by firm whichever is lower:
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|---|---|---|---|---|---|---|---|
|Export|product|Qty.|||SL.|
|No.|
|DOXOFYLLINE|fl|[|]|FTRBOPAVELINE(| 080K0.80kg||||
|CHLOROACETAL|DEHYDE ||0.80kg|||||
|DIMETHYL|ACETAL|||
|ra|[METHANOLPOTASSIUM CARBONATE|0.61|[«(063]|kg|||
|DIMETHYL|FORMAMIDE|040kg||.|
|RA may take appropriate|action as per the decision of|Norms Committee.|||
|Case No.:273/12/82-|Party Name:METROCHEM|—-Meet No/Date:12/82-|Status:|
|ALC4/2018|API PVT. LTD.|ALC4/201812.12.2018|‘Approved|
|HQ File|RLA File|Lic.No/Date:0910066013|||
|-0.1/82/050/00900/AM 19/|:09/24/040/00613/AM18/|26.02.2018|
|Decision:|||The Committee considered case as per agenda and|in the presence|of|the technical|experts,|it|
|60|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.|||
|2-Mercapto-5-( 1-Pyrroly|)|1|kg|2.5-Dimethoxy|Tetrahydrofuran|1.88 kg|||
|RABenzimidazole may take appropriate|action as per the decision of|Norms Committee.|_||
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Case No.:267/12/82Party Name: TAGOOR Meet No/Date:12/82(Status: ~ | ALC4/2018 (CHEMICALS ALC4/2012.12.20 1 88 Approved HQ File ~RLAFile Lic.No/Date:0910066019 | | :01/82/050/00894/AM19/ :09/24/040/00607/AM 18/ 27.02.2018 Decision: |The Committee considered case as per agenda and in the presence of the technical experts, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: 61 | Export product Qty. | SI. Qty. | No. | 3-Chloromethyl-3, 5-Dimethyl-4-Methoxy | I kg 1 |3Sbutidine 1.04 kg Pyridine Hydrochloride ee 3] ra [AcetoneMethanol 250K | [6 | Ammonium Persulphate RA may take appropriate action as per the decision of Norms Committee. |
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Case No.:342/12/82Party Name:MICRO LABS —_-Meet No/Date:12/82-Status: | ALC4/2018 LTD ALC4/2018 ‘Approved | 12.12.2018 HQ File RLA File Lic.No/Date:0710112884 :01/82/050/00969/AM 19/ :07/24/040/00322/AM18/ 27.02.2018 Decision: | The Committee considered case as per agenda and in the presence of the technical experts, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied 6 by firm whichever is lower: | Export product Qty. Sl. Qty. | AMOXICILLIN | GM 40000000 Number AMOXICILLIN 45912.00 kg | DISPERSIBLE TABLETS/ | GM TRIHYDRATE | TABLETS BP/IP/EP/USP | | BP/IP/EP/USP( 40000 KG ) RA may take appropriate action as per the decision of Norms Committee. ‘| Case No.:259/12/82Party Name:MYLAN Meet No/Date:12/82(Status: ALC4/2018 LABORATORIES LIMITED ALC4/2018 ‘Approved | 12.12.2018 | | Lie. No/Date:0910066025 HQ File RLA File -01/82/050/00886/AM 19/ :09/24/040/00593/AM18/ 01.03.2018 Decision: The Committee considered case as per agenda and in the presence of the technical experts, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied | by firm whichever is lower: | | Export product Qty. SL. Qty. | No. I kg |-(2,2-dimethoxyethy!)-5-methoxy1.375 kg 632[DOLUTEGRAVIR SODIUM] 6-(methoxycarbony!)-4-oxo-1 ,4| dihydro pyridine-3-carboxylic acid Or) Dolutegravir Sodium (DSS) I | (R)-3-Aminobutan-1-ol 0.445 kg Methanesulphonic Acid 0.046kg | ta —[Acewnivile ___——SSS—«* S| | 3 | Methanot /6 |«dSMethylene Chloride 45ikg | | /8 2,4-difluoro benzylamine 0.47 kg | 9 | CitricPotassium acid monohydrateCarbonate 0.1 7536 kg | || RA may take appropriate action as per the decision of Norms Committee. Case No.:269/12/82"Party Name:SATYA Meet No/Date:12/82Status: ALC4/2018 DEEPTHA ALC4/2018 Deferred PHARMACEUTICALS LTD 12.12.2018 | | ia HQ File RLA File Lic.No/Date:0910066024 Defer Date: | :01/82/050/00896/AM19/ :09/24/040/00599/AM 18/ (01.03.2018 | Decision: Deferred for comments of TE. _ =
24
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Case No.:275/12/82Party Name:SATY DEEPTHA ALC4/2018 Deferred ALC4/2018 A Meet No/Date:12/82Status: PHARMACEUTICALS LTD _ 12.12.2018 | es | > HQ File RLA File Lic.No/Date:0910066023 DeferDate: — :01/82/050/00902/AM19/ :09/24/040/00606/AM18/ 01.03.2018 i Be as Decision: Deferred for comments of TE. Case No.:262/12/82Party Name:AUROBINDO Meet No/Date:12/82- Status: ~| ALC4/2018 PHARMA LIMITED ALC4/2018 Approved 12.12.2018 | ; : HQ File RLA File ‘Lic. No/Date:09 10066029 | :01/82/050/00889/AM19/ :09/24/040/006 18/AM18/ 05.03.2018 | Decision: | The Committee considered case as per agenda and in the presence of the technical experts, it. was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied | by firm whichever is lower: Export product Qty. | SL Qty. 66 suid | MEROPENEM FOR INJECTION | | kg ft | Meropenem Trihydrate (Non | 0.9586 kg | (MEROPENEM STERILE) Sterile) LP. Condition: The export product should Activated Carbon (Carbon 0.0188kg | | be packed in 1000 Nos. of input at 5 are | S|.No.5 of the Import List that should aes | be accounted for in the Shipping /4 | Methanol : 0.0958 kg Bills : 5 Aluminiumwith ChloroCanistersButyl Plug/ Bottles/ Inner & | Relevantas per sereon / Alu Caps | packing [14 Ltrs (SKg Cap) policy | RA may take appropriate action as per the decision ofNorms Committee. _| ——— Meet No/Date:12/82Status: Case No.:270/12/82Party Name:AKTINOS ALC4/2018 HEALTHCARE PRIVATE ALC4/2018 Approved — LIMITED 12.12.2018 HQ File RLA File Lic.No/Date:09 10066032 | :0.1/82/050/00897/AM 19/ :09/24/040/00592/AM18/ 07.03.2018 | Decision: | The Committee considered case as per agenda and in the presence of the technical experts, it) was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Qty. | SI. Qty. 67 No. |-(2.2-DIMETHYOXYETHYL)S5- | 1 kg | METHYL-4-METHOXY 0.75 kg | METHOXY-6ACETOACETATE (MET’HOXYCARBONYL)-4spallingee 0.735ke | | -1,4OPYRI -3ona -—op 3 AMINODIMETHYL ACETALDEHYDEACETAL 0.591 kg || (DOLUTEGRAVIR SODIUM) “4| DIMETHYL OXALATE Tsiske |. 5 LITHIUM HYDROXIDE 0.323 kg Fe [METHANOLMONOHYDRATE «3 094k |
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|METHYLENE DICHLORIDE|| 3.395kg|||||
|MDC|
|RA|may|take|appropriate|action|as per the decision of Norms Committee.|
|Case No.:219/12/82-|Party Name:INDIA GLYCOLS|Meet No/Date:12/82-|Status:||
|ALC4/2018|LTD.,|ALC4/2018|Approved|—|
|12.12.2018|||
|HQ File|RLA|File|Lic.|No/Date:05 10405825|||
|:01/82/050/00846/AM19/|:05/23/040/00485/AM18/|09.03.2018|
|Decision:|| The Committee considered the case as per|agenda|in the presence|ofTechnical Experts and|in||
|the|light of earlier decision taken by NC|in|its Meeting No. 2/82-ALC4/2018, dated|16.05.2018|in respect of|||
|M/s|India Glycols|Ltd.|against Advance|Authorization No. 0510401982 dated|17.03.2017,|it was decided|to|||
|68|ratifywhicheverthe|ad-hocis lower:input|output|norms|under|para|4.7|of HBP|as|per|details|below|or|as|applied|by|firm||
|||
|Export product|Qty.|||SI.|Qty.|
|No.|||
|Mono Ethylene Glycol (MEG)|||||kg ia|Denatured|Ethyl! Alcohol|1.123 kg|
|Silver Catalyst|0.000228 kg|
|Alumina Catalyst|0.000362 kg|||
|RA may take appropriate|action as per the decision of|Norms Committee.|||
|Case No.:257/12/82-|Party Name:ORTIN|Meet No/Date:12/82-|(Status:|
|ALC4/2018|LABORATORIES LTD|ALC4/2018|Deferred|
|12.12.2018|
|6|HQ File|RLAFile|LicNo/Date:0910066055|Defer Date:|
|Decision::01/82/050/00884/AM19/|[~ Deferred][ for]|[comments]|:09/24/040/0061|[ of][ TE.]|0/AM18/|(12.03.2018|||||
|Case No.:276/12/82-|Party Name:COVALENT|Meet No/Date:12/82-—*(Status:|||
|ALC4/2018|LABORATORIES PRIVATE|ALC4/2018|Approved|—|
|LIMITED|12.12.2018|||||
|HQ File|RLA File|‘Lic.No/Date:09 10066052|||||
|:01/82/050/00903/AM19/|:09/24/040/00629/AM18/|12.03.2018|||
|Decision:||The Committee considered caseasper agenda and|in the presence of|the technical|experts,|i|
|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:|||
|||
|70|
|Export product|Qty.|Sl.|Qty.|||
|No.|||
|Cefixime|7-Phenylacetamideo-3-Chloromethy!|1.4219 kg|
|CephalosporonicMethoxybenzy!|Ester|(GCLEAcid|Para|||
|Tripheny! Phosphine|||
|Activated Carbon|0.05 kg|
|'4|||Dimethyl Formamide|2.80 kg|||
|Methylene Chloride|10.00kg|||||
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26 A ~ [082ke || TJ Mica ster 0B | RA may take appropriate action as per the decision of Norms Committee.
||
‘(Meet No/Date:12/82- Status: | Case No.:24/12/82-ALC4/2018 [Party Name:AMILIFE SCIENCES PRIVATE ALC4/2018 Approved LIMITED 12.12.2018 | | HQ File RLA File Lic.No/Date:3410043975 :01/82/050/0065 1/AM19/ :34/24/040/00367/AM18/ 14.03.2018 | Decision: | The Committee considered case as per agendaand in the presence ofthe technical experts, it | 7 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: | RUTOSIDE TRIHYDRATE EP | 17850 kg CRUDE RUTIN. | 21000.001 kg | QUERCETIN DIHYDRATE 735 kg (ASSAY BY HPLC NLT 90%) RA may take appropriate action as per the decision of Norms Committee. Case No.:274/12/82-rtParty Name:SRIAM LABS ‘Meet No/Date:12/82‘Status: | ALC4/2018 PRIVATE| LIMITED ALC4/2018|12.12.2018 Approved| —| | HQ File RLA File Lic.No/Date:09 10066063 -01/82/050/00901/AM19/ :09/24/040/00636/AM 18/ 14.03.2018 Decision: | The Committee considered case as per agenda and _ in the presence of the technical experts, it | 77 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. | No. FAMCICLOVIR I kg 9-(4-Acetoxy-3-(acetoxymethy!)but-I-yl)-21.275 kg | amino-6-chloro purine | RA may take appropriate action as per the decision of Norms Committee. |
. CaseALC4/2018No.:169/12/82/ PartyINDUSTRIES Name:Y PVT.LTD.ASHO MeetALC4/2018 No/Date: 12/82- Status:Approved || 12.12.2018 | HQ File RLA File Lic.No/Date:0310819912 — | -01/82/050/00796/AM19/ :03/95/040/01128/AM18/ 19.03.2018 | Decision; | The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 3/82-ALC4/2014, dated 08.05.2014 in respect of | 73 M/s Yasho Industries Pvt. Ltd. against Advance Authorization No. 0310760774 dated 05.12.2013, 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 |
firm whichever is lower: | Export product Qty. | SL. Qty. | No. | Methyl Eugenol pike} t | Clove Leaf Oil (Eugenol content 78%) | 1.40 kg
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RA may take appropriate action as« per|[the][decision] of Norms Committee.
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|---|---|---|---|---|---|---|
|Case No.:305/12/82-|Party Name:RELIANCE|Meet No/Date:12/82-|Status:|||
|ALC4/2018|INDUSTRIES LTD.|ALC4/2018|Deferred|
|12.12.2018|
|'|
|HQ|File|RLA|File|LicNo/Date:0310819898 Defer|Date:|||
|:01/82/050/00932/AM19/|:03/95/040/00723/AM18/|19.03.2018|||||
|Decision:||The Committee decided to refer the case to D/o C&PC|for obtaining|its|comments.|;|||
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Case No.:155/12/82Party Name:ETERNIS FINE Meet No/Date:12/82Status: | ALC4/2018 CHEMICALS LIMITED, ALC4/2018 Approved | 12.12.2018 | | HQ File RLA File Lic.No/Date:03 10819947 | :01/82/050/00782/AM19/ ':03/94/040/01053/AM18/ 20.03.2018 | | Decision: | The Committee considered the case as per agenda in the presence of Technical Experts and in. the light of earlier decision taken by NC in its Meeting No. 4/82-ALC4/2018, dated 19.06.2018 in respect of | M/s Eternis Fine Chemicals Limited against Advance Authorization No. 0310817803 dated 15.12.2017, it 75 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: | Para Tertiary Butyl 1 kg fi. | Para Tertiary Butyl Phenol 0.820 kg | Cyclohexy! Acetate 5% Ruthenium on Carbon Catalyst 0.00003 kg | 0300k8 | RA may take appropriate action as per the decision ofNorms Committee. |
~~ CaseALC4/2018No.:161/12/82partyALLIED Name:CAMPHOR PRODUCTS & MeetALC4/2018 No/Date:12/82- (Status:Approved | LIMITED, 12.12.2018 | HQ File RLA File Lic.No/Date:0310819946 — | -01/82/050/00788/AM19/ :03/94/040/01058/AM18/ 20.03.2018 Decision: The Committee considered case as per agenda and in the presence of the technical experts, it | was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied | by firm whichever is lower: | 76 | Export product Qty. | SI. Qty. No. SANJINOL TOCO | 1 | Alpha Pinene 1.47 kg (2-Ethyl-4-(2 2. 3-Trimethylcyclopent-3N-Butyraldehyde 0.77 kg en-yl)-but-2-en-1-0l) 040ks | | 4 | Aluminum Tri-sec-Butoxide 0.072 kg | L Di N Butylamine 0.077 kg | RA may take appropriate action as per the decision of Norms Committee. oe _ |
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Case No.:260/12/82Party Name:GRANULES Meet No/Date:12/82Status: | ALC4/2018 INDIA LIMITED ALC4/2018 ‘Approved | 12.12.2018 HQ File RLA File Lic.No/Date:09 10066065 | Decision::01/82/050/00887/AM19/The Committee considered caseas:09/24/040/00638/AM18/ per agenda and in20.03.2018 the presence of the Sai moon i 77 wasby firm decidedwhichever to ratifyis thelower: ad-hoc input output norms under para 4.7 of HBP as per details below or as applied | Export product Qty. | SI. Qty. | No. Tenofovir Disoproxil Succinate ia (R)Propy!)- 9adenine- (2-Phosphony! Methoxy | 0.769 kg Chloromethy! Isopropy! Carbonate 1.3527kg | | RA may take appropriate action as per the decision of Norms Committee. |
Case No.:317/12/82Party Name:AMI ORGANICS | Meet No/Date:12/82“Status: ALC4/2018 PVT LTD. ALC4/201812.12.2018 |Deferred | 78 : : : Wess ma URE, TRY TT Se eae.| HQ File RLA File Lic.No/Date:5210042570 Defer Date: :01/82/050/00944/AMDecision: Deferred for19/ comments:§2/24/040/00085/AM of TE. - 18/ 20.03.2018.
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Case No.:253/ 12/82Party Name:PI INDUSTRIES 7 ‘Meet No/Date: 12/82Status: —_ ALC4/2018 LTD LieALC4/201812.12.2018No/Date:1310048915 Approved —| HQ File ~IRLAFile -01/82/050/00880/AM19/Decision: The Committee considered':13/24/040/00066/AM18/case as per agenda and in22.03.2018 the presence of the technical experts, al was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied | by firm whichever is lower: Export product Qty. | SL. Qty. | No. | CCIM. Chemical Name: 4- | | kg | 1 | p-methylacetophenone 1.285 kg | Chloro-5-p-toly limidazole-2Hydroxylamine sulfate 2.26 kg carbonitrile Glyoxal 40 % Min. 1.46 kg | /4 _| N-methylpyrrolidone 1.02 kg | Ethylene Dichloride 4.55 kg RA may take appropriate action as per the decision of Norms Committee. Case No.:121/12/82Party Name:VITAL Meet No/Date:12/82‘Status: | ALC4/2018 LABORATORIES PRIVATE ALC4/2018 ‘Approved 80 LIMITED 12.12.2018 HQ File RLA File LicNo/Date:0310820042 | :01/82/050/00748/AM19/ :03/95/040/01064/AM18/ 23.03.2018 —— |
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Decision: | The Committee considered case as per agenda and in the presenceof 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. | No. | METHYLCOBALAMIN JP / USP baa ll VIT(CY A MINNOCOBALAMIN) B12 0.95 kg | RA may take appropriate action as per the decision of Norms Committee. | Case No.:156/12/82Party Name:AMINES & Meet No/Date:12/82‘Status: ALC4/2018 PLASTICIZERS LIMITED ALC4/2018 Approved | 12.12.2018 . Lic. No/Date:03 10820049 | HQ File RLA File :01/82/050/00783/AM19/ :03/94/040/01040/AM18/ 23.03.2018 | Decision: | The Committee considered case as per agenda and in the presence of[the][ technical][ ‘experts,][it,] was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied | g| by firm whichever is lower: || Export product Qty. | SL. Qty. No. N-METHYL MORPHOLINE tkg|1 | MORPHOLINE 0391ke | OXIDE - 50% HYDROGEN PEROXIDE 50% 0.3 kg FORMIC ACID 0.245 kg RA may take appropriate action as per the decision of Norms Committee. ; __ | Case No.:280/12/82Party Name:HETERO LABS Meet No/Date:12/82Status: ALC4/2018 LIMITED ALC4/2018 Approved — 12.12.2018 | | = —~—Lie.No/Date:0910066079 — | HQ File —RLAFile -01/82/050/00907/AM19/ :09/24/040/00663/AM18/ 23.03.2018 ——— | Decision: |The Committee considered case as per agenda and in the presence of the technical experts, it | was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: | | 82 Export product Qty. | SL Qty. | No. | N-METHYL MORPHOLINE 2-Benzothiazolyl-2-amino0.82 kg OXIDE - 50% alpha(methoxycarbonylmethyloxyimino)-4thiazolethioacetate (MICA ester) | Dimethyl Formamide 2.79kg || aT—SSSSCSCSC~dC AcetonitrileMethylene Chloride 8.09kg | RA may take appropriate action as per the decision of Norms Committee. a
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Case No.:8/12/82-ALC4/2018 Party Name:STYRAX Meet No/Date:12/82(Status: PHARMA PRIVATE ALC4/2018 Approved LIMITED 12.12.2018 | | HQ File RLA File Lic.No/Date:09 10066089 | :01/82/050/00635/AM19/ :09/24/040/00646/AM 18/ 26.03.2018 Decision: | The Committee considered case as per agenda and in the presence of the technical experts, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied 83 |by Exportfirm whichever product is lower: Qty. | SI. Qty. | No. | TENOFOVIRFUMARATE DISOPROXIL ft | 9-(2-PHOSPHONYPROPYL ADENINE L METHOXY) | 0.769 kg | 2 CHLOROMETHYL-2-ISOPROPYL 1.3527 kg | SS PIRIETHYLCARBONATE AMINE O77 Kg 4| TRIMETHYL CHLOROSILANE 0.088kg |, METHYLENE DICHLORIDE (MDC) 3.50kg |) RA may take appropriate action as per the decision of Norms Committee. Case No.:137/12/82Party Name:RELIANCE Meet No/Date:12/82Status: | ALC4/2018 INDUSTRIES LTD. ALC4/2018 Deferred 84 12.12.2018 | | - ~RLAFile ‘Lic. No/Date:03 10820089 Defer Date: 11Q File :01/82/050/00764/AM 19/ :03/95/040/01040/AM18/ 26.03.2018 Decision: |The Committee decided to refer the case to D/o C&PC for obtaining its comments. _|
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----- Start of picture text -----<br> Case No.:164/12/82- Party Name:FINE ORGANIC Meet No/Date:12/82- (Status:<br>ALC4/2018 INDUSTRIES LTD ALC4/2018 Approved |<br>HQ [File] RLA File ~_Lic.No/Date:0312.12.2018 10820068 | |<br>:01/82/050/0079 1/AM19/ :03/94/040/01063/AM18/ 26.03.2018<br>Decision: | The Committee considered case as per agenda and in the presence of the technical experts, it<br>gs (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. | SI. Qty.<br>No.<br>STEARYL ERUCAMIDE Ikg|1 | ERUCIC ACID 0.592kg |)<br>STEARYL AMINE 0.471 kg<br>RA may take appropriate action as per the decision of Norms Committee.<br>----- End of picture text -----<br>
Case No.:165/12/82Party Name:RELIANCE Meet No/Date:12/82Status: | ALC4/2018 INDUSTRIES LTD. ALC4/2018 ‘Deferred 12.12.2018 86 HQ File RLA File Lic. No/Date:0310820072 [Defer Date: :01/82/050/00792/AM19/ :03/95/040/009 14/AM18/ 26.03.2018 | Decision: The Committee decided to refer the case to D/o C&PC for obtaining itscomments. |
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----- Start of picture text -----<br> Case No.:258/12/82- Party Name:SYNTHO Meet No/Date:12/82- Status: |<br>ALC4/2018 CHIRALS PRIVATE ALC4/2018 Deferred |<br>LIMITED 12.12.2018<br>ms HQ File RLA File ; Lic.No/Date:09 10066087 ‘Defer Date: |<br>:01/82/050/00885/AM 19/ :09/24/040/00669/AM 18/ 26.03.2018<br>Decision: Deferred for comments of TE.<br>----- End of picture text -----<br>
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----- Start of picture text -----<br> Case No.:160/12/82- Party Name:CAMPHOR & Meet No/Date:12/82- Status:<br>ALC4/2018 ALLIED PRODUCTS ALC4/2018 Approved<br>LIMITED, 12.12.2018<br>HQ File RLAFile Lic.No/Date:03 10820149 |<br>:01/82/050/00787/AM19/ :03/94/040/01083/AM18/ 27.03.2018<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>88<br>Export product Qty. | SL. Qty. |<br>SANJINOL TOCO 1kg|1 | Alpha Pinene 1.47 kg |<br>(2-Ethyl-4(2 2. 3-Trimethyleyclopent-3- N-Butyraldehyde |<br>en-yl) but-2-en-1-ol) 040ks |<br>4 | Aluminum Tri-sec-Butoxide _| 0.072 kg<br>Di N Butylamine 0.077 kg<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.:162/12/82Party Name:GLENMARK Meet No/Date:12/82(Status: ALC4/2018 PHARMACEUTICALS LTD., ALC4/2018 Approved | 12.12.2018 | — . = | , . HQ File RLA File Lic.No/Date:03 10820138 | :01/82/050/00789/AM 19/ :03/94/040/01069/AM18/ 27.03.2018 | Decision: The Committee considered case as per agenda and in the presence ofthe technical experts, it | | was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied | 89 by firm whichever is lower: | Export product Qty. | SI. Qty. No. carboxylic acid | Atovaquone 1 kg ft | Trans-4-(4-chloropheny!) cyclohexane | 1.94 kg 2-Chloro-|,4-Napthoquinone 1.62kg | RA may take appropriate action as per the decision of Norms Committee. | Case No.:163/12/82Party Name:FINE ORGANIC Meet No/Date: 12/82- Status: ALC4/2018 INDUSTRIES LTD ALC4/2018 Approved | 12.12.2018 | ~ RLAFile Lic.No/Date:0310820143_ HQ File :01/82/050/00790/AM 19/ :03/94/040/01062/AM18/ 27.03.2018 Decision: | The Committee considered case as per agenda and in the presence of[the][technical][experts,][it)][to][ratify][the][ ad-hoc][input][ output][norms][ under][ para][ 4.7][ of][ HBP][ as][ per][ details][ below][ or][ as][ applied] 99[38][ decided] by firm whichever is lower: Export product Qty. | SI. Qty. STEARYL ERUCAMIDE HTNo. ERUGIGACID.——SSSS—~*d 8B [2 [STEARYLAMINE «O47 Kg
Qty. |
Case No.:136/12/82~ [Party Name:RELIANCE (Meet No/Date:12/82(Status: | ALC4/2018 INDUSTRIES LTD. ALC4/201812.12.2018 Deferred| 91 HQ File RLA File Lic.No/Date:0310820195 Defer Date: :01/82/050/00763/AM19/ :03/95/040/01091/AM18/ 28.03.2018 Decision: |The Committee decided to refer the case to D/o C&PC for obtaining its comments. |
Case No.189/12/82-—~—~_—iParty Name:J.B.KHOKHANI & [Meet No/Date:12/82- (Status: ALC4/2018 co. ALC4/201812.12.2018 ‘Approved — HQ File RLA File Lic.No/Date:03 10820175 92 :01/82/050/00786/AM19/ :03/94/040/01085/AM 18/ 28.03.2018 Decision: | The Committee considered case as per agenda and in the presence of the technical experts, it” was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied | by firm whichever is lower: | ssrceencemameasasicilininar tient
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35
Export product Qty. ‘Si. Import items a 7 Qty. Erythromycin Oxime Base aes lkg(eB | 1 Erythromycin Thiocyanate5 (ON 100% | 1.20 kg Activity Basis) 2 Isopropanol 0.78 kg 3 Hydroxylamine Hydrochloride 0.60 kg
Case No.:122/12/82Party Name:NEON Meet No/Date: 1 2/82Status: ALC4/2018 LABORATORIES LTD. ALC4/2018 Deferred 12.12.2018 93 HQ File RLA File ‘Lic.No/Date:0310820210 Defer Date: :01/82/050/00749/AM 19/ :03/95/040/00877/AM1 8/ 02.04.2018 Decision: Deferred for comments of TE. Case No.:123/12/82Party Name: NEON Meet No/Date: 1 2/82Status: ALC4/2018 LABORATORIES LTD. ALC4/2018 Deferred 12.12.2018 HQ File RLA File Lic.No/Date:0310820208 Defer Date: :01/82/050/00750/AM 19/ :03/95/040/00709/AM 1 8/ 02.04.2018 Decision: Deferred for comments of TE.
Case No.:139/12/82Party Name:J.B. CHEMICALS Meet No/Date:12/82Status: ALC4/2018 & PHARMACEUTICALS ALC4/2018 Deferred LIMITED 12.12.2018 7 HQ File RLA File Lic.No/Date:0310820214 Defer Date: :01/82/050/00766/AM 19/ :03/94/040/01090/AM18/ 02.04.2018 Decision: Deferred for comments of TE. Case No.:157/12/82Party Name:CHEMICAL Meet No/Date: 12/82Status: ALC4/2018 BROTHERS ENTERPRISES ALC4/2018 Deferred PVT. LTD. 12.12.2018 HQ File RLA File Lic.No/Date:0310820204 Defer Date: :01/82/050/00784/AM19/ :03/94/040/01014/AM18/ 02.04.2018
96 Decision: The Committee considered the case as per agenda and it was decided to call for following information / documents from the firm:
(i) Chemical name of Export product; (ii) Molecular weight of Export Product; (iii) Percentage of yield and (iv) Stoichiometric balance.
Case No.:173/12/82Party Name:SAVLA Mect No/Date: 1 2/82Status: ALC4/2018 CHEMICALS LIMITED ALC4/2018 Approved 12.12.2018 97 HQ File RLA File Lic. No/Date:0310820207 :01/82/050/00800/AM 19/ :03/95/040/01136/AM18/ 02.04.2018 Decision: | The Committee considered case as per agenda and in the presence of the technical experts, it
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was decided to ratify the ad-hoc input output norms under para 4.7 of HBP on net to net basis as given below: Export product Qty. | Sl. | Import items Qty. No. HIGH PURITY METHYL | lkg METHYL TERTIARY BUTYL ETHER TERTIARY BUTYL ETHER (MTBE) RA99.8% may take appropriate action as per the decision of Norms Committee. | Case No.:118/12/82Party Name:SUPRIYA Meet No/Date:12/82- Status: _ | ALC4/2018 LIFESCIENCE LTD ALC4/2018 Approved | 12.12.2018 HQ File RLA File Lic.No/Date:03 10820225 :01/82/050/00745/AM19/ :03/95/040/01176/AM18/ 03.04.2018 Decision: | The Committee considered case as per agenda and in the presence of the technical cxperts, il 98 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. | MECOBALAMINE JP /ikg|1| VITAMIN BI2 EP/USP 0.95 kg RA may take appropriate action as per the decision of Norms Committee. | Case No.:125/12/82Party Name:IPCA Meet No/Date: 12/82‘Status: | ALC4/2018 LABORATORIES LIMITED ALC4/2018 Approved | 12.12.2018 | | HQ File 'RLA File Lic.No/Date:03 10820229 | :01/82/050/00752/AM19/ :03/94/040/01097/AM18/ (03.04.2018 Decision: |The Committee considered case as peragenda 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: | 99 | No. PYRANTEL PAMOATE | 1 | Thiophene 2 Aldehyde 0.30kg | 0.77 kg Iso Propy! Alcohol 0.32kg || r4|[CiicAcid AS kg 0.28 kg RA may take appropriate action as per the decision of Norms Committee.
Case No.:138/12/82Party Name:IPCA Meet No/Date:12/82Status: ALC4/2018 LABORATORIES LIMITED (12.12.2018ALC4/2018 Approved 109 HO File RLA File Lic.No/Date:0310820231 | :01/82/050/00765/AM19/ :03/94/040/01073/AM18/ 03.04.2018 Decision: |The Committee considered case as per agenda and in the presence of the technical experts, it | was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as | applied by firm whichever is lower: _|
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_ 7 SO - Decision: Deferred for comments of TE. Case No.:256/12/82Party Name:VARAHI Meet No/Date:12/82Status: ALC4/2018 PHARMA PRIVATE ALC4/2018 Deferred LIMITED 12.12.2018 1055 ° a “peel - oO ve SEPP PCPSPal oy HQ File RLA File LicNo/Date:0910066111 (Defer Date: :01/82/050/00883/AM19/ :09/24/040/0064 1/AM18/ 05.04.2018 Decision: Deferred for comments of TE. - oe | Case No.:140/12/82Party Name:BELCHEM INDS. Meet No/Date:12/82_—Status: | ALC4/2018 INDIA PVT. LTD. ALC4/2018 Approved — 12.12.2018 HQ File RLA File Lic.No/Date:03 10820299 | :01/82/050/00767/AM19/ :03/94/040/01061/AM18/ 06.04.2018 Decision: |The Committee considered case as per agenda and in the presence of the technical ‘experts, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as 10%[applied][ by][ firm][ whichever][is][ lower:] | No. 13 DIMETHYLOL -5,5- | lkg 5,5 DIMETHYL HYDANTOIN ASSAY | 0.382 kg DIMETHYL (DMDM 99% MIN COLOUR PURE WHITE | HYDANTOIN 52% = -55%) ASSAY 55% MAX BELGUARD DMDMH RA may take appropriate action as per the decision of Norms Committee. | Case No.:141/12/82Party Name:BLISS GVS Meet No/Date:12/82Status: ALC4/2018 PHARMA LTD. ALC4/2018 Deferred 12.12.2018 107 HQ File RLA File LicNo/Date:0310820295 Defer Date: :0.1/82/050/00768/AM19/ :03/94/040/01091/AM18/ 06.04.2018 . ; | Decision: Deferred for comments of TE. Case No.:9/12/82-ALC4/2018 Party Name:STYRAX Meet No/Date:12/82(Status: PHARMA PRIVATE ALC4/2018 ‘Approved LIMITED 12.12.2018 | HQ File RLAFile Lic.No/Date:09 10066119 :01/82/050/00636/AM19/ :09/24/040/00009/AM 19/ 09.04.2018 | Decision: The Committee considered case as per agenda and in the presence of the technical experts, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as_ applied by firm whichever is lower: 108
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----- Start of picture text -----<br> No.<br>4-AMINO-2-OXO- Tkg|1 | GLYOXALIC ACID 50% | 0.746kg |<br>PYRIMIDINYL- 2 | [2,5-DIHYDROXY-1,4-DIATHINE] | 0.327 kg<br>OXATHIOLANE-2- 3 [CYTOSINE«(AK |<br>CARBOXYLIC ACID- '4 | HEXA METHYL DISILAZANE 0.708 kg<br>ISOPROPYL-METHYL- METHYLENE DI CHLORIDE (MDC) _| [2.63] kg |)<br>CYCLOHEXYL ESTER OR| [6 |L-MENTHOL ‘0.751 kp J)<br>----- End of picture text -----<br>
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~ a RA may take appropriate action as per the decision of may take appropriate action as per the decision of take appropriate action as per the decision of action as per the decision of as per the decision of per the decision of the decision of of Norms Committee. Committee.
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|a|||
|RA may take appropriate action as per the decision of may take appropriate action as per the decision of take appropriate action as per the decision of action as per the decision of as per the decision of per the decision of the decision of of|Norms Committee. Committee.|||
|_|‘Party Name:SURVIVAL|Meet No/Date:12/82-|‘Status:|||
|Case No.:124/12/82-|
|ALC4/2018|TECHNOLOGIES PVT.LTD.|ALC4/201812.12.2018|Approved|
|~|RLAFile|~~|Lie.|No/Date:03 10820318|||
|HQ|File|
|-01/82/050/0075 1/AM19/|:03/95/040/00007/AM19/|09.04.2018|||
|was|decided|to|ratify|the|ad-hoc|input|output|norms|under|para|4.7|of HBP|as|per|details|below|or|as|
|Decision:||The Committee considered case asperagenda and|inthe presence ofthetechnical|experts,|it|
|applied|by|firm|whichever|is|lower:|
|109|ExportSUR-742 product|Qty.Ikg|||1 SLNo.|||HYDRAZINE HYDRATE 99 - 100%|Qty.0.707 kg|||
|[1.2.4]|Triazolo|—_[1.5-a]|METHYLENE DI-CHLORIDE|6.564 kg|
|pyridine-6-carbonitrile,|8-|[|[2-|3- AMINO CROTONONITRILE|1.625kg|||
|(dibutylamino)|— -4-phenyl-5-|BOC|ANHYDRIDE|(Ditertbutyl|| 1.902kg||.|
|thiazolyl]|imino]-2-|(1-|Dicarbonate)|DI|—- BOC|||
|ethylpenty!)|-5,8-dihydro-7-|TRIFLICSulfonic|Acid)ACID|(_|Trifluoromethane|1.425 kg||||
|methyl-5|-|oxo|(6|||TRIFUORO ACETIC ACID|2.85kg|||
|RA may take appropriate action as per the decision|of|Norms Committee.|||
|Case No.:271/12/82-|Party Name:SUVEN LIFE|Meet No/Date:12/82-|(Status:|“||
|ALC4/2018|SCIENCES LIMITED|ALC4/201812.12.2018|Deferred|
|~~|
|LieNo/Date:0910066120|(Defer Date:|
|110|4Q|File|RLA|File|
|:01/82/050/00898/AMDecision:|Deferred|for19/ comments_|:09/24/040/00650/AM18/of TE.—|09.04.2018=|———|-|—— an|
|Case No.:130/12/82-|Party Name:S.KANT|Meet No/Date:12/82-|Status:|||
|ALC4/2018|HEALTHCARE LTD.|ALC4/201812.12.2018|‘Approved|—|
|||
|HQ|File|RLA|File|~||Lic.No/Date:03 10820375|||
|:01/82/050/00757/AM19/|:03/95/040/00827/AM 18/|11.04.2018|
|Decision:|The Committee considered case as per agenda and|in the presence of|the technical|experts,|it|||
|was|decided|to|ratify|the|ad-hoc|input|output|norms|under|para|4.7|of HBP|as|per|details|below|or|as|
|111|applied|by|firm|whichever|is|lower:|
|No.|
|LUMEFANTRINE|lkg|2.7|- DICLOROA|- (DIBUTYLAMINO)|0.869 kg|
|METHYL-OH-FLUORENE-4-|
|METHANOL|(DBA)|99% MIN|
|RA may take appropriate|action|as per the decision|of Norms Committee.|
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----- Start of picture text -----<br> Case No.:261/12/82- Party Name:AKTINOS Meet No/Date: 12/82- ‘Status:<br>ALC4/2018 HEALTHCARE PRIVATE ALC4/2018 Deferred<br>LIMITED 12.12.2018 |<br>112 : ec —— = irhe rae<br>HQ File RLA File Lic.No/Date:0910066131 |Defer Date:<br>:01/82/050/00888/AM19/ :09/24/040/00668/AM18/ 11.04.2018<br>Decision: Deferred for comments of TE.<br>CaseALC4/2018 No.:129/12/82- PartyINTERNATIONAL Name:PREGNA LTD. MeetALC4/2018 No/Date:12/82- Status:Approved |<br>12.12.2018<br>HQ File RLA File Lic.No/Date:03 10820433 |<br>-01/82/050/00756/AM19/ :03/95/040/00024/AM 19/ 12.04.2018 |<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. 4/82-ALC4/2018, dated 19.06.2018 in respect<br>of M/s Pregna International Ltd. against Advance Authorization No. 0310818603 dated 18.01.2018, it was<br>decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by<br>firm whichever is lower:<br>Export product Qty. | SL. Qty.<br>No. |<br>CONTRACEPTIVE DEVICE - (99.99% PURITY)<br>SE ae | | geen ee<br>113 MOULDING GRADE |<br>|<br>PURITY)<br>a Ole | |<br>GRANULES (MOULDING<br>GRADE<br>COMPOUND OF LDPE| 0.000415 kg<br>SULPHATE |<br>eee Soa<br>HDPEMOULDINGGRANULES GRADE (OR| 0.000177 kg |<br>GRADE / MOULDING<br> leeruaees|GRADE |<br>RA may take appropriate action as per the decision of Norms Committee. ___|<br>７<br>一<br>----- End of picture text -----<br>
Case No.:264/12/82Party Name: VINDHYA Meet No/Date: 12/82‘Status: ALC4/2018 ORGANICS PVT LTD ALC4/2018 Approved /12.12.2018 | | HQ File RLA File Lic.No/Date:09 10066142 :01/82/050/0089 1/AM19/ :09/24/040/00007/AM 19/ 12.04.2018 | | i 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.10/82-ALC4/2018, dated 16.10.2018 in respect | of M/s Vindhya Organics Pvt. Ltd. against Advance Authorization No. 0910065952 dated 31.01.2018, 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. | Sl. | Import items Qty.<br>No.<br>AFC ABACAVIR (ABV)I. | 1 kg 2-AZABICYCLO (2.2.1) HEPT-5-EN- | 1.41 kg<br>3-ONE; (VINCELACTAM<br>2 N-(2-AMINO-4, 6-DICHLORO-S- | 0.764 kg<br>PYRIMIDINYL) FORMAMIDE<br>14 | SODIUMD(-) TARTARIC BOROHYDRIDE ACID POWDER | 0. 78226 kg kg<br>L + Tartaric Acid 1.20 kg<br>RA may take appropriate action as per the decision ofNorms Committee. |<br>Case No.:314/12/82- Party Name:SUPREET Meet [No/Date:12/82-] [Status:]<br>ALC4/2018 CHEMICALS PVT.LTD. ALC4/2018 Approved<br>12.12.2018<br>HQ File ~RLAFile ~—~—~—_Lic.No/Date:5210042600 |<br>:01/82/050/0094 1/AM19/ :§2/24/040/00006/AM19/ 12.04.2018 |<br>Decision: |The Committee considered case as per agenda and in the presence ofthe 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<br>115 appliedPp by firm whichever is lower:<br>No.<br>6- NITRO- 2- AMINO PHENOL| | kg ORTHO AMINO PHENOL OR OAP 0.568 kg<br>4- SULFONIC ACID Or NP<br>ACID SP-4 |<br>RA may take appropriate action as per the decision of Norms Committee. ;<br>Case No.:120/12/82- Party Name:USV PRIVATE Meet No/Date:12/82- [Status<br>ALC4/2018 LIMITED ALC4/2018 Approved<br>12.12.2018<br>HQ File RLA File Lic.No/Date:0310820456 |<br>:01/82/050/00747/AM19/ :03/95/040/00033/AM19/ 13.04.2018<br>劃<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 116 applied by firm whichever is lower:
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----- Start of picture text -----<br> No.<br>Griseofulvin Tablets USP 500 mg | | Tablet Griseofulvin USP 510 mg / tablet<br>(4,000 Bottles x 100 Per Bottle =<br>400,000 Tablets) (Net Content<br>Weight = 200.000 kgs)<br>RA may take appropriate action as per the decision of Norms Committee.<br>Case No.:144/12/82-.~—~—s~PartyName:BDR——~<C~s*«CMeet No/Date:12/82- _‘|Status: |<br>ALC4/2018 PHARMACEUTICALS ALC4/2018 Deferred<br>INTERNATIONAL PVT. 12.12.2018<br>17 LTD. | |<br>HQ File RLA File Lic.No/Date:0310820452 Defer Date:<br>:01/82/050/0077 1/AM19/ :03/94/040/00022/AM19/ 13.04.2018 |<br>Ｓ‐<br>----- End of picture text -----<br>
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SO - |
Decision: Deferred for comments of TE.
~~ Meet No/Date:12/82- Status: Case No.:117/12/82Party Name:PIDILITE ALC4/2018 INDUSTRIES LIMITED ALC4/2018 Approved 12.12.2018 HQ File RLA File Lic. No/Date:03 10820529 :01/82/050/00744/AM19/ :03/95/040/00896/AM 18/ 18.04.2018 Decision: |The Committee considered case as per agenda and in the presence of the technical “experts, it 11g 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. No. ISOPROPYL ACETATE HAVING 99.8 % rl[_[|ACETICACID] | 0.60kg PURITY PROPYLENE 0.45kg | RA may take appropriate action as per the decision of Norms Committee. a Meet No/Date: 12/82-|Status: Case No.:110/12/82Party Name:ZIM ALC4/2018 LABORATORIES LIMITED ALC4/2018 Approved | (12.12.2018 ~— |Lic.No/Date:03 10820551 HQ File RLA File :01/82/050/00737/AM 19/ :03/95/040/00044/AM19/ 19.04.2018 | | Decision: |The Committee consideredcase as per agenda and in the presence of the technical ‘experts, it | 119 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. Azithromycin for oral suspension 200mg -1kg| 1 | Azithromycin IP/USP 0.078 kg RA may take appropriate action as per the decision of Norms Committee. ~~ Case No.:151/12/82Party Name:AARTI INDUSTRIES LIMITED ALC4/2018 ‘Approved ALC4/2018 /Meet No/Date:12/82Status: (12.12.2018 - RLA File Lic.No/Date:03 10820544 | HQ:01/82/050/00778/AM19/File :03/94/040/01099/AM18/ 19.04.2018 | | Decision: |The Committee considered case as per agenda and in the presence of the technical experts, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: 120 Export product Qty. | SI. oe | No. 2.4 DIFLUORO NITRO BENZENE (2,4 | | kg META DICHLORO 1.33 kg DFNB) BENZENE 2 POTTASSIUM 0.81 kg FLUORIDE (KF) ; 3 SULFOLANE 0.10 kg ANHYDROUS RA may take appropriate action as per the decision of Norms Committee. |
| |
43
~ Case No.:119/12/82-~~—~SParty Name:RELIANCE ——_—Meeet No/Date: 12/82"Status: ALC4/2018 INDUSTRIES LTD. ALC4/2018 Deferred a9 HQ File RLA File _ Lic.No/Date:031082056112.12.2018——— $$Defer Date: || :01/82/050/00746/AM19/ :03/95/040/01122/AM18/ 20.04.2018 Decision: The Committee decided to refer the case to D/o C&PC for obtaining its comments. 4
|
Case No.:149/12/82Party Name:CAMPHOR & MeetNo/Date:12/82_—_ Status: | ALC4/2018 ALLIED PRODUCTS ALC4/2018 Approved LIMITED, 12.12.2018 HQ File RLA File Lic. No/Date:0310820570 :0.1/82/050/00776/AM 19/ :03/94/040/00033/AM19/ 20.04.2018 Decision: The Committee considered case as per agenda and _ in the presence of the technical experts, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below oras | applied by firm whichever is lower: 122 Export product Qty. | Sl. | Import items Qty. | No. SANJINOL TOCO (1| Alpha Pinene 1.47 kg (2-Ethyl-4-(2 2 3-Trimethylcyclopent-3N-Butyraldehyde 0.77 kg en-y- but-2en-1-al 0.40 kg (4 | Aluminum Tri-sec-Butoxide 0.072kg | Di N Butylamine 0.077kg |
Case No.:150/12/82Party Name:CAMPHOR & Meet No/Date:12/82Status: | ALC4/2018 ALLIED PRODUCTS ALC4/2018 Approved LIMITED, 12.12.2018 | | HQ File RLA File Lic.No/Date:03 10820571 _ | :01/82/050/00777/AM19/ :03/94/040/00034/AM19/ 20.04.2018 Decision: |The Committee considered case as per agenda and in the presence of the technical experts, it | was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
123 Export product Qty. | SI. Qty. No. BACDANOL TOCO /1 | Alpha Pinene 1.47 kg (2-Ethyl-4-(2. 2 3-Trimethylcyclopent-3N-Butyraldehyde 0.77 kg en-yl)-but-2-en-I-ol 0.40 kg 4 | Aluminum Tri-sec-Butoxide 0.072 kg Di N Butylamine 0.077 kg RA may take appropriate action as per the decision of Norms Committee.
Case No.:147/12/82Party Name:CAMPHOR & Meet No/Date:12/82Status: | 124 ALC4/2018 ALLIED PRODUCTS ALC4/2018 ‘Approved | LIMITED, (12.12.2018 =~ oe — ee | | HQ File RLA File Lic.No/Date:03 10820593
44
“~
01/82/050/00774/AM19/__-03/94/040/000S0/AM19/ (23.04.2018 Decision: |The Committee considered case as per agenda and in the presence of the technical experts, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
Export product Qty. | SL. Qty. No. CAMPHOR (EP) Pikg|1| ALPHA PINENE 1.146 kg RA may take appropriate action as per the decision of Norms Committee.
Case No.:148/12/82Party Name:CAMPHOR & Meet No/Date:12/827 Status: ALC4/2018 ALLIED PRODUCTS ALC4/2018 Approved LIMITED, 12.12.2018 HQ File RLA File Lic.No/Date:03 10820594 | :01/82/050/00775/AM 19/ :03/94/040/00052/AM19/ 23.04.2018 | Decision: |The Committee considered case as per agenda and in the presence of the technical “experts, it 125 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. CAMPHOR USP }ikg|1| ALPHA PINENE 1.146 kg | RA may take appropriate action as per the decision of Norms Committee. | ([Meet No/Date:12/82-|Status: i Case No.:154/12/82~ [Party NameKAIRAV ALC4/2018 CHEMOFARBE INDUSTRIES ALC4/2018 Deferred LTD. 12.12.2018 HQ File RLA File Lic.No/Date:0310820585 [Defer Date: | 126 :01/82/050/00781/AM19/Decision: The Committee considered:03/94/040/00015/AM19/ the case as per agenda and 23.04.2018it was decided to call for following| | information / documents from the firm: |
(i) COA of import item from foreign supplier from foreign supplier alongwith testing report of the company for export product.
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_ hai
Case No.:143/12/82"Party Name:IPCA Meet No/Date:12/82- (Status: | ALC4/2018 LABORATORIES LIMITED ALC4/2018 ‘Approved 12.12.2018 HQ File -RLA File Lic.No/Date:03 10820643 _ | :01/82/050/00770/AM 19/ :03/94/040/00054/AM19/ 25.04.2018 | | 127 Decision: |The Committee considered the case as per agenda in the presence of Technical Experts and in ~" the light of earlier decision taken by NC in its Meeting No. 3/82-ALC4/2014, dated 08.05.2014, it was[|] decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Qty. | SL No.
45
o
ALLOPURINOL
==> picture [290 x 37] intentionally omitted <==
----- Start of picture text -----<br> ~ | tke | 3-Amino Pyrazole Carboxamide 1.5384<br>Hemisulphate<br>[50kg<br>----- End of picture text -----<br>
Case No.:152/12/82-—~—~—~-~Party Name:CIPLA LIMITED. Meet No/Date:12/82Status: | ALC4/2018 ALC4/2018 Approved 12.12.2018 d | HQ File RLA File Lic.No/Date:03 10820626 ” 128 :01/82/050/00779/AM19/ :03/94/040/00038/AM19/ 25.04.2018 Decision: The Committee considered the case as per agenda and it wasdecided to call for following information / documents from the firm: | (i) Description of Import Item No. 2 and 3 is not clear as Silicone Dioxide is already included in | Import Item No. 2.
==> picture [455 x 292] intentionally omitted <==
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|---|---|---|---|---|---|---|---|
|Case No.:153/12/82-|Party Name:ETERNIS FINE|Meet No/Date:12/82-|Status:|||
|ALC4/2018|CHEMICALS LIMITED,|ALC4/2018|Deferred|
|12.12.2018|||
|%|oniees|=|=|
|129|HQ File|RLA|File|Lic.No/Date:0310820647|[Defer Date:|||
|:01/82/050/00780/AM19/Decision:|Deferred|for comments:03/94/040/00055/AM19/ of TE.|25.04.2018|meni||
|Case No.:170/12/82-|Party Name:RELIANCE|Meet|No/Date:12/82-|(Status:|
|ALC4/2018|INDUSTRIES LTD.|ALC4/2018|Deferred|||
|12.12.2018|||
|130|11Q|File|RLA|File|Lic.No/Date:0310820654|Defer|a|
|:01/82/050/00797/AM19/|:03/95/040/00013/AM19/|25.04.2018|
|Decision:|The Committee decided|to refer the case to D/o C&PC|for obtaining|its comments.|
|Case No.:111/12/82-|Party Name:RELIANCE|Meet No/Date:12/82-|Status:|
|ALC4/2018|INDUSTRIES LTD.|ALC4/2018|Deferred|||
|12.12.2018|||
|131|HQ|File|RLA|File|‘Lic.No/Date:03 10820674|Defer Date:|
|:01/82/050/00738/AM19/|:03/95/040/01137/AM18/|26.04.2018|j|||
|Decision:||The Committee decided to refer the case|to|D/o C&PC|for obtaining|its comments.|
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Case No.:145/12/82"Party Name:CAMPHOR & Meet No/Date:12/82- (Status: ALC4/2018 ALLIED PRODUCTS \ALC4/2018 |Approved LIMITED, 12.12.2018 132 HQ File RLA File Lic.No/Date:03 10820695 :01/82/050/00772/AM19/ :03/94/040/00058/AM19/ 26.04.2018 Decision: |The Committee considered case as per agenda and in the presence of the technical experts, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as[|]
46
~
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||||||||||
|---|---|---|---|---|---|---|---|---|
|Oo|
|applied|by|firm|whichever|is|lower:|
|Export|product|Qty.|||Sl.|||Import|items|Qty.|
|No.|
|CAMPHOR (EP)||}ikg|1||ALPHA PINENE|1.146 kg|
|RA may|take|appropriate|action|as|per the|decision|of|Norms Committee.|
----- End of picture text -----<br>
applied by firm whichever is lower:
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|Case No.:146/12/82-|Party Name:CAMPHOR &|Meet No/Date:12/82-|_[Status:|||
|ALC4/2018|ALLIED PRODUCTS|ALC4/2018|Approved|
|(LIMITED,|(12.12.2018|
|HQ|File|RLAFile|——~—_Lic.No/Date:0310820697|||
|:01/82/050/00773/AM19/|:03/94/040/00059/AM19/|(26.04.2018|||
|Decision:||The Committee considered case as per agenda and|in the presenceofthetechnical|experts,|it|
|133|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.|
|CAMPHOR TECHNICAL|}ikg|1| ALPHA PINENE|1.04 kg|
|RA may|take|appropriate|action|as|per the|decision|of|Norms Committee.|
|Case No.:171/12/82-|Party Name:MATRIX FINE|Meet No/Date: 12/82-|poe|
|ALC4/2018|‘SCIENCES|PVT.LTD.,|ALC4/2018|Deferred|
|12.12.2018|||
|134|11Q File|“RLA File|—|~~|Lie. No/Date:03 10820676|[Defer Date:|
|:01/82/050/00798/AM19/|':03/95/040/00037/AM19/|26.04.2018|
|Decision:|Deferred for comments ofTE.|:|_|ee|||
|Case|No.:206/12/82-|-|"Party Name:IND SWIFT|Meet No/Date:|| 2/82-|A|
|ALC4/2018|LABORATORIES LIMITED|ALC4/2018|Approved|
|12.12.2018|||
|HQ|File|RLA|File|Lic.No/Date:2210015897|||
|:01/82/050/00833/AM19/|:22/24/040/00012/AM19/|26.04.2018|||
|Decision:||The Committee|considered|case|as per agenda and|in the presence of the technical|experts,|it|
|was|decided|to|ratify|the|ad-hoc|input|output|norms|under|para|4.7|of HBP|as|per|details|below|or|as|
|applied|by|firm|whichever|is|lower:|
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||||||||||
|---|---|---|---|---|---|---|---|---|
|Export product|Qty.|||SIL.|Qty.|
|No.|
|135|
|°°|| Atorvastatin Calcium|1kg|fl|||Methyl|Isobutyryl Acetate|1.423 kg|||
|0.100kg|||
|Sodium|Meta Bisulphite|0.030kg||||
|4|||Para Fluoro Benzaldehyde|0.566kg|||
|Isopropyl|Alcohol|5.60 kg|
|Thiazolium|Bromide|
|ie|||3-Ethyl-5-(2 Hydroxyethyl)-4-Methy]|0.262 kg|
|7|(4|R-Cis)-1,1-Dimethylethyl-6-|0.708 kg|
|Cyanomethy!-2,2-Dimethyl-1|-3-Dioxane-|
|4-Acetate|(ATS-8)|
|8|||Tert. Buty!|Methyl Ether|2.78 kg|
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47
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i | RA may take appropriate action as per the decision of Norms Committee.
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|Case No.:172/12/82-|-|Party Name:NEOGEN—|=Meet No/Date:12/82-————|Status:|
|ALC4/2018|CHEMICALS LIMITED|ALC4/2018|Approved|
|12.12.2018|
|HQ File|RLA|File|Lic.|No/Date:0310820729|[|]|
|:01/82/050/00799/AM|19/|:03/95/040/01009/AM|18/|01.05.2018|
|Decision:|Committee|considered|case|as|per|agenda|and|deliberated on|the|matter|in|the|presence|of the|
|136|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:|
|BENZYL BROMIDE|ris||BENZYL ALCOHOL|0.845|kg|
|2|HYDROBROMIC|ACID|||1.450 kg|
|RA concerned may take further necessary action as per48% above decision ofNC|||
|~~|
|Case|No.:326/12/82-|‘Party Name:ACEBRIGHT|Meet No/Date:12/82-|Status:|~|||
|ALC4/2018|(INDIA) PHARMA PVT LTD,|ALC4/2018|Approved|
|~|[Lic.No/Date:0710113202/12.12.2018||||
|HQ|File|RLA|File|
|:01/82/050/00953/AM19/|-07/24/040/00358/AM18/|01.05.2018|
|Decision:|The Committee|considered case as per agenda and|in the presence of|the technical|experts,‘it|
|was|decided|to|ratify|the|ad-hoc|input|output|norms|under|para|4.7|of HBP|as|per|details|below|or|as|
|137|applied|by|firm|whichever|is|lower:|
|Export product|Qty.|| SL|Qty.|||
|No.|||
|TENOFOVIR|DISOPROXIL ||1|kg|(R|) 9-(2-Phosphono|0.69 kg|
|FUMARATE (TDF)|Methoxypropy!) Adenine|
|PMPA|
|RA may take appropriate|action|as per the decision|of Norms Committee.|
|Case No.:327/12/82-|Party Name:AMI|LIFE|Meet No/Date:12/82-|Status:|
|ALC4/2018|SCIENCESLIMITED|PRIVATE|ALC4/201812.12.2018|Deferred|||
|138|HQ File|RLAFile|Lic.No/Date:3410044120|Defer Date:|
|:01/82/050/00954/AM19/|:34/24/040/0002 1/AM19/|01.05.2018|
|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.:135/12/82-|Party Name:S.KANT|||—_—(Meet No/Date:12/82-|Status:|||
|ALC4/2018|HEALTHCARE LTD.|ALC4/2018|Deferred|
|||(12.12.2018|
|~|[Lic|No/Date:0310820748|Defer Date:|
|139|HQ|File|~~|IRLAFile|
|;|
|:01/82/050/00762/AM19/|:03/95/040/00828/AM 18/|02.05.2018|||
|Decision:|Deferred|for comments|of TE.|
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48
|
ra
Case No.:106/12/82Party Name:USV PRIVATE Meet No/Date:12/82Status: ALC4/2018 LIMITED ALC4/2018 Approved 12.12.2018 "Lic.No/Date:03 10820795 HQ File RLA File :01/82/050/00733/AM19/ :03/95/040/0008 1/AM19/ (04.05.2018 | Decision: |The Committee considered case as per agenda and in the presence of[the][ technical][experts,] it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Qty. SL. No. Propafenone Hydrochloride Extended | 16331 140 ReleaseBottles Capsulesx 60 PerUSPBottles225 MG= 9,79,860(16,331 | No. bottle | Capsules) ( Net Content Weight = 220.469 Kgs) Propafenone Hydrochloride Extended | 17502 Release Capsules USP 325 MG (17,502 | bottle Propafenone Bottles x 60 Per Bottles = 10,50,120 Hydrochloride 755.04 kg Capsules) ( Net Content Weight = 341.289 Kgs) Propafenone Hydrochloride Extended | 6999 No. Release Capsules USP 425 MG (6,999 | bottle Bottles x 60 Per Bottles = 4,19,940 Capsules) ( Net Content Weight = 178.475 Kgs) RA may take appropriate action as per the decision of Norms Committee.
Case No.:142/12/82‘Party Name:CAMPHOR & Meet No/Date: 12/82Status: ALC4/2018 ALLIED PRODUCTS ALC4/2018 Approved ‘LIMITED, 12.12.2018 HQ File RLA File "Lie. No/Date:03 10820782 :01/82/050/00769/AM19/ :03/94/040/00082/AM19/ (04.05.2018 | | Decision: |The Committee considered case as per agenda and in the presence of the technical experts, it | 141 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. CAMPHOR (EP) }ikg[1| ALPHA PINENE 1.146 kg RA may take appropriate action as per the decision of Norms Committee. Case No.:105/12/82Party Name:USV PRIVATE Meet No/Date:12/82Status: | ALC4/2018 LIMITED ALC4/2018 Approved | 12.12.2018 | HQ File RLAFile Lic. No/Date:03 10820808 42~ :01/82/050/00732/AM19/ :03/95/040/00098/AM19/ 07.05.2018 Decision: The Committee considered case as per agenda and in the presence of the technical experts, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Gy. [Sk] Importitems | Qty.
49
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----- Start of picture text -----<br> “~<br> a Cs<br>Desipramine Hydrochloride Tablets, 800000<br>USP 10 MG ( 8,000 Bottles x 100 Per | No. tablet<br>Bottles = 8,00,000 Tablets) ( Net Content<br>Weight = 8.000 Kgs<br>Desipramine Hydrochloride Tablets, 600000<br>USP 25 MG ( 6,000 Bottles x 100 Per | No. tablet<br>Bottles = 6,00,000 Tablets) ( Net Content<br>Weight = 15.000 Kgs<br>Desipramine Hydrochloride Tablets, 630000<br>USP 50 MG ( 6,300 Bottles x 100 Per | No. tablet Desipramine HCL 99.75 kg<br>Bottles = 6,30,000 Tablets) ( Net Content<br>Weight = 31.500 Kg<br>Desipramine Hydrochloride Tablets, 157300<br>USP 75 MG ( 1,573 Bottles x 100 Per | No. tablet<br>Bottles = 1,57,300 Tablets) ( Net Content<br>Weight = 11.798 Kgs<br>Desipramine Hydrochloride Tablets, 315000<br>USP 100 MG ( 3,150.00 Bottles x 100 | No. tablet<br>Per Bottles = 3,15,000 Tablets) ( Net |<br>Content Weight = 31.500 Kgs<br>RA may take appropriate action as per the decision of Norms Committee. 刊<br>----- End of picture text -----<br>
50
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Case No.:107/12/82Party Name:Y ASHO Meet No/Date:12/82Status: | ALC4/2018 INDUSTRIES PVT.LTD. ALC4/2018 Approved 12.12.2018 | HQ File RLA File — ‘Lic. No/Date:03 10820806 :01/82/050/00734/AM19/ :03/95/040/00105/AM19/ 07.05.2018 || Decision: | The Committee considered the case as per agenda in the presence of Technical Experts and in | the light of earlier decision taken by NC in its Meeting No. 8/82-ALC4/2018, dated 31.08.2018, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied 143. by firm whichever is lower:
Export product Qty. | SI. Qty. No. DI-OCTYLATED l kg ia DIPHENYLAMINE 0.50 kg DIPHENYLAMINE( YALUB DI-ISOBUTYLENE 0.64 kg DODPA) ACTIVATED CLAY 0.1 kg | may taxe appropriate action taxe appropriate action appropriate action action as per the decision of Norms Committee. per the decision of Norms Committee. the decision of Norms Committee. decision of Norms Committee. of Norms Committee. Norms Committee. Committee. |
RA may taxe appropriate action taxe appropriate action appropriate action action as per the decision of Norms Committee. per the decision of Norms Committee. the decision of Norms Committee. decision of Norms Committee. of Norms Committee. Norms Committee. Committee.
Case No.:294/12/82-~—~—~~—sParty Name: VERVE HUMAN MeetNo/Date:12/82- Status:_ | ALC4/2018 CARE LABORATORIES ALC4/2018 Deferred 12.12.2018 HQ File RLA File ~ |Lic.No/Date:6110001506 | Defer Date: | 144 :01/82/050/0092 1/AM19/ :61/24/040/00002/AM19/ 07.05.2018 | Decision: |The Committee considered the case as per agenda and it was decided to call for following 1 information / documents from the firm:
(i) List of export product and import item alongwith composition approved by Drug Controller. |
Case No.:291/12/82——~éParty Name:ANLON ~~ |Meet No/Date:12/82-[Status: | ALC4/2018 HEALTHCARE ALC4/2018 Deferred 145 PRIVATELIMITED 12.12.2018 | HQ File RLA File Lic.No/Date:2410042416[Defer Date: :01/82/050/009 18/AM19/ :24/24/040/00003/AM 19/ 08.05.2018 Decision: Deferred for comments of TE. OB Case No.:306/12/82Party Name:MALWA ~~ |Meet No/Date:12/82- a | ALC4/2018 OXYGEN & INDUSTRIAL — ALC4/2018 ‘Defrred GASES PVT.LTD., 12.12.2018 ~~ |Li¢.No/Date:5610005395 [Defer Date:| 146 HQ File RLAFile :01/82/050/00933/AM19/ :56/24/040/00048/AM 18/ 08.05.2018 | Decision: The Committee considered the case as per agenda and it was decided to callfor aaa technical details as per Appendix 4E along with Chemical reaction, molecular weight and yield on molar[|] basis from the firm. |
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Case No.:58/12/82Party Name:FDC LTD “Meet No/Date:12/82Status: ALC4/2018 ALC4/2018 ‘Deferred 12.12.2018 147 HQ File RLA File Lic.No/Date:03 10820892 [Defer Date: :01/82/050/00685/AM19/ :03/94/040/00080/AM19/ 09.05.2018 | Decision: Deferred for comments of TE. Sn Case No.:315/12/82Party Name:ARIHANTANAM Meet No/Date:12/82(Status: | ALC4/2018 LIFECARE PVT. LTD. ALC4/2018 ‘Approved 12.12.2018 | HQ File RLA File " Lic.No/Date:52 10042637 :01/82/050/00942/AM19/ :52/24/040/00019/AM19/ (09.05.2018 Decision: |The Committee considered case as per agenda and in the presence of the technical experts, it 148 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. LUMEFANTRINE I kg (DIBUTYLAMINE METHYL)-2,7- | 0.869 kg DICHLORO-4-FLUOREN METHANOL (DBA RA may take appropriate action as per the decision of Norms Committee. Case No.:48/12/82Party Name:ALKYL AMINES Meet No/Date:12/82- (Status: ALC4/2018 CHEMICALS LTD ALC4/2018 Approved 12.12.2018 HQ File RLA File " Lic.No/Date:03 10820910 | :01/82/050/00675/AM19/ :03/94/040/00011/AM19/ 10.05.2018 Decision: |The Committee considered case as per agenda and in the presence of the technical experts, it 149 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. 2ETHYLHEXYLAMINE -Ikg [1 | 2ETHYLHEXANOL )10llkg| RA may take appropriate action as per the decision of Norms Committee. Case No.:196/12/82Party Name:SHREE BANKEY Meet No/Date:12/82- —_Status: | ALC4/2018 BEHARI LAL FLAVORS ALC4/2018 ‘Deferred 12.12.2018 °° HQ File RLA File LLic.No/Date:0510406412 [Defer Date: :01/82/050/00823/AM19/ :05/24/040/00067/AM19/ 10.05.2018 Decision: Deferred for comments of TE. - —
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----- Start of picture text -----<br> Case No.:7/12/82-ALC4/2018 Party Name:OTSUKA ‘Meet No/Date:12/82- Status: |<br>CHEMICAL INDIA ALC4/2018 Approved<br>‘PRIVATE LIMITED 12.12.2018<br>HQ File RLA File Lic.No/Date:05 10406422<br>:01/82/050/00634/AM19/ :05/24/040/00061/AM19/ 11.05.2018 |<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. 6/82 dated 19.06.2018, it was decided to ratify<br>the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever<br>is lower: |<br>Export product Qty. | SI. Qty.<br>151 | AcidoePara Methoxybenzyl Esterene |_|No. [Saupe] |<br>Powder Colourless Liquide<br>J [RSemnesiwiaeMethylene |Chloride | 1.50 kg<br>Powder<br>iadiLiquid<br>Alcohol) Liquid<br>Lil [deen] Powder<br>|liquide |<br>RA may take appropriate action as per the decision of Norms Committee.<br>Case No.:201/12/82- ‘Party Name: VENUS ‘Meet No/Date:12/82- Status:<br>ALC4/2018 REMEDIES LTD., ALC4/2018 ccna<br>(12.12.2018<br>'S2 HQ File RLA File Lic.No/Date:2210015901 [Defer Date:<br>:01/82/050/00828/AM19/ :22/24/040/00002/AM 19/ 11.05.2018 }<br>Decision: Deferred for comments of TE.<br>----- End of picture text -----<br>
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----- Start of picture text -----<br> Case No.:202/12/82- Party Name:SCOTT EDIL ‘Meet No/Date: 12/82- pasa |<br>ALC4/2018 ADVANCE RESEARCH ALC4/2018 ‘Approved<br>LAB AND EDU LTD 12.12.2018 |<br>HQ:01/82/050/00829/AM19/ File RLA:22/24/040/00014/AM19/ File Lic.11.05.2018No/Date:2210015900 | |<br>153°° 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<br>applied by firm whichever is lower:<br>Export product Qty. SI. Qty.<br>No.<br>Amoxicillin & Potassium [1No. |1 | Amoxyeillin Sodium with Potassium [1.10 |<br>----- End of picture text -----<br>
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Clavulanate for Injection | vial Clavulanate (Blend Sterile) 5:1 1.2gm (Each vial contains Amoxicillin Sodium equivalent to Amoxicillin 1000mg and Potassium Clavulanate equivalent to Clavulanic Acid 200mg) (vial size not more than 10 ml) RA may take appropriate action as per the decision of Norms Committee.
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Case No.:79/12/82Party Name:CELOGEN Meet No/Date: 1 2/82Status: | ALC4/2018 PHARMA PVT.LTD. ALC4/2018 Approved 12.12.2018 | HQ File RLA File Lic.No/Date:03 10820961 — :01/82/050/00706/AM 19/ :03/94/040/00062/AM19/ 14.05.2018 | Decision: | The Committee considered case as per agenda and in the presence of the technical experts, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: 154 (Export product [Qu ‘| Importitems «dO SUPHACHLOROPYRAZINE | 200000 Nos. SULPHACHLOROPYRAZINE | 1022.625 kg 30% POWDLER | SACHET SODIUM MONOHYDRATE (1SGM)HiB3 SGM SACHET CAS(102-65-8) Each gram powder contains SulphachloropyrazineMonohydrate 337.50mg.NetSodium | content per 15Gram 5062.50mg,Total net content | 1012.50kgs RA may take appropriate action as per the decision of Norms Committee. | Case No.:92/12/82|Party Name:CELOGEN ‘Meet No/Date: 12/82Status: | ALC4/2018 ‘PHARMA PVT.LTD. ALC4/20112.12.2018 8 Approved :01/82/050/00719/AM19/HQ File :03/94/040/00063/AM19/RLA File Lic.No/Date:0314.05.2018 10820959 | | 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 | 155 applied by firm whichever is lower: | Export product SULPHADIMETHOXINE & | INo. SACHET SULPHADIMETHOXINE | 25.25 gm/ 100 TRIMETHOPRIM 30% CAS;:122-II-2 gm sachet POWDLER (HI TRISULF) 100GM100 gram off whiteSACHET.powder |
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contains Sulphadimethoxine 25gm&Trimethoprim 5gm(Net content per 100gm/ Sulphadimethoxine 25gm(Import item) & Trimethoprim Sgm(indegenious item), Total net content of import itemSulphadimethoxine-1250kgs. RA may take appropriate action as per the decision the decision decision of Norms Norms Committee.
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|---|---|---|---|---|---|---|---|---|---|
|25gm(Import|item)|&|||
|Trimethoprim|
|Sgm(indegenious|item),|Total|
|net|content|of|import|item-|
|Sulphadimethoxine-1250kgs.|
|RA|may|take|appropriate|action|as|per the decision the decision decision|of Norms Norms|Committee.|
|Case No.:93/12/82-ALC4/2018|Party Name:GLENMARK|(Meet|No/Date:12/82-|‘Status:|
|PHARMACEUTICALS LTD.,|ALC4/201812.12.2018|[Deferred|
|156|HQ|File|RLAFile|Lic.No/Date:03 10820963|[Defer Date:|
|:01/82/050/00720/AM19/|:03/94/040/00104/AM19/|14.05.2018|
|Decision:|The|Committee|considered|the caseas per agenda|and|it was decidedto|call|for DML showing|
|the|composition|of all|the|three|export|products|from|the|firm.|
|Case|No.:109/12/82-|Party Name:RELIANCE|Meet No/Date:12/82-|‘Status:|
|ALC4/2018|INDUSTRIES|LTD.|ALC4/2018|Deferred|
|(12.12.2018|||
|57|HQ File|RLA|File|Lic.No/Date:0310820951|[Defer Date:|
|:01/82/050/00736/AM19/|:03/95/040/0000|1/AM19/|(14.05.2018|
|Decision:|The Committee|decided|to refer the|case to D/o C&PC|for obtaining|its|comments.|
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Case No.:200/12/82"|Party Name:DSM SINOCHEM Meet No/Date:12/82- Status: ALC4/2018 PHARMACEUTICALS |ALCA20 18 Approved INDIA PVT.LTD. 12.12.2018 HQ File ~RLAFile ——————S—S—SSCLic.No/Date:2210015905_ :01/82/050/00827/AM19/ :22/24/040/00017/AM19/ 14.05.2018 | | Decision: The Committee considered case as per agenda and in the presence of the technical experts, it! was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as| applied by firm whichever is lower: | Export product Qty. | SI. Qty. | No. 15g. | Atorvastatin Caleium ke [1 | Thorase Enzyme _———~«dsiLIS akg Chloro Acetal Dehyde 1.735 kg Actaldehyde 0.90 kg 0 1.96 kg 6. | Bromine 1.88 kg rs. _|HeptaneEthyl Acetate ——SSS~S~S~ S|1.40 kg 9. 10. | Sodium Cyanide 0.629 kg |11.|| DimethoxyIso Propyl AlcPr o panehol 32 . 40025 kg kg Methyl! Tertiary Buty! Ether 2.17 kg
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----- Start of picture text -----<br> Raney nickel 0.064 kg<br>0<br>"16 0.379 ke<br>“17 [DKTM4—=*dCO98[ Methanol<br>18. |_——SSSS—=dCyclohexane 21.3100kg<br>RA may take appropriate action as per the decision of Norms Committee.<br>Case No.:203/12/82- Party Name:THEON —— Meet No/Date:12/82-. Status: |<br>ALC4/2018 PHARMACEUTICALS LTD., ALC4/2018 ‘Deferred |<br>12.12.2018 |<br>159 HQ File RLA File ] Lic.No/Date:2210015902[Defer Date: |<br>:01/82/050/00830/AM19/Decision: Deferred for comments:22/24/040/00015/AM19/ ofTE. | Oo 14.05.2018 |<br>Case No.:205/12/82- Party Name:NECTAR Meet No/Date:12/82- Status:<br>ALC4/2018 LIFESCIENCES LIMITED ALC4/2018 Approved<br>12.12.2018 |<br>HQ File RLA File Lic.No/Date:2210015904- |<br>:01/82/050/00832/AM19/ :22/24/040/00003/AM19/ 14.05.2018 | |<br>Decision: |The Committee considered case as peragenda and in the presence of the technical experts, i<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as [|]<br>applied by firm whichever is lower:<br>160 |<br>Export product Qty. | Sl. | Import items Qty. |<br>No. |<br>TAVCA re [i [oe —SSCS~S~«~dC<br>Triphenyl Phosphine 1.26 kg |<br>ee<br>fa [Methanol «dT<br>Methylene Chloride 10.31 kg |<br>RA may take appropriate action as per the decision of Norms Committee.<br>Case No.:198/12/82- Party Name:PCL OIL & ‘Meet No/Date:12/82- Status: |<br>ALC4/2018 SOLVENTS LTD. ALC4/2018 Approved<br>(12.12.2018 |<br>~ RLA File<br>HQ File ; Lic.No/Date:05 10406476 |<br>:01/82/050/00825/AM19/ ':05/24/040/00066/AM19/ 15.05.2018 |<br>Decision: |The Committee considered case as per agenda and in the presence of the technical experts, it<br>16) ("38 decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as<br>applied by firm whichever is lower:<br>Export product Qty. | SI. Import items Qty.<br>No.<br>PVC PLASTICIZER (DINP) tkg|1 | PHTHALIC ANHYDRIDE 0.355 kg<br>ISO NONYL ALCOHOL 0.7073 kg<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.:197/12/82Party Name:NAARI PHARMA \Meet No/Date: 12/82‘Status: | ALC4/2018 PRIVATE LIMITED ALC4/201812.12.2018 Approved | —_———| HQ File RLA File Lic.No/Date:05 10406489 | :01/82/050/00824/AM19/ :05/24/040/00073/AM19/ 16.05.2018 | Decision: The Committee considered case as per agenda and in the presence of the technical experts, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as 162 applied by firm whichever is lower: | Export product Qty. SI. Qty. | No. Mifepristone Tablet 200 MG| | Number Mifepristone 204 mg/ tablet | (1200Kg Mg)Mife = 4750 Tab of Mifepristone | RA may take appropriate action as per the decision of Norms Committee. _| Case No.:38/12/82Party Name:CIPLA LIMITED. (Meet No/Date:12/82Status: ~ | ALC4/2018 ALC4/2018 Deferred ~~ 12.12.2018 | | Lie.No/Date:0310821052 [Defer Date:— 05 HQ:01/82/050/00665/AM19/File RLA:03/94/040/00122/AM19/File oo 17.05.2018 | | Oo i Decision: Deferred for comments of TE. — Case No.:49/12/82Party Name:KRISHNA ‘Meet No/Date:12/82- Status:| ALC4/2018 ANTIOXIDANTS PVT. LTD. ALC4/201812.12.2018 Approved || a Lic. No/Date:03 10821043 | HQ‘0 1/82/050/00676/AM19/File RLA:03/94/040/00097/AMFile 19/ 17.05.2018 | | Decision: |The Committee considered case as per agenda and in the presence of the technical experts, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as| 164 applied by firm whichever is lower: | Export product Qty. | SL. Qty. No. >ETHYLHEXYL DIPHENYL | 1kg [1 | YELLOW PHOSPHORUS 0.093 kg PHOSPHITE [EHDP] PHENOL 0.604 kg 3 7-ETHYL HEXYL ALCOHOL / 2- | 0.386 kg ETHYL HEXANOL RA may take appropriate action as per the decision of Norms Committee.
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Case No.:108/12/82Party Name:USV PRIVATE Meet No/Date: 12/82- 7 Status: a ALC4/2018 LIMITED ALC4/2018 Approved 165 12.12.2018 || HQ File RLAFile Lic.No/Date:0310821063 :0.1/82/050/00735/AM 19/ :03/95/040/00147/AM19/ 17.05.2018 | ;
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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:
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|---|---|---|---|---|---|---|---|---|---|---|
|Export|product|Qty.|||SL.|Qty.|
|No.|
|Griseofulvin|Tablets|USP|500|mg|||1|No.|Griseofulvin USP|510 mg/|tablet|
|(2,000|Bottles|x|100|Per|Bottle|=|2,00,000|
|Tablets)|(Net|Content|Weight|=|100.000|
|kgs)|
|RA may take appropriate|action as per the decision|of|Norms Committee.|||
|Case No.:131/12/82-|Party|Name:Y|ASHO|||Meet No/Date:12/82- Status:|
|ALC4/2018|INDUSTRIES LIMITED|ALC4/2018|Approved|||
|12.12.2018|||
|HQ|File|RLA|File|Lic.No/Date:03 10821038|||||
|:01/82/050/00758/AM19/|:03/95/040/00123/AM19/|17.05.2018|||
|wasDecision:decided|The Committeeto|ratify|the|ad-hoc consideredinput caseoutput as pernorms agenda andunder|parain the4.7 presenceof|HBP ofas|theper technicaldetails|below ene,or|as|
|166|applied|by|firm whichever|is|lower:|||
|Export product|Qty.|||SI.|Qty.|||
|DIPENTAMETHYLENE|1kg|1|||PIPERIDINE|0.447kg|||
|THIURAM|TETRA|CARBON DISULPHIDE|0.399kg|||||
|SULPHIDE(QUREACC|DPTT)|HYDROGEN PEROXIDE|O1kg||
|RA|may|take|appropriate|action|as|per the decision|of|Norms Committee.|
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Case No.:132/12/82Party Name:Y ASHO ‘Meet No/Date:12/82Status: | ALC4/2018 INDUSTRIES LIMITED ALC4/2018 Approved 12.12.2018 HQ File RLA File Lic.No/Date:03 10821062 :01/82/050/00759/AM19/ :03/95/040/00141/AM19/ 17.05.2018 | Decision: |The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 2/82-ALC4/2018, dated 16.05.2018, it was | 167 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. OCTYLATEDDIPHENYLAMINE |!| DIPHENYLAMINE 0.405 kg ai ( OCD DI-ISOBUTYLENEACTIVATED CLAY fOlke0.62 kg | | RA may take appropriate action as per the decision of Norms Committee. |
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Case No.:179/12/82“Party Name:MALWA (Meet No/Date:12/82(Status: | ALC4/2018 OXYGEN & INDUSTRIAL — ALC4/2018 Deferred GASES PVT.LTD., 12.12.2018 | 168 HQ File RLA File Lic.No/Date:5610005414 Defer Date: :01/82/050/00806/AMDecision: Deferred 19/for comments:56/24/040/00008/AM19/of TE. 17.05.2018 oO OO Case No.:189/12/82~~ Party Name:MALWA ‘Meet No/Date:12/82Status: ALC4/2018 OXYGEN & INDUSTRIAL — ALC4/2018 Deferred GASES PVT.LTD., \12.12.2018 169 HQ File RLA File LicNo/Date:5610005415_ [Defer Date: :01/82/050/00816/AM19/Decision: Deferred for comments:56/24/040/00009/AM19/of TE. (17.05.2018BO —.)
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Case No.:191/12/827 Party Name:PCL OIL & Meet No/Date: 12/82Status: | ALC4/2018 SOLVENTS LTD. ALC4/201812.12.2018 Approved | HQ File RLA File Lic. No/Date:05 10406493 | :01/82/050/00818/AM19/ :05/24/040/00003/AM19/ (17.05.2018 Decision: | The Committee considered case as per agenda and in the presence of the technical experts, it 170 88 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. PVC PLASTICIZER: (DINP) 1| PHTHALIC ANHYDRIDE 0.355 kg ISO NONYL ALCOHOL 0.7073 kg RA may take appropriate action as per the decision of Norms Committee. | Case No.:195/12/82Party Name:PCL OIL & Meet No/Date:———— 12/82‘Status: ALC4/2018 SOLVENTS LTD. ALC4/201812.12.2018 Approved| | HQ File RLA File ~ Lic.No/Date:0510406495 :01/82/050/00822/AM19/ :05/24/040/00034/AM19/ 17.05.2018 Decision: |The Committee considered case as per agenda and in the presence of the technical experts, it | 171 48 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. PVC PLASTICIZER (DINP) tkg|1 | PHTHALIC ANHYDRIDE 0.355 kg ISO NONYL ALCOHOL 0.7073 kg | RA may take appropriate action as per the decision of Norms Committee. |
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----- Start of picture text -----<br> Case No.:89/12/82- Party Name:GLENMARK Meet No/Date:12/82- Status:<br>ALC4/2018 PHARMACEUTICALS LTD., (12.12.2ALC4/2 01 88 |APProved<br>Tig No/Date:0310821091<br>HQ File RLA File<br>:01/82/050/007 16/AM19/ :03/94/040/00129/AM19/ 18.05.2018<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<br>applied by firm whichever is lower:<br>Export product Qty. Sl. Qty.<br>No. No.<br>Perindopril and — Indapamide | | No. Indapamide EP 1.275 mg/ tablet<br>Tablets 4/1.25 mg( Pack Size 30 | Tablet<br>Tabs.) (Net Wt. of Indapamide<br>EP 4.500 Kgs) |<br>2 Perindopril and Indapamide 1 No. Indapamide EP 1.275 mg / tablet<br>Tablets 4/1.25 mg ( Pack Size 90 Tablet<br>172= Tabs.) ( Net Wt. of Indapamide EP<br>1.688 Kgs)<br>3 Perindopril and Indapamide 1 No. Indapamide EP 1.275 mg/ tablet<br>Tablets 4/1.25 mg( Pack Size 100 | Tablet<br>Tabs.) ( Net Wt. of Indapamide EP<br>15.000 Kgs)<br>4 Perindopril and Indapamide | No. Indapamide EP 0.6375 mg [/] [tablet]<br>Tablets 2/0.625 mg ( Pack Size 30 | Tablet<br>Tabs.) ( Net Wt. of Indapamide EP<br>2.250 Kgs)<br>5 Perindopril and Indapamide EP 1 No. Indapamide EP 0.6375 mg / tablet<br>Tablets 2/0.625 mg( Pack Size 20 | Tablet<br>Tabs.) ( Net Wt. of Indapamide EP<br>1.625 Kgs)<br>RA may take appropriate action as per the decision ofNorms Committee. |<br>Case No.:134/12/82- PartyName:Y ASHO Meet No/Date:12/82- (Status:<br>ALC4/2018 INDUSTRIES LIMITED ALC4/2018 Approved |<br>12.12.2018<br>HQ File RLA File . Lic.No/Date:03 10821081 |<br>:01/82/050/00761/AM19/ :03/95/040/00152/AM19/ 18.05.2018<br>173 WasDecision: decided |Theto ratifyCommittee the ad-hocconsideredinput outputcase as pernorms agendaunder andparain 4.7the presence of HBP ofas perthe technicaldetails belowexperts, or asit<br>appliedExport by productfirm whichever is lower: Qty. | SL Qty. |<br>No. |<br>YAPOX CL 30/10"HYDROQUINONE HYDROQUINONE 0.611 kg<br>BIS"(2 HYDROXY ETHYL ETHER)<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> Case No.:29/12/82- Party Name:ALEMBIC —_—Meet No/Date:12/82- Status: |<br>ALC4/2018 PHARMACEUTICALS LTD ALC4/2018 ‘Approved<br>|12.12.2018 |<br>~ Lic. No/Date:3410044157|<br>HQ File RLA File<br>:01/82/050/00656/AM19/ -34/24/040/00052/AM19/ 21.05.2018<br>Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the<br>light of earlier decision taken by NC in its Meeting No. 10/82-ALC4/2018, dated 16.10.2018, it was<br>decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by<br>firm whichever is lower:<br>No.<br>AZITHROMYCIN STEP - 4 | KG /1 | ERYTHROMYCIN BASE USP 1.58 kg<br>ACTIVITY 15 HYDROXYLAMINE 0.714kg ||<br>HYDROCHLORIDE |<br>[METHANOL 224K<br>METHANE SULFONYL 0.47 kg |<br>CHLORIDE<br>S [acetone —d AS<br>“6 [ETHYL ALCOHOL ————| 28 iter |<br>"7 [PLATINUMMETAL | 0.100.gm<br>RA may take appropriate action as per the decision of Norms Committee. |<br>----- End of picture text -----<br>
Case No.:112/12/82Party NameRUSAN ———Meet No/Date:12/82(Status: | ALC4/2018 PHARMA LTD. ALC4/201812.12.2018 Approved HQ File RLAFile :01/82/050/00739/AM19/ :03/95/040/00148/AM19/ ~~ Lie, No/Date:0321.05.2018 10821117 | Decision: | The Committee considered case as per agenda and in the presence of the technical experts, it | 175 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: | NALBUPHINE HYDROCHLORIDE Tke [1 |THEBAINE | 2.117 kg | RA may take appropriate action as per the decision of Norms Committee. |
Case No.:133/12/82Party Name:Y ASHO ~~ |Meet No/Date: 12/82- Status: ALC4/2018 INDUSTRIES LIMITED ALC4/201812.12.2018 Approved | Lic.No/Date:0310821100 | HQ File RLA File :01/82/050/00760/AM19/ :03/95/040/00158/AM19/ 21.05.2018 | 176 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 appliedExportby productfirm whichever is lower: Qty. | SI. | Import items Qty. |
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YAPOX CL 30/10"HYDROQUINONE | | THYDROQUINONE_| 0.611 kg BIS"(2 HYDROXY ETHYL ETHER)
Case No.:168/12/82Party Name:-MANGALAM Meet No/Date:12/82_|Status: ALC4/2018 ORGANICS LIMITED ALC4/2018 Deferred FORMERLY DUJODWALA 12.12.2018 177 PRODU HQ File RLA File Lic.No/Date:0310821107 [Defer Date: :01/82/050/00795/AM19/ :03/95/040/01140/AM18/ 21.05.2018 | Decision: Deferred for commentsof TE. oe 7 ; Case No.:192/12/82Party Name:SUN ‘Meet No/Date:12/82- Status: | ALC4/2018 PHARMACEUTICAL ALC4/2018 Deferred INDUSTRIES LTD. 12.12.2018 | 178 : : —-| HQ File RLA File Lic.No/Date:05 10406538 ‘Defer Date: | :01/82/050/00819/AM19/ :05/24/040/00087/AM19/ 21.05.2018 | Decision: Deferred for comments of TE. — Be a | Case No.:39/12/82Party Name:CAMPHOR & Meet No/Date:12/82- Status: ALC4/2018 ALLIED PRODUCTS ALC4/2018 ‘Approved HQ[File] “RLAFileLIMITED, = ~~——_Lie.No/Date:031082115712.12.2018 | :01/82/050/00666/AM19/ :03/94/040/00136/AM19/ (22.05.2018 | Decision: The Committee consideredcase 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> 179<br>Export product Qty. | SL. Import items Qty.<br>No.<br>BACDANOL TOCO | 1kg|1 | Alpha Pinene 1.47 kg<br>(2-Ethyl-4-(2 2 3-Trimethylcyclopent-3- N-Butyraldehyde 0.77 kg<br>en-yl)-but-2-en-1-o) 040ks |<br>Aluminum Tri-sec-Butoxide 0.072 kg |<br>Di N Butylamine 0.077kg ||<br>RA may take appropriate action as per the decision of Norms Committee. |<br>Case No.:40/12/82- Party Name:CAMPHOR & Meet No/Date:12/82- Status: |<br>ALC4/2018 ALLIED PRODUCTS ALC4/2018 Approved |<br>HQ [File] RLAFileLIMITED, ~~—~—_Lic.No/Date:031082115912.12.2018 |<br>:03/94/040/00137/AM19/ 22.05.2018 |<br>ses [:01/82/050/00667/AM19/]<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<br>applied by firm whichever is lower:<br>Export product ; Gy.a [Stsi [imporiems~ eh SR SS __——«iay.—«d;RE ES a aN<br>----- End of picture text -----<br>
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‘i ——S om ee SANJINOL TOCO 1kg|1 | Alpha Pinene 1.47 kg (2-Ethyl-4-(2. 2. 3-Trimethylcyclopent-3N-Butyraldehyde 0.77 kg en-yl- but-2-en-I-ol) 0.40 kg (4 | Aluminum Tri-sec-Butoxide 0.072 kg Di N Butylamine 0.077 kg RA may take appropriate action as per the decision of Norms Committee.
Case No.:41/12/82Party Name:AVA Meet No/Date:12/82- Status: ALC4/2018 CHEMICALS PVT.LTD., ALC4/2018 Approved 12.12.2018 | HQ File RLA File Lic. No/Date:03 10821149 | :01/82/050/00668/AM19/ :03/94/040/00146/AM19/ 22.05.2018 | Decision: |The Committee considered case as per agenda and in the presence of the technical experts, it ig) Was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as_ applied by firm whichever is lower: | Export product Qty. | SI. Import items Qty. No. | EDTA DIAMMONIUM (POWDER) Lkg ETHYLENE DIAMINE 0.33 kg TETRA ACETIC ACID RA may take appropriate action as per the decision of Norms Committee.
Case No.:113/12/82Party Name:NEOGEN Meet No/Date:12/82- _Status: | ALC4/2018 CHEMICALS LIMITED ALC4/2018 Approved 12.12.2018 | ~ HQ File RLA File Lie. No/Date:03 10821147 | :(1/82/050/00740/AM19/ :03/95/040/00524/AM18/ 22.05.2018 | Decision: |The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 2/82 dated 16.05.2018, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever 182 is lower: | in Kg 1.4 DIBROMOBUTANE Tkg |1 | TETRAHYDROFURAN rO4i2kg sd] 2 HYDROBROMIC ACID | 1.929 kg | 48% | RA may take appropriate action as per the decision of Norms Committee. - Case No.:167/12/82Party Name:RISHABH Meet No/Date: 12/82‘Status: a ALC4/2018 METALS & CHEMICALS ALC4/2018 Approved PVT LTD 12.12.2018 } Lic.No/Date:0310821129 | HQ File ~RLA File 183 :01/82/050/00794/AM19/ :03/95/040/00018/AM19/ 22.05.2018 Decision: |The Committee considered case as per agenda and in the presence of the technical experts, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
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----- Start of picture text -----<br> Export product OY Qty. Si. mport items if Qty.<br>No.<br>MIN<br>POLY AMINE DERIVATIVES 1 kg LE DICY ANDIAMIDE 99.5% 0.271 kg<br>2 DETA (DIETHYLENE 0.18 kg<br>TRIAMINE<br>EPICHLOROHYDRIN 0.05 kg<br>----- End of picture text -----<br>
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Case No.:207/12/82Party Name:JUBILANT LIFE Meet No/Date:12/82- Status: | ALC4/2018 SCIENCES LIMITED ALC4/2018 Approved 12.12.2018 HQ File RLA File Lic.No/Date:0510406558 :01/82/050/00834/AM19/ :05/23/040/00028/AM19/ 22.05.2018 Decision: |The Committee considered case as per agenda and in the presence of the technical experts, it 1g4 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. Zinc Pyrithone 50% FPS (Fine Particle | 100 kg Zinc Pyrithone 50 kg | Suspension) RA may take appropriate action as per the decision of Norms Committee.
Case No.:88/12/82ALC4/2018 7 ALLIEDPartyName:CAMPHOR PRODUCTS & © ALC4/2018Meet No/Date:12/82‘Status:|Approved | LIMITED, 12.12.2018 | HQ File RLAFile Lic.No/Date:03 10821177 :01/82/050/00715/AM19/ :03/94/040/00138/AM19/ 23.05.2018
Decision: | The Committee considered case as per agenda and in the presence of the technical experts, it igs 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 SL. No. CAMPHOR TECHNICAL }1kg|1| ALPHA PINENE 1.04 kg
Case No.:94/12/82Party Name:GLENMARK ——Meet No/Date:12/82Status: | ALC4/2018 PHARMACEUTICALS LTD., ALC4/2018 Approved | HQ[File] RLA File ~ Lic.No/Date:0312.12.2018 10821178 | :01/82/050/00721/AM19/ ——-:03/94/040/00155/AM19/ 23.05.2018 186 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> Sl. Export product Qty. | SI.<br>No. No.<br>----- End of picture text -----<br>
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||||||||||
|---|---|---|---|---|---|---|---|---|
|BLAXADASINE|100MG|]1|| 1|||[Ciprofibrate][ BP]||102mg/tablet|||||
|TABLETS|MX|(Ciprofibrate|Tab ||No.|
|100mg)|(Pack|Size|30|Tabs.)|
|(Net|wt.|of|Import|Item|
|Ciprofibrate|BP|is|113.616|Kgs)|
|2|GLENLIPID|100MG|TABLETS||||Ciprofibrate BP|||102 mg/|tablet|
|VN|(Ciprofibrate|Tab|100mg) ||No.|
|(Pack|Size|30|Tabs.)|
|(Net|wt.|of|Import|—|Item|
|Ciprofibrate|BP|is|23.616|Kgs)|
|RA|may|take|appropriate|action|as per the decision|of|Norms Committee.|
|—_—(Meet|No/Date:12/82- Status:|||
|Case|No.:115/12/82-——~—~—~-Party Name:RELIANCE|
|ALC4/2018|INDUSTRIES|LTD.|ALC4/2018|Deferred|
|12.12.2018|
|187|HQ|File|RLA|File|~|[Lie|No/Date:0310821193 [Defer Date:|
|:01/82/050/00742/AM|19/|:03/95/040/0001 1/AM19/|23.05.2018|
|Decision:||The Committee|decided to refer the case to D/o C&PC|for obtaining itscomments.|-_|
|Case|No.:116/12/82-|
|~~|Party Name:RELIANCE|Meet|No/Date:12/82-|Status: _|||
|ALC4/2018|INDUSTRIES LTD.|ALC4/2018|Deferred|
|12.12.2018|||||
|188-11|File|RLA|File|‘LicNo/Date:0310821194|Defer Date:|
|:01/82/050/00743/AM19/|:03/95/040/01092/AM18/|(23.05.2018|||
|Decision:|The Committee decided|to refer the case to D/o C&PC|for obtaining|its comments.|
|Case No.:190/12/82-||Party Name:SUN-|Meet No/Date:!|yy|Status:|
|ALC4/2018|PHARMACEUTICAL|ALC4/2018|'Deferred|
|INDUSTRIES|LTD.|12.12.2018|||
|189|HQ|File|RLA|File|eTLic.No/Date:0510406572a|(Defer Date:|
|:01/82/050/00817/AM19/|:05/24/040/00098/AM 19/|23.05.2018|
|Decision:|Deferred|for comments|of TE|
|Case|No.:193/12/82-|Party Name:DHANUKA|—_—s|
|LABORATORIES LTD|ALC4/2018|‘Deferred|
|ALC4/2018|Meet No/Date:12/82-|‘Status:|“||
|12.12.2018|
|—_|J|Saeed|—|
|wy|HQ|File|RLA|File|\Lic.No/Date:05 1040658|[1]|[‘Defer Date:]|—|
|:01/82/050/00820/AM19/|':05/23/040/00086/AM19/|23.05.2018|||
|Decision:|Deferred|for comments|of TE.|
|Case No.:43/12/82-|Party Name:J.B. CHEMICALS|Meet No/Date:12/82-|Status:|||
|ALC4/2018|& PHARMACEUTICALS|ALC4/2018|Deferred|
|LIMITED|112.12.2018|
|~|[Lic|No/Date:03 10821224|[Defer Date:|
|191|4Q|File|~IRLAFile|
|:01/82/050/00670/AM19/|:03/94/040/00127/AM19/|(24.05.2018|
|Decision:|Deferred|for comments|of TE.|_||
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65
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Case No.:199/12/82Party Name:V.D.H. ’/Meet[No/Date:][|][ 2/82-] Status: ALC4/2018 ORGANICS PVT. LTD ALC4/2018 Approved 12.12.2018 HQ File RLA File Lic.No/Date:05 10406602 _ :01/82/050/00826/AM19/ :05/24/040/00090/AM 19/ 24.05.2018 Decision: |The Committee considered case as per agenda and in the presence of the technical experts, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as 192 applied by firm whichever is lower: Export product Qty. | SL Qty. No. THYMOL 99% PURE & ABOVE lkg META-CRESOL ABOVE| 0.785 kg 98.5%PURE 2 ISO PROPYL ALCOHOL| 0.3 kg IPA)
Case No.:194/12/82Party Name:JUBILANT Meet No/Date:12/82Status: ALC4/2018 GENERICS LTD ALC4/2018 Deferred 12.12.2018 193 HQ File RLA File ‘Lic.No/Date:0510406614 [Defer Date: :01/82/050/00821/AM19/Decision: Deferred for comments:05/23/040/00087/AM19/of TE. 25.05.2018_ Oe
Case No.:204/12/82Party Name:DSM SINOCHEM Meet No/Date: 12/82stats: ALC4/2018 PHARMACEUTICALS INDIA ALC4/2018 Approved PVT.LTD. 12.12.2018 | | HQ File RLA File Lic.No/Date:2210015912 | | :01/82/050/0083 1/AM19/7 :22/24/040/00095/AM—— 18/ ——————25.05.2018 —————— Decision: |The Committee considered the case as per agenda in the presence of Technical Experts and, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
==> picture [458 x 226] intentionally omitted <==
----- Start of picture text -----<br> 194<br>Qty.<br>AmpicillinAPA routeTrihydrateThrough ThroughEnzymatic6- | 1 kg fo 6-AMINOACID PENICILLANIC 0.596 kg<br>Route 3 ELCOLASE (ENZYME) —|.0.005kg<br>D(-)Alpha Pheny! Glycine Base | 9.417 kg<br>RA may take appropriate action as per the decision of Norms Committee.<br>Case No.:311/12/82- Party Name:VDH CHEM Meet No/Date:12/82- _|Status:<br>ALC4/2018 TECH PVT. LTD. ALC4/2018 Approved<br>195 12.12.2018 | |<br>HQ File ~IRLA File” Lic.No/Date:0510406607 |<br>:01/82/050/00938/AM19/ :05/24/040/00078/AM19/ (25.05.2018 ; oe |<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:|
|1|ape|i|
|-|
|Export product|Qty.|SI.|||Import items|Qty.|
|BUTYLATED|Gunna|_|NoNo|.|
|—|
|BHT BUTYLATED HYDROXY TOLUENE||257400 ||||CREYSLIC ACID|205920.00 kg|
|77400.00180000.00KGSKGS|&|META|CRESOL||kg|2|ISOBUTYLENE|126126.00 kg|
|a|Se ROSIE|
|Tr|see|i.|eee|ee|
|RA may take appropriate action as per the decision of Norms Committee.|
|Case No.:114/12/82-|Party Name:STERLING|Meet No/Date:12/82-|Status:|
|ALC4/2018|AUXILIARIES PVT LTD|ALC4/2018|Deferred|
|196|12.12.2018|
|HQ File|RLA File|Lic.No/Date:0310821255|Defer Date:|
|:01/82/050/00741/AM19/|:03/95/040/00875/AM18/|28.05.2018|
|Decision:|— Deferred|for comments of TE.|
|Case No.:42/12/82-|Party Name:INDOCO|Meet No/Date:|1 2/82-|Status:|
|ALC4/2018|REMEDIES LIMITED|ALC4/2018|Deferred|
|=|12.12.2018|
|HQ File|RLA File|Lic.No/Date:03 10821290|Defer Date:|
|:01/82/050/00669/AM|19/|:03/94/040/00167/AM19/|29.05.2018|
|Decision:|— Deferred|for comments of|TE.|
|Case No.:234/12/82-|Party Name:KLJ|Meet No/Date:12/82-|Status:|
|ALC4/2018|PLASTICIZERS|LIMITED|ALC4/2018|Approved|
|HQ|12.12.2018|
|File|RLA File|Lic.No/Date:05 10406665|
|:01/82/050/0086 1/AM19/|:05/23/040/0009 1/AM 19/|29.05.2018|
|Decision:|Committee|considered|case|as|per agenda|and|as|per|earlier|decision|taken|by NC|in|its|2/82|
|meeting dated|16.05.2018,|it was decided|to ratify the ad-hoc|input output norms under para 4.7 of HBP as|
|per details|below or as|applied by|firm|whichever|is|lower:|
|198|Export Product|Export|S.No|||Import Product|Quantity|
|(PACKEDotIN|2,554|NOS.|OF|HM-|Quantit|Allowed|
|HDPE|np|a|a|PHTHALIC|;|0.550 kg|
|DRUMS MADE OF HDPE|lk|ANHYDRIDE|
|GRANULES (21,709.000 KGS.|8|Z;|ISO / NORMAL|0.550 kg|
|DRUMWITHOUTSHALL WASTAGE))WEIGHT (EACH 8.5|KG AND|BUTANOL|
|STORAGE CAPACITY|235.000|KGS.)|SS3|ee|ae|
|HDPE GRANULES|As|per|relevant|
|(TOTAL WEIGHT — 22,794.450|packing policy|
|RA|KGS.)|
|maytake appropriate|action as per the|decision|of Norms Committee.|
|Case No.:242/12/82-|Party Name:SENTISS|Meet No/Date:12/82-|Status:|
|199|ALC4/2018|PHARMA PVT.LTD.|ALC4/2018|Deferred|
|HQ|12.12.2018|
|File|RLA|File|Lic.No/Date:0510406674|Defer Date:|
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67
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29.05.2018 fd
:01/82/050/00869/AM19/
-05/24/040/00108/AM19/
Decision: Deferred for comments of TE.
Case No.:248/12/82Party Name:KLJ Meet No/Date:12/82- Status: ALC4/2018 PLASTICIZERS LIMITED ALC4/2018 Approved }12.12.2018 oe Lic.No/Date:05 10406663 HQ File RLA File :01/82/050/00875/AM19/ :05/23/040/00092/AM19/ 29.05.2018 | Decision: Committee considered case as per agenda and as per earlier decision taken by NCin its 8/82 | meeting 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: | . | Export product Exp. | SL Qty. Allowed in Qty. No. kg 300 |KANATOL-DGB (DI|1 | DI-ETHYLENE GLYCOL 0.375 “| ETHYLENE GLYCOL DIBENZOIC ACID 0.863 BENZOATE) 3 HDPE GRANULES As per relevant (PACKED IN 400 NOS. OF packing policy HM-HDPE DRUMS MADE OF HDPE GRANULES (3,280.000 | KGS. WITHOUT WASTAGE)) (EACH DRUM SHALL WEIGHT 8.2 KG AND STORAGE CAPACITY 250.000 KGS.) RA may take appropriate action as per the decision of Norms Committee
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----- Start of picture text -----<br> Case No.:245/12/82- Party Name:MALLADI Meet No/Date:12/82- Status: |<br>ALC4/2018 DRUGS & ALC4/2018 Beferred |<br>PHARMACEUTICALS 12.12.2018 peorroved<br>LIMITED | |<br>HQ File RLA File Lic.No/Date:04 10164367 Defer Date: |<br>:01/82/050/00872/AM19/ :04/24/040/00007/AM 19/ '30.05.2018<br>----- End of picture text -----<br>
Decision: Committee considered case as per agenda and as per earlier decision taken by NC in its 10/82 meeting dated 12.11.2014, 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> 201 | Export product Exp. Qty. Import items Qty. allowed<br>kg<br>Phenylepherine Ikg | 3-hydroxy acetophenone<br>- eaCi<br>4 | Methyl Isobuty! Ketone 0.857<br>----- End of picture text -----<br>
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- Caustic soda flakes 2.33
—Meet No/Date:12/82-_|Status: | Case No.:44/12/82-ALC4/2018 Party Name:KRISHNA ANTIOXIDANTS PVT. LTD. ALC4/2018 ‘Deferred 12.12.2018 204 HQ File ‘RLA File Lic.No/Date:0310821359 |Defer Date: | :01/82/050/0067 1/AM19/ :03/94/040/00145/AM19/ 31.05.2018ee
Decision: Deferred for comments of TE
Case No.:166/12/82Party Name: WANBURY Meet No/Date:12/82-_—Status: | ALC4/2018 LIMITED(FORMERLY ALC4/2018 Deferred PEARL ORGANICS LTD) 12.12.2018 | 33 w ~ — - — —— — $$$ | ————— ans HQ File RLA File Lic.No/Date:03 10821341 Defer Date: :01/82/050/90793/AM19/ :03/95/040/00092/AM19/ 31.05.2018 | Decision: Deferred for comments of TE On |
Case No.:238/12/82Party Name:CADILA Meet No/Date:12/82(Status: ALC4/2018 HEALTHCARE LTD ALC4/2018 Approved 12.12.2018 | HQ File RLA File ~ |Lic.No/Date:0810142708 | Decision::01/82/050/00865/AM19/Committee considered:08/24/040/00062/AM19/case as per agenda and as per earlier31.05.2018 decision taken by NC| in its = meeting 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: | Export Product
NIFEDIPINE EXTENDED RELEASE TABLETS 30 MG, 60 MG & 90 MG
204 S.NO. | Import Items
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----- Start of picture text -----<br> For export of 1 No. Tablet<br>LACTOSE MONOHYDRATE NF 107.25 mg 89.25mg _|63.48 mg<br>3 MICROCRYSTALLINE 4.00 mg 4.00 mg 4.00 mg<br>CELLULOSE NF 102 (COMPRECEL<br>M102D+)<br>RA may take appropriateEUR/NF action as per the decision of Norms Committee. |<br>----- End of picture text -----<br>
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----- Start of picture text -----<br> Case No.:243/12/82- ‘Party Name:SUN Meet No/Date:12/82- Status:<br>ALC4/2018 (PHARMACEUTICAL \ALC4/2018 Approved<br>INDUSTRIES LTD. 12.12.2018<br>HQ File RLA File ~ Lic.No/Date:05 10406698<br>:01/82/050/00870/AM19/ :05/24/040/00116/AM19/ 31.05.2018<br>Decision: Committee considered case as per agenda and deliberated on the matter in the presence of the<br>technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per<br>205 details below or as applied by firm whichever is lower:<br>Export product Exp. Qty. /SI.No. | Importitems | Qty. Allowed<br>Tobramycin 300mg / 5 ml Nebuliser 1 Number Tobramycin 306 mg /S ml pack<br>Solution (Each ml contains Tobramycin | pack<br>Ph. Eur. 60 mg)<br>(Equivalent 42.000Kg of Bulk Drug)<br>RA may take appropriate action as per the decision of Norms Committee<br>Case No.:36/12/82-ALC4/2018 Party Name:CHEMINOVA Meet No/Date:12/82- [Status: |<br>INDIA LIMITED ALC4/2018 Deferred<br>12.12.2018<br>206 HQ File RLA File ~~ Lie.No/Date:0310821376 [Defer Date:<br> ee<br>:01/82/050/00663/AM19/ :03/94/040/00049/AM 19/ 01.06.2018 |<br>Decision: Deferred for comments of TE<br>----- End of picture text -----<br>
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----- Start of picture text -----<br> Case No.:37/12/82- Party Name:AARTI DRUGS Meet No/Date:12/82- roon<br>ALC4/2018 LIMITED (ALC4/2018 Approved<br>12.12.2018<br>HQ File RLA File “Lic.No/Date:03 1082137 |<br>:01/82/050/00664/AM19/ :03/94/040/00150/AM19/ \7<br>01.06.2018 |<br>—_ i ee,<br>Decision: Committee considered case as per agenda and in light of earlier decision taken in 10/82 meeting<br>held on 05.06.2012 and in consultation with technical authority present in meeting decided to ratify norms<br>on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower:-<br>6<br>307 | Ticlopidine Hel | kg. 1. [|] [Thiophene-2-ethanol] 0.72 kg<br>0.25 kg<br>4.| Benzene Sulphony! chloride 0.99 kg<br>Sodium Hydroxide Flakes 0.747 kg<br>(6. Ortho chloro benzy! amine 0.80 kg<br>0.22 kg<br>}10. | Paraformaldehyde 0.300 kg<br>RA concerned may take further necessary action as per above decision of NC.<br>ハ<br>----- End of picture text -----<br>
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Case No.:241/12/82‘Party Name:MOREPEN Meet No/Date:12/82Status: ALC4/2018 LABORATORIES LTD., ALC4/2018 Deferred 12.12.2018 De)ove HQ File - RLA File = SSLic.No/Date:0510406716SSS (Defer Date: :01/82/050/00868/AM19/ :05/24/040/00113/AM19/ 01.06.2018 Decision: Deferred forcommentsof TE Be Case No.:232/12/82Party Name:JUBILANT LIFE Meet No/Date:12/82- Status: ALC4/2018 SCIENCES LIMITED ALC4/2018 Approved 12.12.2018 HQ File RLA File Lic.No/Date:05 10406722. :01/82/050/00859/AM19/ :05/23/040/00076/AM 19/ 04.06.2018 Decision: Committee considered case as per agenda and in light ofearlier decision taken in 10/82 meeting held on 16.10.2018 and in consultation with technical authority present in meeting decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower:209 Q in kg | Beta Picoline | Kg. pt Denatured Ethyl Alcohol 1.120 (2 |76 Methanol '4 __| Alumino Silicate Catalyst 0.0065 Propionaldehyde 0.057
RA concerned may take further necessary action as per above decision of NC
Case No.:233/12/82Party Name:DHANUKA “'Meet No/Date:12/82- Status: | ALC4/2018 LABORATORIES LTD ALC4/2018 ‘Deferred | 12.12.2018 | a710 HQ File RLA File Lic.No/Date:0510406723= ee {Defer Date: :01/82/050/00860/AM19/ :05/23/040/00105/AM19/ 04.06.2018 . Decision: Deferred for comments of TE Case No.:235/12/82"Party Name:DHANUKA Meet No/Date:12/82-[Status: | ALC4/2018 LABORATORIES LTD ALC4/2018 Deferred 12.12.2018 | 211 HQ File RLA File Lic.No/Date:0510406727 {Defer Date: :01/82/050/00862/AM19/ :05/23/040/00106/AM19/ 04.06.2018 | Decision: Deferred for comments of TE | - A " — ee Case No.:318/12/82Party Name:SUPREET Meet No/Date:12/82__[Status: ALC4/2018 CHEMICALS PVT.LTD. \ALC4/2018 Approved 212 12.12.2018 | HQ File RLA File Lic.No/Date:52 10042661 | :01/82/050/00945/AM19/ :52/24/040/0002 1/AM19/ 04.06.2018 |
71
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Decision: Committee considered case as per agenda and in light of earlier decision taken in 5/82 meeting held on 25.07.2018 and in consultation with technical authority present in meeting decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
==> picture [434 x 547] intentionally omitted <==
----- Start of picture text -----<br> Export product | Exp. Import items Qty. allowed<br>2-AMINO PHENOL 4|1kgQty. No. ORTHO AMINO 0.66 kg 7<br>SULFONIC ACID / OAPSA / PHENOL<br>ORTHO AMINO PHENOL<br>PARA SULFONIC/OA ACID | - a<br>RA concerned may take further necessary action as per above as per above per above above decision of NC NC<br>Case No.:71/12/82- Party Name:S M CHEMICAL Meet No/Date:12/82- Status:<br>ALC4/2018 VAPI PRIVATE LIMITED ALC4/2018 Approved<br>12.12.2018<br>HQ File RLA File Lic.No/Date:03 10821454<br>:01/82/050/00698/AM 19/ :03/95/040/00171/AM19/ 05.06.2018<br>Decision: Committee considered case as per agenda and deliberated on the matter in the presence of the the<br>technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP HBP as per<br>details below below or as applied by firm whichever is lower:<br>|<br>Export product Exp. Import items | Qty. allowed- [|]<br>Oty. No.<br>DIPHENYL ISODECYL | 1kg |1 | PHENOL. 0.557k oe<br>PHOSPHITE (DPDP) ISODECYLALCOHOL | 0.386 kg a<br>__| 3 YELLOWPHOSPHORUS _ _0.093 kg |<br>RA concerned may take further necessary action as per above decision of NC.<br>Case No.:72/12/82- Party Name:S M CHEMICAL Meet No/Date:12/82- Status:<br>ALC4/2018 VAPI PRIVATE LIMITED = ALC4/2018 Approved<br>12.12.2018<br>ee<br>HQ File RLA File Lic.No/Date:03 10821460<br>:01/82/050/00699/AM 1 9/ :03/95/040/00172/AM19/ 05.06.2018<br>Decision: Committee considered case as per agenda and deliberated on the matter in the presence of the<br>technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP HBP as per<br>details below or as or as as applied by by firm whichever is lower:<br>“Export product. = ~=~—~—~S™ Exp.| SL. | Importitems =—S*Y| Qty.allowed<br>| Qty. | No. a<br>2 ETHYLHEXYL DIPHENYL | | kg ] PHENOL 0.604 k ee<br>PHOSPHITE (2EHDP) z 2 ETHYLHEXANOL 0.386 k -<br>| id 3 | YELLOW PHOSPHORUS _| 0.09664 kg<br>“<br>「<br>----- End of picture text -----<br>
RA concerned may take further necessary action as per above as per above per above above decision of NC NC
| Case No.:71/12/82- | Party Name:S<br>M CHEMICAL | Meet No/Date:12/82- | Status: |
|---|---|---|---|
| ALC4/2018 | VAPI PRIVATE LIMITED | ALC4/2018 | Approved |
| 12.12.2018 | |||
| HQ File | RLA File | Lic.No/Date:03 1082145410821454 | |
| :01/82/050/00698/AM 19/19/ | :03/95/040/00171/AM19/ | 05.06.2018 |
Decision: Committee considered case as per agenda and deliberated on the matter in the presence of the the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP HBP as per details below below or as applied by firm whichever is lower: Me1
Decision: Committee considered case as per agenda and deliberated on the matter in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP HBP as per 214 details below or as or as as applied by by firm whichever is lower:
RA concerned may take further necessary action as per above decision of NC.
-_
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|72|
|Case No.:34/12/82-—~—~—=«éParty|Name: MAGNOLIA|Meet No/Date:12/82-|Status:|||
|ALC4/2018|LIMITED|ALC4/2018|Approved|
|HQ|File|RLA|File|Lic.No/Date:0312.12.2018|10821492||||
|:01/82/050/00661/AM19/|:03/95/040/00217/AM19/|06.06.2018|||||
|Decision:|Committee|considered|case|as peragenda and|in|light|of earlier|decision|taken|in|5/82|meeting|
|i.|held on 25.07.2018 and|in|consultation|with technical|authority|present|in meeting decided|to|ratify norms|
|215|on|repeat|basis under para 4.7 of HBP as per details below|or as applied by|firm whichever|is|lower:|
|Export|product|Exp.|Sl.|||Import|items|Qty.|allowed|||
|Oty.|No.|
|(1H-Pyrrol-1-yl)-2-|2-Mercapto-5-Methoxy|0.95 kg|
|Mercaptobenzimidazole|Benzimidazole|
|RA|concerned may|take|further necessary|action|as per above|decision|of|NC|
|Case|No.:67/12/82-|Party Name:RELIANCE|Meet No/Date:12/82- Status:|
|ALC4/2018|INDUSTRIES|LTD.|ALC4/2018|Deferred|||
|12.12.2018|
|7716|—-|—--|——$§£§£____ -___—__—_|
|HQ|File|RLA|File|Lic.|No/Date:0310821473|(Defer|Date:|
|:01/82/050/00694/AM19/|':03/95/040/01151/AM18/|(06.06.2018|||
|Decision:|The Committee|decided|to|refer the case to Dio C&PC|for obtaining|its comments.|
|Case No.:228/12/82-|Party Name:RECKITT|‘Meet|No/Date:12/82-|Status:|||
|ALC4/2018|BENCKISER HEALTHCARE|ALC4/2018|Deferred|
|INDIA PRIVATE LIMITED|12.12.2018|||
|)|-|—|_|+=|—_|-|—$_$_$_$_$_$__|
|is|HQ|File|RLA|File|‘Lic.No/Date:0510406755||Defer|Date:|
|:01/82/050/00855/AM19/|:05/24/040/00146/AM19/|(06.06.2018|
|Decision:|Deferred|for comments of|TE|7|
|Case No.:229/12/82-|Party Name:RECKITT|Meet No/Date:12/82-|Status:|
|ALC4/2018|BENCKISER HEALTHCARE|ALC4/2018|Deferred|—|
|INDIA|PRIVATE|LIMITED|12.12.2018|
|718|HQ|File|~RLAFile|Lic.No/Date:0510406756|(Defer Date:|
|:01/82/050/90856/AM19/|:05/24/040/00145/AM19/|06.06.2018|||
|Decision:|Deferred|for comments|of TE|
|Case No.:53/12/82-ALC4/2018 Party|Name:SPAK|Meet No/Date: 12/82-|neo|||
|(ORGOCHEM (INDIA) PVT.|ALC4/2018|Deferred|
|‘LTD.|12.12.2018|||
|219|HQ|File|~|'RLA|File|Lic.No/Date:0310821536|Defer Date:|
|:01/82/050/00680/AM19/|:03/95/040/01129/AM18/|07.06.2018|||
|Decision:|Committee consideredthe|case|as|per agenda|and|it|was|decided|to|call|from|the|firm|complete|
|technical|details as|per appendix 4 E|||
----- End of picture text -----<br>
73
o
||CaseNo.:227/12/82-<br>PartyName:SENTISS|MeetNo/Date:12/82-<br>Status:||
|---|---|---|---|
||ALC4/2018<br>PHARMA PVT.LTD.|ALC4/2018<br>Approved<br>12.12.2018||
||HQ File<br>RLA File|Lic.No/Date:0510406783||
||:01/82/050/00854/AM19/<br>:05/24/040/00134/AM19/<br>07.06.2018<br>|<br>Decision: Committee considered caseasperagendaandinlightofearlierdecisiontaken in5/82meeting|<br>held on 25.07.2018 and in consultation with technical authority present in meeting decided to ratify norms||||
|229|onrepeatbasisunderpara4.7ofHBPasperdetailsbeloworasappliedbyfirmwhicheverislower:||||
||Export product<br>Exp.<br>Sl.<br>| Import items<br>Qty. allowed||||
||Qty.<br>No.|||
||Mydrimax Eye Drops Sml Vial |Number<br>40.8mg /5 ml vial<br>(Each<br>ml<br>containing<br>8<br>mg<br>Tropicamide|||
||Tropicamide)|||
||RAconcernedmaytakefurthernecessaryactionasperabovedecisionofNC<br>||||
||Case No.:244/12/82-<br>PartyName:SUN<br>ALC4/2018<br>‘PHARMACEUTICAL<br>INDUSTRIES LTD.|MeetNo/Date:12/82-<br>‘Status:<br>ALC4/2018<br>Deferred<br>(12.12.2018|||
|—|HQ File<br>RLA File<br>:01/82/050/00871/AM19/<br>:05/24/040/00137/AM19/|Lic.No/Date:0510406779<br>DeferDate:<br>07.06.2018<br>CB<br>—||<br>||
||Decision: Deferred forcomments ofTE|||
|oy<br>222|CaseNo.:265/12/82-<br>PartyName:VARAHI<br>«(Meet No/Date:12/82-_—[Status:<br>ALC4/2018<br>PHARMAPRIVATE<br>|ALC4/2018<br>Deferred<br>(LIMITED<br>}12.12.2018<br>-<br>—<br>—<br>-<br>—<br>——<—<$ $< —————<br>—<br> HQFile<br>RLAFile<br>Lic.No/Date:6610000009 [Defer Date:<br>:01/82/050/00892/AM19/<br>:66/24/040/00001/AM19/<br>07.06.2018<br>|<br>Oe|||<br>||
||Decision: Deferred forcommentsofTE<br>_<br>—<br>.|—<br>SSS re|||
||CaseNo.:295/12/82-<br>PartyName:VERVEHUMAN<br>ALC4/2018<br>CARELABORATORIES|MeetNo/Date:12/82-<br>(Status:<br>ALC4/2018<br>Deferred<br>—||
|||12.12.2018|||
|223<br>“*°|HQFile<br>RLAFile<br>:01/82/050/00922/AM19/<br>:61/24/040/00003/AM19/|a<br>———<br>\Lic.No/Date:6110001511 DeferDate:<br>(07.06.2018<br>|||<br>||
||Decision: Deferred for comments ofTE|||
||CaseNo.:52/12/82-<br>PartyName:LUPINLIMITED[Meet<br>ALC4/2018|[Meet No/Date:12/82-_ Status:<br>ALC4/2018<br>Approved<br>12.12.2018|||
||HQ File<br>RLA File<br>:01/82/050/00679/AM19/<br>:03/95/040/00210/AM19/|Lic.No/Date:0310821596<br>|<br>08.06.2018<br>|||
|224|Decision: Committee considered case as per agenda and in light ofearlier decision taken in 10/82 meeting||meeting||
||held on 16.10.2018 and in consultation with technical authority|present in meeting decided to ratify norms||
||on repeatbasis underpara4.7ofHBPasperdetailsbelow oras|appliedby firm whichever is lower:||
||ExportProduct<br>Qty. | Sl.<br>[Import items<br>No.|Quantity<br>allowedinKg||
224 Decision: Committee considered case as per agenda and in light of earlier decision taken in 10/82 meeting[|] held on 16.10.2018 and in consultation with technical authority present in meeting decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
74
==> picture [420 x 74] intentionally omitted <==
----- Start of picture text -----<br> ETHAMBUTOLHCL ‘| 1kg]1 [DL2AMINOBUTANOL [16014|<br>/ 4 [ISOPROPYETHANO L ALCOHOL 0. 1841 7 2 |<br>THYLENE DICHLORIDE 0.4663<br>----- End of picture text -----<br>
RA concerned may take further necessary action as per above decision of NC Note:- SION A-225 & A-227 to be revised
Case No.:81/12/82-ALC4/2018 PartyName:KOPRANMeetNo/Date:12/82‘Status: RESEARCH ALC4/2018 Deferred LABORATORIES LTD. (12.12.2018 | 22 | -- << <a <—$<< oa HQ File 'RLA File 'Lic.No/Date:0310821554 |Defer Date: :01/82/050/00708/AM19/ :03/94/040/00194/AM19/ 08.06.2018_ SO
Decision: Deferred for comments of TE
Case No.:85/12/82-ALC4/2018 Party Name:CIPLA LIMITED. [Meet No/Date:12/82Status: ALC4/2018 ‘Deferred 12.12.2018 226 ; : oo oo EET ee HQ File RLA File \Lic.No/Date:03 10821559 Defer Date: | :01/82/050/007Decision: Deferred12/AM19/for comments:03/94/040/00134/AM19/of TE (08.06.2018 a | Case No.:222/12/82Party Name: DHANUKA ‘Meet No/Date: 12/82‘Status: ALC4/2018 LABORATORIES LTD ALC4/2018 \Deferred per4% a — — 12.12.2018——— —— | HQ File RLA File Lic.No/Date:05 10406803 | :01/82/050/00849/AM19/ :05/23/040/00109/AM19/ (08.06.2018 Decision: Deferred for comments of TE Case No.:54/12/82Party Name:LUPIN LIMITED Meet No/Date:12/82- Status: | ALC4/2018 ALC4/2018 |Approved 12.12.2018 | HQ File RLAFile ~—~—~—~—_Lic.No/Date:0310821600 | :01/82/050/00681/AM19/ :03/95/040/00209/AM19/ 11.06.2018 Decision: Committee considered case as per agenda and in light of earlier decision taken in 10/82 neaing held on 16.10.2018 and in consultation with technical authority present in meeting decided to ratify norms | 22g on repeat basis 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>----- End of picture text -----<br>
==> picture [421 x 86] intentionally omitted <==
----- Start of picture text -----<br> Export Product Qty. | Sl. [Import items Quantity<br>No. allowed in Kg<br>ETHAMBUTOL HCL Tkg [1 |DL2 AMINOBUTANOL<br>ARTARIC ACID 0.153 |<br>|[ISOPROPYL4 ALCOHOL 0.187 |<br>----- End of picture text -----<br>
75
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aml
| |
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----- Start of picture text -----<br> [5|ETHYLENE DICHLORIDE [04663 | |<br>|<br>----- End of picture text -----<br>
RA concerned may take further necessary action as per above decision of NC Note:- SION A-225 & A-227 to be revised
Case No.:239/12/82-—~—~—~Party Name:NAARI PHARMA Meet No/Date:12/82Status: ALC4/2018 PRIVATE LIMITED ALC4/12.12. 201 88 Approved| | HQ File RLA File Lic.No/Date:05 10406805 _ :01/82/050/00866/AM19/ :05/24/040/00156/AM19/ 11.06.2018
|
Decision: Committee considered case as per agenda and in consultation with technical authority present in | meeting decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by | firm whichever is lower: 229
| No. LEVONORGESTREL 1.5 mg | 3333330.000 5.00 kg | Tablet Nos. LEVONORGESTREL (1 Kg Levo = 666666 Tab of Micronized USP/EP Levonorgestrel 1.5 mg
RA concerned may take further necessary action as per above decision of NC
Case No.:319/12/82ALC4/2018 ~ [PartyCHEMICALS Name:SUPREETPVT.LTD. (MeetALC4/2018 No/Date:12/82- Status:Approved || 12.12.2018 | HQ File RLA File Lic.No/Date:5210042669 | | :01/82/050/00946/AM19/ :52/24/040/00024/AM19/ 11.06.2018
|
Decision: Committee considered case as per agenda and in consultation with technical authority present in __ meeting decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by | 230 firm whichever is lower: Export product Exp. Sl. Qty. allowed ABR ACID / ACID BLUE277 / Qty. No. | SPOORACIDBLUERR. | ® |! | BROMAMINE ACID | TICME | | RA concerned may take further necessary action as per above decision of NC |
Case No.:55/12/82-ALC4/2018 Party Name:SURVIVAL Meet No/Date:12/82-. (Status: TECHNOLOGIES PVT.LTD. ALC4/2018 Deferred — 12.12.2018 | 231 HQ File — RLAFile Lic.No/Date:0310821614 Defer Date: :01/82/050/00682/AM19/ :03/95/040/00220/AM19/ 12.06.2018 | Decision: Committee considered the case as per agenda and it was decided to call from the firm stage of % | of yield along with complete technical details as per appendix. |
76
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|Case No.:178/12/82-|Party Name:VENUS|Meet No/Date:12/82-|Status:|||
|anKe|Wi|ALC4/2018|REMEDIES|LTD.,—___—-|'|ALC4/201812.12.2018|a|||Deferred|
|HQ|File|RLA|File|Lic.No/Date:2210015917||Defer|Date:|
|:01/82/050/00805/AM19/|:22/24/040/0002 1/AM19/|12.06.2018|
|Decision:|Deferrederred|ffor|commentsentsofTEo|—|tsts—S|as|
|a|—|
|Case|No.:220/12/82-|Party Name:CADILA|Meet No/Date:12/82-|Status:|
|ALC4/2018|HEALTHCARE LTD|ALC4/2018|Approved|
|(12.12.2018|
|HQ|File|RLA|File|Lic.No/Date:0810142806|
|:01/82/050/00847/AM19/|:08/24/040/00063/AM19/|12.06.2018|
|Decision:|Committee|considered|case as per agenda and in consultation|with technical authority present|in|||
|meeting|decided|to|ratify|norms|on|repeat|basis|under para 4.7|of HBP|as|per|details below|or|as|applied|by|
|firm|whichever|is|lower:|
|233|||
|No.|
|MESALAMINE|SUPPOSITORIES ||1901220.000|MESALAMINE|1939.24|kg|
|1000 MG|Nos.|USP|
|||
|RA concerned may take further necessary action as per above|decision of|NC|oO|||
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Case No.:223/12/82Party Name:CADILA Meet No/Date:12/82(Status: ALC4/2018 HEALTHCARE LTD ALC4/2018 Deferred 734) — SS 12.12.2018eee | HQ File RLA File Lic.No/Date:0810142808 [Defer Date: | :01/82/050/00850/AM19/ ':08/24/040/00076/AM19/ (12.06.2018 | | Decision: Deferred for comments of TE | _ Case No.:225/12/82Party Name:CADILA | Meet No/Date:12/82Status: | ALC4/2018 HEALTHCARE LTD ALC4/2018 Deferred 235 HQ File ~ IRLA File Lie. No/Date:081014280712.12.2018 [Defer| Date: :01/82/050/00852/AM19/ :08/24/040/00064/AM19/ /12.06.2018 ; Decision: Deferred for comments of TE Case No.:230/12/82|Party Name:V.D.H. | Meet No/Date:12/82- Status: | ALC4/2018 ORGANICS PVT. LTD ALC4/2018 Approved ~ 12.12.2018 | | HQ File RLA File Lic.No/Date:05 10406809 | 236 :01/82/050/00857/AM19/ :05/24/040/00147/AM19/ 12.06.2018 | Decision: The Committee considered case as per agenda and in the presence of the technical experts, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or = applied by firm whichever is lower: |
77
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||
Export product | Qty. | SL | Import items «Qty. sd No. THYMOL 99% PURE & ABOVE ba 98.5%PURMETA-CR E SOL ABOVE| 0.785 kg ISO. PROPYL ALCOHOL| 0.3 kg | IPA) RA may take appropriate action as per the decision of Norms Committee Case No.:231/12/82—~—siParty Name:V.D.H. ‘Meet No/Date:12/82Status: | ALC4/2018 (ORGANICS PVT. LTD ALC4/2018 Approved | (12.12.2018 | HQ File RLA File Lic No/Date:0510406812 :01/82/050/00858/AM19/ :05/24/040/00151/AM19/ 12.06.2018 |
Decision: The Committee considered case as per agenda and in the presence of the technical experts, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as 237 applied by firm whichever is lower: Export product Qty. | SI. Qty. | No. | THYMOL 99% PURE & ABOVE META-CRESOL ABOVE| 0.785 kg 98.5%PURE | 2 ISO PROPYL ALCOHOL| 0.3 kg | IPA RA may take appropriate action as per the decision of Norms Committee Case No.:236/12/82|Party Name:V.D.H. ‘Meet No/Date:12/82- (Status:| ALC4/2018 (ORGANICS PVT. LTD ALC4/201812.12.2018 Approved HQ File ~'RLA File Lic.No/Date:05 10406810 :01/82/050/00863/AM19/ :05/24/040/00149/AM19/ '12.06.2018
Decision: The Committee considered case as per agenda and in the presence of the technical experts, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as 238 applied by firm whichever is lower: Export product SI. Qty. No. THYMOL 99% PURE & ABOVE META-CRESOL ABOVE| 0.785 kg | 98.5%PURE | 2 ISO PROPYL ALCOHOL| 0.3 kg | RA may take appropriate action as per the decision of NormsIPA Committee al|
Case No.:237/12/82Party Name:V.D.H. ‘MeetNo/Date:12/82Status: ALC4/2018 ORGANICS PVT. LTD ALC4/2018 Approved 12.12.2018 | | — RLAFile Lic.No/Date:0510406811 | | 339 HQ File “~~ :01/82/050/00864/AM19/ :05/24/040/00148/AM19/ 12.06.2018 | | Decision: The Committee considered case as per agenda and _in the presence of the technical experts, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
| |A, |
78
| |)
Export product | Qty. TS. Import items _ 7 Qty. No. THYMOL 99% PURE & ABOVE l kg META-CRESOL ABOVE| 0.785 kg 98.5%PURE ISO. PROPYL = ALCOHOL| 0.3 kg RAee ee) a may take appropriate action as per the decision of Norms Committee
Case No.:56/12/82-ALC4/2018 Party Name:SANJIVANI Meet No/Date: 1 2/82Status: PARANTERAL LIMITED ALC4/2018 Deferred 240 12.12.2018 430 File RLA File Lic.No/Date:0310821651 ‘Defer Date: :01/82/050/00683/AM19/ :03/95/040/00227/AM 19/ 13.06.2018 Decision: Deferred for comments of TE
Case No.:224/12/82Party Name:JUBILANT LIFE Meet No/Date:12/82Status: ALC4/2018 SCIENCES LIMITED ALC4/2018 Approved 12.12.2018 HQ File RLA File Lic.No/Date:05 10406849 :01/82/050/0085 1/AM19/ :05/23/040/00075/AM 19/ 13.06.2018
Decision: Committee considered case as per agenda and in light of earlier decision taken in 10/82 meeting held on 16.10.2018 and in consultation with technical authority present in meeting decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower:-
==> picture [445 x 99] intentionally omitted <==
----- Start of picture text -----<br> 241 Export product : Exp.— Sl.No. | Importaitems Qty. allowed<br>Beta Qty. | inkg<br>Picoline 1 Kg. l Denatured Ethyl Alcohol 1.120<br>2 | [Methanol] 0.76<br>3 | Ammonia 0.82<br>pee See serene! {54 AlumProp i onaldehydeno Silicate Catalyst 0.0 57065 _<br>----- End of picture text -----<br>
RA concerned may take further necessary action as per above decision of NC
Case No.:288/12/82Party Name:DEEPAK Meet No/Date: 1 2/82Status: ALC4/2018 NOVOCHEM ALC4/2018 Approved TECHNOLOGIES LTD 12.12.2018 HQ:01/82/050/00915/AM19/File RLA:31/83/040/00027/AMFile 19/ Lic.No/Date:313.06.2018 1 10067079
Decision: Committee considered case as per agenda and in consultation with technical authority present in 242 mecting decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
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----- Start of picture text -----<br> Export product 7 Exp. Qty. Sl. Import items | Qty. allowed<br>_ ikg 1No. |ACETIC<br>ACETONITRILE 2 . ACID Not146kg allowed<br>Catalyst :<br>since not shown<br>a - _ in the process<br>旬<br>軍<br>----- End of picture text -----<br>
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RA concerned may take further necessary actionas per above decision ofNC ©.
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<br>Case No.:240/12/82- |Party Name:STERILE INDIA Meet No/Date:12/82- _|Status:<br>ALC4/2018 PRIVATE LIMITED ALC4/2018 Approved<br>12.12.2018<br>HQ File RLA File Lic.No/Date:05 10406858<br>:01/82/050/00867/AM19/ :05/24/040/00160/AM19/ 14.06.2018 |<br>Decision: Committee considered case as per agenda and in consultation with technical authority present in<br>meeting decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by<br>firm whichever is lower:<br>543 |- Export product Exp. Qty. iNo. | Qty. allowed<br>VANCOMYCIN Vancomycin Non |<br>HYDROCHLORIDE( STERILE) Sterile |<br>|<br>RA concerned may take further necessary action as per above decision of NC<br>Case No.:180/12/82- —~—~—~«~Party Name:INDSWIFT Meet No/Date:12/82-__[Status:<br>ALC4/2018 ‘LABORATORIES LIMITED ALC4/2018 Approved<br>12.12.2018<br> —_Lic.No/Date:2210015919 _ |<br>HQ File ~RLAFile<br>:01/82/050/00807/AM19/ :22/24/040/00024/AM19/ 15.06.2018<br>Decision: Committee considered case as per agenda and in consultation with technical authority present in<br>meeting decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by<br>firm whichever is lower:<br>244<br>Q No.<br>Betamethasone Dipropionate | Ikg |1 | Betamethasone _| 0.868 kg |<br>2 Triethy! Ortho Propionate 0.650 kg<br>RA concerned may take further necessary action as per above decision of NC<br>Ｓ‐<br>ｍ<br>----- End of picture text -----<br>
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----- Start of picture text -----<br> Case No.:226/12/82- Party Name:NAARI PHARMA Meet No/Date:12/82- ‘Status: |<br>ALC4/2018 PRIVATE LIMITED ALC4/2018 Approved<br>12.12.2018<br>HQ File RLA File Lic. No/Date:05 10406869 _ |<br>245 :01/82/050/00853/AM19/ 05/24/040/00125/AM19/ 15.06.2018<br>----- End of picture text -----<br>
Decision: Committee considered case as per agenda and in consultation with technical authority present in meeting decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
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----- Start of picture text -----<br> Export product Exp. Qty. Sl. | Importitems Qty. allowed<br>MisoprostolMisoprostol =Tablet48500-_200Pes Tablet)MCG (1 kg | 1 No.~.--__,] INO; Misoprostola 204 mcg/ tablet<br>RA concerned may take further necessary action as per above decision of NC<br>Case No.:289/12/82- Party Name:CLEAN Meet No/Date: | 2/82- Status:<br>ALC4/2018 SCIENCE AND ALC4/2018 Approved<br>TECHNOLOGY PVT.LTD. 12.12.2018<br>HQ File RLA File Lic.No/Date:3 110067081<br>:01/82/050/009 16/AM19/ :31/83/040/00034/AM19/ 15.06.2018<br>----- End of picture text -----<br>
Decision: Committce considered case as per agenda and in consultation with technical authority present in meeting decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by 246 firm whichever is lower:
|| | |
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----- Start of picture text -----<br> Export product — Exp. ys. Import items —_ Qty. allowed<br>Qty. | No.<br>4-Methoxy Acetophenone ( 4 | lkg |_| Anisole 93% Max 0.800 kg<br>MAP)/ Acetyl Anisole 2 0.752 kg<br>Acetic Anhydride 99%<br>「<br>----- End of picture text -----<br>
RA concerned may take further necessary action as per above decision of NC
Case No.:209/12/82Party Name:SHREE BANKEY Mect No/Date:12/82Status: ALC4/2018 BEHARI LAL AROMATICS — ALC4/2018 Deferred anh 12.12.2018 HQ File RLA File Lic.No/Date:0510406899 Defer Date: :01/82/050/00836/AM 19/ :05/24/040/00117/AM19/ 18.06.2018
Decision: Deferred for comments of TE
Case No.:68/12/82Party Name:USV PRIVATE Meet No/Date:12/82Status: ALC4/2018 LIMITED ALC4/2018 Approved 12.12.2018 HQ File RLA File Lic.No/Date:03 10821764 :01/82/050/00695/AM 19/ :03/95/040/00265/AM 19/ 19.06.2018
Decision: Committee considered case as per agenda and in consultation with technical authority present in meeting decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
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----- Start of picture text -----<br> sit Export product Exp. SI. Import items Qty. allowed<br>Perphenazine ty.| No.<br>(18,000 BottlesTabletsx 100 USPPer Bottle 2 mg = 1 No. | 1 2.04 mg/ 2 mg<br>18,00,000 Tablets (Net Content Weight = PerphenazineJ USP tablet<br>3.600 k<br>PerphenazineeeTablets USP 4 mg7 ee1 No. | a2 ae 4.08 mg/ 4 mg<br>(20,000 Bottles x 100 Per Bottle = : tablet<br>2,000,000 Tablets) (Net Content Weight = camel<br>8.000 kg) as ae<br>一<br>----- End of picture text -----<br>
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----- Start of picture text -----<br> Perphenazine Tablets USP 8 mg an 7s rd 8 mg| |<br>(12,000 Bottles x 100 Per Bottle = Perolickasine USP “<br>1,200,000 Tablets) (Net Content Weight = rpnenazine<br>9.600 kg)<br>Perphenazine Tablets USP 16 mg | No. 16.32 mg/ 16<br>(6,000 Bottles x 100 Per Bottle = 600,000 Perphenazine USP | mg tablet<br>Tablets) (Net Content Weight = 9.600 kg)<br>----- End of picture text -----<br>
RA concerned may take further necessary action as per above decision of NC
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----- Start of picture text -----<br> Case No.:70/12/82- Party Name:NEOGEN Meet No/Date: 12/82- Status: |<br>ALC4/2018 CHEMICALS LIMITED ALC4/2018 Deferred<br>}12.12.2018 |<br>a me Ea a<br>749 Se<br>HQ File RLA File ‘Lic. No/Date:03 10821767 | |<br>:01/82/050/00697/AM19/ :03/95/040/00900/AM 18/ 19.06.2018- | |<br>Decision: Deferred for comments of TE |<br>Case No.:80/12/82- “/Party Name:ETERNIS FINE Meet No/Date:12/82- Status:<br>ALC4/2018 CHEMICALS LIMITED, ALC4/2018 Approved |<br>12.12.2018 |<br>HQ File RLA File — Lic.No/Date:03 10821771<br>:01/82/050/00707/AM 19/ :03/94/040/00234/AM19/ 19.06.2018 |<br>Decision: Committee considered case as per agenda and in consultation with technical authority present in<br>meeting decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by<br>firm whichever is lower:<br>250<br>Qty. | No.<br>MENTHANOL(4-Isopropy! -1 [|][CUMINIQUE][ ALDEHYDE] 1.350 kg<br>CARBON CATALYST<br>Cyclohexyl Methanol) 2 5% RUTHENIUM ON 0.0035 kg |<br>RA concerned may take further necessary action as per above decision of NC |<br>Case No.:45/12/82- Party Name:IPCA Meet No/Date:12/82- Status:<br>ALC4/2018 LABORATORIES LIMITED ALC4/2018 Approved,<br>12.12.2018 | |<br>HQ File RLA File Lic.No/Date:0310821791 | |<br>:01/82/050/00672/AM19/ :03/94/040/00225/AM19/ (20.06.2018<br>Decision: The Committee considered the case as per agenda in the presence «<br>of Technical Experts and 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>25} applied by firm whichever is lower:<br>Export product Exp. | SL. Qty. allowed |<br>Oty. | No.<br>ALLOPURINOL 3-Amino Pyrazole Carboxamide | 1.538 kg |<br>Hemisulphate<br>A<br>|<br>Ｓ‐<br>----- End of picture text -----<br>
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----- Start of picture text -----<br> a pea ae ——---——,<br>|<br>RA concerned may take further necessary action as per above decision of NC<br>Case No.:69/12/82- —-Party Name:MANGALAM _ Meet No/Date:12/82-__(Status: |<br>ALC4/2018 DRUGS AND ORGANICS ALC4/2018 Beterred- |<br>: LIMITED 12.12.2018 Ppepewed<br>HQ ——— : ES We eRSoeea |<br>File RLA File Lic.No/Date:03 10821781 |Defer Date:<br>:01/82/050/00696/AM 19/ :03/95/040/00252/AM 19/ 20.06.2018<br>----- End of picture text -----<br>
Decision: The Committee considered the case as per agenda in the presence of Technical |Experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as 252 applied by firm whichever is lower:
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----- Start of picture text -----<br> Export Product Qty. Import items Quantity<br>allowed |<br>kg<br>PIPERAQUINE PHOSPHATE | | Kg. | Ethoxy Methylene Malonic Acid Ester 1.30 kg<br>(EMME )<br>RA may take appropriate action as per the decision of Norms Committee.<br>Case No.:176/12/82- Party Name:NECTAR ‘Meet No/Date:12/82- Status:<br>ALC4/2018 LIFESCIENCES LIMITED, §(ALC4/2018 Approved<br>12.12.2018 |<br>HQ File RLA File ~Lic.No/Date:2210015924 |<br>:01/82/050/00803/AM19/ :22/24/040/00023/AM 19/ 20.06.2018 | |<br>Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the |<br>light of earlier decision taken by NC in its Meeting No. 4/82, dated 19.06.2018, 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>Export product Qty. | Sl. | Import items Qty. Allowed<br>CEFPODOXIME No. in kg |<br>253 1 kg ial Desacetyl-7-Amino Cephalosporanic | 0.708 |<br>| PROXETIL Acid (D-7-ACA) |<br>Methane Sulfonicacid |<br>4. S-2 Benzothiazoly]-2-Amino-2- 0.8378<br>(methoxyimino)-4-tiazoly] acetate<br>(MAEM) |<br>Triethylamine (TEA) 0.252<br>}6. | Acetone 0.675 |<br>DMAC (Di Methyl Acetamide) 0.684<br>CEIPC (Chloro Ethy! Iso Propyl 0.350<br>Carbonate)<br>1910. ||16TolueneTMG (Tetra Methylene Guanidine) 0.189<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.:60/12/82-|
|ALC4/2018|‘INDUSTRIESParty Name:RELIANCELTD.|—_— MeetALC4/2018 No/Date:12/82-|Status:Deferred|iW|
|‘12.12.2018|||||
|seal5|HQ|File|_|RLA|File|—|ets|‘Lic.No/Date:03=|10821813|a|Defer Date:|
|:01/82/050/00687/AM19/|:03/95/040/00116/AM19/|21.06.2018|||
|Decision:||The Committee|decided|to|refer the case|toDio C&PC for obtaining|itscomments.|
|.|
|Case|No.:208/12/82-|
|ALC4/2018|Party|Name:STRIDES —~—_—|Meet No/Date:12/82-|Status:|
|'SHASUN LIMITED|\ALC4/2018|‘Deferred|||
|12.12.2018|
|255|||||
|HQ|File|RLA File|Lic.No/Date:0410164428|[Defer|Date:|||
|:01/82/050/00835/AM19/|:04/24/040/00063/AM19/|21.06.2018|||
|Decision:|Geferred|for|comments|of TE|.|_ BS|
|Case No.:212/12/82-|Party Name:STRIDES|———_—[Meet|No/Date:12/82-|_[Status:|
|ALC4/2018|'SHASUN|LIMITED||ALC4/2018|‘Deferred|
|12.12.2018|||||
|256|HQ|File|RLA|File|Lic.No/Date:04 10164427|Defer Date:|||
|:01/82/050/00839/AM19/|:04/24/040/00053/AM19/|21.06.2018|||
|Decision:|Deferred|for comments of|TE|
|||
|Case No.:175/12/82-|Party Name:NECTAR|—|‘Meet No/Date:12/82-|Status:|
|ALC4/2018|LIFESCIENCES|LIMITED|ALC4/2018|\Deferred|
|12.12.2018|||
|757|HQ|File|RLAFile|LicNo/Date:2210015928|(Defer Date:|
|:01/82/050/00802/AM19/|:22/24/040/00028/AM19/|22.06.2018|||
|Decision:|Deferred|for comments of|TE|BS|ee|—|
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Case No.:188/12/82Party Name:CADILA Meet No/Date:12/82- __ Status: | ALC4/2018 HEALTHCARE LTD ALC4/2018 Approved 258 |12.12.2018 HQ File RLA File . "Lie. No/Date:08 10142890 [Defer[Date:] :01/82/050/008 15/AM19/ :08/24/040/00100/AM19/ 22.06.2018 Decision: The Committee considered the case as per agenda inthe presence of 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. No. NITROFURANTOINCAPSULES 25 MG Nos. fe | NITROFUMACROC R ANTOINYSTALS USP | 25.50 mg /Capsule (MACROCRYSTALS) 2. LACTOSE 150.00 mg / Capsule MONOHYDRATE | NF/PH.EUR. NITROFURANTOINCAPSULES 50 MG Nos. | NITROFURANTOINMACROCRYSTALSUSP | 51 mg/ Capsule | (MACROCRYSTALS) 2 LACTOSE 180 mg / Capsule MONOHYDRATE | NF/PH.EUR. | NITROFURANTOINCAPSULES 100 MG Nos. a NITROFURANMACROCRYS T ALS)OIN USP_ | 102 mg / Capsule (MACROCRYSTALS) 2 LACTOSE 219 mg / Capsule MONOHYDRATE NF/PH.EUR. RA may take appropriate action as per the decision of Norms Committee. | ————— ——— a! Case No.:215/12/82Party Name:FRESENIUS Meet No/Date: 12/82- (Status: | ALC4/2018 KABI ONCOLOGY LIMITED ALC4/2018 Deferred | 12.12.2018 4259 HQ File RLA— File ‘Lic.No/Date:05————— 10406946 _ —-— ‘Defer—_———$$$$—— Date: :01/82/050/00842/AM19/ :05/23/040/00099/AM19/ 22.06.2018 Decision: Deferred for comments of TE Case No.:82/12/82-ALC4/2018 |PartyName:GLENMARK PHARMACEUTICALS[LTD.,] (MeetALC4/2018 No/Date:12/82Status:Approved | 12.12.2018 HQ File RLA File Lic.No/Date:03 10821897 :01/82/050/00709/AM19/ :03/94/040/00255/AM19/ 25.06.2018
Decision: The Committee considered the case as per agenda in the presence of 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 260 firm whichever is lower:
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----- Start of picture text -----<br> |<br>No. |<br>BLAXADASINE 100MG TABLETS | | No. Ciprofibrate BP 1.02 mg /tablet |<br>MX (Ciprofibrate Tab 100mg) tablet<br>(Pack Size 30 Tabs.) (Net wt. of<br>Import Item Ciprofibrate BP is |<br>----- End of picture text -----<br>
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Case No.:66/12/82Party Name:RELIANCE —_|Meet No/Date:12/82Status: ALC4/2018 INDUSTRIES LTD. ALC4/2018 Deferred 12.12.2018 aneIh2 HQ File RLA File . 'Lic.No/Date:0310821936a ————————— |Defer Date: :01/82/050/00693/AM19/ :03/95/040/00104/AM19/ 26.06.2018 Decision: The Committee decided to refer|the cas e to D/o C&PC for obtaining its comments. Case No.:218/12/82Party Name:JUBILANT LIFE MeetNo/Date:12/82Status: ALC4/2018 SCIENCES LIMITED ALC4/212.12.2 0 1818 ‘Approved || HQ File RLA File Lic.No/Date:0510406966 Defer Date: | :01/82/050/00845/AM19/ :05/23/040/00110/AM19/ 26.06.2018 Decision: Committee considered case as per agenda and as per earlier decision taken by.NC in its 6/82 meeting dated 26.07.2018, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP| 264 as per details below or as applied by firm whichever is lower: | Export product Exp. Qty. Allowed Eeeidine 98%ee Minee | Alumino Silicate Catalyst 0.019k Ethyl Alcohol (Denatured) | 2.194 kg | NARS [4 | MethaPropio n aldehydeol 0.073 kg | RA may take appropriate action as per the decision of Norms Committee | Case No.:290/12/82~ Party Name:BALAJI AMINES [Meet No/Date:12/82- Status: ALC4/2018 LIMITED ALC4/2018 Beterred | 7 ~ 12.12.2018 | yyy HQ File RLA File Lic.No/Date:3110067097 Defer Date: | :01/82/050/00917/AM19/ :31/83/040/00045/AM19/ 26.06.2018 Decision: In the light of earlier decision taken by NC in its 6/82 meeting dated 26.07.2018, it was decided| 265 to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm | ~~ whichever is lower: Export Product Export Sl. | Import Product Quantity | Quanti No Allowed GAMMA BUTYROLACTONE fl | 1.4 BUTANEDIOL pN16kg | GBL CATAYLYST 0.001 kg | RA may take appropriate action as per the decision of Norms Committee Case No.:46/12/82-ALC4/2018 Party Name:IPCA ~ |Meet No/Date:12/82Status: LABORATORIES LIMITED =(ALC4/2018 Approved 12.12.2018 | 266 HQ File ~RLA File Lic.No/Date:03 10822031 :01/82/050/00673/AM19/ :03/94/040/00267/AM19/ 28.06.2018 | | Decision: Committee considered case as per agenda and _ as per earlier decision taken by NC in its 4/82| meeting dated 19.06.2018, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP
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as per details below or as appliedby firm whichever is <_<“ | Export product SI.No. Qty. Allowed | PAROXETINE lkg (-)Trans-4R-(40.810 kg | HYDROCHLORIDE Fluoropheny!)-3S| HEMIHYDRATE Hydroxymethyl-N-Methy] Piperidine | | Dimethyl Sulfoxide 2.930 kg | | RA may take appropriate action as per the decision of Norms Committee Case No.:47/12/82-ALC4/2018 Party Name:ETERNIS FINE Meet No/Date:12/82Status: CHEMICALS LIMITED, ALC4/2018 ‘Approved | 12.12.2018 | HQ File RLA File Lic.No/Date:0310822027 —| :01/82/050/00674/AM19/ :03/94/040/00265/AM19/ (28.06.2018 | | Decision: Committee considered case as per agenda and as per ‘earlier decision taken[by][ NC][in][its][4/82] | meeting dated 19.06.2018, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP.[is][ lower:] | 7=[as][ per][ details][ below][ or][ as applied][ by][ firm][ whichever] | Export Product S.No | Import Product a Allowed HAMBER / HAMBER - BHT / l kg METHYL ETHYL 0.60 kg | HAMBER- Toco (7-AcetylKETONE (MEK | Tetramethy!1,2,3.4,5,6,7,8-OctahydroNaphthalene) 1,1,6,7ae2. MERCENE 1.00 kg RA may take appropriate action as per the decision of Norms Committee. | Case No.:62/12/82Party Name:RELIANCE Meet No/Date:12/82Status: 1 | ALC4/2018 INDUSTRIES LIMITED ‘ALC4/2018 ‘Deferred 12.12.2018 | | SS” __ Lie No/Date:0310822037 (Defer Date: | 768 HQ File BTA File :01/82/050/00689/AM 19/ -03/95/040/00102/AM19/ (28.06.2018 | Decision: ©The Committee decided to refer the case to D/o C&PC for obtaining its comments.
Case No.:90/12/82.~~—~-(ParlyName:RELIANCE INDUSTRIES LTD. ALC4/2018 Deferred | ALC4/2018 (Meet12.12.2018No/Date:12/82aoe| || 769 HQ File -RLAFile———_Lic.No/Date:0310821990 Defer Date: | -01/82/050/00717/AM19/ :03/95/040/001 14/AM19/ '28.06.2018 | Decision: The Committee decided to refer the case to D/o C&PC for obtaining its comments. | >79 Case No.:103/12/82-~—~—~—Party Name: MAGNOLIA ~—~{Meet No/Date:12/82Status: “"" ALC4/2018 ‘LIMITED ALC4/2018 Deferred
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[ OS ~/i212208~—~—~—<“‘;~X]W;*‘“‘C;S HQ File RLA File Lic.No/Date:0310821975 Defer Date: :01/82/050/00730/AM19/ :03/95/040/00286/AM 19/ 28.06.2018 Decision: Deferred for comments of TE 7 BO —— Case No.:210/12/82~~ ‘Party Name:STERILE INDIA Meet No/Date:12/82Status: ALC4/2018 PRIVATE LIMITED ALC4/2018 HQ[File] ; RLA File Lic.No/Date:051040699312.12.2018 AppealDefer Date: | :01/82/050/00837/AM 19/ :05/24/040/00174/AM19/ (28.06.2018 | | Decision: The Committee considered the case as per.agenda in the presence ofTechnical Experts, it was | decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by. firm whichever is lower: | Export product Qty. SI. | Import items Qty. allowed No. MEROPENEM SODIUM kg ata Trihydrate (Non 0.9586 kg | STERILE (MEROPENEM sa | FOR INJECTION) | RA may take appropriate action as per the decision of Norms Committee | Case No.:211/12/82Party Name:HELLO PAINTS Meet No/Date:12/82Status: ALC4/2018 (P) LTD ALC4/2018 \Deferred 12.12.2018 | 272 HQ File ——RrAFile ~~~ Lic.No/Date:0510406995 Defer Date: :01/82/050/00838/AM19/ '-05/23/040/00136/AM19/ (28.06.2018 | Decision: Deferred for comments of TE | Case No.:217/12/82Party Name:HELLO PAINTS Meet No/Date:12/82(Status: ALC4/2018 (P) LTD ‘ALC4/2018 ‘Approved | (12.12.2018 | HQ File ——RLAFile ———_Lic.No/Date:0510406997 | :01/82/050/00844/AM19/ :05/23/040/00137/AM19/ 28.06.2018 | Decision: I: the light of earlier decision taken by NC in its 6/82 meeting dated 26.07.2018 it was decided | to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm 273 whichever is lower: Export product Exp. Import items Aty. Allowed kg | Qty. THYMOL META CERESOL 0.80 kg (ABOVE 95% PURITY) ABOVE 95% PURITY RA may take appropriate action as per the decision of Norms Committee
271
Case No.:101/12/82Party Name:NEOGEN > 7 ‘Meet No/Date:12/82- 4 ‘Status: | 274 ALC4/2018 (CHEMICALS LIMITED ALC4/2018 Approved 12.12.2018
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||HQ File<br>'RLAFile<br>=<br>~~~—_Lic.No/Date:0310822052<br>|<br>|<br>:01/82/050/00728/AM19/<br>:03/95/040/00176/AM19/<br>29.06.2018<br>|<br>Decision: Committee considered case as per agendaand deliberated onthematter in the presence of the<br>|<br>technical expertsand itwasdecided to ratifythead-hoc inputoutputnormsunderpara4.7ofHBPasper|<br>details below or as applied by firm whichever is lower:|||
||in Kg|||
||BENZYL BROMIDE<br>Ikg |1 ~~ |BENZYLALCOHOL<br>0.845 kg<br>2<br>HYDROBROMICACID | 1.450kg||||
||48%<br>RAconcernedmaytake furthernecessary action asperabovedecisionofNC||||
||CaseNo.:187/12/82-<br>PartyName:SYNPOL<br>———s<br>MeetNo/Date:12/82- _|Status:<br>ALC4/2018<br>PRODUCTS PVT. LTD.<br>ALC4/2018<br>Deferred||||
||12.12.2018|||
|975<br>ais|—_—-<br>~<br>——<br> HQ File<br>RLAFile<br>Lic.No/Date:0810142941<br>:01/82/050/00814/AM19/<br>:08/24/040/00107/AM19/<br>29.06.2018||Defer Date:|||
||Decision: Deferred forcomments ofTE<br>-<br>-<br>-<br>—|||
||CaseNo.:213/12/82-—~=sPartyName:STRIDES<br>——(MeetNo/Date:12/82-(Status: —_—|<br>ALC4/2018<br>SHASUN LIMITED<br>ALC4/2018<br>Deferred<br>—|||
||12.12.2018||||
|5<br>216|-<br> HQ File<br>RLA File<br>Lic.No/Date:0410164455|asses)<br>Defer Date:|||
||:01/82/050/00840/AM19/<br>:04/24/040/00075/AM19/<br>29.06.2018||||
||Decision: Deferred for comments ofTE|||
||CaseNo.:214/12/82-<br>"|PartyName:HPLADDITIVES |MeetNo/Date:12/82-<br>ALC4/2018<br>LIMITED(FORMERLY<br>‘ALC4/2018|States |<br>‘Deferred<br>|||
|wi|KNOWN HIGH POLYMER<br>12.12.2018<br> HQ File<br>RLAFile<br>Lic.No/Date:0510407023|‘Defer Date:|||
||:01/82/050/00841/AM19/<br>:05/23/040/00024/AM19/<br>29.06.2018||||
||Decision: Deferred forcomments ofTE|||
|278|Case No.:221/12/82-<br>~<br>PartyName:IOLCHEMICALS MeetNo/Date:12/82-<br>ALC4/2018<br>ANDPHARMACEUTICALS =ALC4/2018<br>LIMITED<br>12.12.2018<br> FQ File<br>RLA File<br>Lic.No/Date:3010104375|Status:<br>Deferred<br>|<br>|<br>|<br>[Defer Date:<br>|||
||:01/82/050/00848/AM19/<br>:30/24/040/00017/AM19/<br>29.06.2018<br>Decision: Deferred forcomments ofTE||<br>|||
||Case No.:50/12/82-ALC4/2018 |PartyName:ORBITLIFE<br>“(MeetNo/Date:12/82-|(Status:||
||SCIENCE PVT. LTD.<br>ALC4/2018|Beterred||
||(12.12.2018||||
|579 <br>a|HQ File<br>RLAFile<br>~<br>|Lic.No/Date:0310822080 {Defer Date:<br>:01/82/050/00677/AM19/<br>:03/95/040/00300/AM 19/<br>(02.07.2018<br>Decision: TheCommittee considered the case as peragenda in thepresenceofTechnical Experts, it was<br>decided to ratify thead-hoc input output normsunderpara4.7 ofHBP as perdetailsbelow or asapplied by|||<br>|<br> ||
||firm whichever is lower:<br>-<br>Be||||
90
“~
Export product Qty. | SI. Qty. | No. CEFPODOXIME PROXETIL | 7-AminoACA Cephalosporanic Acid (7- | 0.8378 kg | Boron Triflouride 2.746 kg | (3(4 ||| MethanolMethylene Chloride 5.81NA Kk g | 5 MAEM (2-MERCAPTO 0.8378 kg BENZOTHIAZOL YL(Z)-2AMINOTHIAZOL-4-YL-2METHOXYIMINO ACETATE) © [Eno-Carbon | OTK 8 | N-N Dimethyl Acetamide 0.2 5 16Kkg | | | 9 | Sodium Iodide 0.28 kg RA may take appropriate action as per the decision of Norms Committee. | Case No.:216/12/82~~ Party Name:JUBILANT LIFE Meet No/Date:12/82- Status: ALC4/2018 ‘SCIENCES LIMITED ALC4/2018 ae ‘12.12.2018 Anprevel HQ File RLA File Lic.No/Date:0510407031 Defer Date: | :01/82/050/00843/AM19/ :05/23/040/00111/AM19/ (02.07.2018 | | Decision: Committee considered case as per agenda and as per earlier decision taken by NC in its 6/82| meeting dated 26.07.2018, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP|| as per details below or as applied by firm whichever is lower:
280
s ridine 98% Mi 0.019 k seaaaaitdiaaiae Ps Alumino Silicate Catalyst | Ethy! Alcohol (Denatured) | 2.194 kg 4 [MethanoPropiona l dehyde_———*| CAT0.073 kg | RA may take appropriate action as per the decision of Norms Committee Case No.:249/12/82a Party Name:SENTISS —«( Meet No/Date:12/82Status: ALC4/2018 ‘PHARMA PVT.LTD. ‘ALC4/2018 Deferred 12.12.2018 2 -- —— — | 781 HQ File RLA File LicNo/Date:0510407060 Defer Date: :01/82/050/00876/AM19/ :05/24/040/00187/AM19/ 03.07.2018 Decision: Deferred for comments of TE 7 _ . | Case No.:250/12/82Party Name:FRESENIUS ~ |Meet No/Date: 12/82Status: | ALC4/2018 KABI ONCOLOGY LIMITED ALC4/2018 ‘Deferred | 282 (12.12.2018 | | HQ File ~-RLA File ‘LicNo/Date:0510407066 [Defer Date: | :01/82/050/00877/AM19/ :05/23/040/00153/AM19/ 04.07.2018
91
~
7 = 4
Decision: Deferred for comments of TE
Case No.:1/12/82-ALC4/2018 Party Name:OTSUKA Meet No/Date:12/82Status: 'CHEMICAL INDIA PRIVATE ALC4/2018 ol LIMITED 12.12.2018 “| HQ:01/82/050/00628/AM19/File RLA:05/24/040/00170/AM19/File 05.07.2018Lic.No/Date:0510407086 | | 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 dated 19.06.2018, it was decided to ratify the onower: input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is = TeNo. egCephalosporanicAe MKWhite/LightYellow Powder Chloromethy! ad 283 | Acid Para Methoxybenzyl Ester | Powder Colourless Liquide Colourless Liquide | Powder Liquid b=[lad] enolAlcohol) Liquid Lil Powder2 ie. RA may take appropriate action as per the decision liquideof Norms Committee. | Case No.:2/12/82-ALC4/2018 |PartyCHEMICAL Name:OTSUKAINDIA PRIVATE ‘Meet No/Date:12/82-ALC4/2018 ‘Status:Approved | LIMITED 12.12.2018 HQ File RLA File Lic.No/Date:05 10407087 | :01/82/050/00629/AM19/ :05/24/040/00182/AM19/ 05.07.2018
Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 4/82 dated 19.06.2018, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
==> picture [430 x 119] intentionally omitted <==
----- Start of picture text -----<br> No.<br>Chloromethy! Cephalosporanic White/LightYellow Powder |<br>Acid Para Methoxybenzyl Ester<br>Deaider Colourless Liquide<br>fe [eiem|Methyl e nes iia Chloride | 1.50 kg<br>Powder<br>----- End of picture text -----<br>
92
“~
|)
==> picture [456 x 688] intentionally omitted <==
----- Start of picture text -----<br>
|||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|[hiqid|
|Sodium|Benzene|Sulfinate|||1.20 kg|
|Powder|
|Para|Anisic|Alcohol|(p_Methoxybenzyl|||0.52|kg|
|Alcohol)|Liquid|
|1,4|Dioxane ||1.20|kg|
|liquide|
|RA|may|take|appropriate|action|as|per|the|decision|of|Norms|Committee.|
|Case|No.:51/12/82-|Party Name:USV PRIVATE||Meet No/Date:12/82-|‘Status:|
|285|ALC4/2018|LIMITED|ALC4/2018(12.12.2018|Approved|
|HQ|File|RLA|File|~||Lic.No/Date:0310822173)|
|:01/82/050/00678/AM19/|:03/95/040/00324/AM19/|(06.07.2018|||
|Decision:|Committee|considered|case|as|per|agendaand|as|per|earlier decision taken|byNC|in6/82its|
|meeting|dated|26.07.2018,|it|was|decided|to|ratify|the|ad-hoc|input|output|norms|under|para|4.7|of HBP|
|as|per|details|below|or|as|applied|by|firm|whichever|is|lower:|
|Export|product|Exp.|SI.|Qty. Allowed|
|Qty.|||No.|
|Perphenazine|Tablets|USP 2 mg|1|No.|2.04 mg|/tablet|
|(48,000|Bottles|x|100|Per|Bottle|=|tablet|‘|
|48,00,000 Tablets|siseaaaadiniaal|||
|(Net|Content|Weight|=|9.600|kg)|
|Perphenazine|Tablets|USP 4 mg|4.08|mg|/tablet|||
|(72,000|Bottles|x|100|Per|Bottle|=|1|No.|Dervihenazine|Likt|
|72,00,000|Tablets)|tablet|P|
|(Net Content|Weight|= 28.800 kg)|||
|Perphenazine|Tablets|USP|8 mg|8.16|mg|/tablet|
|(84,000|Bottles|x|100|Per|Bottle|=|1|No.|ershenssine USP|
|84,00,000 Tablets)|tablet|?|||
|(Net|Content|Weight|=|67.200 kg)|
|Perphenazine|Tablets|USP|16 mg|16.32mg|/tablet|
|(18,000|Bottles|x|100|Per Bottle =|1|No.|ee|
|18,00,000|Tablets)|tablet|=|
|(Net|Content|Weight|=|28.800|kg)|
|RA may take appropriate action|as|per the|decision|of Norms Committee|||
|=|——|ee|
|Case No.:57/12/82-|Party Name:NEOGEN|‘Meet|No/Date:12/82-|\Status:|
|ALC4/2018|CHEMICALS LIMITED|ALC4/2018|‘Approved|
|12.12.2018|
|HQ|File|~—_RLA|File|Lic.No/Date:03|10822178|
|:01/82/050/00684/AM19/|:03/95/040/00299/AM|19/|(06.07.2018|
|Decision:|Committee|considered|case|as|per|agenda|and|deliberated|on|the|matter|in|the|presence|of the||
|286|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:|||
|in|Kg|
|BENZYL BROMIDE|||1|BENZYL ALCOHOL|0.845|kg|
|2|HYDROBROMIC|ACID ||1.450 kg|
|RA|concerned may|take|further|necessary|action|as|per48% above decision|of|NC|||
----- End of picture text -----<br>
93
~
Case No.:63/12/82-ALC4/2018 Party Name:MERCK LIMITED Meet No/Date:12/82Status: (12.12.\ALC4/ 20 1818 Deferred | 87 | HQ File RLA File ‘Lic No/Date:03 10822153 Defer Date: | :01/82/050/00690/AM19/ :03/95/040/00326/AM 19/ 06.07.2018 | Decision: Deferred for comments of TE OO ; | Case No.:64/12/82Party Name:PRIVI Meet No/Date:12/82- _|Status: | ALC4/2018 ORGANICS INDIA LIMITED ALC4/2018 ‘Approved 12.12.2018 HQ File RLA File - Lic.No/Date:0310822147, | :01/82/050/0069 1/AM19/ :03/95/040/00309/AM 19/ (06.07.2018
==> picture [456 x 477] intentionally omitted <==
----- Start of picture text -----<br> Decision: Committee considered case as per agenda and deliberated on the matter in the presence of the<br>288 technical experts and 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:<br>[Export Product | Qty. | Sl.No. | Importitems [| Quantity allowed |<br>AMBER FLEUR 112 |MYRCENEMETHYL ETHYL 80% 0.490.84 kgkg |<br>KETONE |<br>PHOSPHORIC ACID 0.025 kg |<br>RA concerned may take further necessary action as per above decision of NC<br>Case No.:174/12/82- Party Name:SHREE GANESH Meet No/Date:12/82- Status:<br>ALC4/2018 VYAPAR UDYOG ALC4/2018 Deferred |<br>12.12.2018<br>‘aie9 HQ File - - RLA File— — \Lic.No/Date:03a ——— 10822156— —EEE Defer= a Date: ||<br>:01/82/050/00801/AM19/ :03/95/040/00303/AM19/ (06.07.2018<br>Decision: Deferred for comments of TE<br>Case No.:313/12/82- Party Name: ANUPAM Meet No/Date:12/82- Status: —_<br>ALC4/2018 RASAYAN (INDIA) LTD ALC4/2018 Approved —<br>12.12.2018 |<br>HQ:01/82/050/00940/AM19/ File RLA:52/24/040/00027/AM19/File Lic.No/Date:5206.07.2018 10042690 | |<br>Decision: Committee considered caseas.per agenda and in the light of earlier decision taken by NC in its<br>3/82 meeting dated 05.06.2018 and in the presence of the technical experts, 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>290<br>Export product Export S.No. Quantity |<br>Quantity Allowed |<br>2-AMINO-4-TRIFLUORO 3-NITRO-4-CHLORO 1.232 kg<br>METHYL 4 CHLORO BENZOTRIFLUORIDE |<br>; oT 2 0.803 kg<br>DIPHENYL ETHER PARA CHLORO |<br>PHENOL<br>|<br>呻 ｎ<br>¨<br>----- End of picture text -----<br>
94
) ~
|291|~|Case No.:35/12/82-<br>Party Name:LEBEN<br>ALC4/2018<br>LABORATORIES<br>PRIVATE LIMITED|Case No.:35/12/82-<br>Party Name:LEBEN<br>ALC4/2018<br>LABORATORIES<br>PRIVATE LIMITED|Meet No/Date: 12/82-<br>ALC4/2018<br>12.12.2018|‘Status: Befetred<br>|<br>Poyrs-ed|‘Status: Befetred<br>|<br>Poyrs-ed||
|---|---|---|---|---|---|---|---|
|||HQ File<br>RLA|File|‘Lic.No/Date:0310822194||Defer||Defer Date:||
|||:01/82/050/00662/AM19/_<br>:03/95/040/00327/AM19/||09.07.2018||||
|||Decision: Committee considered case as peragenda and deliberated on the matter in the presence ofthe |<br>technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 ofHBP as per|||||||
|||detailsbeloworasappliedbyfirmwhichever islower:<br>ee<br>ee<br>allowed<br>AMOXYCILLIN TABLET<br>321.90 kg<br>125MG.MOXILEB KID||||||<br>||
|||TABLET.||||||
|||(EACH TABLET||||||
|||CONTAINING<br>AMOXYCILLIN<br>TRIHYDRATE|2200000.000<br>Tablet|AMOXYCILLIN<br>TRIHYDRATE BP<br>(COMPACTED)|||||
|||EQUIVALENT TO 125MG<br>OFAMOXYCILLIN).NET<br>CONTENT OF<br>IMPO**R**T/EXEMPT<br>MATE IAL USED IN||||||<br>||
|||EXPORT PRODUCT||||||
|||1)AMOXYCILLIN||||||
|||TRIHYDRATE BP|||||||
|||(COMPACTED)- 315.635||||||
|||KGS (EXCL 2%||||||
|||WASTAGE<br>AMOXYCILLIN TABLET<br>250MG.MOXILEB-250DT<br>(EACH TABLET|2|||321.90 kg||<br>||
|||CONTAINING<br>AMOXYCILLIN<br>TRIHYDRATE|1100000.000<br>Tablet|AMOXYCILLIN<br>TRIHYDRATEBP<br>(COMPACTED)||||
|||EQUIVALENTTO250MG<br>OF AMOXYCILLIN).NET|||||||
|||CONTENT OF<br>IMPORT/EXEMPT<br>MATERIAL USED IN|||||||
|||EXPORT<br>PRODUCT1)AMOXYCILLI<br>NTRIHYDRATEBP<br>(COMPACTED)-3 15.635|||||<br>|||
|||KGS(EXCL 2%<br>WASTAGE|||||||
|||AMOXYCILLIN<br>CAPSULES250MG.<br>MOXILEB-250CAPSULE.|3|AMOXYCILLIN<br>TRIHYDRATEBP<br>(COMPACTED)||2878.538 kg<br>|||
|||(EACH CAPSULE||||||
|||CONTAINING<br>AMOXYCILLIN|9836466.000<br>Nos. tablet|||||
|||TRIHYDRATE||||||
|||EQUIVALENTTO250MG||||||
|||OF AMOXYCILLIN).NET||||||
|||CONTANTOF||||||
<!-- page 95 skipped: FzErrorArgument: code=4: Attempt to use Leptonica from 2 threads at once! -->
| | ra
96
Export product Export S.No. Quantity | Quantity Allowed ISO: tke |b | CLOVELEAFOIL 1.35 kg RUGENGL 2 | RUTHENIUMGID2,4 | 0.001 kg PENTANEDIONATE( RUTHENIUM ACETYLACETONATE RA may take appropriate action as per the decision of Norms Committee. | Case No.:61/12/82-ALC4/2018 Party Name:Y ASHO ~~ Meet No/Date:12/82Status: INDUSTRIES LIMITED ALC4/2018 Approved | 12.12.2018 HQFile = —~——*RLAFile ~ Lie. No/Date:0310822190 | | :01/82/050/00688/AM19/ :03/95/040/00334/AM19/ (09.07.2018 | Decision: Committee considered case as per agenda and in the presence of the technical experts, it was | decidedfirm whichever to ratify theis lower: ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by | 293 Export product Export S.No. Quantity Allowed Quantity METHYL EUGENOL 1 kg OILCLOVE LEAF 1.35 kg | | | RA may take appropriate action as per the decision of Norms Committee. | Case No.:65/12/82-ALC4/2018 Party Name:Y ASHO "Meet No/Date:12/82(Status: INDUSTRIES LIMITED ALC4/2018 Approved | 12.12.2018 | HQ File RLA File / Lic.No/Date:0310822192, 6 :01/82/050/00692/AM19/Decision: Committee considered:03/95/040/00325/AM19/case as per agenda and in the presence(09.07.2018 of the technical experts,| it aa decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by, 294 firm whichever is lower: | | Export product Export S.No. Quantity OCTYLATED Quantity 1.| DIPHENYLAMINE _ | 0.405Allowed kg || - 3. 0.100 kg ACTIVATED CLAY | RA may take appropriate action as per the decision of Norms Committee. n95 Case No:247/12/82Party[Name:-MOREPEN][_—sMeet][No/Date:12/82-][ Status:] ALC4/2018 LABORATORIES LTD., ALC4/2018 Deferred |
293
|
|
97
~
==> picture [455 x 276] intentionally omitted <==
----- Start of picture text -----<br> 7 - 12122088 |. |<br>HQ:01/82/050/00874/AM File 19/ RLA:05/24/040/00203/AM19/File ‘Lic.No/Date:0509.07.2018 10407132 JPefer Date: |<br>Decision: Deferred for comments of TE<br>Case No.:30/12/82- Party Name:NEOGEN _—(MeetNo/Date:12/82-__|Status: |<br>ALC4/2018 CHEMICALS LIMITED ALC4/2018 Approved<br>12.12.2018 | |<br>HQ File RLA File — Lic.No/Date:03 10822235 _ |<br>:01/82/050/00657/AM19/ :03/95/040/00298/AM19/ 11.07.2018 |<br>Decision: Committee considered case as per agenda and deliberated on the matter in the presence of the |<br>296 technical experts and 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: |<br>in Kg<br>BENZYL BROMIDE lkg |1 | BENZYL ALCOHOL 0.845 kg<br>2 HYDROBROMIC ACID | 1.450 kg<br>48% |<br>----- End of picture text -----<br>
RA concerned may take further necessary action as per above decision of NC
297
==> picture [436 x 367] intentionally omitted <==
----- Start of picture text -----<br> Case No.:31/12/82- |Party Name:USV PRIVATE Meet No/Date:12/82- _|Status: |<br>ALC4/2018 LIMITED ALC4/2018 Lemereved |<br>12.12.2018<br>HQ File RLA File Lic.No/Date:0310822234<br>:01/82/050/00658/AM19/ :03/95/040/00322/AM19/ 11.07.2018<br>Decision: Committee considered case as per agenda and deliberated on the matter in the presence of the |<br>technical experts and 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:<br>Export Product SI. No. Quantity |<br>allowed<br>Doxycycline Hyclate DR 1 ‘ 88.275mg/75<br>Tablets USP 75 MG No tablet a Hyclate | inp tablet |<br>( 1,450 Bottles X 100 Per<br>Bottles = 1,45,000 Tablets) |<br>( Net Content Weight =<br>10.875 Kgs)<br>Doxycycline Hyclate DR | 2 Doxycycline Hyclate 117.70 mg/100<br>Tablets USP 100 MG No.tablet USP mg tablet<br>(Bottles16,500= Bottles16,50,000 X 100Tabl P e ts)r |<br>( Net Content Weight =<br>165.000 Kgs) |<br>Doxycycline Hyclate DR l 3 . 176.55 mg / 150<br>Tablets USP 150 MG No.tablet eo | wngteblet |<br>(Bottles54,250 = 54,25,000Bottles X 100 Tablets)Per |<br>( Net Content Weight =<br>813.750 Kgs<br>RA concerned may take further necessary action as per above decision of NC |<br>----- End of picture text -----<br>
98
~«~
||Case No.:32/12/82-ALC4/2018 Party Name:NEOGEN<br>——<br>MeetNo/Date:12/82-<br>Status:|
|---|---|
||CHEMICALS LIMITED<br>ALC4/2018<br>Approved<br>||
|i,<br>798|12.12.2018<br>—<br>oe<br>——-<br>r<br>— KS<br> 1Q File<br>RLA File<br>Lic. No/Date:0310822236<br>|<br>:01/82/050/00659/AM19/<br>:03/95/040/00304/AM19/<br>11.07.2018<br>Decision: Deferred forcommentsofTE<br>-<br>a<br>-<br>||
||CaseNo.:73/12/82-<br>PartyName:PRIVI<br>MeetNo/Date:12/82-<br>Status: 7|<br>ALC4/2018<br>ORGANICS INDIA LIMITED ALC4/2018<br>Approved|
||12.12.2018<br>||
|299|HQ File<br>RLAFile<br>**=** —_Lic.No/Date:0310822233,<br>CS<br>:01/82/050/00700/AM19/<br>:03/95/040/00308/AM19/<br>11.07.2018<br>|<br>Decision: Committee considered case asper agenda and deliberated onthe matter in the presence ofthe|<br>technical expertsand itwasdecided toratifythead-hoc inputoutputnormsunderpara4.7ofHBPasper|<br> details below or as applied by firm whichever is lower:|
||| ExportProduct<br>|Qty. SINo.[importitems<br>| Quantity allowed |<br>|<br>AMBERFLEUR<br>11|MYRCENE80%<br>0.84kg|
||2<br>METHYL ETHYL<br>0.49 kg|
||KETONE<br>||
||PHOSPHORIC ACID<br>0.025 kg|
||RAconcernedmaytake further necessary action asperabove decisionofNC<br>||
|300|CaseNo.:96/12/82-ALC4/2018 PartyName:STERLING<br>MeetNo/Date:12/82-(Status:<br>—_—|<br>AUXILIARIESPVTLTD<br>ALC4/2018<br>Deferred<br>12.12.2018<br>|<br>fQ File<br>RLA File<br>Lic.No/Date:0310822247 [DeferDate: |<br>:01/82/050/00723/AM19/<br>:03/95/040/00332/AM19/<br>11.07.2018|
||Decision: Deferred for comments ofTE<br>i<br>:<br>a<br>i|
||CaseNo.:102/12/82-<br>PartyName:USVPRIVATE MeetNo/Date:12/82-<br>_[Status:<br>|<br>ALC4/2018<br>LIMITED<br>ALC4/2018<br>Approved<br>12.12.2018<br>|<br>|<br>HQ File<br>RLA File<br>Lic.No/Date:0310822217<br>|<br>|<br>:01/82/050/00729/AM19/<br>:03/95/040/00323/AM19/<br>11.07.2018|
Decision: Committee considered case as per agenda and deliberated on the matter in the presence of the | technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per[below][or][as][applied][by][firm][whichever][is][lower:] sis[details]
==> picture [456 x 155] intentionally omitted <==
----- Start of picture text -----<br> | Export Product Qty. _['SI.No. | Importitems ‘| Quantity allowed |<br>Griseofulvin Tablets USP 500 | 1 No. | 3 Griseofulvin USP 510 mg/tablet<br>mg tablet |<br>(2,000 Bottles x 100 Per<br>Bottle = 2,00,000 Tablets)<br>(Net100.000 Contentkgs) Weight = |<br>RA concerned may take further necessary action as per above decision of NC<br>302 Case No.:104/12/82- Party Name: RELIANCE Meet No/Date:12/82- Status:<br>ハ ~ ALC4/2018 INDUSTRIES LIMITED ALC4/2018 Deferred |<br>----- End of picture text -----<br>
99
~«~
re 12.12.2018 a - | HQ:01/82/050/0073File 1/AM19/ :03/95/040/00195/AM19/RLA File ~ Lic.No/Date:0313.07.2018 10822304 Defer Date: Decision: The Committee decided to refer the case to D/o C&PC for obtaining its comments. _ Case No.:246/12/82Party Name: MOREPEN ‘Meet No/Date:12/82Status: | ALC4/2018 LABORATORIES LTD., ALC4/2018 Deferred 12.12.2018 : 303 | | HQ File RLAFile = ==———_Lic.No/Date:0510407178 [Defer Date: | :01/82/050/00873/AM19/ :05/24/040/00213/AM19/ |13.07.2018 | Decision: Deferred for comments of TE i Bn | Case No.:97/12/82Party Name:NEOGEN "Meet No/Date:12/82- Status: | ALC4/2018 CHEMICALS LIMITED ALC4/2018 Approved 12.12.2018 HQ File RLAFile Lic.No/Date:0310822354 | :01/82/050/00724/AM19/ :03/95/040/00254/AM18/ 17.07.2018 Decision: Committee considered case as per agenda and in the light of earlier decision taken by NC in its, 2/82 meeting dated 16.05.2018 and in the presence of the technical experts, it was decided to ratify the | ., 304 ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: in Kg 1,4 DIBROMOBUTANE | TETRAHYDROFURAN | 0.412 kg | 2 (THF) | HYDROBROMIC ACID | 1.929 kg 48% RA concerned may take further necessary action as per above decision of NC |
Case No.:98/12/82-ALC4/2018 Party Name:YASHO — ‘Meet No/Date:12/82Status: | INDUSTRIES LIMITED ALC4/2018 Deferred | 12.12.2018 305 HQ File RLA File LicNo/Date:0310822342 [Defer Date: | :01/82/050/00725/AM19/ :03/95/040/00353/AM19/ 17.07.2018 | | Decision: Deferred for comments of TE Case No.:99/12/82-ALC4/2018 Party Name: YASHO ‘Meet No/Date:12/82- Status: | INDUSTRIES LIMITED ALC4/2018 ‘Deferred — 306 HQ File RLA File Lie. No/Date:031082234512.12.2018 Defer Date: | :01/82/050/00726/AM19/ :03/95/040/00349/AM19/ 17.07.2018 Decision: Deferred for comments of TE Case No.:3/12/82-ALC4/2018 :CHEMICALParty Name:OTSUKA— — —F‘Meet—- No/Date:—_ 1 2/82Status:|| INDIA PRIVATE ALC4/2018 reel 307 LIMITED /12.12.2018 | HQ File RLAFile Lic.No/Date:0510407227 [Defer Date: | :01/82/050/00630/AM19/ :05/24/040/002 15/AM19/ 18.07.2018 |
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Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 4/82 dated 19.06.2018, it was decided to ratify 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. Chloromethy! Cephalosporanic White/LightYellow Powder Acid Para Methoxybenzyl Ester (2 |MethanolLiquid| SO | Powder Colourless Liquide Methylene Chloride [erie5 iis | | > lea|2-Mercaptobenzothiazole Ceramish esLiquid | Liquid bl[Fl] PowderAlcohol) na | ak 1,4 Dioxane RA liquide | may take appropriate action as per the decision ofNorms Committee. i Case No.:4/12/82-ALC4/2018 PartyCHEMICALName:OTSUKAINDIA PRIVATE MeetALC4/2018 No/Date:12/82DeferredStatus: | HQ LIMITED 12.12.2018 ‘Pprored, File ‘RLA File ‘Lic.No/Date:05 10407228 ‘Defer Date: :01/82/050/0063 1/AM19/ :05/24/040/00216/AM19/ 18.07.2018
Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 4/82 dated 19.06.2018, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
Export product Qty. | SI. Qty. | No. | Chloromethyl Cephalosporanic White/LightYellow Powder 308 | Acid Para Methoxybenzyl Ester Powder Colourless Liquide PY leaemies|Methylene tigi Chloride | 1.50 kg 2-Mercaptobenzothiazole Ceramish Liquid Lol b>Powder ca eed ada | Powder Alcohol) Liquid La Para Anisic Alcohol (p_Methoxybenzy! | liquide RA may take appropriate action as per the decisionleof Norms Committee.
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----- Start of picture text -----<br> Case No.:5/12/82-ALC4/2018 Party Name:OTSUKA ——s Meet No/Datte:12/82- Status:<br>CHEMICAL INDIA PRIVATE ALC4/2018<br>LIMITED 12.12.2018<br>HQ File RLA File / ‘Lic.No/Date:0510407229 |Defer Date:<br>:01/82/050/00632/AM 19/ :05/24/040/00222/AM19/ |18.07.2018 |<br>Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the<br>light of earlier decision taken by NC in its Meeting No. 4/82 dated 19.06.2018, it was decided to ratify the<br>ad-hoclower: input output norms under para 4.7 of HBP as per details below or as applied by firm whichever *<br>|<br>Export product Qty. | SI. Qty. |<br>No.<br>Chloromethyl7-PhenylacetamideoCephalosporanic-3- | White/LightYPenicillin G ellowPotassium Powder Ist Crystals | 1.80 kg<br>309 | Acid Para Methoxybenzyl Ester Methanol Liquid 1.50 kg<br>/(GCLE) — White/LightYellow 3 Dimethy! Formamide | 0.80kg | |<br>Power Colourless Liquide<br>Methylene Chloride | 1.50 kg<br>Colourless Liquide<br>5 2-Mercaptobenzothiazole Ceramish | 0.25 kg<br>Powder |<br>Isopropyl Alcohol | 0.80 kg<br>Liquid<br>Sodium Benzene Sulfinate | 1.20kg | |<br>ParaPowderAnisic Alcohol (p_Methoxybenzyl | 0.52 kg |<br>Alcohol) Liquid<br>Pi liquide1,4 Dioxane | 1.20 kg<br>RA may take appropriate action as per the decision of Norms Committee.<br>Case No.:74/12/82-ALC4/2018 Party Name:UPLLTD. ‘Meet No/Date:12/82- (Status:<br>ALC4/2018 Deferred —<br>310 12.12.2018 | |<br>HQ File<br>:01/82/050/00701/AM19/ ~~IRLA':03/95/040/00239/AM19/File ~ |Lie.No/Date:0310822448(19.07.2018 [Defer Date:||<br>Decision: Deferred for comments of TE _ CS |<br>Case No.:75/12/82-ALC4/2018 [Party Name:YASHO ‘Meet No/Date:12/82- (Status: |<br>INDUSTRIES LIMITED ALC4/2018 Deferred |<br>311 12.12.2018 | |<br>iQ File IRLAFile Lic. No/Date:03 10822430 ~ [Defer Date:<br>:01/82/050/00702/AM 19/ :03/95/040/00369/AM19/ (19.07.2018 |<br>Decision: Deferred for comments of TE 7 7<br>Case No.:76/12/82- - "Party Name:RELIANCE Meet No/Date:12/82- ‘Status: -<br>ALC4/2018 INDUSTRIES LTD. ALC4/2018 \Deferred<br>312 12.12.2018 |<br>i ~<br>HQ File RLA File Lic.No/Date:03 10822441 Defer Date:<br>:01/82/050/00703/AM19/ :03/95/040/00297/AM19/ 19.07.2018<br>----- End of picture text -----<br>
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||Decision: |TheCommittee decidedtorefer the casetoDio C&PC for obtaining itscomments.<br>||Decision: |TheCommittee decidedtorefer the casetoDio C&PC for obtaining itscomments.<br>||Decision: |TheCommittee decidedtorefer the casetoDio C&PC for obtaining itscomments.<br>||
|---|---|---|---|
||CaseNo.:77/12/82-<br>ALC4/2018|PartyName:RELIANCE<br>Meet No/Date:12/82- _|Status:<br>INDUSTRIES LTD.<br>ALC4/2018<br>‘Deferred||
|||12.12.2018||
|-_|HQ File<br>RLA File<br>|<br>Lic.No/Date:0310822445 [DeferDate:<br>:01/82/050/00704/AM19/<br>:03/95/040/00269/AM19/<br>19.07.2018<br>Decision:<br>TheCommittee decided to referthecase to D/oC&PCforobtaining itscomments.||||
|314|Case No.:87/12/82-<br>ALC4/2018<br> FQ File|-<br>PartyName:RELIANCE<br>**—**M**e**t No/Date:12/82-_—Status:<br>|<br>INDUSTRIES LIMITED<br>ALC4/2018<br>Deferred<br>|<br>12.12.2018<br>|<br>|<br>RLA File<br>.<br>Lic.No/Date:0310822468 (DeferDate:||
||:01/82/050/00714/AM19/<br>:03/95/040/00188/AM19/<br>20.07.2018<br>|<br>Decision:<br>TheCommittee decided to referthecasetoD/oC&PCfor obtaining itscomments. ||||
||Case No.:91/12/82-<br>ALC4/2018|PartyName:RELIANCE<br>MeetNo/Date:12/82-<br>Status:<br>INDUSTRIESLTD.<br>ALC4/2018<br>Deferred<br>(12.12.2018<br>|||<br>||
|3<br>315|=<br> HQ File|Se<br>RLA File<br>Lic.No/Date:0310822477 |Defer Date:||
||:01/82/050/00718/AM19/|:03/95/040/00273/AM19/<br>(20.07.2018||
||Decision:<br>TheCommittee decided<br>to referthecasetoD/oC&PC forobtaining itscomments.<br>_|||
||CaseNo.:95/12/82-<br>ALC4/2018|‘PartyName:RELIANCE<br>MeetNo/Date:12/82-<br>Status:<br>INDUSTRIES LTD.<br>ALC4/2018<br>(Deferred|||
|316|HQ File|12.12.2018<br>~~RLA File<br>~<br>Lie.No/Date:0310822469 [DeferDate:||<br>||
||:01/82/050/00722/AM19/|:03/95/040/00267/AM19/<br>20.07.2018||
||Decision:<br>The Committeedecided toreferthecasetoD/oC&PC for obtaining itscomments.|||
||Case No.:100/12/82-<br>ALC4/2018|~<br>PartyName:YASHO<br>MeetNo/Date:12/82-_—Status: “|<br>INDUSTRIES LIMITED<br>ALC4/2018<br>Deferred<br>—<br>12.12.2018<br>|||
|317|HQ File<br>:01/82/050/00727/AM19/|RLA File<br>Lic.No/Date:0310822462<br>(Defer Date:<br>:03/95/040/00379/AM19/<br>(20.07.2018<br>|||<br>||
||Decision: Deferred for comments ofTE|||
|318|CaseNo.:185/12/82-<br>ALC4/2018<br> FQ File|~—~—»~PartyName:THEON.<br>~—SMeeettNo/Date:12/82-<br>sehen<br>PHARMACEUTICALS LTD.,<br>|ALC4/2018<br>‘Deferred<br>12.12.2018<br>~~<br>RLAFile<br>~<br>|Lic.No/Date:2210015943<br>Defer Date:||<br>|<br>|<br>||
||:01/82/050/00812/AM19/<br>:22/24/040/00034/AM19/<br>20.07.2018<br>Decision: Deferred forcommentsofTE|||<br>||
|319|CaseNo.:255/12/82-<br> ALC4/2018|**P**artyName:ESKAGPHARMA (MeetNo/Date:12/82-Status:<br>RIVATE LIMITED,<br>ALC4/2018<br>Deferred<br>12.12.2018<br>||||
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|HQ File|RLA File|Lic.No/Date:0210208597|DeferDate:||
|---|---|---|---|---|
|:01/82/050/00882/AM 19/|:02/24/040/00064/AM 19/|20.07.2018|||
|Decision: Deferred forcomments ofTE|||||
|CaseNo.:346/12/82-<br>ALC4/2018|"PartyName:DIVIS<br>LABORATORIESLTD|Meet No/Date:12/82-_[Status:<br>ALC4/2018<br>Approved||||
|||12.12.2018|||
|HQ File|RLA File|Lic.No/Date:0910066495||||
|:01/82/050/00973/AM19/|:09/24/040/00187/AM19/|20.07.2018|||
|
Decision: The Committee considered the caseas per agenda in the presence of Technical Experts and in the | light of earlier decision taken by NC in its Meeting No. 4/82 dated 19.06.2018, it was decided to ratify the 320 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. NABUMETONE 2-ACETYL-6-METHOXY| 2.25 kg NAPHTHALENE METHANOL 6.54 kg | RA may take appropriate action as per the decision of Norms Committee. Case No.:33/12/82-ALC4/2018 Party Name:RELIANCE Meet No/Date:12/82-__[Status: INDUSTRIES| LTD. ALC4/2018}12.12.2018 Deferred oat29 HQ File =<RLAaFile Le\Lic.No/Date:0310822508eS Defer Date: =a | :01/82/050/00660/AM 19/ :03/95/040/003 18/AM19/ 23.07.2018 Decision: The Committee decided to refer the case to D/o C&PC for obtaining its comments. | Case No.:78/12/82-ALC4/2018 Party Name:NAPROD LIFE M e tNo/Date:12/82‘Status: SCIENCES PVT. LTD. ALC4/2018 pene 322i J — ———— —— — |12.12.2018| ee en HQ File 'RLA File ‘Lic.No/Date:0310822552 Defer Date: :01/82/050/00705/AM19/ :03/95/040/00394/AM19/ 24.07.2018 Decision: The Committee decided to refer the case to D/o C&PC for obtaining its comments. Case No.:186/12/82Party Name:ARVEE Meet No/Date:12/82-‘|Status: | ALC4/2018 LABORATORIES (INDIA) ‘ALC4/2018 Approved ‘LIMITED |12.12.2018 HQ:01/82/050/008File 13/AM19/ — :08/24/040/00067/AM19/RLAFile ~Lie.No/Date:081014309424.07.2018 | Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the | 323 light of earlier decision taken by NC in its Meeting No. 4/82 dated 19.06.2018, it was decided to ratify the | ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever * lower:
Export product Qty. | SI. Qty. No. Dimethyl! 5-Nitroisophthalate 1| Isophthalic Acid 0.857 kg |
104
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----- Start of picture text -----<br> ~<br>Case No.:287/12/82-<br>‘Party Name:BALAJI AMINES MeetNo/Date:12/82- Status:<br>ALC4/2018 LIMITED ALC4/2018 ‘Approved<br>12.12.2018 |<br>HQ File RLA File . Lic.No/Date:3110067125 |<br>:01/82/050/00914/AM19/ :31/83/040/00062/AM19/ 24.07.2018 |<br>Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the |<br>light of earlier decision taken by NC in its Meeting No. 8/82 dated 25.07.2018, 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>324an lower:<br>Export product Qty. | SI. Qty. allowed |<br>N-METHYL-2- 1kg|1 No. | METHANOL 0.37 kg ||<br>PYRROLIDONE 2 AMMONIA 0.16 kg |<br>ANHYDROUS |<br>3 GAMMA 0.90 kg<br>BUTYROLACTONE<br>RA may take appropriate action as per the decision of Norms Committee. |<br>----- End of picture text -----<br>
|CaseNo.:181/12/82-||PartyName:DSMSINOCHEM|MeetNo/Date:12/82-|‘Status:|
|---|---|---|---|---|
|ALC4/2018||PHARMACEUTICALS INDIA <br>PVT.LTD.|ALC4/2018<br>12.12.2018|‘Approved|
|HQ File|~|RLAFile|Lic.No/Date:2210015954|||
|:01/82/050/00808/AM19/||:22/24/040/00044/AM19/|26.07.2018||
Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the | light of earlier decision taken by NC in its Meeting No. 10/82 dated 16.10.2018, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is 325 lower:
Qty. Amoxycillin Trihydrate Through 6- | 1 kg | 1. | 6-Amino Pencillanic Acid 0.55 kg APA Route through Enzymatic Elcolase Enzyme 0.005 kg | Route 3; D(-)-p-Hydroxy phenyl glycine | 0.477 kg methyl ester
|CaseNo.:182/12/82-<br>ALC4/2018<br>HQFile<br>:01/82/050/00809/AM19/|PartyName:DSMSINOCHEM <br>PHARMACEUTICALS INDIA <br>PVT.LTD.<br>RLAFile<br>|:22/24/040/00037/AM19/|Meet No/Date:12/82-<br>Status:<br> ALC4/2018<br>‘Approved<br>12.12.2018<br>|<br>Lic.No/Date:2210015953_|<br>26.07.2018||<br>|| |---|---|---|---|
326 Decision: The Committee considered the case as per agenda in the presence of Technical Experts and, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
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105
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----- Start of picture text -----<br> Ampicillin Trihydrate Through 6- | 1 kg | 1. 6-AMINO PENICILLANIC 0.596kg =|<br>APA route Through Enzymatic ACID (6-APA<br>Route ELCOLASE (ENZYME 0.005 kg<br>D(-)Alpha Phenyl! Glycine Base | 0.417 kg<br>|4___| METHANOL 0.322 kg<br>----- End of picture text -----<br>
= —— Case No.:183/12/82"Party Name:IND-SWIFT ‘Meet No/Date:12/82Status: ALC4/2018 LABORATORIES LTD., ALC4/2018 Approved 12.12.2018 HQ File RLA File Lic.No/Date:22100159S2, :01/82/050/008 10/AM19/ :22/24/040/00038/AM 19/ 26.07.2018 Decision: In the light of earlier decision taken in meeting no. 3/82 dated 05.06.2018,it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
==> picture [456 x 465] intentionally omitted <==
----- Start of picture text -----<br> 327 Export product —_———| Export Qty. | SI.No. | Importitems | Qty. allowed<br>Clarithromycin Granules Clarithromycin or 0.3333 kg<br>33% (Suspension Grade) Raw Material of<br>Clarithromycin as per<br>SION A-2263 on pro-<br>rata basis<br>0.25 kg |<br>HPMC Phthalate 0.44 kg<br>RA [4 [Acetone| 2.00 kg |<br>may take appropriate action as per the decision of Norms Committee. |<br>Case No.:17/12/82-ALC4/2018 Party Name:MICROLABS — Meet No/Date:12/82- Status:<br>LTD ALC4/2018 Approved<br>(12.12.2018<br>HQ File ~— IRLA File — ‘Lic.No/Date:0710113652<br>:01/82/050/00644/AM19/ :07/24/040/00097/AM19/ 27.07.2018 | |<br>Decision: Committee considered case as per agenda and deliberated on the matter in the presence of the<br>technical experts and 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:<br>Export product Exp. Import items Qty. allowed<br>Qty.<br>Amoxicillin and Potassium 1 AMOXICILLIN 292.639 mg/tablet | |<br>328 | (Clavulanate Each tablet 375 Contains Amoxicillinmg Tablets TRIHYDRATEBP/EP/IP/USP |<br>Trihydrate equivalent to |<br>Amoxicillin 250 mg and Potassium DILUTED 303.773 mg/tablet | |<br>Clavulanate equivalent to CLAVULANATE<br>Clavulanic Acid 125 mg) POTASSIUM (1.1 )<br>BP/EP/IP/USP 890.63 KG BP/EP/IP/USP<br>Amoxicillin and Potassium AMOXICILLIN 585.279 mg/tablet<br>Clavulanate 625 mg Tablets TRIHYDRATE<br>( Each tablet Contains Amoxicillin BP/EP/IP/USP |<br>Trihydrate equivalent to<br>Amoxicillin 500 mg and Potassium DILUTED 303.773 mg/tablet | |<br>Clavulanate equivalent to CLAVULANATE |<br>Clavulanic Acid 125 mg POTASSIUM (1.1 |<br>----- End of picture text -----<br>
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BP/EP/IP/USP 13964.06KG | ‘|__| BP/EP/IP/USP
|
RA may take appropriate action as per the decision of Norms Committee
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||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|Case|No.:177/12/82-|~||Party Name:SHANKUS|Meet No/Date:12/82-|Status:|
|ALC4/2018|PHARMACEUTICALS|ALC4/2018|Deferred|
|12.12.2018|
|329|HQ File|RLA|File|Lic.No/Date:0810143 149|‘Defer Date:|
|~*:01/82/050/00804/AM19/|:08/24/040/00134/AM19/|01.08.2018|
|Decision:|Committee|considered|as|per|agenda|anditwas|decided|to|ask|the|firm to|furnish. copy|of|
|Certificate|of|Analysis|(COA)|of import|item|from|foreign|supplier|and|pharmacopeia|specification|COA|
|of|export|item.|
|Case|No.:312/12/82-|Party Name:AMI ORGANICS|(Meet|No/Date:12/82-|Status:|
|ALC4/2018|LIMITED|ALC4/2018|Approved|—|
|12.12.2018|
|HQ|File|RLA|File|Lic.No/Date:5210042718|||
|:01/82/050/00939/AM19/|:52/24/040/00037/AM19/|01.08.2018|||
|Decision:|The Committee considered|case|as per agenda and|in the presence of the technical|experts,|it|
|was|decided|to|ratify|the|ad-hoc|input|output|norms|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:|||
|330|Export|Product|Export|| S.No|||Import|Product|Quantity|
|Quantit|Allowed|
|1,2,4|- TRIAZOLO (4,3-a)|oo|2.806 kg|
|PYRIDIN|-3|(2H)|- ONE|- 98%|1Kg|:|
|MIN|er|
|||2-Chloro|Pyridine|137kg|||
|Mono|Ethylene Glycol|||||4< -|||
|RA may take appropriate action as per the decision of|Norms Committee.|—_||
|Case No.:19/12/82-ALC4/2018 Party|Name:JODAS|EXPOIM|[Meet No/Date:12/82-|(Status:|
|PVT.LTD|ALC4/2018|‘Deferred|—|
|12.12.2018|
|331|iO File|~—|RLA File|(Lie.|No/Date:0510407421|Defer Date:|||
|:01/82/050/00646/AM19/|:05/23/040/00214/AM19/|(02.08.2018|||
|Decision:|Deferred|for comments of TE|-|
|Case No.:296/12/82-|Party|Name:|VERVE HUMAN|[Meet No/Date:12/82-|Status:|
|ALC4/2018|CARE LABORATORIES|ALC4/2018|Deferred|||
|12.12.2018|||
|332|HQ|File|RLA|File|-|Lic.No/Date:6110001530|Defer|Date:|||
|:01/82/050/00923/AM19/|:61/24/040/00004/AM19/|02.08.2018|||
|Decision:|Committee|considered as|per agenda and|it was decided|to ask|the firm|to furnish|copy of Drug|
|Manufacturing|Licence|(DML) showing|approved|compsosition.|
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107
||CaseNo.:349/12/82-<br>PartyName:BLUECIRCLE<br>MeetNo/Date:12/82-<br>Status:<br>ALC4/2018<br>ORGANICS PVT.LTD.<br>ALC4/2018<br>Approved<br>12.12.2018||<br>|||
|---|---|---|---|
||||||
||HQ File<br>RLA File<br>~<br>Lic.No/Date:0310822814<br>|<br>||||
||:01/82/050/00976/AM 19/<br>:03/94/040/00389/AM19/<br>02.08.2018|||
||Decision: Committee considered case as per agenda ;and as perearlierdecision taken by NC in its 4/82<br>meeting dated 19.06.2018,<br>itwas decided to ratify the ad-hoc input output norms under para 4.7 ofHBP as||||
||per details below or as applied by firm whichever is lower:|||
|333|Export product<br>Exp.<br>Import items<br>Qty. allowed|||
||Qty.|||
||5-AMINO N.N,-BIS (2,3-<br>1 kg<br>ISOPHTHALIC ACID<br>0.81 kg||||
||DIHYDROXYPROPYL)<br>3-AMINO-1, 2-<br>0.70kg<br>ISOPHTHALAMIDE HCL<br>PROPANEDIOL (APD)<br>(ABA.HCL)<br>13|PALLADIUMCARBON_| 0.001kg<br>[a[METHANOL<br>f7ske<br>RA may take appropriate action as per thedecision ofNorms Committee|||<br>|<br>||
||Case No.:350/12/82-<br>PartyName:BLUE CIRCLE<br>MeetNo/Date:12/82- (Status:|||
||ALC4/2018<br>|ORGANICS PVT. LTD.<br>ALC4/2018<br>|Approved<br>12.12.2018|||
||HQ File<br>RLA File<br>Lic.No/Date:0310822796<br>|||||
||:01/82/050/00977/AM19/<br>:03/94/040/00333/AM19/<br>02.08.2018|||
||Decision: Committee considered case asperagenda andas per earlier decision taken byNC in its 4/82 <br>meetingdated 19.06.2018,<br>itwasdecided to ratify thead-hoc input outputnormsunder para4.7 ofHBP as||||
||per details below or as applied by firm whichever is lower:|||
|334|Export product<br>Exp.<br>Import items<br>Qty. allowed|||
||Qty.|||
||5-AMINON.N,-BIS(2,3-<br>1kg [1 | ISOPHTHALICACID<br>0.81kg|||
||DIHYDROXYPROPYL)<br>3-AMINO-1, 2-<br>0.70 kg|||
||ISOPHTHALAMIDE HCL<br>PROPANEDIOL (APD)<br>(ABA.HCL)<br>13|PALLADIUMCARBON_| 0.001kg<br>|4__| METHANOL<br>|<br>RAmaytake appropriate action asper thedecision ofNormsCommittee<br>||||
||CaseNo.:351/12/82-—~—~—~S@Party Name:BLUECIRCLE<br>MeetNo/Date:12/82- ‘Status:<br>ALC4/2018<br>ORGANICSPVT. LTD.<br>ALC4/2018<br>Approved<br>—<br>.<br>12.12.2018<br>|<br>HQFile<br>RLAFile<br>~—<br>|Lie.No/Date:0310822795<br>|<br>|<br>:01/82/050/00978/AM19/<br>:03/94/040/00332/AM19/<br>(02.08.2018|||
||Decision: Committee considered caseasperagenda and as per earlier decision taken byNC in its 4/82<br>meetingdated 19.06.2018,<br>itwasdecided to ratify thead-hoc input output norms underpara4.7ofHBP as|||<br>||
|335|per detailsbelow orasappliedby firm whichever is lower:|||
||Export product<br>Exp.<br>Import items<br>Qty.allowed|||
||Qty.|||
||5-AMINO N.N,-BIS (2,3-<br>1kg<br>ISOPHTHALIC ACID|||
||DIHYDROXYPROPYL)<br>La 3-AMINO-1,2-<br>0.70 kg<br>ISOPHTHALAMIDE HCL<br>PROPANEDIOL (APD<br>(ABA.HCL)<br>}3<br>| PALLADIUMCARBON_| 0.001kg<br>—<br>———<br>———|||
|
108
o
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----- Start of picture text -----<br> Z METHANOL ~ [1.75 kg |<br>RA may take appropriate action as per the decision of Norms Committee |<br>Case No.:6/12/82-ALC4/2018 Party Name:OTSUKA - ~ |Meet No/Date: [|] [2/82-] Status: |<br>CHEMICAL INDIA PRIVATE ALC4/2018 \Peferred<br>LIMITED 12.12.2018<br>HQ File RLA File Lic.No/Date:0510407432 Defer Date: |<br>:01/82/050/00633/AM19/ :05/24/040/00273/AM19/ 03.08.2018 |<br>Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the |<br>light of earlier decision taken by NC in its Meeting No. 6/82 dated 19.06.2018, 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>Export product Qty. | SI. Qty.<br>No.<br>7-Phenylacetamideo -3- | Penicillin G Potassium Ist Crystals | 1.80kg | |<br>Chloromethyl Cephalosporanic White/LightYellow Powder |<br>336 | Acid Para Methoxybenzyl Ester Methanol Liquid 1.50 kg<br>(GCLE) _ White/LightYellow Dimethy! Formamide | 0.80 kg<br>Powder Colourless Liquide<br>Methylene Chloride | 1.50 kg<br>Colourless Liquide<br>5 2-Mercaptobenzothiazole Ceramish | 0.25 kg<br>Powder<br>Isopropy! Alcohol | 0.80 kg |<br>Liquid<br>7 Sodium Benzene Sulfinate | 1.20 kg<br>Powder<br>Para Anisic Alcohol (pMethoxybenzyl | 0.52kg |<br>Alcohol) Liquid<br>1,4 Dioxane | 1.20 kg<br>liquide<br>RA may take appropriate action as per the decision of Norms Committee.<br>Case No.:184/12/82- Party Name: VENUS ~ [Meet No/Date:12/82- (Status:<br>ALC4/2018 REMEDIES LTD., ALC4/2018 ‘Deferred —<br>12.12.2018 |<br>337 HQ File RLA File Lic.No/Date:2210015956 Defer Date: |<br>:01/82/050/008 1 1/AM19/ :22/24/040/00045/AM19/ 03.08.2018<br>i<br>Decision: Deferred for comments of TE<br>Case No.:347/12/82- Party Name:DIVIS '|Meet No/Date:12/82- Status: |<br>ALC4/2018 LABORATORIES LTD ALC4/2018 Approved |<br>12.12.2018<br>HQ File RLA File Lic.No/Date:0910066548 |<br>338 :01/82/050/00974/AM19/ :09/24/040/00208/AM19/ (06.08.2018 |<br>? Decision: Committee considered case as per agenda and as per earlier decision taken by NC in its 8/82<br>meeting dated 31.08.2018, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as<br>per details below or as applied by firm whichever is lower: |<br>Export product Exp [Sk [Importiems| Q¥. Allowedin<br>ｒ<br>----- End of picture text -----<br>
109
==> picture [471 x 283] intentionally omitted <==
----- Start of picture text -----<br> —"<br>a 2 a|<br>FREE AMINEPIVALATE [kg [1 | CBZAMINONITRILE (149<br>50%<br>100(HEPTANES<br>T[ISO PROPYL ALCOHOL __—=(306 «id<br>TerETHER | [|]<br>|<br>8 [GLYCOLIC ACID 70% WET) [0535<br>(9 [PALLADIUMMETAL [0.0011<br>Tione[HYDROBROMICACID.IODIDE «(098[||<br>|<br>RA may take appropriate action as per theciadecision[TRIETHYLof Norms CommitteeAMINE LS |<br>----- End of picture text -----<br>
Case No.:86/12/82-ALC4/2018 Party Name:NEOGEN ~ MeetNo/Date:12/82Status: ‘CHEMICALS LIMITED ALC4/2018 ‘Approved 12.12.2018 HQ File RLA File Lic.No/Date:03 10822930 | :01/82/050/007 13/AM19/ :03/95/040/00243/AM19/ 08.08.2018
Decision: Committee considered case as per agenda and as per earlier decision taken by NC in its 4/82, meeting dated 19.06.2018, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
339 Export product Exp. Import items Qty. allowed in e e ee l e AMMONIUM BROMIDE RA may take appropriate action as per the decision of Norms Committee | | | — ——— een Case No.:293/12/82Party Name:M/S Meet No/Date:12/82Status: ALC4/2018 HIMALAYAN PRODUCTS & ALC4/2018 Deferred INDUSTRIES CORPN., P.LTD 12.12.2018 340 HQ File RLA File Lic.No/Date:6110001534 Defer Date: :01/82/050/00920/AM19/ :61/24/040/00006/AM19/ 08.08.2018 |
Decision: committee noted that the value addition (value addition 7.5%) is less than 15%. Hence it ; decided to ask the RA Dehradun to Clarify the matter the said advance authorization has been issued.
341 Case No.:286/12/82-
Party Name:BALAJI AMINES (Meet No/Date:12/82-
‘Status:
110
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----- Start of picture text -----<br>
|||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|ALC4/2018|LIMITED|ALC4/2018|[Approved|||
|12.12.2018|
|HQ|File|RLA|File|~||Lic.No/Date:3110067139|
|:01/82/050/009 13/AM19/|:31/83/040/00076/AM19/|13.08.2018|
|Decision:|Committee|considered|case|as|per|agenda|and|deliberated on|the|matterin|the|presence||of the|
|technical|experts and|it was decided|to|ratify the ad-hoc|input|output|norms|as per|earlier decision|taken by|
|NC|in|its|6/82|meeting|dated|26.07.2018|under|para|4.7|of HBP|as|per|details|below|or|as|applied|by|firm|
|whichever|is lower:|||
|Quanti|Allowed|
|GAMMA BUTYROLACTONE ||||kg|||1.4 BUTANEDIOL|p1l6kg|||
|GBL CATAYLYST|0.001|kg|||
|RA may take|appropriate|action|as|per|the decision|of Norms Committee|=|a|a|
|Case|No.:251/12/82-|Party Name:PI|INDUSTRIES|Meet No/Date:12/82-|Status:|
|ALC4/2018|LTD|ALC4/2018|‘Approved|
|12.12.2018|
|HQ|File|RLA File|Lie.|No/Date:1310049051|
|:01/82/050/00878/AM|19/|:13/24/040/00090/AM19/|30.08.2018|||
|Decision:|The|Committee|considered|the caseas per caseas peras per per|agenda|in|the|presence of Technical of Technical Technical|Experts,|it was was|
|decided|to|ratify|the ad-hoc ad-hoc|input|output|norms|under para 4.7 para 4.7 4.7|of HBP as HBP as as|per details details|below|or as applied as applied applied|by|
|firm|whichever|is|lower:|
|342|
|Export|product|Qty.|| Sl.|||Import|items|Qty. Allowed|
|No.|in kg|
|PIA|-|5|Chemical|Name:2-|fl|||3-Chloro -2-Methy!|aniline|||
|chloro-4-(methylsulfony!)-3-|0.656|||
|[(tetrahydrofuran-2-ylmethoxy)|Tetrahydrofurfury!|alcohol|0.506|||
|methyl|]benzoic|acid|4|||Tetrahydrofuran|0.282|||
|Sodium|Methyl|Mercaptide|_||1.625|
|RA may take appropriate action as per the decision of|Norms Committee.|||
|Case No.:10/12/82-ALC4/2018|Party Name:DIVIS|‘Meet|No/Date:12/82-|(Status:|||
|LABORATORIES|LTD|ALC4/2018|Approved|||
|12.12.2018|||
|HQ:01/82/050/00637/AM19/File|:09/24/040/00264/AMRLA|File|19/|‘Lic.No/Date:0910066629(04.09.2018||||
|Decision:|Committee|considered|case|as per agenda|and|deliberated|on|the|matter|in|the|presence|of the|[|]|
|technical|experts and|it was decided|to ratify the ad-hoc|input output norms as per earlier decision taken by|||
|NC|in|its|7/82|meeting dated|24.08.2018|under para|4.7|of HBP|as|per|details|below|or|as|applied|by|firm|
|whichever|is|lower:-|
|343|
|Export|product|Exp.|Sl.|Import|items|Qty.|
|Qty.|||No.|allowed|in||,|
|kg|
|(Z)-2-(2,3-|Ikg.|=|||AMINO GUANIDINE BI|
|DICHLOROPHENYL)-2-|CARBONATE|||
|(GUANIDINOIMINO)|ACETONITRILE|
|ACETONITRILE|3|2,3-DICHLOROCYANIDE|BENZOYL|||
|RA concerned may take|further necessary|action|as|per above|decision|of|NC.|||
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Decision: The Committee considered the caseas per caseas peras per per agenda in the presence of Technical of Technical Technical Experts, it was was decided to ratify the ad-hoc ad-hoc input output norms under para 4.7 para 4.7 4.7 of HBP as HBP as as per details details below or as applied as applied applied by firm whichever is lower: 342
111
A
| Sone ——
Case No.:11/12/82-ALC4/2018 Party Name:DIVIS Meet No/Date:12/82Status: LABORATORIES LTD ALC4/2018 Deterred 12.12.2018 PY, HQ File RLA File Lic.No/Date:0910066630 ‘Defer Date: :01/82/050/00638/AM19/ :09/24/040/00263/AM19/ 04.09.2018 Decision: Committee considered case as per agenda and deliberated on the matter in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms as per earlier decision taken by | NC in its 4/82 meeting dated 19.06.2018 under para 4.7 of HBP as per details below or as applied by firm | whichever is lower: 344
==> picture [456 x 514] intentionally omitted <==
----- Start of picture text -----<br> Export product Exp. Import items Qty. allowed in<br>Qty. kg<br>N-BOC-ETHYLENEDIAMINE 1kg DI-T-BUTYL DI 1.7758<br>CARBONATE<br>/2| ETHYLENE DI AMINE 2.6637<br>13| METHYLENE CHLORIDE |<br>RA may take appropriate action as per the decision of Norms Committee. |<br>Case No.:12/12/82-ALC4/2018 Party Name:DIVIS ‘Meet No/Date:12/82- Status:<br>LABORATORIES LTD ALC4/2018 ‘Approved |<br>12.12.2018 |<br>HQ File RLA File Lic.No/Date:0910066628 si,<br>:01/82/050/00639/AM19/ :09/24/040/00270/AM 19/ 04.09.2018<br>Decision: Committee considered case as per agenda and in consultation with technical expert present in the [|]<br>meeting, it was decided to revise the input output norms under para 4.7 of HBP as per details below or as |<br>applied by firm whichever is lower:-<br>Export product Exp. Qty. | Sl. No. Qty. allowed in |<br>kg }<br>—yas |THIOL ACID fi.| DIBENZYL TOLUENE 1.235 |<br>2. 2,2-BIS(BROMOMETHYL)- | 7.462 |<br>1,3-PROPANEDIOL<br>3 POTASSIUM THIO 2.181<br>ACETATE |<br>N-HEXANE |<br>16 =| ZD I NCMETHYL DUST FORMAMIDE 1.965 |<br>7 METHYL TERT-BUTYL 2.42 |<br>N,N-ETHER |<br>DIMETHYLACETAMIDE<br>RA concerned may take further necessary action as per above decision of NC.<br>Case No.:21/12/82-ALC4/2018 Party Name:ZENITH Meet No/Date:12/82- —[Status: |<br>DYEINTERMEDIATES \ALC4/2018 Deferred<br>346 LIMITED 12.12.2018 |<br>HQ File RLA File Lic.No/Date:03 10823507 Defer Date: |<br>:01/82/050/00648/AM19/ :03/95/040/005 19/AM19/ 04.09.2018 |<br>′<br>----- End of picture text -----<br>
)
112
~«~
|
|
i oO OS Decision: Deferred for comments of TE Case No.:348/12/82Party Name:DIVIS Meet No/Date:12/82Status: | ALC4/2018 LABORATORIES LTD ALC4/2018 Deferred 12.12.2018 347 HQ File RLA File Lic.No/Date:0910066654 {Defer Date: :01/82/050/00975/AM19/ :09/24/040/00269/AM19/ 10.09.2018 Decision: Deferred for comments of TE - ~ Case No.:252/12/82ALC4/2018 Party Name:PI INDUSTRIES — Meet No/Date:12/82- Status:| LTD ALC4/2018 Approved HQ File RLA File Lic.No/Date:131004906712.12.2018 || :01/82/050/00879/AM 19/ :13/24/040/00096/AM19/ (12.09.2018 Decision: Committee considered case as per agenda and deliberated on the matter in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms as per earlier decision taken by NC in its 4/82 meeting dated 19.06.2018 under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
|
| |
348 Export Product Import Product Quantity Quanti Allowed in kg 747- Ether Chemical Name: 2- 3-Chloro -2-Methyl 0.625 chloro-4-(methylsulfony|)-3-[(2,2,2aniline trifluroethoxy)methy!)]benzoic acid 0.350 3 Sodium Methyl! 1.902 Mercaptide 4 [Bromine 065 Ethylene Dichloride 1.065 6 |AcetonitrileHydrogen | 0.218 _8 _| Trifluoro EthanolPeroxide |1.000.503 RA may take appropriate action as per the decision of Norms Committee Case No.:20/12/82-ALC4/2018 Party Name:CROPNOSYS Meet No/Date:12/82(Status: (INDIA) PRIVATE LIMITED ALC4/2018 Approved 12.12.2018 HQ File — RLAFile Lic.No/Date:0310823957 | | :01/82/050/00647/AM19/ :03/94/040/00527/AM19/ 24.09.2018 Decision: Committee considered case as per agenda and deliberated on the matter in the presence of the | technical experts and it was decided to ratify the ad-hoc input output norms as per earlier decision taken by | 349 NC in its 5/82 meeting dated 25.07.2018 under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
==> picture [454 x 134] intentionally omitted <==
----- Start of picture text -----<br> Export product Exp. | SI.No. Qty. Allowed<br>Qty.<br>2-Amino-3-Chloro-5- lkg 2.3-Dichloro-5- 1.08 kg<br>Trifluoromethy! Pyridine trifluoromethy! Pyridine<br>Minimum 98% [F1] [DCTF]<br>RA may take appropriate action as per the decision of Norms Committee<br>Case No.:254/12/82- "Party Name:PI INDUSTRIES Meet No/Date:12/82- (Status: —_|<br>350 ALC4/2018 LTD ALC4/2018 Approved ©<br>12.12.2018 |<br>----- End of picture text -----<br>
113
as
HQ File RLAFile = ~——~——_Lic.No/Date:1310049089 | :01/82/050/0088 1/AM19/ :13/24/040/00106/AM19/ (01.10.2018 | Decision: Committee considered case as per agenda :[and][ deliberated][on][the][matter][in][the][presence][of][the] technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: | | Export Product Export | S.No Import Product Quantity Quanti Allowed in kg HYPE Chemical Name: Methyl 1- lkg 2-Chloro-6-hydrazino | 0.670 (3-chloropyridin-2-yl)-3pyridine hydroxymethyl-1H-pyrazole-52 2-methyl-5-ethy! 0.0224 carboxylate pyridine 3 Tetrahydrofurfury| 0.400 alcohol | RA may take appropriate action as per the decision of Norms Committee ae 7 Case No.:344/12/82Party Name:DIVIS—~—«<(Meet No/Date:12/82(Status: —| ALC4/2018 LABORATORIES LTD ALC4/2018 Approved 12.12.2018 HQ File RLA File . Lic.No/Date:0910066725 :01/82/050/0097 1/AM19/ :09/24/040/003 11/AM19/ 08.10.2018 | Decision: Committee considered case technical experts and it was decided toas perratify agendathe ad-hocanddeliberatedinput output norms on theas matterper earlierin the presencedecision takenof theby NC in its 7/82 meeting dated 24.08.2018 under para 4.7 of HBP as per details below or as applied by firm. whichever is lower: Export product Exp. | Sl. | Import items Qty. | 351 Qty. | No. allowed inkg | VALACYCLOVIR HCL Ikg. | 1. [|ACYCLOVIR | (Valacyclovir Hcl Anhydrous) 2. | N,N DI CYCLO HEXYL 1.15 | CARBODIIMIDE | + FORMICACID-94%DI METHYL [0522.03 ‘| FORMAMIDE | ACETONE 6 | z-1-VALINE PALLADIUM METAL 0.0022 RA concerned may take further necessary action as per above decision of NC. | Case No.:343/12/82“Party Name:MEHTA API PVT Meet No/Date:12/82Status: ALC4/2018 LTD. (ALC4/2018 Approved | 12.12.2018 | HQ File ~ IRLAFile ‘Lic.No/Date:0310824349 | 352 :01/82/050/00970/AM19/Decision: Committee considered:03/95/040/00697/AMcase as per agenda and 19/deliberated10.10.2018on the matter in the presence| of the | technical experts and it was decided to ratify the ad-hoc input output norms as per earlier decision taken by | NC in its 1/82 meeting dated 07.04.2016 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> Expor pric<br>----- End of picture text -----<br>
==> picture [74 x 16] intentionally omitted <==
----- Start of picture text -----<br> Qy. Allowed]<br>----- End of picture text -----<br>
114
~*~ 7 AZITHROMYCIN/AZITHROMYCIN lkg AZITHROMYCIN AMINE 1.07 kg DIHYDRATE BP/EP/USP HAVING PURITY NMT 94% RA may take appropriate action as per the decision of Norms Committee OB Case No.:345/12/82Party Name:DIVIS ~ |Meet No/Date:12/82- Status: | ALC4/2018 LABORATORIES LTD (ALC4/2018 Approved |12.12.2018 HQ File - RLA File ~ Lie.No/Date:0910066812 | :01/82/050/00972/AM 19/ :09/24/040/0036 1/AM19/ 02.11.2018 Decision: Committee considered case as per agenda and as per earlier decision taken by NC in its 10/82) meeting dated 16.10.2018, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as _ per details below or as applied by firm whichever is lower: | 353 Export product Qty. | SI. Qty. Allowed No. in kg DEXTROMETHORPHAN BASE | 1kg|1 | N-FORMYL OCTABASE PHOSPHORUS PENTOXIDE TOLUENE [109 | METHANOL 0.824 ACETONE 0.420 | RA may take appropriate action as per the decision of Norms Committee. |
MANUAL CASES
Case No. B- | M/s. POLYDRUG LABORATORIES PVT.LTD., M.No. 12/AM19 F.No. 01/82/050/00900/AM 16/DES-III Date 12.12.2018 F.No. 03/95/040/00219/AM16 Adv.Auth. No. 0310797101 Dated 07.07.2015 Decision: The Committee re-considered case as per agenda and in the presence of the technical experts, it was decided to revise the ad-hoc input output norms in respect of above mentioned advance authorization under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
==> picture [436 x 71] intentionally omitted <==
----- Start of picture text -----<br> Export Product Export | S.No Import Product Quantity Allowed<br>Quanti<br>Metoprolol Base PHENOL af? Ke<br>Tech. Spec.: Pharmacopeial Grade EPICHLOROHYDRIN | 0.520 kg<br>MONO ISOPROPYL<br>----- End of picture text -----<br>
- RA may take appropriate action as per the decision of Norms Committee.
|
115
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|Case No. B- 2<br>M/s. Panacea Biotec Ltd<br>M.No.<br>12/AM19<br>F. No. 01/82/050/00709/AM 17<br>Date<br>12.12.2018<br>F. No. 01/82/050/00223/AM 17|||
|---|---|---|
|F. No. 01/82/050/01019/AM 16|||
|F. No. 01/82/050/01127/AM 15|||
|| F.No01/82/050/01S17/AM16_—<br>RLA<br>No.05/24/040/00258/AM17<br>Adv.Auth. No.0510399580dated 30.08.2016<br>RLA<br>No.05/24/040/00009/AM 17<br>Adv.Auth. No.0510398392dated 05.05.2016<br>RLA No.05/24/040/00183/AM 16<br>Adv.Auth. No.0510395354 dated 18.08.2015<br>RLANo.05/24/040/00319/AM 15<br>Adv.Auth. No. 0510391623 dated 17.10.2014<br>RLANo.05/24/040/00439/AM16<br>Adv.Auth. No.0510396670 Dated 18.12.2015|||
|Decision: The Committee re-considered case as per agenda and decided to ratify the ad-hoc input output norms<br>based on the recommendation of DBT O.M. No.BT/IL/05/316/2010-PID dated 05.06.2017, and DBT O.M.<br>No.BT/IL/05/422/2016-PID dated 27.07.2018 in respectofabove mentioned advance authorizations underpara 4.7of<br>HBPasperdetailsbeloworasappliedbyfirmwhicheverislower:||||
|Export Product<br>Export<br>S.No | ImportProduct<br>QuantityAllowed<br>ee<br>Se<br>Sees<br>eee|||
|oe<br>a<br>PURIFIED<br>DTwP-HepB -Hib-Pentavalent<br>1 million<br>DIPHTHERIA<br>Vaccine<br>(Easyfive-TT)(Eachvial | dosesvials<br>TOXOID<br>of 0.5 ml / 1 dose/vial)<br>.<br>CONCENTRATE<br>13.64 ltr|||
|ANTIGEN BULK|||
|___| (@2050Lf/ml)|||
|卜<br>PURIFIEDTETANUS<br>TOXOID|||
|―<br>2<br>CONCENTRATE<br>5.23 Ltr.<br>ANTIGEN BULK(@|||
|—_{1900Lfiml)<br>INACTIVATED<br>~~<br>WHOLECELL<br>:<br>PERTUSSISBULK(@ | 86-46Ltr<br>{192 OU/m) |<br>HEPATITIS B<br>i<br>VACCINE<br>14.0gm|||
|‘HAEMOPHILUS<br>a<br>§<br>INFLUENZAE TYPE<br>13.90gm<br>|__|<br>_|Bconucare||||
|Note: In respect ofAdv.Auth.No.0510391623dated 17.10.2014 theapplicant firmhasinformed thatnorms is<br>notrequired to fix forimport itemnamely“Aluminium PhosphateGel”<br>RAmaytakeappropriateaction asperthedecision ofNormsCommittee.<br>peeereeneeeesie||||
|
116
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|||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|CaseNo.B-3—™”|M/s. PANERABIOTECPVT.LTD —————~™|]|
|M.No.|12/AM19|F.|No.|01/82/050/00541/AM17|
|Date|12.12.2018|F.|No.|01/82/050/01436/AM|16|
|F.|No.|01/82/050/00050/AM|17|
|F,|No.|01/82/050/00926/AM|17|
|RLA|No. 05/24/040/00136/AM17.—|1.|Adv.Auth.|No. 0510398951|Dated:30.06.2016|
|RLA|No.05/24/040/00181/AM|16|Pe|Adv.Auth.|No.|0510395496|dated|01.09.2015|
|RLA|No.05/24/040/00597/AM|16|3:|Adv.Auth.|No.|0510397827|dated|04.03.2016|
|RLA|No.05/24/040/00307/AM|17|4.|Adv.Auth.|No.|0510399924|dated|28.09.2016|
|Decision:|The Committee|re-considered|case|as per agenda and|decided|to|ratify|the|ad-hoc|input output|norms|
|based|on|the|recommendation|of|DBT|O.M.|No.BT/IL/05/422/2016-PID|dated|27.07.2018|in|respect|of|above|
|mentioned|3 advance authorizations|at|serial no|||to|3|under para 4.7 of|HBP as per details below or as applied|by|firm|
|whichever|is|lower:|
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|||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
|ExportProduct|=—=~—_—*||Export.||S.|Import Product|||Quantity Allowed|
|AGS|HB|PURIFICATION|
|1 gm|MABS COLUMN also|
|HEPATITIS|B VACCINE’|known as Immuno Affinity|—||,594|wastage)|
|matrix|Sepahrose|CL 4B|AC|
|MABHEP-) ||
|a:|Snen|2|||SEPHADEX G-25 MEDIUM||°:!64 kg|
|HAEMOPHILUS|*|—_______________||(with 5%|wastage)|||||
|INFLUENZAE|4|TETANUS TOXOID FOR|0.463|Ltr.|
|CONJUGATE|TYPE B|jen|___||CONJUGATION|-|___||with 30%|wastage)|-|
|_|4|SEPHADEX G-25 MEDIUM|(with0.164|5%kg|wastage)|
|Norms|allowed|in|respect|of Ady.Auth.|No.|0510399924|dated|28.09.2016|at|serial|No. 4|
|‘ExportProduct|=~=~—~—~*<Y|Export.||S.|| ImportProduct. —~~——SCSCS|Quantity Allowed|
|—|||
|a|uantit|No|
|AGS|BH|PURIFICATIONre|ee|
|MABS COLUMN|(also|known|
|HEPATITIS|B VACCINE|1|gm|1|asSepahroseepanrose ImmunoCLAffinityCh|4B esmatrix MAB|(with— 5% wastage)|
|___||HEP-1 ee|
|=|SBRHADINOG-25:|MEDIUM|_|| with0.164 kg9|wating|
|3|WHATMAN DE-52|0.400 kg|
|CELLULOSE|(with 5%|wastage)|
|HAEMOPHILUS INFLUENZAE|4|ContbertON|me|hue|=|
|TYPE B CONJUGATE|1 gm|Eee weraerery-stcecmesons|com. Kone le|
|RA|pres|a| oar|
|may|take appropriateaction|as|per|the|decisionofNorms|Committee.|aaa seater|ees|J|
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