DGFT Committee Minutes
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— . Office of Directorate General of Foreign Trade New Delhi -
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Minutes of the Norms Committee (NC-3) Meeting No. 10/82-ALC4/2018 MEETING DATE (actually held on 05.11.2018 and 13.11.2018) for considering the cases/issues under Duty Exemption: 16.10.2018Scheme (Chapter-4) of Foreign Trade Policy, 2015-20 pertaining to Chemical and Allied products falling under Chapter New Delhi. 29 and 30, held under the Chairmanship of Shri Satyan Sharda, Addl. DGFT in Room No.11, Udyog Bhawan,
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. 09/82/ALC-4/2018 of 2018-19 dated 18.09.2018 (actually held on 18.09.2018 and 19.09.2018) and approved the same
Para 4.7 Decision MEETING NUMBER : 10/82-ALC4/2018 MEETING DATE - 16.10.2018 (actually held on 05.11.2018 and 13.11.2018) | Case No.:303/10/82Party Name:ADCOCK _ [Meet No/Date: 10/82Status: ; (ALC4/2018 INGRAM LTD, ‘ALC4/2018 Approved | ‘16.10.2018 HO File - —IRLAFile _ Lic.No/Date:07 10092297 | :01/82/050/00590/AM19/ :07/24/040/00351/AM13/ 05.12.2012 | Decision: The Committee considered case as per agenda and in the presence of the technical experts, it bywasfirm decidedwhichever to ratifyis thelower: ad-hoc input output norms under para 4.7 of HBP as per details below or as applied | F Export product Qty. SI. Qty. , No. NORFLEX 100 MG TABLETS 1 tablet 1 ORPHENADRINE CITRATE 102.00 2 BP/EP/USP/PH.EUR mg/tablet ' LACTOSE USP/NF/ BP/ 167.00 : EP/PH.EUR mg/tablet ; | AEROSIL BP/EP/USP/PH.EUR 8.00 ; - U : mg/tablet 4 | ETHYL CELLULOSE N100 - 20.00 RA BP/EP/USP/Ph.EUR/USNF meg/tablet | | may take appropriate action as per the decision of Norms Committee. Case No.:304/10/82“Party Name:ADCOCK. “Meet No/Date:10/82Status: — ALC4/2018 INGRAM LTD, ALC4/2018 Approved 16.10.2018 HQ File RLA File ‘Lic.No/Date:071009633 | 2 ~:01/82/050/00591/AM19/ :07/24/040/00040/AM | 4/ 28.06.2013 _ Decision: The Committee considered case as per agenda and in the presence ofthe technical experts,. it | byWasfirm decidedwhichever to ratifyis thelower: ad-hoc input output norms under para 4.7 of HBP as per details below or as applied
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----- Start of picture text -----<br> | Export product Qty. Sl. Import items Qty.<br>No.<br>| NORFLEX 100 MG TABLETS | | tablet 1 ORPHENADRINE CITRATE 102.00<br>BP/EP/USP/PH.EUR mg/tablet | ||<br>2 LACTOSE USP/NF/ BP/ 167.00 |<br>EP/PH.EUR mg/tablet<br>; AEROSIL /EP/USP/PH.EUR 8.00<br>- BP/EP/U : mg/tablet<br>4 ETHYL CELLULOSE N100 - 20.00<br>BP/EP/USP/Ph.EUR/USNF mg/tablet<br>つ<br>----- End of picture text -----<br>
RA may take appropriate action as per the decision of Norms Committee.
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----- Start of picture text -----<br> |<br>(Case No.:295/10/82- = PartyName:SWATI. ——SWMeet No/Daate:10/82- Status:<br>~ ‘ALC4/2018 ‘MENTHOL & ALLIED ALC4/2018 ‘Approved<br>‘CHEMICALS LTD., 16.10.2018<br>HQ File —RLAFile Lic.No/Date:2910025195 |<br>:01/82/050/00582/AM19/ :29/21/040/00020/AM 15/ 04.02.2015 |<br>_ Decision: | The Committee considered case as per agenda and in the presence of the technical experts, it |<br>3 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>_ | DIDROMYRCENOL ALPHA PINENE L.77kg<br>RA may take appropriate action as per the decision of Norms Committee.<br>Case No.:230/10/82- Party Name:CAPLIN POINT Meet No/Date:10/82- Status:<br>ALC4/2018 LABORATORIES LTD., ALC4/2018 Approved<br>16.10.2018<br> HQ File RLA File Lic.No/Date:04 10160876 |<br>|<br>:01/82/050/00517/AM19/ :04/24/040/00079/AM 16/ 05.08.2015 |<br>Decision: | The Committee considered case as per agenda and in the presence of the technical experts, it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied |<br> by firm whichever is lower:<br>4<br>|<br>|<br>= Export product Qty. No.Sl. | Import items Qty. |<br>| Diclofenac + Nuerotropas | 1 Million Cyanocobalamin 0.204 kg<br>_ | Capsules (Each capsule | Number Cyanocobalamin USP |<br>_ | containing Thiamine Hcl 50 mg 2 Thiamine Hydrochloride 51.0 kg |<br>_ | and cyanocobalamin 200 micro Thiamine Hydrochloride USP<br>|_| grams) |<br>‘RA may take appropriate action as per the decision of Norms Committee.<br>つ<br>----- End of picture text -----<br>
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(Case No.:229/10/82~ Party Name:CAPLIN POINT Meet No/Date:10/82Status: _ ALC4/2018 LABORATORIES LTD., ALC4/2018 ‘Approved | HQ File RLA File Lic.No/Date:0410160882 _ :01/82/050/005 16/AM19/ :04/24/040/00080/AM 16/ 06.08.2015 | ‘Decision: The Committee considered case as per agenda and in the presence of the technical experts, it 5 _wasby firmdecidedwhicheverto ratifyis lower:the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied | | | Export product Qty. Sl. Import items Qty. | || Thiamine and Caffeine tablets 1 No. Thiamine Hydrochloride 306.00 mg | | (each tablets containing Number Thiamine Hydrochloride BP ' _ | Thiamine Hcl 300 mg) | RA may take appropriate action as per the decision of Norms Committee.
| Case No.:124/10/82‘Party Name:AMI ORGANICS - Meet No/Date: 10/82Status: _ ALC4/2018 PVT LTD. ‘ALC4/2018 ‘Approved | | | 16.10.2018 ~ | HQ File RLA File Lic.No/Date:5210041611 | :01/82/050/00411/AM19/ ':52/24/040/00035/AM16/ (14.08.2015 | Decision: ~The Committee considered case as per agenda andin the presence of the technical experts, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied _ _ by firm whichever is lower: | 6 |__| Export product Qty. SI. Import items Qty. | No. |_ || PYRIDIN1,2,4- TRIAZOLO-3 (2H) - (4,3-a) ONE - 98% 1 kg 1 | SEMICARBAZIDETech. Spec. : Powder HCL - 99% MIN | 2.422 kg | | MIN. 2. 2-Chloro Pyridine l.l4kg | i | Tech.spec : Liquid | | 3 Mono Ethylene Glycol 1.20 kg | Tech Spec.: Liquid _ RA may take appropriate action as per the decision of Norms Committee.
| | ; ‘CaseALC4/2018 No.:196/10/82‘PartyPHARMA Name:MAHARSHI CHEM PVT.LTD, MeetALC4/2018 No/Date:10/82Status:‘Approved | io 16.10.2018 | HQFile RLAFile _ ~Lic.No/Date:0810136077 | :01/82/050/00483/AM19/ ':08/24/040/00191/AM16/ 21.09.2015 | Decision: ~The Committee considered case as per agenda and in the presence of the 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: | | Export product Qty. Sl. Import items Qty. | | No. == E=
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||Case No.:197/10/82-<br>PartyName:MAHARSHI<br>"(MeetNo/Date:10/82-|Status: i||||
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||<br>| <br>||ALC4/2018<br>PHARMACHEM PVT.LTD,<br>ALC4/2018<br>|<br>16.10.2018<br> a bie eeeee ieeeRLA=<br>eis(Cie NovDate:0810136408<br>:01/82/050/00484/AM19/<br>':08/24/040/00249/AM16/<br>02.11.2015|‘Approved<br>|<br>|<br>||||<br>|<br>||
|Decision:<br>| The Committeeconsidered case as peragendaand inthepresenceofthetechnical experts,|||it||
|8|was decided to ratify the ad-hoc input output norms underpara4.7 ofHBP as per details below or as applied|||||
||by firm whichever is lower:|||||
||Export product<br>Qty.<br>SIL.<br>Import items|Qty.|||
||No.<br>Freisolonesodiumphosphate_|<br>The [1 | Prednisolone<br>=|O39<br>RA may take appropriate action as per the decision ofNorms Committee.||||<br>||
||“(CaseNo.:198/10/82-. —~—~Party Name: MAHARSHI<br>MeetNo/Date:10/82-<br>ALC4/2018<br>PHARMACHEM PVT.LTD,<br>ALC4/2018|Status:<br>‘Approved|||
||HQFile<br>RLA File<br>_<br>Lic.No/Date:0810136728 <br>:01/82/050/00485/AM19/<br>':08/24/040/00320/AM 16/<br>(15.12.2015|||||<br>||
||Decision: |TheCommittee considered case asperagenda andinthepresence ofthetechnical experts,||it||
|9|was decided to ratify the ad-hoc input outputnorms underpara4.7 ofHBP as per detailsbelow oras applied|||||
||by firm whichever is lower:||||
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||Export product<br>Qty.<br>Sl.<br>Import items|Qty.|||
|||No.<br>|<br>[Beamethasone Dipropionate | Tks [1 | Beamethasone<br>———=*d;O86BKe]<br>RA may take appropriate action as per the decision ofNorms Committee.<br>|||||
|"(CaseNo.:305/10/82-<br>—~—«PartyName:ADCOCK<br>~—SMeetNo/Date:10/82-.||Status:|||
||ALC4/2018<br>INGRAM LTD,<br>ALC4/2018|‘Approved|||
||16.10.2018|||||
||HQ File<br>RLA File<br>~_Lic.No/Date:0710109182||||
||:01/82/050/00592/AM 19/<br>':07/24/040/00320/AM 16/<br>21.12.2015||||
||Decision: |The Committee considered case as peragendaand in the presence ofthe technical experts,||it||
||was decided to ratify the ad-hoc input output norms under para 4.7 ofHBP as per details below or as applied||||
||by firm whichever is lower:|||||
|10. | Export product<br>Qty.<br>Sl.<br>Import items||Qty.|||
|||<br>No.|||||
||NORFLEX 100MGTABLETS| | tablet |<br>1<br>ORPHENADRINECITRATE|102.00||||
|||BP/EP/USP/PH.EUR|mg/Tablet|||.|
||2<br>LACTOSE USP/NF/ BP/|167.00|||
|||EP/PH.EUR|mg/Tablet|||.|
||3|8.00||||
||AEROSIL -BP/EP/USP/PH.EUR|mg/Tablet|||
||4<br>ETHYL CELLULOSE N100 -|20.00|||
||BP/EP/USP/Ph.EUR/USNF|mg/Tablet|||.|
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RA may take appropriate action as per the decision of Norms Committee.
Case No.:199/10/82-—-—~Party Name:MAHARSHI — Meet No/Date:10/82-. Status: — ALC4/2018 PHARMA CHEM PVT.LTD, ALC4/2018 Approved 16.10.2018 | HQ File RLAFile = ~—_Lic.No/Date:0810136906 | _ :01/82/050/00486/AM19/ :08/24/040/00343/AM16/ 31.12.2015 _ Decision: The Committee considered case as per agenda andin 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 11 by firm whichever is lower: | Export product Qty. Sl. Import items Qty. | | No. | BETAMETHASONE 17| 1kg 17 Alpha 21-Dihydroxy16-Beta | 1.10kg | | VALERATE Methyl9-Beta-11-Beta - Epoxy ; | Pregna-1, 4-Diene-3, 20-Dione (DB| | XI) _ RA may take appropriate action as per the decision of Norms Committee. Case No.:310/10/82) Party Name:BELOOR BAYIR Meet No/Date: 10/82Status: — ALC4/2018 BIOTECH LTD, ALC4/2018 Deferred | 16.10.2018 1p HQ File RLA File Lic.No/Date:0710109255 Defer Date: ~ |:01/82/050/00597/AM19/ :07/24/040/00347/AM 16/ 12.01.2016 ‘Decision: The Committee considered the case as per Agenda and it was decided to call for approved ‘composition of each export product from any Competent Authority.
(Case No.:201/10/82-_ "|Party Name:MAHARSHI Meet No/Date:10/82Status: — ALC4/2018 PHARMA CHEM PVT.LTD, ALC4/2018 Approved 16.10.2018 OTe Ee a Sand —::01/82/050/00488/AM19/ :08/24/040/00379/AM16/ 03.02.2016 | 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 13 iby firm whichever is lower: | | Export product Qty. Sl. Import items Qty. | No. | BETAMETHASONE 17 1 kg 1 17 Alpha 21-Dihydroxy16-Beta| 1.10kg |. | | VALERATE Methyl9-Beta-11-Beta - Epoxy | Pregna-1, 4-Diene-3, 20-Dione (DB__RA may take appropriate action as per the decision of NormsXI) Committee. |
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_ Case No.:202/10/82Party Name:MAHARSHI [Meet No/Date:10/82-. Status: _ ALC4/2018 PHARMA CHEM PVT.LTD, ALC4/2018 Approved 16.10.2018 HQ File RLA File Lic.No/Date:0810137113 :01/82/050/00489/AM19/ :08/24/040/00378/AM1 6/ 03.02.2016 | Decision: The Committee considered case as per agenda and in the presence of the technical experts, it. ‘14 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. Sl. Import items Qty. i No. | ee a eeRA may take appropriate action as per theeT decision of Norms Committee. |
‘Case No.:200/10/82Party Name:MAHARSHI Meet No/Date:10/82Status: | - ALC4/2018 PHARMA CHEM PVT.LTD, ALC4/2018 ‘Deferred | Lia HOFa0 nnioe ic | ~—101/82/050/00487/AM19/ :08/24/040/00459/AM 16/ 31.03.2016 | Decision: The Committee considered the case as per agenda and it was decided to call for Appendix 4E _ having all technical details like stage wise yield of production and molecular weight from the firm. |
| . Case No.:231/10/82Party Name:CAPLIN POINT Meet No/Date:10/82- Status: _ ALC4/2018 LABORATORIES LTD., ‘ALC4/2018 Approved HQ 16.10.2018 File RLA File Lic.No/Date:0410161788 | | :01/82/050/00518/AM19/ :04/24/040/00276/AM1 6/ 06.04.2016 Decision: The Committee considered case as per agenda and in the presence of the technical experts, ‘it, 16 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. Import items Qty. allowed fo No. _ | Nystatin Oral Suspension BP | 80000 Nystatin (micronized ) BP 252.00 BOU ~ | 100000 IU /ml, 30 ml pack Number ___RA may take appropriate action as per the decision of Norms Committee. |
Case No.:203/10/82— Party Name:MAHARSHI _ Meet No/Date:10/82- Status: | iALC4/2018 PHARMA CHEM PVT.LTD, ALC4/2018 ‘Deferred | 16.10.2018 | | 17 HQ File RLA File ~ Lic.No/Date:0810137909 ‘Defer Date: Decision:—:01/82/050/00490/AMhaving The Committee19/ considered':08/24/040/00060/AM17/the case as per agenda and13.05.2016it was decided to call for Appendix| 4E | all technical details like stage wise yield of production and molecular weight from the firm.
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| Case No.:3/10/82-ALC4/2018 ‘Party Name:CADILA ‘Meet No/Date:10/82Status: | | | HEALTHCARE LTD ‘ALC4/2018 ‘Approved | | | 16.10.2018 | | (HQ File RLA File ‘Lic.No/Date:0810138076 | | :01/82/050/00290/AM19/ :08/24/040/00084/AM17/ 01.06.2016 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. 4/82-ALC4/2018, dated 19.06.2018, it was. decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by | | firm whichever is lower: Allowed inmg |. HYDROCHLORIDE Tablet HYDROCHLORIDE USP || | TABLETS 200 MG | | NF/PH.EU | | PH.E/NEF/JP | NF || | F_gaersereroe7 225 CC WH HDPE BOTTLE [ee | (As per general policy for packing | 18| materialfinished form: PackingNetmaterialnos. 239000)in | | | NCRC WH CAP 45 MM PULP ; | LINER | (As per general policy for packing | | material : Packing material in | | finished form - Net nos. 239000) } 60 CC WH HDPE BOTTLE Relevant, as per |. | || (As per general policy for packing packing policy | | | material : Packing material in | | | finished form - Net nos. 428000) i || 10 CRCLINERWH(AsCAPper general33 MM policyPULP for | | | packing material : Packing material | | in finished form - Net nos. 428000) | | 11 | PACKING INSERT - | | AMIODARONE HCL TABLET | | | (As per general policy for packing | ;||| materialfinished form: Packing- Netmaterialnos. 667000)in 12 MEDICAL GUIDE - } | AMIODARONE HCL TABLET | | (As per general policy for packing material : Packing material in | | | finished form - Net nos. 214509) | RA may take appropriate action as per the decision of Norms Committee.
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~ ‘Case No.:302/10/82Party Name:BEST VALUE ‘Meet No/Date: 10/82"Status: | ALC4/2018 (CHEM PVT. LTD. ALC4/2018 ‘Approved | — One:01/82/050/00589/AM19/Decision: mae| Committeeeectsconsidered IRLA134/24/040/00046/AM17/ caseFileas per00Sagenda and in light(01.06.2016of earlier decision taken in| Meeting No. ||| 10/82 dated 10.01.2018 and in consultation with technical authority present in meeting, it was decided to 19 ratify 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 Items Quantity allowed | | Quantity | Verdyl Isobutyrate 1 kg a Dicylopentadiene 0.705 kg Isobutyric Acid 0.493 kg RA may take appropriate action as per the decision of Norms Committee. | ‘Case No.:306/10/82Party Name:ADCOCK © Meet No/Date:10/82Status; ALC4/2018 INGRAM LTD, ALC4/2018 Approved | ou essai IRLAain E SSOPT | :01/82/050/00593/AM19/ :07/24/040/00114/AM17/ 04.07.2016 | 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: | | 20 Export product Qty. SL. Import items Qty. | a No. | _ |NORFLEX 100 MG TABLETS 1 Tablet Orphenadrine Citrate BP/EP/ | 102.0mg |. USP/ PH. EUR | 2: Lactose USP/NF/BP/EP/PH. | 167.0mg |. EUR 3 ETHYL CELLULOSE N100 - 20.0 mg | | BP/EP/USP/Ph.EUR/USNF RA may take appropriate action as per the decision of Norms Committee. | Case No.:115/10/82Party Name:DSM SINOCHEM Meet No/Date:10/82Status: ALC4/2018 PHARMACEUTICALS INDIA ALC4/2018 ‘Approved | PVT.LTD. 16.10.2018 | HQ File RLA File ~_Lic.No/Date:2210015522 | :01/82/050/00402/AM19/ :22/24/040/00024/AM17/ 14.07.2016 | _ Decision: |The Committee considered the case as per agenda in the presence of Technical Experts and in | 21 the light of earlier decision taken by NC in its Meeting No. 10/82-ALC4/2013, dated 22.08.2013, 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 Exp. | SI. No. | Import items Qty. allowed | | Qty. | LAmoxycillin Trihydrate Through 6- | 1 kg [1.| 6-Amino Pencillanic Acid 0.55 kg
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|' || APARoute Route through Enzymatic] ; |
| 2. | Elcolase Enzyme | 0.005kg 3. D(-)-p-Hydroxy phenyl glycine | 0.477 kg methyl ester of Norms Committee. Committee. |
RA may take appropriate action as per the decision of Norms Committee. Committee.
Case No.:316/10/82Party Name: ALEMBIC Meet No/Date: 10/82Status:Case | ALC4/2018 PHARMACEUTICALS LTD — ALC4/2018 Added | 16.10.2018 2 HQ File RLAFile == ~~~—~—~—_Lic.No/Date:3410042371 Defer Date: :01/82/050/00603/AM 19/ :34/24/040/00103/AM17/ 22.07.2016 | Decision: ~ Deferred for comments of TE. _ . - - / Case No.:126/10/82‘PartyName:SWATI —— Meet No/Date:10/82-. Status: | | ALC4/2018 MENTHOL & ALLIED ‘ALC4/2018 Approved CHEMICALS LTD., (16.10.2018 | HQFile RLA File | ~Lic.No/Date:2910025260 | 101/82/050/00413/AM19/ :29/24/040/00001/AM17/ (05.09.2016 ‘Decision: |The Committee considered case as per agenda and in the presence of the technical experts, it 23 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. _ | TERPINEOL |ikg[1 | PINEOIL 1.31 kg | RA may take appropriate action as per the decision of Norms Committee.
Case No.:307/10/82Party Name: ADCOCK ‘Meet No/Date:10/82Status: | ALC4/2018 INGRAM LTD, ALC4/2018 Approved ; | 16.10.2018 HQFile -RLA File Lie. No/Date:0710110586 _:01/82/050/00594/AM19/ 107/24/040/00213/AM17/ 27.10.2016
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----- Start of picture text -----<br> Decision: |The Committee considered case as per agenda and in the presence of the technical experts, it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied<br>| by firm whichever is lower: |<br>124 | Export product Qty. Sl. | Import items Qty.<br>| NORFLEX 100 MG TABLETS | | Tablet 1 ORPHENADRINE CITRATE 102.00 |<br>| BP/EP/USP/PH.EUR mg/tablet<br>| 2 | LACTOSE USP/NF/ BP/ 167.00<br>| EP/PH.EUR mg/tablet |.<br>3 ETHYL CELLULOSE N100 - 20.00<br>| | BP/EP/USP/Ph.EUR/USNF mg/tablet<br>RA may take appropriate action as per the decision of Norms Committee.<br>Ｓ‐<br>----- End of picture text -----<br>
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Case No.:313/10/82Party Name: TORRENT ‘Meet No/Date: 10/82‘Status: | ALC4/2018 PHARMACEUTICALS LTD. ALC4/2018 Approved | | ‘16.10.2018 | HQ File RLA File Lic.No/Date:0810138984__ | :01/82/050/00600/AM19/ :08/24/040/00261/AM17/ 27.10.2016 | ‘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. Import items Qty. allowed _ | ISOSORBIDE MONONITRATE | 36132500.000 EXTENDED-RELEASE TABLETS | Tablets | Each film coated extended-release tablets contains: Diluted ISMN (50% diluted | with — lactose = monohydate) ~~ USP | equivelent to ISMN 30mg | | | Colour:Titanium Dioxide Excipients q.s. | _ | Net Content of active ingredient ISMN 25 | should not be less than 2190 Kgs. Isosorbide - 5 - Mononitrate | g1]92.000 _ | ISOSORBIDE MONONITRATE | 32325000.000 | 50% in Lactose 50% (Short kg _. |EXTENDED-RELEASE TABLETS| Tablets form : ISSMN 50%| | USP 60MG LACTOSE 200 50%) | ____ | Each film coated extended-release tablets | | contains: Diluted ISMN (50% diluted _ | with — lactose = monohydrate) + USP | equivelent to ISMN 60mg _ | Colour:Titanium Dioxide Excipients q.s. | Net Content of active ingredient ISMN | should not be less than 3918 Kgs. | ISOSORBIDE MONONITRATE| 8225000.000 | | EXTENDED-RELEASE — TABLETS| Tablets | || | USP 120 MG | | Each film coated extended-release tablets | contains: Diluted ISMN (50% diluted | | withequivelentlactose to monohydrate)ISMN 120mgUSP | | _ | NetColour:TitaniumContent of activeDioxideingredientExcipientsISMNq.s. || | should not be less than 1994 Kgs. | _ RA may take appropriate action as per the decision of Norms Committee.
Case No.:81/10/82-ALC4/2018 Party Name:GLENMARK ‘Meet No/Date:10/82‘Status: | - PHARMACEUTICALS LTD., ALC4/2018 Deferred 16.10.2018 | | 26 :01/82/050/00368/AM19/HQ File 103/94/040/00828/AM17/RLA File Lic.No/Date:031081008823.12.2016 Defer| Date: _ Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. _ Hence, it was decided to call for the 4.07 application of the subject advance authorization from RLA, Mumbai and complete technical details as per 4E along with Chemical reaction, stage wise yield of production and molecular weight from the firm.
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----- Start of picture text -----<br> [ ‘Case No.:317/10/82- a Party Name:ALEMBIC Meet No/Date:10/82-_ Status: |<br>| ALC4/2018 PHARMACEUTICALS LTD = ALC4/2018 Deferred<br>La 16.10.2018 |<br>~ HQ File RLA File ‘Lic.No/Date:3410042941 Defer Date:<br>_ :01/82/050/00604/AM19/ :34/24/040/00333/AM17/ (16.02.2017 |<br>SS nee scsi sa<br>[ Case No.:308/10/82- Party Name: ADCOCK _ ‘Meet No/Date:10/82- Status: |<br>' ALC4/2018 INGRAM LTD, ALC4/2018 Approved<br>} | | (16.10.2018<br>= ~~ ~—Lic.No/Date:0710111271 |<br>HQ File RLAFile<br>| 101/82/050/00595/AM19/ :07/24/040/00387/AM17/ 10.03.2017<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> | Export product Qty. Sl. Import items Qty.<br>| | No. |<br>|. |NORFLEX 100 MG TABLETS | | Tablet | 1 ORPHENADRINE CITRATE 102.00<br>} | BP/EP/USP/PH.EUR mgy/tablet |<br>| | 2 | LACTOSE USP/NF/ BP/ 167.00 |<br>; | EP/PH.EUR mg/tablet |.<br>| | 3 ETHYL CELLULOSE N100 - 20.00 |<br>bo BP/EP/USP/Ph.EUR/USNF mg/tablet |.<br>RA may take appropriate action as per the decision of Norms Committee.<br>| 7 ‘Case No.:128/10/82- . — Party Name:SWATI - Meet No/Date:10/82- Status:<br>| ALC4/2018 MENTHOL & ALLIED ALC4/2018 ‘Approved<br>‘CHEMICALS LTD., 16.10.2018 | |<br>iSa IRLA File certs Deen eee fae NoiDetsaamoDaeRe | |<br>| -:01/82/050/00415/AM19/ :29/24/040/00001/AM18/ 13.04.2017<br>Decision: |The Committee considered case as per agenda and in the presence of the technical experts, it<br>29 ‘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. | SI. Import items Qty.<br>| No.<br>«dT<br>__[ERPINEOL Teer |pNEOR<br>| |RA may take appropriate action as per the decision of Norms Committee. |<br>[Case No.:127/10/82- == PartyName:SWATI {Meet No/Date:10/82- Status:<br>— ALC4/2018 MENTHOL & ALLIED ALC4/2018 Approved<br>| CHEMICALS LTD., 16.10.2018 |<br>|30 HQFile . RLAFile Lic.No/Date:29 10025293<br>| :01/82/050/00414/AM19/ :29/24/040/00002/AM18/ 08.06.2017<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>つ<br>----- End of picture text -----<br>
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| iy firm rar[nr] rR ti
et a —
Export product Qty. SI. Import items Qty. | No. | TERPINEOL 1 kg GUM TURPENTINE OIL 2.00 kg ho (containing 50% Alpha pinene) _ RA may take appropriate action as per the decision of Norms Committee. Case No.:296/10/82~—~—~Party Name:SANMAR Meet No/Date:10/82Status: | - ALC4/2018 ‘SPECIALITY CHEMICALS ALC4/2018 Approved | po LIMITED, 16.10.2018 : HQ File a RLA File ~ Lic.No/Date:0410163231 | :01/82/050/00583/AM19/ :04/24/040/00010/AM18/ 13.06.2017 | 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:
31 | | Export product Exp. SI. Import items: Qty. allowed | Qty. No. | | 4-(2-Aminoethyl)-2-methoxyphenol. | 1 kg ae 1.124 kg | Sodium Cyanide 0.416 kg | 3. | Methyl Tetra Butyl 0.25 kg | Ether _ RA concerned may take further necessary action as per above decision of NC. |
| Case No.:210/10/82———PartyName:ROOPA——=S/Meet No/Date:10/82-. Status: | ALC4/2018 INDUSTRIES LIMITED ‘ALC4/2018 ‘Deferred 16.10.2018 32 HQ File | ORLA File ~ Lic.No/Date:0910065274 Defer Date: — :01/82/050/00497/AM 19/ :09/24/040/00192/AM 18/ 14.07.2017 | Decision: The Committee considered the case as per agenda and it was decided to call from the firm % | | purity of import item and Certificate of Analysis (COA) from foreign supplier. |
‘Case No.:153/10/82Party Name:GLAND PHARMA Meet No/Date:10/82Status: — ALC4/2018 LIMITED ALC4/2018 Deferred 33 HQ File RLA File -_Lic.No/Date:0910065562 ‘Defer Date: ~ 101/82/050/00440/AM19/ 109/24/040/00336/AM 18/ 17.10.2017 | Decision: The Committee considered the case as per agenda and it was decided to call from the firm | complete technical details as per appendix 4E and copy of Drug Manufacturing Licence (DML).
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|| -CaseNo.:162/10/82-<br>PartyName:AUROBINDO_ MeetNo/Date:10/82-<br>Status:<br>ALC4/2018<br>PHARMA LIMITED<br>‘ALC4/2018<br>Approved<br>}<br>|<br>(16.10.2018|||||
|---|---|---|---|---|
||<br>HQ File<br>RLA File<br>Lic.No/Date:0910065557_<br>|<br>:01/82/050/00449/AM19/<br>:09/24/040/00332/AM 18/<br>17.10.2017<br>|||<br>|||||
||<br>(Decision:<br>|TheCommittee considered case as peragendaand in the presence ofthe technical experts, it|||||
||<br>was decided to ratify the ad-hoc input output norms under para 4.7 ofHBP as per details below or as applied|||||
|by firm whichever is lower:||||||
||<br>|<br>Exportproduct<br>Qty.<br>Sl.<br>| Import items<br>Qty.|||||
||<br>No.|||||
|つ<br>|<br>AMPICILLIN<br>SODIUM| 1kg<br>Sulbactam Acid<br>0.328kg<br>|<br>| STERILE & SULBACTAM<br>6-Amino PenicillanicAcid(6-<br>0.462kg<br>|<br>| SODIUM<br>STERILE<br>(2:1)<br>/<br>APA)<br>|<br>AMPICILLIN<br>AND<br>D(-)Alpha Phenyl GlycineBase | 0.350kg<br>|<br>SULBACTAM<br>FOR<br>(PGBase) _<br>34<br>| INJECTION<br>(2:1)<br>SodiumThiocyanate<br>0.192kg<br>| |CONDITION:<br>THE<br>Activatedsma(Carbon<br>0.003kg<br>i<br>noanticromos<br>|<br>|<br>RESULTANT<br>PRODUIT<br>Penicillin<br>GAmidase (Particle<br>0.003 kg<br>_ |SHOULD BE EXPORTED IN<br>size250 -500 micron, Creamish<br>_<br>|<br>10,000 NOS OF INPUT AT<br>to Brown regularly shaped beads)||<br>|||||
||<br>SL.NO.11<br>OF IMPORT LIST<br>or|||||
||<br>AND THAT SHOULD GET<br>(Immobilized Acylase Enzyme)<br>|<br>| REFLECTEDIN SBS.<br>Xinase<br>|<br>|<br>ook<br>|<br>|<br>Ps<br>Acetonitiie<br>__———SS—=*d«6ST<br>|<br>|<br>F9 | Isopropyl Alcohol (IPA)<br>1.12ke<br>|<br>“10 [Methanol<br>«2K<br>Aluminium Canisters/Bottles with | As|per||<br>|<br>|.|||
||<br>|<br>Chloro Butyl Plug/Inner&other | relevant<br>|<br>|<br>lid andGasket/Alu Caps<br>packing<br>[20 Ltrs (10 KgCap)& 14 Ltrs (<br>olic<br>|<br>5 KgCap ]<br>poney|||||
|__RA may take appropriate action as perthe decision ofNorms Committee.|||||
|"(CaseNo.:176/10/82-.<br>—~—~—~PartyName:AUROBINDO MeetNo/Date:10/82-.<br>Status:<br>|<br>(|ALC4/2018<br>PHARMALIMITED<br>“ALC4/2018<br>Approved<br>|<br>|<br>|<br>16.10.2018|||||
|HQ File<br>OO<br>RLA File -<br>~<br>Lic.No/Date:0910065558<br>—<br>101/82/050/00463/AM<br>19/<br>':09/24/040/00339/AM 18/<br>17.10.2017|||||
|_<br>Decision:<br>The Committee considered case as peragenda and in the presence ofthe technical experts,<br>it<br>|<br>wasdecided to ratify the ad-hoc input outputnorms underpara4.7 ofHBP as perdetails below oras applied||||||
|35 by firm whichever is lower:|||||
||<br>|<br>Export product<br>Qty. | SI.<br>Import items<br>Qty.|||||
|No.<br>|<br>CEFUROXIME<br>AXETIL| 1kg<br>7-Aminocephalosporanic acid(7-ACA)| 9.769kg<br>_ |CRYSTALLINE<br>2<br>(Z)-2-Methoxy Imino(Furyl-2-YL)<br>0.615 kg<br>|<br>Acetic AcidAmmonium Salt(SMIA)<br>_<br>Chlorosulfony!Isocyanate<br>0.475kg||||||
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Enoanticromos) | | _ _ | [9 [ NiN-Dimethyl Acetamide —~( 433k | RA may take appropriate action as per the decision of Norms Committee. | Case No.:151/10/82Party Name:EMMENNAR Meet No/Date:10/82-—Status: | — ALC4/2018 PHARMA PRIVATE ALC4/2018 Approved ‘LIMITED 16.10.2018 | HQ File — RLAFile Lic.No/Date:09 10065570 | ~ 101/82/050/00438/AM19/ :09/24/040/003 16/AM18/ 18.10.2017 | | 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: _ | Export product Qty. | SL Import items Qty. | HYDROCHLORIDE BENZENE | | | [TETRAHYDROFURAN [050k i | CAUSTIC POTASH FLAKES Not shown in = |. | ‘io [ METHANOL ___RA may take appropriate action as per the decision——S~CCOOof Norms Committee. Case No.:177/10/82Party Name:HETERO LABS Meet[No/Date:10/82-.][Status:] _ ALC4/2018 LIMITED ALC4/2018 Approved 16.10.2018 HQ:01/82/050/00464/AMFile RLA File - Lic.No/Date:09 10065568 | 19/ 09/24/040/00363/AM 18/ (18.10.2017 | | Decision: The Committee considered caseas 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 37 by firm whichever is lower: | Export product Qty. | SI. Import items Qty. allowed | | 1-[4-(PYRIDINE-2I kg 0.505 kg | YL)PHENYL]-5(S)-2,5HYDROXY-4-PHENYL BUTYL)| | CARBONYL)-AMINO]-BIS[(TERT.BUTYLOXY- a N-ISOBUTYL-4-AMINOBENZENE SULFONAMIDE a |
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~«, || [4(8)-HYDROXY-6~ Methylene Chloride ee | | | PHENYL-2-AZAHEXANE Isopropyl Alcohol 1.35 kg | | RA may take appropriate action as per the decision of Norms Committee. | | CaseNo.:193/10/82- ~—~Party Name: HETERO LABS Meet No/Date:10/82Status: ALC4/2018 LIMITED ALC4/2018 Approved | 16.10.2018 HQ File RLA File Lic.No/Date:0910065569 :01/82/050/00480/AM 19/ :09/24/040/00362/AM 1 8/ 18.10.2017 | _ 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: 38 : ~ | Export product Qty. | SI. Import items Qty. | | | 5-O-Trityl -2,3-anhydrothymidine | 1 kg Betathymidine 0.60 kg | Triethyl amine 0.79 kg | | Trityl chloride 0.794 kg | Methane sulfonyl! chloride 0.31 kg | Tetrabutyl ammonium bromide 0.035 kg CN 8K | | [6 | Toluene _ RA may take appropriate action as per the decision of Norms Committee.
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----- Start of picture text -----<br> / Case No.:152/10/82- ~—~—~PartyName:DIVIS. —SM Meet No/Date:10/82-. Status:<br>‘ALC4/2018 PHARMACEUTICALS ALC4/2018 Approved<br>PRIVATE LIMITED 16.10.2018<br>| HQ File RLA File ~ Lic. No/Date:09 10065585<br>~.101/82/050/00439/AM 19/ :09/24/040/00348/AM 18/ 24.10.2017<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>39<br>| | Export product Qty. | SI. Import items Qty. |<br>| | No.<br>| Alpha-(Methyl Amine) — Ethyl | 1 kg Benzeldehyde 1.72 kg<br> | Benzene Methanol Iso Propyl Acetate 0.78 kg<br>| | Palladium 0.002 kg<br>| Paraformaldehyde 0.40 kg |<br>| L6ke |<br>|| | | 6 | Sodium Boro Hydride 0.11 kg<br>| (RA may take appropriate action as per the decision of Norms Committee.<br>Case No.:195/10/82-. ~~Party Name:SPANSULES Meet No/Date:10/82- _|Status:<br>| ALC4/2018 FORMULATIONS ALC4/2018 Deferred<br>| 16.10.2018<br>40HQFile RLAFile ~Lic.No/Date:0910065592 [Defer Date:<br>| :01/82/050/00482/AM19/ :09/24/040/00351/AM18/ 25.10.2017<br>| Decision: ~The Committee considered the case as per Agenda and it was decided to call for following<br>----- End of picture text -----<br>
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----- Start of picture text -----<br> ; fnformatsay Rereneree menea Bea ee ;<br>| | (i) Copy of Drug Manufacturing Licence showing approved composition of Export Product.<br>| (ii) Amend the description of Export Product in line with DML. |<br>~ |Case No.:143/10/82-.—=—sPartyName:RACHEM ~—S(Meet No/Date:10/82- Status:<br>ALC4/2018 PHARMA LIMITED ALC4/2018 Approved<br>HQ File ~ ~ RLA File ~ Lie.No/Date:0910065595 | |<br>:01/82/050/00430/AM19/ :09/24/040/00360/AM 18/ 26.10.2017 |<br>‘Decision: |The Committee considered case as per agenda and in the presence of the technical experts, it<br>41 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. Import items Qty.<br>__ | KETOPROFEN SR PELLETS 65% KETOPROFEN 0.6565 kg |<br>| |RA may take appropriate action as per the decision of Norms Committee. |<br>Case No.:144/10/82- Party Name:TAGOOR —sOMeeet No/Date:10/82- —Status: |<br>ALC4/2018 (CHEMICALS ALC4/2018 ‘Approved |<br>| 16.10.2018<br>HQ File RLAFile Lic.No/Date:09 10065633 |<br>:01/82/050/0043 1/AM19/ :09/24/040/00367/AM 18/ 02.11.2017 |<br>| Decision: ~ The Committee considered case as per agenda and in the presence of the technical experts, it<br>0 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> | 2-Chloromethyl-3, 4 dimethoxy pyridine | 1 kg | 1 MALTOL 0.91 kg |<br>hydrochloride |<br>_ RA may take appropriate action as per the decision of Norms Committee. |<br>| aie ema Partya ee ec ;<br>ALC4/2018 INGRAM LTD, ALC4/2018 ‘Approved |<br>| 16.10.2018 |<br>HQ File RLA File Lie. No/Date:0710112431<br>:01/82/050/00596/AM 19/ :07/24/040/002 15/AM18/ 20.11.2017 |<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>43 by firm whichever is lower:<br>Export product Qty. Sl. | Import items Qty.<br>| No. |<br>| NORFLEX 100MG TABLETS 1 Tablet ORPHENADRINEBP/EP/USP/PH.EURCITRATE mg/tablet102.00 |<br>| 2 EP/PH.EURLACTOSE USP/NF/ BP/ mg/tablet167.00 |.|<br>----- End of picture text -----<br>
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| 3 | ETHYL CELLULOSE N100 - 20.00 | | BP/EP/USP/Ph.EUR/USNF mg/tablet |. __|RA may take appropriate action as per the decision of Norms Committee. | (Case No.:112/10/82‘Party Name:AMINES _ ALC4/2018 PLASTICIZERS LIMITED& ‘ALC4/2018Meet No/Date:10/82‘ApprovedStatus: | i | | 16.10.2018 | HQ File RLA File } ~ Lic.No/Date:0310817501. | _ :01/82/050/00399/AM 19/ :03/94/040/00692/AM 18/ 05.12.2017 | Decision: |The Committee considered case as per agenda and in the presence of the technical experts, it 44 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. | | N-METHYL MORPHOLINE (NMM) MORPHOLINE 1.001 kg |. __RA may take appropriate action as per the decision of Norms Committee.
__|RA may take appropriate action as per the decision of Norms Committee.
[ ‘Case No.:209/10/82Party Name:AMILIFE Meet No/Date: 10/82Status: | | ALC4/2018 SCIENCES PRIVATE ALC4/2018 Approved || LIMITED 16.10.2018 | HQ File } RLA File Lie. No/Date:34 10043683 | | 101/82/050/00496/AM 19/ :34/24/040/00219/AM18/ 07.12.2017 | Decision: The Committee considered case as per agenda and in the presence of the technical experts, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied ____by firm whichever is lower:
45 : | "> [Export product Qty. | Sl. | Import items Qty. No. | | DOXOFYLLINE. 1 kg ANHYDROUS 0.80 kg | WHITE CRYSTALLINE POWDER. LOD: THEOPHYLLINE. | | NMT 1.0% W/W ASSAY BY HPLC: MOWDER Loo NIT 0.5%, | || BETWEEN 98%0 TO 101.00%0, W/W (ON W/W ASSAY.oe 70 | |_| | DRIED BASIS) BETWEEN 98.0% TO | | | 101.0% | | _RA may take appropriate action as per the decision of Norms Committee.
(Case No.:158/10/82—~—~Party Name:DIVIS . "|Meet No/Date: 10/82Status: — ALC4/2018 LABORATORIES LTD ALC4/2018 Approved | | HO ————————— RLA File’A DESTED | :01/82/050/00445/AM19/ :09/24/040/00452/AM 18/ 19.12.2017 | 46 Decision: |The Committee considered case as per agenda and in the presence of the technical experts, it. | ‘was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied || _ _ by firm whichever is lower: ; | No.
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FUMARALDEHYDE BIS (DIMETHYL | 1kg|1 METHANOL 3.43 kg | ACETAL) | FURAN | 0.60 kg _ RA may take appropriate action as per the decision of Norms Committee. |
~ (Case No.:159/10/82~—~—~—~«@Party Name:HETERO LABS Meet No/Date:10/82Status:_ — ALC4/2018 LIMITED ALC4/2018 Approved 16.10.2018 | | Re —— ee eenne ete era —— ee ooo) | :01/82/050/00446/AM19/ :09/24/040/00478/AM 18/ 19.12.2017 | 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 | 47 by firm whichever is lower: |
Export product Qty. | Sl. | Import items Qty. No. | _ | Capecitabine 1 kg | 1 2,3-Di-O-Acetyl-5-Deoxy-51.19 kg | | Fluorocytidine n-Pentyl Chloro Formate 0.813kg |. RA may take appropriate action as per the decision of Norms Committee. | Case No.:160/10/82-—~«sParty Name:HETEROLABS Meet No/Date:10/82-. Status: ALC4/2018 LIMITED ‘ALC4/2018 Approved | | | (16.10.2018 HQ File LA File — Lic.No/Date:09 10065763 | _ :01/82/050/00447/AM19/ :09/24/040/00479/AM 18/ (19.12.2017 | 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: | Export product Qty. | Sl. | Import items Qty. No. Terbinafine Hydrochloride 1 kg }1 | 1-Chloro-6,6-dimethyl-2-hepten-4-yne 0.87 kg || | MethyleneDimethyl FormamideChloride 2.370.85 kgkg | || Diisopropyl Ether 1.30 kg |
~ Case No.:1/10/82-ALC4/2018 Party Name:JNP PRODUCTS Meet No/Date:10/82-. Status: ALC4/2018 Approved | 16.10.2018 HQ File RLA File . " Lic.No/Date:34 10043718 | _ :01/82/050/00288/AM19/ :34/24/040/00255/AM18/ (20.12.2017 | | 49 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. 1/82-ALC4/2018, dated 01.05.2018 in respect of M/s JNP Products against Advance Authorization No. 3410043487 dated 19.09.2017, 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:
19
| | Spon+ = aoe _ a ee ae saaatetias, | | Para Amino Phenol 1kg | Para Nitro Chloro Benzene 1.222 kg | RA may take appropriate action as per the decision of Norms Committee. | "lease Nowioanogac = =e NGMOVIRGHOW MeaNoDaiel0ga2 Stet _ ALC4/2018 PETROCHEMICAL PVT ALC4/2018 ‘Rejected i | LTD. (16.10.2018 | 50 HQ File RLAFile = ~~—~—~—_Lic.No/Date:0910065770 | _ :01/82/050/00481/AM19/ :09/24/040/0037 1/AM18/ 20.12.2017 ‘Decision: The Committee observed that firm was call for PH before the committee for similar cases, but | the firm neither attended the PH nor submit their reply. Hence the Committee decided to reject the case. / (Case No.:145/10/82Party Name:AUROBINDO —sMeeet No/Date:10/82Status: _ ALC4/2018 PHARMA LIMITED ALC4/2018 Approved HQ File RLA File , Lic.No/Date:09 10065792 | _ :01/82/050/00432/AM 19/ :09/24/040/00463/AM18/ 26.12.2017 | 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: Export product Qty. | SI. | Import items Qty. | Sl. No. | |MEROPENEM FOR | 1 kg Meropenem Trihydrate (Non Sterile) I.P. | 0.9586 kg | | INJECTION (MEROPENEM 2 Activated Carbon (Carbon 0.0188 kg | | STERILE) Enoanticormos) Condition: The firm should 2.64kg | | | account for 1,000 Nos. of input (4 [Methanol 0.0958 kg | _ | at SLNo.5 of the Import List in 5 Aluminium Canisters / Bottles with Relevant | | packing the export product Chloro Butyl Plug/ nner oeLid as per | which should be reflected in ane 7 asket / Alu Caps [ MS fee packing | | gps. Pp policy _ RA may take appropriate action as per the decision of Norms Committee. _ (Case No.:149/10/82Party Name:ORCH — "Meet No/Date:10/82Status: — ALC4/2018 LABORATORIES INDIA ‘ALC4/2018 Approved : | PVT LTD 16.10.2018 | HQFile RLAFile Lic.No/Date:09 10065788 | ':01/82/050/00436/AM19/ :09/24/040/00442/AM18/ (26.12.2017 | | Decision: |The Committee considered case as per agenda and in the presence of the technical experts, it 52. 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. | | | | L-Menthyl Glyoxylate Hydrate | 1 kg fl | Glyoxylic Acid 50% 0.752kg | | (MGH) L (-) menthol 0.795 ke |
20
~
| T S$. SG———- sec fate | | RA may take appropriate action as per the decision of Norms Committee. Case No.:175/10/82~ Party Name:STYRAX — Meet No/Date:10/82Status: _ ALC4/2018 PHARMA PRIVATE ALC4/2018 ‘Approved | HQ File |RLAFile | _ Lic.No/Date:09 10065793 | | —101/82/050/00462/AM19/ :09/24/040/00472/AM 1 8/ 26.12.2017 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: |
| Export product Qty. | Sl. | Import items Qty. 53 | No. | | 1-(2,2-dimethoxyethyl)-51 kg methyl-4-methoxy acetoacetate 0.75 kg | _ | methoxy-6-(methoxycarbonyl) dimethy! formamide dimethy] acetal 0.735kg |, | 4-oxo-1,4(dmf-dma) | acid (DSS) dimethyl! oxalate 1.515 kg | lithium hydroxide monohydrate 0.323 kg | | _methylene di chloride (mdc) 3.375 kg |, __ RA may take appropriate action as per the decision of Norms Committee. | Case No.:221/10/82~ |Party Name:TRANSPEK ‘Meet No/Date:10/82‘Status: _ ALC4/2018 INDUSTRY LIMITED ‘ALC4/2018 Approved | | | | 16.10.2018 | | | none Se ir RUA File mi ifRS[ARMECTTTTOOE][|] | ~ :01/82/050/00508/AM19/ :34/24/040/00217/AM18/ 26.12.2017 | | | Decision: |The Committee considered case as per agenda and in the presence of the technical experts, it 54 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. | i No. | VALERYL CHLORIDE n-VALERIC ACID LIQUID 0.973 kg |. _ RA may take appropriate action as per the decision of Norms Committee. ~~ Case No.:136/10/82~—~—~—~s~PartyName:VEGESNA —s Meet No/Date:10/82-. Status: — ALC4/2018 LABORATORIES PRIVATE ALC4/2018 Approved LIMITED 16.10.2018 HQ File . RLAFile Lic.No/Date:09 10065803 | :01/82/050/00423/AM19/ :09/24/040/00493/AM 18/ (29.12.2017 | '55 Decision: The Committee considered case as per agendaand in thepresence 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. i No. |
21
«,
|_| | FORMAMIDIN ACETAT ORTHOFORMATE | | RA may take appropriate action as per the decision of Norms Committee. |
Case No.:192/10/82‘Party Name:HETERO LABS Meet No/Date:10/82Status: | (ALC4/2018 ‘LIMITED ALC4/2018 Approved i | 16.10.2018 Lie. No/Date:09 10065806 -HQFile RLA File — :01/82/050/00479/AM 19/ :09/24/040/00486/AM 18/ (29.12.2017 | | | |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: | | Export product Qty. | SI. Import items Qty. Tks 56 [[@RaisySeamino-T2-|] | pyFimidinyd-1.3| eeid(28,5R)- methyl ester
_ —
(Case No.:171/10/82Party Name:AUROBINDO Meet No/Date:10/82Status: ALC4/2018 PHARMA LIMITED ALC4/2018 Approved 16.10.2018 HQ File OO ) RLA File - ) . ~ |Lic.No/Date:09 10065808 :01/82/050/00458/AM19/ 109/24/040/00460/AM18/ 01.01.2018
| :01/82/050/00458/AM19/ 109/24/040/00460/AM18/ 01.01.2018 _ 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 | __ by firm whichever is lower:
==> picture [458 x 182] intentionally omitted <==
----- Start of picture text -----<br> || | Export product Qty. | SI. Import items Qty.<br>37 ViMIBENEM AND | Tke [1 |BicyelioKetoester<br>| Hydrochloride== TS26KB<br>| ciLastaTin sopium| [| Cysteammine [056ke |<br>(1) FOR INJECTION 3 [Diphenyt Choro Phosphate | 1292kg ‘|<br>Carboxamide<br>| |<br>i Ga al<br>| [oeCarbon) |<br>; | (or) Alpha-Keto Ester<br>----- End of picture text -----<br>
22
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----- Start of picture text -----<br> |<br>|<br>|<br>----- End of picture text -----<br>
[10 [AcetoneSSK "16 |Tetrahydrofuran———SSS—=d TSK Aluminium Canisters / Bottles with | As per relevant | Lid and Gasket / Alu Caps [14 Ltrs (5Kg Cap)] RA may take appropriate action as per the decision of Norms Committee. | _ Case No.:183/10/82Party Name:PORUS Meet No/Date:10/82‘Status: - ALC4/2018 ‘LABORATORIES PRIVATE ALC4/2018 Approved | | LIMITED (16.10.2018 | | | HQ:01/82/050/00470/AM19/File — RLA:09/24/040/00483/AMFile 18/ Lic.No/Date:09(01.01.2018 10065807 | | _ 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 on net to | net basis as under: 58 | | QUINOLINYL)ETHENYL}}-3-CHLORO?2kg 2-QUINOLINYL)ETHENYL)PHENYL)-3kg | i [2-(1-HY DROXY-1-METHYL HYDROXYPROPYL)PHENYL)| | | ETHYL)PHENYL]-12-PROPANOL(CRUDE) | PROPANOL | _ RA concerned may take further necessary action as per above decision of NC | _ Case No.:184/10/82‘Party Name:DASAMI LAB Meet No/Date:10/82Status: _ ALC4/2018 PRIVATE LIMITED ALC4/2018 ‘Approved | 16.10.2018 | | HQ File RLA File ‘Lic.No/Date:09 10065811 | :01/82/050/00471/AM19/ :09/24/040/00470/AM 18/ 01.01.2018 | _ 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 | by firm whichever is lower: 59 | Export product Qty. | SL. Import items Qty. | Monohydrate (acetyloxy)ethoxy]methy1!]-6H-purin-6| one/ Diacetyl Acyclovir | | 2}[13-Dieyclohexyl] carbodimide | 1067 ka]
23
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| (Case No.:133/10/82~~~ Party Name:S VLABS PVT—Meet No/Date:10/82Status: _ ALC4/2018 LTD ALC4/2018 Approved ~ \Lic.No/Date:0910065818 | HQ File RLA File | :01/82/050/00420/AM 19/ ::09/24/040/00499/AM 18/ 02.01.2018 | 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 | by firm whichever is lower:
- : | Export product Qty. Sl. Import items Qty. || (2R,5S)-(1R,2S,5R)-2isopropyl-2I kg No. 5-Fluoro Cytocine allowed0.50 kg | _ | methylcyclohexyl5-(4-amino-5fluoro-2| | oxypyrimidia-1(2H)—yI-1,3-oxathiolane-2| | | | carboxylate (FCME) | | RA may take appropriate action as per the decision of Norms Committee. | ‘Case No.:137/10/82Party Name:OPTRIX / ‘Meet No/Date:10/82- Status: | (ALC4/2018 LABORATORIES PRIVATE ALC4/2018 Approved | ‘LIMITED 16.10.2018 | HQ File ; RLA File - ~ Lic.No/Date:09 10065813 | :01/82/050/00424/AM 19/ :09/24/040/00469/AM 18/ 02.01.2018 | ‘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 61 by firm whichever is lower: | Export product Qty. | SI. Import items Qty. | | TEDIZOLID PHOSPHATE| 1 kg (R)-3-(3-fluoro-4-(6-(2-methy1-2H1.015 kg | | - In House tetrazol-5-yl)pyridin-3-yl)phenyl)-Si | (hydroxymethyl) oxazolidin-2-one
Case No.:138/10/82‘Party Name:OPTRIX "/Meet No/Date:10/82Status: | ALC4/2018 LABORATORIES PRIVATE ALC4/2018 Approved — | LIMITED 16.10.2018 | | fH Filea ee a Toe | :01/82/050/00425/AM 19/ :09/24/040/00468/AM 18/ 02.01.2018 | Decision: The Committee considered case as per agenda and in the presence of the technical experts, it. 62 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. _ | LINEZOLID 1 kg 3,4-Difluoro nitrobenzene OR 3,4 Di | 0.80 kg ; | fluoro nitrobenzene
24
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| i| ——o4] SSO(chloromethyl)oxirane- a7 aS 80Ko3—_ = | ‘RA may take appropriate action as per the decision of Norms Committee. =e ~ Party Name-SRINT <a M=e caine -| _ ALC4/2018 PHARMACEUTICALS ‘ALC4/2018 Approved | PRIVATE LIMITED 16.10.2018 HQFile ~~~ RLAFile Lic.No/Date:0910065816 | 01/82/050/00426/AM19/ :09/24/040/00477/AM 18/ 02.01.2018 | | | 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 | 63 by firm whichever is lower: | _ | Export product Qty. | SL Import items Qty. | _ | CLONAZEPAM 1 kg 2-AMINO-5-NITRO-2-CHLORO 1.33 kg | BENZOPHENONE | | | BROMO ACETYL BROMIDE L18kg | __ RA may take appropriate action as per the decision of Norms Committee. "Case No.:186/10/82~~ [Party Name:SUVEN LIFE Meet No/Date:10/82Status: _ ALC4/2018 ‘SCIENCES LIMITED ALC4/2018 Approved | | HOan “REA File cacti is coc "=e | ~-:01/82/050/00473/AM 19/ ':09/24/040/00492/AM18/ 02.01.2018 | | Decision: |The Committee considered case as per agenda andin the presence of the technical experts, it ____ wasby firm decidedwhichever to ratifyis thelower:ad-hoc input output norms under para 4.7 of HBP as per details below or as applied | (64 | | Export product Qty. | No.SI. Import items Qty. || | METHYL (E)-2-2- | 1kg [1 | 3-ISOCHROMANONE 0.957kg |. | | CHLOROMETHYLPHENYL)O-XYLENE 1.04kg |, | | 3:METHOXYACRYLATE SODIUM METHOXIDE POWDER _| 0.416kg |. I | METHANOL 231kg | **** RA may take appropriate action as per the decision of Norms Committee. |
[Case No.:163/10/82Party Name:KOPALLE (Meet No/Date:10/82‘Status: — ALC4/2018 PHARMA CHEMICALS ALC4/2018 ‘Approved | PVT.LTD., 16.10.2018 | | HQ File RLA File ~ Lic.No/Date:09 10065827 — 101/82/050/00450/AM19/ :09/24/040/00456/AM18/ 03.01.2018 | | [6 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: |
25
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----- Start of picture text -----<br> | METHYL ®2@[ The [1 |PATHALICANHYDRIDE<br>CHLOROMETHYLPHENYL<br>|__| | 0752 ke |<br>ACETATE<br>BENZYLDEHYDE<br>つ<br>----- End of picture text -----<br>
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| Case No.:169/10/82‘Party Name:AKTINOS Meet No/Date:10/82-. Status: _ ALC4/2018 HEALTHCARE PRIVATE ALC4/2018 Approved | | ‘LIMITED 16.10.2018 | HQ File RLA File | Lic.No/Date:09 10065825 | :01/82/050/00456/AM19/ :09/24/040/00510/AM18/ 03.01.2018 | 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 (66 by firm whichever is lower:
|
==> picture [460 x 326] intentionally omitted <==
----- Start of picture text -----<br> } | Export product Qty. | SL. Import items Qty.<br>«OST<br>— SBENZYLOXY rg [1 [EVALINE |<br>CHLOROFORMATE<br>| CARBONYL-L-VALINE "2 [BENZYL __|0.74ks |<br>«526K<br>| CBZ-L-VALINE) 3 [rowuene |<br>RA may take appropriate action as per the decision of Norms Committee.<br>| ‘Case No.:129/10/82- Party Name: TAGOOR ‘Meet No/Date:10/82- Status:<br>| (ALC4/2018 CHEMICALS (ALC4/2018 Approved<br>| 16.10.2018<br>— HQFile — RLAFile ~ Lic.No/Date:09 10065844<br>| :01/82/050/00416/AM19/ :09/24/040/00505/AM18/ 05.01.2018 |<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>'67 by firm whichever is lower: |<br>| | Export product Qty. | SI. Import items Qty. |<br>— [G-ChloropropyD13- Ike [1 | Ortho phenylene Diamine | 1.003 kg<br>| Dinydro-2H-benzimidazole-2<br>| | Lone<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.:134/10/82-—~—~—«Party Name:TAGOOR Meet No/Date:10/82Status: — ALC4/2018 (CHEMICALS ALC4/2018 ‘Deferred | 16.10.2018 — HQFile —RLAFile " Lic.No/Date:0910065845 Defer Date: | :01/82/050/00421/AM19/ ':09/24/040/00506/AM 18/ 05.01.2018 | | ‘68 ‘Decision: The Committee consideredthe caseas per Agenda and it was decided to call for following| information / documents from the firm: | | | (i) Percentage yield on molar basis for each stage of manufacturing process. | | (ii) Composition with yields shown in the technical literature enclosed in the application. | - Case No.:161/10/82~ ‘Party Name:CAMUS Meet No/Date:10/82Status: _ ALC4/2018 ‘BIOTECH PRIVATE ALC4/2018 Approved _ LIMITED 16.10.2018 | | | nO jae ~IRLAel: Lic No/Date:Sa | | ~ :01/82/050/00448/AM 19/ ':09/24/040/00440/AM 18/ 05.01.2018 | 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 | by firm whichever is lower: | 69° | | | Export product Qty. | SL. Import items Qty. [ETHAMBUTOL HCL ke [1 |DL-3-AMINO-I-BUTANOL__| L604 kg | | | RA may take appropriate action as per the decision of Norms Committee. | Case No.:182/10/82~ 'PartyName:ORCH ——s Meet No/Date:10/82-. Status: ALC4/2018 LABORATORIES INDIA PVT ALC4/2018 Approved LTD 16.10.2018 | | HQ File RLAFile ‘Lic.No/Date:09 10065855 | _ :01/82/050/00469/AM 19/ :09/24/040/00489/AM 18/ 05.01.2018 | _ Decision: |The Committee considered case as per agenda andin 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: 70 | | Export product Qty. | SI. Import items Qty. | ORIRSEHydroy{sr | Tke [1 | Ghyowglie Acid 50% «dT KE || acid.2S-Isopropyl-SR-methyl 3 [2.5-Ditydrony-1.4-Dithiane____—[ 0283 kg_| ~ | ROW) || __ RA may take appropriate action as per the decision of Norms Committee.
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| ‘ALC4/2018 (PRIVATE LIMITED ‘ALC4/2018 Approved | | | 16.10.2018 HQ File RLA File Lic.No/Date:09 10065850 | :01/82/050/00476/AM19/ :09/24/040/00501/AM18/ 05.01.2018 | Decision: |The Committee considered case as per agenda and ‘in the presence of the 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: | | Export product Qty. | SL. Import items Qty. f | No. Famciclovir 1 kg 9-(4-Acetoxy-3-(acetoxymethyl)but-I| 1.275kg | yl)-2-amino-6-chloro purine | __|RA may take appropriate action as per the decision of Norms Committee. [ ~|Case No.:181/10/82- No.:181/10/82Party Name:STYRAX Name:STYRAX Meet No/Date:10/82Status: | ALC4/2018 PHARMA PRIVATE ALC4/2018 Approved |
[ ~|Case No.:181/10/82- No.:181/10/82Party Name:STYRAX Name:STYRAX Meet No/Date:10/82Status: | ALC4/2018 PHARMA PRIVATE ALC4/2018 Approved | LIMITED 16.10.2018 HQ File RLA File ~—_LLie.No/Date:09 10065880 — 101/82/050/00468/AM 19/ :09/24/040/00522/AM18/ 11.01.2018 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 ___ by firm whichever is lower: __ | Export product Qty. | SL. Import items Qty. No. | 1-(2,2-DIMETHOXYETHYL)-51 kg 1 | METHYL-4 CHLORO ACETO 1.364kg | | METHOXY-6ACETATE | (METHOXYCARBONYL) 2 ACETONITRILE 4.50 kg _ | | 4-0X0-1,4| _ | | DIHYDROPYRIDINE-3| | CARBOXYLIC ACID (DSS) | _ RA may take appropriate action as per the decision of Norms Committee.
(Case No.:191/10/82Party Name:SRIAM LABS Meet No/Date:10/82Status: — ALC4/2018 PRIVATE LIMITED |ALC4/2018 Approved i (16.10.2018 | | — HQFile RLA File Lie, No/Date:0910065879 | | :01/82/050/00478/AM 19/ :09/24/040/0049 1/AM18/ (11.01.2018 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 | 73. by firm whichever is lower: | | Export product Qty. | SL Import items Qty. | No. | | Hydroxychloroquinesulfate(HQS-II) or 2-| Ikg pl | 4,7-Dichloroquinoline 0.723 kg | | [[4-[(7-Chloro-4-quinolyl) amino] pentyl] 2 Hydroxynovaldiamine 0.671 kg | ethylamine] ethanol sulfate (HQS) ___RA may take appropriate action as per the decision of Norms Committee. |
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|(Case<br>No.:157/10/82-<br>_<br>ALC4/2018<br>||||PartyName:VIVINDRUGS&<br>PHARMACEUTICALS<br>‘LIMITED|[MeetNo/Date:10/82-<br>‘ALC4/2018<br>(16.10.2018||‘Status:<br>Deferred<br>|<br>||‘Status:<br>Deferred<br>|<br>||
|---|---|---|---|---|---|---|
|oe HQ File OS <br>—<br>:01/82/050/00444/AM<br>19/||—RLA File<br>7<br>:09/24/040/00508/AM18/|Lic.No/Date:0910065882<br>12.01.2018||DeferDate:<br>|||
|Decision:<br>Deferredforcomments|commentsofTE.|||||||
|CaseNo.:156/10/82-<br>|<br>(ALC4/2018<br>||<br>79 HQ File<br>]|- ‘PartyName:AURORE LIFE<br>SCIENCESPRIVATE<br>LIMITED<br>“IRLA File||MeetNo/Date:10/82-<br>‘Status:<br>‘ALC4/2018<br>Deferred<br>16.10.2018<br>Lic.No/Date:0910065896<br>DeferDate:||||<br>||
|_:01/82/050/00443/AM19/<br>|<br>(Decision:<br>F-01 aaer: [|:09/24/040/00455/AM18/<br>apooneneener<--aaeaeaaeaaeeataes||17.01.2018<br>——|||||<br>||
|CaseNo.:164/10/82-<br>ALC4/2018<br>||||_ |PartyName:AURORE<br>LIFE<br>— <br>SCIENCESPRIVATE<br>LIMITED|MeetNo/Date:10/82-.<br>ALC4/2018<br>(16.10.2018||Status:<br>‘Deferred<br>||||
|uQFile=~||~RLAFile ~~~~—~—~—~——_Lic.No/Date:0910065897|||DeferDate:||
|:01/82/050/00451/AM19/||':09/24/040/00454/AM18/|17.01.2018||||
||<br>Decision:<br>Deferred forcomments|comments of<br>TE.<br>.||.<br>7||7|||
|Case No.:168/10/82-||PartyName:OPTRIX<br>—-|MeetNo/Date:10/82-||Status:||
||<br>ALC4/2018||LABORATORIES PRIVATE|ALC4/2018||‘Deferred|||
||<br>77HQFile<br>':01/82/050/00455/AM19/||LIMITED<br>16.10.2018<br>RLA File<br>~__|Lic.No/Date:0910065892 <br>:09/24/040/00416/AM18/<br>17.01.2018||||<br> Defer Date:<br>|||<br>||
|‘Case No.:178/10/82-<br>|<br>|ALC4/2018|||PartyName:OPTIMUS<br>——_—<br>DRUGS PRIVATE LIMITED|MeetNo/Date:10/82-<br>ALC4/2018||Status:<br>)<br>‘Approved|||
||||16.10.2018|||||
|||||||||
|HQ File<br>:01/82/050/00465/AM19/||RLA File —<br>:09/24/040/00507/AM18/|‘Lic.No/Date:0910065893<br>17.01.2018||||<br>||
||<br>Decision: —The Committee||considered case as per agenda and inthepresenceof the technical experts,it|||||
|was decided to ratify the ad-hoc input output norms underpara 4.7 ofHBP as per details below or as applied||||||||
|7g by firm whichever is lower:||||||||
|| | Exportproduct||Qty. | SI.<br>Import items|||Qty.||
|||No.|||||
|LINEZOLID||1 kg<br>"3,4-Difluoro|nitrobenzene<br>OR<br>3,4|Di | 0.80 kg|||
|||fluoro nitrobenzene"|||||
||<br>|||つ<br>2<br>(s)-Epichlorohydrin<br>(OR)<br>(s)-(+)-2- |0.80kg<br>(chloromethyl)oxirane|||||<br>||
|RAmaytakeappropriate|actionasperthedecisionofNormsCommittee.|||||||
29
||<br>_|CaseNo.:185/10/82-<br>(ALC4/2018|CaseNo.:185/10/82-<br>(ALC4/2018|~~|PartyName:SUVENLIFE<br>SCIENCES LIMITED|PartyName:SUVENLIFE<br>SCIENCES LIMITED|Meet No/Date:10/82-.<br>‘ALC4/2018|Status:<br>Approved||
|---|---|---|---|---|---|---|---|---|
|||||||(16.10.2018|||
|||||||||||
|HQ File||||RLA File|Lie.|No/Date:0910065901|||
|||:01/82/050/00472/AM19/|||:09/24/040/00526/AM18/||17.01.2018|||
|Decision:|||The Committee considered case|||asper agendaand|in the presence ofthe technical experts, it|||
|_|was decided|to ratify the ad-hoc||input output|norms under para 4.7 ofHBP as per details below or as applied||||
|**__**|by firm whichever is lower:||||||||
|79|Exportproduct|||Qty.<br>| SI.|Import items||Qty.|||
|||DOXOFYLLINE|||1kg [1|| THEOPHYLLINE||0.80kg||
|||||つ<br>2|CHLOROACETAL DEHYDE||0.80kg||.|
||||||||DIMETHYLACETAL|||||
||||||POTASSIUMCARBONATE|CARBONATE|0.610 kg||
|||||||METHANOL||0.63 kg||
|||||||DIMETHYLFORMAMIDE||0.40kg||
__/RA may take appropriate action as per the decision of Norms Committee.
/ (Case No.:190/10/82-—=—PartyName:STYRAX — — MeetNo/Date:10/82Status: — |ALC4/2018 PHARMA PRIVATE ALC4/2018 Approved LIMITED 16.10.2018 | eR:ea Tt) aCe | :01/82/050/00477/AM 19/ :09/24/040/00530/AM 18/ 17.01.2018 | 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 _ _ by firm whichever is lower: | Export product Qty. | SI. Import items Qty. P| No. | 1-(2,2-dimethoxyethyl)-5- | 1 kg METHYL-4-METHOXY ACETOACETATE| 0.750 kg | | methoxy-6Dimethyl] Oxalate 1.515kg | || | (methoxycarbonyl) 4-oxo3 Methylene Di Chloride (MDC) 3.395 kg 1 ,4-dihydropyridine-3| carboxylic acid (DSS) | | _RA may take appropriate action as per the decision of Norms Committee. - CacNausg Party NameRRSL ea Sa _ ALC4/2018 PVT. LTD. ALC4/2018 Approved | HQ File ee ~—RLAFile ~ |Lic.No/Date:0710112701 | :01/82/050/00569/AM19/ :07/24/040/00337/AM17/ (18.01.2018 | | 81 Decision:| The Committee considered caseas per agenda and _ in the presence of the technical experts, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied | by firm whichever is lower: | No. |
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~
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----- Start of picture text -----<br> | [NORTRIPTYLINE HCL ]1kg [1 | 1BROMO3CHLORO PROPANE | 0.96kg |,<br>| IP/BP/USP TETRA HYDRO FURAN O71 kg |<br>_ RA may take appropriate action as per the decision of Norms Committee. |<br>"Case No.:154/10/82- ——(Party Name:GLAND ~ [Meet No/Date:10/82- Status:<br>| ALC4/2018 PHARMA LIMITED ALC4/2018 ‘Approved |<br>| HO Fie caceaa <7<a ania Lic. No/Date-0910065903 | |<br>—:01/82/050/00441/AM19/ :09/24/040/00519/AM 18/ 19.01.2018 | |<br>| wasDecision:decided to|TheratifyCommitteethe ad-hocconsideredinput outputcase normsas per agendaunder paraand4.7inofthe HBPpresenceas perofdetails the technicalbelow orexperts,as appliedit<br> _ by firm whichever is lower: |<br>~ | Export product Qty. Sl. | Import items Qty.<br>| No. |<br>| Palonosetron Hydrochloride 950000 Palonosetrron Hydrochloride IH | 261.25gm_— |.<br>| Injection, 0.05mg/ml, of Number Barrel Syringes Glass Relevant |<br>| | Palonsetron base 5m fill in Sml Plunger Stoppers Rubber packing |<br>|| Prefilled Syringe Plunger Rods Plastic policy<br>| | | JH Tubing Plastic Consumables |,<br>|| 16 | Filters Plastic not allowed |.<br>RA may take appropriate action as per the decision of Norms Committee. |<br>(Case No.:155/10/82- ‘Party Name:GLAND Meet No/Date:10/82- Status:<br>— ALC4/2018 ‘PHARMA LIMITED ALC4/2018 ‘Approved<br>mole coer 71 <7a ——— Lic No/DaeS THLE |<br>_— :01/82/050/00442/AM19/ :09/24/040/005 18/AM18/ 19.01.2018 |<br>Decision: | The Committee consideredthe 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. 1/82-ALC4/2018, dated 01.05.2018, it was”<br>_firmdecidedwhicheverto ratifyisthelower:ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by|<br>83 | Export product Exp. Qty. | Sl. | Import items Qty. Allowed |<br>| | No. |<br>| Voriconazole Powder for | 1 Number Voriconazole USP 210 mg/vial |<br>| Injection 200 mg /Vial, 30 Kleptose NF 3200 mg/vial<br>| ml Vial USP Vials Glass Relevant as per |<br>Rubber Stoppers Rubber | packing policy<br>i Seals Plastic |<br>i | Filters Plastic Consumables not |<br>allowed<br>| 7 Tubing Plastic Not allowed under |<br>__. RA may take appropriate action as per the decision of Norms Committee.<br>"(Case No.:172/10/82- -—~—~Party Name:VIVIMED LIFE Meet No/Date:10/82- Status:<br>ALC4/2018 ‘SCIENCES PRIVATE ALC4/2018 Approved<br>84. ‘LIMITED (16.10.2018<br>| HQ File RLA File ~Lic.No/Date:09 10065909<br>:01/82/050/00459/AM 19/ :09/24/040/00520/AM 18/ 19.01.2018<br>Ｓ‐<br>----- End of picture text -----<br>
; 81
‘Decision: ~The Committee considered the case as per agenda in the presence of Technical Experts and in | the light of earlier decision taken by NC in its Meeting No. 8/82-ALC4/2018, dated 31.08.2018, it was. | decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by | | firm whichever is lower: | | Export product | ‘Losartan Potasium Tablets USP (Losartan) 50 Mg, 100 Mg |
==> picture [467 x 541] intentionally omitted <==
----- Start of picture text -----<br> | | SL Import items Norms Recommended for one Tablet<br>_ | No. 50 Mg Tablet 100 Mg Tablet<br>| | Losartan Potassium (or) Losartan 51 mg 102 mg<br>; | Potasium USP |<br>| |.2__| Mannitol (Pearlitol 160C) 203.8 mg 407.6 mg<br>| | 3 Microcrystalline Cellulose (Avicel PH | 81.0 mg 162 mg<br>| | 102) |<br>4 | Croscarmellose Sodium (Ac Di Sol) 108 Tg SA eiede |<br>| iz Povidone(PLASDONE K-29/32) Fang amg<br>| Magnesium Stearate (Mallinckrodt 3.6 mg 7.2 mg<br>2257) |<br>| ‘RA may take appropriate action as per the decision of Norms Committee.<br>"Case No.:165/10/82- ~—~—~Party Name:AURORE LIFE — Meet No/Date:10/82- —-Status:Case<br>_ ALC4/2018 ‘SCIENCES PRIVATE ALC4/2018 Added<br>; | LIMITED (16.10.2018 |<br>SSgFile | RLAFile ~ ~—~—~—Lic.No/Date:0910065915 Defer Date:<br>| |:01/82/050/00452/AM19/ ':09/24/040/00438/AM18/ 20.01.2018 | |<br>| Decision: Deferred forcommentsofTE. 7 -<br>| (Case No.:228/10/82- ~—~PartyName:SMILAX —— Meet No/Date:10/82-—Status:Case<br>| (ALC4/2018 ‘LABORATORIES LIMITED ALC4/2018 ‘Added<br>| 16.10.2018<br>ps HQ File Oo RLA File ~—Lie.No/Date:0910065910 Defer Date: —<br>_ :01/82/050/00515/AM19/ :09/24/040/00541/AM18/ 20.01.2018<br>| eT rec Bice |<br>~~ \Case No.:206/10/82- -~—«~PartyName:GLOBAL — Meet No/Date:10/82-. Status:<br>| ALC4/2018 CALCIUM PRIVATE ALC4/2018 ‘Approved<br>| | ‘LIMITED, 16.10.2018<br>| HQ File Be RLA File Oo ~ |Lic.No/Date:07101 12728 |<br>/:01/82/050/00493/AM19/ :07/24/040/00279/AM 18/ 23.01.2018 |<br>87 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>つ<br>―<br>ｒ<br>----- End of picture text -----<br>
32
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----- Start of picture text -----<br> pe — ————<br>si ea r| : |<br>| | Calcium Pidolate L- Pyroglutamic Acid 0.82 kg<br>| | Magnesium Pidolate L- Pyroglutamic Acid 0.90 kg |<br>| _RA may take appropriate action as per the decision of Norms Committee. |<br>~~ Case No218/10/82-.~—~—~PartyName:SYNPOL ~——s MeetNo/Date:10/82-. Status:<br>— ALC4/2018 ‘PRODUCTS PVT. LTD. ‘ALC4/2018 Approved<br>| | | 16.10.2018 |<br>HQ File | — a RLA File. oe Lic.No/Date:0810141863 _ |<br>~ :01/82/050/00505/AM19/ ':08/24/040/00298/AM 18/ 23.01.2018 | |<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>lee by firm whichever is lower:<br>| Export product Qty. | Sl. | Import items Qty. |<br>| No.<br>| EPOXY HARDENER BASED ON | | kg EPOXY RESIN 0.378 kg |<br>| | ALIPHATIC AMINE EPOXY PROPYLENE GLYCOL 0.546 kg<br>| _ |ADDUCT (48% solid content) MONOMETHYL ETHER |<br>| ETHYLENE-DIAMINE 0.0735 kg<br>RA may take appropriate action as per the decision of Norms Committee. |<br>つ<br>----- End of picture text -----<br>
~~ \Case No.:179/10/82-—~—~<(Party Name:SUVEN LIFE [Meet No/Date:10/82‘Status; ALC4/2018 SCIENCES LIMITED /ALC4/2018 ‘Approved | 16.10.2018 HQ File” : RLA File - ‘Lic.No/Date:09 10065922 | _:01/82/050/00466/AM19/ :09/24/040/00534/AM 18/ 24.01.2018 | | | Decision: The Committee considered the case as peragenda in the presence of Technical Expertsand 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 Suven Life Sciences Limited against Advance Authorization No. 0910065145 dated 09.06.2017, it was | 89 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. _ | I-BROMO-2-IODOBENZENE| | kg 2-BROMOANILINE 1.086 kg | | | POTASSIUMCYCLOHEXANEIODIDE 0.7332.75 kgkg | | RA may take appropriate action as per the decision of Norms Committee. |
‘Case No.:188/10/82) Party Name:SATY ADEVA ~|Meet No/Date:10/82Status: _ ALC4/2018 PHARMACEUTICALS PVT = ALC4/2018 Deferred 90) LTD 16.10.2018 HQ File RLA File " Lic.No/Date:0910065921 (Defer Date: ——:01/82/050/00475/AM19/ ':09/24/040/00504/AM18/ 24.01.2018 | |
33
mo "
| Decision: Deferred for comments of TE
|
OO
==> picture [460 x 612] intentionally omitted <==
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|(Case|No.:141/10/82-|‘Party Name:VIVIN|DRUGS|&|Meet No/Date:10/82-|Status:|
|—|ALC4/2018|PHARMACEUTICALS|ALC4/2018|Deferred|
|i|||(LIMITED|16.10.2018|
|ie|HQ File|RLAFile|==|~~—~—~—~—_Lic.No/Date:0910065927|Defer Date:|
|||:01/82/050/00428/AM19/|:09/24/040/0053|1/AM18/|25.01.2018|
|||(Decision:|Deferred|for|comments of TE.|Seen|ieee|se|eeetea|a|e|a|_|—|
|~|[Case|No.:142/10/82-|~—~—Party|Name:|VIVIN DRUGS &|(Meet|No/Date:10/82-|‘Status:|
|||ALC4/2018|PHARMACEUTICALS|‘ALC4/2018|Deferred|||
|||||‘LIMITED|(16.10.2018|||
|9? HQ File|RLAFile|=|~—~—~—_Lic.No/Date:0910065928|Defer Date:|
|_Decision:101/82/050/00429/AMDeferred|19/for comments:09/24/040/00532/AMof TE.|-|1|8/-|29.01.2018|.|
|||(Case No.:146/10/82-|Party Name:KOPALLE|——-Meet No/Date:10/82-.|Status:|
|||(ALC4/2018|PHARMA|CHEMICALS|ALC4/201 8|Approved|
|‘PVT.LTD.,|16.10.2018|
|||HQFile|~~|RLAFile|7|Lic.No/Date:09 10065934|
|||:01/82/050/00433/AM19/|:09/24/040/00517/AM18/|29.01.2018|
|Decision:|The Committee|considered|case|as per agenda and|in the presence of the technical|experts,|it|
|93|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.|
|||Sodium|Cromoglicate|2,6-Dihydroxy|Acetophenone|1.22|kg|
|||/RA|may|take|appropriate|action|as|per the|decision|of|Norms|Committee.|
|-|\Case No.:150/10/82-—~—~—~SPartyName:INCHEM|——Meet No/Date:10/82-.|Status:|
|||ALC4/2018|LABORATORIES|PRIVATE|(ALC4/2018|Approved|
|||LIMITED|16.10.2018|
|—|HQFile|RLAFile|Lic.No/Date:09 10065933|||
|:01/82/050/00437/AM19/|:09/24/040/00540/AM18/|29.01.2018|||
|||‘Decision:|~|TheCommittee considered|case|as per agenda and|in|the|presence|of the|technical|experts,|it|||
||loa wasj|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.|
|i|No.|
|_|||Ractopamine Hel|1kg|[1|||Amino|Acetonitrile Hel|1.00 kg|
|||4-(4-Hydroxy|Phenyl|)-2-Butanone|
|||RA may take|appropriate|action|as|per the|decision|of|Norms|Committee.|
----- End of picture text -----<br>
34
~
~ (Case No.:174/10/82~~ Party Name:HETERO DRUGS Meet No/Date:10/82Status: — ALC4/2018 LIMITED ALC4/2018 Approved | | 16.10.2018 | HQ File oe REAFie Lic.No/Date:0910065931 | _ |:01/82/050/00461/AM19/ :09/24/040/00547/AM18/ 29.01.2018 | | | ‘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 | ‘by firm whichever is lower: |
_ 195 | | Export product Qty. | No.Sl. | Import items Qty. | Valacyclovir HCL/ 1 kg 2-[(2-Acetamido)6-0xo-6,9-dihydro-1H| 1.083 kg | Valacyclovir HCL purine-9-yl) methyl]ethyl Monohydrate acetate/Diacetyl acyclovir (AAEMP) | N,N-Dicyclohexyl Carbodimide 1.061kg | N,N-Dimethyl Formamide 0.70 kg | || 4-Dimethyl Amino Pyridine 0.028 kg 0.603 ks | | 0 __RA may take appropriate action as per the decision of Norms Committee. 260k || "(Case No.:213/10/82—~—“~Party Name: HETERO DRUGS /Meet No/Date:10/82- Status: — ALC4/2018 ‘LIMITED /ALC4/2018 ‘Deferred | |6 HQ File IRLA| File ] Lic.No/Date:091006593216.10.2018 [Defer Date: | _ :01/82/050/00500/AM19/ :09/24/040/00548/AM 18/ (29.01.2018 | yee aan gear ama =| _ (Case No.:148/10/82= —_—‘Party Name: VINDHYA Meet No/Date:10/82Status: ALC4/2018 ORGANICS PVT LTD ‘ALC4/201 8 ‘Approved | _ HQFile RLA File ~ Lic.No/Date:0910065952 | ——:01/82/050/00435/AM 19/ ':09/24/040/00557/AM 18/ 31.01.2018 | || Decision:was decided| Theto ratify Committeethe ad-hocconsideredinput outputcasenormsas perunder agendapara and4.7inofthe HBPpresenceas per ofdetails the technicalbelow orexperts,as appliedit by firm whichever is lower: | 97 _ | Export product Qty. | Sl. | Import items Qty. No. | AFC ABACAVIR (ABV) I lkg 2-AZABICYCLO (2.2.1) HEPT-5-EN-3- | 1.41 kg ONE; (VINCELACTAM) | ay 2 N-(2-AMINO-4, 6-DICHLORO-50.764 kg | Pd PYRIMIDINYL) FORMAMIDE | | | SODIUM BOROHYDRIDE POWDER | 0.226kg |. D(-) TARTARIC ACID 0.78 kg | | L + Tartaric Acid 1.20 kg | RA may take appropriate action as per the decision of Norms Committee.
35
_-,
|‘CaseNo.:180/10/82- ~~<br>PartyName:SUVENLIFE MeetNo/Date:10/82-.<br>ALC4/2018<br>SCIENCESLIMITED<br>'‘ALC4/2018<br>||<br>|<br>16.10.2018|Status:<br>Deferred<br>||||<br>|||||
|---|---|---|---|---|---|---|
|°8 THQ File<br>RLA File<br>~<br>|Lic.No/Date:0910065943<br>__|:01/82/050/00467/AM19/<br>':09/24/040/00539/AM18/<br>31.01.2018|DeferDate:||||||
||<br>Decision:<br>DeferredforcommentsofTE.<br>|<br>-<br>7|.|||||||
|‘CaseNo.:187/10/82-.—~—~—~«SPartyName:NISARG<br>~——SMeet No/Date:10/82-.<br>ALC4/2018<br>BIOSCIENCES PVTLTD<br>ALC4/2018<br>||<br>|<br>16.10.2018<br>°HQ File<br>RLA File<br>.<br>‘Lic.No/Date:0910065945 <br>:01/82/050/00474/AM19/<br>-09/24/040/00497/AM18/<br>31.01.2018<br>|<br>Decision:<br>‘Deferred forcomments ofTE.<br>:<br>OO<br>i|Status:<br>Deferred<br> DeferDate:<br>oo|)||||||
||<br>(CaseNo.:132/10/82-<br>—-—~—~PartyName:AURORE LIFE<br>MeetNo/Date:10/82-.<br>ALC4/2018<br>SCIENCESPRIVATE<br>‘ALC4/2018<br>|_|<br>LIMITED<br>16.10.2018|Status:<br>Deferred<br>|||||||
||<br>:01/82/050/00419/AM19/<br>:09/24/040/00516/AM18/<br>(01.02.2018<br>|<br>SoonDnEe<br>—|||||||
|(Case No.:130/10/82-<br>‘PartyName:NISARG<br>—-MeetNo/Date:10/82-<br>|<br>ALC4/2018<br>BIOSCIENCES PVTLTD<br>—ALC4/2018<br>|<br>|<br>|<br>16.10.2018<br>Ol QFile<br>~RLAFile<br>=———S—S~SCLic.Noo/Daate:0910065956<br>|<br>:01/82/050/00417/AM19/<br>:09/24/040/00496/AM18/<br>(02.02.2018<br>|<br>'Decision: DeferredforcommentsofTE.<br>SS|Status:<br>Deferred<br>Defer Date:|一||||||
|CaseNo.:131/10/82-<br>—~—~=«PartyNName:SUVEN LIFE<br>MeetNo/Date:10/82-<br>_<br>ALC4/2018<br>SCIENCES LIMITED<br>ALC4/2018<br>|<br>|<br>|<br>16.10.2018|Status:<br>Deferred<br>|||||||
|NW02nQFile<br>(RLAFile<br>~Lie-No/Date:0910065961|Defer Date:||||||
||<br>|:01/82/050/00418/AM19/<br>:09/24/040/00561/AM18/<br>(02.02.2018<br>|<br>Decision:<br>Deferred forcomments ofTE.<br>7<br>7||||||<br>|||
|~~ Case No.:135/10/82-<br>—~—~—~=SPartyNName:NISARG<br>——sMeet No/Date:10/82-<br>|<br>ALC4/2018<br>BIOSCIENCESPVTLTD —ALC4/2018<br>|<br>16.10.2018|Status:<br>Deferred||||||
|||||||||
|NOSHQFile<br>~~<br>_-RLAFile<br>Lie.<br>No/Date:0910065963 <br>|<br>:01/82/050/00422/AM19/<br>:09/24/040/00498/AM18/<br>(02.02.2018|DeferDate:<br>||||||||
||<br>Decision:<br>Deferred<br>forcommentsofTE.||||||||
36
-.
| - Case No.:283/10/82(Party Name:R.L.FINE CHEM Meet No/Date:10/82- Status: | | ALC4/2018 |PRIVATE LIMITED ‘ALC4/201816.10.2018 Approved| | HOF—= REA Filnad 1Neo | | | 101/82/050/00570/AM19/ :07/24/040/00336/AM17/ (02.02.2018 | Decision: The Committee considered case as per agenda and in the presence of the technical experts, it 104 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. | | LORAZEPAM BP/EP/USP Ikg | 1 2 AMINO 2,5 DICHLORO 1.60 kg | BENZO PHENONE
| RA may take appropriate action as per the decision of Norms Committee.
‘Case No.:284/10/82~~“ PartyName:R L FINE CHEM Meet No/Date:10/82- _Status: | ‘ALC4/2018 PVT. LTD. ‘ALC4/2018 ‘Approved | HO File eer teretteier RLA File ssc Lic No/Damer aTTER SET | | 01/82/050/00571/AM19/ 107/24/040/00339/AM17/ 02.02.2018 | ‘Decision: The Committee considered case as per agenda and in the presence of the technical experts, it | 105 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. | SIL. Import items Qty. | | No. _ | |DOXYLAMINE — SUCCINATE| 1 kg 2 ACETYL PYRIDINE 0.58 kg || | USP/EP TETRA HYDRO FURAN 1.03 kg | __RA may take appropriate action as per the decision of Norms Committee. | Case‘ALC4/2018 No.:285/10/82-. PartyPVT. Name:RLTD. L FINE CHEM Meet‘ALC4/2018 No/Date:10/82Status:‘Approved | | 16.10.2018 | HQ File RLAFile === ~—Lic.No/Date:0710112774 | | :01/82/050/00572/AM19/ :07/24/040/00338/AM17/ (02.02.2018 | | | 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 106 applied by firm whichever is lower: | Export product Qty. Sl. Import items Qty. | No. | _ | CLOMIPRAMINE HCL | 1 kg 1 BROMO 3 CHLORO 0.85 kg | | | BP/EP/USP/JP PROPANE | 2 3 CHLORO 0.91 kg IMINODIBENZYL i ‘RA may take appropriate action as per the decision of Norms Committee. |
37
—_
_ ALC4/2018 ‘PVT. LTD. ALC4/2018 ‘Approved — HQ File RLA File ~—Lic.No/Date:0710112769_ | :01/82/050/00573/AM19/ :07/24/040/00340/AM17/ 02.02.2018 | | 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" 107 applied by firm whichever is lower: ; Export product Qty. | SI. | Import items Qty. | | [CHLORPROMAZINE HCL | 1kg [1 | 1 BROMO 3 CHLORO PROPANE | 0.95 kg | | IP/BPUSP 2 CHLORO PHENOTHIAZINE 0.90 kg | ACETONE 3.30 kg **** _ RA may take appropriate action as per the decision of Norms Committee.
~ [Case No.:287/10/82-—~—~Party Name:R.L.FINE CHEM Meet No/Date:10/82Status: | _ (ALC4/2018 PRIVATE LIMITED ALC4/2018 ‘Approved | | | | ‘16.10.2018 | | HQ a a tat | | :01/82/050/00574/AM19/ ':07/24/040/00261/AM18/ 02.02.2018 | | Decision: |The Committee considered case as per agenda and in the presence of the technical experts, it no ‘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: _ | |CARBINOXAMINE 1kg [1 | PYRIDINE 2 ALDEHYDE 0.833kg |, || |MALEATE TETRA HYDRO FURAN 0.468kg | _ | USP ACETONE 1.50 kg | | _RA may take appropriate action as per the decision of Norms Committee. |
- [Case No.:288/10/82—~—~(Party Name:RLFINE CHEM |Meet No/Date:10/82Status: —;HQ| ALC4/2018File” ~ RLAFile—SS™S~~~*~SCLice.No/Daate0710112767PVT.| LTD. ALC4/201816.10.2018 Approved | | :01/82/050/00575/AM19/ :07/24/040/00262/AM 18/ 02.02.2018 | | | ‘Decision: TheCommittee considered case as per agenda and in the presence of the technical experts, it. Wee 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. | [CYCLOBENZAPRINE HCL |1kg |1 | 1BROMO3CHLORO PROPANE _| 0.95 kg | | USP TETRA HYDRO FURAN 1.00 kg ‘RA may take appropriate action as per the decision of Norms Committee.
38
-«
~~ 'Case No.:289/10/82-—~—~Party Name:R LFINE CHEM (Meet No/Date:10/82Status: ALC4/2018 (PVT. LTD. ALC4/2018 ‘Approved HQ — a “F< an ‘Lie No/Date-0710112764 | | —— :01/82/050/00576/AM19/ :07/24/040/00263/AM 18/ 02.02.2018 | | 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 ‘1 10 applied by firm whichever is lower: | Export product Qty. | SI. Import items Qty. | No. _ | DOTHIEPIN HCL | 1kg |1 | 1BROMO3CHLORO PROPANE _| 0.92 kg | | BP TETRA HYDRO FURAN 0.50 kg | THIOPHENOL 0.65 kg | RA may take appropriate action as per the decision of Norms Committee. - (Case No.:290/10/82—~—~(Party Name:R.L.FINECHEM Meet No/Date:10/82‘Status: | ALC4/2018 PRIVATE LIMITED ALC4/2018 Approved | | | 16.10.2018 | | | fig File See eetennense meet et RLA Fileey | —:01/82/050/00577/AM19/ :07/24/040/00264/AM 18/ (02.02.2018 |
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. ‘111 applied by firm whichever is lower:
||||Exportproduct|Qty. | Sl.<br>| Import items|Qty. | Sl.<br>| Import items|Qty.||
|---|---|---|---|---|---|---|
||||No.|||||
||||DOXEPIN|HCL<br>|1kg |1 | 1BROMO3CHLOROPROPANE|||1.12kg|||
||_|||BP/USP|つ<br>TETRAHYDROFURAN||0.68 kg||
||||||MAGNESIUM INGOT||0.19 kg|||
|_|RA may take appropriate||action as per the decision ofNorms Committee.||||
|_<br>|<br>112|CaseNo.:140/10/82-<br>ALC4/2018<br> HQ File||Party Name:ORTIN ©<br>/<br>‘LABORATORIES LTD<br>|<br>RLAFile<br>~|‘MeetNo/Date:10/82-<br>ALC4/2018<br>'16.10.2018<br>|Lic.No/Date:0910065968|‘Status:<br>‘Deferred<br> DeferDate:||<br>|<br>||
|||:01/82/050/00427/AM19/|':09/24/040/00527/AM18/|(06.02.2018||||
|||iu Danae|||nee|||
|||Case No.:147/10/82-|—~Party Name:ORTIN|“MeetNo/Date:10/82-|Status:||
|—|ALC4/2018||‘LABORATORIES LTD|‘ALC4/2018|Deferred|||
|||HQ File|RLA File|‘Lic.No/Date:0910065967|DeferDate:|||
|||:01/82/050/00434/AM19/|:09/24/040/00529/AM18/|06.02.2018|||
|||Decision:<br>Deferred<br>forcommentsofTE.<br>oO||a|—|||
~
39 / [CaseNo.:173/10/82-—|PartyName:STYRAX ——Meet No/Date:10/82-. Status: | ALC4/2018 PHARMA PRIVATE ALC4/2018 Approved | | LIMITED (16.10.2018 | __-HQFile RLA File ~ |Lie.No/Date:09 10065966 | __ :01/82/050/00460/AM19/ :09/24/040/00549/AM 1 8/ (06.02.2018 | ‘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 | lapplied by firm whichever is lower: | (114 | Export product Qty. | SI. Import items Qty. | | No. LAMIVUDINE Lkg 5-(4-AMINO-2-OXO-PYRIMIDNYL2.19 kg | | OXATHIOLANE-2-CARBOXYLIC ACID| ISOPROPYL-METHYL-CYCLOHEXYL | | ESTER OR CHE } | SODIUM BOROHYDRIDE 0.48kg |, RA may take appropriate action as per the decision of Norms Committee. (~~ \Case No.:249/10/82- -—=PartyName:AETHER —Meet No/Date:10/82-. Status: ALC4/2018 INDUSTRIES LIMITED ALC4/2018 Deferred | | | '16.10.2018 | TTS HQ File | \RLAFile ~~~—~—~—Lic.No/Date:5210042512 Defer Date: / —101/82/050/00536/AM19/ ':52/24/040/00054/AM 18/ 06.02.2018 7 7 | | | | Decision: Deferred for comments of TE. — / (Case No.:75/10/82-—=«(PartyNName:YASHO—— Meet No/Date:10/82-. Status: ALC4/2018 INDUSTRIES PVT.LTD. ALC4/2018 Approved | 16.10.2018 | | HQ File _ ~ IRLAFile—™ Lic.No/Date:03 10818973 | | /| :01/82/050/00362/AMDecision: The Committee19/ considered:03/95/040/00967/AM the case as per18/ agenda in07.02.2018the presence of Technical Experts and in | | the light of earlier decision taken by NC in its Meeting No. 3/82-ALC4/2018, dated 08.05.2014, it was 116 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 items Quantity Allowed |. ; | Quantity kg/kg | _ | Methyl Eugenol 1 kg Clove Leaf Oil (Eugenol Content | 1.40 | RA may take appropriate action as per the decision of Norms Committee. / (Case No.:76/10/82—~—~—=(Party Name:YASHO ——Meet No/Date:10/82Status: |-IT HQFileALC4/2018| ~ INDUSTRIESIRLA File — PVT.LTD.~ |Lic.No/Date:03ALC4/201816.10.2018 10818970 ‘Approved| ~:01/82/050/00363/AM 19/ :03/95/040/00968/AM 18/ 07.02.2018 | | | Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in i 'the light of earlier decision taken by NC in its Meeting No. 8/82-ALC4/2018, dated 31.08.2018, it was
40
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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> firm whichever is lower: |<br>|bo| Export product Qty.Exp. || No.Sl. | Import items Qty.in kgAllowed |<br>| DIPENTAMETHYLENE THIURAM<br>| , ke |1 | PIPERIDINE 0.447 |<br>| TETRA SULPHIDE( QUREACC 2 CARBON DISULPHIDE 0.399 |<br>DPTT) |<br>| RA may take appropriate action as per the decision of Norms Committee.<br>つ<br>----- End of picture text -----<br>
peat e———aa MSe ee ae es—as | _ ALC4/2018 LABORATORIES LTD ALC4/2018 ‘Deferred |! 18 HQ File | - as RLA File ~~Lic.No/Date:0910065973 Defer Date: | :01/82/050/00453/AM19/ :09/24/040/00528/AM18/ 07.02.2018 | Decision: Deferred for comments of TE. _ . "\Case No.:167/10/82-—~—“~Party Name:AUROBINDO MeetNo/Date:10/82-([Status: | _ ALC4/2018 PHARMA LIMITED ALC4/2018 Deferred | 16.10.2018 | M9hQFile | (RLAFile ~ Lic.No/Date:0910065972 [Defer Date: | :01/82/050/00454/AM19/ :09/24/040/0059 1/AM18/ 07.02.2018 Bi hac Soiree dete eeeeeree te en — "\CaseNo.:170/10/82—~—«Party Name:DR. REDDYS Meet No/Date:10/82- Status: _ (ALC4/2018 (LABORATORIES LIMITED =ALC4/2018 ‘Approved | | 16.10.2018 | | | iO file Sere RUA—————Dalanorooosort | | | :01/82/050/00457/AM19/ :09/24/040/00569/AM 18/ (07.02.2018 | i 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: |
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----- Start of picture text -----<br> 56 | Export product Qty. | SI. Import items Qty. |<br>| | No. |<br>Gemcitabine Hcl 1kg |1 | N-Acetyl Cytosine 2.92kg |.<br>2 Trimethylsily! Trifluoromethane sulfonate 4.23kg |.<br>| (Or) Trimethylsilylfluoromethane |<br>Sulphonate |<br>| | Dibenzoyllactol (or) DBL 4.78kg |<br>| Methylene Chloride 13.60 kg |<br>| RA may take appropriate action as per the decision of Norms Committee. |<br>つ<br>----- End of picture text -----<br>
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| (Case No.:207/10/82-. ——PartyName:FDC LTD — Meet No/Date:10/82Status: ALC4/2018 ALC4/2018 Deferred ; | 16.10.2018 i HQ File RLA File Lic.No/Date:0310818972 Defer Date: _ :01/82/050/00494/AM19/ :03/94/040/00900/AM 18/ 07.02.2018 | Decision: Deferred for comments of TE. _ - . | ~ Case No.:291/10/82Party Name:R.L.FINECHEM Meet No/Date:10/82- Status: | ALC4/2018 PRIVATE LIMITED ALC4/2018 Approved | 16.10.2018 | HQ File RLA File Lic.No/Date:07 10112796 _—101/82/050/00578/AM19/ :07/24/040/00304/AM18/ 08.02.2018
‘Decision: | The Committee considered the case as per agenda in the presence of Technical Experts, itwas. 122 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 Sl. No. | Import items Qty. allowed | Qty. | BP/EP/USPIP g laa romo 3 Chloro ropane 0.85 kg | | 3 Chloro Iminodibenzy] 0.91 kg RA may take appropriate action as per the decision of Norms Committee. "(Case No.:330/10/82-—~—«Party Name:SUNSHIELD ——Meet No/Date:10/82-. Status: | ALC4/2018 CHEMICALS LTD. ‘ALC4/2018 Deferred | 16.10.2018 — LA File ~Lie¢,No/Date:0310819007 Defer Date: | HQFile 123 :01/82/050/00617/AM19/ ':03/95/040/00975/AM18/ '08.02.2018 | | | ‘Decision: | The Committee noted that the 4.07 application of subject Advance Authorization is not | available. Hence, it was decided to call for the 4.07 application of the subject advance authorization from | | RLA, Mumbai and complete technical details as per 4E along with Chemical reaction, stage wise yield of production and molecular weight from the firm. - (Case No.:208/10/82-—_—(Party Name:DSM SINOCHEM /Meet No/Date:10/82Status: | | ALC4/2018 ‘PHARMACEUTICALS ALC4/2018 Approved | | INDIA PVT.LTD. 16.10.2018 - \HQFile ~ IRLA File ; ‘Lic.No/Date:2210015856 | :01/82/050/00495/AM19/ :22/24/040/00081/AM18/ 12.02.2018 _ 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. 124 applied by firm whichever is lower: Export product Qty. | SIL. Import items Qty. || Ampicillin — Trihydrate | 1 kg No. 6-Amino Penicillinic Acid 0.596kg sf, | Through 6-APA route Elcolase (Enzyme) | | Through Enzymatic D(-)Alpha Phenyl Glycine Base 0.417 kg | [Rout 0.322 ke
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| RA may"ake appropr— war the decision of None Committe —
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----- Start of picture text -----<br> Case No.:312/10/82- oe Party Name:ALEMBIC Meet No/Date:10/82- 7 Status: _ |<br>ALC4/2018 PHARMACEUTICALS LTD ALC4/2018 ‘Approved<br>| oa “IRAa TT | |<br>:01/82/050/00599/AM 19/ :34/24/040/00328/AM18/ 12.02.2018 |<br>‘Decision:<br>| The Committee considered case as per agenda and in the presence of the technical experts, |<br>| it 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>125 Export product Qty. | SI. Import items Qty.<br>| No. |<br>| | AZITHROMYCIN STEP | 1kg |1 | ERYTHROMYCIN BASE USP 1.75 kg |<br>| 1 | 4 2 HYDROXYLAMINE 0.856 kg<br>, | METHANOL 2.72 kg<br>|<br>| ACETONEMETHANE SULFONYL CHLORIDE | 6.450.566kgkg |.<br>| [6 | ETHYL ALCOHOL 2.072 Litre |<br>| PLATINUM METAL 0.05 grams |)<br>_ RA may take appropriate action as per the decision of Norms Committee.<br>_ Case No.:47/10/82- "Party Name:MANGALAM Meet No/Date:10/82- Status: ) |<br>| (ALC4/2018 DRUGS & ORGANICS ALC4/2018 ‘Approved<br>— ||HQFile —RLAFileLIMITED 16.10.2018Lic.No/Date:03 10819167 ||<br>_:01/82/050/00334/AM19/ :03/95/040/01003/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. 1/82-ALC4/2018, dated 01.05.2018 in respect<br>| of M/s Mangalam Drugs & Organics Limited against Advance Authorization No. 0310812954 dated<br>126 01.05.2017, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details<br>below or as applied by firm whichever is lower:<br>Export Product Qty. Import items Quantity |<br>| allowed<br>| _ | PIPERAQUINE PHOSPHATE| | Kg. | Ethoxy Methylene Malonic Acid Ester 1.30 kg<br>RA may take appropriate action as per the decision of Norms Committee.<br>| Case No.:49/10/82-ALC4/2018 Party Name:SCOTTISH (Meet No/Date:10/82-. (Status:<br>| | (CHEMICAL INDUSTRIES ALC4/2018 ‘Deferred i<br>‘127 HQ File RLA File -Lic.No/Date:0310819168 ‘Defer Date:<br> :01/82/050/00336/AM19/ :03/95/040/009 19/AM 18/ 15.02.2018 | |<br>| Decision: |The Committee considered the case as per Agenda and it was decided to call for Certificateof _<br>Analysis (COA) of import & export product. |<br>----- End of picture text -----<br>
43
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/ [Case No.:60/10/82= PartyName:FDCLTD —— Meet No/Date:10/82-. ‘Status: | ALC4/2018 ALC4/2018 ‘Approved | | 16.10.2018 | | | HQ File RLA File Lic.No/Date:0310819176 | — 101/82/050/00347/AM19/ ':03/94/040/0093 1/AM18/ 15.02.2018 _ Decision: The Committee considered case as per agenda and in the presence of the technical experts, 1 28 lit 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: | _ | Natoptic Eye Drops 5ml (Natamycin | 120000 vials |[NATAMYCIN][ (MICRONISED)][|][30.6][kg] _ | Ophthalmic Suspension 5% w/v) IP __RA may take appropriate action as per the decision of Norms Committee.
Case No.:102/10/82Party Name:FINE ORGANIC [Meet No/Date:10/82Status: — ALC4/2018 INDUSTRIES LTD ALC4/2018 Approved | 16.10.2018 | | HQ File — RLAFile =———~*~SCLLic. No/Daate:03 1008 19184 | :01/82/050/00389/AM19/ :03/94/040/00904/AM 18/ ‘15.02.2018 | l129 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: | [ BEHENAMIDE }1kg|1 | BEHENIC ACID 1.11 kg | RA may take appropriate action as per the decision of Norms Committee.
| Case No.:223/10/82. Party Name:DELTA —_— Meet No/Date:10/82Status: | ALC4/2018 FINOCHEM PVT.LTD ALC4/2018 Approved f | | (16.10.2018 | HQ File a RLA File ~__|Lic.No/Date:03 10819158 | :01/82/050/00510/AM19/ :03/94/040/0089 1/AM18/ 15.02.2018 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 | 130 firm whichever is lower: | _ | Ethyl Triphenyl Phosphonium | 1 Kg. Tri Phenyl Phosphine 0.780 kg _ | Bromide Ethyl Bromide 0.230 kg | _ RA may take appropriate action as per the decision of Norms Committee. |
Case No.:224/10/82PartyName:DELTA Meet No/Date: 10/82Status: | ALC4/2018 FINOCHEM PVT.LTD. ALC4/2018 Deferred 11311 | 16.10.2018 | HQ File. — RLA File ~~ _Lic.No/Date:0310819156 Defer Date: | | :01/82/050/0051 1/AM19/ ':03/94/040/00879/AM1 8/ 15.02.2018 [ |
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----- Start of picture text -----<br> | or Stee orere| Saenormee on sett att aaa iano<br>- \Case No.:77/10/82- ‘PartyName:MANGALAM —— Meet No/Date:10/82- Status: |<br>| ALC4/2018 ‘DRUGS & ORGANICS ALC4/2018 Approved |<br>| LIMITED 16.10.2018 | |<br>| HQ File. 7 —IRLA File — - ‘Lic.No/Date:0310819207 |<br>:01/82/050/00364/AM19/ ':03/95/040/00988/AM18/ 16.02.2018 | |<br>Decision: |The Committee considered the case as per agenda in the presence of Technical Experts, it was |<br>| 132 decidedfirm whicheverto ratifyisthelower:ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by||<br>| Export product Exp. | SI.No. | Import items Qty. allowed |<br>| TENOFOVIR DISOPROXIL Ikg | 1 [(R)-9-(2-PHOSPHONYL 0.769 kg<br>| FUMARATE METHOXY PROPYL) |<br>| ADENINE] |<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.:80/10/82- (Party Name:CORAL Meet No/Date:10/82- Status:<br>| ALC4/2018 LABORATORIES LTD., ALC4/2018 Deferred |<br>P| 16.10.2018 | |<br>Shgrile RLAFie ‘Lic.No/Date:0310819212 [Defer Date:<br>:01/82/050/00367/AM 19/ ':03/94/040/00938/AM18/ 16.02.2018 |<br>Decision: Deferred forcommentsofTE. = 7 )<br>| (Case No.:222/10/82- PartyName:GLENMARK Meet No/Date:10/82- Status:<br>‘ALC4/2018 PHARMACEUTICALS LTD., ALC4/2018 Approved<br>| HO File ere etter RLA = anni ic No/Date:031081 Parry | |<br>| :01/82/050/00509/AM 19/ ':03/94/040/00936/AM18/ 16.02.2018<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<br>| applied by firm whichever is lower: |<br>1134 |<br>Sl. Export product Qty. Import items Qty. |<br>No.<br>Clobetasol Propionate Foam 0.05% Clobetasol Propionate | 2.93 kg |<br>| 100gm (Net. wt. of Clobetasol 000.000 USP (Micronized)<br>|| 2 PropionateClobetasol USPPropionateis 2.000 Kgs.)Foam 0.05% P |<br>50gm (Net. wt. of Clobetasol fn0.000 |<br>Propionate USP is 0.875 Kgs.) pac |<br>__RA may take appropriate action as per the decision of Norms Committee.<br>Case No.:82/10/82- Party Name:FRESENIUS Meet No/Date:10/82- _[Status:<br>ALC4/2018 KABI INDIA PRIVATE LTD ALC4/2018 Deferred<br>135) | 16.10.2018<br>| HQ File RLA File ~ Lic.No/Date:0310819230 Defer Date:<br>:01/82/050/00369/AM19/ ':03/94/040/00911/AM18/ 19.02.2018 |<br>----- End of picture text -----<br>
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| |Decision: Deferred forcommentsofTE.
= —™S Oe “|
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|/|[Case No.:99/10/82-|——SPartyNName:PRIVI|=——S Meet No/Date:10/82-.|Status:|
|ALC4/2018|ORGANICS|INDIA LIMITED|ALC4/2018|Deferred|
|ft|16.10.2018|
|||
|ag HQ|File|RLA|File|Lic.No/Date:0310819237|Defer Date:|
|/|:01/82/050/00386/AM19/|':03/95/040/00918/AM18/|(19.02.2018|
|=ra|=|ener<—|men|=|||
|Case No.:100/10/82-|~—PartyName:PRIVI.|=—S|Meet No/Date:10/82-.|—|Status:|
|_|ALC4/2018|ORGANICS|INDIA LIMITED|ALC4/2018|Deferred|||
|137 HQ|File|~-RLA|File|-~|Li¢.No/Date:0310819238|Defer Date:|
|||:01/82/050/00387/AM19/|:03/95/040/0098 1/AM18/|(19.02.2018|
|||Decision:|Deferred for comments|of|TE.|-|)|-|;|;|7|:|||
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(Case No.:78/10/82-. —~—~=-Party Name:CAMPHOR &Meet No/Date:10/82Status: _ ALC4/2018 ALLIED PRODUCTS ALC4/2018 ‘Approved | -HQFile ~—RLA File Lie. No/Date:03 10819251 | | :01/82/050/00365/AM19/ ':03/94/040/00937/AM 18/ 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 by firm whichever is lower: |
_ | CAMPHOR USP ALPHA PINENE 1.146 kg __RA may take appropriate action as per the decision of Norms Committee. |
/ (Case No.:79/10/82-—~—~—~—~«/ Party Name:ANUH PHARMA Meet No/Date:10/82- Status: ALC4/2018 LTD. ALC4/2018 Approved ; | | 16.10.2018 | — HQFile RLAFile | Lic.No/Date:03 10819258 __:01/82/050/00366/AM19/ :03/94/040/00942/AM 18/ (20.02.2018 | | Decision: The Committee considered case as per agenda and in the presence of the technical experts, it 139 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. | |||i | AZITHROMYCIN BP/EP/USP No. Azithromycin Amine 1.00kg | __RA may take appropriate action as per the decision of Norms Committee. |
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soa (Case No.S2i0R 5 Party NameUSV TTC Meet No/Dusl0/83. Statues | — ALC4/2018 LIMITED ALC4/2018 Approved | i | 16.10.2018 | HQ File REA File ~Lic.No/Date:03 10819255 _ | :01/82/050/00379/AM 19/ :03/95/040/01008/AM 18/ 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 ‘a6 applied by firm whichever is lower: | | Export product Qty. SI. Import items Qty. allowed No. _ | | Griseofulvin Tablets USP 500 mg | INo. Tablet 1 Griseofulvin USP 510 mg/ _ | (2,000 Bottles x 100 Per Bottle = Tablets | _ | 2,00,000 Tablets) (Net Content | | Weight = 100.000 kgs) | RA may take appropriate action as per the decision of Norms Committee.
- (CaseNo.:93/10/82-ALC4/2018 Party Name:YASHO ——s Meet No/Date:10/82-. Status: ; | INDUSTRIES PVT.LTD. ALC4/2018 Deferred / — |:01/82/050/00380/AM19/ :03/95/040/01007/AM 18/ 20.02.2018 | Decision: Deferred for comments of TE Deferred for comments of TE | / (Case No.:19/10/82-ALC4/2018 PartyName:TATVA —/ MeetNo/Date:10/82-. Status: — (CHINTAN PHARMA CHEM = ALC4/2018 ‘Approved fo | PVT LTD (16.10.2018 | HQ File RLAFile ~ Lic.No/Date:34 10043904 | :01/82/050/00306/AM19/ :34/24/040/00335/AM 18/ (21.02.2018 | 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: | 142 | | | Export product Exp. SI.No. | Import items Qty. allowed | | METHOXY METHYL 1kg 1 TRIPHENYL PHOSPHINE | 0.806 kg _ _ | TRIPHENYL PHOSPHONIUM CAS NO: 603-35-0 ASSAY | | CHLORIDE NLT 98% | |_| CAS No.4009-98-7 ASSAY NLT 2 MARTY Palle 0.233 kg | | | og% CAS NO. 109-87-5 ASSAY | NLT 99% | RA may take appropriate action as per the decision of Norms Committee | | Case No.:20/10/82Party Name:TATVA Meet No/Date: 10/82- - |Status:Deferred ALC4/2018 (CHINTAN PHARMA CHEM ALC4/2018 | HQ File RLA File Lic.No/Date:3410043903 Defer Date: _:01/82/050/00307/AM19/ :34/24/040/0033 1/AM18/ 21.02.2018 | | ‘Decision: Deferred for comments of TE _ 7 . |
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"(Case No.:74/10/82-ALC4/2018PartyName:YASHO—~—S(MeetPartyName:YASHO—~—S(MeetName:YASHO—~—S(Meet No/Date:10/82-. INDUSTRIES PVT.LTD. ALC4/2018 | | (16.10.2018
"(Case No.:74/10/82-ALC4/2018PartyName:YASHO—~—S(MeetPartyName:YASHO—~—S(MeetName:YASHO—~—S(Meet No/Date:10/82-. Status: INDUSTRIES PVT.LTD. ALC4/2018 Approved | | (16.10.2018 HQ File RLA File ~— |Lic.No/Date:0310819304. | :01/82/050/00361/AM19/ :03/95/040/01015/AM18/ 21.02.2018 |
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. (144 details below or as applied by firm whichever is lower:
| Export product Exp. SI.No. | Import items Qty. allowed | | | YAPOX CL 1kg |1 0.611 kg | _ | 30/10"HYDROQUINONE BIS"(2 HYDROQUINONE | | HYDROXY ETHYL ETHER) | RA may take appropriate action as per the decision of Norms Committee | Case No.:48/10/82Party Name:RELIANCE Meet No/Date:10/82Status: | | jALC4/2018 INDUSTRIES LTD. ALC4/2018 Deferred | 16.10.2018 | |145 HQ File RLA File -Lic.No/Date:0310819336 Defer Date: ~~ (:01/82/050/00335/AM19/ :03/95/040/00843/AM 18/ (22.02.2018 | ‘Decision: The Committee considered the case as per agenda in the presence of technical experts and it was _ __ decided to refer the application to Department of C&PC for their examination/comments. The case is | | deferred |
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----- Start of picture text -----<br> / ~~ \Case No.:59/10/82- ~—~PartyName:KAIRAV.—SMeet No/Date:10/82-. Status:<br>| ALC4/2018 CHEMOFARBE ALC4/2018 Approved —<br>| | INDUSTRIES LTD. (16.10.2018<br>— /HQFile ~~~ RLAFile Lie. No/Date:03 10819340<br>| :01/82/050/00346/AM 19/ :03/94/040/00897/AM 18/ 22.02.2018<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>146 details below or as applied by firm whichever is lower: |<br>| | Export product Exp. SI.No. | Import items Qty. allowed |<br>| 1,3 Dioxolane 1kg Monoethylene Glycol 0.882 kg<br>| 'RA may take appropriate action as per the decision of Norms Committee |<br>(Case No.:61/10/82- PartyName:BDR —~—sOMeet No/Date:10/82- _—Sttatus:<br>| (ALC4/2018 PHARMACEUTICALS ALC4/2018 Deferred<br>ne INTERNATIONAL PVT. 16.10.2018<br>47) _ LTD. ee <br>| HQ File RLA File ‘Lic.No/Date:03 10819351 Defer Date:<br>::01/82/050/00348/AM19/Decision: Deferred for comments:03/94/040/0095of TE 1/AM18/ . 22.02.2018 ||<br>…<br>----- End of picture text -----<br>
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|~|\Case|No.:62/10/82-ALC4/2018|Party Name:ETERNIS FINE|Meet No/Date:10/82-|Status:|
|(CHEMICALS|LIMITED,|ALC4/2018|Approved|||
|;|||||16.10.2018|||||
|||HOes RLA 7|cetera|LicYo/ioate:0310819358|||||
|||:01/82/050/00349/AM19/|103/94/040/00949/AM|18/|(22.02.2018|||
|‘Decision:|Committee|considered|case|as|per|agenda|and|in|the|light|of earlier|decision|taken|by NC|in|its|||
|||4/AM19|meeting|dated|19.06.2018,|it|was|decided|to|ratify|the|ad-hoc|input|output|norms|under|para|4.7)|
|148|of HBP|as|per|details|below|or|as|applied|by|firm|whichever|is|lower:|
|||Export Product|Export|S.No|Import|Product|Quantity|||
|1;|||Quantity|Allowed|
|||HAMBER|/ HAMBER|- BHT/|lkg|1,|METHYL ETHYL|0.600|kg|
|||HAMBER|
|||1,2,3,4,5,6,7,8-Octahydro-|Toco (7-Acetyl-1,1,6,7-|2.|KETONE (MEK)|1.00|kg||||
||_||Tetramethyl|Naphthalene)|MRCENE|||
|RA may take appropriate|action|as|per the decision|of Norms Committee|||
|~~|(Case|No.:105/10/82-|-—~—‘Party Name:CIPLA LIMITED.|Meet No/Date:10/82-|Status:|
|—|ALC4/2018|ALC4/2018|‘Approved|||
|||fo i|TS eens|[Lie|No/Date:0310819360|||||
|':01/82/050/00392/AM|19/|':03/94/040/00969/AM|18/|22.02.2018|
|||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)|
|149|details|below or as|applied by|firm|whichever|is|lower:|||
|||Cipcox|2.5%|Solution|Toltrazuril|||1000.000|1|Toltrazuril|25.5|kg|||
||_||Solution 2.5%|w/v|Nos.|||
|||Pack|size|:|1|Ltr Each|100 ml|
|_|||contains|:|Toltrazuril|2.5|gm|||
|||RA may take|appropriate|action|as|per|the|decision|of Norms|Committee|
|-||Case No.:116/10/82-|~—~—PartyName:|AETHER|~—S|Meet No/Date:10/82-|Status:|
|_|ALC4/2018|INDUSTRIES|LIMITED|‘ALC4/2018|Approved|||
|||16.10.2018|
|||HQ|File|RLA|File||Lie.No/Date:5210042534.|
|:01/82/050/00403/AM19/|:52/24/040/00078/AM|18/|22.02.2018|
|150||3/AMI9Decision:meetingCommitteedatedconsidered05.06.2018,caseitaswasperdecidedagendato andratifyin thethelightad-hocof earlierinput|outputdecisionnormstakenunderby|NCparain4.7,its|
|of HBP|as|per|details|below|or as|applied|by|firm|whichever|is|lower:|||
|DELTA-VALEROLACTONE|1kg|1|1.486|kg|||
|;|||1,5|- PENTANEDIOL|||
|||RA may take appropriate action|as per the decision|of Norms Committee|||
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| i ‘Case No.:46/10/82-ALC4/2018 Party Name:ARVEE ——_—s Meet No/Date:10/82Status: | | LABORATORIES INDIA ALC4/2018 Approved ; | PRIVATE LIMITED 16.10.2018 | HQFile RLA File ~ Lie.No/Date:0810142052, _ :01/82/050/00333/AM19/ :08/24/040/00275/AM 18/ 23.02.2018 | | Decision: Committee considered case as per agenda anddeliberatedon 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 151 details below or as applied by firm whichever is lower: |
| Export Product Exp. S.No | Import Product Quantity | Qty. Allowed | |_| Dimethyl 5-Nitroisophthalate | 1 kg Isophthalic Acid 0.818 kg | (RA may take may take take appropriate action as per the the decision of Norms Norms Committee |
(RA may take may take take appropriate action as per the the decision of Norms Norms Committee | "Case No.:63/10/82-ALC4/2018. Party Name:J.B.KHOKHANI & Meet No/Date:10/82Status: | | ‘CO. ‘ALC4/2018 ‘Approved | ; | 16.10.2018 HQ File - RLAFile = ~——~—Lic.No/Date:0310819403 | | :01/82/050/00350/AM19/ ':03/94/040/00935/AM18/ 23.02.2018 | ‘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: | ‘152 Export Product Export S.No Import Product Quantity | | Quantity Allowed | | ERYTHROMYCIN OXIME BASE | | kg 1. ERYTHROMYCIN 1.20 kg ; | THIOCYANATE ( | | ON 100% ACTIVITY | ; | BASIS ) | | ISOPROPANOL 0.78 litre | 3. HYDROXYLAMINE | 0.60 kg | HYDROCHLORIDE | | ‘RA may take appropriate action as per the decision of Norms Committee [ \Case No.:87/10/82Party Name:ATHENA — Meet No/Date:10/82Status:Deferred | ALC4/2018 ‘DRUG DELIVERY ‘ALC4/2018 | a SOLUTIONS PRIVATE 16.10.2018 | 1 53. LIMITED | | HQ File | --RLA File ‘Lic.No/Date:0310819402 Defer Date: _ :01/82/050/00374/AM 19/ :03/94/040/00963/AM 1 8/ 23.02.2018 | ‘Decision: Deferred for comments of TE | ~ Case No.:113/10/82Party Name:AMINES & _ Meet No/Date: 10/82‘Status: | ALC4/2018 PLASTICIZERS LIMITED ALC4/2018 ‘Approved | | 16.10.2018 194 11 File ) RLA File i Lic.No/Date:03 10819400 | :01/82/050/00400/AM 19/ :03/94/040/00808/AM 18/ 23.02.2018 | | ‘Decision: Committee considered case as per agenda and deliberated on the matter in the presence of the
50
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technical experts and itwas decided | details below or as applied by firm whicheverto ratify isthelower: ad-hoc input output norms under para 4.7 of HBP as per.| | Export Product Export Import Product Quantity | | Quantit Allowed | | AMINOSOL CST 115 1 kg PIPERAZINE (N,N0.154 kg | — DIETHYLENEDIAMINE) | | ‘RA may take appropriate action as per the decision of Norms Committee “Case No.:324/10/82Party Name:BEST VALUE Meet No/Date:10/82-. Status: ALC4/2018 ‘CHEM PVT. LTD. ALC4/2018 Approved — 16.10.2018 | | | HQ File RLA File ‘Lic.No/Date:3410043914 | | ~—-:01/82/050/00611/AM19/ '34/24/040/00343/AM18/ 23.02.2018 | Decision:technical expertsCommitteeand consideredit was decidedcaseto asratifyperagendathe ad-hocand inputdeliberatedoutput normson the matterunder inparathe4.7 presenceof HBP ofas per the.| 155 details below or as applied by firm whichever is lower: | | | Export Product Export S.No | Import Product Quantity | | | Quantity Allowed | _ | Undecavertol (Kakdinol) lkg Propionaldehyde 0.842 kg | | 2: N- Chloropentane / 1 - 0.74 kg Chloropentane RA may take appropriate action as per the decision of Norms Committee |
r Case No.103/1082. any Nameenema iniesta Staaa | — ALC4/2018 PHARMACEUTICALS LTD., ALC4/2018 ‘Approved | — RLAFile ~ Lic.No/Date:0310819409 HQ File | :01/82/050/00390/AM 19/ :03/94/040/00977/AM 18/ 26.02.2018 | 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: 156 | Export Product Export Sl. | Import Product Quantity Allowed | | Quantity | No | | Ursodiol Tablets USP 250mg Packs 1. Ursodiol USP 255.0 mg/250 mg tablet | | (Pack Size 100 Tabs.) | | Ursodiol Tablets USP 500mg Packs 1. Ursodiol USP 510.0 mg/500 mg tablet | (Pack Size 100 Tabs.) RA may take appropriate action as per the decision of Norms Committee |
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| (Case No.:86/10/82-ALC4/2018 Party Name:AARTI DRUGS Meet No/Date:10/82Status: iLIMITED ALC4/2018 ‘Approved i | 16.10.2018 | HQ File RLA File Lie. No/Date:03 10819442. C :01/82/050/00373/AM 19/ :03/94/040/00973/AM 18/ 27.02.2018 | | 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: | Item of Export Quantity | SI. Item of Import Quantity allowed | | | No. in kg | | Norfloxacin 1 kg 1. 2,4 Dichloro-5-Fluoro | 0.877 | 157 | Acetophenone(DCFA) pon] Dimethyl Carbonate 0.789 | | Sodium Hydride 0.289 | | |6. | Dimethy! Sulphate 0.670 | | | Dimethyl Formamide 0.385 | | | [8 | Mono Ethyl Amine(70%) 0.439 | | [9 | Caustic Flakes 0.410 | | . . Not importable Sulfuric Acid . item | ‘RA may take appropriate action as per the decision of Norms Committee. | ' [Case No.:84/10/82-—~PartyName:ALTA —SWMeeetNo/Date:10/82-. Status: 'ALC4/2018 ‘LABORATORIES LTD. ‘ALC4/2018 Approved ; | | 16.10.2018 i5 = ‘RIA : eee Lic No/Dateaa i0815474[|] | .:01/82/050/0037 1/AM19/ :03/94/040/00929/AM 1 8/ (28.02.2018 | | Decision: Committee considered case as per agenda and deliberated on the matter in the presence of the 158 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: | RA may take appropriate action as per the decision of Norms Committee
52
—_ ~~ [Case No.:85/10/82-ALC4/2018 |Party Name:AARTI DRUGS Meet No/Date:10/82-. Status: | | LIMITED ‘ALC4/2018 ‘Approved | 16.10.2018 | | \HQFile = ~~ RLAFile ~=———S—S—CLiie.No/Datte:0310819473 —_ :01/82/050/00372/AM19/ :03/94/040/00974/AM 18/ 28.02.2018 | | ‘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: F 59. Export product Exp. | SL Import items Qty. Allowed in | || Qty. | No. kg | | Ciprofloxacin 1 kg Ethyl 3 Cyclopropylamino-2(2,4 1.294 | | Hydrochloride Dichloro-5Fluorobenzoyl) Acrylate | | | 3 ; ; Not importable |. Sulpuric Acid (98%) . | item | i i | | Anhydrous Piperazine (094 RA may take appropriate action as per the decision of Norms Committee | ~ (Case No.:96/10/82Party Name:RELIANCE —Meet No/Date:10/82‘Status:Deferred | /ALC4/2018 INDUSTRIES LTD. ALC4/2018 | Fi 60 HQ File RLA File Lic.No/Date:03 10819451 Defer Date: ~ ~ :01/82/050/00383/AM19/ :03/95/040/00907/AM 18/ (28.02.2018 _ Decision: The Committee considered the case as per agenda in the presence of technical experts and it was | _ decided to refer the application to Department of C&PC for their examination/comments. The case is | deferred [ ‘Case No.:114/10/82—_ ‘Party Name:SIDDHARTH Meet No/Date:10/82‘Status: ALC4/2018 (CARBOCHEM PRODUCTS — ALC4/2018 ‘Approved | HQ File RLAFile ~~—~—~—_Lic.No/Date:0310819448 —— |:01/82/050/00401/AM19/ :03/95/040/00992/AM18/ 28.02.2018 | | | Decision: Committee considered case as per agenda and deliberated on the matter in the presence of the | 161 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 Exp. | SL. Import items Qty. Allowed | | Qty. | No. | | METHYL SALICYLATE (MIN. | 1 kg 0.955 kg i} '|")6 0.244 kg | RA may take appropriate action as per the decision of Norms Committee
53
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----- Start of picture text -----<br> . ‘Case No.:83/10/82- 7 Party Name:IPCA - “Meet No/Date: 10/82- Status: a |<br>_ALC4/2018 LABORATORIES LIMITED ALC4/2018 ‘Approved |<br>f | 16.10.2018 |<br>HQ File RLAFile = =~=~—Lic.No/Date:0310819493 _ } |<br> :01/82/050/00370/AM19/ :03/94/040/00993/AM18/ 01.03.2018<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 Import items Qty. Allowed in |.<br>1 62. Qty. | No. kg<br>| | CILOSTAZOL lkg |1 [ 5- (4-Chlorobutyl)-1-Cyclohexyl- 0.88 kg<br>| | 1H-Tetrazole ] { CBT Cilostazol } |<br>| 2 6-Hydroxy-3,4-Dihydroquinolinone | 0.59 kg |<br>[ HCS Cilostazol ]<br>i Iso Propyl Alcohol 2.90 ke<br>| RA may take appropriate action as per the decision of Norms Committee<br>(Case No.:111/10/82- Party Name:GLENMARK Meet No/Date:10/82- Status:<br>| \ALC4/2018 PHARMACEUTICALS = ALC4/2018 Approved<br>| LTD., 16.10.2018 | |<br>| (0 FiSL TicNomDareo310819498 (|<br>| :01/82/050/00398/AM19/ —:03/94/040/01000/AM18/ 01.03.2018 | |<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>| | SL. | Export product Exp. Qty. Import items Qty. Allowed.<br>| No.<br>1163 Clotrimazole Cream USP 1% ( Pack 425000.000 Packs |<br>| Size 15 Grams)<br>(Net Wt. of Clotrimazole Micronized is<br>63.750 Kgs.) i<br>| 2 Clotrimazole Cream USP 1% (Pack Clotrimazole<br>Size 30:Grants) 525000.000 Packs Microntved 351.9 kg<br>( Net Wt. of Clotrimazole Micronized<br>||| 3 Clotrimazoleis 157.500‘Kgs.) Cream USP 1% (Pack 275000.000 Packs<br>| || (NetSize 45 Wt.Grams)of Clotrimazole Micronized |<br>= is 123.750 Kgs.)<br>RA may take appropriate action as per the decision of Norms Committee |<br>ALC4/2018 ‘PHARMACEUTICALS ALC4/2018<br>i LTD., 16.10.2018<br>| :01/82/050/00499/AM 19/ :03/94/040/00999/AM 18/ 01.03.2018 |<br>Decision: Deferred for comments of TE |<br>‘つ<br>Ｆ<br>Ｓ‐<br>----- End of picture text -----<br>
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/ CaseNo.:26/10/82-ALC4/2018 Party Name:AMI LIFE ‘Meet No/Date:10/82Status: ;|| ||Horie Stet ern seer ‘SCIENCES‘LIMITEDae fie PRIVATE ALC4/2018[Lie16.10.2018No/Date:3410043927 ‘Approved ||| _ :01/82/050/003 13/AM19/ ':34/24/040/00358/AM18/ (05.03.2018 | | | ‘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) 165 details below or as applied by firm whichever is lower: | | Export product Exp. | Sl. | Import items Qty. Allowed Qty. | No. | _ | DOXOFYLLINE. WHITE [kg | 1 ANHYDROUS 0.80 kg | _ | CRYSTALLINE POWDER. THEOPHYLLINE. WHITE CRYSTALLINE POWDER | RA may take appropriate action as per the decision of Norms Committee ~ |Case No.:50/10/82-ALC4/2018 Party Name:INDO AMINES Meet No/Date:10/82Status: | LIMITED ALC4/2018 ‘Approved | | | 16.10.2018 | | | fon ——————————— amd ‘Lic No/Date:03sane | | :01/82/050/00337/AM19/ :03/94/040/00953/AM 18/ 05.03.2018 | Decision: Committee considered case as per agenda and in the light of earlier decision taken by NC in its (166 2/82 meeting dated 16.05.2016, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: | | | Export product Exp. | Sl. | Import items Qty. Allowed | | Qty. | No. | CYANOETHANE (99.5%) PROPIONITRILE 98% 1.02 kg | ‘RA may take appropriate action as per the decision of Norms Committee | (Case No.:52/10/82-ALC4/2018 |Party Name:ELPPE — ‘Meet No/Date:10/82‘Status: (CHEMICALS PRIVATE ALC4/2018 | | ‘LIMITED 16.10.2018 | | | HO File -RLAHIe [Lic No/Date-0310819504 Sy :01/82/050/00339/AM19/ :03/94/040/00975/AM 18/ 05.03.2018 | | _ 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 167 details below or as applied by firm whichever is lower: | | Export product Exp. | Sl. | Import items Qty. Allowed | | **** _ | NICLOSAMIDE Qty.1 kg | No. SALICYLIC ACID 0.66 kg | |__| ANHYDROUS OR TRIETHYL AMINE 0.26 kg | | NICLOSAMIDE 3 0.75 kg | | ANHYDROUS EP/BP OR ISOPROPYL ALCOHOL | NICLOSAMIDE | RA may take appropriate action as per the decision of Norms Committee |
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~*~ | Case No.:12/10/82-ALC4/2018 ‘Party Name:KLJ Meet No/Date:10/82Status: | | | /PLASTICIZERS LIMITED ALC4/2018 ‘Approved | ; | 16.10.2018 | | #H@ File RLA File Lic.No/Date:0510405781 :01/82/050/00299/AM 19/ ':05/23/040/00478/AM 18/ 06.03.2018 | | | Decision: The Committee consideredcase as per agenda andin the light of earlier decision taken by NC in | its 9/82 meeting dated 18.09.2018, it was decided to ratify the ad-hoc input output norms under para 4.7 of 168 HBP as per details below or as applied by firm whichever is lower: | | | Export product Qty. | SL. Import items Qty. i | No. | | KANATOL - 1010 (DI-PROPYL | 1kg |1 [| PROPYL HEPTANOL 0.746 kg ||. | | HEPTYL PHTHALATE) 5 0.350ke } | PHTHALIC ANHYDRIDE | : RA may take appropriate action as per the decision of Norms Committee "(Case No.:97/10/82-ALC4/2018 Party Name:MICRO ORGO- Meet No/Date:10/82- Status: [| ‘CHEM 'ALC4/2018 Approved | a 16.10.2018 | HQ File — RLAFile =——Lic.No/Date:0310819553 | :01/82/050/00384/AM19/ :03/95/040/01022/AM18/ (06.03.2018 | ‘Decision: Committee considered case[as][per][ agenda][and][deliberated] on[the][matter][in][the][presence of][ the.] F 69 ‘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 Exp. | Sl. | Import items Qty. Allowed | | Qty. | No. | Methylcobalamin [kg | 1 Cyanocobalamin (Vitamin B 12) | 9-95 kg | | (Mecobalamin)/Methylcobalamine | (Mecobalamine) | RA may take appropriate action as per the decision of Norms Committee ~~ (Case No.:65/10/82-—~—~—~=«@Party Name:CAMPHOR Meet No/Date:10/82-. Status: || ALC4/2018 ANDPRODUCTS ALLIEDLIMITED ALC4/201816.10.2018 Approved --HQ File oe RLA File _ 7 Lic.No/Date:03 10819583 | | :01/82/050/00352/AM19/ ':03/94/040/01004/AM18/ 07.03.201 8 | | 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: 170 Export product Exp. | Sl.No. | Import items Qty. Allowed in | } | Qty. kg | | | SANJINOL TOCO (2-Ethyl-4(22 | 1kg | 1 . 1.47 | . Alpha Pinene | | 3-Trimethylcyclopent-3-en-yl)| | | but-2-en-I-ol) N-Butyraldehyde 0.7722 4 Aluminum Tri-sec0.072 | Butoxide } | Di - N -Butylamine 0.077 | | ‘RA may take appropriate action as per the decision of Norms Committee
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----- Start of picture text -----<br> ‘Case| No.:95/10/82-ALC4/2018 Party Name:MICRO ORGO- MeetNo/Date:10/82- Status:<br>CHEM ALC4/2018 Approved<br>HO File|. nals Fo eee | |<br>:01/82/050/00382/AM 19/ :03/95/040/01021/AM18/ 07.03.2018 | |<br>171 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. | Sl. | Import items Qty. Allowed |<br>Qty. | No.<br>|<br>‘RA may take appropriate action as per the decision of Norms Committee<br>Case No.:117/10/82- "Party Name:SCOTT EDIL Meet No/Date:10/82- Status:<br>_ (ALC4/2018 ADVANCE RESEARCH LAB |ALC4/2018 ‘Approved |<br>| HQ File OO - RLAFile“AND EDU LTD ‘Lic.No/Date:221001586516.10.2018 ||<br>:01/82/050/00404/AM 19/ :22/24/040/00085/AM18/ 07.03.2018 |<br>----- End of picture text -----<br>
| 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. i? details below or as applied by firm whichever is lower: | _ | Export product Exp. Qty. Qty. Allowed | | Nystatin, Neomycin, Gramicidin with 116520.000 | Gramicidin USP 445.69 gram | Triamcinolone Acetonide Cream (15gm) Nos. | | Each 1gm cream contains: Nystatin USP | |_| Gramicidin100000 units,USP Neomycin0.25mg, SulfTri a temcinolone USP 2.5mg, | Acetonide USP Img ‘RA may take appropriate action as per the decision of Norms Committee | | |Case No.:10/10/82-—“(Party Name:HELLO PAINTS [Meet No/Date:10/82- _|Status:Deferred | _ |ALC4/2018 (P) LTD ALC4/2018 | | | 16.10.2018 | 173 THQ File RLA File Lic.No/Date:0510405814 [Defer Date: | :01/82/050/00297/AM19/ :05/23/040/00484/AM18/ 08.03.2018 | | min ok ae eee —— cocoa
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----- Start of picture text -----<br> | ‘CaseNo.:22/10/82- “(Party Name:CHEMCON Meet No/Date:10/82-—‘Status:.<br>ALC4/2018 SPECIALITY CHEMICALS ALC4/2018 ‘Approved<br>| PVT LTD 16.10.2018 | |<br>HQ File RLA File ——Lie.No/Date:3410043944,<br>_ 101/82/050/00309/AM 19/ :34/24/040/00353/AM18/ (08.03.2018 |<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. | Sl. | Import items Qty. Allowed<br>Qty. | No.<br>|<br>CHLOROMETHYL Ikg ]1 | METHYL 0.943 kg<br>/ | ISOPROPYL CARBONATE CHLOROFORMATE(MCF) |<br>----- End of picture text -----<br>
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| RA may take appropriate actionas per the decision ofNormsCommittee / (Case No.:23/10/82—“PartyName:CHEMCON ——[Meet No/Date:10/82-. Status: | ALC4/2018 SPECIALITY CHEMICALS —ALC4/2018 Approved | (HO File an ae ee | :01/82/050/003 10/AM19/ :34/24/040/00323/AM 18/ 08.03.2018 | Decision: Committee considered case as per agenda and deliberatedon the matter in the presence of[the] | 175 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 Exp. | Sl. | Import items Qty. Allowed | Qty. | No. | | | CHLOROMETHYL 1 kg METHYL 0.943 kg || ISOPROPYL CARBONATE CHLOROFORMATE(MCF) RA may take appropriate action as per the decision of Norms Committee | / [Case No.:45/10/82-.—=«PartyName:CADILA —Meet No/Date:10/82-__Status:Deferred | ALC4/2018 HEALTHCARE LTD ALC4/2018 | 176 Tho File “RLAFile ‘Lic.No/Date:0810142125 Defer Date: :01/82/050/00332/AM19/ ——:08/24/040/00342/AM18/ 08.03.2018 | | | Rein cal pra sort | re ein a Case No:51/10/82—=~PartyName:FDCLTD —Meet No/Date:10/82-. Status: | (ALC4/2018 ALC4/2018 Deferred | | | 16.10.2018 | 177 HQ File | - RLA File ~—|Lic.No/Date:0310819641 Defer Date: | ':01/82/050/00338/AM 19/ :03/94/040/01017/AM18/ '08.03.2018 | | ‘Decision: Committee considered the case as per agenda and it was decided to call from the firm a copy of Drug Manufacturing Licence (DML)
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----- Start of picture text -----<br> / \Case No.:98/10/82-——~*|Party Name: AIMS IMPEX Meet No/Date:10/82- Status:<br>_ ALC4/2018 PVT. LTD., ‘ALC4/2018 Approved<br>bo | 16.10.2018<br>HQ File — REAFile =~=—~S~S~™~CS_ Lic.Noo/Daate0310819648<br>':01/82/050/00385/AM19/ :03/94/040/01024/AM18/ 08.03.2018<br>| Decision: In the light of earlier decision taken by Nc in its 4/82 meeting dated 19.06.2018 it was decided |<br>‘to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm.<br>(178 whichever is lower :<br>| | Export Product Qty. SI.No. | Import items Quantity<br>| allowed in kg<br>_ [| COUMARIN ef SALICYLALDEHY DE 0.92 kg<br>RA concerned may take further necessary action as per above decision of NC<br>----- End of picture text -----<br>
eeere
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cnt : Panty NameGLENMARK ‘hea No/Dates10/82(Status: sates 7 — ALC4/2018 PHARMACEUTICALS —ALC4/2018 Approved | | HQFile = =—— RLAFile =———S~SCLicNo/Date:03108119639 | ':01/82/050/00397/AM19/ —:03/94/040/00987/AM18/ 08.03.2018 | | ‘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: |l179 || Export product Qty.Exp. || No.Sl. | Import items kgQty. Allowed in |, | Linezolid lkg Thioacetic Acid | 2 Methylene Chloride/Methylene 10.30 | | R-GlycidylDichloride/MDCButyrate 0.7178 | | Dimethyl Formamide 4.275 a 16 | 3,4-Difluoronitrobenzene RA may take appropriate action as per the decision of Norms Committee | _ ALC4/2018 ‘SCIENCES LIMITED ‘ALC4/2018 ‘Approved | | | | 16.10.2018 | Orie eee REA File eens ter Lic No/Date:0510405828 r oe | :01/82/050/00298/AM19/ :05/23/040/00460/AM 18/ 09.03.2018 | _ 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 lig0 details below or as applied by firm whichever is lower: | | Export product Exp. | SI. Import items Qty. Allowed in Qty. | No. kg | Pyridine 98% Min lkg Alumino Silicate Catalyst 0.019 ; | Ethyl Alcohol (Denatured) 2.194 3 . Not shown in | a Propionaldehyde process | | ‘RA may take appropriate action as per the decision of Norms Committee ) Case No.:57/10/82Party Name:RELIANCE 7 ‘Meet No/Date:10/82- Status: Deferred | ALC4/2018 INDUSTRIES LTD. ALC4/2018 | 1g, HQ File RLA File Lic.No/Date:03 10819677 |Defer Date: | | :01/82/050/00344/AM19/ —|:03/95/040/00839/AM18/ 09.03.2018 | Decision: The Committee considered the case as per agenda in thepresence of technical experts and it was decided to refer the application to Department of C&PC for their examination/comments. The case is deferred |
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| (Case No.:66/10/82—-Party Name:ETERNIS FINE [Meet No/Date:10/82Status: | ALC4/2018 (CHEMICALS LIMITED, ALC4/2018 Approved | | | 16.10.2018 HQ File RLA File ~— Lic.No/Date:0310819702, :01/82/050/00353/AM19/ —_:03/94/040/01025/AM18/ 09.03.2018 |
| Decision: Committee considered case as per agenda and in the light of earlier decision taken by NCin its | (18/82 meeting dated 10.02.2016 it was decided to ratify the ad-hoc input output norms under para 4.7 of 182 HBP as per details below or as applied by firm whichever is lower:
| | Export product Exp. | Sl. | Import items Qty. Allowed | | 3-METHYL-3-PENTEN-2Qty.lkg || No.1 1.065 kg || | ONE OR METHYL PENTEN (MEK) STEEL KETONE | | | ONE | | ‘RA may take appropriate action as per the decision of Norms Committee
(Case No.:67/10/82) - Party Name:CTX ) 7 Meet No/Date:10/82Status: | | (ALC4/2018 LIFESCIENCES PVT LTD, ALC4/2018 Approved | -HQFile RLA File ~— |Lic.No/Date:03 1081969 | :01/82/050/00354/AM19/ :03/94/040/00907/AM1 8/ 8 Decision: ‘Committee considered case as per agenda and deliberated onthe matter[in][the][presence][of][ the] 183 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 Exp. | Sl. | Import items Qty. Allowed in |. Qty. | No. kg | | Irbesartan lkg |} 1 2 - Cyano -4 -bromomethyl 0.94 kg a biphenyl | | || 2 2-n-butylnon-4-eneHCL1, 3 -diazospiro {4,4) 0.80 kg || RA may take appropriate action as per the decision of Norms Committee | ‘Case No.:68/10/82- ‘Party Name:CTX ~ Meet No/Date: 10/82Status: | ALC4/2018 ‘LIFESCIENCES PVT LTD, =ALC4/2018 ‘Approved | | 16.10.2018 — HQFile ~ 'RLAFile = —~—_Lic.No/Date:0310819699 —:01/82/050/00355/AM19/ :03/94/040/00906/AM 18/ (09.03.2018 | | ‘Decision: Committee considered case as per agenda and deliberated on the matter in the presence of the oad 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 Exp. | Sl. | Import items Qty. Allowed in | | Qty. | No. kg __RA may take appropriate action as per the decision of Norms Committee
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|= (Case No.l‘epee|any|eee TeaLe,|Status: eed|—||
|—_|ALC4/2018|‘SCIENCES|LIMITED|ALC4/2018|Approved|
|||||16.10.2018|||||
|HQFile|=~ RLAFile|=== —~—~—_Lic.No/Date:0510405843|||
|||:01/82/050/00300/AM19/|_:05/23/040/00459/AM18/|12.03.2018|||
|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:|||
|185|||Export product|Exp.|||SI.|||Import items|Qty. Allowed|in||,|
|;|||Qty.|||No.|kg|
|||Pyridine|98%|Min|1|kg|Alumino|Silicate|Catalyst|0.019|
|||Ethyl|Alcohol|(Denatured)|2.194|||
|ii|3|Propionaldehyde;|Not|shown|in|||
|;|||process|
|||RA may|take|appropriate|action|as|per the|decision|of|Norms|Committee|||
|Case—|No.:21/10/82-|Party Name:TRANSPEK|Meet No/Date:10/82-|_Status:Deferred||
|ALC4/2018|INDUSTRY|LIMITED|ALC4/2018|||||
|I|||||16.10.2018|||||
|_|:01/82/050/00308/AM19/|:34/24/040/00365/AM18/|12.03.2018|||
|Decision:|Deferred|for comments|of TE|—|OO|oO|||
|i|-|‘Case No.:64/10/82-|Party Name:GLOBE|.|‘Meet|No/Date:10/82-|~~] ‘Status:Deferred.|
|||ALC4/2018|'TROTTERS PVT LTD|ALC4/2018|
|||||||16.10.2018|||||
|187 110|File|RLA|File|~|[Lic.No/Date:0310819725|[Defer Date:|
|:01/82/050/0035 1/AM19/|:03/94/040/00961/AM18/|12.03.2018|||||
|Decision:|Deferred|forcommentsofTE|.|Oo|.|
|(Case|No.:69/10/82-|-~—~Party|Name:MEDISPRAY Meet|No/Date:10/82-|_‘Status:Deferred_|
|__|ALC4/2018|‘LABORATORIES|PVT.|ALC4/2018|||||
|188|||LTD.|16.10.2018|||
|THO|File|RLAFile|‘Lic.No/Date:0310819735|Defer|Date:|
|i|:01/82/050/00356/AM19/|:03/95/040/01054/AM18/|12.03.2018|||
|Decision:|Deferred|for commentsofTE|OS|OO|/|1|
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61
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r “easSa ean poe eee ke haan | | ALC4/2018 ‘Name:METROPOLITAN ‘ALC4/2018 Approved | | -EXIMCHEM PRIVATE LTD. 16.10.2018 | HQ <r RLA File ———— Nolbateoa10ni9734 ( | | |:01/82/050/00360/AM19/ :03/95/040/00995/AM18/ 12.03.2018 | | Decision: Committee considered case as per agenda and[in][the][ light][of][ earlier][decision][taken][by][ NC][in][its] | 10/82 meeting dated 10.01.2018 it was decided to ratify the ad-hoc input output norms under para 4.7 of 189 HBP as per details below or as applied by firm whichever is lower: | | Export product Exp. Sl. | Import items Qty. Allowed in | } | Qty. | No. kg | | | 2,2-BIS (€4-HYDROXY-31 kg 1 2,2-BIS (4-HYDROXY PHENYL) | 0.98 | | NITROPHENYL) HEXAFLUOROPROPANE | || HEXAFLUOROPROPANE (BPAF) | _ ACTIVATED CARBON | METHANOL | RA may take appropriate action as per the decision of Norms Committee | / (Case No.:311/10/82~—~—~Party Name:ALEMBIC——Meeet No/Date:10/82-._—‘Status:Deferred (ALC4/2018 PHARMACEUTICALS LTD ALC4/2018 ; | | 16.10.2018 | 190 FQ File } RLA File ~Lic.No/Date:3410043955 Defer Date: 01/82/050/00598/AM 19/ :34/24/040/00361/AM18/ (12.03.2018 Decision: Deferredfor comments of TE 7 7 7 . | | (Case No.:15/10/82Party Name:JUBILANT LIFE Meet No/Date:10/82Status: | _ ALC4/2018 ‘SCIENCES LIMITED ‘ALC4/2018 ‘Approved | | | 16.10.2018 | HQ File | 7 ~ IRLA File Lic.No/Date:05 10405866 | :01/82/050/00302/AM19/ :05/23/040/00392/AM18/ (13.03.2018 | | | 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 Exp. Sl. Import items Qty. Allowed in | | Qty. No. kg | Piperidine (Min Purity 99%) | 1 kg Ruthenium Alumina Catalyst 0.00196 | (Ruthenium 5 %) | | Alumina Silicate Catalyst 0.01896 ; | Denatured Ethy! Alcohol 2.242 || Propionaldehyde | __RA may take appropriate action as per the decision of Norms Committee |
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on | Case No.:16/10/82—“Party Name:JUBILANT LIFE Meet No/Date:10/82Status: — ALC4/2018 SCIENCES LIMITED ALC4/2018 Approved | | IO =aa a Sion tema RLA Faee Lic. No/Date:0510405865 | | ':01/82/050/00303/AM19/ ':05/23/040/00352/AM18/ 13.03.2018 | 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: 192, Export product Exp. SI. Import items Qty. Allowed in |. | Qty. No. kg | | 3 Cyano Pyridine lkg Denatured Ethyl Alcohol 2.229 | 1.405 | ; | Alumino Silicate Catalyst 0.023 | i Propionaldehyde | | RA may take appropriate action as per the decision of Norms Committee | | (Case No.:56/10/82-ALC4/2018 Party Name:YASHO Meet No/Date:10/82-. Status: INDUSTRIES PVT.LTD. ‘ALC4/2018 Deferred 16.10.2018 | 193 HQ File RLAFile -Lic.No/Date:0310819759 'Defer Date: :01/82/050/00343/AM19/ ':03/95/040/01089/AM18/ (13.03.2018 _ tD ec hnicalision: Committeedetails as per consideredAppendix the4E. case as per agenda and itwas decided to call from the firm complete || | Case No.:70/10/82-ALC4/2018 PartyName:YASHO—~—SMeeet No/Date:10/82Status: | | INDUSTRIES PVT.LTD. ALC4/2018 Deferred | | | 16.10.2018 194 HQ File RLA File _ |Lic.No/Date:0310819771 [Defer Date: | — 01/82/050/00357/AM19/ :03/95/040/01099/AM 18/ (13.03.2018 | _ Decision: Committee considered the case as per agenda and itwas decided to call from the firm complete | _ technical details as per Appendix 4E | Case No.:89/10/82-ALC4/2018 |Party Name:YASHO.——sMeet No/Date:10/82Status: INDUSTRIES PVT.LTD. ALC4/2018 ‘Deferred | | 16.10.2018 | 195 HQ File RLAFile ===—————LLic.No/Date:0310819757 [Defer Date: || :01/82/050/00376/AM19/ :03/95/040/01086/AM18/ 13.03.2018 | Decision: Committee considered the case as per agenda and it wasdecided to call from the firm complete | technical details as per Appendix 4E
63
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/ (Case No.:90/10/82= PartyName:YASHO Meet No/Datte:10/82-. Status: | ALC4/2018 INDUSTRIES PVT.LTD. ALC4/2018 ‘Approved a (16.10.2018 | HQ File RLAFile = ~~—~—~—Lic.No/Date0310819758, | :01/82/050/00377/AM 19/ ':03/95/040/01072/AM18/ 13.03.2018 | | ‘Decision: Committee considered case as per agenda and in the light of earlier decision taken by NC in its __2/AM19 meeting dated 16.05.2018, it was decided to ratify the ad-hoc input output norms under para 4.7 of | 196 HBP as per details below or as applied by firm whichever is lower: | | Export product Exp. | Sl. Import items Qty. Allowed in kg | | | Qty. | No. _ | OCTYLATED kg DIPHENYLAMINE 0.405 | || DIPHENYLAMINE(OCD DIISOBUTYLENE LFLAKESIPOWDER) ACTIVATEDCLAY [01d __ RA may take appropriate action as per the decision of Norms Committee / Case No.:91/10/82~—~—~PartyName:YASHO.~—Meet No/Date:10/82-. Status: _ (ALC4/2018 INDUSTRIES PVT.LTD. ALC4/2018 Approved | | ‘HQ File | — RLA File _ ~ |Lic.No/Date:03 10819756 | | |:01/82/050/00378/AM19/ ':03/95/040/01073/AM18/ 13.03.2018 | | | Decision: Committee considered case as per agenda and in the light of earlier decision taken by NC in its | 2/AM19 meeting dated 16.05.2018, it was decided to ratify the ad-hoc input output norms under para 4.7 of l197 HBP as per details below or as applied by firm whichever is lower: | Export product Exp. SI. Import items Qty. Allowed in | | | Qty. | No. kg | _ | AROMATIC 1 kg DIPHENYLAMINE 0.447 || DERIVATIVE OF ALPHA METHYL STYRENE | | DIPHENYLAMINE(ADA) ACTIVATED CLAY | | ‘RA may take appropriate action as per the decision of Norms Committee (Case No.:107/10/82-. —~—~—~=~@Party Name:GLENMARK —_—Meet No/Date:10/82-. Status: | |ALC4/2018 |PHARMACEUTICALS LTD., (16.10.2018ALC4/2018 Deferred | 8 QFile ) RLA File Lig, No/Date:0310819774 _ :01/82/050/00394/AM19/ ':03/94/040/01035/AM18/ 13.03.2018 | | | Decision: Deferred for comments of TE |
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- [Case No.:108/10/82-—~—~«-Party Name:GLENMARK M e t No/Date:10/82Status: ALC4/2018 PHARMACEUTICALS LTD., ALC4/2018 Approved 199 | (16.10.2018 | | HO Fi—— RLA File eee | ::01/82/050/00395/AM19/ :03/94/040/01036/AM18/ee reece ie13.03.2018Ta oalosigT7s || || i ~ ‘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: | | | SL. Export product Exp. Import items Qty. Allowed | _— LNo. Qty. | | | Alclometasone Dipropionate USP Cream 0.05% 15gm 70000.000 | ( Pack Size 15gm) Pack } 2 Alclometasone Dipropionate USP | | | Cream 0.05% 45gm ( Pack Size 40000.000 | ; | 45gm) Pack | 3 Alclometasone Dipropionate USP 1 | Cream 0.05% 60gm( Pack Size 30000.000 Alclometasone 4.0933 kg | 60gm) Pack Dipropionate | 14 Alclometasone Dipropionate Ointment 0.05% 15gm ( Pack Size 40000.000 | 15gm) Pack | | 5 Alclometasone Dipropionate P| Ointment 0.05% 45gm ( Pack Size 35000.000 | | 45gm) Pack | | Alclometasone Dipropionate | ; | Ointment 0.05% 60gm ( Pack Size 20000.000 | | 60gm) Pack | RA may take appropriate action as per the decision of Norms Committee | (Case No.:14/10/82—~—«Party Name:JUBILANT LIFE Meet No/Date:10/82Status: | ALC4/2018 SCIENCES LIMITED ALC4/2018 ‘Approved | | ori =. [Lic NovDate:0510405869 | :01/82/050/00301/AM19/ :05/23/040/00472/AM 18/ 14.03.2018 | 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[|] b00 details below or as applied by firm whichever is lower: | “"~ | Export product Exp. Sl. | Import items Qty. Allowed in | Qty. No. kg | Pyridine 98% Min 1kg | 1 | Alumino Silicate Catalyst 0.019, | | Ethyl Alcohol (Denatured) 2.194 | a 3 . Not shown in | | Propionaldehyde process RA may take appropriate action as per the decision of Norms Committee |
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"Case No.:58/10/82- —-~PartyName:YASHO.~—“Meet No/Date:10/82-. Status: _ (ALC4/2018 INDUSTRIES PVT.LTD. ALC4/2018 Approved | HQ File RLA File ) ‘Lic.No/Date:0310819792, | :01/82/050/00345/AM19/ :03/95/040/01095/AM18/ 14.03.2018 | | ‘Decision: Committee considered case as per agenda and in the light of earlier decision taken by NC in its | 201 HBP2/AM19as permeetingdetailsdated below16.05.2018,or as appliedit was by firmdecidedwhicheverto ratifyisthelower:ad-hoc input output norms under para 4.7 of | Export product Exp. Sl. Import items Qty. Allowed in | Qty. No. kg | | ISO EUGENOL 1 kg CLOVE LEAF OIL ri40.Od | 2 RUTHENIUM(III)2,4 | | | PENTANEDIONATE(RUTHENIUM | | ACETYLACETONATE) | ‘RA may take appropriate action as per the decision of Norms Committee ~~ Case No.:34/10/82~—~—~*(iParty Name: MAHIMA LIFE Meet No/Date:10/82‘Status: _ ALC4/2018 ‘SCIENCES PVT.LTD. ALC4/2018 Approved | | | | 16.10.2018 | | HQFile ~~ RLAFile = =———_Lic.No/Date:0510405878 | :01/82/050/00321/AM19/ :05/24/040/00590/AM 18/ 15.03.2018 | Decision: Committee considered case as per agenda and deliberated on the matter in the presence of the| 202 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 Exp. Sl. Import items Qty. Allowed in |. Qty. No. kg | | PREDNISOLONE 1 kg PREDNIGOLONE 0.839 _ | SODIUM PHOSPHATE | _RA may take appropriate action as per the decision of Norms Committee [ ‘Case No.:71/10/827 Party Name:YASHO ~ Meet No/Date:10/82- Status: | _ ALC4/2018 INDUSTRIES PVT.LTD. ALC4/2018 Approved | HQ File . ~ RLA File - ~ |Lic.No/Date:0310819835 | _ :01/82/050/00358/AM19/ :03/95/040/01105/AM18/ 15.03.2018 | | Decision: Committee considered case as per agenda and deliberated on the matter in the presence of the pus technical[\details][below] experts[or][as] and[applied] it was[ by] decided[firm][whichever] to ratify the[is][lower:] ad-hoc input output norms under para 4.7 of HBP as per.| | Export product Exp. | Sl. Import items Qty. Allowed in | | | Qty. | No. kg | | BUTYLATED OCTYLATED 1 kg DIPHENYLAMINE 0.405 | | | DIPHENYLAMINE(YALUB DI-ISOBUTYLENE }0620 | | BoBEa) ACTIVATEDCLAY [015d _ RA may take appropriate action as per the decision of Norms Committee
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Case No.:106/10/82‘PartyName:GLENMARK M e t No/Date:10/82Status: | ALC4/2018 PHARMACEUTICALS LTD., ALC4/2018 Deferred | :01/82/050/00393/AM19/ :03/94/040/01046/AM18/ ‘15.03.2018 | i Decision: Deferred for comments of TE | Case No.:109/10/82- | PartyName:DELTA.—S Meet No/Date:10/82-._—Status: | ALC4/2018 FINOCHEM PVT.LTD. ALC4/2018 Approved | 16.10.2018 | | HQ File a RLA File | ~ Lic.No/Date:03 10819842 —:01/82/050/00396/AM19/ :03/94/040/00997/AM18/ (15.03.2018 | Decision: Committee considered case as per agenda and deliberated on the matter in the presence of the 205 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 Exp. | SI. Import items Qty. Allowed in. |) Qty. | No. kg N Hexyl Bromide lkg Nacol 6-98 ( 1-Hexanol) 0.685 | ‘RA may take appropriate action as per the decision of NormsLiquidCommittee Bromine 0.545 | | | CaseNo.:72/10/82-ALC4/2018 PartyName:OCSPECIALITIES PVT.LTD. ALC4/2018Meet No/Date:10/82Status:Deferred 206HQFile = ~~ RLAFile ~~~—~—~—_Lic.No/Date:0310819894 Defer Date: | 01/82/050/00359/AM19/ ':03/95/040/01114/AM18/ 16.03.2018 | Decision: Committee considered the case as per agenda and it was decided to call from the firm complete ‘technical details as per Appendix 4E Case No.:94/10/82Party Name:YASHOMeet No/Date:10/82‘Status: | — j|ALC4/2018 INDUSTRIES PVT.LTD. ALC4/2018 ‘Approved | | | 16.10.2018 | | HQ File -RLAFile = ——Lic.No/Date:0310819888 | SCS :01/82/050/00381/AM19/ ':03/95/040/01123/AM18/ 16.03.2018 Decision: Committee considered case as per agenda and in the light of earlier decision taken by NC in its | _ 2/AM19 meeting dated 16.05.2018, it was decided to ratify the ad-hoc input output norms under para 4.7 of | 207 ‘HBP as per details below or as applied by firm whichever is lower: | Export product Exp. | SI. Import items Qty. Allowed in | ; Qty. | No. kg | _ | OCTYLATED DIPHENYLAMINE 1 kg DIPHENYLAMINE | 0.405 || (OCD FLAKES/POWDER) DI-ISOBUTYLENE 0.620 | | ACTIVATED CLAY [0.100] RA may take appropriate action as per the decision of Norms Committee |
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| (Case No.:119/10/82-.—Party Name:INDSWIFT Meet No/Date:10/82-. Status: | ALC4/2018 LABORATORIES LIMITED ALC4/2018 Approved HQ File RLA File ~ |Lic.No/Date:2210015871, / :01/82/050/00406/AM19/ :22/24/040/00093/AM 1 8/ (16.03.2018 | | |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 Exp. | SIL. Import items Qty. Allowed in | 208, Qty. | No. kg | || FEXOFENADINE 1 kg Dimethyl Sulfoxide | | HYDROCHLORIDE [2 |Towene80 po 5 Sodium Borohydride 0.332 | Powder | | | [8 [tsopropytAlcohor [193 | RA may take appropriate action as per the decision of Norms Committee | - (Case No.:123/10/82~—~~PartyName:SARNA~—SMeet No/Datte:10/82-. Status: | ALC4/2018 CHEMICALS PVT LTD ALC4/2018 Approved | | ‘16.10.2018 | — HQFile 7 RLAFile = —~—~—_Lic.No/Date:5210042561 | | :01/82/050/00410/AM19/ :52/24/040/00082/AM18/ 16.03.2018 | | | Decision: Committee considered case as per agenda and in the light of earlier decision taken by NC in its | _ 5/AM19 meeting dated 25.07.2018, it was decided to ratify the ad-hoc input output norms under para 4.7 of. ‘HBP as per details below or as applied by firm whichever is lower: | | Export product Exp. SI. Import items Qty. Allowed in |. | Qty. | No. kg | | 2-HYDROXY 4- 1 kg RESORCINOL | | | METHOXY ETHYLENE DICHLORIDE 0.972 || BENZALDEHYDE / DIMETHYL FORMAMIDE 1.378 _ | MOSAL/ DCPC/SR 119 ACETONE 1.000 | a POTASSIUM CARBONATE 0.972 | _ RA may take appropriate action as per the decision of Norms Committee | | (Case No.:53/10/82 Party Name:CAMPHOR & Meet No/Date:10/82Status: | ‘ALC4/2018 ALLIED PRODUCTS ALC4/2018 Approved | | LIMITED, 16.10.2018 | fo File aed 1<a[ “tie][Ne] or | 210 :01/82/050/00340/AM 19/ :03/94/040/01047/AM18/ 9 } | 19.03.2018 | ‘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.
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details below or as applied by firm whichever islower:
|
|
Export product Exp. | Sl.No. | Import items Qty. Allowed in — SANJINOL TOCO (2-Ethyl-4(2-Ethyl-4(22 | 1kg© | 1 Alpha Pinene 1.47 || | 3-Trimethylcyclopent-3-en-yl)| | but-2-en-1-ol) N-Butyraldehyde 0.7722 ; | 4 Aluminum Tri-sec0.072 | | Butoxide | Di - N -Butylamine 0.077 | RA may take appropriate action as per the decision of Norms Committee | (Case| No.:54/10/82-ALC4/2018'&PartyALLIED Name:CAMPHORPRODUCTS MeetALC4/2018 No/Date:10/82Status:Approved ‘LIMITED, 16.10.2018 | | HO ae ed a <5. a OTT | :01/82/050/00341/AM19/ ::03/94/040/01049/AM18/ 19.03.2018 | | | 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: 211 | Export product Exp. | SI.No. | Import items Qty. Allowed in | | BACDANOL TOCO Ikg | 1 Alpha Pi 1.47 | | (2-Bthyl-4-(2 2 3- ae SU | _| Trimethylcyclopent-3-en-yl)- butN-Butyraldehyde 0.7722 | 4 Aluminum Tri-sec0.072 | Butoxide | Di - N -Butylamine 0.077 | RA may take appropriate action as per the decision of Norms Committee | ‘Case No.:55/10/82‘Party Name:BENZO CHEM Meet No/Date:10/82Status: ALC4/2018 INDUSTRIES PRIVATE ALC4/2018 Deferred | | LIMITED, 16.10.2018 | | [212 [HO File Scape RLA FileA CanRIT Defer Dates | | |:01/82/050/00342/AM19/ ':03/94/040/00462/AM18/ (19.03.2018 | | | Decision: Deferred for comments — Ss elec Case No.:211/10/82Party Name:AMINES & Meet No/Date:10/82- Status: ALC4/2018 ‘PLASTICIZERS LIMITED ALC4/2018 Approved | _-HQFile RLA File ; Lic.No/Date:0310819908, 013 :01/82/050/00498/AM19/ :03/94/040/01041/AM18/ ——.19.03.2018 | 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 [St [Import Product
SSS~dCQuattity
69
“™, | ss core =r 5:73 es 7" a ° LINE 1 | | N-METHYLMORPHOLINE lkg [ej MORPHO 0.391 kg ] | OXIDE - 50% HYDROGEN PEROXIDE 50% 0.300kg ; | FORMIC ACID 0.245 g || | ‘RA may take appropriate action as per the decision of Norms Committee © (Case No.:219/10/82Party Name:CHIRAG (Meet No/Date:10/82Status: | ALC4/2018 ENTERPRISE ‘ALC4/2018 Approved | | 16.10.2018 | HQ File RLA File [Lic.No/Date:2410042385, | :01/82/050/00506/AM19/ ':24/24/040/00048/AM 1 8/ 19.03.2018 | | 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[|] 214 details below or as applied by firm whichever is lower : || Quantity allowed | | | CRUDE METHYL 1kg |ACRYLIC PLASTIC 1.10 kg | | | METHACRYLATE STRIPS / OFFCUTS & | _ | MONOMER ACRYLIC PLASTIC | | SCRAP (CTSH NO. | | 39159030) _ RA concerned may take further necessary action as per above decision of NC ' [Case No.:339/10/82~—PartyName:AVA_ ‘Meet No/Date:10/82Status: _ ALC4/2018 (CHEMICALS PVT.LTD., ALC4/2018 Approved | | | 16.10.2018 | HOFae 7 < 2 PTe - | :01/82/050/00626/AM 19/ ':03/94/040/01006/AM18/ (19.03.2018 | | Decision: Committee considered case as per agenda and as per earlier decision taken by NC taken by NC 215 in its 4/82 meeting dated 19.06.201 8, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: ' | Export product Exp. | SI.No. Import items Qty. Allowedkg |. i | COPPER EDTA, Cu Content 14 1kg | 1 ETHYLENE DIAMINE 0.710 kg[(+/-][1)] TETRA ACETIC AICD |[%] | RA may take appropriate action as per the decision of Norms Committee | / ‘Case No.:340/10/82Party Name:AVA Meet No/Date:10/82‘Status: ALC4/2018 CHEMICALS PVT.LTD., ALC4/2018 Deferred | | | | 16.10.2018 | | | HO Fie” nn 7; as |ios eooT Weir Dee | | ::01/82/050/00627/AM 19/ :03/94/040/01008/AM18/ 19.03.2018 | Decision: Committee considered case as per agenda and as per earlier decision taken by NC taken by NC. 216 in its 4/82 meeting dated 19.06.2018, it was decided to ratify the ad-hoc input output norms under para 4.7 ‘of HBP as per details below or as applied by firm whichever is lower: | | | Export product Exp. SI.No. | Import items Qty. allowed | Qty. kg | | DISODIUM MANGANESE EDTA | 1kg | 1 ETHYLENE DIAMINE 0.690 kg | | Content 12.5% (+/- 0.5) TETRA ACETIC ACID
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| [RAmay takeappropriateaction as per the decision ofNorms Committee. | (Case No.:338/10/82~~ [PartyName:AVA———S—S*«wMeeet No/DDaate:10/82Status: - ALC4/2018 ‘CHEMICALS PVT.LTD., ALC4/2018 ‘Approved | i | 16.10.2018 | | foeS a Naamoaosio0de | | _ :01/82/050/00625/AM19/ ':03/94/040/01007/AM18/ 20.03.2018 oie Decision: Committee considered case as per agenda and as per earlier decision taken by NC taken by NC | | ‘in its 24/82 meeting dated 15.11.2012, it was decided to ratify the ad-hoc input output norms under para| 217 4.7 of HBP as per details below or as applied by firm whichever is lower: | Export product Exp. | SI.No. | Import items Qty. Allowed kg | | EDTA FERRIC SODIUM Fe 1kg | 1 ETHYLE DIAMINE 0.730 kg content 13% ( +/- 0.5) TETRA ACETIC ACID RA may take appropriate action as per the decision of Norms Committee | Case No.:25/10/82Party Name:TIDE ‘Meet No/Date:10/82Status: — ALC4/2018 INDUSTRIES ALC4/2018 Approved | ‘Gomn : —— RLA File ON a | _ 101/82/050/003 12/AM19/ :34/24/040/00390/AM18/ 22.03.2018 | Decision: Committee considered case as per agenda and as per earlier decision taken by NC taken by NC | in its 8/82 meeting dated 31.08.2018, it was decided to ratify the ad-hoc input output norms under para 4.7 218 of HBP as per details below or as applied by firm whichever is lower: | Export product Exp. | SI.No. Import items Qty. Allowed kg | | | Aldehyde C-12 MNA 1kg | 1 C-11 Alcohol 1.92 kg | | RA may take appropriate action as per the decision of Norms Committee | || (Case No.:42/10/82PartyName:PCLOIL& (Meet No/Date:10/82-Status:Deferred | ALC4/2018 ‘SOLVENTS LTD. 'ALC4/2018 | | 219 HQ File RLA File Lic.No/Date:0510405952 Defer Date: :01/82/050/00329/AM 19/ ':05/24/040/00619/AM18/ 22.03.2018 | | | Decision: Committee considered case as per agenda and it was decided to call from the firm copy of | _ Shipping Bill / COA of the export product. Case No.:43/10/82- ————SsParty Name:STERILE INDIA Meet No/Date:10/82Status: _ (ALC4/2018 PRIVATE LIMITED ALC4/2018 ‘Approved a 16.10.2018 | | | HQ File RLA File 'Lic.No/Date:0510405953 220 :01/82/050/00330/AM19/ :05/24/040/00628/AM 18/ (22.03.2018 | | **** _ Decision:technicaldetails belowexpertsCommitteeor asandappliedconsideredit wasbydecidedfirm casewhichevertoasratify per agendaisthelowerad-hocand: deliberatedinput output onnormsthe matterunder parain the4.7presenceof HBP of theas per ||'
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| |MEROPENEM SODIUM 1 kg isronmnens Tdhvdiate 0.987 kg |_| STERILE (MEROPENEM FOR (Non‘Sterile) y | _ LINJECTION) | [RA concerned may take further necessary action as per above decision of NC | ‘Case No.:246/10/82Party Name:EVEREST —Meet No/Date:10/82Status: | ALC4/2018 ORGANICS LIMITED —=ALC4/2018 Approved | | | (16.10.2018 | | / ‘HQ File 'RLA File ‘Lic.No/Date:09 10066084 | | :01/82/050/00533/AM 19/ ':09/70/040/00235/AM18/ 23.03.2018 | Decision: Committee considered case as per agenda and deliberated on the matter in the presence of the[|] | technical experts and as per earlier decision taken by NC in its meeting No. 6/82 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:
| | Qty. kg 221 | DEXLANSOPRAZOLE 1 kg 1 2,2,2-TRIFLUORO ETHANOL | 4.87 | | FINISHED PRODUCT LIQUID MATERIAL a LIQUID MATERIAL [| LIQUID MATERIAL | | LIQUID MATERIAL | LIQUID MATERIAL | i | aa LIQUID MATERIAL 1 | 7 ACETONE 1.25 ‘RA may take appropriate action as per the decision of Norms Committee | _ Case No.:248/10/82Party Name: AETHER ‘Meet No/Date:10/82Status: | ‘ALC4/2018 INDUSTRIES LIMITED ‘ALC4/2018 Approved P| 16.10.2018 ‘HQ File RLA File ‘Lic.No/Date:52 10042581 | | :01/82/050/00535/AM19/ :52/24/040/00088/AM 18/ 23.03.2018 | ‘Decision: Committee considered case as per agenda and in the light of earlier decision taken by NC in its | 222 '5/AM19 meeting dated 25.07.2018, it was decided to ratify the ad-hoc input output norms under para 4.7 | of HBP as per details below or as applied by firm whichever is lower : | [ N-OCTYL-Dkg a ANHYDROUS RA concerned may take further necessary action as per above decision of NC
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|---|---|---|
|“GowanPach Name LDRcaelVNC OErtus||||
|(ALC4/2018<br>PHARMA<br>ALC4/2018<br>‘Approved<br>;<br>|<br>|<br>16.10.2018||<br>|||
||<br>|HQFile<br>===<br>~~RLAFile ~=——_Lic,.No/Date:0810142240<br>|<br>|<br>|<br>:01/82/050/00322/AM19/<br>108/24/040/00384/AM18/<br>(26.03.2018<br>||||
||<br>|Decision: Committee consideredcaseas per agenda 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,<br>223 details below or as applied by firm whichever is lower<br>:<br>||||
|つ<br>|<br>| |3-ISOBUTYL<br>lkg |1 | [SOVALERALDEHYDE__| 0.6068 kg<br>GLUTARICACID(CMH<br>[2 __ |ETHYLCYANOACETATE| 0.7814 kg<br>| |DIACID)<br>}3<br>PIETHYLMALONATE<br>0.90kg<br>__|RAconcernedmaytake furthernecessary actionasperabove decision ofNC||<br>|||
||<br>Case No.:36/10/82-ALC4/2018 [PartyName:ARVEE — MeetNo/Date:10/82-.<br>Status:<br>|<br>|<br>‘LABORATORIES INDIA<br>ALC4/2018<br>Approved<br>i<br>|<br>PRIVATE LIMITED<br>(16.10.2018<br>|||||
|HQ File<br>LA File<br>Lie, No/Date:0810142241<br>|<br>:01/82/050/00323/AM19/<br>':08/24/040/00235/AM18/<br>26.03.2018<br>|<br>|<br>|<br>‘Decision: Committee considered case as per agenda and deliberated on the matter in the presence ofthe|<br>|<br>technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 ofHBP as per<br>|<br>224 details below or as applied by firm whichever is lower:<br>||||
|| Export Product<br>Export<br>S.No<br>ImportProduct<br>Quantity<br>|<br>Quantit<br>Allowed<br>| Dimethyl 5-Nitroisophthalate<br>1kg<br>pl<br>| IsophthalicAcid<br>0.818kg||<br>|||
|つ|||
|||||
|RAmay take appropriate action as perthe decision ofNormsCommittee||||
|/<br>CaseNo.:37/10/82-<br>=<br>PartyName:CADILA——<br>Meet No/Date:10/82-<br>__‘Status:Deferred<br>_<br>ALC4/2018<br>HEALTHCARE LTD<br>ALC4/2018||||
||<br>|<br>|<br>16.10.2018<br>|<br>729HQ File<br>RLA File<br>~<br>Lic.No/Date:0810142248<br>DeferDate:<br>|<br>:01/82/050/00324/AM19/<br>::08/24/040/00379/AM 18/<br>27.03.2018<br>|<br>|<br>[SerenSepsaOPTnero<br>aiaa|||
|;CaseNo.:41/10/82-<br>Party Name:V.D.H.<br>‘MeetNo/Date:10/82- Status:Deferred<br>‘ALC4/2018<br>ORGANICS PVT. LTD<br>ALC4/2018||||
|HQFile<br>RLA File<br>Lic.No/Date:0510406013 DeferDate:<br>|<br>:01/82/050/00328/AM19/<br>05/24/040/00645/AM18/<br>28.03.2018<br>|||||
|‘Decision: DeferredforcommentsofTE<br>-<br>a||||
|| CaseNo.:44/10/82-<br>PartyName:JUBILANT<br>[MeetNo/Date:10/82-<br>Status:Deferred <br>lbo7 ALC4/2018<br>GENERICS LTD<br>ALC4/2018<br>|<br>|<br>16.10.2018||<br>|||
||_JHQFile_IRLAFile<br>Lic.No/Date:0510406024DeferDate:|||
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| /:01/82/050/00331/AM19/ _(:05/23/040/00490/AM18/. (28.03.2018 i ss—S | Decision: Deferred for commentsofTE = SO 4
| (Case No.:320/10/82Party Name:HETERO | ALC4/2018 LIMITED LABS ‘ALC4/2018Meet No/Date:10/82-Status:Deferred| | Looe | 16.10.2018 | HQ File RLA File Lic.No/Date:0910066105 Defer Date: :01/82/050/00607/AM 19/ :09/24/040/00666/AM 1 8/ 28.03.2018 / ‘Decision: Deferred for comments of TE | "(Case No.:321/10/82-—-—Party Name: HETERO LABS Meet No/Date:10/82Status: — ALC4/2018 LIMITED ALC4/2018 ‘Approved | HQ File “RLAFile = ~~—~—_Lic.No/Date:0910066106 7 | :01/82/050/00608/AM19/ :09/24/040/00670/AM 18/ 28.03.2018 | | ‘Decision: Committee considered case as per agenda and deliberatedon 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: |
pe | Export Product Export S.No | Import Product Quantity | i Quantit Allowed in kg } | 2-Chloro Nicotinic Acid | | [6[__|][Dimethyl][Formamide] | ‘RA may take appropriate action as per the decision of Norms Committee ~ [Case No.:38/10/82-. —~(Party Name:JUBILANT — Meet No/Date:10/82Status: . — ALC4/2018 ‘LIFE SCIENCES ALC4/2018 Approved HQ File RLAFile - Lic.No/Date:05 10406030 _ :01/82/050/00325/AM19/ ':05/23/040/00495/AM18/ 02.04.2018 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 L 0 details below or as applied by firm whichever is lower: | 3 | Export product Exp. | Sl. | Import items Qty. Allowed in kg | Qty. | No. | Pyridine 98% Min IL kg Alumino Silicate Catalyst f0.01I9, | | Ethyl Alcohol (Denatured) 2.194 ; | 3 } Not shown in | i | Propionaldehyde | | process | ‘RA may take appropriate action as per the decision of Norms Committee
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a.
| Case No.:39/10/82- | Party Name:JUBILANT LIFE Meet No/Date:10/82‘Status: | | ALC4/2018 SCIENCES LIMITED ALC4/2018 ‘Approved | | iO | nl RLA File nn OSOT Defer Date: | | :01/82/050/00326/AM19/ ':05/23/040/00496/AM 18/ 02.04.2018 | | 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 Exp. Sl. Import items Qty. Allowed in | (Ruthenium 5 %) ‘RA may take appropriate action as per the decision of Norms Committee | (Case No.:40/10/82Party Name:JUBILANT LIFE Meet No/Date:10/82‘Status: | ‘ALC4/2018 ‘SCIENCES LIMITED ‘ALC4/2018 ‘Approved | | if0 = Sista IRLA File i tne ct [Lie Nolmortht) —| — :01/82/050/00327/AM19/ :05/23/040/00497/AM 18/ 02.04.2018 | | Decision: Committee considered case as per agenda and deliberatedon 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 Exp. Sl. | Import items Qty. Allowed in | (Ruthenium 5 %) | RA may take appropriate action as per the decision of Norms Committee |
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| (Case No.:104/10/82'PartyName:ENCEE —(Meet No/Date:10/82-. Status: ALC4/2018 AROMATICS PVT. LIMITED ALC4/2018 Approved | po 16.10.2018 | HQ File RLA File ‘Lic.No/Date:3210078439 | | 101/82/050/0039 1/AM19/ :32/24/040/00062/AM 18/ 02.04.2018 | Decision: Committee considered case as per agenda and in the light of earlier decision taken by NC inits[2][|] 233 /AM19[given][below] meeting[or][as] dated[applied] 16.05.2018,[by][ the][firm,] it was[whichever] decided[is] to[less:] ratify norms under Para 4.7 of HBP v1 as per details | | | Export Product Export S.No Import Product Quantity Allowed | Quantity _ | Secondary Buty! 1kg 1. , 2.748 kg i | oo Glycerine | | | Quinoline | | RA may take appropriate action as per the decision of Norms Committee
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----- Start of picture text -----<br> ' (Case No.:336/10/82- —PartyName:AVA- "Meet No/Date:10/82- Status:<br>_ ALC4/2018 CHEMICALS PVT.LTD., ALC4/2018 Deferred<br>[234 HQ File | RLA File Lig. No/Date:0310820211 Defer Date:<br>| :01/82/050/00623/AM 19/ :03/94/040/01086/AM18/ 02.04.2018<br>| ‘Decision: DeferredforcommentsofTE |<br>-\Case No.:214/10/82-.~—~—~-~Party Name:AARTIDRUGS (Meet No/Date:10/82- Status:<br>: ‘ALC4/2018 LIMITED ALC4/2018 Approved |<br>| 16.10.2018<br>| (HQ File RLA File . OO Lic.No/Date:03 10820224 |<br>':01/82/050/00501/AM19/ :03/94/040/01084/AM18/ 03.04.2018 | |<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. Sl. | Import items Qty. Allowed in |)<br>235) Qty. | No. kg |<br>| Clopidogrel Bisulphate lkg 2-Chloropheny1 Glycine F100<br>| | Methylene Di Chloride (MDC) [282<br>| | L-(+)-Tartaric Acid 0.667 |<br>| | 2-Thiophene Ethanol [060<br>RA may take appropriate action as per the decision of Norms Committee<br>訛<br>----- End of picture text -----<br>
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/ Case No.:335/10/82—PartyName:CIPLA Ss MeetNo/Datte:10/82-‘Status:Deferred | ALC4/2018 LIMITED. ALC4/2018 | | ; 16.10.2018 | pee HQ File | RLA File Lie. No/Date:03 10820244 Defer Date: —-:01/82/050/00622/AM19/ :03/94/040/01092/AM18/ (03.04.2018 | | | ‘Decision: Deferred for comments of TE ee /| Case/ No.:17/10/82-ALC4/2018PartyPOLYPLASTName:PAYALPRIVATE ~ [MeetALC4/20No/Date:10/82- 18 ‘Status:‘Approved | LIMITED (16.10.2018 | | | Ho Fileres 10008058 | | | :01/82/050/00304/AM19/ :05/24/040/00629/AM18/ 06.04.2018 | | _ Decision: Committee considered case as per agenda and deliberated on the matter in the presence of the 237 technical[details][below] experts[or][as] and[applied] it was[by] decided[firm][whichever] to ratify the[is][lower:] ad-hoc input output norms under para 4.7 of HBP as per | | Export Product Export | S.No | Import Product Quantity _ | Quantit Allowed | | Di-Octyl Tera Phthalate (DOTP) 1 kg 1. Pure Tera Phthalic 0.437 kg | | Acid | ‘RA may take appropriate action as per the decision of Norms Committee | Case No.:125/10/82-. Party Name:GLOBAL_ ——sMeet No/Date:10/82(Status: + ALC4/2018 PHARMA HEALTH CARE ALC4/2018 ‘Approved i PVTLTD 16.10.2018 | | | HQ File REA File - ~ |Lic.No/Date:04 10164168 | _ _:01/82/050/00412/AM19/ :04/24/040/00272/AM 18/ 06.04.2018 ‘Decision: Committee considered case as per agenda and deliberatedon the matter in the presence ofthe| 238 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 | Quantit Allowed _ | HYOSCINE BUTYL BROMIDE 1 kg HYOSCINE BUTYL 10.2 mg/tablet | __L10MG Tablets BROMIDE IP/BP | | RA may take appropriate action as per the decision of Norms Committee | / Case No.:5/10/82Party Name:DCM SHRIRAM Meet No/Date:10/82-__Status:Deferred. _ _ALC4/2018 INDUSTRIES LTD, ALC4/2018 | | | 16.10.2018 | HQ File RLA File ‘Lic.No/Date:05 10406067 Defer Date: ' _101/82/050/00292/AM19/ :05/23/040/00515/AM18/ 09.04.2018 | | fitucfitieclincnantn eg ne ree “|
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| [Case No.:251/10/82Party Name:GLENMARK [Meet No/Date:10/82Status: _ ALC4/2018 PHARMACEUTICALS LTD., ALC4/2018 ‘Approved | | | | 16.10.2018 HQ File RLA File Lie. No/Date:0310820324. | /—:01/82/050/00538/AM19/ :03/94/040/00002/AM19/ 09.04.2018 | | Decision: Committee considered case as per agenda and as per earlier decision taken by NC in 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 : | | ‘Desogestrel and Ethinyl Estradiol Tablets USP 0.15mg/0.02mg one tablet | | mie Desogestrel and Ethinyl Estradiol Tablets USP 740 | No, | Imort Items 0.15mg/0.02mg | [1] Desogestrel | 0.153 meytablet | || Ethinyl Estradiol 0.0204 mg /tablet | | EXPORT PRODUCT : | | Ethinyl Estradiol Tablets USP 0.01 mg (VIORELE) 1 No. tablet |
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----- Start of picture text -----<br> [SUNo. [Imort Items ___ | Ethinyl Estradiol Tablets USP 0.01 mg (VIORELE)<br>| fh thinyl Estradiol 0.0102 mg/tablet<br>----- End of picture text -----<br>
RA may take appropriate action as per the decision of Norms Committee
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----- Start of picture text -----<br> -~<br>| ‘Case No.:256/10/82- Party Name:GLENMARK Meet No/Date:10/82-. Status:<br>- ALC4/2018 PHARMACEUTICALS LTD., ALC4/2018 ‘Approved |<br>| a oe REA File a a ~ Lie No/Date:03 10820322 |<br>—:01/82/050/00543/AM19/ ':03/94/040/00001/AM19/ (09.04.2018 |<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>| [sn Export product Exp. Import items Qty. Allowed |<br>| No. Qty. |<br>| [100][ Tabs.)] SOOCOEHOL |<br>Pat|a Lithium Carbonate [150mg][ (Pack][ Size] capsule USP packs /<br>| | 2 Lithiumhium CarbCarbonate capsulele USP |<br>| 300mg (Pack Size 100 Tabs.) ebenoaits |<br>— packs |<br>i 3 62/0- Lithium Carbonate capsule . |<br>| | USP 300mg (Pack Size 1000 Tabs.) Paessoe 008 LithiumCarbonate USP 25015.50 kg<br>414 Lithium Carbonate capsule USP<br>600mg (Pack Size 100 Tabs.) 50000.000<br>packs ;<br>41S Lithium Carbonate ER Tab USP<br>| 300mg (Pack Size 100 Tabs.) packsBO000.000 i|<br>Lo Lithium Cabronate ER Tab USP |<br>a packs<br>| Yo 450MG (Pack Size 100 Tabs.) 2000.00 |<br>| RA may take appropriate action as per the decision of Norms Committee<br>/ Case No.:121/10/82- Party Name:CHIRAG Meet No/Date:10/82- Status:<br>- ALC4/2018 ENTERPRISE ‘ALC4/2018 ‘Approved<br>HQ File —RLAFile = Lic.No/Date:2410042399<br>/ :01/82/050/00408/AM19/ :24/24/040/00053/AM18/ 10.04.2018 | |<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>242 details below or as applied by firm whichever is lower : |<br>||<br>Quantity allowed |<br>_ |CRUDE METHYL 1 kg |ACRYLIC PLASTIC 1.10 kg<br>_ | METHACRYLATE STRIPS / OFFCUTS & |<br>i | MONOMER ACRYLIC PLASTIC |<br>| SCRAP (CTSH NO. |<br>| 39159030) |<br>RA concerned may take further necessary action as per above decision of NC<br>汗<br>つ<br>----- End of picture text -----<br>
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----- Start of picture text -----<br> — (Case No.:254/10/82- Party Name:BENZO CHEM Meet No/Date:10/82- ‘Status: |<br> ALC4/2018 INDUSTRIES PRIVATE ALC4/2018 Approved |<br>| | LIMITED, 16.10.2018 | |<br>| HQ File RLA File ~~ Lic.No/Date:0310820357<br>| :01/82/050/00541/AM19/ ':03/94/040/00967/AM18/ 10.04.2018 |<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>243<br>| / No. |<br>| | PARA CHLORO BENZYL 1 kg PARA CHLORO BENZYL | 0.75 kg<br>| | |CYANIDE 75% SOLUTION Y ANIDE OR 4-CHLORO |<br>_ | INN-BUTYL ACETATE (4- BENZYL CYANIDE<br>| | CHLORO BENZYL 0.25 kg<br>| _ | CYANIDE 75% SOLUTION 2 -BUTYL ACETATE<br>___ ‘RA LINconcerned N-BUTYLmayACETATE) take further necessary action as per above decision of NC<br>----- End of picture text -----<br>
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----- Start of picture text -----<br> ~~ \CaseNo.:255/10/82- -—~—~Party Name:BENZO CHEM —_ Meet No/Date:<br>INDUSTRIES PRIVATE ‘ALC4/2018 Approved |<br>ALC4/2018 1 0/82- Status;<br>| | ‘LIMITED, 16.10.2018<br>| HQ File RLA File Lic.No/Date:03 10820359 |<br>:01/82/050/00542/AM19/ :03/94/040/00972/AM 18/ 10.04.2018<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>244° |<br>| Export Product Quantity allowed in<br> | | PARA CHLORO BENZYL Lkg PARA CHLORO BENZYL | 0.75 kg<br>|. | CYANIDE 75% SOLUTION 1 YANIDE OR 4-CHLORO |<br>|<br>_ | INN-BUTYL ACETATE (4- BENZYL CYANIDE |<br>| CHLORO BENZYL 0.25 kg |<br>| CYANIDE 75% SOLUTION 2 -BUTYL ACETATE |<br>| | INN-BUTYL ACETATE)<br>| RA concerned may take further necessary action as per above decision of NC<br>う<br>----- End of picture text -----<br>
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----- Start of picture text -----<br> ~ |Case No.:318/10/82- ‘party Name:CLARIANT Meet No/Date:10/82-. Status:<br>| (ALC4/2018 INDIA LIMITED ALC4/2018 ‘Approved —<br>- iHQFile = ~~~ RLAFile Lic.No/Date:0310820361<br>——::01/82/050/00605/AM19/ :03/94/040/00026/AM 19/ |10.04.2018<br>Decision: Committee considered case as per agenda and deliberated on the matter in the presence of the|<br>\245 detailstechnical belowexpertsor as andappliedit was by decidedfirm whicheverto ratify theis lower: ad-hoc input output norms under para 4.7 of HBP as per<br>| Export product Exp. | SI.No. Import items Qty. Allowed in<br>| | Qty. kg |<br>| | PIROCTONE OLAMINE OR lkg | 1 Dimethylacrylic Acid 0.85<br>_ | VIPIROX Methyl Ester (DAME) |<br>| | Isononanoyl Chloride or f1300 Ci sid:<br>う<br>----- End of picture text -----<br>
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ll Chloride | ; | 3 Hydroxylamine Hel (99% | 0.73 | MIN) Or Hydroxylamine | | Hydro Chloride(99% = 5 Di Chloro Methane | cea (MDC) | Zeea Ethylene(EDC) Di Chloride eee || |; || Hydro Quinoned Not shown in | | process | RA may take appropriate action as per the decision of Norms Committee | ~ (Case No.:334/10/82-—~—sParty Name:Z YTEX BIOTECH Meet No/Date:10/82Status: ALC4/2018 ‘PVT. LTD. ‘ALC4/2018 Approved | | | /16.10.2018 | 246 HQ File Soe ee es. eee ‘Lic.No/Date:03 10820343 | | :01/82/050/0062 1/AM19/ ':03/95/040/01161/AM18/ 10.04.2018 | | Decision: Committee considered the case and it was decided to send the copy of application to Department | of Biotechnology for their comments. | (Case No.:6/10/82~~~ Party Name:JODAS EXPOIM Meet No/Date:10/82- |‘Status:Deferred — ALC4/2018 |PVT.LTD., /ALC4/2018 | Ieiodt | 16.10.2018 | | -*7 THQ fie — |RLAFile =————~SCSSCLLLic. No/Daate05 10406090 [Defer | | ':01/82/050/00293/AM19/ ':05/23/040/0049 1/AM18/ 11.04.2018 | Decision: Deferred forcommentsofTE = eee La, ee on rete oe Case No.:101/10/82|Party Name:PRIVI ORGANICS |Meet No/Date:10/82- (Status: ‘ALC4/2018 INDIA LIMITED ALC4/2018 ‘Approved | (Bate! | 16.10.2018 | | HQ File RLA File | ) ‘Lic.No/Date:03 10820393 | | :01/82/050/00388/AM 19/ :03/95/040/00003/AM 19/ 11.04.2018 | | **** Decision: Committee considered case as per agenda and in light of earlier decision taken in 2/82 meeting. held on 16.05.2018 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:| 1248 | | Export product Exp. SI.No. | Import items Qty. allowed | Amber Fleur 1 Kg. pl. | Myrcene 80% 0.90 kg | Methyl Ethyl Ketone 0.53 kg | Phosphoric Acid 0.025 kg | | RA concerned may take further necessary action as per above decision of NC |
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- |Case No.:118/10/82~—~—S~PartyName:IND SWIFT ——Meeet No/Date:10/82Status: ‘ALC4/2018 LABORATORIES LIMITED =ALC4/2018 Approved | HQ File RLA File Lic.No/Date:2210015879 | |:01/82/050/00405/AM19/ ':22/24/040/00004/AM19/ 11.04.2018 | i ‘Decision: Committee considered case as per agenda and in light of earlier decision taken in[3/82][ meeting][|] | held on 05.06.2018 and in consultation with technical authority present in meeting, decided to ratify| norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:249 | || Export product Import items Qty. allowed |. | | Qty. in kg | | Clarithromycin Granules 42% | | Kg. P| Clarithromycin 0.4242 | || || (Suspension Grade) Carbopol | | RA concerned may take further necessary action as per above decision ofNC
~~ (Case No.:243/10/82-. —«Party Name:ZENITH Meet No/Date:10/82Status: _ ALC4/2018 DYEINTERMEDIATES ‘ALC4/2018 Approved | LIMITED 16.10.2018 | \HQFile RLAFile " [Lic.No/Date:0310820378 | | ':01/82/050/00530/AM19/ —|:03/95/040/01150/AM18/ 11.04.2018 | | | Decision: Committee considered case as per agenda and in consultation with technical authority present in | ‘meeting, it was decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm | | whichever is lower: (250 | | NAS-5 1 1.205 kg | 2-DIAZO-1-NAPTHOL-5vi PURTNY ve990% | SULFONIC ACID, SODIUM z 91%) _ |SALT) | [RA may take appropriate action as per the decision of Norms Committee | [~\Gase No.:232/10/82~«“(iParty Name:DEEPAK ——sMeet No/Date:10/82-—‘Status:Deferred_ — (ALC4/2018 /NOVOCHEM ALC4/2018 | | | ‘TECHNOLOGIES LTD 16.10.2018 | 251 HQFile ~~ RLAFile. ~————Lie,No/Date:3110067030 Defer | | .:01/82/050/00519/AM19/ ':31/83/040/00171/AM18/ 12.04.2018 | Decision: Committee considered the case as per agenda and it was decided to call from the firm complete | technical details as per appendix 4E and exact chemical name of export product. |
[Case No:332/10/82. ~~”-(Party Name:USV PRIVATE [Meet No/Date:10/82Status: ‘ALC4/2018 LIMITED ALC4/2018 Approved [252| |\HOFile ~ RLA File Lie. 16.10.2018No/Date:03 10820440 |- | — :01/82/050/00619/AM19/ ':03/95/040/00026/AM 19/ (12.04.2018 I
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----- Start of picture text -----<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 Qty. | Sl. [Import items Quantity allowed in |<br>| No. Kg<br>Doxycycline Hyclate DR 1 kg 117.7 mg/100 mg |<br>Tablets USP 100 MG Doxycycline Hyclate USP tablet |<br>_ | Doxycycline Hyclate DR 176.55mg/150 mg |<br>| | Tablets USP 150 MG 2 |Doxycycline Hyclate USP | tablet<br>RA concerned may take further necessary action as per above decision of NC |<br> |Case No.:88/10/82- Party Name:PARAGON ‘Meet No/Date: 10/82- ‘Status:Deferred |<br>ALC4/2018 INDUSTRIES ALC4/2018 |<br>(16.10.2018 | |<br>M53 HQFile | (RLAFile | ~~—~—~—{Lic.No/Date:0810142368 [Defer<br>0 1/82/050/00375/AM19/ :08/24/040/00004/AM19/ 13.04.2018 |<br>Decision: Deferred for comments of TE<br>Case No.:7/10/82-ALC4/2018 [Party Name:DHANUKA [Meet No/Date:10/82- Status:<br>‘LABORATORIES LTD ‘ALC4/2018 ‘Approved |<br>| (16.10.2018 | |<br>HQ File al REA Bile ~|Lie.No/Date:0510406124 |<br>:01/82/050/00294/AM19/ :05/23/040/00016/AM19/ 16.04.2018 |<br>Decision: Committee considered caseas 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. SI.No. | Import items Qty. allowed |<br>254 Qty. in kg |<br>7 AVNA POWDER 1 Kg. 7-Phenylacetamideo -3- 2.672<br>Chloromethyl Cephalosporanic |<br>Acid Para Methoxy Benzyl Ester |<br>ee (GCLE) |<br>TRIPHENYL PHOSPHINE e-Sa<br>| BUTYL ACETATE ied. eee ee<br>4 METHYLENE CHLORIDE 12.66 |<br>(MDC) |<br>(6 [ PHENOLMETHANOL 8.000.933 ||<br>RA concerned may take further necessary action as per above decision of NC |<br>Case No.:120/10/82- Party Name:NECTAR —|Meet No/Date:10/82-Status:Deferred<br>| ALC4/2018 ‘LIFESCIENCES LIMITED §|ALC4/2018 | |<br>| 16.10.2018 | |<br>aes<br>“ ~ HQ File 'RLA File or ~ |Lic.No/Date:22 10015885 Deir<br>::01/82/050/00407/AM19/ ::22/24/040/00006/AM 19/ 16.04.2018 | |<br>| ‘Decision: Deferred for comments of TE : me / (Siew ne = en a<br>Ｓ‐<br>町 つ ′ ７ つ<br>----- End of picture text -----<br>
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| (Case No.:2/10/82-ALC4/2018 [PartyName:DRJ Meet No/Date:10/82- Status: || /PHARMACHEM PRIVATE —/ALC4/2018 ‘Approved bo LIMITED 16.10.2018 | | HQ File RLAFile ~~—~—Lic.No/Date:3110067032, :01/82/050/00289/AM 19/ :31/83/040/00003/AM 19/ 18.04.2018 | | **** 256 Decision:technical expertsCommitteeand consideredit was decidedcasetoasratifyper agendathe ad-hocandinputdeliberatedoutput normson the undermatterparain the4.7 presenceof HBP o nf thenet . to net basis as under: | _ Quantity allowed | | | | SODIUM BENZOATE 26532.030 |SODIUM BENZOATE| 26532.030 kg | _ | |MICRONISED kg POWDER | | ‘RA concerned may take further necessary action as per above decision of NC "(Case No.:24/10/82== Party Name:ASCENT Meet No/Date:10/82‘Status:Deferred _ (ALC4/2018 FINECHEM PVT. LTD., ‘ALC4/2018 | | 257 QFile ~~~ IRLAFile =~~~—~—~—_Lic.No/Date:0810142416 Defer | | :01/82/050/00311/AM19/ :08/24/040/00309/AM18/18.04.2018 | | Decision: Deferred for comments of TE | ~~ (CaseNo.:227/10/82-—~—~—~=«(iParty Name:MOREPEN —Meet No/Date:10/82-. Status: | | ‘ALC4/2018 LABORATORIES LTD., ALC4/2018 Approved | | | 16.10.2018 | HQ File | RLAFile ~ Lic.No/Date:05 10406146 | | / :01/82/050/00514/AM19/ :05/24/040/0002 1/AM19/ 18.04.2018 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:|758. Export product Exp. SI.No. | Import items Qty. allowed | / || ATORVASTATIN CALCIUM | | Kg. 1 (4R-Cis)-1,1-Dimethylethy]-60.708 | i | cyanomethyl-2,2-dimethyl-1,3dioxane -4-Acetate || | 2 4-Fluoro-alpha-[2-methy]-10.994 | | | oxopropyl]-gamma-oxo-N-beta| ; | dipheny] benzene butanamide | | | Methylene chloride | | RA concerned may take further necessary action as per above decision ofNC |
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~ [CaseNo.:257/10/82~~‘ Party Name:GLENMARK —Meet No/Date:10/82-. Status: _ ALC4/2018 PHARMACEUTICALS ‘ALC4/2018 Approved i | LTD., 16.10.2018 | monic sts RLAa CS | _ :01/82/050/00544/AM19/ ':03/94/040/00044/AM19/ 18.04.2018 | | | 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 Exp. SI.No. | Import items Cy. allowed | _ | Qty. in kg | | TELMISARTAN 1 Kg. 1 2n-Propyl-4-methyl-6-(1-methyl | 0.763 | ia benzimidazole-2| | l)benzimidazole | | | 2 4-Methyl-2biphenylcarboxylic | Acid Methyl Ester | RA concerned may take further necessary action as per above decision of NC Tease NODS— pai hanowSe nk) _ ALC4/2018 ‘LABORATORIES LTD /ALC4/2018 ‘Approved | | | | 16.10.2018 — HQFile:01/82/050/00584/AM —RLAFile =————~SCLLic.Noo/Daate:0910066158| || 19/ :09/24/040/00019/AM19/ 18.04.2018 | | Decision: Committee considered case as per agenda and deliberatedon the matter in the presence of[the] | detailstechnicalbelowexpertsor asandappliedit wasbydecidedfirm whicheverto ratify isthelower:-ad-hoc input output norms under para 4.7 of HBP as per| ____| Export product Exp. | SI. | Import items Qty. allowed | || Qty. | No. in kg 260 | VALACYCLOVIR HCL Ikg. | 1. | ACYCLOVIR | | (Valacyclovir Hcl Anhydrous) 2. N,N DI CYCLO HEXYL 1.15 | CARBODIIMIDE | | | FORMIC ACID -94% [052 4 DI METHYL 2.00 | ; | FORMAMIDE | | ACETONE | | 6 _[Z-1-VALINE 3d | | PALLADIUM METAL 0.0002 |
RA concerned may take further necessary action as per above decision of NC
| Case No.:4/10/82-ALC4/2018 PartyName:SUN—S MeetNo/Date:10/82-. (Status: | PHARMACEUTICAL ALC4/2018 ‘Approved | ; | INDUSTRIES LTD. 16.10.2018 | 261 HQ File RLA File ~|Lic.No/Date:0510406158 :01/82/050/00291/AM19/ :05/24/040/00017/AM19/ 19.04.2018 | | Decision: Committee considered case as per agenda and deliberatedon the matter in the presence ofthe. technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per)
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details below or as applied by firm whichever is lower:-
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----- Start of picture text -----<br> LExport product |<br>| Ketorolac . Tromethamine. | 188700.000 KETOROLAC 4.812 kg |<br>| Ophthalmic Solution 0.5% | Nos. TROMETHAMINE<br>| | wiv 5 ml,<br> | (Each ml contains Ketorolac<br>| Tromethamine 5 mg |<br>| (Equivalent to 4.718 Kg of |<br>| Bulk Drug) (Pharmaceutical |<br> | Formulations / — Standard |<br>| | Grade)<br>| ‘RA concerned may take further necessary action as per above decision of NC |<br>| Case No.:8/10/82-ALC4/2018 (Party Name: DHANUKA Meet No/Date: 10/82- Status:<br>| LABORATORIES LTD ALC4/2018 Approved |<br>; | | 16.10.2018 |<br>HQ File RLA File Lic.No/Date:0510406170 <br>~— |:01/82/050/00295/AM19/ ':05/23/040/00019/AM19/ 19.04.2018 |<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>| Qty. in kg<br> | AMORPHOUS STEARIC Cephalosporanic Acid) |<br>| | POWDER CHLORIDE (PCLS) |<br>; | 3 SMIA (Z)-2- Methoxy imino-2- | 0.109 |<br>| Amoonium Salt<br>| eo | ISOCY ANATE (CSI) |<br>| GUANIDINE<br>} | aa ACETAMIDE (DMAC)<br>| | | S FINE (SPEZIOL L2SM GF) |<br>| | 13 1-ACETOXYETHYL |<br>RA concerned may take further necessary action as per above decision of NC |<br>う<br>----- End of picture text -----<br>
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"(Case No.:9/10/82-ALC4/2018 Party Name:DHANUKA Meet No/Date:10/82Status: LABORATORIES LTD ALC4/2018 Approved | 16.10.2018 | HQFile = RLAFile ~~ ~~—~—Lic.No/Date:0510406171 | __ :01/82/050/00296/AMDecision: Committee considered19/ :05/23/040/00020/AMcase as per agenda and19/deliberated19.04.2018on the matter in the presence of the || technical experts and it was decided to ratify the ad-hoc input output norms as applied by firm under para| | 4.7 of HBP as per details given below: | Export product Exp. SI.No. | Import items Qty. allowed |) | Qty. in kg | CEFUROXIME AXETIL | 5500.000 D-7ACA (Desacetyl-7- Amino 1298.000 | | | AMORPHOUS STEARIC | Kg. Cephalosporanic Acid ) ‘ | | ACID COATED 30% 2 PHOSPHOROUS PENTA 1347.500 | | Powder CHLORIDE (PCL5) ‘ f | 3 SMIA (Z)-2-Methoxy Imino-2| 063 | (Furyl-2-yl)Acetic Acid 1207.000 | | AmmoniumMETHANOLSalt 5401.000 || _ Methylene Chloride 4543.000 | | CHLOROSULPHONYL B1g008 | | | ISOCYANATE (CSI) ; | — ACETONE 3091.000 | } | a GUANIDINE1,1,3,3, TETRAMETHYL eile? | || || Pe N,NACETAMIDE DIMETHYL (DMAC) o432-000 || | 110| ETHYL ACETATE 3256.000 | _ 11 STEARICS FINE (SPEZIOL ACID (KOLLIWAXL2SM GF) 3766.950 } | ACTIVATED CARBON 176.000 | aa13 BROMIDE1-ACETOXYETHYL (AEB) 1017500 | | ‘RA concerned may take further necessary action as per above decision of NC ‘Case No.:258/10/82‘Party Name:GLENMARK | Meet No/Date: 10/82- - ‘Status:Deferred. | ALC4/2018 PHARMACEUTICALS ALC4/201 8 | | 6 | LTD., 16.10.2018 | HQ File ‘RLA File Lic.No/Date:03 10820569 Defer | | :01/82/050/00545/AM19/ :03/94/040/00047/AM 19/ 20.04.2018 | | | pet : aan _ (CaseNo.:239/10/82(PartyName:SUPREET Meet No/Date:10/82‘Status: Deferred. _ ALC4/2018 CHEMICALS PVT.LTD. ALC4/2018 | “> HQ File RLA File ‘Lic.No/Date:5210042612 Defer —— :01/82/050/00526/AM19/ 152/24/040/00013/AM19/ 23.04.2018 | | | [Decision: Deferred for comments o9fTE |
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Case No.:333/10/82‘Party Name:ZYTEX BIOTECH MeetNo/Date:10/82Status: _ ALC4/2018 PVT. LTD. ALC4/2018 Deferred | 16.10.2018 266 HQ File RLA File _ Lic.No/Date:0310820589 Defer | ::01/82/050/00620/AM19/ :03/95/040/0005 1/AM19/ (23.04.2018 | | ‘Decision: Committee considered the case and it was decided to send the copy of application to Department | ‘of Biotechnology for their comments. | ~ Case No.:18/10/82-ALC4/2018 Party Name:SUN—~—SW MeetNo/Date:10/82-. Status: | | PHARMACEUTICAL ALC4/2018 Approved — ;| lO| nn INDUSTRIES7 > anLTD. 16.10.2018Coe | | :01/82/050/00305/AM19/ :05/24/040/0003 1/AM19/ 24.04.2018 _ 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:| 267, | | | Export product Exp. SI.No. | Import items Qty. allowed | | Volini Gel 30gm Nos. Racementhol 1.53 gm/30 gmtube | _ | (Each tube contains equivalent to || 1.50gm of Racementhol) 660000 Tubes | | of 30gm equivalent to 990.000 Kg of | || bulk drug) | RA concerned may take further necessary action as per above decision of NC |
/ (Case No.:292/10/82‘Party Name:SATYADEVA Meet No/Date:10/82-. Status: —} ALC4/2018| PHARMACEUTICALSLTD PVT (ALC4/201816.10.2018 Approved| | - /HQFile ~IRLA File ~—_ |Lic.No/Date:0910066172 | | (:01/82/050/00579/AM19/ :09/24/040/00028/AM19/ (25.04.2018 | | ‘Decision: Committee considered case as per agenda and in the light of earlier decision taken by NC in its | | 13/82 meeting dated 27.11.2015, it was decided to ratify the ad-hoc input output norms under para 4.7 of | HBP as per details below or as applied by firm whichever is lower :
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----- Start of picture text -----<br> 268 || Export Product Qty. | SI. {Import items Quantity .<br>[| No. allowed in Kg |<br>, | | N-(N-METHYL-N-((2- 1 kg ISOBUTYRAMIDE 0.666 |<br>| | ISOPROPYL-4-THIAZOLYL) Tetrahydrofuran 1.486 |<br>| | METHYL)AMINO) Methylene Chloride 1.272 |<br>| CARBONYL) L-VALINE, Lithium Hydroxide Monohydrate<br>|_| LITHIUM SALT (MTV) III Isopropyl Alcohol<br>| | | 6 |Methy! Tertiary Butyl Ether 1.131 |<br>TOLUENE |<br>[8 | L-VALINE [0.60<br>RA concerned may take further necessary action as per above decision of NC |<br>Ｓｌ<br>----- End of picture text -----<br>
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rN
—(Case|ALC4/2018 No.:319/10/82~ RASAYAN|Party Name:ANUPAM(INDIA) LTD\ALC4/2018‘Meet No/Date:10/82Status:‘Approved — HQFile = = = = = —— RLAFile =———S—SCLic.No/Date:5210042617 | ~ |:01/82/050/00606/AM19/ :52/24/040/00014/AM19/ 25.04.2018 | | Decision: Committee consideredthe case as per agenda and in consultation with technical authority present ‘in meeting, it was decided to ratify norms as per the earlier decision taken in norms committee meeting | b69 No.10/82 held on 10.01.2018 under para 4.7 of HBP as per details below or as applied by firm whichever is | lower:| Export product Exp. Qty. Qty. allowed 11| Para Chloro Phenol 0.9670 kg | | oc hloto 4 Choro phenoxy) 118s Meta Dichloro Benzene 1.3500 kg | | P Dimethyl Sulfoxide 0.8000 kg | | RA may take appropriate action as per the decision of Norms Committee. |
Case No.:253/10/82Party Name:GLENMARK Meet No/Date:10/82-_Status: _ ALC4/2018 [PHARMACEUTICALS LTD., ALC4/2018 Approved - HQFile == —————~*SRLA File = ——S—S—~SCLicNo/Daate:0310820740 6 —— |:01/82/050/00540/AM19/ ':03/94/040/00068/AM19/ 01.05.2018 | | 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: | | | SL Export product Exp. Import items Qty. Allowed | _ | No. Qty. | } | Lamotrigine Tablets CD 25mg (Pack ; | size 100 Tabs.) Pack Lamotrigine 25.50 mg/tablet |. ‘270 | 2 - a 5.1 mg/tablet | ce] Lamotrigine Tablets CD 5mg (Pack Lamotrigine | size 100 Tabs.) Pack yo3 Lamotrigine(Pack size 100Tablets Tabs.)USP 100mg Pack Lamotrigine 102-0 mgyiablet 14 Lamotrigine Tablets USP 150mg | | | (Pack size 60 Tabs.) Pack Lamotrigine 153.0 mplablet | | 5 Lamotrigine Tablets USP 200mg Lamotrigine 204.0 mg/tablet | | | (Pack size 60 Tabs.) Pack | Lamotrigine Tablets USP 25mg | | (Pack size 100 Tabs.) Pack Lamotrigine 29.90 Dieaet __ |RA may take appropriate action as per the decision of Norms Committee |
89
| |Case No.:28/10/82~—~—~PartyName:RECKITT ——-Meet No/Date:10/82_—Status:Deferred _ (ALC4/2018 BENCKISER ALC4/2018 i | HEALTHCARE INDIA 16.10.2018 | | 21 (PRIVATE LIMITED | HQ File RLA File Lic.No/Date:0510406297 Defer | :01/82/050/003 15/AM19/ (:05/24/040/00059/AM19/ 02.05.2018 | Decision: Deferred forcommentsofTE = a | - (Case No.:29/10/82-—=~PartyName:RECKITT Meet No/Date:10/82-_—Status:Deferred. | ALC4/2018 BENCKISER ALC4/2018 | HEALTHCARE INDIA 16.10.2018 | 212. PRIVATE LIMITED | HQ File RLA File Lic.No/Date:05 10406296 Defer | © :01/82/050/003 16/AM19/ :05/24/040/00058/AM 19/ 02.05.2018 | a eece ee slit | / (Case No.:30/10/82-ALC4/2018 Party Name:DHANUKA Meet No/Date:10/82Status: a LABORATORIES LTD /ALC4/2018 Approved | - HQFile - RLAFile ‘Lic.No/Date:0510406299 | | :01/82/050/00317/AM19/ ':05/23/040/00030/AM 19/ (02.05.2018 | ‘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 Exp. SI.No. | Import items Qty. allowed 273 Qty. in kg | | | 7 AVNA POWDER 1 Kg. 1. 7-Phenylacetamideo -32.672 ; Chloromethyl Cephalosporanic | | | Acid Para Methoxy Benzyl Ester ; | (GCLE) | TRIPHENYL PHOSPHINE [1260| || BUTYL ACETATE 4 METHYLENE CHLORIDE( 12.66 | | | PHENOL 0.933 __ RA concerned may take further necessary action as per above decision of NC | / ~~ |CaseNo.:31/10/82-ALC4/2018Party[Name:DHANUKA] Meet No/Date:10/82-. Status: LABORATORIES LTD ALC4/2018 ‘Approved | a | (16.10.2018 | | HQ File ~IRLAFile ~ Lic.No/Date:05 10406309 274 :01/82/050/003 18/AM19/ :05/23/040/0003 1/AM19/ 03.05.2018 | 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:|
|
90
==> picture [14 x 7] intentionally omitted <==
----- Start of picture text -----<br> mo<br>----- End of picture text -----<br>
ro Sy Qty. in kg | | | AMORPHOUS. _USP/BP/IP/JP a aminocephalosporanic acid) | Ge! 2-yl) acetic acid ammonium salt | Pd (SMIA) | bet Pentachloride(PCI5) ISOCY ANATE (CSI) | TETRA METHYL | } 4 (DMAC) | _| | ACETOXYETHYLBROMIDE10.59 | | (AEB) | _ [RA concerned may take further necessary action as per above decision of NC | Case No.:32/10/82-ALC4/2018 ‘Party Name:JUBILANT LIFE Meet No/Date:10/82‘Status: | | SCIENCES LIMITED (ALC4/2018 ‘Approveed | HQ File 'RLA File ‘Lic.No/Date:0510406313 — | | :01/82/050/003 19/AM19/ ':05/23/040/0034 1/AM18/ 03.05.2018 | | | 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:| 275 | | | Export product Exp. SI.No. | Import items Qty. allowed |
i ‘RA concerned may take further necessary action as per above decision of NC
|
i Case No.:33/10/82‘Party Name:JUBILANT LIFE Meet No/Date:10/82‘Status: | | ALC4/2018 SCIENCES LIMITED ALC4/2018 ‘Approved bo | ‘16.10.2018 | | _ _ HQ File RLA File Lic.No/Date:0510406312 | 276 :01/82/050/00320/AM19/ —_—:05/23/040/00415/AM18/ _03.05.2018 |
| ‘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:
91
==> picture [487 x 693] intentionally omitted <==
----- Start of picture text -----<br> oo<br>Tes es — a ficeniean ss ssc = Alowotn<br>| | Qty. | No. kg<br>Pyridine 98% Min 1 kg }1 | Alumino Silicate Catalyst } 0.019<br>| | Ethyl Alcohol (Denatured) 2.194 |<br>| | 3 Not shown i<br>| Propionaldehyde or sown in<br>| process<br>RA may take appropriate action as per the decision of Norms Committee<br>(Case No.:314/10/82- PartyName:CADILA — ( Meet No/Date:10/82- _Status:<br>| ALC4/2018 /HEALTHCARE LTD ‘ALC4/2018 Deferred<br>| | 16.10.2018 Approvest |<br>HQ File RLA File -—Lie.No/Date:0810142503 Defer<br>| :01/82/050/00601/AM19/ :08/24/040/00024/AM19/ (03.05.2018<br>|| Decision:1/82 meetingCommitteedated 01.05.2018 considereditcasewas asdecidedper agendato ratifyand thein thead-hoclightinput of earlieroutputdecisionnorms takenunderbypara NC4.7in itsof<br>| ‘HBP as per details below or as applied by firm whichever is lower: |<br>No.<br>| _ | MOISTURISING NASAL | 1 lakh Nos. OXYMETAZOLINE 1.122 kgs<br>| | | SPRAY HYDROCHLORIDE |<br>(OXYMETAZOLINE USP<br> |HYDROCHLORIDE<br>0.05%) 2. 30 CC HDPE 18 MM<br>;277 || ASBOTTLEPER GENERALNS |<br>i | POLICY FOR<br>| | PACKING<br>MATERIAL : |<br>| PACKING |<br>| MATERIAL IN |<br>| | FINISHED FORM - Relevant as per |<br>| NET NOS. 100000) packing policy<br>3 PUMP/ACTUATOR,<br>0.10 ML<br>| | AS PER GENERAL<br>| POLICY FOR |<br>| || MATERIALPACKING : |<br>| PACKING<br>| | MATERIAL IN<br>| | FINISHED FORM - |<br>| | NET NOS. 100000)<br>| | |RA concerned may take further necessary action as per above decision of NC |<br>| CaseNo.:242/10/82-. Party Name:ZENITH —s MeetNo/Date:10/82-._—Status:Deferred<br>ALC4/2018 /DYEINTERMEDIATES ALC4/2018 | |<br>| LIMITED 16.10.2018<br>278 HQ File — ) ~ RLA File - Lic.No/Date:03 10820789 Defer<br>Decision::01/82/050/00529/AMCommittee considered19/ :03/95/040/00079/AM19/the case as per agenda and it04.05.2018was decided to call from the firm a copy|<br>| Certificate of Analysis (COA) from foreign supplier<br>----- End of picture text -----<br>
92
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||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|Case No.:252/10/82-|Party Name:ETERNIS FINE|Meet No/Date:10/82-|Status:|
|(ALC4/2018|(CHEMICALS|LIMITED,|‘ALC4/2018|Approved|—|
|||||16.10.2018|||||
|||igeel RLA oF|Haag|at|Tic|NofDatex03|wo|||
|||:01/82/050/00539/AM19/|':03/94/040/00078/AM|19/|04.05.2018|||||
|Decision:|Committee|considered|case|as|per agenda|and|in|the|light of earlier|decision|taken by NC|in|its.|
|||5/AM19|meeting|dated|25.07.2018,|it was decided|to|ratify the|ad-hoc|input|output|norms|under|para 4.7|of|
|279|HBP|as|per details|below|or|as|applied|by|firm|whichever|is|lower:|||
|Export product|Exp.|||SLNo.|||Import items|Qty. Allowed|||
|COUMARIN|kg|SALICYLALDEHY|DE|0.92|kg|
|ACETIC ANHYDRIDE|_||Notallowed|
|METHANOL|Not|allowed|
|RA may|take|appropriate|action|as per the|decision of|Norms Committee|||
|‘Case No.:27/10/82-|—~=Party Name:SENTISS|Meet No/Date:10/82-_Status:Deferred_|
|_|(ALC4/2018|PHARMA|PVT.LTD.|ALC4/2018|||||
|':01/82/050/003|14/AM19/|:05/24/040/00052/AM19/|07.05.2018|||||
|Decision:|Deferred|for comments|of|TE|)|
|Case No.:225/10/82-|—‘~Party Name:DRJ|>|~||Meet No/Date:10/82-|—‘Status:Deferred_|
|ALC4/2018|PHARMACHEM|PRIVATE|ALC4/2018|||
|281||FQ|File|~—IRLA‘LIMITEDFile|~~|16.10.2018|Lie.No/Date:3110067038||Defer|||
|':01/82/050/00512/AM19/|':31/83/040/00014/AM19/|07.05.2018|||||
|Seeaa|nore|aaa ee|ath|ee|||
|~|(Case No.i270/10/82-|—~—~*(Party Name:GLENMARK|Meet No/Date:10/82-|Status:|
|||ALC4/2018|PHARMACEUTICALS LTD.,|ALC4/2018|Approved|||
|HQ|File|i|RLA|File|Lie. No/Date:0310820814|Defer|
|||:01/82/050/00557/AM19/|':03/94/040/00048/AM19/|07.05.2018|
----- End of picture text -----<br>
| :01/82/050/00557/AM19/ ':03/94/040/00048/AM19/ 07.05.2018 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:
==> picture [456 x 124] intentionally omitted <==
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||||||||||
|---|---|---|---|---|---|---|---|---|
|282|||SI.|Export product|Exp.|Import|items|Qty.|Allowed|
|||No.|Qty.|||
|Gabapentin|Tablets 600mg (Pack|Pack|Gabapentin|612.0 mg/600 mg|
|||Size|100 Tabs.)|ae|tablet|
|2|Gabapentin|Tablets 600mg (Pack|Pack|Gabapentin|||
|||Size 500 Tabs.)|612.0tablet mg/600 mg|
|3|Gabapentin|Tablets|800mg|(Pack|.|i|
|Size|100 Tabs.)|Pack|Gabapentin|oS mg/800 mg|
----- End of picture text -----<br>
|
|
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==> picture [459 x 628] intentionally omitted <==
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||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|_|[4]|Gabapentin|Tablets|800mg|(Pack|Ll|lo|||
|||||Size 500 Tabs.)|Pack|Gabapentin|816.0 mg/800 mg|
|—|tablet|
|RA may|take|appropriate|action|as per the|decision|of|Norms|Committee|||
|Case No.:271/10/82-|Party Name:DORF KETAL|Meet No/Date:10/82-|Status:|
|ALC4/2018|(CHEMICALS|INDIA|ALC4/2018|‘Approved|||
|PRIVATE|LIMITED|16.10.2018|||
|HQ|File|RLA|File|Oo|~Lic.No/Date:03 10820807|||
|||:01/82/050/00558/AM19/|:03/94/040/00093/AM|19/|(07.05.2018|
|||‘Decision:|Committee|considered|case|as|per|agenda anddeliberated|on the matterin‘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:-|
|283|||Export product|Exp.|||SI.No.|||Import|items|Qty.|Allowed|||
|||||Chemical|-Organic|||Iso Phorone Diamine|/ IPDA|0.680 kg|||
|||Mixture|-|Trade Name|-|||Ikg|
|||Clearlink|1080|(2-Alkyl|2|Platinum|Catalyst 2020 PMC|/ 3%|0.0003|kg|i|
|||Isophoronediamine)|Platinum on|carbon|Catalyst|||
|Sulfided|( Code|2020|and|||
|fo]|B171032-3|)|||
|RA concerned may take|further necessary|action|as|per above|decision|||
|||(Case|No.:272/10/82-|~||Party|Name:DORF KETAL Meet No/Date:10/82-|__Status:Deferred|||
|_|ALC4/2018|‘(CHEMICALS|INDIA|ALC4/2018|||
|||||PRIVATE LIMITED|16.10.2018|||||
|ana HQ File|~|RLA File|Lic.|No/Date:03 10820805|Defer|
|'01/82/050/00559/AM19/|:03/94/040/00090/AM19/|07.05.2018|
|‘Decision:|Deferred|for|comments|of TE|
|-|(Case No.:122/10/82-|—~—~—~sPartyName:SARNA_—SMeeet|No/Date:10/82-._—Status:Deferred.|
|||ALC4/2018|(CHEMICALS|PVT LTD|ALC4/2018|
|oe!|16.10.2018|||
|pes HQ File|)|~ 'RLA|File|OO|Lic.No/Date:52 10042627|‘Defer|
|||:01/82/050/00409/AM19/|':52/24/040/00001/AM19/|08.05.2018|||
|||‘Decision:|Deferred|for comments|of TE|—|||
|-\Case|No.:247/10/82-.|-—~—~—:Party Name:GOPINATH|—_—Meet No/Date:10/82-|_Status:Deferred|
|_|ALC4/2018|(CHEM-TECH|LTD.,|‘ALC4/2018|||
|||::01/82/050/00534/AM19/|:08/24/040/0039 1/AM18/|09.05.2018|||
|Decision:|Deferred|for comments|of TE|
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94
-~
==> picture [461 x 561] intentionally omitted <==
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|||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|~|(CaseNo.:250/10/82-.|—~(PartyName:AETHER ———-Meet|No/Date:10/82-_Status:Deferred_|
|ALC4/2018|INDUSTRIES|LIMITED|ALC4/2018|||
|||
|||(16.10.2018|||
|287 1Q|File|~RLAFile|Lic.No/Date:5210042638|Defer|||
|:01/82/050/00537/AM19/|':52/24/040/00016/AM19/|10.05.2018|||||
|Decision:|Deferred|for|comments|of TE|||
|-|(Case No.:220/10/82-|~—~—~—~'Party Name:SUBHASH|——|Meet No/Date:10/82-.|Status:|
|ALC4/2018|(CHEMICAL INDUSTRIES|‘ALC4/2018|Approved|||
|PVT LTD|16.10.2018|||||
|io=|—|Fie|NorDate:3110067045|||||
|:01/82/050/00507/AM19/|:31/83/040/00016/AM19/|11.05.2018|||
|||Decision:|Committee|considered|case|as|per|agenda|and|as|per|earlier|decision|taken|by NCin|its|2/82|||
|288|‘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:|||
|aty.|||
|RA may take appropriate|action|as per the decision of Norms Committee|||
|.|Gasmein|Party|eerTh|TTnT|Giawar|I|
|‘ALC4/2018|HEALTHCARE|LTD|ALC4/2018|‘Approved|
|||||16.10.2018|||
|HQ ——|=|RLA|a|—|oNat|:|||
|:01/82/050/00602/AM19/|:08/24/040/00040/AM19/|11.05.2018|||
|Decision:|Committee|considered case as per agenda and|as per earlier|decision|taken by NCin 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:|
|289°|||
|Export|product|Exp.|||SI.|||Import|items|Qty.|allowed|||
|||i|Qty.|||No.|||
|FLUOCINONIDE TOPICAL|Nos.|||1.|FLUOCINONIDE|USP|30.6|mg/60|ml|
|||SOLUTION|USP|0.05%|(0.5|bottle|
|||MG/ML)|(60|ML|
|(|)|2|DEHYDRATED|16.59 gm/60|ml|
|;|||ALCOHOL|USP|bottle|||
|RA|may|take|appropriate|action|as|per|the|decision|of Norms|Committee|||
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95
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----- Start of picture text -----<br> | Case No.:276/10/82- ~~~ Party Name:GLENMARK ——sMeet No/Date:10/82-—Status:<br>; |ALC4/2018 |PHARMACEUTICALS LTD., ALC4/201816.10.2018 |Approved |<br>| HQ101/82/050/00563/AMFile 19/ RLA:03/94/040/00092/AM19/File ; Lic.No/Date:0315.05.2018 10820976 || a ||<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>| SL. Export product Exp. Import items Qty. Allowed |<br>290 || No. Gabapentin Tablets 600mg (Pack Qty.— Gabapentin 612.0 mg/600 mg |<br>1<br>| Size 100 Tabs.) ae tablet<br>| | 2 Gabapentin Tablets 600mg (Pack Pack Gabapentin<br>I | Size 500 Tabs.) 612.0 mg/600 mg |<br>| | tablet<br>| | 3 Gabapentin Tablets 800mg (Pack ,<br>| | Size 100 Tabs.) Pack Gabapentin 816.0 mg/800 mg<br>i | tablet |<br>[4 Gabapentin Tablets 800mg (Pack .<br>| | Size 500 Tabs.) Pack Gabapentin 816.0 mg/800 mg |<br>| | tablet |<br>| RA may take appropriate action as per the decision ofNorms Committee<br>Case No.:245/10/82- ———~Party Meet No/Date:10/82- Status:<br>‘ALC4/2018 ‘Name:METROPOLITAN ALC4/2018 Approved |<br>/EXIMCHEM PRIVATE _16.10.2018 |<br>| LTD. |<br>—-HQFile — - RLAFile =—————SCLiie.No/Datte0310821019<br>| :01/82/050/00532/AM19/ ——:03/95/040/00128/AM19/ —- 16.05.2018 |<br>| Decision: Committee considered case as per agenda and in the light of earlier decision taken by NC in its |<br>| 10/82 meeting dated 10.01.2018 it was decided to ratify the ad-hoc input output norms under para 4.7 of<br>291 ‘HBP as per details below or as applied by firm whichever is lower:<br>| | Export product Exp. Sl. | Import items Qty. Allowed<br>| Qty. No. |<br>| 2,2-BIS (4-HYDROXY-3- 1 kg 2,2-BIS (4-HYDROXY PHENYL) | 1.10 kg |<br>NITROPHENYL) HEXAFLUOROPROPANE |<br>| | HEXAFLUOROPROPANE (BRAP)<br>|; || ACTIVATEDMETHANOL CARBON 0.122.80 kgkg |<br>| ‘RA may take appropriate action as per the decision of Norms Committee<br>[ ‘Case No.:327/10/82- Party Name:MANGALAM Meet No/Date:10/82- Status: —<br>|| |ALC4/2018 LIMITEDDRUGS & ORGANICS ALC4/201816.10.2018 Deferred<br>292 ‘HQ File RLA File . ‘Lic.No/Date:03 10821020<br>— — :01/82/050/00614/AM19/ ':03/95/040/00119/AM19/ (16.05.2018<br>| Decision: Deferred for comments of TE<br>”<br>つ<br>つ<br>Ｆ<br>----- End of picture text -----<br>
96
-~ — ca<eNoz204/1082 Party NameRINhi, aan [Meet NoSS— — ALC4/2018 SCIENCE PVT.LTD., ALC4/2018 ‘Approved | i | 16.10.2018 | —-HQ File — RLAFile———~—~SCLiice.No/Daate25610005413 | | ~:01/82/050/00491/AM19/ ':56/24/040/00001/AM19/ 17.05.2018 | | | ‘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 Exp. | SI. No. Qty. Allowed | | GLIMEPIRIDE SULPHONAMIDE 1 kg 3-ETHYL-40.710 kg _ | (4-[2-G-ethyl-4-methy]-2-oxo-3METHYL-3| |__| pyrroline-1-carboxamide)ethy]] PYRROLINE-2-ONE | benzene sulphonamide) | | RA may take appropriate action as per the decision of Norms Committee (Case No.:244/10/82-ALC4/2018 -—«|PartyName:MELOG ~=——=S-Meeet No/Date:10/82-_Status:Deferred| SPECIALITY CHEMICALS = ALC4/2018 | | _ PVT. LTD. 16.10.2018 | Parle ~~ ~*(RLAFile ~ Lic.No/Date:03 10821042 Defer | — :01/82/050/0053 1/AM19/ ':03/95/040/00023/AM 19/ (17.05.2018 Decsiom Deferred forconmeas OTE saan narcestees Nes | Case No.:329/10/82~—Party Name:SHREE BANKEY Meet No/Date:10/82- Status: _ (ALC4/2018 BEHARI LAL AROMATICS — ALC4/2018 ‘Approved | | | 16.10.2018 | | HO =e 5 RLA File spy a [Lic No/Date-031040649127ee : ——:01/82/050/006 16/AM19/ ':05/24/040/00063/AM 19/ 17.05.2018 | Decision: Committee considered case as per agenda and in the light of earlier decision taken by NC in its | | 8/82 meeting dated 31.08.2018, it was decided to ratify the ad-hoc input output norms under para 4.7 of Ls HBP as per details below or as applied by firm whichever is lower: : | Export product Exp. Sl. Import items Qty. Allowed in _ Qty. | No. kg | | CARVACROL D-LIMONENE (LIMONENE 1.48 | | ik CITRUS TERPENE, ORANGE || | 8 TERPENE,TERPENE, STANDARDBRAZILIAN CITRUSCITRUS || | | TERPENE, ORANGE OIL) | | ‘RA may take appropriate action as per the decision of Norms Committee
97
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||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|||(Case|No.:215/10/82-|-—~—|Party|Name:BALAJI|AMINES||Meet No/Date:10/82-|Status:|
|||ALC4/2018|LIMITED|ALC4/2018|‘Approved|—|
|HQ|File|RLA|File|‘Lic.No/Date:3110067058|
|_|:01/82/050/00502/AM19/|131/83/040/0002 1/AM19/|21.05.2018|
|||Decision:|Committee|considered|case|as|per|agenda|and|in|the|light|of earlier|decision|taken|by|NC|in|its|
|||8/82|meeting|dated|25.09.2014,|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:|
|L96 ||Export product|Exp.|Qty.|||SI.No.|Import items|Qty. Allowed|in|||
|||||N-METHYL-2-|1kg|METHANOL|0.370|||
||__||PYRROLIDONE|2|AMMONIA|0.160|
|ANHYDROUS|
|||||METHYLAMINE|0.00080|||
|i|CATALYST|
|||||GBL CATALYST|0.00075|
|||RA may take appropriate|action|as|per the decision|of Norms Committee.|||
|/|(CaseNo.:217/10/82-.|—~—~Party|Name:BALAJI|AMINES|Meet|No/Date:10/82- Status:|
|——|ALC4/2018|LIMITED|ALC4/2018|‘Approved|||
|||HQ file|ir7.nn|Lie|No/Date3110067=|—|=|||
|_101/82/050/00504/AM19/|:31/83/040/00020/AM19/|21.05.2018|||
|||Decision:|:|Committee|considered|case as|per|agenda|and|in|the|light of earlier decision|taken by NC|in|its|
|||6/82|meeting|dated|26.07.2018,|it|was|decided|to|ratify|the|ad-hoc|input|output|norms|under|para|4.7|of|
|297 HBP|as per details|below or|as|applied by firm|whichever|is|lower:|||
|||[| N-ETHYL-2-|1kg|1|GAMMA|0.72|kg|
|||||PYRROLIDONE|BUTYROLACTONE|;|
|||||2|MONOETHYLAMINE|0.533|kg|
|||70%|SOLUTION|||
|||RA may take appropriate|action|as|per the|decision|of Norms Committee|
|[Case|No.:226/10/82- —~—~Party|Name:BALAJI|AMINES|MeetNo/Date:10/82-|Status:|
|_|ALC4/2018|‘LIMITED|ALC4/2018|‘Approved|||
|||HOi|7.|cae|ERR|||||
|——:01/82/050/00513/AM19/|:31/83/040/00019/AM19/|21.05.2018|
|||Decision:|Committee|considered|case|as per|agenda|and|inthe|light of earlier|decision|taken by NC|in|its|
|298 8/82|meeting|dated|25.09.2014,|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:|||
|||||GAMMA|1kg|1,4 BUTANEDIOL|1.16|kg|||
|||BUTYROLACTONE|2|0.001|kg|||
|||GBL CATAYLYST|
----- End of picture text -----<br>
98
~
|
RA may take appropriate action as per the decisionofNorms Committee
Case No.:240/10/82Party Name:SANMAR Meet No/Date:10/82Status: 7 ALC4/2018 ‘SPECIALITY CHEMICALS (ALC4/2018 ‘Approved | | HQ File ~ RLA File — ) Lic.No/Date:0410164357 | :01/82/050/00527/AM 19/ ':04/24/040/00035/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: Export product Exp. Sl. Import items Qty. allowed | | Qty. No. | 4-(2-Aminoethyl)-2-methoxyphenol. 1 kg 1.124 kg | i Sodium Cyanide 0.416 kg | | 3. Methyl Tetra Buty] 0.25 kg | Ether | RA concerned may take further necessary action as per above decision of NC. | Case No.:265/10/82—~Party Name:FINEORGANIC Meet No/Date:10/82-. ‘Status: | ALC4/2018 INDUSTRIES LTD ‘ALC4/2018 Approved | | 16.10.2018 | | ‘lore amie ae RLAFile a 77oe i ——| | -301/82/050/00552/AM19/ :03/94/040/00130/AM19/ (22.05.2018 | | | Decision: The Committee considered case as peragendaand in the presenceof the technical experts, it 300 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: || STEARYLERUCAMIDE 1 kg ERUCICSTEARYL ACID AMINE 0.592kg0.471 kg || ‘RA may take appropriate action as per the decision of Norms Committee |
|||Case No.:216/10/82- |PartyName:DEEPAK<br>><br>ALC4/2018<br>NOVOCHEM|MeetNo/Date:10/82-<br>ALC4/2018|‘Status:Deferred|
|---|---|---|---|
|301|‘TECHNOLOGIESLTD<br>16.10.2018<br> HQ File<br>RLAFile<br>===——_Lic.No/Date:3110067060Defer<br>:01/82/050/00503/AM19/<br>:31/83/040/00005/AM 19/<br>23.05.2018|||<br>|<br>Defer<br>|<br>||
||Decision:a|oteeae||
99
| (Case No.:322/10/82—Party Name:LUPIN LIMITED Meet No/Date:10/82_ Status: | ALC4/2018 | ALC4/2018 Approved | | | 16.10.2018 | | HQ File RLA File Lic.No/Date:0310821192 a :01/82/050/00609/AM 19/ :03/95/040/01050/AM18/ 23.05.2018 ‘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. | detailsExportbelowproductor as applied by firm whicheverExp. | SI. is lower:Import items Qty. Allowed in ||. | | Qty. | No. kg 302 | LEVETIRACETAM 1 kg ACTIVATED CARBON 0.0128 | CELITE | | ACETICMETHYLENEACID CHLORIDE (2260.650 5 SODIUM SULPHATE | | ANHYDROUS | 4-CHLOROBUTYRYL 1.02 | | CHLORIDE | | POTASSIUM HYDROXIDE Pls | | S(+)-2- AMINOBUTYRAMIDE 0.95 | ‘RA may take appropriate action as per the decision of Norms Committee (Case No.:323/10/82|Party Name:LUPIN LIMITED Meet No/Date:10/82Status:Deferred | | ALC4/2018 ‘ALC4/201 8 3° THQ File RLA File " Lic.No/Date:03 10821182 (Defer | | :01/82/050/00610/AM19/ ':03/95/040/00928/AM18/ 23.05.2018 | | Decision: Deferred for comments of TE ‘Case No.:337/10/82-~—~PartyName:CADILA ~—_—sCMeeett No/Date:10/82Status: | ALC4/2018 HEALTHCARE LTD “ALC4/2018 Approved ; | | 16.10.2018 — -HQFile -RLA File ~Lic.No/Date:0810142659 | 101/82/050/00624/AM19/ :08/24/040/00045/AM19/ 23.05.2018 | | 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 304 LEUCOVORIN CALCIUM FOR INJECTION 50 MG/VIAL, 100 MG/ VIAL, 200 MG/ VIAL 350 MG/ | (VIAL and 500 MG/ VIAL | | S.NO. | Import Items For export of 1 No. Tablets | (Quantity in mg) | S50MG/ 100MG/ 200MG/ 350MG/ S500MG/ VIAL VIAL VIAL VIAL VIAL | 1 LEUCOVORIN 55.65mg | 110.74 mg 220.96 mg 386.80 mg |556.5mg | CALCIUM , |
100
~,
f | I CLEAR GLASS | ; VIAL | Relevant, as per packing policy | 43 30 ML 34.5MM BD | | TY I CLEAR GLASS | RUBBER STOPPER | | | 20MM LYO | ; RTU,C1419 | | 6720GC6GV3G |a| I10 CLEARML 22MM GLASSBD, TY — VIAL ||
| RA may take appropriate action as per the decision of Norms Committee.
|
(Case No.:331/10/82—~—~—~Party Name:ANUH PHARMA Meet No/Date:10/82Status: ALC4/2018 LTD. ALC4/2018 Approved | 16.10.2018 HQ File - RLAFile ‘Lic.No/Date:03 10821222 | :01/82/050/00618/AM19/ :03/94/040/00112/AM19/ 24.05.2018
‘Decision: The Committee considered case as per agenda and in the presence of the technical experts, it 305 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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|||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|||Clobetasol|—Propionate|||1|kg|1.00 kg|||
|_||
|||RABP/USP/IP/EPmay|take|appropriate|action|as|per|theadecision|Betamethasof|Norms|C|o|nemmittee BP/USP/IP/EP|||
|Case|No.:268/10/82-|~~|Party Name:GLENMARK|Meet No/Date:10/82-|_—Status:Deferred|
|ALC4/2018|PHARMACEUTICALS|‘ALC4/2018|
|Lo|LTD.,|16.10.2018|||
|306 110|File|.|~RLA File|-|~||Lic.No/Date:03 10821272 Defer|
|:01/82/050/00555/AM19/|:03/94/040/00163/AM19/|28.05.2018|
|Decision:|Deferred|forcommentsofTE|a|-|
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|||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|||Case No.:325/10/82-|===|Party Name:BEST VALUE|——Meet No/Date:10/82-.|Status:|
|||ALC4/2018|CHEM|PVT.|LTD.|ALC4/2018|Approved|||
|||16.10.2018|||
|307 HQ|File|RLAFile|‘Lic.No/Date:3410044182|||
|_:01/82/050/00612/AM19/|(134/24/040/00057/AM 19/|(28.05.2018|||
|||Decision:|Committee|considered the|case|as|per agenda|and|in|the|light of earlier|decision|taken in meeting|
|||no.|4/82|dated|19.06.2018,|it|was|decided|to|ratify|norms|under|Para|4.7|of HBP|v1|as|per|details|given|
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101
==> picture [460 x 702] intentionally omitted <==
----- Start of picture text -----<br> | — apalied -tiie. al si<br>| | Export Product Export | Sl. Import items Qty. |<br>| | Qty. No. allowed |<br>| | Undecavertol (Kakdinol) 4- | 1 kg Propionaldehyde 0.842kg |<br>_ | Methyl-3-decen-5-ol N Amyl Alcohol/ 1-Pentanol | 0.639kg |<br>| RA may take appropriate action as per the decision of Norms Committee<br>(Case No.:264/10/82- ) Party Name:GLENMARK Meet No/Date: 10/82- Status:Deferred<br>| ALC4/2018 PHARMACEUTICALS ALC4/2018<br>| ‘LTD., 16.10.2018 |<br>308 HQ File RLA File ~——Lic.No/Date:0310821286 Defer<br>:01/82/050/00551/AM19/ :03/94/040/00168/AM19/ 29.05.2018<br>| Decision: Deferred for comments of TE _ Be |<br>Case No.:301/10/82- =~—~—~Party Name:DIVIS Meet No/Date:10/82- —Status: |<br>| ALC4/2018 LABORATORIES LTD ALC4/2018 Approved<br>16.10.2018 |<br>| HQ File RLA File ) Lic.No/Date:09 10066284 _ |<br>:01/82/050/00588/AM19/ :09/24/040/00093/AM19/ 29.05.2018<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>| details below or as applied by firm whichever is lower: |<br>309 | Export product Exp. | SI. | Import items Qty. Allowed in |<br>| | Qty. | No. kg<br>| | B-WING (L-VALINE Ikg | 1 | L-VALINE 1.837<br>| | CYCLIC UREA) METHYL CHLORO FORMATE<br>| ACRYLONITRILE 09s<br>CAUSTIC POTASH FLAKES 4.055<br>METHYLENE CHLORIDE<br>| 6 [180 PROPYL ALCOHOL<br>| |RA may take appropriate action as per the decision of Norms Committee<br>[ ~— (Case No.:293/10/82- Party Name:SATY ADEVA Meet No/Date:10/82- Status:<br>_ALC4/2018 PHARMACEUTICALS PVT (ALC4/2018 Deferred<br>i lOhQFie= RLAFile | | Lie.No/Date:0910066289 Defer |<br>| :01/82/050/00580/AM 19/ :09/24/040/00102/AM19/ 31.05.2018 |<br>| Decision: Deferred for comments of TE<br>Case No.:266/10/82- ~—~—~Party Name:FINE ORGANIC MeetNo/Date:10/82- Status:<br>ALC4/2018 INDUSTRIES LTD ‘ALC4/2018 Approved<br>| 16.10.2018<br>pu HQ File | RLA File Lie. No/Date:03 10821382<br>(:01/82/050/00553/AM19/ :03/94/040/00102/AM19/ 01.06.2018 | |<br>Decision:TheCommittee considered case as per agenda and in the presence of the technical experts, it<br>----- End of picture text -----<br>
102
~,
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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|||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|||FATTY ACIDESTER||1kg|[1|||LAURIC ACID|0.749 kg||)|
|GLYCERINE|0.344kg|||
|RA|may|take|appropriate|action|as|per|the|decision|of Norms|Committee|
|~|Case No.:267/10/82-|Party Name:GLENMARK|Meet|No/Date:10/82-__‘Status:Deferred|||
|ALC4/2018|PHARMACEUTICALS|ALC4/2018|
|||LTD.,|16.10.2018|
|312|HQ File|~IRLAFile|‘Lic.|No/Date:03 10821416|[Defer|||
|||:01/82/050/00554/AM|19/|:03/94/040/00190/AM19/|04.06.2018|||||
|||Decision: Deferred for|comments|of TE|||
|||ALC4/2018Case|No.:260/10/82-|PartyFINOCHEMName:DELTAPVT.LTD.—|||‘MeetALC4/2018 No/Date: 10/82-|‘ApprovedStatus:|
|HQ|File|i|RLA|File|a|~|Lic.No/Date:03 10821493|||||
|:01/82/050/00547/AM19/|:03/94/040/00174/AM|19/|06.06.2018|||
|||Decision:|Committee|considered|caseas per|agenda and|in|the|light|of earlier|decision|taken|by NC|in|its|||
|313|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:|||
|Export product|Exp.|||SI.|Import|items|Qty.|Allowed|||
|Qty.|No.|
|Liquid|Bromine|0.545|kg|
|‘RA|may|take|appropriate|action|as|per|the|decision|of|Norms|Committee|
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| CaseNo.:261/10/82—PartyNName:DELTA Meet No/Date:10/82-__Status:Deferred | ALC4/2018 FINOCHEM PVT.LTD. ALC4/2018 | | 16.10.2018 314 1Q File RLAFile = Lic.No/Date:0310821551 Defer | :01/82/050/00548/AM19/ |:03/94/040/00173/AM19/ 08.06.2018 | | | ibehian: Dloeelin GonohutR eS ey |SS ALC4/2018 PFINOCHEMaoePVT.LTD. _=| MecALC4/2018SS(StamerApproved | | 16.10.2018 | | HQ File RLA File _ Lic.No/Date:0310821553 | oe B15| ‘Decision::01/82/050/00549/AM19/The Committee considered:03/94/040/00176/AM19/case as per agenda and08.06.2018 inthe presence of the technical| experts, it| was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as | applied by firm whichever is lower: |
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||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
|Export|product|Exp.|||SI.|Import|items|Qty.|Allowed|
|i|Qty.|||No.|
|||Ethyl Triphenyl|Phosphonium|ike||i|||Tri Phenyl|Phosphine|0.78|kg|||
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103
||||つ<br>[Bromide<br>—<“—s™sS*ézdCN}'S«éCC<br>thy Bromide<br>=**—**—S—=«<br>23KSC)<br>RA may take appropriate action as per the decision ofNorms Committee<br>||つ<br>[Bromide<br>—<“—s™sS*ézdCN}'S«éCC<br>thy Bromide<br>=**—**—S—=«<br>23KSC)<br>RA may take appropriate action as per the decision ofNorms Committee<br>||つ<br>[Bromide<br>—<“—s™sS*ézdCN}'S«éCC<br>thy Bromide<br>=**—**—S—=«<br>23KSC)<br>RA may take appropriate action as per the decision ofNorms Committee<br>||
|---|---|---|---|---|
|[Case No.:263/10/82-<br>PartyName:DELTA<br>‘MeetNo/Date:10/82-<br>‘ALC4/2018<br>FINOCHEM PVT.LTD.<br>—ALC4/2018|||Status;<br>‘Approved||
|;|||<br>|<br>16.10.2018||||
|||HQ File<br>RLA File<br>~ |Lic.No/Date:0310821552,|||
|||:01/82/050/00550/AM19/<br>:03/94/040/00175/AM19/<br>08.06.2018|||
|||Decision: Committee considered caseasper agenda and in thelightofearlier decision|taken byNCin|its|
|||316|2/AM19 meeting dated 16.05.2018, it was decided to ratify the ad-hoc input output norms under para 4.7<br>ofHBP as per details below or as applied by firm whichever is lower:|||
||<br>|<br>|||賄<br>| Exportproduct<br>Exp. | SL.<br>Import items<br>|<br>Qty.<br>| No.<br>| TriEthylPhosphonoAcetate<br>1 kg pl TriPhenylPhosphine|Qty. Allowed<br>0.83kg||<br>||
||||つ<br>|<br>Ethyl Chloro Acetate|0.70kg|||
|||‘RA may take appropriate action as perthe decision ofNorms Committee||||
|(CaseNo.:277/10/82-<br>—Party Name:CIPLALIMITED. MeetNo/Date:10/82-|||Status:||
|||ALC4/2018<br>|<br>ALC4/2018|Deferred||
||||:01/82/050/00564/AM<br>19/<br>:03/94/040/00208/AM19/<br>08.06.2018|||
||||PeSeiGGhaa ae<br>'||||
||||CaseNo.:279/10/82-<br>PartyName:J.B.<br>MeetNo/Date:10/82-|_—_Status:Deferred||
|||<br>(ALC4/2018<br>(CHEMICALS &<br>ALC4/2018<br>|<br>|<br>PHARMACEUTICALS<br>16.10.2018<br>lig<br>LIMITED<br>||||<br>|||<br>||
|||<br>||HQ File<br>RLA File<br>‘Lic.No/Date:0310821556 Defer<br>:01/82/050/00566/AM<br>19/<br>':03/94/040/00207/AM19/<br>08.06.2018<br>|||||
|||Decision: Deferred for comments ofTE|||
||[CaseNo.:280/10/82-<br>Party Name:GLENMARK<br>~ MeetNo/Date:10/82-<br>'ALC4/2018<br>PHARMACEUTICALS LTD., ALC4/2018||Status: _<br>Approved|||
||}||<br>|<br>16.10.2018|||
||-<br>||HQFile<br>= ==<br>—————~*«<RLAFile<br>~Lic.No/Date:0310821555_<br>':01/82/050/00567/AM 19/<br>:03/94/040/00211/AM19/<br>08.06.2018|||
||||‘Decision:Committee considered case as peragenda and deliberated on the matter in|the presence ofthe|||
||||technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 ofHBP asper|||
||319|detailsbeloworas appliedby firm whichever is lower:|||
|||Sl.<br>Exportproduct<br>Exp.<br>Import items | Qty. Allowed|||
|||No.<br>Qty.|||
|||1<br>Carvedilol Tablets USP 3.125mg|||
|||<br>||(Pack Size 100 Tab.)(Netcontent of<br>Pack<br>ImportItemSr.no.1is31.250Kgs)<br>3.1875mg/3.125mg/tablet||||
104
~
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----- Start of picture text -----<br> | [2 | Carvedilol TabletsUSP 3.125mg ~ | Carvedilol OO |<br>| (Pack Size 500 Tab.) (Net content of |<br>i | Import Item Sr.no.1 is 46.875 Kgs) |<br>| 7B Carvedilol Tablets USP 6.25mg |<br>| (Pack Size 100 Tab.) (Net content of |<br>Import Item Sr.no.1 is 31.250 Kgs.) |<br>375 mg/6.25 mg/tablet |<br>\4 Carvedilol Tablets USP 6.25mg Pack | Carvedilol | 6375mg/62omgibet |<br>(Pack Size 500 Tab.) (Net content of <br>| | Import Item Sr.no.1 is 156.250 Kgs.) |<br>| 5 Carvedilol Tablets USP 12.50mg |<br>(Pack Size 100 Tab.) (Net content of<br>Import Item Sr.no.1 is 62.500 Kgs.) |<br>:<br>Carvedilol Tablets USP 12.50mg Carvedilol | 12.75 mg/ 12.50 mg/tablet |,|<br>(Pack Size 500 Tab.) (Net content of Pack<br>Import Item Sr.no.1 is 156.250 Kgs.) |<br>| 7 Carvedilol Tablets USP 25mg (Pack |<br>Size 100 Tab.) (Net content of Import |<br>Item Sr.no.1 is 100.000 Kgs.)<br>| Carvedilol Tablets USP 25mg (Pack | Pack | Carvedilol 25.5 mg/ 25 mg tablet |<br>Size 500 Tab.) (Net content of Import |<br>| | Item Sr.no.1 is 312.500 Kgs.) |<br>RA may take appropriate action as per the decision of Norms Committee |<br>‘Case No.:328/10/82- -—~—~Party Name:LUPIN LIMITED Meet No/Date:10/82- Status:<br> ALC4/2018 ALC4/2018 Approved<br>—<br>HQ File RLAFile ~—~—Lic.No/Date:0310821579,<br>| :01/82/050/00615/AM19/ :03/95/040/00198/AM19/ 08.06.2018 |<br>‘Decision: Committee considered case as per agenda and in the presence of technical expert present in the<br>| meeting, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below [|]<br>or as applied by firm whichever is lower :<br>320 _ | Export Product Qty. | Sl. [Import items Quantity |<br>| | No. allowed in Kg |<br> | | ETHAMBUTOL HCL 1kg [1 [DL2 AMINOBUTANOL<br>| | |{ISOPROPYL4 ALCOHOL |<br>| | [5 |ETHYLENE DICHLORIDE |<br>RA concerned may take further necessary action as per above decision of NC |<br>Note:- SION A-225 & A-227 to be revised<br>う<br>ＳＩ<br>----- End of picture text -----<br>
105
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----- Start of picture text -----<br> | Case No.:273/10/82- ‘Party Name:DORF-KETAL Meet No/Date:10/82-Status:Deferred<br> ALC4/2018 ‘CHEMICALS INDIA ALC4/2018 | |<br>| :01/82/050/00560/AM19/ 103/94/040/00224/AM19/ 19.06.2018<br>Decivion: ee eee ge tenet a es<br>‘Case No.:278/10/82- ~—~Party Name:DORF-KETAL Meet No/Date:10/82- _'Status:Deferred<br>ALC4/2018 CHEMICALS INDIA ALC4/2018 |<br>| PVT.LTD. 16.10.2018 |<br>| 101/82/050/00565/AM19/ 103/94/040/00223/AM19/ 19.06.2018 | |<br>| Spevision: Defeerel for comments of TE cana sepaa : eee Re te ——|<br>Case No.:281/10/82- _ “Party Name:GLENMARK Meet No/Date:10/82- _—Status: |<br>ALC4/2018 PHARMACEUTICALS LTD., ALC4/2018 Approved<br>| 16.10.2018<br>“HO Fite nates IRLA = a Te size<br>| :01/82/050/00568/AM19/ :03/94/040/00233/AM19/ 19.06.2018 | |<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 as per|<br>| details below or as applied by firm whichever is lower:<br>| [SI. Export product Exp. Import items Qty. Allowed |<br>323 | No. Qty.<br>| 4 Acyclovir Ointment USP 5% 15gm |<br>; | ( Net. wt. of Acyclovir USP 50000.000<br>| | Micronized (Chemo) is 37.500 Pack 114.75 kg |<br>| | Kgs.) Acyclovir USP<br>| i Micronized (Chemo)<br>| 2 Acyclovir Ointment USP 5% 30gm<br>( Net. wt. of Acyclovir USP onal<br>| MicronizedKgs.) (Chemo) is 75.000 |i<br>| ‘RA may take appropriate action as per the decision of Norms Committee |<br>Case No.:269/10/82- ‘Party Name:GLENMARK Meet No/Date:10/82- Status:<br>| ALC4/2018 PHARMACEUTICALS LTD., ALC4/2018 Approved i<br>; | | 16.10.2018 |<br>— HQFile ~_RLA File Lic. No/Date:03 10821882 |<br>| :01/82/050/00556/AM19/ ':03/94/040/0025 1/AM19/ 22.06.2018 |<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 as per<br>324 ‘details below or as applied by firm whichever is lower:<br>| Sl. Export product Exp. Import items | Qty. Allowed |<br>No. Qty.<br>1 Carvedilol Tablets USP 3.125mg<br>| (PackImport SizeItem100Sr.no.1 Tab.)is (Net 31.250 contentKgs) of Pack 3.1875 mg / 3.125 mg/tablet |<br>つ<br>う<br>つ<br>----- End of picture text -----<br>
106
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----- Start of picture text -----<br> ! G eSSTENEETT Se 137777 |<br>| | (Pack Size 500 Tab.) (Net content of |<br>| | Import Item Sr.no.1 is 46.875 Kgs) |<br>| | 3 Carvedilol Tablets USP 6.25mg |<br>(Pack Size 100 Tab.) (Net content of |<br>| Import Item Sr.no.1 is 31.250 Kgs.) |<br>bo lol | 6.375mg/6.25 mg/tablet |<br>| 4 Carvedilol Tablets USP 6.25mg Bae | Cavedie mg/6.25mg/tablet |<br>| | (Pack Size 500 Tab.) (Net content of |<br>; | Import Item Sr.no.1 is 156.250 Kgs.) |<br>[5 Carvedilol Tablets USP 12.50mg |<br>| (Pack Size 100 Tab.) (Net content of |<br>| Import Item Sr.no.1 is 62.500 Kgs.) 12.75 mg/ 12.50 mg/tablet |.<br>| | Carvedilol<br>| | Carvedilol Tablets USP 12.50mg |<br>| | (Pack Size 500 Tab.) (Net content of<br>| Import Item Sr.no.1 is 156.250 Kgs.)<br>79 Carvedilol Tablets USP 25mg (Pack<br>Size 100 Tab.) (Net content of Import<br>i Item Sr.no.1 is 100.000 Kgs.)<br>| Carvedilol Tablets USP 25mg (Pack mace | Catvestital 25.5 mg/ 25 mg tablet<br>Size 500 Tab.) (Net content of Import<br>Item Sr.no.1 is 312.500 Kgs.)<br>RA may take appropriate action as per the decision of Norms Committee<br>(Case No.:274/10/82- . Party Name: MELOG Meet No/Date:10/82- Status:Deferred<br>ALC4/2018 SPECIALITY CHEMICALS ALC4/2018<br>i | PVT. LTD. (16.10.2018 |<br>p> HQ File OO RLA File OO Lic.No/Date:03 10821895 Defer a<br>— :01/82/050/00561/AM19/ :03/95/040/00235/AM19/ 25.06.2018<br>| Decision: Deferred forcommentsofTE 7 |<br>(Case No.:259/10/82- Party Name:ENCEE Meet No/Date:10/82- Status:<br>ALC4/2018 AROMATICS PVT. LIMITED ALC4/2018 Approved<br>| 16.10.2018 |<br>HQ File RLA File Lic.No/Date:3210078533 |<br>_ 101/82/050/00546/AM19/ :32/24/040/00013/AM19/ 26.06.2018 |<br>Decision: In the light of earlier decision taken by NC in its 6/82 meeting dated 26.07.2018, it was decided<br>506 to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm |<br>| whichever is lower:<br>| | Export Product Export Import Product Quantity Allowed |<br>| Quantity |<br>| Enamber / Kephalis / Tetrambrone Triethyl Orthoformate |<br>RA may take appropriate action as per the decision of Norms Committee<br>つ<br>一<br>----- End of picture text -----<br>
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‘Case No.:299/10/82Party Name:DIVIS "Meet No/Date: 10/82Status: | | (ALC4/2018 LABORATORIES LTD ALC4/2018 Approved | (Ho File aa aml ForUe — —| :01/82/050/00586/AM 19/ :09/24/040/00160/AM19/ 26.06.2018 | ‘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: | Export product Qty. | SI. Import items Qty. Allowed YL) BUTANOIC ACID | ETHYL AMINE | RA may take appropriate action as per the decision of Norms Committee. | / Case No.:300/10/82_ Party Name:DIVIS ‘Meet No/Date:10/82Status: ALC4/2018 LABORATORIES LTD ALC4/2018 Approved | | | 16.10.2018 | HQ File Oe ~ RLA File ‘Lic.No/Date:09 10066383 | | | 01/82/050/00587/AM19/ :09/24/040/00155/AM19/ 26.06.2018
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:|
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----- Start of picture text -----<br> "| VALACYCLOVIR<br>HCL ike [1 [[acyctovik——~«diO] «id<br>| | CARBODIIMIDE<br>_ RA concerned may take further necessary action as per above decision of NC.<br>つ<br>----- End of picture text -----<br>
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"(Case— ALC4/2018No.:275/10/82-—~—~*(Party PHARMACEUTICALSName:GLENMARK M e t No/Date:10/82-ALC4/2018 Status:Deferred|| _ —101/82/050/00562/AM19/ ':03/94/040/00258/AM 19/ (27.06.2018 | | Decision: Deferred for comments of TE | | Case No.:205/10/82-. Party Name:RINI LIFE —— Meet No/Date:10/82Status: | ALC4/2018 SCIENCE PVT.LTD., ALC4/2018 Approved | | OnE a: 7s. an =e Maes iteaas | | :01/82/050/00492/AM19/ ——:56/24/040/00006/AM19/ 28.06.2018 | 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:
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----- Start of picture text -----<br> | | Export product Exp. | Sl.No. | Import items Qty. Allowed<br>| GLIMEPIRIDE Ikg | 1 3-ETHYL-4-METHYL-3- 0.5667 kg<br>| | (USP/EP/BP/JP) PYRROLINE-2-ONE |<br>| RA may take appropriate action as per the decision of Norms Committee |<br>| Case No.:298/10/82- SSS PartyName:DIVIS. ‘MeetNo/Date:10/82- Status:<br>_ ALC4/2018 ‘LABORATORIES LTD ALC4/2018 ‘Approved |<br>| 16.10.2018 |<br>HQ File RLA File OO Lic.No/Date:0910066410. i |<br>_ 101/82/050/00585/AM19/ ':09/24/040/00163/AM19/ 02.07.2018 |<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>331. |<br>| Export product Qty. | SI. | Import items Qty. Allowed |,<br>| No. in kg |<br>|| DEXTROMETHORPHAN BASE | | kg N-FORMYL OCTABASEPHOSPHORUS PENTOXIDE [120p1S5|<br>| | METHANOL 0.824 |<br>| | ACETONE 0.420<br>i ‘RA may take appropriate action as per the decision of Norms Committee. |<br>Case No.:235/10/82- “Party Name:CLEAN SCIENCE (Meet No/Date:10/82- Status:<br>339 ALC42018 ‘AND TECHNOLOGY ‘ALC4/2018 ‘Approved<br>| PVT.LTD. 16.10.2018 |<br>_HQFile RL File Lic.No/Date:3110067104 |<br>つ<br>----- End of picture text -----<br>
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| |:01/82/050/00522/AM19/. ——:31/83/040/00048/AM19/ (03.07.2018 ; | | Decision: The Committee considered the case as per agenda and in the light of earlier decision taken by | | NC in its 7/82 meeting dated 24.08.2018, it was decided to ratify the ad-hoc input output norms under para | | 4.7 of HBP as per details below or as applied by firm whichever is lower: Guaiacol 1 kg 1 Phenol PURITY 99% AND 1.108 kg |. ABOVE 2 Dimethy! Sulphate PURITY 99% 0.847 kg | | AND ABOVE 3 Caustic Lye PURITY 40% AND 0.35kg |. | | ABOVE (100% basis) | | 4 Hydrogen Peroxide (60%) 0.687 kg |. | | Acetone (Solvent) 0.14 kg | RA may take appropriate action as per the decision of Norms Committee. ‘Case No.:236/10/82Party Name:CLEAN SCIENCE Meet No/Date:10/82Status: ALC4/2018 AND TECHNOLOGY ALC4/2018 Approved | | PVT.LTD. 16.10.2018 | | | iG File REAFile TeWoaesi0sf og | | ':01/82/050/00523/AM 19/ 131/83/040/00047/AM 19/ 03.07.2018 i | Decision: The Committee considered the case as per agenda and_ in the light of earlier decision taken by. | NC in its 9/82 meeting dated 18.09.2018, it was decided to ratify the ad-hoc input output norms under para | 4.7 of HBP as per details below or as applied by firm whichever is lower: 333° Export product Qty. Sl. Import items Qty. | | No. I [Mono Methyl Ether —oF [Tke ork | |_| | Hydroquinone - MEHQ Dimethyl Sulphate 0.8470 kg | | | 3 Caustic Lye PURITY 40% 0.5346 kg || AND ABOVE (100% Basis) | | 4 Hydrogen Peroxide (60%) 0.8 kg | PURITY 60% | Acetone (Solvent) 0.14 kg RA may take appropriate action as per the decision of Norms Committee. (Case No.:234/10/82‘Party Name:SUBHASH ——Meet No/Date:10/82Status: | |ALC4/2018 (CHEMICAL INDUSTRIES ALC4/2018 Approved | | | PVT LTD 16.10.2018 | | | HOPiG R+c an ee eae | | | :01/82/050/00521/AM19/ ':31/83/040/00042/AM19/ 04.07.2018 | | | Decision: Committee considered case as per agenda and_as per earlier decision taken by NC in its 2/82 | 334 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: |
|
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----- Start of picture text -----<br> Qty.<br>----- End of picture text -----<br>
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| Preeen eeaneee aoeeroee ner Lidia 7 | (Case No.:294/10/82Party Name:SATYADEVA_|Meet No/Date:10/82Status: | | ALC4/2018 PHARMACEUTICALS PVT (ALC4/2018 ‘Approved | HQ File RLA File a ‘Lic.No/Date:09 10066421 | | :01/82/050/00581/AM19/ :09/24/040/00157/AM19/ 04.07.2018 | | | Decision: The Committee considered case as per agenda and in the presence of the technical experts, it | was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as 335 applied by firm whichever is lower: | | Export product Exp. | Import items Qty. Allowed _ | (4R-Cis)-1,1-Dimethylethy]-6-(21 kg | (4R-Cis)-1,1-Dimethylethy]-61.01 kg | _ | aminoethyl)-2,2-Dimethyl-1,3cyanomethyl-2,2-Dimethyl-1,3|_| Dioxane-4-acetate (OR) Amino ketal dioxane-4-acetate (ATS-8) | RA concerned may take further necessary action as per above decision of NC | _ Case No.:233/10/82-—-—~Party Name:BALAJI AMINES [Meet No/Date:10/82(Status: ALC4/2018 LIMITED ‘ALC4/2018 ‘Approved | | | 16.10.2018 _ HQFile ~~RLAFile Lic.No/Date:3110067110 __101/82/050/00520/AM19/ :31/83/040/0005 1/AM19/ 09.07.2018 Decision: Committee considered case as per agenda and in the light of earlier decision taken by NC in its | 336 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: 'RA may take appropriate action as per the decision of Norms Committee | Case No.:238/10/82-. —~—~-Party Name:CLEAN SCIENCE Meet No/Date:10/82Status: } |ALC4/2018 PVT.LTD.AND TECHNOLOGY (16.10.2018ALC4/2018 Approved || HQ File RLAFile = Lic.No/Date:3110067113. | — :01/82/050/00525/AM19/ :31/83/040/00049/AM19/ 13.07.2018 | | Decision: The Committee considered the caseas per agenda and in the light of earlier decision taken by _ NC in its 7/82 meeting dated 24.08.2018, it was decided to ratify the ad-hoc input output norms under para | 4.7 of HBP as per details below or as applied by firm whichever is lower: [337 | | | | Guaiacol i kg Phenol PURITY 99% AND 1.108 kg |, ; | ABOVE | ; | 2 Dimethyl Sulphate PURITY 99% 0.847 kg |) ; | AND ABOVE , 3 Caustic Lye PURITY 40% AND 0.35kg |, Do ABOVE (100% basis) P| 4 PURITYHydrogen60%Peroxide (60%) 0.687 kg | |
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| _ RA may take appropriate action as per the decision of Norms Committee. (Case No.:241/10/82= PartyName:MALLADI —— Meet No/Date:10/82Status: — ALC4/2018 DRUGS & ALC4/2018 Approved a PHARMACEUTICALS 16.10.2018 -HQ File RLA File —Lie,No/Date:0410164486 | “| | :01/82/050/00528/AM19/ 04/24/040/00065/AM19/ (13.07.2018 | Decision: The Committee considered case as per agenda and in the presence of the technical experts, it. | was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as 338 applied by firm whichever is lower:
| | Export product Qty. | SI. | Import items Qty. Allowed | — No. in kg | |__| N-t-Boc trans-4-hydroxy-I-proline | 1 kg Trans-4-hydroxy-I-proline 0.886 | | Di-tert butyldicarbonate Pst] | | Causticsoda Flakes | __RA may take appropriate action as per the decision of Norms Committee. | (CaseNo.:237/10/82- -~—~—~Party Name:CLEAN SCIENCE Meet No/Date:10/82- Status: | ALC4/2018 AND TECHNOLOGY ALC4/2018 Deferred | | | PVT.LTD. 16.10.2018 | 339 HQ File RLA File ~—Lie.No/Date:3110067115 Defer | :01/82/050/00524/AM19/ :31/83/040/00050/AM19/ 16.07.2018 | Decision: Deferred for comments of TE | | \Case No.:326/10/82-. —~|-Party Name:BEST VALUE — MeetNo/Date:10/82Status: | ALC4/2018 CHEM PVT. LTD. ALC4/2018 Approved 16.10.2018 — HQFile = = —— RLA File ~ |Lic.No/Date:3410044431 ——:01/82/050/00613/AM19/ :34/24/040/00179/AM19/ 21.08.2018 Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the ‘light of earlier decision taken by NC in its Meeting No. 4/82-ALC4/2018, dated 19.06.2018, it was decided | to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm 340 whichever is lower: | | Export Product Export | SI. | Import items Qty. | a Qty. No. allowed | | | Methyl Heptine Carbonate | 1 kg 1-Heptyne Technical 0.890kg | || a (methyl aoct-2-ynoatae , 1-Pentanol/N-Amy] Alcohol 0.805 kg |.|
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Manual Cases
Case No. B- | M/s. METROPOLITAN EXIMCHEM PRIVATE LTD M.No. 10 /AM19 F. No. 01/82/050/00556/AM18/DES-III Date 13.11.2018 RLA File No: 03/95/040/00216/AM18 Adv.Auth. No. 0310814420 dated 04.07.2017
Decision: Committee considered case as per agenda and in consultation with technical expert present in the meeting, it was decided to amend the description of import item at serial No. 2 to be read as “ETHYL 3-AMINO-4,4,4-TRIFLUOROCROTONATE(EATC)” instead Ethyl 4,4,4 Trifluoro Aceto Acetate. The rest of the minutes of meeting 2/82 dated 16.05.2018 (at serial No. 485) would remain same.
RA concerned may take further necessary action as per above decision of NC Case No. B- 2 M/s. GLENMARK PHARMACEUTICALS LTD M.No. 10 /AM19 F.No. 01/82/050/01037/AM19/DES-III Date 13.11 2018 F.No. 03/94/040/00586/AM18 Adv.Auth. No. 0310816538 Dated:26.10.2017 Decision: Committee considered case as per agenda and in consultation with technical expert present in the meeting, it was decided to amend the description of export item to be read as “Clindamycin & Benzoyl Peroxide Gel 1%/5%” instead of “Clindamycin & Benzoyl Peroxide Gel 1%/0.05%”. The rest of the minutes of meeting 4/82 dated 19.06.2018 (at serial No. 103) would remain same.
RA concerned may take further necessary action as per above decision of NC
Case No. B- 3 M/s. GLENMARK PHARMACEUTICALS LTD M.No. 10 /AM19 F.No. 01/82/050/00132/AM19/DES-III Date 13.11 .2018 F.No. 03/94/040/00880/AM18 Adv.Auth. No. 0310818814 Dated:31.01.2018 Decision: Committee considered the case as per agenda and in consultation with technical expert present in the meeting, it was decided to amend the quantity of import item for the export product at serial No. 1 to be read as “25.50 mg/25 mg tablet instead of 22.50 mg/ 25 mg tablet”. The rest of the minutes of meeting 4/82 dated 19.06.2018 (at serial No. 383) would remain same.
RA concerned may take further necessary action as per above decision of NC
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----- Start of picture text -----<br> Case No. B- 4 M/s. GLENMARK PHARMACEUTICALS LTD<br>M.No. 10 /AM19 F.No. 01/82/050/00037/AM19/DES-III<br>Date 13.11 .2018 F.No. 03/94/040/00691/AM18<br>Adv.Auth. No. 0310817509 dated 06.12.2017<br>Decision: Committee re-considered the case as per agenda and deliberated on the matter in the presence of the<br>technical experts and it was decided to revise 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 Export S.No | Import Product Quantity Allowed<br>Quantit<br>Colesevelam HCL for oral pack 1 Colesevelam 3.9375 gm / pack<br>suspension 3.75 GM Hydrochloride<br>RA concerned may take further necessary action as per above decision of NC<br>----- End of picture text -----<br>
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M.No. 10 /AM19 Date 13.11.2018
F.No. 01/82/050/00112/AM15/DES-II] F.No. 03/94/040/00908/AM 14/
Adv.Auth. No. 0310767733 Dated 24.01.2014
Decision: Committee re-considered the case as per agenda and deliberated on the matter in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
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----- Start of picture text -----<br> 2-Amino-3-Chloro-5- lkg 2,3-Dichloro-5- 1.20 kg<br>Trifluoromethyl Pyridine trifluoromethyl Pyridine<br>Minimum 98% [F1] [DCTF] ae<br>The firm have to pay composition fee of Rs. 5000/- at RA concerned before issuance of EODC as per para 4.17<br>of HBP 2015-20.<br>RA may take appropriate action as per the decision of Norms Committee<br>M.No. 10 /AM19 F. No. 01/82/50/01184/AM14/DES-III<br>Date 13.11 .2018 F.No. 03/95/040/00454/AM14<br>----- End of picture text -----<br>
Adv.Auth. No. 0310753231 dated 11.10.2013
Decision: The Committee considered case as per agenda and firm’s letter dated 13.06.2018 in the presence of the technical experts, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
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----- Start of picture text -----<br> anExport product Qty.ae| Sl. | Import items<br>０<br>----- End of picture text -----<br>
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M.No. 10 /AM19 01/82/050/01449/AM17/DES-III Date 13.11.2018 F.No. 08/24/040/00449/AM17 Adv.Auth. No. 0810139633 dated 01.02.2017 Decision: Committee considered the case as per agenda and in consultation with technical expert present in the meeting, it was decided to correct the quantity of import item to be read as “30.6 mg/tablet instead of 30.06 mg/tablet”. The rest of the minutes of meeting 3/82 dated 05.06.2018 (at serial No. 260) would remain same.
RA concerned may take further necessary action as per above decision of NC
M.No. 10 /AM19 F.No. 01/82/050/00181/AM19/DES-II] Date 13.11.2018 F.No. 08/24/040/00939/AM18 Adv.Auth. No. 0310819252 dated 20.02.2018
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ao meeting, it was decided to amend the description of import item at serial No. 2 to be read as N-OCTYL-DGLUCAMINE instead N-OCTYL-D-GLUCAMINE 2- (3-BENZOYLPHENYL) PROPIONITRILE 99% MIN (KETOPROFEN NITRILE). The rest of the minutes of meeting 4/82 dated 19.06.2018 (at serial No. 429) would remain same. RA concerned may take further necessary action as per above decision of NC Case No. B- 9 M/s. ENALTEC LABS PVT.LTD M.No. 10 /AM19 F.No. 01/82/050/00002/AM 19/DES-III Date 13.11.2018 F.No. 08/24/040/00971/AM18 Adv.Auth. No. 0310819410 dated 26.02.2018 Decision: Committee considered the case as per agenda and in consultation with technical expert present in the meeting, it was decided to correct the description of import item at serial No. 2 to be read as '4-FLUOROALPHA-(2-METHYL-1-OXOPROPYL)-GAMA-OXO-N,BETA-DIPHENYL BENZENEBUTANAMIDE instead of “4-FLUOROALPHA-(2-METHYL-1-OXOPROPYL)GAMA-OXO-N, BETADIPHENYL BENZENEBUTANAMIDE (4R-CIS)-1,1-DIMETHYLETHYL-6-CYANOMETHYL-2,2DIMETHYL-1,3DIOXANE-4-ACETATE”. The rest of the minutes of meeting 4/82 dated 19.06.2018 (at serial No. 436) would remain same. RA concerned may take further necessary action as per above decision of NC Case No. B- 10 M/s. AMINES & PLASTICIZERS LIMITED M.No. 10 /AM19 F.No. 01/82/050/00384/AM18/DES-III Date 13.11.2018 F.No. 03/94/040/00099/AM 18 Adv.Auth. No. 0310813032 Dated:03.05.2017
meeting, it was decided to amend the description of import item at serial No. 2 to be read as N-OCTYL-DGLUCAMINE instead N-OCTYL-D-GLUCAMINE 2- (3-BENZOYLPHENYL) PROPIONITRILE 99% MIN (KETOPROFEN NITRILE). The rest of the minutes of meeting 4/82 dated 19.06.2018 (at serial No. 429) would remain same.
Decision: Committee considered the case as per agenda and in consultation with technical expert present in the meeting, it was decided to amend the quantity of import item “PIPERAZINE (N,NDIETHYLENEDIAMINE)” as 0.155 instead of 0.277”. The rest of the minutes of meeting 7/82 dated 22.11.2017 (at serial No. 286) would remain same.
The firm have to pay composition fee of Rs. 5000/- at RA concerned before issuance of EODC as per para 4.17 of HBP 2015-20 RA concerned may take further necessary action as per above decision of NC
Case No. B- 11 M/s. AMINES & PLASTICIZERS LIMITED M.No. 10 /AM19 F.No. 01/82/050/01630/AM16/DES-III Date 13.11.2018 F.No. 03/94/040/00792/AM16 Adv.Auth. No. 0310801428 Dated 31.12.2015 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 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. allowed N-ACETYLMORPHOLINE [1 kg | 1 | MORPHOLINE 0.732 kg
The firm have to pay composition fee of Rs. 5000/- at RA concerned before issuance of EODC as per para 4.17 of HBP 2015-20.
RA concerned may take further necessary action as per above decision of NC
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----- Start of picture text -----<br> Case No. B- 12 M/s. AKZO NOBEL CHEMICALS (INDIA) LIMITED<br>M.No. 10 /AM18 F. No. 01/82/050/01044/AM12/DES-III<br>Date 13.11.2018 F. No. 01/82/050/00825/AM12/ /DES-III<br>RLA File No: 31/83/040/202/AM12 Adv.Auth. No. 3110052229 dated 03.01.2012<br>RLA File No: 31/83/040/139/AM12 Adv.Auth. No. 3110050876 dated 07.10.2011<br>----- End of picture text -----<br>
Decision: Committee considered the case as per agenda and in consultation with technical expert present in the meeting, it was decided to amend the description and the quantity of import item “import item at SI. No. 2 to be read as “Ethapol XS Quantity as 0.083 kg” instead “Polyvinyl Alcohol quantity as 0.030 kg”. The rest of the minutes of meeting 30/82 dated 25.10.2011 would remain same. The firm have to pay composition fee of Rs. 10000/(@ of Rs. 5000/- per advance authorization) at RA concerned before issuance of EODC as per para 4.17 of HBP 2015-20.
RA concerned may
take further necessary action as per above decision of NC.
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----- Start of picture text -----<br> Case No. B- 13 M/s. GLOBAL CALCIUM PRIVATE LIMITED<br>M.No. 10/AM18 F.No. 01/82/050/01465/AM15/DES-III<br>Date 13.11 .2018 F.No. 07/24/040/00302/AM15<br>Adv.Auth. No. 0710107307 dated 30.12.2014<br>Decision: Committee re-considered the case as per agenda and in consultation with technical<br>present in the meeting, it was decided to revise norms against export item under Para 4.7 of HBP HBP v1 as<br>details given below or as applied by the firm, whichever is less:<br>SI. No.} Export product Exp. | SINo. | Import items Qty.<br>Qty. allowed in<br>kg<br>CALCIUM 0.686<br>GLUCONATE - ORAL<br>CALCIUM LACTATE ik GRADE<br>GLUCONATE & f2. CALCIUM 0.310<br>CARBONATE<br>3 LACTIC ACID - ANY 0.560<br>GRADE<br>2 FERROUS LACTATE lk LACTIC ACID - ANY 1.028<br>6 GRADE<br>3 MAGNESIUM LACTATE 1k 1. LACTIC ACID - ANY 1.19<br>6 GRADE<br>4 ZINC LACTATE ik 1. LACTIC ACID - ANY 0.990<br>6 GRADE<br>> - 0.390<br>| MAGNESIUM LACTATE a RAV ORADE. nh<br>GLUCONATE lke 2 GLUCONO DELTA 0.617<br>LACTONE<br>CALCIUM LACTATE 1 kg 1 LACTIC ACID — 0.922<br>ANY GRADE<br>2 CALCIUM 0.50<br>CARBONATE<br>つ<br>----- End of picture text -----<br>
Decision: Committee re-considered the case as per agenda and in consultation with technical expert present in the meeting, it was decided to revise norms against export item under Para 4.7 of HBP HBP v1 as per details given below or as applied by the firm, whichever is less:
RA may take appropriate action as per the decision of Norms Committee
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Case No. B- 14 M/s. GLOBAL CALCIUM PRIVATE LIMITED M.No. 10/AM18 F.No. 01/82/050/00688/AM15/DES-III Date 13.11 .2018 F.No. 07/24/040/00323/AM14 Adv.Auth. No. 0710101055 Dated:02.01.2014 Decision: Committee considered case as per agenda and deliberated on the matter in the presence of the technical experts and it was decided to maintain status quo as there is no need of any change. RA may take appropriate action as per the decision of Norms Committee
Case No. B- 15 M/s. GLOBAL CALCIUM PRIVATE LIMITED M.No. 10/AM18 F.No. 01/82/050/003 14/AM16/DES-III Date 13.11 .2018 F.No. 07/24/040/00393/AM15 Adv.Auth. No. 0710108142 dated 01.05.2015 Decision: Committee considered the case as per agenda and in the light of earlier decision taken in meeting no. 1/82 dated 01.05.2018, it was decided to revise norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
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----- Start of picture text -----<br> Export product Exp. SI.No. | Import items Qty. allowed<br>Qty. kg/kg<br>i: | [1.][|][ CALCIUM][ CARBONATE] 0.172 kg<br>CALCIUM LACTOBIONATE & 2: 1.16k<br>11.|CALCIUM CARBONATE 0.360 kg<br>CALCIUM Ike LACTOSE 1.021 kg<br>BROMOLACTOBIONATE HYDROBROMIC ACID 0.510 kg<br>11.| LACTOSE 0.515kg<br>CALCIUM GLUBIONATE kg 3. CALCIUMCALCIUM GLUCONATE CARBONATE - 0.1350.444 kgkg=<br>ORAL GRADE<br>LACTOBIONIC CALCIUM CARBONATE 0.234 kg<br> ACID LACTOSE 1.58 ke<br>つ<br>つ<br>----- End of picture text -----<br>
A may take appropriate action as per the decision of Norms Committee
Case No. B- 16 M/s. Global Calcium Pvt. Ltd M.No. 10/AM18 F.No. 01/82/050/00323/AM18/DES-III Date 13.11 .2018 F.No. 07/24/040/00248/AM17 Adv.Auth. No. 0710110659 dated 17.11.2016 Decision: Committee considered the case as per agenda and in consultation with technical expert present in the meeting, it was decided to amend the quantity of import item to be read as “Gluocno Delta Lactone” instead “Gluocnate Delta Lactone”. The rest of the minutes of meeting 10/82 dated 10.01.2018 (at serial No. 355) would remain same.
RA concerned may take further necessary action as per above decision of NC.
Case No. B- 17 M/s. Global Calcium Pvt. Ltd M.No. 10/AM18 F.No. 01/82/050/01246/AM17/DES-III Date 13.11 .2018 F.No. 01/82/050/00670/AM18/DES-III RA F.No. 07/24/040/00217/AM17 Adv.Auth. No. 0710110566 dated 25.10.2016 RA F.No. 07/24/040/00042/AM18 Adv.Auth. No. 0710111633 dated 22.05.2017
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Decision: Committee considered case as per agenda and deliberated on the matter in the presence of the technical experts and it was decided to maintain status quo as there is no need of any change.
RA concerned may
take further necessary action as per above decision of NC.
Case No. B- 18 M/s. GLOBAL CALCIUM PRIVATE LIMITED M.No. 10/AM18 F.No. 01/82/050/00672/AM18/DES-II Date 13.11 .2018 F.No. 03/94/040/00393/AM17 Adv.Auth. No. 0710111246 Dated:07.03.2017
Decision: The Committee considered the case as per agenda and in consultation with technical expert present in the meeting, it was decided to request the firm to furnish compel technical details as per appendix 4E. The case is deferred.
| Case No. B- 19 | M/s. Mangalam Drugs and Organics Ltd., Mumbai |
|---|---|
| nae<br>nen<br>ate<br>3.11 2018 | F.No.01/82/050/00575/AM16<br>F.No. 01/82/050/00965/AM17 |
| RLA F.No. 03/95/040/01037/AM15 | Advance Licence No. 0310794511 dated 11.03.2015 |
| RLAF.No.03/95/040/00322/AM17 | AdvanceLicenceNo.0310808020dated03.09.2016 |
Decision: Committee re-considered the case as per agenda and in consultation with technical expert present in the meeting, it was decided to allow the quantity of import item at SI. No. 3 as “TRIMETHYL ORTHO ACETATE as 0.50 kg”. The rest of the minutes of meeting 5/82 dated 25.06.2015 and meeting No. 01/82 dated 12.04.2017 would remain same.
RA concerned may take further necessary action as per above decision of NC.
Case No. B-20 M/s. Agio Pharmaceuticals Ltd. Meeting No. 19/AM16 F.No. 01/82/50/877/AM14/DES-III Dated: RLA F.No. 03/94/40/542/AM14 Advance Licence No. 0310752494 dated 07.10.2013
Decision: Committee re-considered case as per agenda and deliberated on the matter in the presence of the technical experts and it was decided to revise the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
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----- Start of picture text -----<br> Sl. | Export product Exp. Import items Qty. Allowed in<br>No. Qty.<br>1 BENDAZ 2500 MG 1 No. ALBENDAZOLE USP/BP/EP/CP 2550 mg/2500<br>Albendazole Bolus 2500 mg mg bolus<br>2 612 mg/600 mg<br>Bendaz 600 mg I No. ALBENDAZOLE LE USP/BP/EP/BP/EP/CP bololus<br>Albendazole Bolus 600 mg.<br>3 ALBENDAZOLE USP/BP/EP/CP ea<br>Bendaz 2.5% Suspension 1000 ml<br>Albendazole Oral suspension 1 No.<br>2.5%w/v Albendazole UDP 25 mg<br>----- End of picture text -----<br>
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----- Start of picture text -----<br> Fat<br>0.0255 kg/ | litre<br>Bendaz Super 50 Suspension. Super 50 Suspension. Suspension.. | Ltr ALBENDAZOLE USP/BP/EP/CP/BPIEP? bottle<br>Bottle 1 No<br>Each ml contains Albendazole USP :<br>25 mg Praziquantel USP 25 mg<br>----- End of picture text -----<br>
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----- Start of picture text -----<br> 4<br>Bendaz Super 50 Suspension. Super 50 Suspension. Suspension.. | Ltr<br>Bottle<br>----- End of picture text -----<br>
RA may take appropriate action as per the decision of Norms Committee
Case No. B-21 M/s. PREGNA INTERNATIONAL LTD Meeting No. 19/AM16 F.No. 01/82/50/877/AM14/DES-III Dated: RLA F.No. 03/95/040/00859/AM18 Advance Licence No. 0310818603 Dated 18.01.2018
Decision: Committee considered the case as per agenda and in consultation with technical expert present in the meeting, it was decided to amend the description of Unit of Measurement of export product to be read as 1 Number instead of 1 kg. The rest of the minutes of meeting 4/82 dated 19.06.2018 would remain same.
RA concerned may take further necessary action as per above decision of NC.
Case No. B- 22 M/s. UPL Ltd., Mumbai M.No. 10 /AM19 F.No. 01/82/050/00490/AM15/DES-III Date 13.11.2018 F.No. 03/95/040/00033/AM15/ Adv.Auth. No. 0310782129 Dated 20.05.2014
Decision: Committee re-considered the case as per agenda and in consultation with technical expert present in the meeting, it was decided to revise the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
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----- Start of picture text -----<br> Export product Exp. | SI.No. Import items Qty. Allowed in<br>Qty. kg<br>OLOA 262 (ZnDTP) Lkg 2-Butanol 0.3129<br>4-Methyl Pentanol 0.1404<br>Yellow Phosphorus 0.104<br>027<br>----- End of picture text -----<br>
RA may take appropriate action as per the decision of Norms Committee
Case No. B- 23 M/s. BHAGIRADHA CHEMICALS & INDUSTRIES LIMITED M.No. 10 /AM19 F.No. 01/82/50/01752/AM16 Date 13.11.2018 F.No. 09/24/040/00570/AM 16 Adv.Auth. No. 0910063087 dated 01.01.2016
Decision: Committee re-considered case as per agenda and deliberated on the matter in the presence of the technical experts and it was decided to revise the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
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----- Start of picture text -----<br> Export product<br>[2-(6-CHLOROPYRIMIDIN-4-YLOXY)-<br>----- End of picture text -----<br>
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----- Start of picture text -----<br> Qty. | SI. Import items Qty.<br>No. allowed<br>5) 095k<br>0.90 kg<br>Ｓ‐<br>----- End of picture text -----<br>
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Case No. B-24 M/s. HONOUR LAB LIMITED M.No. 10 /AM19 F. No. 01/82/50/793/AM17/DES-III Date 13.11 .2018 F.No. 09/24/040/00321/AM17 Adv.Auth. No. 0910064126 dated 09.09.2016 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 under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
Export product Qty. Sl. | Import items Qty. allowed No. in kg isopropyl _((S){Perfluorophenoxy) | 1 kg (Phenoxy)Phosphoryl)-L-Alaninate Dimethy! formamide Phenyl dichloro phosphate | 0.931 Triethyl amine Pentafluorophenol | 6. | Diisopropyl ether
The firm have to pay composition fee of Rs. 5000/- at RA concerned before issuance of EODC as per para 4.17 of HBP 2015-20. RA may take appropriate action as per the decision of Norms Committee.
Case No. B- 25 M/s. Encube Ethicals Pvt. Ltd., Mumbai M.No. 10/AM18 F.No. 01/82/50/01083/AM16/DES-III Date 13.11 .2018 RLA F.No. 03/94/40/279/AM16 Advance Licence No. 0310798629 dated 03.09.2015
Decision: Committee considered the case as per agenda and in consultation with technical expert present in the meeting, it was decided to amend the quantity of import item “Eucalyptus Oil” to be read as 107.10 gms for 100 tubes instead of 10.77gms for 100 tubes”. The rest of the minutes of meeting 12/82 dated 28.09.2016 would remain same.
RA concerned may take further necessary action as per above decision of NC
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----- Start of picture text -----<br> M.No. 10 /AM19 F.No. 01/82/050/00985/AM18/DES-III<br>Date 13.11 .2018 F.No. 01/82/050/00492/AM 18/DES-III<br>F.No. 01/82/050/00986/AM18/DES-III<br>----- End of picture text -----<br>
F.No. 34/24/040/00092/AM18
F.No. 34/24/040/00201/AM18
Adv.Auth. No. 3410043328 dated 05.07.2017 Adv.Auth. No. 3410043594 dated 06.11.2017
Decision: The Committee re-considered case as per agenda and in the presence of the technical experts, it was decided to revise the ad-hoc input output norms in respect of above mentioned advance authorization under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
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----- Start of picture text -----<br> Export product Qty. Sl. Import items Qty. allowed in<br>USP<br>HYDROCHLORIDE<br>CHLORIDE<br>(6 [ETHYL ALCOHOL (28ers<br>----- End of picture text -----<br>
The firm have to pay composition fee of Rs. 10000/( @ Rs. 5000/- of each advance authorization except Adv. Auth. No.3410043594 dated 06.11.2017) of two advance authorization at RA concerned before issuance of EODC as per para 4.17 of HBP 2015-20.
M.No. 10 /AM19 F.No. 01/82/050/01346/AM17/DES-III Date 13.11 .2018 F.No. 34/24/040/00184/AM17 Adv.Auth. No. 3410042556 dated 26.09.2016 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:
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----- Start of picture text -----<br> Norms for Export Product: Telmisartan and Hydrochlorothiazide Tablets 40 mg/12.5 mg, 80 mg/12.5<br>mg and 80 mg/25 mg<br>nonSl. ExportTelmisartan product and | Qty.1 No. | SI.1. emImport items 40.8Qty.eeeallowedmg<br>Hydrochlorothiazide tablets 40 Telmisartan<br>mg/12.5 mg<br>Hydrochlorothiazide tablets 80<br>Hydrochlorothiazide tablets 80<br>----- End of picture text -----<br>
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----- Start of picture text -----<br> [mg25mg<br>----- End of picture text -----<br>
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----- Start of picture text -----<br> (B) Norms for Telmisartan<br>No. kg<br>METHYLBENZIMIDAZOLE-2-YL)<br>BENZIMIDAZOLE<br>BIPHENYL-2-CARBOXYLATE OR 4-<br>BROMOMETHYLBIPHENYL-2-<br>CARBOXYLIC ACID METHYL ESTER<br>The firm have to pay composition fee of Rs. 5000/- at RA concerned before issuance of EODC as per para 4.17<br>of HBP 2015-20<br>RA may take appropriate action as per the decision of Norms Committee.<br>M.No. 10 /AM19 F. No. 01/82/050/288//AM17/DES-III<br>Date 13.11.2018<br>Decision: The Committee re-considered case as per agenda and in the presence of the technical experts, it was<br>decided to revise the ad-hoc input output norms in respect of above mentioned advance authorization under para<br>4.7 of HBP as per details below or as applied by firm whichever is lower:<br>Export product Qty. SI. Import items Qty. allowed<br>LaanCEFTAZIDIME bla<br>+ SULBACTAM | 1 No. | 1. | CEFTAZIDIME 1253 mg/1.5 gm<br>POWDER FOR SOLUTION FOR PENTAHYDRATE WITH Injections<br>INJECTION 1.5G SODIUM CARBONATE<br>EACH VIAL CONTAINS STERILE USP<br>CEFTAZIDIME PENTAHYDRATE<br>WITH SODIUM CARBONATE<br>EQV. TO CEFTAZIDIME<br>1000MG, SULBACTAM<br>SODIUM EQV. TO SULBACTAM<br>500MG<br>CEFTAZIDIME + SULBACTAM | | No. | 2. | CEFTAZIDIME 2506 mg/3.0 gm<br>POWDER FOR SOLUTION FOR PENTAHYDRATE WITH Injection<br>INJECTION 3.0G SODIUM CARBONATE<br>EACH VIAL CONTAINS STERILE USP<br>CEFTAZIDIME PENTAHYDRATE<br>WITH SODIUM CARBONATE<br>EQV. TO CEFTAZIDIME<br>2000MG, SULBACTAM<br>SODIUM EQV. TO SULBACTAM<br>1000MG<br>Ｓ‐<br>つ<br>つ<br>----- End of picture text -----<br>
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The firm have to pay composition fee of Rs. 5000/- at RA concerned before issuance of EODC as per para 4.17 of HBP 2015-20.
Case No. B- 29 M/s. THEON PHARMACEUTICALS LTD M.No. 10 /AM19 F. No. 01/82/050/00373/AM18/DES-III Date 13.11.2018 RA File No: 22/24/040/00007/AM18 | Adv. Auth. No. 2210015689 Dated:27.04.2017
Decision: The Committee re-considered case as per agenda and in the presence of the technical experts, it was decided to revise the ad-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:
Export product Qty. SI. Import items Qty. allowed No. CEFTAZIDIME FOR INJECTION | 1 No. Ceftazidime for Injection 1.281 gm USP 1000 mg, 10 mi (mix with Sodium vail (Each vial contains sterile Carbonate) ceftazidime pentahydrate USP eq to ceftazidime 1000mg)
26 ok ok oe ok
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