DGFT Committee Minutes
Recovered from broken page tree (FzErrorArgument: code=4: Attempt to use Leptonica from 2 threads at once!)
1 Office of Directorate General of Foreign Trade New Delhi 110003 Para 4.7 Decision
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Meeting No. 06/82/2018 of 2018-19 dated 26.07.2018 (actually held on 29.08.2018 and 07.09.2018) considered the cases/issues under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy, 2015-20 pertaining to Chemical and Allied products falling under Chapter 29 and 30, held under the Chairmanship of Shri A.K Srivastava, Addl. DGFT, Udyog Bhawan, New Delhi.
Following members were present:Shri Nirmal Kumar, Dy. Director General of Foreign Trade Shri S.K. Panigrahi, Economic Officer Consultant, Technical Expert Pharmaceuticals Consultant, Technical Expert Chemicals
The committee went through the minutes of earlier meeting No. 05/82/2018 of 2018-19 dated 19.06.2018 (actually held on 26.07.2018, 16.08.2018 and 17.08.2018) and approved the same
MEETING NUMBER - 6/82-ALC4/2018 MEETING DATE: 26.07.2018
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----- Start of picture text -----<br> "(Case No.:419/4/82-ALC4/2017 Party Name:MEDICAMEN ‘Meet No/Date:6/82- «Status:<br>| | BIOTECH LTD., ALC4/2018 ‘Approved<br>| 26.07.2018<br>~~ Lie.No/Date:0510386899- ee |:<br>_ (HQ File ~RLA File<br>| :01/82/050/00427/AM 18/ :05/24/040/00062/AM15/ 20.05.2014 |<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>|, [Expomproduct_—___| Exp. Gy. [Tmportitems [allowed]<br>| | Tablets Phenoxymethylpencillin 250mg. 1 Number<br>| Each Tablet Contains: Phenoxymethylpencillin | 282.73 mg/per<br>| | Phenoxymethylpencillin Potassium BP eq. Potassium (Pencillin V | tablet |<br>| | to Phenoxymethylpencillin 250mg. Potassium) BP/CP/USP<br>| Tablets Phenoxymethylpencillin 250mg. 1 Number | - (Powder Form)<br>| Each Tablet Contains :<br>|| Phenoxymethylpencillin Potassium BP eq. |<br>|| to Phenoxymethylpencillin 250mg.<br>----- End of picture text -----<br>
‘RA concerned may take further necessary action as per above decision of NC.
-~ \Gase No.:231/4/82-ALC4/2017 Party Name:SCOTT-EDIL Meet No/Date:6/82Status: | ADVANCE RESEARCH LAB. |ALC4/2018 Approved | AND EDUCATION LTD~ Lie. 26.07.2018 | : HQ File | “RLAFile No/Date:2210015070 5 :01/82/050/00239/AM 18/ :22/24/040/0004 1/AM15/ 27.08.2014 ' | Decision: Committee considered case as per agenda and deliberated on the matter in the presence of the ‘technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: | FExportproduct———=dew. ty. [SUNo. Timportitems __| tv. alowed kg
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|| Cephalexin oral Suspension BP | Numbers 1, “T Cephalexin 1650 mg/60 ml |~ | 125mg/Sml, 60ml Bottle (each Sml Monohydrate IP bottle | Monohydratecontaining Cephalexinequivalent to 125 of |[Cephalexin)] | | ‘RA concerned may take further necessary action as per above decision of NC. (Case ee ert eee | ot No.:491/4/82-ALC4/2017 |Party Name:STERLING Meet No/Date-6/82. ‘Status; | “AUXILIARIES PVT LTD ALC4/2018 ‘Deferred | 3 | 26.07.2018 | HQ File ; _ RLA File OO ‘Lic.No/Date:03 10792906 ‘Defer Date: _ :01/82/050/00499/AM18/ :03/95/040/00847/AM15/ 14.01.2015 | Decision: Deferred for comments ofTE | ‘Case No.:84/13/82-ALC4/2015 PartyName:TIDE "Meet No/Date:6/82Status; ff INDUSTRIES ALC4/2018 Approved | HQFile RLAFie = |Lic.No/Date:341004 1297 | | :01/82/050/01047/AM16/ ':34/24/040/00066/AM16/ (15.06.2015 | , Decision: Committee considered case as per agenda and deliberated on the matter in the presence of the | [4 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. | SI.No. Qty. allowed =| | | Qty. ke | RA may take appropriate action as per the decision of Norms Committee | Case No.:113/13/82SS Party Name:K V AROCHEM (Meet No/Date:6/82Status: | | ALC4/2015 PVT. LTD ‘ALC4/2018 ‘Approved | HQ File RLAFile == TigNo/Date:03 10797897 | | | :01/82/050/01076/AM 16/ :03/94/040/00335/AM16/ 03.08.2015 | Decision: Committee considered case as per agenda and in the light of earlier decisiontaken by NC in its | 5 '5/AM19 meeting dated 25.07.20] 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. Qty. allowed | 'RA may take appropriate action as per the decision of Norms Committee | Case No.:98/20/82-ALC4/2015 Party Name:FRESENIUS KABI ‘Meet No/Date:6/82-. Status: ls ONCOLOGY LIMITED ‘ALC4/2018 ‘Approved | ___HQFile __RLA File - Lic.No/Date:0510397164 [
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|—|:01/82/050/01681/AM16/|/-05/23/040/00338/AM16/|(31.12.2015|
|||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:|
|||No.|kg|
||||18967.000|||1.|RUBBER STOPPERS|Relevant|as||.|
|||Nos.|FOR|per packing||.|
|||PHARMACEUTICAL|olic|||
|Irinotecan|Hydrochloride|ARTICLES USE WPS|poncy|
|||||Injections|500mg.|S10-F451|4432/50G|B240|||
|||||WESTARRS/SP06|
|||||Rubber|Stoppers 20mm|
|;|||dia coated|- for glass|||
|||||bottles.|||
|2|VADIN30R|30 ML|ISO|
|||||TYPE|| TUBULAR|
|||GLASS VIAL, 20MM|/|
|||||CRIMP NECK.|
|||Glass vials, 30ml|
|||||Capacity.|
|||||Assay:|NLT 95%|||
|io|4|IODOBENZENE|48.115|kg|
|||||DIACETATE.|||
|||||Melting Range:|158|to|||
|||||160.|||
|||||5|64.725 kg|
|}|||SILICA GEL.|
|;|Moisture|Content: NUT|
|||Irinotecan Hydrochloride|27347|000|i|ROEDER STOPPERS|nies as|||
|||||||Injections‘acti|300mg.|Os.|PHARMACEUTICAL|alleser|packin&||||
|||||ARTICLES USE WPS|
|L|||S10-F451|4432/50G|B240|
|||||WESTARRS/SP06|
|||||Rubber Stoppers 20mm|||
|||||dia coated|-|for glass|
|||
|||||bottles.|
|||||2|VADIN3OR 30 ML ISO|
|||||TYPE|| TUBULAR|
|||||GLASS VIAL, 20MM|||
|||||CRIMP NECK.|
|||||Glass vials, 30ml|||
|||||Capacity.|
|||||Assay:|NLT 95%|/|
|||||4|IODOBENZENE|41.624kg|||
|||||DIACETATE.|||
|Melting|Range:|158|to|
|||||Moisture|Content: NUT|
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||||||||||||||~|
||||||||||||VADIN20R20ML Iso__|<br>AMBERTYPE |<br>TUBULAR GLASS|Relevantas<br>perpacking<br>policy|||<br>|}|
||||||||||VIAL,20MMCRIMP|||||
||||||||||Glass vial20 ml capacity.||||
||||a<br>i<br>|<br>|<br>Lo<br>i<br>||||i<br>IrinotecanHydrochloride<br>Injections100mg.|194878.000<br>Nos.|CAMPTOTHECIN.<br>fo Assay:NLT95%<br>2<br>IODOBENZENE<br>DIACETATE.<br>7 MeltingRange:158to<br>160.||44.931 kg<br>103.582kg|||<br>|<br>|<br>i<br>||
||||i||||||3|SILICA GEL.<br>Moisture Content: NMT|139.338kg||||
|||||||||||||||
|||||<br>|<br>||||<br>||||4|RUBBERSTOPPERS<br>FOR<br>PHARMACEUTICAL<br>ARTICLESUSEWPS<br>S10-F451 4432/50G B240<br>WESTARRS/SP06OR|Relevant as<br>perpacking<br>policy|||<br>|,<br>|<br>|<br>||
||||||||||1242W 1888/GREY<br>WESTARRS SIL1 -<br>RubberStoppers20mm<br>diacoated - forglass<br>bottles.||||<br>|<br>|<br>|<br>|<br>||
||||||||||||VADIN6R6MLISO<br>TYPE | TUBULAR|||||
||||i|||||||GLASSVIAL20MM<br>CRIMPNECK.|||||
||||||||||Glass Vial 6ml capacity.||||
||||<br>;||||<br>||||Irinotecan Hydrochloride<br>Injections40mg,|Nos.|2|Assay:NLT95%<br>IODOBENZENE<br>DIACETATE.<br>MeltingRange: 158 to|12.614kg|||<br>||
||||||||||160.||||
|||}<br>Po|||<br>||||3||SILICA GEL.<br>Moisture Content:NMT|16.970 kg||||
||||||||||6%||||
||||<br>I<br>|<br>RUBBERSTOPPERS<br>Relevant as<br>|<br>FOR<br>perpacking<br>|.<br>PHARMACEUTICAL<br>Baliey<br>|<br>by<br>ARTICLESUSEWPS<br>|<br>S10-F451 4432/50GB240<br>|<br>/<br>|<br>WESTARRS/SP06 OR|||||||||||
|||||<br>|<br>i<br>|<br>i<br>_<br>||||||S||1242W 1888/GREY<br>WESTARRS SIL1 -<br>RubberStoppers20mm<br>diacoated -forglass<br>bottles.<br>VADINOR 6ML ISO|||<br>|<br>|<br>|||
|i;||||||||||TYPE | TUBULAR|,|||
||||||||||GLASSVIAL20MM||||
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Glass Vial 6 ml capacity. |
|| Glass | RAmay take appropriate action as per the decision of Norms Committee
| Case No.:476/4/82Party Name:NATURAL AND |Meet No/Date:6/82. Status: _— (ALC4/2017 ESSENTIAL OILS PVT LTD =ALC4/2018 Approved ee 26.07.2018 i| | | HQ File RLA File ‘Lic.No/Date:0710109705 _ :01/82/050/00484/AM18/ |:07/24/040/00026/AM17/ (25.04.2016 | Decision: Committee considered case as per agenda 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 of HBP as per || | \details below or as applied by firm whichever is lower: | | affeine Powder 14000.000 kg 1. Crude Caffeine 22000 kg | | | (decaffeination from green | | coffee) Purity 55.32% | | | Powder | | Coffee Extracts Powder — ‘|.: 3200.000 kg 1 Crude Caffeine 6160 kg | | (decaffeination from green | | coffee) Purity 55.32% | | Powder | | The above norms is allowed as one time basis and no repeat licence is allowed | | _RA may take appropriate action as per the decision of Norms Committee i ‘Case No.:477/4/82- i Party Name:NATURAL ) ‘Meet No/Date:6/82‘|Status: Approved | | |ALC4/2017 AND ESSENTIAL OILS ALC4/2018 | PVT LTD 26.07.2018 | OF———= Ti _ Lae veLioo7s! | | ':01/82/050/00485/AM 18/ ':07/24/040/00120/AM17/ —12.07.2016 | | ‘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: (8 | 1. Crude Caffeine 10921 kg | | . (decaffeination from green | | Caffeine Powder 8500.000 kg coffee) Purity 55.32% | | | Powder | | 1 Crude Caffeine 3159 kg | | (decaffeination from green | Coffee Extracts Powder 1600.000 kg coffee) Purity 55.32% | | Powder | The above norms is allowed as one time basis and no repeat licence is allowed | | ‘RA may take appropriate action as per the decision of Norms Committee ~~ |Case No.:21/17/82-ALC4/2016 ‘Party Name:BLUE CIRCLE _——Meet No/Date:6/82Status: ; | ORGANICS PVT. LTD. ALC4/2018 Deferred ~~ ~(RLAFile ~Li¢,No/Date:0310808830 Defer Date: | HOFie | |:01/82/050/00982/AM17/ :03/94/040/00548/AM17/ 27.10.2016 ee | |
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Decision: Committee considered case as per agenda and it was decided to call from the firm complete | | technical details as per Appendix 4E along with Chemical reaction, molecular weight and yield on molar | i~ |Case No.:224/4/82-ALC4/2017 PartyName:OPTIMUSDRUGS [Meet No/Date:6/82‘Status: | | PRIVATE LIMITED “ALC4/2018 Approved HQFile | 26.07.2018 | | | 'RLAFie ‘Lic.No/Date:09 10064446 | | :01/82/050/00232/AM18/ :09/24/040/00397/AM17/ 07.12.2016 Decision:technical Committee considered case as per agenda and deliberated on the matter inee the presence of the | details experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per below or as applied by firm whichever is lower: | | | Export product Exp. SI.No. | Import items Qty. allowed | fo Qty. kg | | Daclatasvir 1kg 4,4-Bis(Chloromethyl)Bipheny! 1.00 kg | 10 | Dihydrochloride1H 2 BOC-L-Proline (OR) N-BOC1.15 kg i PROLINE | 3 N-(Methoxycarbonyl)-L-valine (or) | 0.55 kg | Moc-l-valine | | 1-(3-Dimethylaminopropyl)-30.60 kg | ethylcarbodiimide | i hydrochloride(EDC-HCL) | i or EDC-HCL OR N-(3| | Dimethylaminopropyl)-Nethylcarbodiimide hydrochloride (EDC) |
RA may take appropriate action as per the decision of Norms Committee
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||_|i|||(Case No.:200/4/82-ALC4/2017|LABORATORIESPartyName:MYLANLIMITED[MeetALC4/2018 No/Date-6/82.|‘DeferredStatus:|||
|||26.07.2018|||||
|:01/82/050/00208/AM18/|':09/24/040/00473/AM17/|14.12.2016|||
|||ar|Deferred|Sor conments.of|
|TE|—|
|||(Case No.:29/4/82-ALC4/2017|[Party|Name:ARVEE|//Meet No/Date:6/82-|Status:|
|i|||[LABORATORIES INDIA|‘ALC4/2018|‘Approved|||
|P||PRIVATE|LIMITED|26.07.2018|||
|HQ File|RLA|File|‘Lic.No/Date:0810139459|||
|:01/82/050/00037/AM18/|:08/24/040/00118/AM17/|04.01.2017|
|_|Decision:|Committee|considered|case|as|per agenda and deliberated|on|the|matter|in|the|presence|of the||
|‘technical|||
|12|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|
|___|||Dimethyl 5-Nitroisophthalate|1 kg|Isophthalic Acid|0.818|kg|||
|‘RA may take appropriate action as per the decision of Norms Committee|||
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| Case No.:173/4/82-ALC4/2017 ‘Party Name:OGENE ——*([Meet No/Date:6/82-. = Status: ; | SYSTEMS INDIA LTD. ‘ALC4/2018 ‘Approved | | HQ File RLA aL Lic No/Date:0910064554 ————— _ :01/82/050/00181/AM18/ ':09/24/040/00535/AM17/ 05.01.2017 | 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: 3 | Export product Exp. | SI.No. | Import items Qty. allowed in | || 2-Ethyl-3,4-Ethylenedioxy 1kg Diethyl Thioglycolate | | thiophene (Ethyl EDOT) 1,2, - Butanediol | | | Ethylene dichloride | Sodium methoxide solution 44600 _ RAmay take appropriate action as per the decision of Norms Committee | "(Case No.:229/4/82-ALC4/2017 Party Name:AAP PHARMA ‘Meet No/Date:6/82Status: | | ‘TECHNOLOGIES INDIA ALC4/2018 Approved | | PRIVATE LIMITED 26.07.2018 | HO File a = Ticoes ener | | 0 1/82/050/00237/AM 18/ :09/24/040/005 13/AM17/ 13.01.2017 | ‘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: l14 | | | | Export product Exp. SI.No. | Import items Qty. allowed | |__| Tert-Butyl ((5S,10R,Z)-S-amino-9- | 1 kg Fmoc-Asn(Trt)-OH (N1.20 kg || Fmoc amino-13,13-dimethy|-3,6Fmoc, N-Trityl L-Aspargine) | dioxo-1,1,1-tripheny]-7,12-dioxa 2 Boc-Ser (tBu)-OH 0.75 kg | -2,8-diazatetradec-8-en-10|| ylcarbamate (CNOH-4) | RA may take appropriate action as per the decision of Norms Committee
-—_—Party Name:KOPRAN ~~ |Meet No/Date:6/82-. = Status: ~~ [Case[No.:72/4/82-.] | ALC4/2017 RESEARCH ALC4/2018 ‘Approved | \LABORATORIES LTD.. 26.07.2018 | | HQ File - 'RLA File ‘Lic.No/Date:0310810717 | | ':01/82/050/00080/AM18/ :03/94/040/00969/AM17/ 24.01.2017 1 5 ‘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 Qty. Sl. | Import Product Quantity | |_No. No. Allowed in kg | | [1| CLARITHROMYCIN CLARITHROMYCIN 0.2778 |
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----- Start of picture text -----<br> 8<br>|<br>| GRANULES 27.5% | fa | ACETONE |<br>| CLARITHROMYCIN CLARITHROMYCIN 0.3333 |<br>9 1k |<br>| CLARITHROMYCIN CLARITHROMYCIN 0.404 |<br>| 3 | GRANULES 40% 1 kg 6 | AGETERE |<br>] 1<br>| | CLARITHROMYCIN CLARITHROMYCIN 0.4242 |<br>|<br>I<br>CLARITHROMYCIN |9 | CLARITHROMYCIN 0.4343<br>RA may take appropriate action as per the decision of Norms Committee |<br>|<br>‘Case No.:71/4/82-ALC4/2017 Party Name:FERMENTA (Meet No/Date6/§2. Status:<br>oe | BIOTECH LTD ALC4/2018 Approved |<br>HQ:01/82/050/00079/AM18/ [File] RLA File Lic.No/Date:031081083426.07.2018 |<br>‘Decision: :03/94/040/00970/AM17/ 31.01.2017<br>| 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>16 | |<br>| Export product Exp. SI.No. | Import items Qty. allowed<br>||__| Ergocalciferol(Vitamin D2 1.0Oralto 4.0 Solution MIU USPin 1kg 1. Ergocalciferol (Vitamin D2 ) | 0.0255 kg |<br>| | Edible Oil - |<br>_ | Soyabean/Corn/Arachis/MCT Oil) |<br>| ‘RA may take appropriate action as per the decision of Norms Committee |<br>| Case No.:149/4/82-ALC4/2017 PartyName:MYLAN Meet No/Date:6/82- (Status: |<br>fod ‘LABORATORIES LIMITED ALC4/2018 ‘Approved —<br>| HO File ee | 26.07.2018 |<br>| : RIA Hie TcNoDaiso ioctl “| ee |<br>:01/82/050/00157/AM18/ :09/24/040/00574/AM17/ 31.01.2017<br>technicalDecision: Committee considered case as per agenda and ‘deliberated on‘the matter in the presence| of‘the:<br>details experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per<br> below or as applied by firm whichever is lower: |<br>117 | Export product Exp. SI.No. | Import items Qty. allowed in |<br>_ | LUMEFANTRINE 1 kg 2,7-Dichloro-9H-Fluorene [0.76 |<br>| Sodium Borohydride }0.06<br>; | f4 | p-Chloro Benzaldehyde |<br>| | 5 Activated Carbon (CECA 0.011 |<br>| ENO PC) |<br>Methylene Dichloride p3.2400<br>つ<br>----- End of picture text -----<br>
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| RA may take appropriate action as per the decision of Norms Committee
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| ) ‘CaseNo.:184/4/82-ALC4/2017 Party OO ~|Meet No/Date:6/82Status: — | Name:M.R.LABORATOARIES ALC4/2018 Approved Lod. PVT LTD. 26.07.2018 | | |HQ File RLA File ‘Lic.No/Date:0910064621 | | :01/82/050/00192/AM18/ ':09/24/040/00544/AM17/ 31.01.2017 | Decision: Committee considered case as per agenda 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 of HBP as per details below or as applied by firm whichever is lower:
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----- Start of picture text -----<br> i Export product Exp. SI.No. | Import items Qty. allowed |<br>| | Qty. kg |<br>|__| DICLOFENAC PELLETS 40% 1kg Diclofenac Sodium BP/USP<br>| Ethyl Cellulose NF Grade<br>----- End of picture text -----<br>
| RA may take may take take appropriate action as per the the decision of Norms Committee Norms Committee Committee
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----- Start of picture text -----<br> RA may take may take take appropriate action as per the the decision of Norms Committee Norms Committee Committee |<br>"(Case No.:187/4/82-ALC4/2017 Party Name:COVALENT [Meet No/Date:6/82- Status:<br>| | LABORATORIES PRIVATE ALC4/2018 ‘Approved |<br>|| ‘LIMITED 26.07.2018<br>| HQFile ~—IREAFile=———S~~~~~SCLic.Noo/Date:0910064655 |<br>| ':01/82/050/00195/AM18/ |:09/24/040/00536/AM17/ (07.02.2017 | |<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. SI.No. | Import items Qty. allowed in | |<br>__ [ Cefpodoxim Proxetil 1kg | 1 D-7-AMINO 0.708<br>| CEPHALOSPORANIC<br>| ACID (D-7-ACA)<br>19) 2 2- Mercapto- Benzothiazol- | 0.8378 |<br>| 2- Aminothiazole- 4yl-<br>|; | Methoxyimino Acetate<br>| | (MAEM) |<br>| | Dimethyl Carbonate (DMC) i160 |<br>| | 1,1,3,3, - tetramethyl] 0.189 |<br>} | Guanidine (TMG) |<br>| | [6 | Methane sulfonic acid |<br>; | orthoformate(TMOF)<br>| | Dimethyl Acetamide |<br>|| (DMAC)<br>----- End of picture text -----<br>
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| (Case No.:58/4/82-ALC4/2017 Party Name:OMTECH Meet No/Date:6/82Status: | | (CHEMICAL INDUSTRIES ‘ALC4/2018 ‘Deferred | es PVT.LTD. [26.07.2018 | | HQ File RLA File ‘Lic.No/Date:0310811245 Defer Date:[—] | |:01/82/050/00066/AM1 8/ ':03/95/040/00361/AM17/ }15.02.2017 [22 Decision: Committee considered the case as per agenda and[it][was][ decided][to][ give][the][ firm][final][ reminder][to.] | ithe firm to furnish the following information within 15 day from the upload of minutes of the meeting on| _ DGFT website otherwise case will be treated as reject: | ee Complete chemical reaction molecular weight Structural formula of import and export item | | showing % yield of every stage of reaction. a Past production consumption data duly certified by Central Excise / GST iii. Calculation sheet to | arrive at the row material Case No.:148/4/82-ALC4/2017 Party Name:VINS Meet No/Date:6/82-. Status: |L || BIOPRODUCTS LTD’ ALC4/201826.07.2018 ‘Approved | | | HQ File RLA File ~—Lic.No/Date:0910064689 _01/82/050/00156/AM18/ ':09/24/040/00622/AM17/ 16.02.2017 [23 ‘Decision: Committee considered case as per agenda and in the presence of the technical experts, it was | decided to ratify the ad-hoc input output norms as applied by the firm under para 4.7 of HBP one time basis only no repeat licence allowed. | | ‘The above norms is allowed as one time basis and no repeat licence is allowed | | ‘RA may take appropriate action as per the decision of Norms Committee | ~~ [Case No.:98/4/82-ALC4/2017 Party Name:PANACEA ‘Meet No/Date:6/82Status: | | BIOTEC LTD., ALC4/2018 ‘Approved | | HO FieSn a “LicNo/D<P | :01/82/050/00106/AM °* ‘Decision: Committee 18/considered :05/24/040/0055case as per agenda 1/AM17/and in the presence21.02.2017of the technical experts,| it was.| | decided to ratify the ad-hoc input output norms As applied by the firm under para 4.7 of HBP one time basis | only no repeat licence allowed. | | | RA may take appropriate action as per the decision of Norms Committee / Case No.:143/4/82- -—~Party Name:MICRO LABS ‘Meet No/Date:6/82‘Status: | | ALC4/2017 LTD ALC4/2018 Approved | | 26.07.2018 | HQ File RLA File re Lic.No/Date:0710111158 | | :01/82/050/00151/AM18/ :07/24/040/00375/AM17/ 21.02.2017 | ‘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 9 5 details below or as applied by firm whichever is lower: | | Export product Exp. SI.No. | Import items Qty. allowed i | a , Number | 1. AMOXICILLIN 292.63 me/tablet | | | Amoxicillin and Potassium TRIHYDRATE | Bee caCarains Annoxticil BP/EP/IP/USP | if (Bach tablevContans Amoxic™n 2 DILUTED 303.773 me/tablet | | Trihydrate 250 mg and Potassium CLAVULANATE | || ClavulCtavulanate We125 me )375375kkg POTASSIUM (1.1
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----- Start of picture text -----<br> | number | 1 AMOXICILLIN 292.63 mg/tablet |<br>| TRIHYDRATE<br>Amoxicillin and Potassium BP/EP/IP/USP |<br>| (Each tablet Contains Amoxicillin CLAVULANATE |<br>| Trihydrate 250 mg and Potassium POTASSIUM (1.1) |<br>| Clavulanate 125 mg )375 kg BP/EP/IP/USP |<br>----- End of picture text -----<br>
‘RA may take appropriate action as per the decision of Norms Committee
a —_ ~ Case No.:63/4/82-ALC4/2017 PartyName:ALTA. ‘Meet No/Date:6/82Status: _ LABORATORIES LTD. ALC4/2018 ‘Approved | | 26.07.2018 | | _ ffOFie aes 7a sera [Lie No/Date.03 reaper | | | :01/82/050/00071/AM18/ 1:03/94/040/00998/AM17/ 22.02.2017 | | ‘Decision: Committee considered case as per agenda and deliberated on the matter in the presence of the 26[details] ‘technical[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 | _— [Exportproduct [xp ty. Qty. allowed | | |] Propyl Paraben 1kg 1. Para Hydroxy Benzoic | 0.850 kg | i Acid | ; | N-Propanol 0.500 kg RA may take appropriate action as per the decision of Norms Committee | ; ‘Case No.:64/4/82-ALC4/2017 Party Name:ALTA. SS Meet No/Date:6/82‘Status: | | ‘LABORATORIES LTD. ALC4/2018 ‘Approved | HQ File —RLAFile Lic.No/Date:0310811361 | | :01/82/050/00072/AM18/ ':03/94/040/00997/AM17/ 22.02.2017 | | ‘Decision: Committee considered case technical as per agenda and deliberated on the matter in the presence of the | 7 experts and it was decided to ratify the ad-hoc input output norms under para4.7 of HBPasper | details below or as applied by firm whichever is lower: | | 1 kg Para Hydroxy Benzoic | 0.969 kg |__| METHYL PARABEN Bed 5 = E00; | RA may take appropriate may take appropriate take appropriate action as per the decision of Norms Committee as per the decision of Norms Committee per the decision of Norms Committee decision of Norms Committee of Norms Committee Norms Committee Committee |
RA may take appropriate may take appropriate take appropriate action as per the decision of Norms Committee as per the decision of Norms Committee per the decision of Norms Committee decision of Norms Committee of Norms Committee Norms Committee Committee 1_ Case No.:181/4/82-ALC4/2017PartyName:BRILLIANT BIO M e tNo/Date:6/82(Status: | | PHARMA PRIVATE ALC4/2018 ‘Deferred | 28 | ‘LIMITED (26.07.2018 | HQ File RLAFile =—————SCSWL icNDvates0910064795 ‘Defer Date: :01/82/050/00189/AM18/ :09/24/040/00561/AM17/ 24.02.2017 __ Decision: Committee considered the case as per agenda and it was decided to call the firm for personal _ hearing to explain their case. |
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(Case No.:183/4/82-ALC4/2017 Party Name:GRANULES Meet No/Date:6/82-. ‘Status: | | INDIA LIMITED ALC4/2018 Approved | | HQ File RLA File 'Lic.No/Date:0910064722, 0 | :01/82/050/00191/AM18/ ':09/24/040/00612/AM17/ (24.02.2017 | 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: | Tenofovir Disoproxil 1kg 1. eaten oe a _ | Succinate ethoxy Propyl) | || adenine | | | 2 Chloromethyl Isopropyl | 1.3527 kg | || Carbonate | |RA may take appropriate action as per the decision of Norms Committee | [ ~ [Case No.:155/4/82-ALC4/2017 Party Name:OGENE a ‘Meet No/Date:6/82~ (Status: | | | SYSTEMS INDIA LTD. ‘ALC4/2018 ‘Approved | HQ File “RLAFile ~~~ Lic.No/Date:0910064733 _ 101/82/050/00163/AM18/ :09/24/040/00625/AM17/ 28.02.2017 | ‘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. Iso details below or as applied by firm whichever is lower: | | | Export product Exp. SI.No. | Import items Qty. allowed in | | | _ | 2-Ethyl-3,4-Ethylenedioxy 1kg Diethyl Thioglycolate || | thiophenethi (Ethylhyl EDOTEDOT) Ethylene dichloride; | RA may take appropriate action as per the decision of Norms Committee | "(Case No.:37/4/82-ALC4/2017 Party Name:SARNA_— Meet No/Date:6/82Status: | | (CHEMICALS PVT LTD ALC4/2018 Deferred ; | | 26.07.2018 © ‘Lic.No/Date:5210042198 Defer Date: | Pt HQ File RLA File | ':01/82/050/00045/AM18/ :52/24/040/00048/AM17/ (01.03.2017 | ‘Decision: Deferred for comments of TE [Case No.:76/4/82-ALC4/2017 [Party Name:ATHENA DRUG MeetNo/Date:6/82Status: | | ‘DELIVERY SOLUTIONS ALC4/2018 Deferred — | | (PRIVATE LIMITED (26.07.2018 | | a‘ke Se a Tic No/Date:0310811511 [Defer Date: | 32 |:01/82/050/00084/AM18/ ':03/94/040/01078/AM17/ (01.03.2017 | | ‘Decision: Committee considered the case as per agenda and it was decided to call from the firm | | following information: en) Copy of Drug Manufacturing licence (DML) |_|ii) Copy Master Batch Formula (MBF) eect eam eeemecceiet
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| iii) Generic name of the import and export item. ‘The firm has advised to furnish the information within 15 days, failing which case will be rejected - | | CaseNo.:80/4/82-ALC4/2017 [Party Name:ATHENA DRUG [Meet No/Date:6/82Status: | DELIVERY SOLUTIONS ALC4/2018 ‘Deferred f | PRIVATE LIMITED 26.07.2018 | | : | “ora “IREA FileSt eee ‘ILie NofDate.03 10811513 Deter ie | -:01/82/050/00088/AM18/ ':03/94/040/01072/AM17/ 01.03.2017 33 Decision: Committee considered the case as per agenda and it was decided to call from the firm ' | following information: i) Copy of Drug Manufacturing licence (DML) | ii) Copy Master Batch Formula (MBF) | iii) Generic name of the import and export item. _ (The firm has advised to furnish the information within 15 days, failing which case will be rejected | _ Case No.:133/4/82-ALC4/2017 Party Name: GLOBAL (Meet No/Date:6/82. Status; i | ‘MEDICINES LTD, ALC4/2018 Approved | | 26.07.2018 | | a4| ila,hin. inNTN TYETiT | | _ :01/82/050/00141/AM18/ ':34/24/040/00322/AM17/ 09.03.2017 | technical| Decision: Committee considered case as per agenda and deliberatedon the matterin the presence of the 34[4.7][of][ HBP] experts[as][per] and[details] it was[below:] decided to ratify the ad-hoc input output norms on net to net basis under para | | Export product Exp. SI.No. | Import items Qty. allowed | | Glycine (200 MESH) 176.000 | 1 Glycine (Granular 30-80 176.000 MT | _ | Net Content Per | MT : Glycine MT Mesh) | ‘RA may take appropriate action as per the decision of Norms Committee | (Case No.:154/4/82Party Name:STYRAX. ‘MeetNo/Date:6/82- (Status: | | ALC4/2017 PHARMA PRIVATE ALC4/2018 Approvede | | LIMITED 26.07.2018 | (HQ File RLA File ‘Lic.No/Date:09 10064772 | | :01/82/050/00162/AM18/ ':09/24/040/00651/AM17/ (09.03.2017 | _ **** _ Decision: Committee considered case as per agenda and deliberated on the matterin the presence of the. technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per. | details below or as applied by firm whichever is lower: _ | 4-AMINO-5-FLUORO-11 Kg. Glyoxalic acid 50% (2.234 _ | [QR,S5S)-22 2,5-Dihydroxy-1,4| _ | (HYDROXYMETHYL)-1,3Dithiane | | _ OXATHIOLAN-5-YL}-1,25-Fluoro Cytosine [1348] DIHYDROPYRIMIDIN-24 Di Potassium Hydrogen 2.07 ONE (EMO / EMT) Orthophosphate 5 | Sodium Borohydride 0.50 ' (SBH)
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~ | | a x ee 2 i eS Di Methyl Formamide 0.84 | | | (DMF) | | | Hexa Methyl! Disilazane | i | (HMDS) | | Methylene Di Chloride | | (MDC) | RA concerned may take further necessary action as per above decision of NC | [Case No.:21/4/82-ALC4/2017 Party Name:BIOMIRMeet No/Date:6/82Status: | | VENTURE LLP ALC4/2018 Approved | | | 26.07.2018 | | HQ File RLA File ‘(Lic.No/Date:3110066623 | ~——sS 36 |:01/82/050/00029/AM 18/ ':31/83/040/00174/AM17/ (15.03.2017 | | | (Decision: Committee considered case as per agenda anddeliberatedon thematterin the presenceof the| | technical experts and it was decided to ratify the ad-hoc input output norms as applied subject to DML for | product under export. RA shall verify at the time of EODC. | | RA concerned may take further necessary action as per above decision ofNC | [Case[No.:135/4/82-ALC4/2017][ Party][ Name:RIDDHI][ PHARMA][ (Meet][ No/Date:6/82-] Status: } | | ‘ALC4/2018 Approved | HQFile RLA File ‘Lic.No/Date:3410043042 | :01/82/050/00143/AM18/ :34/24/040/00355/AM17/ 20.03.2017 | | 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 37 details below or as applied by firm whichever is lower: || Export product Exp. SI.No. | Import items Qty. allowed in | | | | aty. kg | | | 1,3 DICHLORO ACETONE 1kg | 1 1, 3 DICHLORO 2- 1.069 | | | PROPANOL | | SODIUM DICHROMATE | ‘RA may take appropriate action as per the decision of Norms Committee | (Case No.:244/4/82-ALC4/2017 Party Name: AARTI «Meet No/Date:6/82Status: _ INDUSTRIES LIMITED ALC4/2018 Approved | | | '26.07.2018 e ~~ Lie No/Date:0310811950 | | | ae =m a | ':01/82/050/00252/AM 18/ ':03/94/040/011 15/AM17/ 20.03.2017 by NC in its 3/82 meeting dated 05.06.2018, it was decided | Decision:In the light of earlier decision taken 38 ‘to ratify 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 in kg | | DICARBOXYLIC ACID / 2,3-
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----- Start of picture text -----<br> _ | NONANE ACID<br>_ [DIAZABICYCLO a PYRIDINEDICARBOXYLIC | |<br>|<br>| |<br>| SODIUM BOROHYDRIDE 0.414 |<br>|<br>| | POWDER |<br>|<br>| 5 1,2-DIMETHOXYETHANE/ | 1.50 |<br>| MONOGLYME |<br>RA may take appropriate action as per the decision of Norms Committee<br>a |<br>| (CaseNo.:245/4/82-ALC4/2017 |Party Name:GLENMARK [Meet No/Date:6/82- ‘Status:<br>i PHARMACEUTICALS LTD., ALC4/2018 ‘Approved |<br>| ngaee ae" soe ioeeee WV isNoDeicontel on | |<br>:01/82/050/00253/AM18/ :03/94/040/01131/AM17/ 20.03.2017 |<br>_ Decision: In the light of earliedr decfition taken by NC in its 4/82 meeting dated 19.06.2018, it was decided |<br>whicheverto ratify theis ad-hoclower: input output norms under para 4.7 of HBP as per details below or as applied by firm|<br>_ [Export] [Product] |<br>|<br>| 39 Clindamycin & Benzoyl Peroxide Gel 1%/0.05%( Pack Size 25gm )<br>_ Clindamycin & Benzoyl! Peroxide Gel 1%/0.05% ( Pack Size 35gm ) |<br>Clindamycin & Benzoyl Peroxide Gel 1%/0.05% ( Pack Size 50gm ) |<br>| | S.NO. For export of 1 No. packs |<br>[1| [ Clindamycin Phosphate USP [262.5mg | 367.5mg_ | 525.0mg | |<br>| | 2 HYDROUSPEROXIDE BENZOYLUSP 1312.50mg {1837.50 mg 2625.0 mg<br>| RA may take appropriate action as per the decision of Norms Committee.<br>_ Case No.:92/4/82-ALC4/2017 ‘Party Name:ORBIT LIFE (Meet No/Date:6/82- ‘Status: |<br>| SCIENCE PVT. LTD. ALC4/2018 ‘Deferred<br>40 | 26.07.2018 |<br>_ TQ File RLA File ~ Lic.No/Date:0310812040 Defer Date: |<br>| :01/82/050/00100/AM18/ :03/95/040/00995/AM17/ 23.03.2017 | |<br>Ipc rs ale Saunier =<br>|<br>|<br>_ (Case No.:193/4/82-ALC4/2017 ‘Party Name:SUVEN LIFE [Meet No/Date:6/82- ‘Status:<br>| | SCIENCES LIMITED 'ALC4/2018 ‘Approved<br>| 26.07.2018 |<br>HQ File RLAFile = “Lic.No/Date:0910064836 | |<br>_ :01/82/050/00201/AM18/ :09/24/040/00659/AM17/ 24.03.2017 |<br>41 Decision: In the light of earlier decision taken by NC inits 4/82 meeting dated 03.07.201 4, itwas decided<br>to |<br>| whicheverratify theis ad-hoclower: input output norms under para 4.7 of HBP as per details below or as applied by firm|<br>Qty.<br>----- End of picture text -----<br>
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| | METHYL (E)-2-21 kg 3-ISOCHROMANONE 0.957 | | | CHLOROMETHYLPHENYL)O-XYLENE | | 3-METHOXY ACRYLATE 3 SODIUM METHOXIDE 0.416 | i | POWDER i= |RA may take appropriate action as per the decision of Norms Committee [Case No.:274/4/82-ALC4/2017 Party Name:GUJARAT Meet No/Date:6/82-. Status: | ORGANICS LIMITED ALC4/2018 Approved — | HQ File RLA File ‘Lic.No/Date:0310812082, / :01/82/050/00282/AM18/ ':03/94/040/01147/AM17/ (25.03.2017 | | | Decision: Committee considered case as per agenda and deliberated on thematterin 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. 42 idetails below or as applied by firm whichever is lower: | | Export product Exp. SI.No. | Import items Qty. allowed | | | aty. || PARA ANISIC ACID Para Hydroxy Benzoic Acid | 1.068 kg | | RA may take appropriate action as per the decision of Norms Committee | [Case No.:114/4/82-ALC4/2017- PartyName:MAHIMALIFE [Meet No/Date:6/82-. Status: | | ‘SCIENCES PVT.LTD. ALC4/2018 Deferred | ) RLAFile ~~~ Lic.No/Date:0510402098 Defer Date: | HQ File \43 :01/82/050/00122/AM18/ :05/24/040/00636/AM17/ (30.03.2017 | | | Decision: The Committee observed that the firm neither attended the PH nor submit the details as asked | _ for vide Minutes of the Meeting No. 1/82/ALC-4/2018, dated 01.05.2018 (actually held on 17.05.2018 and[|] 29.05.2018), hence the Committee decided to give last opportunity to firm to attend PH and submit its reply, || _ _ failing which, its case will be rejected | |CaseNo.:119/4/82-ALC4/2017 ‘Party Name:DSM SINOCHEM Meet No/Date:6/82Status; | PHARMACEUTICALS INDIA |ALC4/2018 Deferred | | | PVT.LTD. 26.07.2018 ~~ [Li¢.No/Date:2210015679 Defer Date: — HQFile ~ IRLAFile 44 ':01/82/050/00127/AM18/ :22/24/040/00114/AM17/ 30.03.2017 | | ‘Decision: The Committee observed that the firm neither attended the PH nor submit the details as asked | | for vide Minutes of the Meeting No. 1/82/ALC-4/2018, dated 01.05.2018 (actually held on 17.05.2018 and[|] | 29.05.2018), hence the Committee decided to give last opportunity to firm to attend PH and submit its reply, failing which, its case will be rejected. No/Date:6/82-. Status: [Case No.:118/4/82-ALC4/2017 |Party Name:IND-SWIFT [Meet i || LABORATORIES LTD., ‘ALC4/2018 Approved | 26.07.2018 | | \45 HQ File oO — IRLA File © ~ Lic.No/Date:2210015682 ':01/82/050/00126/AM18/ ':22/24/040/00121/AM17/ 31.03.2017 | ‘Decision: Committee considered case as per agenda and in the light of earlier decision taken by NC in its,
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_ 3/AM19 meeting dated 05.06.2018, it was decided to ratify the ad-hoc input output norms under para 4.7 of | HBP as per details below or as applied by firm whichever is lower no repeat one time basis only: | | Export product Exp. | SLNo. | Import items Qty. Allowed in kg _ | CLARITHROMYCIN GRANULES | 1 kg |1 | CLARITHROMYCIN 0.4242 kg | |__| 42% (SUSPENSION GRADE) CARBOPOL 0.30 kg | | | HPMC Phthalate 0.30 kg | | | ACETONE 2.00 kg | | ‘RA may take appropriate action as per the decision of Norms Committee i SYSTEMS INDIA LTD. ALC4/2018 Approved — HQ File —IRLAFile ——~C~S ‘Lic.No/Date:09 10064849 | _ :01/82/050/00203/AM18/ ':09/24/040/00692/AM17/ 31.03.2017 | | _ 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 46.‘ details below or as applied by firm whichever is lower: | | | | Export product Exp. SI.No. | Import items Qty. allowed in | | | Qty. kg | 2-Ethyl-3,4-Ethylenedioxy 1kg Diethyl Thioglycolate | Ethylene dichloride | RA may take appropriate action as per the decision of Norms Committee | (Case No.:202/4/82-ALC4/2017 [Party Name:VET BIOCHEM Meet No/Date:6/82- Status: | | INDIA PVT. LTD. ‘ALC4/2018 Approved — HQFile _ |RLAFile ———S*«SwL ieNDate3 110066645 ; tid :01/82/050/00210/AM18/ :31/83/040/00177/AM17/ (31.03.2017 | | 47 Decision: Committee considered case as per agenda and deliberated on the matter in the presence of‘the. technical experts and it was decided to ratify the ad-hoc input output norms as applied by the firm under para | 4.7 of HBP as per details below or as applied by firm whichever is lower: norms.The committee allowed the above norms for one time basis and no repeat licence is allowed on these | _ (RA concerned may take further necessary action as per above decision of NC _ Case No.:109/4/82-ALC4/2017 |Party Name:ASCENT ‘Meet No/Date:6/82Status: | FINECHEM PVT. LTD., ‘ALC4/2018 ‘Approved | HQ File RLA File Lic.No/Date:0810140009 | SS ‘4g :01/82/050/00117/AM18/ :08/24/040/00475/AM17/ 03.04.2017 | | | Decision: In the light of earlier decision taken by NC in its 3/82 meeting dated 05.06.2018, it was decided | ‘to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm) whichever is lower no repeat one time basis only:
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| | Export product Exp. | SILNo. | Import items Qty. Allowed in kg | | | RASPBERRY KETONE/ 4-(4lkg | 1 p-HYDROXY 1.69 kg | | | HYDROXYPHYENYL) BENZALDEHYDE || BUTANE - 2 - ONE WHITE (LIGHT YELLOW || CRYSTALLINE POWDER CRYSTALLINE | | | POWDER), PARA | | | HYDROXY | | | BENZALDEHYDE, 4- | | HYDROXY | BENZALDEHYDE | ACETONE 0.802 kg | | (COLORLESS LIQUID) / | |RA may take appropriate action as per the decision of Norms Committee | |Case No.:112/4/82-ALC4/2017 Party Name: HELLO PAINTS — Meet No/Date:6/82Status: | | (P) LTD ALC4/2018 ‘Approved — ~ \Lic.No/Date:0510402146. | HQ File RLA File | |:01/82/050/00120/AM18/ |:05/23/040/00629/AM17/ (03.04.2017 i[meeting][dated][16.05.2018][ it][was][ decided][ to.] |Decision: In the light of earlier decision taken[by][ NC][in][ its][ 2/82] | ‘ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm 49 whichever is lower: | | Export product Exp. | SI.No. Import items Qty. Allowed kg | | | THYMOL lkg | 1 META CERESOL 0.80 kg | || (ABOVE 95% PURITY) ABOVE 95% PURITY | | ‘RA may take appropriate action as per the decision of Norms Committee Case No.:131/4/82[Party Name:PANOLI ——-Meet No/Date:6/82Status: | ALC4/2017 INTERMEDIATES (INDIA) |ALC4/2018 _ Approved | PVT LTD 26.07.2018 | | iOFa RLA : “a asa ionis0es | | _ :01/82/050/00139/AM1 8/ :34/24/040/00281/AM17/ 03.04.2017 | | | ‘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 Iso details below or as applied by firm whichever is lower: | Export product Exp. SI.No. | Import items Qty. allowed in | | | aty. kg || _ [H-ACID 1 kg REFINE NAPHTHALENE | RA may take appropriate action as per the decision of Norms Committee (Case No.:201/4/82-ALC4/2017[Party Name:UMA —~—sMeet No/Date:6/82“Status: | |_| ENTERPRISE ALC4/2018 ‘Approved — ot 26.07.2018 | HQFile CREA File Lig. No/Date:0810139999 |
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| ':01/82/050/00209/AM18/ :08/24/040/00504/AM17/ 03.04.2017 ee || | Decision:In the lightof earlier decision taken by NC in its 2/82 meeting dated 16.05.2018 it was decided to | | ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm) _ whichever is lower: | | | Export product Exp. | SI.No. | Import items Qty. allowed in | | | Qty. ke | __| META CHLOROPER BENZOIC 1kg 1 META CHLORO 1.00 kg | acIp BENZOYL CHLORIDE | || TERTIARY BUTANOL | 0-50 kg | RA may take appropriate action as per the decision of Norms Committee ae | | ‘Case No.:204/4/82-. ———PartyName:SUN.———«[Meet No/Date:6/82‘Status: | i ALC4/2017 PHARMACEUTICAL ALC4/2018 Approved | | INDUSTRIES LTD. 26.07.2018 | | | rm*eae 7; Lic. No/Dates0310402142 | | :01/82/050/00212/AM18/ ':05/24/040/00655/AM17/ 03.04.2017 | ratifyDecision: In the light ofearlier decision taken by NC in its 3/82 meeting dated 05.06.2018 it was decided to 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 Quantity | | allowed **** | Latanoprost and Timolol Maleate Ophthalmic INo. TIMOLOL MALEATE 17.94 mg | | | Solution, 0.005% / 0.5%w/v, 2.5ml USP | 52. (LATONCURE) re | Each ml contains Timolol Maleate USP 6.83 mg | i equivalent to Timolol 5.0 mg (Equivalent to 55.494 | || Gram ofBulk Drug) | | Timolol Maleate Long Acting Ophthalmic Solution 35.88 | ; | | 0.5%w/v, Sml (TIMATIMSUN) IMOLOL MALEATE gm | | of Each ml contains Timolol Maleate USP 6.83 mg INo. SP | ; equivalent to Timolol 5.0 mg (Equivalent to | || 669.340 Gram of Bulk Drug) | Latanoprost and Timolol Maleate Ophthalmic i i| Solution, 0.005%/ 0.5% w/v, 2.5ml (LATOCOM IMOLOL MALEATE 17.94 mg | | Sterile Eye Drops) SP | i Each ml contains Timolol Maleate 6.83 mg IN | i equivalent to Timolol 5 mg (Equivalent to 227.098 0. | | Gram of Bulk Drug) (Equivalent to 951.931 Gram | a of total Bulk Drug) Drug Formulation/ Formulation Grade RA concerned may take further necessary action as per above decision ofNC | | Case No.:272/4/82-ALC4/2017 |Party Name: AARTI. ‘Meet | No/Date:6/82- (Status: | INDUSTRIES LIMITED ALC4/2018 ‘Approved | 153, HQ File RLA File ‘Lic.No/Date:0310812337 | _ :01/82/050/00280/AM18/ :03/94/040/01145/AM17/ (03.04.2017 | | _ Decision: Committee considered case as per agenda and deliberated on the matter in the presence of the, | detailstechnicalbelowexpertsor asandappliedit wasbydecidedfirm whicheverto ratify theis lower: ad-hoc input output norms under para 4.7 of HBP as per,
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[Preteen Exp. SI.No. | Import items Qty. allowed in | | | 5% PALLADIUM ON 0.200 | | CARBON CATALYST | 'RA may take appropriate action as per the decision of Norms Committee | Case No.:277/4/82-ALC4/2017 Party Name:CIPLA LIMITED. Meet No/Date:6/82‘Status: | | | | ALC4/2018 Deferred | Py | 26.07.2018 | | |HQ File RLA File ‘Lic.No/Date:0310812323 Defer Date: — | :01/82/050/00285/AM18/ ':03/94/040/01181/AM17/ 03.04.2017 | 54 Decision: The Committee considered case as per agenda in the presence of the technical “experts and it was. | decided to call the following information / documents from the firm: | | | i) Copy of DML for each export product || | | ii) Master Batch Formula for each export product | | iii) NOC from Ministry of Environment Forest and Climate Change[[Party][ Name:WAXSEN] Meet No/Date:6/82Status: [ ‘Case[No.:252/4/82-ALC4/2017] || LIFESCIENCE PVT. LTD., ALC4/2018 ‘Approved | ~ |Lic.No/Date:03 10812370 | | | |HQ File RLA File | |:01/82/050/00260/AM18/ :03/95/040/01042/AM17/ '05.04.2017 | ‘Decision: Committee considered case as per agenda and ‘deliberated ‘on the matter in the presence of the | itechnical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per: |55 details below or as applied by firm whichever is lower: |
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----- Start of picture text -----<br> Export product Exp. | SIL.No. Import items Qty. Allowed |<br>| 3,5-DICINNAMOYL-2-DEOXY- 1 kg TRIMETHYSILYL 1.326 kg<br>|__| 2,2-DIFLUOROCYTIDINE TRIFLUOROMETHANE<br>| | SULFONATE |<br>| | DICHLOROMETHANE _ | 3.90 kg |<br>| (RA may take appropriate action as per the decision ofNorms Committee<br>----- End of picture text -----<br>
[Case No.:266/4/82-ALC4/2017 Party Name: APEX PHARMA, |Meet No/Date:6/82Status; | | ALC4/2018 Approved | | | | 26.07.2018 | HQ File OO RLA File as Lic.No/Date:03 10812377 | | ':01/82/050/00274/AM 1 8/ ':03/94/040/00003/AM18/ 05.04.2017 | | pe ‘Decision: In the light of earlier decision taken by NC in its 3/82 meeting dated 05.06.2018, it was decided || towhicheverratify theis ad-hoclower: input output norms under para 4.7 of HBP as per details below or as applied by firm ||
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| [ Selamectin6% SPOT ON, Each | 32000.000 1 = - = _ — -~ ~- ———— = ee} ~~ . | 5.100 kg | | pipetts contain Selamectin BP Boxes Se amectin API 99% |
| 320006% W/VBoxes OR 60MG/ML & 96000 Pipetts) (Total unity | _ | G Pipetts HS/ 1 ml in each | |[boxes)] |
| RA may take appropriate action as per the decision of Norms Committee | ee | | (Case No.:113/4/82-ALC4/2017 |Party Name:PANERA BIOTEC ‘Meet No/Date:6/82Status: | PVT.LTD. ALC4/2018 ‘Approved | | | 26.07.2018 | 57 one esate ee LA[iiscuamoat | | :01/82/050/00121/AM18/ ':05/24/040/00664/AM17/ 06.04.2017 _| Decision: Committee considered the case as per agenda and it was decided to ratify the ad-hoc input output| norms as applied by the firm under para 4.7 of HBP one time basis only no repeat licence allowed. | RA may take appropriate action as per the decision of Norms Committee Case No.:132/4/82-ALC4/2017 |Party Name:NAARI PHARMA ‘Meet No/Date:6/82Status: PRIVATE LIMITED /ALC4/2018 ‘Approved — _ HQFile = ORLA File Lic. No/Date:0510402176 | | 101/82/050/00140/AM18/ :05/24/040/00003/AM18/ (06.04.2017 | | Decision: Committee considered case as per agenda and deliberated on the matter in the presence of the, 58 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. | SILNo. Import items Qty. Allowed | | | ESTRONE 1 kg 1, 4-Androstadiene-3, 171.40 kg Dione (ADD) | | [2 | Lithium metal [0.05 kg |
_ /RA may take appropriate action as per the decision of Norms Committee 0.62 kg || |_— || Case No.:320/4/82-ALC4/2017 Party Name:ALPHAMED [Meet No/Date-6/89. ‘Status: ; FORMULATIONS PLTD. —_ALC4/2018 Deferred | 26.07.2018 _59 HQ File RLA File ‘Lic.No/Date:09 10064868 ‘Defer Date: | :01/82/050/00328/AM18/ :09/24/040/00670/AM17/ 06.04.2017 __. Decision: Committee considered case as per agenda and it was decided to call from the firm a copy of Master Batch Formula (MBF). | i| Case No.:107/4/82-ALC4/2017 Party Name:DEEPAK [Meet No/Date-6/83. ‘Status: | 'NOVOCHEM ‘ALC4/2018 ‘Approved | 60 | TECHNOLOGIES LTD 26.07.2018 | HQ File RLA File Lic.No/Date:3110066691-poy :01/82/050/00115/AM18/ :31/83/040/00161/AM17/ 10.04.2017 | ‘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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| | Export product Exp. | SLNo. | Import items Qty. Allowed | | | Qty. | | DNOVO BP818 2,6 xylenol 1.06 kg | JRA may take appropriate action as per the decision of Norms Committee | _ (Case No.:257/4/82-ALC4/2017 ‘Party Name:MATRIXFINE Meet No/Date:6/82-. Status: | | SCIENCES PVT.LTD., ALC4/2018 Deferred 61 HQ File RLA File ‘Lic.No/Date:0310812435 Defer Date: | | :01/82/050/00265/AM18/ ':03/95/040/00999/AM 17/ (11.04.2017 | Decision: Committee considered case as per agenda and it was decided to call from the firm a copy of | complete technical details as per appendix 4E. {Case No.:259/4/82-ALC4/2017 Party Name:RHODIA _ [Meet No/Date:6/82= Status: | | | ‘SPECIALTY CHEMICALS ‘ALC4/2018 ‘Approved — | | INDIA LTD. 26.07.2018 | "(Lie No/Date:0310812492, || | HQ File RLA File | :01/82/050/00267/AM18/ :03/95/040/00023/AM 18/ 13.04.2017 ‘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.| 62 details below or as applied by firm whichever is lower: | Export product Exp. | SI.No. | Import items Qty. | | | Qty. allowed in |. | | Bricorr flow (Tetrakis (Hydroxymethy!) 1k 1 Bricorr 70a / Tolcide | 0.715 | | [Phos phonium Sulphate (2 : 1) 8 PS 70a | | (RAmay take appropriate action as per the decision of Norms Committee ~\Case No.:340/4/82-ALC4/2017 PartyName:GODAVARI ~~ Meet No/Date:6/82Status: ; | DRUGS LTD ALC4/2018 Deferred | | HQ File. re RLA File ) Lic.No/Date:09 10064920 Defer Date: ©| ':01/82/050/00348/AM 18/ :09/24/040/00694/AM17/ 13.04.2017 ie ‘Decision: Committee considered case as per agenda and it was decided to call from the firm following | information: | | i) Chemical reaction and manufacturing process, | | ii) Stepwise chemical reaction and Molecular Weight, | iii) Percentage of yield on molar basis and details of solvent reactions along with complete technical | | details as per appendix 4E. | [ (CaseNo.:211/4/82-ALC4/2017|Party Name:RECKITT ~~ [Meet No/Date:6/82= Status: | | |BENCKISER HEALTHCARE |ALC4/2018 ‘Approved | | | INDIA PRIVATE LIMITED 26.07.2018 | | | HQ File OO IRLA File ‘Lic.No/Date:0510402237 | 64 :01/82/050/00219/AM18/ :05/24/040/00017/AM18/ 18.04.2017 | | | 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> ~,<br>| | Qty. gm/kg<br>| Nurofen For Children | 1 kg Ibuprofen 17.41 |<br>| | Tween 80 (Polysorbate 80) 0.0862<br>| | Lycasin 80/55 (Maltotol) 383.793<br>| | Saccharin Sodium 40/80 1.724 |<br>_ 6. | Citric Acid Monohydrate 3.448 |<br>Tri Sodium Citrate Dihydrate 4.388<br>| |9. | Sodium Chloride 0.984 |<br>| | Domiphen Bromide (BP) 0.0862 |<br>i | 12 987 PP28mm M-LOC H&A White Relevant as per |<br>| | T/E packing policy |<br>| | 13 DEVC,NURFN,GB,ORAL |<br>| SUSPENSION (Syringe) |<br>| | INSR,NUREN,NN PASTIC PLUGS |<br>| NFC 2 Percent Paper labels<br>/<br>| | NFC 2 Percent Paper Leaflets |<br>| NFC 2 Percent Mono cartons |<br>_ (RA may take appropriate action as per the decision of Norms Committee, |<br>| Case No.:256/4/82-ALC4/2017 (Party Name:RESONANCE ‘Meet No/Date:6/82- ‘Status:<br>‘SPECIALTIES LTD ‘ALC4/2018 ‘Approved<br>- HQFile - RLA File | Lic.No/Date:03 10812525 |<br>_ :01/82/050/00264/AM18/ :03/95/040/00925/AM17/ '18.04.2017 |<br>| Decision: the light of earlier decision taken by NC in its8/82meeting<br>| dated 11.07.2013, it was decided to<br>| 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><br>| Export product Exp. | Sl.No. | Import items Qty. Allowed kg |<br>| | ALPHA PICOLINIC ACID 2 CYANOPYRIDINE 1.23 kg |<br>| _ ZINC PICOLINATE 2 CYANOPYRIDINE 0.948 kg |<br> | CHROMIUM PICOLINATE He ]t | 2 CYANOPYRIDINE 1.00 kg |<br>‘RA may take appropriate action as per the decision of Norms Committee<br>_ (Case No.:341/4/82-ALC4/2017 Party Name: HONOUR LAB [Meet No/Date:6/82- ‘Status:<br>| | ‘LIMITED 'ALC4/2018 Deferred<br>66 HQ File RLA File -|Lie.No/Date:0910064954 [Defer Date: |<br>:01/82/050/00349/AM18/ ':09/24/040/00035/AM18/ 24.04.2017 |<br>[Decision: Deferred for comments of TE ;<br>つ<br>つ<br>----- End of picture text -----<br>
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----- Start of picture text -----<br> [Case No.:373/4/82-ALC4/2017 Party Name:ENCUBE Meet No/Date:6/82- Status:<br>| | ETHICALS PVT LTD ‘ALC4/2018 ‘Deferred<br>| | 26.07.2018<br>| HQ File RLA File ‘Lic.No/Date:0310812788 Defer Date:<br>| :01/82/050/00381/AM1 8/ ':03/94/040/00025/AM18/ 25.04.2017<br>| Decision: DelermedforcommentsofT.E SCS|<br>[Case No.:397/4/82-ALC4/2017 [Party Name:BIOLOGICAL E ‘Meet No/Date:6/82- Status:<br>| | ‘LTD ALC4/2018 ‘Approved |<br>| | 26.07.2018<br>| HQ File RLA File ‘Lic.No/Date:0910064960<br>| 01/82/050/f00405/AM 18/ :09/24/040/00208/AM17/ 25.04.2017 |<br>| Decision: In the light of earlier decision taken by NCin its 11/82 meeting 24.01.2018, it was decided [to] []<br>| ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is |<br>| less: |<br>| | Item of Export Quantity | S.No. | Item of Import Quantity<br>| | allowed per<br>| | million vials |<br>| DTP-HepB-Hib POLYETHYLENE GLYCOL | 76.848 kg<br>|| (Pentavalent vaccine) 6000 (MACROGOL)<br>| | fully liquid combination AEROSIL 380V (COLLIDAL | 20.375 kg<br>|__| vaccine, Single dose vial ANH SILICA BP) cer<br>| (0.5m), pediatric fs [oryceron | 222.842 It |<br>|| dose Diphtheria, tetanus TWEEN-20 (POLYSORBATE | 7.685 Itr. |<br>| pertussis hepatitis B 20) |<br>; joe POTASSIUM THYOCYNATE | 169.742 gms<br>| | recombinant and :<br>| | Haemophilus influenza [6 | TRIS BUFFER 10.216 ke<br>|| type b (Hib) combined ALUMINIUM CHLORIDE 6 | 27.665 kg |<br>|68 || vaccine with Vaccine HYDRATE EXTRA |<br>| Vial Monitor (VVM) - fs [yeasTextract| 22447 ke |<br>- | 10000000 [9 | DEXTROSE (GLUCOSE) 35.937 kg<br>| BACTO CASAMINO ACID _ | 32-758 ke |<br>| | 14. | ADIPIC DIHYDRAZIDE 1.686 kg<br>| (ADH)<br>| | 15 N-3- 167.545 gm<br>| | DIMETHYLAMINOPROPYL- |<br>| | N-ETHYLCARBODIMIDE<br>| | HCL (EDC)<br>| | 16 2-(N-MORPHOLINO) 1.441 kg |<br>| | ETHANE SULFONIC ACID<br>| | (MES)<br>| | ig” |ALUMINIUM PHOSPHATE | 76.991 kg |<br>| | GEL 2% (ADJU.PHOS 2%)<br>| | 20 NZ CASE TT (CASEIN 39.12 kg |<br>| | PEPTONE PLUS) |<br>―<br>―<br>―<br>―<br>１<br>１<br>１<br>１<br>１<br>１<br>１<br>１<br>１<br>１<br>１<br>１<br>１<br>１<br>１<br>１<br>１<br>１<br>１<br>１<br>１<br>１<br>１<br>１<br>１<br>１<br>----- End of picture text -----<br>
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----- Start of picture text -----<br> |<br>a eeaia ————- |<br>| HYDROCHLORIDE)<br>| | RUBBER STOPPERS 1095638 nos |<br>| | ALUMINIUM CAPS/SEALS |<br>} | 25 HEATMARKER VACCINE _ | 1086508 nos<br>| VIAL MONITOR (VVM |<br>26 LABELS) |<br>| SHIPPING INDICATORS (Q_ | 902 nos |<br>| TAG 2 PLUS)<br>FILTERS & FILTER AIDS |<br>_ RA may take appropriate action as per the decision of Norms Committee<br>oe . |<br>| Case No.:380/4/82-ALC4/2017 Party Name:DELTA -|Meet No/Date:6/82- Status:<br>i FINOCHEM PVT.LTD. ALC4/2018 Deferred<br>69 | 26.07.2018 | |<br>Tio File OO RLAFie ~Lic.No/Date:03 10812922 Defer Date:<br>:01/82/050/00388/AM18/ ':03/94/040/00030/AM18/ 27.04.2017 |<br>‘Decision: Deferred for comments of TE |<br>/ (Case No.:55/9/82-ALC4/2017 |Party Name:BIOLOGICAL E ‘Meet No/Date:6/82- “Status:<br>| |<br>i | ILTD ALC4/2018 ‘Approved |<br>HQ | 26.07.2018 | |<br>Fier7 ‘icNeenee | |<br>:01/82/050/00782/AM18/ :09/24/040/00207/AM17/ 27.04.2017 |<br>Decision: Committee considered case as per agenda and In the light of earlier decision taken by NC in its<br>3/82 meeting 05.06.201 8, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below<br>| or as applied by the firm, whichever is less:<br>|<br>i Item of Export Quantity | S.No. | Item of Import Quantity allowed |<br> | per million vials |<br> | DTP-HEPB-HIB 1 million aa POLYETHYLENE GLYCOL | 768.48 kg<br>| (PENTAVALENT vial 6000 (MACROGOL)<br>| VACCINE) FULLY 2. AEROSIL 380 V (COLLIDAL | 203.75 kg<br>70 Ligurp ANH SILICA) |<br>, |COMBINATION [3 [oLvcerol —~* aaa J |<br>| | ML)VACCINE,VIAL, PEDIATRIC10 DOSE( 5 (POLYSORBATE)TWEEN-20 76.58 ltr. |<br>| | DOSE DIPHTHERIA, : POTASSIUM THYOCYNATE| 1697.42 gms ||<br>TETANUS PERTUSSIS, |6. | TRIS BUFFER 102.16 kg |<br>| HEPATITIS B ALUMINIUM CHLORIDE 6 | 276.65 kg |<br>| RECOMBINANT AND HYDRATE EXTRA<br>| |<br>| HAEMOPHILUS /§ |yeasrextract| 22447 Kg |<br>| INFLUENZA TYPE B |9 | DEXTROSE (GLUCOSE) /359.37kg |<br>| ase<br>(2B) compnne Hof icysting<br>| [VACCINE] VACCINE WITH [VIAL] P| 3.79 kg<br>f|_|| MONITOR (vvM) 12 ADIPIC DIHYDRAZIDE 16.86 kg ||<br>| (ADH) |<br>|<br>| 13 N-3- 1675.45 gm |<br>| DIMETHYLAMINOPROPYL- |<br>N ETHYLCARBODIMIDE<br>Ｃ<br>----- End of picture text -----<br>
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----- Start of picture text -----<br> | | ETHANE SULFONIC ACID |<br>i | GEL 2%<br>| PEPTONE PLUS)<br>| | (THIAMINE<br>; | HYDROCHLORIDE) |<br>| | VIAL MONITOR LABELS<br>| | (VVM LABELS)<br>i | (QTAG 2 PLUS) |<br>RA may take appropriate action as per the decision of Norms Committee. |<br>| (Case No.:142/4/82-ALC4/2017 Party Name:DEEPAK ‘Meet No/Date:6/82- Status:<br>| | NOVOCHEM ALC4/2018 ‘Approved<br>} | TECHNOLOGIES LTD ~~ 26.07.2018 |<br>| |HQ File RLA File Lie.No/Date:3110066712<br>| :01/82/050/00150/AM1 8/ ':3.1/83/040/00010/AM18/ 01.05.2017<br>| ‘Decision:decided to Inratify the lightthe ad-hoc of earlierinputdecision output norms taken by under NCparain its 4.7 2/AM19 of HBP meetingas per details dated below16.05.2018or as a ppliednd it was. by,<br>7 | firm whichever is lower:<br>| Export product Exp. SI.No. | Import items Qty. Allowed in MT |<br>| | MT 2 Not allow as specific |<br>escription not given<br>|| |/RA may take appropriate action as per the decision of Norms Committee |<br>| ‘Case No.:205/4/82-ALC4/2017 Party Name:AETHER ‘Meet No/Date:6/82- Status: |<br>i INDUSTRIES LIMITED ‘ALC4/2018 Deferred |<br>|| | 26.07.2018<br>PHQFile ~RLAFile ~~ ~—~—_Lic.No/Date:5210042246 Defer Date: _<br>| ':01/82/050/00213/AM18/ |:52/24/040/00004/AM 18/ 01.05.2017<br>| ‘Decision: Deferred for comments of TE<br>う う<br>う<br>う<br>----- End of picture text -----<br>
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----- Start of picture text -----<br> (Case No.:221/4/82-ALC4/2017 Party Name:BAROQUE Meet No/Date:6/82- Status:<br>; | PHARMACEUTICALS PVT. ALC4/2018 Deferred<br>73 HQFile = RLAFile © ‘Lic.No/Date:08 10140185 Defer Date: |<br>:01/82/050/00229/AM18/ ':08/24/040/00536/AM17/ 01.05.2017 | |<br>| ‘Decision: Deferred for comments of TE |<br>"(Case No.:331/4/82-ALC4/2017 |Party Name:AUROBINDO ‘Meet No/Date:6/82- Status:<br>| | PHARMA LIMITED ALC4/2018 ‘Approved —<br>HQFile ==————S——~~~«SRLile ~=—=—=~SSSS*~ie NoMDates0910064988 Defer Dates<br>— 101/82/050/00339/AM18/ ':09/24/040/00044/AM 18/ 01.05.2017 | |<br>| Decision: In the light of written comments received from department of Pharmaceuticals and in consultation<br>| with technical authority present in meeting decided to ratify norms under para 4.7 of HBP as per details<br>| |<br>below or as applied by firm whichever is lower:- |<br>Export product Export | SI.No. Import items Qty. allowed in |<br>i Carbon Enoanticromos |<br>| | (Activated Carbon) 0.200<br>i GHYH (OR) 7- 2.977 |<br>74) Phenylacetamide-3-Hydroxy- | ~~<br>i 3-Cephem-4-Carboxylic |<br>| Acid Diphenylmethy! Ester<br>| 7 Isopropyl alcohol (IPA)<br>| 14.16 |<br>; | 8 Methanesulfonic acid (MSA) | 0.403 |<br>fo Methanesulfonyl chloride |<br>(MSC) 0.968<br>| | Methanol (Methyl Alcohol) | 24.81<br>i | 11 Methyl 4-Chloro Aceto<br>_ Acetate 1.661<br>i :<br>| | Methylene chloride (MDC) 108.00<br>| | 14 Potassium Carbonate 1.00 |<br>| (Anhydrous)<br>| | Sodium borohydride 0.344<br>_ Triethylamine (TEA)<br>i RA may take appropriate action as per the decision of Norms Committee |<br>一<br>７<br>----- End of picture text -----<br>
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[Case No.:206/4/82-ALC4/2017 ‘Party Name:MOREPEN Meet No/Date:6/82-. Status: | | LABORATORIES LTD., ALC4/2018 Deferred || | 26.07.2018 | |[5][ HQ][File] RLA File Lic.No/Date:0510402443 Defer Date: | /| |:01/82/050/00214/AM18/iov narell fammeneimenis:05/24/040/0004 -_ 1/AM18/ ale(03.05.2017eeesene tee ————| | (Case No.:319/4/82-ALC4/2017 Party Name:HETERO LABS [MeetNo/Date:6/82Status: | | ‘LIMITED ALC4/2018 Approved | ) | | | 26.07.2018 | | HQ File RLA File ‘Lic.No/Date:0910065001 | :01/82/050/00327/AM18/ :09/24/040/00069/AM 18/ 03 05.2017 i | Decision: Committee considered case as per agenda and and 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 no repeat one time basis only: ,1/0)6 Export product Exp. | SI.No. | Import items Qty. Allowed inkg | — |_| 5-O-Trityl -2,3-anhydrothymidine | I kg Betathymidine | | | 4 Methane sulfony] | | | chloride | | | 5 Tetrabutyl ammonium | | bromide [RA may take appropriate action as per the decision ofNorms Committee | [Case No.:39/9/82-ALC4/2017 Party Name:AKTINOS Meet No/Date:6/82Status: | | HEALTHCARE PRIVATE —ALC4/2018 ‘Approved + LIMITED 26.07.2018 | | ~~ Lie.No/Date:0910065003 | | HQFile #8 — (RLAFile | | :01/82/050/00766/AM18/ ':09/24/040/00047/AM 18/ 03.05.2017 | | Decision: 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: || | N-BENZYLOXY CARBONYL-L- | 1 kg fT [L-vALINE 0.51kg |. || | VALINE (CBZ-L-VALINE) 5 BENZYL O74ke | ; | CHLOROFORMATE | RA may take appropriate action as per the decision of Norms Committee
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| Case No.:75/9/82-ALC4/2017 Party Name:VIMAL DRUGS __ [Meet No/Date:6/82Status: | PRIVATE LIMITED ALC4/2018 Approved | | | 26.07.2018 none Sea AS SaaS eataeronena RLA File ao aaacena Lic No/Date:0910065005 | | :01/82/050/00802/AM18/ ':09/24/040/00060/AM18/ 03.05.2017 Decision: 7 | oe _| decided Committee considered case as per agenda and in the presence of the technical experts, it was 78 to ratify 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 repeat one time basis only: | | | Export product Exp. | SI-No. | Import items Qty. Allowed _ | 4-(SULPHAMOYL PHENYL) 4-AMINOBENZENE 0.96 kg _ | HYDRAZINE 1 kg SULFONAMIDE (OR) | HYDROCHLORIDE SULFANILAMIDE __RA may take appropriate action as per the decision of Norms Committee | | (Case No.:212/4/82-ALC4/2017 Party Name:SIMPEX Meet No/Date:6/82Status: | | PHARMA PVT.LTD. (ALC4/2018 Approved | | | 26.07.2018 | OHIe hl LieNoawe GTITE | | | :01/82/050/00220/AM18/ :05/24/040/00024/AM18/ (04.05.2017 | | Decision: Committee considered case as per agenda and 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 repeat one time basis only: | ln: d SI llowed | _ | Export product Exp. ‘ Import items Qty. Allowe | iy Qty. | No. **** | SPIRAMYCIN TABLETS 3.06 MIU/tablet | || || CONTAINSEACH FILM COATEDSPIRAMYCIN TABLETEP 3 Niswee SO, MYCIN BP | _ RA should check DML of the export item and to calculate kg entitlement from MIU after taking conversion | ratio from the applicant |
‘RA may take appropriate action as per the decision of Norms Committee
==> picture [457 x 197] intentionally omitted <==
----- Start of picture text -----<br> (Case No.:378/4/82-ALC4/2017 |Party Name:HIKAL LIMITED Meet No/Date:6/82- (Status:<br>| | | ALC4/2018 ‘Approved |<br>| | | 26.07.2018 |<br>| HQ File RLA File ‘Lic.No/Date:0310813051 |<br>_ :01/82/050/00386/AM18/ :03/94/040/00078/AM18/ (04.05.2017 | |<br>' , Decision: Committee considered case as per. agenda and in light of earlier decision taken in meeting No. |<br>80 49/82 held on 06.03.2012 and in consultation with technical authority present in meeting, decided to ratify |<br>‘norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:-<br>|| Export product Exp. SLNo. Qty. allowed ]<br>| 3:5 Dichloro Aniline | 1 Kg. [1.<br>| | 2,6 Dichloro Para Nitro Aniline |L47kg |.<br>(Purity 99.5%) }2. | Sodium Nitrite ~*d ORT kg),<br>| 3. [04s Methanol ke)<br>Isopropyl Alcohol 0.860 kg |<br>‐<br>----- End of picture text -----<br>
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| | ee 7 — | | 16. __| Sulphuric Acid Not allowed |. 1 | Caustic Soda Lye Not allowed | | ‘RA may take appropriate action as per the decision of Norms Committee. | (Case No.:59/9/82-ALC4/2017 Party Name:AUROBINDO ‘Meet No/Date:6/82Status: | | PHARMA LIMITED ALC4/2018 Deferred | °" HQ File RLA File ‘Lic.No/Date:0910065008 Defer Date: | |:01/82/050/00786/AM18/ :09/24/040/00021/AM18/SO oo04.05.2017 || | ‘Decision: Deferred for comments & (Meet No/Date:6/82Status: [Case No.:478/4/82-ALC4/2017 Party NameNATURAL | | ESSENTIAL OILS PVT.LTD., ALC4/2018 ‘Approved | | | 26.07.2018 | HQ File RLA File Lic.No/Date:0710111546 | /:01/82/050/00486/AM 18/ :07/24/040/00012/AM18/ (05.05.2017 | | | Decision: In the light of earlier decision taken by NC in its 5/82 meeting dated 25.07.201 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:| | | Caffeine 1 Crude Caffeine (decaffeination | | | 10020.000 kg from green coffee) Purity 5600.000 kg | | Coffee Extracts 2 Crude Caffeine (decaffeination | | | 6150.000 kg from green coffee) Purity 12000.000 kg | | | 52.83% ‘The above norms is allowed as one time basis and no repeat licence is allowed |, RA concerned may take further necessary action as per above decision of NC ~ |CaseNo.:41/9/82-ALC4/2017 PartyNameSATYA Meet No/Date:6/82-. Status: | ‘DEEPTHA ALC4/2018 Approved | | | PHARMACEUTICALS LTD 26.07.2018 | | HQ File ~~ IRLA File Lic.No/Date:09 10065014 | :01/82/050/00768/AM 18/ ':09/24/040/00073/AM 18/ 09.05.2017 | Decision: In the light of earlier decision taken by NC in its 7/82 meeting dated 11.09.2014, it was decided | | ito ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm| | whichever is lower: Bs | | Export product Qty. SI.No. | Import items Qty. | | Allowed |. | AFC OR (1S,4R)-4-[(2-AMINO-61 kg N-(2-AMINO-4,60.764 | | CHLORO-S-FORMAMIDO-4DICHLORO-5| | | PYRIMIDINYL)AMINO}-2AIDE. | CYCLO PENTENE-1-METHANOL 5 ()21.298 | | AZABICYCLO[2.2.1]HEPT-
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----- Start of picture text -----<br> | D(-)TARTARIC ACID oe |<br>| SODIUM BOROHYDRIDE | 0.226 |<br>| ISOPROPYL ALCOHOL [418 |<br>(6<br>| METHANOL a7)<br>| L(+) TARTARIC ACID 0.519 |<br>----- End of picture text -----<br>
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----- Start of picture text -----<br> | RA may take appropriate action as per the decision of Norms Committee<br>_ yen lf<br>| Case No.:1/4/82-ALC4/2017 |Party Name:LEE PHARMA ‘Meet No/Date:6/82- ‘Status:<br>| | |LIMITED ALC4/2018 ‘Deferred<br>S'HQFile '26.07.2018 | |<br>| :01/82/050/00009/AM———RLAFle. ——=—=S=S*SLie-NoDates0910065019 (Defer Date |<br>18/ ':09/24/040/00084/AM18/ 11.05.2017 | |<br>| Case No.:48/9/82-ALC4/2017 |Party Name:GLAND Meet No/Date:6/82- (Status:<br>ft PHARMA LIMITED ALC4/2018 Approved |<br>—<br>~ HQFile CS” RLAFile =—————S—S—«<MLic. No/Date:0910065025 | |<br>_ :01/82/050/00775/AM18/ :09/24/040/00005/AM 18/ (11.05.2017 | |<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. Qty. Qty. Allowed |<br>| No. |<br>Ba | VoriconazoleInjection 200 mgPowder/Vial, for30 | 1 Number 1 VoriconazoleUSP 210 mg/vial |<br>1 ml Vial USP 2 Kleptose 3200 mg/vial<br>| | 3 Vials Relevant as per |<br>| | Glass packing policy :<br>} | 4 Rubber Stoppers Relevant as per<br>| | Rubber packing polic |<br>1 | 5 Seals Relevant as soper<br>i Plastic packing policy |<br>i<br>| | Filters Consumable<br>| Plastic |<br>| 7 Tubing Not allowed under |<br>| Plastic policy<br>Ｓ‐<br>Ｖ ‐<br>ａＳｓ<br>----- End of picture text -----<br>
RA concerned may take further necessary action as per above decision of NC
==> picture [456 x 92] intentionally omitted <==
----- Start of picture text -----<br> Case No.:56/9/82-ALC4/2017__ Party Name:AUROBINDO Meet No/Date:6/82-_—‘(Status: |<br>lee | PHARMA LIMITED ‘ALC4/2018 Deferred<br>> | 26.07.2018 |<br>HQ File RLA File ‘Lic.No/Date:0910065017 [Defer Date:<br>| ':01/82/050/00783/AM18/ ':09/24/040/00086/AM18/ 11.05.2017 |<br>Weta necaTE he —<br>----- End of picture text -----<br>
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Case No.:58/9/82-ALC4/2017 PartyName:EYTANLABS Meet No/Date:6/82-. Status: | | LIMITED ALC4/2018 ‘Approved pod | [26.07.2018 | HQ File RLA File ‘Lic.No/Date:0910065035 | | :01/82/050/00785/AM1 8/ |:09/24/040/00034/AM 18/ 12.05.2017 |[the][ matter][in][the presence][ of][the][|] Decision: Committee considered case as per agenda and[deliberated][on] | 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 SI.No. | Import items Quantity allowed © | ERRINOOXO PYRIMIDINYL | T Ke 0.743 | | | XATHIOLANE-2-CARBOXYLIC 2 2,5 DIHYDROXY 1,4 0.325 | | | Acie DITHIANE ; | ISO PROPYL METHYL CYCLO CYTOSINE. |. | HEXYL ESTER (CHE) OR 0.428 | |RA concerned may take further necessary action as per above decision of NC | [Case No.:83/9/82-ALC4/2017 [PartyName:ARENE ‘SCIENCES LIMITED. ALC4/2018 Approved | | LIFE Meet No/Date:6/82Status: | | | (26.07.2018 | HQ File RLA File ~Tie-No/Date:0910065030 | ':01/82/050/008 10/AM18/ ':09/24/040/00050/AM 18/ (12.05.2017 | ‘Decision: Committee considered case as per agenda and deliberated on the matterin the presence of the | | technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per. | details below or as applied by firm whichever is lower: | | Export Product Qty. | SL Quantity 88 | No. allowed Kg | | |ATAZANAVIR 1Kg | 1. | (2R,3S)-3-(tert0.45 | | | SULPHATE Butoxycarbony!)amino-1,2-epoxy-4| | phenylbutane | | | 2 | Hydrazinecarboxylic acid 2 -[[4-(20.43 | pyridinyl)pheny!}methyl]-, 1, 1- | | | dimethylethyl ester | | | 4 | 1-Ethyl-30.65 | | | (dimethylaminopropy!)carbodiimide | ; | hydrochloride | | |RA concerned may take further necessary action as per above decision of NC | [Case No:84/9/82‘Party Name:AAP PHARMA Meet No/Date:6/82Status: — ALC4/2017 ‘TECHNOLOGIES INDIA ALC4/2018 Approved | | (PRIVATE LIMITED 26.07.2018 | a 'RLA File — ‘Lic.No/Date:09 10065032 | | HQ File 89 :01/82/050/0081 1/AM18/ ':09/24/040/00063/AM 18/ (12.05.2017 | | ‘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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[Export product. ~—~—~—~—~«Y| Exp. _| SLNo.| Importitems ty. allowed | | | Tert-Butyl (5S, 10R,Z)-5-amino-9- | 1kg Fmoc-Asn(Trt)-OH (N1.20 kg | _ | Fmoc amino-13,13-dimethyl-3,6Fmoc, N-Trityl L-Aspargine) | | | | dioxo-1,1,1-triphenyl-7,12-dioxa 2 0.75 kg | : | -2,8-diazatetradec-8-en-10Boc-Ser (tBu)-OH | yl)carbamate (CNOH-4) | [RA may take appropriate action as per the decision of Norms Committee ae Case No.:38/9/82——SPartyName:MYLAN. ‘Meet No/Date:6/82‘Status: | ALC4/2017 LABORATORIES LIMITED ALC4/2018 Approved | —HQFile = = = = ~~ RLAFileOt—~—CS “Lic.No/Date:0910065044 | | :01/82/050/00765/AM18/ :09/24/040/00061/AM18/ 15.05.2017 | 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 | Export Product Qty. Sl. | Import items Quantity | _ No. allowed in Kg | | ZOFENOPRIL 1Kg | 1. Cis-4-phenylthio-L-proline 125 | | | |CALCIUM hydrochloric acid | Methylene Dichloride (MDC) | ff 5 S-(-)-3-Benzoylthio-21.05 | Methylpropionicacid (OR) S(| ‘RA )3Benzoylthio2Me.propioacid | concerned may take further necessary action as per above decision of NC i | | Case No.:64/9/82-ALC4/2017 [Party Name: HETERO DRUGS Meet No/Date:6/82‘Status; | LIMITED ALC4/2018 ‘Approved — _ (HQ File RLA File Lic.No/Date:0910065043 | | :01/82/050/0079 1/AM18/ ::09/24/040/00076/AM 18/ 15.05.2017 Decision: Committee considered case as per agenda and deliberated on the matter in the presence of the, | detailstechnical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per| below or as applied by firm whichever is lower: 91 | Export product Exp. | SI.No. | Import items Qty. allowed | | Qty. | Tolvaptan Tkg | 1 7-chloro-1-(2-methy]-41.55 kg | nitrobenzoyl)-5-oxo} 2,3,4,5tetrahydro-1H| benzazepine | | | Dimethy! formamide 0-130 kg ‘RA may take appropriate action as per the decision of Norms Committee __ Case No.:65/9/82-ALC4/2017 [Party Name:HETERO DRUGS Meet No/Date:6/82(Status: 92 | ‘LIMITED ALC4/2018 ‘Approved
==> picture [491 x 727] intentionally omitted <==
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|35|
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|HQ|File|RLAFile|—————~—~—~*WLie No/Date-0910065042 ||
|||::01/82/050/00792/AM1 8/|':09/24/040/00075/AM|18/|(15.05.2017|||
|_|Decision:|Committee|considered case|as|per|agenda|anddeliberatedon|the|matter|in|the presenceof|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|||
||||Aprepitant|1kg|1|(1R)-|2.10|kg|
|||1[3,5bis(Trifluoromethy])|
|;|||phenyl|ethyl(2R,3S)-3-(4-|
|Fluoro|phenyl)morpholiny||
|||||||ether ,p-Toluene|sulfonic|
|i|||Acid|salt|||
|||||Methyl hydrazine|0.56 kg|||
|||||carboxylate|||
|/RA may take appropriate|action|as per the decision of Norms Committee|||
|~~ [CaseNo.:395/4/82-|Party Name:JODAS|EXPOIM|(Meet No/Date:6/82-|Status:|
||||ALC4/2017|(PVT.LTD.,|ALC4/2018|Approved|
|||||(26.07.2018|||||
|||HQ File|—REAFile|Lic.No/Date:05 10402578|||||
|':01/82/050/00403/AM|18/|':05/23/040/0005 1/AM18/|(16.05.2017|||
|||‘Decision:|Committee|considered case|as|per|agenda|and|deliberated|on|thematter|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.|Import items|Qty. allowed|
|||||Qty.|No.|||
|||||PACLITAXEL INJECTION|Nos.|1|33.0 mg/Sm||vial|
|93|||USP|PACLITAXEL|
|||||30 mg/ml.|Sml /Vial.|USP|||
|||[PACLITAXEL INJECTION USP|hos|PA|AXEL|105.0 mg/16.67 ml /Vial.|
|||1100|mgI/ml.|16.67ml|/Vial.|||
|||[PACLITAXEL INJECTION USP|1|PACLITAXEL|273.0 mg/43.4ml|/Vial.|
|||260|megl/ml.|43.4ml|/Vial.|Nos.|
|:|USP|
|||[PACLITAXEL INJECTION USP|1|PACLITAXEL|315.0 mg/50.4ml|/Vial.|
|_|B00 mgl/ml.|SOml|/Vial.|os.|USP|
|RA may take appropriate|action|as|per the|decision|of Norms Committee|||
|-||Case|No.:371/4/82-|————_—~Parrty Name-GLENMARK|Meet|No/Date:6/82-.|Status:|
|_||ALC4/2017|PHARMACEUTICALS LTD.,|ALC4/2018|‘Approved|
|||||||26.07.2018|||
|||HQ File|© RLA File|©|~||Lic.No/Date:03|10813336|
|194 /:01/82/050/00379/AM18/|:03/94/040/00149/AM18/|17.05.2017|||
|||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|:|||
----- End of picture text -----<br>
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----- Start of picture text -----<br> | [ 1. Desonide Cream 0.05% 15em ( Net Wt. of Desonide USP Micronised (Sicor) is 0.563 Kgs) |<br>| 2. Desonide Cream 0.05% 60gm ( Net Wt. of Desonide USP Micronised (Sicor) is 2.250 Kgs)<br>, | 3. Desonide Lotion 0.05% 59ml ( Net Wt. of Desonide USP Micronised (Sicor) is 2.213 Kgs) |<br>| 4 4. Desonide Lotion 0.05% 118ml ( Net Wt. of Desonide USP Micronised (Sicor) is 2.360 Kgs) |<br>| 5. Desonide Ointment 0.05% 15gm ( Net Wt. of Desonide USP Micronised (Sicor) is 0.563 Kgs) |<br>i 6. Desonide Ointment 0.05% 60gm ( Net Wt. of Desonide USP Micronised (Sicor) is 2.250 Kgs)<br>| For the Export of1 No. Tablet |<br>| | 0.05% 0.05% | 0.05% 0.05% 0.05% 0.05% |<br>°<br>| x 15gm pack | 60gm 59ml 118ml 15gm 60gm |<br>pack pack pack pack pack |<br>| Desonide USP. 0.00765 | 0.0306 301 0.602 0.00765 | 0.0306 |<br>|<br>| l Micronised (Sicor) em om 0.301 gm sm gm gm :<br>RA may take appropriate action as per the decision of Norms Committee<br>"(Case No.:385/4/82-ALC4/2017 |Party Name: AARTI DRUGS ~ Meet No/Date:6/82- Status:<br>| ‘LIMITED ALC4/2018 ‘Approved<br>| HQFile = CSL Fille ) Lic.No/Date:0310813319 | |<br>:01/82/050/00393/AM18/ :03/94/040/00090/AM18/ (17.05.2017 | |<br>| technicalDecision: Committee consideredcase as per agenda and deliberated on the matter in the presence of the:<br>details experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per.<br>below or as applied by firm whichever is lower:<br>‘ | Export product Exp. SI.No. | Import items Qty. allowed in<br>|| Qty. kg |<br>|__| Levofloxacin Hemihydrate USP 1kg 1 2,3,4,5 Tetrafluorobenzoyl 1.20 |<br>| | Chloride |<br>| | 3 Ethyl 3nnDimethylamine | 0.641<br>Acrylate |<br>| RA may take appropriate action as per the decision of Norms Committee |<br>Ｓ‐<br>１<br>一<br>一<br>（<br>----- End of picture text -----<br>
| Case No.:53/9/82-ALC4/2017 |Party Name:VIVIMED LABS ‘/Meet No/Date:6/82(Status: | | ‘LIMITED ALC4/2018 ‘Approved | HQ File RLA File ~— Lic.No/Date:0910065060 | _ :01/82/050/00780/AM18/ |:09/24/040/00088/AM18/ | 17.05.2017 | 196_ Decision: In the light of earlier decision takenby NC in its 2/82 meeting dated 16.05.2018 it was decided to ~* vatifywhicheverthe ad-hocis lower:input output norms under para 4.7 of HBP as per details below or as applied by firm| | | Export product Exp. SI.No. | Import items Qty. allowed in | | Qty. kg | |_| HYDROXY HYDRO QUINONE __| 1kg PARA BENZO QUINONE OR 1,2,4-THB 2 VANISPERSE / 0.01 KRAFTSPERSE 1251 |
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| \RA may take appropriate action as per the decision may take appropriate action as per the decision take appropriate action as per the decision appropriate action as per the decision action as per the decision per the decision the decision decision of Norms Committee Norms Committee Committee
\RA may take appropriate action as per the decision may take appropriate action as per the decision take appropriate action as per the decision appropriate action as per the decision action as per the decision per the decision the decision decision of Norms Committee Norms Committee Committee | \Case No.:61/9/82-ALC4/2017 Party Name:PORUS —~—(Meet No/Date:6/82-. Status: ; | LABORATORIES PVT LTD =ALC4/2018 Approved | (26.07.2018 | pot | | HQFile RLA File ‘Lic.No/Date:0910065058 | :01/82/050/00788/AM18/ ':09/24/040/0004 1/AM18/ (17.05.2017 | [Decision: In the light of earlier decision taken by NC in its 4/82meetingdated 19.06.2018 it wasdecided to. | ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm. whichever is lower: | 97 | Export product Exp. SI.No. | Import items Qty. allowed | | | Qty. kg || 2-Phenyl-3,3-bis(4-hydroxy 1kg PTHALIC ANHYDRIDE [0.927 |. [aaa __| phenybpithaimide (PPP-BP) fo [preNon | | [6 | ACTIVATEDCARBON [0.200 | | CAUSTICSODALYE [231 | |RA may take appropriate action as per the decision of Norms Committee [Case No.:89/9/82-ALC4/2017 'PartyName:ORCH ——«(Meet No/Date:6/82‘Status: | | LABORATORIES INDIA PVT ALC4/2018 Approved | HQ File re IRLA File ~ ILic.No/Date:0910065055 | | :01/82/050/0081 6/AM18/ ':09/24/040/00089/AM 18/ (17.05.2017 | | | ‘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: Qty. | No. kg 8 | Export product Exp. | SI. | Import items Qty. Allowed | | [| 4-AMINO-2-OXO-PYRIMIDINYL1 kg Glyoxylic Acid 50% 0.743 || OXATHIOLANE-2-CARBOXYLIC [2 |[L()menthol| 0.751 | || ACID-ISOPROPYL-METHYLCyclohexane || CYCLOHEXYLESTER (CHE) 4 2,5-Dihydroxy-1,4-Dithiane | 0.325 | | | |6 | Hexamethyl Disilazane 0.698 | | | Methylene Dichloride [156 | | RA concerned may take further necessary action as per above decision ofNC | "(Case No.:45/9/82-ALC4/2017 |Party Name:GRANULES ‘Meet No/Date:6/82«Status: ; | INDIA LIMITED ‘ALC4/2018 Approved | 26.07.2018 | 199 | HQ File | Oo ~ IRLA File OO ~ 'Lic.No/Date:09 10065073 :01/82/050/00772/AM 18/ ':09/24/040/00074/AM 18/ (18.05.2017
38
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|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|
|details below or as applied by firm|whichever|is lower:|||
|||Export product|Exp.|||SI.No.|||Import items|Qty. allowed|in|||
|||Compresso CIP|65(Ciprofloxacin|1kg|Ciprofloxacin HCL|0.6565|
|RA may take appropriate action|as|per the|decision|of Norms Committee|
|oe|||
|~|Case No.:304/4/82-ALC4/2017|Party|Name:CIPLA|LIMITED.|[Meet|No/Date:6/82.|‘Status:|
|||||ALC4/2018|Approved|||
|HQ File|||RLA|File OO|‘Lic.No/Date:03 10813433|||||
|:01/82/050/003 12/AM18/|:03/94/040/00162/AM18/|22.05.2017|||
|||‘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:|
|100|||Export|product|Exp.|SI.No.|||Import|items|Qty.|allowed|
|Qty.|||
|||Triamist Nasal Spray (120 MD)|Number }|1|oy|;|6.732 mg/|
||||Triamcinoloneee|Acetonide.|55mcg|Triamcinolone|Acetonide|pack||||
|||Nasal Spray (120 MD)|2|PUMP VP3/100 FCS|Relevant as|||
|Each Spray delivers:|20MM|per packing|||
|_|||Triamcinolone Acetonide 55mcg|3|20ML WHITE OPAQUE|policy|||
|;|||HDPE VIAL WITH 20MM|||
|;|||NECK FINISH|||
|i||[4||NASAL ACTUATOR|||
|'RA may take appropriate|action|as|per the decision|of Norms Committee|||
|||Case No.:353/4/82-ALC4/2017 |PartyName:STERILE|INDIA|‘MeetNo/Date:6/82- (Status:||
|;|||PRIVATE LIMITED|ALC4/2018|‘Approved|—|
|HQ|File|RLA|File|Lic.No/Date:0510402657|
|/|:01/82/050/00361/AM18/|:05/24/040/00078/AM18/|22.05.2017|||
|___|Decision:|Committee|considered|case|as per|agenda and|deliberated|on|the matterin the presence of|the|||
|101|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|||
|_|_|||Qty.|||
|||MEROPENEM SODIUM STERILE|||1 kg||1|Meropenem Trihydrate (Non|||0.987 kg|||
|_|USP|Sterile)|
|||(MEROPENEM FOR INJECTION)|
|||RA may take appropriate action as per the decision|of Norms Committee|
|102___ (Case|No.:356/4/82-|[Party|Name:MAHIMALIFE|‘Meet|No/Date:6/82-|(Status:|
|ALC4/2017|SCIENCES PVT.LTD.|ALC4/2018|‘Deferred|
----- End of picture text -----<br>
39 im | HQ File RLAFile ~—~—~—~——Lic.No/Date:0510402665 Defer Date: | :01/82/050/00364/AM 1 8/ :05/24/040/00045/AM18/ (22.05.2017 | | Decision: The Committee observed that the firm neither attended the PHnor submit the details as asked | for vide Minutes of[the][ Meeting][ No.][1/82/ALC-4/2018,][dated][ 01.05.2018][(actually][ held][ on][17.05.2018][and] | | 29.05.2018), hence the Committee decided to give last opportunity to firm to attend PH and submit its | reply, failing which, its case will be rejected | ALC4/2017 (CHEMICALS PRIVATE ALC4/2018 ‘Deferred a | ‘LIMITED 26.07.2018 ~~ Lie.No/Date:0810140332 Defer Date: > HQ File RLA File | :01/82/050/00367/AM18/ :08/24/040/00530/AM17/ 23.05.2017a . | | ‘Decision: Deferred for comments of TE Oe (~~ (Case No.:46/9/82-ALC4/2017 “|Party Name:SUVEN LIFE Meet No/Date:6/82Status: fo SCIENCES LIMITED ALC4/2018 Approved — ~ Lic.No/Date:09 10065089 || | ‘HQ File RLA File | :01/82/050/00773/AM1 8/ :09/24/040/00052/AM 18/ 23.05.2017 | | ‘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 104 details below or as applied by firm whichever is lower: | | Export product Exp. SI.No. | Import items Qty. allowed in | || 1-BROMO-2-IODOBENZENE 1kg 2-BROMOANILINE RA may take appropriate action as per the decision of Norms Committee > [Case No.:57/9/82-ALC4/2017 Party Name:SUVEN LIFE _ Meet No/Date:6/82Status: | ‘SCIENCES| LIMITED ALC4/201826.07.2018 Approved| | Fs yonate-0910065000 | | | monk,a a | (01/82/050/00784/AM[1 8/] ':09/24/040/00010/AM1 8/ 23.05.2017 | ‘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’ 1105 idetails below or as applied by firm whichever is lower: Export product Exp. SI.No. | Import items Qty. allowed | | AMANTADINE Nos. 1 AMANTADINE 102 mg /100 mg | | HYDROCHLORIDE CAPSULES HYDROCHLORIDE capsule || USP 100 mg | | RA may take appropriate action as per the decision of Norms Committee ~~ (Case No.:93/9/82-ALC4/2017 [Party Name:BIOLOGICAL E Meet No/Date:6/82--—=« Status: | LTD ‘ALC4/2018 Approved HQ File RLA File Lic.No/Date:09 10065091 | ':01/82/050/00820/AM 18/ ':09/24/040/00057/AM 18/ 24.05.20ee
40
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----- Start of picture text -----<br> ‘Decision: Committee considered caseas per agenda<br>| and in thepresenceof the technical experts, it was|<br>basisdecided onlyto noratify repeat thelicence ad-hocallowed.input output norms As applied by the firm under para 4.7 of HBP one time}<br>|<br>____RA may take appropriate action as per the decision of Norms Committee<br>tec eenpegiest oe |<br>| INDUSTRIES LIMITED ALC4/2018 ‘Approved<br>- 26.07.2018 |<br>HQFile —RLAFile ‘Lic.No/Date:03 10813643 |<br>:01/82/050/00398/AM18/ :03/94/040/00132/AMI 8/ 29.05.2017<br>technicalDecision: Committee considered case as per agenda and deliberated on the matter in the presence of the|<br>107 details belowexperts or as and appliedit wasby decidedfirm whicheverto ratify theis lower: ad-hoc input output norms under para 4.7 of HBP as per |<br>| ||<br>Export product Exp. SI.No. Qty. allowed in |<br>i | 3 5% PALLADIUM ON 0.200<br>RA CARBON CATALYST |<br> may take appropriate action as per the decision of Norms Committee<br>| (Case No.:404/4/82- SS Party Name:FRESENIUS- ‘Meet No/Date:6/82- Status: |<br>| |<br>-— ALC4/2017 KABI ONCOLOGY LIMITED ALC4/2018 ‘Approved |<br>|| HOfile IRLAFile Lic26.07.2018No/Date:0510402750 | en |<br>:01/82/050/00412/AM18/ :05/23/040/00088/AM18/ 30.05.2017 | |<br>|Decision: In the light of earlier decision taken<br>| by NC in its 1/82 meeting dated 01.05.20 18 it was decided<br>whichever is lower:<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>| No.<br>;} _| | VinorelbineExport Product Qty.1 Number SL. rienIP/USPVinorelbine Tartrate IP/USP. Quantity allowed15.239 mg/ vial |<br>‘(108 _ | Injections 2 Rubber Stoppers for Relevant as per |<br>a| | 10mg/Iml. Pharmaceutical13mm Daikyo Fluorotec Article Use§2- R/S packing policy |<br>F451W D777-1.<br>Rubber Stoppers 13mm dia |<br>| |<br>; coated. |<br>| | Number Vinorelbine Tartrate IP/USP. 76.195mg/ vial<br>| Vinorelbine IP/USP<br>| |<br>|| a 2 Rubber Stoppers for Relevant as per<br>; | Pharmaceutical Article Use R/S packing policy |<br>20mm Fluorotec 1242-1888 |<br>f Rubber Stoppers 20mm dia<br>| coated. |<br>RA concerned may take further necessa action as per above decision ofNC |<br>十<br>----- End of picture text -----<br>
41
4
| Case No.:425/4/82-ALC4/2017 |Party Name:USV PRIVATE ‘Meet No/Date:6/82Status: | | LIMITED (FORMERLY USV ALC4/2018 ‘Approved ————————— LIMITED) 26.07.2018 | | HO File RLA File LicNo/Date:0310813655 | | |:01/82/050/00433/AM18/ ':03/95/040/00147/AM 18/ (30.05.2017 |[4/82][meeting][dated][19.06.2018] it was decided | | (Decision: In the light of earlier decision taken[by][ NC][ in][ its] , to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm) | whichever is lower: | 109 | | Export product Exp. SI.No. | Import items Qty. Allowed |. | | Qty. || Griseofulvin Tablets USP 500 Bottles | 1 510.0 mg | | | mg Griseofulvin USP Itablet | || (2,000 Bottles x 100 Per Bottle = |_| 2,00,000 Tablets) (Net Content | | Weight = 100.000 kgs) | | [RA may take appropriate action as per the decision of Norms Committee
[Case No.:42/9/82-ALC4/2017 Party Name:GLAND —_—(Meet No/Date:6/82-. Status: | | PHARMA LIMITED ‘ALC4/2018 ‘Approved | [HQ File ~—REAFile —————S—S~SCSCL icNoo/Dates0910065110 | :01/82/050/00769/AM1 8/ :09/24/040/00099/AM 18/ 30.05.2017 | | ‘Decision: Committee considered case as per agenda and in the presence of the technical experts, it was | decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by , ‘firm whichever is lower no repeat one time basis only:
==> picture [462 x 320] intentionally omitted <==
----- Start of picture text -----<br> | Export product Exp. Qty. Sl.No. | Import items Qty. Allowed in<br>| | kg |<br>| | Haloperidol Injection USP 400000.000 Haloperidol 2.200 kg<br>| 5mg/ml, 1ml Single dose Nos. USP |<br>i! 10 | Prefilled Syringe Barrel Syringes Relevan as per |<br>| | USP Glass packing policy |<br>| | 3 OVS Tip Caps |<br>| | Plastic |<br>; | 4 Plunger Stoppers<br>|<br>| | Rubber<br>| | 5 Plunger Rods<br>} | Plastic |<br>| | Preventis |<br>| | Plastic |<br>, | 7 Medical Grade Paper |<br>| Paper<br>Tubing Not allowed |<br>| | Plastic (Consumable)<br>| RA may take appropriate action as per the decision ofNorms Committee |<br>[Case No.:413/4/82- ‘Party Name:ALEMBIC Meet No/Date:6/82- Status:<br>| |ALC4/2017 PHARMACEUTICALS LTD ALC4/2018 Approved<br>au | | 26.07.2018 | |<br>| HQ. [File] [OO] ~ 'RLA FileOO ‘Lic.No/Date:34 10043248<br>| .01/82/050/00421/AM18/ _:34/24/040/00051/AMI8/ 31.05.2017<br>う<br>----- End of picture text -----<br>
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----- Start of picture text -----<br> 42<br>oo<br>| Decision: Committee considered case as per agenda and deliberated on the matter in the presence of the<br>|| details‘technical belowexperts or as and appliedit wasby decidedfirm whichever to ratify theis lower: ad-hoc input output norms under para 4.7 of HBP as per<br>‘Export Product<br>|| __ OlmesartanOlmesartan Medoxomil Medoxomil Tablets Tablets 510 mg mg ||<br>| | Olmesartan Medoxomil Tablets 20 mg |<br>| |<br>| _ Olmesartan +Medoxomilhetz 20mg Tablets /12.5 40 mg |<br>| — Olmesartan + hetz 20mg /25<br>_ Olmesartan + hetz 40mg /12.5 |<br>| _ Olmesartan + hetz 40mg /25 |<br>Norms |<br>Sl. allowed for Olmesartan Tablet |<br>No Export product Sl. . flowed<br>| _ Import item allowe |<br>| | 1 | Olmesartan Medoxomil Tablets 5 mg Ht | Tablets 5.10 mg /5.0 mg tablet<br>|<br>; Olmesartan Medoxomil Tablets 10 mg Tablets 10.20 mg / 10 mg tablet<br>Olmesartan Medoxomil Tablets 20 mg Tablets 20.4 mg / 20 me tablet |<br>Olmesartan Medoxomil Tablets 40 mg Tablets 40.8 mg / 40 mg tablet<br>Norms allowed for 1 kg Olmesartan Medoxomil |<br>|__| Dichloromethane [2 [270ke SS |<br>RA may take appropriate action as per the decision of Norms Committee |<br>|(Case No.:62/9/82- SS Party Name: VIRCHOW ‘Meet No/Date:6/82- Status:<br>ALC4/2017 PETROCHEMICAL PVT 'ALC4/2018 ‘Deferred<br>HQ LTD. 26.07.2018 | |<br>(112 File — RLAFie SO -[Lic.No/Date:0910065116 [Defer Date: |<br>:01/82/050/00789/AM18/ ':09/24/040/003 16/AM17/ 31.05.2017<br>Decision: The Committee observed that the firm neither attended the PH nor submit the details as asked<br>for vide Minutes ofthe Meeting No. 1/82/ALC-4/2018, dated 01.05.2018 (actually held on 17.05.2018 and |<br>29.05.2018), hence the Committee decided to give last Opportunity to firm to attend PH and submit its |<br>‘Teply, failing which, its case will be rejected |<br>_ (Case No.:71/9/82-ALC4/2017 Party Name:VIRCHOW (Meet No/Date:6/82- (Status:<br>; | PETROCHEMICAL PVT LTD. 'ALC4/2018 Deferred |<br>; | | 26.07.2018<br>HQ File RLA File ~ |Lic.No/Date:0910065113 ‘Defer Date:<br>113 |:01/82/050/00798/AM18/ :09/24/040/00590/AM17/ 31.05.2017 |<br>| ‘forDecision:vide Minutes The Committeeof observed that the firm neither attended the PH nor submit the details as asked<br>29.05.2018), the Meeting No. 1/82/ALC-4/2018, dated 01 -05.2018 (actually held on 17.05.2018 and |<br>Teply, hence the Committee decided to give last opportunity to firm to attend PH and submit its<br>failing which, its case will be rejected<br>----- End of picture text -----<br>
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----- Start of picture text -----<br> | [Case No.:87/9/82-ALC4/2017- PartyName:VIRCHOW —_—=|Meet No/Date:6/82-. Status:<br>| | PETROCHEMICAL PVT LTD. ALC4/2018 Deferred |<br>Pot 26.07.2018 | |<br>| HQ File RLA File Lic.No/Date:0910065115 Defer Date:<br>114 |:01/82/050/00814/AM18/ ':09/24/040/00606/AM17/ 31.05.2017 | |<br>| ‘Decision: The Committee observed that the firm neither attendedthe PH norsubmitthe details asasked <br>| for vide Minutes of the Meeting No. 1/82/ALC-4/2018, dated 01.05.2018 (actually held on 17.05.2018 and<br>| 29.05.2018), hence the Committee decided to give last opportunity to firm to attend PH and submit its<br>| reply, failing which, its case will be rejected |<br>/ Case No.:43/9/82- ‘(Party Name:EVEREST ~[Meet No/Date:6/82- Ss Status;<br> ALC4/2017 ORGANICS LIMITED ‘ALC4/2018 ‘Approved<br>| | | 26.07.2018 |<br>| HQ File RLA File ‘Lic.No/Date:0910065127, |<br>| :01/82/050/00770/AM 18/ ':09/24/040/00098/AM18/ = 01.06.2017 | |<br>| ‘Decision: Committee considered case as 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 of HBP as per |<br>| details below or as applied by firm whichever is lower:<br>| Export product Exp. | Sl.No. | Import items Qty. Allowed in<br>; | Qty. kg<br>| DEXLANSOPRAZOLE 1 kg 1 2,2,2-TRI FLUORO ETHANOL 4.87<br>15 LIQUID MATERIAL<br>} | 2 2,3 LUTIDINE 5.60<br>| | LIQUID MATERIAL<br>| | 3 CUMENE HYDRO PEROXIDE| 3.09<br>| | LIQUID MATERIAL<br>| 4 HYDROGEN PEROXIDE 4.76 |<br>| | LIQUID MATERIAL |<br>| | 5 METHYLENE CHLORIDE 12.50<br>; | LIQUID MATERIAL |<br>| | PIPERIDINE 1.64 |<br>| LIQUID MATERIAL<br>; | 7 ACETONE 1.25<br>; | LIQUID MATERIAL<br>| RA may take appropriate action as per the decision of Norms Committee |<br>[ase No.:488/4/82-ALC4/2017 [Party Name:V.D.H. ~~"|Meet No/Date:6/82-. Status:<br>; | ORGANICS PVT. LTD ALC4/2018 ‘Approved —<br>| | | 26.07.2018<br>| HQ File” re RLA File a | Lic.No/Date:0510403024<br>| ':01/82/050/00496/AM18/ ':05/24/040/00109/AM18/ 05.06.2017 |<br>| Decision: Committee considered case as per agenda and in the presence of the technical experts it was<br>| decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by<br>|! 16 firm whichever is lower: |<br>| | Export product Exp. | SI.No. Import items Qty. Allowed<br>| THYMOL 1kg | 1 META CERESOL 0.80 kg |<br>| (ABOVE 98% PURITY) ABOVE 98.5% PURITY<br>| IRA may take appropriate action as per the decision of Norms Committee ee<br>―<br>―<br>―<br>―<br>‐ ‐<br>―<br>― つ<br>―<br>―<br>‐<br>‐<br>―<br>―<br>―<br>―<br>―<br>―<br>′‘‘―<br>一<br>----- End of picture text -----<br>
44
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Case No.:439/4/82———PartyName:ZYTEX ——(Meet No/Date:6/82‘Status: | ALC4/2017 [BIOTECH PVT. LTD. ‘ALC4/2018 ‘Approved | | 26.07.2018 | | | Hoiinet RLA | ili, [Lic No/Date-03 10813814 | | :01/82/050/00447/AM18/ ':03/95/040/00188/AM18/ 07.06.2017 cheesea| | ‘Decision: In the light of earlier decision taken by NC in its 1/82 meeting dated 01.05.2018, it was decided | ‘117 to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is | less: | | | Item of Export Item of Import Quantity allowed kg | | | BACILLUS CEREUS (B.C.) PEPTONES 2.1 kg | _ RA may take appropriate action as per the decision of Norms Committee. ‘CaseNo.:286/4/82-ALC4/2017 PartyName:NEULAND (Meet No/Date:6/82. ‘Status: bof LABORATORIES LTD ‘ALC4/2018 ‘Approved | — HQFile LA File ; Lic.No/Date:0910065148 | | _ :01/82/050/00294/AM18/ :09/24/040/00139/AM18/ (09.06.2017 | Decision: The committee decided to ratify the norms based on the recommendation of Department of | 2 18 asPharmaceuticals applied by the vide firm letterwhichever No.35011/608/2012-PIis less:(Norms) dt. 27.12.2012 as per details given below or, | | [Export product Qty. [ Si.No.| importitems | Gay allowed | : | ENTACAPONE 1kg al 3-4,Dihydroxy 5 1.14 kg | 2 Nitrobenzaldehyde | i N,N-Diethyl 2 Cyano 1.55 kg | Acetamide 'RA may take further action accordingly. | | (Case No.:532/4/82-.—~—(Party Name:CAMPHOR Meet No/Date:6/82(Status: ALC4/2017 & ALLIED PRODUCTS ALC4/2018 Approved | | ‘LIMITED, 26.07.2018 | | HO File IRLA File iSA eeren——— T st ace =| :01/82/050/00540/AM18/ :03/94/040/00179/AM18/ 12.06.2017 | | 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: | 119 | Export product Exp. | SI.No. | Import items Qty. Allowed in ; | Qty. kg | | | BACDANOL TOCO (2-Ethy]-41 kg | | (2 2 3-Trimethylcyclopent-3-enAlpha Pinene. 1.47 | | yD- but-2-en-1-ol) N-Butyraldehyde 0.777 4 Aluminum Tri-sec0.072 || Butoxide | RA Di - N -Butylamine 0.077 | may take appropriate action as per the decision ofNorms Committee |
45
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| [Case No.:521/4/82-ALC4/2017 [Party Name:J.B. CHEMICALS Meet No/Date:6/82Status: | | | & PHARMACEUTICALS ALC4/2018 Approved — ees Ee [26.07.2018 | | | HQ File RLA File ‘Lic.No/Date:0310814019 ——::01/82/050/00529/AM18/ :03/94/040/00219/AM18/ 15.06.2017 | | 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: 79 [Exportitem «Qty. Tmportitem__| Qty. Allowed | | | Cetylpyridinium Chloride 1344000 Nos. Cetylpyridinium 1.823 kg | || Antiseptic Sugar Free Lozenges Chloride }| || with: all Flavours. | | |__| Each lozenge contains Isomalt ST-M 3553.129 kg | Cetylpyridinium Chloride 1.33 | | mg, Isomalt ST-M 2591.86 mg. | | | Net Content Cetylpyridinium || Chloride 1.787 Kgs, Isomalt ST| M 3483.46 Kgs. | | /RA concerned may take necessary action as per decision of Norms Committee. (Case No.:86/9/82Party Name:SYNTHO ~~ [Meet No/Date:6/82Status: | /ALC4/2017 (CHIRALS PVT. LTD (ALC4/2018 Approved | ~ |Lic.No/Date:09 10065178 | | HQ File RLA File | ':01/82/050/00813/AM18/ |:09/24/040/00164/AM18/ |19.06.2017 | | and deliberated on the matter in the presence of the | ‘Decision: Committee considered case as peragenda | technical representative of Department of Industrial Policy & Promotion (DIPP, Chemical) and it was. 121 decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied | \by firm whichever is lower: | | Export product Exp. Sl. No. | Import items Qty. allowed | | O-3,4,5-trifluorophenyl 1 Kg. 1. 3, 4, 5-TRIFLUOROPHENOL 0.846 kg | |_chlorothioformate | | RA concerned may take further necessary action as per above decision of NC.[Party][ Name:][ ASIATIC][ DRUGS][Meet][ No/Date:6/82-] ‘Status: / \Case[No.:447/4/82-ALC4/2017] | | '&PHARMACEUTICALS PVT. ALC4/2018 ‘Approved — | | LTD. 26.07.2018 | | HOFile eee RLAnl tig No/Date:0510403173 | | | |:01/82/050/00455/AM18/ ':05/23/040/00028/AM 18/ 20.06.2017 | ‘Decision: The Committee‘considered the 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” ‘on applied by firm whichever is lower: Export product Qty. | SL. Qty. | | No. Ampicillin Trihydrate lkg 6-Amino penicillanic acid(6-APA) 0.596 kg | | | tem 6-APA Route) D-C-Alpha phenyl glycine base(PG 0.417kg | ; | ase)
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----- Start of picture text -----<br> | |<br>RA may take appropriate action as per the decision of Norms Committee.<br>oe a|<br>| (Case No.:507/4/82-ALC4/2017 Party Name:CAMPHOR & ‘Meet No/Date:6/82- ‘Status: |<br>ALLIED PRODUCTS ALC4/2018 Approved<br>— HQFile RLA File Lic.No/Date:03 10814175 | |<br>:01/82/050/00515/AM18/ :03/94/040/00230/AM18/ 21.06.2017 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>(123 | Export product Exp. | SLNo. Import items Qty. Allowed in<br>|| | Qty. kg<br>_ | BACDANOL TOCO (2-Ethyl-4- | 1 kg 1.47<br>| | (2 2 3-Trimethylcyclopent-3-en- @ipha PFimene<br>| yl)- but-2-en-1-ol) N-Butyraldehyde 0.777 |<br>| | 4 Aluminum Tri-sec- 0.072 |<br>|<br>; Butoxide |<br>| Di - N -Butylamine 0.077 |<br>RA may take appropriate action as per the decision of Norms Committee<br>(Case No.:523/4/82- SS Party Name:CORAL ‘Meet No/Date:6/82- ‘Status:<br>_ ALC4/2017 LABORATORIES LTD., ‘ALC4/2018 ‘Approved |<br>| | 26.07.2018 |<br>HQ File RLA File _ ‘Lic.No/Date:03 10814172 |<br>_ :01/82/050/0053 1/AM18/ :03/94/040/00203/AM18/ 21.06.2017 | |<br>| Decision: Committee considered caseas peragenda<br>and deliberated on the matter in<br>technical the Presence of the<br>details belowexpertsor as andappliedit was by decidedfirm whicheverto ratify the [is] lower: ad-hoc input output norms under para 4.7 of HBP as per<br>124| |/and[EXPORTAugmathex PRODUCT281.25: Augmathex,Oral Suspension 457,1 No. Augmathexbottle, 156.25, Augmathex 312.50, Augmathex 228.50 i|<br>For Export of N No. bottle i<br>| No. Augmathex Augmathex | Augmathex Augmathex | Augmathex<br>| | i 57 Suspension| 156.25. 312.50 : 228.50: 281.25<br>; | Amoxicillin Suspension Suspension Suspension Suspension. |/i<br>(Plain)Trihydrate BP 5.88 gm 2.625 gm 3.15 gm 2.94 gm 3.15 gm<br>| | Potassium Clavulanate 1.98 |<br>| | 2 With Silicon Dioxide _ [1-98 gm 1551gm /1.861gm —-|0.99gm_ —_—|0.93 gm |<br>| RA may take appropriate action as per the decision ofNorms Committee |<br>| (Case No.:558/4/82- ‘Party Name:TITAN [Meet No/Date:6/82- (Status: SS<br>(125 ALC4/2017 ‘LABORATORIES PVT. 'ALC4/2018 Approved |<br>「<br>つ<br>----- End of picture text -----<br>
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|47|
|||HQ File|RLAFile|=|——_Lic,No/Date:0310814205,|||
|||:01/82/050/00566/AM|1 8/|:03/95/040/00260/AM|1 8/|22.06.2017|
|[the]|[matter][ in][ the][ presence of][ the]|[|]|
||||Decision:|Committee|considered|case as per|agenda|and deliberated|[on]|
|||‘technical|experts and|it was|decided to|ratify|the|ad-hoc|input|output|norms|under para 4.7|of HBP|as|per.|
|details below or as applied by|firm whichever|is|lower:|||
|;|||No.|||
|||||| PREGABALIN|IR|1|kg|0.2525|kg|
|||PELLETS|25 %|PREGABALIN|
||||||PREGABALIN|IR PELLETS|1|0.505|kg|
|||||50 %|1|kg|PREGABALIN|
|||
|||||[PREGABALIN|IR PELLETS|0.7575|kg|
|||||f5%|kg|PREGABALIN|
|||[RA concerned may|take further necessary action as|per above decision ofNC|||
|[|[Case|No.:561/4/82-|Party|Name:YASHO|—_—s(Meeet No/Date:6/82-|‘Status:|
||||ALC4/2017|INDUSTRIES PVT.LTD.|\ALC4/2018|Approved|
|,|||||26.07.2018|||
|7|~IRLAFile|_ ‘Lic.No/Date:031081421|1 ||
|||HQ|File|
|||':01/82/050/00569/AM18/|':03/95/040/00266/AM18/|22.06.2017|||||
|||‘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.|
|L196|details below or as applied by firm whichever|is lower:|
|||Export product|Exp.|||SI.No.|||Import items|Qty.|Allowed|
|||||Qty.|||
|||DI-OCTYLATED|lkg|||1|DIPHENYLAMINE|0.50|kg|
|||DIPHENYLAMINE( YALUB|||
|}|||Popra)|DI-ISOBUTYLENE|0.64 kg|||
|||ACTIVATED CLAY|0.1 ke|||
|||‘RA may take appropriate|action as per the decision of|Norms Committee|||
|/|~~|\Case No.:49/9/82-|Party Name: HETERO|[Meet No/Date:6/82-.|«Status:|
|||(ALC4/2017|LABS LIMITED|'ALC4/2018|Approved|
|||HQFile|re|'RLA|File|OO|‘Lic.No/Date:09 10065201|||
|||':01/82/050/00776/AM|18/|':09/24/040/00178/AM18/|22.06.2017|
|||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’|
|127|details below or as applied by firm whichever|is lower:|||
|||||Export product|Exp.|||SI.No.|Import|items|Qty.|Allowedin|
|||||Qty.|kg|
|||||||5-O-Trityl5-O-Trityl|--|2,3-anhydrothymidine2,3-|drothymidi|1kg|ft1|||Seiathyntidine|0.600|
|||||Triethyl amine|0.79|
----- End of picture text -----<br>
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— = see <= =I -Souk = | | Methane sulfonyl chloride | 0.310 | | | 5 Tetrabutyl ammonium 0.035 bromide | RA may take may take take appropriate action as per the decision of per the decision of the decision of decision of of Norms Committee
RA may take may take take appropriate action as per the decision of per the decision of the decision of decision of of Norms Committee oe|
| Case No.:52/9/82-ALC4/2017 Party Name:VIRCHOW [Meet No/Date:6/82. ‘Status: | PETROCHEMICAL PVT LTD. ALC4/2018 Deferred | | 26.07.2018 | |- 128 HQFile:01/82/050/00779/AM18/—RLAFile:09/24/040/00040/AM18/} ‘Lic.No/Date:091006519622.06.2017 |Defer Date: || ‘Decision: The Committee observed that the firm neither attended the PH nor submit the details as asked | for vide Minutes of the Meeting No. 1/82/ALC-4/2018, dated 01.05.2018 (actually held on 17.05.2018 and | || 29.05.2018), hence the Committee decided to give last opportunity to firm to attend PH and submit its| ‘reply, failing which, its case will be rejected | (Case No.:67/9/82-ALC4/2017 |PartyName:TAGOOR (Meet No/Date:6/82. “Status: | | 'CHEMICALS ‘ALC4/2018 Approved | oe RLA ———eee ie NoDEpIOGnE Le -——— | ~:01/82/050/00794/AM18/ :09/24/040/00136/AM18/ 22.06.2017 | | 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 | No. | 1-(3-Chloropropyl)1,3lkg Ortho phenylene Di amine | 1.00 kg | | | 2-OneDihydro-2H-benzimidazoleMethyl Aceto acetate f0.90kg> sd | ; | 1-Bromo 3-chloro propane 1.17 kg | IRA concerned may take further necessar action as per above decision ofNC | | ‘ALC4/2017 LABS LIMITED ALC4/2018 ‘Approved ; | | 26.07.2018 | | HQ File RLA File ‘Lic.No/Date:09 10065202 | | :01/82/050/00809/AM18/ :09/24/040/00179/AM18/ 22.06.2017 | | Decision: Committee considered case as per agenda and deliberated on the matter in the presence of the | 130 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 in |__| (2R-cis)-5-(4-amino-1,2-dihydro- | 1 kg | 1 . 0.743 | | 2-oxo-1-pyrimidinyl)-1,3Glyoxylic acid 50% | | | oxathiolane-2-carboxylic Sodium bisulphite 0.60 | | _ L2cid(2S,5R)-Methyl ester. 2,5-dihydroxy-1,4-dithiane | 0.325 |
49
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| | Triethyl amine 0.034 i | | [6 Methane sulfonic acid 0.017 | Dimethy! formamide 0.26 | [9 Hexamethy! disilazane 0.698 ] | | P| Methylene dichloride 2.63 | RA may take appropriate action as per the decision of Norms Committee | (Case No.:85/9/82-ALC4/2017 Party Name:TAGOOR _[Meet No/Date:6/82-. Status: | | (CHEMICALS 'ALC4/2018 Approved | ; | | 26.07.2018 ~ [Lie.No/Date:0910065198 | HQ File RLA File | :01/82/050/00812/AM18/ :09/24/040/00137/AM18/ (22.06.2017 | ‘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: 131] | | | Export Product Qty. Sl. | Import items Quantity allowed in | | | No. kg || | 5-Chloro-1-Piperidine-4-yl- | I kg Methyl Acrylate | | | 1,3-Dihydro-2HEthyl chloro formate |_| | Benzimidazole-2-One 3 | 2,5 Dichloro Nitro 2.27 | | Benzene | | RA concerned may take further necessary action as per above decision of NC
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----- Start of picture text -----<br> LABS |Meet No/Date:6/82- Status:<br>[~~ (CaseNo.:88/9/82-ALC4/2017 Party Name:VIVIMED<br>| | ‘LIMITED \ALC4/2018 ‘Approved |<br>| | | 26.07.2018 | |<br>| |HQFile ~ RLAFile =—————S—S—SCLic.No/Date:0910065206<br>| :01/82/050/00815/AM18/ ':09/24/040/00141/AM18/ (22.06.2017 |<br>| ‘Decision: In the light of earlier decision taken by NC in its 14/82 meeting dated 24.10.2013, it was decided |<br>| ‘to ratify norms under Para 4.7 of HBP vl as per details given below or as applied by the firm, whichever is |<br>| less:<br>| | Export product Exp. S.No. | Import items Qty. allowed |<br>| | Qty.<br>132 | REVERSACOL 1 kg 4,4 DIMETHYL BENZOPHENONE | 1.400 kg |<br>| | OCEAN BLUE<br>| | DIMETHYL SUCCINATE 4.000 kg<br>| | SODIUM ACETATE 0.600 kg |<br>| | ETHANOL 6.00 kg |<br>| 5. TRIMETHYL SILYL ACETYLENE | 0.800 kg<br>| | (TMSA) |<br>| | aa SIRALOX 1.200 kg |<br>つ<br>----- End of picture text -----<br>
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; | aa TETRA HYDRO FURAN (THF) 9.000 kg | | aa METHANOL 15.000 kg | | | ca HEXANE 3.000 kg | ‘RA may take appropriate action as per the decision of Norms Committee. hee | | (Case No.:51/9/82-ALC4/2017 Party Name:VIRCHOW Meet No/Date:6/82‘Status: | , og PETROCHEMICAL PVT LTD. |ALC4/2018 Deferred | ; | | 26.07.2018 | | ae = ae REA| ieee Fic Nomeinosiooeent [Defer Date: | 133 :01/82/050/00778/AM18/ ':09/24/040/00078/AM18/ 23.06.2017 | Decision: The Committee observed that the firm neither attended the PH nor submit the details as asked | 29.05.2018),for vide Minutes ofthe Meeting No. 1/82/ALC-4/2018, dated 01.05.2018 (actually held on 17.05.2018 and | | hence the Committee decided to give last opportunity to firm to attend PH and submit its | reply, failing which, its case will be rejected i | Case No.:91/9/82-ALC4/2017 |Party Name:SUVEN LIFE Meet No/Date:6/82(Status: | | ‘SCIENCES LIMITED ALC4/2018 Approved | HQ 26.07.2018 | File —RLA File Lic. No/Date:0910065217 | | :01/82/050/00818/AM18/ ':09/24/040/00154/AM18/ (23.06.2017 | | | Decision: In the light of earlier decision taken by NC in its 14/82 meeting dated 31.07.2012 it was decided __ | to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm| whichever is lower: | Export Product Qty. Sl. | Import items Quantity allowed in 1,2,3,5-TETRA-ONo. kg | | 1 kg D-RIBOSE P1230 | ACETYL-B-DISO PROPYL ALCOHOL [3.1200 Os], | RIBOFURANOSE 3 0.35 | | RA concerned may take further necessar action as per above decision of NC | po| (Case No.:513/4/82-ALC4/2017 Party Name:BELCHEMINDS. [Meet No/Date:6/82. ‘Status: INDIA PVT. LTD. /ALC4/2018 ‘Approved | | HQ File RLA File ‘Lic.No/Date:0310814264 [| _ :01/82/050/00521/AM18/ ':03/94/040/00254/AM18/ 27.06.2017 | | 135 Decision: Committee considered case as per agenda and in light of decision taken in meeting no.12/82_ ~ ‘dated 20.03.2018, decided to ratify 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 | 1-3,DIMETHYLOL-5,5-DIMETHYL |1 kg i. 5,5 Dimethyl 0.382 kg [HYDANTOIN (DMDM Hydantoin Hydantoin Assay | 62%-55%) Assay 55% Max. min.99%ColourPure |
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|
iePACTS HAY>RT
| ‘A may take appropriate action as per the decision of Norms Committee. | ~~ (Case No.:538/4/82-ALC4/2017 [Party Name:REANNON Meet No/Date:6/82-. Status: | | PHARMACEUTICALS ‘ALC4/2018 ‘Approved — HQ File RLA File ‘Lic.No/Date:03 10814437 | .:01/82/050/00546/AM18/ :03/95/040/00288/AM1 8/ (04.07.2017 | | Decision: Committee considered case as per agenda and and in the presence of the technical experts, it '136 Was decided to ratify 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. Qty. Qty. Allowed[|][ 400000] 1 APROTININ 0.896 kg | | INJECTIONS (RENONTRIKAL[/] | | KONTRISTAT / APROKAL) vials | RA may take appropriate action as per the decision ofNorms Committee | "Case No.:460/4/82-ALC4/2017, Party Name:HERBOCHEM Meet No/Date:6/82Status: en INDUSTRIES ALC4/2018 Deferred | | HQ File RLAFile - ‘|Lic.No/Date:0610038656 Defer Date: 137 ':01/82/050/00468/AM18/ :06/24/040/00013/AM18/ 05.07.2017 | | | Decision:following Committeeinformation considered the case as per agenda and it was decided to call from the firm | | i. complete technical details as per appendix 4E 6 i Molecular of weight and % of yield | | | iii. Production and consumption data certified by central excise authority or CA | | [Case No.:481 /4/82.ALC4/2017 [Party Name:DALAS BIOTECH [Meet No/Date:6/82‘Status: | | | ‘LTD. ‘ALC4/2018 ‘Approved | | | | 26.07.2018 | | Ho Filehe — Lie NovDate:0510403357 | | |:01/82/050/00489/AM18/ ':05/23/040/00040/AM 18/ (07.07.2017 | | Decision:In the light of earlier decision taken by NC in its 3/82 meeting dated 05.06.2018, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm | (138 whichever is lower: | | | Export product Exp. | SI.No. | Import items Qty. Allowed |, | | Qty. inkg |_| DC) P-HYDROXY PHENYL lkg | 1 D (-) Para Hydroxy Phenyl 1.025 | | | GLYCINE METHYL ESTER Glycin Base | | RA may take appropriate action as per the decision of Norms Committee | |Case No.:516/4/82-ALC4/2017 Party Name:WANBURY ‘Meet No/Date:6/82Status: | | LIMITED ‘ALC4/2018 ‘Approved | | HQ File RLA File Lic.No/Date:03 10814571 | :01/82/050/00524/AM18/ :03/95/040/00306/AM18/ 12.07.2017, |
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_ _ toDecision: In the lightof earlier decision taken by NC in its 16/82 meeting dated 23.01.2015, it was decided _ whicheverratify theis ad-hoclower: input output norms under para 4.7 of HBP as per details below or as applied by firm | | | | | Export product Exp. SLNo. Import items Qty. allowed kg | | Qty. P| _ | HYDROCHLORIDE ISOPROPYL ALCOHOL | D MANDELIC ACID 0.392 [RA may take appropriate action as per the decision of Norms Committee. oe | — _ (Case No.:470/4/82-——~(PartyNName:RONAK ‘Meet No/Date:6/82(Status: | | i ALC4/2017 (CHEMICALS ‘ALC4/2018 Approved | '26.07.2018 | | ee = aAae ‘Lic No/Date:3410043342 | | /-:01/82/050/00478/AM18/ :34/24/040/00080/AM18/ 18.07.2017 Decision: | _ , Committee considered case as per agenda and and in the presence of the technical experts, it 140 Was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as | applied by firm whichever is lower: | | Export Product Qty. Sl. | Import items Quantity allowed in | fof No. kg | RA concerned may take further necessary action as per above decision ofNC l (ees Party NamesaManube canree | | ‘SURFACTANTS PVT.LTD. ‘ALC4/2018 ‘Approved | | | 26.07.2018 | | HQ File RLA File LLic.No/Date:0310814753 | | :01/82/050/00559/AM18/ :03/95/040/00224/AM18/ 21.07.2017 | | (141 Decision: Committee considered case as per agenda and in the presence of the technical experts, it was | _ firmdecidedwhichever to ratifyis thelower:: ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by| |_ | Export product Exp. | SI.No. Qty. Allowed inkg — | | _ | Qty. | | SORBITAN MONO OLEATE 1 kg Sorbitol 70% Solution | 0.425 kg | RA Oleic Acid 0.658 kg | may take appropriate action as per the decision of Norms Committee | | (CaseNo.:483/4/82-ALC4/2017 Party Name:CURETECH [Meet No/Date:6/$2. ‘Status; ; | SKINCARE ‘ALC4/2018 ‘Approved HQ File RLA File \Lic.No/Date:2210015742 | | | 142 :01/82/050/00491/AM18/ ':22/24/040/00004/AM18/ (24.07.2017 | decidedDecision: Committee considered case as per agendaand in the presenceof the technical experts, it was basis onlytonoratifyrepeatthelicencead-hocallowed.input output norms As applied by the firm under para 4.7 of HBP one time,
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L _IRA may take appropriate action as per the decision of Norms Committee
Case No.:500/4/82-ALC4/2017 [Party Name:RECKITT _|Meet No/Date:6/82Status: ; | BENCKISER HEALTHCARE ‘ALC4/2018 ‘Approved pol INDIA PRIVATE LIMITED 26.07.2018 | ~— [Lie.No/Date:0510403484 | | | HO .Bile RLA File | ':01/82/050/00508/AM18/ ':05/24/040/00148/AM18/ (24.07.2017 | | 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 | | | Nurofen For Children | 1 kg Ibuprofen 17.41 | | Tween 80 (Polysorbate 80) 0.0862 | | Lycasin 80/55 (Maltotol) 383.793 | l a | Saccharin Sodium 40/80 1.724 1143 | 6. ___ | Citric Acid Monohydrate 3.448 | | | Tri Sodium Citrate Dihydrate 4.388 | | (9. | Sodium Chloride 0.984 | | | Domiphen Bromide (BP) 0.0862 ; | 12 987 PP28mm M-LOC H&A White Relevant as per || | T/E packing policy i | | 13 DEVC,NURFN,GB,ORAL | | SUSPENSION (Syringe) | | INSR,NUREN.NN PASTIC PLUGS | | | NFC2 Percent Paper labels | | | NFC2 Percent Paper Leaflets | | | NFC2 Percent Mono cartons || | ‘RA may take appropriate action as per the decision of Norms Committee. [Case No.:549/4/82-ALC4/2017 Party Name:ROYAL PHARMA [Meet No/Date:6/82Status: | | | ALC4/2018 ‘Approved | | HQ File ~ RL File OO ~_Lic.No/Date:0310814834 | | ':01/82/050/00557/AM 18/ ':03/95/040/00345/AM 18/ 25.07.2017 ‘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. | Qty. Allowed in | | | BICALUTAMIDE SULFIDE 1kg. | 1. N-[4-CY ANO-3- (TRIFLUORO | 0.709 | | CHEMICAL NAME: N-[4METHYL) PHENYL] ; | METHACRYLAMIDE
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| | METHYL)PHENYL]-3-[(42. 0.30 | | | FLUOROPHENYL THIO)] -24- FLUOROTHIOPHENOL i| || PROPIONALIDEHYDROXY-2-METHYL | | RA may take appropriate action as per the decision of Norms Committee || ee | Case No.:482/4/82-. (Party Name:JODAS EXPOIM [Meet No/Date-6/@. ‘Status: | ‘ALC4/2017 PVT.LTD., ‘ALC4/2018 ‘Approved | | | 26.07.2018 | HQFile RLAFile ==———LLic. No/Date:05 10403522 | | | :01/82/050/00490/AM18/ :05/23/040/00170/AM 18/ 27.07.2017 | 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: | 145 | Export product Exp. SI. Import items Qty. allowed | | Qty. No. | LEVOSIMENDAN Nos. 1 RELEVANT BULK DRUG | 13.75 mg/5ml vial | |__| INJECTION USP 2.5mgl/ml. LEVOSIMENDAN | | 5ml /Vial. | | | RELEVANT BULK DRUG | 97. 10 ml /Vial. JUSP|LEVOSIMENDAN2.5mgI/ml. 10ml INJECTION/Vial. os. LEVOSIMENIAN 50 mg/10 ml /Via | | | RA may take appropriate action as per the decision of Norms Committee | | (Case No.:530/4/82-. ————~*(Party Name: MALLADI ‘Meet No/Date:6/82- (Status: i ALC4/2017 ‘DRUGS & ALC4/2018 ‘Approved | ‘PHARMACEUTICALS 26.07.2018 | | | | ‘LIMITED | | | | HQFile RLAFile - |Lic.No/Date:0410163381 | | :01/82/050/00538/AM18/ ':04/24/040/00079/AM18/ 28.07.2017 | | |Decision: In the light of earlie decision taken by NC in its 3/82 meeting dated05.06.2018 it was decided to, whichever is lower : | ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm | | | Pyrrolidine Nor Ephedrine or | Ikg |! [ Propiophenone «3.21, (1R,2S)-Pyrrolidinyl nor }2 [Bromine«a3 | Causticsoda Flakes [5.98 | IRA concerned may take further necessary action as per above decision ofNC
147 Case No.:537/4/82‘Party Name:USV PRIVATE Meet No/Date:6/82- (Status: “| ___ ALC4/2017 ‘LIMITED (FORMERLY USV 'ALC4/2018 ‘Approved |
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LIMITED) [26.07.2018 | HQeceerneersemcmammecenee File RLA File ‘Lic. No/Date:03 1087aa sisi | :01/82/050/00545/AM18/ :03/95/040/00358/AM18/ 31.07.2017 | ‘Decision: Committee considered case as per agenda and deliberatedon thematterin 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. Import items Qty. allowed | ; | aty. No. | | Desipramine Hydrochloride Nos. 1 . . 51.0 mg/50 me tablet | |__| Tablets, USP 50 MG Des ernie | [Desipramine Hydrochloride : Desioraming 102.0 mg/100 mg tablet | | | ablets, USP 100 MG HCL | | [Desi i i | | | pramine Hydrochloride . : 153.0 mg/150 mg tablet | Ifablets, USP 150 MG os. Desipramine | | | HCL | | _ RA may take appropriate action as per the decision of Norms Committee | / (Case No.:531/4/82=== Party Name:-MALLADI ‘Meet No/Date:6/82Status: | ALC4/2017 (DRUGS & (ALC4/2018 Approved | | PHARMACEUTICALS 26.07.2018 | | | (LIMITED | _ - Lic.No/Date:0410163391 | HQ File RLA File | :01/82/050/00539/AM18/ ':04/24/040/0009 1/AM18/ 01.08.2017 case as per agenda and deliberated on the matter inthe presence of the. | (Decision: Committee considered | _ 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 148 | S i ||H | d-Threo Ritalinic Acid Hel Ikg 2-Chloro Pyridine | | Benzyl Cyanide | | Potasium Hydroxide 15.52 | | Dimethyl Sulphoxide 15.00 | | | Iso Propyl Alcohol [2.00 |;|| [6[_|][Dichloromethane] | ||RA concerned may take further necessary action as per above decision of NC | [Case No.:100/9/82-ALC4/2017 |Party ‘Name:CHEMCON _Meet No/Date:6/82‘Status: ; | SPECIALITY CHEMICALS —ALC4/2018 Approved | | PVT LTD (26.07.2018 | HQ File.—RLA FileLig. No/Date:3410043411 | | |:01/82/050/00827/AM 18/ :34/24/040/00069/AM 18/ 29.08.2017 | ly 49 ‘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 HBPasper | | details below or as applied by firm whichever is lower: | Export product Exp. Qty. Qty. allowed | | CHLOROMETHYL 1 kg METHYLCHLORO 0.943 kg | ISOPROPYL CARBONATE FORMATE
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RA may take appropriate action as per the decision of Norms Committee
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|||Case No.:97/9/82-ALC4/2017|Party|Name:|VERGO|PHARMA |Meet No/Date:6/82-|Status:|||
|;|||RESEARCH|ALC4/2018|Approved|—|
|||||LABORATORIES PVT. LTD.,|26.07.2018|||||
|||mone coca an RLA|File pote|eae ce|LSNE|al|||
|||:01/82/050/00824/AM|18/|:17/24/040/00046/AM18/|05.09.2017|I|_||
|Decision:|Committee|considered|case as per|agenda|and|deliberated|on|the|matter|in|the|presence|of the|
|technical|||
|||details|belowexpertsor|asandappliedit wasbydecidedfirm|whicheverto|ratify|isthelower: ad-hoc|input output norms under para 4.7|of HBP as|per|||
|‘150|||Export product|Exp.|Import items|Qty.|allowed|
|LIOTHYRONINE SODIUM 20MCG|NGS.|SOpIUN|Ne|20 ANCHO|wricg|
|_|TABLET,|tablet|||
|||NET CONTENT OF IMPORT ITEM|-|||
||__||LIOTHYRONINE SODIUM- 0.02mcg FOR|||
|||||EACH TABLET|||
|RA may take appropriate|action|as|per the|decision|of Norms Committee|
|(Case|No.:98/9/82-ALC4/2017|Party|Name:SAVANNAH|Meet|No/Date:6/82-|(Status:|
|||SURFACTANTS|LTD.,|/ALC4/2018|‘Approved|||
|HQ|File|RLA|File|‘Lic.No/Date:1710006664|||||
|—:01/82/050/00825/AM18/|:17/24/040/00049/AM 18/|08.09.2017|
|__|Decision:|Committee considered|case as per agenda and deliberated|on the matterin the presence of|the|||
|technical|experts and|it was decided to ratify the ad-hoc|input output norms under para 4.7 of|HBP as per|
|||details|below or as applied by|firm|whichever|is|lower:|
|[151]|Export product|Exp.|Sl.|Import items|Qty. allowed|||
|i|Qty.|No.|
|||||SODIUM STEAROYL|1kg|1.|a. ACID, MASCID|0.33 kg|||
|||LACTYLATE (SSL)|||
|;|
|||
|||2|TRIPLE PRESSED STEARIC|||0.33 kg|||
|ACID MASCID|1801|||
|RA may take|appropriate|action|as per the decision|of Norms Committee|
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| (Case No.:101/9/82-ALC4/2017 (Party Name:NROILS ‘Meet No/Date:6/82(Status: | ‘ALC4/2018 ‘Approved ‘159 HQ File RLA File ‘Lic.No/Date:3410043460 | :01/82/050/00828/AM18/ :34/24/040/00113/AM18/ (11.09.2017 | | ‘toDecision: In the light of earlier decision taken by NC in its 4/82 meeting dated 19.06.2018it was ¢decided ratify 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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RA may take appropriate action as per the decision of Norms Committee | "Case No.:104/9/82-ALC4/2017 Party Name:RONAK —(Meet No/Date:6/82-. Status: | | (CHEMICALS ALC4/2018 Approved 26.07.2018 | | HQ File RLA File Lic.No/Date:3410043478 | | :01/82/050/0083 1/AM18/ ':34/24/040/00138/AM18/ (18.09.2017 | | ‘Decision: Committee considered case as per agenda and deliberated on the matter in the presence ofthe | | 153 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: | 1 |_| SODIUM 2 - ETHYL 1 kg 1 2- ETHYL HEXANOIC | 0.912 kg | | HEXANOATE ACID | | RA may take appropriate action as per the decision of Norms Committee |
| |CaseNo.:7/9/82-ALC4/2017 Party Name:CATAPHARMA Meet No/Date:6/82-. Status: ; | \CHEMICALS PVT. LTD. ALC4/2018 Approved | | | 26.07.2018 | | ~~ RLAFile Lic.No/Date:3 1 10066876 | HQFie | ':01/82/050/00734/AM 18/ '31/83/040/00141/AM17/ 20.09.2017 | ‘Decision: Committee considered case as per agenda and deliberated onthe 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| 154 details below or as applied by firm whichever is lower: | | Export product Exp. Qty. Qty. Allowed | | N- Methyl Piperazine (Pharma | 1kg 1 ; . 1.01 kg i | . N - Methyl Piperazine of | || Grade) of purity not less than . 0 i | purity not more than 98%. | [RA may take appropriate action as per the decision of Norms Committee [Case No.:15/9/82-ALC4/2017 ‘PartyName:PARAMOUNT —_ Meet No/Date:6/82- Status: ; | AROMACHEM PRIVATE ALC4/2018 Approved — | | LIMITED 26.07.2018 | HQ File © RLA File ~ Lie,No/Date:0510404104 | ':01/82/050/00742/AM 18/ :05/24/040/00279/AM 18/ (25.09.2017 | | Decision:In the light of earlier decision taken by NC in its 2/82 meeting dated 16.05.2018 it was decided[|] | to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm pS whichever is lower:
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----- Start of picture text -----<br> | | L-CARVONE 1kg 1 D-LIMONENE 1.9 kg |<br>| (LIMONENE, CITRUS |<br>| | TERPENE, ORANGE |<br>| TERPENE, BRAZALIAN<br>| | CITRUS<br>----- End of picture text -----<br>
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| | CITRUS TERPENE | | RA may take appropriate action as per the decision of Norms Committee a | | (Case No.:109/9/82-ALC4/2017 Party Name:ASTRAL (Meet No/Date:6/82Status: | bo | 'STERITECH PVT. LTD. ALC4/2018 Approved | | (26.07.2018 | | HO = mes a): an (LieN a PY TEYCT | | | :01/82/050/00836/AM18/ :34/24/040/00166/AM18/ 26.09.2017 | | _ ‘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 | ‘156 details below or as applied by firm whichever is lower: | Export product Exp. Import items Qty. Allowed | | | Ceftriaxone Sodium for injection USP 1 gm | Nos. | STERILE CEFTRIAXONE | 1.16 gm per | | (Total qty 140000 vials of 1gm, Net content SODIUM USP vial | 140 Kgs) | | (Each vial contains ceftriaxone Sodium | | gm) | ‘RA may take appropriate action as per the decision of Norms Committee | | CaseNo.:110/9/82-ALC4/2017 |PartyName:SONGWON ‘Meet No/Date:6/82Status: | a SPECIALTY CHEMICALS ‘ALC4/2018 ‘Deferred } | INDIA PVT. LTD. 26.07.2018 9 [HO File eterna RAKE ticki eas Defer es _ :01/82/050/00837/AM18/ :34/24/040/00167/AM18/ 27.09.2017 Decision: Committee considered the case as per agenda and it wasdecided to call from the firm Chemistry, ‘Molecular weight and recovering percentage of yield on methyl isobutyl Keton (MIBK) | Case No.:16/9/82-ALC4/2017 Party Name:PCL OIL & ‘Meet No/Date:6/82Status: | SOLVENTS LTD. /ALC4/2018 ‘Approved | | | 26.07.2018 | HQ File RLA File (Lie. No/Date:0510404164 | | :01/82/050/00743/AM18/ :05/24/040/00271/AM18/ '03.10.2017 | | | ‘technicalDecision: Committee considered caseas peragendaand deliberated on the matter in the presence of the 158 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 | | | 1kg Phthalic Anhydride 0.355 | ; |] Plasticizer ((DINP ) Iso Nonyl Alcohol 0.726 | | RA may take appropriate action as per the decision of Norms Committee |159 Case No.:17/9/82-ALC4/2017 |Party Name:PCLOIL& [Meet No/Date:6/82Status: Pt SOLVENTS LTD. ALC4/2018 Approved —
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| HQ File RLA File ‘Lic.No/Date:0510404163 | 101/82/050/00744/AM18/ :05/24/040/00261/AM18/ (03.10.2017 | | Decision: Committee considered case as per agenda and deliberated on the matter in the presence ofthe 7 | | ‘technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per idetails below or as applied by firm whichever is lower: | | Export product Exp. SI.No. | Import items Qty. allowed | | 1kg Phthalic Anhydride 0.355 | | | Plasticizer (DINP | [RA may take appropriate action as per the decision of Norms Committee | ~~ [Case No.:14/9/82-ALC4/2017 |Party Name:PCLOIL& Meet No/Date:6/82Status: ; | SOLVENTS LTD. ALC4/2018 Approved | ~~~ LLic.No/Date:0510404191 | HQ File RLAFile | (0 1/82/050/00741/AM18/ ':05/24/040/00280/AM18/ (04.10.2017 | Decision: Committee considered case as per agenda 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 of HBP as per | ne0 details below or as applied by firm whichever is lower: | | | Export product Exp. SI.No. | Import items Qty. allowed | | 1kg Phthalic Anhydride 0.355 _ | Plastici DINP | |RA may take appropriate action as per the decision of Norms Committee | | (Case No.:21/9/82-ALC4/2017 Party Name:PCL OIL& Meet No/Date:6/82“Status: — | | ‘SOLVENTS LTD. (ALC4/2018 Approved | | (26.07.2018 ~ [Lic.No/Date:05 10404193 | HQ File “(RLAFile | ':01/82/050/00748/AM 18/ :05/24/040/00284/AM18/ (04.10.2017 | ‘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 | | L161 details below or as applied by firm whichever is lower: por | | | Export product Exp. SI.No. | Import items Qty. allowed | | | Qty. | | 1kg Phthalic Anhydride 0.3797 kg | | || HIRACIZERPlasticizer |(DOP) 2 Ethyl Hexanol 0.7008 || |RA may take appropriate action as per the decision of Norms Committee | (CaseNo.:3/9/82-ALC4/2017 Party Name:STRIDES ———-Meet No/Date:6/82‘Status: 1162. 'SHASUN LIMITED ALC4/2018 ‘Approved — } | | 26.07.2018
60
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| fH = = A ees LONE Ts 163566 —— — | :01/82/050/00730/AM18/ :04/24/040/00131/AM18/ (05.10.2017 | | **** Decision: In the light of earlier decision taken by NC in its 4/82 meeting dated 19.06.2018, it was decided | to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm | _ whichever is lower: | | | Export Product Export S.No | Import Product Quantity Allowed | ; | Quantit | | | POTASSIUM CITRATE Number TRIPOTASSIUM | 550.8 mg/ 5 mEq /540 | | EXTENDED - RELEASE CITRATE USP mg tablet | | TABLETS USP S5mEq - 540MG | _ | NET API CONT:572.400MG/ | | PER TABLETS INCL WASTAGE | | POTASSIUM CITRATE Number | 2 TRIPOTASSIUM| 1101.6 mg/ 10 mEq /1080 | | EXTENDED RELEASE CITRATE USP mg tablet | |__| TABLETS USP 10mEq - 1080MG | || || NETTABLETAPI INCLCONT: WASTAGE.1144.8MG/ PER | | | POTASSIUM CITRATE Number | 3 TRIPOTASSIUM| 1652.4 mg/ 15 mEq /1620 |, | | EXTENDED RELEASE CITRATE mg tablet | TABLETS USP 15mEq - 1620MG | NET API CONT:1717.200MG/ {PER TABLET INCL WASTAGE | ‘RA may take appropriate action as per the decision of Norms Committee. | Case No.:26/9/82-ALC4/2017 "PartySCIENCES Name:JUBILANTLIFE [Meet No/Date:6/82- Status: LIMITED ALC4/2018 ‘Approved | HQ 26.07.2018 | | | File RLAFile ==———SsLic. No/Date:0510404200 SSS | :01/82/050/00753/AM18/ ':05/23/040/00223/AM18/ (05.10.2017 | Decision: Committee considered case as per agenda and as per earlier decision taken by NC in its 2/82 ‘meeting dated 16.05.2018, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP | 163 ‘as per details below or as applied by firm whichever is lower: | | | | | Export product Exp. SI.No. | Import items Qty. Allowed | Pyridine 98% Min 1k 1 0.019 k ; | - ° Alumino Silicate Catalyst | | | ; | Ethyl Alcohol (Denatured) | 2.194 kg Propionaldehyde 0.073 kg ‘RA may take appropriate action as per the decision of Norms Committee _ Case No.:25/9/82-ALC4/2017 [Party Name:JODAS EXPOIM Meet No/Date:6/82- (Status: | PVT.LTD., ‘ALC4/2018 Deferred HQ File RLA File ‘Lic.No/Date:0510404221 [Defer Date: | __:01/82/050/00752/AM18/ :05/23/040/00254/AM18/ (09.10.2017 | | | Decision: Deferred for comments of tE Se | ‘1465 CaseNo.:2/9/82-ALC4/2017 [Party Name:GLOBAL Meet No/Date:6/82- (Status: er steerer eps PHARMA HEALTH CARE /ALC4/2018 ‘Approved |
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| |HQ File RLA File ~ |Lic.No/Date:0410163585 | :01/82/050/00729/AM 18/ :04/24/040/00137/AM18/ (10.10.2017 | | | ‘Decision: In the light of earlier decision taken by NC in its 4/82 meeting dated 1 9.06.2018, it was decided | _ ito ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm | | whichever is lower: || || bom[HYOSCINE BUTYL BROMIDE tabletsQty. |? , |HYoscrNEBUTYL [202 ™m#/tablet || | | IBROMIDE IP/BP | RA may take appropriate action as per the decision of Norms Committee | | (Case No.:11/9/82-ALC4/2017 PartyName:ARIHANTANAM Meet No/Date:6/82-. Status: ; | ‘LIFECARE PVT. LTD. ‘ALC4/2018 ‘Approved — | HQ File RLA File Lic.No/Date:52 10042405 | | ::01/82/050/00738/AM18/ :52/24/040/00038/AM1 8/ 11.10.2017 | ‘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[|] (166 \details below or as applied by firm whichever is lower: | | Export product Exp. Qty. Qty. Allowed |. | | ARTEMETHER ARTEMISININ 1.235 kg
RA may take appropriate action as per the decision of Norms Committee
| [CaseNo.:4/9/82-ALC4/2017 |Party Name:DEEPAK ——Meet No/Date:6/82-. Status: - } | NOVOCHEM ALC4/2018 Approved — | | ‘TECHNOLOGIES LTD 26.07.2018 | HQ File REA File i ‘Lic.No/Date:3 110066888 | | ::01/82/050/0073 1/AM18/ :31/83/040/00085/AM18/ (12.10.2017 | | Decision: In the light of earlier decision taken by NC in its 2 and it was decided to ratify the ad-hoc input | ee 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 | | 2,6 Xylidine Ikg [1|[2,6][xylenol] 1.40 kg | | | 2 Not allow as specific | i | Catalyst . ’ ; | description not given | ‘RA may take appropriate action as per the decision of Norms Committee |
' [CaseNo.:10/9/82-ALC4/2017 PartyName:CADILA— Meet No/Date:6/82Status: ; | HEALTHCARE LTD ALC4/2018 Approved | 168° 26.07.2018 | HO ee Ce ee a ies ae ':01/82/050/00737/AM 18/ ':08/24/040/00207/AM 18/ (12.10.2017 |
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| ‘RA may take appropriate may take appropriate take appropriate appropriate action as per the decision per the decision the decision decision of Norms Committee Norms Committee Committee
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|---|---|---|---|---|---|---|---|---|---|
|||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.|
|||FLUOCINONIDE TOPICAL|Nos.|||1.|| FLUOCINONIDE USP|30.6 mg/60 ml|
||||||SOLUTION USP 0.05%|(0.5|bottle|
|||MG/ML)|(60 ML|||
|||ALCOHOL USP|bottle|||
|‘RA may take appropriate may take appropriate take appropriate appropriate|action|as per the decision per the decision the decision decision|of Norms Committee Norms Committee Committee|||
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| (CaseNo.:8/9/82-ALC4/2017 Party Name:FINECURE Meet No/Date:6/82. ‘Status: PHARMACEUTICALS LTD. |ALC4/2018 ‘Approved HQFile = ~~ RLAFile—~CS Lic.No/Date:0810141158 | | :01/82/050/00735/AM18/ ':08/24/040/00041/AM18/ (13.10.2017 | | Decision: Committee considered case as per agenda and as per earlier decision taken by NCin its 2/82 | meeting dated 16.05.2018, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: |
==> picture [461 x 381] intentionally omitted <==
----- Start of picture text -----<br> | Export product Exp. Qty. | SI.No. Import items Qty. Allowed |<br>, | mg/tablet<br>| CO- AMOXICLAV Nos. 1 AMOXICILLIN 585.36 |<br>|__| TABLETS BP 625 MG OR TRIHYDRATE |<br>169) AMOXICILLIN WITH IP/USP/BP 1.16 Kg |<br>| CLAVULANATE equivalent to I Kg |<br>| POTASSIUM TABLETS 625 Amoxicillin<br>2 POTASSIUM 303.4 |<br>| 4 MG IP/ CLAVULANATE<br>| | DILUTED IP/ |<br>; | MICROCRYSTALLINE |<br>| CELLULOSE (1:1) |<br>| 3 ALUMINIUM Relevant as per |<br>|<br>| | LAMINATED FOIL packing policy |<br>| PRINTED |<br>| ALU ALU BOTTOM |<br>/ FOIL FOR BLISTER<br>PACK<br>RA may take appropriate action as per the decision of Norms Committee |<br>|<br>| CaseNo.:33/9/82-ALC4/2017 |Party Name:STRIDES [MeetNo/Date:6/82. SS Status:<br>70 | SHASUN LIMITED ALC4/2018 Deferred<br>HQ 26.07.2018 |<br>| File RLA File / |Lic.No/Date:0410163599 [Defer Date:<br>01/82/050/00760/AM18/ :04/24/040/00144/AM18/ (16.10.2017<br>ies Deelee Se) ee ;<br>|171 Case No.:111/9/82-ALC4/2017 [Party Name:REINE Meet No/Date:6/82- —‘|Status:<br>| : |ee oe LIFESCIENCE ALC4/2018 ‘Approved |<br>----- End of picture text -----<br>
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| :01/82/050/00838/AM18/HQ File RLA:34/24/040/00177/AM18/ File Lic.No/Date:3416.10.2017 10043546 || | Decision:technical Committee considered case as peragendaand deliberated on the matter in the presence of the|
[or][as][applied][by][firm][whichever][is][lower:] details[below] experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per | Export product Exp. SI.No. | Import items Qty. allowed in kg | RA may take appropriate action as per the decision of Norms Committee | |CaseNo.:19/9/82-ALC4/2017 PartyName:CADILA —Meet No/Date:6/82-. Status: _ HEALTHCARE LTD /ALC4/2018 Approved | [HQ File RLA File ‘Lic.No/Date:0810141214 | | :01/82/050/00746/AM18/ 108/24/040/00215/AM18/ (18.10.2017 | Decision:technical Committee considered caseas peragendaand deliberated on the matter in the presence of the | details belowexpertsor as andappliedit was by decidedfirm whichever to ratify theis ad-hoclower: input output norms under para 4.7 of HBP as per | | | Export product Exp. | SI. | Import items Qty. allowed | | aty. | No. | | | Nos. | 1. | BISOPROLOL 1.275 mg/1.25mg | | | BISOPROLOL TABLETS 1.25 MG FUMARATE USP/PH tablet 1177 | BISOPROLOL TABLETS 2.5 MG/ | N°SA AR AEE USPjon 2.55 mg/2.5 mg | |” | BISOPROLOL FUMARATE AND ae able | | HYDROCHLOROTHIAZIDE | | TABLETS 2.5/6.25 MG | | BISOPROLOL TABLETS 5 MG/ Nos. BISOPROLOL 5.10 mg/5 mg || BISOPROLOL FUMARATE AND FUMARATE USP/PH tablet | | HYDROCHLOROTHIAZIDE EUR | | TABLETS 5/6.25 MG | | BISOPROLOL TABLETS 10 MG/ | NOS: Be ReTRUSPPH Je etome || BISOPROLOL FUMARATE AND EUR tablet | | | HYDROCHLOROTHIAZIDE | | TABLETS 10/6.25 MG |._.|RA may take appropriate action as perthe decision ofNorms Committee | — Case No.35/9/82-ALCANeee Party Name-AETHER pe ot Ma+ || INDUSTRIES LIMITED ‘ALC4/2018 Deferred | QFie RLA FileSSS AM Dek: Dae |
64
| Decision: Deferred for comments of TE ; oe | —_ Case No.:18/9/82-ALC4/2017|PartyName:PCL OIL& Meet No/Date:6/82Status: | SOLVENTS LTD. /ALC4/2018 Approved | | | 26.07.2018 | | | aoeee = ~IRLA | 7 in "ican | :01/82/050/00745/AM18/ 105/24/040/003 12/AM18/ 24.10.2017 | | _ Decision: Committee considered case as per agenda and deliberated on the matter in the presence of the (174 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. Qty. Qty. Allowed | | PVC PLASTICIZER (DINP) 1kg 1 PHTHALIC 0.355 kg _ ANHYDRIDE | ISO NONYL ALCOHOL | 0.726 kg | | RA may take appropriate action as per the decision of Norms Committee / (Case No.:22/9/82-ALC4/2017 Party Name:SYNNAT ‘Meet No/Date:6/82Status: f | PHARMA PRIVATE ALC4/2018 Approved | | HO 7 RLAsas emai TST | | / _ :01/82/050/00749/AM18/ :02/24/040/00108/AM18/ 24.10.2017 | | Decision:technical Committee considered case as per agenda and deliberated on the matter in the presence of the| 175 details belowexpertsor asandappliedit wasbydecidedfirm whicheverto ratify theis lower: ad-hoc input output norms under para 4.7 of HBP as per | Export product Exp. Qty. Qty. Allowed |, |__| Noscapine BP USP Ph.Eur JP 1kg 1 1.10 kg | **** _ | CP/Noscapine Hydrochloride peeping Cuude: Content || BP Ph.Eur ° RA may take appropriate action as per the decision of Norms Committee | Case No.:23/9/82-ALC4/2017 |Party Name:SYNNAT ‘Meet No/Date:6/82Status: | fo | PHARMA PRIVATE ‘ALC4/2018 ‘Approved | ‘LIMITED 26.07.2018 | | HQ File RLAFile ‘Lic.No/Date:0210207904. | | :01/82/050/00750/AM18/ :02/24/040/00109/AM18/ 24.10.2017 | | | __Decision: Committee considercas e asd per agenda and deliberatedon thematterin thepresence ofthe 176 | |” 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: | | Papaverine Hydrochloride 1kg 1 Papaverine Crude Content | 1.10 kg | _ | BP/Ph.Eur/USP/JP 95% | RA may take appropriate action as per the decision of Norms Committee
65
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| (Case No.:34/9/82‘Party Name:STRIDES SHASUN [Meet No/Date:6/82Status: | |ALC4/2017 ‘LIMITED ‘ALC4/2018 ‘Approved | | | 26.07.2018 ~ Lie.No/Date:0410163619 HQ File RLA File | | :01/82/050/00761/AM18/ :04/24/040/00125/AM18/ 25.10.2017 | ‘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:
||<br>| Exportproduct<br>177]<br>;<br>|<br>|<br>| AMANTADINE<br>|__| HYDROCHLORIDE<br>|<br>| TABLETSUSP100MG<br>|<br>| (TOTAL2697500NOS)<br>|<br>||帥<br>Exp.<br>aty.<br>1kg|SI.No. | Importitems<br>Qty. allowed<br>1;<br>102 mg/100 mg<br>AMANTADINE HYDROCHLORIDE USP<br>Tablet<br>2.<br>AVICELPH 101 (MICROCRYSTALLINE | 40-0mg/100mg<br>CELLULOSE101NF)<br>Tablet<br>3.<br>MAGNESIUMSTEARATEVEG<br>1.50 mg/100 mg||<br>|<br>|<br>||
|---|---|---|---|
||<br>i<br>|||NF/PH.EUR<br>Tablet||
| RA may take appropriate action as per the decision of Norms Committee
|
( \Case No.:6/9/82-ALC4/2017 Party Name:MALLADI_ —_—Meet No/Date:6/82Status: | | DRUGS & ‘ALC4/2018 Approved | | | PHARMACEUTICALS 26.07.2018 | i5 ‘ie RLA File ca ESTTee | |:01/82/050/00733/AM18/ :04/24/040/00142/AM 18/ (26.10.2017 | ‘Decision: In the light of earlier decision taken by NC in its 7/82 meeting dated 11.09.2014, it was decided | to ratify 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/kg | | Trifluoromethane | | sulfonic anhydride | | RA concerned may take further necessary action as per above decision of NC. | ~~ \CaseNo.:24/9/82-ALC4/2017 Party Name:RECKITT (Meet No/Date:6/82Status: | | BENCKISER HEALTHCARE |ALC4/2018 ‘Approved | 1179 | INDIA PRIVATE LIMITED — 26.07.2018 | | (HQFile (RLAFile ~~ ~———_Lic.No/Date:0510404401 | | | ':01/82/050/00751/AM18/ ':05/24/040/00320/AM 1 8/ 30.10.2017 |
==> picture [464 x 725] intentionally omitted <==
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|66|
|||Decision:|Committee|considered|case|as|per agendaand|deliberatedon|the|matter|in|the|presence|
|technical|of|the||
|||details|belowexpertsor|asandappliedit wasby decidedfirm|whicheverto ratify|isthelower: ad-hoc|input output norms under para 4.7|of HBP as per|
|||||Export product|Exp.|SLNo.|Import items|Qty. allowed|||
|Nurofen|Qty.|gm/kg|
|For Children|||1|kg|pl.|||Ibuprofen|17.41|||
|Tween|80|(Polysorbate|80)|0.0862|||
|||
|||
|||
|||Lycasin|80/55 (Maltotol)|383.793|||
|||Saccharin Sodium 40/80|1.724|||
|||16.|__||Citric Acid|Monohydrate|3.448|
|||Tri Sodium|Citrate|Dihydrate|4.388|
|||Xanthan Gum|[485|||
|;||||__[11|Domiphen Bromide|(BP)|0.0862|||
|12|987 PP28mm M-LOC H&A|White|Relevant|as per|
|f|T/E|packing policy|
|||
|fo|||13|DEVC,NURFN,GB,ORAL|||
|SUSPENSION|(Syringe)|||
|||||INSR,NUREN,NN|PASTIC PLUGS|||
|_|| 16|||NFC 2|Percent Paper labels|||
|||NFC|2|Percent Paper Leaflets|||
|||[18|__| NFC 2 Percent Mono cartons|||
|RA may take|appropriate action|as per the decision|of|Norms|Committee|
|Case No.:95/9/82-ALC4/2017|Party|Name:ENCEE|‘Meet No/Date:6/82-|‘Status:|
|||AROMATICS|PVT.|LIMITED|ALC4/2018|‘Approved|—|
|||||26.07.2018|
|aeae|“IREA|File|eee|eee|[Lic|No/Dates|
|||
|||Eee|||
|||:01/82/050/00822/AM18/|:32/24/040/00024/AM18/|01.11.2017|||||
|186|Decision:to|ratify|theIn thead-hoc lightinput of earlieroutput decisionnorms|takenunder bypara NC4.7 inofits HBP 2/82 meetingas|per|details datedbelow16.05.2018,or as|appliedit was decidedby|firm||||
|whichever|is|lower:|i|
|||Export Product|Export|Import Product|Quantity Allowed|||
|||Quantity|||
|||Enamber/ Kephalis|/ Tetrambrone|Triethyl|Orthoformate|||
|/RA|may take|appropriate|action|as|per the|decision|of Norms Committee|
|||(Case No.:28/9/82-ALC4/2017||Party|Name:BALAJI|AMINES|[Meet|No/Date:6/82-|(Status:|
|||||‘LIMITED|‘ALC4/2018|Approved|_|
|||||(26.07.2018|
|181 HQ:01/82/050/00755/AM18/ File|RLA|File|/——|[Lie.No/Date:3110066900|||||
|Decision:|:31/83/040/00091/AM18/|(02.11.2017|||
|In|the|light of earlier|decision|taken by NC|in|its 4/82|meeting|dated|19.06.2018,|it was decided|
|_|to|ratify|the|ad-hoc|input|output|norms|under para|4.7|of HBP|as|per|details|below|or|as|applied|by|firm|||
----- End of picture text -----<br>
67
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| whicseverglow@
. tc ct i ta a |
|__| Export Product Import Product Quantity | | | Quantit Allowed in kg | i | BUTYROLACTONE | GBL CATAYLYST 0.001 | | RA may take appropriate action as per the decision of Norms Committee | [CaseNo.:29/9/82-ALC4/2017 [Party Name:BALAJI AMINES [Meet No/Date:6/82-. Status: | ‘LIMITED \ALC4/2018 Approved | | | (26.07.2018 | | | HQ File RLAFile == ~—~—~—_Lic.No/Date:3110066899 | :01/82/050/00756/AM 18/ :31/83/040/00090/AM18/ (02.11.2017 | | | ‘Decision: In the light of earlier decision taken by NC in its 5/82 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 | 182 whichever is lower: | Export product Exp. Qty. Qty. Allowed |
i RA may take appropriate action as per the decision of Norms Committee.
|
| (Case No.:30/9/82-ALC4/2017 Party Name:BALAJI AMINES Meet No/Date:6/82Status: | ; | ‘LIMITED ALC4/2018 Approved — | | | 26.07.2018 | | HQFile — 'RLAFile =—SCLic.No/Daate:3 110066901 | | :01/82/050/00757/AM18/ :31/83/040/00092/AM18/ 02.11.2017 | Decision: In the light of earlier decision taken by NCin 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 | 183 whichever is lower: | | Export product Exp. Qty. Qty. Allowed | | N-ETHYL-21 kg | 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 | | [CaseNo.:31/9/82-ALC4/2017 PartyName:JUBILANT LIFE [Meet No/Date:6/82-. Status: | | ‘SCIENCES LIMITED ALC4/2018 Approved | ; | | 26.07.2018 | | | EG ———————— : RLA File se oe cena te fe Noles paoaaen | ::01/82/050/00758/AM18/ :05/23/040/00255/AM18/ (02.11.2017 | | 184 ‘Decision: In the light of earlier decision taken by NC in its 2/82 meeting dated 16.05.2018 it was decided | to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm | whichever is lower: | | | Export product Exp. | SI.No. Import items Qty. Allowed
68
| | Beta Picalme 1kg Denatured Ethyl Alcohol Pel NE | | || 14_| AluminoPropionaldehyde Silicate Catalyst | 0.82 kg0.007 kg || RA may take appropriate action as per the decision of Norms Committee |
/(Case No.:32/9/82-ALC4/2017 PartyName:JUBILANT LIFE [Meet No/Date:6/82Status: | | SCIENCES LIMITED ‘ALC4/2018 ‘Deferred 85 | 26.07.2018 | fQFie RLAFile ===——Lic.No/Date:0510404483 [Defer Date: | ——-:01/82/050/00759/AM18/ :05/23/040/00256/AM18/ (02.11.2017 | | Decision: Deferred for commentsofTE a | | Case No.:67/12/82-ALC4/2017 |Party Name:KRISHNA Meet No/Date:6/82-. Status: | ANTIOXIDANTS PVT. LTD. ALC4/2018 ‘Approved © | | 26.07.2018 | | | oe 12h an Foreojosi7ti7 |= — :01/82/050/01022/AM18/ :03/94/040/00595/AM18/ 16.11.2017 | | ‘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 186 details below or as applied by firm whichever is lower: | | Export Product Export S.No | Import Product Quantity a Quantity Allowed | — pIPHENYL ocTYL 1kg YELLOW PHOSPHORUS __| 0.096 ke | | PHOSPHITE PHENOL 0.59 kg | 3. 2-ETHYL HEXYL ALCOHOL| 0.415 kg | | /2-ETHYL HEXANOL | ‘RA may take appropriate action as per the decision of Norms Committee. |
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