DGFT Committee Minutes
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Minutes of the Norms Committee — 3 Meeting No. 6/82-ALC4/2020 dated 13.11.2020 (actually held on 18.11.2020 and 25.11.2020) for considering the cases/issues under Duty Exemption Scheme (Chapter-4) of . Foreign Trade Policy, 2015-20 pertaining to Chemical and Allied products falling under Chapter 29 and 30, held under the Chairmanship of Shri Rajbir Sharma, Jt. DGFT in Room No.4 and 11, Udyog Bhawan. New Delhi. ; Following members were preseni in the Meeting:
SI. No. | Name & Designation Department | Shri Shaish Kumar, Technical — | Consultant ; 2 Shri DN. Mathur, Technical — 2 Consultant _, {_In attendance . . So I Shri Munish Kumar, Dy. DGFT DGFT 2 Shri Ajay Kumar, Assistant Director DGFT 2. The Norms Committee has taken-decision only with respect to technical aspect/ wastage norms. While redeeming the application, RAs should check that the applicant has fulfilled all requirements as prescribed in - policy/procedureFIP/HBPFIP/HBP for issuanceincludingof Advancethoseincludingof Advancethoseof Advancethose Advancethose inAuthorizationpolicyAuthorizationpolicycircularsandand circularsandand regularizationissuedfrom timeof timeofof from timeof timeofof[[the]] to[[case.]] time. or any,, other provisions under , ‘The committee went through the minutes of earlier meeting No. 5/82-ALC4/2020 dated 09.10.2020 (actually held on 26.10.2020 26.10.2020 and 09.11.2020) 09.11.2020) ,
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|7|-|those|policy|issued|to|[[case.]]|time.|or|any,,|other|provisions|under|
|L|policy/procedureFIP/HBPFIP/HBP|for|issuanceincludingof Advancethoseincludingof Advancethoseof Advancethose Advancethose|inAuthorizationpolicyAuthorizationpolicycircularsandand|regularizationissuedfrom timeof timeofof|[[the]]|
|,|
|‘The|committee|went|through|the|minutes|of|earlier|meeting|No.|5/82-ALC4/2020|dated|09.10.2020|
|(actually|held|on 26.10.2020 26.10.2020|and 09.11.2020) 09.11.2020)|
|:|.|ONLINE CASES|oe|.|
|;|a|‘Case No.:40/6/82-ALC4/2020|= ‘Party Name:GLAND PHARMA|\Meet No/Date:6/82-|Status:|||
|oo|,|‘LIMITED|‘ALC4/2020|(Deferred|||
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|es|||13.11.2020|||
|'|“HQ|File|-|RLA|File|‘Lic.|No/Date:09 10061513|||
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|:01/82/050/0 1649/AM2 Ii|£09/24/040/00563/AM|I5/|:08.01.2015-|4|
|Decision:|‘This|case|appeared|for|the|first|time|before|Norms|Committee.|Deferred|for comments|of TE. TE.|||
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|Case|No.:93/20/82-|“Party Name:INTAS|\Meet No/Date:6/82-|Status:|||
|ALC4/2015|(PHARMACEUTICALS|LTD.,||A1.C4/2020|‘Approved|
|113.11.2020|||||
|-01/82/050/01676/AMHQ File|16/|*|IRLA :08/24/040/00329/AMFile|1|6/|(06iLic|.|No/Date:0801.2016|10136966||-|||
|Decision:|‘The|Committee|considered|case as|per agenda|in the|presence|ofthe|technical|experts|and|it was!|
|decided|to|ratify|the|ad-hoc|input|output|norms|under|para|4.07|of HBP|as|per|details|below|or|as|applied|by|||
|firm|whichever|is|lower:|
|l|0.|AZITHROMYCIN;|1|Number|No.|AZITHROMYCIN|261.809 mg/|'||
|TABLETS|250|MG|MONOHYDRATE|EP|/|250|mg|
|EACH|FILM|COATED|BP|/ USP /IP/ PH.EUR.|Tablet|||
|TABLET|CONTAINS:|
|AZITHROMYCIN|
|MONOHYDRATE|
|||AZITHROMYCINEQUIVALENT|250|MGTO|
|5*|||TAVERAGE:CONTENT|NLT|—.|WATER5%]|---|
|268.42|MG/TABLET|
|2|AZITHROMYCIN|||Number|AZITHROMYCIN|§22.26mg/||:|
|TABLETS|500|MG|MONOHYDRATE|EP|/|500 mg|
|EACH|FILM|COATED|BP /USP/IP/|PH.EUR.|Tablet|
|,|TABLET|CONTAINS:|
|,|
|AZITHROMYCIN|
|.|MONOHYDRATEEQUIVALENT|-|TO|||
|AZITHROMYCIN|500|MG|
|[AVERAGE|WATER|
|,|CONTENT|NLT|5%]|---|
|536.84|MG/TABLET|[IN|||
|WHICH|ACTIVE|||
|INGREDIENT|
|AZITHROMYCIN|:|
|MONOHYDRATE|USED|
|1S|300.000|KGS]|
|RA concerned may take further necessary action as per above decision|of NC.|,|||
|Case No.:6/11/85-ALC3/2016|Party Name:GELTEC|Meet No/Date:6/82-|‘Status:|||
|PRIVATE|LIMITED|‘ALC4/2020|\Transferred|||
|.|||13.11.2020|ito|Different|||
|Section|||
|,|HOQFile|;|RLA|File|_|Lic.No/Date:0310807611|||||
|>|-01/85/050/00103/AM17/|-03/94/040/00502/AM|1 7/|06.09.2016|||||
|[experts]|[and]|[t|]|
|Decision:|The|Committee|considered|the|case|as|per|agenda|in|the|presence|of|[technical]|
|wasIn view ofobservedabove,that|the theITC CommittceHS|Code decidedof Export to transferProduct|thestarts casewith to21, NC-VI.which|pertains|to NC-VI.|||
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Case-_ No.:28/6/82-ALC4/2020 Party‘CHEMICALSName:SIRMAXO PVT LTD —'Meet:ALC4/2020No/Date:6/82-. =Status:‘Approved its 'HQFile~~ RLAFile ~————_ Lic. No/Date:0310814209(i (tsti‘éSCé*S ':01/82/050/01637/AM21/ ':03/95/040/00192/AM18/ 22.06.2017 ;
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| (Decision: The Committee considered the case as per agenda and in the light of earlier decision taken in | imeeting no. 1/82-ALC4/2019 dated 03.06.2019 against advance authorization No. 0310807807 dated. '4 15.09.2016, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as: - ‘applied by the firm, whichever is less: . | | | Povidone lodine Topical Solution USP} ikg | 1 Povidone Iodine 0.098 kg | | | 10%(Available Iodine NLT 1% w/v) , | | | | (Net content of Povidone fodine - ne _ [.6862.740(KGS) |
| | | Povidone lodine Topical Solution USP} ikg | 1 Povidone Iodine 0.098 kg 4 | | | 10%(Available Iodine NLT 1% w/v) , | | | | (Net content of Povidone fodine - ne f _ [.6862.740(KGS) | ' =RA concerned may take further necessary action as per above decision of Norms Committee. a ~~ (CaseNo.:33/6/82-ALC4/2020 [PartyName:SIRMAXO Meet No/Date:6/82- Status: (ti | ICHEMICALSPVTLTD . ‘:ALC4/2020 ‘Approved i - : . . 13.11.2020 - | | HQ File __ {RLA File \Lic.No/Date:03 10816499 | , :01/82/050/01642/AM21/ :03/95/040/00544/AM18/ 25.10.2017 D | ' ‘Decision: — The Committee considered the case as per agenda and in the light of earlier decision taken in | ‘meeting no. 1/82-ALC4/2019 dated 03.06.2019 against advance authorization No. 0310807807 dated | 5 15.09.2016, it was decided to ratify norms under Para 4.07 of HBP Vol. I as_per details given below or as_ . : ‘applied by the firm, whichever is less: : .° | Povidone Iodine Topical Solution USP | 1 kg Povidone lodine 0.098 kg i ; | | 10%(Available lodine NLT 1% w/v) |
iRA concerned may take further necessary action as per above decision of Norms Committee.
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----- Start of picture text -----<br> | (Case No.:39/6/82-ALC4/2020 |Party Name:MEDREICH ‘Meet No/Date:6/82- Status:<br>a LIMITED *ALC4/2020 Deferred<br>6 HQFile — RLA File Lic.No/Date:0710112322, |<br>:01/82/050/01648/AM21/ =. —3:07/24/040/00192/AM18/ (27.10.2017<br>| Decision: — This caseappearedfor thefirst time before Norms Committee. Deferred for comments of<br>----- End of picture text -----<br>
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-[Case No.:43/6/82-ALC4/2020 PartyPVT LTDName:ENVEE DRUGS "MeetJALC4/2020No/Date:6/82- Status:‘Approved: —(HQFile =———<is~*é‘“ :‘«RCLAQR ile == SS~S=~iL eNotes 3410043680 00—O—O—~CS~CS ; $:01/82/050/01652/AM21/ |'34/24/040/00218/AM18/ '06.12.2017 ; Decision: | The Committee considered the case as per agenda and in the light of earlier decision taken in '7, {meeting no. 10/82-ALC4/2019 dated 29.11.2019 against advance authorization No. 0310831597 dated: : {applied117.09.2019,by theit wasfirm, decidedwhicheverto ratifyis less: norms urider Para 4.07 of HBP Vol. I as_per details given below or as: ; : No. : CLOBETASOL PROPIONATE lkg BETAMETHASONE 1.00 kg BP/USP IP/BP/USP/EP . | RA concerned may take further necessary action as per above decision of Norms Committee. ! r - CaseNo3s/6/82, ALoar2030" Panty NameSIRMAXOa Meet Nobna aSame i CHEMICALS PVT LTD ALC4/2020 ‘Approved | HQ File RLA File. ‘Lic.No/Date:0310818035 : |i, Decision: — The Committee consideredthe case as peragendaand in the light of earlier decision taken in. i imeeting no. 1/82-ALC4/2019 dated 03.06.2019 against advance authorization No. 0310807807 dated | applied(15.09.2016,by theit wasfirm, decwh i cheverded to ratifyis less: norms under Para 4.07 of HBP Vol. I as per details given below or as | "| | Povidone Iodine Topical Solution USP] 1 kg | 1 Povidone Iodine 0.098 kg | | |10%(Available lodine NLT 1% w/v) : RA concemed may take further necessary action as per above decision of Norms Committee. : '” (Case No.:37/6/82-ALC4/2020 ‘Party Name:SIRMAXO (MeetNo/Date:6/82-. «Status: i | ‘CHEMICALS PVT LTD |aLca/2020 ‘Approved / HQ File RLA File ; jLic.No/Date:03 10819689 ae : :01/82/050/01646/AM21/ 1:03/95/040/01061/AM18/ 09.03.2018 i | (Decision: © The Committee considered the case as per agenda and in the light of earlier decision taken in | imeeting no. 1/82-ALC4/2019 dated 03.06.2019 against advance authorization No. 0310807807 dated | 9 15.09.2016, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as | _ applied by the firm, whichever is less: . _ | Povidone Iodine Topical Solution USP} 1kg | 1 Povidone Iodine 0.098 kg | + LfAvailable Iodine NLT 1% w/v) | | RA concerned may take further necessary action as per above decision of Norms Committee.
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~~ [CaseNo.:29/6/82-ALC4/2020 (PartyName:SIRMAXO(Meet No/Date:6/82-. Status: Ss CHEMICALS PVT LTD ‘ALC4/2020 ‘Approved EEE . 1HQ File RTA File Lig, No/Date:0310821782 | «i - :01/82/050/01638/AM21/ —::03/95/040/00221/AMI19/. 20.06.2018 sO __/ (meeting|Decision:no. The1/82-ALC4/2019Committee considereddated 03.06.2019the case asagainstper'agendaadvanceand inauthorizationthe lightof earlierNo. 0310807807 decision takendated in; ; '\ . 10 15.09.2016, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as - "| applied by the firm, whichever is less: | | F || [Export Product i | | [Povidone Iodine Topical Solution USP | Ikg [1 Povidone lodine 0.098 kg | 3 : | - 10%(Available Iodine NLT 1% w/v) , | I RA concernedmay take further necessary action as per above decision of Norms Committee. _ i | [Case No.:31/6/82-ALC4/2020 |Party Name:SIRMAXO ‘Meet No/Date:6/82|Status: a | CHEMICALS PVTLTD. —ALC4/2020 [Approved : 1HQ File ‘RLA File iLic.No/Date:0310822067 | ; | _ |:01/82/050/01640/AM21/ —:03/95/040/00306/AM19/ 02.07.2018 ee en: _ |Decision: The Committee considered the case as per agenda and in the light of earlier decision taken in HM **** , {meeting no. 1/82-ALC4/2019 dated 03.06.2019 against advance authorization No. 0310807807 dated. 11115.09.2016, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details, given below or as, japplied by the firm, whichever is less: ; i | Export Product | Povidone lodine Topical Solution USP | | kg ] Povidone Iodine 0.098 kg : i | 10%(Available Iodine NLT 1% w/v) | i {RA concerned may take further necessary action as per above decision of Norms Committee. aq _ {Case No.:32/6/82-ALC4/2020 No.:32/6/82-ALC4/2020 |Party Name:SIRMAXO Name:SIRMAXO ‘Meet No/Date:6/82- No/Date:6/82‘Status: | i | THQ File ) ‘CHEMICALS|| PVT;; LTD “13.11.2020ALC4/20200 Approved:: an= ss| | |:01/82/050/01641/AM21/ RLA——:03/95/040/00409/AM19/ File——:03/95/040/00409/AM19/ File File + 01.08.2018‘Lic.No/Date:03 10822769=‘Lic.No/Date:03 10822769= 10822769== —i Decision: |The Committee considered the case as per agenda and in the light of of earlier decision taken in. ; "|, {meeting no. 1/82-ALC4/2019 dated 03.06.2019 against advance authorization No. 0310807807 dated; HI jl2 15.09.2016, it was decided decided to ratify norms norms under Para 4.07 4.07 of HBP HBP Vol. | as per details given below or as. as. Hl | applied by the firm, whichever by the firm, whichever the firm, whichever firm, whichever whichever is less: less: i : | | Povidone ‘Iodine Topical Solution USP | 1 kg Povidone Iodine 0.098 kg er [10% (Available lodine NLT 1% w/v) off : {RA concerned may take further necessary action as per above decision of Norms Committee. - bi . a
_ {Case No.:32/6/82-ALC4/2020 No.:32/6/82-ALC4/2020 |Party Name:SIRMAXO Name:SIRMAXO ‘Meet No/Date:6/82- No/Date:6/82‘Status: | ‘CHEMICALS|| LTD ALC4/20200 = | THQ File ) PVT;; “13.11.2020ALC4/20200 Approved:: an= | |:01/82/050/01641/AM21/ RLA——:03/95/040/00409/AM19/ File——:03/95/040/00409/AM19/ File File + 01.08.2018‘Lic.No/Date:03 10822769=‘Lic.No/Date:03 10822769= 10822769== Decision: |The Committee considered the case as per agenda and in the light of of earlier decision taken in. "|, {meeting no. 1/82-ALC4/2019 dated 03.06.2019 against advance authorization No. 0310807807 dated; jl2 15.09.2016, it was decided decided to ratify norms norms under Para 4.07 4.07 of HBP HBP Vol. | as per details given below or as. as. | applied by the firm, whichever by the firm, whichever the firm, whichever firm, whichever whichever is less: less:
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----- Start of picture text -----<br> | [CaseNo.:34/6/82-ALC4/2020 Party Name:SIRMAXO——s MeetNo/Date:6/82-. Status:<br>‘CHEMICALS PVT LTD ~ ALC4/2020 ‘Approved<br>HQ File — RLA File - ‘Lic.No/Date:0310824350 |<br>| (Decision:— The Committee considered the case as per agenda and in the light of earlier decision taken in.<br>; {meeting no. 1/82-ALC4/2019 dated 03.06.2019 against advance authorization No. 0310807807 dated<br>113 |15.09.2016, it was decided to ratify norms under Para 4.07 of HBP Vol. | as per details given below or as),<br>: japplied by the firm, whichever is less: : :<br>| Export Product |<br>Povidone Iodine Topical Solution USP | 1kg | 1 Povidone Iodine 0.098 kg<br>10% (Available lodine NLT 1% w/v) ,<br>RA concerned may take further necessary action as per above decision of Norms Committee. |<br>a Case No.:36/6/82-ALC4/2020 |Party Name:SIRMAXO \Meet No/Date:6/82- ‘Status: |<br>i od. ‘CHEMICALS PVT LTD |ALC4/2020 |Approved<br>| - + 413,11.2020<br>| [HQFile== —————<C—S~‘~@RCLA‘QFile =S—™:—~SS™SC*SLicNo/DDate0310825266 |<br>| |Decision: The Committee considered the case as per agenda and in the light of earlier decision taken in:<br>| imeeting no. 1/82-ALC4/2019 dated 03:06.2019 ‘against advance authorization No. 0310807807 dated .<br>'14|15.09.2016, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as<br>: {applied by the firm, whichever is less: - :<br>) | Export Product i :<br>Povidone Iodine Topical Solution USP | 1 kg ] : Povidone Iodine 0.098 kg<br>10% (Available lodine NLT 1% w/v)<br>| |RA concerned may take further necessary action as per above decision of Norms Committee. 7<br>| | [Case No.:136/6/82-ALC4/2019 [PartyName:ENCUBE<br>P| ETHICALS PVT LTD —‘([MeetNo/Date:6/82-.jALC4/2020 (Status:Deferred:<br>/ ‘HQ File RLA File - {Lic.No/Date:0310827548 |<br>----- End of picture text -----<br>
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; ae) ; : | [Case No.:12/1/82-—~—~=«( Party NaitieSUVENLIFE.[|Meet] No/Date:6/82- (Status: | | |ALC4/2019 SCIENCES LIMITED .. —|ALC4/2020 Approved =f | THQFile RLA File Lic.No/Date:0910067365 o£ / . :01/82/050/00012/AM20/ —|:09/24/040/00661/AM19/ 04.04.2019 7 Jo | a _ |Decision: The Committee consfdered case as per agenda in the presence of the technical experts and it). . was decided to ratify’the ad-hoc input output norms under para 4.07 of HBP as per details below or as;. . & 16 applied by firm whichever is lower: , ; : . a | i (3S)-OXOLAN-3-AMINE lkg | No.1 D (+) - MALIC ACID 2.05ke |, ofl§ HYDROGEN CHLORIDE i . IRA concemed may take further necessary action as per above decision of NC. . _ ; j Case No.:42/1/82-ALC4/2019 poe . = {PartyPVT.LTD NameJODAS- EXPOIM. - ALC4/2020(MeetNo/Date:6/82-. ( Deferred.Status: <>, -, FF 17 HQ File RLA File ‘Lic.No/Date:0510410233 a |:01/82/050/00042/AM20/ :05/23/040/00015/AM20/, 15.04.2019, 4 | [Decision: — The Committee considered the case as peragenda Show[Cause][Notice][vide][letter][dated][10.10.2019.] and7 it was observed that the firm wasoYissued, _ “fp. /~[€aseNo.:43/1/82-ALC4/2019 (PartyName:HEMADYE -. MeetNo/Date-6/82- Status: =: § . Lo ICHEM PVT. LTD. ‘ALC4/2020 . Approved | 5 ) (HQ File — RLAFile - Lic.No/Date:0310828400 | id oo / — |:01/82/050/00043/AM20/ 1:03/94/040/01141/AM19/ 16.04.2019, ae : _ [Decision: The Committee considered case as per agenda in the presence of the technical experts and it) > | . - + |was decided to ratify the ad-hoc input output norms under para 4.07 of HBP as per details below or as_ : lig applied by firm whichever islower: =~ - 6°: . OC , ps i : Export Product Qty.-| Sl. | Import items - . Qty. . io fi | , ; No. oir vo : 1,3 DIMETHOXY | | kg RESORCINOL/1,3DIHY DROXYBENZENE | 0.8778 kg i : | | BENZENE/RESORCINOL ; an: | DIMETHOXYBEZENE ; bi. ff , le concerned may take further necessary action as per abové decision of NC.
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----- Start of picture text -----<br> _ [CaseNo.:66/1/82-ALC4/2019‘PartyName:SUVENLIFE MeetNo/Date:6/82-. ‘Status:<br>a7 SO 82020SCIENCES LIMITED ‘ALC4/202 0 ‘Approved po<br>' 1HQ File ~RLAFile ———————~™~SCSSLic.No/Dates0910067405 60<br>i |:01/82/050/00066/AM20/ :09/24/040/00013/AM20/ 124.04.2019 .<br>; |Decision: | The Committee considered case as per agenda in the presence of the technical experts and it<br>"twas decided to ratify the ad-hoc input output norms under para 4.07 of HBP as per details below or as |<br> 19 lapplied by firm whichever is lower:<br>No.<br>| 3-FLUORO-4- 1kg [1 _[3-FLUORO PHENOL 1427kg | |<br>. NITROPHENOL. {2| METHYL TERTIARY BUTYL ETHER | 2.28 kg<br>: RA concerned may take further necessary actionas per above decision of NC. a |<br>[Case No.:67/1/82-ALC4/2019 |Party Name:AUROBINDO MeetNo/Date:6/82-. (Status:<br>| . PHARMA LIMITED |ALC4/2020 Deferred<br>| [HQ File RLAFile = ——~—_Lic.No/Date:0910067414 [SS<br>| |:01/82/050/00067/AM20/ :09/24/040/00025/AM20/ "(24.04.2019<br>. 20 |Decision: The Committee considered the case as per agenda in the presence of technical experts and it<br>: jwas decided to call for following information from the firm:<br>Po ; . (i)(ii) _ CopyStandardof relevant compositionDML. of Export Item. !<br>= - (iii) COA of Export Item. .<br>----- End of picture text -----<br>
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----- Start of picture text -----<br> [Case No.:75/1/82-ALC4/2019 ‘PartyName:LABORATE (MeetNo/Date:6/82- Status:<br>| +» PHARMACEUTICAL INDIA (ALC4/2020 . Approved<br>| [HQ File ~IRLA File iLic. No/Date:3310030529 | I<br>Decision: ~~ The Committee considered the case as per agenda and in the light of earlier decision taken in<br>| |jmeeting no. 2/82-ALC4/2020 dated 10.07.2020 against advance authorization No. 3310030519 dated|<br>. 114.03.2019, it was decided to ratify norms under Para 4.07 of HBP Vol. 1 as per details given below or as_<br>lo applied by the firm, whichever is less:<br>No.<br>* -| | Clindamycin Phosphate Cream /Gel | 1 Number | 1 Clindamycin Phosphate 364.14 mg |<br>30gm 1% w/w (Clindamycin | Tube of 30 IP/BP/USP<br>Phosphate 0.41gm is equivalent to | gms A raw material in powder<br>30 gm Clindamycin) form<br>| RA concerned may take further necessary action as per above decision of Norms Committee. |<br>----- End of picture text -----<br>
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----- Start of picture text -----<br> jutemes pinnenennngitns eccenvintteemeemmtei retin1 tine, perenne ananent fash immmmntnmeeeenenenen<br>| Case No.:86/1/82-ALC4/2019 |Party Name:ASCENT ‘Meet No/Date:6/82-of mmimtneememenen ‘Status:Pergo enema<br>|FINECHEM PVT. LTD., |ALC4/2020 ‘Deferred<br>22 THOFile | RLAFile / |Lic.No/ Date:0810145144<br>: : (:01/82/050/00086/AM20/ :08/24/040/00005/AM20/ 101.05.2019 io.<br>(Decision: Deferredfor comments of TE.<br>----- End of picture text -----<br>
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----- Start of picture text -----<br> |[Case No.:101/1/82-ALC4/2019 [Party Name:JODAS EXPOIM Meet No/Date:6/82- Status:<br>Do PVT.LTD ‘ALC4/2020 Deferred 1<br>|23 [:01/82/0S0/00101/AM20/HOF |:05/23/040/00048/ARAFoo)M20/ (03.05.2019LeNabateasiouioa7s | |4<br>: ‘Decision: |The Committee considered the case as per agenda and it was observed that the firm was issued :<br>_ Show Cause Notice vide letter dated 10.10.2019. |<br>' Case No.:106/1/82-ALC4/2019 ‘Party Name:PRACHEM ‘Meet No/Date:6/82- iStatus: i<br>|i [LABORATORIES ALC4/202013.11.2020 Deferred |ff<br>_HQFile:24 |:01/82/050/00106/AM20/~™~CS~SRLA|08/24/040/00003/AM20/PileSSC(Lic.108.05.2019No/Date:0810145205 || —<br>: ‘Decision:{was noted that| Thethe Committeefirm still hasconsiderednot furnishedthe casetheas4.07 per agendaapplication in theasked presencefor byofNC-3 techn i ncalitsexpertsMeeting andNo.)it! :<br>: | 4.073/82-ALC4/2020application asdatedper policy07.08.2020,circularfollowed no 23/2015-20by Reminderdated 15.05.2019.to firm on 18.11.2020Hence, the casefor furnishingis deferred.a copy of| |.:<br>‘Case No.:107/1/82-ALC4/2019 [Party Name:SHANKUS iMeet No/Date:6/82- ‘Status: | :<br>i| PHARMACEUTICALS _ javce/zoa{13.11.2020 - ‘Withdrawn|<br>: | HQFile ———<“<i«~‘“‘“‘é‘SRA Wile SSC LicNo/Daates0810145203Zeg<br>i {:01/82/050/00107/AM20/ (:08/24/040/00040/AM20/ {08.05.2019 i :<br>> Decision: The firm vide e-mail dated 07.10.2020 has informed that they have submitted the subject | '<br>‘Advance Authorization in RLA Ahmedabad for cancellation.<br>In view of above, the Committee decided to withdraw the case. ; F<br>a RA concerned may verify the same and take further necessary action as per policy /| i<br>- iprocedures. : a<br>|~~ (CaseNo.:113/1/82-ALC4/2019 (Party Name:AURORE LIFE MeetNo/Date:6/82-(Status: =<br>| SCIENCES PRIVATE ALC4/2020 Deferred sj<br>76 LIMITED 13.11.2020 | 4<br>| |(:01/82/050/00113/AM20/HO File RLA(:09/24/040/00011/AM20/Rig7[09.05.2019 ‘Lic No/Date:0910067466|i.ai *€<br>| |Decision: Deferred for comments of TE. |<br>; ereeeeernee meus eeneeemnnenneennreernren stn eeeneeenteesrerereemaresnsrenusimeusesitemanitnntectaiatt i fenesenen oon ~ -renee serermnérs Sscheron Semhetitums nee encbumrmmeetns ob omcmdestesuthAtinetty on ee ou oc mu es oe 20 ou 39 9:<9/—ELSPEETRSRSEFESESSEOSOEIEE i<br>j<br>----- End of picture text -----<br>
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"| [CaseNo.:109/1/82-ALC4/2019(Party Name:SAURAV. [Meet No/Date:6/82‘Status: i ‘CHEMICALS LIMITED ‘ALC4/2020 ‘Deferred "HQ File IRLA File - . “'Lic.No/Date:2210016146| _ }:01/82/050/00109/AM20/ |:22/24/040/00011/AM20/ (10.05.2019 Decision: Deferred for comments of TE.
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| |Case No.:251/1/82-ALC4/2019 (PartyName:GLAND ——~'Meet No/Date:6/82-. ‘Status: | /PHARMA LIMITED ~(ALC4/2020 ‘Deferred i “° THQ File ) ~ IRLA File : ~ |Lic.No/Date:0910067519 | | §:01/82/050/00157/AM20/ |:09/24/040/00043/AM20/ (14.05.2019 | | (Decision: Deemed Forcanon oFi.So eneorn : Case No.:276/1/82-ALC4/2019 |Party Name:PIRAMAL ‘Meet No/Date:6/82‘Status: i | . ; ‘ENTERPRISES' LIMITED 13.11.2020iALC4/2020 ‘Deferred jot QolHQFile =——s—iss—<i*=“‘< RAPile ~SS—S~SCSwL ic.N/Dates0310829108 | {:01/82/050/00182/AM20/ 1:03/95/040/00143/AM20/ 17.05.2019
, Decision: —§ The Committee considered the case as per agenda in the presence of technical experts and it, was noted that the firm vide e-mail dated 25.02.2020 has furnished its reply. Deferred for comments of TE. |
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----- Start of picture text -----<br> Case No.:280/1/82- Party Name:SMS |Meet No/Date:6/82- ‘Status:<br>ALC4/2019 , LIFESCIENCES INDIA ALC4/2020 ‘Approved i<br>: Hofile RLRig ee [Lic No/Date:091000736ia<br>, — §:01/82/050/00186/AM20/ 1:09/24/040/00084/AM20/ 122.05.2019 :<br>Decision: | The Committee considered caseas per agenda in the presence of the technical experts and it<br>: 4was decided to ratify the ad-hoc input output norms under para 4.07 of HBP as per details below or as<br>pene by firm whichever is lower: . . ;<br>: ‘Export Product Qty. | Sl. | Import items Qty.<br>. | No.<br>30 -EZETIMIBE (ETZ-IV) 1kg [1<br>| INTERMEDIATE | (S)-4-PHENYL-OXAZOLIDIN-2-ONEIMMCALA-T2-150 (ENZYME) | 0. 45kg_066 kg | |<br>oS ; METHYLENE DICHLORIDE 6.00kg |<br>METHANOL 440 kg |<br>| . N-HEPTANE 320kg_| -<br>aot |. 16| TOLUENE 7:80kg |<br>POTASSIUM HYDROXIDE FLAKES | 0.90kg |<br>18<br>J 19|| ISO DIMETHYL FORMAMIDE PROPYL ALCOHOL 0.40kg3.00kg || |<br>RA concemed may take further necessary action as per above decision of NC.<br>----- End of picture text -----<br>
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Tase No:299/1/82-—~—~—~«*(PartyName:RUBICON Meet No/Date:6/82-.Status: = | |ALC4/2019 {RESEARCH PVT. LTD., “ALC4/2020 ‘Approved / |HQFile = ~~~ RLAFile~=———~S™CSCSCWLicNo/Date20310829246 [|= tC _— |:01/82/050/00205/AM20/ 1:03/95/040/00103/AM20/ 24.05.2019 y ] Decision: |The Committee considered the case as per agenda and in the light of earlier decision taken in| ; ' {meeting no. 3/82-ALC4/2020 dated 07.08.2020 against advance authorization No. 0310830404) : : dated 18.07.2019, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below; ! | for as applied by the firm, whichever is less: i ; Sl. Export product Qty. Sl. Import items , No. No. H 1 Cyclobenzaprine Tablet 5 MG 1 Number | 1 Anhydrous Lactose | 95.00 mg/ ‘(Net content of Super Tab 3990 USP (Super Tab 21 | 5 mg tablet 2 _kg)Cyclobenzaprine Tablet 10 mg 1 Number I AnhydrousAN) Lactose; | 90.00 mg/ aii (Net content of Super Tab 12015 USP (Super Tab 21 | 10 mg tablet | | q lea concemed may take further necessary action as per above decision of Norms Committee. [Case No.:301/1/82-ALC4/2019 [Party Name:GLENMARK LIFE Meet No/Date:6/82[Status | i SCIENCES LIMITED i:ALC4/2020 ‘Deferred | 7 i | 13.11.2020 | a i §:01/82/050/00207/AM20/ 4:03/94/040/00134/AM20/ 27.05.2019 | a : | Decision Se eeeeearsrnc / (Case No.:305/1/82-ALC4/2019 |Party Name:RUMIT _Meet No/Date:6/82Status: i | (CHEMISYNTH PRIVATE —_ALC4/2020 Deferred = ff i iLIMITED 13.11.2020 / | / {HQ File iRLA File ‘Lic. No/Date:03 10829292 | | 1:0.1/82/050/0021 1/AM20/ :03/95/040/00196/AM20/ _ (28.05.2019 i ?3 Decision: ‘The Committee considered the case as per agenda in the presence of technical experts and it! | was decided to call for following information from the firm: ; (i) Complete chemistry, molecular weight, % yield, material balance and ; i stoichiometric balance. a
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| |CaseNo.:319/1/82-ALC4/2019(Party Name:RAVESHIA MeetNo/Date:6/82- (Status: . P| ORGANICS LLP ‘ALC4/2020 Deferred | | [HQ File IRLA File ‘Lic.No/Date:0310829355 | ; /— 101/82/050/00225/AM20/ :03/95/040/00204/AM20/_ 30.05.2019 i . 34: Decision: jwas noted thatThetheCommitteefirm still hasconsiderednot furnishedthe casethe as4.07per applicagend a tionin theasked presencefor byofNC-3technical expin its Me e rtsting andNo. it 0 ; i 13/82-ALC4/2020 dated 07.08.2020, followed by Reminder to firm on 10.09.2020 for furnishing a copy of: - 4 : - |4.07 application as per policy circular no 23/2015-20 dated 15.05.2019. Application is still awaited. Hence, : . . . | it was decided to issue Final Reminder to firm for furnishing a copy of 4.07 application as per policy: | circular no 23/2015-20 dated 15.05.2019. = | pySe PTC aseNow:1/6/82-ALC4/2019 [Party Name:MALLADI Meet No/Date:6/82(Status: ~ bo: DRUGS & ‘ALC4/2020 Deferred | ay _. (HQ File iRLA File ‘Lic.No/Date:0410165665 , oO cp ; (:01/82/050/00227/AM20/Decision: Deferred for comments|:04/24/040/00048/AM20/of TE. , 31.05.2019 — boss. | Case No.:18/6/82-ALC4/2019 [PartyName:SMILAX Meet No/Date:6/82-. (Status: ar Pope Gg . (LABORATORIES LIMITED {ALC4/2020 - ‘Approved Doe | “13.11.2020 _ _ ete ee THQ File ~ (RLAFiIe ~ Lie.No/Date:0910067628 [ pee ! 1:01/82/050/00244/AM20/ j:09/24/640/00103/AM20/ 06.06.2019 - in bo Ss 4 Decision: ‘The Committee considered case as per agenda in the presence of the technical experts and it: coe "+ +. "2 + 1was decided to ratify-the .ad-hoc input output norms under para 4.07 of HBP as per details below -or as applied by firm whichever is lower: : , * -| Export Product Qty.” | SL | tmport items Qty. re | Tert-butyl 2-((4R,6R)-6-(2-(2- | 1 kg (4R,6R)-Tert-Butyl-6-Cyanomethyl-2,20.588kg |. Pee, os oy | (4-fluorophenyl)-5-isopropyl: Dimethyl-1,3-Dioxane-4-Acetate (ATS: + | 3-phenyl-4-(phenytcarbamoyl) 9 |. | | -LH-pyrrol-l-ylethyl)-2, 2- 4 ; | dimethylt-1, 3-dioxan-4: , i roe _ | _{ ylacetate ‘RA concerned may take further necessary action as per above decision of NC. ‘ ,
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----- Start of picture text -----<br> [Case No.:30/6/82-ALC4/2019 ‘PartyName:TIDE —~—«(MeetNo/Date:6/82-. (Status: =i<br>INDUSTRIES |ALC4/2020 ‘(Deferred d<br>_ 113.11.2020 an.<br>JHQFile =——~<C~:*C“‘<éRCLAQRile ~=—S—S~SCLicNeDate:3410045200 a<br>':01/82/050/00256/AM20/ . :34/24/040/00083/AM20/ '10.06.2019 ee<br>3 7 (Decision: The Committee considered the case as per agenda in the presence of technical experts and it, Gs<br> _ |was decided to call for following information from the firm: :<br>| (i) Justification for very low yield of 45.78%. :<br>| (ii) Commercial value of low boiler and high boiler. ' 4<br>/ | (iii) Production / Consumption data duly certified by GST for last one year. |<br>mnerrienenenerierisrrnecyrebeyenssies Se seeee oh of ee ee esnttAen een eeNnen eee erTeeTL Een RETRETEETREEREMRETTETRETITIPPUFIGRISI Aoeeeenen oan eoneenshstesin none none oe = de A ne AHosRTF Fnmenmpenpenme ne ne nn ne nt anh ne ntenee mtnentrantnem eer err reer i<br>I<br>[Case No.:36/6/82-ALC4/2019 |Party Name:NOVEL iMeet No/Date:6/82- ‘Status: q<br>| INUTRIENTS PVT LTD |ALC4/2020 \Deferred ;<br>| [13.11.2020 a<br>—HQFileRL File I Lic.No/Date:0710115041 | |<br>— |:01/82/050/00262/AM20/ ':07/24/040/00056/AM20/ - {11.06.2019 | - a<br>: (Decision: | The Committee considered the case as per online agenda in the presence of technical experts | .<br>,. {and it was noted that the firm still has not furnished the following information asked for by NC-3 in its:<br>pe ‘Meeting No. 3/82-ALC4/2020 dated 07.08.2020, followed by Reminder on 06.10.2020:<br>| ~ (i) Copy of Approval from Food & Drugs Administration (FDA) for the export | ;<br>product. d<br> (ii) COA for import item from foreign supplier. F<br>: _ ;In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which | 1<br>, {the case will be rejected. , po<br>ne one wo me 0 = emmmntets wee 20 20 on emerremnnwae wenee © 2 no en mation eatenan weed wrweuants “enmmnvanermmcaremaenatinaracaannaancmananane aan mac anna na td re<br>| ~~ {Case No.:33/6/82-ALC4/2019 (Party Name:ASHISH LIFE. Meet No/Date:6/82- ‘Status: =<br>| ; SCIENCE PVT.LTD. iALC4/2020 [Deferred =<br>: 3° THO File IRLA File ‘Lic.No/Date:0310829569 |“ a.<br>|:01/82/050/00259/AM20/ . {:03/94/040/00197/AM20/ ° ; :12.06.2019 7<br>|Decision: Deferred for comments of TE. | 3<br>| [Case No.:34/6/82-ALC4/2019 |PartyName:DIPS ~~~ Meet No/Date:6/82-.—= (Status: =—Ssi(‘iér<br>ty [BIOSCIENCE PVT.LTD. iALC4/2020 (Deferred = =f<br>: {13.11.2020 | |<br>, — 1:01/82/050/00260/AM20/ :03/94/040/00199/AM20/ ; l12.06.2019 ee | i<br>40 Decision: The Committee considered the case as per online agenda in the presence of technical experts)<br>-"~ and it was noted that the firm still has not furnished the following information asked for by NC-3 in its) — |<br>_ {Meeting No. 3/82-ALC4/2020 dated 07.08.2020, followed by Reminder on 06.10.2020: i<br>| (id Copy of DML for each export product item showing Approved composition i<br>| ~ In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, ; 7<br>: failing which the case will be rejected. i<br>seenetememninene ninanna tnisenemmmamernniriteneieerenennanti tae tnrenenenennisaHifiittwannein aineimnenesieneinimeltl<Atetsitemetseetnatinesita t stnend cenec ot smes es ee eso nyeos dette sett sneyetsenenenteeeeiercrthiererennenenenensnerienarnnenemetmermrnremenenceemmnreneniewenenenniisensssumin son al i<br>----- End of picture text -----<br>
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| [CaseNo.:45/6/82-ALC4/2019 |PartyName:OPTRIX MeetNo/Date:6/82-. «Status: _ ..LABORATORIES PRIVATE |ALC4/2020 ‘Approved ee IMITED BR L20200 tal THQ File RLAFile —_[Lic.No/Date:0910067604, SS : |:01/82/050/0027 1/AM20/ :09/24/040/00114/AM20/ (13.06.2019 : , ‘Decision:{was decided toTheratify Committeethe ad-hoc consideredinput output case asnorms per agendaunder parain the4.07presericeof HBP of theas technicalper detailsexpertsbelow andor asit.: ; _ lapplied by firm whichever is lower:
Export Product Qty. - | SL | Import items : Qty. a No. | (i | VELPATASVIR-COPOVIDONE | 1 kg 1 Methyl [(2S)-1-[(2S8,5S)-2-[9-[2- | 0.555 kg (1:1) [(28,48)-1-[(2R)-2. : . | [(methoxycarbonyl)amino]-2i phenylacetyl]4-(methoxymethyl)pyrrolidin-2-yl]; . 1H-imidazol-5-yl]-1,11. . ; . . **** | dihydroisochromeno[4,3:6,7]naphtha[1,2-d]imidazol-2-yl]-5{| . methylpyrrolidin-1-y!]-3-methyl-1i oxobutan-2-yl)carbamate ; Po,
RA concerned may take further necessary action as per above decision of NC.
Case No.:49/6/82-ALC4/2019 |Party Name:DHANUKA ‘Meet 'No/Date:6/82‘|Status: (LABORATORIES LTD ~ (ALC4/2020 ‘Deferred |. ' fo oo 13.11.2020 . po ore [RLA File Tie.No/Date:0510410949 |oy » :01/82/050/00275/AM20/ {:05/23/040/00104/AM20/ 14.06.2019 | (Decision: Deferred for comments of TE. . ) . _
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_ PRIVATE LIMITED . (ALC4/2020 Deferred | RRQ ie REAFle TiN e ibatoTO0GTIRD F tment | (Decision? Detened for coments of TE. one ednaene ee - | a
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(CaseNo.:53/6/82-ALC4/2019 Party[Name:KAIRAV][ [Meet][No/Date:6/82-.][Status:] | _ . . ‘CHEMOFARBE‘LTD. : INDUSTRIES, |ALC4/2020{13.11.2020 to‘Deferred i| : GORE RLABile “SS Noibate:0310829703- a : ; }:01/82/050/00279/AM20/ ::03/94/040/0020 1/AM20/ 17.06.2019 i 44 ‘Decision: | The Committee considered the case as per agenda in the presence of technical experts and it: | ;was decided to call for following information from the firm: i (i) Manufacturing process in detail. . | . | (ii) Wastage at each stage of manufacturing. j i INDUSTRIES ‘ALC4/2020 Deferred | 7 i 13.11.2020 a | cHQFile ~—~—S*YIRLAFile’ ig[:01/82/050/00286/AM20/] 34/24/040/00101/AM20/==————CSs—~SCS—SS Lic.18.06.2019Nco/Daate3.410045217|4tC : ‘Decision: ywas decided|to Thecall Committeefor following consideredinformation the casefrom theas perfirm: agenda in the presence of technical experts and it | t {i} Exact chemical name of Export Product. | ‘CaseNo.:61/6/82-ALC4/2019 (PartyName:ASTRALSTERITECH —=s Meet No/Date:6/82-. «Status: | PVT. LTD. : “ALC4/2020 ‘Deferred i | HQ File IRLA File ‘Lic.No/Date:3410045218 4 46 :01/82/050/00287/AM20/ |:34/24/040/00102/AM20/ 19.06.2019 — ‘Decision: The Committee considered the case as per agenda in the presence of technical experts and it ( : /was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No.| H : per(019 dated 06.03.2020,Policy Circular No. followed23/2015-20, by Reminderdated 15.05.2019. to firm onHence, 07.08.2020the caseandis deferred.Final Reminder on 06.10.2020m, as i ee . i /[Case No.:67/6/82-ALC4/2019 Party Name:ASTRAL "Meet No/Date:6/82‘Status: | . ‘STERITECH PVT. LTD. + ‘ALC4/2020 ‘Deferred ; 13.11.2020 | | iQ a RLAgg ‘Lie No/Daie 3410085503”oo | | '47 |:01/82/050/00293/AM20/ (:34/24/040/00100/AM20/, 20.06.2019, | | Decision: — The Committee considered the case as per agenda in the presence of technical experts and it : |was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No.| 7 ' |14/82-ALC4/2019 dated 06.03.2020, followed by Reminder to firm on 07.08.2020 and Final Reminder on. i 7 (06.10.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019. Hence, the case is deferred. /
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|i(CaseNo.:75/6/82-ALC4/2019 [PartyPRIVATE Name:NAARI LIMITED PHARMA~ | Meet:ALC4/2020 No/Date-682-[Status:"(Deferred ' :01/82/050/00301/AM20/ :05/24/040/00172/AM20/ 24.06.2019 _ (Decision: Deferred for comments of TE. :
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{Case| No.:76/6/82-ALC4/2019|PartyiLABORATORIES Name:ORTINLTD Meet‘ALC4/2020 No/Date:6/82-.Status:‘Approved | [HQ File RLAFile | ~_ Lic.No/Date:0910067687 _ |:01/82/050/00302/AM20/ :09/24/040/00132/AM20/ (24.06.2019 | {wasDecision:decided toTheratify Committeethe ad-hocconsideredinput outputcase asnorms perunder agendapara in4.07 the presenceof HBP Vol.of theI as technical per detailsexpertsbelowandor asit. - : lapplied by firm whichever is lower: | | [28,38,58]-5-tLkg 1,2-dimethoxy ethane(1,2-DME) | 4.74 kg butyloxycarbonylamino-2SODIUM BORO HYDRIDE 0.45 kg , Amino-3-hydroxy-1,643 METHANE SULPHONIC 1.50-kg diphenylhexane succinate(BDH ACID ‘ . Succinic Acid RIT) 4 L-Phenylalanine Not shown | inthe - . process RA concerned may take further necessary action as per above decision of NC.
[Case No.:77/6/82-ALC4/2019 |Party Name:ORTIN Meet No/Date:6/82Status: | LABORATORIES LTD * ALC4/2020 ‘Approved | i 13.11.2020 | | BieRe eboeREO | |:01/82/050/00303/AM20/ ‘|:09/24/040/00133/AM20/ 24.06.2019 i | || (Decision: — The Committee considered case as per agenda in the presence of thetechnicalexperts and it | |applied|was decidedby firm to ratifywhichever the ad-hocis lower: input output norms under para 4.07 of HBP Vol. [ as per details below or as | | Export Product | '50| | 2S.3S,5S)-2-AMINO-3Lkg L-PHENYLALANINE 0473 kg | | HY DROXY-5-(1-TETRA-DRO PYRIMID-2-ONLY)-313{| SODIUM1,2 DIMETHOXYETHANEBORO HYDRIDE 06 . 74406kg kg -) METHYL BUTANOYL) 4. |METHANE SULPHONIC 157 kg - |. AMINO-1,6-DIPHENYL ACID _ _ | | HEXANE-S-PYRO a L- VALINE 0.63kg < |) _ | | GLUTAMATE(THP) N.N- CARBONYL O443kg ; DIMIDAZOLE __L-PYROGLUTAMIC ACID 0.295kg | Ra concerned may take further necessary action as per above decision of NC. ,
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|_|‘BIOTECH|LTD|ALC4/2020|Deferred|=|||
|Dod|.|||(13.11.2020|||_|
|ClQFile|== ~~~~~~|IRLA File~—~—S*~*~*~*~S~S~S~ST|LicNo/Daate:0810145581||||
|:|(:01/82/050/00319/AM20/|°||:08/24/040/00101/AM20/|27.06.2019|}|
|||‘Decision:|Deferred|for comments of TE.|||:|
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‘Case No.:30/6/82-ALC4/2020 |Party Name:NOCIL LIMITED [Meet No/Date:6/82- (Status: -_ |ALC4/2020 Deferred =f _ . . 13.11.2020 | — QFile~~~ 'RLAFile ~~~ [Lic.No/Date:0310829992 | — :01/82/050/01639/AM21/ 1:03/95/040/00284/AM20/ (28.06.2019 H | (Decision: This case appeared for the first time before Norms Committee. Deferred for comments of TE | — CaseALC4/2019 No.:103/6/82; [Paty MILAX LABORATORIES Meet No/Date:6/82[Status: : Name:SMILAX LABORATORIES |ALC4/2020 \Deferred 3 LIMITED 13.11.2020 | 4_ THO File �� [RLA File :09/24/040/00146/AM20/ |Lic.No/Date:0910067735 | | :01/82/050/00329/AM20/ | 02.07.2019 i : | |Decision: Deferred for comments of TE. - a | (Case No.:114/6/82-ALC4/2019 [Party Name:TITAN Meet No/Date:6/82Status: i . a LABORATORIES7 PVT. LTD. ;ALC4/202013.11.2020 - Deferred 7g: S4HQFile' was':01/82/050/00340/AM20/‘Decision: noted that== theThe Committee firm = vide—'[RLAFilee-mail_ considered:03/95/040/003dated the07.10.2020 case————~S~SCSCSCLic 18/AM20/as perhas agendafurnished in03.07.2019its the reply. ND presenceate-0310830043Deferredof technicalfor commentsexperts[| =oftSts:*C«S@Cd and TE. it, .
P {Case No.:117/6/82-ALC4/2019 |Party Name:SYNTHO 'Meet No/Date:6/82Status: | | CHIRALS PRIVATE LIMITED |ALC4/2020 Deferred = i 13.11.2020 '55 HO1:01/82/050/00343/AM20/ File cal :09/24/040/00172/AM20/47 Lic03.07.2019Nowpeeaioog7a9 | Decision: — The Committee considered the case as per agenda in the presence of technical experts and it : {was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. | | 14/82-ALC4/2019 dated 06.03.2020, followed by Reminder to firm on 07.08.2020 and Final Reminder on. ; {06.10.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019. Hence, the case is deferred.
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‘CaseNo.:122/6/82-ALC4/2019Party Name:PROLIFE ~~MeetNo/Date-6/82.= Status _ ‘INDUSTRIES LIMITED :ALC4/2020 “Deferred | ps |HQ File a RLAFile ~ |Lic.No/Date:0310830123 |:01/82/050/00348/AM20/ |:03/95/040/00329/AM20/ (05.07.2019 (Decision: _ Deferred for comments of TE. ~~ [CaseNo.:127/6/82-ALC4/2019|Party Name:APNAR PHARMA Meet No/Date:6/82-(Status: boi. PRIVATE LIMITED 'ALC4/2020 Deferred | | HQFile / IRLAFile——~—~™—SCSLic.No/DDate:3410045258 [ 10 1/82/050/00353/AM20/ :34/24/040/00098/AM20/ 05.07.2019 | ‘Decision: The Committee considered the caseas per agenda in the presence of technical experts and itwas| 7 ‘noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. ; p 14/82-ALC4/2019 dated 06.03.2020, followed by Reminder on 11.06.2020 and Final Reminder on °° _ (i )i) ExportDetailed quantityworkingto of be inputs given inapplied. number of‘ Tablets / Capsules. (iii) Master Batch Formula for each export product. , Hence, the case is deferred. SO . a Oo | [Case No.:130/6/82-ALC4/2019 PartyName:ACME‘(Meet No/Date:6/82-. (Status: ‘GENERICS LLP : ALC4/2020 ‘Deferred ; 8 File - IRLA File Lic.No/Date:2210016194 | | ':01/82/050/00356/AM20/ ':22/24/040/00026/A M20/ (08.07.2019 | | (Decision: Deferred for comments of TE. . . . | _ |[Case No.:145/6/82-ALC4/2019 Party Name:-MAHARSHI [Meet No/Date:6/82-. Status: po 'PHARMA CHEM PRIVATE |ALC4/2020 Deferred so reae IRLA File [Lic NovDate-0810GeeSoo | /:01/82/050/0037 1/AM20/ :08/24/040/001 14/AM20/ i09.07.2019 7 | | Decision:‘was noted thatThethe firmCommitteevide e-mailconsidered datedthe 30.10.2020caseas has perfurnished agenda inits thereply. presenceDeferred of technicalfor comments expertsof and TE. it
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|(|CasePlNo.:150/6/82-ALC4/2019[PartyName:MAHARSHI|Meet|No/Date:6/82-|Status:|
|i|||=|[PHARMA(LIMITED|CHEM PRIVATE|_|:ALC4/202013.11.2020|Deferred|i:|
|OHO|File|RLA|File|Lic|No/Date:0810145668|i|
|||§201/82/050/00376/AM20/|08/24/040/00116/AM20/.|09.07.2019|||a|
||||Decision:|Deferred|for|comments|of|TE.|—|||—|
|~~|[Case No.:151/6/82-ALC4/2019 Party Name:MAHARSHI|[Meet No/Date:6/82-|Status:|a|
|‘PHARMA CHEM|PRIVATE|=|}ALC4/2020|Deferred|i|
|ol(HOFile|||(RLAFile~~ 4Lic.No/Date:0810145669|||ee|
||||:01/82/050/00377/AM20/|:108/24/040/00117/AM20/|109.07.2019|||:|
|.||||Decision:|| The Committee|considered|the|case|as|per|agenda|in|the|presence|of technical|experts|and|it:|
|:|{was|noted|that|the|firm|vide e-mail|dated|30.10.2020|has|furnished|its|reply.|Deferred|for comments|of TE.|4|
|||[€aseNo.:148/6/82-ALC4/2019|[Party|Name:THINQ|PHARMA Meet|[No/Date:6/82-][ (Status:]|
|||CRO|LIMITED|ALC4/2020|Deferred|||=|||
|||(13.11.2020|||
|!62|WO|:01/82/0S0/00374/AM20/ Fie|ee enn—_|LAF(:03/95/040/00338/AMcen20/|Lic:10.07.2019 No/Date-0310830207 oe||>:|
|‘Decision:|||The|Committee|considered|the|case|as|per|agenda|in|the|presence|of technical|experts|and|it.|
|_||was|noted|that|the|firm|still|has|not|furnished|the|4.07|application|asked|for|by|NC-3|in|its|Meeting|No.||j|
|14/82-ALC4/2019|dated|06.03.2020,|followed|by|Reminder|to|firm|on|07.08.2020|and|Final|Reminder|on:|:|
|/|{06.10.2020|as|per|Policy|Circular|No.|23/2015-20,|dated|15.05.2019.|Hence,|the|case|is|deferred.|
|~~ {Case No.:155/6/82-ALC4/2019|‘Party Name:ORIENTAL|Meet No/Date:6/82-|‘Status:|
|Pp:|AROMATICS|LTD|/ALC4/2020|Deferred|=f|
|||:|13.11.2020|||
|||li mig|eeeRAR|Lie|No/baten031083034607|an|:|
|163|(:01/82/050/00381/AM20/|——_:03/95/040/00335/AM20/|/12.07.2019|.|i|||
|_|(Decision:|— The|Committee|considered|the|case|as|per|agenda|in|the|presence|of|technical|experts|and it’|
|[was decided|to|call|for following|information from|the|firm:|ft|4|
|(i)|Complete|chemistry,|material|balance, %|yield|and|molecular|weight.|
|(ii)|Exact|chemical name|of Export|Product.|||||
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"(Case No.:160/6/82-ALC4/2019 [PartyName:ORIENTAL MeetNo/Date:6/82-. (Status: : ; AROMATICS LTD ‘ALC4/2020 Deferred; -_ 13.11.2020 of. -' HQFile “66 ~~~—~—~—S RLAFile ~——~SCLicNo/Daate:0310830298 | ::01/82/050/00386/AM20/Decision: The Committee considered':03/95/040/00363/AMthe case as per20/ agenda © in{15.07.2019the presence— of technical experts and it| | |was decided to call for following information from the firm: | Lo | (i) .Complete chemistry, molecular wéight and %yield. i H | (ii) Stoichiometric balance. oe | - | (Case No.:169/6/82-ALC4/2019 [Party Name:PRACHEM — __ .;Meet No/Date:6/82Status: i ; i - {LABORATORIES ALC4/2020 Deferred , Pe id ee ny 19-11-2020 ~~ ; ; 167 }:01/82/050/00395/AM20/ |:08/24/040/00 123/AM20/ :17.07.2019 l , “| [Decision: — The Committee considered the case as per agenda in the presence of technical experts and it! 4 : [was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No.[|] . | 13/82-ALC4/2020 dated 07.08.2020, followed by Reminder to firm on 18.11.2020 for furnishing a copy of bt ' 14:07 application as per policy circular no 23/2015-20 dated 15.05.2019. Hence, the case is deferred. vi . _ .|Case No.:199/6/82‘Party Name:CIRON DRUGS Meet No/Date:6/82Status: 4 _. |ALC4/2019 '& PHARMACEUTICALS P. |ALC4/2020 ‘Approved . BM . (HQ File RLAFile . == ——TLic.No/Date:0310830435/ £ 1:01/82/050/00425/AM20/ :03/94/040/003 12/AM20/ | 19.07.2019 . i i i . : 7 “|Decision:: | The Committee considered case as per agenda in the presence of the technical experts and it SB . Lo | was decided to ratify the ‘ad-hoc input output norms under para 4.07 of HBP as per details below or as: ak : lapplied by firm whichever is lower: a 0 Export Product * Qty. Import items Qty, ff | ERYTHROMYCIN ESTOLATE FOR ORAL | 2028.000 kg | ERYTHROMYCIN | 2600 mg / — 68 | SUSPENSION USP 60 ML (EACH 5 ML| (7,80,000 No. |ESTOLATE 60 ml Bottle. | | i ia| AFTERERYTHROMYCINRECONSTITUTIONESTOLATE USP-EQ© CONTAINTO| Bottles) eei. |“h | i ERYTHROMYCIN (125. MG) NET | of “ CONTENT: I)ERYTHROMYCIN @ : ESTOLATE :2,028.000 KILOGRAM | i | 2 | ERYTHROMYCIN ESTOLATE FOR ORAL| 6240.000kg | ERYTHROMYCIN | 5200mg7 |, * | SUSPENSION USP 60 ML (EACH 5 ML| (12,00,000° ESTOLATE 60.ml Bottle) i AFTER RECONSTITUTION CONTAIN| No. Bottté) Do , ERYTHROMYCIN ESTOLATE USP-EQ TO . |" ERYTHROMYCIN (250 MG) NET a. ~ | | CONTENT: 1JERYTHROMYCIN ’ —— E , . ESTOLATE :6,240.000 KILOGRAM . i | {RA concerned may take further necessary action as per above decision of NC. . al i
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[Casei No.:215/6/82-ALC4/2019| . ‘NOVOCHEMParty Name:DEEPAK 'ALC4/2020MeetNo/Date:6/82. (Deferred[Status: 7 | [HQ File IRLA File _ Lic.No/Date:3110067483 | {Deeision:The Committee considered the case as per agenda in the presence of technical experts and itwas . : noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 14/82-. : ' -ALC4/2019 dated 06.03.2020, followed by Reminder on 07.08.2020 and Final Reminder on 16.10.2020 as | : lper Policy Circular No. 23/2015-20, dated 15.05.2019. Application awaited from the firm. 7
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- ‘Case'No.:216/6/82-ALC4/2019 [PartyName:ORIENTAL Meet No/Date:6/82-—*(Status: tof _ iAROMATICS LTD :ALC4/2020 . Deferred | | 13.11.2020 HQ File © - ; RLA File. _ ee Lic.No/Date:0310830547 : 79 :01/82/050/00442/AM20/ ___:03/95/040/00413/AM20/ 24.07.2019 to ; ‘Decision: The Committee considered the case as per agenda in the presence of technical experts and it ' was decided to call for following information from the firm: | (i) Complete chemistry, material balance, % yield and molecular weight. Pol (ii) Exact chemical name of Export Product.
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----- Start of picture text -----<br> : iCase No.:220/6/82-ALC4/2019 |Party Name:BHARAT ‘Meet No/Date:6/82- Status:<br>| ; iSERUMS & VACCINES LTD [ALC4/2020 Deferred<br>Lr igre Reng LicNo/Daiei3108305017 a<br>}:01/82/050/00446/AM20/ ~ $:03/94/040/003 13/AM20/ 25.07.2019<br>_ (Decision: The Committee considered the case as per agenda in the presetice of technical experts and after<br>| {forideliberation, obtaining ititswascomments. decided toa forward aOC copy of 4.07 application tooeDepartmentaof Biotechnologyoe (DBT)ok|<br>----- End of picture text -----<br>
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|||<br>iCase No.:221/6/82-ALC4/2019 |PartyName:ALPHAMED<br>‘MeetNo/Date:6/82-<br>Status:<br>:<br>|<br>FORMULATIONS PRIVATE<br>.ALC4/2020<br>Approved<br>|<br>-<br>LIMITED<br>.<br>13.11.2020<br>os|
|---|---|
||HQFile<br>ewIRLA<br>File<br>t—=<CSststS~SN<br>Lic. No/Date:0910067834<br>;<br>+<br>.:01/82/050/00447/AM20/<br>:09/24/040/00222/AM20/<br>(25.07.2019<br>7<br>(Decision: TheCommittee consideredthecase asperagendaand inthelightofearlierdecision taken in:<br>i<br>|<br>|meeting no. 3/82-ALC4/2018 dated 05.06.2018 against advance authorization No. 091006377!dated<br>|<br>|<br>(08.06.2016, it was decided to ratify norms under Para 4.07 ofHBP Vol. 1 as per details given below oras<br>i<br>|<br>applied by the firm, whichever is less:|
|:|| Export product<br>Qty.<br>SI.<br>| Importitems<br>"<br>Qty.Allowed<br>.<br>ot<br>No.<br>.<br>in mg/tablet<br>;<br>i<br>| GURONSAN<br>~ C¢| 1 Number<br>Glucuronolactone<br>51.00<br>| EFFERVESCENT TABLETS;<br>OR<br>D-Glucuronolactone<br>|<br>|<br>| (Each<br>Tablet Contains<br>-<br>(Synonym)<br>_ oval<br>3060<br>|<br>Glucuronolactone<br>50<br>AscorbicAcid(Crystalline)<br>r<br>| mg,Ascorbic<br>Acid<br>Caffeine Anhydrous<br>4<br>| 300mg,Caffeine50mg)<br>**Sodium**Polyphosphate<br>(5000<br>;<br>_<br>5<br>Hydrogen Carbonate<br>950.0<br>4|
||-<br>OR Sodium Bicarbonate<br>4<br>(Synonym)<br>—_<br>}<br>|<br>| 6 | Gin Fizz Micron Flavour<br>-_<br>Macrogol 6000<br>135.00mg<br>j|
||leaconcernedmaytakefurthernecessaryactionasperabovedecisionofNormsCommittee.<br>|<br>;|
||[CaseNo.:231/6/82-<br>‘PartyName:SMS<br>‘Meet No/Date:6/82-<br>‘Status:<br>“|<br>|<br>|ALC4/2019<br>LIFESCIENCES INDIA<br>/ALC4/2020<br>‘Approved<br>|<br>‘LIMITED<br>13.11.2020<br>|<br>igre<br>RLARIeSnTic No/bate09i006784[—a—|<br>/ — (:01/82/050/00457/AM20/<br>-/:09/24/040/00215/AM20/ 26.07.2019<br>od<br>oo<br>3<br>_<br>|Decision: —TheCommittee considered case as per agenda inthe presence ofthe technicalexperts<br>and it|<br>,<br>{was decided to ratify the ad-hoc input output norms underpara 4.07 ofHBP Vol. I asper details below or as |<br>ty<br>_<br>japplied byfirm whichever is lower:<br>po<br>4|
||No.<br>a|
||73<br>EZETIMIBE<br>INTERMEDIATE|<br>1 kg<br>(S)-4-PHENYL-OXAZOLIDIN-} 0.45kg<br>|<br>:<br>IV - (ETZ-IV)<br>2-ONE|
||IMMCALA-T2-150 (ENZYME)| 0.066kg<br>|<br>METHYLENE DICHLORIDE | 6.00kg<br>-<br>|<br>[<br>METHANOL<br>440kg<br>.<br>|<br>ff|
||N-HEPTANE<br>3.20kg:<br>—<br>16|TOLUENE<br>7.80kg° |>|
||7<br>POTASSIUM HYDROXIDE<br>0.90 kg<br>.<br>4<br>,<br>FLAKES<br>—<br>18<br>| ISOPROPYLALCOHOL<br>3.00kg<br>|<br>&<br>,<br>19°|DIMETHYLFORMAMIDE<br>040kg<br>-|:.<br>§|
||leaconcernedmaytakefurthernecessaryactionasperabovedecisionofNC.<br>.<br>||
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| CaseNo.:236/6/82-ALC4/2019Party Name:ACME —~—(MeetNo/Date-6/82.—~—~Status:.—SCS ot iGENERICS LLP : ‘ALC4/2020 (Deferred : HQ File ~ IRLA File ‘Lic.No/Date:2210016214 | _ :01/82/050/00462/AM20/ ~ —:22/24/040/00031/AM20/ [26.07.2019 po | (Decision? Deferred for Comments ofTE 7 |Case No.:237/6/82-ALC4/2019 [Party Name:ACME GENERICS Meet No/Date:6/82. Status: | J | LLP ALC4/2020 Deferred | i | . (13.11.2020 | :01/82/050/00463/AM20/ ———:22/24/040/00030/AM20/ 26.07.2019 . | : ‘Decision: Deferredforcomments of TE. a | (CaseNo.:238/6/82-ALC4/2019 |PartyName:WOCKHARDT‘MeetNo/Date:6/82- (Status: / | LIMITED ‘ALC4/2020 Deferred aa a 13.11.2020 | | 76 HO File—RLA File SSCL ic.Nov/Date:0310830632 | _ |:01/82/050/00464/AM20/ ——_—|:03/95/040/00426/AM20/, 29.07.2019 | | [Decisions ” Betered trsoaiens TE ‘Case No.:243/6/82-ALC4/2019 Party Name:MAHAVIR Meet No/Date:6/82-. (Status: | SYNTHESIS PRIVATE ‘ALC4/2020 [Deferred ae . ‘LIMITED 13.11.2020 7 HHQFile [RLA File " iLic.No/Date:5210043127 | | (:01/82/050/00469/AM20/ ':52/24/040/00023/AM20/ 29.07.2019 | | ‘Decision: -Deferredforcomments of TE. a ee a ; |[Case No.:249/6/82-ALC4/2019 (Party Name:AUROBINDO —__Meet No/Date:6/82Status: ooi - |PHARMA LIMITED “ALC4/2020 Deferred | PHQFile Oo 13.11.2020, | (:01/82/050/00475/AM20/= ~~~~SY(RLAFile.=~=~=—~SSSS~~*”:CSSSCS——|:09/24/040/00232/AM20/ — 30.07.2019Lic Neate 30910067851 | (Decision:Deferred forcommentsof TE. |
; . ,
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----- Start of picture text -----<br> '"TCase No.:256/6/82-.~—~—~«~PartyName: WEXFORD —/Meet No/Date:6/82-_ Status: |<br>» |ALC4/2019 ‘LABORATORIES P LTD ALC4/2020 ‘Approved |<br>' 4$:01/82/050/00482/AM20/ 07/24/040/00100/AM20/ 01.08.2019 oe ;<br>| (Decision:|was decided toTheratifyCommitteethe ad-ho c onsideredinput outputcase asnormsperunder agendaparain 4.07 the presenceof HBP Vol. of the technical| as per details experts below andor itas '‘<br>| lapplied by firm whichever is lower: ;<br>i279 Sk. Export Product Qty. Sl. Import items ;<br>1 CEFADROXIL 500MG CAPSULES | 365300.000 | 1 CEFADROXIL 186.303 kg |, :<br>Number MONOHYDRATE| --. |<br>2 CEFADROXIL 250MG/SML . | 18228.000 | 2 CEFADROXIL 95.67 kg<br>SUSPENSION 100ML BOTTLE Number MONOHYDRATE Lae i<br>| RA concerned may take further necessary action as per above decision of NC.<br>| Case No.:257/6/82- ‘Party Name:EMMENNAR |Meet No/Date:6/82- 1Status: ~<br>i /ALC4/2019 ‘PHARMA PRIVATE . |ALC4/2020 |Approved<br>: HQFile |RLAFile~~ ~~——~—|Lic.No/Date:0910067855 }- :<br> ‘Decision: The Committee considered case as per agenda in the presence of the technical experts and it<br>| - |wasjas applied decidedby tofirm ratifywhichever the ad-hocis lower: input output norms under para 4.07 of HBP Vol. | as per details below or; ‘j<br>80 Export Product Qty. | SL Import items Qty. '<br>: No. | Es<br>| | | SG)-2-AMINOBUTYRAMIDE | I kg PROPIONALDEHYDE 127kg. | of<br> | |HYDROCHLORIDE SODIUM CYANIDE LO8kg, |<br>P| L(+) TARTARIC ACID li2kg. |<br>| . METHYLENE DICHLORIDE | 1.12kg- | f<br>| ACETONE 186kg- | |<br>16|METHANOL 1.39 kg —<br>| IRA concerned may take further necessary action as per above decision of NC. 3 :<br>: Case No.:264/6/82-ALC4/2019; (Party‘NOVOCHEMName: DEEPAK ALC4/2020Meet No/Date:6/82- Status:Deferred iE<br>{ | iTECHNOLOGIES LTD 13.11.2020 q<br>/ |HQ File RLA File Lic.No/Date:3 110067490 a<br>81 |:01/82/050/00490/AM20/ ::31/83/040/0005 1/AM20/ (02.08.2019 —<br>| noted|Decision: ~The Committee considered the case as.per agenda in the presence of technical expertsand it was|/<br>that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 14/82-. i<br> “{ALC4/201916. 10.2020 as perdated Policy06.03.2020, Circularfollowed No. 23/2015-20,by Reminderdated 15.05.2019.to firm on Hence,07.08.2020 the caseandis deferredFinal Reminder on, &= |<br>----- End of picture text -----<br>
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a [SCIENCES LIMITED /ALC4/2020 Deferred HQ File - IRLA File | ‘Lic.No/Date:0910067866 [SS | :01/82/050/00488/AM20/ —_—:09/24/040/00244/AM20/ (05.08.2019
|[Case No.:268/6/82-ALC4/2019 ‘Party(VAPI)LTD., Name:CHEMIESYNTH No/Date:6/82-iALC4/2020[Meet [Deferred(Status: | HQ File iRLA File~— ‘Li¢,No/Date:0310830809 ;SS | |:01/82/050/00494/AM20/. _':03/94/040/00363/AM20/ (05.08.2019 a 83 (Decision: The Committee considered the case as per agenda in the presence of technical experts and it [was decided to call for following information from the firm: ; Pot (i) Exact chemical name of Export Product with molecular weight. i - | (ii) Complete chemistry, molecular weight, material balance and % yield.
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
||(Case No.:1/10/82-ALC4/2019|[Party|Name:|MALLADI|“Meet No/Date:6/82-|Status:|
|i|.|IDRUGS &|/ALC4/2020|Deferred|
|i|(HQ|File|RLA|File|:|‘Lic.No/Date:0410166026|.|
|||(Decision:|Deferred forcommentsofTE.|eee|
|||(Case No.:15/10/82-ALC4/2019||Party Name:SRINI|~|(Meet|No/Date:6/82-|Status:|
|:|[PHARMACEUTICALS|+ ALC4/2020|Deferred|
|||iPRIVATE|LIMITED|'13.11.2020|:|
|||01/82/050/00589/AM20/|°_-|:09/24/040/00304/AM20/|05.09.2019|i|
|7|Case|No.:16/10/82-ALC4/2019 {Party|Name:VIVIN|DRUGS|&|[MeetNo/Date:6/82- Status:|
|Dy|.|PHARMACEUTICALS||ALC4/2020|Deferred|||
|i|LIMITED|(13.11.2020|||
|86|'101/82/050/00590/A|M20/||:09/24/040/00289/AM20/|_|(05.09.2019|,|
|‘Decision:|The|Committee|considered|the|case|as|per|agenda|in|the|presence|of technical|experts|and|it.|
|:|!was|noted|that|the|firm|still|has|not|furnished|the|4.07|application|asked|for|by|NC-3|in|its|Meeting|No.||
||||14/82-ALC4/2019|dated|06.03.2020,|followed|by|Reminder|to|firm|on|07.08.2020|and|Final|Reminder|on:|
|||16.10.2020|as per|Policy|Circular|No.|23/2015-20,|dated|15.05.2019.|Hence,|the|case|is|deferred.|
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, a /=(CaseNo.:18/10/82-ALC4/2019- PartyPHARMACEUTICALSName‘CADILA.LTD.Ss MeetALC4/2020. No/Datte:6/82-=(CaseNo.:18/10/82-ALC4/2019- PartyPHARMACEUTICALSName‘CADILA.LTD.Ss MeetALC4/2020. No/Datte:6/82-(CaseNo.:18/10/82-ALC4/2019- PartyPHARMACEUTICALSName‘CADILA.LTD.Ss MeetALC4/2020. No/Datte:6/82-No.:18/10/82-ALC4/2019- PartyPHARMACEUTICALSName‘CADILA.LTD.Ss MeetALC4/2020. No/Datte:6/82- PartyPHARMACEUTICALSName‘CADILA.LTD.Ss MeetALC4/2020. No/Datte:6/82-PHARMACEUTICALSName‘CADILA.LTD.Ss MeetALC4/2020. No/Datte:6/82-Name‘CADILA.LTD.Ss MeetALC4/2020. No/Datte:6/82-‘CADILA.LTD.Ss MeetALC4/2020. No/Datte:6/82-LTD.Ss MeetALC4/2020. No/Datte:6/82-Ss MeetALC4/2020. No/Datte:6/82- MeetALC4/2020. No/Datte:6/82-ALC4/2020. No/Datte:6/82- No/Datte:6/82‘Status:DeferredDeferred :| ; | 13.11.2020 z S7uQFiie ~~~ IRLAFile =~ —~—~—~—~— Lic.No/Date:0810146100No/Date:0810146100 ( | ” 01/82/050/00S92/AM20/ |.08/24/040/00175/AM20/ (05.09.2019 at Deferred for for comments of of TE. | | Case No.:19/10/82-ALC4/2019 |Party Name: MEHK Meet No/Date:6/82(Status: - | ‘CHEMICALS PVT. LTD. jALC4/2020 - ‘Deferred Bi | (13.11.2020 | - JHQFile ”~CS:~<CSs~ RL Fle Lic. No/Date:0510831392 i | A i 88 |:01/82/050/00593/AM20/ —|:03/95/040/00555/AM20/ » (06.09.2019, |, gf ‘Decision: The Committee considered the case as per agenda in the presence of technical experts and it, 1 | iwas decided to call for following information from the firm: i | | | (i) Complete chemistry, molecular weight, % yield and material balance. a t [CaseNo.:27/10/82-ALC4/2019 | [PartyHIMALAYAN Name:M/S PRODUCTS & Meet:ALC4/2020No/Date:6/82- (Status:Deferred | i“4 ;] = lINDUSTRIES CORPN., P.LTD ‘13.11.2020 i SoHoFile ~~*(RLAFile. LicNo/Dateso110001014. | Ss~—~—<isi:sé«S ; |:01/82/050/0060 1/AM20/_ °61/24/040/00007/AM20/ 06.09.2019 ob mt - ‘Decision: Deferred for comments of TE. | , - H
/=(CaseNo.:18/10/82-ALC4/2019- PartyPHARMACEUTICALSName‘CADILA.LTD.Ss MeetALC4/2020. No/Datte:6/82-=(CaseNo.:18/10/82-ALC4/2019- PartyPHARMACEUTICALSName‘CADILA.LTD.Ss MeetALC4/2020. No/Datte:6/82-(CaseNo.:18/10/82-ALC4/2019- PartyPHARMACEUTICALSName‘CADILA.LTD.Ss MeetALC4/2020. No/Datte:6/82-No.:18/10/82-ALC4/2019- PartyPHARMACEUTICALSName‘CADILA.LTD.Ss MeetALC4/2020. No/Datte:6/82- PartyPHARMACEUTICALSName‘CADILA.LTD.Ss MeetALC4/2020. No/Datte:6/82-PHARMACEUTICALSName‘CADILA.LTD.Ss MeetALC4/2020. No/Datte:6/82-Name‘CADILA.LTD.Ss MeetALC4/2020. No/Datte:6/82-‘CADILA.LTD.Ss MeetALC4/2020. No/Datte:6/82-LTD.Ss MeetALC4/2020. No/Datte:6/82-Ss MeetALC4/2020. No/Datte:6/82- MeetALC4/2020. No/Datte:6/82-ALC4/2020. No/Datte:6/82- No/Datte:6/82‘Status:DeferredDeferred on | 13.11.2020 S7uQFiie ~~~ IRLAFile =~ —~—~—~—~— Lic.No/Date:0810146100No/Date:0810146100 | ” 01/82/050/00S92/AM20/ |.08/24/040/00175/AM20/ (05.09.2019 Deferred for for comments of of TE.
|_'Case No.:28/10/82-ALC4/2019. [Party Name:SRF LIMITED Meet‘ALC4/2020 No/Date:6/82Status:Deferred 0 TQ File IRLA File ~~ Lic.No/Date:0510411778 | ; 101/82/050/00602/AM20/ |:05/24/040/00296/AM20/ 06.09.2019 a to | | Decision: : Deferred for comments ofTE
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- ‘Case No.:30/10/82- “PartyName:MANGALAM (Meet No/Date:6/82-.—~<Status:—S<br>. |ALC42019 . ‘DRUGS AND ORGANICS i/ALC4/2020 ‘Approved <br>) Lo LIMITED (13.11.2020 3 oe<br>THQ File IRLAFile ~~ ~—Lic.No/Date:0310831434.,SCS<br>. _ |:01/82/050/00604/AM20/ 1:03/95/040/00483/AM20/ '09.09.2019 |<br>-<br>;<br>. | |Decision: | The Committee considered the case as per agenda and in the light of earlier decision taken in: ;<br> {meeting no: 10/82-ALC4/2019 dated 29.11.2019 against advance authorization No. 0310832757 dated:<br>; | (14.11.2019, it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per: ;<br>ll jdetalls below or as applied by firm whichever is lower: ,<br>, | “Export Product Qty. | Sl | Import items Qty. |<br>if : No. : :<br>F i | PIPERAQUINE PHOSPHATE Lkg | 1 ETHOXY METHYLENE MALONIC | 1.30 kg _ ,<br>! . ACID ESTER (EMME) an<br>‘ PIPERAZINE ANHY DROUS 0.832 kg: | .<br>- | IRA concerned may take further necessary action as per above decision of NC. - ot<br>i” {Case No.:31/10/82-ALC4/2019 Party Name‘SUVEN LIFE [Meet No/Date:6/82- Status a<br>| | a, SCIENCES LIMITED tALC4/2020 ‘Deferred<br>. op be ol eg HSML2020 ee<br>.<br>: *, ' HOFile © (RCA Fle anon (itnNovDatesoot0067982 [|<br>. | :01/82/050/00605/AM20/ :09/24/040/00307/AM20/ (09.09.2019 ~ | Bo<br>|<br>; | [Decision Deferred for comments of TE”a | |<br>-be ~~ [CaseNo.:32/10/82-AL.C4/2019|Party Name:DEEPAK NITRITE MeetNo/Date:6/82- (Status: ee<br>= boa. 7 LIMITED _ * :ALC4/2020 Deferred |<br>; oO i | Oe 13.11.2020 | | Poo<br>. . 93 IHQFile. OIRLAFile ‘Lic.No/Date:34 10045437 a. : .<br>i | [Decision: Deferred for comments of TE. ee a 7 . : - )<br>ee [Case No.:33/10/82-ALC4/2019 |Party Name:NISARG ‘Meet No/Date:6/82-. (Status: =~<br>ot Py Do IBIOsCIENCES PVT LTD iALC4/2020 Deferred — | .<br>: HQFile = RLAFile © Lic. No/Date:0910067984<br>. | |:01/82/050/00607/AM20/ :09/24/040/00309/AM20/ 11.09.2019 | Do,<br>wo oe iDecision: ~ .The Committee considered the case as per online agenda in the presence of technical experts;<br>Lo land it was noted that the firm still has not furnished the following information asked for by NC-3 in its’<br>P4 Meeting No. 3/82-ALC4/2020 dated 07.08.2020, followed by Reminder on 06.10.2020:<br>, | (i) “% yield at each stageof manufacturing. .<br> (ii) . Calculationmolecular weight..Sheet for requirement of quantity asked on the basis of % yield and;<br>7 . | “In view of above, the Committee decided to issue Final Reminder to firm to furnish its<br>| |reply, failing which the case will be rejected. ee<br>----- End of picture text -----<br>
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| (Case No.:34/10/82-ALC4/2019 ‘Party Name:OPTRIX , Meet No/Date:6/82‘Status: } -_ “LABORATORIES PRIVATE |ALC4/2020 _ Approved 7 = - (LIMITED. (13.11.2020 | HOfie RA Bile LiesNorae0910067089 | 7 ; |:01/82/050/00608/AM20/ 09/24/040/003 10/AM20/ 111.09.2019 | (Decision: The Committee considered the case as per agenda and in the light of earlier decision taken in” | imeeting no. 2/82-ALC4/2020 , dated . | §10.07.2020 - against advance authorization No. - 0910067270 dated — | '13.03.2019,lapplied by theit wasfirm, dec wh i cheverded to ratifyis less: norms under Para 4.07 of HBP Vol. I as per details given below or as, . | VELPATASVIR-COPOVIDONE | ikg | 1 Methyl [(2S)-1-[(2S,55)-2-[9-[2| 0.555kg ay : . [(2S,4S)-1-[(2R)-2| | i [(methoxycarbonyl)amino]-2a : phenylacetyl]-4, ; | . (methoxymethy!)pyrrolidin-2-yl]| : dihydroisochromeno[4,3 6,7] | ; | naphtha[1,2-d]imidazol-2-yl]-5, a metliylpyrrolidin-1-yl]-3-methyl| i 1-oxobutan-2-yl)carbamate i ‘RA concerned may take further necessary action as per above decision of Norms Committee.
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----- Start of picture text -----<br> i |Case No.:37/10/82- \Party Name:MANKIND ‘Meet No/Date:6/82- [Status | E.<br>: |ALC4/2019 (PHARMA LTD - ‘“ALC4/2020 ‘Approved E<br>| . os NN 2020 OY<br>, | lO File RLAF | Tic NovDate-051 oaiiaox fo i<br>|:01/82/050/0061 1/AM20/ 1:05/24/040/00336/AM20/ 11.09.2019 | i is<br>_ |Decision: — The Committee considered the case as per agenda and in the light of earlierdecision taken<br>| |meeting no. 3/82-ALC4/2020 dated 07.08.2020 against advance -authorization No. 0510410328 datedin<br>| (23.04.2019, it was decided to ratify norms under Para 4.07 of HBP Vol. 1 as per details given below or as|| i&<br>: _ lapplied by the firm, whichever is less: . . i<br>96 | : og<br>SI. | Export product Qty. SI. | Import items’ _ Qty. sp i<br>i No. - No. ; J HP<br>co, 1 CLOMIPRAMINE HCL | | Number | 1 ‘| CLOMIPRAMINE HCL | 25.50 mg/ ; 5<br>CAPSULES, USP 25 MG USP | 25mgcapsule | ff<br>2 CLOMIPRAMINE HCL} 1 Number | 1 | CLOMIPRAMINE HCL | 51.00 mg/ — | |.<br>-_ | CAPSULES, USP 50 MG USP 50-mg capsule |},<br>CLOMIPRAMINE HCL} 1Number | | CLOMIPRAMINE HCL |°76.50 mg/ | i<br>CAPSULES, USP 75 MG USP 75 mg capsule | | i?<br>| {RA concemed may take further necessary action as per above decision of Norms-‘Committee. :<br>ovonneetenennimanieannenantuunsesanstninsueynpuiynauaymnrnnineinenanivarninnrnnmntuninnnititirittniti nt: iannnntnnnanenaunitannnenunnuaNeneenANnannininninAnNeLMNNNnKietnilrierined I<br>----- End of picture text -----<br>
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"|oa CaseNo.:38/10/82-ALC4/2019, [Party& PHARMACEUTICALSName:J.B. CHEMICALS. Meet {ALC4/2020No/Date:6/82-© (Status:Deferred » /HQ :01/82/050/00612/AM20/_ File - ~IRLA:03/94/040/00455/AM20/File ‘Lic.No/Date:031083148311.09.2019 , . | i ‘Decision: Deferred forcommentsofTE. . eee : i | [Case No.:43/10/82-ALC4/2019 PartyName:KEVA«(Meet No/Date:6/82- (Status: oo _ |FRAGRANCES PRIVATE (ALC4/2020 Deferred | i LIMITED 13.11.2020 ; , | °8 ThiQ File IRLA File (Lic. No/Date:0310831524 , , Decision: Deferred forcommenis ofTE. SS sven meas p : J ‘Case No.:48/10/82-ALC4/2019 |Party Name:ENCUBE Meet No/Date:6/82Status: on {ETHICALS PVT LTD j|ALC4/2020 [Deferred bog bo to . we SLE 20200 °? THQ File IRLA File ~ Lie.No/Date:0310831546. , | |:01/82/050/00622/AM20/ (:03/94/040/00395/AM20/ (13.09.2019 | [Decision Deferred for commen .7 wrenemy namin Saas | | _ Case No.:51/10/82-ALC4/2019 |Party Name:ALPHAMED Meet No/Date:6/82Status: " Po a /FORMULATIONS PRIVATE jALC4/2020 (Deferred | oo | {LIMITED 113.11.2020 | 7 THQ File . (RLAFile —————S—S—~™CL ic,No/Daate:0910067997 [| ) |Decision: The Committee considered the case as per agenda in the presence of technical experts and it) : _fwas noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No.| oO : '(14/82-ALC4/2019 dated 06.03.2020, followed by Reminder to firm on 14.08.2020 and Final Reminder oni | 06.10.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019. Hence, the case is deferred. | . ~~ » "[CaseIALC4/2019No.:54/10/82- SS(PartyName:SANDHYAORGANIC CHEMICALS [Meet No/Date:6/82..—(ALC4/2020 ‘Approved(Status: , "THQ File RLA File " |Lic.No/Date:031083 :01/82/050/00628/AM20/ :03/95/040/00423/AM20/ 16.09.2019 1560 | - : [Desision: The Committee considered case as per agenda in the presence of the technical experts and it ' twas decided to ratify the. ad-hoc input output norms under: para 4.07 of HBP as per details below or as: 101 [applied by firm whichever is lower: po: No. | | DE. PHENYL ISODECYL | 1 kg PHENOL 0.557 kg | | | PHOSPHITE (DPDP) ISODECYL ALCOHOL 0.419 kg. a | YELLOW PHOSPHROUS _ | 0.087 kg : : [RA concemed may take further necessary action as per above decision of NC. ©. sO
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----- Start of picture text -----<br> [Case No.:55/10/82- [Party Name:SANDHYA ‘Meet No/Date:6/82- Status: | 3 |<br> (ALC4/2019 j(ORGANIC CHEMICALS ‘ALC4/2020 Approved . +t<br>an “PRIVATE LIMITED 13.11.2020 . i<br>| /HQFile ~—~—~—”—CRLLA File =——<—té‘“‘—~~CSCSCSCL ie No/Daate:0310831562] bo : .<br><br>;<br>: __ Decision:|was decided Theto ratifyCommitteethe ad-hocconsideredinput output case asnorms per agendaunder inpara the4.07 presenceof HBP of the tas p e rchnicdet a ilsl expb e lowrts andor it!as/ iat} I<br>(102 applied by firm whichever is lower: : . : | 7<br>Export Product . Qty. Sl. | Import items Qty. a<br>— TRIPHENYL PHOSPHITE ikg YELLOWPHENOL PHSOPHORUS _ || 0.9370.1 kg kg || 7| i<br>, se sina meuenecnenmeneremenenenerenenenJRA concerned“fps is conecehits mayon ok take tht ft mmiminfurthermnmenenin nanan necessaryrmernriomenenensnaneatte actionsite nen sitet as persetnemntintateeenerenen abovennn decision nannies chan ofitieeeaeetNC.teeter a erAf Am ces dee one temanst semen nner. ememnerereerdi aita H ,<br>| {Case No.:56/10/82- Party Name:CADILA .|Meet No/Date:6/82- |Status: | x<br>| |ALC4/2019 '. |HEALTHCARE LTD . |ALC4/2020 [Approved ut<br>| HQ File RLA File ‘ILic.No/Date:0810146177 | _ i<br>1:01/82/050/00630/AM20/ 108/24/040/00172/AM20/ {16.09.2019 | i<br>_ [Decision: The Committee considered the case as per agenda and in the light of earlier decision taken in. i<br>| (meeting no. 4/82-ALC4/2020 dated 18.09.2020 against advance authorization No. 0810143413 dated<br>ot 07.09.2018, it was decided to ratify norms under Para 4.07 of HBP Vol. I as_ per details given below or as:| 1!<br>: applied by the firm, whichever is less: ; - 7 S<br>Export Product Qty. SI. ] Import Items Qty. allowed in mg for 1 Number | ‘ ie<br>tT. i. No. >. Tablet i<br>|| [PROMETHAZINE | 1 1 | PROMETHAZINE. | 12.75mg | 25.50mg | 51.0mg | fi<br>103} | TABLETSHYDROCHLORIDEUSP 12.5 | NumberTablet | HYDROCHLORIDEUSP. ee|; ia| 1<br>. MG / 25 MG / 50 2 HYDROXY - 1200mg |4.00mg | 8.00mg |: if<br>i MG Tablet PROPYL |<br>EL CELLULOSE (LOW i<br>,<br>| . 3 | HYDROXYPROPYLSUBSTITUTE) | 4.00 mg | 8.00mg | 16.00 mg_||. i |<br>_ ' [4 | LACTOSE -[ 81.00 mg | 162.00 [324.00 | [ff<br>i DC 5 STEARATE|MAGNESIUM [050mg | 100mg : |2.00mg | @<br>_ ; PH.E/NF/JP ot<br>eeeenennneesRAsmemes opments concernedos penne oe neppeeto may snae sennesnnsnnaieneeromenauninanennsannasinananeninenesiscsuiuts/ take further necessary actioniui as shnasunin per aboveascinninnysnin fanisinitioinseensismenunesinnssnnnantinnsisnseiinieinusinitttNiLuplt decision of Norms Committee. bien on seme"oeiis 4h!<br>----- End of picture text -----<br>
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||||||||"TCaseNo.:57/10/82-ALC4/2019 PartyName:CADILA<br>HEALTHCARE LTD|"TCaseNo.:57/10/82-ALC4/2019 PartyName:CADILA<br>HEALTHCARE LTD|"TCaseNo.:57/10/82-ALC4/2019 PartyName:CADILA<br>HEALTHCARE LTD||‘MeetNo/Date:6/82-<br>‘Status:<br>1ALC4/2020<br>Approved|||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|||||(HQFile<br>IRLA File<br>©<br>|:01/82/050/00631/AM20/<br>|:08/24/040/00173/AM20/|||||||[Lic.No/Date:0810146178<br>|<br>16.09.2019|;|||
|||,||i<br>:||Decision:<br>|The Committee considered the case asper agendaand in the light ofearlier decision taken in:<br>meeting no. 12/82-ALC4/2019 dated 17.01.2020 against advance authorization No. 0810141617 dated||||||||
|||||(27.12.2017, it wasdecided to ratifynorms under Para 4.07 ofHBP<br>:<br>japplied by the firm,whichever is less:<br>:||||||HBP Vol. las per details given below or|as!|||
|||||><br>4<br>><br>bo|f|ISL<br>Export product<br>INo.<br>DIVALPROEX SODIUM<br>SPRINKLECAPSULESUSP 125|Qty.<br>9625000.0001<br> | Number|No.<br>1||Import items<br>Qty.<br>| RgATPROEXSODIUM | 1295.75kg<br>USP||||
|||||||(EACH CAPSULE CONTAIN||||2910 USP||||
|||||i||134.50MGOF DIVALPROEX<br>SODIUM USP EQUIVALENT|,|3||MICROCRYSTALLINE | 863.05 kg<br>CELLULOSE NF,||||
|||||||TO 125 MGOFVALPORIC||||PH.EUR||||
||||,|i<br>|||DIVALPROEX SODIUM USP -<br>NETWT. 1294.563KGS)<br>DIVALPROEXSODIUM<br>- <br>DELAYED RELEASE TABLETS||4400000.0001|"5 <br>1||COPOLY DISPERNF<br> PIRIETHYL CITRATENF [3375Re]<br>| BALPROEXSODIUM | 59241ke<br>|<br>USP<br>;<br>.||||
|;||||—<br>po<br>‘104<br>a<br>a<br>a<br>Po||(EACHTABLETCONTAIN<br>|<br>134.50MGOFDIVALPROEX<br>SODIUMUSPEQUIVALENT<br>TO 125 MG OF VALPORIC<br>ACID)(ACTIVEINGREDIENT :<br>DIVALPROEXSODIUMUSP -<br>NETWT.591.800 KGS)||(6 <br>7|COPOLY DISPERNF<br> | POVIDONEUSP (K-30<br>WICROCRYSTALLINE<br>338:<br>CELLULOSE<br>7OKE<br>NE/IP/PH.E/BP(AVICEL<br>PHO)<br>MAGNESIUM||i<br>_|||
|||;||||3<br>DIVALPROEX SODIUM<br>DELAYEDRELEASETABLETS||3950000.000<br>| Number|||USP||||
||_|||P|<br>(EACH TABLET CONTAIN 269<br>|<br>MGOFDIVALPROEX SODIUM||||”<br> |<br>[3|||COPOLYDISPERNF<br> TRIETHYLCITRATENF<br>[948k@|||||
|||||_<br>Ot||INGREDIENT «DIVALPROEX<br>SODIUMUSP-NETWT.<br>{062.550KGS)|-|7||MICROCRYSTALLINE ]418.185kg <br>NPIIP/PHE/BP AVICEL<br>Paige|||||
|||||yo||||||STEARATE PH.E/NF/JP||||
|||||||F<br>DIVALPROEX SODIUM<br>DELAYEDRELEASETABLETS|2950000.000<br> |Number|||USP||||
||.|Bo||bP<br>,<br>|||<br>|| <br>-<br>|||(EACHTABLETCONTAIN 538<br>| [MGorpivatproex sopium<br> | | USPEQUIVALENT<br>ToS00MG<br>OF VALPORICACID)(ACTIVE<br>INGREDIENT :DIVALPROEX<br>SODIUMUSP -NETWT.<br>1587,100KGS)|||COPOLY DISPERNF<br>[5__[TRIETHYL<br>CITRATENF | 1416kg<br>[5 | POVIDONE USP(K-30) [112.10kg<br>7 |MICROCRYSTALLINE | 624.66 k<br>:<br>66<br>kg<br>:<br>CELLULOSE<br>:<br>NF/IP/PH.E/BP(AVICEL<br>|,<br>_|<br>PHIOIL)||||||
||||||||||||||.|
||oy|||'||||||STEARATEPH.E/NEF/JP||||
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----- Start of picture text -----<br> a|p DIVALPROEXEXTENDED RELEASE SODIUM ~ | 8050000.000.Number ft | DIVALPROEX SODIUMUSP _ | 2167.46kg = |: t‘i<br>_ TABLETS(EACH TABLET USP 250 CONTAIN.269 MG eT MAGNESIUMSTEARATE PH.E/NF/JP 74.5 kg .en @|<br>| . | MGUSP OF EQU D IVAL ENTPROEX SODIUM TO 250 MG HYPROMELLOSECPS, 2208 USP 15000 | 1835.40kg |. EL|<br>oy OF VALPORIC ACID) (ACTIVE 10 | HYPROMELLOSE 5 CPS, | 338.10 kg fe<br>ani INGREDIENT : DIVALPROEX 2910 USP if<br>a SODIUM USP - NET WT. 1} HYDROXYPROPYL 652.05 kg z<br>—_ 2165.450 KGS) - * | CELLULOSE NF : ys<br>— 12 | HYDROXYPROPYL 265.65kg |. i<br>CELLULOSE NF f<br>a 6. | DIVALPROEXEXTENDED RELEASE SODIUM 6250000.000Number pt DIVALPROEXUSP SODIUM | 3365.625kg | ie|<br>TABLETS USP 500 MG MAGNESIUM 115.69kg |: ‘I<br>oe (EACH TABLET CONTAIN 538 STEARATE PH.E/NF/JP | 4<br>i MG OF DIVALPROEX SODIUM HYPROMELLOSE 15000 | 2850.00kg | fi<br>a USP EQUIVALENT TO 500 MG |’ CPS, 2208 USP u |<br>Do. OF VALPORIC ACID) (ACTIVE 10 HYPROMELLOSE 5 CPS, | 525.00 kg ! <br> INGREDIENT : DIVALPROEX 2910 USP ahi<br>SODIUM USP~ NET WT. 11 | HYDROXYPROPYL 1012.50kg | i<br>| 3362.500 KGS) | : | CELLULOSE NF | i<br>_ 12 |(KLUCELHYDROXYPROPYL HXF) 412.50 kg _} ai }<br>| CELLULOSEKLUCEL EXF) NF iiy<br>RA concerned may take further necessary action as per above decision of Norms Committee. 4<br>Case No.:70/10/82-ALC4/2019 Party Name: THERAPIVA iMeet No/Date:6/82- Status: cl "<br>mood, ‘PRIVATE LIMITED 1ALC4/2020 Deferred | Fi<br>— [HQFileREAFile [SSt*~~S~S:CS] [Lic.][Nc/Daate:0.910068000] [|]<br>105 |:01/82/050/00644/AM20/ 109/24/040/00294/AM20/" 16.09.2019 _<br>| |Decision: | The Committee considered the case as per agenda in the presence of technical experts and it} ‘| |<br>| [was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. il<br>» — 14/82-ALC4/2019 dated 06.03.2020, followed by Reminder to firm on 07.08.2020 and Final Reminder on’ ia<br>| 106.10.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019. Hence, the case is deferred. \ |<br>----- End of picture text -----<br>
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"|(CaseNo.:71/10/82-" ———=*[PartyNName-OPTRIX ‘Meet No/Date-6/82. ‘Status. ALC4/2019 LABORATORIES PRIVATE |ALC4/2020 ‘Approved tot LIMITED "}13.11.2020 ° , {Ho File RLA File ~ [Lic.No/Date:0910068001,. SC, | Decision: |The Committee considered the case as per agenda and in the light of earlier decision taken in meeting no. 4/82-ALC4/2020 dated 18.09.2020 against advance authorization No. 0910066086 dated + 26.03.2018, it was decided to ratify norms under Para 4.07 of HBP Vol. I as_per details given below or as | \applied by the firm, whichever is less: . . | . No. | | EMPAGLIFLOZIN-IH | 1 kg 1 (1S)-1 5-Anhydro-1-C-[4-chloro -3-[[4-[[(3S)1525 kg | boos tetrahydro-3o . furanyl]oxy]phenyl]methyl]pheny!]-D-glucitol i | tetraacetate ml . : OR (1S)-1 5-Anhydro-1-C-[4-chloro -3-[[4[[(3S)-tetrahydro-3. | | furanyl]oxy]phenyl]methyl]phenyl]-D-glucitol., 7 concerned may take further necessary action as per above decision of Norms Committee. |
/[Case No.:63/10/82-ALC4/2019[|] Party Name:RENOWN Meet No/Date:6/82(Status: Pood. “PHARMACEUTICALS ALC4/2020 Deferred | ‘PRIVATE LIMITED — - 13.11.2020 | , |Decision: Deferred for comments of TE. ee ee . os - | [Case No.:73/10/82-ALC4/2019, |Party Name:CLEAN SCIENCE (Meet No/Date:6/82- (Status: ‘AND TECHNOLOGY YALC4/2020 Deferred | | . PVT.LTD. 13.11.2020 . {HQ File IRLA File ~~ [Lie.No/Date:3110067535 [0 :01/82/050/00647/AM20/ = ——j:31/82/040/00056/AM20/ . h19.09.2019 | | 108 Decision: The firm vide e-mail dated 24.11.2020 has informed that due to current scenario of COVID- | | 419, they are working with limited staff. The person handling all DGFT activities is not available for few - |’ idays to send the required documents related to above mentioned Advance Authorisation. Accordingly,| | they have requested to allow them 45 days to send the required application. . , . The Committee considered the request of firm and decided to grant 45 days time to firm to| . {furnish 4.07 application of subject Advance Authorization.
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|“"IGase|Noz129/10/82.|~~|(PartyName:TRANSPEK MeetNo/Date:6/82-—[Status:|
|ALC4/2019|INDUSTRY|LIMITED|ALC4/2020|Approved|
|13.11.2020|
|||THO|File|IRLA|File|‘Lic.No/Date:3410045471|
|mo|:01/82/050/00703/AM20/|——_,:34/24/040/00187/AM20/|:20.09.2019|.|
|||Decision:|The|Committee considered case as per agenda.in considered case as per agenda.in case as per agenda.in as per agenda.in per agenda.in agenda.in|the presence presence|of the technical experts and it the technical experts and it technical experts and it experts and it and it it|
||109.|was|[[as]]|[[applied]]|decided|[[by]]|to|[[firm]]|ratify|[[whichever]]|the ad-hoc ad-hoc|[[is]]|[[lower:]]|input output norms under para 4.07 of HBP output norms under para 4.07 of HBP norms under para 4.07 of HBP under para 4.07 of HBP para 4.07 of HBP of HBP HBP|Vol.|I as per details below as per details below per details below details below below|or:|
|No.|
|2,4,6 TRIMETHYL BENZOYL TRIMETHYL BENZOYL BENZOYL|Lkg|1|MESITY LENE|1.132|kg|
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|:01/82/050/00703/AM20/|——_,:34/24/040/00187/AM20/|:20.09.2019|.|7|
|Decision:|The|Committee considered case as per agenda.in considered case as per agenda.in case as per agenda.in as per agenda.in per agenda.in agenda.in|the presence presence|of the technical experts and it the technical experts and it technical experts and it experts and it and it it|j|
||109.|was|[[as]]|[[applied]]|decided|[[by]]|to|[[firm]]|ratify|[[whichever]]|the ad-hoc ad-hoc|[[is]]|[[lower:]]|input output norms under para 4.07 of HBP output norms under para 4.07 of HBP norms under para 4.07 of HBP under para 4.07 of HBP para 4.07 of HBP of HBP HBP|Vol.|I as per details below as per details below per details below details below below|or:|i‘|
|No.|:|
|2,4,6 TRIMETHYL BENZOYL TRIMETHYL BENZOYL BENZOYL|Lkg|1|MESITY LENE|1.132|kg|-|
|IRA|concerned may|take|further necessary|action as per above|decision|of NC.|Oo|a|4|
|ase|No.:131/10/82-—~—~—~—~*(PartyNName:TRANSPEK|Meet No/Date:6/82-|(Status: =||
|ALC4/2019|INDUSTRY|LIMITED|‘ALC4/2020|Approved|4|
|||HQ|File|RLA|File|Lic.No/Date:34 10045470|7|
|||}:01/82/050/00705/AM20/|—_—:34/24/040/00189/AM20/|20.09.2019|.|_|
|_|[Decision:|||TheCommittee consideredcase|as|per|agenda|in|the|[presence][of][the]|[technical][ experts]|and it,|J|
|was|decided|to|ratify|the|ad-hoc|input|output norms|under|para|4.07|of HBP|Vo.l.|||as|per|details|below|or||7|
|10|as applied by firm|whichever|is lower:|f|
|No.|Ht|
|_|||| ISOPHTHALOYL|kg|1|ISOPHTHALIC ACID|0.845|kg|a|
|CHLORIDE/TEREPHTHALOYL|r|
|CHLORIDE|MIXTURE (93%/7%)|||;|
||RA concerned may take|further|necessary action as per above|decision of|NC.|(|:|
|[Case No.:78/10/82-ALC4/2019 PartyName:STERLING|[Meet|No/Date:6/82-|Status:|
|_|.|AUXILIARIES PVTLTD|=||ALC4/2020|||[Deferred|§|
|||13.41.2020|—|
|111L|.||HQ$01/82/050/00652/AM20/File||:03/95/040/00621/AM20/IRLA|File|123.09.2019Lic.No/Date:0310831732|‘|||_foo|
|_||_|was[Decision:noted|that— Thethe Committeefirm|vide|e-mailconsidereddated|06.10.2020the caseas|hasperagendafurnishedin theits|reply.presenceDeferred of technicalfor commentsexpertsofand TE. it|:j|
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( ALC4/2019 «SCIENCES LIMITED ALC4/2020 [Deferred . 1210 File IRLAFile ~~ [Lie.No/Date:0910068026 [ __ :{[01/82/050/00750/AM20/ 109/24/040/00322/AM 20/ 23.09.2019 —_— | - |Decision: Deferred for comments of TE.
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----- Start of picture text -----<br> _ [CaseNo.:79/10/82--——~—~—~=S~Party Name:AUROBINDO Meet No/Date:6/82, Status:<br>JALC4/2019 _ PHARMA LIMITED ‘ALC4/2020 [Approved<br>81-2020 | !<br>"| THQ File RLAFile —————«Lic.No/Date:0910068031..=——SSS™C~CS<br>401/82/050/00653/AM20/ '109/24/040/00327/AM20/ '24.09.2019<br>| |Decision: The Committee consideredcase as per agendain the presenceof thetechnicalexpertsand it,<br>| {was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or|<br>: ‘las applied by firm whichever is lower:<br>po Export Product . Qty. | No.SI. Import items Qty. ar<br>» DARUNAVIR PROPYLENE | | kg (2S,3S)-1,2-Epoxy-3-(Boc- 0.587kg |.<br>113 | | GLYCOLATE ; amino)-4-phenylbutaneBOC-Epoxide (or)<br>pS . © 4/2 Activated Carbon (Carbon | 0.100kg |,<br>, Enoanticromos) |<br>Cb, a - «73 __ | [3R,3aS,6aR]-3-Hydroxyhexahydrofuro[2,3- 0480kg |.<br>b]furany! succicinamidy| po<br>, ; carbonate<br>ft {sobutylamine 0.330kg |<br>Po, - Methanol (Methyl Alcohol) 1.92 kg |<br>, 16| Methylene Chloride 2.51 kg<br>|8 | Triethylamine 0.60 kg |<br>| RA concemed may take further necessary action as per above decision of NC. |<br>----- End of picture text -----<br>
_ Case No.:82/10/82-ALC4/2019 |Party Name:DANOPHARM _ ‘Meet No/Date:6/82Status: (CHEMICALS PRIVATE LTD, |ALC4/2020 Deferred _ 13.11.2020 > 4 jli4 HQ:01/82/050/00656/AM20/ File cccanma ATE aoazzamsoy (yt ovDate:0310831769 =, :03/94/040/00422/AM20/ 24.09.2019 an
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| {Case No.:87/10/82-ALC4/2019 [Party Name:OPES HEALTH (Meet No/Date:6/82-.Status: | |CARE PRIVATE LIMITED = |ALC4/2013.11.20 20 (DeferredL. | 115 {HQ File RLA File (Lic.No/Date:0810146231 | — 4:01/82/050/00661/AM20/ :08/24/040/00202/AM20/ '25.09.2019 r ‘|Decision:was noted that| The Committ the firm vid e ee-mail consi d ater ed the20.11.2020 case as perhas agendafurnished in i t shereply. presence ofDeferred technicalfor commentsexpertsof and TE.it:| ~~ [Case No.:96/10/82-ALC4/2019 PartyName:KAIRAV [MeetNo/Date:6/82-. (Status: ‘CHEMOFARBE INDUSTRIES j|ALC4/2020 Deferred | i LTD. 13.11.2020 of DleqiQFie:01/82/050/00670/AM20/$:03/94/040/00484/AMRLAFile.~—~—~—~™20/ (Lic.27.09.2019No/Date-03108318607 |. [Decision: Deferred for comments of TE. . [(CaseNo.:97/10/82-ALC4/2019 [Party Name:KAIRAV ‘(MeetNo/Date:6/82- (Status: _ }CHEMOFARBE INDUSTRIES |ALC4/2020 iDeferred L TIT ILTD. 13.11.2020 | | | |:01/82/050/00671/AM20/File [RLA|:03/94/040/00485/AM20/File (27.09.2Lic. No/Date: 0 31083186119, | | | |Decision: Deferred forcommentsof TE.—(i‘“‘sSs~<‘“‘“ RS; YE ; [Case No.:98/10/82-ALC4/2019 [PartyName:OC= —~—«([Meet No/Date:6/82- Status: SPECIALITIES PVT.LTD. ALC4/2020 Deferred | — 1HQ File . RLAFile ~~ ~—_|[Lic.No/Date:0310831873| (astitst~:*é«Cd | :01/82/050/00672/AM20/ :03/95/040/00625/AM20/ 27.09.2019 , | Pf | [Decision: ~The Committee considered the case as per online agenda in the presence of technical experts. and it was noted that the firm still has not furnished the following information asked for by NC-3 in its: | Meeting No. 3/82-ALC4/2020 dated 07.08.2020, followed by Reminder on 06.10.2020: i | 11g (i) Justification for quantity asked for import item No. 3 -5% Palladium on Carbon | ' Paste Type 87, 5R 487 (Pd/C) on Dry Basis. (ii) Material balance on % metal content for export product No. 2 — Palladium Metal; Sponge and import item No. 4 - RECOVERABLE WASTAGE GENERATED. ' po FROM 5% PALLADIUM ON CARBON PASTE TYPE 487,5R 487 (Pd/C) ON | DRY BASIS. |ai (iii) Production / Consumption Data till date for both export products separately duly | certified by GST. i | ‘In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing | 4 which the case will be rejected. | I
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. : ie |(ALC4/2019 - (PHARMACEUTICAL; LTD., erin113.11.2020° {Deferred a [HQ File iRLA File : jLic.No/Date:03 10831896 i 1:01/82/050/00677/A M20/ |:03/94/040/00494/AM20/ ‘(27.09.2019 | mc (Decision: Deferred for comments of TE. - | [Case No.:109/10/82-=ParlyName:CHIRAG Meet No/Date:6/82. —‘(Status:. | |ALC4/2019 [ENTERPRISE ‘ALC4/2020 Approved _— {HQ File [RLA File j ~ [Lic.No/Date:2410042868 | .01/82/050/00683/AM20/ :24/24/040/00028/AM20/ 27.09.2019 , . | Decision: The Committee considered case as per agendain the presence of the technical experts and it, . was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. Ias per details below or as | 120 applied by firm whichever is lower: , . | . ‘| | Export Product Qty. SI. | Import items Qty. DO No. - i. |. |CRUDE METHYL | 1 kg 1 ACRYLIC PLASTIC 1.10 kg ; ; ; METHACRYLATE MONOMER ; STRIPS / OFFCUTS RA concerned may take further necessary action as per above decisionof NC. j (Case No.:110/10/82-SS PartyName:GOPINATH : |ALC4/2019 [MeetNo/Date:6/82-. (Status: , |}CHEM-TECH LTD., ALC4/2020 ; {Deferred | HO File a IRLA File Lic.No/Date:0810146246 So 121 4:01/82/050/00684/AM20/ . 1:08/24/040/00190/AM20/ (27.09.2019 : _ [Deeision: — The Committee considered the case as per agenda in thepresence of technical experts and it i was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. | 14/82-ALC4/2019 dated 06.03.2020, followed by Reminder to firm on 14.08.2020 and Final Reminder on, 06.10.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019. Hence, the case is deferred.
)
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----- Start of picture text -----<br> — ALC4/2019 ‘PHARMACEUTICALS ALC4/2020 ‘Approved<br>:a(Case No.:112/10/82- |PartyPVT Name:SATYADEVALTD seta13.11.2020 - ‘Status:i<br>| HQ File ~ IRLAFile Lic.No/Date:0910068049 |<br>-|:01/82/050/00686/AM20/ —|:09/24/040/00318/AM20/ [27.09.2019 <br>The Committee considered case as per agenda in the presence of the technical experts andit. -<br>‘was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or |<br>‘as applied by firm whichever is lower: * |<br>|, [(@S3S58)}-2-Amino-3-Hydroxy- [Tkg [1 [DAHA sd 006 kg’ |<br>|| only)-3-Methy! butanoyl) |<br> | | Amino-1,6-diphenyl — Hexane-s- 4 METHANE SULFONIC Ls7kg |<br>| | pyro glutamate (THP) ACID : . i<br>C ACID a<br>122 | 7 N.N-DIMETHYL 160kg |<br>po | DIMETHYL ACETAMIDE ff<br>a ETHER (OR)TERTIARY ° a<br>| BUTYL METHYL ETHER ae 4<br>pod 14 N,N-CARBONYL 0.443 kg a<br>a -_| (99.95% MIN)<br>RA concerned may take further necessary action as per above decision of NC. - i<br>----- End of picture text -----<br>
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a Case No.113/10/82-—~—~—~*{PartyNName‘STERLING ‘Meet No/Date:/82. Status | » |ALC4/2019 ~ |AUXILIARIES PVT LTD (ALC4/2020 [Deferred "THQ File [RLAFile = =——————S—SCLic.No/Date:0310831915-) | |:01/82/050/00687/AM20/ {:03/95/040/00340/AM20/ 30.09.2019 |Decision: | The Committee considered the case as per online agenda in the presence of technical experts 123-jand it was noted that the firm still has not furnished the following information asked for by NC-3 in its | | '|Meeting No. 3/82-ALC4/2020 dated 07.08.2020, followed by Reminder on 06.10.2020: : . (i) Recovery of Methanol and its Commercial Value for in production of Export. Product No. I - STEROCARE CMEA (Coco Mono Ethanol Amide). , i | In view of above, the Committee decided to issue Final Reminder to firm to furnish its. ireply, failing which the case willbe rejected. “ | . | JALC4/2019 AUXILIARIESPVTLTD —|ALC4/2020 Deferred a . (13.11.2020 ; [HQ File RLA File (Lic.No/Date:0310831916 :01/82/050/00688/AM20/ :03/95/040/00135/AM20/ [30.09.2019 Decision: | The Committee considered the case as per online agenda in the presence of technical experts: 124 jand it was noted that the firm still has not furnished the following information asked for by NC-3 in its” Meeting No. 3/82-ALC4/2020 dated 07.08.2020, followed by Reminder on 06.10.2020: , i @ PHENOL+p-TERT.BUTYLBlend ratio of Export ProductPHENOLNo. 3 -FORMADEHYDEM 2653 (OXYALKYLATEDRESIN). NONYL| In view of above, the Committee decided to issue Final Reminder to firm to furnish its: | reply, failing which the case will be rejected. [Case No.:115/10/82‘Party Name:DEEPAK ‘Meet No/Date:6/82Status: — |ALC4/2019 _ |NOVOCHEM ALC4/2020 “Deferred | | TECHNOLOGIES LTD :13.11.2020 a |:01/82/050/00689/AM20/ :31/83/040/00087/AM20/ i 30.09.2019 . - a _ (Decision: Deferred for commentsofTE. | ~~[CaseNo.:120/10/82-—=——PartyName:TADIMETY- —[Meet No/Date:6/82-- Status: ' TALC4/2019 | LIMITEDAROMATICS PRIVATE 1ALC4/‘11.11. 202 00 | Deferred (126770 File | “RLA File |Lic.No/Date:0710115523 | ‘1:01/82/050/00694/AM20/ '07/24/040/0014 1/AM20/ 103.10.201 9 _ Decision: — Deferred for comments of TE. . . :
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|/||ALC4/2019|& PHARMACEUTICALS|—_‘ALC4/2020|[Deferred|
|1270OFile~~.|RLAFile.~—~——~SCSCSC«LIMITED|.|13.11.2020Lic.|N/Daate:0310832013||||oo|
|:01/82/050/00696/AM20/||,03/94/040/005 14/AM20/|104.10.2019|J|
|Decision:|Deferred|for comments|of TE.|:|
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— |ALC4/2019 |CHEM LIMITED ALC4/2020 |Deferred —s (128 HQFile © | RLAFile ‘{Lic.No/Date:3410045519 ; | :01/82/050/00714/AM20/ |:34/24/040/00099/AM20/ 07.10.2019 | (Decision: Deferred for[comments] of TE.
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|~||Case|No.:145/10/82-|Party Name:STERILE INDIA|(Meet No/Date:6/82-|Status:|=|
|—||ALC4/2019|PRIVATE|LIMITED||ALC4/2020|[Deferred|=|=|
|(129 FQ:01/82/050/00719/AM20/ Fite|ano|1:05/24/040/00377/AMREARS|eosyaiaqoo20/|—penNo/Date:0510412070(10.10.2019|oei|
|‘Decision:|Deferred|for comments of TE.|E|
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(~~ \GaseNo.:146/10/82-—~—~=—~—=PartyNName:RAJASTHAN—_.|Meet No/Date:6/82- ‘(Statu: = ' 1ALC4/2019 |ANTIBIOTICS LTD ALC4/2020 Rejected = _ (HQFile -”~~CSéRCEA 130[:01/82/050/00720/AM20/] ::05/24/040/00357/AM20/Pile SSSS~~S~«*iCLc410.10.2019 N/Daate0510412071 | ; ff _ |Decision: ‘The Committee considered the case as per agenda and in light of reply received from firm and, | lit was observed that the DML for mixture of Ampicillin Sodium Sterile + Sulbactam Sodium Sterile is not found in the list of Approved items. ¥ in view of above, the Committee decided to reject the case. - , | F
~ [Case No.:147/10/82Party[Name:GLENMARK] Meet} | |ALC4/2019 iPHARMACEUTICALS LTD |ALC4/2020__—.No/Date:6/82(Status:|Deferred = a | 13.11.2020 | _ -” |HQ File jRLA File ; \Lic.No/Date:03 10832145 ; i | :01/82/050/0072 1/AM20/ 1:03/94/040/00541/AM20/ r 1.10.2019 So. |
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FALC4/2019 ‘LIFE SCIENCES LIMITED —|ALC4/2020 Deferred | i | | |13.11.2020 192 TQ File 'RLA File . Lic. No/Date:0310832312 **** :01/82/050/00745/AM20/ —.:03/94/040/00S66/AM20/ - 18.10.2019 : | ‘Decision: Deferred for commentsofTE.as [Care Naz175/10162- —[Party Name:BENZO CHEM Meet No/Date:6/82- (Status: ALC4/2019 “INDUSTRIES PRIVATE iALC4/2020 Approved | : LIMITED — 13.11.2020 | |HQFile REAFile SS~~~S~SCSSCS LicNep/DDate-0310832317 |” :01/82/050/00747/AM20/—|:03/94/040/00518/AM20/ 18.10.2019 | Decision: |[The][Committee][considered][case] as per agenda in the presence of the technical experts and it | | was decided to ratify the ad-hoc input output norms under para 4.07 of HBP as per details below or as[by][ firm][whichever][is][lower:] 33[applied] | Export Product a Qty. | SL Import items Qty. | No. _ | [4-HYDROXYBENZYL lkg | 1 4-HY DROXYBENZALDEHYDE | 1.2 kg ALCOHOL OR PARA HYDROXY | , BENZALDEHYDESODIUM BOROHYDRIDE 0.23ke |7 ° IRA concerned may take further necessary action as per above decision of NC. | | [Case No.:179/10/82Party Name:PANACEA Meet No/Date:6/82‘Status: {ALC4/2019 BIOTEC LTD., |ALC4/2020 Deferred | iQ tiie REA eeNomates0$ 10419108 | . | 334 91/82/050/00753/AM20/ [:05/24/040/00410/AM20/ 21.10.2019 | _ Decision: The Committee considered the case as per agenda in the presence of technical experts and | after deliberation, it was decided to forward a copy of 4.07 application to Department of Biotechnology "| ° (DBT) for obtainingitscomments, etd
| IALC4/2019 NITRITE LIMITED |ALC4/2020 Deferred THQ File RLA File ‘Lic.No/Date:3410045560 * — i “ ‘was(Decision: decided|toThe callCommitteefor following consideredinformation the casefrom asthe perfirm: agenda in the; presence of technical experts and it | 7 @ Production / Consumption Data from GST Authorities for. imported inputs for. the licensing period. So a
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[Case No.:188/10/82Party Name:SPC LIFE ‘Meet No/Date:6/82|Status:. | ' 1ALC4/2019 SCIENCES PVT. LTD. |ALC4/2020 ‘Deferred i {HQ File * _IRLA File . 'Lic.No/Date:3410045565 ~ 136 |:01/82/050/00762/AM20/ ° —|:34/24/040/00143/AM20/ 23.10.2019 ae ' (Decision: | The Committee considered the case as per agenda in the presence of technical experts and it, was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. _ '|14/82-ALC4/2019 dated 06.03.2020, followed by Reminder to firm on 14.08.2020 and Final Reminder on: ; | 06.10.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019. Hence, the case is deferred.
"
|Case No.:189/10/82-<br>{PartyName:MENTHA&<br>'|Meet No/Date:6/82-<br>Status:<br>:<br>ALC4/2019<br>;<br>‘ALLIEDPRODUCTS<br>(ALC4/2020<br>‘Deferred<br>|<br>I<br>“PRIVATE LIMITED<br>13.11.2020<br>yo<br>|<br>37.HQ File<br>JRLA File<br>,<br>Lic.No/Date:0510412231<br>i I<br>|<br>-(:01/82/050/00763/AM20/<br>:05/24/040/00375/AM20/" -<br>23.10.2019<br>.<br>t 1<br>|<br>[Decision: Deferredforcommentsof<br>TE. =<br>7<br>||Case No.:189/10/82-<br>{PartyName:MENTHA&<br>'|Meet No/Date:6/82-<br>Status:<br>:<br>ALC4/2019<br>;<br>‘ALLIEDPRODUCTS<br>(ALC4/2020<br>‘Deferred<br>|<br>I<br>“PRIVATE LIMITED<br>13.11.2020<br>yo<br>|<br>37.HQ File<br>JRLA File<br>,<br>Lic.No/Date:0510412231<br>i I<br>|<br>-(:01/82/050/00763/AM20/<br>:05/24/040/00375/AM20/" -<br>23.10.2019<br>.<br>t 1<br>|<br>[Decision: Deferredforcommentsof<br>TE. =<br>7<br>||
|---|---|
|( "(Case No.:191/10/82-——~—~—«(PartyName:ASHISHLIFE[Meet No/Date:6/82-. Status:=<br>|<br>IALC4/2019<br>SCIENCEPVT.LTD.<br>j/ALC4/2020<br>‘Deferred<br>|<br>|||
|BS TQ File<br>RLA File<br>iLic.No/Date:0310832396<br>©<br>-4:01/82/050/00765/AM20/<br>_ :03/94/040/00526/AM<br>20/<br>23.10.2019<br>1<br>4|ff<br>i|
|‘Decision:<br>Deferred forcommentsofTE.<br>co|||
|~'Case No.:194/10/82-<br>|<br>|PartyName:NATURALAND. MeetNo/Date:6/82-<br>Status:<br>:<br>sALC4/2019<br>‘ESSENTIAL OILS PVTLTD<br>:ALC4/2020<br>‘Deferred<br>| 7<br>Eo<br>:<br>13.11.2020<br>|<br>Tt<br>(HQ FileRLAFileLic.No/Date:0710115596<br>I:<br>:01/82/050/00768/AM 20/<br>:07/24/040/00158/AM20/<br>:24.10.2019<br>i<br>Ey :||
||<br>_<br>iDecision: |The Committee considered thecase asper online agenda inthepresence oftechnical experts<br>/139jand it was noted that the firm still has not furnished the following information asked for by NC-3 in its.<br>Meeting No. 3/82-ALC4/2020 dated07.08.2020,followedbyReminderon06.10.2020:<br>;<br>/|/ :<br>|<br>,<br>%|
||<br>(i)<br>NetcontentofChlorogenic Acidinimportitem.<br>|<br>oe<br>(ii)<br>COAofimportitemfromForeignSupplier.<br>‘<br>||; (<br>; U|
|i<br>{In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing:|I|
||<br>{whichthecasewillberejected.|:|
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. Ad . . , ho | _ ‘Case No.:198/10/82——~—~«-PartyName:EMMENNAR MeetNo/Date-6/82. Status: : _ | |ALC4/2019 ; ‘PHARMA PRIVATE ALC4/2020 - Approved =: a i . ‘LIMITED © 13.11.2020 of pe - “THQ File RLAFile Lic. No/Date:0910068138—=OC~~CSS~S _ -01/82/080/00772/AM20/ _:09/24/040/00376/AM20/ 28.10.2019 oo oo | (Decision: The Committee considered case as per agenda in the presence of the technical experts and it 7 . | ‘iwas decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. | as per details below or. : . {as applied by firm whichever is lower: | Po 7 1«| Export Product Qty. | SI. Import items Qty. . No. 7 rok S(+)-2-AMINOBUTYRAMIDE | 1 kg (i PROPIONALDEHY DE 1.27 kg ; _ ‘| | HYDROCHLORIDE SODIUM CYANIDE 1.08 kg |. oy | . . . L(+) TARTARIC ACID 1.12 kg " , METHYLENE DICHLORIDE | 1.12 kg _ _ . ACETONE 1.86 kg | oe 16| METHANOL 1.39 kg a IRA concerned may take further necessary-action as per above decision of NC.
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----- Start of picture text -----<br> -(Case Nowti7i10%82. [Party NameSUN IMec Nobel Sana<br>| jAbca/zo19 [PHARMACEUTICAL ~ JALC4/2020 Approved<br>"THQ File REA File ——~SCL'icNov/DDate:0510412361 |<br>|:01/82/050/00791/AM20/ ':05/24/040/0043 9/AM 20/ los. 114.2019<br>| ' |Decision: The Committee considered the case as per agenda and in the light of earlier decision taken in<br>| {meeting:123.05.2018,no. it12/82-ALC4/2019was decided to ratifydatednorms17.01.2020 under Paraagainst 4.07 ofadvance HBP Vol.authorizationI as_per detailsNo. 0510406572given belowdatedor as:<br>applied by the firm, whichever is less:<br>a No.<br>Azelastine Hydrochloride Nasal | 520000.000 | 1 Azelastine 14532.96 Gram<br>1447 Solution (Nasal Spray) 0.1% (137 | Number Hydrochloride a |<br>| | meg per spray) 30ML (Each spray * | (Relevant Bulk Drug) -<br>: 4 containsequivalentAzelastineto 30.00mg)Hydrochloride(Equivalent ; |<br>| ‘|to 15600.000Grams of bulk drug) |<br>| | Azelastine Hydrochloride | 240000.000 Azelastine 734.40Gram |<br>; | Ophthalmic Solution 0.05% W/V | Number Hydrochloride _ i"<br>‘| 6ML.Azelastine(Each solutionHydrochloridecontains ( Relevant Bulk Drug) - at<br>- |. | equivalent to 3.000 mg) (Equivalent<br>_ | to 720.000 Grams of bulk drug)<br>"| ) (Equivalent to total<br>| | 16320.000Grams of bulk drug) ; |<br>' IRA concerned may take further necessary action as per above decision of Norms Committee.<br>----- End of picture text -----<br>
: Case No.:223/10/82[Party Name:MAPAEX iMeet No/Date:6/82‘Status: | |ALC4/2019 CONSUMER HEALTHCARE /ALC4/2020 Deferred a |PRIVATE LIMITED 13.11.2020 i " THQFile =————<—~é‘;:é‘«@RLA Rte =S—S—~<CSLic ND ate 5610005722. 145 |:01/82/0S0/00797/AM20/ ——|:56/24/040/00018/AM20/, 07.11.2019 - [Deeision: - The Committee considered the case as per agenda in thepresenceof technical experts and it _ _ was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. j 14/82-ALC4/2019 dated 06.03.2020, followed by Reminder to firm on 14.08.2020 and Final Reminder on: - g 06.10.2020 as per Policy Circular No: 23/2015-20, dated 15.05.2019. Hence, the case is deferred. _ 7
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|_|1"||GaseNo235/10/82- ——~—~—=S/PartyNName:SUVENLIFE|[Meet No/Date:6/82-_‘|Status:||:|
|ALC4/2019|(SCIENCES|LIMITED|ALC4/2020|Deferred|||7|
|||13.11.2020|a|
|-|fHQFile|—~——~—”—CORLA|Fle~——~<CSs~si‘Cs~sSC|Lic.|No/Date20910068176|t|
|:01/82/050/00809/AM20/|::09/24/040/00407/AM|20/|| 13.11.2019|||.|
|||and[Decision:~~|The|Committee considered the case as per online agenda|in the presence of technical|experts;|||
|it|was|noted|that|the|firm|still|has|not|furnished|the|following information|asked|for|by|NC-3|in|its:|
|146|MR|e|etingminder onNo.|06.10.10/8|2|020:-ALC4/2019|dated|29.11.2019,|followed|by|Reminder|on|20.01.2020|and|Final:i:|
|(i)|Complete|chemical|name|of export|product.|7|
|(ii)|Stepwise|complete|and|balanced|chemical|reactions showing|molecular weight|:|
|||and %|yield|on|molar|basis.|
|(iii)|Technical justification|for|the|yields|at various|steps.|:|
|In|view|of above,|the|Committee|decided|to|issue|Final|Reminder|to|firm|to|furnish|its|reply,|failing|:|
|which|the|case|will|be|rejected.|:|
|;|
|~IGage|Now2aei1018e|PartyName:ATULLIMED”|[“Meat]|NovDate-6/820°77|WStarwsr|:|r|
|||1ALC4/2019|ALC4/2020|Deferred|©|j|
|||||13.11.2020|a|
|47|HQ|File|'RLA|File|Lic.No/Date:08 10146544|||
|||:01/82/050/008|12/AM20/|:08/24/040/00258/AM20/|413.111.2019|
||||Decision:|DeferredforcommentsofTE.|4|
||||Case No.:239/10/82-|"'Party Name:INDOCO|Meet No/Date:6/82-|Status:|
||||ALC4/2019|[REMEDIES|LIMITED|ALC4/2020|‘Deferred|§|fj|
|(148|HQFile|.|RLAFile|~~*~—~—_{Lic.No/Date0310832731 | i (i‘(;;”*C*@S|
|:01/82/050/00813/AM20/|=|:03/94/040/00587/AM20/|13.11.2019|.|
|||(Decision?|Deferred|for comments of TEaee|||||
|[Case|No.:241/10/82-———~—=«(PartyName:SMILAX|«(Meet No/Date:6/82-|(Status:||S|
||ALC4/2019|:|iLABORATORIES|LIMITED|=||ALC4/2020|Deferred|||:|
|||13.11.2020|
|MoT File|‘IRLA|File|Lic,No/Date:0910068 182|a|
|_—||:01/82/050/00815/AM20/||:09/24/040/0041 1/AM20/|14.11.2019|a|
|[Decision:|Deferred for comments of TE.|:|
|||(Case|No.:244/10/82-|‘Party Name:GLENMARK|[Meet No/Date:6/82-|(Status:||||
|ALC4/2019|‘PHARMACEUTICALS|LTD|=||ALC4/2020|Deferred|||L|
|13.11.2020|i|
|:|150|HO|File|;|“TRLA Fileoe|No/Date-03 10832767 a|
|:01/82/050/008|18/AM20/||03/94/040/00636/AM20/|414.11.2019|
|||Decision:|Deferred|forcommentsof|TE.|= =|s—<i‘<OW|
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. | {ALC4/2019[CaseNo.:245/10/82-PartyJSCIENCESName:SUVENLIMITEDLIFEIALC4/2020 [MeetNo/Date:6/82-(Status:Deferred 1S) HQ File RLA File 'LicNo/Date:0910068184 | | | :01/82/050/008 19/AM20/ :09/24/040/004 14/AM20/. 141 1.2019 . | i Decision: Deferred for comments of TE. ,
:
| [Case No.:246/10/82- ————s[PartyName:NISARG ~————~—«([Meet No/Date:6/82-. Status: / J ALC4/2019 ‘BIOSCIENCES PRIVATE JALC4/2020 |Deferred THQ File ". IRLAFile————~*~SCSCS LicNeo/Date:0910068187| ; 152 |:01/82/050/00820/AM20/ ':09/24/040/00403/AM20/ 14.11.2019 - 7 | Decision: _ The Committee considered the case as per agenda in the ‘presence. oftechnical experts and it was14/82-ALC4/2019noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No.| | 06.10.2020 as per Policydated 06.03.2020,Circular No. followed23/2015-20.by Reminderdated 15.05.2019.to firm onHence,14.08.2020the caseandis Finaldeferred.Reminder on|'
| [Case No.:249/10/82-—~—=S|PartyName:YASHO.—™ [Meet No/Date:6/82‘Status: 'ALC4/2019 INDUSTRIES LIMITED 1ALC4/2020 ‘Deferred . | SHQ File IRLA File [Lic.No/Date:03 10832783 . :01/82/050/00823/AM20/ |:03/95/040/00791/AM20/ )14.11.2019 | | [Decision:— TheCommittee-consideredthe case as per online agenda in thepresenceof technical experts. 4 il 53 jand it was noted that the firm still has not furnished the following information asked for by NC-3 in its! | {Meeting No. 3/82-ALC4/2020 dated 07.08.2020 and Reminder on 06.10.2020: | : (i) ' Recovery of Methanol in kgs in the process and its commercial value. ; : : (ii) Justification for low yield of 63%. [' In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing | | |which the case will be rejected. |
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—_ Case No.:250/10/82Party Name: MANGALAM Meet No/Date:6/82Status: i ALC4/2019 jORGANICS LIMITED =. - JALC4/2020 ‘Deferred FORMERLY DUJODWALA 13.11.2020 . ot4 __.. PRODU ee ee File IRLA File ‘Lic.No/Date:0310832785 }:01/82/050/00824/AM20/ 03/95/040/00702/AM20/ 14.11.2019 Z| ‘Decision: | The Committee considered the case as per agenda in the presence of technical experts and it! was noted that the firm vide e-mail dated 12.10.2020 has furnished its reply. Deferred for comments ofTE. |
7
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|“IGaseNo:252/10/82.~~PartyName:CLARIANT <br>JALC4/2019<br>INDIALIMITED|—_|Meet No/Date:6/82-<br>ALC4/2020|Status:<br>Deferred|
|---|---|---|
|.<br>:<br>ISS ig Rie<br>ERAile<br>:01/82/050/00826/AM20/<br>:':03/94/040/00639/AM20/|13.11.2020<br>ieNorate6310832792 <br>14.11.2019|—<br> ;<br>|ir|
|(GaseNow247/10/82.~~PartyName:VEKOCARE<br>[MeetNo/Date:6/82- (Status:|
|---|
|ALC4/2019<br>‘PRIVATE LIMITED<br>ALC4/2020<br>Deferred<br>|<br>_<br>13.11.2020<br>.<br>_<br>BST<br>File<br>IRLAFile<br>Lic No/Date:3110067591<br>|<br>|<br>:01/82/050/00821/AM20/<br>|:31/83/040/00104/AM20/<br>15.11.2019<br>.<br>:<br>i|
|7 IGaseNo.:253/10/82-,~~—~iPartyName:VINS.—-~—*([MeetNo/Date:6/82- (Status:<br>ALC4/2019<br>,<br>|BIOPRODUCTSLTD<br>tALC4/2020<br>Deferred;<br>M|
|1157 HOFile+IRLAFile©~~~{Lic.No/Date:0910068189<br>|<br>,<br>:01/82/050/00827/AM20/<br>|:09/24/040/00410/AM20/<br>.<br>15.11.2019<br>.<br>4|
|(Decision:<br>TheCommittee considered thecase asperagenda inthepresence oftechnical expertsandafter<br>|<br>L<br>ideliberation, itwas decided toforward acopyof4.07 application to Department of Biotechnology (DBT):.<br>:<br>:<br>|forobtaining itscomments.<br>'|
||[CaseNo.:254/10/82-[PartyName:GLENMARK[Meet No/Date:6/82-<br>Status:<br>i<br>ALC4/2019<br>iLIFE SCIENCES LIMITED<br>ALC4/2020<br>{Deferred<br>|<br>mo<br>"<br>—(413.11.2020<br>|<br>S80<br>File<br>—<br>RLAFile<br>|Lic.No/Date:0310832799<br>—<br>|<br>j:01/82/050/00828/AM20/<br>}:03/94/040/00628/AM20/<br>“FISA1.2019<br>"<br>|. [Decision:<br>DeferredforcommentsofTE.<br>==|
|_ [CaseNo.:255/10/82-<br>==PartyName:PORUS —=sMeetNo/Date:6/82-.—~(Status:<br>=»<br>|<br>[ALC472019<br>LABORATORIES PRIVATE<br>:ALC4/2020<br>‘Deferred<br>F<br>4<br>LIMITED<br>,<br>13.11.2020<br>a|
||<br>fidFile<br>a<br>RISEE Nolbates0o 1006801 —<br>l<br>1:01/82/050/00829/AM20/<br>:09/24/040/00421/AM20/<br>(15.11.2019<br>|<br>:<br>159, Decision: 1 TheCommittee considered thecase as peragenda in thepresence oftechnical experts and it:<br>was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No.|<br>ij<br>14/82-ALC4/2019 dated 06.03.2020, followed by Reminder to firm on 14.08.2020 for furnishing acopy of!<br>°|
|;<br>4.07 application as per policy circular no 23/2015-20 dated 15.05.2019.<br>Hence, it was decided to issue<br>|<br>.<br>3<br>Final Reminder to firm for furnishing a copy of4.07 application as per policy circular no 23/2015-20-<br>dated 15.05.2019.<br>a<br>a<br>3|
;
‘
.
[Case No.:258/10/82[Party Name:WEXFORD [Meet No/Date:6/82- ‘(Status: ALC4/2019 LABORATORIES PLTD JALC4/2020 Deferred 160 |:01/82/050/00832/AM20/HQ File :07/24/040/00178/AM20/[RLA File Lic.No/Date:071011570018.11.2019 [|, Decision: _ / {was noted thatThethe Committeefirm still has considerednot furnished the casethe as4.07 per agendaapplicationin theasked presencefor byofNC-3 technicalin itsexpertsMeeting andNo.it | i 14/82-ALC4/2019 dated 06.03.2020, followed by Reminder to firm on 14.08.2020 and Final Reminder on|; | ; 06.10.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019. Hence, the case is deferred. | : | [Case No.:259/10/82Party Name:NISARG (Meet No/Date:6/82(Status: ALC4/2019 BIOSCIENCES PRIVATE |ALC4/2020 ‘Deferred | | (HQ File | [RLA File ~~ [LieNovDate:0910068197 161 |:01/82/050/00833/AM20/ :09/24/040/00424/AM20/ 18.11.2019 7 , |Decision: | The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No.| : 14/82-ALC4/2019dated 06.03.2020, followed by Reminder to firm on 14.08.2020 and Final Reminder on: © 106.10.2020as.per Policy Circular No. 23/2015-20, dated 15.05.2019. Hence, the case is deferred. [Casei No.:261/10/82- |PartyName:AVIEUMLIFE Meet No/Date:6/82- (Status: +ALC4/2019 SCIENCES PRIVATE |ALC4/2020 [Deferred LIMITED / 13.11.2020 . | . : | |HQFile —™ IRLA File ogy 'Lic.No/Date:3110067594 [| | 162 Decision:|:01/82/050/00835/AM20/| The Committee considered1:31/83/040/00101/AM20/the case as per agenda -|18.11.2019in the presence of technical experts and it | was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No.: ; Do 14/82-ALC4/2019 dated 06.03.2020, followed by Reminder to firm on 14.08.2020 and Final Reminder on} | }06.10.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019. Hence, the case is deferred. ~~ [Case No.:262/10/82- ~ ~ Party Name:REYAANSH Meet No/Date:6/82(Status: ; ALC4/2019 HEALTHCARE 4ALC4/2020 Deferred | (HQFile “RLAFile ~~ _[Lic.No/Date:0310832850 | | :01/82/050/00836/AM20/ :103/95/040/00757/AM20/ _ {18.11.2019 , : 163 Decision: “The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No.| : , 3/82-ALC4/2020 dated 07.08.2020, followed by Reminder to firm on 10.09.2020 for furnishing a copy of; 4.07 application as per policy circular no 23/2015-20 dated 15.05.2019. Hence, it was decided to issue, Final Reminder to firm for furnishing a copy of 4.07 application as per policy circular no 23/2015-20 | dated 15.05.2019.
:=f
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----- Start of picture text -----<br> — Case|ALC4/2019 No.:263/10/82- " iParty|AUXILIARIES Name:STERLING PVT LTD ‘MeetALC4/2020 No/Date:6/82- Status:Deferred<br>HOFile | RLAFile [Lic.NovDate:03 10832853<br>:01/82/050/00837/AM20/ 103/95/040/00812/AM20/. . 19.11.2019 |<br>i ‘Decision: | The Committee considered the case as per online agenda in the presence of technical experts |<br>: 164 and it was noted that the firm still has not furnished the following information asked for by NC-3 in its.<br>Meeting No. 3/82-ALC4/2020 dated 07.08.2020, followed by Reminder on 06.10.2020:<br>----- End of picture text -----<br>
(i) Exact specification and blend ratio of Export Product No. 1 and 2.
;
/
In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, : {failing which the case will be rejected. De
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----- Start of picture text -----<br> : \Case No.:266/10/82- |Party Name:OPTIMUS Meet No/Date:6/82- (Status: :<br>7 ALC4/2019 {DRUGS| PRIVATE LIMITED 13.11.2020{|ALC4/2020 . Deferred a4<br>:01/82/050/00840/A M20/ "1:09/24/040/004 12/AM20/ (19.11.2019<br>| [Decision: Deferred forcomments FTE eesnnnnnnnenn — 7<br>Case No.:267/10/82- — Party Name:AVIEUM LIFE ‘Meet No/Date:6/82- Status: i<br>ALC4/2019 SCIENCES PRIVATE ALC4/2020 ‘Deferred<br>; ‘HQ File [RLA File :Lic.No/Date:3110067598 |<br>. i166i |.01/82/050/00841/AM20/noDecision:oe sem mon on ony ene uve nnuonar| Thesee aa snaneasnnnsnnsntertutAiAtstontenpeenteatn Committee consideredsactnmes':31/83/040/00108/AM20/oe are aememenevomamervarnsnsniaietehiesAinherOnanasanuahsesunhbesnhtesstinttetecnntetcecnmethe case as per agenda in19.11.2019wethealoe oo one presence ones ol atedae app oo neeofoo eens technical comneesssyenemmnvennmuestenunsnnnenuanansgintnnetictinmepeeme|experts and it;fe 20 |i<br>was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No.;.<br>3/82-ALC4/2020 dated 07.08.2020, followed by Reminder to firm on 14.08.2020 for furnishing a copy of:<br>i 4.07 application as per policy circular no 23/2015-20 dated 15.05.2019. Hence, it was decided to issue! :<br>| datedFinal 15.05.2019,Reminder to_ firm for furnishing. aoecopy of 4.07 application as per policy circular no 23/2015-20'|:<br>- | [Case No.:268/10/82- ~~ Party Name:JODAS EXPOIM (Meet No/Date:6/82- (Status: ><br>ALC4/2019 ‘PVT.LTD ALC4/2020 Deferred<br>167 [HQ File RLA File Lic.No/Date:0910068207 |<br>| |:01/82/050/00842/AM20/ ——:09/24/040/00365/AM20/ 20.11.2019 fo |<br>|| Decision: ~The Committee considered the case as peragenda and it wasobservedthat the firm was issued<br>|Show Cause Notice vide letter dated 10.10.2019. : |<br>----- End of picture text -----<br>
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_ [CaseNo.:45/6/82-ALC4/2020 PartyName:MALWA MeetNo/Date-6/82.—~=sStatus:. OXYGEN & INDUSTRIAL ALC4/2020 "Approved | _.|GASES PVT.LTD, - 13.11.2020 — THQ File " IRLAFile —S~SSCL'ic.Noo/Daate:5610005735.—~*~S~S~*Y fo :01/82/050/01654/AM21/ :56/24/040/00023/AM20/ 22.11.2019 _ |Decision: _ The Committee Committee considered the case as per agenda and agenda and and in the the light of earlier decision earlier decision decision taken in. meeting no. 5/82-ALC4/2020 dated 09.10.2020 against advance authorization No. 5610005606 dated , _ applied09.05.2019,by09.05.2019,byby theit wasfirm, decwhit wasfirm, decwh wasfirm, decwhfirm, decwh decwhwh i dedchever to ratifyischever to ratifyis to ratifyis ratifyisis less: norms under norms under under Para 4.07 of HBP of HBP HBP Vol. | as_per details given below as_per details given below details given below given below below or as/ as/ 4.4-DIHYDROXY -lkg [1 - | PARA CHLORO BENZOTRICHLORIDE |1.73kg |. _ | |BENZOPHENONE PHENOL ; 0.71 kg i ALUMINIUM CHLORIDE Lookg |. i * | 4 [| SODIUM HYDROXIDE 0.23kg | i DICHLOROETHEN [2:50kg | | Se, | 6 | CUPROUS CHLORIDE O.10kg. | | a METHYLE ALCOHOL 2.50kg: | |
|Decision: _ The Committee Committee considered the case as per agenda and agenda and and in the the light of earlier decision earlier decision decision taken in. meeting no. 5/82-ALC4/2020 dated 09.10.2020 against advance authorization No. 5610005606 dated , _ applied09.05.2019,by09.05.2019,byby theit wasfirm, decwhit wasfirm, decwh wasfirm, decwhfirm, decwh decwhwh i dedchever to ratifyischever to ratifyis to ratifyis ratifyisis less: norms under norms under under Para 4.07 of HBP of HBP HBP Vol. | as_per details given below as_per details given below details given below given below below or as/ as/
'|RA concerned may take further necessary action as per above decision of Norms Committee.
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: ~— [Case No.:44/6/82-ALC4/2020 |Party Name: MALWA Meet No/Date:6/82Status: Cd OXYGEN & INDUSTRIAL —_ALC4/2020 ‘Approved |HQFile © - RLAFile Lic. No/Date:5610005778 po :01/82/050/01653/AM21/ ':56/24/040/00016/AM20/ 10.01.2020 :a ' || ‘|Decision:|meeting no. The5/82-ALC4/2020Committee considereddated 09.10.2020the case asagainst per[agenda] advanceand inauthorizationthe light of earlierNo. 5610005606decision takendated,in. , a 09.05.2019, it was decided to ratify norms under Para 4.07 of HBP Vol. ! as per details’given below or as) _ Japplied by the firm, whichever is less: : No. | | | 4,4-DIHYDROXY 1 kg PARA CHLORO BENZOTRICHLORIDE | 1.73 kg | | || | BENZOPHENONE . PHENOL O71 kg- | | oe a ALUMINIUM CHLORIDE - 1.00kg || , a SODIUM HYDROXIDE 0.23kg | | —— DICHLOROETHEN 2.50kg | | - a, . |6 | CUPROUS CHLORIDE 0.10kg | aL. . METHYLE ALCOHOL 2.50kg. | |”
RA concerned may take further necessary action as per above decision of Norms Committee.
;
53
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i[Case No.:46/6/82-ALC4/2020 iParty Name:MALWA ‘Meet No/Date:6/82Status: | (OXYGEN‘GASES PVT.LTD., & INDUSTRIAL =ALC4/13.11. 202 00 ‘Approved 3 | vHQFile ~~ RLAFile.—~—~—~C~SCS Lic, NoDates 5610005845 | | |:01/82/050/01655/AM21/ ——|:56/24/040/00044/AM20/ 16.03.2020 Co Decision: The Committee considered the case as per agenda andin the light of earlier decision taken in; , meeting no. 5/82-ALC4/2020 dated 09.10.2020 against advance authorization No. 5610005606 dated. | 09.05.2019,applied by theit wasfirm, decidedwhichever to ratifyis less: norms under, Para 4.07 of HBP Vol. | as_per details given below or as
.
||<br>vHQFile<br>~~ RLAFile.—~—~—~C~SCS<br>Lic, NoDates 56100058455610005845<br>|<br>|<br>|:01/82/050/01655/AM21/<br>_—_—|:56/24/040/00044/AM20/<br>16.03.2020<br>Co<br>Decision: The Committee considered the case as per agenda andinper agenda andinagenda andinandin<br>in the light of earlier decisionof earlier decisionearlier decisiondecision taken in;<br>meeting no. 5/82-ALC4/2020 dated 09.10.2020 against advance authorization No.No. 5610005606 dated.<br>,<br>09.05.2019,applied it wasfirm, decidedwhichever to ratifyiswasfirm, decidedwhichever to ratifyisdecidedwhichever to ratifyisto ratifyisnorms under, Para 4.07 of HBP Vol.under, Para 4.07 of HBP Vol.Para 4.07 of HBP Vol.4.07 of HBP Vol.HBP Vol.Vol. | as_per details given below or asgiven below or asbelow or asor asas<br>|<br>applied by theit wasfirm, decidedwhichever to ratifyis firm, decidedwhichever to ratifyis whichever to ratifyis is less: norms under, Para 4.07 of HBP Vol.<br>, Para 4.07 of HBP Vol.|ifs<br>i <br>Fh<br>*<br>: |*|
|---|---|
|170}<br>| Exportproduct<br>Oty. | SI.<br>| Import items|oe|
||<br>| |4,4-DIHYDROXY<br>1 kg<br>PARACHLOROBENZOTRICHLORIDE | 1.73kg | -<br>i,<br>_<br>| |BENZOPHENONE<br>.<br>[2 |PHENOL<br>O7ike |<br>ALUMINIUMCHLORIDE<br>|<br>100kg |<br>|<br>i:a<br>i<br>SODIUMHYDROXIDE<br>__<br>| 0.23kg<br>a<br>DICHLOROETHEN<br>|<br>2.50 kg<br>a<br>_<br>[6|CUPROUSCHLORIDE<br>_-<br>en |<br>METHYLEALCOHOL<br>250kg<br>|||
||<br>RAconcernedmaytakefurthernecessary action asperabovedecision ofNormsCommittee.|F|
||CaseNo.:38/6/82-ALC4/2020[Party Name:YASHO<br>(MeetNo/Date:6/82-.(Status:<br>=<br>|<br>INDUSTRIES LIMITED<br>-<br>—|ALC4/2020<br>[Approved<br>=|(i(itséiff ||<br>ff ||
|(AQFile<br>RLAFile<br>LicNo/Date:0310835578<br>|<br>ig<br>-01/82/050/01647/AM2/<br>:03/95/040/01220/AM20/<br>'20.03.2020<br>i<br>q !||
||<br>[Decision:<br>— The Committee considered case as peragendain the presence of the technical experts and it,<br>was decided to ratify the ad-hoc input output norms under para 4.07 of HBP as per details below or as<br>{71 |appliedbyfirmwhicheverislower:<br>,|il<br>i<br>| ||
|Export Product<br>Qty.<br>|<br>Sl.<br>| Import items<br>Qty.||
|/<br>|<br>[YAPOX = (2275.<br>(DI-TERT- Tikg [1 [|HYDROQUINONE<br>0.575ke<br>|<br>i<br>|.<br>AMYLHYDROQUINONE)<br>2<br>TERTIARY<br>AMYL| 0.431'kg ii||
|»<br>‘RAconcernedmay take furthernecessaryaction asperabove decision ofNC.<br>,|Ee :|
|:<br>CaseNo.:1/3/82-ALC4/2020<br>[PartyName:ZEISS<br>MeetNo/Date:6/82-<br>Status:<br>Pood.<br>|PHARMACEUTICALS<br>1ALC4/2020<br>Deferred<br>=<br>i<br>|PVT.LTD.,<br>[13.11.2020|ei.|
|“THQFile<br>**~**<br>IRLA File<br>__|Lic.No/Date:3010105262<br>_<br>&§f<br>-<br>(:01/82/050/01428/AM21/<br>——:30/22/040/00037/AM21/,<br>{25.06.2020<br>—<br>|<br>[Decision:<br>This caseappeared<br>forthefirsttimebeforeNormsCommittee.DeferredforcommentsofTE.||
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. : 54 . - ||CaseNo.:3/3/82-ALC4/2020PartyName:ALTA—~~~‘([Meet No/Date-6/82- (Status: OS * LABORATORIES LIMITED —/|ALC4/2020 ’ {Approved | . oo | JHQ File ~|RLA File _ |Lic.No/Date:0310836920 | |) }:01/82/050/01430/AM21/ |:03/94/040/00205/AM21/ '129.06.2020 poo + Decision: ~— The Committee considered the case as per agenda and in the light of earlier decision taken in . | imeeting no. 10/82-ALC4/2019 dated 29.11.2019 against advance authorization No. 0310832261 dated : : 173 16.10.2019, it was decided to ratify norms under Para 4.07 of HBP Vol. I as_per details given below or as , lapplied by the firm, whichever is less: " i No. ; , | SODIUM SALICYLATE . pikg} 1 | SALICYLIC ACID 0.80kg |: : - RA concerned may take further necessary action as per above decision of Norms Committee. - : 7 (Case No.:4/3/82-ALC4/2020 (Party Name:GLOBAL —*'[MeetNo/Date:6/82-. (Status: = CALCIUM PRIVATE ALC4/2020 Deferred 7 = |LIMITED 13.11.2020 i ' {HQ File ; RLA File iLic.No/Date:0710116675 i 7 174 4:01/82/050/0143 17AM21/ 1:07/24/040/00092/AM21/ - - (29.06.2020 ; i wasDecision:noted that|Thethe Committeefirm still has considerednot furnished the.casethe as4.07 per agendaapplicationin theasked presencefor byofNC-3technicalin its expMe e rtsting andNo.it| _ |3/82-ALC4/2020 dated 07.08.2020, followed by Reminder to firm on 18.09.2020 for furnishing a copy of| ’ . |. [4.07 application as per policy circular no 23/2015-20 dated 15.05.2019. Hence, it was decided to issue’ an r “i Final Reminder to firm for furnishing a copy of 4.07 application as per policy circular no 23/2015-20) .
"Case No.:5/3/82-ALC4/2020 PartyName:MANGALAM— Meet No/Date:6/82- (Status: ; : DRUGS AND ORGANICS. |ALca2020 Deferred | - ISO File (RIAFile ~~ {LieNo/Date:0310836938 |.
) . J [Decision::01/82/050/01432/AM21/__ Deferred forcommentsofTE,—— :03/95/040/00198/AM21/ 29.06.2020a : _ : Case No.:6/3/82-ALC4/2020 = Party Name:SHIRDI iMeet No/Date:6/82‘Status: ae ' / CHEMICALSLIMITED PRIVATE _ ‘ALC4/202013.11.2020 |‘Deferred a a
| 1:01/82/050/01433/AM21/[HQ File �� RLA:03/95/040/00196/AM21/File ‘Lic.(30.06.2020No/Date:0310836944 || | :
. ; 176 Decision:The Committee considered the case as per agenda in the presence of technical experts and it | _ was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. : .
|/ 44.07_|3/82-ALC4/2020application asdatedper 07.08.2020,policy circularfollowedno 23/2015-20by Reminderdatedto firm15.05.2019.on 18.09.2020Hence, forit wasfurnishingdecideda tocopyissueof:| - - : {Final Reminder to firm for furnishing a copy of 4.07 application as per policy circular no 23/2015-20 . / {dated 15.05.2019. a |
. ;
° oO yt _ -\Case No.:8/3/82-ALC4/2020 Party Name:NAARI PHARMA \Meet No/Date:6/82‘Status: ( PRIVATE LIMITED ‘ALC4/2020.. = (Deferred . | 13.11.2020 | 7 ie | HO FiieTTT | 1:01/82/050/01435/AM21/ {:05/24/040/00143/AM21/RA le —,30'Lic . 06.2020No/Date:0510414507 |i ti L Av Decision: . The Committee considered the case as per agenda in the presence of technical experts and it” | twas noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. ; | | 13/82-ALC4/2020 dated 07.08.2020, followed by Reminder to firm on 18.09.2020 for furnishing a copy of a * 4.07 application as per, policy circular no 23/2015-20 dated 15.05.2019. Hence. it was decided to issue: r | {Final Reminder to firm for furnishing a copy of 4.07 application as per policy circular no 23/2015-20 : = | Idated 15.05.2019. . gl [Case No.:9/3/82-ALC4/2020 [Party Name:NAARI PHARMA Meet No/Date:6/82Status: — | (PRIVATE LIMITED ALC4/2020 Deferred «si | (Hotie set nea neeeneeeng “RAFI Tic NoiBaesi04 14508 Sian : | i :01/82/050/01436/AM21/ |:05/24/040/00144/AM21/ 130.06.2020 i rh {178 ‘Decision: | The Committee considered the case as per agenda in the presence of technical experts and it) 4 was noted that the firm still has not fumished the 4.07 application asked for by NC-3 in its Meeting No.| A |3/82-ALC4/20204.07 application asdatedper 07.08.2020,policy circularfollowedno 23/2015-20by Reminderdated-to 15.05.2019.firm on 18.09.2020Hence, forit furnishingwas decideda copyto issue:of | i!‘: | Final Reminder to firm for furnishing a copy of 4.07 application as per policy circular no 23/2015-20) H ; dated 15.05.2019. - - | Case No.:10/3/82-ALC4/2020 {Party Name:ATHENA DRUG Meet No/Date:6/82‘Status: St a i DELIVERY SOLUTIONS —.ALC4/2020 [Deferred = a, PRIVATE LIMITED 13.11.2020 i | | THofile iRLA fig ‘Lic Novbate-0310836060"a : | 4:01/82/050/01437/AM21/ (:03/94/040/00210/AM21/ (30.06.2020 . i ct 79. Decision: | The Committee considered the case as per agenda in the presence of technical experts and it! } was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. | Hi 3/82-ALC4/2020 dated 07.08.2020, followed by Reminder to firm on’ 18.09.2020 for furnishing a copy of. : 14.07 application as per policy circular no 23/2015-20 dated 15.05.2019. Hence, it was decided to issue| 4 , i. Final Reminder to firm for furnishing a copy of 4.07 application as per policy circular no 23/2015-20' rh t | {dated 15.05.2019. . | : Case No.:11/3/82-ALC4/2020 |Party Name:MAHI DRUGS Meet No/Date:6/82Status: | 72 | | |PRIVATE LIMITED VALC4/2020 Deferred = ff 0 | 13.11.2020 HQ File iRLA File |Lic.No/Date:2610012912 a i _ © :01/82/050/01438/AM21/ ———:26/24/040/00003/AM21/ 30.06.2020 : oe Decision: “Deferred forcommentsof TE. ss—‘i‘“‘“‘<_ua‘_étee i { | . . ‘ . Ha ee . PH . at ih
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==> picture [468 x 175] intentionally omitted <==
----- Start of picture text -----<br> <br>CaseNo.:12/3/82-ALC4/2020Party Name:FDC LID [MeetNo/Date:6/82. (Status<br>oo | . JALC4/2020 Approved |<br>| |HQ File : -RLA File |Lic.No/Date:0310836966 |<br>:01/82/050/01439/AM21/ __ 103/94/040/00216/AM21/ [30.06.2020 :<br> |Decision: The Committee Committee considered the case as per agenda and in the light of earlier decision taken in,<br>181 meeting no. 10/82-ALC4/2019 dated 29.11.2019 against advance authorization No. 0310831779dated,<br>s 25.09.2019, it was decided to ratify norms under Para 4.07 of HBP HBP Vol. I as_per details given below or as_<br>‘applied by the by the the firm, whichever is less: whichever is less: is less: less:<br>BRIMONIDINE TARTRATE EYE | 1 Number | BRIMONIDINEL-TARTRATE BRIMONIDINEL-TARTRATE | 0.0102 gm/vial |<br>DROPS 0.2% W/V 5ML<br>RA concerned may take may take take further necessary action as per above above decision of Norms Committee. Norms Committee. Committee.<br>----- End of picture text -----<br>
: :01/82/050/01439/AM21/ __ 103/94/040/00216/AM21/ [30.06.2020 : _ |Decision: The Committee Committee considered the case as per agenda and in the light of earlier decision taken in, 181 meeting no. 10/82-ALC4/2019 dated 29.11.2019 against advance authorization No. 0310831779dated, . s 25.09.2019, it was decided to ratify norms under Para 4.07 of HBP HBP Vol. I as_per details given below or as_ , ‘applied by the by the the firm, whichever is less: whichever is less: is less: less: BRIMONIDINE TARTRATE EYE | 1 Number | BRIMONIDINEL-TARTRATE BRIMONIDINEL-TARTRATE | 0.0102 gm/vial | DROPS 0.2% W/V 5ML ° RA concerned may take may take take further necessary action as per above above decision of Norms Committee. Norms Committee. Committee. . oe ; jPHARMACEUTICALS ALC4/2020 {Deferred Lo, ; {PRIVATE LIMITED {13.11.2020 . HQ File ; , IRLA File ' {Lic.No/Date:0910068917 ' |182. Decision: | The Committee considered the case as per agenda in the presence of technical experts and it, | twas noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No.; ; 3/82-ALC4/2020 dated 07.08.2020, followed by Reminder to firm on 18.09.2020 for furnishing a copy of! 4.07 application as per policy circular no 23/2015-20 dated 15.05.2019. Hence, it was decided to issue | | ‘datedFinal 15.05.2019.Reminder to firm for furnishing a copy of 4.07«application as perapolicy circular-no 23/2015-20) 4 Case No.:13/3/82-ALC4/2020 [Party Name:AARTI DRUGS Meet No/Date:6/82\Status: | ; LIMITED _ |ALC4/2020 ‘Deferred | . | (HQFile REA FileSSCL No/Daate:0310836986 [| 1:01/82/050/01440/AM21/ :03/94/040/00201/AM21/ (01.07.2020. | i183| Decision:‘was noted that| Thethe Committeefirm still has considerednot furnishedthe case asthe 4.07 per agendaapplication in theasked presencefor byof technicalNC-3 in itsexpertsMeeting andNo. it : 13/82-ALC4/2020 dated 07.08.2020, followed by Reminder-to firm on 18.09.2020 for furnishing a copy of: | : 14.07 application as per policy circular no 23/2015-20 dated 15.05.2019. Hence, it was decided to issue’. ; i Final Reminder to firm for furnishing a copy of 4.07 application as per policy circular no 23/2015-20: = * ‘|dated 15.05.2019. a[Case No.:14/3/82-ALC4/2020 (Party Name:AARTI DRUGS Meet No/Date:6/82-. Status: ; i [UMITED ; :ALC4/2020 ‘Deferred . : HQ �� File RLA File ‘Lic.No/Date:03 10836987 |:01/82/050/01441/AM21/ (:03/94/040/00202/AM21/ |01.07.2020 Lo | 184 Decision: |The Committee considered the case as per agenda in the presence of technical experts and it: | ‘Iwas noted that the firm still has not furnished the 4.07 application. asked for by NC-3 in its Meeting No. | 3/82-ALC4/2020 dated 07.08.2020, followed by Reminder to firm on 18.09.2020 for furnishinga copy of| . _ 14.07 application as per policy circular no 23/2015-20 dated 15.05.2019. Hence, it was decided to issue : ‘(Final Reminder to firm for furnishing a copy of 4.07 application as per policy circular no 23/2015-20 dated 15.05.2019. ; ; ,
vo
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----- Start of picture text -----<br> ‘a<br>metersarroamanee yo tee we nese ne ne semeee oe mtoe wene eae nn gone aren on sontentnassnsssnequnsanssosansansansanssnsnnsnasaseatsasenassnSsnanes184 sam a s n srememem- weer ook yotesea tncsatessesnesaasoouamomeomecianantemanans 2+ steps os os ap on cemmmetsmanssinnas onetime aH i <br>Case No.:15/3/82-ALC4/2020 |Party Name:AARTI DRUGS —/Meet No/Date:6/82- ‘Status: 4<br>LIMITED |ALC4/2020 (Deferred ct<br>| HQFile | [REA File ‘Lic.No/Date:03 10836988 4 oe 7 a A<br>185 Decision:(:01/82/050/01442/AM21/| The Committee considered|:03/94/040/00200/AM21/the case as per agenda in01.07.2020the presence of technical iexperts and it) i i“|<br>was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No.| i<br>_ | + 3/82-ALC4/2020 dated 07.08.2020, followed by Reminder to firm on 18.09.2020 for furnishing a copy of a<br>| (4.07 application as per policy circular no 23/2015-20 dated 15.05.2019. Hence, it was decided to issue| 5 f<br>; : Final Reminder to firm for furnishing a copy of 4.07 application as per policy circular no 23/2015-20 | 7 {<br>| dated 15.05.2019. f<br>~~[Case No.:16/3/82-ALC4/2020[PartyName:AARTIDRUGS [MeetNo/Date:6/82- (Status: i t<br>. LIMITED ALC4/2020 Deferred i<br>| HQFile|:01/82/050/01443/AM21/ (RLAFile——:03/94/040/00979/AM20/ {01.07.202Lic.No/Date: 0 3 10836990re | - i| |<br>186 Decision: |The Committee considered the case as per agenda in the presence of technical experts and it | 1<br>. ‘Iwas noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. : i i<br> |3/82-ALC4/2020 dated 07.08.2020, followed by Reminder to firm on 18.09.2020 for furnishing a copy of<br>4.07 application as per policy circular no 23/2015-20 dated 15.05.2019. Hence, it was decided to issue: 4<br>Final Reminder to firm for furnishing a copy of 4.07 application as per policy circular no 23/2015-20) Ha<br>; dated 15.05.2019. , ie |<br>Case No.:17/3/82-ALC4/2020 |Party Name:AARTI DRUGS Meet No/Date:6/82- Status: a<br>— |LIMITED (/ALC4/202013.11.2020 Deferredpo | =A:<br>| HO File ee TH File Tie NofBate-0310836090 f .<br>| |:01/82/050/01444/AM21/ :03/94/040/0107 1/AM20/ 01.07.2020 ; |<br>[187 Decision: | The Committee considered the case as per agenda in the presence of technical experts andit | 3<br>:| was3/82-ALC4/2020noted that thedatedfirm 07.08.2020,still has notfollowedfurnishedbytheReminder4.07 applicationto firm onasked18.09.2020for by NC-3for furnishingin its Meetinga copyNo. of| 7<br>14.07 application as per policy circular no 23/2015-20 dated 15.05.2019. Hence, it was decided to issue. i |<br>|: — |dated(Final 15.05.2019.Reminder to firm for furnishing a copy of 4.07 application. as per- policy circular no 23/2015-20mo: |7<br>| |Case No.:18/3/82-ALC4/2020 Party Name:TOJO VIKAS —_|Meet No/Date:6/82- (Status:<br>INTERNATIONAL PRIVATE |ALC4/2020 Deferred “| it<br>(188 HQ File RLA File |Lic.No/Date:0510414531 — a<br>i :01/82/050/01445/AM21/ ((05/24/040/00149/AM21/ 01.07.2020 i <br>----- End of picture text -----<br>
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. 53 OC . ee| [Case No.:19/3/82-ALC4/2020 (PartyName:AARTIDRUGS (MeetNo/Date:6/82-. (Status: Se : {LIMITED ALC4/202013.11.2020 Deferred | |HQ File . IRLA File ‘Lic.No/Date:0310837001 [SS : 189 Decision::01/82/050/01446/AM21/| The Committee considered':03/94/040/00157/AM21/the case as per agenda in'01.07.2020the presence of technical experts and it. was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 3/82-ALC4/2020 dated 07.08.2020, followed by Reminder to firm on 18.09.2020 for furnishing a copy of! | 4.07FinalapplicationReminderastoperfirm policyfor furnishingcircular noa copy23/2015-20of 4.07datedapplication15.05.2019.as per Hence,policy itcircular was decidedno 23/2015-20:to issue | jdated 15.05.2019. . so : ; . jCase No.:22/3/82-ALC4/2020 ‘PartyAROMATICS Name:ENCEEPVT LTD iMeetjALC4/2020 No/Date:6/82‘Status:‘Deferred "190 |HQ{:01/82/050/01449/AM21/File OO RLAj:32/24/040/000File —oo19/AM21/ TLic.No/Date:3210079591(02.07.2020 | a _ (Decision: The Committee considered the case as per agenda in the presence of technical experts and it _ |was noted that the firm vide e-mail dated 17.10.2020 has furnished its reply. Deferredfor comments of TE. : -t [Case No.:23/3/82-ALC4/2020 [Party& INDUSTRYName:SA ISONSPVT LTDTRADE[Meet:ALC4/2020 No/Date:6/82- (Status:‘Deferred | ; Jt HQ File RLA File ‘Lic.No/Date:0310837035 — §:01/82/050/01450/AM21/ :03/95/040/00201/AM21/ _ :06.07.2020 DeferredforcommentsofTE.= ~~ {Case No.:24/3/82-ALC4/2020 |Party Name: MANKIND Meet No/Date:6/82Status: PHARMA LTD ALC4/2020 Approved / , JHQFile - ~~~—~—~—S(RLAFile~—~S™~™C—S Lic.Nc/Daate05104145055 |-01/82/050/0145/AM21/. |:05/24/040/00161/AM21/ 06.07.2020 . | (Decision: The Committee considered the case as per agenda and[3/82-ALC4/2020][dated][07.08.2020][against][advance][authorization][No.][0510410328][dated] meeting23.04.2019,[no.] in the light of earlier decision taken in’; | “applied by theit was firm, dec wh i dedcheverto ratifyis less: norms under .Para 4.07 of HBP Vol. I as per details given below or as: Sl. | Export product , Qty. Sl. | Import items Qty. No. ° No. | el CLOMIPRAMINE ‘HCL| 1 Number | | CLOMIPRAMINE | 25.50 mg/ . . CAPSULES, USP 25 MG ; HCL USP 25 mg capsule 2 CLOMIPRAMINE HCL | 1 Number | 1 CLOMIPRAMINE | 51.00 mg/ r CAPSULES, USP 50 MG HCL USP 50 mg capsule : : | 3 CLOMIPRAMINE HCL | 1 Number | 1 CLOMIPRAMINE | 76.50 mg/ “ _ | CAPSULES, USP 75 MG HCL USP 75 mg capsule | | RA concerned may take further necessary action as per above decision of Norms Committee. .
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----- Start of picture text -----<br> /[Gase| No.:26/3/82-ALC4/2020| {PartyLIMITEDName:AARTI: DRUGS_ — [Meet |ALC4/2020No/Date:6/82- ‘Status:Deferred i<br>13.11.2020 | i<br>; | (HOFie ~—~—S(RLAFile ~=—————S~SCLic. NcDaate-03 10837056 /<br>"| -4:01/82/050/01453/AM21/ |:03/94/040/01083/AM20/ ~ {07.07.2020 | a i<br>193 Decision: The Committee considered the case as per agenda in the presence oftechnical experts and it ]<br>hvas noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. | :<br>| [3/82-ALC4/2020 dated 07.08.2020, followed by Reminder to firm on 18.09.2020 for furnishing a copy of !<br>| -|Final14.07 applicationReminderasto per policyfirm for furnishingcircular noa copy23/2015-20of 4.07datedapplication15.05.2019.as perHence,policy itcircular was decidedno 23/2015-20to issue;| - ;<br>| dated 15.05.2019. . _ ; :<br>[Case No.:27/3/82-ALC4/2020 ‘Party Name:CLEAN iMeet No/Date:6/82- Status: !<br>Dt ; SCIENCE AND » ALC4/2020 Approved<br>a M|L I MITT E D PRIVATE 13.1_ 1.2020 |<br>! FiO Fe Ra Bg = Nolte 110067787 | |<br>| :01/82/050/01454/AM21/ _—|:31/83/040/00025/AM21/ (07.07.2020 . . |<br>Decision: | The Committee considered case as per agenda in the presence of the technical experts and it<br>oy was decided to ratify the ad-hoc input output norms under para 4.07 of HBP as per details below or as. |<br>‘1904 applied by firm whichever is lower: i<br>Export Product Qty. | Sl. ] Import items<br>No. 5<br>| Guaiacol Lkg 0.97kg | Sf<br>Hydrogen Peroxide PURITY 60% 0.687 kg .<br>Acetone (Solvent) Olkg - |)<br>RA concerned may take further necessary action as per above decision of NC.<br>----- End of picture text -----<br>
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| {Case No.:35/3/82-ALC4/2020 |Party Name:GLAND Meet No/Date:6/82Status: : ‘PHARMA LIMITED {ALC4/2020 Deferred | :01/82/050/01462/AM21/ - ::09/24/040/00070/AM21/ 07.07.2020 | armnnnmnermmreernrnrnrnnenemnnarertrararensintrieninritinrrtimnaeennnteennnenennnmn|Decision: Deferredforcomments of TE. triaaninimenninininints toe wins een cine oe eine settee stata proninterneteeremeeeeennenee meena beneren naemen enim wtiee ete eee | |Case No.:28/3/82-ALC4/2020 Party Name:SAVLA Meet No/Date:6/82Status: . CHEMICALS LIMITED ALC4/2020 ‘Deferred | 13.11.2020 an | |HQ File — IRLAFile Lic.No/Date:0310837078 :01/82/050/01455/AM21/ :03/95/040/00192/AM21/ (08.07.2020 oo i| . 196 Decision: The Committee considered the case as per agenda in the presence of technical experts and it. was3/82-ALC4/2020noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No.| : dated 07.08.2020, followed by Reminder to firm on 18.09.2020 for furnishing a copy of: J :- (4.07 application as per policy circular no 23/2015-20 dated 15.05.2019. Hence, it was decided to issue, Final Reminder to firm for furnishing a copy of 4.07 application as per policy circular no 23/2015-20) ; . , __4dated 15.05.2019. oe - i. |
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| [CaseNo.:29/3/82-ALC4/2020Party Name:GLENMARK |MeetNo/Date:6/82- (Status: ‘PHARMACEUTICALS LTD ‘|ALC4/2020 Deferred | . | |:01/82/050/01456/AM21/, —:03/94/040/00227/AM21/ — 08.07.2020 | _ | | Decision: Defaited ey Connon OEE on [Case No.:30/3/82-ALC4/2020 |Party Name:CLEAN Meet No/Date:6/82(Status: | ae ‘SCIENCE AND ALC4/2020 Deferred oo TECHNOLOGY PRIVATE 13.11.2020 ; | THQ File —IRLAFile——S—S~™~™~S«S(Lic.No/Datte:3110067788 [SCS 19g ((01/82/050/01457/AM21/ (:31/83/040/00020/AM21/ 08.07.2020 . |»| Deeision: ~The Committee consideredthecase as per agenda in the presence of technical experts and it. | ‘lwas13/82-ALC4/2020noted that thedatedfirm 07.08.2020,still has notfollowedfurnishedbytheReminder4.07 applicationto firm onasked18.09.2020for by NC-3for furnishingin its Meetinga copyNo.of!| | 14.07 application as per policy circular no 23/2015-20 dated 15.05.2019. Hence, it was decided to issue: 4 Final Reminder to firm for furnishing a copy of 4.07 application as per policy circular no 23/2015-20) | |dated 15.05.2019. . ~~ |CaseNo.:31/3/82-ALC4/2020[Party Name:KEVA —~—~—~«(MeetNo/Date:6/82-.—~sStatus: — FRAGRANCES PRIVATE JALC4/2020 Deferred: jLIMITED {13.11.2020 : _ 189. HQFile = ‘RLAFile~~ |Lic.No/Date:0310837120 - _ -|:01/82/0S0/01458/AM21/ —-1:03/94/040/00218/AM21/ 09.07.2020 od _ [Decision:Deferred for comments ofTE. | [Case No.:32/3/82-ALC4/2020 |Party Name:SHARON BIO __|Meet No/Date:6/82‘Status: |MEDICINE LTD jALC4/2020 {Deferred © | |Decision: DeferredforcommentsofTE. . | |. [Case No.:34/3/82-ALC4/2020 |Party Name:MANKIND {Meet No/Date:6/82-. (Status: J/PHARMA LTD IALC4/2020 Deferred | :01/82/0S0/01461/AM21/ —_—:05/24/040/00168/AM21/ 10.07.2020. ef, _ |Decision:Deferred for comments of TE. a
61
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‘CHEM LIMITED ALC4/2020 Deferred :01/82/050/01463/AM21/ :134/24/040/00085/AM21/ [10.07.2020 : | [Decision: Deferred for comments of TE. * eee Re ne RN RN A ERE PSPHSNIRON PRSPHCPHCRHCSHSnHenHemye sonnet ce tonne = ntentemes on AMMAR RA PN RR ERE TE ER RETREAT TEER RAEN NRE eNNR ATEN eet ererRe yyy Hl . ‘l [bo[CaseNo.:37/3/82-ALC4/2020 |Party‘CALCIUMName:GLOBALPRIVATE (MeetALC4/2020No/Date:6/82- Status:Deferred | :E 7 | . LIMITED {13.11.2020 | | | || HQFile | JRLAFille E Lic.No/Date:0710116730 | . |203[Decision:] :01/82/050/01464/AM21/— The Committee considered the|:07/24/040/00102/AM21/case as peragenda in10.07.2020the presence of technical experts and it,| 4. was3/82-ALC4/2020noted that thedatedfirm 07.08.2020,still has notfollowedfurnishedbytheReminder4.07 applicationto firm onasked18.09.2020for by NC-3for furnishingin its Meetinga copyNo.of!| zd i 4.07 application as per policy circular no 23/2015-20 dated 15.05.2019. Hence, it was decided to issue | : | [datedFinal 15.05.2019.Reminder to firm for furnishing a copy of 4.07 application as per policy circular no 23/2015-20:4J
/ [CaseNo.:43/3/82-ALC4/2020 Party Name:HETEROLABS [MeetNo/Date:6/82- Status: ‘LIMITED ‘ALC4/2020 ‘Approved || |HQ:01/82/050/01470/AM21/File ) :09/24/040/00148/AM21/RLA File Lie,:10.07.2020 No/Date:0910068954|| sO | |Decision: The Committee considered case as per agenda in the presence of the technical expertsandit. was decided to ratify the ad-hoc input output norms under para 4.07 of HBP HBP Vol. I as per details below below or|| as applied by firm whichever is lower:
==> picture [455 x 173] intentionally omitted <==
----- Start of picture text -----<br> was decided to ratify the ad-hoc input output norms under para 4.07 of HBP HBP Vol. I as per details below below or|| i<br>as applied by firm whichever is lower: Fe<br>Export Product Qty. | SL Import items Qty. |:<br>(28,38,58)-2-(2,6-DIMETHYL lkg [1 (2S,3S,5S)-2-amino-3-hydroxy- [1.345kg | ff<br>PHENOXYACETYL)AMINO-3- 5-tert butyl carbonyl amino-1,6- ‘ i<br>i HY DROXY-5-AMINO-1,6- -| diphenyl-hexane ~ a ij<br>i DIPHENYL HEXANE METHANOL 0.40 ke 7<br>Methylene Chloride" 0.769kg | |<br>ETHYL BROMO ACETATE 0.84 kg —<br>2,6 XYLENOL 0.59kg, |i<br>16|NNDIISOPROPYLETHER | 0.27kg —<br>RA concerned may take further necessary action as per above decision of NC. . :<br>----- End of picture text -----<br>
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----- Start of picture text -----<br> TE,<br>----- End of picture text -----<br>
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Hs: —/ |CaseNo.:44/3/82-ALC4/2020-7 -FORMULATIONSParty Name:ALPHAMEDPLTD. © [Meet—_ALC4/2020No/Date:6/82(Status:Deferred | | | | : HO File enni NorDuiconioa0sa ‘ 4 7:01/82/050/01471/AM21/ “|:09/24/040/00159/AM21/ 110.07.2020 : . so, 25 Decision: The Committee considered the case as per agenda in the presence of technical experts and.it i . was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No.: , . | |3/82-ALC4/2020 dated 07.08.2020, followed by Reminder to firm on 18.09.2020 for furnishing a copy of; : 4.07Finalapplication as per policy circular no 23/2015-20 dated 15.05.2019. Hence, it was decided to issue| | -Idated 15.05.2019.Reminder to firm for furnishing- a copy of 4.07 application as per policy circular no 23/2015-20,| so . : Case No.:45/3/82-ALC4/2020 Party Name:AUROBINDO iMeet No/Date:6/82Status: ; ’ a )PHARMA LIMITED }ALC4/2020 ‘(Deferred : 206 TOFile —RLAFile SSC (Lic.No/Date:0910068952 [SC : :01/82/050/01472/AM21/ “:09/24/040/00144/AM21/ |10.07.2020 | . vo “Decision: Deferred for comments of TE. [Case No.:38/3/82-ALC4/2020 [PartyName:KLI[Meet No/Date:6/82-a [Status: “| 7 to, PLASTICIZERS LIMITED. ‘!ALC4/2020 ‘Approved i | ——.+413,11.2020 — | | liofile RLA File os— ST CTTTAT | a | mo :01/82/050/01465/AM21/ : :05/23/040/00071/AM21/ 13.07.2020 _ oe ' : ‘ Decision:was decided| toTheratifyCommitteethe ad-hoc consideredinput output case asnorms per agendaunder parain the4.07 presenceof HBP of theas technical expertsper details below andor as.it! | _ japplied by firm whichever is lower: | CO, 207 No: ; : - _ ‘| | DI-BUTYL PHTHALATE 1 kg PHTHALIC ANHYDRIDE 0.56 kg 7 _ | | (GRADE-M) (DBP-M) SABUTOL 0.56 kg _ oy (PACKED IN 2554 NOS. OF HM|3 | HDPE * GRANULES | Relevant . | HDPE DRUMS MADE OF HDPE (TOTAL WEIGHT = | as per : ae ' | GRANULES (21,709.000 KGS. ~ | 22,794.450 KGS.) packing WITHOUT WASTAGE)) (EACH © policy Oo | | | DRUM SHALL WEIGHT 8.5 KG 7 . Po AND STORAGE CAPACITY . . RA concerned may take further necessary action as per above decision of NC. ;
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[Case No.:39/3/82-ALC4/2020 |Party Name:GLOBAL “Meet No/Date:6/82Status: : Po - ~ {LIMITED{CALCIUM PRIVATE{CALCIUM PRIVATE (131120‘ALC4/‘ALC4/ 2 0200 0 0 Deferred - - | (HQFile ~~ IRLAFile IRLAFile ~~ ~—~. ~—_[Lic.No/Date:0710116735 | a 208:01/82/050/0 1466/AM21/01/82/050/0 1466/AM21/ 1466/AM21/ |:07/24/040/00105/AM21/ 13.07.2020 ; | Decision: | The Committee The Committee Committee considered the case case as per agenda per agenda agenda in the presence of technical technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. | / ° 13/82-ALC4/2020 dated 07.08.2020, followed by Reminder to firm firm on 18.09.2020 for furnishing a copy copy of i i | 14,07 application as per policy circular no 23/2015-20 dated 15.05.2019. Hence, it was decided to issue|| | Final Reminder to firm for furnishing a copy of 4.07 copy of 4.07 of 4.07 4.07 application as per policy circular no 23/2015-20) no 23/2015-20) 23/2015-20) -.|dated 15.05.2019. _ 7 |
: Po - ~ {LIMITED{CALCIUM PRIVATE{CALCIUM PRIVATE (131120‘ALC4/‘ALC4/ 2 0200 0 0 Deferred - - cilil | (HQFile ~~ IRLAFile IRLAFile ~~ ~—~. ~—_[Lic.No/Date:0710116735 | a i" 208:01/82/050/0 1466/AM21/01/82/050/0 1466/AM21/ 1466/AM21/ |:07/24/040/00105/AM21/ 13.07.2020 ; | i | Decision: | The Committee The Committee Committee considered the case case as per agenda per agenda agenda in the presence of technical technical experts and it a . was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. | E | / ° 13/82-ALC4/2020 dated 07.08.2020, followed by Reminder to firm firm on 18.09.2020 for furnishing a copy copy of i i i | ; | 14,07 application as per policy circular no 23/2015-20 dated 15.05.2019. Hence, it was decided to issue|| ul | Final Reminder to firm for furnishing a copy of 4.07 copy of 4.07 of 4.07 4.07 application as per policy circular no 23/2015-20) no 23/2015-20) 23/2015-20) i -.|dated 15.05.2019. _ 7 | a " ~ [Case No.:40/3/82-ALC4/2020 |Party Name: TIDE Meet No/Date:6/82(Status: A : i : INDUSTRIES : “{ALC4/2020 . {Deferred | ny an | {13.11.2020 | t | 209 HQ File aevamaty le eooséamans Lit NovDate:s410046210 ae: /— :01/82/050/01467/AM21/ ":34/24/040/00086/AM21/ 13.07.2020 : ny emrerenerserieeretevernentectenertiety(Decision:seat efattnDeferred for comments of TE. , i | ee eeftte eAtedOuit a CPUS 6 SOREEN Ot ETRE TE RRSEITERTENENSTTEPECTERUETLETSRETTEPENRPITTRI-OIAISAPRINAIWORITIer WF sep peysename op npsemp cus canemecanyee oe oe = (te de eaetih oe sea ~a| i. ; i /|Case No.:41/3/82-ALC4/2020 ‘Party Name:ATUL LIMITED Meet No/Date:6/82Status: | el Bo | ALC4/2020 Deferred = = _ i |13.11.2020 | 210 TO File “RLA File Lie No‘Date:0810148122 —: —-(101/82/050/01468/AM21/ —"':08/24/040/00075/AM21/. 14.07.2020 fC _ |Decision: Deferredforcommentsof TE. = iistSstsi‘i—sSSSSSSSS | i'.'. (Case No.:42/3/82-ALC4/2020 No.:42/3/82-ALC4/2020 |Partyaeeenereeneenn Name:INTAS ninePartyaeeenereeneenn Name:INTAS nineaeeenereeneenn Name:INTAS nine Name:INTAS nine nine fiMeet No/Date:6/82-iMeet No/Date:6/82|Status: iii mel4 . - : . [PHARMACEUTICALS LTD. |ALC4/2020 Deferred § , ; _ 13.11.2020 | _ 2
i'.'. (Case No.:42/3/82-ALC4/2020 No.:42/3/82-ALC4/2020 |Partyaeeenereeneenn Name:INTAS ninePartyaeeenereeneenn Name:INTAS nineaeeenereeneenn Name:INTAS nine Name:INTAS nine nine fiMeet No/Date:6/82-iMeet No/Date:6/82|Status: iii 4 . - : . [PHARMACEUTICALS LTD. |ALC4/2020 Deferred § , ; _ 13.11.2020 | _ : ——-(:01/82/050/01469/AM21/ ———|:08/24/040/00077/AM21/ 14.07.2020 op | ‘Decision:Deferred forcommentsof TE. ssts—Ss | Case No.:46/3/82-ALC4/2020 (Party Name:KEVA ‘|Meet No/Date:6/82Status: t De [FRAGRANCES PRIVATE —_.|ALC4/2020 Deferred | j be LIMITED 13.11.2020 | ' | | 212 HQ File (RLA File ~ [Lic.No/Date:0310837163 | | 4:01/82/050/01473/AM21/. ::03/94/040/00254/AM21/ 14.07.2020 : . i | | (Decision: Deferred forcommentsof TE. ss—<“<‘;OS!~S:~<CS*~<‘<s;~;é~‘;~;~;~:*S:SCS:*z
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& Case; No.:47/3/82-ALC4/2020: {PHARMACEUTICALS[PartyName:GLENMARKLTD [MestjALC4/2020NovtDai:6/62’“Status:(Deferred: on 13.11.2020 “THQ File ) RLA File ~|Lic.No/Date:0310837175 [| :01/82/050/01474/AM21/ a -:03/94/040/00257/AM21/ ‘ 14.07.2020 _ ; ; ‘ | |Decision: Deferred forcommentsofTE.=== —
~ [CaseNo.:48/3/82-ALC4/2020 |PartyName:THINQ. [MeetNo/Date:6/82- (Status: — PHARMA-CRO LIMITED —ALC4/2020 “Approved | ‘igre Saal Ti 67Sa TieNoiDate-03 10837005 a | :01/82/0S0/0147S/AM21/ ——_|:03/95/040/00224/AM21/ 15.07.2020 ss | Decision: | The Committee considered the case as per agenda and in the tight of earlier decision taken in , . |214 ‘Imeeting05.04.2019,no. it14/82-ALC4/2019was decided to ratifydatednorms06.03.2020under Paraagainst4.07 ofadvance HBP Vol.authorizationI as per detailsNo. 0310828192 given below datedor as :| : lapplied by the firm, whichever is less:
Export product Qty. | Sl. | Import items Qty.
.
_ IRA concerned may take further necessary action as per above decision of Norms Committee. _ : |
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/ [Case : No.:49/3/82-ALC4/2020 PartyName:NEOGEN “Meet No/Date:6/82-[Status: ; ‘CHEMICALS LIMITED ‘ALC4/2020 Deferred - | [HQ File | ‘RLA File - |Lic.No/Date:0310837205 | : :01/82/050/01476/AM21/ :03/95/040/0005 1/AM21/ 115.07.2020 213 Decision:— The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not fumished the 4.07 application asked for by NC-3 in its Meeting No. | (4.073/82-ALC4/2020application asdatedper 07.08.2020,policy circularfollowedno 23/2015-20by Reminderdatedto 15.05.2019.firm on 18.09.2020Hence, forit wasfurnishingdecideda tocopyissueof|| | |Final Reminder to firm for furnishing a copy of 4.07 application as per policy circular no 23/2015-20 | |dated 15.05.2019. ;
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||‘HEALTH CAREPRIVATE =.ALC4/2020<br>‘Approved<br>,|
|||HQFile<br>~~ RLAFile~=~——_Lie.No/Date:0310837210<br>|<br>:01/82/050/01477/AM21/<br>:03/94/040/00211/AM21/<br>-<br>(15.07.2020<br>ij|
||‘Decision:<br>|The Committee considered the case as per agenda and in the light ofearlier decision taken in:<br>:<br>meeting no. 1/82-ALC4/2019 dated 03.06.2019against advance authorization No. 0310827953 dated<br>a<br>27.03.2019, it was decided to ratify norms under Para 4.07 ofHBP Vol. 1 as_per details given below or as,<br>:|
|||lapplied by the firm, whichever is less:<br>L|
|i216|Export Product<br>Qty. | SL<br>Importitems<br>Qty.<br>;<br>H|
||||<br>| Fenofibrate BulkGranulate<br>1 kg<br>Fenofibrate MicronizedIH/PhEur_|'0.320kg<br>:<br>Hypromellose (2910, 3 cps) Ph. Eur | 0.0633 kg<br>_||
||Docusate Sodium Ph.Eur<br>0.0062 kg<br>|<br>i|
|_<br>Sodium Lauril Sulfate Ph.Eur<br>0.0216 kg<br>|<br>'<br>16_| Lactose Monohydrate Ph.Eur<br>0.2804kg<br>|<br>f||
|||RAconcernedmaytakefurthernecessary action asperabove decisionofNormsCommittee.<br>.|
|��<br>[CaseNo.:51/3/82-ALC4/2020PartyName:BDR<br>—~—~—«*(MeetNo/Date:6/82-.(Status:<br>iPHARMACEUTICALS<br>4ALC4/2020<br>{Deferred<br>|<br>7<br>INTERNATIONALPRIVATE {13.11.2020<br>i<br>217<br>a<br>.<br>|LIMITED<br>.<br>.<br>§<br>|<br>(HQ File<br>_<br>IRLA File<br>|Lic.No/Date:0310837216<br>i<br>_—<br>4:01/82/050/01478/AM21/<br>|:03/94/040/00232/AM21/<br>415.07.2020<br>j||
|||Decision: DeferredforcommentsofTE.==<br>siitstsi‘i;;!!!!<br>OE|
|/™[CaseNo.:52/3/82-ALC4/2020(|PartyName:J.B.CHEMICALS [MeetNo/Date:6/82-.(Status:<br>|<br>&PHARMACEUTICALS<br>jALC4/2020<br>Deferred<br>|<br>a<br>i<br>(LIMITED<br>1b1.2020<br>‘<br>CW QFile<br>“IRLAFile=————~*~*~SC«SL<br>ic.No/Datez0310837228 |—(‘éCS@<br>:01/82/050/01479/AM21/<br>|:03/94/040/00260/AM21/<br>16.07.2020<br>3<br>{Decision:<br>Deferred forcommentsofTE. eeOE OO||
|[CaseNo.:55/3/82-ALC4/2020[Party Name:STYRAX LIFE“MeetNo/Date:6/82- Status:<br>SCIENCES PRIVATE<br>JALC4/2020<br>‘Deferred||
|[HQ File<br>[RLA File<br>~-_[Lig,No/Date:0910068964<br>i ti(sts<br>:01/82/050/01482/AM21/<br>1:09/24/040/00166/AM21/<br>+17.07.2020<br>i<br>219 Decision:<br>TheCommittee considered the case as per agenda in the presence of technicalexperts<br>andit<br>twas noted that the firm still has not furnished the 4.07application asked for by NC-3 in its Meeting No.:<br>j||
||3/82-ALC4/2020 dated 07.08.2020, followed by Reminder to firm on<br>18.09.2020 for furnishing a copy of|
||4.07 application as per policy circular no 23/2015-20 dated 15.05.2019.<br>Hence, it was decided to issue!<br>.|
|||Final Reminder to firm for furnishing acopy of 4.07 application as per policy circularno 23/2015-20.<br>i<br>‘Idated 15.05.2019.<br>.<br>c,d|
‘HEALTH CARE PRIVATE =. ALC4/2020 ‘Approved | HQFile ~~ RLAFile~=~——_Lie.No/Date:0310837210 :01/82/050/01477/AM21/ :03/94/040/00211/AM21/ - (15.07.2020
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|F | Case No.:53/3/82-ALC4/2020- iParty Name:MEHTA API (MeetNo/Date:6/82-.—<Status: a PRIVATE LIMITED | :ALC4/2020 ; ‘Deferred _ — IHQFile:01/82/050/01480/AM21/ RLA File ~~ ~~" |Lic.No/Date:0310837276| :03/95/040/0023 1/AM21/ 20.07.2020 4 : , 220 Decision: | The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No.; ° : i_ 3/82-ALC4/2020 dated 07.08.2020, followed by Reminder to firm on 18.09.2020 for furnishing a copy of| y 14.07 application as per policy circular no 23/2015-20 dated 15.05.2019. Hence, it was decided to issue | ; datedFinal 15.05.2019.Reminder to firm for furnishing a copy of 4.07 application as per policy circular no 23/2015-20_ ~~ [Case No.:54/3/82-ALC4/2020 (Party Name:ASTRAL [Meet No/Date:6/82(Status: | po STERITECH{LIMITED PRIVATE ; . |ALC4/2020:13.11.2020 4|Deferred | HQi File - IRLAFile [Lic.No/Date:3410046228| 221. |:01/82/050/01481/AM21/Decision: | The Committee considered:34/24/040/00096/AM21/"the case as per agenda in20.07.2020.the presence of technical \experts and it. i was3/82-ALC4/2020noted that thedatedfirm 07.08.2020,still has notfollowedfurnishedbytheReminder4.07 applicationto firm onasked18.09.2020-forfor by NC-3furnishingin its Meetinga copyNo.of.| ; : 14.07 application as per policy circular no 23/2015-20 dated 15.05.2019. Hence, it was decided to issue | | fdatedFinal 15.05.2019.Reminder to firm for furnishing a copy, of 4.07 application, as per policy circular no 23/2015-20:
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i Case No.:56/3/82-ALC4/2020 'Party Name:INNOVARE (Meet No/Date:6/82Status: : bo: ; iLABS PRIVATE LIMITED —_|ALC4/2020 Deferred i a 13.11.2020 _ . (AQFile == RLA File—SSSSCLic.No/Daate:0910068965 |, 222 Decision: The Committee considered the case as per agenda in the presence of technical experts and it, : was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. | 3/82-ALC4/2020 dated 07.08.2020, followed by Reminder to firm on 18.09.2020 for furnishing a copy of| : 4.07 application as per policy circular no 23/2015-20 dated 15.05.2019. Hence, it was decided to issue: {Final Reminder to firm for furnishing a copy of 4.07 application as per policy circular no 23/2015-20)
67
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, Case No.:57/3/82-ALC4/2020. Party Name:OPTRIX Meet No/Date:6/82Status: =| ; . . LABORATORIES PRIVATE 'ALC4/2020 ‘Approved | i LIMITED 13.11.2020 | : HQ File RLA File ~ Lic.No/Date:0910068980 ; :01/82/050/0 §484/AM21/ :09/24/040/00199/AM21/ 20.07.2020 i | Decision: — The Committee considered the case as per agenda and in the light of earlier decision taken in i 26.03.2018,mecting no. 4/82-ALC4/2020 dated 18.09.2020 against advance authorization No. 0910066086 dated| t applicd bytheit wasfirm. decwh i dedcheverto ratifyis less:norms under Para 4.07 of HBP Vol. Las per details given below or as | i
223 Export Product Qty. SL. Import items Qty. . No. EMPAGLIFLOZIN-IF 7 1 ke (1S)-1 5-Anhydro-1-C-|4-chloro -3-[f4-{[(3S)- | 1.525 kg | tetrahydro-3i furanyl}oxy }pheny!]methv!]pheny!]-D-glucitot | tetraacetaté OR (1S)-f S-Anhydro-t-C-[4-chloro -3-[[4| : [[(3S)-tetrahydro-3furanyl]oxy]phenyl]methyl]phenyl]-D-glucitol | RA concerned may take further necessary action as per above decision of Norms Committee. | Case No.:58/3/82-ALC4/2020 Party Name:SUN Mect No/Date:6/82‘Status: ' PHARMACEUTICAL ALC4/2020 iDeferred ; - 724 CO . INDUSTRIES LTD. 13:11:2020 a. 4Q File RLA File Lic.No/Date:0510414657 | | O1/82/0S0/0148S/AM21/ ss :05/24/040/00176/AM21/ . 21.07.2020 - a | . oo we ee eee me ee me eee ee meme eee ee ee ee ce annem | Decision: Deferred for comments of TE. oo, Case No.:59/3/82-ALC4/2020 Party Name:ADVANCE ———-Meet No/Date:6/82Status: | 7 ; ‘PETROCHEMICALS =~ | -ALC4/2020_—j Deferred i LIMITED , ‘13.14.2020 ; ‘ HQ File” RLA File Lic.No/Date:0810148200 5 sO :01/82/050/0 1486/AM2i/ :08/24/040/00095/AM2 1/ 21.07.2020 L | H 225 Vecision: The Committee considered the case as per agenda in the presence of technical experts and it| 5 was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No.| 3/82-A1.C4/2020 dated 07.08.2020, followed by Reminder to firm on. 18.09.2020 for furnishing.a copy of; jj 4.07. application as per policy circular no 23/2015-20 dated 15.05.2019. Hence, it was decided to issue | : Final Reminder to firny for furnishing a copy of 4.07 application as per policy circular no 23/2015-20: i dated 15.05.2019. , i
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|---|---|---|---|---|---|---|---|---|---|---|
|Case No.:60/3/82-|Party Name:BRAWN|iMeet|No/Date:6/82-|iStatus:|So|
|ALC4/2029|LABORATORIES|LTD|‘ALC4/2020|‘Approved|fo|
|13.11.2020|
|HQ|File|RLA|File|‘Lic.No/Date:05 10414674|||||
|:01/82/050/01487/AM21/|:05/23/040/00085/AM2|t/|21.07.2020|;|j|||,|
|wasDecision:decided=toTheratifyCommittcethe|ad-hocconsideredinput|outputcase|asnormsper|agendaunder|inparathe4.07presenceof|HBPoftheas technicalper|detailsexpertsbelow andor||as!|-|.|
|applied by|firm whichever|is|lower:|.|||,|
|0.|
|1|AZITHROMYCIN|J|Number|| AZITHROMYCIN|267.24|mg|
|CAPSULE|/|||
|(HARD|250|MG|DIHYDRATE|||USP ||250mg|
|CAPSULES|CONTAININGGELATIN|(WHITEWHITE|POWDER)OR|ALMOST||capsule|~~|:|
|-|| WHITE|CRANULAR|i|
|||POWDER)|||||
|2|AZITHROMYCIN|||Number|| AZITHROMYCIN|534.48|mg|/|
|_|||CAPSULE|500|MG|DIHYDRATE|USP|| 500mg.|
|(HARD|_|GELATIN|(WHITE|OR|ALMOST||capsule|
|CAPSULES|CONTAINING|WHITE|POWDER)|
|276|~~|«OXI:|||WHITE|GRANULAR|
|POWDER)|
|.|3|AZITHROMYCIN|||Number|| AZITHROMYCIN|267.24 me/|||no|
|(WHITE|ROUND|(WHITE|OR|ALMOST|‘|-|
|TABLET|250MG|Py|DIHYDRATE|USP | 250 mg Tablet|||
|BICONVEX|FILM|WHITE POWDER)|.|a|
|COATED TABLETS)|7|oO|
|4|AZITHROMYCIN|]|Number|| AZITHROMYCIN|534.48 mg/|
|TABLET|500|MG|DIHYDRATE|USP||}|500|mg|Tablet|
|||(WHITEBICONVEX|ELONGATEDSCORED|ON|(WHITEWHITE|POWDER)OR|ALMOST|:|
|ONE|SIDE|FILM|COATED|
|TABLETS)|
|5|AZITHROMYCIN|ORAL|||||Number|| AZITHROMYCIN|1320.48 mg/|||
|SUSPENSION|200MG_|/|DIHYDRATE|USP ||30 ml|bottle|||
|S5ML-30ML|(WHITE|OR|ALMOST|-;|i|
|(PINKISH|WHITE|WHITE|POWDER)|
|GRANULAR|POWDER|
|FORMING|PINK|i|
|COLOURED|SUSPENSION|
|ON|RECONSITITUTIN)|||,|
|RA|concerned|may|take|further necessary|action|as|per above decision|of NC.|_||
|Case No.:67/3/82-ALC4/2020|Party|Name:|AUROBINDO|.Meet|No/Date:6/82-|(Status:|||
|:|‘PHARMA|LIMITED|“ALC4/2020|iDeferred|;|
|13.11.2020|,|
|227|HO File|RLA|File|Lic.No/Date:09 10068983|||_|
|:01/82/050/0 1494/AM21/|:09/24/040/00209/A M2|V/|21.07.2020|i|||
|Becision:|Deferred|for|comments|of TE.|.|
----- End of picture text -----<br>
; — MAREE RREAIR A , 7 irs "Case No.:68/3/82-ALC4/2020 Party Name:STYRAX iMeet No/Date:6/82‘Status: F , oe PHARMA PRIVATE ‘ALC4/2020 ; Deferred il i \HQFile - LIMITED . ‘13.11.2020 oe 7 4 |, |:01/82/050/01495/AM21/= ~~~——*SRLAFile. ~~————~S™S™CSCSSCLic.Nv/Datte::09/24/040/00208/AM21/ 21.07.202 0 9100689866 || Ear |228 Decision: The Committee considered the case as per agenda in the presence of technical experts and it; i ; was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 3/82-ALC4/2020 | fa 4.07 dated 07.08.2020, followed by Reminder to firm on 18.09.2020 for furnishing a copy of, ty ‘|. application as per policy circular no 23/2015-20 dated 15.05.2019. Hence, it was decided to issue, ay } | \Final Reminder to firm for furnishing a copy of 4.07 application as per.policy circular no 23/2015-20: hy |dated 15.05.2019. . j | / [CaseNo.:41/6/82-ALC4/2020|Party Name:AUROBINDO — Meet No/Date:6/82-' (Status: = tts . [PHARMA LIMITED /ALC4/2020 Approved =f | {HQ File LA File ~~ _|Li¢.No/Date:0910068985 ff {:01/82/050/01650/AM21/ |:09/24/040/00615/AM20/ ~ 21.07.2020 oy a , | ‘Decision: | The Committee considered the case as per agenda and in the light of earlier decision taken in) iH jmeeting no. 5/82-ALC4/2020 dated 02.08.2019 against advance authorization No. 0310828072 dated : 02.04.2019, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as|| i= | ‘prplied by the firm, whichever is less: . [i , i | | Export Product Qty. | Sl. | Import items | Qty. ; | | [MEROPENEM FOR INJECTION 1kg [1 | Meropenem Trihydrate (Non Sterile) | 0.958kg ] && . | | | (STERILE BULK ) USP LP. a “19 Aluminium Canisters / Bottles with Relevant i fF | ; = ChloroLid and GasketButyl Plug/AluCaps/ Inner [14Lts&Outer | packingas per! | | Hl ee (The firm has to account for packing ! rt , material 2000 sets in the export : i \ . product duly authenticated by | | . ; customs authorities in the s.bills.) i! , RA concemed may take further necessary action as per above decision of NC. . i Th oe | «Case No.:62/3/82-ALC4/2020 Party Name:USV PRIVATE _|Meet No/Date:6/82(Status: | t Do, ; LIMITED (FORMERLY USV j|ALC4/2020 Deferred , 4 " bag cette HMITED) WS -11-2020 | 730.71Q File RLA File Lic. No/Date:0310837311 [fl » —-{:01/82/050/01489/AM21/ 4:03/95/040/00240/AM21/ 22.07.2020 : | el i [Decision: Deferred for comments of TE. . fi i kA I . . . N : . ie
a se
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|;||Or<br>~<br>,|[~~(Case No.:63/3/82-ALC4/2020 [PartyName:SUPERMINT<br>(MeetNo/Date:6/82-(Status:<br>;<br>-<br>IEXPORTS PRIVATE<br>|ALC4/2020<br>-<br>"Deferred<br>ee, [IMITED<br>_<br>13.11.2020<br>|<br>|<br>THOFile<br>—<br>IRLAFile<br>-[Li¢,No/Date:0510414685<br>:01/82/050/01490/AM21/<br>1:05/24/040/00191/AM21/<br>'22.07.2020<br>|<br>23l Decision:<br>TheCommittee considered the case as per agenda in the presence oftechnical experts and it!<br>was noted that the firm.still has not furnished the 4.07 application asked for by NC-3 in its Meeting No.||
|---|---|---|---|---|
|||poe<br>3/82-ALC4/2020 dated 07.08.2020, followed by Reminder to firm on<br>18.09.2020 for furnishing a copy of|||
||||‘14.07 application as perpolicy circular no23/2015-20 dated.15.05.2019. Hence, itwas decided to issue<br>|<br>|<br>{Final Reminder to firm for furnishing a copy of 4.07 application as per policy circular no 23/2015-20:|.|
|||||<br>Idated 15.05.2019.||
||||~'[CaseNo.:64/3/82-ALC4/2020<br>PartyName:USVPRIVATE<br>[MeetNo/Date:6/82-<br>[Status:<br>_<br>LIMITED<br>-<br>|ALC4/2020.<br>[Deferred||
||.<br>'|:|oo<br>|<br>.<br>~<br>113.11.2020<br>-<br>.<br>|<br>232 HQFile<br>==—————~<CS~S*st*‘<br>RL Pile~=——SS~S*~*~S«dCLicNDaates0310837333[=<br>:01/82/050/01491/AM21/<br>“:03/95/040/00236/AM21/<br>_:122.07.2020<br>|<br>|Decision:<br>Deferred forcommentsofTE.<br>|<br>_||
||me<br>_||1 [€aseNo.:65/3/82-ALC4/2020<br>PartyName:ALEOR<br>MeetNo/Date:6/82-(Status:<br>i<br>.DERMACEUTICALS<br>4ALC4/2020<br>Deferred<br>|<br>ne<br>LIMITED<br>13.11.2020<br>po,<br>331HQFile~~<br>RLAFile~~~<br>{Lic.No/Date:3410046235<br>|<br>fo<br>|<br>Hovszosooiaszam2u<br>——:34/24/040/00098/AMa1/<br>22.07.2020.<br>_<br>|Decision:Deferred<br>for comments of TE.<br>.||
|.||||<br>[CaseNo.:69/3/82-ALC4/2020<br>[PartyName:SYNTHO<br>MeetNo/Date:6/82-<br>Status:<br>|<br>=<br>iCHIRALS PVT. LTD<br>“ALC4/2020<br>Deferred<br>oo:<br>ee<br>|<br>13.11.2020<br>.<br>|<br>O4iQFile~~'IRLAFile<br>(Lie.No/Date:0910068991Po<br>|<br>|:01/82/050/01496/AM21/<br>———:09/24/040/00185/AM21/<br>>(22.07.2020||
me , _
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4 . i B | 4||||| r=: |h
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==> picture [446 x 129] intentionally omitted <==
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|;|
|Pinenamnees|orcasCaseLaeaptananalnnnninamnnnnrnens No.:66/3/82-|eons|sechones|ontnet meal|Partypotency Name:ETERNISaewece ee|oe nee|atteFINEsasunesssununnsasnnsnar|Meeta eeeTL tah No/Date:6/82-elanualamaesaereiaente|coe cee oo|oe annnnssanonmamaaraim proce‘Status:te|neta|
|ALC4/2020|a|CHEMICALS|LIMITED|‘ALC4/2020|‘Approved|
|*|(HQFile|ORLA Fileee|Lic. No/Date:03 10837390|||;|
|~—_}:91/82/050/01493/AM21/|_|:03/94/040/00267/AM21/|23.07.2020|||_|
|Decision:|The|Committee|considered|case|as per agenda|in|the|presence|of the|technical|experts and|it|
|iwas|decided|to|ratify|the|ad-hoc|input|output|norms|under|para|4.07|of HBP|as|per|details|below|or|as:|
|applied by firm whichever|is|lower:|
----- End of picture text -----<br>
:
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|||||||||||
|---|---|---|---|---|---|---|---|---|---|
|Export|Product|Qty.|Sl.|||Import|items|Qty.|i|
|||||[METHYL-3-OX0-2-|1|kg|PENTYL ENDO (85%)|(2.|||0.760 kg|Af|
|_L|CYCLOPENTANEPENTYL|-|i -|ACETATE|one)Pentyt|-2-Cyclopentene-1-|;|7|T4 |4 | ||
|:|2|| DIMETHYL|0.660 kg|«de|
|||MALONATE|'|
|SODIUM|METHOXIDE _|||0.130|kg|ey|
|_|4|MS BARREL (Lacquered)||| Relevantaspackingpolicy per|||||
|,|Ina concerned may take further necessary action as per above decision of|NC.|r|
|.|"4|{Case No.:70/3/82-ALC4/2020|Party|Name:VERVE HUMAN|Meet No/Date:6/82-|‘Status:|i|||
|.|De|CARE LABORATORIES|jalcar2020|‘Deferred|=|
|13.11.2020|ge|||
|||(01/82/0S0/01497/AM21/|_|:05/24/040/001S9/AM21/|24.07.2020,|fs|
|||[Decision:|DeferredforcommentsofTE.|si‘|Sé;SO™”*”*”*”!”!!O!O!”!O!!O!O!!OOCU|
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|||||||||
|---|---|---|---|---|---|---|---|
|.|Case|No.:71/3/82-ALC4/2020||Party Name:DEEPAK|-|‘Meet No/Date:6/82-|Status:|4|
|,|NITRITE LIMITED|—|°|JALC4/2020|Deferred:|i|
|237|FQ|File|||IRLA|File|Lic.No/Date:3410046248|B|
||||:01/82/050/01498/AM21/|[:34/24/040/00404/AM20/|(24.07.2020|||||
|__|[Decision: “Deferred forcommentsof|
|TE.|sis;|4||||||
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----- Start of picture text -----<br> [Case No.:72/3/82-ALC4/2020 Party Name:CIPLA LIMITED. [MeetNo/Date:6/82. (Status:<br>7 ALC4/2020 “|Approved |<br>-_1HQ File ARLAFile oy Leit/NovDatesos10837414 -ee<br>: -1:01/82/050/01499/AM21/ 1:03/94/040/00264/AM21/ ‘127.07.2020 ‘<br>Decision: The Committee considered the case as per agenda and in the tight of earlier decision taken in :<br>i meeting no. 4/82-ALC4/2019 dated 19.07.2019 against advance authorization No. 0310820244 dated:<br>| }03.04.2018, it was decided to ratify norms under Para 4.07 of HBP Vol. I as_per details given below or as:<br>: japplied by the firm, whichever is less:<br>ing Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray / Dymista | 1 Number :<br>238 | Nasal Spray (Pack 120MD) . .<br>- | ‘| Each Spray delivers: Azelastine Hydrochloride BP 137meg Fluticasone<br>' _Propionate 50meg ;<br>| Azelastine Hydrochloride 16.44 mg<br>Fluticasone Propionate 6.00 mg<br>| —4| [25ml] [USP] [type] [1] [amber] [glass] [vial]<br>----- End of picture text -----<br>
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----- Start of picture text -----<br> "IRA concerned may take further necessary action as per above decision of Norms Committee.<br>----- End of picture text -----<br>
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----- Start of picture text -----<br> [Case No.:74/3/82-ALC4/2020 [Party Name:GLOBAL(MeetNo/Date:6/82-. ‘Status: “y<br>2 CALCIUM PRIVATE |ALC4/2020 [Deferred<br>| HQ File IRLA File. |Lic.No/Date:0710116798 "|<br>1:01/82/050/01501/AM21/ (:07/24/040/00118/AM21/_ [27.07.2020 |<br>239 Decision:The Committee considered thecaseas per agendain the presence oftechnical expertsand it,<br>| ‘|was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. |<br>l. 3/82-ALC4/2020 dated 07.08.2020, followed by Reminder to firm on 18.09.2020 for furnishing a copy of:<br>i 4.07 application as per policy circular no 23/2015-20 dated 15.05.2019. Hence, it was decided to issue!<br>: -|| Final‘|dated 15.05.2019.Reminder to firm for furnishingoea copy of 4.07anapplication as peraepolicy circularno 23/2015-20'<br>| [Case [No.:1/6/82-ALC4/2020] [|PartyName:SHITAL] ——«([Meet No/Date:6/82-. (Status: ys<br>CHEMICAL INDUSTRIES ALC4/2020 Deferred<br>POT File RLA File ~ fLie.No/Date:3410046347 | |<br> — 1:01/82/050/01610/AM21/ ———4:34/24/040/00140/AM21/ (02.09.2020 - od |<br>: Decision: ~ This «case appeared for the first time before Norms Committee. Deferred for comments of TE.<br>----- End of picture text -----<br>
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st tino pate mre ere erernriererenenrennenet rrr ene tet oe te rennet encanto ee oncenennene anemone ete F ii } ; Ease No.:2/6/82-ALC4/2020 Party Name:ATUL LIMITED [Meet No/Date:6/82Status: | ‘ Poop ALC4/2020 ‘Approved # | (HQFile — RLA File Lic.No/Date:0810148472, ia | (:01/82/0S0/01611/AM21/ ——08/24/040/00162/AM21/. 03.09.2020, ! Decision: — The ‘Committee considered case as per agenda in the presence of the technical experts and it 7 | " |was decided to ratify the ad-hoc input output norms under para 4.07 of HBP asper details below or as; ay i . ; I.i 94] japplied by firm whichever is lower: i } : | | | Export Product Oty. Sl. | Import items Qty. | | _ | | Amine Chain Extender kg [1 [Methanol 0.153 kg —. | © 12 Ortho Ethyl Aniline (2 Ethyl | 1.058 kg : is SO a. "| Aniline) | i ’ JRA concerned may take further necessary action asun per abovecabecbhtrrearicenen decision of NC. re4 \a , {em feta etereneetarennieentreriini penne erent ene nen etn mt A Ne | ‘Case No.:3/6/82-ALC4/2020 |Party Name:CADILA ‘Meet No/Date:6/82‘Status: ik po ‘HEALTHCARE LIMITED —ALC4/2020 ‘Approved | aw ; | 7 13.11.2020 | hi | -HOQFile JRLA File © - ‘Lic.No/Date:0810148474 | oo | | :01/82/0S0/01612/AM21/ | :08/24/040/00158/AM21/ * 03.09.2020 = | = | | Decision:The Committee considered case as per agenda in the presence of the technical experts and it - ‘was decided to ratify the ad-hoc input output-norms under para 4.07 of HBP as.per details below or as hi applied by firm whichever is lower: | if i | SL. Export Product Qty. a \ rn er ae PAROXETINE TABLETS ~~ USP 10. MG | 1 Number | ii | ’ | (ACTIVEUSP EQUIVALENTINGREDIENT:TO PAROXETINE.-PAROXETINE NETHCLWT.HEMIHYDRATE1199.801 KGS. | ~ :4 | ED PAROXETINE TABLETS USP 20 MG| 1 Number if : .| (ACTIVE INGREDIENT: PAROXETINE HCL HEMIHYDRATE . a ; 242 USP EQUIVALENT TO PAROXETINE - NET WT. 4919.584 KGS: i . a & GROSS WT. 5977.295 KGS.) i [8 PAROXETINE TABLETS USP 30. MG/INumber | i a (ACTIVE INGREDIENT: PAROXETINE HCL HEMIHYDRATE USP EQUIVALENT TO PAROXETINE - NET WT. 2670.290 KGS. i i S| & GROSS WT. 3244.402 KGS.) , en | | fa PAROXETINE TABLETS USP 40 MG| 1 Number (ACTIVE INGREDIENT: PAROXETINE HCL’ HEMIHYDRATE ae USP EQUIVALENT TO PAROXETINE - NET WT. 4899.661 KGS. aE i : | | ° | & GROSS WT. 5953.088 KGS.) (TOTAL NET WT. 13689.335 a - | | KGS. & GROSS WT. 16632.543 KGS OF. PAROXETINE HCL oo Hi DO HEMIHYDRATE USP) > 3 ‘ | . : et
.
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||||||en|eee<br>a<br>a|||.||||PIPERIDINE<br> |ALCOHOL<br>[(-)<br>ALCOHOL]<br>_OR(-<br>TRANS-1-N-||9.00|mg|:|18.00 mg<br>;||27.00mg|36.00mg|;|7|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|mo||||re|-<br>-|a<br>ob]<br>bf<br>po<br>i<br>|||’|||<br>‘_||<br>-||HYDROXY<br>|.<br>|.<br>METHYL-4-(4-<br> |FLUORO PHENYL)<br>PIPERIDINE<br>_-<br>SODIUM<br>STARCH| 6.00mg<br>GLYCOLATENF eeee|||||;<br>.<br>12.00 mg<br>ee||18.00mg|,<br>.<br>24.00mg|||<br>|<br>|<br>i<br>i:|
|||||.||bo|||||||30)|||||||||||
|so||,|.|||D4<br>||||||||MAGNESIUM<br>. <br>STEARATE<br>PH.E/NF/JP.|||1.25|mg||2.50 mg|||3.75 mg|5.00 mg|||<br>||
|_<br>;<br>oS<br>,|||||Po<br>Tbe<br>416<br>pod<br>|<br>po<br>mY<br>ae<br>Po|||||_|||LACTOSE NF/BP<br>DIBASIC CALCIUM| <br>PHOSPHATE<br>ANHYDROUS<br>USP|<br>|(THIS LICENCE<br>IS|<br>ISSUED<br>|<br>WITH<br>CONDITION THAT<br>IMPORT:OF ANY<br>DRUG<br>AGAINST||26.37mg<br>|<br>-||.|52.74mg<br>an||:|79.11 mg<br>,|105.48 mg||=<br>7<br>||
|;||||||a|||||||WILL<br>. BE<br>ALLOWED<br>(~—<br>°||||.|||.||||
|!|||||||||||||THROUGH|||||||||||
|||||||pot}|||||||REGISTERED||.|,||.||||||
|!<br>Ot|.|||,|-|Po<br>a<br>;<br>|<br>a|||||||SOURCES AS<br>PER]<br>PROVISION<br>LAID<br>DOWN:IN DRUG &<br>COSMETIC<br>=ACT<br>AND AS PER PARA||.<br>||7<br>;||:|,<br>.|||||—<br>;|
|||||||a|||||||4.07OFHBP 2015-20||||||,|||||
|;<br>;||||en|P|<br>oe<br>||||>||||||SUBJECT<br>TO<br>FIXATION<br>OF<br>|NORMS<br>BY<br>ALC,<br>NEWDELHI)|||||i.|||||ale|
,
| |RA concerned may take further necessary action as per above decision of NC.
|
,
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;
||:<br>.<br>.<br>.|sa<br>|||
|---|---|---|---|
|.|~~(CaseNo.:4/6/82-ALC4/2020PartyName:VERVE<br>HUMAN<br>[MeetNo/Date:6/82-Status:=—sstsé<br>A<br>,<br>:<br>‘CARELABORATORIES<br>ALC4/2020<br>[Deferred<br>°° gi<br>13.11.2020<br>|<br>.<br>—<br>HQFile=<br>RAFile» Lic.No/Date:0510415104ae |<br>243|:01/82/050/01613/AM21/<br>::05/24/040/00255/AM21/<br>03.09.2020<br>|<br>a7<br>:<br>a<br>“Soentimannennaimneeeteneenmanraranetniateneta enamel<br>nar i<br>i j<br>(Decision:<br>ThiscaseappearedforthefirsttimebeforeNormsCommittee. TheCommitteenotedthatthe;<br>i t<br>:<br>14.07 application ofsubjectAdvance Authorization isnot available. Hence, itwasdecided tocall foracopy:<br>i l<br>of4.07 application ofthe subject advance authorization directly from the firm as per Policy Circular No. |<br>i<br>'53/2015-20, dated 15.05.2019.<br>7<br>i|||
|||Case No.:5/6/82-ALC4/2020<br>PartyName:CONCORD<br>MeetNo/Date:6/82-<br>Status:<br>Po<br>/BIOTECH LTD<br>1ALC4/2020<br>Deferred<br>|<br>|<br>13.11.2020<br>onHO File<br>RLA File<br>[Lic.No/Date:0810148478<br>|<br>:<br>1301/82/050/01614/AM21/<br>:|:08/24/040/00395/AM20/<br>. 03.09.2020_ a<br>|<br>[Decision: Thiscase appeared forthe first time before Norms Committee. Deferred forcomments<br>of TE. ||Ht<br>Ht<br>||<br>Ay<br>| \<br>i<br>.||
||.|ae||
||CaseNo.:6/6/82-ALC4/2020 Party Name: YASHO<br>MeetNo/Date:6/82-<br>Status:<br>|<br>i<br>INDUSTRIESLIMITED<br>‘ALC4/2020<br>Approved<br>|<br>|<br>|<br>13.11.2020<br>/<br>—|:<br>iH||
||~<br>(HQFile<br>——i—<“—~sSRLAQFile=<br>S—*~*~*~s~SsCLeicNoo/Daatez03108380670t—=<C~S*=i~‘CS:*«i<br>:01/82/050/01615/AM21/<br>':03/95/040/00343/AM21/<br>'03.09.2020<br>:<br>i<br>|<br>|Decision:<br>|TheCommitteeconsideredcase asperagenda inthe presence ofthe technical expertsand it |<br>a *<br>was decided to ratify the ad-hoc input output norms under para 4.07 of HBP as per details below or as!<br>ia<br>appliedbyfirm whichever islower:<br>.<br>—<br>i<br>! i|||
|245°<br>No.<br>|<br>|<br>|<br>YALUBPA 135(3,5-DI-<br>Lkg<br>1<br>2,6-DI-TERTIARY-BUTYL<br>0.825kg<br>i<br>; i<br>| | TERTIARY-BUTYL-4-<br>|<br>PHENOL<br>|<br>ok<br>HYDROXYHYDROCINNAMIC<br>METHYLACRYLATE<br>0.349kg |<br>|<br>i i<br>po<br>ACID)<br>3<br>EXXAL8(ISOOCTANOL)<br>Not<br>| t<br>—<br>allowed,<br>|<br>| "<br>=<br>,<br>sincenot<br>|<br>|<br>|<br>ro<br>:<br>shown in<br>4 c||||
|||<br>process.<br>||FA||
||RA concernedmaytakefurthernecessaryaction asperabovedecision ofNC.<br>.|Ht||
||t|rf||
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==> picture [1 x 17] intentionally omitted <==
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|||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|_—|PHARMACEUTICAL|LTD|—_ALC4/2020|‘Approved|
|||-|||13.11.2020.|-|
|_||HQFileCRA File|sic.|NoDate0310838076|
|:01/82/050/01616/AM21/|:03/94/040/0039 1/AM21/|03.09.2020|
|:|||‘jwasDecision:decided|toTheratify Committeethe|ad-hocconsideredinput|output case as pernorms|agendaunder parain the4.07 presence ofof HBP|Vol. the technicalI|as|per|detailsexpertsbelow and|orit,||
|as applied by|firm whichever|is lower:|||
|i|No.|:|
|246)|| BECLOMETHASONE|Ike|||1|PREGNA-1,4-DIEN-9,11-|0.88kg|||
|||||| DIPROPIONATE|EPOXIDE-16 BETA METHYL-17|I|
|MICRONIZED|(EP/BP/USP)|ALPHA,21-DIHYDROXYL-3,20-|!|
|.|DIONE0)/|(DBXI) (CAS NO:|981-34-|
|17 ALPHA 21-DIHYDROXY-|16-|
|||;|BETA|METHYL-|9-BETA-11-|
|i|BETA|- EPOXY|PREGNA-I,|4-|
|a|DIENE-3,|20- DIONE|(DB-X]I)|
|_|(CAS|NO:.981-34-0)|yo,|
|, RA concerned may take further necessary action|as per above decision of|NC.|;|
|7|{Case|No.:8/6/82-ALC4/2020||Party|Name:|VERVE HUMAN|[Meet No/Date:6/82-|Status:|
|‘CARE LABORATORIES|4ALC4/2020|‘Deferred|
||:01/82/050/01617/AM21/|:05/24/040/00248/AM21/|04.09.2020|
||||Decision:|This|case|appeared|for|the first|time|before|Norms|Committee.|Deferred|for|comments|of|TE.|
|.|:|INDUSTRIES|LIMITED|ALC4/2020|Deferred|||
|io|,|—|13.11.2020|.|7|
|248|FQ|File|[RLA|File|||[Lic|No/Date:0310838091|
|»|—-|(:01/82/050/01618/AM21/|:03/95/040/00350/AM21/|{04.09.2020|—|||
|_||Decision:|This|case appearedfor|the|first|time|before|Norms|Committee.|Deferredfor|comments of|TE. ||
|i Case No.:10/6/82-ALC4/2020|‘Party Name:ZIM|‘Meet No/Date:6/82-|Status:|||
|.|“LABORATORIES|LIMITED|{|ALC4/2020|Deferred|||
|:|13.11.2020.|
|||:01/82/050/01619/AM21/|-:03/95/040/003 10/AM21/||07.09.2020|ae|
||Decision:|This case appeared|for the|[first][ time][ before]|Norms|[Committee.]|[Deferred]|[for]|comments|[ of]|TE.|
----- End of picture text -----<br>
.
. ,
77 7 ~~: [CaseNo.:11/6/82-ALC4/2020 PartyName:TADIMETY Meet No/Date:6/82- (Status: | i j|AROMATICS PVT. LTD 13.11.2020ALC4/2020 ' (Deferred | ,: THQ File * RLAFile = ~——~—_Lic.No/Date:0710116964. | ati its t sC@d Decision: This case appeared for the first time before Norms Committee. The Committee noted that the. i 14.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy ; : 123/2015-20,G3 4.07 applicationdated 15.05.2019.of the subject advance authorization directly from the firm as per Policy Circular No. | / [Case No.:12/6/82-ALC4/2020 [PartyName:CHIRAG—s' Meet No/Date:6/82- (Status:= (its te iENTERPRISE ‘ALC4/2020 [Deferred THO Fite �� [RLA File *|Lic,No/Date:2410043228 | | 251 }:01/82/050/01621/AM21/ |}:24/24/040/00040/AM21/ 107.09.2020 | . : Ns Decision: This case appeared for the first time before NormsCommittee.The Committee noted that the F 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call fora copy. . | ios 4.07|23/2015-20, applicationdated 15.05.2019.of the subject advance authorization directly from the firm as per Policy Circular No.| '4 [Case No.:76/6/82-ALC4/2020|Party Name:ZENITH (MeetNo/Date:6/82- (Status:= IDYEINTERMEDIATES ALC4/2020 Deferred H . 2520 File IRLA File - {Lic.No/Date:0310838112 a | :01/82/050/01685/AM21/ = :03/95/040/00328/AM21/ (07.09.2020 i ff Case No.:13/6/82-ALC4/2020 |Party Name:TADIMETY ‘Meet No/Date:6/82‘Status: 4 7 |Anomarics PVT. LTD ‘ALC4/2020 Deferred 3 | 13.11.2020 | ; [HQ File JRLAFile === ——SLic.No/Date:0710116971 5S 253 |:01/82/050/01622/AM21/ = |:07/24/040/00153/AM21/ '08.09.2020 i . ) ! ‘Decision: — This case appeared for the first time before Norms Committee. The Committee noted that the i ; 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. | if ' ct 123/2015-20, dated 15.05.2019. | | t i"
,
7
. . ;
;
: | : | .
;
: ) |i|CaseNo.:14/6/82-ALC4/2020[Party{LIMITEDName:BALAJI AMINES [Meet1ALC4/2020No/Date:6/82‘DeferredStatus: | : 13.11.2020 THQ File -RLAFile =————~SCSCSLic. NDates3110067847| (254 |:01/82/050/01623/AM21/ :31/83/040/0006 1/AM21/ a 08.09.2020 . ; _ *[Decision: — This case appearedfor the firsttime before NormsCommittThe Committe e notede.that the| . 4.07of 4.07applicationapplicationof subjectof the subjectAdvanceadvanceAuthorizationauthorizationis not available.directly fromHence,the itfirmwasasdecidedper. Policyto callCircularfor a copy’No. : ‘ ;| 23/2015-20, dated 15.05.2019. . 7 ||CaseNo.:15/6/82-ALC4/2020 [Party Name:BALAJI AMINES (MeetNo/Date:6/82-(Status: jLIMITED iALC4/2020 Deferred | JHO File ~~ {RLA File Lic.No/Date:3110067848 | 255 |:01/82/050/01624/AM21/ —_—|:31/83/040/00060/AM21/ ——_08.09.2020 ae : _ [Decision: This caseappearedfor the first time before NormsCommittee.TheCommitteenoted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy. . of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No.| . : 23/2015-20, dated: 15.05.2019.
;
==> picture [457 x 247] intentionally omitted <==
----- Start of picture text -----<br> | ‘Case No.:16/6/82-ALC4/2020 Party Name:AMINES AND (Meet [No/Date:6/82-.—Status:]<br>if ‘PLASTICIZERS LIMITED ALC4/2020 ‘Deferred<br>| HQFile =. RLF ile ~ Lic.No/Date:0310838163<br>(256 |:01/82/050/01625/AM21/ j03/94/040/00370/AM21/ + 08.09.2020 — |<br>| |Decision:— This case appeared for the first time before Norms Committee.The Committee noted that the|<br>. 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy|<br>!' lof 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No.|<br>— 423/2015-20, dated 15.05.2019. . . |<br>"Case No.:17/6/82-ALC4/2020 |Party Name: MANKIND [MeetNo/Date:6/82- (Status:<br>- bot ; ‘PHARMA LTD ‘ALC4/2020 [Deferred<br>. | (13.11.2020 . |<br>| ‘THQ File . iRLA File , ‘Lic.No/Date:0510415162 |<br>257 |:01/82/050/01626/AM21/ | :05/24/040/00277/AM21/ 09.09.2020 | |<br>: Decision: This case appeared for the first time before Norms Committee. The Committee noted that the<br>/ 14.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy:<br>| Jof 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. '<br>| _|23/2015-20, dated 15.05.2019.<br>----- End of picture text -----<br>
.
. |
==> picture [114 x 16] intentionally omitted <==
----- Start of picture text -----<br> : :<br>79<br>----- End of picture text -----<br>
||||||||"(CaseNo.:18/6/82-ALC4/2020[PartyName:VISWAATMeetNo/Date:6/82-Status:=,<br>CHEMICALS LIMITED<br>‘ALC4/2020<br>‘Deferred||"(CaseNo.:18/6/82-ALC4/2020[PartyName:VISWAATMeetNo/Date:6/82-Status:=,<br>CHEMICALS LIMITED<br>‘ALC4/2020<br>‘Deferred||"(CaseNo.:18/6/82-ALC4/2020[PartyName:VISWAATMeetNo/Date:6/82-Status:=,<br>CHEMICALS LIMITED<br>‘ALC4/2020<br>‘Deferred||
|---|---|---|---|---|---|---|---|---|---|
|‘|||,|||:|_<br>258|{HQ File<br>——— IRLAFile<br>"Lic. No/Date:0310838181<br> °01/82/050/01627/AM21/<br>1:03/95/040/00327/AM21/<br>(09.09.2020<br>ie|;|
||||||;|||Decision:<br>Thiscase appeared for the first time before NormsCommittee. TheCommittee noted thatthe.<br>4.07 application ofsubject Advance Authorization is not available. Hence, it was decided to call for acopy<br>of4.07 application ofthe subject advance authorization directly from the firm as per Policy Circular No.<br>23/2015-20, dated 15.05.2019.<br>~|;<br>4<br>i.|
||||||||[Case No.:19/6/82-ALC4/2020 PartyName:;GLENMARK[MeetNo/Date:6/82-(Status:<br>‘PHARMACEUTICALS LTD = |ALC4/2020<br>Deferred<br>©:||'|
||||||||259 Tid File<br>IRLA File<br>Lic No/Date:0310838186<br>|<br>101/82/050/01628/AM21/<br>103/94/040/0034 1/AM21/<br>}10.09.2020<br>;<br>i<br>_<br>[Decision:This case appeared forthe first time before Norms Committee. DeferredforcommentsofTE.<br>jf<br>cstemaasattneamemae ssn asameetintanatineanainn.tuanmanieaynnyminanevannnnnannanvanenientsentnttectntttttate tettetera tare ttre wrrrarereirenttenersieetnesteittysnntintte tA ARR<br>TORTA OT CA ER COTeT er rrr nea<br>i|||
||||||||[Case No.:20/6/82-ALC4/2020 |Party Name:ANUPAM (MeetNo/Date:6/82-—*(Status:||=—(‘éd|
|||||||||‘RASAYAN (INDIA) LTD<br>ALC4/2020<br>Deferred<br>||A|
||||||||||HO File”<br>sc ssneuanneemeemimnnceRLAIg<br>IrisNo/Date§210043333<br>ennenae |<br>:01/82/050/01629/AM21/<br>1:52/24/040/00043/AM21/<br>[10.09.2020<br>1|:<br>||
||.|||||||260|Decision:<br>Thiscaseappeared forthe firsttime beforeNormsCommittee. TheCommittee considered the<br>.|a|
|||||||||case as peragenda in the presence oftechnical experts and it was decided to call forfollowing information<br>fromthe firm:|5<br>=|
|||||||||(ii)<br>Complete chemistry, molecular weight, % yield and stoichiometric balance.||
|||||||||.||
|||;|||||||<br>[CaseNo.:21/6/82-ALC4/2020<br>[PartyName:J.B.CHEMICALS<br>[MeetNo/Date:6/82-<br>Status;<br>i& PHARMACEUTICALS<br>VALC4/2020<br>Deferred<br>|<br>:<br>:<br>iLIMITED<br>13.11.2020<br>.<br>201g File<br>RCAFileWieNovDateso3i083¢i8s |<br>:01/82/050/01630/AM21/<br>|:03/94/040/00407/AM21/<br>10.09.2020<br>.<br>|<br>4<br>Decision:<br>Thiscaseappeared forthe firsttimebeforeNormsCommittee. DeferredforcommentsofTE.<br>.|||
||||||||||[CaseNo.:22/6/82-ALC4/2020- PartyName:STRATECHEMMeet No/Date:6/82- (Status:<br>i(INDIA) PVT. LTD.<br>:ALC4/2020<br>iDeferred<br>:<br>|<br>‘<br>(13.11.2020<br>|||<br>4|
||||||||(HQ File<br>RLAFile<br>=~<br>~—~——~—_Lic.No/Date:0310838204 |<br>|<br>262 :01/82/050/0163 1/AM21/<br>':03/95/040/00359/AM21/<br>10.09.2020<br>'|||
|||.||||||Decision:<br>Thiscaseappeared forthe first time before NormsCommittee. TheCommittee noted that the|:|
|||||||||<br>:|4.07 application ofsubject Advance Authorization is not available. Hence, it was decided to call for acopy:<br>of4.07 application ofthesubject advance authorization directly from the firm as per Policy Circular No.<br>:<br>-(23/2015-20,dated15.05.2019.<br>a<br>a<br>a|.<br>q|
80-5
|
: .
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. :
==> picture [521 x 565] intentionally omitted <==
----- Start of picture text -----<br> . |‘CaseNo.:27/6/82-ALC4/2020|PartyName:ALTA ——~—s MeetNo/Date:6/82-.—=s Status:<br>. .<br>" |LABORATORIES LIMITED —ALC4/2020 Deferred<br>or | | Hone RA — heen ic NolDates0310838006<br>.<br> :263 1:01/82/050/01636/AM21/. |.03/94/040/00422/AM21/ 110.09.2020<br>| ‘Decision: — This case appeared for the first time before Norms Committee. The Committee noted that the:<br>‘ . {4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy |<br>, __ jof 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No.:<br>i ‘/23/2015-20, dated 15.05.2019. ‘<br>|[CaseNo.:42/6/82-ALC4/2020 Party Name:SRIAMLABS {M e tNo/Date:6/82-(Status:<br>“PRIVATE LIMITED /ALC4/2020 Deferred |<br>> |HQ File “RLA File Lic.No/Date:09 10069 160 :<br>pOL/82/050/01651/AM21/ ———:09/71/040/00084/AM21/ _ 10.09.2020 |<br>_ _ |Decision: This case appearedfor the first time before Norms Committee. Deferred forcommentsof TE.<br>[Case No.:23/6/82-ALC4/2020 IPHARMACEUTICALSPartyName:GLENMARKLTD [Meet/ALC4/2020No/Date:6/82-.——[Status:Deferred<br>��<br>POlRQFile = = ~~~ 'RLAFile~SSSOSCS™” |Lic.No/Date:0310838214 [<br>:01/82/050/01632/AM21/ |:03/94/040/00340/AM21/ 11.09.2020<br>| [Decision: This case appeared for the first time before Norms Committee. Deferredfor comments of TE.|<br>|- (Case No.:24/6/82- ———«[PartyName:KOPRANMeet No/Date:6/82-. (Status:<br>bo ALC4/2020| RESEARCHLABORATORIES LIMITED ‘ALC4/2020[13.11.2020 Approved <br>| HQFile= = ~—SRLAFile—~SC™CS—S Lic. No/Date0310838231 |<br>:01/82/050/01633/AM21/ |.03/94/040/00396/AM21/ '11.09.2020 ;<br>| Decision: ~~ The Committee considered the case as per agenda and in the light of earlier decision taken in<br>meeting no. 5/82-ALC4/2019 dated 02.08.2019 against advance authorization No. 0310828072 dated.<br>02.04.2019, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as:<br>applied by the firm, whichever is less:<br>266 Export product Qty. Sl. -| Import items Qty.<br> [| MEROPENEM FOR | 1 kg | | MEROPENEM NON-STERILE |.0.958 kg<br>i : | INSECTIONMEROPENEM (MEROPENEM TRIHYDRATE NON-<br>. : ; | BUFFERED STERILE) STERILE)<br>2 "| PACKING MATERIALS:ALUMINIUM| Relevant as | |<br>| CANISTER(SKG)/ALU.BOTL.ANO.2M( | per packing |<br>20L000T.8020XY)(ONE “SET | policy<br>et : |.CONT.ONE+IN LID+OUT— CAN./ALU.BOTL.ANO.LID+BROMO BUTYL<br>: GASKET/CHL.BUTYL PLUG -<br>. a : ; ; 802/2T.802 AND TEAR OFF ALU CAP) |<br>‘RA concerned may take further necessary action as per above decision of Norms Committee, | .<br>----- End of picture text -----<br>
==> picture [32 x 94] intentionally omitted <==
----- Start of picture text -----<br> .<br>,<br>----- End of picture text -----<br>
| oo 81 .
,
.
==> picture [474 x 549] intentionally omitted <==
----- Start of picture text -----<br>
|||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|LIFESCIENCES|LTD|iALC4/2020|‘Deferred|:|
|||HO|Fle|RA|Lic|No/Date:0310838327"|oo|:|
|267||:01/82/050/01634/AM21/||:03/94/040/00406/AM21/|:11.09.2020|a|:|||
|Decision:|This|case|appeared|for|the|first|time|before|Norms|Committee.|The|Committee|noted|that|the|_|Gf|
|4.07|application|of subject|Advance|Authorization|is|not|available.|Hence,|it|was|decided|to|call|for|a|copy:|||
|||of 4.07|application|of the|subject|advance|authorization|directly|from|the|firm|as|per|Policy|Circular|No.:|
||23/2015-20, dated 15.05.2019.|a|ae|.|——|||
|i|Case|No.:26/6/82-ALC4/2020||Party Name:J.B.|CHEMICALS||Meet|No/Date:6/82-|Status:|i|
|i||& PHARMACEUTICALS|jALC4/2020|Deferred|||
|POSiQFile|~~|~~|IRLAFile.|~~~~~—~—~SCT”S LicNoDatesO3ios38219||——SSt=~<CS:sts«CS@Y|
|:01/82/050/01635/AM21/||:03/94/040/00408/AM21/_|11.09.2020|q|
|[Decision:|This case appeared|for|the|first|time before Norms Committee.|Deferred for comments of TE.|
||||Case|No.:52/6/82-ALC4/2020||PartyName:ALPA|—~—«([MeetNo/Date-6/82- (Status:|||
|||LABORATORIES|LTD.,|JALC4/2020|Deferred|=«s|J|
|||||_-{13.11.2020-|.|’|
|||:01/82/050/01661/AM21/|i:56/24/040/00020/AM21/|11.09.2020|:|;|
||||Decision:|This caseappeared|for the first time|before|Norms|Committee.|Deferred|for|comments of|TE.|||
|~~|[CaseNo.:47/6/82-ALC4/2020‘Party Name:AUROBINDO|[Meet|No/Date:6/82-.|(Status:|||
|PHARMA|LIMITED|ALC4/2020|‘Deferred|{|
|270|HQ|File|:‘RLA File|Lic.No/Date:0910069173|||:|
|:01/82/050/01656/AM21/|':09/24/040/00317/AM21/|)|14.09.2020|||;|
|Decision:|This case appeared|for the|first time before Norms Committee.|Deferred|for comments of TE.|f|
|[Case|No.:53/6/82-ALC4/2020 [PartyName:KRITI|——»s(Meet No/Date:6/82-.|(Status:|
|Do|‘NUTRIENTS. LIMITED|iALC4/2020|[Deferred|||;|
|:|||||13.11.2020|
|[HO|File|RLA|File|“|[Lic.No/Date:5610005948|||||
|271||:01/82/050/01662/AM21/|56/24/040/00021/AM21/|14.09.2020|||i|i|
||||4.07[Decision:applicationThisofcase subjectappearedAdvancefor|theAuthorizationfirst|time|beforeis|not|available.NormsCommittee.Hence,|it|wasTheCommitteedecided|to|cal!noted thatfor|a|copy:the..|:|
|of 4.07|application|of the|subject|advance|authorization|directly|from|the|firm|as|per|Policy|Circular|No.|||F|
|23/2015-20,|dated|15.05.2019.|-|:|i|
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----- End of picture text -----<br>
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----- Start of picture text -----<br> a . - {Case No.:48/6/82-ALC4/2020 “PartyRESEARCH Name:KOPRAN ALC4/2020Meet No/Date:6/82- statu:Deferred. 7<br>-_ - -. * LABORATORIES LIMITED ° 13.11.2020 - | "|<br>27 HQ File | {IRLAFile . Lic.No/Date:0310838273 |:<br>: 7 4:0 1/82/050/01657/AM21/ 1:03/94/040/00403/AM21/ 15.09.2020 :<br>: Decision: _ This case appeared for the first time before Norms Committee. Deferred for comments of TE.<br>4LfLf _- 1Case No.:49/6/82-ALC4/2020 .&LIMITEDParty PHARMACEUTICALS Name:J.B. CHEMICALS.- ALC4/2020|Meet|13.11.2020 No/Date:6/82- (Status:‘Approved| |<br>, | |e|:01/82/050/01658/AM21/ File *‘RLA:03/94/040/00287/AM21/ File Lie15.09.2020NovDate0310838274 | |<br>: InetnDecision:no.| The10/82-ALC4/2019Committee considereddated 29.11.2019the case as‘peragainstagendaadvanceand inauthorizationthe light of earlierNo. 0310832727decision takendatedin!<br>| 13.11.2019, it was decided to ratify norms under Para 4.07 of HBP Vol. | as ‘per details given below or as.| ~<br>. | lapplied by the firm, whichever is less:<br>Export Product<br>a GLIPIZIDE EXTENDED RELEASE TABLETS 10 MG. Each tablet | 1 Number<br>. : . contains (i) Glipizide USP- 10 mg (ii) Eastman (TM Cellulose<br>co Acetate (CA 398-10NF/EP)- 29.70 mg (iii) Sentry Polyox WSR N80 FP<br>: NF- 178.10 mg (iv) Sentry Polyox WSR 303 NF- 100 mg. Net content<br>(i) 150.44 Kgs (ii) 446.81 Kgs (iii) 2679.37 Kgs (iv) 1504.42 Kgs. fo<br>; 2 GLIPIZIDE EXTENDED RELEASE TABLETS 5 MG. Each tablet | 1 Number<br>. 273 contains (i) Glipizide USP- 5 mg (ii) Eastman (TM Cellulose<br>; Acetate (CA 398-1ONF/EP)- 20.40 mg (iii) Sentry Polyox WSR N80 FP :<br>an 58.70NF- 89.05Kgs mg(ii) (iv)239.48 SentryKgs Polyox(iii) 1045.37 WSR-303Kgs (iv)NF-586.9650 mg. NetKgs. content (i)<br>: 13 GLIPIZIDE EXTENDED RELEASE TABLETS 2.5 MG. Each tablet | 1 Number<br>contains (i) Glipizide USP- 2.5 mg (ii) Eastman (TM Cellulose<br>‘ Acetate (CA 398-10NF/EP)- 20:40 mg (iii) Sentry Polyox WSR N80 FP<br>Co a . NF-11.0689.05Kgs (ii)mg90.27(iv) SentryKgs (iit)Polyox394.03WSRKgs303(iv) NF-221.2450 Kgs.mg. Net content (i) :<br>. 7 Import Items | ___ Forexport of 1 Number of Tablet |<br>; (CA 398-10NF/EP) |<br>, . RA concerned may take further necessary action as per above decision of Norms Committee.<br>----- End of picture text -----<br>
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Oo —_ | oe a a . " ‘|Case No.:50/6/82-ALC4/2020 Party Name:DANASHMAND Meet No/Date:6/82‘Status: "| | ?ORGANIC PVT.LTD. ALC4/13.11. 202 00 ‘Approved og| i , | |HQFile ~ ——~— RLAFile ~ |Lie.No/Date:0310838276 it . | '|:01/82/0S0/01659/AM21/ —_—:03/94/040/00441/AM21/ 15.09.2020 ae | | | _ | Decision: The Committee considered case as per agenda in the presence of the technical experts and it, | {was decided to ratify the ad-hoc input output norms under para 4.07 of HBP as per details below or as af 274 applied by firm whichever is lower: ; | a i Export product . Qty. | Sl. | Import items Qty. Fi : | | | BENFOTHIAMINE _ - Tike [1 | THIAMINE 0.922 kg A boy (VITAMIN B1 HCL.) a | la concernedmay take further necessary action as per above decision of Norms Committee. | i: | [Case No.:51/6/82-ALC4/2020 Party Name:FINE ORGANIC _ [Meet No/Date:6/82Status; | sd _ INDUSTRIES LIMITED + — 4ALC4/2020 [Deferred | H sp i 143.11.2020 FI | {HQ File RLA File |Lic.No/Date:0310838277 . Fl __ (:01/82/050/01660/AM21/ ':03/94/040/00426/AM21/ 15.09.2020 foo: | i i P7| [p}caseecision:as per agendaThis casein theappearedpresenceforofthe technicalfirst timeexperts beforeand Normsit wasCommittee.decided to callThe Committeefor followingconsideredinformationthe || |Wy rom the firm: : - | i a a (i)(ji) | Complete% wastage chemistry, claimed. material balance,— molecular weighta andee % yield. ‘ iitn _ _ |Case No.:54/6/82-ALC4/2020 |Party Name: VIBRANT iMeet No/Date:6/82‘Status: | : " > ‘PHARMACHEM PVT.LTD, © ALC4/2020 Deferred | LI | . 13.11.2020 c ; \HQFie IRLAFilefie. No/Date:07101170140 _ 7 "276 4:01/82/050/01663/AM21/ (:07/24/040/00163/AM21/ (15.09.2020 _ i - _ [Decision:— This case appeared for the first time before NormsCommittee. : 14,07 application of subject Advance Authorization is not available. Hence, it :was The decidedCommitteeto callnotedfor that the.a copy| LIfi - || jof|23/2015-20, 4.07 applicationdated 15.05.2019.of the subject advance osauthorization directly from the firm as perOoPolicy Circular No.| + || {Case No.:55/6/82-ALC4/2020 |Party Name:SUVEN - _ |Meet No/Date:6/82jStatus: ; : * |PHARMACEUTICALS ALC4/2020 ‘Deferred i} _ }:01/82/050/01664/AM21/ |:09/24/040/00274/AM21/ ‘115.09.2020 _ he _ |Decision: This case appeared for the first time before Norms Committee. Deferred for comments of TE. i . I |
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----- Start of picture text -----<br> : [[Case No.:56/6/82-ALC4/2020 [PartyName:PORUS «(MeetNo/Date:6/82-(Status:<br>| | “J L IMITEDABORATORIES PRIVATE |ALC4/13.11. 20 2020 Approved |<br>oo, | [HQ File. ~IRLA File ~—. [Li¢,No/Date:0910069189 [<br>:01/82/050/01665/AM21/ — :09/24/040/00332/AM21/" 15.09.2020<br>- | |Decision: ~The Committee considered the case as per agenda and in the light of earlier decision taken in<br>meeting no. 5/82-ALC4/2019 dated -02.08.2019against advance authorization No. 091006760Idated. .<br>30.05.2019, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as.<br>- applied by the firm, whichever is less: ;<br>: i278 Export product Qty. | SI. Import items Qty.<br>Oe No.<br>| | 2-Phenyl-3,3-bis(4-hydroxy ikg {1 | PHTHALIC ANHYDRIDE | 0.927 kg<br>|. | phenyl)phthalimide (PPP-BP) ; PHENOL | 1.145 kg<br>ZINC CHLORIDE 0.104 kg<br>| 14 ‘| ANILINE 0.596 kg<br>METHANOL 0.715 kg<br>_ [6| ACTIVATED CARBON | 0.100ke ‘|<br>.<br>RA concerned may take further necessary action as per above decision of Norms Committee.<br>| |foo.(CaseNo.:57/6/82-ALC4/2020 |Party Name:KEVA. (MeetNo/Date:6/82-.Status:<br>bop : FRAGRANCESLIMITED PRIVATE ‘ALC4/202013.11.2020 :‘Deferred |<br>© THQ File RLA File ~ Lie.No/Date:03 10838311 |<br>: a| 14.07Decision:applicationThisof case subject appearedAdvancefor theAuthorizationfirst time beforeis not available.NormsCommittee.Hence, it wasThe Committeedecided to callnotedforthata copythe<br>: ‘[23/2015-20,‘of 4.07 applicationdated 15.05.2019.of the subject advance authorization directly from the firm as per Policy Circular No.”<br>, ; | jCase No.:58/6/82-ALC4/2020 |Party Name: VPL CHEMICALS |Meet No/Date:6/82- (Status:<br>- :PVT.LTD, ALC4/2020 Deferred |<br>_ (280 HQFile = ~~ RLAFile = ———~——SLic.No/Date:0710117023 [.<br>. :01/82/050/01667/AM21/ :07/24/040/00158/AM21/ * 417.09.2020<br>| [Decision: This case appeared for the first time before Norms Committee. Deferred for comments of TE.<br>Case No.:59/6/82-ALC4/2020 |Party Name:M/S {Meet No/Date:6/82- Status: i<br>“ : ‘HIMALAYAN PRODUCTS & |ALC4/2020 Deferred<br>: : INDUSTRIES CORPN., 13.11.2020<br>, 981 HQ File [RUA File ~|Lic.No/Date:0510415240<br>p~ 4:01/82/050/01668/AM21/ 1:05/24/040/00283/AM21/ 17.09.2020<br>|_ {4.07[Decision:applicationThisofcase subject appearedAdvancefor theAuthorizationfirst time beforeis not Normsavailable. CommittHenc e e., it wasTheCommitteedecided to callnotedfor thata copy the ||<br>of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No.<br>. | |23/2015-20, dated 15.05.2019. oo ee<br>----- End of picture text -----<br>
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ents: preanntannatnaarninenenSnaentintone new yn ennagee enna pin etfne necesenna inane nanainnm a} 7 ICase No.:60/6/82-ALC4/2020: ;PartyINARAYANAName: VENKATA ACTIVE ‘|MeetHALC4/2020 No/Date:6/82|Status:Deferred | 4 HQ File RLA File iLic.No/Date:0410167074 .- |Decision: This caseappeared for the first time before Norms Committee. Deferred for comments of TE. i Case No.:61/6/82-ALC4/2020 |Party Name:STERIL-GENE [Meet No/Date:6/82Status: mt_ a |LTD‘LIFE SCIENCES PRIVATE H'3.11.2020ALC4/2020 Approved | THQ File RLA File ; Lic.No/Date:0410167077 . . | 4:01/82/050/01670/AM21/ |:04/24/040/00089/AM21/ 18.09.2020 - | {m[D e cision:eting no.~~ The14/82-ALC4/2018 Committee considereddated the14,02.2019against case as per agena d a andvance inauthot the l i zagh t ofion earlierNo. decision0310819351 taken dated;in . :/22.02.2018, it was decided to ratify norms under Para 4.07 of HBP Vol. 1! as per details. given below or as! 983 applied by the firm, whichever is less: ; | Export product Qty. SL. Import items Qty. ; | TAMOXIFEN 20 MG 1 Number | 1 TAMOXIFEN CITRATE | 31 mg/tablet |. || TABLETS 7 . . - | (EOP 12 months As per SI.No.7 | Appendix 4J) (As per Para 4.07 . yo |
RA concerned may take further necessary action as per above decision of Norms Committee. _
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: io: Case No.:66/6/82-ALC4/2020; No.:66/6/82-ALC4/2020;; ‘ |PartySCIENCES Name:AMI PRIVATE LIFESCIENCES Name:AMI PRIVATE LIFE Name:AMI PRIVATE LIFE PRIVATE LIFE LIFE . ~ ./MeetHALC4/2020 No/Date:6/82-HALC4/2020 No/Date:6/82- No/Date:6/82‘Status:[Deferred[Deferred — P8iQrile= ~~~~—~S~~«SRLA= ~~~~—~S~~«SRLA ~~~~—~S~~«SRLA File ~=S*~~~S*~S:«S ~=S*~~~S*~S:«S LicNDate3410046407 |NDate3410046407 | | :01/82/050/01675/AM21/ |:34/24/040/00171/AM21/° 18.09.2020 ; ‘|Decision: This case appeared for the case appeared for the appeared for the for the the first time before Norms Committee.” Deferred time before Norms Committee.” Deferred before Norms Committee.” Deferred Norms Committee.” Deferred Committee.” Deferred Deferred for comments of TE. comments of TE. of TE. TE. |
i io: Case No.:66/6/82-ALC4/2020; No.:66/6/82-ALC4/2020;; ‘ |PartySCIENCES Name:AMI PRIVATE LIFESCIENCES Name:AMI PRIVATE LIFE Name:AMI PRIVATE LIFE PRIVATE LIFE LIFE . ~ ./MeetHALC4/2020 No/Date:6/82-HALC4/2020 No/Date:6/82- No/Date:6/82‘Status:[Deferred[Deferred — HH |{ P8iQrile= ~~~~—~S~~«SRLA= ~~~~—~S~~«SRLA ~~~~—~S~~«SRLA File ~=S*~~~S*~S:«S ~=S*~~~S*~S:«S LicNDate3410046407 |NDate3410046407 | | i | :01/82/050/01675/AM21/ |:34/24/040/00171/AM21/° 18.09.2020 ; y | ‘|Decision: This case appeared for the case appeared for the appeared for the for the the first time before Norms Committee.” Deferred time before Norms Committee.” Deferred before Norms Committee.” Deferred Norms Committee.” Deferred Committee.” Deferred Deferred for comments of TE. comments of TE. of TE. TE. | ie - : Lt i’ (Case No.:62/6/82-ALC4/2020 Party Name:FDC LTD . (Meet No/Date:6/82Status: : Le i | ALC4/2020 Deferred ff THQ File RLA File [Lic.No/Date:03 10838377 | : i :285 |:01/82/050/01671/AM21/ ::03/94/040/00421/AM21/ "21.09.2020 | ‘ i _ |Decision: — This case appeared for the first time before Norms Committee. The Committee noted that the, if || 14.07jof 4.07applicationapplicationof subjectof the subjectAdvanceadvanceAuthorizationauthorizationis not directlyavailable.fromHence,the itfirmwasasdecidedper Policyto callCircularfor a copyNo.| ot - : . ! | "|23/2015-20, dated 15.05.2019. : E
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----- Start of picture text -----<br> oe| | (CaseNo.:63/6/82-ALC4/2020. Party Name:GLENMARK Meet No/Date:6/82-.—<‘Status:———<br>a JLIFE SCIENCES LIMITED ‘ALC4/2020 ‘Deferred<br>: 13.11.2020 |<br>_ THQ File YRLAFile ‘Lic.No/Date:0310838378<br>i 286 j:01/82/050/01672/AM21/ j:03/94/040/0043 1/AM21/ 21.09.2020 en<br>Decision:_ {4.07 application— Thisofcase subjectappearedAdvance for theAuthorization first time beforeis not Normsavailable. Committee.Hence, it wasThe Committeedecided to notedcall for thata copy the. i<br>of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. |<br>23/2015-20, dated 15.05.2019. :<br>: . ~ [Case No.:64/6/82-ALC4/2020 PartyName:GLENMARK Meet No/Date:6/82- (Status:<br>‘LIFE SCIENCES LIMITED = 'ALC4/2020 ‘Deferred<br>| [HQ File 'RLA File ‘Lic.No/Date:03 10838379 | /<br>oO 287 }:01/82/050/01673/AM21/ 1:03/94/040/00430/AM21/ 21.09.2020. | |<br>: , Decision: . This case appeared forthe first time before NormsCommittee. TheCommitteenoted that the |<br>i 4.07of 4.07 applicationapplication of subjectof the Advancesubject advance Authorizationauthorizationis not available.directly fromHence,the itfirm wasas decidedper Policyto callCircular for a copyNo.|<br>; | |23/2015-20, dated 15.05.2019.<br>. a"Case No.:65/6/82-ALC4/2020 [Party Name:STERILE INDIA Meet No/Date:6/82- Status:<br>ee ; ‘|PRIVATE LIMITED iALC4/2020 iDeferred<br>HQ File [RLA File ) ‘Lic.No/Date:0510415273 | !<br>2 8 j:01/82/050/01674/AM21/ 05/24/040/00295/AM21/ 21.09.2020 |<br>_ [Decision: This case appeared for the first time before Norms Committee. The Committee noted that the<br>4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy.<br>; : lof 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No.<br>123/2015-20, dated 15.05.2019.<br>----- End of picture text -----<br>
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----- Start of picture text -----<br> /|CaseNo.:67/6/82-ALC4/2020|Party Name:NASENSE LABS [Meet No/Date:6/82- (Status:<br>oe , Pvt LTD . ; {ALC4/2020 ‘Deferred<br>_ | 13.11.2020 |<br>|. HQ File IRLA File Lic.No/Date:09 10069226<br>289>:01/82/050/01676/AM21/ ':09/24/040/00306/AM21/ {21.09.2020 | ;<br>| Decision:This case appeared for thefirst time before Norms Committee. The Committee noted that the<br>4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy|<br>‘lof 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No.:<br>23/2015-20, dated 15.05.2019. -<br>----- End of picture text -----<br>
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; .' 3, {Case No.:68/6/82-ALC4/2020 Party Name:CLEAN SCIENCE [Meet No/Date:6/82Status: a ; | "AND TECHNOLOGY ALC4/2020 Deferred . Li ee PRIVATE LIMITED _ 413.11:202000 “t :01/82/050/01677/AM21/ 131/83/040/00058/AM21/ {22.09.2020 fo oo a t ; |Decision: This case appeared for the first time before Norms Committee. Deferred for comments of TE. | i nts ence een menenennt nene nae sce te oe he ne ea nnn nes on cemented " ||Case No.:69/6/82-ALC4/2020 :INDUSTRIESParty Name:Y ASHOLIMITED |Meet1ALC4/2020 No/Date:6/82|Status:Deferred | Alul : _ - POLTQFile ~~RLAFile ———————SSS—S=«[Lie.No/Date:0310838408 [ i | |:01/82/050/01678/AM21/ ‘ :03/95/040/00378/AM21/ 22.09.2020 . | H ) | |Decision: This case appearedfor the first time[before] Norms Committee. Deferredforcomments of TE. | | : | [Case No.:70/6/82-ALC4/2020 Party Name:BIOLOGICAL E [Meet No/Date:6/82Status: £ _ LTD _ {ALC4/2020 ‘Deferred | Lay : nono rete cnerenee nemarmmrnrenrmereneeereteearieerenetnitttint eemectmaiernnnt wins cians te cnenne oem oan amenen coon saeranennane Bomannen neat titre senna errr ieee meena it. 292 [HQ File RLA File ‘TLic.No/Date:0910069236 - ia oo 1:01/82/0S0/01679/AM21/ ':09/24/040/00303/AM21/ 22.09.2020. 1. i | {Decision: This case appeared for the first time before Norms Committee. Deferred for comments of TE. i ; (ask TE whether to send it to DBT) ; ; | I mo | {Case No.:73/6/82-ALC4/2020 Party Name:SIDMAK !Meet No/Date:6/82iStatus: fi _ . JLABORATORIES (INDIA) |ALC4/2020 Deferred at ne er PVT LT S11 2020 J. .)6)©6hi 293 |:01/82/050/01682/AM21/ 1:52/24/040/00047/AM21/ . — [22.09.2020 J i | |. |Decision: — This case appeared for the first time before Norms Committee. The Committee noted that the! 4 | ||” of+|23/2015-20,4.07 4.07applicationapplicationdatedof subject15.05.2019,of the subjectAdvanceadvanceAuthorizationauthorizationis not available.directly fromHence,. the itfirm wasasdecidedper Policyto callCircularfor. a copyNo.||| |a]H ' (Case No.:74/6/82-ALC4/2020 [Party Name:JODAS EXPOIM [Meet No/Date:6/82(Status: |! a : Po PVT.LTD , |ALC4/2020 ‘Deferred a nog HQFile. RLAFile LieNo/Date:0910069242| ! “°"1:01/82/050/01683/AM21/ |:09/24/040/00282/AM21/ /22.09.2020 4 fe | | |Decision: — This case appeared for the first time before Norms Committee.TheCommittee considered the | a - | ‘lease as per agenda and it was observed that the firm was issued Show Cause Notice vide letter dated ty
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|bs (CaseNo.:71/6/82-ALC4/2020[Party Name:MAHARSHI MeetNo/Date:6/82Status: Do: ‘ LIMITEDPHARMA CHEM PRIVATE -13.11.|ALC4/ 2 020020 ‘Deferred _ (HQFile RLAFile ~~ Lie,No/Date:0810148644 | _ Decision:4.07 This caseappearedfor the first time before Norms Committee.The Committee noted that the | _ jf 4.07applicationapplicationof subjectof the Advancesubject advance Authorizationauthorizationis not available.directly fromHence,the itfirm wasas decidedper Policyto callCircularfor a copy) No. 23/2015-20, dated 15.05.2019. , i
_ [Case No.:72/6/82-ALC4/2020[PartyName:MAHARSHI MeetNo/Date:6/82-.—sStatus: = . PHARMA CHEM PRIVATE =(ALC4/2020 iDeferred | LIMITED 13.11.2020 | |HQ File : RLA File ———_Lic.No/Date:0810148645 296 :01/82/050/01681/AM21/ - |:08/24/040/00187/AM21/ _ (23.09.2020 - i | | 4.07Decision: This caseappearedforthe first timebeforeNorms Committee.The Committee noted that the of application of subject Advance Authorization is not available. Hence, it was decided to call for a copy. 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. | , 23/2015-20, dated 15.05.2019, , | [CaseNo.:75/6/82-ALC4/2020 (PartyName:CLEAN ~~ MeetNo/Date:6/82- (Status: a SCIENCE AND |ALC4/2020 Approved Do ow UMITEDTECHNOLOGY PRIVATE 13.11.2020, a| HQ File —TRLAFile —~—*CLicNo/Date:3110067868[ 4:01/82/050/01684/AM21/ ‘|:3.1/83/040/00068/AM21/ 23.09.2020 , ; (Decision: | The Committee considered case as per agenda in the presence of the technical experts and it 997 was[(applied] decided[by][firm] to[whichever] ratify the ad-hoc[is][lower:] input output norms under para 4.07 of HBP as per details below or as: | | [Export Product Qty. | Sl. | Import items Qty. 7 No. | | Guaiacol Ikg [t [PhenolCd[97][KG] Hydrogen Peroxide PURITY 60% 0.687 kg. Do Acetone (Solvent) ‘| 0.1 kg IRA concerned may take further necessary action as per above decision of NC.
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Ss Case No.:77/6/82-ALC4/2020 |Party Name:NAARI PHARMA /Meet No/Date:6/82. ‘Status: i ; po ‘PRIVATE LIMITED ‘ALC4/2020 \Deferred i ; | HQFile -— ~RLA File Lie. No/Date:05 10415286 | ; | i] | (298 |:01/82/050/01686/AM21/' ——:05/24/040/00299/AM21/ 23.09.2020 | oo H | Decision: This caseappearedfor the first timebeforeNorms Committee.The Committee noted that the. i . | |4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy: oH | of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. | - fe |23/2015-20, dated 15.05.2019. ; ; fr a | | |Case No.:78/6/82-ALC4/2020 |Party Name:NAARI PHARMA Meet No/Date:6/82Status: | ae [PRIVATE LIMITED ‘ ALC4/2020 - Deferred i 1 | | 13.11.2020 | |: [HQ File IRLA File Lic.No/Date:0510415287 | il 299 |:01/82/050/01687/AM21/ ——:05/24/040/00300/AM21/ 23.09.2020, | | fi _ Decision: This case appeared for the first time before Norms Committee. TheCommittee noted that the Ht _ sof(4.07 4.07 applicationapplicati o fn subjectof the Advancesubject advance Authorizationauthorizatiis n o nt available.directly from Hence,the itfirm wasas decidedper Policyto callCirculfor a r copyNo.| d t '23/2015-20, dated 15.05.2019. , | art ‘t / [Case No.:79/6/82-ALC4/2020 ‘Party Name: MANKIND [Meet No/Date:6/82‘Status: | : PHARMA LTD -ALC4/2020 ‘Deferred | HQ File - ~IRLA File " Lic.No/Date:0510415295 , a 300 |:01/82/0S0/01688/AM21/ __|:05/24/040/00308/AM21/. 23.09.2020 | : 4.07Decision:applicationThisof case subject appeared Advancefor theAuthorizationfirst time beforeis not Normsavailable.[Committee.] Hence, it wasThe decidedCommitteeto call notedforthata copythe,| E}i : | of|23/2015-20, 4.07 applicationdated 15.05.2019.of the subject advance: authorization directly from the firm as per Policy Circular No.| ii | | | | | {Case No.:80/6/82-ALC4/2020 PartyName:AUROBINDO — [Meet No/Date:6/82‘{Status: a : |PHARMA LIMITED JALC4/2020 Deferred | ian 301 HQ File RLAFie WieNofDate-0910060345 _ & | |:01/82/0S0/01689/AM21/ _—:09/24/040/00344/AM21/ ‘23.09.2020 : iE | |Decision: This case appeared for the first time before Norms Committee. Deferred for comments ofTE.| Bi
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- Casei No.:86/6/82-ALC4/2020Party Name:JODAS EXPOIM [Meet No/Date:6/82-.—‘([Status: oe eo“PVT.LTD ; . 312020000ALC4/2020 © ‘Deferred | . "gop {HQ File ~URLAFile Lic.No/Date:0910069254 [ ; : :01/82/050/01695/AM21/ |:09/24/040/00305/AM21/ 23.09.2020 | ‘Decision: | This case appeared for the first time before Norms Committee. The Committee considered the i . | |easé as per agenda and it was observed that the firm was issued Show Cause Notice vide letter dated i- , / (10.10.2019. ; | [Case No.:81/6/82-ALC4/2020 PartyName:OTSUKAMeet No/Date-6/82-‘Status: : a ‘CHEMICAL INDIA |ALC4/2020 ‘Approved | OC | . (PRIVATE LIMITED 13.11.2020 I 5 HQ File RLA File ‘Lic.No/Date:05 10415302 | . — :01/82/0S0/01690/AM21/ ——':05/24/040/00304/AM21/ 24.09.2020 | oh, | ‘Decision: ~The Committee considered case as per agenda in the presence of the technical experts and it. . was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. | as per details below or| as applied by firm whichever is lower: ; . . | Export Product . Qty. | Sl. | [Import items Qty. , : 4 |-7-Phenylacetamideo —-3- | 1 kg l Penicillin G Potassium Ist Crystals White / | 1.80kg |; . 303 Chloromethy! LightYellow Powder | |. | Cephalosporanic Acid MethanolLiquid 1.50 kg | | | Para Methoxybenzyl Ester Dimethyl Formamide Colourless Liquide | | (GCLE) Methylene Chloride Colourless Liquide 0.80kg|150kg J) . || White/LightYellow 2-Mercaptobenzothiazole Ceramish Powder [0.25 kg |, Powder 16 | Isopropyl Alcohol Liquid . |[0.80] kg | ; , Sodium Benzene Sulfinate Powder 1.20 kg io Para Anisic Alcohol (p_Methoxybenzyl | 0.52kg |: . | ae Alcohol) Liquid | po ; 19 | 1,4 Dioxane liquide 1.20kg |) : -RA concerned may take further necessary action as per above decision of NC. Y ) | \Case No.:82/6/82-ALC4/2020 (Party Name:FINE ORGANIC [MeetNo/Date:6/82- (Status: _ ‘INDUSTRIES LIMITED |ALC4/2020| Deferred | '| |HQ File 'RLA File Lic. No/Date:0310838429 | | :01/82/050/01691/AM21/ :03/94/040/0045 V/AM21/ . (24.09.2020 me 1304 (Decision: Thiscase appeared for the first time before Norms[Committee.] The Committee considered the . icase as per agenda in the presence of technical experts and it was decided to call for following information , | {from the firm: : _ (i) _ . Complete chemistry, material balance, molecular weight and % yield, Oo io (ii) % wastage claimed. |
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_ [CaseNo:83/6/82-ALC4/2020Party Name:VERVE HUMAN MeetNo/Date:6/82-. (Status: ‘CARE LABORATORIES ALC4/2020 Deferred BS HQFie~~ RLAFile ~~ [Lic.No/Date:0510415306 — | }:01/82/050/01692/AM21/ 4:05/24/040/00274/AM21/ 24.09.2020 _ . 7 | (Decision: _ This case appeared for the first t[time][before][Norms][ Committee.][Deferred][for][ comments][ of][ TE.]
[Case No.:84/6/82-ALC4/2020 |Party Name:ETERNIS FINE Meet No/Date:6/82‘Status: iCHEMICALS LIMITED, * “ALC4/2020 ‘Deferred |306fAQFile|:01/82/050/01693/AM21/= = =————<—~St:~“CSRLA:03/94/040/00283/AM21/File ——<—~sé‘—s~~SCSCSCLic24.09 . Noo/Dates03108384532020 _ | : | Decision: | This case appeared for the first time before Norms Committee. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy, of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. | 123/2015-20, dated 15.05.2019. |
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~i {CaseNo.:87/6/82-ALC4/2020 [Party‘PHARMAName:GLANLIMITE D ~"fMeet; ALC4/2020No/Date:6/82(Status:\Deferred | 307 HQFile (RLAFile~~~ Lic.No/Date0910069256 | : :01/82/050/01696/AM21/ ':09/24/040/003 18/AM21/ 24.09.2020 : oo ‘Decision: This case appeared case appeared appeared for the the first time time before Norms Committee. Norms Committee. Committee. Deferred for comments of TE. comments of TE. of TE. TE.
- ‘Decision: This case appeared case appeared appeared for the the first time time before Norms Committee. Norms Committee. Committee. Deferred for comments of TE. comments of TE. of TE. TE. : Case No.:88/6/82-ALC4/2020 Party Name:SRIAM LABS Meet No/Date:6/82Status: ‘PRIVATE LIMITED YALC4/2020 Deferred | d 308 FQ File RLA File “ ILi¢.No/Date:0910069259 | =itsts—Cts*é«SS :01/82/050/01697/AM21/ :09/24/040/00353/AM21/_ {24.09.2020 h | [Decision: This case appeared for the first time before Norms Committee. Deferred for comments of TE.| |
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----- Start of picture text -----<br> 0| * TCaseNo.:85/6/82-ALC4/2020 (PartyName:ADCOCK MeetNo/Date-6/82- (Status:<br>: . ‘INGRAM LTD, ‘ALC4/2020 Approved<br>) pe, Locos (13.11.2020. | |<br>mc , | — ::01/82/050/01694/AM21/[HQ File :07/24/040/00125/AM21/IRLA File ~~ Lic.No/Date:0710117061,25.09.2020 SSS|<br>Decision: | The Committee considered the case as per agenda and in the light of earlier decision taken in OO<br>: ; meeting no. 15/82-ALC4/2018 dated 22.03.2019against advance authorization No. 0710113284 dated<br>15.05.2018, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as<br>; | japplied by the firm, whichever is less: :<br>- ; -| | Export product Qty. Sl. Import items Qty.<br>309 No. —<br>| | |NORFLEX 100MGTABLETS- | 1 Number ORPHENADRINE CITRATE | 102.00<br> | | (Orphenadrine Citrate 100mg + BP/EP/USP/PH.EUR | mg/tablet |<br>: . ‘| | Lactose 167mg + Aerosil 200 - 2 PHARMATOSE R_ 130M | 167.00<br>- | | | 8mg + Ethyl Cellulose’20mg )| MILLED LACTOSE| mg/tablet | |<br>| | (COrphen-1000.000+ —_Lactose- MONOHYDRATE USP-NF/ |)<br>. | | 80.000+Ethyl-200.0001670.000+Acrosil- 5 ErHVECELLULOSE i001] 200 |<br>No: Tablets: 10000000KGS) : BP/EP/USP/Ph. EUR/USNF mg/tablet |iz<br>+ | | BP/EP/USP/PH.EUR/NF/USNF .<br>. RA concerned may take further necessary action as per above decision of NC. . ;<br>: | (Case No.:89/6/82- ——~—=«|(PartyName:ALEOR —~—~—« MeetNo/Date:6/82-.—sStatus: =<br>; : ALC4/2020 . , DERMACEUTICALS (ALC4/2020 ° ‘Approved<br>Po IMITED . 1311202000<br>-| fHQFile =i SRA File ——S—SCSCiLicNo/DDate: 34100464196<br>, :01/82/050/01698/AM21/ :34/24/040/00169/AM21/ :25.09.2020 ;<br>: (Decision: | The Committee considered case as per agenda in the presence of the technical experts and it!<br>. was decided to ratify the ad-hoc input output norms under para 4.07 of HBP as per details below or as’<br>applied by firm whichever is lower: |<br>, | | SI. -] Export Product Qty. SI. ] Import items] Qty.<br>; | 0. . No.<br>, ; | “| Clobetasol Propionate Cream , 0.05% 15 | 28000.000 | 1 ~ | Clobetasol 2547.45 |<br>. 310 | gm (net content of active ingredients =| Number _ Propionate USP | Gram<br>i | | 210 gm) oo { Micronized) |<br>7 4 |2 Clobetasol Propionate Cream , 0.05% 30 | 14500.000 |<br>gm (net content of active ingredients = | Number<br>va'ae , 4 13 Clobetasolgm (net contentPropionateof activeCreamingredients, 0.05% 45= || Number20000.000 :<br>| 450 gm)<br>| 14 Clobetasol Propionate Cream , 0.05% 60 | 54000.000 . :<br>Co, gm (net content of active ingredients |Number<br>. | =1620 gm) ; |<br>| RA concerned may take further necessary action as per above decision of NC. , /<br>----- End of picture text -----<br>
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|7|_|[Case|No.:90/6/82-ALC4/2020.|PartyName:KOPRAN|MeetNo/Date:6/82-|(Status:|
|a|‘RESEARCH|#ALC4/2020°|Approved|i ||
|||_|LABORATORIES LIMITED|13.11.2020.|f|
|;|HOFile|RLAFile|-|'Lic.No/Date:03 10838501|a|
||||:01/82/050/01699/AM21/—_-/:03/94/040/00454/AM21/|28.09.2020|a|||
|||‘Decision:|
|||Iwas|decided|toTheratify Committeethe|ad-hoccons|i|nputderedoutputcase|asnorms peragendaunder. in para the4.07 presenceof HBP ‘of theas tp|e|rchnicdet|a|ilsl expb|e|rtslow andor|as_it,|HHai‘|
|||applied by firm whichever|is lower:|i|
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|||||[STERILE|~|CEFTRIAXONE|||1|kg|CEFTRIAXONE SODIUM (NON- ||1.04 kg|i \|
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|fo|.|MATERIAL:ALUMINIIUM|{as|per}|=|at|
|i|,|CANISTER(10KG)/ALU.BOTTLE ||packing|||ct|
|_|ANODIZED|"||policy|||||
|ho|,|,|2M(20LO00T.8020XY)|~|i:|BI|
|—|(ONE|SET CONTAINS ONE|!|a|
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|—_|LID+OUT LID+BROMO BUTYL|||4]|
|GASKET/CHLORO BUTYL|||Hl!|
|—_|PLUG|802/2|T.802|AND|TEAR|||eS|
|||RA concerned may|-take|;|further necessary action as per aboveOFF:ALU.CAP) decision of|NC.|.||||:|i |||
|;|Case No.:91/6/82-ALC4/2020||Party Name:NEOGEN|‘Meet No/Date:6/82-|/Status:|lf|
|i|||.|CHEMICALS LIMITED|—~°_ALC4/2020|‘|Approved|le|
|||fQ|File|RE|Bg|ie|Novae|031083851spo|||:|
|||1:01/82/050/01700/AM21/|——_—_:03/95/040/00349/AM21/|28.09.2020|||i|
|||||Decision:|— The Committeeconsiderecase|as|per|agen|d|a|in|the|[presence]|of|the technical|expertsand|it)|
|3 12|_jwas‘applieddecided by firmto whicheverratify|the ad-hocis|lower:input|output|norms|under para 4.07.|of HBP|as per|details below|or|as||ifal i 1|
|Export|Product|Qty.|||SL|Import|items|Qty.|HH|
|1-BROMO-S5-|1 kg|1,5 PENTANEDIOL|1.335kg||,|1|
|©:|||LCHLOROPENTANE|—|fF|LIQUID BROMINE|2310ke|||i|
|:|IRA|concerned may take|further necessary action as per above decision|of NC.|©,|||sh|
|:|Case|No,:92/6/82-ALC4/2020|«Party Name:SUVEN|Meet No/Date:6/82-|Status:|iH|
|.|-||PHARMACEUTICALS|ALC4/2020|Deferred|
|m|LIMITED|*|—.||13.11,2020|i|
|©||:01/82/050/01701/AM21/|:09/24/040/00275/AM21/|28.09.2020|.|&§|
||Decision:|This|case|appeared for|the|first|time|before|Norms|Committee.|Deferred|for|comments|of|TE.||fi|
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+" [Case No.:126/6/82-ALC4/2020 PartyName:ZENITH [MeetNo/Date-6/82-. (Status: ; “DYEINTERMEDIATES ALC4/2020 Deferred — B14 0 File | IRLA File [Dic No/Dateosi0ge5i4| | :01/82/050/01735/AM21/ :1:03/95/040/0036 1/AM21/ {28.09.2020 oe _ [Decision: This case appeared for the first time before NormsCommittee.Deferredfor comments of TE. | , | [Case No.:93/6/82-ALC4/2020 [Party Name:U SQUARE ‘Meet No/Date:6/82-__[Status: i LIFESCIENCE PRIVATE ‘ALC4/2020 /Approved L | ‘THQ File — — RLAFile 2 © [Lic-No/Date:0810148685 | | |Decision: | The Committee considered the case as per agenda and in the light of earlier decision taken in, | . 315|» |meeting no. 4/82-ALC4/2020 dated 18.09.2020 against advance authorization No. 0810144243 dated| | (07.01.2019,applied by theit wasfirm, decidedwhichever to ratifyis less: norms under Para 4.07 of HBP Vol. I as per details given below or as Export Product _ | Qty. Sl. Import items Qty. . _ No. | CLINDAMYCIN INJECTION | 1 Number| 1 CLINDAMYCIN 831.13 mg | | 600MG/4ML PHOSPHATE USP . | RA concerned may take further nécessary action as per above decision of NC. {Case No.:97/6/82-ALC4/2020 PartyName:EMMENNAR Meet No/Date:6/82-(Status: | PHARMA PRIVATE |ALC4/2020 ‘Approved _ ‘LIMITED 13.11.2020 | ; HQ File ‘RLA File ; Lic.No/Date:0910069270 i | [Decision: The Committee considered case as per agenda in the presence of the technical experts and it |was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or | . as applied by firm whichever is lower: 316 Export Product Qty. | Sl. ‘| Import items Qty. | > No. | FS@)2-AMINOBUTYRAMIDE [1kg [1| PROPIONALDEHYDE 1.27 kg i. HYDROCHLORIDE SODIUM CYANIDE 1.08 kg . 7 L(+) TARTARIC ACID 1.12 kg , FD ' |4 | METHYLENE DICHLORIDE [| 1.12 kg - _ ACETONE 1.86 kg — 16| METHANOL 1.39 kg i Ira concerned may take further necessary action as per above decision of NC. . ;
'
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[Case No.:98/6/82-ALC4/2020 iParty Name:EMMENNAR ‘Meet No/Date:6/82Status: : ‘PHARMA PRIVATE :ALC4/2020 Approved : ‘LIMITED /13.11.2020. | | : : HQFile �� ~~ -RLAFile ‘Lic.No/Date:0910069271 ; Decision: The Committee considered case as per agenda in the presence of the technical experts and it ; _ jaswas applie deci d edby to fi r atifym whichever the ad-hocis lower: input output norms under para 4.07 of HBP Vol. I as per details below or; -; : No. ' S(4)-2-AMINOBUTYRAMIDE |1kg |! | PROPIONALDEHYDE 1.27 kg | HYDROCHLORIDE SODIUM CYANIDE 1.08 kg 5 L(+) TARTARIC ACID 1.12 kg METHYLENE DICHLORIDE | 1.12 kg i _ ACETONE 1.86 kg . | [6 | METHANOL 1.39kg | - ‘RA concerned may take further necessary action as per above decision of NC. : i Case No.:94/6/82-ALC4/2020 Party Name:DHANUKA ‘Meet No/Date:6/82Status: : a ‘LABORATORIES LTD . ‘ALC4/2020 Deferred | | 13.11.2020 LG 318 |HQFile|:01/82/050/01703/AM21/=——~<“«tst:CSRLA:05/23/040/00197/AM21/File=S™S~*~SCS_ Lic30.09.2020NoDates0510415370; | |4a | 4.07of[Decision:applicationThisofcase subject appearedAdvance for theAuthorization firsttime beforeis not Normsavailable. Committee.Hence, it wasThe Committeedecided to notedcall for thata copy the)| 7 _ _|23/2015-20,4.07 applicationdated 15.05.2019.of the subject advance authorization directly from the firm as per Policy Circular No.i 3i ~~ [CaseNo.:95/6/82-ALC4/2020(CHEMOFARBEPartyName:KAIRAV‘(MeetiALC4/2020No/Date:6/82-. Status:‘(Deferred (iti1 jHQ File IRLAFile ‘Lic.No/Date:03 10838594 319 }:01/82/050/01704/AM21/ |:03/94/040/00467/AM21/ 30.09.2020 a / : | |Decision: This case appeared for the first time before Norms Committee. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy P | lof 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. ' | }23/2015-20, dated 15.05.2019." t
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[Case No.:99/6/82-ALC4/2020 PartyName:ORTIN (Meet No/Date-6/82- ‘Status. ne re eeLABORATORIESSe LTD, 13.11.ALC4/ 202 00 4‘Approved / HQ File RLA File (LicNo/Date:0910060285| . -— }:01/82/050/01708/AM21/ ‘:09/24/040/00359/AM21/ 30.09.2020 | ' Decision: |The Committee considered case as per agenda inthe presence of the technical experts and it 320 was[as applied decided by tofirm ratifywhichever the ad-hocis lower:input output norms under para 4.07. of HBP Vol. | as per details below or! No. . , (3R,3aS,6aR)I kg 2,3-dihydrofuran 1.05 kg - / +} | ol(BIS-IV)Hexahydrofuro[2,3-b] furan-32 Sodium borohydride 0.72 kg oO . IRA concerned may take further necessary action as per above decision of NC. | a | |ALC4/2020 PHARMA PRIVATE ALC4/2020 - ‘Approved a LIMITED. {13.11.2020 po | ho [HQ File RLA File : [Lic.No/Date:0910069286[| - |:01/82/050/01709/AM21/ ——::09/24/040/00642/AM20/ 30.09.2020 ; +| Decision:jwas decided toTheratify Committeethe ad-hocconsideredinput outputcasenormsas per agendaunder parain the4.07 presenceof HBP ofVol. the technical[ as per detailsexpertsbelowandorit jas applied by firm whichever is lower: No. : | | | SG)-2-AMINOBUTYRAMIDE |1kg | 1 | PROPIONALDEHYDE 1.27 kg | HYDROCHLORIDE SODIUM CYANIDE 1.08 kg — L(+) TARTARIC ACID 1.12 kg z . 7 METHYLENE DI CHLORIDE | 1.12 kg . ACETONE | 1.86 kg : [6 | METHANOL 1.39 kg RA concerned may take further necessary action as per above decision of NC. | / [Case No.:101/6/82-ALC4/2020 |Party Name:AURORE LIFE [Meet No/Date:6/82Status: ee LIMITEDISCIENCES PRIVATE 2020ALC4/2020 Deferred _ ; (p22| HQFile}:01/82/050/01710/AM21/ (RLAFile|:09/24/040/00362/AM21/~~ 30.09.2020~——_|Lic.No/Date:0910069287 — . / | Decision: This case appeared for the first time before Norms Committee. Deferred for comments of TE. :
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----- Start of picture text -----<br> a Case No.:96/6/82-ALC4/2020 Party‘LIMITED Name:USV(FORMERLY PRIVATE USV Meet:ALC4/2020 No/Date:6/82- ‘Status:Approved |<br>LIMITED) 13.11.2020 |<br>:01/82/050/01705/AM21/ ::03/95/040/00386/AM21/ ‘01.10.2020 :<br>Decision: | The Committee The Committee Committee considered case as per agenda per agenda agenda in the presence of the technical the technical technical experts and it<br>| was decided to ratify the ad-hoc input output norms under para 4.07 of HBP HBP Vol. I as per details below or<br>' _ las applied by by firm whichever is lower:<br>----- End of picture text -----<br>
Decision: | The Committee The Committee Committee considered case as per agenda per agenda agenda in the presence of the technical the technical technical experts and it F | was decided to ratify the ad-hoc input output norms under para 4.07 of HBP HBP Vol. I as per details below or ' _ las applied by by firm whichever is lower: 3 Export Product Po Doxycycline Tablets, USP 100 1Number | 1 - | Doxycycline USP 102.908 : / | |MG500S Tablet (Monohydrate) mg/ Tablet | : 4 | (28,000 Bottles x 500 Per Bottles _ ‘| | = 1,40,00,000 Tablets) ( Net i | 4 | Content Weight = 1,400.000 Kgs) J : | IRA concerned may take further necessary action as per above decision of NC. | f . |Case No.:102/6/82[Party Name:ANLON ‘Meet No/Date:6/82‘Status: a ALC4/2020 HEALTHCARE ‘ALC4/2020 ‘Deferred | i /PRIVATELIMITED 13.11.2020 en: | HQFile~~ RLAFile.——~O™—~—SSSCLic. NoDate:2410043265 | — 324 :01/82/050/01711/AM21/ :|:24/24/040/00050/AM21/ 01.10.2020 a . ae i | Decision: | This case appeared for the first time before Norms Committee. The Committee noted that the: - 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy : b3/2015-20,of 4.07 applicationdated 15.05.2019.of the subject advance authorization directly from the firm as per Policy Circular No.| ‘5 | |Case No.:103/6/82-—=—~—~—~—~=«PartyName:CADILA—~— MeetNo/Date:6/82[Status: : ALC4/2020 |HEALTHCARE LIMITED iALC4/2020 ‘Deferred [HQ File |RLA File ‘Lic.No/Date:0810148710 | | @ 325 :01/82/050/01712/AM21/ j:08/24/040/00207/AM21/ :01.10.2020 | i _ 4.07[Decision:applicationThisof case subjectappearedAdvancefor theAuthorization first time beforeis not available.Norms Committee.Hence, it wasTheCommitteedecided to callnotedfor thata copy;the - || ‘lof|23/2015-20, 4.07 applicationdated 15.05.2019.of the subject advance authorization directly7 from the firm—as per Policy Circular. No.. | | _ {Case No.:104/6/82"Party Name:BENZO CHEM _ [Meet No/Date:6/82Status: | :ae |ALC4/2020 ‘(LIMITEDINDUSTRIES PRIVATE 113.11.2020ALC4/2020 Deferred / : iQ Fie TR FleScan ERTS TCT a - : 326 :01/82/050/01713/AM21/ '103/94/040/00468/AM21/ - 101.10.2020 : _ (Decision: This case appeared for the first time before Norms Committee. The Committee noted that the | 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy | i of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No.| i : |23/2015-20, dated 15.05.2019. ; 7 F
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----- Start of picture text -----<br> | OO. Pod| (Case No.:105/6/82-ALC4/2020. . + &|Party PHARMACEUTICALS. Name:J.B. CHEMICALS —-|ALC4/2020Mec No/Date:6/82-(Status:"Approved<br>, _ ___, LIMITED [13.11.2020 =<br>.<br>- , - Ko01/82/050/01714/AM21/File ':03/94/040/00471/AM21/IRLA File 01.10.2020[bieNowDae:o310838681 : | eo<br>: : . (Decision:meeting no. 10/82-ALC4/2019The Committee considereddated29.11.2019 the case asagainst per agendaadvance and authorizationin the light of earlierNo. 0310832727decision takendated. in<br>13.11.2019, it was decided to ratify norms under Para 4.07 of HBP Vol. | as per details given below or as.<br>: ‘japplied by the firm, whichever is less: ; ; |<br>| |Export Product - , ,<br>----- End of picture text -----<br>
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----- Start of picture text -----<br> | |Export Product - , ,<br>1 GLIPIZIDE EXTENDED RELEASE TABLETS 10 MG. Each tablet | 1 Number<br>contains |<br>(i) Glipizide USP- 10 mg (ii) Eastman (TM Cellulose Acetate (CA 398-<br>| IONF/EP)- 29.70 mg (iii) Sentry Polyox WSR N80 FP NF- 178.10 mg (iv)<br>Sentry Polyox WSR 303 NF- 100 mg. Net content (i) 150.44 Kgs (ii)<br>: .__. | 446.81 Kgs (iii) 2679.37 Kgs (iv) 1504.42 Kgs. .<br>2 GLIPIZIDE EXTENDED RELEASE TABLETS 5 MG. Each tablet | 1 Number a<br>; 327 contains ; .<br>(i) Glipizide USP- 5 mg (ii) Eastman (TM Cellulose Acetate (CA 398- | —<br>1ONF/EP)- 20.40 mg (iii) Sentry Polyox WSR N80 FP NF- 89.05 mg (iv) | -<br>| Sentry Polyox WSR 303 NF- 50 mg. Net content (i) 58.70 Kgs (ii) 239.48<br>| ; Kgs (iii) 1045.37 Kgs (iv) 586.96 Kgs. _<br>: 3 GLIPIZIDE EXTENDED RELEASE TABLETS 2.5 MG. Each tablet | 1 Number.<br>— contains .<br>: (i) Glipizide USP- 2.5 mg (ii) Eastman (TM Cellulose Acetate (CA 398-<br>i 10NF/EP)- 20.40 mg (iii) Sentry Polyox WSR N80 FP NF- 89.05 mg (iv) |<br>: Sentry Polyox WSR 303 NF- 50 mg. Net content (i) 11.06 Kgs (ii) 90.27 ol<br>poe Kgs (iii) 394.03 Kgs (iv) 221.24 Kgs.<br>| [8 [import tems [For export of | Number of Tablet]<br>i| P|Te (CAEASTMAN 398-10NF/EP) (TM) CELLULOSE ACETATE 204mg | 240mg | 29-70mB<br>‘IRA concerned may take further necessary action as per above decision of Norms Committee. |<br>----- End of picture text -----<br>
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[ [Case No.:106/6/82-, -—~—«‘PartyName:KOPRAN Meet No/Date:6/82-.Status: ALC4/2020 ‘RESEARCH ‘ALC4/2020 Approved | ‘LABORATORIES LIMITED 13.11.2020 | | HQFile | . ~ RLA File OO — ‘Lic.No/Date:03 10838654 (01/82/050/01715/AM21/ ——_—.:03/94/040/00455/AM21/ :01.10.2020 | ee . | [Decision: The Committee considered case as per agenda in thepresence of the technical experts and it 328 aswasapplie deci d edby to fi r atifym whichever the ad-hocis lower: input output norms under para 4.07 of HBP Vol. I as per details below or : Export Product Qty. | SL Import items Qty. 5 . AZITHROMYCINco 1 kg No. AZITHROMYCIN AMINE 1.00 kg i | DIBYDRATE __ ACETONE 090k J | |RA concerned may take further necessary action as per above decision of NC.
"(Case No.:107/6/82-ALC4/2020 |Party Name:SATYADIVIS [Meet No/Date:6/82Status: : :PHARMACEUTICALS {ALC4/2020 Deferred | ee a IPRIVATELIMITED 13.11.2020 en | §:01/82/050/01716/AM21/ :09/24/040/003 19/AM21/ 01.10.2020 : | Decision: This case appeared for the first time before Norms Committee. Deferred for comments of TE. > |Case No.:108/6/82[Party Name:ASTEC ‘Meet No/Date:6/82‘Status: ALC4/2020 {LIFESCIENCES LTD ‘ALC4/2020 ‘Deferred '330 |:01/82/050/01717/AM21/HQ File “IRLAFile,:03/94/040/00425/AM21/=————~<C*«~~«~CL05.10.2020NDate:0310838661(0| t:tCt~«Sl |Decision: This case appeared for thefirst time before NormsCommittee.TheCommittee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy: of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No,| : — 123/2015-20, dated 15.05.2019. : |
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‘Case No.:109/6/82‘Party Name:CIPLA ‘Meet No/Date:6/82Status: Lo . | ALC4/2020 “LIMITED. 'ALC4/2020 _ Approved. | - , 13.11.2020 . HQ File / IRLA File ~Lie.No/Date:0310838683, '01/82/050/01718/AM21/ |:03/94/040/00475/AM21/ (05.10.2020 © 7 _Decision:meeting no.~The6/82-ALC4/2019Committee considereddated the16.08.2019 case as peragainst agenda andadvance in the authorizationlight of earlierNo.decision0310805840.taken in. 30.06.2016, it was decided to ratify norms under Para 4.07 of HBP Vol. | as -per details given below or as. applied by the firm, whichever is less: . } Export product Qty. SL. | Import items Qty. | . | No. . . ‘ _ | | Potassium Chloride | 1 Number | 1 | POTASSIUM CHLORIDE USP 765.0 mg | | Extended Release) of Capsule > CiTRIC ACID (MONOHYDRATE | 10.0 me | ; 4 '| || CapsulesPotassium 750mgChlor / : USP) i | 331 | ER Caps USP DIBUTYL SEBACATE NF 12.0 mg ! | | 750mg (Pack Size 4 ETHANOL USP 99,9% 2.62 ml. , | >| | 100 Capsules Each) 5 | 100CC WHITE HDPE BOTTLE Relevantas | | | | | Each extended ’ | WITH 38MM NECK DB-02 per packing | |; | Release Capsule TRIVENI PLASTIC policy ; : , : | contains: c i os : | Potassium Chloride 38/400 FG, CRC HAVING UNIPAC . i «| | USP 750mg SG-75M LINER PTD. WITH SFYP _— IN BLACK (REXAM CLOSURES) | | , (90 Count ) (100 Count) 750mg / (100 ; count) 600mg a 7 "| | 53/400 LSC, SCREW CAP HAVING UNIPAC SG-75M LINER PTD. i pos! WITH SFYP IN BLACK (REXAM ofa. | (100 Count) (500 Count) 750mg
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RA concerned may take further necessary action as per above decision of Norms Committee.
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[Case No.:110/6/82-—~—~=«(PartyName:NEOGEN —s'Meet No/Date:6/82- (Status: | |ALC4/2020 CHEMICALS LIMITED | _ALC4/2020 [Approved bo (13.11.2020 | | (HQFile ~~. ~(RLAFile ~~. ~——Lic.No/Date:0310838696[ | :01/82/050/01719/AM21/ ——|:03/95/040/00052/AM21/ 05.10.2020 | Decision: The Committee‘considered case as per agenda in the presence of the technical experts and it ' __-twas decided to ratify the ad-hoc input output norms under para 4.07 of HBP as per details below or asi 332 lapplied by firm whichever is lower: _ No. ; CHLOROPENTANEt-BROMO-5: lkg |1| 1,5 PENTANEDIOL 1.335kg |, LIQUID BROMINE 2.310kg | ‘RA concerned may take further necessary action as per above decision of NC. !
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----- Start of picture text -----<br> _ CaseNoc111/6/82- OS™” [Party Name:RENOWN Meet No/Date:6/82-0 Status: .<br>» JALC4/2020 ; PHARM ACEUTICALS - :ALC4/2020 ‘Deferred ;<br>HOFile ©-RLAFile Lic.No/Date:3410046439 ql<br>333 |:01/82/050/01720/AM21/_ :34/24/040/00182/AM21/ 05.10.2020 Ob | .<br>| 14.07Decision:applicationThisof case subject appearedAdvance for theAuthorizationfirst time beforeis not Normsavailable. Committee.Hence, it wasThe Committeedecided to notedcall for thata copy: the E4<br>| lof 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No.|<br>23/2015-20, dated 15.05.2019.<br>~~ICase No:112/6/82-.~—~—sPartyName:SVLABS PVT MeetNo/Date:6/82-—[Status:=<br>ALC4/2020 ‘LTD ‘ALC4/2020 [Approved fe<br>| |HQFile RA FileSSCS Lic No/Daate:0910069302,0 —<br>| :01/82/050/01721/AM21/ 1:09/24/040/00181/AM21/ 06.10.2020 :<br>‘Decision: | The Committee considered case as per agenda in the presence of the technical experts and it 7<br>was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or: a<br>: las applied by firm whichever is lower: ; 4<br>334 | a<br>2R 58-5 (4 Amino 5 fluoro 2 oxo 2H | I kg 4<br>Pyrimidin 1 yi ) [ 1,3 ] oxathiolane 2 2,5 DIHYDROXY 1,4 DITHIANE 0.28kg | f<br>2 carboxylic acid, 2S - isopropyl 5 R DIOL) . Hi<br>methyl 1R cyclohexyl ester 5-FLUORO CYTOSINE i<br>_ 4 METHYLENE DICHLORIDE 3.00kg | §<br>: HEXAMETHYLMDC ) DISILAZANE 0.53kg |: -i:<br>| (HMDS) ¥<br>: {RA concerned may take further necessary action as per above decision of NC. ’<br>| [Case No.:113/6/82- Party Name:S VLABS PVT Meet No/Date:6/82- (Status: =—=S=<“‘édd<br>» JALC4/2020 ¢ a ‘LTD 13.11.2020iALC4/2020 i| Approved oo<br>| THO Fite IRLA File LicNomDare0910060303<br>| :01/82/050/01722/AM21/ 1:09/24/040/00310/AM21/ 06.10.2020 | 3<br>_ |Decision: ~The Committee considered case as per agenda in the presence of the technicalexpertsand it<br>was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or : i<br>as applied by firm whichever is lower: ; ; i<br>No. i t<br>/ | | 2R5S-5(4Pyrimidin Amino 5 fluoro 20x02H [1 kg {| 1 [GLYOXYLICACID-50% ss 0.68 kg f]<br>; carboxylic 1acid,yl) (2S1,3- ]isopropyloxathiolane5 R2 2 | 2,5DIOL) DIHYDROXY 1,4 DITHIANE 0.28 kg . ae.i<br>pO 'R cyclohexyl ester ; HEXAMETHYL DISILAZANE 0.53 kg |<br>_ HMDS) ~] 4<br>RA concerned may take further necessary action as per above decision of NC. . , q<br>U<br>----- End of picture text -----<br>
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----- Start of picture text -----<br> — | [Case No.:114/6/82-———*Party Name:USV PRIVATE (MeetNo/Date6/82. (Status:<br>» ALC4/2020 LIMITED (FORMERLY USV |ALC4/2020 Approved’<br>| i LIMITED) 13.11.2020 oo<br>| JHQFile RLA File| ~~ ILie.No/Date:0310838714, SSS<br>, | _ |Decision: ~The Committee considered case as per agenda in the presence of the technical experts and it.<br>"| Jappliedwas decidedby firmto whicheverratify the ad-hocis lower:input output norms under para 4.07 of HBP as per details below or as|<br>| [St Export Product Qty. Si. Import items Qty.<br>“i. 0. ; No. ;<br>I Griseofulvin Tablets USP 500 mg | 400000.000 | 1 Griseofulvin USP | 489.6kg |:<br>. B36 100s (4,000 Bottles x 100 Per Bottle = | Tablets<br>; 4,00,000 Tablets) (Net Content J oi<br>, Po Weight = 200.000 kgs)<br>. | 2 Ultramicrosize Griseofulvin Tablets, | 280000.000 : od<br>' USP 125 mg 100s (2,800 Bottles x | Tablets . i<br>| 100 Per Bottle = 2,80,000 Tablets)<br>(Net Content Weight = 35.000 kgs)<br>' | 3 Ultramicrosize Griseofulvin Tablets, | 980000.000 . Po<br>| USP100 Per:250 mgBottle100s = 9,80,(9,8 00 0 BottlesTablets)x | Tablets<br>i. (Net Content Weight = 245.000 kgs) |<br>, IRA concemed may take further necessary action as per above decision ofNC. |<br>| [CaseNo.:115/6/82-~~ iPartyName:HALDIA—~«<(MeetNo/Date-6/82-. (Statusa<br>: IALC4/2020 PETROCHEMICALS {ALC4/2020 Deferred<br>a EIMITED 3102020<br>" | THO File =RLA File - ‘Lic.No/Date:0210210144 |<br>- 337 :01/82/050/01724/AM21/ —- *1:02/24/040/00087/AM21/ — (06.10.2020 . | |<br>. Decision: — This case appeared for the first time before Norms Committee. The Committee noted that the, .<br>‘ , ‘14,07 application of subject Advance Authorization is not available. Hence, it was decided to call fora copy |<br>, |I of23/2015-20, 4.07 applicationdated 15.05.2019,of the subject advance authorizationetdirectly from the firm as per Policy Circulared No.<br>----- End of picture text -----<br>
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|||atcNo.:116/6/82-<br>ALC4/2020<br>;||Party Name: ALEMBIC<br>‘PHARMACEUTICALSLTD||neNo/Date:6/82-<br>|ALC4/2020||||||Status:<br>[Approved|||:<br>i|
||K File<br>~<br>RLAFile<br>:01/82/050/01725/AM21/ — }:34/24/040/00179/AM21/||||ic agate <br>07.10.2020||||54100%6451|||a||:|
||Decision:<br>|TheCommittee consideredcaseasperagenda inthe presence ofthe <br>was decided to ratify the ad-hoc input output norms under para 4.07 ofHBP as <br>applied by firm whichever is lower:|||||||||technical expertsand<br> per details below||and it’<br> oras|||3<br>H<br>..|
||0.|||||No.||||||||:|
|||(Net content|of active ingredients |Tablets||||||USP|||||,|
|||0.900 kgs )|||||||||||||
|.<br>338|2|Haloperidot <br>(Net content <br>0.900 kgs)|Tablets USP<br>1 mg **|**900000.000<br> of active ingredients<br>Tablets||||||||||||
|||(Net content <br>0.900 kgs)|of active ingredients |Tablets||||||||||||
||4|Haloperidol<br>(Net content <br>13.500kgs )|Tablets USP<br>5 mg |} 2700000.000<br> of active ingredients |Tablets|||||.|||||||4<br>i|
|||(Net content|of active ingredients | Tablets|||||||||||°|
|||18.000 kgs )|.|-||||||.|||||
|||(Net content <br>13.500 kgs )|of active ingredients | Tablets’||||||||-||7|r<br>||
||RA concerned may take||further necessary action as pet above|||decision||ofNC.|NC.|||||.|
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----- Start of picture text -----<br> .— (Case|ALC4/2020 No.:117/6/82-: === PartyNName:ALEMBICPHARMACEUTICALS LTD=ALC4/2020MeetNo/Date:6/82-.Status:‘Approved<br>{HQ File " RLAFile SS~S~™~SCSCLic.Nov/Date3.4100464520—OS<br>| :01/82/050/01726/AM21/ /:34/24/040/00180/AM21/ 07.10.2020 po<br>| Decision:|was decided| Theto ratify Committeethe ad-hocconsideredinput outputcase as pernorms agendaunder parain the4.07 presenceof HBPof the technicalas per detailsexpertsbelow andor itas: ;<br>| lapplied by firm whichever is lower: F<br>| Export Product Qty. SI. | Importitems | Qty.<br>339] |No. _ | No. . |<br>. 1 Midodrine HCL Tabs USP 2.5 mg | 1800000.000 1 - | Midodrine 58.14 kg<br>cg {Net content of active ingredients Tablets Hydrochloride .<br>aef 4 [2 4.500Midodrinekgs) HCL Tabs USP 5 mg 4500000.000 _ | USP(Micronized) |<br>(Net content of active ingredients Tablets .<br>Lo 22.500 kgs)<br>a 3 | Midodrine HCL Tabs USP 10 mg | 3000000.000<br>(Net content of active ingredients Tablets |<br> 30.000 kgs )<br>RA concerned may take further necessary action as per above decision of NC. |<br>----- End of picture text -----<br>
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----- Start of picture text -----<br> Casebo No.:118/6/82-ALC4/2020 PartyName:FDC; LTD ALC4/2020[MeetNo/Date:6/82-. —‘|Status:|Approved |<br>_ {AOFile RLA File Lic.No/Date:03 10838763<br>----- End of picture text -----<br>
_ |Decision: The Committee considered the case as per agenda and in the light of earlier decision taken in| meeting no. 10/82-ALC4/2019 dated 29.11.2019against advance authorization No. 0310831779) 340[japplied] 25.09.2019,[by][the] it was[firm,] decided[whichever] to ratify[is][less:] norms under Para 4.07 of HBP Vol: I as’ per details given below or as |
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----- Start of picture text -----<br> ; ; No. : :<br>:<br>1 | BRIMONIDINE | 1 Number 1 BRIMONIDINE L-TARTRATE 0.0102<br>' 4 | TARTRATE EYE DROPS a gm/vial<br>: 0.2% W/V SML ( IOBRIM<br>. | LEYE DRops sML)<br>. "JRA concerned may take further necessary action as per above decision of Norms Committee.<br>----- End of picture text -----<br>
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. . _ Case Case No.:119/6/82~~ [Party Name:SRI CHEMICALS ‘Meet No/Date:6/82‘Status: | |ALC4/2020 : . : ALC4/2020 Deferred -HQFile “"—~SOS”~~<“C~<iSéRCLAQRite=SSSS~*~S~SSCL ieNoDaates0410167147 | | |Decision: This case appeared for the first time before Norms Committee. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for acopy: of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No.; | |23/2015-20, dated 15.05.2019. . | (CaseALC4/2020 No.:120/6/82jParty Name:SRF LIMITED MeetALC4/2020 No/Date:6/82‘Status:Deferred . HQ File : - RLA File , ‘Lic.No/Date:05 10415443 | ; (342 |:01/82/050/01729/AM21/ 1:05/24/040/00333/AM21/ 08.10.2020 _ | et || [Decision:14.07 applicationThisofcase subjectappearedAdvance for theAutho fi r stization time beforeis not available.Norms Committee.Hence, it wasThe Committeedecided to call notedfor thata copy the, | sof 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No.; |23/2015-20, dated 15.05.2019. ;
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----- Start of picture text -----<br> ~ CaseNo.:121/6/82-——~—=—= Party Name:GLENMARK[MeetNo/Date:6/82. (Status:<br>: ALC4/2020 ; ‘PHARMACEUTICALS LTD (ALC4/2020 ’ {Approved<br>| HQFile {RLA File ‘Lic.No/Date:0310838803 {SS<br>_7 Decision: The Committee considered thecaseas per agendaand in the light of earlier decisiontakenin.<br>meeting no. 6/82-ALC4/2018 dated 26.07.2018against advance authorization No. 0310813336 dated)<br>|17.05.2017, it was decided to ratify norms under Para 4.07 of HBP Vol. | as _per details given below or as<br>japplied by the firm, whichever is less: . : |<br>; |) LNo.Sl. | Export Product|. , _ ; . Qty.<br>i of. Desonide Cream 0.05% 15gm | LNumber |)<br>| (Net Wt. of Desonide USP Micronised (Sicor) is 0.375 Kgs)<br>ee: Desonide Cream 0.05% 60gm 1Number |<br>| (Net Wt. of Desonide USP Micronised (Sicor) is 0.900 Kgs) |<br>P73 Desonide Lotion 0.05% 59ml 1Number |<br>343 (Net Wt. of Desonide USP Micronised (Sicor) is 0.885 Kgs) ;<br>| |4 ‘| Desonide Lotion 0.05% 118ml 1Number |.<br>(Net Wt. of Desonide USP Micronised (Sicor) is 1.770 Kgs) a<br>bo TS Desonide Ointment 0.05% 15gm 1 Number |:<br>ae ( Net Wt. of Desonide USP Micronised (Sicor) is 0.188 Kgs) |<br>| Desonide Ointment 0.05% 60gm ; 1 Number |<br>(Net Wt. of Desonide USP Micronised (Sicor) is 0.750 Kgs) . |<br>| US. Import [tems - For the Export of1 No. Pack ' ;<br>| LNo. 0.05% 10.05% [0.05% [0.05% | 0.05% [0.05% |<br>4 | - 15gm pack | 60gm 59ml 118ml 15gm 60gm<br>| pack pack . pack - pack - pack «<br>DesonideMicronised USP(Sicor) | gm0.00765-. 0.0306gm 0.301Lotgm | 0.6027 gm|0.00765gm | 0.0306gm<br>IRA concerned may take further necessary action as per above. decision of Norms Committee.<br>----- End of picture text -----<br>
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----- Start of picture text -----<br> [Ease No.:122/6/82- =~ Party Name:CLEAN Meet No/Date:6/82- Status:<br>| 1ALC4/2020 : “SCIENCE AND |ALC4/2020 Approved<br>fo | TECHNOLOGY PRIVATE (13.11.2020<br>7 IOFie REA le —_ ‘Lic No/Date:31 10067877 C |<br>| |:01/82/050/0173 1/AM21/ (:31/83/040/00073/AM21/ 08.10.2020<br>‘Decision: The Committee considered case as per agenda in the presence of the technical experts and it,<br>was decided to ratify the ad-hoc input output norms under para 4.07 of HBP as per details below or as<br>. 344 applied by firm whichever is lower: |<br>No.<br>| | Guaiacol Ikg [1 [PhenolTg]<br>Hydrogen Peroxide PURITY 60% 0.687 kg<br>Acetone (Solvent) 0.1 kg j<br>----- End of picture text -----<br>
| JRA concerned may take further necessary action as per above decision of NC.
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Case No.:123/6/82Party Name:GLAND :Meet No/Date:6/82iStatus: / |ALC4/2020 PHARMA LIMITED jALC4/2020 [Deferred i HQfie IRA le [Lic No/Date.0910060308 | a 345 :01/82/050/01732/AM21/ ':09/24/040/00295/AM21/ 08.10.2020 : ~ |Decision: This case appeared for the first time before Norms Committee. The Committee noted that the | 4.07 application of subject: Advance Authorization is not available. Hence, it was decided to call for a copy; | of|23/2 4. 0 15-20,7 applicd at edion of15.05.2019. the subject advance authorization directly from the firm as pero P o licy Circular No.—4 | Case No.:124/6/82‘Party Name:DIVIS ‘Meet No/Date:6/82‘Status: |ALC4/2020 LABORATORIES LTD ‘ALC4/2020 Deferred HQ File 346 |:01/82/050/01733/AM21/OO iRLA::09/24/040/00328/AM21/ File ~‘Lic.No/Date:091006931008.10.2020 : i| —_ | [Decision: This case appeared for the first time before Norms Committee. The Committee noted that the) || jof 4.074.07 applicationapplicationof subjectof the subjectAdvanceadvanceAuthorizationauthorizationis not available.directly fromHence,the itfirmwasasdecidedper Policyto callCircularfor a copyNo. ;| 23/2015-20, dated 15.05.2019. . || [Case|ALC4/2020No.:125/6/82Party)‘Name:SMILAX=—ss—i=<“‘«‘;‘;é;;;CLABORATORIES |ALC4/2020Meet[NDate6/82-] =~ CaseStatus: Added =f | HQ File ~RLA File:09/24/040/00358/AM21/ Lic.No/Date:0910069312,sti(“‘i‘C:;é‘@r �� Decision: This case appeared for the first time before Norms Committee. The Committee noted that the | ! - 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy | of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. fj _ | (23/2015-20, dated 15.05.2019. Oo : _
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ae. | [CaseNo.:127/6/82-ALC4/2020 Party“PHARMACEUTICALSName:GLENMARKLTD [Meet|ALC4/2020.No/Date:6/82.«© (Status:(Deferred - 5348 113.11,2020 | THQ File IRLA File . |Lic.No/Date:0310838813 | CS | (:01/82/050/01736/AM21/ 1:03/94/040/00490/AM21/ 409.10.2020 —. i | Decision: — This case appeared for the first time before Norms Committee. Deferred for comments of TE. | | ~ "Case No.:128/6/82-—=—~«(PartyNName:SUPERMINT (MeetNo/Date:6/82.Status: » JALC4/2020 {EXPORTS PRIVATE iALC4/2020 Deferred . | |HQ File RLA File ~— Lie.No/Date:0510415463| 349 |:01/82/050/01737/AM21/ 1:05/24/040/00340/AM21/ (09.10.2020 _ |Decision: This case appeared for the first time before Norms Committee. The Committee noted that the. ; 7 4.07 application of subject Advance Authorization is not available, Hence, it was decided to call for a copy| : of 4.0723/2015-20,applicationdated 15.05.2019,of the subject advance authorization directly from. theBefirm as per Policy Circular No.| . : Case No.:129/6/82jParty Name:BELCHEM Meet No/Date:6/82Status: ALC4/2020 INDUSTRIES INDIA PVT. |ALC4/2020_ Deferred ; THQ File RLAFile —SSSs«S Lic. '350 |:01/82/050/01738/AM21/ 1:03/94/040/00504/AM21/ 13.10.2020No/Date:0310838842 [0 | Decision: This case appeared for the first time before Norms Committee. The Committee noted that the: 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy : : of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No., ~ , . |23/2015-20, dated 15.05.2019. . . Case No.: 130/6/82; ‘Party Name:SWISS ‘Meet No/Date:6/82Status: : ALC4/2020 iPARENTERALS LTD ‘ALC4/2020 [Approved (HQFile=RLAFile SS ‘Liic.No/Date:08 10148798 ——: :01/82/050/01739/AM21/ ——_.:08/24/040/00227/AM21/ 14.10.2020 os :. Decision:The Committee considered caseas per agendain the presence of the technical experts and it. | lappliedwas decidedby firmto whicheverratify the ad-hocis lower:input output norms under para 4.07 of HBP as per details . below or as’ . ; . No. i 4 BENSERAZIDE 300000.000 | 1 BENSERAZIDE 7.65 kg oe , HYDROCHLORIDE AND }| Number , HYDROCHLORIDE LEVODOPA CAPSULES. BP USP/BP/IP/CEP/EP/ChP tL 125MG (CO-BENELDOPA CAPSULES BP-25 MG / 100 MG) | | |NET CONTENTS OF INPUT: °7.5 : RA concerned may take further necessary action as per above decision of NC.
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(~~ [CaseNo.:131/6/82-ALC4/2020 |Party Name:KOPRAN Meet No/Date:6/82Status: au of ; IRESEARCHLABORATORIES LIMITED ALC4/2020{13.11.2020 = | ' | jApproved | li ‘.| ‘| |HQFile —~—S—S”~=C*«é‘é‘RCLAC‘@Rle=~SS™S~~~™S:~*~SCSC Lic.Neo/Date:0310838888. | gf | |:01/82/050/01740/AM21/ :03/94/040/00505/AM21/ - {15.10.2020 i i | Decision:| |The Committee considered the case as per agefida and in the light of earlier decision taken in i : meeting no. 1/82-ALC4/2019 dated 03.06.2019against advance authorization No. 0310827587 dated | al d 11.03.2019, it was decided applied by the firm, whicheverto ratifyis less: norms under Para 4.07 of HBP Vol. I as per details given below or as i ‘| | Export product Qty. | Sl.- | Import items Qty. Z a t fo: No. i , 3521 [CEFEPIME FORINJECTION .|ikg]1 | CEFEPIME HCL (NON-|0.655kg |, Bi | —_ : _— . ; |. __| STERILE) ey | | ACETONE L8l6kg ia L-ARGININE osTke | iSO PROPYL ALCOHOL 0.392 kg i 5 PACKING MATERIAL:ALU. Relevant as |} ia | . CANISTER(10KG)/ALUMINIUM po . BOTTLE ANODIZED | __, | p erolicypacking |.Gli a CONT.ONE CAN/ALU.BOTL. , | : IRA concerned may take further necessary action as per above decision of Norms Committee. ios " [Case No.:132/6/82(Party Name:ALTA . Meet No/Date:6/82(Status: a“ | |ALC4/2020 [LABORATORIES LIMITED —ALC4/2020 [Deferred ay! THQ File IRLA File Lic.No/Date:0310838904 [| gM 353 |:01/82/050/01741/AM21/ 1:03/94/040/00536/AM21/ '15.10.2020 it Decision: This case appeared for the first time before Norms Committee. The Committee noted that the . | (4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy. a || of|23/2015-20, 4.07 applicationdated 15.05.2019.of the subject advance authorization directly from the firm as per Policy Circular No. | ia scientists sennnnnenananenaleanunutenaan a eunnaipnn n unipa ni e niunininatnnunen na h ninnuetetenmnennitysnuti n nUEEun Wrrerarenmiet interne rivet minut tt wunsununastntennnunanneininntniaunytcenne ceed eh . . . . fe mrt | . : : : Hh : - th
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|| [CaseNo.:133/6/82-ALC4/2020; i|Party. Name:ROYALPHARMA|MeetIALC4/2020No/Date:6/82. (Status:Approved | THQ Fite "-RLA File —.|Lic.No/Date:0310838908 | . i :01/82/050/01742/AM21/ |:03/95/040/00439/AM21/ ——_}15.10.2020 | ; {meeting|Decision:no.. The15/82-ALC4/2019 Committee considereddated 22.03.2019 the case as peragainst agendaadvance and inauthorization the light of earlierNo. 0310824487decision takendated in:| 17.10.2018, it was decided to ratify norms under Para 4.07 of HBP Vol. I as_per details given below or as | applied by the firm, whichever is less: ; | 354) Export product Qty. | Sl. | Import items _ Qty. : BICALUTAMIDE SULFIDE |} 1 kg | No.1 N - . - | [4-CYANO-3 - | 0.709 kg: 7 CHEMICAL NAME: N-[4(TRIFLUOROMETHYL) PHENYL] _ ro CY ANO-3-(TRIFLUORO *“METHACRYLAMIDE ne | METHYL)PHENYL]-3-[(4M. F C12H9ON2F3 M. Wt. 254 FLUOROPHENYL THIO)} -22 4- FLUOROTHIOPHENOL| 0.30kg |, “HYDROXY-2-METHYL M. F C6HSFS M. Wt. 128 - || | PROPIONALIDE | [Ra concerned may take further necessary action as per above decision of Norms Committee. ) | | Case No.:134/6/82-SSPartyName:OPTRIX——= Meet No/Date:6/82-.—|Status: |atcao20 ©... (LABORATORIES PRIVATE —ALC4/2020 [Deferred | |Oo Rie —LA Fie Lic Norate-0910060335-—a—| 355 j:01/82/050/01743/AM21/ (:09/24/040/00272/AM21/ :15.10.2020 . | ; ‘Decision: . This case appeared for the first time before Norms Committee. The Committee noted that the | 4:07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy; ‘lof 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No.| - | (23/2015-20, dated 15.05.2019. . a 7 et | ‘Case No.:135/6/82: Party Name:OPTRIX ‘Meet No/Date:6/82‘Status: | |ALC4/2020 * LABORATORIES PRIVATE ~ALC4/2020 ° ‘Deferred _ LIMITED 13.11.2020 | | | JHQFile ———s—<“<ité‘“‘éCSRWLAC‘@Rile :356 |:01/82/050/01744/AM21/ = }:09/24/040/00273/AM21/|| Lic'15.10.2020 No/Dates0910069336. | ‘Decision: | This case appeared for the first time before Norms Committee. The Committee noted that the: | +|4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy| i ‘of 4.07133/2015-20,applicationdated 15.05.2019.of the subject- advance authorizationOo directly fromae the firm asBC per Policy Circular No.|
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/ [aseNo.:136/6/82- —~—~—~—~—~PartyName:AARTIDRUGS Meet No/Date:6/82-. Status:=f ALC4/2020 ‘LIMITED :ALC4/2020 ‘Deferred r ; | (13.11.2020 ; Ps — (HQFile—SRLAFile= Lic.No/Date:0310838931 | og ‘357 :01/82/050/01745/AM21/ _ ' 103/94/040/00304/AM21/ . 16.10.2020 . po , | : | (Decision: This case appeared for the first time before Norms Committee. The Committee noted that the ; | 14.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy i | of23/2015-20, 4.07 applicationdated 15.05.2019.of the subject advance authorization directly from the firm as per Policy Circular; No. | }. [Case' 1ALC4/2020No.:137/6/82-—=—~—~—~=<(Party Name:AARTIDRUGSLIMITED ALC4/2020Meet No/Date:6/82-.Status:‘Deferred = Hi(itsé@d | |HQFile 358- :01/82/050/01746/AM21/~~~—~— :03/94/040/005(RLAFile =————_Lic.Noo/Date:0310838932 16/AM21/ (16.10.2020 | ag: (Decision: This case appeared for the first time before Norms Committee. The Committee noted that the | 7 : j0f\4.07 4.07 applicationapplicati o fn subjectof the Advancesubject advance Authorizationauthorizatiis n o nt available.directly fromHence,the itfirm wasas decidedper Policy to callCirculfor a r copyNo.:: :jl "(Case No.:138/6/82[PartyName:AVIK [MeetNo/Date:6/82-. Status:—st—i‘ésd i ‘ALC4/2020 ‘PHARMACEUTICALLTD j|ALC4/2020 ‘Approved Sp | 13.11.2020 | HQ File IRLA File Lic. No/Date:03 10838937 | | ':01/82/050/01747/AM21/ ':03/94/040/00532/AM21/ 16.10.2020 | 7 ; : meeting27.09.2019,no. 10/82-ALC4/2019 dated 29.11.2019 against advance authorization No. 0310831898 dated| :. 359 applied by theit wasfirm, decwh i dedchever to ratifyis less: norms under Para 4.07 of HBP Vol. I as per details given below or as :| i' / | SL | Export Product Qty. | Import items Qty. . | SO CLOBETASOL 17. PROPIONATE] 1kg | BETAMETHASONE | 1.00kg en: ; EP/BP/USP | ee BETAMETHASONE DIPROPIONATE | 1 kg | BETAMETHASONE |0.368kg | f | EP/BP/USP | -- | RA concemed may take further necessary action as per above decision of NC. . | , || [Case[No.:139/6/82-] ——~—=«(Party Name:BENZOCHEM [Meet No/Date:6/82-.(Status: == |. |ALC4/2020 JINDUSTRIESLIMITED. - PRIVATE —|ALC4/202013.11.2020 [Deferred -4 THQ File ‘RLA File ‘Lic.No/Date:03 10838947 . : 360 :01/82/050/01748/AM21/ :03/94/040/005 14/AM21/ 16.10.2020 _ t _ [Petision:4.07 applicationThis caseof subject appearedAdvance for theAuthorizationfirsttime beforeis not available.NormsCommittee.Hence, it wasThe decidedCommitteeto notedcall forthata copy the Z | of|23/2015-20, 4.07 applicationdated 15.05.2019.of the subject advance authorization directly from the firm as per Policy Circular No.}.:
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----- Start of picture text -----<br> _— TCaseALC4/2020No.:140/6/82-———SS—«PartyName:AARTIDRUGSMeet No/Date:6/82- (Status:<br>LIMITED (ALC4/2020 Deferred<br>{HQ File REA File ~~ Lic¢.No/Date:03108389495<br>361 {:01/82/050/01749/AM21/ ‘{:03/94/040/01019/AM20/ 16.10.2020 |<br>|Decision: This case appeared for the first time before Norms Committee. The Committee noted that the<br>4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy<br>|, _ |0f {23/2015-20, 4.07 applicationdated 15.05.2019.of the subject advance authorizationa directly from the firm as per Policy Circular No.|<br>----- End of picture text -----<br>
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----- Start of picture text -----<br> ~~\Case No.:141/6/82- {Party Name:AARTI DRUGS [Moet No/Date:6'82- (Status:<br>ALC4/2020 {LIMITED [ALC4/2020 Deferred<br>| THO File IRLA File ~tLie.No/Date:0310838950 |<br>* 1362 :01/82/050/01750/AM21/ |:03/94/040/00978/AM20/ (16.10.2020. |<br>| [Pesision:4.07 applicationThisof case subject appearedAdvance for theAuthofi r stization timebeforeis not Normsavailable.Committee.Hence, it wasThedecidedCommitteeto callnotedfor thata copy!the |<br>| of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No.|<br>; 23/2015-20, dated 15.05.2019. |<br>----- End of picture text -----<br>
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----- Start of picture text -----<br> | |Case No.:142/6/82- ‘Party Name:AARTI DRUGS —_—Meet No/Date:6/82- ‘Status:<br>ALC4/2020 :|LIMITED ALC4/2020 ‘Deferred<br>| . io fie cnet ne iniAnie Ce Lic No/Dates03 10838951an<br>363 |:01/82/050/017S1/AM21/ -|:03/94/040/00297/AM21/ 16.10.2020 . | |<br>|F -|4.07|23/2015-20,Decision:of 4.07applicationapplication Thisdatedof case subject15.05.2019.of the appearedsubjectAdvanceforadvance theAutho fi r stizationauthorization time; beforeis not Normsavailable.-Hence,directly Committee.from the itfirmwasTheas Committeedecidedper Policyto call notedCircularfor thata copy the.No.|||<br>----- End of picture text -----<br>
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----- Start of picture text -----<br> }Case No.:143/6/82- |Party Name:BENZO CHEM ‘Meet No/Date:6/82- ‘Status: .<br>i |ALC4/2020 INDUSTRIES PRIVATE (ALC4/2020 [Deferred<br>ee ee _, LIMITED oe 3-11-2020 wl _<br>| lige RLA Fie {Lie No/Date-0310838050 r vee - oan :<br>364 :01/82/050/01752/AM21/ {:03/94/040/00523/AM21/ 16.10.2020 ; |<br>| 14.07jof(Decision: 4.07applicationapplicationThisofcase subjectof theappearedsubjectAdvanceforadvancetheAuthorization firstauthorization time beforeis not Normsavailable.directlyCommittee.fromHence,the itfirm wasTheasdecidedCommitteeper Policyto notedcallCircularforthat thea copy No.|| .<br>23/2015-20, dated 15.05.2019, a | a,<br>----- End of picture text -----<br>
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'("\Case No.:144/6/82- |ALC4/2020 .~~ ~PartyNName:AARTIDRUGS‘LIMITED . — jALC4/2020Meet No/Date:6/82-(Deferred ‘Status: 4d “1365 HOFie|:01/82/050/01753/AM21/| RLA':03/94/040/00524/AM21/ File es ‘Lic.No/Date:03(16.10.2020 10838953 r4 | Decision: | This case appeared for the first time before Norms Committee. The Committee noted that the Hl : 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy| H of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No.: ‘ | |23/2015-20, dated 15.05.2019. ; a »J Case No.:145/6/82iParty Name:AVIK iMeet No/Date:6/82‘Status: ES ALC4/2020 |PHARMACEUTICALLTD —ALC4/2020 Deferred . | liofie 0 a Lic Novtate:0310838084 | ceca em : E . 366 :01/82/050/01754/AM21/ :03/94/040/0053 1/AM21/ :16.10.2020 7 r (Decision: This caseappearedfor the first time before Norms Committee.The Committee noted that the, 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy | q | _ of|23/2015-20, 4.07 applicationdated 15.05.2019.of the subject advance authorization directly from the firm as per Policy Circular No.|| qjl Case No.:146/6/82‘Party Name:AARTI DRUGS ‘Meet No/Date:6/82Status: 7 ALC4/2020 {LIMITED : ALC4/2020 [Deferred i 5 — fAQFile (RLAFile —~—~—~—~—Lic.No/Date:0310838958| i‘ ;:*éCSd 367 |:01/82/050/01755/AM21/ ':03/94/040/00184/AM21/ (16.10.2020 ~ jo Decision: This case appeared for the first time before Norms Committee. The Committee noted that the | q {4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy| E _ of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No.! i | |23/2015-20, dated 15.05.2019. . | . / ~~ T€ase No.:147/6/82[Party Name:AARTI DRUGS [Meet No/Date:6/82‘Status: | | |ALC4/2020 (LIMITED | ALC4/2020 [Deferred =f] | oh welt cae REARig fi< NomDaesésio83e080 TT 368 |:01/82/050/01756/AM21/ :03/94/040/00825/AM20/ '16.10.2020 9 | [Decision: This case appeared for the first time before Norms Committee. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy: i of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No.| 23/2015-20, dated 15.05.2019. i
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----- Start of picture text -----<br> | [CaseNo.:148/6/82-~~ “Party Name:NEON Meet No/Date:6/82- (Status:<br>ALC4/2020 |LABORATORIES LTD. ‘ALC4/2020 . ‘Deferred<br>1369THQ|:01/82/050/01757/AM21/File -1:03/95/040/00409/AM21/"RLA File — Lic.No/Date:0310838968119.10.2020. ||<br>|Decision: This case appeared for the first time before Norms Committee. The Committee noted that the |<br>: {4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy:<br>_ of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No.<br>| 123/2015-20, dated 15.05.2019. :<br>; Case No.:149/6/82- {Party Name:AARTI DRUGS — [Meet No/Date:6/82- Status:<br>ALC4/2020 LIMITED ‘ALC4/2020 Deferred i<br>: iio File Bonn RLAFile” Lie Nosbaies03i08380740 .<br>370 :01/82/050/01758/AM21/ :/:03/94/040/00525/AM21/ :19.10.2020<br>Decision:4.07 applicationThisof case subjectappearedAdvancefor theAuthorizationfirst time beforeis not available.NormsCommittee.Hence, it wasThedecidedCommitteeto callnotedforthata copy.the<br>of 4.07 application of the subject advance authorization directly from the firm as per, Policy Circular No. ;<br>» _ [{23/2015-20,] [dated] [15.05.2019.] ;<br>i Case No.:150/6/82- ‘Party Name:AARTI DRUGS Meet No/Date:6/82- Status:<br>» {ALC4/2020 7 LIMITED ~ (ALC4/2020 Deferred —-<br>(HO FieRA BileLic Novate310838075 |<br>371, :01/82/050/01759/AM21/ }:03/94/040/00528/AM21/ (19.10.2020 . |<br>Decision: | This case appeared for the first time before Norms Committee. The Committee noted that the<br>: : 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy<br>a jof 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. |<br>| |23/2015-20, dated 15.05.2019.<br>r Case No.:151/6/82- . Party Name:NEOGEN ‘Meet No/Date:6/82- . Status:<br>ALC4/2020 (CHEMICALS LIMITED - jALC4/2020 ‘Deferred<br>© fQ File La File ip NerDatesos108380839 |<br>372 :01/82/050/01760/AM21/ :03/95/040/00053/AM21/ 19.10.2020 | :<br>-| (Decision: This case appeared for the first time before Norms Committee. The Committee noted that the<br>| ‘lof4.07 4.07 applicationapplication of subjectof the Advancesubject advance Authorizationauthorizationis not available.directly fromHence,the itfirm wasas decidedper Policyto callCircular for a copyNo. :|<br>{23/2015-20, dated 15.05.2019.<br>----- End of picture text -----<br>
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|iiica No.:152/6/82-ALC4/2020|PartySCIENCESName:PRIVATEAURORE|LIFE|MeetALC4/2020 No/Date:6/82-|Status:Deferred|||
|||7||LIMITED|-|“+||13.11.2020|
|373. HO|File|IRLA|File|Lic.No/Date:09 10069343|:|
|:|-:01/82/050/01761/AM21/|:09/24/040/00382/AM21/|.|19.10.2020|_|
|||(Decision:This case|appeared|for|the|first|time|beforeNorms|Committee.|Deferred|for comments of|TE.|
|[~~|[Gase No.:153/6/82-ALC4/2020(Party|Name:AURORE|LIFE|{Meet|No/Date:6/82- (Status:|
|i|SCIENCES|PRIVATE|ALC4/2020|Deferred|||
|LIMITED|13.11.2020|||
|374 fiOFie|RLAFile|{Lic.No/Date:0910069344|||
|:01/82/050/01762/AM21/|4:09/24/040/00383/AM21/|19.10.2020|
|Decision:|This|case appeared|for the|first time|before Norms Committee.|Deferred|for comments|of TE.|||
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|7|[Case|No.:154/6/82-ALC4/2020|-[Party SCIENCESName:AURORE PRIVATE|LIFE||(MeetALC4/2020 No/Date:6/82- (Status:‘Deferred|
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|5|‘LIMITED|13.11.2020|||
|/|13— HQFie4:01/82/050/01763/AM21/|§:09/24/040/0038RLAFile|1/AM21/|{19.10.2020‘{Lic.No/Date:0910069345|~|
||||Decision:|~ This|case appeared|for the|first time|before|Norms Committee.|Deferred|for comments of TE.|||
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| (Case No.:155/6/82Party Name:ANUH PHARMA-Meet No/Date:6/82‘Status: a _ |ALC4/2020 LIMITED ‘ALC4/2020 [Deferred = BS 1 13,11,.2020 po / | Wowie Rae LicNaina 10838008"asnes“ :376 [:01/82/050/01764/AM21/ ':03/94/040/00414/AM21/ ‘20.10.2020 Decision: This case appeared for the first time before Norms Committee. The Committee noted that the: . 4.07 application of subject Advance Authorization is not available. Hence, it was decided to cal! for a copy: : |>3/2013-20,of 4.07 application dated 15.05.2019.of the subject advance authorization directly from the, firm as per Policy Circular No. :: :; [CaseNo.:156/6/82- —=—~—=s~Party Name:ANUH' . JALC4/2020 (LIMITED PHARMA ‘Meet{ALC4/2020 No/Date:6/82-Status:(Deferred q | [HQ File ) ~ IRLAFile————S—S™~~~*~SCSSL-ic.Nc/DDatez0310838999 50st 377 |:01/82/050/01765/AM21/ |:03/94/040/00415/AM21/ (20.10.2020 | Decision: This case appeared for the first time before Norms Committee. The Committee noted that the: : 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy: : . - of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. | i 23/2015-20, dated 15.05.2019. : ; :
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~—[CaseNo.:157/6/82-—=—=—~—=«Party Name:AARTIDRUGS Meet No/Date-6/82Status: | ALC4/2020 LIMITED ‘ALC4/2020 : ‘Deferred - 378 THQ|:01/82/050/01766/AM21/File ~ IRLAFile1:03/94/040/00548/AM21/ SSCL N/DDate031083900020.10.2020 5 ——SSOS~C~S«S Decision: This case appeared for the first time before Norms Committee. The Committee noted that the. 14.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy | of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. | 23/2015-20, dated 15.05.2019. ;
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----- Start of picture text -----<br> -_ Case No.:158/6/82- [Party Name:AARTI DRUGS iMeet No/Date:6/82- ‘Status:<br>{ALC4/2020 |MMITED ‘ALC4/2020 ‘Deferred<br>| ioFie iRLA ig TicNeiDaeosi0 gis001 PO oa<br>379 :01/82/050/01767/AM21/ :03/94/040/00526/AM21/ :20.10.2020 | |<br>| [Decision: — This case appearfor the first tim e befored NormsCommittee.TheCommitteenoted that the |<br>| 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy<br>| Jof 4.07|23/2015-20,applicd at edion15.05.2019.of the subject advance authorization directly from :the firm as per Policy Circular No.<br>(Case No.:159/6/82- |Party Name:STERILE INDIA :Meet No/Date:6/82- (Status: |<br>—_ ALC4/2020 {PRIVATE LIMITED “ALC4/2020 [Deferred<br>be ee 13102020<br>_ [HQFile~~ CREA FileSS™~SCSCSL ic [N/Daate:0510415575]<br>380 |:01/82/050/01768/AM21/_ : 105/24/040/00355/AM21/ '20.10.2020 |<br>. Decision: - This case appeared for the first time before Norms Committee. The Committee noted that the<br>| 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy<br>of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No.<br>_ |23/2015-20, dated 15.05.2019. 7 . .<br>----- End of picture text -----<br>
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----- Start of picture text -----<br> i: “Case No.:160/6/82- ‘Party Name:AARTI DRUGS Meet No/Date:6/82- Status: oo,<br>| ALC4/2020 LIMITED ALC4/2020 Deferred<br>= ce ISN 202000 Z<br>. | lot iA Flie re iRe RTAT CTT 1 |<br>. 381 :01/82/050/01769/AM21/ {:03/94/040/00527/AM21/ {20.10.2020 | ,<br>| Decision: This case appeared for the first time before Norms Committee. The Committee noted that the<br>{4.07 application of subject Advance Authorization is not available. Hence, it was decided to calt for a copy)<br>| lof.4.07 application of the subject advance authorization directly from the firm as per Policy Circular No.<br>| {23/2015-20, dated 15.05.2019. ;<br>----- End of picture text -----<br>
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“|'[€ase No:161/6/82-. ~—~—~«PartyName:INNOVARE: MeetNo/Date:6/82‘Status: a7 4ALC4/2020 ‘LABS PRIVATE LIMITED jALC4/2020 ‘ |Deferred if | e u3120000C—ti“‘<i‘ SS”! 382| IHQFiie™~~ REA File SSCL No/Date:2610012921 | ie. |:01/82/050/01770/AM21/ |:26/24/040/00018/AM21/ 20.10.2020 | iF |Decision: This case appeared for the first time before Norms Committee. The Committee noted that the. He | 14.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy ; a | of123/2 4. 0 15-20,7 applicd at edion15.05.2019.of the subject advance authorization directly from the firm as per Policy Circular No. i lvv Case No.:162/6/82[Party Name:SYNNAT iMeet No/Date:6/82|Status: ye ALC4/2020 ; iPHARMA PRIVATE . ALC4/2020 \Deferred a | ce JUMITED ——.,itSet.2020 eb, : | HO Ric”as 7; ae Lig Norbate-0310210167 pore s 383 :01/82/050/01771/AM21/ *102/24/040/00094/AM21/ 20.10.2020 1 ‘ || 14.07(Decision: application Thisofcase subjectappearedAdvancefor theAuthorizationfirst time beforeis not Normsavailable. Committee.Hence, it wasThe decided Committee notedto call for a that copy the | ir :|r :| :|| | ‘jof 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No.| [= | 23/2015-20, dated 15.05.2019. ‘ = Case No.:163/6/82‘Party Name:NEOGEN ‘Meet No/Date:6/82‘Status: eV | |ALC4/2020 (CHEMICALS LIMITED _ ‘ALC4/2020 Deferred = = i _ |HQFile ~——~<CS~s*‘“‘s«é‘<éRLA Pile =SSSSCL'ic.No/Date0310839070, (384 |:01/82/050/01772/AM21/ (:03/95/040/00202/AM21/ 22.10.2020 / if Decision: _ This case appeared for the first time before Norms Committee. The Committee noted that the, | 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy, BL of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No.| | **** |23/2015-20, dated 15.05.2019. . ff ot Case No.:164/6/82-ALC4/2020 Party Name:‘JODAS EXPOIM Meet No/Date:6/82Status: ; iW /PVT.LTD ALC4/2020 Deferred = sas HO Fig RR LicNoiDate-001006034a pos i / case:01/82/050/01773/AM21/(Decision:as per agendaThis caseandappearedit was forobserved':09/24/040/00356/AM21/the firstthattimethebeforefirm wasNormsissuedCommittee.22.10.2020Show CauseThe CommitteeNotice videconsidered' letter dated:the| i7iyf 10.10.2019. | |
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118
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Poy~—(CaseNo.:165/6/82-ALC4/2020[Party Name:AURORE LIFE [MeetNo/Date-6/82- (Status: . LIMITED . 13.11.2020 op L386 SCIENCES PRIVATE 4iALC4/2020 Deferred "(HQ File _ RLA File Lic.No/Date:0910069368 | °01/82/0S0/01774/AM21/ = :09/24/040/00365/AM21/ 32.10.2020 Decision: This case appeared for the first time before Norms Committee. Deferred for comments of TE.
;
.
Case No.:166/6/82-ALC4/2020 Party Name: AURORE LIFE Meet No/Date:6/82Status: oe ‘SCIENCES PRIVATE ALC4/2020 Deferred | pet HQ File IRLAFile —~—™S LLic.No/Date:0910069369 po 201/82/050/0177S5/AM21/ |:09/24/040/00384/AM21/ 22.10.2020 - [Decision: _ This case appeared for the first time before Norms Committee. Deferred for comments of TE. |—[CaseNo.:167/6/82-ALC4/2020 /INDUSTRY[Party Name:TRANSPEKLIMITED [MeetALC4/2020No/Date:6/82-‘Status:Deferred | _ B88QFile ~——~S*~~~“—~~“SRLA ileSS™”:~C~S~SS*@dCL ie NoVDaate 3410046491 | | Decision:This case appeared for the first time before Norms Committee. Deferred for comments of TE. ' {Case No.:168/6/82-ALC4/2020 PartyName:TRANSPEK[Meet No/Date:6/82- (Status: ‘INDUSTRY LIMITED |ALC4/2020 \Deferred | p89 HQ File - 4'RLA File {13.11.2020‘Lic.No/Date:3410046492 . : | $:01/82/050/01777/AM21/ 134/24/040/00197/AM21/ |22.10.2020 Decision: _ This case appeared for the first time before Norms Committee. Deferred for comments of TE.
[Case No.:169/6/82‘Party Name:AARTI DRUGS ~~ Meet No/Date:6/82‘Status: ' 1ALC4/2020 [LIMITED ‘ALC4/2020 ‘Deferred — fHQFile= IRLAFile Lic. No/Date:0310839084 +390 /:01/82/050/01778/AM21/ :03/94/040/004 12/AM21/ :23.10.2020 +_ + [Decision:{4.07 application— This.caseof subject appeared Advance for Authorizationthe first timebeforeis notNormsavailable.Committee.Hence, it wasThe decidedCommitteeto callnotedfor athat copy the.| of23/2015-20, 4.07 applicd at edion of15.05.2019, the subject0 advance authorization directly from the firm. as pera Policy Circularoe No. |
7
119 . -
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[Case No.:170/6/82-~—~—~=«PartyName:AARTIDRUGS MeetNo/Date:6/82-. Status: : | ALC4/2020 “LIMITED . (ALC4/2020 ‘Deferred | q i | 13.11.2020 fp hs [HQFileRA File ~~ Lie.No/Date:0310839085 | ot ; 391 |:01/82/050/01779/AM21/ (:03/94/040/0041 1/AM21/ 23.10.2020 : - |Decision: | This case appeared for the first time before Norms Committee. The Committee noted that the, i : | 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy, : __ \of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 7 !23/2015-20, dated 15.05.2019. i | Case No.:171/6/82-ALC4/2020 |Party Name:AURORE LIFE [Meet No/Date:6/82Status: 4 , SCIENCES PRIVATE 1ALC4/2020 _ {Deferred | j :01/82/050/01780/AM21/ :109/24/040/00407/AM21/ (23.10.2020 a | (Decision: This case appeared for the first time before Norms Committee. Deferred for comments of TE. "(CaseCo No.:172/6/82-ALC4/2020‘Party Name:AURORE LIFE {Meet No/Date:6/82-. —[Status: «= i LIMITED“SCIENCES PRIVATE jALC4/202013.11.2020 {Deferred |—i 393 THQ File IRLA File {Lie No/Date:0910069377 | i :01/82/050/01781/AM21/ 1:09/24/040/00408/AM21/ {23.10.2020 - i |Decision: This case appeared for the first time before Norms Committee. Deferred for comments of TE. | ; / [Case No.:173/6/82- ———=«[PartyName:MAKCUR —s-MeetNo/Date:6/82-. (Status: = sO | ALC4/2020 LABORATORIES LTD. ‘ALC4/2020 [Deferred E - |HQFile =————<“<i—~si‘;™SC‘RLA‘@Rile:~S—~<CS~*sts~sSCSCSLic.Noo/Daates0810148803 | tC 394 |:01/82/050/01782/AM21/ :08/24/040/00249/AM21/ _ 26.10.2020 i _ |Decision: — This case appeared for the first time beforeNorms Committee. The Committee noted that the. i : }4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy | ' : of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No.| i '23/2015-20, dated 15.05.2019. , ; | |Case No.:174/6/82|Party Name:ASHISH LIFE — Meet No/Date:6/82(Status: L : JALC4/2020 [SCIENCE PRIVATE ‘ALC4/2020 Deferred i | JHQFile = =———<“<s~s—i‘“‘s«‘“ RAQl “‘Lic.No/Date:0310839148 | 395 |:01/82/050/01783/AM21/ -(:03/94/040/00571/AM21/ (27.10.2020 | } |Decision: | This case appeared for the first time before Norms Committee. The Committee noted that the | . 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call fora copy, @ of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No., ff . 23/2015-20, dated 15.05.2019. . : — H
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~ “|| [CasejALC4/2020No.:175/6/82- SS(CHEMICALSPairtyNName:SHIRDIPVT. LTD.=== iALC4/2020Meet No/Date:6/82- (Status:‘Deferred | HQ File TRLA File | “'Lie.No/Date:0310839149 |S * 13961:01/82/050/01784/AM21/ 03/95/040/00469/AM21/ 27.10.2020 [Decision: This case appeared for the first time before Norms Committee. The Committee noted that the |
: 4of4.07 4.07applicationapplicationof subjectof the subjectAdvanceadvanceAuthorizationauthorizationis not available.directly fromHence,the itfirmwasasdecidedper Policyto callCircularfor a copyNo. || | 123/2015-20, dated 15.05.2019. ,
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|||(Case No.:176/6/82-ALC4/2020|‘Party|Name:|LACTOSE|Meet No/Date:6/82-||Status:|
|oy|(INDIA)|LTD.,|ALC4/2020|Deferred|||
|:01/82/050/01785/AM21/|:03/95/040/00472/AM21/|27.10.2020|.-|||
|_||Decision:|This|case|appeared for|the|first|time|before|Norms|Committee.|Deferred|for|comments|of|TE.|||
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~~[CaseNo.:177/6/82-- ~—~—~—«(Party Name:AUROBINDO [Meet No/Date:6/82-—‘(Status: i {ALC4/2020 |PHARMA LIMITED |ALC4/2020 [Deferred - | . | (13.11.2020 - THQ File IRLA File : 'Lic.No/Date:0910069393 | | 398 |:01/82/050/01786/AM21/ 1:09/24/040/00337/AM21/. 27.10.2020 — : || |Decision:14.07 applicationThisof case subjectappeared Advancefor theAuthorization first time beforeis not Normsavailable.Committee.Hence, it wasThe decidedCommitteeto callnotedfor that a copythe, | of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No.| i (23/2015-20, dated 15.05.2019.
.[Case No.:178/6/82-ALC4/2020 ===“PRIVATEParty Name:R.L.FINECHEMLIMITED MeetALC4/2020 No/Date:6/82-‘Status:[Deferred | "HQ FileOe —RLAFile Lic.No/Date:0710117187 fo | 399 |:01/82/050/01787/AM21/ :07/24/040/00209/AM21/ 27.10.2020 (Decision: This case appeared for the first time before Nortns Committee. The Committee noted that the | -|4.07of application of subject Advance Authorization is not available. Hence, it was decided to call for a copy| : 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. ; 23/20 15-20, dated 15.05.2019. , . ; po
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pene| sere (Casepoe annaneaetnatseseneensnnununneuetn No.:179/6/82-<n -omeeeteeteanentennenaannansuenemeiesanens somepemreet stet ‘Partypttteemamsnemerr Name:AARTIwarmer[reenactment] DRUGS[an][neteeesnoteonaamanemas poecae] Meet[ la] aeNo/Date:6/82-[ wea][ near][nnaat][ nnnamnaitrmee][ seen,] eter‘Status:[oer][omon][>][“i] | iq ALC4/2020 (LIMITED :ALC4/2020 (Deferred | HorieREAFile S—~SCLic.NoDaate:03 10839173 | sCS ( 400 :01/82/050/01788/AM21/ ::03/94/040/004 10/AM21/ :28.10.2020 H Decision: This case appeared for the first time before Norms Committee. The Committee noted that the: : 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy | q | of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. | i | 423/2015-20, dated 15.05.2019. [Case No.:180/6/82[Party Name:AARTI DRUGS ‘Meet No/Date:6/82‘Status: . ALC4/2020 LIMITED jALC4/2020 ‘Deferred i 4 4 a 13.10.2020 9 | | HO Filenana RLA fig ionos OR01RToo vee : : 401 |:01/82/050/01789/AM21/ :03/94/040/00346/AM21/ 28.10.2020 | : _ — (Decision: This case appeared for the first time before Norms Committee. The Committee noted that the ‘4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy | 7 of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. H 23/2015-20, dated 15.05.2019. f : -_ emeeetnnanannrneeereretcetiniiiaananenenenenttstttittttettitmtatineane a Case No.:181/6/82‘Party Name:J.B. CHEMICALS |Meet No/Date:6/82'Status: i ALC4/2020 & PHARMACEUTICALS ‘ALC4/2020 Deferred ' SO . ‘LIMITED 13.11.2020 fe a | fHOFile ~~ ——”~”CRLA ile~——S~S~S~S~S™:~CS—~SCLic.NoDaates0310839187 | :402 |:01/82/050/01790/AM21/ |:03/94/040/00569/AM21/ (28.10.2020 I ; |Decision: This case appeared for the first time before Norms Committee. The Committee noted that the : i 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy. _ jof 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. | 4 | .{23/2015-20, dated 15.05.2019. 5 Case No.:182/6/82‘Party. Name:ASHISH LIFE ‘Meet No/Date:6/82|Status: i. | ALC4/2020 ‘SCIENCE PRIVATE ALC4/2020 (Deferred | | HQ File a Fle del eine Lic No/Date:0310839193ope | 403 |:01/82/050/01791/AM21/ 1:03/94/040/00570/AM21/'28.10.2020 | H _ (Decision: This case appeared for the first time before NormsCommittee. TheCommittee noted thatthe) 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy | 1 of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. : 9 23/2015-20, dated 15.05.2019. | i |
oo. . . [Case No.:183/6/82-ALC4/2020(INDIA)Party Name:LACTOSELTD., - 1ALC4/2020(MeetNo/Date:6/82-——‘([Status:_ [Deferred | . — | I 13.11.2020 os 404 FQ File |RLA File ~~ [Lic.No/Date:03 10839208 | O1/82/050/01792/AM21/ —__|:03/95/040/0046/AM21/ 29.10.2020. | |
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