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Office of Directorate General of Foreign Trade New Delhi MEETINC NUMBER

Para 4.7 Decision(DRA「r)

:13/82-ALC42014 MEETING DATE:19122014 But actually held on 07.01.2015 The Meeting No. 13/82 ol 2014-15 to consider the cases/issues under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy, 2OOg-14 pertaining to Chemical and Allied products and falling under Chapter 29 and 30 was scheduled lor 19.12.2014 but actually held on 07.01.2015 under the Chairmanship of Shri Jaikant Singh, Addt. DGFT in Room No.11, Udyog Bhawan, New Delhi. Following members were present:- Shri Nirmal Kumar, Deputy Director General of Foreign Trade Ms. Swati Kumari, O/o DC (MSME) Shri D.N. Mathur. Consultant, Department of Pharmaceutical Shri Mahendra Vikram Singh, Foreign Trade Development Officer The committee went through the minutes of earlier NC -lll meeting No. 12182 scheduled for 10.12.2014 but actually held on 15.12.2014 and approved the same. The following cases/issues were discussed and the committee took the decision as mentioned against each case.

Case No B-121

M/s Rohan Expons lndia Ltd&M/a Mahesh RaJ Chemicals Ltd Meeting No.l3lAMl5 dared - 26.12.2014 FNo 01/83/162/00654/AM12/DES-111 Against order ofthe Jt. DGFT, Ahmedabad in pursuance of order dated 20.01.2010 ofthe Hon'ble High Court of Decision: Committee considered case as per agenda and in consultation with technical authority present in the meeting it has been found that despite repeated reminders the lnstitute of Chemical Technology Mumbai, has not given their opinion as to whether the export product "4,4 Diamino Sulfanilide " is manufactured only of purity 93% on commercial scale. Further, whether the product always contained 7%o or more of impurities. It was also decided to remind the Department of C&PC to take appropriate action and furnish their comments as the case has been pending for long. The case is dcfcrrcd fOr 05 02 2015

M/s PIRAMAL HEALTHCARE LTD FORMERLY NICHOLAS PI r. tto ill ez / So I OOssTlAM13/DES-lll Meeting No.13/AM15 dated - 26.12.2014 adv「Lic No 0310701405 dated 10 07 2012 dulY certified bY central Excise Authority The Case is deferred fOr 05 02 2015 ¨ ALTHCARE LTD Y NICHOLAS PIRAMAL 「 k』開%0/256/AM 131DES― III F」Vο θノβ2ガ∽6f//ν′JノDES―I〃二痰Oθfβ2′5じ126b■A′ シDESIJJ F JVο θf82/DO/255′Aルff3/DES―I〃 F. No.O 1 /82/ 5 0/9 2 8/A M I 2 /DES-ill Mee■ng No 13/AM15 dated-26122014 adv Lic No 0310694731 datcd 15 05 2012 adv Lic No 0310694936 dated 16 05 2012 adv Lic No 0310694925 dated 16 05 2012 adv Lic No 0310694706 datcd 15 05 2012 adv Lic No 0310642739 dated 18 07 20H Data dulY certified bY Central Excise Authority.

Lic No 0310694936 dated 16 05 2012 adv Lic No 0310694925 dated 16 05 2012 adv Lic No 0310694706 datcd 15 05 2012 adv Lic No 0310642739 dated 18 07 20H Data dulY certified bY Central Excise Authority. The case is defened for 05'02'2015' M7s PIRAMAL HEALTHCARE LTD (FORMERLY NiCHOLAS PIRAMAL)

Case No B‐ 124

F No01/82/50/00556/AM13/DES― II F No01/82/50/00001/AM13/DES‐ III F No01/82/50/Ol173/AM13/DES― III Meeting No 13/AM15 dated-26122014 adv Lic No 0310701402 dated 10 07 2012 adv Lic No 0310688849 datcd 30 03 2012 adv Lic No 0310721416 datcd 18 01 2013 Data dulY certified bY Central Excise Authority. The case is defened for 05'02'2015' M/s lNDIAN IMMUNOLOGICALS LTD F. No. 01/82/osO/00902/AM 14lDES-lll Meeung No 13/AM15 dated-26122014 AdvJiC No 0910057931 dated 15 10 2013 RLA F No 09/24/040/00345/AM 14 Decision : Committee considered the Case as per agenda and in consultation with technical authority present in the meeting,it was decided to amend the description of lmport item at sl. No. 1l and 13 in the nlinutes of the NC meeting no 19/82 dated 02 01 2014 as details given below The rest ofthe minutes would remain same …゛舗嘲議魃珈

Case No 8-125

From lmportitems To import tems RUBBER STOPPER V 50 4405/50 GREY RUBBER STOPPER V 50 4023/50 GREYEPP RSSiL 1/4A PS ROLLER CULTURE BOTTLE 4250 {DISpOsABLE) ROLLER 80π LE PETG 5X ST INO WRAP 1/12 4200 CM2 662006--0430 RA concerned may take further necessary action as per above decision of Norms committee.

Case No B‐ 126

M/s Techno Drugs & Intermediates(P) Meeung No 13/AM15 dated-26122014 FNo 01/83/050/00530′ AM07/DES― HI RLA'sF‖ eno 03/95/040/00486/AM07 Adv Lic No 0310392619 dt 02 08 2006 Decision: lt was decided to defer the case for 05.02.2015 for comments of Department of Ph arm aceutica ls.

Case No B-127

M/s Chirag Enterprise, Jamnagar, Gujarat MeeJng No 13/AM15 dated-26122014 FNo 01/82/050/00256/AMll′1)ES‐ III FNo 01/82/050/01090/AMll′1)ES―HI RLA's File no 2424/040/00009/AMll RLA'sF‖ cno 2424/040/00014/AMll Adv Lic No 2410029974 dt 27 10 2010 Adv Lic No 2410030871 dt 27 10 2010 Decision: It was decided reject the request of the firm as no justification has been given for enhancement of ouantitv ofinDut. Maintain status quo.

Case No B-128

ヽυs Coral Labs Ltd ゝ Meeting No 13/AM15 dated-26122014 F No 01782/162/00275/AM14月)ES― III Decision : In the light of written comments received from Department of Pharmaceuticals vide therr OM No. 3501 l/l4ll2014-Pl(Norms) dated September 2014, it was decided to call from the firm the following technical details: i) Copy of DML for export product. ii) Copy ofCOA from the Foreign Supplier showing Actual Potency of imported Raw Material The case was deferred for 05.02.2015. 孤

Case No B-129

M/s Scott‐ Edil Pharma Ltd Meeting No 13/AM15 dated-26122014 FNo 01/82/050/00222/AM14/DES‐ HI RAF No 2224/040/00015/AM14 Adv Lic No 2210013866 dt 17 05 2013 Decision :Commiftee considered the case as per agenda and in consultation with technical authority present in meeting, it was decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lowerr Export product ExpOrt Qty SI No lmport items Qty. allowed per unit of export product Ampic‖ ‖n Capsules BP 500 mg lkg 1 Ampicillin Tryhydrate Compacted lP 544.5 mg/500 mg capsule RA concerned may take further necessary action as per above decision of Norms committee. Casc No B‐ 130 1ヽ4/s Shiva Phanlna Ltd Meeting No 13/AM15 dated-26122014 FNo 01/82/162/00016/AM13/DES‐ HI ＶＶＶＶｄｄｄｄＡＡＡＡ Lic No 3410025487 dtted 30 10 2009 Lic No 3410025693 dated 25 11 2009 Lic No 341002651l datcd 03 03 2010 Lic No 3410027522 dated 16 07 2010 Decision: It was decided to defer the case for 05.02.2015 for comments of Department of C&PC.

Case No B‐ 131

M/S Aianta Pharma Ltd Meeting No 13/AM 15 dated-26122014 FNo 01/82Ю50Ю0004/AM05/DES‐ 1■ RA F No 03724Ю 40/02714/AM04 Adv Lic No 0310262053 dated 31 03 2004 Decision: It was decided to defer the case for 18.02.2015 for comments of Department of Pharmaceuticals.

Case No B-132

M/s GENER:X CHEM:EO)PVr.LTD, Meelng No 13/AM15 dated-26122014 F No01/82/050/00537/AM06/DES■‖ RLA F No 03/94/040/00571/AM06 Adv ‖c No 0310343371 dated 18 08 2005 Decision: lt was decided to defer the case for 05.02.2015 for comments of Department of c&Pc. 4

Case No B‐ 133

M/s Yasho lndustries Pvt., Ltd. Meeting No 13/AM 15 dated-26122014 F. No. o1ls2loso/01121/AM13/DES-ll I RA No o3/95/040/00735/AM13 Adv. Lic. No 0310718082 d ated 24.\2.2072 Decision: lt was decided to deferthe case for 05.02.2015 for comments of Department of c&Pc.

Case No B-134

M/s. Suven Life Sciences Ltd., Meeting No 13/AM15 dated-26122014 F No 01/82/050/01206/AMl1/DES I‖ RAF.No 09/24/040/00414ノAMll Adv Lice No 0910044683dated 15 12 2010 Decision: Committee considered the case as per agenda and in consultation with the technical authority present in the meeting, it was decided to amend the descrlption of import item at Sl. No. 1 in the minutes of the NC meeting No. 48/82 dated 01.03.201 1 as details given below. From To 2,5-Diamino-4, 5-Hydroxy Pyrimidine Hcl 2,5‐D:amino-4,6-D:HYDROXY Pyrimidine Hcl The Rest of minutes would remain same RA may take appropriate action as per the decision of Norms Committee.

Case No B-135

M/s. sorrcrl xmtrH cARE Pw. rrD., MeeJng No 13/AM15 dated-26122014 F No 01/82/050/00581/AM 12/DES■ || RAF.No. 04l24lo4ol00363/AM 11 Adv Lice No 0410126761 dated 03 08 2011 Decision: Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to ratifu norms under para 4.7 of HBP as per SION A-412 with 2o/o wastage. RA concemed may take further necessary action as per above decision ofNC. M/s. Wanbury LTD. (Formerly Known as Doctors Organic Chemicals Ltd.) Meejng No 13/AM15 dated― 26122014 FNo 01/82/50/01175/AM08/DES― :‖ Adv Lic No 2610006381 dated 14092007 RAF No 26/80/040/00002/AM08 Decision: lt was decided to defer the case for 18.02.2015 for comments of Department of Ph a rmaceutica ls. 雪覇鋪蛛 : ハ

Meet No/Date:13/82‐ Decision :ln the light of earlier decision taken in meeting no. LLl82 dated 26.11.2014, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp.Qty. Sl.No. Import items Qty.

l82 dated 26.11.2014, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp.Qty. Sl.No. Import items Qty. allowed Doxilamine Succinate BP/USP l Kg. 1 2 Acetyl Pyridine 0.58 kg 2. Tetrahydrofuran 1.03 kg Ｆ ‐ ‐ ‐ ‐ ２ ‐ ‐ ‐ ‐ lflじ 1)l∫fF/13ノ 82- Paty Name:MAITHRI LABORATORIES(P)LTD。 , Date:05.022015 Paty Name:REANNON PHARMACEUTICALS 鷺λ∫IIiOノ00325/AM15/ F「FEIEiC:0310786993B:IIし,02211 Decision: It was decided to defer the case for 05.02.2015 for comments of Department of S. ２お３０Ｎｏ・‥２ ‐ 州ａｓｅＬＣＣＡ臨畑劉晨my :01/82/050/01092/AM15/ ＦＩＩＦＦＩＩＩ No。:89/13/82‐ALC4/2014 ALC4/2014 19.12.2014 No/Date:13/82- 19.12.2014 File /AM15/ 112.05.2014 : It was decided to defer the case for 05.02.2015 for comments of Department No。:248/13/82¨ No/Date:13/82‐ 19.12.2014 Namc:ARIHANTANAM No/Date:13/82‐ PVT.LTD. 12.2014

⌒ ― ― 一 IHQ File:01/82/050/01213/AM15/ | ::03/94/040/00360/AM15/ 「RLA File B鮨お 5.02.2015 d t° difer the cTi f° r Decision : It was decided to defer the caie for rPharmaceuticals 05.02.20t5 for comments of Department of 1淵FSe | Lic.No/Datc:0310787389 り8.07.2014 05.02.2015 for corlllnents of ~F猥嘲跳ル鳳Cttm4[wttHΨ ttD I打QⅢ∝O1/87“ OЮ И ttmyttt刷 :υO∝72ハm夕 ~~ :Mcet No/Date:13/82‐ :ALC4/2014 119.12.2014 Export product Exp. Qty. SI No lmport items Qty AIlowed Koノko (lS,4R)-4-[(2‐AMINO-6-CHLORO― 5-FORMAMIDO‐ 4- PYRIMIDINYL)AMINO]-2¨ CYCLO PENTENE-1-METHANOL l kg 1 N―(2-AMINO-4,6¨ DICHLORO-5- PYRIMIDINYL) FORMAMIDE 0.764 2 (十)…2- AZABICYCLO[2.2.1]HEPT‐ 5‐EN‐3‐ ONE(VINCELACTAM) 141 3

6-CHLORO― 5-FORMAMIDO‐ 4- PYRIMIDINYL)AMINO]-2¨ CYCLO PENTENE-1-METHANOL l kg 1 N―(2-AMINO-4,6¨ DICHLORO-5- PYRIMIDINYL) FORMAMIDE 0.764 2 (十)…2- AZABICYCLO[2.2.1]HEPT‐ 5‐EN‐3‐ ONE(VINCELACTAM) 141 3 D(‐)TARTARIC ACID 0.78 4 SODIUM BOROHYDRIDE 0226 5 ISOPROPYL ALCOHOL 4.70 6 ⅣlETHANOL 423 7 L(十)TARTARIC ACID 123 | IRA∞ncerned may take funher necessary aclon as per above decision of NC. | | ; lDecision : Committee considered the case as per agenda and in light of written comments received from i i iDepartment of Pharmaceuticals vide their OM No.350lll238l2}l4-Pl(Norms) dated 10.10.2014 and in, ] l"on.uttution with technical authority present in meeting, decided to ratiSz norns under para 4.7 of HBP as l ]lp".detailsbeloworasappliedbyfirmwhicheverislower:- ＦＩＩ， ‐ 汗購需 MCHEMIMI~M13/82‐ : IHQ Fit Ю1/82/050/01212/AM15/:RLAFme Lic・ No/Dac0310787473 1 ::03/94/040/00379/AM15/ 131.07.2014 r"脇 ALC4/2014 :Date:05.022015 lStatus:Case lDeferred i ,Decision :It was decided to defer the case for 05.02.2015 for comments of Department of C&PC. Stalus: rApproved Name:DORF‐ KETAL No/Date:13/82- INDIA PVT.LTD. 4

e:05.022015 lStatus:Case lDeferred i ,Decision :It was decided to defer the case for 05.02.2015 for comments of Department of C&PC. Stalus: rApproved Name:DORF‐ KETAL No/Date:13/82- INDIA PVT.LTD. 4

lmport Product Polymer Additives - Bis (N- Alkylaminocycohexyl) methane Trade Name: Clearlink 1000 PAC‐2M(4,4‐ Methylenebi Scyc10 Hexanamine),synonym: Methyl EthylKetone / MEK Catalyst: 30% Platinum on carbon powder (on dry may take appropriate action as per the oecision oittormGEEG ― ― ルーーー 1型器肌TD貯T… ド QⅢ∝∝お2Юm畑2“晨myttλ 淵 OЮ “ 49/Amy l淵鼎 C"Ю ・ %“ Dedsion:in the light Of w百tten cOmments rさcきi亮a Frち品6とお :11品き rlt of Chemica!s and Petrochemicals U.O No.14010/176/2011/ch ll dated 22.12.2014′ it was decided to ratify norms under Para 4.7 of HBP vide their vl as per given below or as applied by the firm, whichever is less: Status: Export Product Chemicals- Organic Mixture, Trade Name - Clearlink 1080 (2-Alkyl Isophoronediamine) Iso Phorone Diamine / IPDA Platinum Catalyst 2020 PMc /3%oPlatinum on carbon Catalyst Sulfided (Code 2020 and B 171032-3 may take apprOpnate actiOn as perthe decisiOn of Norms COmmittee. Case No。:237/13/82‐ ALC4/2014 P征けName:GITANJALI CHEMICALS PVT LTD Status:Approved Export Product Export Quantity S.No lmport Product Quantky Allowed 4‐BROMO ANISOLE kg 1. PHENOL 0.820 kg 2. DIⅣIETIIYL SULFATE 0.627 kg 雪
器 R D繋野電謙咄 de 器譜晰8:::篤F:設ll誡 udy。聾肌謀誡 :籠」 File:01/82/050/01242/AM15/ sion : ln the light of written comments received rrom oepaiir".i ,i cn";;;i;."d p;i;;;ffiGt, ,il tG;

TIIYL SULFATE 0.627 kg 雪
器 R D繋野電謙咄 de 器譜晰8:::篤F:設ll誡 udy。聾肌謀誡 :籠」 File:01/82/050/01242/AM15/ sion : ln the light of written comments received rrom oepaiir".i ,i cn";;;i;."d p;i;;;ffiGt, ,il tG; ,I"^,.r^o3r.Y_r!.?l:?:r!:!,.1,,L.,:l !0.!o.2ot4;it was decided to ratify norms under para 4.7 of HBp vl as per given below or as applied by the firm, whichever is less: Export Quantitv S.No lmport Product Quantity Allowed L kg 1. 0.680 kg 2. 0.0004 kg No/Date:13/82- | 雨 o■:h the nght of wnten comments recdvさぎ fr。稿5品岳1品hl ofを聰nlica!s and Petrochemica!s vide their No.14010/41/2011/ch:‖ dated ol.lo.2014′ it was decided to ratify norms under Para 4.7 of HBP vl as per is given be10w Or as app‖ ed by the firm′ whichever is!ess:

HYDROBROMIC ACID, 48% 1.560 kg 4. HYDROGEN PERIOXIDE, 50% 0.757 kg may take appropriate action as per the decision of Norms Committee. ~F… 13/82‐ ALα T“ 騨閻紺誡狩鮮… | lDecision : It was decided to defer the case for 05.02.2015 for comments of Department of C&PC.

Case No.:204l13t82-ALC4t2Ol4 iParty Name:GLENMARK lMeet No/Date:13/82- lstutrrt

iGENERICS LIMITED iALC4/2014 JApprovt r |D.t2.2ot4 I " Ha Ftl. f l/82l0s0/0t2o?/AMw W -[fi"N"/D"t"o31078770s F"f.. D, l:03/94/040/00401/AM l s/ 106.08.2014 I D;.i.ir, 'rc"ritt ;;;d*.d ."* ;;;; G"rd, unJ in rieht of ;iitt"n "o*r"rti ffii".d fi'o, D.prrd Pharmaceuticals and in consultation with technical authority present in meeting, decided to ratifr norms unde 4.7 of HBP as per details below or as applied by firm whichever is lower:- 12 Export product Exp.Oty. Si.No. Import items Oty,a1loWed Linezolid l kg 1 Thioacetic Acid 1.43 kg 2. Methylene Chloride/Methylene Dichloride/MDC 10.30 kg R Glvcidvl Bufvrate 0.7178 kR 4. Dimethyl Formamide 4.275 kg Terahydrofuran 5.44 kg 6. 3.4-Difl uoronitrobenzene 0.9324 kg 7. Methanol 7.75 kg RA concerned may take further necessary action as per above decision of NC Department of ms under para

Case No.:40/13ノ82‐ALC4/2014

「蕊蕩F~~ 〕irOM No. of HBP vl | ド‖出γ ~ HQ File:01/82/050/01043/AM15/ :09/24/040/00236/AM15/ Decision :In the light of written comments received from Department of Pharmaceuticals vide the 3501114812014-PI(Norms) dated 24.09.2014, it was decided to ratifu the norms under Para 4.7 r as per details given below or as applied by the firm, whichever is less: Export Product Export Oty. S.No. Import ltem Qty. Allowed ke/ke EPLEMNONE l kg 1 Methyl hydrogen - l Talpha -hydroxy -3- oxopregna -4,9(l l) -diene -7 alpha,2 I -dicarboxylate, gamma- lactone 1.764 1蹴器α対∞晰2 Name:MSN TORIES PRIVATE File 10060823 Date: No/Date:13/82- No.:238ノ13/82‐ALC4/2014 14 鷺

HQ Fib:01/82/050/01241′AM15/ | ~ |り鯰。20И I鵬鵬OЮ""晨m夕 1蹴鼎α“Ю ・ηЮ Defer Date: Decisio■ : ln the!ight Of written comments received frOm Department Of chemicais and PetrOchemica!s vide their U.O No. 14010/176/2011/ch ii dated 03 04.2014′ it was decided to ratify norms under Para 4.7 of HBP vl as per detalls given below Or as app‖ ed by the firm′ whichever is less: Chemical‐ Antifoulant ,Tradc Nalne― DA 2339/DA 2313/DA 2316/DA 2339‐ h4 /DA 2394/DA 2304-C/DA 2309/DA 2331/DA 7315 2,6,Di tertiary butyl phenol(purity-99%tO 100%)/2,6DTPB t\ooh Di-n-Propyl Amine Dimethyl sebacate /DMS 4 Hydroxy Tempo 14 Hydroxy 12,2,6,6 Tetramethyl/P I iperi d ins-N- Di butyltin oxide/ DBTO / &q"at 4201IBNT CAT 430 Hitec 64 H Aromatic Solvent/Solvant C- l0/Kocosol 150/HAR/ Heavy Aromatic Solgad 150/K-l50MC_10 A/Garasol- 1 50/ C-9lRemax- l/Aromatic Solvent 1 50/C09 Plus/Aromatic Solvent (C l0-

t 4201IBNT CAT 430 Hitec 64 H Aromatic Solvent/Solvant C- l0/Kocosol 150/HAR/ Heavy Aromatic Solgad 150/K-l50MC_10 A/Garasol- 1 50/ C-9lRemax- l/Aromatic Solvent 1 50/C09 Plus/Aromatic Solvent (C l0- RA may●ke apprOp●試e actiOn as per he dedttOn of Norms COmmた "a Case No。:42/13/82‐ALC4/2014 Party Name:INCHEM LABORATORIES PRIVATE `円而而面而画面面 ~1騰危鵬υ 007‐2ハM百温 ided to defer the case for l:識 h:」ic』s 05.02.20 Mcet No/Date:13/82‐ ALC4/2014 119.12.2014 ∬… F鮮 ∩汗ヽ.+.・n,lA●o■ぅ0う |、 ● |

Case No.:205/13/82… ALC4/2014

Status: lApproved No.:240/13/82¨ ALC4/2014 Name:DORF-KETAL Meet No/Date:13/82- IALC4/2014 INDIA PVT.LTD. 19.12.2014

「 ~1蹴器α“Ю ・・“ １１１１ ← :Decision:ln the light of w百tten comments received from Department of Chemicals and Petrochemica!s宙de their i胤撲iぷ蹴倒子壁瑞i晶樹il昇請・ i胤:tよTl:rdedmu～ n∝msundg hm 47 J HBP颯ぉ pα | l l ExpOrtProduct l Export lS.No l lmpOrtProduct l Quantity l Export Product Export Quantity S.No lmport Product Quantity Allowed Chemical Name: Antipolymerant - frade Name -2666 (Blend of N- rxylcompound, Glycol and amine) l kg 1. 4 Hydroxy Tempo / 4 Hydroxy / 2,2,6,6 Tetramethyl/ Piperridine-N-Oxyl I 4 HT 0.350 kg γ ト erthe decision of Norms Committee. 「 1
浙 : | | IALC4/2014 119.12.2014 Approved ド QⅢ∝∝お 2Ю剛∝刻 0晨my剛臨蕊y―寵鼎α“Ю ・・% Decision :In the light of earlier decision taken by NC in its 9/82 meeting dated20.10.2014, it was decided to ratifo the norms under Para 4.7 of HBP vl as per details given below or as applied by the firm, whichever is less: Export product Exp. Qtv. Sl.No lmport items Qtv.

dated20.10.2014, it was decided to ratifo the norms under Para 4.7 of HBP vl as per details given below or as applied by the firm, whichever is less: Export product Exp. Qtv. Sl.No lmport items Qtv. allowed Artemether l Kq Artemisinin 1.235 kg RA concerned may take further necessary action as per above decision of NC. 臨一 Status:Case Deferred Date:05.02.2015 | ＦＩＬｆ 'Case No.:203/13/82-ALC4/2014 ParりName:GLENMARK ‐GENERICS LIMITED 「 Q Π b Юν 82Ю5υ∝ 206ハMly~[::蕊魚葛蔦蔦 ~陣 eet NoDttα 13/恵 '1 IALC4/2014 119.12.2014 n :tn the tight of eartier decision taken by Na 3/s, ;;ii";;i;;&orro14 ,"d i" .""rrttrti;, tl authority present in meeting decided to ratify norms under para 4.7 of HBP as per details below by firm whichever is lower:- Export product Exoort Qtv. SI.No. lmport items Qtv. allowed Atovaquone l Kg. Trans-4-(4-Chlorophenyl) cyclohexane carboxylic Acid 2.00 kg Methylene Dichloride 6.25 kg 11 No/Date:13/82- り狂〕世 11饗 Ⅳ 鵬λ鵬 OЮ"“ 晨my l蹴鼎品面 7982 :Dedsbn:It was decided to remind the irIIn to fumish the fo110wing technical details: l. COA for foreign supplier indicating Potency of Nystatin imported under present A.A 2. Detailed calculation of arriving at the quantity of API applied. case was deferred for 05.02.2015.

l details: l. COA for foreign supplier indicating Potency of Nystatin imported under present A.A 2. Detailed calculation of arriving at the quantity of API applied. case was deferred for 05.02.2015.

Acetonitrile 6.50 kg 4. 2-Chloro- 1,4-Napthoquinone 1.62 kg 5. Dimethyl Formamide 0.74kg concerned may take further necessary action as per above decision of NC. 44/1 3/82‐ ALC4/2014 ParりNameiSRIAM LABS PRIVATE LIMITED - 1鷺ら鵬υ00237Amy 囲肥繭ご臨,022∝5 /82/050/01047/AM15/ It was decided to defer the case for 05.02.2015 for comments of Department of uticals FttcN∝ 218/1ン"■LCttm4蘊聴:躙評雨~ | Meet No/Date:13/82- J ALC4/2014 19.12.2014 )ecision:ln the light of earlier decision taken in meeting no.3l82 dated 08.05.2014,i| was decided to ratify norms nder Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. SI.No. lmport items Qty.al10Wed(kg) Lumefantrine l kg (Dibutylamine Methyl)-2′ 7- Dichloro-4-fluoren Methano!(DBA) 0.8693 kg ＦＩＩＩＬｒｌｌ臨¨3/82-ALC4/2014甲飩"町鮮… FT 器3児5剛22ハmy ~指 λ鵬 OЮ “ 31/Am夕 ~~寵鼎 α "Ю 7880鉾 Date: Decision: ln the light of earlier decision taken in meeting no.3l82 dated 08.05.2014,i|was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. SI.No. lmport items Qty.al!OWed(kg) 12 ＦＩＩＩ（（ ″ ― ― ― lё aseNo.:43ノ13ノ82‐ALC4/2014 Name:SMILAX No/1Date:13/82- 14 TORIES LIMITED : It was decided to defer the case for 05.02.2015 for comments of Department Lic No/Date:0910060852 ＦＩＩＩＩＩＩ＾＾ｒ

― ― lё aseNo.:43ノ13ノ82‐ALC4/2014 Name:SMILAX No/1Date:13/82- 14 TORIES LIMITED : It was decided to defer the case for 05.02.2015 for comments of Department Lic No/Date:0910060852 ＦＩＩＩＩＩＩ＾＾ｒ

Lumefantrine l kg 1 (Dibutylamine Methyl)-2,7- Dichloro-4-fluoren Methanol(DBA) 0.8693 kg 「 | 1 LC4l20l4 iParty Name:AVA CHEMICALS PVT.LTD., :Meet No/Date: IALC4/2014 119.12.2014 3.No/Date:03 .08.2014 ・ ‥ ２．．　　　一側ｅＮ。．　　　一眈Ｆ一雷一　　　　　５ 3/82- ¨ IИ.0&20И 1078 Decision :It was decided to defer the case for 05.02.2015 for comments of Department of Chemical Decision :ln the light of earlier decision taken in meeting no. 18/82 dated 30.08 .2012, it was decided to ratify rnorms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export Product Export Qty. Si.No. import items Qty. allowed Chloramphenicol Eye Drops 0.5% w/v l0 ml Vial made out of LDPE l No. 1 Chloramphenicol 0.05 gram 2. LDPE Granules As per packing policy ／８２﹈Ａ　　　一颯¨ 　　　一 ¨ 孵 | || ヌ~~ ~浮瀞下 ny l悧鼎 C“Ю ・Ю68鳶ぉ 5Ю2期5 02.2015 for coIIments ofDepartment of Ｆ卜Ｆ 127 Date:05.02.2015 13/82- 〓 ‥ ― ― ― ‐ １１２８ ‐ Ψ ALC4/2014 lHQ File珈穐う画面209/AM百胃閉ｅ４Ｆｉ ‐ 仙 AM15/ ＦＤＣ ‐ 　　　一　醐Ｎａｍｅ ‥ 　　一Ｆｉ ‐ ｅ脚 TD IMeet No/Dtte:13/82- iStatus:Approv;l p商も r Date:~~~~ :ALC4/2014 119.12.2014 Liよ｀3/D黒 'bilo78意 02恩 114.08.2014 ision :In the light of earlier decision taken in meeting no.

ａｍｅ ‥ 　　一Ｆｉ ‐ ｅ脚 TD IMeet No/Dtte:13/82- iStatus:Approv;l p商も r Date:~~~~ :ALC4/2014 119.12.2014 Liよ｀3/D黒 'bilo78意 02恩 114.08.2014 ision :In the light of earlier decision taken in meeting no. 18/82 dated 30.08.2012, it was decided to ms under Para 4.7 of HBP vl as per details given below or as applied by the firm, whichever is less: Export Product Export Qty. Sl.No. import items Qty. allowed Chloramphenicol Eye Drops 0.5% w/v 10 ml l No. 1 Chloramphenicol 0.05 gram つん LDPE Granules As per packing policy rati取幕 _MF 13 Petrochemicals. No.:200/13/82¨ ALC4/2014 :Ptt Name:FDC LTD No/Date:13/82‐

Vial made out ofLDPE | HQ Π b Юν 82Ю50畑239ハmyl鷺 tttνO“50/AM15/ 1造き』肩跡 tC 13/82- 119.12.2014 0788029 29 per Decision :ln the light of earlier decision taken by NC in its 3ll82 meeting dated 0l.l 1.201 I and it was decided to rati$ norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:- Export product Exp. Oty. Sl.No. Import items Qty.a110Wed Ezetimibe l Kg. 1 Dimethyl Amino Pyridine 0.09 kg 2. N,N― DirnethyI Forlnanlide 1.52 kg S(十)4-Phenyl-2-Oxazolidinone 0.93 kg 4. Borane Dimethyl Sulfide 0.424 kg (R)-2-Methyl-CBS-Oxazaborolidine (l M Solution in Toluene) 0.057 kg 6. N,0‐ Bis(Trimethylsilyl)Acetamide 1.07 kg 7. Tetrahydrofuran 0.074 kA ~F画面画面画面~ LS IStatus:Approved 130 HQ File:01/82/050/01215/AM15/ RLA File :03/94/040/00437/AM15/ Decision:ln the:ight of written comments rece:ved from Department of Chemicals and Petrochemicals vide their U.O No 14010/157/2011/Ch‖ dated 9.12.2013′

050/01215/AM15/ RLA File :03/94/040/00437/AM15/ Decision:ln the:ight of written comments rece:ved from Department of Chemicals and Petrochemicals vide their U.O No 14010/157/2011/Ch‖ dated 9.12.2013′ it was decided to ratify norms under Para 4.7 of HBP vl as per detalls given below or as apphed by the firm′ whicheveris!ess: H Export Product Export Quantity S.No lmport Product Quantity Allowed EOPPER EDTA,Cu Content 14% 1+/‐ 1) l kg 1. ETHYLENE DIAMINE TETRA ACETIC ACID 0.719 kg A may take appropriate actlon as per the decision of Norms Committee. Lic.No/Date:0310788108 19.08.2014 iCaseNo.:213/13ノ 82‐ALC4/2014 「QⅢ痢1/82/050/O12mmy Pel山 Decision : ln the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/157/2011/Ch !:dated 25.10.2014′ details given below or as applied by the firm, whichever is less: Export Product Export Quantity S.No lmport Product Quantity Allowed P釘けName:AVA CHEMICALS PVToLTD., 智MAR 爛瞬靴搬輛1搬螂聴肌澱鰺莉殿:¨:1為。 Q凛趙鯰 14 「 |

en below or as applied by the firm, whichever is less: Export Product Export Quantity S.No lmport Product Quantity Allowed P釘けName:AVA CHEMICALS PVToLTD., 智MAR 爛瞬靴搬輛1搬螂聴肌澱鰺莉殿:¨:1為。 Q凛趙鯰 14 「 |

P額りName:FDC LTD Decision : It was decided to defer the case for Pharmaceuticals 0.690 kg ― ― ~1翻鼎“釧 "“ BO 05.02.2015 for comments of Department of Meet No/Date:13/82- ALC4/2014 19.12.2014 Lic.No/Date:0910060864 1Defer for comments of Department of Date:05.02.2015 ― コ推‖… ICase No。:243/13ノ82‐ALё4/2014 | | Paty Name:ALTA ILABORATORIES LTD. -l ν82¨ IALC4/2014 i19。12.2014 1鷺λ ttυ00398/AM15/ 1淵ma“ Ю ・囲 IDeferDate: s decided to whichever is IMeet No/Date:13/82‐ IALC4/2014 119.12.2014 %FQⅢ∝∝慇ν“ 0畑25晨m5「圏瓶:浚語洒冨面高TIt was decided to deferthこ■百ge forb5.o2.2015 fo長33高五Is ofDepartment ofC&PC. :cision : ln the light of earlier de tify norms under Para 4.7 of HBt cision taken in meeting no. Sl82 dated 24.07.2014, it was ) v1 as per details given below or as applied by the firm, v Export Product Export Qty. SI.No. lmport item Qtv. allowed Sodium Salicylate l Kg 1. Salicylic Acid 0.80 kg ZINC EDTA COntent 5%∈/‐ 0.5%) ETHYLENE DIAMINE TETRA ACETIC ACID No.:198/13/82-ALC4/2014 File:01/82/050/01058/AM15/ RLA File FaseNQ=6γ13月2‐ALC42014に認飽讐ξ :皿李FTHFE | |I I FQⅢ釧郷剛“ 3晨my 1淵辮側∞ω%9開蕊蔦

COntent 5%∈/‐ 0.5%) ETHYLENE DIAMINE TETRA ACETIC ACID No.:198/13/82-ALC4/2014 File:01/82/050/01058/AM15/ RLA File FaseNQ=6γ13月2‐ALC42014に認飽讐ξ :皿李FTHFE | |I I FQⅢ釧郷剛“ 3晨my 1淵辮側∞ω%9開蕊蔦

嬌由∝∝おν “ OЮ T2ハ my l躙鼎 α “ Ю器"BttL5Ю 2期5 Decision : It was decided to defer the case for 05.02.2015 for comments of Department of C&PC. CHEMICALS PVT.LTD., IALC4/2014 Decision:It was decided to defcrthe case for 05.02.2015 for comments ofDepartment of C&PC. Party Name:HETERO DRUGS LIMITED, Nl解5/13/82ALC4側4田皿蘊 w鰊 |｀か 119.12.2014 : It was decided to defer the case for 05.02.2015 for comments of Department No.:229/13/82‐ ALC4/2014 Name:AVA CHEMICALS iMcetNo/Date:13/82- PVT.LTD., IALC4/2014 「 Q Fne Ю 1/82/050/01230/AM15/1鷺λ刷 : No.:228/13/82-ALC4/2014 1P冨けName:CROWN No/Date:13/82- No。:226/13/82‐ ALC4/2014 Name:BLISS GVS IMeet No/Date:13/82- LTD. IALC4/2014 :It was decided to defer the case for 05.02.2015 for comments of Department 1器魃器需▼ …… 麗蒲戸 3/82- 119,12.2014 汗 Q File Ю1/82/050/01218/AM15/ lli:λ ];::0/00358/AM15ノ [i[::輛 e:0310788338 No.:45/13/82-ALC4/2014 下 1912.2014

the case for 05.02.2015 for comments of Department 1器魃器需▼ …… 麗蒲戸 3/82- 119,12.2014 汗 Q File Ю1/82/050/01218/AM15/ lli:λ ];::0/00358/AM15ノ [i[::輛 e:0310788338 No.:45/13/82-ALC4/2014 下 1912.2014

No。:264/13/82‐ ＦＩ猿獅 ― ― II写鼎α "1° 060田5障話萬I Decision : It was decided to defer the case for 05.02.2015 for comments of Department of Pharmaceuticals HQ File:01/82/050/01049/AM15/ loecision , it *ur decided to aireithe-case for os.$.iots-i; io-*tn.rtr A D.purtr.nt oi lPharmaceuticals :
・臨鳳I ALC4/2014~甲聴耐臨籠」 ~~獅獅膏 y丁ゞ ´

fAq Fite:01/8;atosuon6T/Awts/ lm-eTifu 
-ll-i"N;/D.-ut.'osr07ss3e7-E;f*
I 
i :03t941040t0040s/AM l s/ 
lze .otzotn 
loate'os.oz.zo t s
iDecision : It was decided to defer the case for 05.02.2015 for comments of Department of
lPharmaceuticals
F
:09/24/040/00275/Aヽ415/
ICase No.:46/13/82-ALC4/2014
P征りName:HETERO LABS
ALC4/2014
19.12.2014
09/24/040/00271/AM15/
Ｆ
‐
，
‐
―
驚
拌
…
…
…
Ｆ
‐
‐
４
９‐
‐
ト
:Decisbn:It was decided to dcfcrthc casc for 05.02.2015 for commcnts of Dcpartmcnt of C&PC.
IDecisbn:It was decided to dcfcr thc casc for 05.02.2015 for comments ofDepartttent OfC驚
『
lL十(1
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… …
…
… … …
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Ⅲ
、。/Datま0310788373
'                              I:03/95/040/00431/AM15/        126.08.2014
Mcet No/Date:13/82‐
No.:244/13/82‐ ALC4/2014
: It was decided to defer the case for 05.02.2015 for comments of Department of C&PC.
No.:255/13/82‐ ALC4/2014
Name:THE DHARAMSI
No/Date:13/82‐
CHEMICAL CO LTD

No/Date:13/82‐
No.:244/13/82‐ ALC4/2014
: It was decided to defer the case for 05.02.2015 for comments of Department of C&PC.
No.:255/13/82‐ ALC4/2014
Name:THE DHARAMSI
No/Date:13/82‐
CHEMICAL CO LTD
: It was decided to defer the case for 05.02.2015 for comments of Department of C&PC.
No.:224/13/82‐ ALC4/2014 1Paty Name:DELTA FINOCHEM MeetNo/Date:13/82‐
PVT.LTD.
IALC4/2014
19.12.2014
b蒟砲両活
13~~:
No.:225/13/82¨ ALC4/2014
Name:DELTA FINOCHEM
No/Date:13/82-
.LTD.
19.12.2014
Nalne:DELTA FINOCHEM IMeet No/Date:13/82‐

Ｆ
Ｉ
Ｉ
イ
ParサName:NAVIN FLUORINE IMcet No/Date:13/82-
INTERNATIONAL LIMITED  IALC4/2014
Decision : It was decided to defer the case for 05.02.2015 for comments of Department of C&PC.
Decision:It was dccided to deferthe case for 05.02.2015 for comments of Departmcnt ofC&PC.
HQ File :0u82/050t0t257tAutst lRre pite
:03/95/040/00459/AM15/
Decision : It was decided to defer the case for 05.02.2015 for comments of Department of C&PC.
ALC4/2014
19.12.2014
HQ Πle:01/82/050/01264/AM15/IRLA Fit
IDefer Date:
:03/94/040/00961/AM14/
Decision: !n the light of written comments received from Department of Chemicals and Petrochemicals vide their
U.O No.

12.2014
HQ Πle:01/82/050/01264/AM15/IRLA Fit
IDefer Date:
:03/94/040/00961/AM14/
Decision: !n the light of written comments received from Department of Chemicals and Petrochemicals vide their
U.O No. 14010/55/2012/Ch !! dated 10.07.2012′  it was decided to ratifv normS under Para 4.7 of HBP vl as per
given below or as applied by the firm, whichever is less:
Export Product
Export
Quantitv
S.No
lmport Product
Quantity
Allowed
「RICYCLODECANE KETON
ⅥIN.PURITY 93.5%
l kg
1.
DICYCLOPENTADIENE
MIN.PURITY 90%
1.15 kg
Meet No/Date:13/82¨
ALC4/2014
19.12.2014
ヽ
喘
l::b 
Юl慇2050Ю tt6αAMl夕
1鷺λ刷,OЮ0962晨MИ/ 
な¶ 鼎
α0310788558
D島醒
隧
趣
l藷讐
墨
冷
R
臨輔酢黎灘L
糟鼈
賦
■雪覇∬笛鑽
UdttL凛毀黒輛

## Case No.:256/13ノ82‐ALC4/2014
ICase No.:257/13/82-ALC4/2014
Lic No/Date:0310788557
.01.09.2014
社鍍鮮…
耐″ 圏鼎α“Ю霧おω
B鳶ぉ
,∞2m5
02.2015 for collllments ofDepartment ofC&PC.
ICase No.:263/13/82-ALC4/2014
Party Name:ANTHEA
AROMATICS PVT.LTD.,
Date:05.02.2015
融朧黒:識計
「QⅢ∝側郷∽陽
9ハmy囲
T10NAL LIMITED
19.12.2014
1汗QⅢ∝側
"肪
的蜘
Amy剛
ICaseNo.:254ノ
13/82‐ALC4/2014 1:〔
ilitl:翌ξi〕:♀:ENT
10788508
4
No/Date:13/82¨
14
No。:261/13/82‐ ALC4/2014
Name:ANTHEA
No/Date:13/82‐

IDecおlon:It was decided to deferthe case for 05.02.2015 for comments of Department of C&PC.
Party Name:KRISHNA
ANTIOXIDANTS PVT.LTD.

## Case No.:222/13/82‐ ALC4/2014
‐ALC4/2014
19.12.2014
:03/94/040/00439/AM15/
HQ File:01/82/050/01225/AM15/
悧鼎α“Ю
788539 BttL,舵
2m5
Decision:ln the light of written comments received from Department of Chemicals and Petrochemicals vide their
U.O No. 14010/100/2012/Ch ‖dated 12.11.2013′
ails given below or as applied by the firm, whichever is less:
Export Product
Export
Quantitv
S.No
lmport Product
Quantity
Allowed
l kg
1.
YELLOW PHOSPHORUS
0.096 kg
DIPHENYL OCTYL PHOSPHITE
2.
PHENOL
0.603 kg
3.
2-ETHYL HEXYL ALCOHOL
/2-ETHYL HEXANOL
0.418 kg
Ｉ
‐
Paty Name:SATYADEVA     Mect No/Date:13/82-
PHARMACEUTICALS/P/LTD.,IALC4/2014
119.12.2014
File
Paty Name:SATYADEVA
LC4/2014
1066/AM15/
陽ち刷:υ∞%8/AMW 
椰
器
α
"Ю “"mB鳶
ち,舵2∝5
|
HQ Rb Ю1/82/050/01220/AM15/IRLARL
Lic.No/Date:0310788620
:03/94/040/00494/AM15/
d to defer the case for 05.02.2015 fsor conlments of Department of
Ｆ
‐
‐
‐
‐
６
０
‐
‐
‐
‐
珈
1岬
滉
糖賞誓墨廼蔓曇鷺震
「Te
ICasc No.:223/13/82-ALC4/2014
ANT10XIDANTS PVT.LTD.
鱚
鷲黒葛潔い
IMeet No/Date:13/82¨
「QⅢ∝側郷剛“
7晨my囲
No.:54/13/82‐ALC4/2014
:It was decidcd to deferthe case for 05.02.2015 for comments of Department of
Name:ENCUBE
No/Date:13/82-
Name:KRISHNA
No/Date:13/82-
/AM15/間蕊

eet No/Date:13/82¨
「QⅢ∝側郷剛“
7晨my囲
No.:54/13/82‐ALC4/2014
:It was decidcd to deferthe case for 05.02.2015 for comments of Department of
Name:ENCUBE
No/Date:13/82-
Name:KRISHNA
No/Date:13/82-
/AM15/間蕊

「
眈
W13/82‐AК 例
“
甲
閻
図
可
‖
…
汗
QⅢ∝剛
2Ю 50/OI Ю6晨my陽
鵬0仰γ5ハmy l淵
鼎
α"Ю
∝5078
Status:
Defer
Date:05.02.2015
decided to ratiry
Decision : In the light of earlier decision taken by NC in its 10/82 meeting dated 12.11.2014, it was deci
the norms under Para 4.7 of HBP vl as per details given below or as applied by the firm, whichever is less:
Export Product
Export
Quantity
S.No.
lmport ltem
Qty.AI!owed
kg/kg
Cefuroxime Axetil
Amorphous
l kg
1.
Desacetyl-7-amino
cephalosporanic acid(D-7-
ACA)
0.79
2.
Ethyl acetate
3.74
3.
Methanol
0.62
4.
Syn― methoxvirnino furanyl
acetic acid ammonium salt
(SM!A)
0.835
5.
Activated carbon
0.100
6.
Phosphorous
pentachloride
0。97
7.
Methylene chloride
2.29
8.
Sodium hydroxide
0.43
9.
Acetic acid
0.048
10.
Acetonitrile
0.98
11.
Chlorosulphonyl
lsocyanate
0.53
12
Acetone
1.76
13
N,N-dimethyl acetamide
1.12
14
Acetoxy ethyl bromide
0.59
15
Cyclohexane
0.92
16
Sodium carbonate
0.125
17
Sodium bicarbonate
0.080
18
Sodium chloride
Not an importable
item
19
Sodium metabisulfite
Notshownin RXN
20
Hydrochloric acid
Not an importable
item
RA may take appropriate action as per tlre decision of Norms Committee
appropnate
per
~ぽ続疏硫
HQ Ⅲ∝∝お2TO畑
"ンAm夕
陽λ席
蕊
5リハm" 1蹴
鼎
α
“
Ю器
∞
BttL5Ю2知5
:In the light of earlier decision taken by NC in its 9/82 mecting dated 20.10.2014,it was decided to rati″
the

rms Committee
appropnate
per
~ぽ続疏硫
HQ Ⅲ∝∝お2TO畑
"ンAm夕
陽λ席
蕊
5リハm" 1蹴
鼎
α
“
Ю器
∞
BttL5Ю2知5
:In the light of earlier decision taken by NC in its 9/82 mecting dated 20.10.2014,it was decided to rati″
the
norms under Para 4.7 of HBP vl as per details given below or as applied by the firm, whichever is less:
62
20

I
,
諄鮮…
^
ided totteferthe case fbr 05。02.2015 for comments of Department of

## Case No.:259/13/82‐ ALC4/2014
Party Name:DANOPHARM
CHEMICALS PRIVATE LTD.
Date:05.02.2015
ICaseNo。:260/13ノ82‐ALC4/2014
|
IHQ File:01/82/050/01263/AM15/
1
|
Decision :Committee considered case as per agenda and in light of written comments received from
Department of Pharmaceuticals and in consultation with technical authority present in meeting decided to
ratifr norms on repeat basis under para4.7 of HBP as per details below or as applied by firm whichever is
lower:-
Export product
Export Qty.
SI.No.
Import items
Qty.
allowed
Bupropion Hydrochloride
BP
l kg
1
M-Chloropropiophenone
0.85 kg
つ
ん
Methylene
Chloride/\,Iethylene
Dichloride/ MDC
2.00 kg
り
，
Methanol
0.23 kg
|
RA concemed may take fu■her necessary action as per above decision ofNC.
Case No。:221/13/82‐ ALC4/2014 :鱚憔HMπD ttre而
HQTttν
“
0畑"仏my鵬
淵
υ∞m5ハmy l翻
鼎
α
“
Ю
・
%"
1悧鼎α
"Ю獅%PebDた
Decision :ln the light of written comments received from Department of Pharmaceuticals vide their C
35011/32612014-PI(Norms) datedDecember 2014, it was decided to ratiff the norms under Para 4.7 of HBP v
details given below or as applied by the firm, whichever is less:
Export product
Exp.Qty.
SI.No.
lmport items
Qty.AIlowed
Kg/kg
Prednisolone Sodium
Phosphate
l Kg.
Prednisolone (Prednisolone Base)
0.857
OM No.
vl as per
Status:
|66@F",ty 
N".-ropnaN r-rr"rnso M".t N"/D"t.l3l81
IStatlls:                          |
21
File :01/821050/ot262t AM.I 5/ IRLA File
GENERICS LIMITED
No/Date:13/82‐
14

)
0.857
OM No.
vl as per
Status:
|66@F",ty 
N".-ropnaN r-rr"rnso M".t N"/D"t.l3l81
IStatlls:                          |
21
File :01/821050/ot262t AM.I 5/ IRLA File
GENERICS LIMITED
No/Date:13/82‐
14

|          |          1徴
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     ttppЮ
Ved
l画
面画面面面
閉薦蔦蕊
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pecぉbn:conllnitee consdeК d ctte as per agenda and h Hgh Of writen collmentsおmarded by
lDepartment of Pharlnaceuticals and in consultatiOn with technical authoHty present in meeting,
decided to ratify nO.11ls llnder para 4.7 ofHBP as per details be10w Or as applied by f1111l whichever
is lower:―
Export
product
Export
Qty.
Sl.No.
Import items
Qty.
allowed
kg/kg
Meropenem
for Injection
USP
l kg
1
Meropenem Trihydrate Non-Sterile
0.987
RA may take appropriate action as per the decision of Norms committee.
ド
Namα KOPRAN ЫMTED‐ Meet No/Date:13/82‐
ALC4/2014
19.12.2014
汗
Q Ⅲe Юν82Ю5υm236晨醐
1鷺λttυ∝
“
7晨MW
Lic No/Date:0310788689
03.09.2014
Decision :In the light of written comments received from Department of Pharmaceuticais
OM No. 35011/12/2014-PI(Norms) dated September 2014, it was decided to ratifu no
Para4.7 of HBP vl as per details given below or as applied by the firm, whichever ij less
vide their
rms under
Export product
Exp.
Qty.
SI.No.
Import items
Qty.

mber 2014, it was decided to ratifu no
Para4.7 of HBP vl as per details given below or as applied by the firm, whichever ij less
vide their
rms under
Export product
Exp.
Qty.
SI.No.
Import items
Qty. a110Wed
kttg
Cefepime for injection
l kg
1
Cefepime HCL (Non Sterile)
0。655
2.
Methanol
0.742
つ
，
Acetone
1.816
4.
L-Arginine (Non-Sterile)
0.370
5.
Isopropyl Alcohol
0.392
RA may take appropriate action as per the decision of Norms committee.
「蹴賛Ъ淵
=N
ICase No。:127/13/82‐ ALC4/2014
Mcet No/Date:13/82‐
ALC4/2014
19.12.2014
凶
HQ Ⅲe Юν82Ю50畑BαAmyl鶴
危棚
OЮ釧97/AM15/
Decision:In the light ofearlier decision taken by NC in its 9/82 mecting dated 20.10.2014,it was decided to ratitt the
norms under Pata4.7 of HBP vl as per details given below or as applied by the firm, whichever is less:
13aseNo.:233/13/82-ALC4/2014

Ｓ
‐
．
Ｎ
。
Export Product
Import Items
SOFT
BOTTLE
WHITE
CAP
DROPPER
SODIUM
HYALURONATE
NaF100
1
VIZULIZE
MOISTURIZING AND
COMFORT EYE
DROPS O。1%-10ML
Relevant as per packing policy
0.01 gm per bottle
つ
４
VIZULIZE
LUBRICATING AND
REWETTING EYE
DROPS 15ML
¨Do―
NIL
●
フ
90/0… VIZULIZE EYE
BRIGHTENER EYE
DROPS 10ML
―Do―
NIL
concerned may take further necessary action as per above decision of NC.
may
necessary
per
~1蹴
鼎α“Ю
・%の開蕊温～
Mcet No/Date:13/82-
ALC4/2014
19.12.2014
Defer
Date:05.02.2015
一
‐
‐
‐
７
。
Ｆ
‐
‐
It was decided to defer the case for 05.02.2015 for comments of Department of C&PC.
1慧だ露酬
D
|
Meet No/Date:13/82¨
|
「
Q Ⅲ
e劇お
:Ю
50畑256ハmyl鷺
tttυ00462/AM15/
IDecision:It was decidcd to d"f*lhe "^" 
fio.

was decided to defer the case for 05.02.2015 for comments of Department of C&PC.
1慧だ露酬
D
|
Meet No/Date:13/82¨
|
「
Q Ⅲ
e劇お
:Ю
50畑256ハmyl鷺
tttυ00462/AM15/
IDecision:It was decidcd to d"f*lhe "^" 
fio. OSOZ:Of Slor c"rn**@
|町
ALC4/2014
119.12.2014
Export Product
Export
Quantity
S.No
lmport Product
Quantity
Allowed
Dimethyl Diphenyl Thiuram
Disulnde(MPID)
l kg
1.
N-Methyl Aniline
0.651 kg
23
No。:251/13/82‐ ALC4/2014
Name:STERLING
No.:253/13/82-ALC4/2014
No.:252/13/82‐ ALC4/2014
円赫赫肩my剛漏扁~
: ln the light of written comments received from Department of Chemicals and Petrochemicals vide their
No.14010/95/2011/Ch l:dated 19.08.2014′
it was decided to ratify norms under Para 4.7 of HBP vl as per deta‖ s
below or as applied by the firm, whichever is less:
Party Name:YASHO
INDUSTRIES PVT.LTD.

Case No。:56/13/82‐ALC4/2014
HQ File:01/82/050/01059/AM15/
RLA File
:09/24/040/00499/AM14/
1蹴鼎α酬∞ω%2
Defer Date:
Decision : Committee considered case as per earlier decision taken by NC in its 4182 meeting dated 03.07.2014 and in
Itation with technical authority present in meeting, decided to ratit/ norms under para 4.7 of HBP as per details
'or as applied by firm whichever is lower:-
Export product
Exp.Qty.
S.No.
Import items
Qty. allowed
7-PHENYLACETAMIDEO‐
3‐CHLOROMETHYL
CEPHttOSPORONIC ACID
PARA METHOXY BENZYL
ESTER(GCLE)
l kg
1
PENICILLIN G‐POTASSIUM
FIRST CRYSTAL
2.81 kg
2.
ACETONE
1.971 kg
ISOPROPYL ALCOHOL
0.66 kg
4.
DIMETHYL FORMAMIDE
1.314 kg
METHYLENE CHLORIDE
3.29 kg
6.
2 MERCAPTO BENZO THIAZOLE
0.51l kg
7.
METHANOL
1.971k負

## Case No.:73/13/82‐ ALC4/2014
Pa●y Name:VIRCHOW
PETROCHEMICAL PVT LTD.
Meet No/Date:13/82‐
ALC4/2014
1912.2014
町
「
Q「回
κ2側∝
"6ハmy膨
鵬OЮり
“
ハmツ 1蹴
鼎
α
"Ю06091l PebD犯
~F霞
蘭鴻綱3/82-ALα 側4「MttHttD諄
鮮
d釧'F璃
潔T・
HQ File:01/82/050/01087/AM15/
Decision : Committee considered case as per earlier decision taken by NC in its 4/82 meeting dated 03.07.2014 and in
Itation with technical authority present in the meeting, it was decided to ratifr norms under para 4.7 of HBP as
details below or as applied by firm whichever is lower:-
Export product
Exp.Qty.
S,No.
Import items
Qty. allowed
7‐ PHENYLACETAMIDEO‐
3‐CHLOROMETHYL
CEPHALOSPORONIC ACID
PARA METHOXY BENZYL
ESTER(GCLE)
l kg
1
PENICILLIN G¨POTASSIUM
FIRST CRYSTAL
2.81 kg
2.
ACETONE
1.971 kg
ISOPROPYL ALCOHOL
0.66 kg
4.
DIMETHYL FORMAMIDE
1.314 kg
METHYLENE CHLORIDE
3.29 kg
6.
2 MERCAPTO BENZO THIAZOLE
0.51l kg
7.
METHANOL
1.971 kg
1蹴鼎α
tt Ю“
4857
Pharmaceuticals
「冨
o.:258ノ13/82‐ALC4/2014
諄鮮…
fや争ョ3■1、′NIRyttL KりMAR
:
…
枷
Department of Commerce
u調聾轟謀誡
:m
Status:Approved
24
NameiVIRCHOW
Mcet No/Date:13/82-
IALC4/2014
19.12.2014
concerned may take further necessary action as per above decision of NC.
1/83/040/00132/AM15/

partment of Commerce
u調聾轟謀誡
:m
Status:Approved
24
NameiVIRCHOW
Mcet No/Date:13/82-
IALC4/2014
19.12.2014
concerned may take further necessary action as per above decision of NC.
1/83/040/00132/AM15/

ハ
1器星児
50Ю鯰
61ハMl"
1鷺λ刷:OЮ“
69/AM15/
1翻鼎α∞Ю器“
Decision : ln the light of earlier decision taken in meeting no. 23/82 dated 06.03.2014 and in consu
with technical authority present in the meeting, it was decided to ratify norms under Para 4.7 of HBP vl.
details given below or as applied by the firm, whichever is less:
Export Product
Export Qty.
SI.No.
lmport item
Qty.
AIlowed
Kg/kg
NITAZOXANIDE
l Kg.
1.
2‐AMINO‐5-NITRO
THIAZOLE
0.59
「      
臓‖… 邪藤
|
1鷺念鵬υ
0053mmζ~~~~       F而薦丁
IDecおbn:In the light ofwri■en comments rece市ed from Department ofPharmaceuticals宙de their
OM No. 3501111212014-PlQllorms) dated September 2014, it was decided to ratify norns under
Para4.7 of HBP vl as per details given below or as applied by the firm, whichever is less
Export product
Exp.
Qty.
Sl.No.
lmport items
Qty. a110Wed
kttg
Cefepime for injection
l kg
1
Cefepime HCL (Non Sterile)
0.655
2.
Methanol
0.742
3.
Acetone
1.816
4.
L-Arginine (Non-Sterile)
0.370
5.
Isopropyl Alcohol
0.392
奉
」
F
Namα KOPMN HMTr降
囃
げ
腰
町
「QⅢ∝側郷剛
"4ハmy   
」
1悧辮“Ю■8820匹
als vide their 
i
norrns under i
less:
recision : In the light of written comments
)M No. 35011 I l2l20l4-Pl(Norms) dated
ara4.7 of HBP vl as per details given be
received from Department of Pharmaceuticals
September 2014, it was decided to ratify no
low or as applied by the firm, whichever is less
Export product
Exp.
Qty.
Si.No.
Import items
Qty.

ils given be
received from Department of Pharmaceuticals
September 2014, it was decided to ratify no
low or as applied by the firm, whichever is less
Export product
Exp.
Qty.
Si.No.
Import items
Qty. a110Wed
kg/kg
25
No.:231ノ13/82-ALC4/2014

Cefepime for injection
l kg
1
Cefepime HCL (Non Sterile)
0.655
2.
Methanol
0.742
り
，
Acetone
1.816
4.
L-Arginine (Non-Sterile)
0.370
Isopropyl Alcohol
0.392
RA may take appropriate action as per the decision of Norms committee.

## Case No.:234/13/82-ALC4/2014
ParりName:KUSUMA PHARMA
Mcet No/Date:13/82-
IALC4/2014
19.12.2014
:03/94/040/00501/AM15/
IDecisbn:It was decided to deferthe case for 05.02.2015 for comments ofDepartment ofC&PC.
FeNa23ylン
82ALё 4/2014
HQ Fib:01/82/050/01238/AM15/
RLA File
:03/94/040/00500/AM15/
Decision : It was decided to defer the case for 05.02.2015 for comments of Department of C&pC.
Decision : It was decided to defer the case for 05.02.2015 for comments of Department of C&pC.
「
Q ΠL Юν82Ю50/01041/AM15/IЪ
ち刷10/00282/AM15/
ParりName:KUSUMA PHARMA
ALC4/2014
1912.2014

## Case No.:38/13/82-ALC4/2014
Decision :ln the light of written comments received from Department of pharmaceutica
consultation with technical authority present in the meeting, it was decided to ratify norms under p
HBP v1 as per details given below or as applied by the firm, whichever is less:
Export product
Exp.
Qty.
S:.No.
lmport items
Qty.Al:owed
kg/kg
GABAPENTIN
l kg
1
Cyclohexa ne-1, 1-Diacetic Acid
Monoamide
●
′
‘
υ
t,.t'.$;E?,F_L-!9.1?","8to"
ooraurloo lo lueruuedao&[ig hldlb
eoe.l t uote:o3 1o lBJeueO eleJolsJlo
-'L-rorritst ltqs ;.1hr6 tlEg
eoa t u6re)of 1o leJ€uaC Jol'aJlo 'Ao
-'ItfiJre rrFg at>?Ut?t* le
U\d!\rnx fvr^rur N I Ur'-€ e+ld}
ffa 
q;<rqrNtRMAL KUMAR
gq qgft-qrro r+qcl qrqr{
Oy. Director General of Foreign Trade
- fritr Earqrq qErfu{qTrtrq
Directorato General of Foreign Trado
qIFF q frqr.Iroepartment of commerce
sdFr $rqq. q-€ Rd
Udiog Bhawan. N€w Oelhi
26
File :01/821050/01237 I AMl5/ iRLA Fite
4
No/Date:13/82-
12.2014
10788810
4
1

q
Directorato General of Foreign Trado
qIFF q frqr.Iroepartment of commerce
sdFr $rqq. q-€ Rd
Udiog Bhawan. N€w Oelhi
26
File :01/821050/01237 I AMl5/ iRLA Fite
4
No/Date:13/82-
12.2014
10788810
4
1

2.
Acetone
1.541
Ptt Name:CIPLA LIMITED.
HQ Ⅲ∝∝κ
205υ∝り
8晨Myl性λ
ttυ00542ハmy
82
: ln the light of written comments received from Department of Pharmaceuticals vide their OM
35017/75512015-Pl(Norms) dated January 2015, it was decided to ratify norms under Para 4.7 of HBP
as per details given below or as applied by the firm, whichever is less:
S.NO.
Import Items
For export of 1000 No. Pack
75 1nl
100 1nl
150 1nl
1
Amoxyci llinTrihydrate
4.200
5.649
8.274
2
Clavulanate Potassium Syloid
mix
2.3444
3.126
4.6888
●
，
Silicon Dioxide(Sy10id AL‐
lFP)NF
1.500
2.00
3.00
4to 7
Packing Materials
Relevant as per packing policy
賠λ刷
:υ∞
"νAm y ~1翻鼎α“Ю
788915
Decision :ln the light of earlier decision taken in meeting no. 8/82 dated 25.09.2014and in consultation with
technical authority present in the meeting, it was decided to ratifu norns under Para 4.7 of HBP vl as per
details given below or as applied by the firm, whichever is less:
Export product
Exp.
Qtv.
SI.No
lmport items
Qty. allowed
ROSUVASTATIN
CALCIUM
l kg
(4R― CIS)‐ 6-[(ACETYLOXY)‐
METI‐IYL]-2,2‐ DIMETIIYL‐ 1,3‐
DIOXANE-4-ACETIC ACID-1,1-
DIMETI‐WLETHYL ESTER
1 871 kg
2
4‐(4-FLUOROPHENYL)¨ 6-
ISOPROPYL-2-[oヾ―METI‐IYL―N‐
METIIYLSULPHONYL)AMINO]
PYRIMIDINE-5-YL‐ METHANOL
1.871 kg
回
P冨り｀五me:KOPRAN LIMITED

## Case No.:195/13/82‐ ALC4ノ2014
ALC4/2014
19.12.2014
RA concerned may take further necessary action as per above decision of NC
PTりName:ENALTEC LABS
PVT.LTD.
Case No。:216/13/82‐ ALC4/2014
lCase No. : I 9 6 t 13 t82- ALC4t20l 4
27
IMeetNo/Dtte:13/82‐
10788909
Date:
No/Date:13/82‐
No/Date:13/82‐
14
19.12.2014

Ｆ
Ｉ
Ｉ
Ｉ
Ｉ
Ｉ
Pharmaceuticals
Mcet No/Date:13/82‐
ALC4/2014
19。12.2014
1鷺λ鵬OЮ0533/AM15/
ALC4/2014
19.122014

## Case No.:246/13/82‐ ALC4/2014
Paty Name:KOPRAN LIMITED
HQ File:01/82/050/01249/AM15/
Lic.No/Date:0310788932
109.09.2014
Decision : Committee considered case as per agenda and in light of written comments forwarded by
Department of Pharmaceuticals and in consultation with technical authority present in meeting,
decided to ratify norns under para4.7 of HBP as per details below or as applied by firm whichever
is lower:-
Export
product
Export
Qty.
Sl.No.
Import items
Qty.
allowed
kg/kg
Meropenem
for Injection
USP
l kg
1
Meropenem Trihydrate Non-Sterile
0.987

## Case No.:247/13/82-ALC4/2014
PaコリName:KOPRAN LIMITED

## Case No.:201/13/82¨ ALC4/2014 Pa●y Name:KRISHNA
ANT10XIDANTS PVT.LTD.
町
Defer Date:
「
Q HL Юν
82Ю5νm250晨myl鷺λ
ttυ00532/AM15/
forwarded by
rt in meeting,
rm whichever
86
per
Mcet No/Date:13/82¨
ALC4/2014
19.12.2014
1翻鼎α“Ю
・""
Decision :Committee considered case as per agenda and in light of written comments forv
Department of Pharmaceuticals and in consultation with technical authority present in
decided to ratify norrns under para 4.7 of HBP as per details below or as applied by firm v
is lower:-
Export
product
Export
Qty.
Sl.No.
Import items
Qty.
a1lowed
kノkg
Meropenem
for Injection
USP
l kg
1
Meropenem Trihydrate Non-Sterile
0。987
lHq rire :01/82/050t0t2o4tAMtst iRLA Fite
28
ILic.No/Date:0310788928
「
Q RL劇慇705υ∝り
"A面
夕
1鷺念糀
OЮ0545/AM15/
10788934
No/Date:13/82-
14
19.12.2014

103/94/040/00499/AM15/
.09.09.2014
¨
而
Dedsion:It was decided to dcfcrthc case for 05.02.2015 for comments of Department of C&PC.
Ｆ
‐
‐
８
９
卜
‐
ICase No。:26/13/82‐ALC4/2014
:
|
叩吻戸諄鮮…
押QRにЮ1/82/050/01029/AM15/IRLARL
:                             :03/95/040/00493/AM15/
囲
109.09.2014
Date:05.02.2015
…
2/13/82‐ 出
側
4卜
辮
珈
ふ
「
D貯
‖
…
町
Ⅲ∝∝慇2/050/01205ハM15戸
1競
脇
ふ
鳳
:|~~1語
嶽欝膏
而而而而r―
汗
面扇肩一
ision::n the light of written comments received from Department of Chemicals and Petrochemica:s vide their
No.14010/100/2012/Ch :l dated 22.12.2014′
l‖s given below or as app‖
ed by the firm′ whicheveris:ess:
Export Product
Export
Quantity
S.No
lmport Product
ｔ
ｙ
ｄ
Ｑ
ｕ
ａ
ｎ
ｔ
ｉ
Ａ
‐
‐
。
ｗ
ｅ
「RIPttNYL PHOSPHITE
l kg
1.
PHENOL
0.937 kg
2.
YELLOW PHΘ SPHORUS
0.100 kg

or as app‖
ed by the firm′ whicheveris:ess:
Export Product
Export
Quantity
S.No
lmport Product
ｔ
ｙ
ｄ
Ｑ
ｕ
ａ
ｎ
ｔ
ｉ
Ａ
‐
‐
。
ｗ
ｅ
「RIPttNYL PHOSPHITE
l kg
1.
PHENOL
0.937 kg
2.
YELLOW PHΘ SPHORUS
0.100 kg
'Decision : It was decided to defer the case for 05.02.2015 for comments of Department of C&PC.
I Decision:It was dccided to deferthe casc for 05.02.2015 for comments of Department of C&PC.

## Case No.:62/13/82‐ ALC4/2014
Paty Name:EYTAN LABS
LIMITED
29
ヘ
File
File:01/82/050/01253/AM
Ｆ
Ｉ
ヽ
‐
，
―
―
＾
．
押
―
―
―
‐
Ｆ
‐
‐
９
２
‐
‐
No.:27/13/82‐ALC4/2014
NameiSTERLING
No/Date:13/82¨
4
No。:23/13/82‐ALC4/2014  Par"Name:YASHO
No/Datc:13/82-
File:01/82/050/01026/AM15/ 1RLA File
iDecision : It was decided to defer the case for 05.02.2015 for comments of Department of C&PC.
No/Date:13/82‐
19.12.2014
15/IRLA File
10788892
14
iDecision : It was decided to defer the case for 05.02.2015 for comments of Department of C&PC.
No/Date:13/82-
1》瀑風
14

…珈…ぼ
[鮒学WE躍ぽ7
「QⅢ∝∝慇ν“
0畑
"4ハmy腸翻蕊瓦蕊戸~躙鼎α
"Ю%0931B為
5般2m5
諄鮮…
購淵
:υ∞zO晨my l悧
鼎
α
"Ю060936B鳶
ぉ5Ю2期5

## Case No.:53/13/82-ALC4/2014
Pharmaceuticals
|:lilll:』|ど[醤∫
eCided to defer the case for 05.02.2015 for conllnents ofDepartment of
「
ase No.:64/13/82-ALC4/2014
Export Product
ｙ
呻
Ｑ
ｕ
ａ
ｎ
ｔ
ｉ
S.No
lmport Product
ｔ
ｙ
ｄ
Ｑ
ｕ
ａ
ｎ
ｔ
ｉ
Ａ
‐
‐
。
ｗ
ｅ
ヽCETONITRILE
l kg
1.
ACETIC ACID
1.766 kg
「
QⅢ∝∝慇2ЮWm“ 7ハmy陽
酬
:υ∞27/AMV I悧
鼎
α酬∞ω鯰9B鳶
ぉ5Ю2矧5
11:胤l:棚
∫
ecided to defer the case for 05.02.2015 for colllunents ofDepartment of
「露:Ξ=製翌螢ザl_主鮮…
i fnd nrr;ovsaosiaotwqtrurv i[A]ir. 
_---iit"N"/D"t"tr310?8e061
i I 
l:$/eafia0fio36s/AMtst ltt.oe.zott
I mfrf"" , tn th. t',gtt of *ritt"n .orr"nt, ,;"iGT;;;6;tr;i"f 
demrc.tr ."d p"i;;
1.,, lU.O No. 14010/8sl2lt2lch ll dated 0t.!2.2014, it was decided to ratify norms under Para 4.
l'' ldetails given below or as applied by the firm, whichever is less:
Yl_
ii
i il 
lQuantitYl I 
lRllowed
llItti rr 
I i 
11' lo.rr,.o.,o 
lt.zostc
i 
IRA may take appropriate action as per the decision of Norms Committee
嬬棚珊D.ド‖…
:艦υ
Om引晨my
'日
商
3■:、′NIR～lAL「く∪MAR
「
Q Π
b Ю
1/82Ю50/01065/AM15/1鷺λ測
:
: It was decided to defer the case for 05.02.2015 for comments of Department of
TORIES LIMITED   IALC4/2014

Committee
嬬棚珊D.ド‖…
:艦υ
Om引晨my
'日
商
3■:、′NIR～lAL「く∪MAR
「
Q Π
b Ю
1/82Ю50/01065/AM15/1鷺λ測
:
: It was decided to defer the case for 05.02.2015 for comments of Department of
TORIES LIMITED   IALC4/2014

ヘ
Decision : ln the light of written comments received from Department of Chemicals and Petrochemicals vide their
.O No.14010/3/2012/Ch‖
dated 22.12.2014′ ■was decided to raJfy norms under Para 4.7 of HBP vl as per detalls
below or as applied by the firm, whichever is less:
Export Product
Export
Quantity
S.No
lmport Product
Quantity Allowed
へnisole
)9.50%PURITY
l kg
1.
Anisole
PURITY 93%MINIMUM
1.10 kg
ゾ
may take appropriate action as per the decision of Norms Committee
PTりName:DIVIS
LABORATORIES LTD.,
Mcet No/Date:13/82-
ALC4/2014
RLA Filc
:09/24/040/00303/AM15/

## Case No.:66ノ13/82-ALC4/2014
19.12.2014
991HQFile:01/82/050/01069/AM15/
It was decided to defer the case for 05.02.2015 for comments of Department of

## Case No.:85/13/82‐ ALC4/2014
Pharmaceuticals
Lic.No/Date:0910060941  1Defer
11.09.2014
Date:05.02.2015
~F躍
…
…
α側4「
器
皿
L2~翻
F=胃
F
呻
QⅢ∝∝慇ν
“
0畑
"2晨my膨
淵
OЮ
“
∽ハmy 
田
鼎
α酬∞ω%2B鮨
ぉ,舵2∝5
mttν050畑072晨myl跳
危淵
OЮ0302/AM15/
:It was decided to defer the case for 05。02.20
Deuticals
102
[:lCaSeNo.:278/13/82-ALC4/2014
HQ File:01/82/050/01281/AM15/
IPar"Nalne:GLENMARK
IGENERICSLIMITED
M15/
Lic.No/Date:0310789050
11.09.2014
＾
υ
31
lDecision :Committee considered case as per agenda and in light of written comments received from
一
―
―
‐
‐
即
‐
Meet No/Date:13/82‐
ALC4/2014
19.12.2014
事鮒"
File:01/82/050/01088/AM15/

'harmaceuticals and in consultation with technical authority present in meeting, decided to ratifi norms under para
.7 of HBP as per details below or as applied by firm whichever is lower:-
Export product
Exp. Qty.
Sl.No.
Import items
Otv.a1lowed
Linezolid
l kg
1
Thioacetic Acid
1.43 kg
2.
Methylcnc Ch10ride/Methylene Dichloride/MDC
10.30 kg
R GlycidyI Butyrate
0 7178 kA
4.
Dimethyl Formamide
4.275k負
5。
Tetrahydrofuran
5.44 kg
6.
3,4-Difl uoronitrobenzene
0.9324 kg
7.
Methanol
7.75 kg
RA concerned may take further necessary action as per above decision of NC

## Case No.:197/13/82-ALC4/2014
Case No。:80/13/82‐ALC4/2014
円躙湯f留・「
訂躍F耐
1跳居瓶0/00140晨my 丁
町
applied
decided
he flrln,
per
liaseNo.:ilノ
13ノ82‐ALC4/2014
HQ File:01/82/050/01084/AM15/ 押趙鶏温
RLA File
:31/83/040/00138/AM15/
Lic.No/Date:3110064879
11.09.2014
n : In the light of earlier decision taken in meeting no. 8/82 dated 25.09.2014, it was
to ratiff norns under Para 4.7 of HBP v1 as per details given below or as
whichever is less:
by the fi
Export product
Export
Otv.
Sl.No.
Import items
Qty.
allowed
Orlistat Pellets 50%
l kg
1
Orlistat
0.505kg/kg
RA may take appropriate action as per the decision of Norms committee.
Lic.No/Date:3110064878
11.09.2014
Decision : In the light of earlier decision taken in meeting no. 8/82 dated 25.09.2014, it was deci
to ratifu norns under Para 4.7 of HBP vl as per details given below or as applied by the fi
whichever is less:
Export product
Export
Qtv.
Sl.No.
Import items
Qty.
allowed
Orlistat Pcllets 50%
l kg
1
Orlistat
0.505kg/kg
may take appropriate action as per the decision of Norms committee.
則ド
QⅢ∝
O1/82鰤¨ 0晨my厩

:
Export product
Export
Qtv.
Sl.No.
Import items
Qty.
allowed
Orlistat Pcllets 50%
l kg
1
Orlistat
0.505kg/kg
may take appropriate action as per the decision of Norms committee.
則ド
QⅢ∝
O1/82鰤¨ 0晨my厩

（
　
　
　
　
一
ParりName:SRIAM LABS
PRIVATE LIMITED
Meet No/Date:13/82-
ALC4/2014
19.12.2014
Pharmaceuticals
「
~~~i3驀
=玉
肩
「]藁″Iラ蔑F百三更】Й云預7
Paty Name:ALKYL AMINES
HEMICALS LTD
|
HQ File :0U82/050/01197/AMt5/ lru-a Fite
Lic.No/Date:0310789134
12.09.2014
Defer Date:
:03/94/040/00002/AM15/
Decision : ln the light of written comments received from Department of Chemicals and Petrochemicals vide their
O No.14010/85/2012/Ch‖
dated 13.06.2013′
性was decided to raufy nOrms under Para 4.7 of HBP vl as per
ls given below or as applied by the firm, whichever is less:
Export Product
Export
Quantity
S.No
lmport Product
Quantity
Allowed
2ETHYLHEXYLAMINE
l kg
1.
2ETHYLHEXANOL
1.06 kg
may take appropriate action as per the decision of Norms Committee
婚‖…
:09/24/040/00296/AM15/
lDecision : It was decided to defer the case for 05.02.2015 for comments of Department of
iPharmaceuticals.
Mect No/Date:13/82‐
ALC4/2014
19.12.2014
HQ File:01/82/050/01280/AM15/
RLA File
:03/94/040/00562/AM15/
町
IDeferDate:
to
Lic.No/Date:0310789113
Decision :In the light of earlier decision taken by NC in its lll82 meeting dated 26.11.2014 and it was decided
rati$t norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:-
Export product
Exp.oty.
Sl.No.
Import items
Qty.

s lll82 meeting dated 26.11.2014 and it was decided
rati$t norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:-
Export product
Exp.oty.
Sl.No.
Import items
Qty. allowed
Ezetimibe
l Kg.
1
Dimethyl Amino Pyridine
0.09 kg
2.
N,N¨ DimethyI Fomamide
1.52 kg /
S(+)4-Phenyl-2-OxazoHdinone
0.93 kg
4.
Borane Dimethvl Sulflde
0.424 kg
(R)-2-Methyl-CB S-Oxazaborolidine
(1 M Solution in Toluene)
0.057 kg
6.
N,0‐ Bis(Trimethylsilyl)Acetamide
1.07 kg
7.
Tetrahydrofuran
0.074 kg
concemed may take nlrther necessary action as per above decision ofNC.
110
per
33
No.:72/13/82‐ALC4/2014
File:01/82/050/01075/AM15/
Flle
10060939
1.092014
|
File:01/82/050/01071/AM15/IRLA Flle
12.09.2014
No.:277ノ13/82‐ALC4/2014
12.09.2014
ド柵
:E涸念K~鵬ドル

ICaseNo.:65/13/82-ALC4/2014  1:il‖ さ:[器
営tPRIVATE
Hl「Q Hb Юν
"Ю
mЮ Ю68/Amyl脱
淵
OЮ∞
“
晨my
ALC4/2014
19.12.2014
Pharmaceuticals
Pa■y NamelMYLAN
LABORATORIES LIMITED
Defer
Date:05.02.2015
Status:Approved
ALC4/2014
19.12.2014
陽ち糀
υ∞Ю9晨My l蹴
鼎
α酬∞ω 蜘
Lic.No/Date:0910060955
12.09.2014
ICase No.:37/13/82-ALC4/2014
:01/82/050/01040/AM15/
Decision : Committee considered'
Department of Pharmaceuticals v
consultation with technical autho
as per details given below or as ap
the case as per agenda and in light of written comments received i
'ide their OM No.35011/752/2014-PI(Norms)dated 09.o9.2014 ar
百ty presentin meeJng′
decided to ratify norms under para 4.7 of
,p‖ed by firm whicheverisiower:―
Export product
恥
Ｑ
ｔ
ｙ
．
SI.No.
lmport items
Qty.AIlowed
Kg/kq
Lamivudine (Cyclohexyl
Ester Route)
l kg
1
Cyclohexyl Ester
2.19
2

ed to ratify norms under para 4.7 of
,p‖ed by firm whicheverisiower:―
Export product
恥
Ｑ
ｔ
ｙ
．
SI.No.
lmport items
Qty.AIlowed
Kg/kq
Lamivudine (Cyclohexyl
Ester Route)
l kg
1
Cyclohexyl Ester
2.19
2
Sodium Borohydride
0.48
3
Dipotassium Hydrogen
Phosphate
1.9849
4
Methanol
0.167
5
Toluene
0.200
6
Triethylamine
0.575
7
Isopropyl Alcohol
1.427
RA concerned may take further necessary action as
necessary
per above decision of NC.
「
~F‐雨而蘭こ
ICaseNo.:36ノ
13ノ82-ALC4/2014   11ζ
ttli)Iきli」:11)早:L
「QⅢッ別
5Ψ“
9ハmy
lDecislom::n the iight of wr‖ lon rnmmontc r●r●市●H frnn檸
:『Tttt鴇儒    |
||::::lI::::|::::::::I::::I::::I:I::::::::::::::::::::::|:::II:::::::I:::::::] |
||      | |
Export Product
ExpOrt
Qty.
S.No
lmport Product
Quantity
Allowed
PPPBP or 2-Phenyl-3,3 -bis(4-
hydroxyphenyl)phthal im ide
l kg
1.
Phenol
1.145 kg
No/Date:13/82‐
112

may take appropriate action as per the decision of Norms Committee
ず
QⅢ∝側認“剛
0“ハmy
:It was decided to defer the case for 05.02.2015 for comments of Department of
uticals
冨
~
蹴器醐∞ω
%2B為
5Ю2劉5
RLA File
:09/24/040/00291/AM15/

## Case No.:70/13/82‐ ALC4ノ2014
:震ぷ泄露
fК需性デ肥~開
∬"
H5「QⅢ∝m慇2Ю50/O1073/Amy指
淵
:υ∞引0ハmy l蹴
鼎
α酬∞ω%4需
蕊
蔦
M15/    112.09.2014
ision : It was decided to defer the case for 05 .02.20 1 5 for comments of Department of
uticals

## Case No.:25/13ノ82-ALC4/2014
丁
1蹴鼎α“Ю
・兜∞
Defer
Date:05.02.2015
晰
   m雨
耐the Flrm to f面鍋followi¨m酬
…
;Copy of valid Drug Manufacturing License for the export product; and
lCopy of Master Batch Formula duly certified by Quality Control lncharge.
l
iThe case was deferred for 05.02.2015
{
ICaseNo.:28/13/82…
ALC4/2014
|
Paty NamelTITAN
LABORATORIES PVT.LTD.
薄
∬
“
般‐~
.02.2015
Lic.No/Date:0310789099
12.09.2014
H8ドQⅢ∝∝慇2Ю剛∝r7ハm夕
間
蕊
蕊
薦
y―
1悧器
α
“
Ю霧剣η
Decision : [t was decided to defer the case for 05.02.2015 for comments of Department of
Pharmaceuticals
Decision : Committee considered the case as per agenda and in light of written comments received from
Department of Pharmaceuticals vide their OM No. 35O1L1292/2014-Pl(Norms) dated November 2014 and
in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of ヽ
一
―
―
一
― 一
コ
ICase No。:174/13/82‐ ALC4/2014
Paty NameiCIPLA LIMITED.
Meet No/Date:13/82‐
19.12.2014
No.:61/13/82‐ALC4ノ2014
Name:SHODHANA
TORIES LTD

ting, decided to ratify norms under para 4.7 of ヽ
一
―
―
一
― 一
コ
ICase No。:174/13/82‐ ALC4/2014
Paty NameiCIPLA LIMITED.
Meet No/Date:13/82‐
19.12.2014
No.:61/13/82‐ALC4ノ2014
Name:SHODHANA
TORIES LTD

as per details given below or as applied by firm whichever is lower:-
S.NO.
Export ltems
lmport recommended per Tablets (ety in mg1
Tenofovir
Disoproxil
Fumarate
Emtricitabinc
Efavirenz
Lamuvdine
1
Tcnofovir I)isOprOxil Fumarate 300mg/
Tabicts
306.0
NIL
N:L
NIL
2
Tenofovir Disoproxil Fumarate 300mg +
Emtricitabine 20Omg Tablets
306.0
204.0
NIL
NIL
3
Larnivudinc 300 mg+Tenofovir
DisoprOxil Fumaratc 300mg Tabiets
306.0
NIL
NIL
306.0
4
Efavirenz 600 mg+[mlligitabine 200mg +
Tenofovir Disoproxil Fumarate 300mg,
Tablets
306.0
204.0
612.0
NIL
5
Efavlrenz 600mg+Tenofovir DisopЮxil~
Fumarate300mg+Emtricitabine 200mg,
Tablets
306.0
204.0
612.0
NIL
6
Tenofovir Disoproxil fumarate 300mg
+Lamivudine 300mg + Efavirenz 600ms
306.0
NIL
612.0
306.0
tBl
Tenofovir
Fumarate
Sl.No.
lmport items
Qty reCommended
kg/kg
1.
9-[2-(Phosphonyl Methoxy) Propyl] Adenine (pMpA)
0.80
2.
Chloromethyl Isopropyl Carbonate
1.3527
3.
N-Methyl 2-Pyrrolidone
1.4878
4.
Fumaric Acid
0.26
5.
Methylene Dichloride
6.70
6
Isopropyl Acetate
2.35
CI
三mtricr
SI.No.
1.
Qty recommended
kdke
『Tttl榔写臨蘊甕蘊薫瓢薦
Sodium Borohydride
Dipotassium Hydrogen phosphate
Qサrecommended
kg/kg
8象:島認鯉麗
:造ξ
3鳥孵剛:H肌Ⅷ」
篇
棚
鸞
f
36
ヽ
lmport items
2.50
2.
0.51
3.
2.075
Si.No.
lmport items
1.
2.19

ecommended
kdke
『Tttl榔写臨蘊甕蘊薫瓢薦
Sodium Borohydride
Dipotassium Hydrogen phosphate
Qサrecommended
kg/kg
8象:島認鯉麗
:造ξ
3鳥孵剛:H肌Ⅷ」
篇
棚
鸞
f
36
ヽ
lmport items
2.50
2.
0.51
3.
2.075
Si.No.
lmport items
1.
2.19

DIPOTASSIUM HYDROGEN PHOSPHATE
Qty reCOmmended
kg/kg
(S)-5 -Chloro-alpha-(Cyclopropylethynyl)-2-Amino-alpha-
(Trifluoromethyl) Benzenemethanol (EV-l compound)
concerned may take further necessary action as per above decision of NC
onsultation with technical authority present in meeting, decided to ratify norms under para 4.7 of H
s per details given below or as applied by firm whichever is lower:-
Export product
Exp.
Otv.
Sl.No.
Import items
Qty.Allowed
Kノkg
ENTECAVIR
MONOHYDRATE
l kg
1
Dibenzyloxy Guanine (2-amino-
1,9-Dihydro-g I I S,3R,4S)-4-
(benryloxy)-3-
(benzyloxymethyl)-
2-Methylenecyclopentyll-6H-
purin-6-one)
1.928
打グiやIユNo■93/13/82‐ALC4/201'~|:高Na高まЁ｀ALiEC LABS
一
Ｍ
0
喩
:冊
H
1臨
r嘲
|
糖調笏
鸞「
Te
37
eet No/Date:13/82-
吻
鷲黒纂
1‖
ヘ
2.
SODIUM BOROHYDRIDE
0.48
3.
1.9849
4.
SALICYLIC ACID
0.79
5.
TRIETHYLAMINE
0.575
6
ETHYL ACETATE
1.795
SI.No.
lmport items
1.
0。987
2.
n‐HEPTANE
3.653
No/Date:13/82¨
汗
QⅢ∝側授肪剛
鵬晨Ⅲy
: Committee considered the case as per agenda and in light of written comments received from
No.:186/13/82‐ ALC4/2014
Name:CIPLA LIMITED.
File:01/82/050/01189/AL〔15/IRLA File
No/Date:13/82-
14
14

Ⅲy
: Committee considered the case as per agenda and in light of written comments received from
No.:186/13/82‐ ALC4/2014
Name:CIPLA LIMITED.
File:01/82/050/01189/AL〔15/IRLA File
No/Date:13/82-
14
14

PVToLTD.
匿渕繭耐靡
、
123
:It was decided to deferthe case for 05.02.2015 for comments of Department of
諄‖…
HaffimAFit.
Decision : It was decided to defer the case for 05.02.2015 for comments of Department of C&PC.
P釘りName:INDO AMINES
LIMITED
HQ File:01/82/050/01193/AM15/RLA File
:03/94/040/00444/AM15/
Decision:in the light of written comments received from Department of Chemica:s and Petrochemica:s vide their
U.O No.14010/81/2011/Ch il dated 05.11.2014′
deta‖ s given below or as applied by the firm′
whichever is less:
Export Product
Export
Qtv.
S.No
lmport Product
Quantity
Allowed
DI‐ISOBUTYL CARBINOL
l kg
1.
DI‐ISOBUTYL KETONE
1.048 kg
RA may take appropriate action as per the decision of Norms Committee
Paty Name:RELIANCE
INDUSTRIES LTD.
Lic.No/Date:0310789322
17.09.2014
124
Div。).
Pa■y Name:BEST VALUE
臓‖都脇~
-
ALC4/2014
19.12.2014
「
Q Ⅲe Юν82Ю5α∝りαAM夕
1鷺λ鵬
OЮOЯ νAmy
Lic.No/Date:0310789281
16.09.2014

## Case No.:39/13ノ82‐ALC4/2014
Meet No/Date:13/82¨
19.12.2014

## Case No.:188ノ13ノ82‐ALC4/2014
Paty Name:DELTA FTNOCHEM
PVT.LTD
ICase No.:190ノ13/82‐ALC4ノ2014
Mect No/Date:13/82-
19.12.2014
Lic.No/Date:0310789419  1Defer Date:
18.09.2014
Case No。:101/13/82‐ ALC4/2014
Meet No/Date:13/82‐
Casc No.:18/13/82-ALC4/2014
CHEM PVT.LTD.
38
Ｆ
Ｌ
Ｆ
Ｉ
4
File:01/82/050/01042/AM15/IRLA Flle

「QⅢ∝∝おν
“
OЮ Ю創ハⅦ夕
障ち淵Oρm52/A蔦
~丁
1悧鼎
“
4∞価°
BttЬ5Ю2節I
IDecおlon:It was decided to defer the case for 12.06.2014 for comments of Department of C&PC.
Pa●y Name:FINE ORGANIC
INDUSTRIES PVT LTD
…
ision : ln the light of written comments received from Department of Chemicals and Petrochemicals vide their
.O No.14010/129/2011/Ch‖ dated 26.10.2013′ it was decided to ratify norms under Para 4.7 of HBP vl as per
given below or as applied by the firm, whichever is less:
Export Product
Export
Quantity
S.No
lmport Product
Quantity
Allowed
3LYCERYL OLEATE
l kg
1.
GLYCERINE
0.272 kg
2.
OLEIC ACID
0.832 kg
lRA may take appropriate action as per the decision of Norms Committee.
1悧鼎α“Ю
7T佃雷面
27
「
ICaSel。
.:57ノ13/82-ALi4/2014
IMeet No/Date:13/82‐
1ALC4l20l4
le.t2.2ot4
Status:Case
Deferred
鯰8P而繭両面闘蕊蕊Iw
翻辮“Ю
391246
6""iri", r It r"* d""id"d t" d"f*
I
|C&PC(PC Divi).
the case for 12.06.2014 for comments of Department of
129
|
rthe case for 12.06.2014 for comments ofDepartment of
ICaseNo.:16/13ノ
82-AL(C4/2014
汗::「
醜
鰤剛m9晨m7既
危鵬0叩
"ハ
団
;

d t" d"f*
I
|C&PC(PC Divi).
the case for 12.06.2014 for comments of Department of
129
|
rthe case for 12.06.2014 for comments ofDepartment of
ICaseNo.:16/13ノ
82-AL(C4/2014
汗::「
醜
鰤剛m9晨m7既
危鵬0叩
"ハ
団
; l" th" Cht "f ;ritt"";rr""tt-"*ir"A 
from o"prrtr*nt of Cffii*[."d p"tr*fr"rrcrft ria" in"i,
No.14010/76/2010/Ch‖
dated 12 06 2013′
given below or as applied by the firm, whichever is less:
Export Product
Export
Quantity
S.No
lmport Product
Quanttty
Allowed
¨AMINO l,2,4 TRIAZOLE
l kg
1.
FORⅣIIC ACID
(850/O Puritv)
1.350 kg
2.
HYDRAZINE HYDRATE
1.252 kg  ッ
//
HQ File:01/82/050/01062/AM15/ RLA File
|:05/23/040/00276/AM15/
Lic.No/Date:0510391245
19.09。2014
39
ALC4/2014
19.12.2014
No.:59/13/82‐ALC4/2014
Name:HELLO PAINTS (P)
No/Date:13/82-
諜
thl
…
れ
い
tJ (

## Case No.:24/13/82‐ ALC4/2014
ハ
諄湧"冨枷
Id
賠λ詰
OЮtt1/AMW I翻
器
α∞Ю
・
%"
謳
|
1133児50/01027/AM15/
ision :In the light of written comments received from Department of Chemicals and Petrochemicals
ide their U.O No.14010/5/2012/Ch Ⅱ dated 22.12.2014,it was decided to ratitt n0111lS under Para 4.7 of
HBP vl as per details given below or as applied by the firm, whichever is less:
Export Product
Export
Quantity
S.No
lmport Product
Quantity
Allowed
「EXTILE AUXILLIARIES:
ROSSACID/ROSSACID― N/
ROSSACID―PD/C/SHAQ― F/
3LITTER LIQUID/ECO ACID
l kg
1.
SATURATED ACYCLIC
ORGANIC ACID(METHANE
CARBOXYLIC ACID/
GLACIAL ACETIC ACID)
0.503 kg
2.
MONO CARBOXYLIC ACID
(METHANOIC ACID)
0.200 kg
3.
HDPE GRANULES
(PACKING MATERIAL)
As per
packing
policy
iDecision : It was decided to defer the case for 12.06.2014 for comments of Department of C&PC.

## Case No.:249/13/82‐ ALC4/2014
ParりName:YASHO
INDUSTRIES PVT.LTD.
ALC4/2014
19.12.2014
HQ File:01/82/050/01252/AM15/
CEFIXIME USP
/BP/1P/EP
Powder
7-AVCA (7-Amino-3 -Vinyl-
Dimethyl Acetamide
Methylene Chloride
Meet No/Date:13/82‐
No。:58/13/82‐ALC4/2014
Name:DHANUKA
No/Date:13/82-
TORIES LTD.
: In the light of written comments received from Department of Pharmaceuticals vide their OM No.
11349/2014-PI(Norms) dated 28.11.2014, it was decided to rati$ the norms under Para 4.7 of HBP vl as
given below or as applied by the firm, whichever is less:
給

A
'I 
IRA may take appropriate action as per the decision of Norms Committee.
Paty Name:DHANUKA
ILABORATORIES LTD.
一
ヨ
冨
~
ず
QⅢ錮И
ttmttAⅢy  篇~    B鳶お
5回5
[liIIlillilll:姦
要
1西E百¬お
=こ
こ戻募¬正蕗萬
&暴要二姦
1lσ3.o2.2015 for comments ofDepartment of
Meet No/Date:13/82-
Ｆ
‐
‐
‐
３
６
‐
‐
「QⅢ∝側郷剛鵬ハmy
05008薫
漁
「
´―
ヽ
「
二
lParry Name:CONSTECH
leNrrnrzusEs PVT.LTD.
RLA File
:05/23/040/00282/AM15/
:Decおion:It was decided to defer the case for 05.02.2015 for comments ofDepartment ofC&PC.
Pharmaceuticals
~~liCaseNo.:148/13ノ
82‐ ALC4ノ2014
Paty Name:MICRO LABS LTD
139汗Q Π
L Ю
l慇2Ю50/01151/AM15/1鷺会理,
::07/24/040/00208/AM15/
o*irir" : Ii *i A""ia"d to defer tfre iase fo, OIOZZ1IS for "offi""tr ;f D"prrfi"rt;f
Pharmaceuticals
隔
―
―
Meet No/Date:13/82-
ALC4/2014
19.12.2014
町
~|
「的
Namα RI「N::TM
1西F
e No.:30/13/82¨ ALC4ノ2014
41
B5汗QⅢ∝∝慇705υ∝020晨myl境
角革υOり。5晨my
|
: It was decided to defer the case for 05.02.2015 for comments of Department of C&PC.
No.:74ノ13/82-ALC4/2014
No/Date:13/82‐
14
19.12.2014

o.:30/13/82¨ ALC4ノ2014
41
B5汗QⅢ∝∝慇705υ∝020晨myl境
角革υOり。5晨my
|
: It was decided to defer the case for 05.02.2015 for comments of Department of C&PC.
No.:74ノ13/82-ALC4/2014
No/Date:13/82‐
14
19.12.2014

],re.tz.zott
||;認l:棚
∫
ecided to defer the case for 05.02.2015 for comments ofDepartment of
:ln the light of written comments received from Department of Chemicals and Petrochemicals vide their
No.14010/151/2011/Ch:!dated 05.12.2014′
s given below or as applied by the firm, whichever is less:
Export Product
Export
Qty.
S.No
lmport Product
Quantity
Allowed
Ethyl 3 Ethoxy Propionate
3 Ethoxy Ethyl Ester Ethoxy
Propionate
l kg
1.
Propionic Acid
0.564kg
may take appropriate action as per the decision of Norms Committee
F霞¨3/82-ALψ田   
諄
鵬星泥50Ю Ю
"ハmy 
膨
糀
OЮ∽ηttm夕 1劉
鼎
α囲∝%"8雷
面
臨
:
: It was decided to remind the firm to furnish following technical details:
Actual content of Digoxin in imported digitalis Lanata Leares supported by COA from foreigner
supporter
Assay of Export Product
Past production vis-a-vis Actual consumption of leaves for the last 3years duly certified by
諄湧"|
「QⅢ∝側ツ“剛“
0ハmy
搬R
「
眈
…
3/82‐ ALα 側
4胃
続
嚇
耐
臓
‖
…
汗
Q田∝mttν
“
0畑
“
″AM夕
陽
糀
OЮ曖
ハmy l蹴
鼎
α07101∞70 BttL5″
2∝5
■£朧認碇
1露TT郡綸雛
Export Product
Export
Qtv.
SI.No.
lmport items
Qty. allowed
Clomipramine Hcl
l Kg.
1.
1 Bromo 3 Chloro Propane
0.85 kg
2.
3 Chloro lminodibenzyl
0.91 kg
RA may take appropriate action as per the decision of Norms Committee
Case No。:47ノ13/82-ALC4/2014
ParりName:ALCHEM
INTERNATIONAL LTD.
Lic.No/Date:0510391347
2509.2014
ハ
File:01/82/050/01033/AM15/

kg
RA may take appropriate action as per the decision of Norms Committee
Case No。:47ノ13/82-ALC4/2014
ParりName:ALCHEM
INTERNATIONAL LTD.
Lic.No/Date:0510391347
2509.2014
ハ
File:01/82/050/01033/AM15/

ll~
Central Excise Authorities.
The case was deferred for 05.02.2015.
諄‖…
ずい¨ 鰤
0/Ol161ハm夕 
蕊
1蹴鼎α“Ю
・%η
B鳶1502m5
Ｆ
Ｌ
Ｆ
‐
INTERNATIONAL PVT.LTD. 19.12.2014
1跳λ
ttν0052″Amy
1蹴me“Ю
・%・需蕊蔦
Patty Name:BDR
PHARMACEUTICALS
Pa“y Name:PROLIFE
INDUSTRIES LIMITED
Mcet No/Date:13/82‐
ALC4/2014
pattN∝2my82‐ ALC″2∝4
|
1腑"
ド
QⅢ∝剛
2Ю50/Ol∽3ハmy臨
蹴
υ剛24/Amy l躙
鼎
α08101"“9 BttL5Ю
2節百
Pharmaceuticals
ICase No.:159/13/82‐ ALC4ノ2014
F甕霊
:I~~
|

## Case No.:21/13/82-ALC4/2014
HQ File:01/82/050/01024/AM15/
RLA File
:05/23/040/00260/AM15/
甲
ド‖… 町
~
Pharmaceuticals
43
Meet No/Date:13/82¨
:ALC4/2014
119.12.2014
Lic.No/Date:0310789690
26.09.2014
Decision :Committee considered case as per agenda and in light of earlier decision taken in meeting No. 8/82 held on
25.09.2014 and in consultation with technical authority present in meeting, decided to ratify norms under para4.7 of
HBP as per details below or as applied by firm whichever is lower:-
Export product
Exp.
Qty.
Sl.No.
Import items
Qty. allowed
Febuxostat
l Kg.
1
2 - (3 -Cy ano -4-(2 - Methy lpropoxy) Phenyl)-4 -
Methyl-5-Thiazolecarboxylic Acid ethvl Ester
1.512 kgご
concerned may take further
action as per above decision of NC
No/Date:13/82¨
4
No。:156/13/82… ALC4/2014
Name:ENALTEC LABS
.LTD.
Ｔ
Ｎ
Ａ
Ｌ
Ｊ
Ｕ
Ｂ
‐
」
Ｔ
Ｄ
α
【
ｂ
Ｎ
ａ
ｍ
順
: It was decided to defer the case for 05.02-2015 for comments of Department of
File:01/82/050/01159/AM15/ RLA File
148

6/13/82… ALC4/2014
Name:ENALTEC LABS
.LTD.
Ｔ
Ｎ
Ａ
Ｌ
Ｊ
Ｕ
Ｂ
‐
」
Ｔ
Ｄ
α
【
ｂ
Ｎ
ａ
ｍ
順
: It was decided to defer the case for 05.02-2015 for comments of Department of
File:01/82/050/01159/AM15/ RLA File
148

ハ
HQ Ⅲ∝m慇2肪0畑051/Amy鵬
蹴
OЮ舵
"ハmy l劉
辮
傷Ю391375
悧器α“Ю郷8 BttL5Ю
2劉5
Mcet No/Date:13/82-
ALC4/2014
19.12.2014
Ｆ
Ｌ
Ｆ
Ｉ
HQ File:01/82/050/01055/AM15/
RLA File
:05/24/040/00231/AM15/
iDecision : It was decided to defer the case for 05.02.2015 for comments of Department of C&PC.
Meet No/Date:13/82-
ALC4/2014
19.12.2014
蔦~岡
F而
]
悧器α“Ю郷9 BttL5Ю
2劉5
諄‖…
Defer Date:
Decision : Committee considered the case as per agenda and in light of written comments received from
Department of Pharmaceuticals vide their OM No. 35011118312014-PI(Norms) dated 12.11.2014 and in
consultation with technical authority present in meeting, decided to ratifo norrns under para 4.7 of HBP as
per details below or as applied by firm whichever is lower:-
Export product
Exp.
Qty.
SI.No.
lmport items
Qty.
AIlowed
Kgノkq
Rosuvastatin Calcium
lkg
1
Tert-butyl-2-(4R,6S)-6-((E)-2-(4 (-
(4-fl uorophenyl)-6-isopropyl -2-IN-
methyl (methylsulphonyl) aminol
pyrimidin-5-yl) vinyl)-2,2-dimethyl-
1,3 -dioxane-4-yl) acetate
1.425
2
Methanol
2.53
3
Tert-butyl methyl ether (MTBE)
0.79
Case No。:50ノ13/82‐ALC4/2014

## Case No.:51ノ13/82¨ALC4/2014
Parfy Name:PAYAL
PETROCHEM PRIVATE

## Case No.:14ノ13/82‐ALC4/2014
ParりName:PIINDUSTRIES
LTD.,
lHq rite :0 t /82/050/0to t7 I AMl 5 I
udラ理翼:織炉く
J烏再発
lhi
lLic.No/Date : 13 1 0047 642
ICaseNooi4i/13/82-ALC4/2014
Party Name:MOREPEN
LABORATORIES LTD.,
Ы
「QⅢ∝側爾“∽鰤
4ハmy囲
Name:PAYAL
No/Date:13/82-
14
File:01/82/050/01053/AM15/IRLA File
No.:52/13/82-ALC4/2014

,6092“ 4
Decision : In the light of written comments received from Petrochemical Division
icals and Pctrochenlicals vide their U.O No. 14012/4/2011-50 Ch. II dated
ided to ratifu norms under Para 4.7 of HBP vl as per details given below or as
of Department of
24.07.2014, it was
applied by the firm,
ン
Import items
Qty.Allowed
kgs.
Ethyl- 4-Chloro-2 Fluoro-
5 [( { [isopropyl(methyl)
aminolsulfonyl ) amino)
carbonyl ] phenylcarbamate
(PCM)
2-Chloro-4-Fluoro Toluene
Methvl Iso Propyl Amine
NOBLYST(R)P8086(Pt/C Catalyst
(+1%PT+2%V/C,64%H20))or
Catalyst(+0.8%PT-0.30/O MoC
SulfurylChloride
ICaseNo。:117/13/82‐ ALC4ノ2014
|
HQ Fne:01/82/050/01120/AM15/
ParりName:R L FINE CHEM
RLA File
:07/24/040/00229/AM15/
日薫y~
1用器α剛∝“η
2PebD犯
Decision : ln the light of earlier decision taken in meeting no. tO/82 dated 12.11.2014, it was decided to ratify
norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
Export product
Exp.
Qtv.
S:.No.
lmport items
Qty.

82 dated 12.11.2014, it was decided to ratify
norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
Export product
Exp.
Qtv.
S:.No.
lmport items
Qty. allowed
Methane Su!fonate of 10′ 11′ D:hydro― N′ N
Betatnmethy15H Benzo(B′ F)Azepine-5
Propanam:ne
l kg
1 Bromo 3 Chloro 2
Methyl Propane
0.72 kg
lminodibenzyl
0.74 kg
ase No.:118/13/82-ALC4/2014
目
―
―
:13/82‐
∝開ハmy開麒獅蔦
LicNo/Dtte:0710106771
126.09.2014
IDeferDate:
155
Decision : ln the light of earlier decision taken in meeting no. Ll82 dated 10.04.2014, it was decided to ratify
under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
Export product
Exp.
Otv.
Sl.No.
Import items
Qty. allowed
Cyclobenzaprine Hcl
l kg
1
1 Bromo 3 Chloro Propane
0.95 kg
2.
Tetra Hvdro Furan
l.00 kg
3.
Acetone
Not allowed as not
shown in process
45
Export product
町
韓
Si.No.
l kg
1
0.615
2
0.346
り
，
0.008
4
Methanol
2.274
Toluene
0.743
6
Ethvl Chloroformate
0.370
7
0.715
1154

## Case No.:49/13/82‐ ALC4/2014
Party Name:SENTISS PHARMA lMeet No/Da te:13 I g2-
ALC4/2014
19.12.2014
PaロッName:SANO MEDICAL  IMeet No/Date:13/82-
::Ⅲ
∝∝慇ν
“γ
∝博3ハmyl鵬
非0響"叫m夕 1棚
鼎
α
“
Ю翻%PebD配
:It was decided to deferthe case for 05.02.2015 for corlllnents ofDepartment of
ParりNamcAVA CHEMICALS IMcetNo/Date:13ノ82‐
ALC4/2014
19.12.2014
lslon:!n the light of written comments received from Department of Chemicals and Petrochemica:s vide their
No.14010/157/2011/Ch‖
dated 25.11.2014′ たwas decided to ratify norms under Para 4.7 of HBP vl as per
‖sg:ven be!ow oras app!ied by the nrm,whichever is less:
Export Product
ExpOrt
Qtv.
S.No
lmport Product
Quantity
Allowed
EDTA FERRIC SODIUM Fe
〕ontent 13%(十/_0.5)
l kg
1.
ETHYLENE DIAMINE
TETRA ACETIC ACID
(EDTA)
0.730 kg
RA may take appropriate action as per the decision of Norms Committee
P釘りName:DELTA FINOCHEM
Lic.No/Date:0310789867  1Defer
Date:05.02.2015
:It was dccided to defer the case for 05.02.2015 for corllments OfDepartment ofC&PC.
Paty Namc:HINDUSTAN
Mcet No/Date:13/82-
POLYAMIDES&FIBRES    IALC4/2014
1躙鼎α“剛
""4 BttL5ω 2∝5
~B誌
お
5¨ 5
:It was decided to deferthe case for 05.02.2015 for conlments OfDepartment of C&Pc。
ParりName:KRISHNA
ANTIOXIDANTS PVT.LTD.
Meet No/Date:13/82‐
ALC4/2014

## Case No.:19/13ノ82‐ALC4/2014

## Case No. : 1 80 tl3 /82- ALC4t20l4

## Case No.:187/13/82-ALC4ノ2014
ICase No.:178/13/82‐ ALC4/2014

## Case No.:177/13/82-ALC4/2014
19.12.2014
鮮
;l-i".NofOiteO: t OZSeA+e
juq rite :01/82t050/0fi 80/AIvily IRLA File
File :01 t82/050/0 I 052/AM I 5/ IRLA File
:It was decided to deferthe case for 05.02.2015 for cOlllllnentS ofDepartment ofC&PC.
4
Ｆ
Ｌ
Ｆ
‐
守
QⅢ釧郷¨ 2晨my囮
.LTD。,
IMeet No/Date:13/82‐
.LTD.
ALC4/2014
19.12.2014
File:01/82/050/01190/AM15/IRLA File
File:01/82/050/OH81/AM15/RLA File
46

162
| :03 I 9 4 I 040 / 005 86/,{M I s/
130.09.2014
師
bbII
Party Name:MALLADI DRUGS lMeet No/Date:13182-
ALC4/2014
19.12.2014
HQ Fit:01/82/050/01085/AM15/1RLA File
Lic.No/Date:04101595H  IDefer
Date:05.02.2015
icals.
Party Name:TATVA CHINTAN lMeet No/Dat e:13 /82-
PHARMA CHEM PVT LTD   
‐ALC4/2014
HQ File:01/82/050/01018/AM15/
Decision:It was decided tO dcferthe case for 05.02.2015 for corrllnents ofDepartment ofC&PC.
: It was decided to defer the case for 05.02.2015 for comments of Oepartment of
:euticals.
:It was decided to defer the case for 05.02.2015 for collrllnents ofDepartment ofC&PC.
Decision:It was decidcd tO defer the case for 05.02.2015 for cOmments OfDepartment of
icals.
膨
棚
OЮmaハmy~~1悧
鼎
α
“
Ю餌∞%BttЪ
5Ю2期:
F眠¨3/82‐AL"田ド……剛Ⅲ
I
%4ドQⅢ∝mおν
“
剛Bttmy璧
2おOЮ∝
“
ハmy 
貯∬鼎
α知∞mB胤
5Ю2期5
獅耐理
『
駆~
_a15/ 卜
IIり輛α“Ю
7T"5B鮨
1,∽2∝5

## Case No.:15/13/82‐ ALC4/2014

## Case No.:128/13/82‐ ALC4/2014

## Case No.:92ノ13/82-ALC4/2014
Paty Namc:NECTAR
LIFESCIENCES LIMITED,
: ln the light of written comments received from Department of Pharmaceuticals vide their OM No.
L/L3/2o!4-Pl(Norms) dated 24.09.2O!4, it was decided to ratiry norms under para 4.7 of HBp v1 as per details
r below or as applied by the firm, whichever is less:
:
PHARMACEUTICALS
哺
7/13/82‐AL¨41椰叩町孵¨ 貯
F rle :01 /82/050/0 I 080/AM I 5/ IRLA File

Item of Export
Quantity
S′No
Item of lmport
Quantity
allowed ke/ks
Cefixime Trihydrate
l kg
1.
GCLE
1.507
2.
Sodium bromide
0.3628
3.
Tri Phenyl Phosphine
0.820
4.
DMF
1.869
5.
Methylene Chloride
1.546
6.
Formaldehyde
1.H8
7
Methanol
5.117
8
Phenol
0.3808
9
Butyl Acetate
0302
10
Eno Carbon
0.100
11
Acetone
0.793
12
EDTA
0.0182
13
MICA Ester
0.820
14
Acetic Acid
0.030
15
Triethylamine (TEA)
0.2717
16
EthylAcetate
0.376
PTりName:llNICHEM
LABORATORIES LIMITED
Fご
面語焉罰面扇面冨し両ol万
門
般肪剛∵
4ハm夕
卜
F∬器α“Ю
・剛6B鮨ぉ
,舵2m5
Meet No/Date:13/82-
ALC4/2014
19.12.2014
Case
Deferred
B島,021i5
:It was decided to deferthe case for 05。02.2015 for comments of Department of
Pharmaceuticals.
~FttTttT憂面而
「
U
CROPSCIENCE LIMITED
:03/94/040/00544/AM15/
:It was decided to deferthe case for 05.02.2015
icals.

## Case No.:176ノ13/82‐ALC4/2014
[i:::il:::li::;:1:i::~
RLA File
i03/94/040/00361/AM15/
ALC4/2014
19.12.2014
HQ File:01/82/050/01179/AM15/
lt was decided to defer the case for 05.02.2015 for comments of Department of
u配兄轟話駐鬼薄
48
Name:BAYER
No/Date:13/82‐
No/Date:13/82‐
]鄭
0

ヘ
Pharlnaceuticals.
::1~~~~~~~――
―
-1-――
~~~~~――
―
i:――
~~~~~――
-1-1:~~‐ ~~~‐‐
―
―
―
‐
‐
‐
―
‐
‐
―
‐
―
‐
"‐‐
‐
―
―
‐
―
―
‐
―
―
―
―
―
‐
―
‐
|
ICase No。:13/13ノ82-ALC4/2014
HQ File:01/82/050/01016/AM15/
Pa■y Name:FINE CURE
PHARMACEUTICALS LTD.
RLA File
:08/24/040/00233/AM15/
Mcet No/Date:13/82‐
ALC4/2014
19。12.2014
Decision : [t was decided to defer the case for 05.02.2015 for comments of Department of
Pharmaceuticals.
Meet No/Date:13/82-
ALC4/2014
19.12.2014
HQ File:01/82/050/01037/AM15/ RLA File
:05/23/040/00258/AM15/
翻鼎α“Ю
"И“B誰お
,∞2m5
Decision : It was decided to callfrom the firm copy of DML (Drug Manufacturing Licence)for the export
products and copy of Master Batch Formula duly authenticated by Quality Control Incharge.

お
,∞2m5
Decision : It was decided to callfrom the firm copy of DML (Drug Manufacturing Licence)for the export
products and copy of Master Batch Formula duly authenticated by Quality Control Incharge. The case was
ferred for 05.02.2015.
Pa“y Namc:KLJ PLASTICIZERS
LTD。
,
Meet No/Date:13/82¨
ALC4/2014
19.12.2014
，
′
HQ ΠL Юソ授Ю側
∞6ハM百IRLAFile~~~…
… ……… LI而5爵」面
面
戸
躊
祗
I
I:05/23/040/00256/AM15/     107.10.2014
一
　
　
　
　
７
４
一
　
　
　
　
１
ICaseNo。
:134ノ13ノ82‐ALC4/2014 1:li:::::ξ
i]11[:,][]:
ALC4/2014
19.12.2014
IDecision:It was decided to deferthe case for 05.02.2015 for comments ofDepartment ofC&PC.
汗
Q ΠL Юl慇2Ю50Ю l137AMlyttλ
刷:υ00031ハM百
囲鼎覇0041r~B誰お
5″測:
隔開蕊蕊y~~  
蕊」
[lilil:IIlil::lililttill.defer the case for
ParサName:AVA CHEMICALS
PVT.LTD.,
ALC4/2014
119.12.2014
05.02.2015 for comments of Department of
F眼
眈
12/13/82‐
出
皿4甲
甲
赫
町
鮮
…
Decision : It was decided to defer the case for 05 .02.201 5 for comments of Department of

## Case No.:33/13/82‐ ALC4/2014
Case No。:179/13ノ82‐ALC4/2014
Pharmaceuticals
49
Udy。9
No.:34/13ノ82-ALC4/2014
No/Date:13/82-
Ｔ
Ｎ
Ａ
Ｌ
Ｊ
Ｕ
Ｂ
‐
」
Ｔ
Ｄ
ｅ
Ｓ
Ｎ
ａ
ｍ
К
Ｆ
Ｌ
ド
ー
File
/82/050/01185/AM15/

lCase No. : 29 I 13182- ALC4l20l 4
HQ File:01/82/050/01032/AM15/
PaJりName:」UBILANT LIFE  IMeet No/Date:13/82‐
″8P硫
繭
繭
W賠
ち鵬υ∞劉8晨mγ  
蹴
鼎
α
“
Ю
"И
釧
Decision:It was decided to defer the case for 05.02.2015 for collrunents ofDepartment of
Meet No/Date:13/82-
ALC4/2014
19.12.2014
HQ Filc:01/82/050/01081/AM15/ RLA File
:04/24/040/00173/AM15/
RLA File
:05/23/040/00268/AM15/
諸∬鼎α“Ю
"И"B席お
,"2∝5
BttL韓∝
5
179
180
Decision :It was decided to call from the firm a copy of Master Batch Formula duly certified by
Quality Control In charge. The case was deferred for 05.02.2015.
P釘りName:SHASUN
PHARMACEUTICALS
LIMITED
HQ File:01/82/050/01089/AM15/
RLA File
:04/24/040/00172/AM15/
Decision :It was decided to call from the firm a copy of Master Batch Formula duly certified by
ity Control In charge. The case was deferred for 05.02.2015.
ALC4/2014
19.12.2014

## Case No.:35/13/82‐ ALC4/2014
SCIENCES LIMITED

## Case No.:86/13/82-ALC4/2014
19.12.2014

## Case No.:162/13/82-ALC4/2014
鷺λ
ttυ00549ハⅢy~~闘蕩語面画面
:It was decided to deferthe case for 05.02.2015 for commcnts ofDepartment of
StJN~~~陣
ea Noわ江α13/o2‐  
面
Case l
50
Meet No/Date:13/82‐
ALC4/2014
19.12.2014
No。:78/13/82-ALC4ノ2014
Name:SHASUN
No/Date:13/82-
Name:M.J.BIOPHARM
IMeetNo/Date:13/82-
1徴″鰍F
。LTD.
No.:146/13/82‐ ALC4/2014
Name:RECKITT
No/Date:13/82‐
HEALTHCARE
File :01/821050/01 149/AMl5/ IRLA File
ision : It was decided to send copy of application to Department of Ayush. The case was defer
05.02.2015.

競ち糀∽∝
vttmy
ICaseNo.:275/13/82-ALC4/2014 1:蹴
賛:疱
S LTD.
PHARMACEUTICALS
LIMITED
ALC4/2014
19.12.2014
Deferred
B鮨お知
"∝
5
Pharmaceuticals
圏    
剛鶉
蔦
臨蕊
陣
雨この江α13/82‐
:ALC4/2014
119.12.2014
to defer the case for 040 
"f D.pa.t-"rt "f
Decision : It was
Pharmaceuticals
~F霞¨朗…側4甲ジ赫可鮮… 町
|
185
臨
/∞
"7AM戸
    
町
Decision : ln the light of written comments received from Department of Chemicals and Petrochemicals vide their
.O No.14010/157/2011/Ch::dated 13.08.2014′
given below or as applied by the firm, whichever is less:
Export Product
Export
Quantity
S.No
lmport Product
Quantity
Allowed
MELOXICAM BP
l kg
1.
SODlUM SACCHARIN
1.40 kg
ゾ
Party NameiCAPLIN POINT
LABORATORIES LTD。,
~~~~iCaseNo。
:76/13/82-ALC4/2014
|
186
RLA File
:04/24/040/00163/AM15/
HQ File:01/82/050/01079/AM15/
Ｅ
Ｄ
一
Ｕ
Ｂ
Ｌ
Ｔ
Ｃ
Ｔ
Ｎ
Ｖ
Ｅ
Ｐ
ｅ
Ｓ
一
Ｎ
ａ
ｍ
Ｃ
Ａ
Ｌ
一
呻
Ｔ
Ｈ
‐
Ｐ
Ｅ
Case No。:173/13/82-ALC4/2014
HQ File:01/82/050/01176/AM15/
IMeet No/Date:13/82-
IALC4/2014
119.12.2014
1腎似堰彎003Ю790209繭
113.10.2014
Date:05.02.2015
Decision : It was decided
Pharmaceuticals

Ｔ
Ｈ
‐
Ｐ
Ｅ
Case No。:173/13/82-ALC4/2014
HQ File:01/82/050/01176/AM15/
IMeet No/Date:13/82-
IALC4/2014
119.12.2014
1腎似堰彎003Ю790209繭
113.10.2014
Date:05.02.2015
Decision : It was decided
Pharmaceuticals
to defer the case for 05.02.2015 for comments of Department of
」

## Case No.:131ノ13/82…ALC4/2014
ParりName:GLOBAL CALCIUM
PRIVATE LIMITED,
Mcet No/Date:13/82-
1器為
ed
ALC4/2014
1912.2014
51
Ｆ
ト
ト
ト

汗
QⅢ釧
認
“
剛
劇
A面y
Decision : In the light of written comments received from Department of Chemicals and Petrochemicals
ide their U.O No. 14010156120l l/Ch II dated 10.07.2013, it was decided to ratiff norrns under Para 4.7 of
HBP vl as per details given below or as applied by the firm, whichever is less:
Export Product
Export
Quantity
S.No
lmport Product
Quantity
Allowed
30PPER GLUCONATE
l kg
1.
GLUCONO DELTA
LACTONE
0.901 kg
2.
COPPER OXIDE― ANY
GRADE
0.225 kg
ICaseNo。
:137/13ノ82-ALC4/2014
町
HQ File:01/82/050/O H40/AM15/
15/
Decision : In the light of written comments received from Department of Chemicals and Petrochemicals
vide their U.O No. 1401015612011/Ch II dated 19.07.2014, it was decided to ratiflz norrns under Para 4.7 of
HBP vl as per details given below or as applied by the firm, whichever is less:
Export Product
Export
Quantity
S.No
lmport Product
Quantity
Allowed
ALCIUM PIDOLATE
l kg
1.
L―PYROGLUTAMIC ACID
1.02 kg
MAGNESIUNIIPIDOLATE
1.
L‐PYROGLUTAMIC ACID
1.02 kg
圏器α
"剛“
"4 PcbD配
1鶴λ刷:OЮ0231/AM
Lic.No/Date:0710106823
13.10.2014
「
F艘
¨
3/82-ALα 側4阿
顆
赫
Ⅶ
即
…
Date:05.02.2015
|::謂lc:Icr delided t°
 defer the case for 05.02.2015 for corllmentS Of Department of
潜
¨
3/82‐ALC伽4甲
趾
赫
町
‖
…
Lic.No/Date:0310790186
IDeferDate:
喘
鴫凛戚罵:識I
52
113.10.2014
輔
稚1鞣R
:   i語
:
臨静
毒
閻
閻
Name:GLOBAL CALCIUM
ATE LIMITED,
No/Date:13/82¨
り
,「QⅢ∝
mttν“
o畑″
8ハmyttλ淵
OЮ““ハmy~圏鼎α
"Ю"m紗

3/82‐ALC伽4甲
趾
赫
町
‖
…
Lic.No/Date:0310790186
IDeferDate:
喘
鴫凛戚罵:識I
52
113.10.2014
輔
稚1鞣R
:   i語
:
臨静
毒
閻
閻
Name:GLOBAL CALCIUM
ATE LIMITED,
No/Date:13/82¨
り
,「QⅢ∝
mttν“
o畑″
8ハmyttλ淵
OЮ““ハmy~圏鼎α
"Ю"m紗
: ln the light of written comments of Department of Pharmaceuticals and in consultation with
authority present in the meeting, it was decided to ratify the norms under Para 4.7 ol HBP v1 as
details given below or as applied by the firm, whichever is less:

51 mg   /50
mg tablet
-1
DIMENHYDRINATE 50MG
TABLETS.
DIMENHYDRINATE
Ｆ
Ｌ
ｒ
ｌ
P釘りName:INTAS
PHARMACEUTICALS LTD.,
Meet No/Date:13/82‐
ALC4/2014
19.12.2014
l::i:|:|::l;l::[11'1「
Iそテ
1lJ[「;11こ「
~~~¨
Decision : It was
Pharmaceuticals
:05.02.2015
to defer the case for 05.02.2015 for comments of Department of
ICase No.:140/13/82‐ ALC4/2014
Patty Name:MICRO LABS LTD
―
り3FQΠ bЮ νttЮWmИ3晨M鶴
ち淵υO鬱28ハ1蔦
|
BttL5口百
ICase No.:271ノ13/82‐ALC4/2014
19.12.2014
「

## Case No.:184/13/82¨ ALC4/2014
Patt NameJ.B.CHEMICALS&降
INoク5薦玉蘇
pHARMACFHTICAIS       IAI C4″
014
C4/207「椰夢蘊PLSa IALC4/2014
119.12.2014
ion : It was decided to defer the case for 05.02.2015 for comments of Department of
Pharmaceuticals
Mect No/Date:13/82-
ALC4/2014
19.12.2014
Ｆ
Ｌ
Ｆ
Ｉ
F百高画面画面to defer the case for 05.02.2015 for comments of Department of C&PC.
~ICaseNo。
:133ノ13/82‐ALC4/2014
甲
般鰤剛
136/AШ 夕
FaoNam&NECTAR
LIFESCIENCES LIMITED,
IRLA File
i:22/24/040/00059/AM15/
囲
鼎
C劉剛
Я %PettD犯
ided to ratifo
V/
篇
e
196
|
Decision :In the light of earlier decision taken by NC in its l0/82 meeting dated 12.11.2014, it was deci<
the norms under Para 4.7 of HBP vl as per details given below or as applied by the firm, whichever is less
Export Product
Export
Quantity
S.No.
lmport ltem
Qty.AIlowed
kg/kg
Cefuroxime Axeti!
Amorphous
/N:RyttL K∪MAR
l kg
1.
Desacety!-7-amino
cepha!osporanic acid(D-7-
ACA)
0.フ9
2.
Ethyl acetate
3.74
Of
53
l Kg.
No/Date:13/82-
.12.2014

S.No.
lmport ltem
Qty.AIlowed
kg/kg
Cefuroxime Axeti!
Amorphous
/N:RyttL K∪MAR
l kg
1.
Desacety!-7-amino
cepha!osporanic acid(D-7-
ACA)
0.フ9
2.
Ethyl acetate
3.74
Of
53
l Kg.
No/Date:13/82-
.12.2014

3.
Methanol
0.62
4.
Syn― methoxyimino furanyl
acetic acid ammonium salt
(SM!A)
0.835
5.
Activated carbon
0.100
6.
Phosphorous
pentachloride
0.97
7.
Methylene chloride
2.29
8.
Sodium hydroxide
0.43
9.
Acetic acid
0.048
10.
Acetonitrile
0.98
11.
Chlorosulphonyl
lsocyanate
0.53
12
Acetone
1.76
13
N,N-dimethyl acetamide
1.12
14
Acetoxv ethvl bromide
0.59
15
Cyclohexane
0.92
16
Sodium carbonate
0.125
17
Sodium bicarbonate
0.080
18
Sodium chloride
Not an importable
item
19
Sodium metabisulfite
Not shown in RXN
20
Hydrochloric acid
Not an importable
item
ICase No.:163/13ノ82-ALC4/2014
Paty Name:S.M.CHEMICALS
:It was decided to deferthe case for 05.02.2015
icals
Meet No/Date:13/82‐
ALC4/2014
19.12.2014
tus:Case
Deferred
Defer
Date:05.02.2015
~FTl調
B慇2ALC4/2m4貯
響
ll:iCHEMCALS
攣
汗
QⅢ釧
認
“
¨
ハm夕
陽λttυ∞
“
拡m夕
ALC4/2014
19.12.2014
Lic.No/Datei03 1 0790361
1710.2014
lnecision : It was decided to defer the case for 05.02.20tS foi"ornr*"tr of O"pu.tment of C&PC
Meet No/Date:13/82-
m―
 T
indicating Potency ofNystatin imported under present A.A
1譜ガ
l盤嘗α
0310790285 BttЬ
5.02.2015

## Case No.:183/13/82-ALC4ノ2014
Party Name:BLISS GVS
PHARMA LTD.
Date:05.02.2015
IALC4/2014
19.12.2014
Lic.No/Date:0310790362
17.10.2014
54
No/Date:13/82‐
File :01/821050/01 1 86/AM l 5/ IRLA File
KuMAR
gn T_

. Detailed calculation of arriving at the quantity of API applied.
case was defelTed for 05.02.2015.

## Case No.:136/13/82-ALC4/2014
Party Name:DHANUKA
LABORATORIES LTD.
ALC4/2014
19.12.2014
200 1HQ File:01/82/050/01139/AM15/IRLA F‖
c
Lic.No/Date:0510391614  1Defer
:05/23/040/00309/AM15/
Date:05.022015
Pharmaceuticals
Ｆ
Ｌ
Ｆ
Ｉ
‐
Ｆ
Ｌ
Ｆ
Ｉ
Ｆ
Ｌ
Ｆ
Ｉ
Ｆ
Ｌ
Ｆ
Ｉ
ICase No.:154/13/82-ALC4/2014
Paty Name:GEM AROMATICS iMcetNo/Date:13/82-
ALC4/2014
19.12.2014
lDecision : [t was decided to defer the case for 05.02.2015 for comments of Department of C&PC.
「
QⅢ釧
爾
“
¨
ハm夕
陽角淵
∽囲9ハmy
ision : It was decided to defer the case for 05.02.2015 for comments of Department
fPharmaceuticals
Lic.No/Date:0510391639
17.10.2014
臨蒜
Party Name:SUN
ParりName:StJN
PHARMACEUTICAL
INDUSTRIES LTD.,
RLA File
:03/95/040/00594/AM15/
Meet No/Date:13/82‐
Lic.No/Date:0310790350

## Case No.:124/13/82-ALC4/2014
PaりName:PANACEA BIOTEC
ALC4/2014
19.122014
Lic.No/Date:0510391623
17.10.2014

## Case No.:135/13/82‐ ALC4ノ2014
Pa●y Name:SHREE BANKEY
BEHARILAL AROMATICS
HQ Ⅲ∝∝慇
2/050/m B8ハ而厩蕊蕊薦ξ
ICase No。:164/13/82‐ ALC4/2014

## Case No.:165ノ13ノ82‐ALC4/2014
File:01/82/050/01168/AM15/
55
17.10.2014
No/Date:13/82-
.LTD.
File:01/82/050/01157/AM15/IRLA File
′TD.,
No/Date:13/82-
No/Date:13/82-
14
LTD。,        119.12.2014
F画
面
而
繭
而
指λttυ∞
"3晨m" 
聞
鼎
mm0790332
4

DecisiOn:It was decided to deferthe case for 05.02.20 15 for comments of Department of

## Case No.:273/13/82‐ ALC4/2014
HQ File:01/82/050/01276/AM15/
RLA File
:08/24/040/00277/AM15/
ド柵翻稔・
,
爾‖… 邪
囲鼎α囲昭“
6 PebDttα
decision of Norms Committee.
)ecision:In the light Of written comments received fbm Department Of Phallllaceuticals vide their OM No.
50H/406/2012‐ PI(NollllS)dated OctOber 2012,it was decided tO rati″
the nOmls under Para 4.7 ofHBP vl as per
etails given below Or as apphed by the fli111,whichever is less:
Export Product
Export
Qtv
SI No
lmport items
Qty.allowed in mg fOr
tablet of
５
唸
　
ｍ
ｇ
Ｏ
　
　
ｇ
５
　
　
ｍ
２
０
・Ｏ
　
ｍ
ｇ
５
Promethazine  HcL
12.5  MG  ttablet
25MG ttablet &50
MG tablet
1
Tablet
Promethazine Hcl usP
1275
25.50
510
2
Hydroxypropyl Cellulose NF
40
8.0
16.0
3
Lacotse tVtononydrate tW
81.0
162.0
3240
4
4 to 9 packing materials
As per packing policy
xA may take
lte action as per the

## Case No.:274/13/82-ALC4/2014
HQ F‖ e:01/82/050/01277/AM15/
Party NameiCADILA
HEALTHCARE LTD。
,
:08/24/040/00255/AM15/
ALC4/2014
19.12.2014
゛
Decision : ln the light of earlier decision taken by NC in its ri/e2 meeting dated ,6112014 *,d i, -
consultation with technical authority present in the meeting, it was decided to ratify norms under para
4-7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
Export Product
Gabapentin,600 MG and 800MG Tablets
S.NO.
:mportltems
For export of 1 No. Tablet
600mg ttablets
800 rng Tab!ets
1
GABAPENTIN
612.O mg
816.0
MANNITOL
75.375
100.50
3
COPOVIDONE
37.54
50.0
4
POVIDONE K 30
26.25
35.0
5
LOW SuBsTITuTED
YL CELLULOSE
41.25
55.0
6
MAGNESIUM STEARATE
12.24
16.32
No/Date:13/82-

7
150 WHITE HDPE BOTTLE
Relevant, as per packing policy
8
CRC WHITE CAP38 MM
9
750 CC WHITE HDPE BOTTLE
10
NCRC WHITE CAP 53 NIIM
225 CC WHITE HDPE CRC BOTTLE
12
CRC WHITE CAP45 MM
950 CC WHITE HDPE BOTTLE
14
DESICANT CANISTER 2 G
ICase No.:152/13ノ82‐
HQ Ⅲ∝∝お2ЮWm“ 5晨my開
脇
蕊
薦
~鵬
器
α
"Ю"“
斃
BttL,鬱2∝5
Mcet No/Date:13/82-
ALC4/2014
19.12.2014
Pharmaceuticals
Party Name:MOREPEN
Meet No/Date:13/82‐
Ｆ
↑
LABORATORIES LTD.,
icals
~~~ICaseNo.:144/13ノ
82-ALC4/2014
P冨りName:PAYAL
剛
~
打
QⅢ∝∝慇ν
“
0畑B5晨my膨
棚
υ∞
"2ハmy 
圏
鼎
α
“
Ю鯛
“
3B島
,舵2∝5
PETROCHEM PRIVATE
LIMITED
I
ノ
1 9.12.2014
1210 HQ File:01/82/050/01147/AM15/
ICase No.:132/13/82‐ ALC4/2014
19.12.2014
Mcet No/Date:13/82‐
ALC4/2014
lDecision : It was decided to defer the case for 05.02 .2113for33F,I五3面ζ
3F,3pmm3113Fこ夏
EEEI]
Ｆ
Ｌ
声
‐
Meet No/Date:13/82-
HQ Ⅲ∝∝κν∞0畑И8ハmy膨
鵬
OЮ∞%晨my ttmC“
Ю訓
“

.12.2014
Mcet No/Date:13/82‐
ALC4/2014
lDecision : It was decided to defer the case for 05.02 .2113for33F,I五3面ζ
3F,3pmm3113Fこ夏
EEEI]
Ｆ
Ｌ
声
‐
Meet No/Date:13/82-
HQ Ⅲ∝∝κν∞0畑И8ハmy膨
鵬
OЮ∞%晨my ttmC“
Ю訓
“
9B鳶
ぉ,∽2∝5
: It was decided to defer the case for 05.02.2015 for comments of Department of C&PC
ALC4/2014
19.12.2014
Pharmaceuticals
57
Name:INDOCO
No.:145/13/82‐ ALC4/2014 1Party Name:PAYAL
No.:138/13/82-ALC4/2014 1Pary Name:RECKITT
No/Date:13/82‐
HEALTHCARE

isio■:It was decided to defcrthe case for 05.02.2015 for comments of Department of C&PC
Decision:It was decided to deferthe case fbr 05.02.2015 for conllnents ofDepartment of(〕
ゼ%PC
Pharmaceuticals
「
QⅢ∝∝お2Ю 5γm″0晨myttλ
蠍
OЮ剛0ハmy 
♭ドだ鼎
α
“
Ю
"餌
釧
BttL,∞2m5
1:;認l:棚
∫
ecided to defer the case for 05.02.2015 for comments ofDepartment of
No.:139/13/82-ALC4/2014
Name:RECKITT
No/Date:13/82-
HEALTHCARE
4
Fib:01/82/050/OH42/AM15/1RLA Fib
:It was decided to defer the case for 05.02.2015 for collments ofDepartment of
No.:169/13/82‐ ALC4/2014
Name:YASHO
No/Date:13/82‐
4
12.2014
Ч吸… 獅剛172/AMly漱
10.2014
No.:153/13ノ82‐ALC4/2014
NamelDORF― KETAL
No/Date:13/82‐
INDIA PVToLTD.
File:01/82/050/01156/AM15/IRLA Filc
5/
: It was decided to defer the case for 05.02.2015 for comments of Department of C&pC.
No.:167ノ13/82…ALC4/2014 1Pa"Name:SMB
No/Date:13/82-
TION OFINDIA
4
No.:130ノ13/82-ALC4/2014
Name:ALEMBIC
No/Date:13/82‐
181HQ Fit:01/82/050/OH 33/AM15/IRLA Fib

015 for comments of Department of C&pC.
No.:167ノ13/82…ALC4/2014 1Pa"Name:SMB
No/Date:13/82-
TION OFINDIA
4
No.:130ノ13/82-ALC4/2014
Name:ALEMBIC
No/Date:13/82‐
181HQ Fit:01/82/050/OH 33/AM15/IRLA Fib

@-__WlD"t"trsJr20ls
―
・
Ｆ
Ｉ
‐
嚇
Ｆ
‐
‐
‐
:Declslon: It was decided to defer the case for 05.02.2015 for comments of Department of C&PC.
Mcet No/Date:13/82-
ALC4/2014
19.12.2014
us:Case
Deferred
ド
Q Πb Юν8ν050Ю H7夕Amyl鷺
λ乳
OЮ0362ハMⅣ
 
囲
耐
繭
耐
B鮨■0220b
g defer the c蒸8 for o5。02.2015 foFcomments ofDepartment ofC&PC
Ｆ
打
ド
QⅢ∝∝おν∞υ∝″νAmyttλ
乳
OЮ剛9晨m夕 ~囲
需
而
繭
戸
BttL5舵洲
5
田話面薔面
「
姦I面勇面gごぉ百嘉票葛
=高
百こfor o5.02.2015 for comments ofDepartment ofC&PC.
Ｆ
‐
２
２
２
‐
Paty Name:SHANPAR
INDUSTRIES PVT.LTD.
HQ Πb劇慇7050畑H9晨myl跳
危棚
νO∝7ツAttζ
臨
扁
Decおion:It was decided to defer the case for 05.02.2015 for comments of Department of C&PC.
Case No。:172ノ13/82…ALC4/2014
Party Name:PRASOL
CHEMICALS LIMITED
ALC4/2014
19.12.2014
Case No。:116/13ノ82‐ALC4/2014
ALC4/2014
19,12.2014
:ln the light of written comments received from Department of Chemicals and Petrochemicals vide their
.O No.14010/2/2012/Ch il dated 21.05.2014′ lt was decided to ratify norms under Para 4.7 of HBP vl as per deta‖ s
1223
below or as applied by the firm, whichever is less:
/
Export Product
Export
Quantity
S.No
lmport Product
Quantity
Allowed
〕,3,5‐ TRIMETHYL
EYCLOI‐IEXANOL
l kg
1.
ACETONE
1.536 kg
Party Name:TATVA CHINTAN
PHARMA CHEM PVT LTD
Paty NameiSI GROUP INDIA
LIMITED
RLA File
:03/95/040/00567/AM15/
囲鼎α“Ю
"“"B脂お
,鬱2∝5
Mcet No/1Date:13/82‐
ALC4/2014
19.12.2014
B鳶お知″
m5
HQ Fil釧
獅
畑鵬晨my  
扁
5話面語丁

Name:TATVA CHINTAN
PHARMA CHEM PVT LTD
Paty NameiSI GROUP INDIA
LIMITED
RLA File
:03/95/040/00567/AM15/
囲鼎α“Ю
"“"B脂お
,鬱2∝5
Mcet No/1Date:13/82‐
ALC4/2014
19.12.2014
B鳶お知″
m5
HQ Fil釧
獅
畑鵬晨my  
扁
5話面語丁
ITas decided to defer the case for 05.02.2015
for comments of Department of C&PC.
鴨
翌
FT耐
1鵠N ttGS匿
∬
1秘
|:器
艶
HQ File:01/82/050/OH71/AM15/
3■:、′N:RyttL
s.r fficr6 
E-*sr qrqrc
y. Direclor General of Foreign Tl.ad
Dy謁讐辛%
'frtvr qrqrv q-6rfrlriEiq
Directorate G6n6ral of Foreign Trade
of Foreign TEdo
赫
合町守Department Of Commerce
ud§猥聾ζ轟月ヽ議t_:hi
Mcet No/Date:13/82-

## Case No.:170/13/82‐ ALC4/2014 1PatyName:SAVLA
CHEMICALS LIMITED
No/Date:13/82‐
No.:110/13/82‐ ALC4/2014
No/Date:13/82-

It-ttrrnEo
HQ File:01/82/050/01090/AM15/IRLA File
No.:276ノ13/82‐ALC4/2014
:04/24/040/00196/AM15/
Paty Name:INTAS
PHARMACEUTICALS LTD,
:08/24/040/00288/AM15/
je.tz.zot+
Meet No/Date:13/82‐
tus:Case
ALC4/2014
Deferred
19.12.2014
Lic.No/Date:0810133688  1Defer
Date:05.02.2015
囲鼎α
m∝
"°4臨蕊
Ｆ
Ｌ
Ｆ
Ｉ
HQ Fne:01/82/050/01279/AM15/IRLA Fne
icals
Pa.ty N"ffi 
Mr.t N"/Drt.. t3l82
ALC4/2014
BttL知"m5
iDecision : It was decided to defer the case for 05.02.2015 for comments of Department of C&PC.
Case No。:126/13/82‐ ALC4/2014 1ParりNamc:KLJ PLASTICIZERS iMeetNo/Date:13/82-
ALC4/2014
"た
.No/DtteЮ510391765隔
izt.to.zoq
t
Date:05,02.2015
iDecision : It was decided to defer the case for 05.02.2015 for comments of Department of C&PC.
ParりName:YASHASHVI
RASAYAN PVT.LTD
Mcet No/Date:13/82-
ALC4/2014
lstatus:Case
ヽ
Mcet No/Date:13/82‐
ALC4/2014
;euticals
Meet No/Date:13/82¨
ALC4/2014
ff..a g;q-gTNrRMAL KUMAR
sq q<rRero G-iq qrqr{
Dy. Director General of Foreiqn Trads
fr-<sI qrqrq e-rrA<srre-q
Diroctor-ate G6neral ot Foreign Trade
qlttfq f+.{f.Uoepanment of commerce
s-drq arqq. qii ffi
Udyog Bhawan, New Delhi
Pharmaceuticals

## Case No.:125/13/82‐ ALC4/2014

## Case No.:141/13/82-ALC4/2014

## Case No.:142/13/82‐ ALC4/2014
Pa●y Name:DHANUKA
LABORATORIES LTD.
Date:05.02.2015
File:01/82/050/OH28/AM15/1RLA File
File:01/82/050/01129/AM15/1RLA File
File:01/82/050/01144/AM15/1RLA Flle
Flle:01/82/050/OH45/AM15/1RLA Rle
122014
Name:DHANUKA
60
1.10.2014

ision : It was decided to defer the case for 05.02.2015 for comments of Department of
Case No。:104/13/82-ALC4/2014 ParりName:AMOL
PHARMACEUTICALS PVT.
i-----
iLrD.
:造き』別貯
ta 13/82-
「
Q Π
L Юν
82/050Ю l107ハM15/1学
:ち刷
:0/00029ノAM15/
icals

## Case No.:266/13/82-ALC4/2014
Party Name:ATUL LIMITED,

## Case No.:268/13/82‐ ALC4/2014
Party Name:ATUL LIMITED,
Mcet No/Date:13/82-
19.12.2014
:
可ゃ雨Чn_epartment o'Commerce
udy。提肌謀勝■:籠
to dcfcr the case for 05.02.2015 for corrllnents ofDepartment of
BttL""m5
Ｆ
Ｌ
Ｆ
Ｉ
B脂お知
"∝
5
郎6「QⅢ∝mttν
“
0畑り4ハmy脇
刷iυttHハm夕 
け∬mC囲
∽
“
″6B鮨
ぉψ 2∝5
IDecヽion:It was dccided to dcferthc case for 05.02.2015 for comments of Department of C&PC.
,Decision: It was decided to defer the case for 05.02.2015 for comments of Department of C&PC.
:Meet No/Date:13/82-
lALC4/2014
119.12.2014
Meet No/Date:13/82-
ALC4/2014
RLA File
:08/24/040/00295/AM15/
Defer Date:
ln the light of earlier decision taken by NC in its 9/82 meeting dated 2O.tO.2Ot4 and in
rn with technical authority present in the meeting, it was decided to ratify norms under Para
師
IMeet No/Dtte:13/82‐
1徴
"鰍
Υ
Lic.No/Date:3410040655
05.11.2014

## Case No.:270/13/82-ALC4/2014
ParりName:CADILA
HEALTHCARE LTD.,
19,12.2014
Lic No/Date:0810133737
61
No/Date:13/82-
4
12.2014
「QⅢ∝∝慇ν
“
0畑%りAmttλ
ttυ∞露りAm夕 
圏
器
α囲∝33735
IALC4/2014
File:01/82/050/01110/AM15/1RLA File

.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
Export Product
Export
Qty.
S.No.
Import Item
Qサ.A1lowed
kヵ/kg
6-chloro-4-hydroxy-
2methy l-N-(2- Pyridiny l)-
2H-Thieno-12,3)-1,2-
Thiazine-3 -carboxam ide-
l,l -dioxide
(LORNOXTCAM)
l kg
1
2-AMINOPYRIDINE
0.45
つ
ん
3-AMINOTHIOPHENYL-2‐
CARBONACIDMETIIYL
ESTER
2.82
3.
ACETttNE
1.726
4.
DIISOPROPYL ETHER
2.40
ξ
υ
GLYCINMETHYL ESTER
HYDROCHLORIDE
0.507
6.
METHANOL
1.40
7.
N―BUTYL LITI‐IIUM(20%IN
TOLUENE)
2.305
8.
POTASSIUM TERTIARY
BUTYLATE
0.86
9.
TETRAHYDROFURAN
6.515
10.
TOLUENE
0.638
per
日鼎α∝Ш73
:05.02.2015

## Case No.:1/13/82-ALC4/2014
:09/24/040/00417/AM15/
日鼎α醐∞
a蟷8
隅柵l器げ
N〕A
|

## Case No.:150/13/82‐ ALC4/2014
卜ic.No/DtteЮ310790827
p7.11.2014
町
Defer Date:
L1.09.2014 and in
norms under Para
: ln the light of earlier decision taken by NC in its 7/g2 meeting dated
with technical authority present in the meeting, it was decided to ratify
7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
62
ParりName:ELIXIR PHARMA  Meet No/Date:13/82-
IALC4/2014
19.12.2014
ド
Q ΠL Юν82Ю 50/01270/AMlyl鷺
λ刷:OЮ0294AM15/
P冨サName:HETEROLABS   IMcetNo/Date:13/82‐
ALC4/2014
19.12.2014
No/Date:13/82‐
4
File:01/82/050/01153/AM15/ RLA File

1 kg Export Product
Silnethicone 1 00%USP or BP
or EP
Silicone Fluid / Oil of
relevant Viscosity
0.96 kgノkg
2
Simethicone Emulsion USP
30%
Silicone Fluid / Oil of
relevant Viscosity
0.288 kgノkg
3
Dimethicone USP or BP or EP
(Various Viscositv)
Silicone Fluid / Oil of
relevant Viscosiff
1.01 kg/kg
concerned may take further necessary action as per above decision of NC.
ぃeN∝HИン
8年ALC42∝4
|
PttNam,SHⅣA
PHARMACHEM LTD,
:01/82/050/01116/AM15/
Export Product
Export
Quantity
S.No
lmport Product
Quantity
Allowed
3,5-DimethylbenzoyI Chloride
(DMBC)
Assay Min 99%
l kg
1.
Mesitylene / 1,3,5-Trimethyl
Benzene.
Assay Min99Yo
1.128 kg
241
ド
Q田∝∝慇ν“剛b2/AMl翻蒻脇萬扁戸~圏
鼎α“Ю
"昭需蕊蔦
~
IDecision:ln the light of wtttten comments received from Department of Chemicals and Petrochemicals vide their
・om Department of Chemicals and Petrochemicals vide their
as decided to ratify norms under Para 4.7 of HBP vl as per
is less:
Export Product
Export
Quantity
S.No
lmport Product
Quantity
Allowed
ΞDPA(CUMYLATED DI
PHENYL AMINE)
l kg
1.

trochemicals vide their
as decided to ratify norms under Para 4.7 of HBP vl as per
is less:
Export Product
Export
Quantity
S.No
lmport Product
Quantity
Allowed
ΞDPA(CUMYLATED DI
PHENYL AMINE)
l kg
1.
DIPHENYLAMINE
0.489 kg
ト
Mect No/Date:13/82-
ALC4/2014
lilll:iiI:ilillI:iilii::i:1~~~~~~~~|
Status:Approved
ALC4/2014
19.12.2014
lDecision : ln the light of written comments received from Department of Chemicals and Petrochemicals vide their
jU.O No. t40L0lt64/20tLlch ll dated L2.L2.20L4, it was decided to ratify norms under Para 4.7 of HBP v1 as per
idetails given below or as applied by the firm, whichever is less:
I
i
;l 
lQuantityl I 
lnttoweo I
l' 
J 
J 
I 
l- 
lMesitylene/1,3,5-Trimethyl I 
" 
I
IDMBC) 
l' r,e I 
I ;;;;,". 
I 
I
lAssavMinee%o 
I 
I 
lR..uyMingeoh 
I 
I
ll              l    l   l
RA may take appropHate action as perthe decision of Norms Comm■
tee.
ICase No.:149/13/82-ALC4/2014

## Case No.:2/13/82-ALC4/2014
19.12.2014
⌒
詰鴇
。

Decision:It was decided tO deferthe casc for 05.02.2015 for corllments OfDepartment of
Phannaceuticals
Party Name:AUROBINDO
PHARMA LIMITED
DecisiOn:It was decided tO deferthe case for 05.02.2015 for cOrnments OfDepartment ofC&Pc.
iion : It was decided l"_.g9 a copy of applicati"r, t" o.p"rt*;i;f Ail.h fb, thfi;"r-"rt,
case is deferred fro 05.02.2015.
f-ffiW@bt"t,,c*l
IIiLiLesoRAroRreslrp' lty.r;:::l; P;;;ffi* I
lz+e IHO Fite:01/82/0sototo,ottlruty 
ffiiD"f.r--i
\n'l\ i 
E:ii;ffi"'vTtvvetzt ' ffi;|L' 'o.-'.,o"l
\\-I ffin;.Jl,;na 
i
ffi 
64
Ｆ
Ｌ
Ｆ
‐
No。:3/13/82‐ ALC4/2014
: It was decided to defer the case for 05.02.20i j fbrm
No.:265/13/82-ALC4/2014
Name:H.J.AROCHEM itut.rtNolUot.,tySZ-
t4
:It was decided tO deferthe case for 05.02.2015 fOr conlments OfDepartment ofC&Pc.
No.:l5l/t3/82-ALC4/2014 parryName:REANNON MeetNo/Date:13/g2_
File :01/82/050/0 1 I s4lAMr St lRLe pile
鳳my 貯∬鼎α“Ю
"0870
: It was decided to defer the case for 05.02.2015 for-;;;rnt, orffi.rt-.rt "f
No.:111/13/82‐ ALC4/2014 1ParけヽameiÅBEERζ
No/Date:13/82¨
PVT   IALC4/2014
TD

/0 1 I s4lAMr St lRLe pile
鳳my 貯∬鼎α“Ю
"0870
: It was decided to defer the case for 05.02.2015 for-;;;rnt, orffi.rt-.rt "f
No.:111/13/82‐ ALC4/2014 1ParけヽameiÅBEERζ
No/Date:13/82¨
PVT   IALC4/2014
TD

ICase No.:5/13/82‐ ALC4/2014
50111QFile:01/82/050/01008/AM15/ RLA File
:09/24/040/00325/AM15/
「祠躙聡
,
Mcet No/Date:13/82‐
ALC4/2014
19.12.2014
Lic.No/Date:0910061212
11.11.2014
Ｆ
‐
―
‐
‐
‐
‐
‐
‐
‐
１
２
５
‐
，
Pharmaceuticals
Petrochemicals
under Para 4.7
「QTe劇だ7050畑H2晨myl鷺
ち淵
OЮ0345/AM15/
1造圏器計α
13/82-
119.12.2014
: Committee cOnsidered the case as per agenda and in light Of written comments received from
Department of PhalHlaceuticals vide their OM No.350H/183/2014‐
PI(Norms)dated 12.H.2014 and in
ultation with technical authority present in meeting, decided to ratifo norrns under para 4.7 of HBp as
details below or as applied by firm whichever is lower:-
gq ffirs; 
i - tqr qrqr<
Oy. Dir€ctor General i)l ' oreign Trade
frig rqrcx Er6rl {icrrcr{I
Directorate General of I'oreign Trade
qlfilq F{trrrupgpartment of commer@
3r-drrl rrqrl1. TC R66ft
Udyog Bhawan, New Oolhi
Date:05.02.2015

## Case No.:6/13ノ82¨ALC4/2014
Decisio■:ln the light of written comments recei
vide their u.O No.14010/30/2014-Ch.‖
dated 21
of HBP vl as per deta‖ s given below or as applied
ived from Department of Chemicals and
2.L2.201.4, it was decided to ratify norms
by the firm, whichever is less:
Export product
Export
Quantity
S.No.
Import items
け
ｅｄ
ａ
ｎ
ｔ
　
ｏ
ｗ
ｕ
　
Ｈ
Ｑ
Ａ
4,4 DIAMINO SULFANILIDE(DASA)
l kg
l
PARA NITRO ANILINE
0.728 kg
2.
ANILINE OIL
0.468 kg
3.
ACETIC ACID
0.304 kg
4.
SODA ASH
2.00 kg
may take appropriate action as per the decision of Norms committee
lmport items
Rosuvastatin Calcium
Tert-butyl -2 -((4 R, 6 S )-6- ((E)-2 -(4 (-
(4-fl uorophenyl)-6-isopropyl-2-[N-
methyl (methylsulphonyl) aminol
pyrimidin-5-yl) vinyl)-2,2-dimethyl-
1,3-dioxane-4-yl) acetate
Tert―butyl methyl ether(MTBE)
」
Party Name:ASTRIX
LABORATORIES LTD.,

IRAconcemed may take further necessary aclon as perabove decision of NC
Ｆ
Ｌ
Ｆ
Ｉ
Ｆ
Ｌ
Ｆ
Ｉ
CiきもNo■108ノ13/82‐ALC4/2014 1Pttυ Name:SHREE BANKEY
Mcet No/Date:13/82‐
BEHARILAL BOARD MILLS
ALC4/2014
19.12.2014
Lic.NoノlDate:0510391926
11.11.2014
BttL知"m5
IDecisbn:It was decided to defer the casc for 05.02.2015 for commcnts ofDepartment of C&PC。
Party Name:SOLARIS
lMeet No/Date:13182-
[器YTECHNDUSTⅢ
ES I徴
"鰍
Υ
吸
Ⅲ∝側"鰤
剛
5ハmy
Ｆ
Ｌ
Ｆ
Ｉ
Lic.No/Dttα 3410040672 1Deたr
Date:05.02.2015
: It was decided to defer the case for 05.02.2015 for comments of Department of C&PC.
Paty Name:HETERO LABS   iMeet No/Date:13/82‐
LIMITED
19.12.2014
HQ File:01/82/050/01010/AM15/RLA File
:09/24/040/00446/AM15/
12.11.2014
Patt Name:JUBILANT LIFE  IMcetNo/Dde:13/82‐
19.12.2014

of C&PC.
Paty Name:HETERO LABS   iMeet No/Date:13/82‐
LIMITED
19.12.2014
HQ File:01/82/050/01010/AM15/RLA File
:09/24/040/00446/AM15/
12.11.2014
Patt Name:JUBILANT LIFE  IMcetNo/Dde:13/82‐
19.12.2014
: It was decided to defer the case for 05 .02.20 I 5 for comments of Department of
S
Paty Name:PAYAL
PETROCHEM PRIVATE
LIMITED
「
ftrNq EF.q;<TNIRMAL KUMAR
sq qgqft;er+' fi'ivr arrqg
Dy. Oir€ctor General of Fo'ergrr Trade
RcI qrq[{ r<rFrisrr<a-q
Directorate General of Foreign Trade
rtlFrq frqFuoepa(ment ot commem
gdfq sfqEl- q:i frla;ti
Uclyog Bhawan, New D€lhi
HQ Ⅲ釧
郷
剛
Ю8晨m夕
爾図
蕊
諦
~け
∬辮
“
Ю"邸7 BttL卸
卿
5
一
　
　
　
　
　
　
　
５
８
Ｆ
Ｉ
Ｉ
‐
‐
‐
‐
―
―
ｌ
ｈ
Ｆ
ｉ
‐
，
１
１
‐
―
―
，
‐
―「
い
郷        :il'1ここ
a to dcferthe case for 05.02.2015 for comments ofDepartment ofC&PC.
Pa●y Name:NIFTY LABS PVT  Mcet No/Date:13/82‐
ion :In light of earlier decision taken by NC in its l8/82 meeting dated l9.l2.20l3and in consultation
ith technical authority present in meeting, decided to ratifu norms under para 4.1 of HBP as per details
low or as applied by firm whichever is lower:-

## Case No.:112/13/82-ALC4/2014

## Case No.:7/13/82‐ ALC4/2014
Case No。:120/13/82‐ ALC4/2014
ICase No.:105ノ13/82‐ALC4/2014
Meet No/Date:13/82¨
ICase No.:8/13ノ82-ALC4/2014
66
File:01/82/050/01H1/AM15/IRLA File
Ｆ
Ｌ
Ｆ
Ｉ
14
ALC4/2014
19.12.2014
Flle:01/82/050/01011/AM15/IRLA File
File:01/82/050/01123/AM15/1RLA File

^
Export Product
Exo.Otv.
S.No
Import Item
Oty.a110Wed kg/kg
N-[dibenzo[b,f][ I ,4]
thiazepin-l l-YLl
Piperazine
Hydrochloride
l kg
1
Thiophenol
0.68
2.
Hydrazine Hydrate 80%
0.793
3.
Acetone
0。661
4.
Poly Phosphoric Acid 840/0
5.10
ξ
υ
Piperzine Anhydrous
1.41
6.
Iso Propyl Alcohol
0.938
RA may take appropriate action as per the dec ision of Norms Committee.
IMeetNo/Dttα  13/82‐
1徴
"盤
Υ
Pharmaceuticals
Mect No/Date:13/82‐
ALC4/2014
19.12.2014
剛
00329/AMy  囲
Lic.No/Date:0510391989 lDeferDate:
l:05t24/040l0o329lAl..{lsl 114.11.2014
consultation with technical authority
in mee‖ ng decided to ratify norms under para 4 7 of HBP as per SION A-412 wlh 2%wastage. :
concerned may take further necessary action as per above decision of NC.

## Case No.:106/13/82-ALC4/2014
諸∬鼎α酬∞
a%8 BttLi鬱ふ
5
Party Name:HETERO LABS
LIMITED
ALC4/2014
19.12.2014
HQ Ⅲ∝mttνo5υmm3ハmダ
1鷺危鵬υ0044りAmtt     B鳶
お.922∝5
Fあ鴻4滋o/00,49/AMl,/   IDi11.う014     
い江α05。92.2015
:It was decided to defer the casc for 05.02.2015 for cornlnents ofDepartment of
icals
No.:119/13/82‐ ALC4/2014
No。:9/13ノ82-ALC4/2014
Name:HETERO DRUGS
No/Datei13/82-
19.12.2014
File:01/82/050/01012/AM15/1RLA File
:It was decided to deferthe case for 05.02.2015 for comments of Departrnent of
No.:10/13/82‐ALC4/2014
IMcct No/Date:13/82¨
Ｔ
Ｎ
Ａ
Ｌ
Ｊ
Ｕ
Ｂ
‐
」
Ｔ
Ｄ
α
＾
ｂ
Ｎ
ａ
ｍ
虹
No.:11/13/82‐ALC4/2014
Namc:HETERO LABS
No/Date:13/82-
12.2014
Lic.No/Date:0910061271
19.11.2014
Name:RANBAXY
Flle:01/82/050/01014/AM15/IRLA File
:It was decided to defer the case for 05.02.2015 for conlments of Department of

## Case No.:122/13/82_ALC4/2014
Party Name:PAYAL
PETROCHEM PRIVATE
Ｆ
Ｌ
Ｆ
‐
Ｆ
Ｌ
Ｆ
‐
ALC4/2014
19.12.2014
islon:It was decided tO deferthe case fOr 05.02.2015 fOr comments OfDepartment ofC&Pc.
:■was dedded b detr■e ctt」ぉro■022015 for c
ド
QⅢ∝岬切∞
mm5晨my
1脇棚
OЮ““ん
=蔦
authority
l, as per
further recessar@cision 
of NC.
ICase No.:123ノ13/82‐ALC4/2014
Party Name:PAYAL
PETROCHEM PRIVATE
Meet No/Date:13/82¨
lCase No. : 12 t 13t82- ALC4t2Ot4
ParりName:RA CHEM
PHARMA LIMITED
Decision : committee considerea .arJ ar per uffi u"Jir-*nrurtutior;thG.h"ilL
present in meeting, decided to ratify norns undir paru 4.7 of HBp ur u, p.. sioN 4-261
details given below or as appried by the firm, whichere. is L.s,
Export Product
Export
Qtv.
Ｓ
‐
．
Ｎ
。
lmport Items
Qty.
allowed
2-Amino methyl-Tihioro-
2,3-Dihydro-5-(2-
Fluorophenyl) - I H- 1,4-
B enzo diazepine Dimaleate
lKg.
1
2-Amino-5-chloro-2-
Fluoro Benzophenone
0.932 Kg.
2.
Chloro acetalGhfle
Dimethyl acetal
0.696 Kg.
3.
Manganese DioxidE
0.852 Kg.
4.
Dimethyl Suljfoxide
0.405 Kg.
5.
Acetone
0.405 Kg.
RA concerned mav take
Fite :01/82/050/01 125lAMl5/ IRLA Fite
No/Datc:13/82‐
11.2014
ALC4/2014
19.122014
Fite :01 /82/0sotot net eut y IRLA Fil"
No/Date:13/82¨
No。:269/13/82-ALC4/2014
Name:SHREE VALLABH
No/Date:13/82-
F ite :0 t / 82/ 0 so / o t 2i2J iMt 7 RLn n r.
:It was decided tO deferthe case fOr 05.02.2015 fOr10mmentsOfDep五
五葛:高IF:Ftiifil
―

te:13/82¨
No。:269/13/82-ALC4/2014
Name:SHREE VALLABH
No/Date:13/82-
F ite :0 t / 82/ 0 so / o t 2i2J iMt 7 RLn n r.
:It was decided tO deferthe case fOr 05.02.2015 fOr10mmentsOfDep五
五葛:高IF:Ftiifil
―

|
IDeferDate:
: : In the light in the light of earlier decision taken by NC in its 3182 meeting dated 08.05 .2014, it
decided to ratifu norrns under para 4.7 of HBP v I as per details given below or as applied by the firm,
r is less:
Export product
Exp.
Qty.
S:.No.
lmport items
Qty.
a‖owed
kg/kg
CEFIXIME(CEFIXIME
1.
Acetone
0.816
TRIHYDRATE)
2.
Activated Carbon I Carbon
Enoanticromos I
0.100
3.
DimethvI Formamidc(DMF)
1.252
4.
G.C.L.E
1.50
5.
Methylene Chloride
3.253
6.
Methanol
7.913
7.
2-Mercaptobenzothiazoyl -(Z)-2-(2-
Aminothiazovl-4vl)-2- ( MICA Ester )
0.820
8.
Triphenyl Phosphine
0.820
HQ File:01/82/050/01094/AM15/IRLA File
:09/24/040/00421/AM15/
Date:05.02.2015
1912.2014
Lic.No/Date:0910061284
21.11.2014
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Pharmaceuticals
lCase No. : 97 I 13 182- ALC4l20l4
Pa●y Name:AUROBINDO
PHARMA LIMITED
Mcet No/Date:13/82‐
ALC4/2014
19.12.2014
270 HQ File:01/82/050/01100/AM15/IRLA File
:09/24/040/00457/AM15/
Decision : It was decided to defer the case for 05 .02.20 I 5 for comments of Department of
harmaceuticals
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Meet No/Date:13/82‐
ALC4/2014
ALC4/2014
19.12.2014

## Case No.:93/13/82‐ ALC4/2014
19.12.2014
No.:91/13/82‐ALC4/2014
Name:INCHEM
No/Date:13/82‐
TORIES PRIVATE
No.:98/13/82-ALC4/2014
Name:AUROBINDO
No/Date:13/82-

Decision:Itwasdecidedtodeferthecasefor05.02.20'
Pharmaceuticals
Decision:It was decided to defer the case fbr 05.02.2015 for comments OfDepartment Of
Pharmaceuticals
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Parfy Name:HETERO LABS
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File :01/821050/01096/AM l5/ RLA File
ICaseNo.:94/13/82‐
ALC4/2014
No/Date:13/82‐
4
No/Date:13/82-
File:01/82/050/01102/AM15/
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No。:102/13/82-ALC4/2014
Name:DR REDDYS
Meet No/Date:13/82-
ALC4/2014
File:01/82/050/01lo5/AM15/
File:01/82/050/01103/AM15/
TORIES LIMITED
19.12.2014

「
i:09 /24/ 040 / 00487 / AMt 5 I
loqsz.zou
Decision: It was decided to defer the case for 05.02.2015
Pharmaceuticals
ICase No.:280ノ13ノ82‐ ALC4ノ2014
而百聞FT~
Ⅶ夕 躙鼎α酬∞a%5日蕊蕊
;

TORIES LIMITED
19.12.2014

「
i:09 /24/ 040 / 00487 / AMt 5 I
loqsz.zou
Decision: It was decided to defer the case for 05.02.2015
Pharmaceuticals
ICase No.:280ノ13ノ82‐ ALC4ノ2014
而百聞FT~
Ⅶ夕 躙鼎α酬∞a%5日蕊蕊
; 
lDecision : It was decided to defer the case for 05.02.2015 for comments of Department of
i 
lPharmaceuticals
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Mcct No/Date:13/82‐
IALC4/2014
119.12.2014
Status:Case
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decided to defer the case for 05.02.2015 for comments of Department of
lDecision : It was
:Pharmaceuticals
1111111誕
~~~
:05.02.2015
283 HQ Filc:01/82/050/01282/AM15/
RLA File
:09/24/040/00510/AM15/
Lic.No/Date:0910061362
It was dccided to deferthe case for 05.02.2015 for comments of Department of
S
:09/24/040/00509/AM15/
Lic.No/Date:0910061372
12.12.2014
墨1臨
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「
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defer the case fOr 05.02.2015 for commcnts ofDepartmcnt of

Datel8.12.2014
Place:New Delhi
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72

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