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t Office of Directorate General of Foreign Trade New Delhi -0
Para 4.7 Decision(DRAFT)
Meeting No. 0l/8212018 of 2018-19 dated 01.05.2018 (actually held on 17.05.2018 and 29.05.2018) consideied the cases/issues under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy,2015-20 pertaining to Chemical and Allied products falling under Chapter 29 and 30, held under the Chairmanship of ShriJ.V. Patil, Addl. DGFT in Room No.1l, Udyog Bhawan, New Delhi. Following members were present:- Shri Nirmal Kumar, Dy. Director General of Foreign Trade Consultant, Technical Expert Pharmaceuticals Consultant, Technical Expert Chemicals The committee went thrbugh the minutes of earlier meeting No. l2l82 dated 20.03.2018 (actually held on 01.05.2018) and approved the same. ⅣlEETING NUⅣlBER :1/82-ALC4/2018 MEETING DATE:01.05.2018 (aCtuaHy hCld on 17.05.2018 and 29.05.2018) | ICase No.:76/4/82¨ ALC4/2012 Party Name:CADILA IHEALTHCARE LTD., HQ File :01/82/050/00156/AM13/ ,Mcet No/Date:1/82- IALC4/2018 101.05.2018 IRLA File :08/24/040/00301/AM12/ on the mafter in the ,technical experts and it was decided to rati8/ the ad-hoc input ouQut ;details below or as applied by firm whichever is lower: under para 4.7 of HBP as Per '
Case No.:184/10/82¨ ParりName:ALKAL01DS IMeet No/Date:1/82- |
‐ALC4/2013 ‐CORPORAT10N IALC4/2018 1Approved '01.05.2018 1 IHQ File lRLA File lLic.No/Date:0210190503 1 101/82/050/00367/AM14/ .102/24/040/00030/AM14/ 110.06.2013 1 Decision : Committee considered the cases as per agenda and in the light ol earlier decision taken in ,meeting no. 13lS2dated 05.09.2013, it was decided to ratiff norms under Para 4'7 of HBP vl as per details ; given below or as applied by the firm, whichever is less: , Ｆ ， ‐ １ １ Export product Exo. Oty. Imoort items Otv. allowed RIVASTIGMINE ZYDUS l.5 MC CAPSULES lNumber RIVASTIGMINE TARTRATE 2.45 mgll.5 mg caPsule RIVASTIGMINE ZYDUS 3 MG CAPSULES lNumber RIVASTIGMINE TARTRATE 4.90 mgl3.0 mg caPsule RIVASTIGMINE ZYDUS 4.5 MG CAPSULES lNumber RIVASTIGMINE TARTRATE 7.35 mg/4.5 mg caPsule RIVASTIGMINE ZYDUS 6 MG CAPSULES lNumber RIVASTIGMINE TARTRATE 9.80 mg/6 mg caPsule 一―轟 ⌒ IStatus: Approved Lic.No/Date:0810110001 1 22.032012 ,RA concemed may take further necessary action as per above decision of NC' つ ４
CAPSULES lNumber RIVASTIGMINE TARTRATE 9.80 mg/6 mg caPsule 一―轟 ⌒ IStatus: Approved Lic.No/Date:0810110001 1 22.032012 ,RA concemed may take further necessary action as per above decision of NC' つ ４
（ ´ ´ Expon product Export Quantity Sl.No. Import items Qty. allowed Noscapine BPA.ioscapine Hcl BP 0.049 kg 1 1 X Papaverine (Wet)-Crude containing Noscapine not more than 8%o and crude Papaverine not more than 25Yo (on dry basis) Moisture content NLT 32% w/w lkg Papaverine Hcl BP 0.153 kg RA may take appropriate action as per the decision of Norms Committee. Ｓ ‐ ． Ｎ 。 Export product Exp.Qty. Ｓ ‐ ． Ｎ 。 Import items Qty. allowed 1 CO―AMOXICLAV TABLETS B.P625 MG OR AMOXICILLIN WITH CLAVULANATE POTASSIUM TABLETS 625 MG IP/USP 20000000.000 Tablets 1 AMOXICILLIN TRIHYDRATE IP/USP/BP 1170.56 kg 2 POTASSIUM CLAVULANATE DILUTED IP/BP WITH MICROCRYSTALLINE CELLULOSE(1:1) 601 800 kg ALUMINIUM LAMINATED FOIL PRINTED Relevant as ｇ ｎ ｋ ｐ ａ ｃ ｙ ｅ ｒ ｏ ‐ ｐ ｐ 4 ALU ALU BOTTOM FOIL FOR BLISTER PACK Relevant as per packing policy 2 CO―AMOXICLAV TABLETS B.P375 MG OR AMOXICILLIN WITH CLAVULANATE POTASSIUM TABLETS 375 MG IP/USP 300000.000 Tablets 1 AMOXICILLIN TRIHYDRATE IP/USP/BP 87.79 kg 2 POTASSIUM CLAVULANATE DILUTEDIP/BP WITH MICROCRYSTALLINE CELLULOSE(1:1) 90.270 3 ALUMINIUM LAMINATED FOIL PRINTED Relevant as per packing policy 4 ALU ALU BOTTOM FOIL FOR BLISTER PACK Relevant as per packing policv CO―AMOxlcLAV TABLETS B.PlGM OR AMOxlcILLIN WITH 3000oo.ooo Tablets 1 AMOXIcILLIN TRIHYDRATE IP/USP/BP 307 27 kg 2 | ICase No.:1/9 IP額けName:FINE CURE PHARMACEUTICALS LTD. IMeet No/Date:1/82-
ng policv CO―AMOxlcLAV TABLETS B.PlGM OR AMOxlcILLIN WITH 3000oo.ooo Tablets 1 AMOXIcILLIN TRIHYDRATE IP/USP/BP 307 27 kg 2 | ICase No.:1/9 IP額けName:FINE CURE PHARMACEUTICALS LTD. IMeet No/Date:1/82- IALC4/2018 ‐01.05.2018 Status: Approved :HQ File i:01/82/050/00728/AM18/ IDecision:Committee considered case as per agenda and deliberated on the ma"er in the presence of thel iteChnical experts and■was decided to ranfy the ad― hOc input Output norllls under para 4.7 ofHBP as peri ldetailS belowOras appliedby arm whicheveris lower i IRLA File i:08/24/040/00478/AM14/ 19.02.2014
CLAVULANATE POTASSIUM TABLETS l GM IP/USP 2 POTASSIUM CLAVULANATE DILUTED IP/BP WITH MICROCRYSTALLINE CELLULOSE(1:1) 90.270 kg ALUMINIUM LAMINATED FOIL PRINTED Relevant as per packing oolicv 4 ALU ALU BOTTOM FOIL FOR BLISTER PACK Relevant as per packing oolicv 4 CO―AMOXICLAV FOR ORAL SUSPENS10N BP 457 DRY SYRUP(100ML) 10000.000 Tablets l AMOXICILLIN TRIHYDRATE IP/USP/BP 84.O kg 2 POTASSIUM CLAVULANATE DlLUTED IP/BP WITH SILICON DIOXIDE (1:1) 28.24 kg 5 CO‐AMOXICLAV FOR ORAL SUSPENS10N BP 457 DRY SYRUP(70ML) 10000.000 Tablets 1 AMOXICILLIN TRIHYDRATE IP/USP/BP 58.8 kg つ ４ POTASSIUM CLAVULANATE DlLUTED IP/BP WITH SILICON DIOXIDE (1:1) 19 8 kg 6 CO―AMOXICLAV FOR ORAL SUSPENSION BP 312.5 DRY SYRUP (100ML) 60000.000 Tablets 1 AMOXICILLIN TRIHYDRATE IP/USP/BP 315,O kg 2 POTASSIUM CLAVULANATE DILUTED IP/BP WITH SILICON D10XIDE (1:1) 186.08 kg 7 CO―AMOXICLAV FOR ORAL SUSPENSION BP 156.25 DRY SYRUP (100ML) 50000.000 Tablets 1 AMOXICILLIN TRIHYDRATE IP/USP/BP 131.25 kg 2 POTASSIUM CLAVULANATE
ILUTED IP/BP WITH SILICON D10XIDE (1:1) 186.08 kg 7 CO―AMOXICLAV FOR ORAL SUSPENSION BP 156.25 DRY SYRUP (100ML) 50000.000 Tablets 1 AMOXICILLIN TRIHYDRATE IP/USP/BP 131.25 kg 2 POTASSIUM CLAVULANATE DILUTED IP/BP WITH SILICON D10XIDE (1:1) 77.53 kg CO‐AMOXlCLAV FOR ORAL SUSPENS10N BP 156.25 DRY SYRUP (60ML) 20000.000 Tablets 1 AMOXICILLIN TRIHYDRATE IP/USP/BP 31.50 kg 2 POTASSIUM CLAVULANATE DlLUTED IP/BP WITH SILICON D10XIDE (1:1) 18.61 kg 9 CO―AMOXICLAV FOR ORAL SUSPENS10N BP 20000.000 Tablets 1 AMOXICILLIN TRIHYDRATE 58.8 kg 3
RA concerned may take further necessary action as per above decision of NC. 228.5 DRY SYRUP(70ML) IP/USP/BP つ ４ POTASSIUM CLAVULANATE DILUTED IP/BP WITH SILICON DIOXIDE (1:1) 19.80 kg | ision : Committee considered case as per agenda and deliberated on the matter in the presence nical experts and it was decided to ratifu the ad-hoc input output norms under para 4.7 of HBp ils below or as applied by firm whichever is lower: Export product Exp. Otv. Import items Qty. allowed I ablets Phenoxymethylpencillin 250m9. Each Tablet Contains : Phenoxymethylpencillin Potassium BP eq. to Phenoxymethylpencillin 250mg. I Number Phenoxymethylpencillin Potassium (Pencillin V Potassium) BP/CP/USP
- (Powder Form) 282.73 mg/per tablet Tablets Phenoxymethylpencillin 250mg. Each Tablet Contains : Phenoxymethylpencillin Potassium BP eq. to Phenoxymethylpencillin 250mg. I Number RA concerned may take furthcr necessary action as per above decisiOn OfNC. 亜亜ⅢⅢⅢ … 5111 Ｓ ｍ Ｔ ‐ ｃ Ａ Ｌ IStatus: Approved 4 as per
lpencillin Potassium BP eq. to Phenoxymethylpencillin 250mg. I Number RA concerned may take furthcr necessary action as per above decisiOn OfNC. 亜亜ⅢⅢⅢ … 5111 Ｓ ｍ Ｔ ‐ ｃ Ａ Ｌ IStatus: Approved 4 as per
| :HQ File l 101/82/050/00105/AM18/ ILic.No/Date:0410160674 115.062015 一 っ ４ 一 ８ 一 ２ 一 ８ 一 Ｎ ｏ ・ ‥ ８ ４ ／ ‐ ３ 外 ・ 一 ， Ｃ ａ ｓ ｅ 肛 ‘ 一 〓 ‐ １ ・ ‘ ， ， ・ ― 狡 ギ ー ， Ｉ iRA concerned may take further necessary action as per above decision of NC. IHQ File IRLA File |:01/82/050/01047/AM16/ ::34/24/040/00066/AM16/ L'■IⅢDeferred for comments of TE ― | of thel as perl Decision : Committee considered case as per agenda and deliberated on the matter in the presence technical experts and it was decided to ratifr the ad-hoc input output norms under para 4.7 of HBP details below or as applied by firm whichever is lower: Export product Exp.otv. Sl.No. Import items Oty.allowed NYSTTIN TABLETS USP 500000 11NITS I Number 1 NYSTATIN USP 85.87 mg/tablet l iCa:ぎ｀ま:fiJijたふ~~… | :ALC4/2015 , I 'Mcct NoDate:1/82- Status:Deffered l謂獄f lndRe珈“К d lLic.No/Datc:0710109705 1Defer 25.04.2016 1Date126 07.2018 IMect No/Datc:1/82- lALC42018 01.05.2018 :_ _____ _ iStatus: lApproved a 1 ‐ :ёiきもヽま:,o/9/82‐ ALこ4/201' ParりNamciVERDANT LIFE I i SCIENCES PVT LTD う ４ Ex Sl. I Import items .Allowed 5 V AROCHEM IALC4/2018 101.05.2018 |:01/82/050/01076/AM16/ lDecision : A copy of reply dated23.03.2016 received from the firm has been sent to the Deptt. of C&PC on \06.04.2016.
Import items .Allowed 5 V AROCHEM IALC4/2018 101.05.2018 |:01/82/050/01076/AM16/ lDecision : A copy of reply dated23.03.2016 received from the firm has been sent to the Deptt. of C&PC on \06.04.2016. Deferred for comments of TE iCase No。:98/20/82‐ :ALC4/2015 lmttg認 澗 朧 「 ED難 嘲 T“ 脇 | ,1.05.2018 ll0 rHQ File 1 ti0l1821050/01681/AM16/ , lDecision : Information received and sent to DoP on 28.1 1.2017 . The Committee accordingly defer the case. I iCase No.:47614/82- iALC4t2ot7 IPa●y Name:NATURAL AND IESSENTIAL OILS PVT LTD File :U1/6Z/U)U/UU464/AIV11 6/ : Deferred for comments of TE
Oty. No. CARISOPRODOL l kg l Propionaldchyde Liould 1.024 2 DimtthyI Carbonate Liquid 0.80 Mono lsopropylanline Liquid 0.737 4 Para Follllaldehyde Solid 0.390 5 Methanol Liquid 0.121 6 Caustic Soda Flakes Liquid 0,975 7 Chloroform Liouid 0.183 Palladiunl carbon Solid 0.164 gm/kg 9 Trichloro Acetic Acid Solid 1.28 kg 10 Sodium Cyanate Solid 0.508 kg Toluene Liquid 0.664 kg RA concerned may take further necessary action as per above decision of NC i iCascNo.:477/4/82‐ 1 lALC4/2017 1B Io十五8 ~ , |:01/82/050/00485/AM18/ [辮酬需i菅: IRLA File 107/24/040/00120/AM17/ | ICase No.:224/4/82- IPaりName:OPTIMUS iMect No/Datc:1/82- Status:Deffered i l FLα 2側7 :RU∝ 関VAttЫMttD I謂 鰍f lndRe価 “ Кdl : 10iだ~… …… IRLA Fi18~~~~ 仁お :ヽレ5証よ bうlooも4446 1De庭: ■ 14101/82/050/00232/AM18/ :09/24/040/00397/AM17/ 107.12.2016 1Date:26.07.2018' Oecision : The Committee decided give final reminder to the firm to furnish the inlormation based on the
庭: ■ 14101/82/050/00232/AM18/ :09/24/040/00397/AM17/ 107.12.2016 1Date:26.07.2018' Oecision : The Committee decided give final reminder to the firm to furnish the inlormation based on the ,recommendationofD/oPharmaceuticalsforwardedo.M.No350lll22ll2o16-PI(Norms)dated26,09,20l1, 1 iuploaded at the end of these minutes of 7 182 meeting dated 22.11 .2017 failing which case will be rejected. : Case is deferred. 肝 ― .Case No.:225/4/82- IALC4/2017 Paty Name:ORCH ILABORATORIESINDIA ILTD PVT:ALC4/2018 101.05.2018 rstatus: : rApproved : IMもも 1ヽo'51おliた,1 1Stitiζ : ~| | IHQ File 101/82/050/00233/AM18/ IRLA File ::09/24/040/005061AM17/ ILic.No/Date:0910064459 1 p8.12.2016 1 Decision : Committee considered case as per agenda and deliberated on the matter in the presence technical experts and it was decided to ratify the ad-hoc input output norms under para4.7 of HBP Export product Exp. Otv. Ｓ ‐ ． Ｎ 。 Import items Qty A1lowed kg 6 :Mcet No/Date:1/82- :冊盤ぜ ILic.No/Date:0710110078 1Defer 112.07.2016 IDate:26.07.2018 i lDecision : Deferred for comments of TE
of HBP Export product Exp. Otv. Ｓ ‐ ． Ｎ 。 Import items Qty A1lowed kg 6 :Mcet No/Date:1/82- :冊盤ぜ ILic.No/Date:0710110078 1Defer 112.07.2016 IDate:26.07.2018 i lDecision : Deferred for comments of TE
4-AMINO-2-OXO― PYRIMIDINYL‐ OXATHIOLANE-2-CARBOXYLIC ACID-lSOPROPYL― METHYL‐ CYCLOHEXYLESTER(CHE) l kg 1 Glyoxylic Acid 500/0 0.743 kg 2 L(―)menthol 0.751 kg Cyclohexane 0.79k負 4 2,5¨Dihydroxy‐ 1,4-E)ithiane (2,5-DHT) 0.325 kg Cvtosine 0.428 kg 6 Hexamethyl Disilazane 0.698 kg :RA concerned may take further necessary action as per above decision of NC ,u,rO i,,. ICase No。:200/4/82- ALC4/2017 IPaty Name:MYLAN :LABORATORIES LIMITED .Mcet No/Date:1/82- ALC4/2018 101.05.2018 IStatus:Deffered and Re‐ lndexed lDefer Date:26.072018 IRLA File 109/24/040/00473/AM17/ ILic.No/Date:0910064484 14.122016 :01/82/050/00208/AM18/ iDecision:Deferred for comments of TE ICase No.:199/4/82- Parり Name:OPTIMUS Mcet No/Date:1/82- IStatus: :ALC4/2017 DRUGS PRIVATE LIMITED ALC4/2018 Approved 101.052018 IHQ File RLA File Lic.No/Date:0910064489 101/82/050/00207/AM18/ :09/24/040/00512/AM17/ 120.12.2016 Decision : Committee considered case as per agenda and deliberated on the matter in the presence of the 'technical experts and it was decided to ratifu the ad-hoc input output norms under para 4.7 of HBP as per Exoort oroduct Exp. Qty. Import items Qty.
deliberated on the matter in the presence of the
'technical experts and it was decided to ratifu the ad-hoc input output norms under para 4.7 of HBP as per
Exoort oroduct
Exp. Qty.
Import items
Qty. allowed
LORNOXICAM
l kg
LORNOXICAM
1.395 kg
181責。File l良LA 11 ~ :01/82/050/00037/AM18/ :08/24/040/00118/AM17/ IDecision:Deferred for comments of TE and Re-indexed 01.05.2018 1 ~ Lばヽ 3′bふ直 16意idi」94」うIDe庭: ~ 104.01.2017 1Date:26.07.2018 iCase No.:29/4/82- IALC4/2017 Paty Name:ARVEE LABORATORIES INDIA IPRIVATE LIMITED l iCasc No。:173/4/82‐ IALC4/2017 191青0「i18 1:01/82/050/00181/AM18/ IPa●y Name:OGENE SYSTEMSINDlA LTD. RLA File 109/24/040/00535/AM17/ IMもよヽ 6′bi:i/慧
'」 ヽ
titi:ibもfferど | IALC4/2018 101.05.2018 and Re-indexed I Lic.No/Date:0910064554 1Defer 05.01.2017 1Date:26.07.2018 11食ぶ身′薦: :辮趾曲 6「~“&面b品磁■鳳 : ンPvT IALC4/2018 1Approved i l lLTD_ 01.05.2018 1 : ち01HQAお ― ― RLA由 8 ~ ~ |ふ とヽル5嘉 :60166`4ζ
め
―
|
…
1
1 101/82/050/00179/AM18/ 1:09/24/040/00317/AM17/ 109.01.2017 1 1
1 :b“ ヽお1l ё
6轟拓
1188 88Add813とあξも五ξおも
f igendiょia‐ aまぉも品きさ
6五iも襦血群1l theお:3ζも
16も61lAも
|
| ltechnical experts and l was decidcd to ratitt the ad‐ hoc input output nomns under para 4.7 of HBP as peri
7
|
1RA concemed may take further necessary action as per above decision of NC-
Decision :Deferred for comments of TE
s decidcd to ratitt the ad‐ hoc input output nomns under para 4.7 of HBP as peri 7 | 1RA concemed may take further necessary action as per above decision of NC- Decision :Deferred for comments of TE
Export product
Exp.
Otv.
Sl.
No.
Import items
Qty.Allowed
kg
GCLE(7-PEHNYL ACETAMIDEO―
3‐CHLORO METHYL
CEPHALOSPORANIC ACID PARA
METHOXY BENZYL ESTER)
kg
1
PENICILLIN G
POTASSIUM FIRST
CRYSTAL
1.61 kg
つ
ろ
ACETONE
1.971 kg
ISOPROPYL ALCOHOL
0.66 kg
4
METHYLENE
CHLORIDE(MDC)
3.29 kg
2 MERCAPTO BENZ0
THIAZOLE(MBT)
0.51lkg
6
METHANOL
1.971 kg
ldetails below or as applied by flrm whichever is lower:
|
as perl
IRA concemed maytake mihernecessary action as per above decision ofNC
Decision : Committee considered case as per agenda and deliberated on the matter in the presence
technical experts and it was decided to ratifu the ad-hoc input output norms under para 4.7 of HBP
Export product
Exp.
Oty.
Ｓ
‐
．
Ｎ
。
Import items
Qty.Allowed
kg
GCLE(7-PEHNYL ACETAMIDEO‐
3¨CHLORO METHYL
CEPHALOSPORANIC ACID PARA
METHOXY BENZYL ESTER)
l kg
1
PENICILLIN G
POTASSIUM FIRST
CRYSTAL
1.61 kg
2
ACETONE
1.971 kg
ISOPROPYL ALCOHOL
0.66 kg
4
METHYLENE
CHLORIDE(MDC)
3.29 kg
5
2 MERCAPTO BENZ0
THIAZOLE(MBT)
0.51lkg
6
METHANOL
1.971k負
IP釘りName:SUVEN LIFE :Mcet No/Date:1/82- IStatus: |
ISCIENCES LIMITED IALC4/2018 1Approved l
22
l ol.05.2018 : |
| |
。1・UD・ZU16 : |
聴薫蔦蔦蕊戸鴨ち刷
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蕊需而蔽百奮
~…1
/24/040/00527/AM17/ 110.01`
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……
獅五而扇画面面扇百
1
1Approved l
22
l ol.05.2018 : |
| |
。1・UD・ZU16 : |
聴薫蔦蔦蕊戸鴨ち刷
iO蔦~~~~瑶
蕊需而蔽百奮
~…1
/24/040/00527/AM17/ 110.01`
障Q nb ~~~IRLARL~…
……
獅五而扇画面面扇百
1
101/82/050/00174/AM18/ :09/24/040/00527/AM17/ 110.01.2017 1
Decision : Committee considered case as per agenda and deliberated on the matter in the presence of the '
technical expefts and it was decided to ratifo the ad-hoc input output norms under para 4.7 of HBP as per I
nical experts and it was decided to rati$r the ad-hoc input output norms under para 4.
ils below or as applied by firm whichever is lower:
Export product
Exp.
Otv.
Ｓ
‐
．
Ｎ
。
Import items
Qty.Allowed
Kg
METHYL (E)-2-(2-
CHLOROMETHYLPHENYL) 3-
METHOXYACRYLATE
l kg
1
3-
ISOCHROMANONE
0.957 kg
つ
４
0-XYLENE
1.04 kg
8
| ICase No.:230/4/82‐
F躙嘲WT
:LTD.
IMeet No/Datel1/82- IStatus:
:ALC4/2017
IALC4/2018
101.05.2018
,Approved
|
121
, IHQ File RLA File lLic.No/Date:0910064564 1
I Case No.:166/4/82-
IALC4/2017
‐ F躙嘲WT :LTD. IMeet No/Datel1/82- IStatus: :ALC4/2017 IALC4/2018 101.05.2018 ,Approved | 121 , IHQ File RLA File lLic.No/Date:0910064564 1 I Case No.:166/4/82- IALC4/2017
SODIUM METHOXIDE POWDER 0.416 kg 4 METHANOL 2 31 kg | 壼 ,RA concerned may take further necessary action as per above decision of NC | ICase No.:159/4/82- ParりName:GLAND IMeet No/Datel1/82- Status: | 'ALC4/2017 PHARMA LIMITED IALC4/2018 Approved 101.05.2018 1 1HQ File lRLA File iLic.No/Date:0910064579 1 101/82/050/00167/AM18/ :09/24/040/00543/AM17/ 12.01.2017 1)ecision : Committee considered case as per agenda and deliberated on the matter in the presence of the lteChnical expelts and it was decided to rati″ the ad― hoc input output norms under para 4.7 of HBP as per 'details below or as applied by firm whichever is lower: Export product Exp.Qty. Si. No. Import items Qty. Allowed Voriconazole Powder for ltteCtiOn 200 mg/Vial,30 mi Vial USP I Number 1 Voriconazole USP 210 mg/vial 2 Kleptose NF 3200 mg/vial ‐ ｓ ｓ ｓ ａ ａ Ｖ Ｇ Relevant as per oackins policy 4 Rubber Stoppers Rubber Relevant as per packing policy Seals Plastic Relevant as per oackins oolicy 6 Filters Plastic Consumable 7 Tubing Plastic Ｖ Ｎ 。 ｔ Ｏ 。‐ ｉ allowed under IRA concerned may take further necessary action as per above decision ofNC I Case No.:229/4/82¨ ParりName:AAP PHARMA I :ALC4/2017 1TECHNOLOGIES INDIA :OLC42017 TECIINOLOGESNDR l .
RA concerned may take further necessary action as per above decision ofNC
I Case No.:229/4/82¨ ParりName:AAP PHARMA
I :ALC4/2017 1TECHNOLOGIES INDIA
:OLC42017 TECIINOLOGESNDR
l . lPRIVATE LIMITED
Meet No/Datei1/82- Status:Deffered
ALC4/2018 1and Re‐ indexed
10105.2018
1Lic.No/Date:0910064583 Defer
13.01.2017 1Datc:26.07.2018
)n'* Hq Fil.
RLA File
:
":01
1821050100237 1 AM181 ' :0912410401005 1 3/AM l 7/
| 'Casc No■1604/82‐ IPatt N品
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‐ No/Date:1/82- Status: |
| IALC4/2017 PETROCHEMICAL PVT IALC4/2018 1Approved i
: | ILTD. 101.05.2018 1 1
-一
――――――″――――――
―
一一～―r―=―
――
=‐ ■■~~~~■‐ 1■■1,■■■■=~「
|
| IDecision:Deferred for comments of TE
澁
蕊jtt」~聴
翻蕊島扁戸
~臨
萬繭蒟64605~「~~~~
2017 1
125 1Decision:Committee considered case as per agenda and deliberated on the matter in the presence of thei
technたd expeis and l was decided to rtti″ the ad_hoc hput output norlns under para 4 7 ofHBP as peri
ldetJヽbdOW or as applおd by■rm whicheverヽlower l
Export product
Exp
Otv.
Ｓ
‐
．
Ｎ
。
Import items
Qty.Allowed
k負
GCLE(7‐PEHNYL
l kg
1
PENICILLIN G
1.61 kg
」
轟
9
123
7 ofHBP as peri
ldetJヽbdOW or as applおd by■rm whicheverヽlower l
Export product
Exp
Otv.
Ｓ
‐
．
Ｎ
。
Import items
Qty.Allowed
k負
GCLE(7‐PEHNYL
l kg
1
PENICILLIN G
1.61 kg
」
轟
9
123
10
3-CHLORO METHYL
CEPHALOSPORANIC ACID PARA
METHOXY BENZYL ESTER)
POTASSIUM FIRST
CRYSTAL
2
ACETONE
1.971 kg
3
ISOPROPYL ALCOHOL
0.66k負
4
METHYLENE
CHLORIDE(MDC)
3.29 kg
2 MERCAPTO BENZ0
THlAZOLE(MBT)
0.51lkg
6
METHANOL
1.971 kg
: | | 13 1面百〒面天雨δE
l lRAconcemedmaytakenirthernecessaryactionasperabovedecislo■ofNC
,い
eN∝つた/82‐
'aゥ
NamαKOPRA｀
控:漱摯
よ磁
濡
糧li漱:
:6輛既ふ鳳鳥ij越筋滋蔦LI野弊崩面面デ
:れふ漁
I Dettioli b`felたJf。}あ品tit:61十二 ~‐ ‐~~~ ‐ ~ ~‐ 1
Ｆ
Ｉ
‐
ICase
lALC
IHQ File
l:01/82/01
No.:185/4/82-
LC4/2017
警
漱
辮
評
:翻
r由
/82-~警
濡
:
鶴濡品二詰; 謝需b満品■ 1
:01/82/050/00193/AM18/
IDecislon:COmmittee
leChniCal cxperts and it
considered case as per agenda and deliberated on the matter in the presence of the
: was decided to ratify the ad-hoc input output norms under para 4.7 of HBp as per
,RA concerned may take further necessary action as per above decision of NC
ls below or as applied by firm whichever is lower:
Export product
Exp.
Otv.
Ｓ
‐
．
Ｎ
。
Import items
ｙ
Ｑ
ｔ
ｈ
AHowed
(S)‐ 卜(3-ETHOXY¨4-
METHOXYPHENYL)‐ 2-METHANE
SULFONYL ETHYL AMINE
l kg
1
ISOVANLLINE
0.968
2
ACETONITRILE
0.95
3
SODIUM BOROHYDRIDE
0.26
4
TETRAHYDROFURAN
2.34
S(― )‐ALPHA―METHYL
BENZYL AMINE
0.593
6
ISO PROPYL ALCOHOL
(IPA)
3.77
7
2-METHYL
TETRAHYDROFURAN
0.71
11壺脇脅
/4/8が｀‐
11群繋1奮雪
i由
′
81。Fi` ~ lLAri`
騨ぎ橘メ
~,蕊靖曲
:
101/82/050/00079/AN(18/ :03/94/040/00970/AM17/
―METHYL
BENZYL AMINE
0.593
6
ISO PROPYL ALCOHOL
(IPA)
3.77
7
2-METHYL
TETRAHYDROFURAN
0.71
11壺脇脅
/4/8が｀‐
11群繋1奮雪
i由
′
81。Fi` ~ lLAri`
騨ぎ橘メ
~,蕊靖曲
:
101/82/050/00079/AN(18/ :03/94/040/00970/AM17/
IDecision:Deferred fOr comments Of TE
２
８
４
４
Ｎ
ｏ
・
‥
‐
８
”
・
寂
」
Ｃ
一
Ｃ
Ａ
一
江
一
Party lMeet No/Date:1/82-
Name:M.R.LABORATOARIES'ALC4/2018
,PVT LTD. lol.05.2018
127
ILic.No/Date:0310810834 1Defer
i31.01.2017 1Date:26.07.2018
.and Re-indexed
11
IHQ Fllc
RLA F‖ e
101/82/050/00192/ANl18/ :09/24/040/00544/AM17/
IDecision:Deferred for comments of TE
ILic.No/Date:0910064621 1Dcfer l
131.01.2017 1Date126.07.20181
,Case No.:149/4/82‐
IALC4/2017
101/82/050/00157/AM18/
RLA File
i09/24/040/00574/AM17/
ILic.No/Date:0910064617
:31.01.2017
Status:Deffered ,
land Re-indexed
,
'Defer
Date:26.07.2018
Party Name:MYLAN IMeetNo/Date:1/82-
LABORATORIES LIMITED IALC4/2018
10105.2018
30,責。rile
,HQ File RLA File Lic.No/Date:03108109721 1
:01/82/050/00081/AM18/ 103/94/040/00991/AM17/ 10602.2017 1 :
IDecislon:Committee considered case as per agenda and deliberated on the matter in the presence ofthel
technical expens and l was decided to rati″
the ad― hOC input output norms under para 4.7 ofHBP as perl
31 details below or as applied by flrm whicheveris iower: |
Export product
Exp.
Otv.
Sl.No
Import items
Qty.
he ad― hOC input output norms under para 4.7 ofHBP as perl
31 details below or as applied by flrm whicheveris iower: |
Export product
Exp.
Otv.
Sl.No
Import items
Qty. allowed
Natoptic Eye Drops 5ml
(Natamycin Ophthalmic Suspension
5%o wlv )
vial
1
NATAMYCIN
‐
MICRONISED AND
STERILE
262.5 mg/5 ml
vial
,RA conce.ned may take funher necessary action as per above decision of NC'
CHEMiCALS PRIVATE
:ALC4/2018
101.05.2018
‐
IHQ Flle
l l:01/82/050/00202/AM18/
:LIMITED
IRLA File
::09/24/040/00569/AM17/
agenda and deliberated on the matter in
Decision : Committec considered case as per agenda and delib
lechniCJ CXpeis and l was decided to rad～
the ad_hoc mput Output noms under para 4.7 ofHBP as pcri
,d"taits below or as applied by firm whichever is lower:
ICase No.:73/4/82-
ALC4/2017
ICase No.:187/4/82¨
‐ALC4/2017
1HQ File
l:01/82/050/00195/AM18/
rParty Name:FDC LTD
IMeet No/Date:1/82-
:ALC4/2018
101.05.2018
―
|
illI蕊11「
~~~|
ヽ
132
Export product
Exp. Qty.
Ｓ
Ｉ
．
Ｎ
。
Import items
Qty.
e No.:187/4/82¨
‐ALC4/2017
1HQ File
l:01/82/050/00195/AM18/
rParty Name:FDC LTD
IMeet No/Date:1/82-
:ALC4/2018
101.05.2018
―
|
illI蕊11「
~~~|
ヽ
132
Export product
Exp. Qty.
Ｓ
Ｉ
．
Ｎ
。
Import items
Qty. Allowed kg
BROSALIDOX‐ L
(Containing minimum100/O of
100000.000 kg
1
PROPYLENE
GLYCOL
90000000
5 Bromo‐ 5 Nitro‐ 1,3-PIoxane)
2
5-BROMO‐ 5-
NITRO‐ 1,3‐
DIOXANE
10000000
RA concemed may take further necessary action as per above decision ofNC
…
壼
鑑IIムEII.´ ⌒vAl口ヽlT
Party NameiCOVALENT
LABORATORIES PRIVATE
LIMITED
RLA File
:09/24/040/00536/AM17/
IMcct No/Date:1/82-
IALC4/2018
101.05_2018
Lic.No/Date:0910064655
,07.022017
lstatus:Deffered t
land Re‐ lndexed l
Defer l
‐Date:26.07.2018:
IDecision:Deferred for comments of TE
1
1
, rCase No.:194/4/82 -ALC4t2Ol7 :Party Name:SALICYLATES & IMeet No/Date:1/82¨
rStatus:
l
,Approved
l
_:…
…
…
…
…
…
|
ILic.No/Date:0910064646
106.02.2017
Decision : Deferred for comments of TE
12
Ｆ
‐
‐
３
４
蕊FT勁脇蕊IF~硼鰤輌42169~「~~
:Decおlon:cOmmittee considered case as per agenda and dehberated on the matter in the presence of the
iteChnical experts and it was decided tO ratiヶ
thC ad_hOc input output
under para 4.7 of HBP as per
||ご誌
=面高薫瓦蔦蔦五百恵瓦菓瓦
Itth蔦蔦
iCase No.:190/4/82…
lALC4/2017
IPatyName:DISCOVERY
INTERMEDIATES PVT LTD.
RLA File
:09/24/040/00547/AM17/
iHQ Fllc
:01/82/050/00198/AM18/
IDecision:Deferred for comments of TE
「
:Case No。:449/4/82‐
:ALC4/2017
IPa●y Name:SARNA
ICHEMICALS PVT LTD
称Ъよ｀o/Dttliた,1
:ALC4/2018
Statui:
Approved
―
一
|
101.05.2018
:n
norm
para
0
ils below or as applied by firm whichever is lower:
Export product
Exp.
Qty.
Sl.
No.
17
IPa●y Name:SARNA
ICHEMICALS PVT LTD
称Ъよ｀o/Dttliた,1
:ALC4/2018
Statui:
Approved
―
一
|
101.05.2018
:n
norm
para
0
ils below or as applied by firm whichever is lower:
Export product
Exp.
Qty.
Sl.
No.
Import items
Qty.Allowed
Kg
N‐ETHYL LACTUM/N―
ETHYL-1:8-
NAPHTHOLACTUM / NEL /
ORGANIC DYE INTERMEDIATE SR―
102
l kg
1
NAPHTHO
STYRIL
0.985
2
CAUSTIC SODA
(100%)
0.580
:
1
:~摯
品
94/4/8メÅ面茄デ
請
11:1菱
ittЁbiё責Ⅲ
面品
ル″
~
. IALC4/2018
: 1 1 101.05.2018
1お憾雇話
iふ話し
~指
:鑑:胤ユζ
l話1 :総鸞
&山面池
`
St"irti
Approved
―
|
Decision : Decision : ln the light of written comments received from Department of Biotechnology vide
36 ltheir oM No. BTIIL/05/383120I3-P|D dated 29.11.2013, it was decided to ratify norms under para 4.7 of
::HBP Vl as perd∝前ヒ」ven bdOW Orasap口たd bytte nrm′ whcheverisles
: :
Item of Export
Qty.
SIo No.
Item of lmport
Quantity allowed kg
BACILLUS CEREUS(B.C.)
kg
1
PEP丁ONES
2.l kg
may take appropriate action as
the decision of Norms
per the decision of Norms Committee.
.:霊胤∬〃
8か 留路ズ訛織洲:懸ALS雄き淵Tαν"~:∬糧鼈蠍1
171。品― IWIr l[鷺驚ettЮ田
n亀te書
| IΠ マr HC IKLA[lie lLic.No/Date:0310811143 1Defer
‐ 1:01/82/050/00076/AM18/ :o3/94/040/01005/AM17/ 113.02.2017 Date:26.07.2018
1 :b``iまbi「bbfelユa‐ f。,ご61ttLIt:61it… ……~ ‐… ‐ ――‐‐ …… …… ……‐― _ _
1:謙
詢流
ALC4/2017榊
柵
1脚
純
~糧
11
1 1HQ「118~ IRLA Fii8~…
~ ~～
ILib.｀8,5乱さ
:0,lbiliibう | |
|_191`17イ9,99917,々ヽγl14 197(71イ919イ991,1`今M17/ 115.022017 1 1
‐ ___ 1 _ __ _ 1 1
醤∬蹴搬::
101.05.2018
IRLA Fii8~…
~ ~～
ILib.｀8,5乱さ
:0,lbiliibう | |
|_191`17イ9,99917,々ヽγl14 197(71イ919イ991,1`今M17/ 115.022017 1 1
‐ ___ 1 _ __ _ 1 1
醤∬蹴搬::
101.05.2018
IDefcr l
'Date:26.07.20181
ILic.No/Date:0910064659
107.02.2017
13
Decision r co*rnitt"" consideied ;h; ;ur; ; p"i ug"rou una i, it. iigtrt or earlier decision taken in mieting
no.6182 dated29.08.2014, it was decided to ratifo norms 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. allowed
kg
ALCIUM LACTOBIONATE
l kg
1
CALCIUM CARBONATE
0.172 kg
2.
LACTOSE
1.16 kg
CALCIUM
BROMOLACTOBIONATE
l kg
1
CALCIUM CARBONATE
0.360 kg
2.
LACTOSE
1 021 kg
HYDROBROMIC ACID
0.510 kg
ALCIUM GLUBIONATE
l kg
1
CALCIUM CARBONATE
0.259 kg
2.
LACTOSE
0.829 kg
CALCIUM GLUCONATE‐ ORAL
GRADE
0.430 kg
LACTOB10NIC ACID
l kg
1
CALCIUM CARBONATE
0.234 kg
2.
LACTOSE
1.58 kg
IMcet No/Date:1/82¨
Status: Deffered
and Re-indexed
ICHEMICAL INDUSTRIES iALC4/2018
1 lфL 、
tr品 ~i∴
~津
驚需品
1081めお鶯Lllふ::
| :01/82/050/00066/AM18/ :03/95/040/00361/AT
139 1Decision:Committee considered the case as per agenda and it was decided to call from the rlrm l
: lfOnOWing information:
| ■. COmplete chemical reaction molecular weight Structural formula ofimport and export item l
: I ShOWhg%"e‖
Of every stage of reacu毬
}.ned by CentrJ Excおe/GST I
l l‖ .
ing information:
| ■. COmplete chemical reaction molecular weight Structural formula ofimport and export item l
: I ShOWhg%"e‖
Of every stage of reacu毬
}.ned by CentrJ Excおe/GST I
l l‖ . Past production consumption data duly(
: ‐ilio Calculation sheet to arrive at the row material l
l
‐
: ICase No.:148/4/82- Parり
Name:VINS IMeet No/Date:1/82- Status:Deffered l
| IALC4/2017 .B10PRODUCTS LTD｀ ALC4/2018 and Re‐ indexed l
101。品
lLA乱
'型
l
‐
:
ILic.No/Date:0910064689 1Defer l
l :01/82/050/00156/AM18/ 1:09/24/040/00622/AM17/ 116.02.2017 Date:26.07.20181
| :01/82/050/00156/AM18/ 1:09/24/040/00622/AM17/ 116.02.2017 Date:26.07.20181
1 1 Decision:It was decided to remind DBT to expedite their commentso Case is deferred. |
| ICase No.:58/4/82‐
‐ IALC4/2017
14
|
ICase No.:143/4/82-
IALC4/2017
11HQ Filも ~~
‐
‐:01/82/050/00151/AM18/
| ICase No.:98/4/82-
1421ALC4/2017
Paty Name:PANACEA
IB10TEC LTD.,
IMeet No/Date:1/82-
:ALC4/2018
101.052018
Status:Deffered r
and Re-indexed
'Status: Deffered
'
and Re-indexed
l
ParりName:MICRO LABS IMcetNo/Date:1/82-
LTD
‐ALC4/2018
101.05.2018
RLA File Lic.No/Date:0710H l158 1Defer
:07/24/040/00375/AM17/ 121.02.2017 1Datc:26.07.2018
|コ)ecision:DeferredforCommentsofTE 11lIIIIIIIIIIIIIIIII111lli_」
A may take appropriate action as per the decision of Norms Committee.
¨壼
Party Name:OMTECH
1Datc:26.07.2018
|コ)ecision:DeferredforCommentsofTE 11lIIIIIIIIIIIIIIIII111lli_」
A may take appropriate action as per the decision of Norms Committee.
¨壼
Party Name:OMTECH
14
lHQ File
::011821050100 I 06/AM I 8/
一
〇
一
〇
一
〇
一
Ｃ
‘
４
一
Ｆ
ｉ
ｌ
仙
Ａ
２
一
Ｒ
Ｌ
“
51/AM17/
Lic.No/Date:0510401730
121.02.2017
|
Decision : It was decided to remind DBT to expedite their comments. Case is deferred
|
J
1郷滞″が ~躍燻需:|ま
~燎
璃濤滋~辮由臨
141。鳥 - lLAれ~ :点棚ょ
“
血
n比「
:もヽ
「 :
1嚢露∬Ⅷ翻比。lTPttΨ―″ 響しヽい2ッ洲|
|… Ⅲlζき｀こibi″′
j】
「 ~~,:■N品まЁRILLIA｀↑Lib lM8ぎ｀6/D品17ib」
~|ま
1ltζ :5effeたII
I :ALC4/2017 PHARMA PRIVATE IALC4/2018 1and Re―
indexed l
15HQhぉ
― ~ ~~~~tWIi『
‐― …
…
…
ど《認
おib・0064ウ
'ζ
‐
:き驀|｀
一
|
| 101/82/050/00189/AM18/ 1:09/24/040/00561/AM17/ 124.02.2017 Date:26.07.20181
1 1ι ふ
`お
I:itttζ b`tぬta t」ュha i t35,`iJ``れメiお1おb二十foriまrt品■きiti caユta`“lled i
lLЁS~ M“ :ヽ6′b五:まi′な,1 も
1ltiまb`ffeita l
l冊盤ぜ 1祠
k珈“逓
di
lLic.No/Date:0910064722 1Defer i
: 101/82/050/00191/AM18/ 1:09/24/040/00612/AM17/ 124.02.2017 1Date:26.07.2018:
| :Decision:Deferred for Comments of TE I
1舞濡
5/4/82‐
:嬬蕊需|よ 址漱需滋¨ :蕊摯漱
|
m蕊
蕊訂
‐
協脇議蕊
1靱嚇
海転漁
| :Decision:Deferred for COmments of TE ,
'491ALC4/2017
器Xttlt瀾3°MI躍盤げ 1劇k価“К
di
~lkLAri18 ‐ ― Ё
i`:ヽ8′bttie:bjibを113ib 15`庭r l
l lム品｀ま■浄4た2‐
… ……
,1もヽ:高さ:Åデ古ЁヽAbRUd lM品tヽル5滸よi′なう:
‐
:stitiζ DeffeFed l
l :ALC4/2017 1DELIVERY SOLUT10NS :ALC4/2018 and Re‐
indexed i
181漑
漁
萩
話j―
鷲続
i革鳳
″
-1奉
葬
品
面
面
「
皇[焼ti
lム品｀ま■浄4た2‐
… ……
,1もヽ:高さ:Åデ古ЁヽAbRUd lM品tヽル5滸よi′なう:
‐
:stitiζ DeffeFed l
l :ALC4/2017 1DELIVERY SOLUT10NS :ALC4/2018 and Re‐
indexed i
181漑
漁
萩
話j―
鷲続
i革鳳
″
-1奉
葬
品
面
面
「
皇[焼ti
l lDecislon:Deferred for Comments of TE
‐
| IHQFit~~^
ICase No.:63/4/82¨
IALC4/2017
ParサName:ALTA
ILABORATORIES LTD.
I
‐Meet No/Date:1/82-
IALC4/2018
101.05.2018
:Status:lDeffered
iand Re‐ indexed
143な
IHQ File
IRLA File
103/94/040/00998/AM17/
ILic.No/Date:0310811363:Defer
122.02.2017
,Date:26.07.2018
Decision:Deferred for Comments of TE
101/82/050/000881AM 18/
IDecision : It was decided
(ⅣIBF)。
15
103/94/040/01072/AM17/
tO can frOm the rlrm cOpy of
10103.2017
DML and copy
Date:26.07.20181
of「燿aster Batch Formulal
## Case No.:37/4/82-
IALC4/2017
Party NameiSARNA
ICHEMICALS PVT LTD
IMeet No/Date:1/82‐
1計″獄f
滞蹴膿:|
HQ File
IRLA File
:01/82/050/00045/AM18/ :52/24/040/00048/AM17/
‐Decislon:Deferred for Comments of TE
iLic.No/Datei5210042198 1Defer
IDate:26.07.20181
Status:
:Approved l
lDefer l
lDate:26.07.2018 1
## Case No.:39/4/82-
ALC4/2017
ParりNameiCADILA
IHEALTHCARE LTD
101.03.2017
:Mect No/Date:1/82‐
lALC4/2018
101.05.2018
:Lic.No/Date:0810139818
102.03.2017
IHQ File RLA File
:01/82/050/00047/AM18/ 1:08/24/040/00496/AM17/
IDecision : Committee considered casc as per agenda and
technical expens and it was decided to ratitt the ad_hoc i
ldetails below or as applied by flrm whichever is lower:
t deliberated on the matter in the presence of the ;
input output norms under para 4.7 of HBP as per r
| |
卜
|
―
‐
一
ICase No.:169/4/82¨
‐ALC4/2017
―
―
Status:
the presence of the
4.7 of HBP as Per
HQ Filc
一
一
―
一
一
嚇
Lic.No/Date:0910064766
:01/82/050/00177/AM18/ :09/24/040/00634/AM17/
03.03.2017
Decision : Committee considered case as per agenda and deliberated on the matter in
Itechnical experts and it was decided to ratifu the ad-hoc input output norms under para
,details below or as applied by firm whichever is lo-werl
Export Product
Qty.
Sl.No.
lmport items
Quantity allowed
Ks
MOISTURISING NASAL
SPRAY
(OXYMETAZOLINE
HYDROCHLORIDE
O.05%)lX22ML/
OXYSPRAY
MOISTURISING
lX22ML
llakh Nos.
1
OXYMETAZOLINE
HYDROCHLORIDE
USP
(
l.t22kgs
2.
30 CC HDPE18 MM
BOπ LE NS
AS PER GENERAL
POLICY FOR
PACKING MATERIAL
:PACKING
MATERIAL IN
FINISHED FORM‐
NET NOS.100000)
Relevant as per
packing policy
PUMP/ACTUATOR,
0.10 ML
AS PER GENERAL
POLICY FOR
PACKING MATERIAL
:PACKING
MATERIAL IN
FINISHED FORM‐
NET NOS.100000)
Relevant as Per
packing policy
RA concerned may take further necessary action as per above !g!lq!en i!NC
う
‘
R GENERAL
POLICY FOR
PACKING MATERIAL
:PACKING
MATERIAL IN
FINISHED FORM‐
NET NOS.100000)
Relevant as Per
packing policy
RA concerned may take further necessary action as per above !g!lq!en i!NC
う
‘
16
ー
rRA concerned may take further necessary action as per above decision of NC
Export product
Exp.
Otv.
Ｓ
‐
．
Ｎ
。
Import items
Qty.
AHowed kg
(lS)‐ 1‐ (3‐ETHOXY-4-
METHOXYPHENYL)-2‐
METHANESULFONYLETHYLAMINE
l kg
1
ISOVANLLINE
0.968
つ
４
ACETONITRILE
095
SODIUM
BOROHYDRIDE
0.260
4
TETRAHYDRO FURAN
2.34
S(― )‐ALPHA― METHYL
BENZYL AMINE
0.593
6
ISO PROPYL ALCOHOL
(IPA)
3.77
7
2-METHYL
TETRAHYDROFURAN
0.71
: ド
1きもヽこ′
42/4/8ふ ‐~,1■
Naふさ
liNDOムMiNEζ
1 lALC4ノ2017 :LIMITED
: 1 1
: IHQ File lRLA File
l 101/82/050/00450/AM18/ :03/94/040/01096/AM17/
IMeet No/Date:1/82-
ALC4/2018
101.05.2018
Status:
Approved
ILic.No/Date:0310811634
06.032017
Decision : Decision : Committee considered case as per agenda and deliberated on the matter in the
presence of the technical experts and it was decided to rati$ the ad-hoc input output norms under para 4.7 of
HBP as per details below or as applied by firm whichever is lower:
Export product
Exp.
Oty.
Sl.No.
Import items
Qty.
xperts and it was decided to rati$ the ad-hoc input output norms under para 4.7 of
HBP as per details below or as applied by firm whichever is lower:
Export product
Exp.
Oty.
Sl.No.
Import items
Qty. allowed
N METHYL MORPHOLINE
OXIDE 50%/1AL NMM0 50%
lKg
1
MORPHOLINE
0.391 kg
壼
Paty Name:GLOBAL
MEDICINES LTD,
‐
‐
‐
５
４
‐
‐
‐
‐
一
Ｆ
Ｉ
Ｉ
１
５
５
IMeet No/Date:1/82¨
IALC4/2018
.01.05.2018
iStatus:Deffered:
and Re-lndexed‐
IDefer l
lDate:26.07.20181
ILic.No/Date:34100433014
Decision : It was decided to call from the firm copy of COA of import item from foreign supplier
,showing particle size analysing.
iCase No.:154/4/82‐
lALC4/2017
HQ File
:01/82/050/00141/AM18/
IHQ File
:01/82/050/00162/AM18/
:34/24/040/00322/AM17/
109.03.2017
IRLA File
l:09/24/040/00651/AM17/
IDecisiom:Deferred for comments of TE
Party Name:STYRAX
IPHARMA PRIVATE
LIMITED
.Mect No/Date:1/82- :status:
:「″鰍ザ lpproVed
Lic.No/Date:05104019081
0903.2017 1
1
| ICase No。:133/4/82-
IALC4/2017
ILic.No/Date:0910064772 1Defer
109.03.2017 11)atei26.072018
Mect No/Date:1/82-
ALC4/2018
01.052018
醤需糧鼈鷲
I:::
iCase No.:13ノ4/82‐ ALC4/2017 1ParりName:SUN
I IPHARMACEUTICAL
I INDUSTRIES LTD.
File
IRLA File
11)atei26.072018
Mect No/Date:1/82-
ALC4/2018
01.052018
醤需糧鼈鷲
I:::
iCase No.:13ノ4/82‐ ALC4/2017 1ParりName:SUN
I IPHARMACEUTICAL
I INDUSTRIES LTD.
File
IRLA File
17
Decision : Committee considered case as per agenda and deliberated
technical experts and it was decided to ratifu the ad-hoc input output
,details below or as applied by firm whichever is lower:
Export Product
Qty
Sl.
No.
Import items
Quantity
allowed
Caffeine Citrate Injection USP,
60mg/3ml (2Omg/ml) 3ml, Each ml
contains Caffeine Citrate 20mg
equivalent to l0 mg of Caffeine
Anhydrous USP (Equivalent to 29.930
Ke of Bulk Drue)
I Number
1
CAFFEINE
ANHYDROUS
USP
33 mg/3 ml
vial
Caffeine Citrate Oral Solution USP,
60mg/3ml (20mg/ml) 3ml, Each ml
contains Caffeine Citrate 20mg
equivalent to l0 mg of Caffeine
Anhydrous USP (Equivalent to 20.000
Kg of Bulk Drug) (Equivalent to total
49930 Kg of Bulk Drug)
(Pharmaceutical Formulation / Standard
Grade)
I Number
1
CAFFEINE
ANHYDROUS
USP
33 mg/3 ml
vial
RA concerned may take further necessary action as per atrove decision of NC
ICase No.:46/4/82‐ ALC4/2017.Party Name:BIO TECH
IMeetNo/Dtte:1/82-
lStatus:
10PHTHALMICS PVT LTD IALC4/2018
‐ 1010く
つnl父
| 10PHTHALMICS PVT LTD IALC4/2018 1Approved
101.05.2018
1HQ File iRLA File Lic.No/Date:0810139896 1
|:01/82/050/00054/AM18/
IRLA File
:Lic.No/Date:0810139896 1
115.03.2017 1
1/050/00054//AM18/ :08/24/040/005081ヽM17/
Export Product
Qty.
Ｓ
ｌ
．
Ｎ
。
Import items
Quantity allowed
SODIUM CHONDROITrN
54/AM18/
IRLA File
:Lic.No/Date:0810139896 1
115.03.2017 1
1/050/00054//AM18/ :08/24/040/005081ヽM17/
Export Product
Qty.
Ｓ
ｌ
．
Ｎ
。
Import items
Quantity allowed
SODIUM CHONDROITrN
SULPHATE INJECTION 16%W/
V ( 6 ML VIAL)
NET CONTENTS OF BULK
DRUG l.152 KGS
1
Number
1
SODIUM
CHONDR01TIN
SULPHATE EP
1.056 Gm/6 ml vial
RA concemed may take further necessary action ls per above decision of NC
on the matter in the presence of the ,
norms under para 4.7 of HBP as per
汗
―
ヨ
「
―
―
―
―
―
―
―
―
・
―
―
―
も9faseN∝5V″82-ALC42m7曇的NamcNOαLЫMTED vedttTα
ν82- 1澪
:鵠ed l
‐ ‐ , :ALC4
な
71
::棚
F乱l∬評〕ξtt」iri∫甜
↓朧
Thttd叩
・
耐
四mmSm“
r“m47 J HBP器
"r
.Case No.:21/4/82‐
‐ALC4/2017
ParりName:BIOMIR
IVENTURE LLP
IMeet No/Date:1/82-
lALC4/2018
:01.05.2018
iStatus:Deffered
and Re… indexed
58 HQ File
RLA File
l:31/83/040/00174/AM17/
:Lic.No/Date:3110066623 1Defcr
:15.03.2017
IDate:26.07.20181
Decision : It was decided to call from the firm copy of DML and copy of COA of import item from
ifOreign supplier.
:31/83/040/00174/AM17/
:Lic.No/Date:3110066623 1Defcr
:15.03.2017
IDate:26.07.20181
Decision : It was decided to call from the firm copy of DML and copy of COA of import item from
ifOreign supplier.
18
「| | ~わ
1・05.2018 1
1聞麒蕊薦Ⅷ蕊薦蔦戸閣ポ画面|~
―――――一―
|
O""itio, : Committee considered case as per agenda and deliberated on the matter in the presence of the
technical experts and it was decided to ratifo the ad-hoc input output norms under para4.7 of HBP as per
ils below or as applied by firm whichever is lower:
Export product
Exp.
Oty.
Ｓ
‐
．
Ｎ
。
Import items
Qty.A1lowed
Kg
N―(Cyc10hexylthio‐
)
phthalimide
Our Brand Name
PILGARD PVI
l kg
1
Phthalic Anyhdride(PAN)
0.603
2
DICYCLOHEXYL
DISULPHIDE(DCDS)
0.486
3
CAUSTIC POTASH
FLAKES(PotaSSium
Hvdroxide)(KOH)
0.020
I ,M concerned may take further necessary action as per above decision of NC
一
２
８
４
・
Ｎ
Ｏ
・
‥
５
２
如
一
ａ
ｓ
ｅ
」
Ｃ
Ｃ
Ａ
IHQ File
101/82/050/00060/AM18/
Decision : Committee considered case as per agenda and deliberated on the matter in the presence
technical experts and it was decided to ratii/ the ad-hoc input output norms under para 4.7 of HBP
Export product
Exp.
Otv.
Ｓ
‐
．
Ｎ
。
Import items
Qty.A1lowed
Kg
N―(Cyc10hexylthio―
)
phthalinlide
Our Brand Name
PILGARD PVI
l kg
1
Phthalic Anyhdride(PAN)
0.603
2
DICYCLOHEXYL
DISULPHIDE(DCDS)
0.486
CAUSTIC POTASH
FLAKES(PotaSSium
Hydro対de)(KOH)
0.020
:IHQFiざ ~~
ヽAnお
… ~~Lic｀
ル5農よ0」商憲li036 oしfer ~■
161191`'?(0,949Y平件Ml,4_ :9,(91/91949111,管M17/ 120.03.2017 Dtte:26.0720181
1 佑認導
11」f出認
I:il°
nS‖ ered the case as per agenda and tt was decmed tO c州■。
~
ヽAnお
… ~~Lic｀
ル5農よ0」商憲li036 oしfer ~■
161191`'?(0,949Y平件Ml,4_ :9,(91/91949111,管M17/ 120.03.2017 Dtte:26.0720181
1 佑認導
11」f出認
I:il°
nS‖ ered the case as per agenda and tt was decmed tO c州■。
m me■rm l
: 1市。 COmplete chemical reaction showing O/O yield on molar basis for each steps
rv.
\-olrlplete cnemlcal reacllon snowlng "/o ylel0 On molar basts lor each Steps
].v.PastproductionconsumptiondatadulycertifiedbyCentralExcise&ServiceTax
Association.
IMcet No/Date:1/82‐ Status:Deffered
lALC4/2018 and Re― indexed
'01.05.2018 1
ILic.No/Date:0310811953 1Defer i
120.03.2017 1Date:2607.20181
:群
淵
“
般~岬
憔
鑑
TD絆
酬
r副
般―
i鮒
胤器
|
: ld人
~=:if… ~
‐~ |`11■:II … ~~~
■11ヽ11,■11::A^再↓二:ス,大
|ミ「
~‐ |
冨¨側Ш¨絆鮮¨
,Status:
Approved
IRLA File
ILic.No/Date:0310811900,
117.03.2017 1
iCase No.:245/4ノ82-
IALC4/2017
ParりName:GLENMARK
IPHARMACEUTICALS LTD,
162
IHQ File
IRLA F‖e
i:03/94/040/01131/AM17/
鮮¨
,Status:
Approved
IRLA File
ILic.No/Date:0310811900,
117.03.2017 1
iCase No.:245/4ノ82-
IALC4/2017
ParりName:GLENMARK
IPHARMACEUTICALS LTD,
162
IHQ File
IRLA F‖e
i:03/94/040/01131/AM17/
19
1 lCase No.:135/4/82‐
‐ IALC4/2017
631由。lile ~ ‐
| |:01/82/050/00143/AM18/
Paty Name:RIDDHI
PHARMA
IRLA File
i34/24/040/00355/AM17/
IMeet No/Date:1/82-
IALC4/2018
'01.05.2018
‐Lic.No/Date:3410043042
120.03.2017
Status: Deffered '
and Re-indexed
Defer
Date:26.07.2018
ICase No.:130/4/82-
IALC4/2017
1HQ File
Paty Name:ASTRAL
ISTERITECH PVT.LTD.
IRLA File
Meet No/Date:1/82-
ALC4/2018
10105.2018
Lic.No/Date:3410043052 1
23.03.2017 1
Status:
Approved
:01/82/050/00138/AM18/ 134/24/040/00365/AM17/
, ,Decision : Committee considered case as per agenda and deliberated on the
:technical experts and it was decided to ratifl, the ad-hoc input output norms
, ,details below or as applied by firm whichever is lower:
IRA concemed may take fu■her necessary ac宙on as per above decision ofNC
ICase No.:26/4/82-ALC4/2017 1Paty Name:FRESENIUS IMcet No/Date:1/82‐
IKABI ONCOLOGY LlMITED IALC4/2018
101.05.2018
matter in the presence of the ,
under para 4.7 of HBP as per
Status:
Approved
‘
υ
IHQ File lRLA Flle Lic.No/Date:0510402049 1
101/82/050/00034/AM18/ 1:05/23/040/00602/AM17/ 123.03.2017 1 1
11)ecision : Colninittee considered case as per agenda and delibcrated on the matter in the presencc of the‐
leChniCal experts and it was decided to rati″
the ad_hoc input output norms under para 4 7 of HBP as perl
lninittee considered case as per agenda and delibcrated on the matter in the presencc of the‐
leChniCal experts and it was decided to rati″
the ad_hoc input output norms under para 4 7 of HBP as perl
details below or as applied by nrm whichever is lower l
Export Product
Qty.
Ｓ
ｌ
．
Ｎ
。
Import items
Quantity allowed
Vinorelbine
Injections
l0mg/lml.
I Number
1
Vinorelbine Tartratc IP/USP.
IP/USP
15.239 mg/ vial
2
Rubber Stoppers for
Pharmaceutical Article Use R/S
13mm Daikyo Fluorotec 52-
F45lW D777-1.
Rubber Stoppers l3mm dia
coated.
Relevant as per
packing policy
Vinorelbine
Injections
50mg/5ml
I Number
1
Vinorelbine Tartrate IP/USP.
IP/USP
76.l95mglvial
2
Rubber Stoppers for
Pharmaceutical Article Use R/S
20Hlln Fluorotec 1242‐ 1888
WSTR.
Relevant as per
packing policy
Export product
Exp. Qty.
Sl.No.
Import items
Qty. allowed
CEFEPIME FOR
INJECTION lGM
I Number
1
STERILE
CEFEPIME FOR
INJECTION
1.8975 gm/vial
2.
GLASS
BOTTELS
Relevant as per
oackins oolicy
RUBBER
STOPERS
Relevant as per
oackins policy
ν⌒
IDecision:Deferred for comments of TE
:Decision:Deferred for comments of TE
INJECTION
1.8975 gm/vial
2.
GLASS
BOTTELS
Relevant as per
oackins oolicy
RUBBER
STOPERS
Relevant as per
oackins policy
ν⌒
IDecision:Deferred for comments of TE
:Decision:Deferred for comments of TE
20
ヘ
Rubber Stoppers 20mm dia
coated.
take further necessary action as per above decision of NC
「
ICase No。:92/4/82-
IPa●y Name:ORBIT LIFE
iSCIENCE PVT.LTD.
IMcct No/Date:1/82-
IALC4/2018
101.05.2018
: :ALC4/2017
| ICase No。:193/4/82‐ ParりName:SUVEN LIFE Meet No/Date:1/82- Status:Deffered‐
1 1ALC4/2017 1SCIENCES LIMITED IALC4/2018 and Re‐
indexed i
,7=藤
蕊鳳11話j
鳥ら聴鳳基jl↓1,1嘉
幕
ぎ面赫蘊
`轟焼tふ
|
汀
―
| 101/82/050/00201/AM18/ 1:09/24/040/00659/AM17/ 124.03.2017 Date:26.07.2018
1 1Decision:Deferred for comments of TE
if霊淵″
4〃
"― 1拙熊港∬隠 性:淵Tαν紗~:∬糧蹂慰
::
181。‐
乱… …… lA.ぼ ――一-1点驚まれ血12082ゝ悪~
| :01/82/050/00282/AM18/ :03/94/040/01147/AM17/ 125.03.2017 Date:26.07.2018
: lbもti`ibi i bbferたa foi t6鳥品きit:61it ~ ~ ~~ ‐
No.:127/4/82‐
ALC4ノ2017
IHQ File
1101/82/050/00135/AM18/
Decision : Committee considered case as per agenda and deliberated on the matter in the presence
technical experts and it was decided to ratifu the ad-hoc input output norms under para4.7 of HBP
Export product
Exp.
Otv.
Ｓ
‐
．
Ｎ
。
Import items
Qty.A1lowed
Kg
N―ETHYL LACTUM / N‐
ETHYL‐ 1:8-
NAPHTHOLACTUM/NEL/
ORGANIC DYE
INTERMEDIATE SR-102
lkg
1
NAPHTHOSTYRIL
0.985
2
CAUSTIC SODA(100%)
0.580
IRA concemed may take mrther necessary action as per above decision ofNC I
of the
as per
69
1lё:ξき｀ま:iij/4/82」
~ IPaoヽ
TE SR-102
lkg
1
NAPHTHOSTYRIL
0.985
2
CAUSTIC SODA(100%)
0.580
IRA concemed may take mrther necessary action as per above decision ofNC I
of the
as per
69
1lё:ξき｀ま:iij/4/82」
~ IPaoヽ
:ふま5もM SiヽOё舌ЁM IM881ヽ3/b農よi′ 82¨ Statisib`ffeたと|
| IALC4/2017 PHARMACEUTICALS IALC4/2018 and Re‐
indexed i
170 1 1NDIA PVT.LTD. 01.05.2018 1 1
:IHQiお ~ ~■
RLA Fiざ‐ ~… …~ Lもヽ6,5品うう
ibbiζ
`ケ
リbeおF I
: 101/82/050/00127/AM18/ 1:22/24/040/00114/AM17/ 130.03.2017 Date:26.07.20181
lStatus:Deffered
land Re-indexed
I
661HQ File
:RLA File
ILic.No/Date:0310812040 1Defer
23.03.2017 1Date:26.07.2018
iDecision : It was decided to call from the firm to furnish complete technical details as per appendix 33
,or 4E.
:ParりName:SARNA
iCHEMICALS PVT LTD
IMeet No/Date:1/82-
IALC4/2018
101.05.2018
Status:
Approved
:RLA File
i:52/24/040/00087/AM17/
29.03.2017
Decision : It was decided to call from
,Excise & Service Tax Association
‐Case No.:111/4/82‐ ALC4/2017
IHQ Filc
2L
the firm production consumption data duly certified by Central'
l
l cittヽこli4'4/8'1‐ |11■｀1およMAHiMA LttЁ IM881ヽ8′bi811′恵夕 も
tatiまbきffelta l
l :ALC4/2017 SCIENCES PVT LTD. :ALC4/2018 1and Re‐
indexed i
101.052018 1 ‐
17●HQ Fii3 1kLA Filき
‐ ~ ~
■tiしヽも
'biも
lo3ib46'60な
|うもfei
‐
|
| 101/82/050/00122/AM18/ .:05/24/040/00636/AM17/ 130.03.2017 1Date:26.07.20181
.
1 ‐
17●HQ Fii3 1kLA Filき
‐ ~ ~
■tiしヽも
'biも
lo3ib46'60な
|うもfei
‐
|
| 101/82/050/00122/AM18/ .:05/24/040/00636/AM17/ 130.03.2017 1Date:26.07.20181
. :Decision:Import and export items not properly derlne,it was decided to call the rlrm fOr personal l
l :heanng。 1
一
…
…
…
IALC4/2018
01.05.2018
.Lic.No/Date:0810139981
....
:
Status:
rApproved
172
1 101/82/050/00119/AM18/ :08/24/040/00519/AM17/ 131.03.2017 1
. IDecislon :Comlllittcc considered the case as per agenda and in light of、
vritten comments receivcd ■om‐
| IDcpaiment of PhalHlaceuucals vide their OM No 35011/625/2014¨
PI(Norms)dated May 2015 and inl
iconsultation with technical authority present in meeting,decided to rad～
nOrlns under para 4.7 ofHBP asi
per details below or as applied by firm whichever is lower:-
Export product
Exp.
Otv.
Sl.No.
Import items
Qty.A1lowed
Kg
3-Isobutyl Glutaric Acid
(CMH Diacid)
lkg
1
Isovaleraldehyde
0.6068 kg
つ
ん
Ethyl Cyanoacetate
0.7814 kg
DiethylMalonate
0.9784 kg
,RA concerned may take further necessary action as per above decision
IStatus:Deffered
land Re¨ indexed l
lDefer l
Date:2607.2018‐
ICasc No.:118/4/82‐
:ALC4/2017
lHe pite
iDecision : Deferred for comments of TE
―
″
―
―
一
“
―
―
一
た01/82/050/00126/AM18/
IPatt NamcllND‐SWIFT
ILABORATORIES LTD.,
IRLA File
i:22/24/040/00121/AM17/
IMcet No/Date:1/82-
IALC4/2018
10105.2018
1Lic.No/Date:2210015682
131.03.2017
ICase No.:195/4/82¨
IALC4/2017
HQ File
:01/82/050/00203/AM18/
‐
ICase No.:202/4/82-
,
IRLA File
i:22/24/040/00121/AM17/
IMcet No/Date:1/82-
IALC4/2018
10105.2018
1Lic.No/Date:2210015682
131.03.2017
ICase No.:195/4/82¨
IALC4/2017
HQ File
:01/82/050/00203/AM18/
‐
ICase No.:202/4/82-
| IALC4/2017
,Decision : Deferred for comments of TE
IParりName:OGENE
SYSTEMSINDlA LTD.
IRLA File
:09/24/040/00692/AM17/
IMeet No/Date:1/82-
:ALC4/2018
101.05.2018
1Lic.No/Date:0910064849
131.03.2017
,Status:Deffered
r
and Re-indexed
Defer
:Date:26.07 .2018'
'status:Deffered
i
and Re-indexed
理
,轟ヽ品ぎヤ三十iocttEM~IMe&｀0/D品|ル直
INDIA PVTo LTD. :ALC4/2018
|l i pL05.2018 :
75 HQFile~~~~~lRLAFile
蔦罵i「
~圏
ヽ」丁両6屁a3B温
蔦
: |:01/82/050/00719イ今
Yl'イ ll,111'彎9997贅慨■…………__………―――一……………
Decision : It was decided to call from the firm copy of DML for the export product
22
⌒
ICasc No.:272/4/82‐ ParりName:AARTI
IALC4/2017 1NDUSTRIES LIMITED
761器3掲5蕊議0鳳蔦
~~RLA Fiお~~~……~~~
|:03/94/040/OH45/AM17/
Decision : Committee considered the case as per agenda and it
information:-
% Yield in molar basis for each steps
lMaterial balance for each steps
IMcet No/Date:1/82‐ status:Deffered l
,ALC4/2018 and Re¨ indexed l
10105.2018 1
＞
Ｄ
| |
F7鏡。
iぉ
,Paty Name:ASCENT
,FINECHEM PVT.LTD.,
Party Name:ASCENT
,Mcet No/Date:1/82-
IALC4/2018
101.05.2018
F71。iぉ
、LA品‐
~
1 101/82/050/00117/AM18/ 1:08/24/040/00475/AM17/
,Decision : Deferred for comments of TE
:
11ど6‐｀1“よёilLA LiMITЁ 51 M8よヽル5嘉
`liた
う1
‐
も1lil:ibきffettd l
l 鉾キ留鴛f rndRe■
ndexedi
1 獄r猫∵ 「
nd Re■ndexedi
扁」~~鶉
厖
|~~~~Ⅷ需続甲臨高i重
―
―
一
for comments of TE
for comments of TE
:
11ど6‐｀1“よёilLA LiMITЁ 51 M8よヽル5嘉
`liた
う1
‐
も1lil:ibきffettd l
l 鉾キ留鴛f rndRe■
ndexedi
1 獄r猫∵ 「
nd Re■ndexedi
扁」~~鶉
厖
|~~~~Ⅷ需続甲臨高i重
―
―
一
for comments of TE
10器脱鳳iLi話し ヽ
1ら魔鳳111話; lm需議10043面Bれ∴
t∴
|
1 lDecislo■
:COmmittee considered the case ns ner,σ
end,,nH:` w●
。A“ :AOH`ハ
^01l F..^… `L^■__|
Decision : Committee considered the case as per agenda and it was decided to call from the firm
Complete chemical reaction shsowing description for import and export molecular weight and oh
yield on molar basis for each steps of manufacturing process.
¨―――――一―一―――………………
～一―t…………=___… ………
…
=・―
・‐T~ .__ 1
11需脇″
4カ82‐ ~ :漱
鶴1鹿:ヽ:11~ 1荒漱普ま
iたメ
~:詰鷺喩誌
i:11
11●・― IWドリl… 獄勒
`Mぬ″:`ぶ
■
| ::01/82/050/00212/AM18/ 1:05/24/040/00655/AY17仁
19,fl′ 917 1P,,17,f7′ 91,I
I ltcisibi:i高:bet僣
`a t6
ι
li fr。l tit hFi“byOfDMLbrtheexportproduct l
| ICase No。:131/4/82‐ IParりName:PANOLI IMeet No/Date:1/82- lstatus:Deffered l
l :ALC4/2017 1NTERMEDIATES(INDIA) :ALC4/2018 and Re―
indexed'
| I IPVT LTD lol o5.2018 1 1
IMcet No/Dtte:1/82- status:Deffered l
lALC4/2018 and Re‐ indexed l
101.05.2018 1 i
ltitiヽ6′ b:i`ibζ ib46うi4ど158fer l
P,・91′ :
“'4輌幽
|
::,需脇″ル
4蔑L E需識IPA 難
:脇学ょ″み 濡鷺
li±1::
‐ ｀ | 101.05.2018 1
‐
ILic.No/Date:0310812337 1Defer
103.04.2017
:
‐Date:26.072018
醤驚糧蹂鷲
I:1:
103.04.2017
:Defer i
lDate:26.07.20181
―
| 101.05.2018 1
‐
ILic.No/Date:0310812337 1Defer
103.04.2017
:
‐Date:26.072018
醤驚糧蹂鷲
I:1:
103.04.2017
:Defer i
lDate:26.07.20181
―
―
―
|
| ICase No.:277/4/82¨
ALC4/2017
面
―
―
一
ｌ
Ｈ
け
８
７
| ICase No.:112/4/82-
| IALC4/2017
iParりName:HELLO PAINTS
i(P)LTD
7911。T18 ~
:RLA File
l:05/23/040/00629/AM17/
lDecision : Deferred for comments of TE
HQ Filc
23
RLA File lLic.No/Date:0810139999 1Defer
:01/82/050/00209/AM18/ ::08/24/040/00504/AM17/ :03.04.2017
Date:26.07.20181
Decision : Committee considered the case as per agenda and it was decided to call from the firm
following information:-
i.Completechemicalreactionshsowingdescriptionforimportandexportmolecularweight
and oh yield on molar basis for each steps of manufacturing process.
, ii.
Requirement and recovering of lTertiary Butanol
,Case No.:267/4/82¨
:ALC4/2017
1HQ File
Paty Namc:CENTAUR
Mcet No/Date:1/82-
PHARMACEUTICALS PVT. ALC4/2018
'status:
:
Approved l
:01/82/050/00275/AM18/ 1:03/94/040/01134/AM17/ 104.04.2017
1Decision:Committee considered case as per agenda and dcliberated on the
technical experts and tt was decided to ratl″ the ad_hoc input output norms
ldetailS bCloMノor as applied by fIInl、vhichever is loweri
器命―一― ―騒淵鵠5108123591~……
|
*uu.i il-ih; p.;;r" oitr,.
rated on the
technical experts and tt was decided to ratl″ the ad_hoc input output norms
ldetailS bCloMノor as applied by fIInl、vhichever is loweri
器命―一― ―騒淵鵠5108123591~……
|
*uu.i il-ih; p.;;r" oitr,. t
under para 4.7 of HBP as per'
- - .pu.tyN"..'apbx PHARMA, naeetNoloati,:llsi 'Strir.tn.n t.o
ALCA]2OI8
and Re-indexed
r01.05.2018
HQ File lRLA File Lic.No/Date:0310812377‐ Defer l
:01/82/050/00274/AM18/ :03/94/040/00003/AM18/ 105.04.2017 1Date:26.07.20181
Decision:Committee considered the case as per agenda and it was decided to can frOm the rlrm Of
‐
the volume of Selamectin rl‖ ed in each pipetts.
ICase No.:203/4/82‐ ALC4/2017 ParりName:NAARIPHARMA IMcetNo/Date:1/82-
PRIVATE LIMITED :ALC4/2018
101.05.2018
HQ File~~~~~~~一
|こ蔚F~~~~~一
‐
―
―
¨
而
磁
面
―
「
~~~|
,^-,:011821050/00211/AM18/ :0512410401006681AM171 05.04.2017
' :
-p..i"n".oiir,.
85
I
Decision : Committee considered case as per agenda and deliberated on the matter in th(
:
technical experts and it was decided to ratify the ad-hoc input output norms on net to net (as applied) subject
,
to condition that the firm will furnish the DML to concerned RA.
,
l
‐
## Case No.:266/4/82¨
IALC4/2017
| ‐Case No.:252/4/82-
86 ALC4/2017
Status:
rApproved ,
Status:Deffered r
and Re-indexed
Pa口けName:WAXSEN
‐
Mcet No/Dttei1/82-
:LIFESCIENCE PVT LTD。, IALC4/2018
1 101.052018
Export Product
Qty.
Ｓ
‐
．
Ｎ
。
Import items
Quantity allowed
Tiagabine Hydrochloride
Tablets 2 mg
I Number
Tiagabine
Hydrochloride
2.04 mgl2 mg tablet
Tiagabine Hydrochloride
Tablets 4 mg
I Number
Tiagabine
Hydrochloride
4.08 mg/4 mgtabtt
Tiagabine Hydrochloride
Tablets 12 mg
1 Number
Tiagabine
Hydrochloride
12.24 mg/12 mg
tablet
Tiagabine Hydrochloride
Tablets 16 mg
I Number
Tiagabine
Hydrochloride
16.32 mg/16 mg
tablet
RA concerned may take further necessary action as per above decision ofNC
|
24
:01/82/050/00260/AM18/
‐RLA File
:03/95/040/01042/AM17/
Ｆ
‐
‐
８
７
‐
曖従腸∫″
04/82‐
IHQ File
:01/82/050/00328/AM18/
RLA File
l:09/24/040/00670/AM17/
:Mcet No/Date:1/82- IStatus:Deffered
lALC4/2018 1and Re¨ indexed
101.05.2018 1
ILic.No/Date:0910064868:Defer
i0604.2017 1Date:26.07.2018
ParりName:ALPHAMED
FORMULAT10NS P LTD.
| :Decision:Deferred for comments of TE
隅柵船鍔3鳥D
|
IMcet No/Date:1/82-
IALC4/2018
101.05.2018
1Lic.No/Date:0910064882
107.04.2017
|
l iCaStNよlif3/4た
'1 1:島
Na品いANЁttA~~~■
もまヽ6′b::よi′:,:~ ~ヽ111蔽b`fferta l
l FLC″
2∝7 BЮ
TEC PVT.LTD.
E
隅柵船鍔3鳥D
|
IMcet No/Date:1/82-
IALC4/2018
101.05.2018
1Lic.No/Date:0910064882
107.04.2017
|
l iCaStNよlif3/4た
'1 1:島
Na品いANЁttA~~~■
もまヽ6′b::よi′:,:~ ~ヽ111蔽b`fferta l
l FLC″
2∝7 BЮ
TEC PVT.LTD. 1計
χ ttT 'nd Re■
ndexedl
1910面
よ
~~~‐
RLA品
‐
~1;
需」鸞
ま
“
血ぬ
力
‐
B驚
:.島ふ
|
1 1:01/82/050/00121/AM18/ 105/24/040/00664/Al
l :Decision:Deferred for comments of TE
l iCase No.:222/4/82‐
IALC4/2017
HQ Flle
:01/82/050/00230/AM18/
IRLA File
109/24/040/00667/AM17/
Decision : Committee considered case as per agenda and deliberated on the matter in the presence
lechnical experts and it was decided to ratifo the ad-hoc input output norms under para 4.7 of HBP
Export product
Exp. Qty.
Sl.No.
Import items
Qty.A1lowed kg
Gemcitabine Hcl
l kg
1
N-Acetyl Cytosine
3.66 kg
2.
Trimethylsilyl
Trifluoromethane sulfonate
(o0
Trimethylsilylfl uoromethane
Sulphonate
5.30 kg
Dibenzovllactol(or)DBL
5.14 kg
4
Methylene Chloride
13.60 kg
5
Methanol
8.80 kg
6
Acetone
15.00 kg
of thct
as perl
| ICase No.:335/4/82-
9「ALC4/2017
IParty Name:EYTAN LABS IMeet No/Datei1/82-
ILIMITED ‐ALC4/2018
1 101.05.2018
Staius:
Approved
ILic.No/Date:0310812370:Defer
i05.042017 :Datc:26.07.2018
ICase No.:132/4/82-
IALC4/2017
ParりName:NAARI PHARMA IMcet No/Date:1/82-
IPRIVATE LIⅣIITED
:ALC4/2018
:0105.2018
ptatu∬Deffered
:and Re‐ indexed
881HQ File
RLA File
:Lic.No/Date:0510402176 1Defer
.06.04.2017
IDate:26.07.2018
iDecision : Committee considered the case as per agenda and it was decided to call from the firm
rcomplete technical details as per 4E.
:
|
Lic.No/Date:0510402176 1Defer
.06.04.2017
IDate:26.07.2018
iDecision : Committee considered the case as per agenda and it was decided to call from the firm
rcomplete technical details as per 4E.
:
|
25
記Ъ島児
5υ∞期Amy
IRLA File
l:09/24/040/00661/AM17/
「~ |
Decision:Committee considered case as per agenda and
technical experts and it was decided to ratiry the ad-hoc
deliberated on the matter in the presence of the
details bclow or as applied by flrm whichever is lowe「
hput o載put noms under ptta 4.7 ofHBP as perl
RA concerned may take further necessary action as per above decision ofNC
Export Product
Qty.
Sl.No.
Import items
Quantity allowed
Ks
AMINO‐ 2-OX0
PYRIMIDINYL
OXATHIOLANE‐2-
CARBOXYLIC AClD ISO
PROPYL
METHYL CYCLO HEXYL
ESTER(CYCLO HEXYL
ESTER)OR(CHE)OR
(CHE-lH)
l Kg.
1
GLYOXYLIC ACID―
50%
0.743
2
2,5 DIHYDROXY l,4
DITHIANE
0.325
CYTOSINE
0428
4
HEXAMETHYL
DISILAZANE
0.698
DIMETHYL
FORMAMIDE
0.26
6
TRIETHYLAMINE
0.67
7
M ETHYLENE
CHLORIDE
1.56
L―MENTHOL
0.751
9
TRIPHOSGENE
0.50
ICase No.:336/4/82- Party Name:MYLAN IMeet No/Date:1/82-
IALC4/2017 LABORATORIES LIMITED IALC4/2018
'01.05.2018
RA concerned may take htther necessary action as per above decision ofNC
,額y κ L10n^PCI aυ υvc uoし1、lυ l■υ■1ヽし 1
Status:
lApproved
‐92
汀
―
ICase No.:323/4/82-
IALC4/2017
IHQ File
Pa■y Name:SPANSULES
IFORMULAT10NS
|
Status:
'Approved
IRLA File
:09/24/040/00690/AM17/
Export product
Exo.
lυ l■υ■1ヽし 1
Status:
lApproved
‐92
汀
―
ICase No.:323/4/82-
IALC4/2017
IHQ File
Pa■y Name:SPANSULES
IFORMULAT10NS
|
Status:
'Approved
IRLA File
:09/24/040/00690/AM17/
Export product
Exo. Otv.
Sl.No.
Import items
Qty.Allowed kg
LEVOFLOXACIN
HEMIHYDRATE
l kg
1
Levo ethyl ester
(Or)
Ethyl(―)9,10-
difluoro‐ 3(S)‐
methyl-7‐ oxo―
2,3-dihydro‐ 7H‐
pyrido[1,2,3-de]―
1,4-Benzoxazine―
6-carboxylate
1.05
2.
Toluene
0.219
Isopropyl Alcohol
(IPA)
0.880
4.
N―Methyl
Piperazine
0.432
|:01/82/050/00331/AM18/
:HQ File
RLA File
:Lic.No/Date:0910064872
:07.04.2017
,technical experts and it was decided to ratiry the ad-hoc input output norms under para 4.7 of HBP as per,
101.05.2018
107.04.2017
26
,Decision: committee considered case as per agenda and deriberated on the
"eChntd expens and tt was decmcd to ratify the ad‐
hOc hp耐Output norlns
idetailS belowOras appliedby flm whicheveris loweE
―
―
―
Ｉ
Ｊ
Export Product
Qty.
Sl.No.
Import items
Quantity allowed
Ke
ORLISTAT 500/OWW
PELLETS
l Kg.
1
ORLISTAT USP
0.50 kg
:ALC4/2018
101.05.2018
:Lic.No/Date:3H0066691 1Defer
:10.04.2017
IDate:26.07.201翌
|
汗
―
―
―
Status:
:Approved
under para 4.7 of HBP as pcl
Export Product
Qty.
Sl.No.
Import items
Quantity allowed
Ke
5 Chloro Salicylic Acid
l Kg.
1
Para Chloro Phenol
0 87 kg
RA concerned may take further necessary actiom
r
_
;.v,,-_tvavtvvvvJ/nlvlltt
:ll.V.+.ZVll
.,
l:::_,rl' :
tG;r'iA;;;d:;*;'-ryI agenda and detiberated;; iil.nu[.
l Kg.
1
Para Chloro Phenol
0 87 kg
RA concerned may take further necessary actiom
r
_
;.v,,-_tvavtvvvvJ/nlvlltt
:ll.V.+.ZVll
.,
l:::_,rl' :
tG;r'iA;;;d:;*;'-ryI agenda and detiberated;; iil.nu[. in ine fier.nce of rhe
Export Product
Qty.
Sl.No.
Import items
Quantity allowed
KS
VALSARTAN
l Kg.
1
4-bromomethyl-2-
cyanobiphenyl
0.856
０
４
Acetone
0.80
3
Activated Carbon
(Carbon Enoanticromos)
0.10
4
L‐Valine
0.661
Methanol
1.00
6
Potassium Carbonate
(Anhydrous)
1.434
7
Toluene
6.69
ValerOyI Ch10ride
0.55
:辞脇酔ふ lmit蕊雪“ 群靱品メ
ⅢⅢ
l lⅢll:11■■ ~…ⅢÅ
iお~~~……‐ェ淋漸濃bうib6`4う0う|… ………
|
11じ虚児50/00341/AM18/ 1鷺
λfib ibC.No/D江
3/040/00665/AM17/ ,11.04.2017
1臨蕊:漱!驚[蕊淵鮪I鷺謂ぷ‖儡鰍朧
rぶ
Tヂ∬器器
3r:
‐
1 1
|
^
iCasc No.:107/4/82‐
:ALC4/2017
ParサName:DEEPAK
INOVOCHEM
ITECHNOLOGIES LTD
IStatus:Deffered
iand Re‐ indexed
IHQ File
IRLA File
131/83/040/00161/AM17/
iDecision : Deferred for comments of TE
ICase No.:273/4/82-
IALC4/2017
P冨″Name:GUJARAT
10RGANICS LIMITED
IM861ヽ6'5131iシ慧
2-
IALC4/2018
,01.052018
:03/94/040/00009/AM18/ 110.o4.2017
040/00161/AM17/
iDecision : Deferred for comments of TE
ICase No.:273/4/82-
IALC4/2017
P冨″Name:GUJARAT
10RGANICS LIMITED
IM861ヽ6'5131iシ慧
2-
IALC4/2018
,01.052018
:03/94/040/00009/AM18/ 110.o4.2017
27
'RA concerned may take further necessary action as per above decision of NC
ICase No.:215/4/82-
IALC4/2017
HQ File
Pan Namet面荒静
「
~
lHEALTHCARE LTD
i
RLA File…
… …… ~~T
IMect No/Date:1/82‐
‐ALC4/2018
101.05.2018
1Lic.No/Date:0810140061
111.04.2017 1 1
deliberated on the matter in thc prcscnce of thei
input output norms under para 4 7 of HBP as perl
:O1/82/050/00223/AM18/ :08/24/040/00002/AM18/
I Decision: Conllnittee considered case as per agenda and
technical experts and it was decided to rati～the ad_hoc
details below or as applied by flrln whichever is lower
:97
iCase No.:257/4/82-
‐ALC4/2017
981HQ File
ParりName:MATRIX FINE IMcet No/Date:1/82-
ISCIENCES PVT.LTD, ALC4/2018
1 101.05.2018
RLA File
Lic.No/Date:0310812435 1Defer
lstatus:Deffered
,
land Re-indexed
1
101/82/050/00265/AM18/ :03/95/040/00999/AM17/ 11.04 2017 Date:26.07.2018
1Decision:Conl■littee considered the case as per agenda and it was decided to call from the nrm
lcomplete technical details as per Appendix 4E
| ICase No.:327/4/82‐ ALC4/2017 ParりNamc:BIOLOGICAL E Mcet No/Datc:1/82‐
LTD
‐ALC4/2018
101.05.2018
| IHQ Filc
l l:01/82/050/00335/AM18/
RLA File
ILic.No/Date:0910064919
:09/24/040/00676/AM17/
13.042017
99 Decision:lnthelightofearlierdecisiontakenbyNCinits3/82meeting08.05.20
l4.itwasdecidedto
018
| IHQ Filc
l l:01/82/050/00335/AM18/
RLA File
ILic.No/Date:0910064919
:09/24/040/00676/AM17/
13.042017
99 Decision:lnthelightofearlierdecisiontakenbyNCinits3/82meeting08.05.20
l4.itwasdecidedto
rratifl norms under Para 4.7 of HBP vl as per details given below or as applied by the firm, whichever is
r
less:
Item of Export
Quantity
S,No
Item of Import
Quantity allowed kg
ADSORBED TETANUS
2000000
vials
1
L―CYSTINE
As per A 2304 ofHBP― II
つ
４
TH10MERSAL
As per A 2304 of HBP‐ II
Status:
Approved
(Pentanovl Chloride)
9
Steam/Thermal Coal
(Non-Cooking) in Bulk
Relevant as per
packing policy
Export Product
Qty.
SI.No.
Import items
Quantity
allowed Kg
IVABRADINE HCL
l Kg.
1
(lS)‐4,5-DIMETHOXY-1-
(METHYLAMINOMETHYL)―
BENZOCYCLOBUTANE
HYDROCHLORIDE
1.075 kg
う
乙
HOMO VERATRIC
ACID/3,4‐
DIMETHOXYPHENYL
ACETIC ACID
0.804
3
AMINO ACETALDEHYDE
DIMETHYL ACETAL
(ThiS liCencc is issued as pcr
## Para 4.7 ofH.B AM 2015… 2020
with suttect tO F破ation of
NollilS bV ALC Delhi.)
0.431
Status:
Approved
28
VACCINE
BP/TETANUS TOXOID
VACCINE
ADSORBED-10ML 20
DOSES
(EACH DOSEIS
EQUIVALENT T0 0.5
ML)
N Z CASE TT(CASEIN
PEPTONE PLUS)
As per A 2304 ofHBP―II
4.
L―TYROSINE
As per A 2304 of HBP― II
ALUMINIUM
CHLORIDE 6
HYDRATE EXTRA
As per A 2304 ofHBP‐II
6.
SILICON EMULS10N
0.043 kg
7
TRISODIUM ORTHO
PHOSPHATE
As per A 2304 ofHBP-11
GLASS VIALS
As per A 2304 ofHBP‐
II
9
RUBBER STOPPERS
As per A 2304 ofHBP―II
10
ALUMINIUM
CAPS/SEALS
As per A 2304 ofHBP―
II
SHIPPING
INDICATORS(Q TAG
2 PLUS)
As pcr A 2304 of HBP― II
つ
４
VVM LABELS
(HEATMARKER
VACCINE VIAL
MONITOR LABELS)
5005 Nos.
FILTERS AND FILTER
AIDS
2 5 Nos.
RA may take appropriate action as per the decision of Norms Committee.
Ｆ
…
Ｌ
滞
ICase No.:144/4/82‐ IParりName:CAPLIN POINTIMcet No/Date:1/82- IStatus:
:ALC4/2017 1LABORATORIES LTD, IALC4/2018 :Approved l
l : .01.052018 1 1
: , , .
ORATORIES LTD, IALC4/2018 :Approved l
l : .01.052018 1 1
: , , . :
1青O Fiiも ~ ‐ ~ ‐ ~1良
LA Fiiも … … ‐
Liよヽ。
/5農
`ib4ibi`う
0恵41 ~ 「
|
::01/82/050/00152/AM18/ 1:04/24/040/00004/AM18/ 113.04.2017 : :
rDecision : Committee considered case as per agenda and deliberated on the matter in the presence of the
ltechnical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per
tdetails below or as applied by firm whichever is lower:
Export Product
Otv.
Si.No.
lmport items
Ouantitv allowed
Diclofenac + Nuerotropas
Capsules
1
Number
1
Cyanocobalamin
204.0mcg/capsule
RA concemed may take further necessary action as per above decision of NC
|
「鉾
|
|
## Case No.:32514/82-ALC4l20l7 PaW Name:GRANULES MeetNo/Date:]182- Status:
I :
,INDIA LIMITED
ALC4l2otg
iApproved
I I
or.o5.2ol8
102 HQ pit"
RLA File
Lic.No/Date:0910064911
':
':011821050/00333/AM l8/
:091241040100017/AM l8/
13.04.2017
Decision :tn the light of .*ti.r aecision raten by NC in its 18/82 meeting dated 18.02.2015 and in
ハ
1
:
|
ICase No.:340/4/82‐
:ALC4/2017
ParりName:GODAVARI
IDRUGS LTD
IMcet No/Datc:1/82¨
:ALC4/2018
101.05.2018
:Status:Deffered
'and Re-indexed
IHQ File
IЪち刷:OЮ069″AM17
13.04.2017
IDefer
iDate:26.07.2018
29
consultation with technical authority present in meeting decided to ratifl norms under para 4.7 of HBP as
per details below or as applied by firm whichever is lower:-
Export product
Export
Otv.
Sl.No.
Import items
Qty.
Allowed kg
Compresso GEM 70
(Gemflbrozil Granules
DC 70%)
l Kg
1
Gemfibrozil
0.707k負
2.
Maize Starch
0.1485 kg
3.
Povldone lく-30
0.0270 kg
4.
Sodium Starch Glycollate
0.030 kg
Sodium Lauryl Sulphate
0.00150 kg
6.
Starch Pregelatinised
0.083 kg
7.
Stearic Acid
0.0100 kg
ICase No.:259/4/82‐
IALC4/2017
IHQ File
11031:01/82/050/00267/AM18/
Party Name:RHODIA
SPECIALTY CHEMICALS
INDIA LTD.
性き淵Tαν82 滞糧蹂盟」
ρl.05.2018 1
Lic No/Date:0310812492,Defer
113.04.2017 1Date:26.07.20181
|
Decision : Decision : Committee considered the case as
the firm following information :
i)
Composition of export and import product.
iD
Wastage claimed in the manufacture
per agenda and it was decided to call from
,case No.:25514182- ,Party Name:OM
,Meet No/Date:.1182- Status:
tion :
i)
Composition of export and import product.
iD
Wastage claimed in the manufacture
per agenda and it was decided to call from
,case No.:25514182- ,Party Name:OM
,Meet No/Date:.1182- Status:
| IALC4/2017 11NTERCONTINENTAL IALC4/2018 1Approved l
1 1 1 10105.2018 1 1
1 1器3梶5υ0026νAMlν ttλ
51:OЮ 002y,
・
に・NJDatc0310812544 1
へM18/ 118.04.2017
‐ |
| I Decision:Committee considered case as per agenda and deliberated on the matter in the presence ofthe
‐
technical experts and it was decidcd to rati″
thC ad_hoc input output norlns undcr para 4.7 of HBP as perl
1104 detailsbeloworasappliedbyflllHwhicheverislower l
Export Product
Oty.
Sl.No.
Import items
Ouantitv allowed
OXO TH10XANTHENYL
OXYETHANOIC ACID(CX
ACID)
l kg
1
22
DITHIODIBENZOIC
ACID
0.743 kg
つ
ん
PHENOXY ACETIC
ACID
0 886 kg
RA concerned may take further necessary action as per above decision ofNC
:status: Deffered
and Re-indexed
| ICase No.:211/4/82‐
| IALC4/2017
IRLA File
i:03/95/040/00023/AM18/
Party Name:RECKITT IMeet No/Date11/82-
IBENCKISER 'ALC4/2018
1HEALTHCAREINDIA 01.052018
"RIVATELIMITED i
lo5 Hq rit"
RLA Fite
:01/82/050/00219lAMl8l :051241040100017/AMl8/
1腎∬
%Rttα
05104022373鳶ち
6.07.2018
Decision : Committee considered the case as per agenda and it was decided to call from the firm
copy of Drug Manufacturing Licence (DML) and copy of Master Batch Formula.
| ICase No.:256/4/82-
■06.ALC4/2017
Party Name:RESONANCE
SPECIALTIES LTD
er agenda and it was decided to call from the firm
copy of Drug Manufacturing Licence (DML) and copy of Master Batch Formula.
| ICase No.:256/4/82-
■06.ALC4/2017
Party Name:RESONANCE
SPECIALTIES LTD
IMcet No/Date:1/82¨
:ALC4/2018
101.05.2018
Status: Deffered
and Re-indexed
^
Ｄ
ｖ＞
Complete chemical reaction showing molecular weight of each item and oh yield on molar
basis.
CA certificate showing past production consumption data.
luq ntte
iRLA File
l:03/95/040/00925/AM17/
:Lic.No/Date:0310812525 1Defer
18.04.2017
IDate:26.072018
jDecision : Decision : Committee considered the case as per agenda and it was decided to call from
Ithe firm following information :
」
31
…
…
…
―
ド
轟
Status:
Approved
|
IHQ ΠL IRLA RL
……
FLici馬75鳥1316048`04
1101/82/050/00116/AM18/ 1:1324/040/00002/AM18/ :20.04.2017
「
I)ecision : In the light of earlier decision taken by NC in its 18/82 meeting dated 18.02.2015 and in
consultation with technical authorly present in meeting decided to rati″
norms under para 4.7 of HBP as
rper details below or as applied by firm whichever is lower:-
Export product
Export
Otv.
SI No.
Import items
Qty.Allowed
in kg
AE-473(2‐ {2‐ chloro‐4-mesyl―
3-[(RS)]― tetrahydro-2-
furylmethoxymethyl}benzOyl)―
cyclohexanc‐ 1,3-Dione)
lg
1
3‐ Chloro… 2-Methyl aniline
0.725
2.
Toluene
3.306
Bromine
0.705
4.
Tetrahydrofurfuryl alcohol
0.238
1,3-Cyclohexanedione
0.327
6.
Sodium Methyl Mercaptide
1.836
7.
Sodium Nitritc
0.429
Ethylene Dichloride
0.719
RA concemed may take mrther necessary ac●on as per above decision ofNC
Export Product
Qty
Sl.No.
Import items
0.327
6.
Sodium Methyl Mercaptide
1.836
7.
Sodium Nitritc
0.429
Ethylene Dichloride
0.719
RA concemed may take mrther necessary ac●on as per above decision ofNC
Export Product
Qty
Sl.No.
Import items
Quantity allowed
Ke
Tetra Butyl Ammonium Bromide
50%o solution in water
l kg
1
Tetra Butyl
Ammonium
Bromide
0.50 kg
Export Product
Qty.
Sl.No.
Import items
Quantity allowed
kg
Esomeprazole Magnesium
l kg
l
3,5-Dimethyl
ovridine
1.06 kg
つ
４
Methylene Di
Chloride
3.13 kg
## Case No.:108/4/82-ALC4/2017 Paty Name:PIINDUSTRIES
LTD
‐Meet No/Date:1/82-
IALC4/2018
101.05.2018
| ,Case No.:265/4/82‐
‐ IALC4/2017
Pa●y Name:DELTA
FINOCHEM PVT.LTD.
Meet No/Date:1/82-
:ALC4/2018
101.05.2018
iStatus:
Approved
.HQ File
IRLA File
:03/94/040/01081/AM17/
ぢ
1悧%器α
03108126571
technical experts and it was decided to ratifo the ad-hoc input output norms under para 4.7 of HBP as per ,
108 6.1ui1r below or as applied by firm whichever is lower:
iCase No.:339/4/82‐
IALC4/2017
P汀けName:NIFTY LABS
IPVT LTD.,
Mcet No/Date:1/82-
IALC4/2018
101.05.2018
'Status:
rApproved
HQ Filc
i01/82/050/00347/AM18/
ILic.No/Date:09100649351
121.04.2017 1
RLA File
,
,technical experts and it was decided to ratifu the ad-hoc input output norms under para 4.7 of HBP as per ,
il09 16s611s below or as applied by firm whichever is lower:
32
IHQ File ~~~~~…
…
RLA File
~躍
F82‐
~隅
「
~~洸而藻面o812697●~~~
::01/82/050/00271/AM18/ :03/94/040/01080/AM17/ 124.04.2017 1
1Decおbn:Commtttee consdered case as per agenda and ddberated on the matter in the presence ofthe
technical experts and it was decided to ratl″ the ad_hoc input output nolllls under para 4.7 of HBP as per
details below or as applied by flrln whichever is lower:
Export Product
Qty.
Sl.No.
Import items
Quantity allowed
Ks
N Hexyl Bromide ( 1-Bromo
Hexane)
l kg
l
Nacol6-98 ( l-Hexanol or
N-Hexanol)
0.686 kg
2
Liquid Bromine
0.545 kg
IRA concemcd maytake m■her necessary action as per above decision ofNC
Paty Name:DELTA
FINOCHEM PVT LTD.
Patty Name:DELTA IMeet No/Date:1/82-
FINOCHEM PVT.LTD.
0.686 kg
2
Liquid Bromine
0.545 kg
IRA concemcd maytake m■her necessary action as per above decision ofNC
Paty Name:DELTA
FINOCHEM PVT LTD.
Patty Name:DELTA IMeet No/Date:1/82-
FINOCHEM PVT.LTD. IALC4/2018
101.05.2018
~| ~
(
:
江
0
:
絆
:HQFi`…
… … ‐~~‐
lRLA‐ Filざ
~… …… ……‐‐‐
ILぉヽも
'5温
8161ibtti,69う~ ~~ … ……
|
|:01/82/050/00272/AM18/ 1:03/94/040/01082/AM17/ 124.04.2017 1 1
1Decision:Committee considered case as per agenda and deliberated on the matter in the presence ofthe
糧llFttl∬就∫器胤∫悧品肌鵠∬謂
dnput∞
"耐
mmsm“r ptta 47」HBPぉ
"r
allowed
0.785 kg
0.230
concerned
take further
action as
above decision of NC
iCase No.:264/4/82‐
:ALC4/2017
鐙謎淵〃
2だ慇
2‐
lHQ File
Status:
'Approved
Status:
Approved
112
RLA File
:Lic.No/Date:0910064951 1
101/82/050/00350/AM18/ 1:09/24/040/00681/AM17/ 24.04.2017 1
:Decision:Committee considered casc as per agenda and deliberatcd on the matter in the presence ofthe
lteChnical experts and l was decided to ratl取the ad¨ hoc input Output norms under para 4.7 of HBP as pcr
idetailS below or as applied by Arm whichever is lower
Export product
Exp.
Otv.
Sl.No.
Import items
Qty.Allowed
kg
1-[4-(PYRIDINE-2-
YL)PHENYL]-5(S)‐ 2,5-
BISI(TERT.BUTYLOXY‐
CARBONYL)‐AMINO]‐4(S)―
HYDROXY-6‐PHENYL-2-
AZAHEXANE
l kg
1
(2R,3R)― N―(3-AMINO―
2-HYDROXY-4‐
PHENYL BUTYL)― N―
lSOBUTYL-4-AMINO
BENZENE
SULFONAMIDE
0 50 kg
つ
４
Toluene
1.05 kg
3.
Methylene Chloride
2.30 kg
4
Isopropyl Alcohol
3.68 kg
Ethyl Triphenyl Phosphonium
Bromide
Tri Phenyl Phosphine
ハ
HENYL BUTYL)― N―
lSOBUTYL-4-AMINO
BENZENE
SULFONAMIDE
0 50 kg
つ
４
Toluene
1.05 kg
3.
Methylene Chloride
2.30 kg
4
Isopropyl Alcohol
3.68 kg
Ethyl Triphenyl Phosphonium
Bromide
Tri Phenyl Phosphine
ハ
33
iCase No.:343/4/82- Paty Name:HETERO LABS I MeetNo/Date:1/82‐ ,Status:
IALC4/2017 1LIMITED :ALC4/2018 :Approved
l 1 lol.o5.2018 :
IRA concemed may take nlrthcr necessary action as pcr above decision ofNC I
器既鳳
:ユil↓iし
~1協
濡:1品鳳1'~~
r agenda and ddiberated on the matter in the presence ofthel
the ad‐ hoc input output nolllls under para 4.7 of HBP as perl
: Committee considered case as per agenda and deliberated on the matter in the presence of the
ical experts and it was decided to ratiS the ad-hoc input output norms under para4.7 of HBP as per
ils below or as applied by firm whichever is lower:
Export product
Exp
Otv.
Sl.No.
Import items
Qty.Allowcd
kg
Abacavir Sulfate
l kg
1
(lS,4R)-4-AMINO… 2¨
CYCLOPENTENE‐ 1‐
METHANOL
HYDROCHLORIDE
0.79
つ
４
N‐(2‐AMINO‐4,6‐
DICHLORO‐
PYRIMIDIN―
5YL)FORMAMIDE
1.042
TRIETHYL ORTHO
FORMATE
1.375
4.
CYCLOPROPYL
AMINE
0.19
5.
ISOPROPYL
ALCOHOL
7.20
:
PTけName:HONOUR LAB
LIA41TED
`
1
|
:114
:
:
iCase No.:341/4/82-
:ALC4/2017
|
:HQ File
i:01/82/050/00349/AM18/
| ICase No。:346/4/82‐
| :ALC4/2017
Party Name:SRIAM LABS IMcet No/Date:1/82- IStatus:
IPRIVATE LIMITED iALC4/2018 :Approved
1 101.05.2018 1
IHQ File lRLA File iLic.No/Date:0910064937
y Name:SRIAM LABS IMcet No/Date:1/82- IStatus:
IPRIVATE LIMITED iALC4/2018 :Approved
1 101.05.2018 1
IHQ File lRLA File iLic.No/Date:0910064937
101/82/050/00354/AM18/ :09/24/040/00699/AM17/ 124.04.2017
: IDecision:Deferred for comments of TE
Decision : Committee considered case as per agenda and deliberated on the
technical experts and it was decided to ratif, the ad-hoc input output norms
matter in the presence of the
under para 4.7 of HBP as per
IRLA File…
:09/24/040/00035/AM18/
Export Product
Otv.
Sl.No.
Import items
Ouantitv allowed
N-1‐ (2,4-Difluorobenzyl)-4-
ethoxy-3-oxobutanamide
(ATFD/11)
l kg
1
2,4-
Difluorobenzylamine
0.825 kg
:1161Case No.:397/4/82…
IParty Name:BIOLOGICAL E I
Meet No/Date:1/82¨
IStatus:Deffered i
34
1 lALC4/2017
`and Re‐ lndexed
HQ pif e
RLA File
Lic.No/Date:09 t0064960 Defer
t:011821050100405/AM l8/
:09l24l040l0)2}8lAMl7l ,25.04.2017
',Date:26.07 .2018
:LTD
|
Paty Name:ENCUBE
IETHICALS PVT LTD
ALC4t2ot8
lor.os.zor a
顧
:Lic.No/Date:0310812788 1Defer
125 04 2017 1Date:26.07.2018
IDecision:It was decided to rernind DBT to expedite their comments.Case is deferred l
RLA Fiiざ~~………
|:03/94/040/00025/AM18/
:
iDecision : Deferred for comments of TE
118
ratify the ad-hoc input output norms under para 4.7 of HBP as per
idetailS below or as applied by flrln whichever is lower:
|
Export product
Exp.
0".
Sl.No.
Import items
Qty.A1lowed
kg
ZOFENOPRIL CALCIUM
l kg
1
Trans-4-hydroxv-L-orol ine
1.25
2.
S-(-)-3 -Benzoylth io-2-
Methylpropionicacid (OR)
s(-
rln whichever is lower:
|
Export product
Exp.
0".
Sl.No.
Import items
Qty.A1lowed
kg
ZOFENOPRIL CALCIUM
l kg
1
Trans-4-hydroxv-L-orol ine
1.25
2.
S-(-)-3 -Benzoylth io-2-
Methylpropionicacid (OR)
s(-
)3 Benzoylthio2Me.orooioacid
1.17
4
Triethylamine(TEA)
1.92
「
Committee considered the case as per agenda and in consultation with technical authority present in
meeting, it was decided to ratiS, norrns as per the earlier decision taken in norms committee meeting No.
l4l82held on24.10.2013 under para4.7 of HBP as per details below or as applied by firm whichever is
,lower:
l19l
Export product
Exp.
Oty.
Sl.No.
Import items
Qty. allowed
ヽEUTRALIZED AMIDE
ESTER/(ETHANOL
ヽMIDE STEARATE)
kg
1
STEARIC ACID
1.06 kg
つ
４
MONO ETHANOL AMINE
0.114 kg
,
lA may take appropriate action as per the decision of Norms Committee.
ハ
## Case No.:373/4/82-
:ALC4/2017
1117
IH′ 1器島掲
50Ю038VAMlν
ICase No.:70/9/82-ALC4/2017 1ParりName:MYLAN
ILABORATORIES LIMITED
IMeet No/Date:1/82-
IALC4/2018
101.05.2018
Status:
Approved
:HQ File
l:01/82/050/00797/AM18/
ILic.No/Date:0910064961
125.04.2017
|
ICase No.:372/4/82‐ ALC4/2017 ParりName:FINE ORGANIC
INDUSTRIES,
Meet No/Date:1/82‐
IALC4/2018
101.05.2018
tStatus:
',
,Approved
:
IHQ Flle
RLA File
l:03/94/040/00065/AM18/
i Lic.No/Date :03 I 08 127 99
lze.oq.zon
‐
## Case No.:377/4/82¨
IALC4/2017
35
Paty Name:GUJARAT
10RGANICS LIMITED
IMeet No/Datel1/82-
lALC4/2018
101.05.2018
,Status:
lApproved
i
1120
HQ File
RLA File
Lic.No/Date:0310812840
;:011821050100385/AMl8/ ::031941040100087/AM18/'26.04.2017
Decision : Committee considered case as per agenda and deliberated on the matter in the piesence of the
technical expertsanditwasdecidedtoratifothead-hocinputoutputnormsunderpara4.T
ofHBPasper
rdetails below or as applied by firm whichever is lower:
i
Export Product
Otv.
Sl.No.
Import items
Ouantity allowed
5 Chloro Salicylic Acid
l kg
1
Para Chloro Phenol
0.87 kg
RA concerned may take further necessary action as per above decision ofNC
レ
|
ICase No.:55/9/82‐ALC4/2017 ParりName:B10LOGICAL E
lLrD
Iffi
101/82/050/00782/AM18/ 109/24/040/00207/AM17/
IDecision:Deferred for comments of TE
ILic.No/Date:0910064972 1Defer
127.04.2017
IHQ File
IMcet No/Date:1/82-
IALC4/2018
101.05.2018
醤∬糧
littI::|
IDate:2607.20181
## Case No.:305/4/82¨
ALC4/2017
IHQ File
lLrD.,
IRLA File
IParty NameiCENTAUR IMcet No/Datei1/82- Status:
PHARMACEUTICALS PVT.:ALC4/2018 1Approved
101.05.2018 :
ILic.No/Datei0310812927 1
|
:
1122
:01/82/050/00313/AM18/ :03/94/040/01149/AM17/ 127.04.2017
technical experts and it was decided to ratifu the ad-hoc input output norms under para 4.7 of HBP as per r
Export Product
Otv.
Sl.No.
Import items
Ouantitv allowed
Sodium Cromoglicate 100 mg
Capsules Each hard gelatin
capsule Contains : Sodium
Cromoglicate Ph. Eur 100 mg
I Number
1
Sodium Cromoglycate
100 mg/capsule
,RA concemed may take further necessary action as per above decision of NC
| ICase No.:379/4/82¨
| IALC4/2017
1 1HQ File
1 101/82/050/00387/AM18/
Pa■y Name:DELTA
FINOCHEM PVT.LTD.
~IRLA HL ~~~~
IALC4/2018
101.05.2018
1Lic.No/Date10310812911
:Status:
:Approved
:
:
:03/94/040/00026/AM18/ 127.04.2017
ltechnical experts and it was decided to rafiS, thi ad-hoc input output norms under para 4.7 of HBP as per
123 details below or as applied by firm whichever is lower:
Export Product
Qty.
Sl.No.
Import items
Quantity allowed
Kg
Praziquantel BP/USP
l kg
1
Phenyl Ethyl Amine
1.00
う
４
Methylene Dichloride
6.00
Potassium Carbonate
0.94
4
Cyclo Hexane Carbonyl
Chloride
0.77
t Product
Qty.
Sl.No.
Import items
Quantity allowed
Kg
Praziquantel BP/USP
l kg
1
Phenyl Ethyl Amine
1.00
う
４
Methylene Dichloride
6.00
Potassium Carbonate
0.94
4
Cyclo Hexane Carbonyl
Chloride
0.77
36
Ｆ
Ｉ
Ｉ
Mcthyl Tertiary Bu"l
Ether
1.50
6
Caustic Soda
1.50
Ｆ
‐
‐
‐
２
４
‐
‐
一
ICase No.:380/4/82¨
:ALC4/2017
IHQ File
l:01/82/050/00388/AM18/
狙鳥器淵缶
D.
i
RLA File~~~~~
|:03/94/040/00030/AM18/
「
~冨赫商甲甲漑~翻ぽ薦剛
| IHo卜liと ~ だilム11: lic Nn/Dnte・OR10140179 1 1
IHQ File lRLA File lLic.No/Date:0810140179 1 1
101/82/050/00416/AM18/ :08/24/040/00016/AM18/ 128.04.2017 : |
IDecision:Committee considered case as per agenda and deliberated on the mattcr in thc presence ofthe
leChniCd expeis andれ
was decidcd to ratitt thC ad― hOC input output norms undcr para 4.7 of HBP as per
idetails belo、v or as applied by fl:lH whichever is loweri
lExport Product
lBUPROPION HYDROCHLORIDE EXTENDED RELEASE TABLETS 150 MG:
IBUPROP10N HYDROCHLORIDE EXTENDED RELEASE TABLETS 300 MG
For export of I No.
elo、v or as applied by fl:lH whichever is loweri
lExport Product
lBUPROPION HYDROCHLORIDE EXTENDED RELEASE TABLETS 150 MG:
IBUPROP10N HYDROCHLORIDE EXTENDED RELEASE TABLETS 300 MG
For export of I No. Tablets
(Quantity in mg)
BUPROPION HYDROCHLORIDE
USP
MAGNESIUM STEARATE NF
METHACRYLIC ACID COPOLY
DISPER NF
18.514 mg
IRA may take approp五ate action as per the dedsion ofNorlns Committee.
1躍ぽ
1/82‐ ~琴鳳暉
|:;:il'i:1:li; [ 「
モ
「
51 「
51 「
Iう,5う,デ
l:I:l:::::i:::llllit:|
126
一
|
-1
Decision: Committee considered case as per agenda and deliberated on the matter in the presence of the
technical experts and it was decided to rati$ the ad-hoc input output norms under para 4.7 of HBP as per
Export Product
Qty.
Sl.No.
Import items
Quandty allowed
K2
5-(4¨ AMINO-2-OXA―
PYRIMIDINYL―
OXATHIOLANE-2-
CARBOXYLIC ACID―
ISOPROPYL― MENTHYL―
l Kg。
1
GLYOXALIC ACID
50%
0.743
つ
４
2,5‐DIHYDROXY… 1,4-
DITHIANE
0.325
CYCLOHEXANE
0.790
|
ハ
;
S.NO.
Import Items
150m2
Tahiets
300m2Tablets
153 mg
306 mg
2
3.00 mg
6.O m2
27.222mg
| ICase No.:40/9/82-ALC4/2017 1Party Name:STYRAX
I IPHARMA PRIVATE
Meet No/Date:1/82-
:ALC4/2018
101.05.2018
stlliζI ~■
:Approved l
| 卜IMITED
| IHQ File
IRLA File
Lic.No/Date:0910064985
128.04.2017
arty Name:STYRAX
I IPHARMA PRIVATE
Meet No/Date:1/82-
:ALC4/2018
101.05.2018
stlliζI ~■
:Approved l
| 卜IMITED
| IHQ File
IRLA File
Lic.No/Date:0910064985
128.04.2017
37
Ｆ
Ｉ
Ｉ
Ｉ
Ｉ
Ｉ
Ｉ
Ｉ
Ｉ
Ｉ
Ｉ
Ｉ
RA concemed may take further necessary action as per above decision of NC
CYCLOHEXYL ESTER
(CYCLOHEXYL EASTER)
CHE
4
TOLUENE
0.56
DI METHYL
FORMAMIDE
0.26
6
CYTOSINE
0.428
7
HEXA METHYL
DISILAZANE(HMDS)
0.698
METHYLENE DI
CHLORIDE(MDC)
1.00
9
L―MENTHOL
0.751
|
」
ICase No.:221/4/82- ParりName:BAROQUE Mect No/Date:1/82‐ Status:Deffered l
ALC4/2017 PHARMACEUTICALS PVT.・
ALC4/2018 and Re¨ indexed l
LTD 01.05.2018
129 HQ File RLA File Lic No/Date:0810140185‐
Defer
l :01/82/050/00229/AM18/ :08/24/040/00536/AM17/ 101.05.2017 1Date:26.07.2018
1 1Decision:Committee considered the case as per agenda and it was decided to call from the rlrm list l
l lfapprOved items in DML along with their composition.
1.05.2017 1Date:26.07.2018
1 1Decision:Committee considered the case as per agenda and it was decided to call from the rlrm list l
l lfapprOved items in DML along with their composition. |
■ |むiユヽ6:Lとi'4/82‐ |larty｀:ふも
:MAヽこALAM ~IM88:ヽも
/D五18:iた2‐ ‐
IStttit: |
|
■LC42017 1DRUGS&ORGANCS I針
″ 獄ゞ ,ppr°
Ved
‐
| ILIMITED
IHQ File lRLA Flle lLic.No/Date:03108129541 1
1 :01/82/050/00269/AM18/ 103/95/040/00073/AM18/ 101.05.2017 1 1
1131 bιtiξ i`i:ёも轟mi18e`もnsiaきた
a ciξさ五ζぉも
':Lenda and deliberated on the matter in thc presence ofthe
l technical experts and it was decided to ra衝
～
the ad_hoc input output norms under para 4.7 of HBP as pcr‐
l detd｀bdOW or as applたd by arln whchever`bwer l
Export Product
Qty.
Import items
Quantity
allowed
‐Meet No/Date:1/82- IStatus:Deffered l
:ALC4/2018 and Re‐ indexed l
101.05.2018 1 1
1Lic.No/Datei5210042246 1Defer l
101.05.2017 1 Datc:26.07.20181
| ICase No.:142/4/82- ParりName:DEEPAK IMeet No/Date:1/82‐ Status:Deffered l
lALC4/2017 1NOVOCHEM IALC4/2018 and Re‐
indexed l
l l lTECHNOLOGIES LTD 01.05.2018
130 1HQ File lRLA Filc Lic.No/Datc13110066712 Dcfer l
l l:01/82/050/00150/AM18/ :31/83/040/00010/AM18/ 01.05.2017 1Date:26.07.20181
Decision : It was decided to ask the firm to furnish complete technical details as per Appendix 4E.
Deferred .
l:01/82/050/00150/AM18/ :31/83/040/00010/AM18/ 01.05.2017 1Date:26.07.20181
Decision : It was decided to ask the firm to furnish complete technical details as per Appendix 4E.
Deferred .
|IEゃ
o威PrOd直 IQy lh"“ "ms l∫器P I
|
ICase No。:205/4/82‐
IALC4ノ2017
ParりName:AETHER
INDUSTRIES LIMITED
11271
・~:HQ File
IRLA File
ICase No.:331/4/82‐
ALC4/2017
IPa“y Name:AUROBINDO
PHARMA LIMITED
IMeet No/Datei1/82-
IALC4/2018
101.05.2018
醤需1濫膿:|
128
1器3泥5υ00339ハMlν
IRLA File
t:09/24/040/00044/AM18/
Lic.No/Date:0910064988 Defer l
101.05.2017
IDate:26.07.20181
,
」
38
ハ
kg
PIPERAQUINE PHOSPHATE
l Kg.
Ethoxy Methylene Malonic Acid Ester
(EMME)
1.30 kg
lё基もヽ8:li41/4/8'1 ~lpany N:ie:ё LЁAヽ ~~ IMeもt No/Date:1/82- status:
IALC4ノ2017 scIENCE AND IALC4/2018 1Approved
l lTECHNOLOGY PVT.LTD. 01.05.2018 1
HQ File iRLA File Lic.No/Date:31100667161
:01/82/050/00149/AM18/ 1:31/83/040/00012/AM18/ 102.05.2017 1
圏濡t燎:1勇鴛
1需需:濡需i:鳴語お漁喩庸認:F詩撫温1詣
|
ldetailS below Or as applied by fll11l whichever is 10wer: |
i l
|
lary action as per above decision ofNC
Export Product
Oty.
Sl.No.
Import items
Quantity allowed
Mono MethyI Ether of
Hydroquinone― MEHQ 99%
PURITY
Number
1
Phenoxy methane /
Anisole PURITY 99%
& Above.
0.97
2
Hydrogen Peroxlde
(60%)PURITY 60%
0.65
Acetone(SolVent)
PURITY 99%AND
ABOVE
0.14
‐
ICase No.:206/4/82‐ IParりName:MOREPEN
I IALC4/2017 LABORATORIES LTD.,
IB51憾胤j:ふ1話j l協:盤j:::ふ1鳥」
Hydrogen Peroxlde
(60%)PURITY 60%
0.65
Acetone(SolVent)
PURITY 99%AND
ABOVE
0.14
‐
ICase No.:206/4/82‐ IParりName:MOREPEN
I IALC4/2017 LABORATORIES LTD.,
IB51憾胤j:ふ1話j l協:盤j:::ふ1鳥」
IMcet No/Date:1/82‐ status:Deffered
lALC4/2018 and Re¨ indexed
10105.2018 1
lm需よ桃面あ
2443B藷嗅tふ
| IDecision:DeFerred fOr comments Of TE
IRLA Filc
:09/24/040/00030/AM18/
=…_… … … … … … … … … … … … …… … …
‐ l
iCaseNo.:39/9/82¨ ALC4/2017:ParりName:AKTINOS IMeet No/Date:1/82‐
: :魃
CARE PⅢVATE AL∽
矧
8
) 101.05.2018
|醤需糧蹂脆翻
|
IDefer
103.05.2017
:Date:26.07.2018
IDecision:Deferred for comments Of TE
iCase No.:319/4/82¨ :ParサName:HETERO LABS IMcetNo/Date:1/82‐ status:Deffered
幽鋭
i上蕊1航λ
鶉∫1淵嚇笙‖
―
―― ―
―
―― 一二
一
―― ―
IDecision:Deferred fOr cOmments Of TE
: Case No. : 37 I 9 / 82 - ALC 4 120 l7',p arty Name : M y LAN
IMeet No/Date:1/82-
IALC4/2018
101.05.2018
Status:
Approved
11361
1 :HQ File
1 1:01/82/050/00764/AM18/
ILABORATORIES LIMITED
ρ3.05.2017
RA concemcd may take further necessary action as per above decision ofNC
## Case No.:75/9/82‐ ALC4/2017 ParりName:VIMAL DRUGS IMcetNo/Date:1/82-
PRIVATE LIMITED
:ALC4/2018
:01.05.2018
137 uq rit"
RLA File
Lic.No/Date:0910065005
:01/82/050/00802/AMl8/,:091241040100060/AMl8/
103.05.2017
## Case No.:59/9/82¨ ALC4/2017 Party Name:AUROBINDO
PHARMA LIMITED
IMect No/Date:1/82- lStatus:Deffered
,and Re-indexed
39
Decision: Committee .oniia.i.a .urc ur pi. ug"nau uno
technical experts and it was decided to ratify the ad-hoc
IHQ Flle lRLA Flle
:01/82/050/00786/AM18/ 109/24/040/00021/AM18/
I Decision:Deferred for comments of TE
deliberated on the matter in the presence of the
input output norms under para 4.7 of HBP as per
|
卜
38
| ICase No.:378/4/82-
ALC4/2017
1139‐ HQ Fi18
1 101/82/050/00386/AM18/
ICase No.:212ノ4/82‐
ALC4/2017
140責。lile
Party Name:HIKAL
ILIMITED
IRLA File
:03/94/040/00078/AM18/
Status:Deifered
and Re-indexed
Pefei
'Date:26.07 .2018
IDate:2607.2018
Status: Deffered
and Re-indexed
,Date:26.072018
lStatus:
'Approved
104.052017
ALC4/2018
‐01.05.2018
IALC4/2018
101.05.2018
ILic.No/Date:0910065008 1Defcr
104.05.2017
IMcet No/Date:1/82‐
ALC4/2018
‐0105.2018
:Lic.No/Date:0310813051 1Defer
Paty Name:SIMPEX
PHARMA PVT.LTD.
PRIVATE LIMITED
IMeet No/Date:1/82‐ IStatus:Deffered
lALC4/2018 and Re― indexed
101.052018 1
RLA File lLic No/Date:0510402447 1Defer
01/82/050/00220/AM18/ :05/24/040/00024/AM18/ 104.05.2017 1Date:26.07.2018
caseNo.:36/9/82-ALC412017 PartyName:SRIAM LABS
MeetNo/Date:l182-
141 HQ File lRLA File Lic.No/Date:09100650061
1 1:01/82/050/00763/AM18/ :09/24/040/00062/AM18/ 104.05.2017 1
‐
IDecision:Conlinittee considered case as per agenda and deliberated on the matter in the presence of the
te:09100650061
1 1:01/82/050/00763/AM18/ :09/24/040/00062/AM18/ 104.05.2017 1
‐
IDecision:Conlinittee considered case as per agenda and deliberated on the matter in the presence of the
1 leChnical experts and it was decided to ratitt the ad― hoc input output norms under para 4.7 of HBP as per
Export Product
Qty.
Sl.No.
Import items
Quantity allowed
Kg
SERTRALINE
HYDROCHLORIDE
l Kg.
l
(3, 4-dichloro-phenyl)-3,
4-dihydro-2H-
naphthalen- I -one
(Tetralone)
3.27
2
D(¨ )―Mandelic Acid
0.392
Sodium Borohydrate
0331
4
n-Heptane
0.56
5
Methanol
4.44
ヘ
|
|
40
below or as applied by firm whichever is lower:
Export Product
Otv.
Sl,No.
Import items
Quantity allowed
N‐ 1‐ (2,4-Difluorobenzyl)‐ 4-
ethoxy-3‐ oxobutananlide
(ATFD/11)
kg
1
2,4-
Difluorobenzylamine
0.825 kg
Mcet No/Date:1/82-
:ALC4/2018
:01.052018
Lic.No/Date:0710111546
105.05.2017
Status: Deffered
and Re-indexed
Date:2607.2018
| IDecision:Deferred fOr comments of TE
'Status: Deffered
and Re-indexed
‐
## Case No.:94/9/82‐
ALC4/2017
IHQ Filc
101/82/050/00821/AM18/
IRLA File
l:09/24/040/00349/AM15/
ILic.No/Date:0910065022 1
111.05.2017 1
:脅
Namぬbttё ёicAL Ё
‐
監
まNJb巖
`シ
ユ
~1露
識lei~
|
℃1.05.2018 1
145
euticals
I expert
HBP as
J
:ision : Committee decided to ratifo norms based on the recommendation of D/o Pharmaceut
varded O.M. No350l114361201s-Pl(Norms) dated Oct.20l5 and in consultation with technicale>
;ent in the meeting, it was decided to ratiS the ad-hoc input output norms under para 4.7 of HB
Export product
Exp. Qtv.
SI.No.
Import items
Qty.A1lowed kg
NOSCAPINE
l Kg
1
NOSCAPINE CRUDE
950/0
1 158 kg
necessary
per
IMeet No/Date:1/82- Status:Deffered l
lALC4/2018 and Re‐ indexed‐
101.05.2018 1 ‐
ICase No。:478/4/82-
IALC4/2017
EttN顎淵
RAL&
:PVT.LTD.,
つ
４
И
付
IHQ File
RLA File
iCase
|
N o.: 4l 19 I 82- ALC4 12017, Parry Name : SATYA
Mcct No/Datc:1/82-
IALC4/2018
LTD 0105.2018
lStatus:Deffered
tand Re-indexed
IИ
3画
II:II
:RLA File
ILic.No/Date:0910065014 1Defer
109.05.2017
Date:26.07.2018
ICasc No.:56/9/82‐ALC4/2017 1Parり
IPHARMA LIMITED
IMeet No/Datc:1/82‐
IALC4/2018
101.05.2018
11441
・‐‐
IHQ File
IRLA File
:01/82/050/00783/AM18/ 109/24/040/00086/AM18/
IDecision:Deferred fOr comments Of TE
ILic.No/Date:0910065017 1Defer
11.05.2017
‐Date:26.07.2018:
|
l lCase No.:48/9/82‐ ALC4/2017:ParりName:GLAND
l l
:146 1PHARMA LIMITED
IHQFile ~~~ IRLA File
ILic.No/Date:0910065025 1Defer
910065017 1Defer
11.05.2017
‐Date:26.07.2018:
|
l lCase No.:48/9/82‐ ALC4/2017:ParりName:GLAND
l l
:146 1PHARMA LIMITED
IHQFile ~~~ IRLA File
ILic.No/Date:0910065025 1Defer
41
101/82/050/00775/AM18/ :09/24/040/00005/AM18/
jDecision : Deferred for comments of TE
| ICase No.:1/4/82-ALC4/2017 :Parけ
Name:LEE PHARMA ,Meet No/Date:1/82- Status:Deffered l
l ‐ ILIMITED ALC4/2018 ‐
and Re― indexed l
101.05.2018 ‐
147 uQ Fit.
RLA File
Lic.No/Date:0910065019 Defer
:011821050/00009/AM l8/
:091241040100084/AM l8/
I I .05.2017
Date:26.07 .2018
Pai"Nihe:PRASOL IMcet No/Date:1/82- IStatus: :
ICase No.:430/4/82-
ICHEMICALS LIMITED :ALC4/2018 1Approved l
:ALC4/2017 01.05.2018
‐ ~ ~ Li`:ヽ
6′ b農8:63108131871 :
IRLA F‖ e
lHQ File
1101/82/050/00438/AM18/ 103/95/040/00063/AM18/ 111.05.2017 _ 1 _ __
‐
.
01.05.2018
‐ ~ ~ Li`:ヽ
6′ b農8:63108131871 :
IRLA F‖ e
lHQ File
1101/82/050/00438/AM18/ 103/95/040/00063/AM18/ 111.05.2017 _ 1 _ __
‐
. ,.;*;; , a;-;t*" considered case as p.i ug.nau u.a a"iiueiut"a on the matter in thi pi"iir." ofirri
,14g ,technical experts and it was decided to ratifo the ad-hoc input output norms under para 4.7 of HBP as per '
,details below or as applied by firm whichever is lower:
Export Product
Oty.
SI.No.
Import items
Ouantiw allowed
3,3,5 TRIMETHYL
CYCLOHEXANONE
l MT
1
ACETONE(BACKWARD
INTEGRAT10N FOR
ISOPHORONE)
2.054 MT
,RA concerned may take further necessary action as per above decision of NC
I Case No■41lμ/82-ALC42017鳳窯摺肥ゾlC鮮紫K lwttl澪腎
tC l慇2- :Tll鷺。ハ
|
1
|
ド
El‐USTRY LIMITED
出
盤T____ザ
ゞ
ム
IHQ File lRLA Filc Lic.No/Date:3410043170 1 1
1.ハl′0う′ハくn/An/410/Aヽ■lQ/ .・2/1/つ/t/n40/n∩∩2つ/△ヽ/1l R/ 11 0S,017
|:01/82/050/00419/AM18/ 134/24/040/00032/AM18/ 11.05.2017
: :Decision:Committce considered case as per agenda and as per earlier decision taken by NC in its 49/82
1149imeedng dated 06.03.2012 and in consuhation whh technical expert present in meeting, decided to ra伍取
l inOrms underpara4.7 ofHBP as per details below or as applied by f111:I whichever is lower¨
Export Product
Export Qty.
Sl.No.
Import items
Qty.
technical expert present in meeting, decided to ra伍取
l inOrms underpara4.7 ofHBP as per details below or as applied by f111:I whichever is lower¨
Export Product
Export Qty.
Sl.No.
Import items
Qty. allowed
2,4,6 Trimethyl Benzoyl Chloride
l kg
1
Mesitylene
1.132 kg
IRA maytake appropnate action asperthe decisionofNorlns Committee.
ICase No.:84/9/82-ALC4/2017 Pa“ y Name:AAP PHARMA
TECHNOLOGIES INDIA
1 1 1DDIヽ
/AT口
IIヽ711T口n
| | IPRIVATE LIMITED
1501責011i` RLA lilと
‐
| |:01/82/050/00811/AM18/ 1:09/24/040/00063/AM18/
IMeet No/Date:1/82‐ Status:Deffered
lALC4/2018 1and Re‐ indexed
101052018
1Lic.No/Datei091 0065032 1Defer
1205.2017 1Date:26.07.2018
1 1Case No.:83ノ9/82-ALC4/2017
1511
1
′
― ―
‐ ‐―― ‐
―
―
^
― ‐
l iHQ File
l l:01/82/050/00810/AM18/
earty NameieieNp Lf ie - V."t No/Date:l/82- Status:Deffered
SCIENCES LIMITED. 'ALC4l20l8
and Re-indexed
I
0l .05.201 8
RLA File
Lic.No/Date:0910065030 Defer
.Aot.^t\Ant.}.rn<n/ar\,lQ/ rl, OS ?Ol1
,Date.26.07.2018
.
IRLA File Lic.No/Date:0910065030 1Defer i
l:09/24/040/00050/AM18/ 112.05.2017 Date:26.07.20181
111.05.2017
IDate:26.07.2018
Ant.}.rn<n/ar\,lQ/ rl, OS ?Ol1
,Date.26.07.2018
.
IRLA File Lic.No/Date:0910065030 1Defer i
l:09/24/040/00050/AM18/ 112.05.2017 Date:26.07.20181
111.05.2017
IDate:26.07.2018
42
―
|
| ICaseNo.:65/9/82‐ ALC4/2017 ParりName:HETERO Mcet No/Date:1/82- :status:Deffered
l
‐DRUGS LIMITED ALC4/2018 1and Re― indexed
l l l 101.05.2018 1
115411。Fiど~ ~ ~IRLAヽ
お… …~~~~tidNo'b::`bう
i00`304'b`“ :‐
~
: 191/82/050/00792/AM18/ 1:09/24/040/00075/AM18/ 115.05.2017 :Dtte:26.07.2018
Export Product
Qty.
Sl.No.
Import items
Quantity
Betamethasone Sodium
Phosphate
l Kg.
1
Betamethasone
0.78 kg
concerned
take further
action as per above decision of NC
| IDecision:Deferred for cOmm(
I I蔽
罐
:
‐‐ ―…――一―――一―一―――――――――
―……………………―
―― _～
__……………壺
IT
|
Meet No/Date:1/82- status:Deffered
ALC4/2018 1and Re¨indexed
101.05.2018 1
1Lic.No/Date:0910065044 1Defer
15.05.2017 1Date:26.07.2018
ICase No.:58/9/82‐ALC4/2017 Party Name:EYTAN LABS
Mcet No/Date:1/82- lstatus:Deffered l
1521。乱――― 1茸:1-¨ ‐
謂盤
f lndRe価“К
dl
｀Lic.No/Date:0910065035 1Defer l
l 101/82/050/00785/AM18/ :09/24/040/00034/AM18/ 112.05.2017 1Date:26.07.20181
1 tDecision:Deferred fOr cOmments Of TE I
iCase
Pa■y Name:HETERO
IDRUGS LIMITED
,Meet No/Date:1/82‐
ALC4/2018
01.05.2018
醤需糧蹂脆翻
:Date:26.07.2018
1153¨面戸――~~~~―慧亜面:
Liciヽも′
bit`:6う16b``64j lbもfei
15.05.2017
## Case No.:38/9182- ALC4/201 7 Party Name:MyLAN
ILABORATORIES LIMITED
r'"" HQ File
1鴨ち』
:,0/00061/AM18/
101/82/050/00765/AM18/
## Case No.:465/4/82- IPaロッName:STERMONE
IALC4/2017 1cHEMICALS PVT LTD
rMeet No/Date:L182-
,ALC4t2ot8
101.05.2018
Status:
Approved
IHQ File
IRLA File
Lic.No/Date:3410043187
|
|
:01/8210501004731AM18t :34/24t040/0o2l2tAMt7t 16.05.2017
|■111■1111ス ::: ~ ~:「
1‐
― ―
.::,"t,"r: ,-S::T:l.j,::.Tld,.::9,:ase as per asenda. and. detiberared on the maner in the presence of rhe
43
| ICase No.:385/4/82- Paty Name:AARTI DRUGS
‐ IALC4/2017 1LIMITED
1 1 1
1581責
Q「ilも ,良LA Filも
101/82/050/00393/AM18/ 103/94/040/00090/AM18/
1 :Decision:Deferred for comments of TE
Mcet No/Date:1/82- Status:Deffered
ALC4/2018 'and Re― indexed
101.05.2018 1
Lic No/Date:0310813319 1Defer
117.05.2017
Date:26.07.2018
| ICase No.:371/4/82-
| IALC4/2017
159‐責。,iiも
| .:01/82/050/00379/AM18/
ILTD。,
Meet No/Date:1/82-
:ALC4/2018
101.052018
'Status: Deffered
and Re-indexed
|
L0
1 101/82/050/00816/AM18/ :09/24/040/00089/AM18/
1 1Decision:Deferred for comments of TE
[1
ICase No。:61/9/82-ALC4/2017 1Paty Name:PORUS
: ILABORATORIES PVT LTD
蠅
3島児
50Ю0788/AM18/ IЪ ち漏
liO/00041/AMlν
:Decision:Deferred for comments of TE
:ALC4/2018
:01.05.2018
ILic.No/Date:0910065058 1Defer
IRLA File
i:03/94/040/00149/AM18/
ILic.No/Date:03108133361Detr
117.05.2017 Datc:26.07.2018
Mcet No/Date:1/82- IStatus:Deffered
lALC4/2018 1and Re‐
indexed
101.05.2018
ILic.No/Date:0910065055 1Dcfcr
17.05.2017 1Date126.07.2018
1M`まヽ夕5品:iたダ~｀
ヽ
1群iζDeffered
一
一
:17.05.2017
Ijand Re-indexed
I
IStatus:Deffered
lALC4/2018 1and Re‐
indexed
101.05.2018
ILic.No/Date:0910065055 1Dcfcr
17.05.2017 1Date126.07.2018
1M`まヽ夕5品:iたダ~｀
ヽ
1群iζDeffered
一
一
:17.05.2017
Ijand Re-indexed
I
'Date:26.07.2018
:1621。File
:RLA File
i09/24/040/00088/AM18/
.Case No.:53/9/82¨ALC4/2017 IParty Name:VIVIMED LABS
ILIMITED
Status: Deffered
,and Re-indexed
Defer
'Date:26.07 .2018
Meet No/Date:1/82‐ Status:Deffered
lALC4/2018 and Re‐ indexed
i01.05.2018
1Lic.No/Date:0910065073 1Defer
118.05.2017 1Date:26.07.2018
:01/82/050/00780/AM18/
ICase No。:45/9/82‐ ALC4/2017 ParりNamc:GRANULES
I IINDIA LIMITED
19晶泥
50/00772/AM18/ IЪち刷:0/00074/AM18/
1163
|
|
Decision:Deferred for comments of TE
## Case No.:388/4/82‐ ALC4/2017 Party Name:AIMSIMPEX Meet No/Date:1/82‐
Status:
IPVT LTD., ALC4/2018 ‐Approved
.01.05.2018
1164 1HQ File RLA File lLic.No/Date:0310813436
1 :01/82/050/00396/AM18/ :03/94/040/00150/AM18/ 12205.2017
1 btttおi:ё6品hitt`c861ζ Йしたる
:A`tiζさふζ
`ざ
iLenda and in consdta●on wih technicd authoHty present
l lin meeting,■was decided to ratl″ nOrms as perthe eadier deciJon taken in norlns commi■
ee meeting No
ヘ
:Case No.:89/9/82‐ALC4/20171Paty Name:ORCH
: ILABORATORIES INDIA
PVT LTD
,HQ File
IRLA File
IALC4/2018
10105.2018
117.05.2017
44
ハ
l/82 held on .2013 under para4.7 of igP as per details below or as applied Uy nrm whichever is lower:-
Export product
Exp.
Qty.
Sl.No.
Import items
Qty. Allowed
Coumarin
l kg
1
Salicylaldehyde
1.09 kg
|‐
ICase No.:304/4/82-
:ALC4/2017
HQ File
:01/82/050/00312/AM18/
IMcet No/Date:1/82- Status:Deffered
lALC4/2018 and Re―indexed
.01.05.2018 1
:ParりNameiCIPLA
:LIMITED.
|
:RLA File Lic.No/Date:0310813433 1Defer
|:03/94/040/00162/AM18/ 1
Lic.No/Date:0310813433 1Defer
122.05.2017 1Date:26.07.20
, 鐙従淵″α″
"‐
:
:
:
ParりName
SCIENCES
IRLA File
105/24/040/00045/AM18/
:MAHIMA LIFE
PVT.LTD.
一
一
６
５
一
一
６
０
４
・
．
２
．
一
４
０
．
８
０
．
Ｗ
一
５
‐
一
「離脇F/4/821~路納濡縄
『憫Ы
A萱漱普轟夕濡曲需
|
1167Ⅲ゛ile… … …‐
lLA由ど… ・~ tiヽル
bttbζ
“
4める
j●
`ふ
~‐ ■
| ::01/82/050/00361/AM18/ 1:0524/040/00078/AM18/ 122.05.2017 Date:26.0720181
０
．
Ｗ
一
５
‐
一
「離脇F/4/821~路納濡縄
『憫Ы
A萱漱普轟夕濡曲需
|
1167Ⅲ゛ile… … …‐
lLA由ど… ・~ tiヽル
bttbζ
“
4める
j●
`ふ
~‐ ■
| ::01/82/050/00361/AM18/ 1:0524/040/00078/AM18/ 122.05.2017 Date:26.0720181
i :Decision:Deferred for comments of TE I
ヽLIFE :Mcet No/Date:1/82- IStatus:Deffered:
ED IALC4/2018 and Re― indexed l
101.05.2018 1 1
1Lic.No/Date:0910065089 1Defer l
: ::01/82/050/00773/AM18/ 1109/24/040/00052/AM18/ 123.05.2017 1Date:26.07.20181
: :Deciζ 161~:bおferred forあ詰品きIiξ 6fit~
‐ ‐ ‐‐~~~
‐ ― ― ― ―
¨
―■
: ICase No.:57/9/82‐ ALC4/2017 1Pa,y NameiSUVEN LIFE
I : ISCIENCESLIMITED
1169ⅢoFiぼ… … … lLAiお…~…
1 101/82/050/00784/AM18/ 1:09/24/040/00010/AM18/
lt需濡庁う
力
jふ~~ :億
濡庄
:常熱11: 址:漱学よ″み 1濡鷺
:驚:颯
11701。ⅢI‐ - lWIT lttζ
:13:6説“ム。
jj,18高 ~
rl'{ rlre
,RLA File
,Lic.No/Date:0gl0140332 Defer
:01/82t050t00367/AMr18t :08t24t040t0o53otAMl7 /
23.05.2017
'Date:26.07 .2018
――――――――――――― 一― ― ―――― ― ― ―…………―～～―～―‐――¨―――～～― ― ―=――――___… ………………‐‐‐¨― ――――¨～――‐―― :
|
| |
: i:01/82/050/00364/AM18/
iDecision :
IALC4/2018
101.05.2018
lStatus:Deffered
land Re-indexed
Lic.No/Date:0910065090 Defer
23.05 2017 1Date:26.07.20181
;
,Decision : Deferred for comments of TE
:01/82/050/00364/AM18/
iDecision :
IALC4/2018
101.05.2018
lStatus:Deffered
land Re-indexed
Lic.No/Date:0910065090 Defer
23.05 2017 1Date:26.07.20181
;
,Decision : Deferred for comments of TE
45
ICase No.:93/9/82‐ALC4/2017 IPaty Name:B10LOGICAL E IMeetNo/Date:1/82- Status:Deffered l
,LTD IALC4/2018 tand Re―
indexed‐
‐ 101.05.2018 ‐
Lic.No/Date:0910065091 1Defer l
2405.2017 1Date:26.07.20181
171 揮Q Fne
RLA File
l:09/24/040/00057/AM18/
:01/82/050/00820/AM 18/
|
1 lCase No.:390/4/82- Pa=y Name:AARTI
IMeet No/Date:1/82¨
'Strtur,b"ri"."J
and Re-indexed
‐ALC4/2017
IINDUSTRIES LIMITED
IRLA File
|口21
|・′´IHQ File
. :01/82/050/00398/AM18/
. :01/82/050/00398/AM18/ :03/94/040/0013277AM18/
1 1Decislon:Deferred for comments ofTE
I
iDecision : Deferred for comments of TE
tl
●
′
ICase No.:76/9/82-ALC4/2017.ParりNamc:AUROBINDO IMcet No/Date:1/82- Status:
‐ PHARMA
ЫM「ED I計
″ 鰍T 'pproVed .
■0青お ~~
‐
RLA ile‐ ~~~‐ ‐… tiょ、ルb品もう
ib6`ζib3 1 ~ ■
101/82/050/00803/AM18/ :09/24/040/00096/AM18/ :30.05.2017 1 :
Decおbn:Committee conddered case as per agenda and ddiberated on the matter in the presence ofthel
ltechnical experts and it was decided to rati″
the ad_hoc input output norms under para 4.7 of HBP as perl
details belo、v or as applied by flrlll、vhichever is lower: |
Export Product
Qty.
Sl.No.
Import items
Quantity allowed
Ke
ABACAVIR SULFATE
l Kg.
1
FADCP[N¨ (2‐Amino―
o、v or as applied by flrlll、vhichever is lower: |
Export Product
Qty.
Sl.No.
Import items
Quantity allowed
Ke
ABACAVIR SULFATE
l Kg.
1
FADCP[N¨ (2‐Amino―
4,6‐ E)ichloro-5-
Pyrimidinyl)― Follllamide
1
1.042
2
Amino Carbinol Tarffate
1.39
Tri Ethy1 0rtho Fomate
1.375
4
Cyclopropylamine
0.19
Activated Carbon
(Enoanticromos)
0.100
6
Isopropvl Alcohol(IPA)
3.78
7
Steam/Thermal Coal
(Non-Cookine) in Bulk
Relevant as per
packins policy
rl
|
|
l(ron-uoormg,
,RA concerned may take further necessary action as per above decision of NC
'
## Case No.:404/4182-
Party Name:FRESENIUS Meet No/Date:1182- Status:Deffered
'ttcq?}ll
KABI ONCOLOGY
tALC4l2Ol8
and Re-indexed
'LIMITED
,01.05.2018
I
l
t1a
"* Hq Fil.
rru-e pite
,Lic.No/Date:05104027501Defer
,
;011821050/00412/AMl8/ ,:051231040100088/AMl8/ :30.05.2017
lDate:26.07.2018,
Dec.ision : Deferred for qomments of TE
..
I
,Case No.:42 lgt82-ALc4l20l7 Party Name:GLAND
lMeet No/Date:'l182- ,status:DeffereO
,
i
,
PHARMA LIMITED
ALC4l20l8
rand Re-indexed
l7s
'01 .05.201 8
i
i
HQ File
RLA File
Lic.No/Date:0910065 I l0 Defer
',:01t82t0.50/00769/AM l8/
:091241040100099/AM 18/
130.05.2017
tDate,z! 07 ,201s
:
,I)ate:26.07.2018
Lic.No/Date:0310813643 1Defer
'9.05.2017
46
Meet No/Date:1/82-
IALC4/2018
101.05.2018
,Status:
'Approved
||
Export Product
Qty.
Sl.No.
Import items
Quantity allowed
Ks
Compresso GEM 70
(Gemabrozil Granules DC
70%)
l Kg。
1
Gemttbrozil
0.707
2
Starch Preselatinised
0.083
Maize starch
0.1485
4
Sodium Starch Glycollate
0.030
Povidone K-30
0.027
6
Sodium Lauryl Sulphate
0.0015
7
Stearic acid
0.010
IRA concemed may takc hrther neccssary action as pcr above decision ofNC
帯辮滋……器織ザ:管:輩翌霞■11翌:讐社
1177正一―― ―_____1里)II盟と__
汗
7臨所扁語墓
I話|」~~~臨
蕊
ill:
I FDedsbn:Defettd¨ brcomments o両
「
~~～…
I Case No。:413/4/82‐ ParサName:ALEMBIC IMeet No/Dtte:1/82- status:Deffered
i :ALC4/2017 PHARMACEUTICALS LTD
‐ALC4/2018 ‐
and Re― indexed
l : .
o両
「
~~～…
I Case No。:413/4/82‐ ParサName:ALEMBIC IMeet No/Dtte:1/82- status:Deffered
i :ALC4/2017 PHARMACEUTICALS LTD
‐ALC4/2018 ‐
and Re― indexed
l : . 01・
05.2018
1・器3泥5υ∞柁νAm y 亀
:ち漏脱υ∞“
vAM ν :ドバ辮α釧004328襟ち
6Ю7劉8
1 :Decision:Committee considered the case as per agenda and it was decided to call frOm the ttrm
l ICOpy ofDrug Manufacturing Licence(DML)for eaCh export product and complete technical details
I ls per 4E.
|~11きさNよ:331/4/8う」 |お
｀
`鳥
もjbbASEXldM■
もよ｀レb岳と,t,1~ ~もittliま
~
1 lALC4/2017 PVT.LTD., ,ALC4/2018 1Approved
i l 1 101・
05.2018
‐
1鶏脱鳳黒鳥j胤鑑蕊
::詰1↓L~:F蕊需ぎ
0510施
"り
~
Export product
Exp. Otv.
Import items
Oty. allowed
Capecitabine Tablets USP
500mg.
Number
CAPECITABINE
510 mg/500 mg tablets
Capecitabine Tablets USP
Number
CAPECITABINE
153 mg/150 mg tablets
I
'Decision : Committee considered case as per agenda and deliberated on the matter in the presence of the
ll79 rtechnical experts and it was decided to rati$r the ad-hoc input output norms under para4.i of HBP as per
I
:'
iCase No.:50/9/82‐ALC4/2017
|
Paty Name:GRANULES
INDIA LIMITED
IHQ File
:01/82/050/00777/AM18/
IRLA File
:Lic No/Date:0910065109 1
13005.2017 1
: :
葬鰤謝珊鶴T鋼∫糧脳
i∫l品T鍬鰐il:‖:器罵点朧轟
:∵ヂ
『離
::∫欝
|
idetdIS below or as applおd by nm whtheverislower i
No/Date:0910065109 1
13005.2017 1
: :
葬鰤謝珊鶴T鋼∫糧脳
i∫l品T鍬鰐il:‖:器罵点朧轟
:∵ヂ
『離
::∫欝
|
idetdIS below or as applおd by nm whtheverislower i
47
l50mg.
IMIPENEM十
CILASTATIN
INJECT10N.lGM.Drug
Formulations
ltteCtiOns(ampules/宙als
above 20 ML)
Number
IMIPENEM AND
CILASTATIN SODIUM
FOR INJECTION
(STERILE BULK)
1106.25 mg/vial
IRA concemed may take mrther necessary action as per above decision ofNC.
## Case No.:62l9182-ALC4I20l7 Party Name:VIRCHOW
PETROCHEMICAL PVT
ILTD.
IRLA File
Meet No/Date:1/82-
ALC4/2018
.0105.2018
Lic.No/Date:0910065116 1Defer
ぼ需糧鷺鷲
I::
一
８
一
|
|
1180
|
IHQ Filc
';011821050100789/AM I 8/
,:0912410401003161 AMIT L3l
.05.2017
IDate:26.07.201
;Decision : Committee considered the case as per agenda and it has been observed that there is wide i
,variation in the norms applied by the firm, it was decided to call from the firm following.
information :
I D
CA certificate past consumption norms and the consumption coefficient claimed in the
I
process details. Technical justification for such variation may be furnished.
, iil
The fi.rn may be advised to appear PH along with Central Excise /CST Authorities
'
certificate past production consumption data.
rIt was also decided to call the firm to appear before norms committee for Personal Hearing to
explain their case.
ICase No.:71/9/82‐ Party Name:VIRCHOW IMeet No/Date:1/82- Status:Deffered l
:ALC4/2017 1PETROCHEMICAL PVT 'ALC4/2018 and Re‐
indexed l
l lLTD.
r case.
ICase No.:71/9/82‐ Party Name:VIRCHOW IMeet No/Date:1/82- Status:Deffered l
:ALC4/2017 1PETROCHEMICAL PVT 'ALC4/2018 and Re‐
indexed l
l lLTD. :01.05.2018 1
ヽ
IHQ File lRLA File lLic No/Date:0910065113 1Defer l
101/82/050/00798/AM18/ 109/24/040/00590/AM17/ 131.05.2017 1)ate:26.07.2018 1
1Decision:Committee considered the case as per agenda and it has been observed that there is wide
181 Variation in the norms applied by the nrm,it was decided to call from the nrm followingl
linformation:
l ili) CA certirlcate past consumption ■orms and the consumption coefrlcient claimed in thel
l
process details. Technical justification for such variation may be furnished.
:
iv)
The firm may be advised to appear PH along with Central Excise /GST Authorities
I
certificate past production consumption data.
, v)
It was also decided to call the firm to appear before norms committee for Personal Hearingl
to explain their case.
ntral Excise /GST Authorities
I
certificate past production consumption data.
, v)
It was also decided to call the firm to appear before norms committee for Personal Hearingl
to explain their case.
, _ -
_;
ICase No.:87/9/82‐
IALC4/2017
1HQ File
:01/82/050/00814/AM18/
,Party Name:VIRCHOW
IMcet No/Date:1/82- Status:Deffered
lALC4/2018 and Re― indexed
101052018 1
1Lic No/Date:0910065115 1Defer
131.05.2017 1Date:26.07.2018
PETROCHEMICAL PVT
LTD.
RLA File
:09/24/040/00606/AM17/
^^ rDecision : Committee considered the case as per agenda and it has been observed that there is wide '
82 variation in the norms applied by the firm, it was decided to call from the firm following,
information :
vi)
CA certificate past consumption norms and the consumption coefficient claimed in ther
process details. Technical justification for such variation may be furnished.
vii)
ih" fi.* may be advised to appear PH along with Central Excise /GST Authorities
certificate past production consumption data.
i)
It was also decided to call the firm to appear before norms committee for Personal Hearing
d to appear PH along with Central Excise /GST Authorities
certificate past production consumption data.
i)
It was also decided to call the firm to appear before norms committee for Personal Hearing
48
IFど
｀JЙJ肋患猟Laた6″
1需聴翌訥キ::~1鸞
漱曽
よ1/82
鷺鷺:鸞驚J
18=島λふ講
7誠話j｀協魔鵬11話j 縞幕αめ満
“
わ毛議.講1:
| :Decおlon:Deferred for comments of TE ,
= ~~
蔦
11841。「i8 1LAhお ~
| 101/82/050/00496/AM18/ 1:05/24/040/00109/AM18/
1 1bιcitibi:b`fell`b foi t6語島
`lit tfit
‐ ~
to explain their case.
|
¨ …
…
…
…
…
…
…
…
…
…
…
…
…
…
…
1
Export Product
Qty.
Sl.No.
Import items
Quantity allowed
Kg
N Hexyl Bromide ( I -Bromo
Hexane)
l kg
1
Naco1 6‐98(ト
Hexano1 0r N―
Hexanol)
0.686 kg
2
Liquid Bromine
0.545 kg
Export product
Exp.
Otv.
Ｓ
‐
．
Ｎ
。
Import items
Qty.Allowed
kg
LEVETIRACETAM
l kg
1
ACTIVATED CARBON
0.0128
2
CELITE
0.100
ETHYL ACETATE
0.86
4
METHYLENE CHLORIDE
2.26
SODIUM SULPHATE
ANHYDROUS
1.00
6
TETRA BUTYL
AMMONIUM BROMIDE
0.10
7
4-CHLORO BUTYRYL
1.02
## Case No.:44114t82-
Party Name:LUPIN LIMITED Meet No/Dat e:t/82-
Status:
,
,ALC4l20l7
N.C.AD}:rR
)
1
'
',01.05.2019
HQ File
RLA File
Lic.No/Date:031081380t
,,:01/8210501004491AM18/ :::03t95t040t00196/AMl8/ :07.06.2017
I l,t^*l"llfryt^ll1 lj,y,u: decided,to mtii, th; ad-hoc input output norms under para 4.7 of HBp as per i
: ド
dJ｀bdO↓Orぉap口おdbynm↓il高酢ごI鳥l
|
:~tiζきヽま島4/4たが
‐~~‐
,aO Ni品
=5Ё
計Å~… …
IMe&ヽ諦btti1/8'I~311llζ
… … ｀
:
| :ALC4/2017 FINOCHEM PVT.LTD. IALC4/2018 1Approved l
l l l 101・
05.2018 1 :
赫鶉i詳脇馘Ю
■嚢
Decision : Committee.considered.ut. ui per agenda and deliberated on the matter in the presence of the
:technical experts and it was decided to ratiff the ad-hoc input output norms under para + .i of H B p as per
,
195 idetails below or as applied by firm whichever is lower:
| :L
,Meet No/Date:1/82-
:ALC4/2018
101.052018
lStatus:Deffered
r
rand Re-indexed ,
ILic.No/Datei051 0403024 1Defer
i05.06.2017
IDate:2607.2018
―
:
applied by firm whichever is lower:
| :L
,Meet No/Date:1/82-
:ALC4/2018
101.052018
lStatus:Deffered
r
rand Re-indexed ,
ILic.No/Datei051 0403024 1Defer
i05.06.2017
IDate:2607.2018
―
:
49
RA concerned may take further necessary action as per above decision ofNC
|
:
CHLORIDE
8
POTASSIUM
HYDROXIDE
9
S(十)-2-
AMINOBUTYRAMIDE
HCL
0.95
‐Case No.:439/4/82-
ALC4/2017
,Party Name:ZYTEX
IBIOTECH PVT.LTD.
IMeet No/Datel1/82- IStatus:Deffered
lALC4/2018 1and Re―
indexed
01052018 1
187.責
O File
101/82/050/00447/AM18/
RLA File Lic.NoノDatei0310813814 1Defer
i03/95/040/00188/AM18/ 107.06 2017 1Date:2607.2018
| ICase No。:63/9/82-ALC4/2017 1Paty Name:PORUS Meet No/Date:1/82- IStatus: i
l LABORATORIES PVT LTD IALC4/2018 1Approved i
‐ ‐
‐ 101.05.2018 1 1
1 ‐HQ File lRLA File lLic.No/Date:09100651431 :
: |.nl′ oぅ′nξ n′An,ハn′ Aヽ′10′ :.ハ0′ ぅ′′n′ n/An12く/Aヽイ10′ |ハQ nκ っn17 1 1
|
1 101/82/050/00790/AM18/ 1:09/24/040/00135/AM18/ 108.06.2017 1
Decision: Committee considered case as per agenda and deliberated on the matter in thi presence of the
,technical experts and it was decided to rati0/ the ad-hoc input output norms under para 4.7 of HBP as per
: LCCillHC41 じXPCIし｀こllu lt was uoしluou ιυ :oしlly Lll●
`u‐
11
1 details below or as appliedby flrm whichever is lower:
1188
Export Product
Qty.
Sl.No.
Import items
Quantity allowed
Ke
HBP as per
: LCCillHC41 じXPCIし｀こllu lt was uoしluou ιυ :oしlly Lll●
`u‐
11
1 details below or as appliedby flrm whichever is lower:
1188
Export Product
Qty.
Sl.No.
Import items
Quantity allowed
Ke
2‐ Phenyl-3,3-bis(4-hydroxy
phenyl)phthalimide(PPP― BP)
l Kg.
1
PTHALiC ANHYDRIDE
0.927
つ
４
PHENOL
1.145
ZINC CHLORIDE
0.104
4
ANILINE
0.596
5
METHANOL
0,715
6
ACTIVATED CARBON
0.200
7
CAUSTIC SODA LYE
2.31
|
|
|
RA concemed may take further necessary action as per above decision ofNC
IHQ File iRLA Flle Lic No/Datc:09100651381
101/82/050/00795/AM18/ :09/24/040/00107/AM18/ 108.06.2017 1
1Decision:Committee considered case as per agenda and deliberated on the matter in the presence of the
‐
technical experts and it was decided to r江1取the ad_hoc input output norlns under para 4.7 of HBP as per
ldetails below or as apphed by flrln whichever is lo、
ver:
)arりName:SHREEJAYA IMeetNo/Dtte:1/82‐ IStatus: |
ICase No.:68/9/82-ALC4/20171F
、
| ILABORATORIES PVT LTD.:ALC4/2018 1Approved l
l 101.05.2018 1 1
189
Export Product
Qty.
Sl.No.
Import items
Quantity a1lowed
K負
5-Methoxy‐2‐ [[(4-Methoxy‐
3,5‐ Dimethyl-2‐ Pyridinyl)… 2‐
Methy]thio]lH―
Benzimidazole
l Kg.
1
3.5 LUTIDINE
0.80
2
TOLUENE
METHYLENE
DICHLORIDE
2.00
4
AMMONIUM PER
SULPHATE
1.20
|||
. .. RA .ol:.rned yay take furth.gl nece:.sarl acl.iol as per aboye d3cisfon of NC
io]lH―
Benzimidazole
l Kg.
1
3.5 LUTIDINE
0.80
2
TOLUENE
METHYLENE
DICHLORIDE
2.00
4
AMMONIUM PER
SULPHATE
1.20
|||
. .. RA .ol:.rned yay take furth.gl nece:.sarl acl.iol as per aboye d3cisfon of NC
50
ヘ
| 1滉
lision高
ふ
´
懲
品
品ents of TE~~~~______一
― ― ―一一
―一
一
―
――
―― 一一
轟
Status:
―
|
Approved
| ::01/62/Uう0/UU/81/AM18/ 109/24/040/00150/AM18/ 09.06.2017 1
1 :Dedsbn:Commi■ce consmered case as per agenda and delibcrated on the matter h the presence ofthcl
Ⅲ
畔l異l∫瀾お錦
I』常
濯憮
認
肌
獄
∝h四釧い正mmSund∝
“
n47 J HBPぉ
"rl
Export Product
Qty.
Sl.No.
Import items
Quantity allowed
Ke
1-BROMO-2‐
IODOBENZENE
l Kg.
1
2-BROMOANILINE
1.086
2
POTASSIUM IODIDE
0.733
CYCLOHEXANE
2.75
| = |
|・
′ユ
:uctalis oc10W Or as appnea Dy llrrn wnlcnever is 10weri :
per above decζ lon ofNC I
| IALC4/2(
1 1
1り
21。「18
1o1/Rつ/n4
101/82/050/00540/AM18/
ParサNameiCAMPHOR& IMeet No/Date:1/82-
lALLIED PRODUCTS IALC4/2018
1LIMITED, ol.o5.2018
1RLA F‖e lLic.No/Date:0310813905
:03/94/040/00179/AM18/ 112.06.2017
一
９
iCase No。:44/9/82-ALC4/2017
IHQ File
l:01/82/050/00771/AM18/
Paty Name:EYTAN LABS
LIMITED
‐RLA File
109/24/040/00144/AM18/
,Decision: Committee considered .ur.
９
iCase No。:44/9/82-ALC4/2017
IHQ File
l:01/82/050/00771/AM18/
Paty Name:EYTAN LABS
LIMITED
‐RLA File
109/24/040/00144/AM18/
,Decision: Committee considered .ur. u, p"i ugenda and
rtechnical experts and it was decided to rati$r the ad-hoc
,details below or as applied by firm whichever is lower:
deliberated
input output
on the matter in the presence of the
norms under para 4.7 of HBP as per
Export Product
Qty.
SI.No
Import items
Quantity allowed
Ke
4‐AMINO-5-FLURO-1-
((2R,5S)-2‐
HYDROXYMETHYL―
[1,3]OXATHIOLANE-5-
YL)… lH―PYRIMIDIN-2-
ONE(EMO‐ 1)OREMO― IOR
EMO
l Kg.
1
(2R5S)-5-(4-AMINO-5-
FLUORO-2-OXO-2H―
PYRIMIDIN‐ 1-YL)―
[1,3]‐OXATH10LANE―
2‐CARBOXYLIC ACID
2S¨ISOPROPYL‐ 5R―
METHYL-lR―
CYCLOHEXYL
ESTER(FCE)
2.075
つ
ん
SODIUM
BOROHYDRIDE
0.46
DIPOTASSIUM
1.90
ICase No.:54/9/82¨ALC4/2017
ParりName:SUVEN LIFE
ISCIENCES LIMITED
IMcet No/Date:1/82-
lALC4/2018
101.05.2018
IHQ File
IRLA File
jstatus:Deffered j
iand Re-indexed I
IDate:26.07.2018
IMect No/Date:1/82-
lALC4/2018
101.05.2018
rStatus:
Approved
Lic.No/Date:0910065152
12.06.2017
e:1/82-
lALC4/2018
101.05.2018
IHQ File
IRLA File
jstatus:Deffered j
iand Re-indexed I
IDate:26.07.2018
IMect No/Date:1/82-
lALC4/2018
101.05.2018
rStatus:
Approved
Lic.No/Date:0910065152
12.06.2017
HYDROGEN
PHOSPHATE
further necessary action as per above decision of NC
51
1194
1195
RA concemed may take
ICase No.:535/4/82‐ ALC4/2017 Party Name:FINE ORGANIC Meet No/Datel1/82- Status:
I INDUSTRIES PVT.LTD. IALC4/2018 'Approved
10105.2018 ‐
IHQ File lRLA File Lic No/Date:0310813901
101/82/050/00543/AM18/ :03/94/040/00199/AM18/ 12.06.2017
1COnllnittee considered the case as per agenda and in consultation with technical authority present in
‐
meeting,it was decided to ral～normS as per the earlier decision taken in norms committcc meeting No.
‐14/82 held on 24.10.2013 under para 4.7 of HBP as per details belo、
v or as applied by flrnl、vhichever is
lo、veri―
Export product
Exp.
Otv.
Sl.No
lmport items
Qty. allowed
Sodium Stearyl Lactylate
l Kg.
1
Lactic Acid
0.440 kg
2.
Stearic Acid
0.700 kg
,RA concerned may take further necessary action as per above decision of NC.
IParty Name:INCHEM IMcet No/Date:1/82- IStatus:
ILABORATORIES PRIVATE I全19F′ 01f lApproved
:LIMITED
Ha Ftt.
kg
,RA concerned may take further necessary action as per above decision of NC.
IParty Name:INCHEM IMcet No/Date:1/82- IStatus:
ILABORATORIES PRIVATE I全19F′ 01f lApproved
:LIMITED
Ha Ftt.
FrA Ftt.
101/82/050/00796/AM18/ 1:09/24/040/00110/AM18/ 112.06.2017
1Decision:Committee considered case as per agenda and deliberated on the
ltechnical expetts and it was decided to rati″
the ad_hoc input output norms
letailS below or as applied by flrm whicheveris lowcI
ICase No。:69/9/82‐
‐ALC4/2017
101.05.2018
lLic.No/Date:Og r OOOSiSa
matter in the presence of the
under para 4.7 of HBP as per
l iCase No.:467/4/82-
| IALC4/2017
1 ‐
HQ File
1 101/82/050/00475/AM18/
ParりNameiSUPRIYA
ILIFESCIENCE LTD
Meet No/Date:1/82‐
ALC4/2018
01.05.2018
,Status:
Approved
RLA File Lic.No/Datc:03108139101
:03/95/040/00187/AM18/
‐1206.2017 1
Decision: Committee considered case as per agenda and deliberated on the matter in the preience of
r196 technical experts and it was decided to ratii/ the ad-hoc input output norms under para 4.7 of HBP as
r
rdetails below or as applied by firm whichever is lower:
一
ｔ
ｈ
ｅ
四
Export Product
Qty.
SI No
Import items
Quantity allowed
Kg
MECOBALAMINE
JP
l Kg.
1
VITAMIN B12
EP/USP
0.95
RA concemed may take futther necessary action as per above decision ofNC
Export Product
Qty.
Sl.No.
Import items
Quantity allowed
Ks
Ractopamine Hcl
l Kg.
1
Amino acetonitrile Hcl
100
2
Phenol
1.21
3
Aluminium Chloride
1.717
4
4-(4-Hydroxyphenyl)-
2 - Butanone
0.70
may take
:RA concerned
y.
Sl.No.
Import items
Quantity allowed
Ks
Ractopamine Hcl
l Kg.
1
Amino acetonitrile Hcl
100
2
Phenol
1.21
3
Aluminium Chloride
1.717
4
4-(4-Hydroxyphenyl)-
2 - Butanone
0.70
may take
:RA concerned
52
ヘ
1 穣霊枷
″
2〃8か FttNamα
ASTML Mは
NげDttα ν授―
SttШ
STERITECH PVT.LTD. :ALC4/2018 1Approl
1辞淵
2/4/82‐
ξT朧冊D.姓棚T副秘
淵hed
,, | lol.o5.2018 1
| :
|1惚
鵠
鵬
議
詰j性
蹴
0畑
“
νA耐
甘
∬辮
“
鋼∞
“
盤21
紀
3島掲
50/00470/AM18/ 1跳ち刷:0/00062/AM18/ 1皆∬
%品彎
C34100432821 1
う
ttiζお
h:ё6島孟i1888。hふdeiga t共8::ュ:‐ lL8hai and ddiberated on the ma■er in the presence of the
ltechnical experts and it was decided to ratitt the ad―
hoc input output norms under para 4.7 of HBP as peri
technical experts and it was decided to ratitt the ad_hoc input output norms under para 4.7 of HBP as peri
details below or as applied by fl111l whichever is lo、
ver: |
197
Export Product
Qty.
Sl.No.
Import items
Quantity
allowed
CEFEPIME FOR
INJECTION lGM
(EACH VIAL VONTAINS
CEFEPIME
HYDROCHLORIDE USP
lgm EQUIVALENT TO
2gm A STERILE
MIXTURE OF CEFEPIME
HYDROCHLORIDE&L―
AFGININE)
1 Number
1
STERILE CEFEPIME
FOR INJECTION USP
STERILE MIXTURE
OF CEFEPIME
HYDROCLORIDED
AND L ARGININE
STERILE CEFEPIME
FOR INJECT10N USP
STERILE MIXTURE
OF CEFEPIME
HYDROCLORIDED
AND L ARGININE
1.8975 gm/vial
2
GLASS BOTTELS
0077131002LV
INFUSION CLEAR
CHOICE‐ P15ml
CLEARE GLASS TYPE
GLASS BOTTELS
0077131002LV
INFUSION CLEARE
CHOICE― P15ml
CLEARE TYPE
Relevant as per
packing policy
3
RUBBER STOPERS
C14746720GC 6 TP 3
20mm INJECTION
STOPPER BROMO
BUTYL GREY ULTRA
CLEAN 6WAHSING
PE
GLASS BOTTELS
0077131002LV
INFUSION CLEARE
CHOICE― P15ml
CLEARE TYPE
Relevant as per
packing policy
3
RUBBER STOPERS
C14746720GC 6 TP 3
20mm INJECTION
STOPPER BROMO
BUTYL GREY ULTRA
CLEAN 6WAHSING
WITH HlGHLY
PURIFIEDH WATER
RINSED WITH WFI
READY TO
STERILLIZE TYVEK
BAGES AS PER
GENERAL NOTES
Relevant as per
packing policy
RA concerned may take further necessary action as per above decision ofNC
:~猛誌脱需
'/4/821 :需
需,I税|よ
監漱普罷
「
1濡温 |
| : 1 0105.2018 1 1
198:綿底鬼
::鳳:il↓ij‐ 競ち
j澄il:::11話:; 僣譜」
R"よ
j4ibttbう■
|｀ ~|
Decision: Committee considered case as per agenda and deliberated on the matter in the presence of the
,technical experts and it was decided to rati$ the ad-hoc input output norms under para4.7 of HBP as per,
;
rdetails below or as applied by firm whichever is lower:
53
Export Product
Oty.
Sl.No.
Import items
Ouantitv allowed
NAFCILLIN FOR
INJECTION USP 2 GM
NAFCILLIN FOR
INJECT10N USP 2 GM
l Number
1
NAFCILLIN SODIUM
FOR INJECT10N
(STERILE BULK)
2.350 gm/2gm
injection
つ
４
GLASS BOTTELS)
0077047005
ANTIB10TIC 10ML
CLEAR GLASS TYPEI
GLASS BOTTELS)
Relevant as per
packing policy
RUBBER STOPPER)
C14746720GC 6 TP3
20mm INJECTION
STOPPER
Relevant as per
packing policy
NAFCILLIN FOR
INJECTION USP 10 GM
NAFCILLIN FOR
INJECT10N USP 10 GM
I Number
1
NAFCILLIN SODIUM
FOR INJECTION
(STERILE BULK
DRUG)
I1.615 gm/10
gmlnjection
う
乙
GLASS BOTTELS)
2047201005 1NFUS10N
CLEAR CHOICE― P
100miCLEAR GLASS
TYPE I
GLASS BOTTELS)
3
RUBBER STOPPER)
C16436720GC 6 TP3
28mm
|
|
|
lzorrrrrr
(STERILE BULK
DRUG)
I1.615 gm/10
gmlnjection
う
乙
GLASS BOTTELS)
2047201005 1NFUS10N
CLEAR CHOICE― P
100miCLEAR GLASS
TYPE I
GLASS BOTTELS)
3
RUBBER STOPPER)
C16436720GC 6 TP3
28mm
|
|
|
lzorrrrrr
'RA concerned may take further necessary action as per above decision of NC
Decision : Committee considered case aS per agenda and clellberated on the matter ln tne presence or
technical experts and it was decided to ratify the ad-hoc input output norms under para4.1 of HBP as
Export product
Exp.
Oty.
Ｓ
ｌ
．
Ｎ
。
Imporl items
Qty.Allowed
kg
Valacyclovir HCL
l kg
1
2- [(2-Acetamido)-6-oxo-
6,9-dihydro- 1 H-purine-9-
Yl)methyll ethyl acetate /
Diacetyl
acyclovir(AAEMP)
1.083
つ
４
N N-Dicyclohexyl
carbodimide
1.061
3
N N Di MethyI Formamide
2.54
4
4-Dimethyl Amino Pyridine
0.028
5
L―Valine
0.603
6
Methanol
1.69
7
Acetone
2.55
"
,''
'"----"'
1:
1lI
lne concerned may take further necessary action as per above decision of NC
|
―
―
―
―
―
―
轟
,
rCase No.:7219182-ALC4l2Ol7 iParty Name:HETERO DRUGS rMeet No/Date:t182- Status:
i
I
jLIMITED
taLc4l2olS
,APProved
I i
1
iol'os'2018
I
i
rl
|1
澁
薦
辮漑蹴l二
|
, r― ‐
―――――一―一―――‐――I一~~~~~=
― ―‐ ―~~~~
・ _ _ __ _‐ ^ 一― ― ‐‐¨ ― ― ……__1
148/AM18/ '13.06.2017
agenda and deliberated on the matter in the presence of thel
he ad‐hoc input output norlns under para 4.7 of HBP as perl
clハ■■
70r・
|
cision : It was decided to call from the firm to furnish Master Batch Formulah (MBF) and Drug
I
:Manufacturing Licence (DML). Deferred .
23410118 ~´ ~胤
:男ililli:1鳥lj
101/82/050/00557/AM18/
I
'Crr. No .:aSila&ii-
Parry Name:JODAS EXPOIM Meet No/Date:l182- 'status:Deffered
, 'ALC4l20l1
PVT.LTD.,
'ALC4l20l8
'and Re-indexed
t01.05.2018
.
:%盤月蕊:鳳|」
~■痣璃漏lllこIオ
'躍
IT'T争:率■IⅢ
l :Decision:Deferred for wants of comments _ _ _ . _
■
## Case No.:sS Oiltyz-
ParU Name:trlAlLAol 'Meet No/Date:|182- ,status:Deffered
',.tctr2ort
3,1;fl;f.rurrcALs ,fffili11'J
rand Re-indexed
LIMITED
|
inCr eir"
,r{fA rie
ilic.NolDate:0410163381 iDefer
,:01182t050t00538/AMl8/ 1,:0424rc40rc0079/AMl8/ l.Zg.Ol.ZOtl
':Date:26.07.2018
ICase No.:537/4/82‐
IALC4/2017
)11
--' HQ File
t
::011821050/00545/AMl8/
ParfyName:USVPRIVATE MeetNo/Date:l/82- Status:Deffered
LIMITED (FoRMERLY USV ALC4/2018
and Re-indexed
LTMTTED)
0l.05.2018
|■LA Fi18 ~ ~
‐
1二ic.No/Date:0310814934 1Defer l
l:03/95/040/00358/AM18/ 31.07.2017 1Date:26.07.20181
,Decision : Deferred for wants of comments
ICase No。:549/4/82‐
ALC4/2017
Party Name:ROYAL
PHARMA
:Mcet No/Date:1/82-
:ALC4/2018
01.05.2018
醤需糧li憮」
|
Ю田椒
B窮ち
6Ю7矧81
1236
62
1覇応薦菰IT~務競蕊肌
1 扉面肝b面高面高高稿
:高L「―――
聯
雨罰両藤~IPag端
そHEMCON玉
:ALC4ノ2017
i IPVT LTD
| IDecision:Deferred fOr wants of cOmments
′
391HQiお ~~RLA嵐お……… …
1 101/82/050/00827/AM18/ i:34/24/040/00069/AM18/
129.08.2017
Date:26.07.2018
鰈
面たダ
Status:Deffered ,
and Re-indexed
t.
:ALC4/201〔
101.05.2018
「
ｌ
ｌ
ｌ
鷹
| やムζも｀
b・:"/う/821ALё 4んjiデ
|larty｀品8ゝ百
iヤA ~~IM8よヽも
'bitま
i′慧夕 も1ltiζ l
l l :HARMACHEMLTD I計
″ 鰍ザ lpproVed l
1 lHQ Fi18 ~
‐~ ~ ‐
lktA「i18 ~ ~ ~ ~ ltiぎヽo/D岳
`:j′
ibb4j443 1 ~|
| |:01/82/050/00826/AM18/ 1:3424/040/00025/AM18/ lo7.09.2017 1 1
1 :Dι ti:お五:ё6島轟i"品あnξ僣もた
a thもあξも五ξぉも
「亀8ia五ふb ih iI`i亀A161もarli3f aさtiξぉ
n tak`五島
|
: lmeeting nO.3/82 dated o8.05.2014,it was decided to ratifv nOrtns llnHer p,r,47ハf口pD、,1^_^^_J^`^11^|
1 1
1 :Dι ti:お五:ё6島轟i"品あnξ僣もた
a thもあξも五ξぉも
「亀8ia五ふb ih iI`i亀A161もarli3f aさtiξぉ
n tak`五島
|
: lmeeting nO.3/82 dated o8.05.2014,it was decided to ratifv nOrtns llnHer p,r,47ハf口pD、,1^_^^_J^`^11^|
DecisiOn : cOmlnittee considered the case as per agenda and in the light Of earlier decision taken in
meeting no.3/82 dated o8.05.2014,it was decided to ratitt nOrlnS under Para 4 7 ofHBP vl as per details
givcn bc10、v Or as applied by thc nrm,whichever is lcss:
Export product
Export
Quantity
S.No.
Import items
Quantity
Allowed
OCTANOYL CHLORIDE/
CAPRYLOYL CHLORIDE
l kg
1
CAPRYLIC ACID/
OCTANOIc ACID
0 982 kg
:1灘
ざ踏∫駄朧
` 1喚
111認
i_1ヽ■,y,,apPIΨ H江e ac10n as perthe decおbn ofNoms COmmittec.
」
| ICase No.:105/9/82‐ ALC4/2017 1ParりName:SONGWON ,Mcよ
ヽ。/5五iも:i′ 恵2- IStitis: |
: | |,PECIALTY CHEMICALS IALC4/2018 1ADnrOVed l
.
,SpECTALTy CHEMICALS ALC4I2018
Appi"r"O
. ,
'INDIA PVT. LTD.
iOt.Os.zor8
i
rHQ File
- ,RaA Fii;
-.' --- ,ai".N;rout.,iqroo+i+so
:,242 :011821050/00832/AMl8/ ::341241040/00147tAMIB/ 07.0g.2017
.J1tL-twawtwwt+ultlytlo/
U l.U9.ZUl /
iDecision : In the light of written ";;;"i; i"..ir.a n.o, D.p;,r;;;;iaii;;i;ui, una p"troi1,.rni.uri,
:vide their U.o No. r4o10r1or2o15-ch.
147tAMIB/ 07.0g.2017
.J1tL-twawtwwt+ultlytlo/
U l.U9.ZUl /
iDecision : In the light of written ";;;"i; i"..ir.a n.o, D.p;,r;;;;iaii;;i;ui, una p"troi1,.rni.uri,
:vide their U.o No. r4o10r1or2o15-ch. II dated 12.02.2016, it was decided to ratiflu norms under para4..r of
'HBP vl as per details given below or as applied by the firm, whichever is less:
⌒
:Mcet No/Dtte:1/82-
:ALC4/2018
101.05.2018
Status:Deffered ,
rand Re-indexed ,
IPHARMA RESEARCH
:LABORATORIES PVT
ILTD.,
IHQ File
:RLA File
:17/24/040/00046/AM18/
:05.09.2017
jDecision : Deferred for wants of comments
63
Export product
Exp.
Qty.
Sl.No.
Import items
Qty.Allowed
EDOT(3,4-
Ethylenedioxythiophene)
l kg
1
Dimethy1 2,2-thiobisacetate
2.160 kg
2
Dimethyl oxalate
1.510 kg
3
Sodium Methoxide Solution
30%(Sodium Methylate)
4.92 kg
4
Dimethylformamide
0.360 kg
1,2- Dichloroethane
1.94 kg
6
Sulfolane
0.600 kg
RA may take appropriate action as per the decision of Norms Committee'
## Case No.:98/9/82‐ ALC4/2017
IParty NameiSAVANNAH
iSURFACTANTS LTD.,
'Mect No/Date:1/82‐
ヽALC4/2018
,01.052018
iStatus:Deffered
land Re-indexed
IStatus:Deffered
land Re‐ lndexed
:Defer
lDtte:26.07.2018
′4310百に
IRLA File
l:17/24/040/00049/AM18/
:01/82/050/00825/AM18/
## Case No.:l0l /g182-ALC4l20l7 Party Name:N R OILS
244 Hq nit.
RLA File
r:0 1/82l050/00828/AM I 8/
.:3412410401001 I 3/AM I 8/
ILic.No/Date:1710006664
10809.2017
IMeet No/Datc:1/82‐
IALC4/2018
101.05.2018
1Lic.No/Date:3410043460
111.09.2017
:1)ecision:Deferred for wants ofcomments
lCase No.:106/9/82-ALC4/2017 .Party Name:BEST VALUE
I ICHEM PVT LTD.
IHQ File
:01/82/050/00833/AM18/
~~~lRLA File
い4/24/040/00156/AM18/ 118.哩_____ |_____ヽ、
lb..irion , Cor*itt.. consiJered the case as per agenda and in the light of earlier decision taken in meeting no. i
'
25182 dated 29.1 l.2Ol2, it was decided to rati! norms under Para 4.7 of HBP vl as per details given below or as
245 'applied by the firm, whichever is less:
Exporl Product
Export
Qtv.
Sl.
No.
lmport items
Qty.
allowed
Undecavertol (Kakdinol) 4-
Methyl-3-decen-5-ol
l kg
1
Propionaldehyde
0.842 kg
2.
N Amyl Alcohol l- Pentanol
0.639 kg
IRA mりtakc approp面atc ac■on as pcrthe dccision ofNorms Committee
Status: Deffered
I
and Re-indexed l
IDefer l
lDate:26.07.20181
:Decision:Deferred for comments of TE
IMcct No/Date:1/82‐ IStatus:
IALC4/2018 1Approved
101.05.2018 1
1Lic.No/Date:3410043482 1
′
46簿Ohだ‐~~~ ~鶴
崩蕊λ
:L識話」
~
: |:01/82/050/00831/AM18/
:tiζeヽ
`libム
′
|′ j2‐ALを4/2Jiウ IPartyNl鳥8:良6ヽÅk
l CHEMICALS
IMeet No/Date:1/82‐
:ALC4/2018
101.05.2018
ILic.No/Date:3410043478
:18.09.2017
| `V5｀・'・V・■o νし■‐ロニ‐Ч ●‐● ‐‐
・・……――‐――‐_二
___…
…、一 ―――
ウ IPartyNl鳥8:良6ヽÅk
l CHEMICALS
IMeet No/Date:1/82‐
:ALC4/2018
101.05.2018
ILic.No/Date:3410043478
:18.09.2017
| `V5｀・'・V・■o νし■‐ロニ‐Ч ●‐● ‐‐
・・……――‐――‐_二
___…
…、一 ―――
64
~T・Sh汗
甲
馘
而
面
司
磁
ぽ
而~~琴
漏
…
:247
―
‐
ヽ
ヽ
‥
一
IHQ File lRLA File Lic.No/Date:3410043487 1
:01/82/050/00834/AM18/ 134/24/040/00158/AM18/ 119.092017 1
Decision : Committee considered the case as per agenda and in the presence of technical expeft. it was decided
to ratify norms under Para 4.7 of HBP v I as per details given below or as applied by the firm, whichever is less:
Export Product
Export
Qry.
Import items
Qty. allowed
Para Amino Phenol
l kg
Para Nitro Chloro Benzene
1.222 kg
|
IRA may take appropnate action as perthe decislon ofNorlns COmmittce
: ICaseNo。
:7/9/82‐ALC4/2017 1Party Name:CATAPHARMA
: : ICHEMICALS PVT.LTD.
ICHEMICALS PVT.LTD.
1漸品iヽも,5滉
`:1/8'1 ~
lALC4/2018
120.09.2017
Status:Deffered
and Re-indexed
IDate:26.07.20181
: |
: | |
:48器既嘉
::7島1↓lj~ :鶴発男
,
101.05.2018
ILic No/Date:3110066876 1Defcr
:31/83/040/00141/AM17/
I
iCaseNo.:15/9/82-4LC4/2017 partyName:pARAMOLINT
,
I
.AROMACHEM PRIVATE
Mcet No/Date:1/82-
|^.^|
ILIMITED
: :01/82/050/00742/AM18/ :o5/24/040/00279/AM18/
Status:Deffered l
IALC4/2018
101.05.2018
land Re‐ indexed i
:Lに,No/Dtte:0510404104 1Defer
125.09.2017 :Date:26.07.
:91脇鳳;ιl二j~嘉鳳胤
i
20181
iCase No.:109/9/82‐ ALC4/2017 1Party Name:ASTRAL
, ISTERITECH PvT.LTD.
lz5o ir-rq iii"
: |:0ル82/050/00836/AM18/
IMeet No/Date:1/82¨
17 :Date:26.07.
:91脇鳳;ιl二j~嘉鳳胤
i
20181
iCase No.:109/9/82‐ ALC4/2017 1Party Name:ASTRAL
, ISTERITECH PvT.LTD.
lz5o ir-rq iii"
: |:0ル82/050/00836/AM18/
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1 101/82/050/00744/AM18/
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| ,01.05.2018 .
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:05/24/040/00261/AM18/ 103.10.2017 1Date:26.07.2018
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' ICase No.:14/9/82¨ ALC4/2017
ParりName:PCL OIL&
SOLVENTS LTD.
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land Re― indexed
lDefer
lDate:2607.2018
| ICase No.:3/9/82‐ ALC4/2017
| ICase No.:3/9/82‐ ALC4/2017 Party NameiSTRIDES
l ‐ iSHAStlN LIMITED
1 ‐ iSHAStlN LIMITED
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i l:01/82/050/00730/AM18/
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l ‐ iSHAStlN LIMITED
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| ICase No.:2/9/82‐ ALC4/2017 Party Name:GLOBAL
| . :PHARMA HEALTH CARE
レ
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Meet No/Date:1/82‐ iStatus:Deffered
lALC4/2018 and Re‐ indexed
101.05.2018 1
1Lic No/Datc:0410163585 1Defer
110.10.2017 1Date:26.07.2018
|ヽleet No/Date:1/82‐ IStatus:Deffered
lALC4/2018 and Re―
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101.05.2018 1
1Lic.No/Date:0510404191
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10410.2017 1Date:26.07.2018
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101.05.2018 1 1
1Lic No/Date:0410163566 1Dcfcr l
05.10.2017 1Date:26.07.20181
| :01/82/050/00729/AM18/ 104/24/040/00137/AM18/
1 :Decision:Deferred for comments of TE
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ICase No.:26/9/82-ALC4/2017 Party Name:JUBILANT LIFE N(cet No/Datel1/82‐
iSCIENCES LIMITED
1
:ALC4/2018
101.05.2018
1256
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105.10.2017
l iCase No.:25/9/82-ALC4/2017 Party Name:」
ODAS EXPOIM IMcetNo/Date:1/82‐ IStatus:Deffered l
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'tDate:26.07.2018
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loecision : Deferred for comments of TE
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::01/82/0 5O(OO752;AM18/ :05l23lO4Ol0O254lAM18l ,09.10.2017
'tDate:26.07.2018
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loecision : Deferred for comments of TE
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,Date:26.07.20r8
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ICase No.:27/9/82- IPat/Namc:HLE IMcet No/Datc:1/82- IStatus: |
ALC4/2017 ENGINEERS PRIVATE IALC4/2018 1Approved l
: ・LIMITED 01 05.2018 1
1HQ File RLA File lLic.No/Datc:52100424161 1
:01/82/050/00754/AM18/ :52/24/040/00041/AM18/ 123.102017 1 1
1Decision : Comlnittee considered the case as per agenda and in the light of earlier decision takcn in‐
lmec」ng no.7/82 dated 24.07.2015,l was decided to ratitt nOrms under Para 4.7 of HBP vl as per detailsl
given below or as applied by the firm, whichever is less:
268
Export Product
Qty.
lmport items
Quantity
allowed
ke
2-TRIFL
METHYLBENZOLSULFONAMID
TR.BBHAWA
l Kg。
2-
AMINOBENZOTRIFLUORIDE
1.17 kg
IRA concerned may take further necessary action as per above decision of NC
Meet No/Datei1/82‐ lStatus:Deffered l
lALC4/2018 1and Re― indexed.
0105.2018 : :
Lおヽふ′
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124.10.2017 1Date:26.0720181
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101/82/050/00750/AM18/ 1:02/24/040/00109/AM18/ 24.102017 :Date:26.07.20181
lDecision:Deferred for comments of TE
‐
'
ICasc No.:6/9/82¨ ALC4/2017
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:
1 ,Case No.:18/9/82‐ ALC4/2017:ParりName:PCL OIL&
| I SOLVENTS LTD.
1269
HQ File
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i:05/24/040/00312/AM18/
ICase No.:34/9/82-ALC4/2017 1Paty NameiSTRIDES
I SHASUN LIMITED
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II)ate:26.07.2018
SHASUN LIMITED
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lALC4/2018
101.052018
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and Re-indexed
:Lic.No/Datc:0410163619 1Defer
II)ate:26.07.2018
68
ハ
101/82/050/00733/AM18/ 104/24/040/00142/AM18/ 126.10.2017
¨ 面鷲
IDecision:Deferred for comments of TE
「
No.:24/9/82¨ ALC4/2017 Patty Namc:RECKITT
IBENCKISER
IHEALTHCARE INDlA
IPRIVATE LIMITED
HQ File
:01/82/050/00751/AM18/
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::05/24/040/00320/AM18/
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101.05.2018
ILic.No/Date:3H0066900
102.11.2017
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,and Re-indexed
Defer
Date:26.07.2018
| IDecision:Deferred for comments of TE
,Meet No/Date:1/82- Status:Deffered
lALC4/2018 and Re― indexed
101.05.2018 ‐
ILic.No/Datei3 110066899 1Defer
102.11 2017 Date:26.07.2018
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l iCaζざヽも高i′う
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l l 'SCIENCES LIMITED IALC4/2018 and Re― indexed l
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1 101/82/050/00758/AM18/ 1:05/23/040/00255/AM18/ 102.H.2017 Date:26.07.2018:
| IDecision:Deferred for comments of TE :
## Case No.:32/9/82-
ALC4/2017
.280‐
:Lic.No/Datei051 0404483:Defer
IParts/Name:JUBILANT
ILIFE SCIENCES LIMITED
IRLA File
MeetNo/Date:lt182- Status:Deffered
IALC4/2018
'01.05.2018
and Re-indexed
1 1HQ File
l l :
ICase No.:95/9/82-ALC4/2017 Paty Name:ENCEE
I AROMATICS PVT.
I LIMITED
′
751HQAぉ~~
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101.11.2017
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AMINES LIMITED
1276:
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l:31/83/040/00091/AM18/
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I :AMINES LIMITED
izll
F′ ′HQ File
IRLA File
iDecision : Deferred for comments of TE
69
101/82/050/00759/AM18/ 105/23/040/00256/AM18/
102.11.2017
Manual Agenda
Mノs.J.B Chemicals&Pharmaceuucals Ltd
F‖ e No.01ノ82ノ050′00590rAM16
RLA No.03ノ94/040/01114/AM15
Adv.Auth.No.0310794517 dated.11.03.2015
## Case No.B-01
M.No.12ノAM18
Date 04.05.2018
Decision: Committee considered the request of the firm for enhancement of the norms The
matter deliberated in the presence of technical experts and it was decided to maintain Status quo.
action as per the decision of Norms Committee.
M/s.J.B Chcmicals&Phallllaceuticals Ltd
File No.01/82/050/01084/AⅣl16
RLA No.03/94/040/00406/AM16
Adv.Autho No.0310798528 dated.27.08.2015
Casc No.B-02
M.No.12/AM18
Date 04.05.2018
Decision: Committee considered case as per agenda and deliberated on the matter in the presence of the technical
experts and it was decided to allow the norms for the export item at serial No. 2 & 3 are as under / or as applied by the
firm whichever is lower:
RA may take appropriate action as per the decision of Nqrmqlgrnrnlttge.
Export Product
Qty.
Ｓ
‐
Ｎ
。
lmport ltem
Qty allowed in
gm
Difflam AAA Sugar Free Lozenges Flavours
/Eucalyptus & Menthol/Honey & Lemon/Black
Currant/Berry.
Each lozenge contains Benzydamine
Hydrchloride 3.00 mg, Isomalt ST-M 2141.64
mg.Net Content Benzydamine Hydrchloride
15.825 Kgs, Isomalt ST-M 11297.168 Kgs
Number
1
Isomalt ST― M
257
う
ん
Benzydamine
Hydrochloride
0.306
Difflam Sugar Free Lozenges Mint Fresh
Flavour.
Each lozenge contains Benzydamine
Hydrchloride 3.00 mg, Isomalt ST-M 2141.64
mg. Net Content Benzydamine Hydrchloride
15.825 Kss, Isomalt ST-M 11297.168 Kgs
1
Isomalt ST― M
259.48
う
４
Benzydamine
Hydrochloride
0.306
## Case No.B-03
M/s. J.B Chemicals & Pharmaceuticals Ltd
M.No.'12lAM18
| rite wo. 011821050100279/AM 16
Date 04.05.2018
I nm No.03/94/04OlOO872lAM 15
Adv.Autho No.0310791890 dated.10.12.2014
st of the firm for enhancement of the norms The
matterdeliberatedinthepreSenceoftechnicalexpertsa
Date:26.07.2018
70
RA may take appropriate action as per the decision of Norms Committee.
## Case No.B-04
M.No.12ノAM18
Date 04.052018
M/s.J.B Chemicals&Pharmaceuucals Ltd
F‖e No.01ノ82ノ050ノ00409ノAM 16
RLA No.03/94ノ040/01006ノAM 15
Adv.Auth.No.0310793301 dated.27.01.2015
Decision: Committee considered the request of the firm for enhancement of the norms The
matter deliberated in the presence of technical experts and it was decided to maintain Status quo.
RA may take appropriate action as per the decision of Norms Committee.
## Case No.B-05
M.No.12ノAM18
Date 04.05.2018
M/s.J.B Chemicals&Pharmaceuticals Ltd
File No.01/82ノ050ノ00424/メヽM16
RLA No.03/94/040/01053/AM 15
Adv.Auth.No.0310793620 dated.05.02.2015
Decision: Committee considered the request of the firm for amendment of norms as per agenda
and in consultation with technical expert present in the meeting, it was decided to allow the import
item at the serial No.3 "Cetylpyridinium Chloride" and Quantity allowed as 0.135 gm/100 lozenges
for export item No. 1 Difflam Sugar Free lozenges. Rest of minutes would remain same.
## Case No.B-06
M.No.12ノAM18
Date 04.05.2018
M/s.J.B Chemicals&Pharmaceulcals Ltd
F‖e No.01/82ノ050ノ01439/AM 16
RLA No.03/94ノ040/00402ノAM 16
Adv.Auth.No.0310798725 dated.08.09.2015
Decision. Committee considered the request of the firm for enhancement of the norms The
matter deliberated in the presence of technical experts and it was decided to maintain Status quo.
e action as per the decision of Norms Committee.
## Case No.B-07
M.No 12ノAM18
Date 04.052018
Mノs 」.B Chem:cals&Pharmaceulcals Ltd
F‖e No.01/82ノ050ノ00236/AM16
RLA No 03ノ94/040/00912ノAM15
Adv.Auth.No.0310792310 dated 23.12.2014
Decision: Committee considered case as per agenda and deliberated on the matter in the presence of the technical
experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as
applied by firm whichever is lower:
Export Product
Difflam AAA Lozenges Sugar Free Eucalyptus &
Menthol/Honey & Lemon/B lackcurrant.Each
Lozenges Contains Isomalt ST-M
2l4l.64mg,Benzydamine Hcl 3mg. Net Content -
Isomalt ST-M l2 195. l49kgs,Benzydamine Hcl
Isomalt ST― M
71
take
ropriate action as
the decision of Norms Committee.
259.48
Difflam Lozenges Mint fresh Sugar Free.
Each Lozenges Contains Isomalt ST-M 2l4l .64mg,
Benzydamine Hcl 3mg. Net Content of lsomalt ST-M
-1016.30kgs,Benzydanlinc Hcl 1 423
Andolex Lozenges Sugar Free Mint.
Each lozenges Contains Isomalt ST-M 2141.64mg,
Benzydamine Hcl 3mg. Net Content Isomalt ST-M
I 0l 6.3kgs,Benzydamine Hcl l.423kgs
Andolex-C Lozenges Sugar Free
Raspberry/Eucalyptus & Menthol/Honey &
Lemon/Orange
Each Lozenges Contains Isomalt ST-M
2 1 4 1 .64mg,Benzydamine Hydrochloride
3mg,Cetylpyridinium Chloride l 33mg.
3kgs
Andolex-C Lozenges Sugar Free
Raspberry/Eucalyptus & Menthol/Honey &
Lemon/Orange
Each Lozenges Contains Isomalt ST-M
2 1 4 1 .64mg,Benzydamine Hydrochloride
3mg,Cetylpyridinium Chloride l 33mg. Net content
Isomalt ST-M 4065.07 2kgs,Benzydamine
Hydrochloride 5.694kgs,Cetylpyridinium Chloride
2.524k9s
Benzydamine
Cetylpyridinium
Chloride
ZecufHerbal Cough Lozenges Sugar Free
Each Lozenges contains Isomalt ST-M 2141.64mg.
Net content of Isomalt ST-M 5488kgs
214.164
Isomalt ST― M
Difflam Lozenges Sugar Free Blackcurrant.
Each lozenges Contains Isomalt ST-M 2l4l .64mg,
Benzydamine Hcl 1.50mg, Cetylpyridinium Chloride
1.33mg. Net Content Isomalt ST-M 2744kgs,
Benzydamine Hcl 1.92 lkgs, Cetylpyridinium
Mノs.」.B Chemicals&Pharmaceulcals Ltd
File No.01ノ82ノ050/01085ノAM 16
RLA No.03/94/040/00408ノAM16
Adv.Auth.No.0310798530 dated.27.08.2015
## Case No B-08
M.No.12ノAM18
Date 04.05.2018
Decision: C"*mittee considered case as per agenda and deliberated on the matter in the presence of the technical
experts and it was decided to ratiff the ad-hoc input output norms for the export product serial No. 2 and3 and export
product senal No.l has already7 been Axed by the NC in its meeting No.21/82 dated 20.03.2016 vide DOP O.M.No.
350H/383/2015-Pl(Norlns)dated 17.03.2016 already availablc in DGFT webshe ln respect of Adv.Auth.No.
0310798530 dated.27.08.20 15 under para 4 7 ofHBP as per details below or as applied by flrm whichever is lower.
Rest oftlle minutes would remain same.
Export Product
Difflam AAA Lozenges Sugar Free Eucalyptus &
Menthol/Honey & Lemon/Blackcurrant.Each
Lozenges Contains Isomalt ST-M
2l4l .64mg,Benzydamine Hcl 3mg. Net Content -
Isomalt ST-M l2l95.l4gkgs,Benzydamine Hcl
l7.082kgs
Benzydamine
Hydrochloride
Difflam Lozenges Mint fresh Sugar Free.
Each Lozenges Contains Isomalt ST-M 2141.64mg,
Benzydamine Hcl 3mg. Net Content of Isomalt ST-M
-1016.30kgs,Benzydanline Hcl l.423
72
八
RA may take
ate action as
the decision of Norms Committee.
## Case No.B-09
M.No.12ノAM18
Date 04.05.2018
Mノs.RA Chem Pharma
F‖e No.01/82ノ050/00651ノAM 15
Adv.Auth.No.0910055973 dated.09.05.2013
Adv.Auth.No.0910057516 dated.10.09.2013
Adv.Auth.No.0910059417 dated.25.02.2014
Decision: Committee considered the request of the firm for re-fixation of norms as per agenda and
in consultation with technical expert present in the meeting, it was decided to allow the import
item "4-Hydroxyactophenone" and Quantity allowed as 0.91 kg for export product Ractopamine
HCL. Rest of minutes would remain same.
## Case No.B-10
M.No.12ノAM18
Date 04.05.2018
Mノs.Shasun Pharrnaceuticals Ltd
F‖e No.01/82ノ050ノ00387ノAM 14
RLA No.04/24ノ040/00065ノAM 14
Adv.Auth.No.0410147559 dated.27.06.2013
Decision:cOnllnittee considered case as per agenda and deliberated on the lnatter in the presence of the technical
expe■s and it was decided to ratl～
the ad_hoc input output norlns under para 4.7 of HBP as per details below or as
applied by flllll WhiChever is lower:
ExpOrt product
METOPROLOL TARTRATE TABLETS 100 MG
METOPROLOL TARTRATE TABLETS 100 MG
SNO.
lmport ltems
L00 mgTab!ets
METOPROLOL TARTRATE
102.O mg/per tab!et
2
METOPROLOL TARTRATE
4.2mg
3
STEAR O WET/MAGNESIUM
STEARATE/SLS.
190.8 mg
4
STEAR O WET/MAGNESIUM
STEARATE/SLS.
33.6 mg
5
AVICEL 102(MICRO
CRYSTALLINE CELLULOSE
NtPh,Eur,J.P)
Relevant as per packing policy
RA may take appropriate action as per the decision of Norms Committee.
## Case No.B-11
M.No.12/AM18
Date 04.05.2018
Mノs.Shasun Pharrnaceuticals Ltd
F‖ e No 01/82′ 050/00384/AM 14
RLへNo.04/24ノ040ノ00063/AM14
Adv.Auth.No.0410147551 dated.27.06.2013
Decision:CommitteeconsideredcaSeaSperagendaandde1iberatedonthe,-,uti.@
experts and it was decided to ratiSr the ad-hoc input output norms under par a 4.7 of HBp as per details below or as
73
applied by flm whichever is lower:
Export product
METOPROLOL TARTRATE TABLETS 25
METOPROLOL TARTRATE TABLETS 25
Ｇ
Ｇ
Ｍ
Ｍ
take
action as
the decision of Norms Committee.
S.NO.
lmport ltems
25 mg Tab:ets
METOPROLOL TARTRATE
25.5 mg/tablet
METOPROLOL TARTRATE
1.49 mg
3
STEAR O WET/MAGNESIUM
STEARATE/SLS.
75.2Lmg
4
STEAR O WET/MAGNESIUM
STEARATE/SLS.
1192 mg
5
AVICEL 102(MICRO
CRYSTALLINE CELLULOSE
NlPh,Eur,J.P)
Relevant as per packing
policy
Mノs.Shasun Pharrnaceuticals Ltd
File No.01/82ノ050ノ01124/AM 14
RLA No.04ノ24ノ040ノ00183/AM 14
Adv.Auth.No.0410152258 dated.27.11.2013
## Case No.B-12
M.No.12/AM18
Date 04.05.2018
Oecision Committee considered case as per agenda and deliberated on the matter in the presence of the technical
experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as
applied by flrm whichever is lo、ver:
ExpOrt product
METOPROLOL TARTRATE TABLETS 25 MG
METOPROLOL TARTRATE TABLETS 25 MG
METOPROLOL TARTRATE TABLETS 100 MG
RA mav take appropriate action as per the decision ol t\tglrnglgrnrnI!9e'
S.NO
lmport ltems
25 mg Tablets
L00 mgTab!ets
1
METOPROLOL TARTRATE
25.5 ms/tablet
1.02 mg/tablet
METOPROLOL TARTRATE
1.49 mg
1.2 me
3
STEAR O WET/MAGNESIUM
STEARATE/SLS
75.21 mg
L90.08 mg
4
STEAR O WET/MAGNESIUM
STEARATE/SLS
11.92 mg
33.6 mg
AVICEL 102(MICRO
CRYSTALLINE CELLULOSE
NtPh,Eur,J.P) _
Relevant as per
packing policy
lelevant as per Packing
lolicy
74
八
CaseNo.B-13
lfrlls.taketa@
M.No.12lAM18
| File No. 011821050t01443tAM15
Date 04.05.2018
I nm No.03/95/04OtOO629tAM14
Adv.Auth.No.0310790966 dated.12.11.2014
Decision:CommitteeconsideredcaSeaSperagendaandinlig
held on 17.05.2011 and in consultation with technical authority present in meeting, decided to ratify normi
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
Qtv
allowed
LakpOI E1 250(Sorbitan
Mono Oleate)
l kg
1
Oleic Acid
0.658 kg
2
Sorblol(70%)
0 425 kg
## case No. B-14
| uls. Laketand Cnemicatsgnoia;t
M.No.12lAM18
| rie ruo. o1t82to5oto14o8/AM 15
Date 04.05.2018
I nLA No.03/95/04OtOO628tAM14
Adv.Auth.No.0310791049 dated.13.112014
Decision:CommitteeconsideredcaSeaSperagenda
held on 26.04.2011 and in consultation with technical authority present in meeting, decided to ratify normi
under para 4 7 of HBP as perdeta‖ s below or as app‖ ed by firm whicheveris loweri‐
Export product
Exp. Qtv.
SI No
lmport items
Qty. allowed
Sorbitan Mono Oleate
l Kg
Oleic Acid
0.658 kq
2
Sorblol(70%)
0.425 kg
## Case No. B-15
M.No.12tAM18
| rite No. o1t82to5otoo421t$M17
Date 04.05.2018
I nm No.05/23l04otooo76tAu17
Adv.Auth.No.0510398582 dated.24.05.2016
Decision: The committee considered reques
4qatter is under examination. Case is deferred.
## Case No.B-16
M.No.12/AM18
Date 04.05.2018
M/s.」ubilant Generics Ltd
File No.01ノ82ノ050/00890/AM 17
RLA No.05ノ23/040/00298ノAM17
Adv.Auth.No.0510400076 dated.07.10.2016
Decision: The committee consi
matter is under examination. Case is deferred.
## Case No B-17
M.No.12/AM18
Date 04.05.2018
Mノs.Jubi!ant Generics Ltd
F‖e No.01ノ82/050/00891/AM 17
RLA No.05ノ23/040/00323/AM17
Adv.Autho No.0510400088 dated.
13.10.2016
75
Decision: Committee considered case for revision of norms as per agenda and deliberated on the matter in the
presence of the technical experts and it was decided to rati8/ the ad-hoc input output norms under para 4.7 of HBP as
per details below or as applied by firm whichever is lower:
RA concerned may take further necessary action as per above degElq! !ltl!C.
Export product
Exp
Qty
SI No.
lmport items
Qty. allowed
Valacyclov:rF‖ m Coated ttablet 500
mg
l Tablet
Valacyclovir
Hydrochloride USP
556 mgノ500
mg tablet
Va!acyclovir F‖ m Coated Tablet 1000
mg
Tablet
1
Valacyclovir
Hydrochloride USP
1112 mg/1000
mg tablet
## Case No B-18 1M/s.Amol Pharmaceuticals Pvt Ltd
M.No.12lAM18
| rite trto. 011821050101608/AM 16
Date 04.05.2018
I RLA No.13/2410401000271AM16
Adv.Auth.No.1310047981 dated 23.09.2015
sbasedontherecommendationofD/oPharmaceuticalso.M'
No.350l 1l47l2}l6-Pl(Norms) dated 08.09.2016, or as applied by the firm whichever is less under para 4.07
of HBP Vol.l . decided to ratify norms under para 4.7 ol HBP as per details below or as applied by firm
whichever is lower:-
Export product
Exp. Qty.
SI No
lmport items
Qty
allowed
AZO Urinary Tract Defense
(each tablet containing 162 mg
Methenamine)
1 000 tablets
1
Methenamine USP
153.5 gm
Mノs.Pregna lnternational Ltd
F‖e No 01/82ノ050′01473/AM 15
F‖e No.01ノ82′050ノ00063/AM 18
F‖e No.01/82/050ノ00025ノAAl1 1 7
## Case No.B-19
MoNo.12ノAM18
Date 04.05.2018
RLA No.03ノ95ノ040ノ00661/AM 15
RLA No.03/95ノ040/00931/AM 17
RLA No.03/95/040/00953ノAM 16
Adv.Auth.No.0310791082 dated.14.11.2014
Adv.Auth.No.031081181l dated.14.03.2017
Adv.Auth.No.0310803237 dated.11.03.2016
the matter in the
presence of the technical experts and it was decided to rati$, the ad-hoc input output norms under para 4.7 of HBP as
per details below or as applied by firm whichever is lower:
0.000455 kg
Copper Wire With
Silver Core
INTRA UTERINE
CONTRACEPTIVE
DEVICE― CU 380
AG
0.000130 kg
HDPE Granules
(Moulding Grade)
76
RA concerned may taKe further necessary action as per above decision of NC
Pouches ( Plastic)
Frame Made of LDPE
Resin & Barium
Sulphate
PVC Granules
(Moulding Grade)
HDPE Granules (OR
Nylon Resin) Medical
Grade
Solid Rod Made Of
Polypropylene Granules
## Case No B-20
M No.12/AM18
Datc 04.05.2018
M/s.Shalina Laboratories Ltd
Flle No.01/82/050/00259/AM16
File No.01/82/050/00905/AM16
RLA No,03/95/040/00843/AM15
RLA No.03/95/040/00038/AM16
Adv.Auth.No.0310792869 dated.13.012015
Adv.Auth.No.0310796997 dated.01.07.2015
Decision: Committee considered the case as per agenda and in consultation *ith technical e*pert presert in
the meeting, it was decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm
whichever is lower:-
Export product
Exp. Qty.
SI
No
lmport items
Qty. allowed for
1000 Botles
Diproson Lotion 30 ml
bottle
1 000 Botles
1
Betamethasone
BP/1P/USP
15.300 gm
2
Propylcne Glycol[Mono
Propylcne Glycol]
BP/1P/USP
18000.00 gm
Casc No.B-21
M.No.12/AM18
Date 04.05.2018
M/s. Shalina Laboratories Ltd
File No.01/82/050/00294/AM
File No.01/82/050/00551/AM
６
６
RLA No.03/95/040/00740/AM15
RLA No.03/95/040/01033/AM15
Adv.Auth.No 0310791735 dated.05.12.2014
Adv.Auth.No.0310795186 dated 08.04.2015
Decision:Committeedecidedtorati$normsbased
No.350l l/815/201s-Pl(Norms) dated06.09.2016, or as applied by the firm whichever is less under para4.07 of HBp
Vol. l. decided to ratifu norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:-
Qty. allowed
1000 bottle
77
Each bottle contains Clobetasol
Propionate equivalent to Betamethasone
l5.3Omg
## Case No B… 22
M.No 12/AM18
Date 04.05.2018
M/s.Shalina Laboratories Ltd
Ｆ
Ｆ
le No.01/82/050/00567/AM16
1e No.01/82/050/00713/AM16
RLA No.03/95/040/01071/AM15
RLA No.03/95/040/00003/AM16
Adv.Auth.No.0310794916 dated.26.03.2015
Adv.Auth.No.0310795745 dated.07.05.2015
Decision: Committee considered hte case as per agenda and it was decided to ratiff norrns on repeat basis as per the
earlier recommendation of D/o Pharmaceuticals O.M. No.35011177912015-PI (Norms) dated 16.12.2016, or as
applied by the firm whichever is less as under:-
Export product
Exp. Qty.
Sl.No.
Import items
Qty.
recommended per
I 000 tubes
Epiderm Cream l5 gm
Each Tube contains
Betamethasone
Dipropionate equivalent to
Betamethsone 8.555mg,
1000 tubes
1
Betamethasone
BP/1P/USP
7.650 gm
2
Iodochlorohydroxy Quinoline
152.00 gm
Gentamycin Sulphate
BP/1P/USP
15.30 gm
4
Cetosteryl Alcohol
BP/1P/USP
1200.00 gm
White Soft Parafln
「Petrolium Jellv]
1500.00 gm
6
Propylene Glycol
lMono Propylene Glycol'l
750.00 gm
Epiderm Cream 30 gm
Each Tube contains
Betamethasone
Dipropionate equivalent to
Betamethasone l7.l I mo
Iodochlorohydroxy
Quinoline 306 mg,
Gentamycin 30.60 mg,
Cetosteryl 2.448 gm, P.Jelly
3.06 gm, Propylene Glycol
1.53 gm
1000 tubes
1
Betamethasone
BP/1P/USP
15.300 gm
う
４
lodochlorohydroxy Qu inol i ne
306.00 gm
Gentamycin Sulphate
BP/1P/USP
30.600 gm
4
Cetosteryl Alcohol
BP/1P/USP
2399.00 gm
White Soft Parafln
「Petrollunl Je‖ yl
3000.00 gm
6
Propylene Glycol
IMono Propylene Glycol]
1500.00 gm
## Case No.B-23
M.No.12ノAM18
Date 04.05.2018
Mノs.Sha‖ na Laboratories Ltd
File No 01ノ82/050ノ0030ノAM16
RLA No 03/95/040/00639/AM15
78
No.350l1177912015-PI(Norms) dated 16.12.2016, or as applied by the firm whichever is less under para4.07 of HBP
Vol.1. decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is
lower:-
Export product
Exp. Qty.
st.
No.
lmport items
Qtv.
recommended
per 1000 tubes
Betasol Cream 15 gm
1000 tubes
1
Betamethasone
BPAP/USP
7.65 gm
Cetosteryl Alcohol
BP/IP/USP
1199.52 gm
3
White Soft Parafin I
Petroleum Jellyl
1499.40 gm
4
Propylene Glycol
BP/IP/USP
740.90 gm
Betasol Cream 30 gm
1000 tubes
Betamethasone
BP/IP/USP
15.30 gm
Cetosteryl Alcohol
BP/IPruSP
2399.00 gm
3
White Soft Parafin I
Petroleum Jellyl
3000.00 gm
4
Propylene Glycol
BP/IP/USP
1510.00 gm
## Case No. B-24
| M/s. Sequent Scientific Ltd
M.No.12lAM18
I rire ruo. 01t82t050t01608/AM 16
Date 04.05.2018 1 RLA No.03/95/040/00459/AM15
Adv.Auth.No.0510400076 dated.07.10.2016
Decision : Committee considered case as per agenda and deliberated on the matter in the presence of the technical
experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as
applied by firm whichever is lower:
Export product
Exp. Qty.
sl.
No.
lmport items
Qty. allowed
CLOZASOLE 3400 (net
content of import item
Tetramisole HCL in export
qty:2564.571 Kg)
l Number
1
TETRANIIISOLE HCL
2040 mg/Bolus
CLOZASOLE 900 (net
content of import item
Tetramisole HCL in export
qty:536.229 Kg)
1 Number
1
TETRAⅣIISOLE HCL
459.0 mg/Bolus
RA concerned may take further necessarv action as per above decision of NC.
79
## Case No. B-25
| M/s. Navin Fluorine lnternational Ltd
MoNo.12/AM18 1 File No.01/82/050/00648/AM ll
Date 04.05.2018 1 RLA No.03/95/040/00331/AMH
Adv.Auth.No.0310587462 dated 13.08.2010
Decision: Committee considered case as per agenda and deliberated on the matter in the presence of the technical
experts and it was decided to ratifo the ad-hoc input output norms under para 4.7 of HBP as per details below or as
applied by firm whichever is lower:-
Export product
Exp.
Qty.
Sl.No.
lmport items
Qty. allowed kg
3 Chloro 4 Fluoro Benzotrifluoride
l kg
1
4 Fluoro Benzotrifluoride
1.48 kg
## Case No.B‐ 26
M.No.12/AM18
Date 04.05.2018
M/s.Sunshield Chemicals Ltd
File No.01/82ノ050ノ00145ノAM 17
File No.01/82ノ050/01854/AM 16
RLA No.03/95ノ040/00967ノAM 16
RLA No.03/95′ 040/00771ノAM16
Adv.Auth.No.0310803283 dated.14.03.2016
Adv.Auth.No.0310801856 dated.18.01.2016
Decision: Committee considered case as per agenda and deliberated on the matter in the presence of the technical
experts and it was decided to ratifu the ad-hoc input output norms under para 4.7 of HBP as per details below or as
applied by firm whichever is lower:-
Export product
Exp. Qty.
SI.
No
lmport items
Qty allowed in
kg
TH EIC-TRIS (2-Hyd roxy Ethyl)
lsocya nurate
l kg
1
Cyanuric Acid
0.548 kg
Ethylene Oxide
0.598 kg
Methanol
0.118 kg
Firm will submit Central Excise Certified production consumption data to RA at the time of redemption. RA
would compare this with the quantity applied by the firm and allow lower of the two, for redemption.
RA concerned mav take further necessary action as per above decision of NC
## Case No B-27 1M/s.Tide lndustries Ltd
M.No.12ノAM-18 1 File No.01/82ノ050/00531/AM 16
Date 04.05.2018 1 RLA No 34′ 24/040/00138ノAM15
Adv.Auth.No.3410040551 dated.15.09.2014
Decision : Committee considered the request of the firm for revision of norms as per agenda and deliberated on the
matter in the presence of the technical experts and it was decided to revise the ad-hoc input output norms under para
4.7 of HBP as per details below or as applied by firm whichever is lower:-
Export product
Exp. Qty.
SI.No
lmport items
Qtv.
allowed kg
A!dehyde C10(CapriC
Aldehyde)
lkg
Fatty A!cohol C10-98
1.12 kg
RA concerned mav take further necessarv action as per above decision of NC
80
ハ
## Case No.B‐ 28 1Mノs.Tide lndustries
M.No12ノAM… 18 1 File No.01/82ノ050/00458ノAM 16
Date 04.05.2018 1 RLA No.34ノ24/040/00310/AM15
Adv.Auth.No.3410040978 dated.23.02.2015
Decision : Committee considered the request of the firm for fixation of norms as per agenda and deliberated on the
matter in the presence of the technical experts and it was decided to ratif,i the ad-hoc input output norms under para
4.7 of HBP as per details below or as applied by firm whichever is lower:-
Export product
Exp. Qty.
SI No
lmport items
Qty
a‖owed kg
A:dehyde C-12 Lauric
lkg
C12 Fatty Alcohol (Lauryl Alcohol)
1.725 kg
RA concerned may take furthernecessary action as per above decision of NC.
## Case No. B- 29
| M/s. Forace Polymers (P) Ltd
M.NoI2/AM-I8
| File No. 01182/050/012981A}d13 AM 13
Date 04.05.2018 1 RLA No 05/23/040/00459/AM13
Adv.Auth.No.0510345208 dated.07.02.2013
Decision : Committee considered the request of the firm for fixation of norms as per agenda and deliberated on the
matter in the presence of the technical experts and it was decided to ratit/ the ad-hoc input output norms under para
4.7 of HBP as per details below or as applied by firm whichever is lower:-
Export product
Exp
Qty.
Sl.No.
Import items
Qty.al10Wed
kg
HARDNER FORTECH 1000
(COntaining minimum 95%
Gama‐ Butyrolactone)
lkg.
1
GAMA― BUTYROLACTONE
PURITY‐ 98%MINIMUM
0.96 kg
2
TRIACETINE(FOUNDRY GRADE)
PURITY¨ 98%MINIMUM
0.05 kg
RA concerned mav take further necessary action as per above decision of NC.
## Case No.B-30
M.No12/AM-18
Date 04.05.2018
Mノs.Jub‖ant Life Sciences Ltd
F‖e No.01ノ82/171/00168/AM 15
DeCisiOn: Committee considered the request of the firm fort revision of SION A-3270 and it was decided not to
revise the SION A-3270. Firm is advised to apply under para 4.7 of HBP. I .
81
## Case No.B-31
MoNo12ノAM… 18
Date 04.05.2018
M/s 」ub‖ ant Generics Ltd
File No 01ノ82ノ050/00085ノAM 17
RLA No.05ノ23ノ040ノ00471/AM16
Adv.Autho No 0510397645 dated 18.022016
Decision: Committee considered the request of the firm for revision of norms for import item at serial No. 6
Croscarmellose Sodium JP and deliberated on the matter in the presence of the technical experts. It was decided to
revise the revise the norms as under:
Other items and quantity allowed earlier would remain unchanged
RA concerned may take further necessary action as per alqye !e9!9!9! ilNq
Export Product
Quantity
lmport ltem
Quantity a‖ owed for l No
tablet
Atorvastatin Tablets 5 mg
l No Tablet
Croscarmellose Sodium JP
4.20 mg / per 5 mg tablet
Atorvastatin Tablets 10 mg
l No ttablet
Croscarmellose Sodiu m JP
510m9/per 10 mg tablet
## Case No.B-32
MoNo12ノAM-18
Date 04.05.2018
M/s.」.B Chemicals&Pharmaceuticals Ltd
File No.01ノ82ノ050ノ01441ノAM 16
RLA No.03ノ94ノ040ノ00405ノAM16
Adv.Auth.No.0310798727dated.08.09.2015
ffinSideredtherequestofthefirmforamendmentinnorms.Thematter
is under examination. Case is deferred
i.B Chemicals & Pharmaceuticals Ltd
M.No12/AM-18
| rirc ruo. 011821050100423/AM 16
Date 04.05.2018
I nLA No.03/94/040/01084/AM15
Adv.Auth.No.0310793953 dated.18.02.2015
equeStofthefirmforreviSionofnorms.Thematteris
under examination. Case is deferred
IM/S Sequent Scienllc Ltd
M No12/AM-18 1 File No 01/83/050/01061/AM07
Date 04 05 2018 1 RLA No 03/95ノ040/01189/AM 07
Adv.Auth No.0310413404 dated 22 12 2006
sea'pe.uge,dau,dinconsultationwithtechnicalauthoritiespresentin
meeting, decided to ratify norms under pala 4.7 of HBP as per details below or as applied by firm whichever is
lower:-
Exoort oroduct
Exo. Otv.
Sl.No。
lmoort items
Qtv. allowed
L-(+)-Selenomethionine
l Kg.
1
L‐Methionine
2.5 kg
M
further necessqry action as per above decision ofNC.
82
## Case No.3-35
M.No.12ノAM-18
Date 04.05.2018
M/s.Biological E Ltd
F‖e No.01/82ノ050ノ01473ノAM13
RLA No.09ノ24/040ノ00535/AM13
Adv.Auth.No.091005501l dated.11.02.2013
F‖e No.01/82ノ050ノ01475ノAM 13
RLA No.09ノ24/040/00534/AM 13
Adv.Auth.No.0910055012 dated.11.02.2013
F‖ e No.01/82ノ050ノ00665ノAM 14
RLA No.09ノ24ノ040ノ00118ノAM 14
Adv.Auth.No.0910056424 dated.21.06.2013
F‖e No.01/82ノ050ノ00097ノAM 15
RLA No.09ノ24/040/00549ノAM 14
Adv.Auth.No.0910059124 dated.30.01.2014
Decision:Committeeconsideredtherequestofthefirmfora
for the export product. ln the presence of technical expert and it was decided to amend the Unit of
Measurement in export quantity from 1 kg to 100000 Doses (As per SION A-23041in respect of
abovementionedadvanceauthorizations.Restofminuteswouldremainunchanged
RA concerned may take further
action as per above decision of NC
## Case No.B-36
M.No12ノAM-18
Date 04.05.2018
Ⅳ1/s.Biological E Ltd
F‖e No.01/82/050ノ00268ノノヽM14
RLA No.09/24/040/00636/AM 13
Adv.Auth.No 0910055652 dated.02.042013
Decision:lnthelightofearlierdecisiontakenbyNCinits11/8
under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
Item of lmport
Quantity allowed
per million vials
DTP¨ HEPB― HIB
(PENTAVALENT
VACCINE)FULLY
LIQUID
COMBANITA10N
VACCINE 10 DOSE
VIAL PEDIATRIC
DOSE DIPHTHERIA,
TETANUS,
PERTUSSIS,
HEPATITIS B
RECOMBINANT AND
HAEMOPHILLUS
INFLUENZA TYPE B
(HIB)COMBINED
VACCINE WITH
VACCINE VIAL
MONITOR(VVM)
lm‖ lion
Via!s
POLYETHYLENE GLYCOL
6000(MACROGOL
AEROSIL 380 V(COLLIDAL
ANH SILICA
POTASSIUM THYOCYNATE
102.16 kg
ALUMINIUM CHLORIDE 6
HYDRATE EXTRA
276.65 kg
YEAST EXTRACT
THIOMERSOL
ADIPIC DIHYDRAZIDE
N-3‐
DIMETHYLAMINOPROPYL¨
N ETHYLCARBODIMIDE
83
RA may take appropriate action as per the decision of Norms Committee.
SILICON EMULSION
2¨oヽ―MORPHOLINO)
ETHANE SULFONIC ACID
CETAVLON
ALUMINIUM PHOSPHATE
GEL 2%
L‐TYROSINE
NZ CASE TT(CASEIN
VITABIN Bl HCL
(THIAMINE
HYDROCHLORIDE
GLASS VIALS SILCONISED
5ML
RUBBER STOPPERS
ALUMINIUM CAPS/SEALS
HEATMARKER VACCINE
VIAL MONITOR LABELS
VVM LABE
SHIPPING INDICATORS
FILTERS&FILTER AIDS
BACTO CASAMINO ACID
## Case No.B-37
M.No12ノAM-18
Date 04.05.2018
Al1/s.Biological E Ltd
File No.01/82ノ050ノ00225ノARЛ 14
RLA No.09/24ノ040ノ00635/AM 13
Adv.Auth.No.0910055653dated.02.04.2013
DeCiSiOn. ln the light of earlier decision taken by NC in its 11182 meetin g24.01.2078, 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:
Item of lmport
Quantity
allowed per
million vials
lm‖ !ion
Vials
POLYETHYLENE GLYCOL
DTP‐ HEPB‐ HIB
(PENTAVALENT
VACCINE)FULLY
LIQUID
COMBINAT10N
VACCINE SINGLE
DOSE VIAL,
PEDIATRIC DOSE
DIPHTHERIA,
TETANUS
PERTUSSIS,
HEPATITIS B
RECOMBINANT AND
AEROSIL 380V(COLLIDAL
ANH SILICA
GLYCEROL
122.841 1tr.
TWEEN-20(POLYSORBATE
POTASSIUM THYOCYNATE
ALUMINIUM CHLORIDE 6
HYDRATE EXTRA
22.447 kg
DEXTROSE(GLUCOSE)
ta ke
te action as per the decision of Norms Committee
HAEMOPHILUS
INFLUENZA TYPE B
(HIB)COMBINED
VACCINE WITH
VACCINE VIAL
MONITOR(VVM)
L―CYSTINE
BACTO CASAMINO ACID
THIOMERSOL
SILICON EMULSION
ADIPIC DIHYDRAZIDE
N‐ 3‐
DIMETHYLAMINOPROPYL―
N―ETHYLCARBODIMIDE
2-(N―MORPHOLINO)
ETHANE SULFONIC ACID
ALUMINIUM PHOSPHATE
GEL 2%(ADJU.PHOS 2%
NZ CASE TT(CASEIN
PEPTONE PLUS
VITAMIN BI HCL
(THIAMINE
HYDROCHLORI
GLASS VIALS
RUBBER STOPPERS
ALUMINIUM CAPS/SEALS
HEATMARKER VACCINE
VIAL MONITOR(VVM
SHIPPING INDICATORS(Q
TAG 2 PLUS
FILTERS&FILTER AIDS
## Case No.B-38
M.No.12ノAM18
Date 04.05.2018
M/s.Yasho lndustttes Pvt Ltd
F‖e No.01ノ82ノ050/00688/AM 17
File No.01ノ82ノ050ノ00766/AM 17
File No.01/82ノ050/01117/AM 17
File No.01/82ノ050/01118/AM 17
RLA No.03/95/040/00434/AM 17
RLA No.03/95ノ040ノ00467ノAM 17
RLA No.03ノ95ノ040ノ00718ノAM 17
RLA No.03/95ノ040/00719ノAM 17
Adv.Auth.
Adv.Auth.
Adv.Auth.
Adv.Auth.
0310807413 dated
0310807656 dated.
0310809765 dated.
0310809768 dated.
０
０
０
０
Ｎ
Ｎ
Ｎ
Ｎ
26.08.2016
07.092016
13.122016
13.12.2016
Decision:Thecommitteeconsideredrequestofthefirmforrevis
under examination. Case is deferred.
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