;

”

Office of Directorate General of Foreign Trade

New Delhi -0

Para 4.7 Decision(DRAFT)

MEETING NUMBER_ : 10/82-ALC4/2014 MEETING DATE: 12.11.2014 But actually held on 13.11.2014

The Meeting No. 10/82 of 2014-15 to consider the cases/issues under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy, 2009-14 pertaining to Chemical and Allied products and falling under Chapter 29 and 30 was scheduled for 12.11.2014 but actually held on 13.11.2014 under the Chairmanship of Shri Jaikant Singh, Addl. DGFT in Room No.11, Udyog Bhawan, New Delhi.

Following members were present:-

Dr. Nitin Jain D/o Biotechnology

A-—~e,

Shri Nirmal Kumar, Deputy Director General of Foreign Trade Shri D.N. Mathur. Consultant, Department of Pharmaceutical Shri Jasbir Singh, Consultant, Department of C&PC

The committee went through the minutes of earlier NC —I!| meeting No. 9/82 scheduled for 20.10.2014 but actually held on 31.10.2014 and approved the same.

The following cases/issues were discussed and the committee took the decision as mentioned against each case.

||CaseNo. A-11|M/sPharmazell<br>(India) Pvt Ltd.|
|---|---|---|
|||MeetingNo.10/AM15dated—13.11.2014|F.No.01/82/162/00059/AM14/DES-HI|

Decision: It was decided to defer the case for 10.12.2014 for comments of Department of Pharmaceuticals.

MeetingNo.10/AM15 dated— 13.11.2014<br>F.No.01/82/162/00016/AM13/DES-Ill
Adv. Lic.No.3410025487 dated 30.10.2009<br>Adv. Lic.No. 3410025693 dated 25.11.2009<br>Adv. Lic.No. 3410026511 dated 03.03.2010<br>Adv. Lic.No. 3410027522 dated 16.07.2010<br>Decision: It was decided to defer the case for 10.12.2014 for comments of Department of<br>C&PC.

Meeting No.10/AM15 dated — 13.11.2014 F.No.01/82/50/00111/AM14/DES-Ill Adv. Lic. No. 0410144366 dated 25.03.2013 RLA F.No.04/24/40/00279/AM-13 Decision : It was decided to call from the a copy of Certificate of Analysis from foreign supplier and authenticdeferred fortechnical10.12.2014.literature in support of yield obtained for the export product. The case is

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.

Meeting No.10/AM15 dated — 13.11.2014 F. No. 01/82/050/00461/AM 14/DES-IIl RLA F.No. 09/24/040/00150/AM14 Adv. lic. No. 0910056692 dated 05.07.2013

Decision : It was decided to defer the case for 10.12.2014 for comments ofDepartment of Pharmaceuticals.

Meeting M/s Saurav Chemicals Ud No.10/AMI15 dated — 13.10.2014 F.No. 01/82/050/00865/AM12/DES-III RLA’s F.No. 01/82/050/01382/AM13/DES-III RLA’s File no. 22/24/040/00039/AM12 Adv. Lic. No. 2210011843 dt. 01.09.2011 File no. 22/24/040/00074/AM13 Adv. Lic. No. 2210013689 dt. 05.03.2013 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/297/2014-PI(Norms) dated 30.10.2014, it was decided to ratify the norms under Para 4.7 of HBP vl as per details given below or as applied by the firm, whichever is less:

==> picture [433 x 109] intentionally omitted <==

----- Start of picture text -----<br>

|||||
|---|---|---|---|
|Export product|Exp.|Qty. allowed|
|Qty.|kg/kg|
|ILC|3-Cyclohexene-1-Carboxylic|[||1.773|
|(|18,4S,5S)-4-IODO-6-|Acid|
|OXABICYCLO|2|[toting|
|*:HOCTAN-7-ONE|[3aa|
|[ Potassium Todide|foal|
||4.| R4+}1|Phenylethylamine|1.353|

----- End of picture text -----<br>

RA may take appropriate action as per the decision of Norms Committee.

Case No. B-88

_Meeting No.10/AM15 dated — 13.11.2014 F.No. 01/83/050/01147/AM13/DES-IIl RLA’s File no. 05/24/040/00405/AM13 Adv. Lic. No. 0510347194 dt. 22.02.2013

Decision : in the light of written comments received from Petrochemical Division of Department of Chemicals and Petrochemicals vide their U.O No. 46011/104/2009-PC- II dated 21.10.2014, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

==> picture [468 x 162] intentionally omitted <==

----- Start of picture text -----<br> Export product Exp. | SI.No. | Import items Qty. allowed<br>Qty.<br>Dettol Medicated 1 NO. Woven Dyed Fabric of 100% | 0.001320 Sq. Meter<br>Fabric Plaster Size 19 Texturised Polyester Filament,<br>mmx65mm GSM115 + 10%<br>\ \ 2. Non+ 15% Woven Rolls , GSM 100 | 0.000315 Sq. Meter<br>)<br>sere PNURAT TS MARFS<br>Dy ee ve<br>Be ee _ rgaw ei<br>----- End of picture text -----<br>

ie

| Case No. B-89 : Decision: Committee considered the case as per agenda and in consultation with the technical authority present in the meeting, it was decided to amend the description of export product in the minutes of the NC meeting no. 47/82 dated 22.02.2011 as details given below. The rest of the minutes would remain same.

==> picture [409 x 54] intentionally omitted <==

----- Start of picture text -----<br>

||||||||||
|---|---|---|---|---|---|---|---|---|
|Amoxycillin and|Clavulanate|Potassium|Amoxyciilin and|Clavulanate|Potassium|Tablets|
|Tablets 375 mg|375 mg|(Myclav tablets 375 Mg)|
|Amoxycillin|and|Clavulanate|Potassium|Amoxycillin|and|Clavulanate|Potassium|Tablets|
|Tablets 625 mg|625 mg (Myclav|tablets 625 Mg|}|

----- End of picture text -----<br>

RA may take appropriate action as per the decision of Norms Committee.

Decision: It was decided to defer the case for 10.12.2014 for comments of Department of Pharmaceuticals.

==> picture [446 x 96] intentionally omitted <==

----- Start of picture text -----<br>

||||||||
|---|---|---|---|---|---|---|
|Case No.|B-91|M/s.|Sainor|Laboratories|Pvt.Ltd..|Ltd|
|Meeting No.10/AM15|dated —|13.10.2014|File No.01/82/50/528/AM10/DES-III|
|File No.01/82/50/621/AM10/DES-III|
|RAF.No.09/24/040/00040/AM1|1|Adv.|Lice. No.|0910039225|dated|01.09.2009|
|RAF.No.09/24/040/00040/AM1|1|Adv.|Lice. No.|0910039590|dated|14.10.2009|

----- End of picture text -----<br>

Decision: It was decided to defer the case for 10.12.2014 for comments of Department of C&PC

==> picture [37 x 41] intentionally omitted <==

----- Start of picture text -----<br> \<br>----- End of picture text -----<br>

==> picture [468 x 98] intentionally omitted <==

----- Start of picture text -----<br>

||||||||
|---|---|---|---|---|---|---|
|Case No.|B-92|M/s.|Sainor|Laboratories|Pvt.Ltd..|Ltd|
|Meeting No.10/AM15|dated ~|13.11.2014|F.|No. 01/82/050/00350/AM11/DES-III|
|RAF.No.09/24/040/00040/AM11|Adv.|Lice. No.|0910042075|dated|19.05.2010|
|Decision|: It was decided to defer the case for 10.12.2014 for|comments ofDepartment ofC&PC|

----- End of picture text -----<br>

Dire: ; re au coe west

&

==> picture [470 x 119] intentionally omitted <==

----- Start of picture text -----<br> Case No. B-93 M/s. Shiva Pharma. Ltd.,<br>Meeting No.10/AM15 dated — 13.11.2014 File No. 01/82/050/01586/AM1 1/DES-III<br>RAF.No. 34/24/040/00271/AM11 Adv. Lice. No. 3410029154 dated 24.01.2011<br>Decision : Committee considered the case as per agenda and in consultation with the technical<br>authority present in the meeting, it was decided to amend the description of export product in<br>the minutes of the NC meeting no. 46/82 dated 15.02.2011 as details given below. The rest of<br>the minutes would remain same.<br>----- End of picture text -----<br>

Export Product as allowed by NC Export Product as applied by the firm n-Valeryl Chloride Valeryl Chloride / n-Valery! Chloride Import items as allowed by NC Import items as applied by the firm n-Valeric Acid Valeric Acid / n-Valeric Acid

RA may take appropriate action as per the decision of Norms Committee.

Meeting No.10/AM15 dated — 13.11.2014 F.No. 01/82/050/01598/AMO09/DES-III Adv. F.No. 01/82/050/00522/AM10/DES-II) Adv. Lic. No. 0310504544 dated 29.01.2009 RLA F.No. 03/94/040/00955/AM09 Lic. No. 0310535978 dated 01.09.2009 RLA F.No. 03/94/040/00409/AM10

Decision: Committee considered case as per agenda and observed that the ad-hoc norms against Advance licence No. 0310535978 dated 01.09.2009 have been fixed in 28/82 meeting held on 06.10.2009 and Adv. Lic. No. 0310504544 dated 29.01.2009 have been fixed in 46/82 meeting held on 10.02.2009 under para 4.7 of HBP. The firm has requested for issue of NOC for import of Bromofluoromethane in terms of Policy Circular No.52 dated 06.01.2009. It was also observed that NOC for import of 8 kgs. Of Bromo fluoro methane has been received from Ministry of Environment and Forests vide their O.M. No.11/2/2013-OC dated 14.08.2013. decided Committee, after detailed deliberations and in consultation of technical authority present in meeting, to grant “NOC” to the firm for import of 8 kgs of Bromo fluoro methane for feedstock use only. Vk RA concerned may take further necessary action as p et above decision ofNC.

==> picture [81 x 33] intentionally omitted <==

----- Start of picture text -----<br> Or gs we<br>NaCI)<br>o><br>----- End of picture text -----<br>

ia )

|

|

M/s_SATYA DEEPTHA PHARMACEUTICALS LTD Meeting No.10/AM15 dated — 13.11.2014 F.No.01/82/50/00601/AM1/DESF.No.01/82/50/00789/AM10/DES-I!! RAF.No. 09/24/040/00135/AM11 adv. Lice. No.0910042749 dated 20.07.2010 RAF.No. 09/24/040/00352/AM10 adv. Lice. No. 0910040145 dated 03.12.2009

{A] Norms ratified in respect of adv. Lice. No.0910042749 dated_20.07.2010

Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 3501 1/793/2014-PI(Norms) dated 05.09.2014, it was decided to ratify the norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

==> picture [420 x 243] intentionally omitted <==

----- Start of picture text -----<br> Export product Exp. Qty.<br>Qty. Allowed<br>Ka/kq<br>Sana insv 0-6-CHLORO- 1 N5 - (2-Amino-4,6-Dichloro-Pyrimidinyl)Formamide 0.764<br>PYRIMIDINYL)AMINO}]-2- (+)-2-<br>CYCLO PENTENE-1-METHANOL Azabicyclo(2.2.1] HEPT-5-<br>EN-3-One(Vincelactam) 1.832<br>4 Sodium Borohydride 0.226<br>La<br>aa Isopropyl! Alcohol<br>}B | Dichloro Methane<br>----- End of picture text -----<br>

[B] Decision of NC In respect of Advance authorization adv. Lice. No. 0910040145 dated 03.12.2009.

It was decided to defer the case for 10.12.2014 for comments of Department of Pharmaceuticals

RA concerned may take further necessary action as per above decision of NC.

	M/s. INDIAN IMMUNOLOGICALS LTD
MeetingNo.10/AM15 dated— 13.11.2014	F. No. 01/82/050/00902/AM14/DES-III
RLA F.No.09/24/040/00345/AM14	Adv.lic.No.0910057931 dated 15.10.2013
Decision : It was decided to defer the case for 10.12.2014 for comments of Department of
Biotechnology.

i a forpresent enhancement in the meeting. maintainIt wasStatus decidedqua to reject the request of the firm as there was no justifications

==> picture [477 x 194] intentionally omitted <==

----- Start of picture text -----<br>

||||||
|---|---|---|---|---|
|Adv.|Lic.|No. 0310411160|dated 07.12.2006|
|Adv.|Lic.|No. 0310529903|dated 21.07.2009|
|Adv.|Lic.|No. 0310418037 dated 01.02.2007|
|Adv.|Lic.|No. 0310491961 dated 24.10.2008|
|Adv.|Lic.|No. 0310526499 dated 30.06.2009|
|Adv.|Lic.|No. 0310541892 dated 23.10.2009|
|Adv.|Lic. No. 0310548591|dated 01.12.2009|
|Adv.|Lic.|No. 0310560279 dated|15.02.2010|
|Adv.|Lic. No. 0310495213 dated|21.11.2008|
|Adv.|Lic.|No. 0310478565 dated|14.07.2008|
|Adv.|Lic.|No. 0310585032|dated|26.07.2010|
|Decision|Adv.|Lic. No. 0310594926 dated 04.10.2010|
|C&PC.|:|It was decided to defer the case for 20.10.2014 for comments of Department of|y|

----- End of picture text -----<br>

Meeting No.10/AM15 dated — 13.1 1.2014 F. No. 01/83/050/00780/AM1 2/DES-II ee Ee oan gaRIDES TT —— RAF.No. 52/24/040/00033/AM12 Adv. Lic. No. 5210037002 dated 15.11.2011 Decision : Committee considered the case as per agenda and it was decided to amend the UOM (Unit of Measurement) from KG to Number for the export product “HBV (ELISA)TEST KIT MICROSCREEN (96 TESTS) HBsAg TEST KIT” in respect of Adv. Lic. No. 5210037002 dated 15.11.2011 and amend the (Unit of Measurement) UOM from kg to Pack of export product “ParaHIT-F (Device) Test Kit [50 tests - in I kit/packs]. [RAPID DIAGNOSTIC TEST KITS]” in respect of Adv. Lic. No. 5210039825 dated 05.06.2013 without any other change in the earlier decision of NC. Details of amendments in UOM are given below:

a1. LeLic. No. and date |To Adv. Lic. No. 5210037002 dated 15.11.2011 1kg (export product “HBV (ELISA)TEST KIT MICROSCREEN (96 TESTS) HBsAg TEST KIT”) a | Adv.export Lic. No.product 5210039825 “ParaHIT-F dated 05.06.2013(Device) Test Kit 1 kg Pars | a

—_ b

Udsas Bhawan, New Delhi

‘4 q i

| |

“ S| [ 50RAPIDtestsDIAGNOSTIC in 1 kit/packs}. TEST KITS]” The rest of the minutes would remain same. RA concerned may take further necessary action as per above decision of NC.

Case No, 6-100 Meeting No.10/AM15 dated — 13.11.2014 F. No. 01/82/050/00902/AM14/DES-III

RLA F.No. 09/24/040/00345/AM14

Decision :!t was decided to defer the case for 20.10.2014 for comments of Department

of Bio-technology.

Case Nob 101 Meeting No.10/AM15 dated — 13.11.2014 F.No.01/82/50/01072/AM14 RA F.No. 03/94/040/00885/AM14 Adv. Lic. No. 0310766291 dated 15.01.2014

!

Decision : Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/149/2014-PI(Norms) dated 10.10.2014 and in consultation with technical authority present in meeting, decided to amend the description of import item Sl. No. 1 and SI. No.3 under para 4.7 of HBP as per ‘| details below or as applied by firm whichever is lower:-

==> picture [417 x 68] intentionally omitted <==

----- Start of picture text -----<br> From To<br>(Import item SI. No. 1 and SI. No.3 ) {Import item SI. No. 1 and SI. No.3 )<br>4-4(Chlorophenyl) Cyclohexane Trans-4-4(Chlorophenyl) Cyclohexane<br>Carboxylic Acid Carboxylic Acid<br>12.| Methylene Chloride Methylene Dichloride<br>----- End of picture text -----<br>

RA concemed may take further necessary action as per above decision of NC.

| ! }

==> picture [452 x 71] intentionally omitted <==

----- Start of picture text -----<br> Case No.:132/8/82- Party Name:PROVENTUS Meet No/Date:10/82- Status:Deffered<br>ALC4/2014 LIFE SCIENCES PRIVATE |ALC4/2014 ‘jand Re-indexed<br>LIMITED, 12.11.2014 :<br>1 |HQ File RLA File Lic.No/Date:04 10094357 |Defer<br>:01/82/050/00796/AM15/ :04/24/040/00395/AM08/ 12.03.2008 __|Date:10.12.2014<br>----- End of picture text -----<br>

Decision : It was decided to defer the case for 10.12.2014 for comments of Department of Pharmaceuticals.

==> picture [454 x 115] intentionally omitted <==

----- Start of picture text -----<br> [ [Case No.:11/20/82- Party Name:NEULAND Meet No/Date:10/82- _[Status:Deffered<br>ALC4/2009. LABORATORIES LTD ALC4/201412.11.2014 and Re-indexed7<br>HQ File RLA File Lic.No/Date:0910038818 |Defer<br>2 :01/82/050/00422/AM10/ :09/24/040/00144/AM10/ —s [06.08.2009 ___ [Date:10.12.2014<br>Decision : Copy of production and consumption data of all inputs has been received from<br>the firm and same has been sent to Department of Pharmaceuticals for their comments.<br>Case is deferred for 10.12.2014. -<br>----- End of picture text -----<br>

rte pars NIRMAL KUMAR wy Fetes fee amie Dy. Director Gencial of Foreign? ‘a anfersgpice fam.BUATy atmentof F of Con.oT - UayooB tesmAi OS

~J7-

==> picture [454 x 87] intentionally omitted <==

----- Start of picture text -----<br>

|||||||
|---|---|---|---|---|---|
|||
|{Case No.:14/24/82-|Party Name:SAINOR|‘Meet No/Date: 10/82-|Status:|Deffered|
|||ALC4/2010|LABORATORIES PVT LTD||ALC4/2014|and Re-indexed|
|.|{12.11.2014|
|3||HQ File|RLA|File|Lic.No/Date:0910043414||Defer|
|:01/82/050/00814/AM1|1/|:09/24/040/00210/AM11/|{08.09.2010|Date:10.12.2014|
|Decision|:|It was decided to defer the case for|10.12.2014|for comments ofDepartment of|

----- End of picture text -----<br>

==> picture [452 x 115] intentionally omitted <==

----- Start of picture text -----<br>

|||||||
|---|---|---|---|---|---|
|Case No.:17/19/82-|Party|Name:VIVIMED LABS|[Meet No/Date:10/82.|[StatussDefierea|
|ALC4/2011|LIMITED|ALC4/2014|and Re-indexed|
|a|42.11.2014|
|4|HQ File|RLA File||Lic.No/Date:0910047175|(Defer|)|
||:01/82/050/0053 1/AM12/|:09/24/040/00137/AM12/|_|[20.06.2011|Date:10.12.2014|
|Decision|: Copy ofproduction and consumption data of|all inputs has been received from|
|the firm and same has been sent to Department|of|Pharmaceuticals|for their comments.|
|Case|is deferred|for|10.12.2014.|

----- End of picture text -----<br>

[Case No.:90/42/82Party Name:VIVIMED LABS [Meet No/Date:10/82[StatusDeffered. ALC4/2011 LIMITED |ALC4/2014 and Re-indexed 5 HQ File RLA File Lic.No/Date:0910049191 |Defer }:01/82/050/01125/AM12/ 09/24/040/00318/AM12/ [30.09.2011 Date: 10.12.2014 Decision : Copy ofproduction and consumption data of all inputs has been received from the firm and same has been sent to Department of Pharmaceuticals for their comments, Case is deferred for 10.12.2014. . . : . Case No.:93/42/82Party Name: VIVIMED LABS [Meet No/Date-10/82Status:Deffered ALC4/2011 LIMITED ALC4/2014 and Re-indexed . : HQ : W220 ff 6 File RLA File ‘|Lic.No/Date:09 10049339 |Defer |:01/82/050/01128/AM12/ :09/24/040/00337/AM 12/ 14.10.2011 Date:10.12.2014 Decision : Copy of production and consumption data of all inputs has been received from the firm and same has been sent to Department of Pharmaceuticals for their comments. Case is deferred for 10.12.2014.

Case No.:28/28/82Party Name:MYLAN [Meet No/Date:10/82(Status:Defferea ALC4/2012 LABORATORIES LIMITED /ALC4/2014 and Re-indexed _ 12.11.2014 | 7 |HQ File RLA File Lic.No/Date:0910053660 [Defer 2Q182/050/00995/AM13/__|:09/24/040/00270/AM13/ —|04.09.2012 Date: 10.12.2014 [Decision : It was decided to defer the case for 10.1 2.2014 for comments ofDepartment of Pharmaceuticals.

oe oe _ Case No.:88/1/82-ALC4/2013 [Party Name:MYLAN [Meet No/Date:10/82[Statuary 1. ; ; LABORATORIES LIMITED |ALC4/2014 approved _ 12.11.2014 7 . | |HQ File RLA File Lic.No/Date:0910054034 |Defer Date: . _1:01/82/0S0/01446/AM13/ __|:09/24/040/00287/AM13/ 11.10.2012 wad fe Vp Dy. Director 6 ' —§ - Directorfaae cite: + ; hiawa anf He og eT Udyog Biever, iwew Deini

==> picture [534 x 741] intentionally omitted <==

----- Start of picture text -----<br>

||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
|ad|Decision|:|In the|light of|written comments received from Department of Pharmaceuticals|vide their OM|
|No. 3501 1/301/2014-PI(Norms) dated|10.11.2014,|it was decided|to ratify the norms under Para 4.7 of|HBP|
|vl|as per details given below|or as applied by the|firm,|whichever|is|less:|
|||Lsbc|
|||Cac|
|\|||A|[eer|ceontnes|ss|
|'|=|
|a a|CL|
|||[erent|
|||eer|
|||JRA may|take|appropriate|action asper the decision ofNorms Committee.|__|:|
|||[Case No.:4/27/82-ALC4/2012||Party Name:PORUS|Meet No/Date:10/82-|__[Status:Deffered|
|LABORATORIES|PVT LTD.||ALC4/2014|and|Re-indexed|
|12.11.2014|
|.|
|9||HQ|File|RLA|File|Lic.No/Date:09 10054464||Defer|
|:01/82/050/00959/AM13/|_|:09/24/040/00408/AM13/|—[07.12.2012|Date:10.12.2014|
|Decision|:|It was|decided|to|defer the case|for|10.12.2014|for comments of Department of|
||||Pharmaceuticals.|.|
|Case No.:16/3/85-|Party Name:RA CHEM|Meet No/Date: 10/82-|Status:Deffered|
|ALC3/2013|PHARMA LIMITED|ALC4/2014|and Re-indexed|
|12.11.2014|oo|
|10||HQ|File|RLA|File|Lic.No/Date:0910054777||Defer|
|:01/85/050/00016/AM14/|_|:09/24/040/00468/AM13/|15.01.2013|;|Date: 10.12.2014|
||||Decision|:|It was decided|to defer the case|for|10.12.2014|for comments of|Department of|||
|Pharmaceuticals.|_|.|
|~|[Case No.:142/10/82-|Party Name:WOCKHARDT|[Meet No/Date:10/82-|__|Status:Deffered|
|ALC4/2013|LIMITED|ALC4/2014|and Re-indexed|
|12.11.2014|
|1]|[HQ File|RLA|File|Lic.No/Date:03 10734494||Defer|
|01/82/0$0/00325/AM14/|—_|:03/95/040/00101/AM14/|15.05.2013|Date: 10.12.2014|
|Decision|:|It was|decided|to|remind DCGI|to|furnish|their comments.|The|case was|
|[12 Casdef|e|rredNo.:42/20/82- for10.12.2014.|Party Name:GLAND|;|[MeetNo/Date:10/82-|.|[Status:Deffered|||iaAL KUMAR|
|Dy.|Director General|nt|
|faze|taTay were|Ut|
|—|9|~~|Diractorate|Con ere|ol cu|ta:|ve|

----- End of picture text -----<br>

ren

!

| | | ,

|

==> picture [462 x 609] intentionally omitted <==

----- Start of picture text -----<br>

|||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|||
|:|}ALC4/2013|jPHARMA.|LIMITED|42.11.2014ALC4/2014|and Re-indexed|
|HQ File|RLA File|Lic.No/Date:09 10056110|[Defer|
|Sor|so|i0zwaMa|:09/24/040/00058/AM14/|—_[23.05.2013|Date:10.12.2014|
|Decision|:|Reply|received|from|the|firm|and|sent|to|Department|of Pharmaceuticals|for|their|
|comments.|The case was|deferred|for|10.12.2014.|
|Case No.:134/14/82-|Party Name:CALYX|Meet No/Date: 10/82-|Status:Deffered|
|ALC4/2013|CHEMICALS &|ALC4/2014|and Re-indexed|
|_|PHARMACEUTICALS LTD.|[12.11.2014|
|113|[HQ File|RLA File|Lic.No/Date:03 10735499|||Defer|
|:01/82/050/007|19/AM14/|:03/94/040/00508/AM13/|_|
|Decision|{24.05.2013|Date: 10.12.2014|
|:|It was decided|to defer the case for 10.12.2014|for comments ofDepartment of|
|Pharmaceuticals.|
|||Case No.:28/12/82-|Party Name:BLISS GVS|Meet|No/Date: 10/82-|Status:Deffered|
||AL€4/2013|PHARMA LTD.|ALC4/2014|and Re-indexed:|
|.|;|.|
|.|(12.11.2014|
|.|HQ File|RLA|File|Lic.No/Date:0310738193||Defer|-|
|14|:01/82/050/00452/AM14/|:03/94/040/00245/AM14/|19.06.2013|Date:|10.12.2014|
|Decision|:|It was decided to remind the firm to furnish the following technical details:|1. COA for|
|foreign supplier indicating Potency ofNystatin imported under present A.A 2. Detailed calculation|
|of arriving at the quantity of|API applied. The case was|deferred for|10.12.2014|.|
|Case No.:183/10/82-|Party|Name:|VIVEK|Meet No/Date:|10/82-|Status:Deffered|
|ALC4/2013|PHARMACHEM (INDIA)|ALC4/2014|and Re-indexed|
|.|LTD.,|12.11.2014|
|15|HQ File|RLA File|Lic.No/Date: 1310043416||Defer|
|Decision|:01/82/050/00366/AM14/:|It was decided to call—_|:13/24/040/00032/AM12/ from the firm Copy of relevant19.06.2013 DML for each export—_|product[Date:10.12.2014|
|alongwith|detailed working on the requirement of|API|in each case. The case was deferred for|
|Case N0.:172/14/82-|Party|Name:RECKON|Meet No/Date:10/82-|Status: Deffered|
|||
||ALC4/2013|DIAGNOSTICS PVT.LTD.||ALC4/2014|and Re-indexed|
|_|12.11.2014|
|HQ File|RLA File|Lic.No/Date:34 10037268|Defer|
|'|:01/82/050/00757/AM14/|:34/24/040/00044/AM14/|27.06.2013|Date: 10.12.2014|
|Decision|:|It was decided to remind the firm to furnish the copy of|Manufacturing process flow|
|chart, copy DML (Drug Manufacturing Licence),Batch Manufacturing Record and clarification on|
|the quantities of import inputs (whether|it is in Grams or in Milligrams) mentioned in the|
|application.|The case was deferred|for|10.12.2014.|

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----- Start of picture text -----<br> Case No.:201/10/82- Party Name:SHASUN {Meet No/Date:10/82- [Status:Defferea<br>|, _ |ALC4/2013 PHARMACEUTICALS ALC4/2014 and Re-indexed.<br>17 LIMITED 202014<br>[HQ File - IRLA File - [Lic.No/Date:0410147551 [Defer hi! Shar<br>Directora e ‘ vant --8<br>Udyors feral, New<br>----- End of picture text -----<br>

| ,

|

• f.01782/0s0/00384/AMi4/ __[:04/24/040/00063/AM14/ [27.06.2013 [Date:10.12.2014 Decision ; It was decided to remind the firm to furnish a copy of Master Batch Formula duly | Icertified by Quality Control Incharge. The case was deferred for 10.12.2014.

Case No.:24/12/82Party Name:WOCKHARDT (Meet No/Date:10/82-_[Status:Deffered ALC4/2013 LIMITED ALC4/2014 {and Re-indexed HQ File ; RLA File Z Lic.No/Date:0310739850[12.11.2014] 7 [Defer a :01/82/050/00448/AM14/ _|:03/95/040/00256/AM14/ 02.07.2013 Pete a 122014 8 Decision : Committee considered the case and it has been observed that the export of | ‘lEntacapone Tablets 200 mg and the input is also Entacapone Tablets 200 mg with 2% wastage. It appears to be a case of refer ding only and no manufacturing activity is involved. It was decided to remind DCGI to furnish their comments. The case was deferred for 10.12.2014.

:

==> picture [517 x 481] intentionally omitted <==

----- Start of picture text -----<br> |<br>[Case No.:27/13/82- Party Name:ADVY Meet No/Date:10/82- |Status:Deffered<br>ALC4/2013 CHEMICAL PVT.LTD. ALC4/2014 and Re-indexed<br>; 19 [HQ7 File RLA File Lic.No/Date:031074092712.11.2014 [Defer- —<br>:01/82/050/00503/AM14/ |:03/94/040/00269/AM14/ 10.07.2013 Date:10.12.2014<br>Decision : It was decided to defer the case for 10.12.2014 for comments of Department of<br>| |Biotechnology.<br>[|} jJALC4/2013{Case No.:160/14/82- PartyICM SM Name:ALCHYMARS PRIVATE LIMITED [Meet|ALC4/2014 No/Date:10/82- (Status:Approved<br>12.11.2014 a<br>HQ File RLA File Lic.No/Date:0410147942 {Defer Date:<br>:01/82/050/00745/AM14/ :04/24/040/00050/AM14/ 11.07.2013<br>Decision : In the light of earlier decision taken by NC in its 34/82 meeting dated<br>|23.11.2010, Committee considered the case as per agenda and in consultation with technical<br>authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details<br>20 |below or as applied by firm whichever is lower:-<br>| Export product Export Import items Qty. allowed<br>| 4 Qty. per unit of |<br>|| 2-Methyl Mercapto | 1kg. 1. 3-Methyl Mercapto. || export product2.36 kg/kg<br>| [Phenothiazene] Aniline<br> (RA concerned may take further necessary action as per above decision of Norms committee.<br>Case No.:60/14/82-~~‘([Party Name:GLAND Meet No/Date:10/82-__(Status:Deffered<br>ALC4/2013 PHARMA LIMITED ALC4/2014 and Re-indexed<br>12.11.2014 .<br>21 TQ File RLA File Lic.No/Date:0910056772 {Defer<br>Decision:01/82/050/00645/AM14/——— : It— was decided—— to_|:09/24/040/00085/AM14/ defer the" case for— 10.12.201416.07.2013for comments — — of Department[Date:10.12.2014.Pari of NIRMAL NN KUMAR<br>Dy. Director General of Fore 2<br>----- End of picture text -----<br>

| | : 7

: :

|” {Case No.:21/12/82Party Name:WOCKHARDT [Meet No/Date:10/82- ~~ [StatussDeliercd ALC4/2013| | LIMITED ALC4/2014 and Re-indexed . 12.11.2014 a HQ File IRLA File | :01/82/050/00445/AM |Lic.No/Date:03 10741992 ‘Defer 14/ :03/95/040/00306/AM14/ 18.07.2013 Date:10.12.2014 Decision : Committee considered the case and it has been observed that the export of Entacapone Tablets 200 mg and the input is also Entacapone Tablets 200 mg with 2% wastage. It appears to be a case of refer ding only and no manufacturing activity is involved. It was decided to remind DCGI to furnish their comments. The case was _ deferred for 10.12.2014. Case No.:68/17/82Party Name:BHARAT |Meet No/Date:10/82Status:Deffered ALC4/2013 PARENTERALS LTD, ALC4/2014 and Re-indexed ) 12.11.2014 123 HQ File RLA File |Lic.No/Date:3410037475| [Defer ONS2I050/00930/AM14/|:34/21/040/00163/AM14/ [23.07.2013 Decision — [Date:10.12.2014 for : It was decided to send a copy of application again to Department of Pharmaceuticals their comments. The casewas deferred for 10.12.2014 - oo Case No.:52/12/82Party Name:UNIJULES LIFE [Meet No/Date:10/82[Status:Defferea ALC4/2013 SCIENCES LTD. ALC4/2014 and Re-indexed 12.11.2014 HQ File RLA File Lic.No/Date:03 10742481 (Defer 4h.:01/82/050/00476/AM14/ :03/95/040/00305/AM14/24 AMES N69 23.07.2013OF Date:10.12.2014 DecisionTechnical : It was decided to remind the firm to furnish the followingss technical details:aa 1. details as per Appendix 33 for conversion of Gadolinium to Gadopenteate Dimeglumine. 2. Volume of the Injection /Vial to be exported. The case was deferred for 10.12.2014 Case No.:1/10/82Party Name:MICRO LABS [Meet No/Date:10/82[Statua:Defferea ALC4/2013 LTD |ALC4/2014 and Re-indexed 12.11.2014 25 |HQ File RLA File Lic.No/Date:0710097180 {Defer OU82/050/00184/AM14/ —|:07/24/040/00111/AM14/ [30.07.2013 _[Date:10.12.2014 Decision: It was decided to call from the firm detailed justification for the import of 1039.076 kg of API against the present advance authorization. The case was deferred for 10. 12.2014

Case No.117/13/82Party Name:PAB ORGANICS [Meet No/Date:10/82Status:Deffered ALC4/2013 PVT.LTD, ALC4/2014 and Re-indexed ; tl. _ [12.11.2014 26 [HQ File RLA File Lic.No/Date:34 10037541 [Defer ; *01/82/050/00493/AM14/ |:34/24/040/00085/AM14/ 31.07.2013 Date:10.12.2014 Decision : It was decided to send a copy ofapplication again to Department of Pharmaceuticals for their comments. The case was deferred for 10.12.2014. Fi Dy.faasienDirector Govnsa eos en —— / - - mrssUdscgiow_ Jeihioele

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----- Start of picture text -----<br> ® [Case Nosi/are2- Party NameUNIVERSAL [Meet No/Date:10/82- [Status:Deffered<br>ALC4/2014 BIOFUELS PRIVATE ALC4/2014 and Re-indexed<br>|LIMITED — NRN2014 ;<br>27 |HQ File RLA File Lic.No/Date:0910056959 |Defer<br>01/82/050/00279/AM15/ _|:09/24/040/00155/AM14/—([31.07.2013 Date:10.12.2014<br>----- End of picture text -----<br>

Pecision : It was decided to defer the case for 12.11.2014 for comments ofDepartment ofC&PC.

• Case No.40/14/82(PartyName:CTX [Meet No/Date:10/82- _(Status:Deffered ALC4/2013 LIFESCIENCES PVT LTD, |ALC4/2014 and Re-indexed 12.11.2014

• . |

• 28 HQ File RLA File Lic.No/Date:03 10744552 ||Defer |.01/82/050/00625/AM14/ |:03/94/040/00307/AM14/—{07..08.2013 Date:10.12.2014

Decision : It was decided to call from the firm following information:- (a) Complete technical details as per Appendix 33. (b) Past production vis-a-vis actual consumption of inputs duly | |certified by Central Excise Authority. The case was deferred for 10.12.2014

==> picture [454 x 116] intentionally omitted <==

----- Start of picture text -----<br> ‘Case No.:1 1/13/82- Party Name: WANBURY Meet No/Date: 10/82- Status:Deffered<br>ALC4/2013 LIMITED(FORMERLY ALC4/2014 and Re-indexed<br>a PEARL ORGANICS LTD) {12.11.2014 -<br>129JHQ|:01/82/050/00487/AM14/ File RLA|:03/95/040/00134/AM14/ File Lic.No/Date:0307.08.2013 10744468 |DeferDate:10.12.2014<br>| |Decision ; It was decided to call the following information from the firm : i) Complete technical<br>details as per Appendix 33 for the export product (ii) Past production vis-a-vis actual consumption<br>of input duly certified by Central Excise Authorities. The case was deferred for 10.12.2014<br>----- End of picture text -----<br>

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----- Start of picture text -----<br> |<br>Case No.134/13/82- —_ Party Name: WANBURY Meet No/Date: 10/82- Status:Deffered<br>ALC4/2013 LIMITED(FORMERLY ALC4/2014 and Re-indexed<br>oe PEARL ORGANICS LTD) 12.11.2014 | 7<br>HQ File RLA File Lic.No/Date:03 10744838 |Defer<br>|39 :01/82/050/00510/AM14/ —_|:03/95/040/00132/AM14/ 12.08.2013 __|Date:10.12.2014<br>----- End of picture text -----<br>

Decision : It was decided to call the following information from the firm : i) Complete technical details as per Appendix 33 for the export product (ii) Past production vis-a-vis actual consumption of input duly certified by Central Excise Authorities. The case was deferred for 10.12.2014

==> picture [450 x 114] intentionally omitted <==

----- Start of picture text -----<br> ~ [Case No.:73/13/82- Party Name:WANBURY [Meet No/Date:10/82- __[Status:Deffered<br>ALC4/2013 LIMITED(FORMERLY ALC4/2014 and Re-indexed<br>PEARL ORGANICS LTD) [12.11.2014 fo<br>HQ File RLA File Lic.No/Date:03 10744832 |Defer<br>31 |:01/82/050/00549/AM14/ :03/95/040/00133/AM14/ 12.08.2013 _ Date: 10.12.2014<br>Decision It was decided to call the following information from the firm : i) Complete technical<br>details as per Appendix 33 for the export product (ii) Past production vis-a-vis actual consumption<br>of input duly certified by Central Excise Authorities. The case was deferred for 10.12.2014<br>----- End of picture text -----<br>

| {Case No.:76/13/82Party Name: WANBURY Meet No/Date: 10/82Status: Deffered 132 |ALC4/2013 LIMITED(FORMERLY ALC4/2014 and Re-indexed Pee i MAR PEARL ORGANICS LTD) 12.11.2014 Se oats «de Dy. Direct™ oe ‘de Directors : bain ~ . _. : Dyeiht

Q File RLA File Lic.No/Date:03 10744834 [Defer :01/82/050/00552/AM14/ 03/95/040/0012S/AM14/ ‘12.08.2013 Date:10.12.2014 Decision : It was decided to call the following information from the firm : i) Complete technical details as per Appendix 33 for the €xport product (ii) Past production vis-a-vis actual consumption of input duly certified by Central Excise Authorities. The case was deferred for 10.12.2014 Case No75/13/82. Party Name: WOCKHARDT [Meet No/Dais 10/83 |Status:Deffered ALC42013a LIMITED {12.11.2014ALC4/2014 jand Re-indexed. HQ File RLA File Lic.No/Date:03 10744861 [Defer ; 33 :01/82/0S0/00551/AM14/ —_|:03/95/040/00320/AM14/ __/12.08.2013 Date:10.12,2014 Decision : Committee considered the case and it has been observed that the export of Entacapone Tablets 200 mg and the input is also Entacapone Tablets 200 mg with 2% wastage. It appears to be a case ofrefer ding only and no manufacturing activity is involved. It was decided to temind DCGI to furnish their comments. The case was deferred for 10.12.2014. | _ ee a Case No.:107/13/82. Party Name:DR REDDYS [Meet No/Date: 10/83. [Status:Deffered ALC4/2013 LABORATORIES LIMITED | ALC4/2014 and Re-indexed 34 . [12.11.2014 . |HQ File RLA File Lic.No/Date:0910057189 {Defer ‘01/82/050/00583/AM14/ _|:09/24/040/00222/AM14/ 14.08.2013 fDatez10.12.2014 Decision : Reply received from the firm and sent to Department of Pharmaceuticals for their (comments. The case is deferred for 10.12.2014.

ee Case No.:118/14/82Party Name:WANBURY [Meet No/Dais 10/83 (Status: ALC4/2013 LIMITED(FORMERLY ALC4/2014 Approved 35 . PEARL ORGANICS LTD) 12.11.2014 |HQ File RLA File Lic.No/Date:03 10745568 [DeferDate: :01/82/050/00703/AM14/ :03/95/040/00517/AM13/_ 16.08.2013 [25.09.2014Decision : Withdraw as the case was already approved by NC in its 8/82 oto.meeting dated

ee Case No117/14/82Party Name:MAC CHEM [Meet No/Date:10/82[Status:Defferai ALC4/2013 PRODUCTS (INDIA) ALC4/2014 and Re-indexed 36 HQeeFile RLAPRIVATE File LIMITED Lic.No/Date:0312.11.2014 10745962 [Defer. a | |:01/82/050/00702/AM14/ :03/95/040/00407/AM14/ [20.08.2013 Date: 10. 12.2014 |Decision : It was decided to call from the firm following technical details: . i) Content of Buffering agent in the export product. |. ii) Complete technical details as per Appendix 33 |The case was deferred for 10.12.2014

Case No.:3/12/82Party Name:ACTAVIS Meet No/Date: 10/82Status: Deffered I37 ALC4/2013 PHARMA ALC4/2014 and Re-indexed MANUFACTURING 12.11.2014 [HQ File IRLA File [Lic. No/Date:0410148864 Re be —14ae en ' soe Udsee Bruwan, NeW Beihi

==> picture [474 x 51] intentionally omitted <==

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• | fows2/oso/o04z7/amia/ —[:04/24/040/0009S/AMI47__[22.08.2013. [Date:10.12.2014<br>Decision : It was decided to send a copy of application again to DCGI for their comments<br>_|(solution ofimport items contains 8% water). The case was deferred for 10.12.2014,<br>----- End of picture text -----<br>

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----- Start of picture text -----<br>

|||||||||
|---|---|---|---|---|---|---|---|
|~|[CaseNo.:9/30/83-ALC1/2013[PartyName:STERICON|[Meet|No/Date: 10/82.|[Status:Defferea|
|PHARMA|PVT.LTD.,|ALC4/2014|land|Re-indexed|
|3g|[HQ-|File|;|RLA File|Lic.No/Date:0712.11.2014|10097668||Defer_.|
|:01/83/050/00471/AM14/|—_|:07/24/040/00152/AM14/__—_—|22.08.2013|_|Date:10.12.2014|

----- End of picture text -----<br>

Decision : It was decided to defer the case for 10.12.2014 for comments ofDepartment of Pharmaceuticals.

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----- Start of picture text -----<br>

||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|_|_|
|Case|No.:88/13/82-|"|Party Name:MAKCUR|Meet No/Date:10/82-|(Status:|
||||ALC4/2013|LABORATORIES LTD.|ALC4/2014|Approved|
|39||HQ|File|RLA|File|Lic.No/Date:08 10124120|Defer Date:|
||||ol/s2voso/oos6a/aMi4/|—_|:08/24/040/00232/AM14/|[26.08.2013|oe|
||||Decision|:|Withdraw|as|the|case|was|already|approved|by|NC|in|its|8/82|meeting|dated|
|[25.09.2014|__|
|Case No.:43/16/82-|[Party Name:SYMBIOTEC|[Meet No/Date:10/82-|[Status:Deffered|
|ALC4/2013|PHARMALAB LTD.,|ALC4/2014|and Re-indexed:|
|.|12.11.2014|foo|
|40|[HQ|File|RLA|File|Lic.No/Date:5610002765|(Defer|
|||[O1/82/050/00856/AM14/|__|:56/24/040/00017/AM14/|__j03.09.2013|____[Date:10.12.2014|
|||‘Decision|:|It was decided to defer the case|for 10.12.2014|for comments ofDepartment of|
|Pharmaceuticals.|_|-|_.|

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|||||||
|---|---|---|---|---|---|
|~|[Case No.:47/16/82-|Party Name:SHASUN|[Meet No/Date:10/82-|_|Status:Deffered|
|ALC4/2013|PHARMACEUTICALS|ALC4/2014|and Re-indexed|
|os|LIMITED|—|202014|_|
|141|}HQ File||RLA|File|Lic.No/Date:0410149741||Defer|
|:01/82/050/00860/AM14/|—_|:04/24/040/00130/AM14/|{11.09.2013|=| Date:10.12.2014|
|Decision|:|:|It was decided to call from the firm|a copy of|Master Batch Formula duly certified by|
|Quality Control|In charge. The case was deferred for|10.12.2014|

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||||||
|---|---|---|---|---|
|[~|[ase No.:10/16/82-ALC4/2013||Party Name:STERICON|Meet No/Date:10/82-|(Status:|
||PHARMA PVTLTD.,|ALC4/2014|°|Approved|
|;|{HQ File|RLA File|Lic.No/Date:0710098284|:|Defer Date:|

----- End of picture text -----<br>

a: Decision : Committee considered the case as per agenda and in light of written comments | ‘received from Department of Pharmaceuticals vide their OM No. 3501 1/766/2013-PI(Norms) | dated 05.09.2014 and in consultation with technical authority present in meeting, decided to |ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:{Export Product Product

{Export Product Product Ny. |__ [VIZULIZE MOISTURIZING AND COMFORTEYE DROPS a : iRMaAy. KUMAR eT ST TT ~— — Dy. Dien a wiles Serta / 4 ee pet oe rns ~' ign Trade Uayos iS “eihi

==> picture [503 x 710] intentionally omitted <==

----- Start of picture text -----<br> | For Export of 1 No. Bottle<br>Export Item | Export Item | Export Item | Export Item<br>/ No. 1 No. 2 No. 3 No. 4<br>[| soetporme resnoer<br>12__| ware Car es17/0001___| Relevant as per packing policy<br>[3_[provren<br>coo |<br>[sooumnvauunonate [001 gm [003 am<br>| _ |RA concerned may take further necessary action as per above decision of NC. <br>[- [Case No.:38/17/82- [PartyNameSMS Meet No/Date:10/82- __{Status:Deffered<br>ALC4/2013 PHARMACEUTICALS LTD ‘|ALC4/2014 and Re-indexed<br>. {12.11.2014| <br>143. |HQ File RLA File Lic.No/Date:09 10057602 |Defer :<br>| |:01/82/050/00897/AM14/ —|:09/24/040/00083/AM14/ ——{18.09.2013 ‘[Date:10.12.2014<br>Decision : It was decided remind the firm to furnish complete technical details as per Appendix<br>33. The case was deferred for 10.12.2014. - -<br>Case No.:46/16/82- Party Name:SHASUN ‘(Meet No/Date:10/82- __|Status:Deffered<br>ALC4/2013 PHARMACEUTICALS JALC4/2014 and Re-indexed:<br>44 |HQ File RLA File Lic.No/Date:04 10149960 |Defer<br>:01/82/0S0/00859/AM14/ —|:04/24/040/00127/AM14/ 18.09.2013. [Date10.12.2014<br>| |Decision : It was decided to call from the firm a copy of Master Batch Formula duly certified by -<br>| |Quality Control In charge. The case was deferred for 10.12.2014 ae<br>[7|) [CaseJALC4/2014 No.:171/6/82- [PartyBIOSCIENCE LIMITED Name:ATUL ~~ [MeetALC4/2014 No/Date:10/82- |Approved(Status: :<br> ot P2201 Z<br>HQ File RLA File Lic.No/Date:52 10040265 |Defer Date:<br>:01/82/050/00573/AM15/ ___ [52/24/040/00025/AM14/ 10.10.2013 7 7 <br>| |Decision: tn the light of written comments received from Department of Pharmaceuticals vide their OM<br>45 No. 35011/523/2013-Pl{Norms) dated 11.09.2013, it was decided to ratify norms under Para 4.7 of HBP v1<br>| as per details given below or as applied by the firm, whichever is less:<br>ka/ko<br>‘ | Item of Export Quantity] S.No | Item of Import Quantity allowed<br>| 1] | CARBONYL-L-VALINE(CBZ-L-VALINE 2<br>RA may take appropriate action as per the decision of Norms Committee. a<br>Case No.:38/17/82- Party Name: MYLAN [Meet No/Date:10/82- __|Status:Deffered<br>ALC4/2013 LABORATORIES LIMITED 'ALC4/2014 and Re-indexed:<br>49 [HQ File IRLA File Lic.No/Date:0910057914 (Defer<br>01/82/050/00900/AM14/ —|:09/24/040/00322/AM14/ —|14.10.2013 __[Date:10.12.2014: |<br>[Decision: It was decided to call from the firm the following technical details: 45BT/NIRMAL Me<br>raayt WITTPES ron fepererrereyForeign Tra<br>—| L - AMPTsYDirectorateWeg BBE Generasie. yer utote.baai otuagn Trac Commer.<br>Udyeg bt)... ivew Delhi<br>----- End of picture text -----<br>

==> picture [500 x 741] intentionally omitted <==

----- Start of picture text -----<br> i) Molecular weight of each input and output product.<br>ii) % Yield on molar basis along with copy oftechnical literature in support of yield<br>envisaged.<br>iii) Past production vis-a-vis actual consumption of inputs duly certified by Central Excise<br>Authorities.<br>| _ | The case was deferred for 10.12.2014. . oe<br>Case No.:22/17/82-<br>ALC4/2013 / PartyDELIVERYName:ATHENA SOLUTIONS DRUG MeetALC4/2014No/Date:10/82- Status:Defferedand Re-indexed<br>PRIVATE LIMITED 12.11.2014 :<br>7<br>47 |HQ File RLA File Lic.No/Date:0310753955 |Defer<br>:01/82/050/00884/AM14/ —_|:03/94/040/00458/AM14/ 17.10.2013 _ {Date:10.12.2014<br>Decision : It was decided to call from the firm copy of relevant Drug Manufacturing Licence.<br>The case was deferred for 10.12.2014 . —<br>Case No.:19/4/82- Party Name:SAVLA Meet No/Date: 10/82- Status: "<br>ALC4/2014 CHEMICALS LIMITED ALC4/2014 Approved<br>. a 12.11.2014 ;<br>HQ File RLA File Lic.No/Date:03 10754070 |Defer Date:<br>:01/82/050/00267/AM15/ :03/95/040/00566/AM14/ 17.10.2013 Z<br>Decision: In the light of earlier decision taken by NC in its 7/82 meeting dated 17.05.2011 and in:<br>| consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of<br>148 IHBP as per details below or as applied by firm whichever is lower:-<br>| Export product Import items Qty.<br>1 | allowed<br>| High Purity Methyl MTBE (Methyl Tertiary Buty!<br>| Tertiary Buty! Ether Purity Ether) (Purity max.98%)<br>Min. 99.8%<br>RA concerned may take further necessary action as per above decisionofNC.<br>Case No.:213/3/82- Party Name:TATVA Meet No/Date:10/82- __[Status:Deffered<br>ALC4/2014 CHINTAN PHARMA CHEM |ALC4/2014 and Re-indexed<br>PVT LTD 12.11.2014<br>. |<br>HQ File RLA File Lic.No/Date:3410038266 [Defer<br>:01/82/050/00217/AM15/ _|:34/24/040/00184/AM14/ 21.10.2013 __[Date:10.12.2014<br>Decision : It was decided call form the firm following information:<br>149] i) Details of manufacturing process with chemical equations, molecular formula,<br>molecular weights<br>ii) Yield obtained in each step<br>iii) | Authentic technical literature in support of yield obtained<br>iv) CA certificate certifying the production of export item achieved by you for the<br>past three years and corresponding consumption of each input.<br>The case is deferred for 10.12.2014<br>Case No.:6/20/82- Party Name:ZIM Meet No/Date: 10/82- Status: Deffered<br>50 |ALC4/2013 LABORATORIES LTD. ALC4/2014 and Re-indexed<br>12.11.2014<br>. . Oo<br>$ aI MAL FL PAAR<br>soSeer,fae eo iade<br>pies * : serse<br>Dae, Parad<br>Udyog s+<br>----- End of picture text -----<br>

FQ File RLA File Lic.No/Date:03 10754588 (Defer & :01/82/050/00992/AM14/ |:03/95/040/00S91/AM14/ [21.10.2013 Date:10.12.2014 | {Decision : It was decided to defer the case for 10.12.2014 for comments of Department of | |Pharmaceuticals. . 7 [Case No.:28/4/82Party Meet No/Date: 10/82Status:Deffered ALC4/2014 IName:S.R.S.PHARMACEUTICALS |ALC4/2014 and Re-indexed PVT. LTD. 12.11.2014 7 51 JHQ File RLA File :03/95/040/00575/AM14/|Lic.No/Date:03 10754848 |Defer :01/82/050/00276/AM15/ a (22.10.2013 Date:10.12.2014 Decision : It was decided to defer the case for 10.12.2014 for comments of Department of Pharmaceuticals.

Case No.:46/4/82Party Name:ZIM Meet No/Date: 10/82Status:Deffered | ||/ALC4/2014 LABORATORIES LTD. ALC4/2014 and Re-indexed 52|HQ File RLA File Lic.No/Date:0310754827 [Defer | :01/82/050/00294/AM15/ :03/95/040/00595/AM14/ 22.10.2013 Date: 10.12.2014 ‘Decision : It was decided to defer the case for 10.12.2014 for comments of Department of |Pharmaceuticals. 7

|“(CaseNo1/3/82-ALC42014|[PartyName-EYTANLABS|[MeetNo/Date:10/82-|_[Status:Deffered|
|---|---|---|---|
||LIMITED|ALC4/2014|andRe-indexed|
|||12.11.2014||
|53HQ File<br>01/82/050/00005/AM15/|RLA File<br>—_|:09/24/040/00354/AM14/|Lic.No/Date:0910057999 [Defer<br>24.10.2013<br>[Date:10.12.2014||
|Decision : It,wasdecided|to deferthe case for 10.12.2014 forcomments ofDepartmentof|||
|_|Pharmaceuticals.||||

‘Case No.:18/24/82Party Name:RA CHEM Meet No/Date:10/82Status: ALC4/2013 PHARMA LIMITED ALC4/2014 Approved | - — fiaan2014 HQ File RLA File |Lic.No/Date:0910058173 |Defer Date: :01/82/050/01217/AM14/ :09/24/040/00388/AM14/ 08.11.2013 Decision: In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/245/2014-P!(Norms) dated 30.10.2014, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

==> picture [493 x 200] intentionally omitted <==

----- Start of picture text -----<br> 54.) Item of Export Quantity Item of Import Quantity<br>allowed kg/kg<br>) MEBEVERINE HCL 1kg N-Ethyl-1-(4-Methoxy<br>Phenoxy )<br>lsopropylamine<br>4-Bromobutyl-(3,4- 0.796<br>Dimethoxy Benzoate<br>[3___| Dichloromethane 10.29<br>[4 [__|] [Ethyl][ Acetate] [0.35<br>_ [RA may take appropriate action asaa per the{ "4decisionf— of Norms Committee. prapy, Bice" oeeo 7 oe! wa BTradeMAR<br>pintraro B78 Snyiere<br>yang BNewe" ine D wn<br>----- End of picture text -----<br>

| |

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,

7}

‘|Case No.:42/24/82Party Name:AHLCON Meet No/Date:10/82Status: Approved ALC4/2013 PARENTERALS INDIA ALC4/2014 _ ETD IN 2014 oe JHQ File RLA File Lic.No/Date:05 1037102 |Defer Date: :01/82/050/01241/AM14/ |:05/23/040/00330/AM14/ 1 {13.11.2013 a —— Decision : Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 3501 1/247/2014-PI(Norms) dated 30.10.2014 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is ‘lower:-

| |Dextrose{Export Product(Glucose) 5% 500 ml with euro head Bottle(I.V.Infusion) (4 Export Item)

:

==> picture [488 x 519] intentionally omitted <==

----- Start of picture text -----<br> SI. Export Item Import Recommended for 1 No.Bottle<br>\55 4 No. LDPE Granules | Dextrose Sodium Euro Head<br>of Relevant Monohydrate/ | Chloride cap(Plastic/<br>Grade anhydrous(po | powder Foil cap)<br>Dextrose 27.3 gm 26.25 gm<br>| (Glucose) 5% wder form<br>500ml Bottle<br>2. | Dextrose 27.3 gm 26.25 gm 4.725 gm<br>| 5%+Sodium<br>| | Chloride 0.9%,<br>500m! Bottle<br>| 7 3. | Sodium 27.3 gm NIL 4.725 gm<br>| Chloride 0.9%<br>: 500ml Bottle<br>Sodium 13.65 gm NIL 0.945 gm<br>| Chloride 0.9%<br>J}: 100ml Bottle<br>RA concemed may take further necessary action as per above decision of NC.<br>Case No.:37/4/82- Party Name:EMCURE Meet No/Date:10/82- _|Status:Deffered<br>ALC4/2014 PHARMACEUTICALS LTD. |ALC4/2014 and Re-indexed<br>{12.11.2014 a<br>156 |HQ File RLA File Lic.No/Date:3 110061152 |Defer<br>01/82/050/00285/AM15/ _{:31/83/040/00141/AM14/ 25.11.2013 __ [Date:10.12.2014:<br>Decision : It was decided to defer the case for 10.12.2014 for comments of Department of<br>| |Pharmaceuticals. .<br>Case No.:14/24/82- Party Name:DRREDDYS [Meet No/Date:10/82- (Status:<br>ALC4/2013 LABORATORIES LIMITED jALC4/2014 Approved<br>57 12.11.2014<br>HQ File RLA File Lic.No/Date:0910058344 |Defer Date:<br>:01/82/050/01213/AM14/ :09/24/040/0038 1/AM14/ 26.11.2013 an<br>PAR/NIRMAL FL<br>wa wesc feast <<br>Dy Mires rar seal aa :<br>Bay tat, Fg v.<br>Udyog Bhawan, New ..<br>----- End of picture text -----<br>

==> picture [4 x 7] intentionally omitted <==

----- Start of picture text -----<br> oH<br>----- End of picture text -----<br>

‘

Decision : in the light of written comments received from Department of Pharmaceuticals vide their OM & No. 35011/230/2014-Pl(Norms) dated 30.10.2013, 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:

==> picture [436 x 137] intentionally omitted <==

----- Start of picture text -----<br>

||||||
|---|---|---|---|---|
|I|item of Export|Quantity|Item of Import|Quantity|
|||allowed kg/kg|
|!|Ranitidine Hel|1kg|pa|Caustic potash flakes|
|[eat|
|||[4|
|||__||Cysteamine1-methyi amino hel flakes1-methy!|
|thio|2-nitroethene|

----- End of picture text -----<br>

IRA may take appropriate action as per the decision of Norms Committee.

==> picture [456 x 131] intentionally omitted <==

----- Start of picture text -----<br>

||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|||| Case No.:24/24/82-|Party Name:GLAND|Meet|No/Date: 10/82-|Status:|
|\ALC4/2013|PHARMA LIMITED|ALC4/2014|Approved|
|||-|.|12.11.2014|||
|:09/24/040/004|19/AM14/|26.11.2013|
|||HQ|[:01/82/050/01223/AM14/]|File|RLA File|‘|Lic.No/Date:09|10058352||Defer Date:|
||Decision|:|Committee|considered|the|case|as|per|agenda|and|in|light|of|written|comments|
|received|from|Department|of|Pharmaceuticals|vide|their|OM|No.|35011/218/2014-PI(Norms)|
|dated|30.10.2014|and|in|consultation|with|technical|authority|present|in|meeting,|decided|to|
|ratify norms under para|4.7 of|HBP as per details below or as applied by firm whichever|is|lower:-|

----- End of picture text -----<br>

==> picture [508 x 337] intentionally omitted <==

----- Start of picture text -----<br> JExport Product<br>| |Acetylcysteine Solution USP 200mg/ml(20%), 4ml vial USP<br>S1.No. Import Item Norms As per Batch Lowest of<br>58. Applied Central Logsheet | (2) to (4)<br>Excise<br>. (1) (2) Certificate (4) (5)<br>3<br>11 |Acetylcysteine_—|880mg/vial As per SION 880mg/vial<br>Vials Glass 1.1137 1.0912<br>3 Rubber Stoppers| 1.076 nos. 1.1292 1.076<br>Rubber<br>4 AluminiumSeals Plastic &| 1.064 nos. 1.0795 1.0499 1.0499<br>[5 | Droppersplastic | 1.05nos. [ - =| - | 1.05<br>|6| Filters Plastic 0.0003 nos. | = S| SS - CNet to Net|<br>Tubing Plastic 0.00067 foot| = - | = | NettoNet<br>In accordance with the earlier decisions of Norms-Committee, present case may be<br>considered specific to USFDA project and Export to USA only. :<br>_ |RA may take appropriate action as per the decision of Norms Committee. a<br>PAR /NIRMAL KUN”:<br>ae oft onn<br>. . New De...<br>----- End of picture text -----<br>

ot 1 !

|.||CaseNo.:66/3/82-<br>ALC4/2014|PartyName:GLAND<br>PHARMALIMITED|MeetNo/Date:10/82-<br>Status:Deffered<br>ALC4/2014<br>andRe-indexed|
|---|---|---|---|---|
||59keFile<br>:01/82/050/00070/AM15/||RLAFile<br>:09/24/040/00422/AM14/|12.11.2014<br>!<br>Lic.No/Date:0910058454 |Defer<br>04.12.2013<br>Date:10.12.2014|
||_|Decision : Itwasdecidedto<br>|Pharmaceuticals.|todefer thecasefor 10.12.2014 forcommentsofDepartment of||

|CaseNo.:116/23/82-<br>ALC4/2013|PartyName:ALCHEM<br>INTERNATIONALLTD.|MeetNo/Date:10/82-<br>ALC4/2014|Status:Deffered<br>andRe-indexed|
|---|---|---|---|
|.||12.11.2014||
|leeFile<br>:01/82/050/01163/AM14/|RLAFile<br>:05/23/040/00341/AM14/|Lic.No/Date:0510372635 <br>05.12.2013||Defer<br>Date:10.12.2014|

Decision : It was decided to remind the firm to furnish following technical details:

• i) Actual content of Digoxin in imported digitalis Lanata Leares supported by COA from foreigner supporter

• it) Assay of Export Product

• . lii) Past production vis-a-vis Actual consumption of leaves for the last 3years duly certified by Central Excise Authorities. The case was deferred for 12.11.2014.

Case No.:138/3/82Party Name:AUROBINDO Meet No/Date:10/82Status: ALC4/2014 PHARMA LIMITED ALC4/2014 Approved 12.11.2014 HQ File RLA File Lic.No/Date:09 10058481 ‘|Defer Date: 01/82/050/00142/AM15/ :09/24/040/00424/AM14/ 06.12.2013

Decision: in the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/284/2014-P1(Norms) dated 30.10.2014, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

==> picture [444 x 154] intentionally omitted <==

----- Start of picture text -----<br> ‘et | Item of Export | Qty | [S,No][|] [Item][ of][ Import] Quantity allowed kg/kg<br>4 Activated carbon 0.060<br>Ei<br>Aluminium Canisters Relevant, As per packing<br>policy.<br>RA may take appropriate action as per the decision of Norms Committee.<br>----- End of picture text -----<br>

==> picture [514 x 127] intentionally omitted <==

----- Start of picture text -----<br> Case No.:8/18/82- Party Name:TITAN Meet No/Date:10/82- Status: Deffered<br>ALC4/2013 LABORATORIES PVT. LTD. |ALC4/2014 and Re-indexed<br>12.11.2014<br>62 TQ File RLA File Lic.No/Date:0310761921 {Defer .<br>:01/82/050/00943/AM14/ —_|:03/95/040/00637/AM14/ 16.12.2013 Date:10.12.2014<br>. [Decision : It was decided to defer the case for 10.12.2014 for comments of OfifmaL KUMAR<br>Oy. Director Ges. . “6<br>, Deel Ba .<br>~~ 2 ) ~~ aReep S : : a);<br>Udyog ° “al<br>----- End of picture text -----<br>

a

==> picture [476 x 356] intentionally omitted <==

----- Start of picture text -----<br> | &<br>| Pharmaceuticals.<br>Case No.:91/23/82- Party Name:INTAS Meet No/Date: 10/82- Status:<br>ALC4/2013 PHARMACEUTICALS LTD., |ALC4/2014 Approved<br>12.11.2014<br>HQ File RLA File Lic.No/Date:0810127281 Pete Date:<br>:01/82/050/01 138/AM14/ :08/24/040/00408/AM14/ 20.12.2013<br>Decision : In the light of written comments received from Department of Pharmaceuticals vide<br>their OM No. 35011/161/2014-Pl(Norms) dated 02.09.2014, it was decided to ratify norms under<br>Para 4.7 of HBP vi as per details given below or as applied by the firm, whichever is less:<br>Qty.<br>634 Aspirin Enteric 1kg 1 Acetyl Salicylic Acid<br>| Coated Tablets 81 mg EP/BP/USP 82.62 mg/tablets<br>} “Ecotrin 81 - :<br>| Microcrystalline Cellulose<br>| PH102 101.0<br>|<br>| 5. | 1Gsilica Gel Canister Relevant, As per<br>50 ml HDPE white bottle packing policy.<br>, with CR cap & seal<br>----- End of picture text -----<br>

jRAmay take appropriate action as per the decision of Norms Committee.

==> picture [2 x 1] intentionally omitted <==

----- Start of picture text -----<br> _<br>----- End of picture text -----<br>

|CaseNo.:181/3/82-|PartyName:AKZONOBEL|_—(MeetNo/Date:10/82-||Status:Deffered|
|---|---|---|---|---|
|ALC4/2014|INDIALIMITED|ALC4/2014<br>12.11.2014||andRe-indexed|
||||.||
|64:\HQ File<br>:01/82/050/00185/AM15/|RLAFile<br>:02/24/040/00053/AM14/|Lic.No/Date:0210198392 <br>02.01.2014|||Defer<br>Date:10.12.2014|

Decision : It was decided to defer the case for 10.12.2014 for comments of Department of _ |Pharmaceuticals. .

• Case No.:24/8/82|Party Name:GLOBAL Meet No/Date: 10/82Status:Deffered ALC4/2014 CALCIUM PRIVATE ALC4/2014 and Re-indexed LIMITED, 12.11.2014

• 65 |HQ File RLA File Lic.No/Date:0710101055 ||Defer :01/82/050/00688/AM15/ :07/24/040/00323/AM 14/ 02.01.2014 — Date: 10.12.2014

Decision : It was decided to defer the case for 10.12.2014 for comments of Department of |C&PC.

==> picture [2 x 2] intentionally omitted <==

----- Start of picture text -----<br> —<br>----- End of picture text -----<br>

Case No.:45/3/82Party Name:AKZO NOBEL [Meet No/Date:10/82Status:Deffered ALC4/2014 {NDIA LIMITED ALC4/2014 and Re-indexed 66 HQ File RLA File Lic.No/Date:021019845812.11.2014 |Defer . V _ |:01/82/050/00049/AM15/ _|:02/24/040/00168/AM13/ 03.01.2014 Date:10.12.2014 RMAL KUMAR

wo, Nex Delhi

|

|

:

|

|

: |

Decision : It was decided to defer the case for 10.12.2014 for comments of Department of Pharmaceuticals. Case No.:89/3/82Party Name:ASTRIX Meet No/Date: 10/82Status: Deffered ALC4/2014 LABORATORIES LTD., ALC4/2014 and Re-indexed 12.11.2014 67 |HQ File RLA File Lic.No/Date:09 10058826 [Defer :01/82/050/00093/AM1 5/ :09/24/040/00496/AM 14/ 06.01.2014 Date: 10.12.2014 Decision : It was decided to defer the case for 10.12.2014 for comments of Department of Pharmaceuticals.

==> picture [443 x 67] intentionally omitted <==

----- Start of picture text -----<br>

|||||||||
|---|---|---|---|---|---|---|---|
|Case No.:117/6/82-|Party|Name:|VIVIMED|LABS||Meet No/Date:10/82-|Status: Deffered|
|ALC4/2014|LIMITED|ALC4/2014|and|Re-indexed|
|12.11.2014|
|68|fee|[|-01/82/050/00519/AM15/]|File|RLA:09/24/040/005 File|17/AM14/|09.01.2014Lic.No/Date:0910058894|{Date:|Defer 10.12.2014|

----- End of picture text -----<br>

Decision : It was decided to defer the case for 10.12.2014 for comments of Department of Pharmaceuticals.

==> picture [450 x 62] intentionally omitted <==

----- Start of picture text -----<br>

||||||||
|---|---|---|---|---|---|---|
|Case No.:192/3/82-|Party Name:VIVIMED LABS||Meet No/Date:10/82-|Status:Deffered|
|ALC4/2014|LIMITED|ALC4/2014|and Re-indexed|
|12.11.2014|
|69||HQ|File|RLA|File|Lic.No/Date:0910058896||Defer|
|:01/82/050/00196/AM15/|:09/24/040/005 13/AM14/|10.01.2014|Date: 10.12.2014|

----- End of picture text -----<br>

Decision : It was decided to defer the case for 10.12.2014 for comments of Department of D/o Pharma.

==> picture [451 x 83] intentionally omitted <==

----- Start of picture text -----<br>

||||||||
|---|---|---|---|---|---|---|
|Case|No.:204/3/82-|Party Name:VIVIMED LABS|Meet No/Date:10/82-|Status:Deffered|
|ALC4/2014|LIMITED|ALC4/2014|and Re-indexed|
|12.11.2014|
|70|THQ File|RLA File|Lic.No/Date-0910058895|[Defer|
|:01/82/050/00208/AM15/|:09/24/040/005 14/AM14/|10.01.2014|‘Date: 10.12.2014|
|[Decision|:|It was decided to defer the case for|10.12.2014|for comments of|Department of|C&PC.|

----- End of picture text -----<br>

• Case No.:197/3/82-ALC4/2014 |Party Name:MALLADI Meet No/Date:10/82Status: DRUGS & ALC4/2014 Approved PHARMACEUTICALS 12.11.2014 LIMITED

• HQ File RLA File Lic.No/Date:0410154188 |Defer Date: :01/82/050/00201/AM15/ :04/24/040/002 18/AM14/ 13.01.2014

71 |Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/265/2014-PI(Norms) dated 30.10.2014, it was decided to ratify norms under Para 4.7 of HBP V1 as per details given below or as applied by the firm, whichever is less: 1 Export product Exp. Qty. Import items Qty.ke/kg allowed l\

“ade =e iT sov Gelni

==> picture [432 x 192] intentionally omitted <==

----- Start of picture text -----<br> | Phenylepherine | ikg 1. 3-hydroxy acetophenone 2.95<br>3 L(+) tartaric acid | 184<br>4 Methy] Isobutyl Ketone 0.857<br>a<br>RA may take appropriate action as per the decision of Norms Committee.<br>----- End of picture text -----<br>

||CaseNo.:208/3/82-<br>ALC4/2014|PartyName:OGENE<br>MeetNo/Date:10/82-<br>SYSTEMSINDIAPVT. LTD. |ALC4/2014|PartyName:OGENE<br>MeetNo/Date:10/82-<br>SYSTEMSINDIAPVT. LTD. |ALC4/2014|Status:Deffered<br>and Re-indexed|
|---|---|---|---|---|
||)||12.11.2014||
|||||a|
|72||HQ File<br>:01/82/050/00212/AM15/|RLA File<br>:09/24/040/00515/AM14/|Lic.No/Date:0910059017<br>22.01.2014|{Defer<br>Date:10.12.2014|

Decision : It was decided to defer the case for 10.12.2014 for comments of Department of Pharmaceuticals.

||Decision : It was decided to defer the case forwas decided to defer the case fordecided to defer the case forto defer the case for<br>Pharmaceuticals.|It was decided to defer the case forwas decided to defer the case fordecided to defer the case forto defer the case fordefer the case forthe case forcase forfor 10.12.2014 for comments of Department of|10.12.2014 for comments of Department offor comments of Department ofcomments of Department ofof Department of|10.12.2014 for comments of Department offor comments of Department ofcomments of Department ofof Department ofDepartment ofof|
|---|---|---|---|---|
||CaseNo.:55/3/82-<br>ALC42014|PartyName:AUROBINDO<br>PHARMALIMITED|[MeetNo/Date:10/82-<br>ALC4/2014|_[Status:Deffered<br>andRe-indexed|
||||12.11.2014||
|73||HQFile<br>:01/82/050/00059/AM15/|RLAFile<br>:09/24/040/00529/AM14/|Lic.No/Date:0910059025<br>23.01.2014|[Defer<br>Date:10.12.2014|
||Decision : Itwasdecidedto<br>Pharmaceuticals.|todefer thecasefor 10.12.2014 forcommentsofDepartmentof|||

Case No.:87/3/82Party Name: VIVIMED LABS /Meet No/Date:10/82Status: Deffered ALC4/2014 LIMITED ALC4/2014 and Re-indexed . 12.11.2014 74 |HQ File RLA File Lic.No/Date:0910059155 |Defer 70 1/82/050/00091/AM15/ :09/24/040/00544/AM14/ 04.02.2014 Date:10.12.2014 Decision : It was decided to defer the case for 10.12.2014 for comments of Department of C&PC. Case No.:117/3/82Party Name:VIVIMED LABS [Meet No/Date:10/82(Status:Deffered ALC4/2014 LIMITED ALC4/2014 and Re-indexed 75 12.11.2014 fee File RLA File Lic.No/Date:0910059156 (Defer :01/82/050/00121/AM15/ —_|:09/24/040/00543/AM14/ 04.02.2014 {Date:10.12.2014 Decision : It was decided to defer the case for 10.12.2014 for comments ofDepartment ofC&PC. Case No.:54/3/82Party Name: ASTRIX Meet No/Date:10/82Status:Deffered 76|ALC4/2014 LABORATORIES LTD., ALC4/2014 and Re-indexed 12.11.2014 Dy. PAR=r /NIRMAL TieKUMAbade Direc" " ; 7 ee 1 lou yey Le laweally Now Deini

|

| |

| ; | |

| |}

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||||||||||
|---|---|---|---|---|---|---|---|---|
|;|
|“|ze01/82/050/00058/AM15/ File|~|IRLA—_|:09/24/040/00552/AM14/ File|—_~|[Lic.No/Date:0910059230[10.02.2014|Pete[Defer 12.2014|
|Decision|:|It was decided to defer the case|for|10.12.2014|for comments of|Department of|
|Pharmaceuticals.|
|CaseNowl673/82-|Party Name:CIPLA LIMITED|[Meet|No/Date:10/82-|__[Status:Deffered|
|4|ALC4/2014|land Re-indexed|
|_||2.11.2014|
|77||HQ|File|RLA|File|Lic.No/Date:03 10769983||Defer|
|HO|yo0r7|AMIS!|Ra|i|or2waMa|(10.02.2014|_—|[Date:10.12.2014|
|Decision|:|It was decided to defer the case for|10.12.2014|for comments ofDepartment of|
|Pharmaceuticals.|
|Case No.:64/3/82-|Party Name:ARENE LIFE|Meet No/Date:10/82-|Status:Deffered|
|ALC4/2014|SCIENCES LIMITED.|ALC4/2014|and Re-indexed|
|12.11.2014|-|.|
|78||HQ File|RLA|File|Lic.No/Date:0910059247||Defer|
|:01/82/050/00068/AM15/|—_|:09/24/040/00SS4/AM14/—|11.02.2014__||Date:10.12.2014|
|Decision|:|It was decided remind the firm to|furnish complete|technical|details|as per Appendix|
|33. The case was deferred|for|10.12.2014.|
|Case|No.:46/3/82-|Party Name:ARENE LIFE|Meet No/Date:10/82-|Status:|
|ALC4/2014|SCIENCES LIMITED.|ALC4/2014|Approved|
|HQ File——|RLA File|.|‘lLic.No/Date:0912.11.2014|10059260||Defer Date:|.|
|:01/82/050/00050/AM1 5/|:09/24/040/00555/AM14/|12.02.2014|oo,|
|Decision:|In the|light of written comments received from Department of Pharmaceuticals vide|
|their OM|No. 35011/307/2014-PI(Norms) dated|11.11.2014,|it was decided to|ratify norms under|
|Para 4.7|of HBP v1 as per details given below or as applied|by the firm, whichever|is|less:|
|||Qty.|ke/kg|
|||GABAPENTIN/|1kg|1|1,1-Cyclohexane|Diacetic Acid|
|||Monoamide|
|i|a|Ce|
|RA may take appropriate|action as per the decision of Norms Committee.|
|||[Case Noz47/3/82-|Party Name:ARENE LIFE|[Meet No/Date:10/82-_[Status:|
|ALC4/2014|SCIENCES LIMITED.|ALC4/2014|Approved|
|12.11.2014|
|80|HQ|-01/82/050/00051/AM15/ File|RLA_|:09/24/040/00535/AM14/ File|Lic.No/Date:091005925912.02.2014|||Defer Date:|
|Decision|:|In the light of written comments received from Department of Pharmaceuticals vide|
|their OM No. 35011/296/2014-Pi(Norms) dated 11.11.2014,|it was decided to ratify norms under|||||Mdinee|
|Para 4.7 of HBP v1 as per details given below or as applied by the firm, whicheverftstessroe/|[NIST]|[E,]|[ante]|

----- End of picture text -----<br>

==> picture [108 x 14] intentionally omitted <==

----- Start of picture text -----<br> lisyoy BF rawart, NEW Deihi<br>----- End of picture text -----<br>

|||Export product<br>Exp.<br>Importitems<br>Qty.Allowed<br>Qty.<br>kg/kg<br>| AMLODIPINE<br>1kg<br>1<br>ETHYL-4-CHLORO<br>‘oss<br>| BESYLATE<br>ACETOACETATE<br>0.858<br>|<br>|<br>|2. **|**ORTHOCHLOROBENZALDEHYDE| 0.670<br>1<br>3, MONOETHANOL AMINE<br>|<br>[4.__|METHANOL<br>|S.__|ACETICACID<br>JRAmaytake appropriate action as per the decision ofNormsCommittee.|Export product<br>Exp.<br>Importitems<br>Qty.Allowed<br>Qty.<br>kg/kg<br>| AMLODIPINE<br>1kg<br>1<br>ETHYL-4-CHLORO<br>‘oss<br>| BESYLATE<br>ACETOACETATE<br>0.858<br>|<br>|<br>|2. **|**ORTHOCHLOROBENZALDEHYDE| 0.670<br>1<br>3, MONOETHANOL AMINE<br>|<br>[4.__|METHANOL<br>|S.__|ACETICACID<br>JRAmaytake appropriate action as per the decision ofNormsCommittee.|Export product<br>Exp.<br>Importitems<br>Qty.Allowed<br>Qty.<br>kg/kg<br>| AMLODIPINE<br>1kg<br>1<br>ETHYL-4-CHLORO<br>‘oss<br>| BESYLATE<br>ACETOACETATE<br>0.858<br>|<br>|<br>|2. **|**ORTHOCHLOROBENZALDEHYDE| 0.670<br>1<br>3, MONOETHANOL AMINE<br>|<br>[4.__|METHANOL<br>|S.__|ACETICACID<br>JRAmaytake appropriate action as per the decision ofNormsCommittee.|Export product<br>Exp.<br>Importitems<br>Qty.Allowed<br>Qty.<br>kg/kg<br>| AMLODIPINE<br>1kg<br>1<br>ETHYL-4-CHLORO<br>‘oss<br>| BESYLATE<br>ACETOACETATE<br>0.858<br>|<br>|<br>|2. **|**ORTHOCHLOROBENZALDEHYDE| 0.670<br>1<br>3, MONOETHANOL AMINE<br>|<br>[4.__|METHANOL<br>|S.__|ACETICACID<br>JRAmaytake appropriate action as per the decision ofNormsCommittee.|
|---|---|---|---|---|---|
||||||;|
||"|||||
|||[CaseNo.:61/3/82-<br>ALC4/2014||PartyName:INCHEM<br>MeetNo/Date:10/82-<br>LABORATORIES PRIVATE<br>|ALC4/2014|Status: Deffered<br>andRe-indexed|
|||||LIMITED<br>—<br>{12.11.2014||
|1.|81|||HQ File<br> |:01/82/080/00065/AM15/|RLA File<br>Lic.No/Date:0910059258<br>|Defer<br>—_|:09/24/040/00568/AM14/<br>12.02.2014<br>Date:10.12.2014||
||||Decision : Itwasdecided to call fromthe firm the complete technical details||asperAppendix33|
||||and<br>(ii) past production vis-avis actual consumption of inputs duly certified by Central Excise|||
||||jAuthority. The casewas deferred for 10.12.2014.|||
||_|||||
||||CaseNo.:113/3/82-<br>ALC4/2014|PartyName:RANBAXY<br>Meet No/Date:10/82-<br>LABORATORIESLTD<br>ALC4/2014|Status:Deffered<br>andRe-indexed|
|||||12.11.2014||
|||||;||
||82||[HQ File|RLA File<br>Lic.No/Date:0510379132<br>|Defer||
||||:01/82/050/00117/AM15/|:05/24/040/00332/AM14/<br>12.02.2014|Date:10.12.2014|

Decision : It was decided to defer the case for 10.12.2014 for comments ofDepartment of _ |Pharmaceuticals.

• Case No.:48/3/82Party Name:VIVIMED LABS (Meet No/Date:10/82_[Status:Deffered ALC4/2014 LIMITED JALC42014 and Re-indexed 12.11.2014

• 183 |HQ File RLA File Lic.No/Date:0910059263 |Defer :01/82/050/00052/AM15/ :09/24/040/005 82/AM14/ 12.02.2014 Date:10.12,2014

• | |Decision : It was decided to defer the case for 10.12.2014 for comments of Department of C&PC.

==> picture [480 x 98] intentionally omitted <==

----- Start of picture text -----<br> |<br>[Case No.:112/3/82- Party Name:VIVIMED LABS [Meet No/Date:10/82- Status:Deffered<br>ALC4/2014 LIMITED ALC4/2014 and Re-indexed<br>, . 12.11.2014<br>184 lke File RLA File Lic.No/Date:09 10059262 'Defer<br>:01/82/050/001 16/AM15/ :09/24/040/00564/AM14/ 12.02.2014 Date:10.12.2014<br>| |Decision : It was decided to defer the case for 10.12.2014 for comments of Department of<br>| |C&PC.<br>----- End of picture text -----<br>

==> picture [496 x 79] intentionally omitted <==

----- Start of picture text -----<br> | {Case No.:2/3/82-ALC4/2014 [Party Name:SCOTT-EDIL [Meet No/Date-10/82- [Statas: )<br>85 PHARMACIA LTD., {ALC4/2014 Approved<br>[HQ 12.11.2014<br> File IRLA File [Lic.No/Date:2210014609ic.No/Date:221001460 Be wie<br>- ais Sell L KUMAR<br>Pra en Ceneral - Tone<br>----- End of picture text -----<br>

"sew Delhi

| Decision:01/82/050/00006/AM15/: : tn the [i ‘22/24/040/00089/AM14/i ; [13.02.3014 = fo 3 ight of written commen i their : ; Para OM No. 35011/269/2014-Pl(Norms) dated 1112018 temamenta Pharmaceuticals vide

4.7 of HBP v1 as per detailsiia) given below or as appliedait by theTwas firm,decided whicheverto ratify is less: norms under ||[Bxp0r producAmoxycillin and eae Oo [sine][importitems 780 moe ene 1 Clavulanate Amoxycillin Trihydrate - bott! mg/100 mi

| SuspensionPottasium for oralBottle Dry)Purimox Powder (Extra ottle RA may take appropriate action as per the decision of Norms Committee. . ALC4/2014Case Ni0.:73/3/82Party Name:ARENE LIFE Meet No/Date: : 10/82Status:Deffered SCIENCES LIMITED. 'ALC4/2014 and Re-indexed

Ie6 ig*01/82/050/00077/AM15/ File a IRLA—_|:09/24/040/00536/AM14/ File Lic.14.02.201412.11.2014 No/Date:0910059285 eteDate:10.12.2014~ Pharmaceuticals.Decision : It was decided to defer the case for 10.12.2014 for comments of Department of

Case No.:63/6/82-ALC4/2014 {Party Name:ARIHANTANAM [Meet No/Dais 10/82(Status: }LIFECARE PVT. LTD. ALC42014 Approved fo 12.11.2014 HQ File RLA File Lic.No/Date:0310770866 [Defer Date: ‘01/82/050/00465/AMI5/ _|:03/94/040/01037/AM14/ ——‘{18.02.2014 Decision: In the light of written comments received from Department of Pharmaceuticals vide 87 their OM No. 35011/296/2013-PI(Norms) dated 03.07.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

| Export product Exp. Qty. Import items Qty. allowed : kg/kg Laces [tke | RA may take appropriate action as per the decision of Norms Committee. Case No.:64/6/82Party Name:FDC LTD Meet No/Date: 10/82Status: Deffered ALC4/2014 ALC4/2014 and Re-indexed | 12.11.2014 88 |HQ:01/82/050/00466/AM15/File RLA:03/94/040/00707/AM14/File ‘|Lic.No/Date:03| 18.02.2014 10770862 Pete|Defer10.12.2014 Decision : It was decided to defer the case for 10.12.2014 for comments of Department of Pharmaceuticals. ALCA20A * PERFUMES PVT.LTD. ALC4/2014 and Re-indexed 89 ' 2. Name:VUAY me12.11.2014No/Date:10/82_[Status:Deffered aS : i HO : 668 |Defer . File RLA File Lic.No/Date:03 10770 ai Oi/EZMOSO/OOITO/AMI 5/ :03/95/040/009 16/AM14/ 18.02.2014 Date:10.12.2014 Prta PAR/NIRMAL KUMAR BE yt te ere : Udyag Esivarcaei. Pleo

Ld

ts of Department of - ; Decision : It was decided to defer the case for 10.12.2014 for ohn oon ¥8.08.2014, Pharmaceuticals. (Application already sent to Departmen har 15.05.2014 and 18.11.2014)

==> picture [457 x 391] intentionally omitted <==

----- Start of picture text -----<br>

||||||||
|---|---|---|---|---|---|---|
|=|:|No/Date: 10/82-|Status:|
|:125/3/82-|Party|Name:|MYLAN|Meet|
|LABORATORIES LIMITED||ALC4/2014|Approved|
|ALcan0l|[‘]|12.11.2014|
|HQ-01/82/050/00129/AM15/ File|IRLA_|:09/24/040/00570/AM14/ File|Lic.No/Date:0919.02.2014|10059353||Defer Date:|
|Decision|:|in the light of written comments received from Department of Pharmaceuticals vide|
|their OM No. 35011/248/2014-PI(Norms)|dated 30.10.2014,|it was decided to ratify norms under|
|Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:|
|90:| Export product|Exp.|Aty. Allowed|
|||Qty.|kge/kg|
|||11-cyclopropyl-5,|11-|| 1 kg|1|2-chloro-N-(2-chloro-4-methyl-|
|||dihydro-4-methyl-6h-|3-pyridiny!)-3-pyridine|
|||dipyrido[3,2-b:2,3-|carboxamide|1.37|
||||eta) diazepins|Tomine|dS|
||_||one(Nevirapine(NVP)|3.|[Cyclopropylamine|| 057|
|||
||||L_- n)|ra.|S.|[Methanol Dimethyl|formamide|OL|
|RA may take|appropriate action as per the decision of Norms Committee.|
|Case No.:216/3/82-|Party Name:SENTISS|Meet|No/Date: 10/82-|Status:Deffered|
|ALC4/2014|PHARMA PVT.LTD.|ALC4/2014|and Re-indexed|
|||g||HQ File|||RLA File|Lic.No/Date:0512.11.2014|10379833.||Defer|
|:01/82/050/00220/AM15/|:05/24/040/0043 1/AM14/|19.02.2014|Date: 10.12.2014|
|Decision|:|It was decided to defer the case for|10.12.2014|for comments of|Department of|
|Pharmaceuticals.|_|7|

----- End of picture text -----<br>

==> picture [453 x 104] intentionally omitted <==

----- Start of picture text -----<br>

||||||||||
|---|---|---|---|---|---|---|---|---|
|Case No.:86/3/82-|Party Name:AKZO NOBEL|[Meet No/Date:10/82-|_[Status:Deffered|
|ALC4/2014|INDIA LIMITED|ALC4/2014|and Re-indexed|
|12.11.2014|
|lo2 fe:01/82/050/00090/AM15/ File|RLA:02/24/040/00197/AM14/ File|21.02.2014Lic.No/Date:02|10200380|Date:|Defer 10.12.2014|
|Decision|:|It was|decided|to defer the|case|for|10.12.2014|for comments of Department of|
|Pharmaceuticals.|

----- End of picture text -----<br>

==> picture [454 x 113] intentionally omitted <==

----- Start of picture text -----<br>

|||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|Case No.:15/3/82-|Party Name:VIVIMED LABS|[Meet No/Date:10/82-|(Status:|
|ALC4/2014|LIMITED|ALC4/2014|Approved|
|12.11.2014|
|93|HQ File|RLA File|Lic.No/Date:0910059372||Defer Date:|
||:01/82/050/00019/AM15/|:09/24/040/00598/AM14/|21.02.2014|||,|
||||Decision|:|In|the|light|of earlier|decision|taken|in|meeting|no.|6/82|dated|29.08.2014,|it|
|was decided|to|ratify|norms under|Para|4.7|of HBP|vi|as|per|details|given|below|or as|
|applied by the firm, whichever|is less:|

----- End of picture text -----<br>

. KUMAR Dy. Director Gono-al of Fe n Trade

| i)

==> picture [526 x 807] intentionally omitted <==

----- Start of picture text -----<br> |<br>| Expor Product [ Export Op 3<br>as Qty. allowed }<br>| ch kg Chloro Ether Ketone (1, Chloro,(4-<br>| (Climbazole) Chlorophenoxy 3,3-Dimethy! 2-<br>Butanone S<br>| [3._| Potassium Carbonate 0.600 kg<br>RA may take appropriate action as per the decision ofNorms Committee.<br>Ag L632. Party Name: VIVIMED LABS [Meet No/Date:10/82- Status:Deffered<br>. LIMITED ALC4/2014 and Re-indexed<br>7<br> 12.11.2014<br>j94 HQ File RLA File Lic.No/Date:0910059375 ‘Defer<br>RO 00020/AMIS/ Ro re o0sozAMa 21.02.2014 [Date:10.12.2014<br>Decision : It was decided to defer the case for 10. 12.2014 for comments ofDepartment of<br>C&PC.<br>Case No.:105/3/82- Party Name: THINQ Meet No/Date:10/82- ~ (Status:Deffered<br>ALC4/2014 PHARMA-CRO LIMITED ALC4/2014 and Re-indexed<br>95 [HQ File RLA File Lic.No/Date:03 10771596 |Defer<br>01/82/050/00109/AM15/ —|:03/95/040/00842/AM14/ 24.02.2014 Date:10.12.2014<br>| {Decision : it was decided to call from the firm the complete technical details as per Appendix 33. The<br>case was deferred for 10.12.2014<br>Case No.:161/3/82- ] Party Name: UNIMAX Meet No/Date:10/82- Status:Deffered<br>| |ALC4/2014 CHEMICALS PVT LTD. ALC4/2014 and Re-indexed<br>. ; 12.11.2014<br>96 |HQ File RLA File Lic.No/Date:0310771527 |Defer<br>01/82/050/00165/AM15/ —|:03/95/040/00889/AM14/ [24.02.2014 [Date:10.12.2014<br>| |Decision : It was decided to defer the case for 10.12.2014 for comments of Department of<br>Pharmaceuticals.<br>[7 [Case No.:30/6/82- “(Party Name:AARTI Meet No/Date:10/82- (Status:<br>ALC4/2014 INDUSTRIES LIMITED ALC4/2014 Approved<br>12.11.2014<br>HQ:01/82/050/00432/AM15/File RLA:03/94/040/009File 12/AM14/ Lic.No/Date:0325.02.2014 10771896 |Defer Date:<br>Decision : In the light of written comments received from Department of Chemicals and<br>Petrochemicals vide their U.O No. 14010/137/2011-Ch. || dated 13.11.2014, it was decided to<br>97 |ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm,<br>| {whichever is less:<br>|<br>|<br>[export product Fae, | SIN. Import items Qty. allowed<br>| 2,4 DICHLORO ANILINE Qty.1kg META DICHLORO 1.055 kg<br>BENZENE . .<br>—= - -<br>RA may take appropriate action as per the decision of Norms Committee. Preiss Sra /WiRMAL KUMAR<br>Dy. Director GeneralFer ae eau<br>fae earae es tery<br>Oirectorate Generis: 5 weit 2<br>aaferse Prune: 68 Commence<br>~ 2 9 a Uayoy) Etna wa Ry So<br>----- End of picture text -----<br>

SN aaa

|

||-.<br>;<br>:10/82-<br>Status:Deffered &<br>CaseNo.:233/3/82-<br>PartyName:CADILA<br>MeetNo/Date:10/8<br>,<br>1ALC4/2014<br>HEALTHCARELTD.,<br>ALC4/2014<br>andRe-indexed<br>12.11.2014|
|---|---|
|||98HQFile<br>IRLAFile<br>Lic.No/Date:0810129185 [Defer<br>.01/82/050/00237/AM15/<br>_|:08/24/040/00526/AM14/<br>Pep<br>|<br>Pet e-122014<br>{Decision :Itwasdecidedtodefer thecasefor10.12.2014forcommentsofDepartmentof<br>; Pharmaceuticals.|
||CaseNo.:14/3/82-<br>PartyName:RACHEM<br>MeetNo/Date:10/82-<br>—'|Status:<br>ALC4/2014<br>PHARMALIMITED<br>ALC4/2014<br>Approved<br>12.11.2014|
||HQFile<br>RLAFile<br>Lic.No/Date:0910059417 |DeferDate:<br>:01/82/050/00018/AM15/<br>-09/24/040/00589/AM14/<br>25.02.2014<br>Decision :In thelightof writtencommentsreceivedfromDepartmentofPharmaceuticals<br>vide theirOM No. 35011/270/2014-PI(Norms) dated 30.10.2014, and it was decided to<br>ratify norms under Para 4.7 of HBP vi as per details given below or as applied by the firm,|
||whicheverisless:|

==> picture [452 x 140] intentionally omitted <==

----- Start of picture text -----<br> | Quanti Allowed ke/kg<br>RACTOPAMINE HCL 1 kg | 4-(4-HydroxyButanone Phenyl) -2-<br>4-Hyd toph<br>3. [Methanol«(287ydroxyactophenone | the process<br>Ethy! Acetate<br>| [6 _|Acetone (22<br>----- End of picture text -----<br>

| RA may take appropriate action as per the decision of Norms Committee.

Case No.:129/3/82Party Name:HETERO LABS |Meet No/Date:10/82Status:Deffered ALC4/2014 LIMITED ALC4/2014 and Re-indexed 12.11.2014 100 HQ:01/82/050/00133/AM15/ File RLA:09/24/040/00605/AM14/ File Lic,26.02.2014No/Date:0910059425 DetDate:10.12.2014 Decision : It was decided to defer the case for 10.12.2014 for comments of Department | jof Pharmaceuticals.

_ Case No.:7/3/82-ALC4/2014 [Party Name:MYLAN. Meet No/Date:10/82; LABORATORIES LIMITED |ALC4/2014 and Re-indexed 12.11.2014 | - Status:Deffered .No/Date:09100; 59427 |Def 101 HOF:01/82/050/00011/AM15/Oo VAMIS) RLA—_|:09/24/040/00604/AM14/ File r _——'[26.02.2014iene1 91005907n Pete————10.12.2014 Decision °: It was decided to defer the case ftor 10.12.2014 for comments of Departmentartm \ ofPharmaceuticals. . . . rie garcia a sé Né-/5/9/82-ALC4/2014 [Party Name:INDO PHYTO [Meet No/Date:10/82- [Status:Deffered Dy. Director Ge: - Directorate Geis - : —— Udyog Bhawan. New bot

|

==> picture [460 x 451] intentionally omitted <==

----- Start of picture text -----<br> fo HEMICALS PVTLTD ——[ALC4/2014 and Re-indexed<br>HOF . ; [12.11.2014<br>: me |RLA; File Lic.No/Date-05 10380433 h a<br>—DOOOOS/AMIS/ (05/23/040/00494/AMI4/ 27.02.2014. °0510380433 Pet[Def e r raa014<br>ecision : It was decided to defer the case for 10.12.201 fi epartment<br>Jof Pharmaceuticals, 12.2014 for comments of Department<br>Case No.118/6/82- [Party Name:SPECTRUM [Meet No/Date:1078 Defi<br>ALC4/2014 . :10/82- Status:Deffered<br>LIFE SCIENCES PRIVATE ALC4/2014 land Re-indexed<br>103 LIMITED 12.11.2014 |<br>:01/82/050/00520/AM15/|HQ File [RLA:04/24/040/002 Fe colaamia 14/AM14/ 27.02.2014Lr a OTO158675 PeDa te :10.r 12.2014—<br>Decision : It was decided to defer the case for 10.12.2014 for comments of Department<br>of Pharmaceuticals.<br>Case No.:162/3/82- |Party Name:ZIM Meet No/Date:10/82- Status:Deffered<br>ALC4/2014 LABORATORIES LTD. ALC4/2014 and Re-indexed<br>104 |JHQ File RLA File Lic.No/Date:0312.11.2014 10772330 |Defer .<br>:01/82/050/00166/AM1 i/ :03/95/040/00967/AM14/ ‘27.02.2014 Date: 10.12.2014<br>| Decision : It was decided to defer the case for 10.12.2014 for comments ofDepartment<br> |of Pharmaceuticals.<br>, Case No.:58/6/82-ALC4/2014 Party Name:BAYER Meet No/Date:10/82- Status: Deffered<br>|CROPSCIENCE LIMITED |ALC4/2014 and Re-indexed<br>105 [HQ File RLA File| Lic.No/Date:0312.11.2014 10772503 [Defer| ;)<br>01/82/050/00460/AM15/ ——|:03/94/040/00797/AM14/ —‘|28.02.2014 Date:10.12.2014<br>Decision : It was decided to defer the case for 10.12.2014 for comments ofDepartment<br> lof Pharmaceuticals. _ .<br>----- End of picture text -----<br>

• | [Case No.:79/3/82-ALC42014 Party Name:GLAND Meet No/Date:10/82—_|Status:Deffered. (PHARMA LIMITED JALC4/2014 and Re-indexed 12.11.2014

• 106 |HQ:01/82/050/00083/AM15/ File IRLA:09/24/040/00610/AM14/ File 28.02.2014Lic.No/Date:09 10059455 PeteDate:10.12.2014 Decision : It was decided to defer the case for 10.12.2014 for comments of Department

• __ jof Pharmaceuticals. .

==> picture [516 x 163] intentionally omitted <==

----- Start of picture text -----<br> Case No.:106/3/82- 7 Party Name:PERFECT Meet No/Date: 10/82- Status:Deffered<br>ALC4/2014 VITAMINS PVT.LTD. ALC4/2014 and Re-indexed<br>12.11.2014<br>107 [HQ:01/82/050/00110/AM15/ File —|:03/95/040/00960/AM14/RLA File ——[28.02.2014Lic NorDat:0310772411 etDef e r10.12.2014oo<br>of Pharmaceuticals.<br>| |Decision : It was decided to defer the case for 10.12.2014 for comments ofDepartment atIAMMAR<br>— 3 } ~ fae Carels! toe °<br>Dig FTO PST foe, a<br>anion eit wad. a4 ow vel<br>Udyog Bhaw2<br>----- End of picture text -----<br>

ae

|2|.<br>:<br>/Date:10/82-<br>Status:Deffered<br>Case<br>No.:184/3/82-<br>PartyName:ARUDAAVIS<br>(MeetNo<br>‘<br>ALCA/2014<br>LABSPRIVATELIMITED jALC4/2**01**4<br>andRe-indexed<br>12.11.2<br>4<br>.|&|
|---|---|---|
|1081|HO File<br>RLAFile<br>Lic.No/Date:0410155776Defer<br>1782/080/00188/AMIS/<br>:04/24/040/00266/AM14/<br>03.03.2014<br>Pet o12201<br>Decision ; Itwasdecidedtodeferthecasefor10.12.2014forcommentsofDepartment||
||lofPharmaceuticals||
|__|||
||CaseNo.:228/3/82-<br>PartyName:GOPINATH<br>MeetNo/Date:10/82-<br>Status:<br>ALC4/2014<br>CHEM-TECHLTD.,<br>ALC4/2014<br>Approved<br>12.11.2014||
||HQFile<br>RLAFile<br>Lic.No/Date:0810129315 |DeferDate:<br>:01/82/050/00232/AM15/<br>:08/24/040/00521/AM14/<br>03.03.2014<br>Decision<br>: in the light of written comments received from Department of Chemicals and<br>Petrochemicals vide their U.O No. 14010/30/2014-Ch. Il dated 14.11.2014, it was decided to||
||ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm,||
||whicheverisless:||

|109<br>|<br>|] <br>|<br>|||Exportproduct<br> 4,4DIAMINOSULFANILIDE(DASA)|Export | S.No. |Importitems<br>Quantity<br>PARA<br>ikg<br>PHENYLENEDIAMINE<br>PPD|Quantity<br>Allowed<br>0.620kg<br>Oa6tkg|
|---|---|---|---|---|
|||||||0304kg|

RA may take appropriate action as per the decision of Norms Committee.

Case No.:122/3/82Party Name:NANDU Meet No/Date:10/82Status:Deffered ALC4/2014 CHEMICAL INDUSTRIES _ |ALC4/2014 and Re-indexed 12.11.2014 - \110 [HQ File RLA File Lic.No/Date:0710102530 [Defer ! :01/82/050/00126/AM15/ :07/24/040/00408/AM14/ 03.03.2014 Date: 10.12.2014 | |Decision : It was decided to defer the case for 10.12.2014 for comments of Department jof PC&PC

| (— [Case No.:25/3/82-ALC4/2014 [Party Name:CATAPHARMA [Meet No/Date:10/82(Status: ; CHEMICALS PVT. LTD., ALC4/2014 Rejected 12.11.2014 , sree: :01/82/050/00029/AM15/ :31/83/040/00207/AM 14/ 04.03.2014 | 111 lee File RLA File ie NoyDate31 10062928 Pes Date: Decision : It was decided to reject the case as the firm has not furnished information despite repeated reminders. 112 |ALC4/2014 PHARMACEUTICALS: LTD. |ALC4/2014 : a Status:De!snd Ra indered \vPris gare Case :No.:119/6/82Pn Name:EMCURE Meet12.11.2014No/Date:10/82-— OY egector Gone: alc . .

Udyog Bhawan, Woe:

==> picture [516 x 772] intentionally omitted <==

----- Start of picture text -----<br> HQ File —— a<br>. RLA File : ~~ = <br>Deasecision AMIS/ __[31/83/040/00235/AM14/ 10032014" enn Date:10<br>lof : It was decided to defer the case for 10.12.2014; eee<br>Pharmaceuticals ¢ case for 10.12.2014 for comments of Department<br>ase No.:3/3/82-ALC4/2014 [Party Name-SHASUN Meet No/Date:10/82- |Status:<br>PHARMACEUTICALS ALC4/2014 tus:<br>LIMITED Rejected<br>113 12.11.2014<br>* Date:<br>nHQecision Fil e a 5/ RLA:04/24/040/00258/AM14/ File Lic.No/Date:041015607111.03.2014. ie: 190078 |[Defer+ Date:.<br>| [despite: repeated: It was reminders decided to reject the case as the€ fi3firm has not furnishedi informationi :<br>Case No.:6/3/82-ALC4/2014 _ [Party Name:SHASUN Meet No/Date:10/82- (Status:<br>PHARMACEUTICALS ALC4/2014 Rejected<br>{LIMITED 12.11.2014<br>:01/82/050/00010/AM15/ . : 76 |Defer Date:<br> [:04/24/040/00257/AM14/ 11.03.2014<br>1114 |HQ File Ra File ie No/Date:04101560 | a<br>Decision : It was decided to reject the case as the firm has not furnished information<br>despite repeated reminders.<br>Case No.:62/3/82- |Party Name:SHASUN Meet No/Date: 10/82- Status: Rejected<br>ALC4/2014 PHARMACEUTICALS ALC4/2014<br>1115 |HQ File LIMITEDRLA File Lic.No/Date:041015607712.11.2014 |Defer Date: .<br>:01/82/050/00066/AM15/ ——|:04/24/040/00259/AM14/ ——{11.03.2014<br>Decision : It was decided to reject the case as the firm has not furnished information<br>despite repeated reminders.<br>[~ [Case No.:45/10/82- ‘|Party Name:AUROBINDO [Meet No/Date:10/82- _ [Status:Deffered<br>ALC4/2014 PHARMA LIMITED ALC4/2014 and Re-indexed<br>| 12.11.2014<br>116 |HQ File RLA File Lic.No/Date:09 10059555 |Defer<br>:01/82/050/00959/AM15/ __|:09/24/040/00619/AM14/ |13.03.2014 - [Date:10.12.2014<br>Decision : It was decided to defer the case for 10.12.2014 for comments of Department<br>of Pharmaceuticals ; .<br>Case No.:33/10/82-~~~—‘[Party Name:SMILAX Meet No/Date:10/82- __|Status:Deffered<br>ALC4/2014 LABORATORIES LIMITED |ALC4/2014 and Re-indexed<br>12.11.2014<br>117 |HQ File RLA File Lic.No/Date:09 10059557 Pete<br>Decision : It was decided to defer the case for 10.12.2014 for comments of Department<br>| of Pharmaceuticals oo <br>~ [Case No.:231/3/82- ~—~—[Party Name:SWISS ~ [Meet No/Date:10/82- __[Status:<br>118|ALC4/2014 EXPORTS PVT. LTD. ALC4/2014 Approved<br>12.11.2014<br>- | _ 34mar<br>— x4 S£ — Dy. Dieter ee wet me<br>Directorate Genera © , 2<br>. Ddayeg Bhawer. ‘<br>----- End of picture text -----<br>

&

t

. F Li ‘No/Date:08 10129646 Defer Date: HQ File Re 11040/00537/AM14I 13.03.2014 -01/82/050/00235/AM15/ :08/24/040/0053 4! wa a ten n comments Decision : Committee considered the case as per agenda and in light of 5/2014 oi(Norms) received from Department of Pharmaceuticals vide their OM No. 3501/23 ae decided to | ldated 30.10.2014 and in consultation with technical authority present in ne hi never is ratify norms under para 4.7 of HBP as per details given below or as applied by firm whic lower:. Allowed | conmons Teg [Sm [mores [et re enestensClavulanate 300.90 mg/625 | Amoxicillin and Diluted IP with mg tablet | Clavulanate Potassium | 1 kg mu € wi Tablet USP 625 mg Microcrystalline Cellulose (1:1)

RA concerned may take further necessary action as per above decision of NC.

==> picture [453 x 102] intentionally omitted <==

----- Start of picture text -----<br>

||||||||
|---|---|---|---|---|---|---|
|Case No.:27/10/82-|Party Name:SHREEGEN|Meet No/Date: 10/82-|Status:Deffered|
|ALC4/2014|PHARMA LTD|ALC4/2014|and Re-indexed|
|12.11.2014|
|119||HQ File|RLA File|Lic.No/Date:09 10059561||Defer|
|||:01/82/050/0094 1/AM15/|:09/24/040/00637/AM14/|{14.03.2014|Date:10.12.2014|
|||—||Decision|:|It was decided|to defer the case for|10.12.2014 for comments of Department|
|jof Pharmaceuticals|

----- End of picture text -----<br>

==> picture [482 x 337] intentionally omitted <==

----- Start of picture text -----<br> Case No.:179/6/82- Party Name:BEST VALUE [Meet No/Date:10/82- Status:<br>ALC4/2014 CHEM PVT. LTD. ALC4/2014 Approved<br>12.11.2014<br>HQ File RLA File Lic.No/Date:3410039577 |Defer Date:<br>: :01/82/050/00581/AM15/ :34/24/040/00308/AM14/ 18.03.2014<br>| Decision : In the fight of written comments received from Department of Chemicals and<br>Petrochemicals vide their U.O No. 14010/58/2011-Ch. || dated 15.09.2014, it was decided to<br>ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm,<br>whichever is less:<br>| 120<br>Allowed<br>: | Hexyl Salicylate n-Hexanol (Loro! C 6/Nacol 6- | 0.510kg<br>! Ikg 99)<br>Salicylic Acid 0.682 kg<br>!<br>RA may take appropriate action as perthe decision of Norms Committee. a<br>Preis WAR! NR re<br>Dy. Director General me a iq<br>a "$ y ~ piktorte Cu ede<br>aera func nese<br>Udyog ths vues, yw Deihi<br>----- End of picture text -----<br>

|CaseNo.:57/3/82.<br>"<br>—<br>arty Name:JUBIL<br>,<br>ALC42014<br>SCIENCESLiMiTED “EEALCanoIgOS<br>tatus:Deltered<br>LC4/2014<br>andRe-indexed<br>=<br>-<br>.<br>12.11.2014||
|---|---|
|:01/<br>|.<br>Ic.<br>ate:05 10.<br>O182/050/00061/AM15/<br>‘05/23/040/00S06/AM14/<br>—_!18.93.20<br>382053 Defer<br>oe<br>chibi<br>14<br>Date: 10.12.2014<br>Decision : Itwasdecidedtodeferthecasefor10.12.<br>oe<br>of<br>Pharmaceuticals<br>‘4.2014forcommentsofDepartment||
|CaseNo.:180/6/82-<br>Party<br>Name:<br>—<br>—_-<br>ALC4/2014<br>,<br>.CHEMPVE beyVALUE<br>{MeetNo/Date:10/82-<br>{Status:Deffered<br>.<br>.<br>ALC4/**20**14<br>jandRe-indexed<br>one<br>——<br>12.11.<br>14<br>122<br>HHOFile oseag<br>RLAFile<br>Lic.N.<br>*<br>;<br>-**No**/D**ate**:3**4**1003**9601** [Def<br>-<br>a<br>OnSBIAM15/<br>:34/24/040/00298/AM14/<br>ie<br>D<br>3 1003<br>Date:10.12.2014<br>ecision<br>:<br>i<br>J<br>ofCaMa Itwasdecidedtodeferthecasefor10.12.2014 forcommentsofDepartment||
|CaseNo.:38/6/82-<br>Name:CROWN<br>[MeetNo/Date:10/82-<br>[gi<br>,<br>:<br>-<br>Status:Deffered<br>ALC4/2014<br>{CHEMICALSPVT.LTD.,<br>|ALC42014<br>andRe-indexed<br>.<br>12.11.2014<br>123<br>[HQFile<br>IRLAFile<br>Lic.No/Date:0310775042Pete<br>~<br>‘O1/82/0S0/00440/AM15/<br>_|:03/94/040/01135/AM14/{19.03.2014<br>[Date:10,12.2014<br>Decision : Itwasdecidedtodeferthecasefor10.12.2014forcommentsofDepartment<br>ofC&PC.||
|[<br>[CaseNo.:55/10/82-<br>PartyName:SATYA<br>MeetNo/Date:10/82-<br>[Status:Deffercd<br>’<br>ALC4/2014<br>||DEEPTHA<br>ALC4/2014<br>andRe-indexed<br>_..PHARMACEUTICALSLTD [12.11.2014<br>_<br>124 JHQFile<br>IRLAFile<br>Lic.No/Date:0910059590 [Defer<br>*01/82/050/00969/AM15/<br>_|:09/24/040/00645/AM14/_[19.03.2014<br>___<br>[Date:10.12.2014<br>Decision<br>: Itwasdecidedtodeferthecasefor 10.12.2014forcommentsofDepartment<br>jofPharmaceuticals||
|~||
|[CaseNo.:45/24/82-<br>[PartyName-VIVIMEDLABS[Meet NoDaie10/483-<br>Status:Deffered<br>ALC4/2013<br>(ALATHUR)PRIVATE<br>IALC4/2014<br>landRe-indexed<br>LIMITED<br>12.11.2014||
|125 |HQFile<br>RLA File<br>Lic.No/Date:0410156358 |Defer<br>‘:01/82/050/01244/AM14/<br>:04/24/040/00264/AM14/<br>_<br>{19.03.2014<br>et10.12.2014||
|Decision : Itwasdecidedtodeferthecasefor 10.12.2014 forcommentsofDepartment<br>ofC&PC.||
||||
|[EaseNo.:13/10/82-<br>[PartyName:BRUNDAVAN<br>[MeetNo/Date:10/82.[Stams:Defferca<br>ALC4/2014<br>LABORATORIES PRIVATE jALC4/2014<br>andRe-indexed<br>LTD.,<br>12.11.2014||
|HO<br>File<br>RLAFile<br>Lic.No/Date:0910059593 Defer<br>126Oi 00927/AMIS)<br>RF<br>0064VAM<br>Pen<br>ef<br>122014||
||<br>|Decision : Itwas decidedto deferthecase for 10.12.2014 forcommentsofDepartment||
|;<br>ofPharmaceuticals||
|.<br>=<br>:||
|L|KUMAR|
|Dy.Oe "||
|Sa Wa,<br>-is||
|UdyogBhawan,Newwin||

==> picture [1 x 2] intentionally omitted <==

----- Start of picture text -----<br> |<br>----- End of picture text -----<br>

&

|

° . No/Date: 10/82Status: Deffered Case No.:123/3/82|Party Name:JUBILANT LIFE |Meet | |aLca2014 SCIENCES LIMITED ALC4/201412.11.2014 and Re-indexed ‘ i -0510382292 |Defer 7. HQ File RLA File Lic.No/Date 127 |.91/82/050/00127/AM15/ -05/23/040/00508/AM14/ Livos 014 Pet o22014 Decision : It was decided to call from the firm copy of Drug Manufacturing Licence alongwith list ofapproved items), and copy ofMaster Batch Formula duly authenticated by Quality Control Incharge. The case was deferred for 26.11.2014. [Ease No.:133/8/82Party NameMETROCHEM [Meet No/Date:10/82Status: ALC4/2014 API PVT. LTD. ALC4/201412.11.2014 Approved HQ File RLA File Lic.No/Date:09 10059597 Pete Date: -01/82/050/00797/AM15/ -09/24/040/00636/AM14/ — 21.03.2014 | Decision : Committee considered the case as per agenda and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details given below or as applied by firm whichever is lower:|r= sere ie | Qty. Kge/kg | ORLISTAT PELLETS 50% | 1 kg a TorustaT ss SSSSC*i OS HYDROXY PROPYL METHYL 0.130 CELLULOSE (HPMC-ES)

RA concerned may take further necessary action as per above decision of NC.

Case No.:181/6/82Party Name:BEST. VALUE {Meet No/Date:10/8:10/82Status: Deffered ALC4/2 12.11.2014 feta CHEM PVT. LTD. ALC4/2014 and Re-indexed . te:34 10039647 |Defer . } 129FoF cosmamisr SEA CMoosvAMIA cNorDaw oeofecisionC&PC.neon: It was degdecided to:34/24/040/00299/AMdefer the case for14/10.12.2014i25.03.2014for comments ofDepartmentDate:10.12.2014 Case No.:81/5/82[Pai ALC4/2014 Party Name:KOPRAN MeetALC4/2014 No/Date:10/82—|Status:Defferand Re-index ed 12.11.2014 AO Fi Lic.No/Date:03 10775960 Defe: .:01/82/0 . — 130FoF cooweamns; Roary teoaMia — —ecision Sons: It BAMwas decided5/ __ |:03/94/040/01160/AM14/to defer the case for 10.12.2014—_|26.03.2014for comments of DepartmentDate-10 12.2014 of Pharmaceuticals Case No.:82/5/82P. : 2 D ALC4/2014 and Re-indexed 131 ALC42014 Pa ame: KOPRAN Meet No/Date:10/82- — |Status:Deffered 12.11.2014 ; lHQFile[RLAFie Lic.No/Date:03 10775954 [Defer L KU wa x a) — %[b] Dy. Directorbiteante GeneralGer[eral][ of] of[ ahha] Foreign arftsa {PTUDepartmentcf Cor eeu BAA ag 1aee Udyoy Bhawan, New ©

|

==> picture [457 x 54] intentionally omitted <==

----- Start of picture text -----<br> “ [:01/82/050/00399/AM15/ [:03/94/040/01 152/AM14/ 26.03.2014 (Date: 10.12.2014<br>Decision : It was decided to defer the case for 10.12.2014 for comments of Department<br>of Pharmaceuticals<br>----- End of picture text -----<br>

| | |

• Case No.:57/10/82Party Name:AUROBINDO __ [Meet No/Date:10/82Status: Deffered ALC4/2014 PHARMA LIMITED ALC4/2014 and Re-indexed 12.11.2014 ;

• 132 [HQ File RLA File Lic.No/Date:09 10059640 [Defer :01/82/050/0097 1/AM15/ :09/24/040/00628/AM14/ 27.03.2014 Date:10.12.2014 Decision : It was decided to defer the case for 10.12.2014 for comments of Department of Pharmaceuticals Case No.:51/5/82Party Name:JINDAL DRUGS {Meet No/Date:10/82Status:Deffered ALC4/2014 LIMITED ALC4/2014 and Re-indexed 12.11.2014

• 133 [HQ File RLA File Lic.No/Date:03 10776087 [Defer :01/82/050/00368/AM15/ :03/94/040/01098/AM14/ 27.03.2014 Date:10.12.2014

Decision : It was decided to defer the case for 10.12.2014 for comments of Department of Pharmaceuticals

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----- Start of picture text -----<br>

|||||||
|---|---|---|---|---|---|
|Case|No.:48/5/82-|Party Name:KOPRAN|Meet No/Date: 10/82-|Status: Deffered|
|ALC4/2014|LIMITED|ALC4/2014|land Re-indexed|
|12.11.2014|
|134|{HQ File|RLA File|Lic.No/Date:03|10776170||Defer|
|:01/82/050/00365/AM15/|:03/94/040/01168/AM14/|27.03.2014|Date:10.12.2014|

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|||||||
|---|---|---|---|---|---|
|Case No.:110/6/82-|Party Name:NEULAND|Meet No/Date:10/82-|Status:|Deffered|
|ALC4/2014|LABORATORIES LTD|ALC4/2014|and Re-indexed|
|12.11.2014|
|135|[HQ File|RLA|File|Lic.No/Date:09 10059642|[Defer|
|:01/82/050/00512/AM15/|:09/24/040/00606/AM|14/|27.03.2014|Date: 10.12.2014|

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|||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
|Case|No.:35/8/82-|Party Name:SATYA|Meet|No/Date: 10/82-|Status:Deffered|
|ALC4/2014|DEEPTHA|ALC4/2014|and|Re-indexed|
|PHARMACEUTICALS|LTD|[12.11.2014|
|136|(File|RLA File|Lic.No/Date:0910059643|[Defer|
|:01/82/050/00699/AM15/|:09/24/040/00639/AM14/|27.03.2014|Date: 10.12.2014|
|Decision|:|It was|decided|to|defer the|case|for|10.12.2014|for comments|of Department|of Pharmaceuticals|

----- End of picture text -----<br>

Case No.:56/10/82Party Name:SATYA Meet No/Date: 10/82Status: Approved ALC4/2014 DEEPTHA ALC4/2014 137 PHARMACEUTICALS LTD }12.11.2014 HQ File RLA File Lic.No/Date:09 10059648 |Defer :01/82/050/00970/AM 15/ :09/24/040/00665/AM14/ 27.03.2014 Bare /NIRMAL KUMAR — , Dy. Director _ Digits ton : _ Ss 7 aifiisa Pure, : SUN Wei, - Udyog Bhawan), isso weil

Decision : Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 3501 1/238/2014-PI(Norms) dated 10.10.2014 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is

|||dated 10.10.2014 and in consultation <br>ratifynormsunderpara4.7of HBPHBP|with technical authority present in meeting,<br>asperdetailsbeloworasappliedbyfirm|meeting, decided to<br>whicheveris|
|---|---|---|---|---|
|||ratify norms under para 4.7 of HBPHBP <br>lower:-|as per details below or as applied by firm|whichever is|
|||Exportproduct|Exp.<br>Qty.|Qty.<br>Allowed|
||:|(1S,4R)-4-[(2-AMINO-6-CHLORO-<br>5-FORMAMIDO-4-<br>PYRIMIDINYL)AMINO]-2-CYCLO<br>PENTENE-1-METHANOL|N-(2-AMINO-4,6-<br>DICHLORO-5-<br>PYRIMIDINYL)<br>aE<br>AZABICYCLO[2.2.1JHEPT-<br>5-EN-3-|Kg/ka<br>0.764|
||||ONE(VINCELACTAM<br>|3_|D@TARTARICACID<br>|4__| SODIUMBOROHYDRIDE<br>15__| ISOPROPYLALCOHOL||0.226|
|||||L(+)TARTARICACID|11.23||

RA concerned may take further necessary action as per above decision of NC.

• Case No.:40/10/82Party Name:COVALENT Meet No/Date:10/82Status:Deffered ALC4/2014 LABORATORIES PRIVATE |ALC4/2014 and Re-indexed LIMITED 12.11.2014

• 138 [HQ File RLA File Lic.No/Date:0910059680 |Defer :01/82/050/00954/AM15/ :09/24/040/00661/AM14/ 28.03.2014 Date: 10.12.2014 Decision : It was decided to defer the case for 10.12.2014 for comments of Department of Pharmaceuticals . . -

||||CaseNo.:112/6/82-<br>ALC4/2014|PartyName:DIVIS<br>LABORATORIESLTD.,|MeetNo/Date:10/82-<br>Status:Deffered<br>ALC4/2014<br>andRe-indexed|
|---|---|---|---|---|
|||.||12.11.2014|
||139||HQFile<br>:01/82/050/00514/AM15/<br>Decision : Itwasdecidedto<br>ofPharmaceuticals|RLAFile<br>Lic.No/Date:0910059678 |Defer<br>:09/24/040/00658/AM14/<br>28.03.2014<br>Date:10.12.2014<br>todefer thecasefor 10.12.2014forcommentsofDepartment||

==> picture [503 x 203] intentionally omitted <==

----- Start of picture text -----<br> [Case No.:44/5/82- Party Name:KOPRAN Meet No/Date:10/82- |Status:Deffered<br>ALC4/2014 LIMITED ALC4/2014 and Re-indexed<br>; 12.11.2014<br>140 [HQ File RLA File Lic.No/Date:03 10776372 |Defer<br>:01/82/050/00361/AM15/ 7 :03/94/040/01157/AM14/ 28.03.2014 Date:10.12.2014<br>|<br>|Decision : It was decided to defer the case for 10.12.2014 for comments of Department<br>| _ of Pharmaceuticals . .<br>.<br>141 ALC4/2014[C88e No.:47/5/82- LIMITEDParty Name:KOPRAN _ (Meet No/Date:10/82- (Status: Delfexea .th.<br>_|ALC4/2014 and a A a<br>arGreutot Guneal ee. ae ee “418<br>nr ry. UN wus ri TBS rca<br>fae v cp ee ot Co :<br>aul ‘gnawan .<br>wayod<br>----- End of picture text -----<br>

a

| | | | |

==> picture [447 x 387] intentionally omitted <==

----- Start of picture text -----<br> | ) | | 12.11.2014 [<br>HQ File RLA File Lic.No/Date:03 10776351 :|Defer<br>:01/82/050/00364/AM15/ |:03/94/040/01169/AM14/ [28.03.2014 _ (Date: 10.12.2014<br>Decision : It was decided to defer the case for 10.12.2014 for comments of Department<br>_ jof Pharmaceuticals ; oo a<br>Case No.:129/6/82- Party Name:KLJ Meet No/Date:10/82- (Status:<br>ALC4/2014 PLASTICIZERS LTD., ALC4/2014 Approved<br>12.11.2014 fe<br>HQ File RLA File Lic.No/Date:05 10383276.|Defer Date:<br>:01/82/050/0053 1/AM15/ :05/23/040/00554/AM 14/ 01.04.2014 = ;<br>Decision:: In the the light of written comments received from of written comments received from written comments received from comments received from received from from Department of Chemicals and Petrochemicals of Chemicals and Petrochemicals Chemicals and Petrochemicals and Petrochemicals Petrochemicals<br>vide their U.O No. 14010/36/2011/Ch Il dated 14.11.2014, it was was decided to ratify norms under Para<br>of HBP v1 HBP v1 v1 as per details given details given given below or as applied by the firm, whichever the firm, whichever firm, whichever whichever is less:<br>142 Export Product S.No | Import Product Quantity<br>Qua Allowed<br>KANATOL<br>BUTYL PHTHALATE)- 400 (DI-ISO/N- a ANHYDRIDEPHTHALIC 0.560 kg<br>(PACKED IN 2,554 NOS. OF 2. ISO / NORMAL 0.560 kg<br>HM-HDPE DRUMS MADE OF BUTANOL<br>GRADE)E BLOWING 3. | HM-HDPE DRUMS as ber packing<br>MADE OF HM-HDPE policy<br>BLOWING GRADE<br>(TOTAL NO. OF DRUMS<br>= 2,554 NOS.)<br>RA may take appropriate action.as per the decision of Norms Committee.<br>----- End of picture text -----<br>

Decision:: In the the light of written comments received from of written comments received from written comments received from comments received from received from from Department of Chemicals and Petrochemicals of Chemicals and Petrochemicals Chemicals and Petrochemicals and Petrochemicals Petrochemicals vide their U.O No. 14010/36/2011/Ch Il dated 14.11.2014, it was was decided to ratify norms under Para 4.7 of HBP v1 HBP v1 v1 as per details given details given given below or as applied by the firm, whichever the firm, whichever firm, whichever whichever is less:

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----- Start of picture text -----<br> ” [Case No.:8/10/82-ALC4/2014 [Party Name:SATYADEVA [Meet No/Date:10/82- (Status:Deffered<br>PHARMACEUTICALS /P/ |ALC4/2014 and Re-indexed<br>. LTD., 12.11.2014<br>143 |HQ File RLA File Lic.No/Date:09 10059684 |Defer<br>:01/82/050/00922/AM15/ |:09/24/040/00651/AM14/ [01.04.2014 _ Date:10.12.2014<br>Decision : It was decided to defer the case for 10.12.2014 for comments of Department<br> of Pharmaceuticals _<br>Case No.:52/6/82- Party Name:UPL LTD. Meet No/Date:10/82- _ |Status:Deffered<br>ALC4/2014 ALC4/2014 and Re-indexed<br>12.11.2014 .<br>144 |HQ File RLA File Lic.No/Date:03 10776594 |Defer<br>:01/82/050/00454/AM15/ :03/95/040/01043/AM14/ 01.04.2014 Date:10.12.2014<br>Decision : It was decided to defer the case for 10.12.2014 for comments of Department<br>of Pharmaceuticals<br>. a<br>Case No.:73/5/82- Party Meet No/Date: 10/82- Status:Deffered<br>ALC4/2014 IName:ARIHANTANAM ALC4/2014 and Re-indexed<br>145 LIFECARE PVT. LTD. 12.11.2014 .<br>HQ File RLA File Lic.No/Date:03 10776770 |Defer<br>:01/82/050/00390/AM15/ _|:03/94/040/01189/AM14/ _|02.04.2014 A012,2014 1 be MY<br>----- End of picture text -----<br>

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----- Start of picture text -----<br> Decision : It was decided to defer the case for 10.12.2014 for comments of Department<br>of Pharmaceuticals 7<br>Case No.:130/6/82- Party Name:MOREPEN [Meet No/Date:10/82- (Status:<br>ALC4/2014 LABORATORIES LTD., ALC4/2014 Approved<br>12.11.2014<br>HQ| File RLA File \Lic.No/Date:05 10383452 |Defer Date:<br>:0 1/82/050/00532/AM15/ :05/24/040/00495/AM14/ 02.04.2014<br>Decision : Committee considered the case as per agenda and in light of written comments<br>received from Department of Pharmaceuticals vide their OM No. 35011/183/2014-PI(Norms)<br>dated 12.11.2014 and in consultation with technical authority present in meeting, decided to<br>ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is<br>lower:-<br>| Export product Exp. Import items Qty.<br>146| Qty. AllowedKg/kg<br>| Rosuvastatin Calcium Tert-butyl-2-((4R,6S)-6-((E)-2-(4 (- 1.425<br>(4-fluorophenyl)-6-isopropyl-2-[N-<br>methyl (methylsulphony!) amino)<br>pyrimidin-5-yl) vinyl)-2,2-dimethy]-<br>| 1.3-dioxane-4-yl) acetate<br>Er<br>Tert-butyl methyl ether (MTBE)<br>----- End of picture text -----<br>

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----- Start of picture text -----<br> RA concerned may take further necessary action as per above decision of NC.<br>----- End of picture text -----<br>

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----- Start of picture text -----<br> Case No.:47/10/82- Party Name:MYLAN [Meet No/Date:10/82- _[Status:Deffered<br>ALC4/2014 LABORATORIES LIMITED |ALC4/2014 and Re-indexed<br>12.11.2014<br>147 |HQ File RLA File Lic.No/Date:09 10059694 |Defer<br>:01/82/050/00961/AM15/ :09/24/040/00638/AM14/ 02.04.2014 ; Date: 10.12.2014<br>Decision : It was decided to defer the case for 10.12.2014 for comments of Department<br>lof Pharmaceuticals .<br>----- End of picture text -----<br>

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----- Start of picture text -----<br> (Gaze No4/10/82-ALC4/2014 [Party Name:BIOLOGICAL E. [Meet No/Date:10/82- |[Status:Deffered<br>LTD ALC4/2014 and Re-indexed<br>12.11.2014<br>148 |HQ File RLA File Lic.No/Date:09 10059706 |Defer<br>:01/82/050/00918/AM15/ :09/24/040/00670/AM14/ 403.04.2014 : Date: 10.12.2014<br>Decision : It was decided to defer the case for 10.12.2014 for comments of Department<br>of Pharmaceuticals .<br>Case No.:15/10/82- PartyName:BIOLOGICAL E [Meet No/Date: 10/82- Status:Deffered<br>ALC4/2014 LTD 1ALC4/2014 and Re-indexed<br>49, - . [211.2014 . |<br>[HQ File | [RLA File [Lic.No/Date:0910059705 [Defer<br>Pia aR / NIRMAT KUMAR<br>? — oT “at (Clgna ade<br>Diets , 7 obtnmeree<br>Uc Sn, New Delhi<br>----- End of picture text -----<br>

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----- Start of picture text -----<br>

|||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
|[:01/82/050/00929/AMi5/|_||:09/24/040/00671/AM14/|[03.04.2014|~|fDate:10.12.2014|
|Decision|:|It was decided to defer the case for|10.12.2014|for comments of Department|
|of|Pharmaceuticals|.|7|.|
|Case No.:22/10/82-|Party Name:OGENE|Meet No/Date:10/82-|__(Status:Deffered|
|ALC4/2014|SYSTEMS INDIA PVT. LTD.||ALC4/2014|and|Re-indexed|
|12.11.2014|.|
|150|[HQ File|RLA|File|Lic.No/Date:09 10059697||Defer|
|:01/82/050/00936/AM15/|:09/24/040/00669/AM14/|03.04.2014|Date:10.12.2014|
||||Decision|:|It was decided|to|defer the case|for|10.12.2014|for comments of|Department|
|of|Pharmaceuticals|_|;|
|Case No.:67/5/82-|Party Name:FDC LTD|Meet No/Date:10/82-|Status:Deffered|
|ALC4/2014|ra|ALC4/2014|and Re-indexed|
|12.11.2014|
|151||HQ File|RLA|File||Lic.No/Date:03 10777658||Defer|
||||:01/82/050/00384/AM15/|—_|:03/94/040/00001/AM15/|—_|09.04.2014|Date:10.12.2014|
||||Decision|:|It was decided|to|defer the|case|for|10.12.2014|for comments|of|Department|
|of Pharmaceuticals|

----- End of picture text -----<br>

• Case No.:72/5/82Party Name:GLOBE Meet No/Date: 10/82Status:Deffered ALC4/2014 TROTTERS PVT LTD ALC4/2014 and Re-indexed . a 12.11.2014

• 1152 |HQ File RLA File Lic.No/Date:03 10777795 [Defer :01/82/050/00389/AM15/ :03/94/040/01100/AM14/ 09.04.2014 Date: 10.12.2014 Decision : It was decided to defer the case for 10.12.2014 for comments of Department of Pharmaceuticals .

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----- Start of picture text -----<br>

||||||||
|---|---|---|---|---|---|---|
|Case No.:23/6/82-|Party Name:KUDOS|Meet No/Date:10/82-|Status: Deffered|
|ALC4/2014|CHEMIE|LTD.,|ALC4/2014|and Re-indexed|
|||12.11.2014|7|
|1153|[HQ|File|RLA|File|Lic.No/Date:2210014788|{Defer|
|:01/82/050/00425/AM15/|:22/24/040/00098/AM|14/|09.04.2014|__{Date:10,12.2014|
|Decision|:|It was decided to defer the|case for|10.12.2014|for comments of Department|
|of Pharmaceuticals|
|.|.|
|Case No.:24/6/82-|Party Name:KUDOS|Meet No/Date:10/82-|__[Status:Deffered|
|ALC4/2014|CHEMIE LTD.,|ALC4/2014|jand|Re-indexed|
|12.11.2014|
|.|.|
|1154||HQ File|RLA|File|Lic.No/Date:22 10014787||Defer|
|01/82/050/00426/AM15/|—_|:22/24/040/00107/AM14/|_—‘|09.04.2014|_||Date:10.12.2014|

----- End of picture text -----<br>

‘Case No.:65/5/82Party Name:CROWN Meet No/Date: 10/82Status:Deffered 155 |ALC4/2014 CHEMICALS PVT.LTD., ALC4/2014 and Re-indexed - 12.11.2014 /NIRM AR Dy. Director * » FP oregnT - r pee i ‘ THT Vy } _ arf: M ae ; ” cen Udyog biiaiee ev Did

: |

.

HQ File RLA File Lic.No/Date:03 10777887 |Defer :01/82/050/00382/AM 1 5/ :03/94/040/00004/AM15/ 10.04.2014 Date: 10.12.2014 Decision : It was decided to defer the case for 10.12.2014 for comments of Department | [of C&PC Case No.:66/5/82Party Name:CROWN Meet No/Date: 10/82Status: Deffered ALC4/2014 CHEMICALS PVT.LTD., ALC4/2014 and Re-indexed 156 [HQ. File . {RLA File. (12.11.2014Lic.No/Date:03 10777897 |Defer :01/82/050/00383/AM15/ —_|:03/94/040/00005/AM15/ _|10.04.2014 . Date: 10.12.2014

Decision : It was decided to defer the case for 10.12.2014 for comments of Department of C&PC

Case No.:70/10/82Party Name:STERICON (Meet No/Date:10/82-[Status: ALC4/2014 PHARMA PVT.LTD., ALC4/2014 Approved HQ| File RLA File _ Lic.No/Date:07(12.11.2014 10103585 |Defer Date: :01/82/050/00984/AM15/ —|:07/24/040/00001/AM15/ _ {10.04.2014 ; Decision : Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 3501 1/766/2013-PI(Norms) dated 05.09.2014 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:-

==> picture [441 x 177] intentionally omitted <==

----- Start of picture text -----<br> 157 |Export Product<br>VIZULIZE MOISTURIZING AND COMFORT EYE DROPS<br>Import Item<br>For Export of 1 No. Bottle<br>| Export Item | Export item | Export Item<br>(| No. 1 No. 2 No. 3 Item No. 4<br>[2 SOFT BOTTLE 706007<br>[3 | wHrrecapsai70001__—_—|DROPPER W801 Relevant as per packing policy<br>[4 [soonnnvatvnonaTe<br>| 00Tgm [003 gm<br>RA concerned may take further necessary action as per above decision of NC.<br>----- End of picture text -----<br>

Case No.:1/2/82-ALC4/2014 |Party Name:CADILA Meet No/Date:10/82Status:Deffered HEALTHCARE LTD., ALC4/2014 and Re-indexed 12.11.2014 158 [HQ. File . RLA File Lic.No/Date:0810130534 [Defer :01/82/050/00003/AM15/ :08/24/040/00008/AM15/ 11.04.2014 Date: 10.12.2014 Decision : It was decided to defer the case for 10.12.2014 for comments of Department of Pharmaceuticals ' -

Case No.:32/5/82Party Name-EMCURE [Meet No/Date:10/82_[Status:Deffered 159. |ALC4/2014 PHARMACEUTICALS LTD. |ALC4/2014 and Re-indexed . 12.11.2014 pe BrectorapareGe/NIRMALeralOeFU [L][—] piemrate‘eedur carparyGeneralffeil’Ot etcon aia fart epanmen feel weil MAT, CO New Dev udyog Bhawan

| | | :

| | : | : | |

| | | | | : |

|

|

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----- Start of picture text -----<br>

||||||||
|---|---|---|---|---|---|---|
|HQ File|RLA|File|Lic.No/Date:3 110063481||Defer|
|:01/82/050/00349/AM15/|_|:31/83/040/00008/AM15/|—_—‘{11.04.2014|__|[Date:10.12.2014|
|Decision|:|It was decided to defer the case|for|10.12.2014|for comments of|Department|
|jof|Pharmaceuticals|.|a|a|_|
|Case No.:68/5/82-|Party Name:FDC|LTD|Meet No/Date: 10/82-|Status:Deffered|
|ALC4/2014|ALC4/2014|and Re-indexed|
|{12.11.2014|a|;|
|160|:01/82/050/00385/AM15/|HQ|File|RLA|File|Lic.No/Date:0310778 140||Defer|
|—_|:03/94/040/01125/AM14/_—_—‘{11.04.2014|Date:10.12.2014|
|Decision|:|It was decided to defer the case|for|10.12.2014|for comments of|Department|
|of Pharmaceuticals|

----- End of picture text -----<br>

• . '|Case No.:27/5/82Party Name:ALEMBIC Meet No/Date: 10/82Status:Deffered ALC4/2014 PHARMACEUTICALS LTD jALC4/2014 and Re-indexed

• 161 |HQ File |RLA File Lic.No/Date:34 10039801 |Defer :01/82/050/00344/AM15/ __ |:34/24/040/00006/AM15/ 15.04.2014 |Date:10.12.2014

  • Decision : It was decided to defer the case for 10.12.2014 for comments ofDepartment of Pharmaceuticals

?

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----- Start of picture text -----<br> Case No.:34/5/82- ~~ [Party Name:ALEMBIC [Meet No/Date:10/82- _|Status:Deffered<br>ALC4/2014 JPHARMACEUTICALS LTD {ALC4/2014 land Re-indexed<br>. , 12.11.2014<br>162 |HQ File RLA File Lic.No/Date:34 10039800 |Defer<br>:01/82/050/00351/AM15/ :34/24/040/00003/AM15/ 15.04.2014 Date: 10.12.2014<br>Decision : It was decided to defer the case for 10.12.2014 for comments ofDepartment<br>of Pharmaceuticals os<br>~ [Case No.:39/8/82- Party Name:MYLAN [Meet No/Date:10/82- _[Status:Deffered<br>ALC4/2014 LABORATORIES LIMITED |ALC4/2014 and Re-indexed<br>12.11.2014<br>163 [HQ File RLA File Lic.No/Date:09 10059757 [Defer<br>:0 1/82/050/00703/AM15/ :09/24/040/00009/AM1 5/ 16.04.2014 ; |Date:10.1 2.2014<br>| |Decision : It was decided to defer the case for 10.12.2014 for comments of Department<br>of Pharmaceuticals _<br>----- End of picture text -----<br>

• [~ [Case No.:30/5/82- ~ [Party Name:PRECISE Meet No/Date:10/82__[Status: ALC4/2014 CHEMIPHARMA ALC4/2014 |Approved PVT.LTD., 12.11.2014 ;

• HQ File RLA File Lic.No/Date:3 1 10063517 |Defer Date: :01/82/050/00347/AM15/ :31/83/040/00013/AM15/ 16.04.2014

• 164 |Decision : Committee considered the case as per agenda and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details given below or as applied by firm whichever is lower:-

==> picture [11 x 16] intentionally omitted <==

----- Start of picture text -----<br> ~<br>----- End of picture text -----<br>

rr

Dy. Director Gu ieral of Foreign Trad: Boi UR mnie a ichil) Trad: A’ partnieect of Commerce Udyog Bhawan, New Delhi

: | i

| | ORLISTAT PELLETS 50% ORLISTAT RA concerned may take further necessary action as per above decision of NC.

==> picture [229 x 32] intentionally omitted <==

----- Start of picture text -----<br> ORLISTAT oso<br>----- End of picture text -----<br>

Case No.:21/10/82Party Name:BIOLOGICAL E {Meet No/Date:10/82Status:Deffered ALC4/2014 LTD ALC4/2014 and Re-indexed 12.11.2014 165 |HQ_ File RLA File Lic.No/Date:0910059795 |Defer :01/82/050/00935/AM15/ :09/24/040/00678/AM14/ 21.04.2014 Date:10.12.2014 Decision : It was decided to defer the case for 10.12.2014 for comments of Department | jof Pharmaceuticals Case No.:69/5/82Party Name:FDC LTD Meet No/Date:10/82Status:Deffered ALC4/2014 ALC4/2014 and Re-indexed : 12.11.2014 . 166 |HQ| File RLA File Lic.No/Date:03 10778812 |Defer :01/82/050/00386/AM15/ —|:03/94/040/00041/AMI5/__ [21.04.2014 -[Date:10.12.2014 | [Decision : It was decided to defer the case for 10.12.2014 for comments of Department of Pharmaceuticals Case No.:31/5/82Party Name:GOPINATH Meet No/Date:10/82Status: ALC4/2014 CHEM-TECH LTD., ALC4/2014 Approved {12.11.2014 . HQoo File RLA File Lic.No/Date:0810130717 [Defer Date: :01/82/050/00348/AM15/ :08/24/040/00017/AM15/ 21.04.2014 Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/30/2014-Ch. II dated 14.11.2014, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: 167 || Export product Export Quantity |[4][ CAPS][ (4][ CHLORO][ 2][ AMINO] Quantity PHENOL Allowed1.55 kg | PHENOL 6 SULPHONIC ACID) CAUSTIC SODA LYE | 2.00 kg | (100% REAL BASIS) | ACETIC ACID 0.500 kg | 13. SODA ASH Not required in the process RA may take appropriate action as per the decision of Norms Committee. Case No.:58/10/82Party Name:AUROBINDO [Meet No/Date:10/82[Status:Deffered 168 | | 12.11.2014 ; ALC4/2014 PHARMA LIMITED ALC4/2014 and Re-indexed HQ File RLA File Lic.No/Date:09 10059797 |Defer :01/82/050/00972/AM1 5/ :09/24/040/00674/AM14/ 22.04.2014 Date:10.12.2 aly Ver wd se , Oy Cyast earns i, Cages tol ate Gene . — G Y —_— ayaa paeae -

|

.

(Case No.:78/5/82Party NameIPCA [Meet No/Date:10/82|Status:Deffered ALC4/2014 LABORATORIES LIMITED |ALC4/2014 land Re-indexed 169 }HQ File RLA File Lic.No/Date:03 10779054 |Defer :01/82/050/00395/AM15/ :03/94/040/00012/AM15/ 22.04.2014 Date: 10.12.2014 Decision : It was decided to defer the case for 10.12.2014 for comments of Department of Pharmaceuticals _ .

||CaseNo.:48/10/82-<br>ALC4/2014|[Party Name: MYLAN<br>LABORATORIESLIMITED|[Party Name: MYLAN<br>LABORATORIESLIMITED|MeetNo/Date:10/82-<br>|ALC4/2014||__(Status:Deffered<br>and Re-indexed|
|---|---|---|---|---|---|---|
|||||12.11.2014|||
||.||||||
||170:}HQ File<br>:01/82/050/00962/AM15/||RLA File<br>:09/24/040/00650/AM14/|Lic.No/Date:0910059803 <br>22.04.2014|||Defer<br>Date:10.12.2014|
||||Decision : Itwasdecidedto<br>ofPharmaceuticals<br>=||todefer thecase for 10.12.2014 forcommentsofDepartment||||
||||.|_<br>-||.<br>.|
|||7|||||
||Case No.:49/10/82-<br>ALC4/2014||PartyName:-MYLAN<br>LABORATORIES LIMITED|MeetNo/Date:10/82-<br>|ALC4/2014||Status:Deff**e**r**ed**<br>and Re-ind x|
|||||12.11.2014<br>.||.|
||171 [HQFile<br>:01/82/050/00963/AM15/||RLA File<br>—_|:09/24/040/00006/AM15/|Lic.No/Date:0910059802 <br>{22.04.2014|[Defer<br>|Date:10.12.2014||

==> picture [499 x 344] intentionally omitted <==

----- Start of picture text -----<br> Case No.:50/10/82- Party Name:HETERO DRUGS [Meet No/Date:10/82- _[Status:<br>; ALC4/2014 LIMITED, ALC4/2014 Approved<br>| . 12.11.2014 Le |<br>HQ File RLA File Lic.No/Date:0910059809 |Defer Date:<br>:01/82/050/00964/AM15/ :09/24/040/00024/AM15/ 23.04.2014<br>Decision : In the light of written comments received from Department of Pharmaceuticals vide<br>their OM No. 35011/286/2014-PI(Norms) dated 11.11.2014, it was decided to ratify the norms<br>under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:<br>172} Qh kg/kg<br>[Lisinopril Ike |1. | 2,2,2-Trifluoro acetic acid<br>2. L-Lysine<br>P| monohydrochloride 1.545<br>ester<br>| 3-Benzoy! acrylic acid ethy] | 08s<br>| }4. | Lithium hydroxide 0.184<br>-. -.-<br>: }6. | N,N-Carbonyl diimidazole | 0-400 aN<br>: — pore nt ery 4 LORCA<br>Dy. Director". TST ee te<br>45 pte cunt ty<br>Udyog Uiiawar, Noo Bini<br>----- End of picture text -----<br>

| | ,

En RA may take appropriate action as per the decision ofNorms Committee.

• Case No.:38/10/82Party Name:HETERO LABS Meet No/Date: 10/82Status:Deffered ALC4/2014 LIMITED ALC4/201412.11.2014 and Re-indexed .

• 173 |HQ File RLA File Lic.No/Date:09 10059807 |Defer :01/82/050/00952/AM1 5/ -09/24/040/00656/AM14/ 23.04.2014 Date: 10.12.2014 Decision : It was decided to defer the case for 10.12.2014 for comments of Department of Pharmaceuticals

• Case No.:77/5/82Party Name:INDOCO Meet No/Date:10/82Status:Deffered ALC4/2014 REMEDIES LIMITED ALC4/2014 and Re-indexed 12.11.2014

• |

• 174 |HQ File RLA File Lic.No/Date:03 10779207 (Defer :01/82/050/00394/AM15/ :03/94/040/00997/AM 14/ 23.04.2014 Date: 10.12.2014 Decision : It was decided to defer the case for 10. 12.2014 for comments ofDepartment of Pharmaceuticals 7

• Case No.:53/5/82PartyName:UNIMAX MeetNo/Date: 10/82Status:Deffered ALC4/2014 CHEMICALS PVT LTD. ALC4/2014 and Re-indexed 12.11.2014

• 175 |HQ File RLA File Lic.No/Date:03 10779 156 |Defer -01/82/050/00370/AM15/ |:03/95/040/00015/AMIS/|23.04.2014 — — Date:10.12.2014 Decision : It was decided to defer the case for 10.12.2014 for comments of Department of Pharmaceuticals

• Case No.:138/6/82Party Name:EMCURE Meet No/Date:10/82_[Status:Deffered ALC4/2014 PHARMACEUTICALS LTD. |ALC4/2014 and Re-indexed 12.11.2014

• 176 |HQ File RLA File Lic.No/Date:3 1 10063590 |Defer :01/82/050/00540/AM15/ :31/83/040/00015/AM15/ 24.04.2014 Date: 10.12.2014 Decision : It was decided to defer the case for 10.12.2014 for comments ofDepartment of Pharmaceuticals

(Case Noa6/S/82-ALC4/2014 (Party Name:UNITED Mest No/Date:10/82_(Status:Deffered BIOTECH PVT.LTD. ALC4/2014 and Re-indexed 12.11.2014 . 177 |HQ File RLA File Lic.No/Date:05 10384810 (Defer :01/82/050/00323/AM15/ :05/24/040/00034/AM15/ 24.04.2014 Date: 10.12.2014 Decision : It was decided to defer the case for 10.12.2014 for comments of Department of Pharmaceuticals a

Case No.:53/10/82Party Name:BRUNDAVAN Meet No/Date: 10/82Status:Deffered 178 |ALC4/2014 LABORATORIES PRIVATE |ALC4/2014 and Re-indexed . LTD., 12.11.2014 ——— y £ ~ pies” " afte tae: woe Udyog Brave, vs) Ouihi

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----- Start of picture text -----<br>

||||||||||
|---|---|---|---|---|---|---|---|---|
|HQ|File|RLA|File|Lic.No/Date:0910059856|(Defer|
|:01/82/050/00967/AM15/|—_—_|:09/24/040/00677/AM14/|[25.04.2014|Date:10.12.2014|
|Decision|:|It was decided|to defer the case|for|10.12.2014|for comments ofDepartment|
|of|Pharmaceuticals|.|7|
|Case No.:74/6/82-|Party Name:DIVIS|Meet No/Date:10/82-|Status:Deffered|
|ALC4/2014|LABORATORIES|LTD.,|ALC4/2014|and Re-indexed|
|.|12.11.2014|
|179||HQ File|RLA|File|Lic.No/Date:09 10059860||Defer|
|||—||:01/82/050/00476/AM15/|—_|:09/24/040/00014/AM15/|—_|25.04.2014|__-Date:10,12.2014|
||||Decision|:|It was decided to|defer the|case|for|10.12.2014 for comments of|Department|
|of Pharmaceuticals|
|Case No.:63/5/82-|Party Name:MACLEODS|Meet No/Date:10/82-|Status: Deffered|
|;|ALC4/2014|PHARMACEUTICALS|LTD.||ALC4/2014|and|Re-indexed|
|12.11.2014|
|1180.{HQ|File|RLA|File|Lic.No/Date:03|10779501||Defer|
|01/82/050/003|80/AM15/|03/95/040/00028/AM15/|25.04.2014|Date: 10.12.2014|
|Decision|:|It was decided|to|defer the case|for|10.12.2014|for comments|of Department|
|of Pharmaceuticals|

----- End of picture text -----<br>

• Case No.:8/5/82-ALC4/2014 |Party Name:MOREPEN [Meet No/Date:10/82_[Status:Deffered LABORATORIES LTD., ALC4/2014 and Re-indexed

• a : 12.11.2014

• 181 |HQ File RLA File Lic.No/Date:05 10384943 |Defer :01/82/050/00325/AM15/ —_|:05/24/040/00016/AM15/ {25.04.2014 Date: 10.12.2014

  • Decision : It was decided to defer the case for 10.12.2014 for comments of Department of Pharmaceuticals

==> picture [447 x 97] intentionally omitted <==

----- Start of picture text -----<br>

||||||||
|---|---|---|---|---|---|---|
|Case No.:64/5/82-|Party Name:SURVIVAL|Meet No/Date: 10/82-|Status:Deffered|
|ALC4/2014|TECHNOLOGIES PVT.LTD.||ALC4/2014|and|Re-indexed|
|.|12.11.2014|.|
|182|[HQ File|RLA File|Lic.No/Date:03 10779504|[Defer|
|:01/82/050/0038 1/AM15/|:03/95/040/00026/AM15/|25.04.2014|Date: 10.12.2014|
|Decision|:|It was|decided to defer the case for|10.12.2014|for comments|of Department|
|of|C&PC|
|.|

----- End of picture text -----<br>

• [ [Case No.:41/10/82Party Name: VIVIMED LABS [Meet No/Date:10/82_ (Status:Deffered ALC4/2014 LIMITED ALC4/2014 and Re-indexed 12.11.2014

• 183 [HQ File RLA File Lic.No/Date:09 10059852 [Defera 01/82/050/00955/AM15/ —_|:09/24/040/00028/AM15/ [25.04.2014 Date:10.12.2014 Decision : It was decided to defer the case for 10.12.2014 for comments of Department

• | jof C&PC ; a 7 Case No.:46/10/82Party Name:VIVIMED LABS !|Meet No/Date:10/82Status:Deffered

• 1184 |ALC4/2014 LIMITED IALC4/2014 and Re-indexed . ; 12.11.2014 PAR /NIRMAL KART ar Dy. Diractor Genera! of Fore. oe i ora out irene : Udyog Bnawan Woe Ubini

FT

:

|,||HQFile<br>:01/82/050/00960/AM15/|‘IRLAFile<br>Lic.No/Date:0910059853:|Defer<br>—_|:09/24/040/00029/AMI5/_|25.04.2014<br>Date:10.12.2014|‘IRLAFile<br>Lic.No/Date:0910059853:|Defer<br>—_|:09/24/040/00029/AMI5/_|25.04.2014<br>Date:10.12.2014|
|---|---|---|---|---|
|||Decision : Itwasdecided|to deferthecasefor 10.12.2014 forcommentsofDepartment||
|||ofC&PC|||
|||CaseNo.:54/10/82-<br>ALC4/2014|PartyName:VIVIMEDLABS ‘|MeetNo/Date:10/82-<br>LIMITED<br>JALC4/2014<br>12.11.2014|Status:Deffered<br>andRe-indexed|
|||.|||
||185||HQFile<br>:01/82/050/00968/AM15/|RLAFile<br>|Lic.No/Date:0910059858 <br>:09/24/040/00037/AM15/<br>25.04.2014||Defer<br>Date:10.12.2014|
|||Decision : Itwasdecidedto|to deferthe casefor 10.12.2014 forcommentsofDepartment|Department|
|||ofC&PC|||
|||CaseNo.:42/10/82-<br>ALC4/2014<br>.<br>.|PartyName:VIVIMEDLABS<br>[MeetNo/Date:10/82-<br>LIMITED<br>ALC4/2014<br>.<br>12.11.2014<br>.|__[Status:<br>Approved|
|||HQFile<br>:01/82/050/00956/AM15/|RLAFile<br>Lic.No/Date:0910059885<br>|DeferDate:<br>:09/24/040/00043/AM15/<br>28.04.2014||

Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/43/2012-Ch. I! dated 13.11.2014, it was decided to 186 ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

|||Exportproduct<br>Er<br>Qty.<br>NITRO BLUE(OR)JAROCOL | 1kg||SiNO. | Importitems<br>Qty.Allowed<br>1<br>VIOLET14DN,N-BIS-{2- | 1.70 kg|Allowed<br>1.70 kg|
|---|---|---|---|---|
||H|BLUE 12|Hydroxyethyl)-2-Nitro-||
||||P-Phenylenediamine||
|||RAmaytakeappropriate actionasperthedecisionofNormsCommittee.|||
|||CaseNo.:51/10/82-ALC4/2014 [PartyName:VIVIMEDLABS [MeetNo/Date:10/82-<br>LIMITED<br>ALC4/2014||_[Status:Case<br>Added|
||||12.11.2014||
|187|||HQFile<br>RLA File<br>Lic.No/Date:0910059887 <br>:01/82/050/00965/AM15/<br>:09/24/040/00039/AM15/<br>28.04.2014||{DeferDate:|
|||Decision : Itwasdecidedtodeferthe|case for 10.12.2014 forcommentsofDepartment||
|||ofC&PC|||

.

Case No.:43/8/82Panty Name:COVALENT [Meet No/Date:10/82_|Status:Deffered ALC4/2014 LABORATORIES PRIVATE j|ALC4/2014 and Re-indexed LIMITED {12.11.2014 | 188 |HQ File RLA File Lic.No/Date:09 10059930 |Defer :01/82/050/00707/AM15/ :09/24/040/00012/AM15/ 29.04.2014 ‘Date: 10.12.2014 Decision : It was decided to defer the case for 10.12.2014 for comments of Department of Pharmaceuticals . .

[go (Case No.:76/10/82Party Name:KUDOS [Meet No/Date:10/82_[Status:Deffered | °"|ALC42014 CHEMIE LTD., |ALC4/2014 [and Re-indexed met - aan Trade — Uy g a PryCw ; dol7 “lade Commerce

| |

| | | : : |

| | fiz 1.2014 ; HQ File RLA File Lic.No/Date:22 10014839:iDefer :01/82/050/00990/AM 15/ :22/24/040/00099/AM14/ 29.04.2014 _|Date:10.12.2014 Decision : It was decided to defer the case for 10.12.2014 for comments ofDepartment of Pharmaceuticals - ; . Case No.:75/8/82Party Name:METROCHEM [Meet No/Date:10/82- _ [Status:Deffered ALC4/2014 API PVT. LTD. ALC4/2014 and Re-indexed 12.11.2014 HQ File RLA File Lic.No/Date:09 10059927 |Defer :01/82/050/00739/AM15/ :09/24/040/00034/AM 15/ 29.04.2014 _ Date:10.12.2014 Decision : It was decided to call the following information from the firm :

• i) Complete and balanced chemical reaction showing molecular weight of input

• 190 and output product. iii) | % yield on molar basis iv) Material balance for entire process v) Bye-products recovered, if any. vi) Copy of technical literature in support of yield envisaged in the reaction. vii) Past production vis-a-vis actual consumption of input duly certified by Central Excise Authorities.

==> picture [207 x 14] intentionally omitted <==

----- Start of picture text -----<br> The case was deferred for 10.12.2014<br>.<br>----- End of picture text -----<br>

a Case No.:77/10/82Party Name:NECTAR Meet No/Date: 10/82Status:Deffered ALC4/2014 LIFESCIENCES LIMITED, |ALC4/2014 and Re-indexed a - 12.11.2014 191 [HQ File RLA File Lic.No/Date:22 10014838 [Defer :01/82/050/0099 1/AM15/ :22/24/040/00003/AM15/_ 29.04.2014 Date:10.12.2014 Decision : It was decided to defer the case for 10.12.2014 for comments of Department of Pharmaceuticals

Case No.:243/3/82Party Name:POLYGON Meet No/Date: 10/82Status: ALC4/2014 CHEMICALS ALC4/2014 Approved 12.11.2014 - HQ File RLA File Lic.No/Date:08 10130958 |Defer Date: :01/82/050/00247/AM15/ :08/24/040/00043/AM15/ 29.04.2014

Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/9/2010-Ch. II dated 07.03.2013, it was decided to 192 |ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

==> picture [315 x 90] intentionally omitted <==

----- Start of picture text -----<br> Qty.<br>3-Methyl 5-Pyrazolone | Acetic Methyl Ester<br>|2__<br>| Hydrazine Hydrate<br>— fi )<br>----- End of picture text -----<br>

==> picture [137 x 82] intentionally omitted <==

----- Start of picture text -----<br> 1.287 kg<br>Ob Sa kgereser fl[Mee<br>a 1 ” te<br>Directorate Ger tte<br>BEM Wa4, ip<br>Udyog Bhawan, New Delt<br>----- End of picture text -----<br>

• | (Purity 80%) | RA may take appropriate action as per the decision of Norms Committee. Case No.:61/10/82Party Name:STERLING [Meet No/Date:10/82_[Status:Deffered ALC4/2014 AUXILIARIES PVT LTD ALC4/2014 and Re-indexed 12.11.2014

• 193 [HQ File RLA File Lic.No/Date:03 10779831 |Defer :01/82/050/00975/AM15/ :03/95/040/00913/AM14/ —s [29.04.2014 | Date:10.12.2014 Decision : It was decided to defer the case for 10.12.2014 for comments of Department of C&PC

• Case No.:74/5/82Party Meet No/Date:10/82Status: ALC4/2014 IName:ARIHANTANAM ALC4/2014 Approved LIFECARE PVT. LTD. 12.11.2014 .

• HQ; File RLA File Lic.No/Date:03 10780141 '|Defer Date: :01/82/050/0039 1/AM15/ :03/94/040/00080/AM15/ 30.04.2014 Decision : In the light of written comments received from Department of Pharmaceuticals vide

• 194 their OM No. 35011/296/2013-Pl(Norms) dated 03.07.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Qty. allowed kg/kg

• DIHYDRO

• | [BER [ee PE famtenasme RA may take appropriate action as per the decision of Norms Committee. Case No.:20/10/82Party Name:INCHEM Meet No/Date:10/82Status:Deffered ALC4/2014 LABORATORIES PRIVATE |ALC4/2014 and Re-indexed

• 195 |HQ. File LIMITEDRLA File Lic.No/Date:0912.11.2014 10059969 |Defer :01/82/050/00934/AM15/ :09/24/040/00044/AM15/ = [01.05.2014 Date:10.12.2014 Decision : It was decided to defer the case for 10.12.2014 for comments of Department of Pharmaceuticals . Case No.:3/5/82-ALC4/2014 |Party Name:NEW Meet No/Date: 10/82Status:Deffered ALLIANCE DYE-CHEM ALC4/2014 and Re-indexed PVT. LTD., 12.11.2014

• 196 |HQ File RLA File Lic.No/Date:03 10780255 |Defer

• | ~~ }:01/82/050/00320/AM15/ _|:03/95/040/00017/AM15/ _|01.05.2014 Date:10.12.2014 Decision : It was decided to defer the case for 10.12.2014 for comments of Department of C&PC

Case No.:19/10/82Party Name:SRINI Meet No/Date: 10/82Status: Deffered 197 ALC4/2014 PHARMACEUTICALS ALC4/2014 and Re-indexed LTD., 12.11.2014 | {HQ File IRLA File : [Lic.No/Date:0910059967 [Defer K i ane a Spey an e Director ; anfroa : . Udgey Base

| |

.

a

[:01/82/0S0/00933/AM15/: _[:09/24/040/00020/AMI5/ {01.05.2014 [Date:10.12.2014 Decision : It was decided to defer the case for 10.12.2014 for comments ofDepartment ofPharmaceuticals

• Case No.:43/10/82Party Name:SRINI —_ Meet No/Date:10/82- ) Status:Deffered ALC4/2014 PHARMACEUTICALS ALC4/2014 and Re-indexed

• 198 |HQ File RLALTD., File Lic.No/Date:0912.11.2014 10059968 |Defer . ) :01/82/050/009S7/AMI5/ —_|:09/24/040/00021/AM15/ 01.05.2014 Date:10.12.2014 Decision : It was decided to defer the case for 10.12.2014 for comments of Department of Pharmaceuticals . . |

• Case No.:9/5/82-ALC4/2014 |Party Name:DHANUKA Meet No/Date: 10/82Status:Deffered LABORATORIES LTD. ALC4/2014 and Re-indexed 12.11.2014 |

• 199 [HQ File |RLA File Lic.No/Date:0510385706 |Defer :01/82/050/00326/AM15/ {:05/23/040/00041/AM15/ —|05.05.2014 - [Date:10.12.2014

Decision : It was decided to defer the case for 10.12.2014 for comments ofDepartment of Pharmaceuticals .

||CaseNo.:12/5/82-<br>ALC4/2014|PartyName:DHANUKA<br>LABORATORIESLTD.|MeetNo/Date:10/82-<br>ALC4/2014|Status:Deffered<br>landRe-indexed|
|---|---|---|---|---|
||||12.11.2014||
||.||||
|200||HQ File<br>01/82/050/00329/AMI15/|JRLA File<br>—_|:05/23/040/00042/AM15/|Lic.No/Date:0510385707 <br>{05.05.2014|[Defer<br>Date:10.12.2014|

Decision : It was decided to defer the case for 10.12.2014 for comments ofDepartment of Pharmaceuticals

||Case No.:54/5/82-<br>ALC4/2014|PartyName:NEW<br>ALLIANCEDYE-CHEM|Meet No/Date: 10/82-<br>ALC4/2014|Status:Deffered<br>andRe-indexed|
|---|---|---|---|---|
||-<br>.|PVT. LTD.,|12.11.2014|||
|201||HQFile<br>01/82/0S0/00371/AM15/|RLA File<br>_|:03/95/040/00077/AM15/|Lic.No/Date:03 10780621 |Defer<br>{05.05.2014<br>_[Date:10.12.2014||
||Decision : Itwasdecidedtodefer thecase for 10.12.2014 forcommentsofDepartment|||ofDepartment|
||ofC&PC||||
|||||||
||Case No.:57/5/82-|PartyName:NEW|MeetNo/Date:10/82-|Status:Deffered|
||ALC4/2014|ALLIANCEDYE-CHEM|ALC4/2014|andRe-indexed|
|||PVT. LTD.,|12.31.2014||
||202|[HQ File|RLA File|Lic.No/Date:0310780627 |Defer||
||:01/82/050/00374/AM15/|:03/95/040/00085/AM15/|05.05.2014|Date:10.12.2014|
||Decision : Itwasdecided to deferthecase for 10.12.2014forcommentsof|||ofDepartment|
||ofC&PC||||

Case No.:10/5/82Party Name:JUBILANT LIFE |Meet No/Date: 10/82Status:Deffered 203 |ALC4/2014 SCIENCES LIMITED ALC4/2014 and Re-indexed 12.11.2014 ae Dy.wTDirector bai dlpGenevalGRabie off ForFO” ‘ — PaaeT PCeneral of Fer. Cc) rr airs fTVOvpariment c+ : weir saat, Ef. \ Udyog &iawan, Ne-

HieHQ FileaS0/00327/AMIS/ s40/b001S/AMIS/RLA File epeeLic.No/Date:0510385902. Pete|Defer 122014 Decision : It was decided to defer the case for 10.12.2014 for comments of Department of C&PC

|HQ FileaS0/00327/AMIS/FileaS0/00327/AMIS/<br>RLA FileFile<br>Lic.No/Date:0510385902. |Defer<br>HieHQ FileaS0/00327/AMIS/ aS0/00327/AMIS/<br>s40/b001S/AMIS/RLA File<br>epeeLic.No/Date:0510385902.<br>. Pete|Defer 122014<br>Decision : It was decidedwas decideddecided to defer thedefer thethe case for 10.12.2014 for comments of Departmentcomments of Departmentof DepartmentDepartment<br>ofC&PC|HQ FileaS0/00327/AMIS/FileaS0/00327/AMIS/<br>RLA FileFile<br>Lic.No/Date:0510385902. |Defer<br>HieHQ FileaS0/00327/AMIS/ aS0/00327/AMIS/<br>s40/b001S/AMIS/RLA File<br>epeeLic.No/Date:0510385902.<br>. Pete|Defer 122014<br>Decision : It was decidedwas decideddecided to defer thedefer thethe case for 10.12.2014 for comments of Departmentcomments of Departmentof DepartmentDepartment<br>ofC&PC|
|---|---|
|CaseNo.:35/5/82-<br>PartyName:ELIXIR<br>MeetNo/Date:10/82-<br>Status:Deffered<br>ican<br>Prat<br>ica<br>~Re-indexed<br>12.11.2014<br>204 [HQFile<br>LAFile<br>Lice ostolstiaeDefer<br>:01/82/050/00352/AM15/<br>:08/24/040/00047/AM 15/<br>07.05.2014<br>Date: 10.12.2014<br>Decision : Itwasdecidedtodeferthecase for 10.12.2014 forcommentsofDepartment||
||ofPharmaceuticals.|
||‘CaseNo.:75/10/82-<br>|PartyName:NECTAR<br>MeetNo/Date:10/82-<br>Status:Approved<br>ALC4/2014<br>LIFESCIENCESLIMITED,<br>|ALC4/2014<br>| .<br>|<br>cia<br>|<br>.<br>HQFile<br>RLAFile<br>Lic.No/Date:2210014855 |DeferDate:<br>Be Fres0/00080/AMis<br>:22/24/040/00008/AM15/ Pree<br>Decision: Inthe lightofwrittencommentsreceivedfromDepartment ofPharmaceuticalsvidetheirOM<br>INo. 35011/274/2014-PI(Nomns) dated 30.10.2014, it was decided to ratify the norms under Para 4.7 of<br>HBPv1 asperdetailsgivenbeloworasappliedbythe firm, whichever is less:|
||Tey oeee<br>Quantity<br>kg/kg|
|.<br>.|Amorphous<br>cephalosporanic acid (D-7-<br>|<br>ACA)<br>|<br>| evecetate_<br>acetate<br>(374<br>[Methanol<br>62<br>Ee<br>acetic acid ammonium salt<br>205<br>(SMIA)<br>(5. __|Activatedcarbon —=[..100<br>epee fe<br>pentachloride<br>[7.____[Methylenechloride<br>[2.290<br>8.<br>[Sodiumhydroxide<br>[0.43<br>|<br>fo.<br>{Aceticacid<br>0.048<br>(10, [Acetonitrile<br>1.98<br>La ee<br>Isocyanate<br>:<br>faz [Acetone<br>2-76<br>1<br>|<br>[43 [NN-dimethylacetamide [2.12<br>.<br>{a4 [Acetoxyethyl<br>bromide [0.59<br>fas<br>|Cyclohexane<br>[0**.**92<br>[16 | Sodiumcarbonate<br>[0 125|
|||<br>I|
||t— $2—<br>pigteet,mTOR Le een<br>arfers::<br>30 Trade|
||Commerce|

| 1

|

||

|

“a — —= — ———— — a = — = — ——— — | Sodium metabisulfite Not shown in RXN 70 Hydrochloric acid itemNot an importable IRA . . SS may take appropriate action as per the decision ofNorms Committee. Case No.:74/10/82{Party Name:NECTAR Meet No/Date:10/82—|Status: ALC4/2014 LIFESCIENCES LIMITED, jALC4/2014 Approved 12.11.2014 HQ File RLA File Lic.No/Date:22 10014859 |Defer| Date:; :01/82/050/00988/AM15/ —|:22/24/040/00009/AM15/ 09.05.2014 Decision : In the light of written comments received from Department of Pharmaceuticals vide their. OM No. 35011/198/2014-PI(Norms) dated 27.10.2014, it was decided to ratify the norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export Product Export S. No. Qty. Allowed CefiximeTrihydhrate 1Quanti kg fl |GCLE«1.507Sodium Bromide kg/kg0.3628 206 Tri Phenyl Phosphine 0.820 | (4. {DMF C*'1.869 | Methylene Chloride 1.546 . 16.| Formaldehyde 1.118 5.117 } | [8. [Phenol CS (0.3808 | | 19. | Butyl Acetate | (0.302 |10. | EnoCarbon «(0.793 |11. |100 Acetone | EDTA 0.0182 | | MICA ESTER 0.820 | }14_ | Acetic Acid «(0.030 Triethylamine (TEA 0.2717 RA 116 | Ethyl Acetate 0.376 may take appropriate action as per the decision ofNorms Committee. Case No.:13/5/82Party Name:PARABOLIC Meet No/Date:10/82Status:Deffered ALC4/2014 DRUGS LTD., ALC4/2014 and Re-indexed 12.11.2014 4207.|HQ File RLA File Lic.No/Date:05 10386137 |Defer :01/82/050/00330/AM 15/ :05/24/040/00049/AM15/ 09.05.2014 Date: 10.12.2014 Decision : It was decided to defer the case for 10.12.2014 for comments of Department of Pharmaceuticals _ Case No.:15/5/82Party Name:PARABOLIC Meet No/Date:10/82tatus:Deffered ALC4/2014 DRUGS LTD., ALC4/2014 and Re-indexed 208 12.11.2014 7 AQ01/82/050/00332/AM15/ File RLA|:05/24/040/00036/AM15/ File |09.05.2014Lic.No/Date:05 10386135__ '|Defer[Date:10.12.2014 Ne Pete ST /NIRMAL KUMAR —_ Dy Dire Te TF F FE wy > 3 ~ waivefacea: anise 7ee LP of Conenena Usyog Bhawan! NEES ni

&

• Decision: : It was decided to defer the case for 10.12.2014 for comments ofDepartment of Pharmaceuticals

||:<br>Decision: : It was decided to defer the case for 10.12.2014 for comments ofDepartmentwas decided to defer the case for 10.12.2014 for comments ofDepartmentdecided to defer the case for 10.12.2014 for comments ofDepartmentto defer the case for 10.12.2014 for comments ofDepartment<br>ofPharmaceuticals|It was decided to defer the case for 10.12.2014 for comments ofDepartmentwas decided to defer the case for 10.12.2014 for comments ofDepartmentdecided to defer the case for 10.12.2014 for comments ofDepartmentto defer the case for 10.12.2014 for comments ofDepartmentdefer the case for 10.12.2014 for comments ofDepartmentthe case for 10.12.2014 for comments ofDepartmentcase for 10.12.2014 for comments ofDepartmentfor 10.12.2014 for comments ofDepartment10.12.2014 for comments ofDepartmentfor comments ofDepartmentcomments ofDepartmentofDepartment|
|---|---|---|
||CaseNo.:21/5/82-<br>ALC4/2014|PartyName:PARABOLIC<br>MeetNo/Date:10/82-<br>Status:Deffered<br>DRUGSLTD.,<br>ALC4/2014<br>andRe-indexed<br>12.11.2014|
|209||HQFile<br>:01/82/050/00338/AM15/<br>Decision : Itwasdecided|RLAFile<br>Lic.No/Date:0510386136 \Defer<br>_|:08/24/040/00039/AM15/__}09.05.2014<br>_—<br>[Date:10.12.2014<br> todeferthe casefor 10.12.2014 forcommentsofDepartment|
||ofPharmaceuticals||

||ofPharmaceuticals|||
|---|---|---|---|
|||CaseNo.:17/5/82-<br>ALC4/2014<br>:<br>210 [HQFile<br>:01/82/050/00334/AM15/<br>Decision : Itwasdecidedto|PartyName:RECKITT<br>MeetNo/Date:10/82-<br>Status:Deffered<br>BENCKISER<br>ALC4/2014<br>andRe-indexed<br>HEALTHCARE INDIA<br>12.11.2014<br>LIMITED<br>|.<br>RLAFile<br>Lic.No/Date:0510386224 |Defer<br>__|:05/24/040/00053/AM15/__<br>[09.05.2014<br>|Date:10.12.2014<br>todefer thecasefor 10.12.2014forcommentsofDepartment||
||ofPharmaceuticals||.|
||CaseNo.:18/5/82-<br>ALC4/2014<br>21iHQFile<br>'|:01/82/050/00335/AM15/|PartyName:RECKITT<br>BENCKISER<br>HEALTHCAREINDIA<br>LIMITED<br>RLAFile<br>:05/24/040/00021/AM15/|-|MeetNo/Date:10/82-<br>Status:Deffered<br>ALC4/2014<br>andRe-indexed<br>12.11.2014<br>.<br>.<br>Lic.No/Date:0510386223 |Defer<br>09.05.2014<br>Date:10.12.2014|

• {Decision ; It was decided to defer the case for 10.12.2014 for comments of Department {of Pharmaceuticals

212	CaseNo.:19/5/82-<br>ALC4/2014<br> [HQFile<br>:01/82/050/00336/AM15/	PartyName:RECKITT<br>BENCKISER<br>HEALTHCAREINDIA<br>LIMITED<br>.<br>RLAFile<br>:05/24/040/00020/AM15/	MeetNo/Date:10/82-<br>ALC4/2014<br>12.11.2014<br>Lic.No/Date:0510386217 <br>109.05.2014	Status:Deffered<br>andRe-indexed<br>.<br> [Defer<br>Date:10.12.2014

• Decision : It was decided to defer the case for 10.12.2014 for comments of Department

• _ jof Pharmaceuticals . Case No.:18/10/82Paty NameSATYA (Meet No/Date:10/82Status:Deffered ALC4/2014 DEEPTHA ALC4/2014 ‘and Re-indexed PHARMACEUTICALS LTD |12.11.2014

• 713 |HQ File RLA File Lic.No/Date:09 10060039 |Defer :01/82/050/00932/AM15/ :09/24/040/00064/AM15/ 09.05.2014 Date: 10.12.2014 Decision : It was decided to defer the case for 10.12.2014 for comments of Department

• of Pharmaceuticals

==> picture [486 x 81] intentionally omitted <==

----- Start of picture text -----<br> 14 Case No.:37/10/82- Party Name:SATYA Meet No/Date:10/82- Status:Deffered |<br>“"" ALC4/2014 DEEPTHA ALC4/2014 and Re-indexed<br>wa RP, of Foreign Trade<br>pe OS eh eT de<br>ae aa 4 [i] Beans<br>Loe iid<br>----- End of picture text -----<br>

| _ [PHARMACEUTICALS LTD [12.11.2014 | HQ File RLA File Lic.No/Date:09 10060032 |Defer HOF 005 /AM15/ —|:09/24/040/00062/AM15/ 09.05.2014 Date:10.12.2014 Decision : It was decided to defer the case for 10.12.2014 for comments of Department | jof Pharmaceuticals . . Case No.:17/10/82Party Name:HETERO LABS [Meet No/Date:10/82__|Status:Deffered ALC4/2014 LIMITED ALC4/2014 and Re-indexed : 12.11.2014 — '215 |HQ File RLA File Lic.No/Date:09 10060072 |Defer 01/82/050/00931/AM15/ ———{:09/24/040/000S4/AMI15/ ——[12.05.2014 Date: 10.12.2014 Decision : It was decided to defer the case for 10.12.2014 for comments of Department of Pharmaceuticals [ [Gase No.:5/10/82-AL.C4/2014 [Party Name: MYLAN Meet No/Date:10/82-[Status:Deffered LABORATORIES LIMITED jALC4/2014 and Re-indexed , . (2112014 _ 216 |HQ File RLA File Lic.No/Date:09 10060057. |Defer :01/82/050/00919/AM15/ |:09/24/040/00676/AM14/ ——|12.05.2014 - |Date:10.12.2014 Decision : It was decided to defer the case for 10.12.2014 for comments of Department of Pharmaceuticals ; Case No.:10/10/82[Party Name: VIVIMED LABS (Meet No/Date:10/82- _ [Status:Deffered ALC4/2014 LIMITED ALC4/2014 and Re-indexed . (12.11.2014 a HQ File RLA File Lic.No/Date:09 10060073 |Defer :01/82/050/00924/AM15/ —|:09/24/040/00074/AMI15S/ {12.05.2014 Date:10.12.2014 Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/138/2011-Ch. II dated 09.12.2013, 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 fess: |217| | Export product Exp. Qty. allowed Qty. AVIS(AVOBENZONE) PARA TERTIATORY BUTYL 1.148 kg BENZOIC ACID }2.| ACETYL ANISOLE 0.929 kg | /3.| ACTIVATED CARBON 0.025 kg |4.| SODAMIDE 0.206 kg [S.[ METHANOL |6._| TOLUENE

RA may take appropriate action as per the decision of Norms Committee.

Case No.:52/10/82Party Name:AUROBINDO Meet No/Date: 10/82Status:Deffered ALC4/2014 PHARMA LIMITED ALC4/2014 and Re-indexed 418 HQ File RLA File Lic.No/Date:09 1006008012.11.2014 |Defer it :01/82/050/00966/AM15/= :09/24/040/00055/AM15/ 13.05.2014 Date:10.12.2014: TI yehAAR —_y. Diractor General of f ue ira e wrfrsa fruPyDepartmet of commer? Udseg Bhawan,New Deihi

I

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----- Start of picture text -----<br> Decision ; It was decided to defer the case for 10.12.2014 for comments ofDepartment<br>of Pharmaceuticals<br>Case No.:34/10/82- Party Name:DR REDDYS Meet No/Date:10/82- Status:Deffered<br>ALC4/2014 LABORATORIES LIMITED |ALC4/2014 and Re-indexed<br>42.11.2014<br>219 |HQ File RLA File Lic.No/Date:09 10060082 |Defer<br>:01/82/050/00948/AM15/ :09/24/040/00017/AM15/ 13.05.2014 Date: 10.12.2014<br>Decision : It was decided to defer the case for 10.12.2014 for comments of Department<br>of Pharmaceuticals <br>[Case No.:3/10/82-ALC4/2014 [Party Name:GLAND Meet No/Date:10/82- [Status:Deffered<br>PHARMA LIMITED ALC4/2014 and Re-indexed<br>12.11.2014<br>220 |HQ File RLA File Lic.No/Date:09 10060092 |Defer<br>:01/82/050/00917/AM15/ :09/24/040/00065/AM15/ 13.05.2014 Date: 10.12.2014<br>Decision : It was decided to defer the case for 10.12.2014 for comments of Department<br>of Pharmaceuticals .<br>[Case No.:44/10/82- Party Name:MYLAN Meet No/Date:10/82- __[Status:Deffered<br>ALC4/2014 LABORATORIES LIMITED |ALC4/2014 and Re-indexed<br>, 12.11.2014<br>971 ||HQ File RLA File Lic. No/Date:09 10060088 [Defer<br>}:01/82/050/00958/AM15/ :09/24/040/00053/AM15/ 13.05.2014 Date: 10.12.2014<br>Decision : It was decided to defer the case for 10.12.2014 for comments of Department<br>lof Pharmaceuticals<br>Case No.:59/10/82- Party Name:MYLAN Meet No/Date:10/82- [Status:Deffered<br>ALC4/2014 LABORATORIES LIMITED |ALC4/2014 and Re-indexed<br>12.11.2014<br>222 |HQ File RLA File Lic.No/Date:09 10060084 |Defer<br>:01/82/050/00973/AM15/ :09/24/040/00045/AM15/ 13.05.2014 Date:10.12.2014<br>Decision : It was decided to defer the case for 10.12.2014 for comments ofDepartment<br> {of Pharmaceuticals . .<br>Case No.:11/10/82- Party Name:ASTRIX Meet No/Date: 10/82- Status:Deffered<br>ALC4/2014 LABORATORIES LTD., ALC4/2014 and Re-indexed<br>273 (HQ. File RLA File {12.11.2014Lic.No/Date:0910060121 [Defer .<br>:01/82/050/00925/AM15/ —|:09/24/040/00069/AM15/ __|15.05.2014 Date: 10.12.2014<br>Decision : It was decided to defer the case for 10.12.2014 for comments of Department<br>__jof Pharmaceuticals .<br>Case No.:14/10/82- Party Name:EMCURE Meet No/Date:10/82- [Status:Deffered<br>ALC4/2014 PHARMACEUTICALS LTD. |ALC4/2014 and Re-indexed<br>224) 12.11.2014<br>HQ File RLA File Lic.No/Date:3 110063976 |Defer<br> }:01/82/050/00928/AM15/ —|:31/83/040/00035/AM15/ _|15.05.2014 Date:10.12,2014 | ,duidar<br>D, ‘eign Trade<br>meee gS b ~ Dies a ‘ign Trade<br>ais | Sager<br>Udyog biawan, New Deint<br>----- End of picture text -----<br>

|

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||||||||||
|---|---|---|---|---|---|---|---|---|
|Decision|:|It was decided to defer the case for 10.12.2014|for comments ofDepartment|
|of Pharmaceuticals|
|Case No.:25/10/82-|Party Name:GLAND|Meet No/Date:10/82-|Status:Deffered|
|ALC4/2014|PHARMA LIMITED|ALC4/2014|and Re-indexed|
|12.11.2014|
|225||HQ|File|RLA|File|Lic.No/Date:09|10060107||Defer|||
|.|:01/82/050/00939/AM15/|:09/24/040/00078/AM15/|15.05.2014|Date:10.12.2014|
|Decision|:|It was decided to defer the|case|for|10.12.2014|for comments of|Department|
|of Pharmaceuticals|
|Case No.:37/5/82-|Party Name:ATUL|Meet No/Date: 10/82-|Status:|
|ALC42014|BIOSCIENCE LIMITED|ALC4/2014|Approved|
|12.11.2014|
|HQ|File|RLA|File|Lic.No/Date:5210041051||Defer Date:|
|:01/82/050/00354/AM15/|:52/24/040/00002/AM|15/|19.05.2014|

----- End of picture text -----<br>

|

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----- Start of picture text -----<br>

|||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|Decision|:|in|the|light|of written|comments|received|from|Department|of|Pharmaceuticals vide|their|
|226|OM|No.|35011/523/2013-Pl(Norms)|dated|11.09.2013,|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:|
|1|Item of Export|| Quantity,|| SNo|Item of Import|Quantity allowed|
||||N-BENZYLOXYCARBONYL-L-VALINE|[4|eVALLINE|0522 KQ|
|||care|vain|[2|Pnerrane|—__———«*d AKG|
|RA may take appropriate|action as per the|decision|of Norms Committee.|
|Case No.:39/10/82-|Party Name:MYLAN|Meet No/Date:10/82-|Status:Deffered|
|ALC4/2014|LABORATORIES LIMITED||ALC4/2014|and Re-indexed|
|12.11.2014|
|227||HQ File|RLA|File|Lic.No/Date:09|10060145||Defer|
|:01/82/050/00953/AM15/|:09/24/040/00060/AM15/|19.05.2014|Date: 10.12.2014|

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||||||||||
|---|---|---|---|---|---|---|---|---|
|Case|No.:101/6/82-|Party Name:PREGNA|Meet No/Date: 10/82-|Status:Deffered|
|ALC4/2014|INTERNATIONAL LTD.|ALC4/2014|and|Re-indexed|
|12.11.2014|
|228||HQ File|RLA|File|Lic.No/Date:03 10781971||Defer|
|:01/82/050/00503/AM15/|:03/95/040/00122/AM15/|19.05.2014|_||Date:10.12.2014|
|Decision|:|It was decided to|defer the|case|for|10.12.2014|for comments|ofDepartment|
|of|Petrochemicals|Division ofD/o C&PC.|

----- End of picture text -----<br>

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----- Start of picture text -----<br> Case No.:120/8/82- Party Name: INDOCO Meet No/Date:10/82- Status: Deffered<br>ALC4/2014 REMEDIES LIMITED ALC4/2014 and Re-indexed<br>12.11.2014<br>229 THQ File RLA File Lic.No/Date:03 10782171 [Defer<br>[Decision:01/82/050/00784/AM15/: It was decided to:03/94/040/00111/AM15/ defer the case for 10.12.201420.05.2014for comments ofDepartment_ {Date:10.12.2014 Nh<br>MIRMAL KSMs<br>----- End of picture text -----<br>

ferre Genwrat oF of COME uayes Ve”

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----- Start of picture text -----<br> | ,<br>lof Pharmaceuticals<br>----- End of picture text -----<br>

• , &

• lof Pharmaceuticals | Case No.:38/5/82Party Name:INTAS Meet No/Date:10/82_|Status:Deffered ALC4/2014 PHARMACEUTICALS JALC4/2014 and Re-indexed LTD., 12.11.2014

• 230 |HQ File RLA File Lic.No/Date:08 10131456 |Defer :01/82/050/00355/AM15/ :08/24/040/00076/AM15/ 20.05.2014 Date: 10.12.2014 Decision : It was decided to defer the case for 10.12.2014 for comments of Department of Pharmaceuticals

Case No.:9/10/82-ALC 4/2014 |Party Name:EMCURE Meet No/Date: 1 0/82Status: Deffered PHARMACEUTICALS LTD. |ALC4/2014 and Re-indexed 12.11.2014 231 |HQ File RLA File Lic.No/Date:3 110064004 |Defer :01/82/050/00923/AM 15/ :31/83/040/00032/AM15/ _ {21.05.2014 _ |Date:10.12.2014 Decision : It was decided to defer the case for 10.12.2014 for comments of Department ofPharmaceuticals . oo, Case No.:6/10/82-ALC4/2014 |Party Name:JUBILANT LIFE |Meet No/Date:10/82Status:Deffered SCIENCES LIMITED ALC4/2014 and Re-indexed 12.11.2014 Z . . . Z HQ File RLA File Lic.No/Date:05 10387078: |Defer :01/82/050/00920/AM15/ :05/23/040/00067/AM15/ {21.05.2014 .|Date: 10.12.2014 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 3501 1/672/2013-PI(Norms) dated 01.04.2014, and it was decided to ratify norms under Para 4.7 of HP v1 as per details given below or as applied by the firm, whichever is less:

[1] Export Product : Enrofloxacin Flavored Tablets 22.7 mg

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----- Start of picture text -----<br> 23212. __| Artificial Powder Beef Flavor 79.282 mg<br>[3&4 | Packing materials | Relevant as per packing policy<br>----- End of picture text -----<br>

[2] Export Product : Enrofloxacin Flavored Tablets 68 mg

==> picture [339 x 82] intentionally omitted <==

----- Start of picture text -----<br> i a<br>maa Artificial Powder Beef Flavor 237.5<br>[3&4 |Packing materials | Relevant as per packing policy<br>----- End of picture text -----<br>

{3] Export Product : Enrofloxacin Flavored Tablets 136 mg

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----- Start of picture text -----<br> Import = AP<br> Item Quantity recommended 50<br>— a ae<br>— ne<br>— fas a aAlgmni<br>—S6 Bp e es Ayo<br>yaye?<br>----- End of picture text -----<br>

| |

| | | : | : | ) |

) : | |

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----- Start of picture text -----<br> 12.| Artificial Powder Beef Flavor 475 mg /tablet<br>[3&4] Packing materials ——|_ Relevant as per packing policy<br>----- End of picture text -----<br>

RA may take appropriate action as per the decision of Norms Committee.

• Case No.:35/10/82Party Name:MYLAN Meet No/Date: 10/82Status: Deffered ALC4/2014 LABORATORIES LIMITED jALC4/2014 and Re-indexed 12.11.2014 -

• 233 [HQ File RLA File Lic. No/Date:09 10060166 [Defer :01/82/050/00949/AM15/ :09/24/040/00076/AM15/ {21.05.2014 Date: 10.12.2014

• Case No.:36/10/82Party Name: MYLAN Meet No/Date:10/82_[Status:Deffered ALC4/2014 LABORATORIES LIMITED |ALC4/2014 and Re-indexed 12.11.2014 .

• 234 |HQ File RLA File Lic.No/Date:09 10060165 |Defer :01/82/050/00950/AM1 5/ :09/24/040/00072/AM15/ 21.05.2014 Date: 10.12.2014

• Case No.:220/6/82Party Name:ANUH Meet No/Date:10/82= |Status:Deffered ALC4/2014 PHARMA LTD. ALC4/2014 and Re-indexed 12.11.2014

• 235 [HQ File RLA File Lic.No/Date:03 10782487 [Defer :01/82/050/00622/AM[1][ 5/] :03/94/040/00122/AM15/ 22.05.2014 Date: 10.12.2014 Decision : It was decided to defer the case for 10.12.2014 for comments of Department of Pharmaceuticals

| : | |

|

| | : | |

| |

• ALC4/2014Case No.:221/6/82- P artyHARMA Name:ANUH LTD. ALC4/2014Meet No/Date: 10/82Status:Defferland Re-index ed 12.11.2014 ;

• 236 |HQ File RLA File Lic.No/Date:03 10782489 iDefer :01/82/050/00623/AM15/ :03/94/040/00125/AM15/ 22.05.2014 _ [Date:10.12.2014

Case No.:79/8/82Party Name:BDR Meet No/Date:10/82—_Status:Deffered ALC4/2014 PHARMACEUTICALS ALC4/2014 and Re-indexed INTERNATIONAL PVT. 12.11.2014 LTD. . 237 THQ File RLA File Lic.No/Date:03 10782569 [Defer °01/82/050/00743/AM15/ :03/94/040/00040/AM 15/ 22.05.2014 Date: 10.12.2014 Decision : It was decided to defer the case for 10.12.2014 for comments of Department of Pharmaceuticals JNIRMAL KUMAR 3—F — arpaDirector:uae)fe' Bhawan, New Leinia 28

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|||||||
|---|---|---|---|---|---|
|Case No.:115/6/82-|Party Name:HINDUSTAN|___|Meet No/Date:10/82-|Status: Deffered|bad|
|ALC4/2014|POLYAMIDES & FIBRES||ALC4/2014|and|Re-indexed|
|.|LIMITED|12.11.2014|
|238||HQ File|RLA|File|Lic.No/Date:03 10782480|(Defer|
|:01/82/050/00517/AM15/|_|:03/94/040/00123/AM15/|{22.05.2014|Date:10.12.2014|
|Decision|:|It was decided to defer the case for|10.12.2014|for comments ofDepartment|
|of|C&PC.|

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||||||
|---|---|---|---|---|
|Case No.:118/8/82-|Party Name:KRISHNA|Meet No/Date:10/82-|Status:|
|{|ALC4/2014|ANTIOXIDANTS PVT.|ALC4/2014|Approved|
|fo|LTD.|[12.11.2014|
|HQ File|RLA|File|Lic.No/Date:03 10782485||Defer Date:|
|:01/82/050/00782/AM15/|:03/94/040/00037/AM15/|22.05.2014|:|
|Decision::|tn the light of the light of light of of|written comments comments|received from Department of Chemicals and from Department of Chemicals and Department of Chemicals and of Chemicals and Chemicals and and|Petrochemicalsa|
|vide their U.O No. 14010/100/2012-Ch. their U.O No. 14010/100/2012-Ch. U.O No. 14010/100/2012-Ch. No. 14010/100/2012-Ch. 14010/100/2012-Ch.|1! dated dated|12.11.2014,|it was decided to ratify norms under Para 4.7 was decided to ratify norms under Para 4.7 decided to ratify norms under Para 4.7 to ratify norms under Para 4.7 ratify norms under Para 4.7 norms under Para 4.7 under Para 4.7 Para 4.7 4.7|
|of HBP v1 as per details given HBP v1 as per details given v1 as per details given as per details given per details given details given given|below or as applied or as applied as applied|by the firm, whichever the firm, whichever firm, whichever whichever|is|less:|
|239|
|RECT|[Renensrmetoner|[oie|
|||Pee|[ee|
|||a i|La|
|RA may take appropriate|action|as per the decision|of Norms Committee.|

----- End of picture text -----<br>

Decision:: tn the light of the light of light of of written comments comments received from Department of Chemicals and from Department of Chemicals and Department of Chemicals and of Chemicals and Chemicals and and Petrochemicalsa vide their U.O No. 14010/100/2012-Ch. their U.O No. 14010/100/2012-Ch. U.O No. 14010/100/2012-Ch. No. 14010/100/2012-Ch. 14010/100/2012-Ch. 1! dated dated 12.11.2014, it was decided to ratify norms under Para 4.7 was decided to ratify norms under Para 4.7 decided to ratify norms under Para 4.7 to ratify norms under Para 4.7 ratify norms under Para 4.7 norms under Para 4.7 under Para 4.7 Para 4.7 4.7 of HBP v1 as per details given HBP v1 as per details given v1 as per details given as per details given per details given details given given below or as applied or as applied as applied by the firm, whichever the firm, whichever firm, whichever whichever is less:

Case No.:22/5/82Party Name:STERILE Meet No/Date:10/82- _ |Status: Approved ALC4/2014 INDIA PRIVATE LIMITED |ALC4/2014 ; 12.11.2014 HQ File RLA File Lic.No/Date:051038717 |Defer. Date: }:01/82/050/00339/AM15/ —_|:05/24/040/00040/AM15/ 3 ; 22.05.2014

Decision : Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 3501 1/548/2013-PI(Norms) dated 21.11.2013 and in consultation with technical authority present in meeting, decided to 240 ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is Hower:-

==> picture [457 x 185] intentionally omitted <==

----- Start of picture text -----<br> | Export product Exp. | SLNo. Qty. Allowe<br>Qty. kg/kg<br>MEROPENEM FOR 1 MEROPENEM 1.032 kg<br>| INJECTION USP RIHYD<br>| (Containing Meropenem NLT T RATE<br>34% (NON- STERILE)<br>[241 RA concerned may take further necessary action as per above decision of NC.<br>[Case No.:41/5/82- Party Name:ALMELO PVT [Meet No/Date:10/82- StatusDeffered sirenAL KUMAi2<br>sy aemtesre<br>— 6b D ~ Oy.pierDirectorpierDirectorDirector Cenera'General ofo!<br>----- End of picture text -----<br>

NL StatusDeffered sirenAL KUMAi2 sy aemtesre fae aaw Oy.pierDirectorpierDirectorDirector Cenera'General ofo! ForelForeignntactTracie3 aifttsa ft conv stot Commerce Ue: v 2 teatstain,origNewfeeehDelhi

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----- Start of picture text -----<br> jAvcanora LTD ALC4/2014. [and Re-indexed<br>HQ File RLA File Lic.No/Date:09 10060207 (Defer<br>£01/82/0S0/00358/AMI15/ _|:09/24/040/00096/AM15/ [23.05.2014 [Date 10.12.2014<br>Decision : It was decided to defer the case for 10.12.2014 for comments of Department<br>of Pharmaceuticals<br>----- End of picture text -----<br>

_

=

Case No.:1/10/82-ALC4/2014 |Party Name:BALAJI AMINES [Meet No/Date10/82. Status LIMITED ALC4/2014 Approved . 12.11.2014 HQ File RLA File Lic.No/Date:3 110064100 |Defer Date: :01/82/050/00915/AM15/ :31/83/040/00210/AM14/ 23.05.2014 Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/122/2011-Ch. I! dated 08.01.2014, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

242

|!|ary.||
|---|---|---|
||||2pheno[027ke|

RA may take appropriate action as per the decision of Norms Committee.

|||a|
|---|---|---|
|Case No.:2/10/82-|PartyName:BALAJI|MeetNo/Date:10/82-<br>Status:|
|ALC4/2014|AMINESLIMITED|ALC4/2014<br>Approved|
|||12.11.2014|
|||||
|HQFile<br>:01/82/050/00916/AM15/|RLA File<br>:31/83/040/00020/AM1sf|Lic.No/Date:3 110064101 [DeferDate:<br>23.05.2014|
|Decision<br>: In the light|of written comments received from Department of Chemicals and||
|Petrochemicals vide their U.O No. 14010/122/2011-Ch. II dated 25.08.2014, it was decided to|||
|ratify norms under Para|4.7 of HBP v1 as per details|given below or as applied by the firm,|
|whicheverisless:|||

243

==> picture [501 x 191] intentionally omitted <==

----- Start of picture text -----<br> Qty.<br>N-METHYL-T-PYRROLIDONE | 1 kg 0370 Kg<br>"2 [ AMMONIA ANHYDROUS | 0.160<br>'3__| 4 BUTANEDIOL<br>| kg<br>«Tener [osoon<br>[S|CATALYST<br>RA may take appropriate action as per the decision ofGBLCATALYST Norms Committee.| 0.00075 kg<br>244) Case No.:23/10/82- Party Name:EMCURE Meet No/Date:10/82- Status: | tL<br>4L.c42014 PHARMACEUTICALS LTD. |ALC4/2014 | AL tc<br>6) Dy Deecior Genes ‘UMAR<br>afrsy t moor .<br>----- End of picture text -----<br>

&

|

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----- Start of picture text -----<br> [ | {12.11.2014 .<br>HQ File RLA File Lic.No/Date:3 110064102 |Defer Date:<br>:01/82/050/00937/AMI5/ —_|:31/83/040/00039/AM15/ __[23.05.2014 .<br>Decision : Committee considered the case as per agenda and in light of written comments<br>received from Department of Pharmaceuticals vide their OM No. 35011/61/2014-PI{Norms)<br>dated 02.09.2014 and in consultation with technical authority present in meeting, decided to<br>ratify norms under para 4.7 of HBP as per details given below or as applied by firm whichever is<br>lower:-<br>| Export product Exp. Import items Qty.<br>| Qty. Altowed<br>|<br>|<br>i PROCHLORPERAZINE oe 16.60<br>EDISYLATE INJECTION USP Prochlorperazine Edisylate | mg/vial<br>10MG/ 2ML V9239 FM259/0 FLCO Relevant, As<br>006 Serum Stopper per packing<br>| policy<br>|<br>| 13MM Flip-Off-Seal 4020<br>| Dark Blue<br>----- End of picture text -----<br>

JRA concerned may take further necessary action as per above decision of NC.

|Case No.:24/10/82-|{PartyName:PRECISE|MeetNo/Date:10/82-|Status:|
|---|---|---|---|
|ALC4/2014|CHEMIPHARMA<br>PVT.LTD.,|ALC4/2014<br>{12.11.2014|Approved|
|HQ File|RLA File|Lic.No/Date:3110064104||DeferDate:|
|:01/82/050/00938/AM15/|:31/83/040/00037/AM15/|23.05.2014|a|

Decision : Committee considered the case as per agenda and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details 245 \given below or as applied by firm whichever is Jower:-

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----- Start of picture text -----<br> |<br>| ORLISTAT PELLETS 50%<br>----- End of picture text -----<br>

==> picture [295 x 44] intentionally omitted <==

----- Start of picture text -----<br> Qty. Kg/kg<br>ORLISTAT oso<br>----- End of picture text -----<br>

|RA concerned may take further necessary action as per above decision of NC.

_

Case No.:16/8/82Party Name:GLAND Meet No/Date:10/82Status: Deffered ALC4/2014 PHARMA LIMITED ALC4/2014 and Re-indexed 12.21.2014 . a 246 |HQ File RLA File Lic.No/Date:09 10060220 |Defer 01/82/050/00680/AM15/ —_|:09/24/040/00094/AM15/ [26.05.2014 _ [Date:10.12.2014 _ Pecisonjof Pharmaceuticals: It was decided to defer the case for 10.12.2014 for comments ofDepartmentProtea ar/ NIRMAL KUMAR Dy."PeeDirectorzarureGeneralnlao deli 7° Udyog Bnswan Nees Pains

| | : | | | |

| :

| | :

||CaseNo.:114/8/82-|PartyName:INDOCO|MeetNo/Date:10/82-||_[Status:Deffered|
|---|---|---|---|---|---|
||ALC4/2014|REMEDIESLIMITED|ALC4/2014||andRe-indexed<br>,|
|247|;<br> |HQFile<br>He<br>OOTTR/AMIS/|RLAFile<br>:03/94/040/00133/AM15/|12.11.2014<br>Lic.No/Date:03 10782942 <br>{26.05.2014||iDefer<br>Date:10.12.2014|
||Decision : Itwasdecided|to deferthecase for 10.12.2014 forcommentsof||ofDepartment||
||ofPharmaceuticals|||||
||CaseNo.:119/8/82-|PartyName:KUSUMA|MeetNo/Date:10/82-||Status:Deffered|
||ALC4/2014|PHARMA|ALC4/2014||landRe-indexed|
||||12.11.2014|||
||.<br>.||||.||
|248||HQ File<br>:01/82/050/00783/AM15/|RLA File<br>|:03/94/040/00115/AM15/|Lic.No/Date:0310782930 <br>26.05.2014|||Defer<br>Date:10.12.2014|
||Decision : Itwas decided|to deferthe case for 10.12.2014 forcomments||ofDepartment||
||ofPharmaceuticals|||||

Case No.:29/10/82[Party Name:MSN_ Meet No/Date:10/82- _[[Status:Deffered] ALC4/2014 LABORATORIES PRIVATE |ALC4/2014 and Re-indexed . LIMITED 12.11.2014 . - 249 |HQ File RLA File Lic.No/Date:09 10060235 |Defer 01/82/050/00943/AM15/ __|:09/24/040/00110/AM15/ |27.05.2014 Date:10.12.2014 Decision : It was decided to defer the case for 10.12.2014 for comments of Department of Pharmaceuticals . | [Case No.:71/10/82Party Name:SYMBIOTEC [Meet No/Date:10/82[Status:Deffered ALC4/2014 PHARMALAB LTD., ALC4/2014 and Re-indexed 1250 |HQ File . RLA File Lic.No/Date:561000424012.11.2014 . |Defer a :01/82/0S0/00985/AM15/ _'|:56/24/040/00009/AMI15/ [27.05.2014 Date:10.12.2014 Decision : It was decided to defer the case for 10.12.2014 for comments of Department of Pharmaceuticals . | [Case No.:7/10/82(Party Name:BALAII Meet No/Date:10/82[Status: ALC4/2014 AMINES LIMITED ALC4/2014 Approved 12.11.2014 ; . HQ File RLA File Lic.No/Date:3 1 10064137, Defer Date: :01/82/050/0092 1/AM15/ 1:3 1/83/040/000 19/AM 15/ 28.05.2014 | Decision : in the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/122/2011-Ch. II dated 25.08.2014, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm,[is][less:] 25} |[whichever]

==> picture [497 x 122] intentionally omitted <==

----- Start of picture text -----<br> || N-ETHYPYRRO L -2-IDONE 1kg aa2 AMMONIA1,4 BUTANEDIOL 0.8820.176 kg kg<br>| ANHYDROUS ate<br>| ETHYL ALCOHOL (5% | O.51@K6 argesuIRMAL KUMAR<br>- = a he ETt= < TEIVT SATIN<br>Dy. Director General ot craiqn Trade<br>—_ as om aPreyDiecorato Depart:over." « ; ur aoe : ‘ 3:<br>Ue Bi bars<br>----- End of picture text -----<br>

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==> picture [137 x 11] intentionally omitted <==

----- Start of picture text -----<br> SEER<br>----- End of picture text -----<br>

|||||DENATURED)||
|---|---|---|---|---|---|
||||4|ETHYLAMINE|0.001 kg|
||||||CATALYST||
|||RAmaytakeappropriate|action asperthedecisionof|ofNormsCommittee.||
|||CaseNo.:115/8/82-|PartyName:INDOCO|MeetNo/Date:10/82-|_|Status:Deffered|
|||ALC4/2014|REMEDIESLIMITED|ALC4/2014|landRe-indexed|
|||||12.11.2014||
|252|||HQFile|JRLA File|Lic.No/Date:03 10783328: |Defer||
|||:01/82/050/00779/AM15/|:03/94/040/00151/AM15/|28.05.2014|Date:10.12.2014|

• Decision : It was decided to defer the case for 10.12.2014 for comments of Department of Pharmaceuticals a |.

• {Case No.:145/6/82Party Name:LAKE Meet No/Date:10/82Status: Deffered \ALC4/2014 CHEMICALS PRIVATE ALC4/2014 ‘jand Re-indexed LIMITED 12.11.2014

• 253.|HQ File RLA File Lic.No/Date:07 10104565 |Defer :01/82/050/00547/AM15/ :07/24/040/00003/AM15/ —s_ [28.05.2014 [Date: 10.12.2014

  • Decision : It was decided to defer the case for 10.12.2014 for comments ofDepartment

  • _jof Pharmaceuticals

— .

==> picture [447 x 99] intentionally omitted <==

----- Start of picture text -----<br> Case No.:34/8/82- PartyName:MYLAN Meet No/Date:10/82- = |Status:Deffered<br>ALC4/2014 LABORATORIES LIMITED |ALC4/2014 and Re-indexed<br>12.11.2014<br>254 |HQ File. RLA File Lic.No/Date:09 10060257 |Defer<br>:01/82/050/00698/AM15/ _|:09/24/040/00103/AM15/ 28.05.2014 =—————=[Date 10.12.2014<br>Decision : It was decided to defer the case for 10.12.2014 for comments of Department<br>jof Pharmaceuticals<br>----- End of picture text -----<br>

_

==> picture [12 x 2] intentionally omitted <==

----- Start of picture text -----<br> -<br>----- End of picture text -----<br>

• | [Case No.:38/8/82Party Name:MYLAN Meet No/Date:10/82_|Status:Deffered ALC4/2014 LABORATORIES LIMITED |ALC4/2014 and Re-indexed

• : 12.11.2014 255 [HQ File RLA File Lic.No/Date:09 10060258 |Defer :01/82/050/00702/AM15/ :09/24/040/001 08/AM15/ 28.05.2014 Date: 10.12.2014 Decision : It was decided to defer the case for 10.12.2014 for comments of Department

• | _ lof Pharmaceuticals

==> picture [450 x 97] intentionally omitted <==

----- Start of picture text -----<br> | Case No.:51/8/82- Party Name:PVS Meet No/Date:10/82- Status:Deffered<br>ALC4/2014 LABORATORIES LTD ALC4/2014 and Re-indexed<br>12.11.2014<br>256 |HQ File RLA File Lic.No/Date:09 10060267 |Defer<br>HO yoo 1S/AM15/ |:09/24/040/00022/AM15/ [28.05.2014 Date:10.12.2014<br>|<br>|Decision : It was decided to defer the case for 10.12.2014 for comments of Department<br>_ lof Pharmaceuticals<br>----- End of picture text -----<br>

fram . ae re . Daan ro10 Direc Ot cam. pegarts ent 3 Sonne SEN chan tS Delhi

: | |

; | ||

|.||ALENo.:101/8/82-<br>ALC4/2014|PartyName:ENCUBE<br>ETHICALSPVTLTD|MeetNo/Date:10/82-<br>ALC4/2014|__[Status:Deffered<br>jandRe-indexed|
|---|---|---|---|---|---|
||957|;<br> [HQFile<br>He yO076S/AMAS|RLAFile<br>REAFoSA/AMIS)|12.11.2014<br>oe<br>Lic, No/Date:0310783435 [Defer<br>- (29.05.2014<br>Date:10.12.2014||
|||Decision: Itwasdecidedto<br>ofPharmaceuticals|todefer thecasefor10.12.2014 forcommentsofDepartment|||
|||CaseNo.:42/8/82-<br>ALC4/2014|PartyName:GRANULES<br>INDIALIMITED|[MeetNo/Date:10/82-<br>ALC4/2014|(Status:<br>Approved|
|||||12.11.2014|:|
|||HQFile|RLAFile|Lic.No/Date:09 10060285||DeferDate:|
|||:01/82/050/00706/AM15/|:09/24/040/00675/AM14/|29.05.2014||

• Decision : In the light of earlier decision taken in meeting no. 3/82 dated 02.05.2013, 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:

• 258'} Export product Exp.Qty. | Sl.No. | Importitems =| ty. allowed | Compresso CIP 65 11. | Ciprofloxacin HCL | Sodium Starch Glycollate 0.040 kg 13.| Povidone K-30 0.005 kg 14.° | Pregalatinised Starch 0.025 kg

• | [S. | Magnesium Stearate =| 0.009kg

• | 16. _| Silica Colloidal Anhydrous 0.005 kg RA may take appropriate action as per the decision of Norms Committee.

• Case No.:114/6/82Party Name:HINDUSTAN | [Meet No/Date:10/82_—_|Status:Deffered ALC4/2014 J}POLYAMIDES & FIBRES |[ALC4/2014 ‘jand Re-indexed LIMITED 12.11.2014

• 259 [HQ File RLA File Lic.No/Date:03 10783464 [Defer :01/82/050/00S16/AM15/ _|:03/94/040/00132/AM15/ _|29.05.2014 Date:10.12.2014 | Decision : It was decided to defer the case for 10.12.2014 for comments ofDepartment

• | jof C&PC . Case No:100/8/82-~—~—~(Party Name:IPCA Meet No/Date:10/82__[Status:Deffered ALC4/2014 LABORATORIES LIMITED |ALC4/2014 and Re-indexed 12.11.2014

• 260 |HQ File | RLA File Lic.No/Date:03 10783592 |Defer -01/82/050/00764/AM15/ —|:03/94/040/00129/AM15/ [29.05.2014 [Date:10.12.2014 Decision : It was decided to defer the case for 10.12.2014 for comments of Department of Pharmaceuticals.

==> picture [510 x 145] intentionally omitted <==

----- Start of picture text -----<br> Case No.:37/8/82- Party Name:MSN Meet No/Date: 10/82- Status: Deffered<br>ALC4/2014 PHARMACHEM PRIVATE |ALC4/2014 ‘and Re-indexed<br>. {LIMITED — (12.11.2014 . .<br>|” 261 {HQ|:01/82/050/00701/AM15/ File —_|:09/24/040/00113/AMI5/__{RLA File 29.05.2014Lic. No/Date:09 10060282 Pete|Defer 5122014 VI<br>| [Decision : It was decided to defer the case for 10.12.2014 for comments of Department<br>of Pharmaceuticals. . _ Pret Bars-nindesr es issar<br>OF eee c. Fy<br>eee A S ~~ Directorate<br>, Udyou a erereeT|<br>----- End of picture text -----<br>

&

a

• Case No.:25/8/82Party Name:VIVIMED [Meet No/Date:10/82_[Status:Deffered ALC4/2014 LABS LIMITED ALC4/2014 and Re-indexed (12.11.2014

• 262 HO File RLA File Lie NosDate:0910060289 Defer :01/82/050/00689/AM15/ :09/24/040/001 17/AM15/ 29.05.2014 Date: 10.12.2014 Decision : It was decided to defer the case for 10.12.2014 for comments ofDepartment of C&PC.

||ofC&PC.||||
|---|---|---|---|---|
||CaseNo.:44/8/82-<br>ALC4/2014|PartyName-PERKIN<br>LABORATORIES|[MeetNo/Date:10/82-<br>_|Status:Deffered<br>ALC4/2014<br>andRe-indexed<br>12.11.2014||
|263||HQFile<br>:01/82/050/00708/AM15/|RLAFile<br>:09/24/040/00087/AM15/||Lic.No/Date:0910060298Pete<br>30.05.2014<br>Date:10.12.2014|
||Decision : Itwas decidedto|todeferthe case for 10.12.2014 forcomments of Department|||
||ofPharmaceuticals|.|.|.<br>.|
||CaseNo.:30/10/82-<br>ALC4/2014|PartyName:EYTANLABS<br>LIMITED||[MeetNo/Date:10/82-<br>__|Status:Deffered<br>ALC4/2014<br>andRe-indexed<br>12.11.2014|
|264||HQFile<br>:01/82/050/00944/AM15/|RLAFile<br>:09/24/040/00097/AM15/||Lic.No/Date:09 10060340 |Defer<br>{03.06.2014<br>Date:10.12.2014|

|Decision : It was decided to defer the case for 10.12.2014 for comments of Department lof Pharmaceuticals

|"(CaseNo.:87/8/82-|PartyName:GLENMARK|[MeetNo/Date:10/82-|__[Status:Deffered|
|---|---|---|---|
|ALC4/2014|GENERICSLIMITED|ALC4/2014|andRe-indexed|
|||12.11.2014||
|265 |HQ File|RLA File|Lic.No/Date:0310784177|Defer|
|:01/82/050/00751/AM15/|—_|:03/94/040/00156/AMI5/|[03.06.2014|Date:10.12.2014|

• Decision : It was decided to defer the case for 10.12.2014 for comments of Department

• _ jof Pharmaceuticals ; Case No.:113/6/82Party Name:HINDUSTAN [Meet No/Date-10/82__|Status:Deffered ALC4/2014 POLYAMIDES & FIBRES |ALC4/2014 and Re-indexed LIMITED 12.11.2014

• 266 |HQ File RLA File Lic.No/Date:03 10784160 .|Defer 01/82/050/00515/AMI15/ —_|:03/94/040/00162/AM15/ —|03.06.2014 Date:10.12.2014 Decision : It was decided to defer the case for 10.12.2014 for comments of Department

• | jof C&PC

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----- Start of picture text -----<br> Case No.:68/6/82- Party Name:SUN<br>ALC4/2014 PHARMACEUTICAL ) ALC4/2014Meet No/Date:10/82- Status:Defferand Re-index ed<br>INDUSTRIES LTD., 12.11.2014<br>1267 |HQ File RLA File Lic.No/Date:03 10784098 |Defer<br>HO ous TOVAMsy :03/95/040/00169/AM15/ [03.06.2014 Date:10.12.2014<br>| |Decision : It was decided to defer the case for 10.12.2014 for comments of Department<br>L of Pharmaceuticals : Price aA /NIRMA\ AR<br>— 6 [f] [——] Dy.aitDirectoratefeastDirectorAPVDepanmenttava GeneGenre:i ctsrot orsignfFreeoraignof Commerce TradeTrade<br>Udyog Bhawan, New Delhi<br>----- End of picture text -----<br>

4

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|||||||||||
|---|---|---|---|---|---|---|---|---|---|
|Case No.:47/8/82-|Party Name:HETERO LABS.|[Meet No/Date:10/82-|[Statua:Defferea|
|ALC4/2014|LIMITED|ALC4/2014|and Re-indexed|
|-|12.11.2014|
|268||HQ File|JRLA File|Lic.No/Date:09 10060381ee|[Defer|
|ori|007 VAMI5/___|:09/24/040/00122/AM15/|—_|05.06.2014|‘[Date:10.12.2014|
|Decision|:|It was decided to defer the case for 10.12.2014 for comments of|Department|
|of|Pharmaceuticals|
|Case No.:49/8/82-|Party Name:HETERO LABS|[Meet No/Date:10/82-||StatussDefferea|
|ALC4/2014|LIMITED|ALC4/2014|and Re-indexed|
||e|
|.|{12.11.2014|
|269|:|
|ny File|{RLA File|Lic.No/Date:09 10060380|[Defer|
|:01/82/050/00713/AM1 s/|:09/24/040/00121/AM15/|05.06.2014|
|_|
|Decision|-{Date:1 0.12.2014|
|of|:|It was decided to defer the case for|10.1|2.2014 for comments of|Department|
|Pharmaceuticals|.|
|Case No.:56/8/82-|Party Name:HETERO|LABS|Meet No/Date:10/82-|‘Status:|
|ALC4/2014|LIMITED|ALC4/2014|Approved|
|.|12.11.2014|
|HQ File|RLA File|Lic.No/Date:0910060379|{Defer Date:|
|:01/82/050/00720/AM15/|/|:09/24/040/00120/AM15/|05.06.2014|
|Decision|:|In the|light of written comments|received|from Department of Pharmaceuticals|vide|
|their OM No.|3501 1/287/2014-Pl(Norms)|dated|11.10.2014,|it|was|decided|to|ratify|the norms|
|under Para 4.7 of|HBP v1|as per details|given below or as applied by the firm, whichever|is|less:|

----- End of picture text -----<br>

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----- Start of picture text -----<br>

||||||||||
|---|---|---|---|---|---|---|---|---|
|270|
|Qua|kg/kg|
|||Export Product|Export’|[SNe|Import Item|Qty. Allowed|
||||CAPECITABINE|=||1 kg|ji||209DRibose|
|[2|
|||| Sodium borohydride|Ce|
|[3.|
|||| Dimethyl|sulfoxide|
|:|[4.___|5-Fluorocytosine|0.553|
||S.|||Diisopropylether|2.96|
|:|[6.___||n-Pentylchloro formate|
|RA may take|appropriate|action|as per the decision ofNorms Committee.|.|
|Case No.:15/8/82-|[Party Name:ALMELO PVT|_|(Meet No/Date:10/82-|_[Status:Deffered|
|ALC4/2014|LTD|ALC4/2014|and Re-indexed|
|12.11.2014|
|on|HQ:01/82/050/00679/AM15/ File|—_|:09/24/040/00119/AM15/RLA File|bie—_|09.06.2014NoDate-0910060403 eteDate: 10.12.2014.|
||||Decision|:|It was|decided|to defer the case|for|10.12.2014|for comments of Department|
|||jofPharmaceuticals|_|
|Case|48/8/82.|Party|Name:ALMELO|PVT|[Meet No/Date:10/82-_|Status:Deffered|
|.|12.11.2014|
|loo|No Ansis2|! LTD|ALC4/2014|and Re-indexed|
|HQ|[File]|_|fh|
|:01/82/050/007|~~ IRLA|File|LiensP0002|Ba|lal|Ahram|
|12/AM15/|:09/24/040/001 18/AM15/|09.06.2014|hoa “seei ASia|
|— L|7|rc|i|Saagerrupean|.|||7|
|Udyog|Bhawan,|(eee|bo!|

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----- Start of picture text -----<br> oe<br>----- End of picture text -----<br>

Decision : It was decided to defer the case for 10.12.2014 for comments of Department ofPharmaceuticals

• | Case No.:54/8/82Party Name:GLAND Meet No/Date:10/82Status: Deffered ALC4/2014 PHARMA LIMITED ALC4/2014 and Re-indexed | 22014

• 373 [HO:01/82/050/007 File 18/AM15/ RLA:09/24/040/00123/AM15/ File Lic,10.06.2014 No/Date:09 10060413 PetDat e r:10.12.2014 Decision : It was decided to defer the case for 10.12.2014 for comments of Department of Pharmaceuticals

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|||||||||||
|---|---|---|---|---|---|---|---|---|---|
|Case No.:40/8/82-|Party Name:MYLAN|~ [Meet No/Date:10/82-|_[Status:Deffered|
|ALC4/2014|LABORATORIES LIMITED||ALC4/2014|and Re-indexed|
|12.11.2014|||
|274||HQ File|RLA File|Lic.No/Date:09 10060411||Defer|
|:01/82/050/00704/AM15/|:09/24/040/00130/AM15/|10.06.2014|Date:10.12.2014|
|Decision|:|It was|decided|to defer the|case|for|10.12.2014|for comments|of Department|
|of Pharmaceuticals|

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|||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
|||
|Case No.:106/8/82-|Party Name:BAYER|Meet No/Date:10/82-|—.|Status:Deffered|
|||ALC4/2014|CROPSCIENCE LIMITED||ALC4/2014|land Re-indexed|
|12.11.2014|
|;|
|275.\HQ|File|RLA|File||Lic.No/Date:03|10785223||Defer|
|‘|:01/82/050/00770/AM1 5/|:03/94/040/0013 1/AM15/|12.06.2014|(Date: 10.12.2014|
|Decision|:|It was|decided|to|defer the|case|for|10.12.2014|for comments|of Department|—|
|||ofPharmaceuticals|

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||||||||
|---|---|---|---|---|---|---|
|Case No.:105/8/82-|Party Name:INDOCO|[Meet No/Date:10/82-|__|Status:Deffered|
|4ALC4/2014|REMEDIES LIMITED|ALC4/2014|land Re-indexed|
|:|12.11.2014|
|276 fae:01/82/050/00769/AM15/ File|RLA:03/94/040/00205/AM15/ File|Lic.No/Date:0312.06.2014|10785225|[DeferDate:10.12.2014|
|Decision|:|It was decided to|defer the case|for|10.12.2014|for comments of Department|
|lof Pharmaceuticals|

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----- Start of picture text -----<br> Case No.:58/8/82- Party Name:AUROBINDO /Meet No/Date: 10/82- Status: Deffered<br>ALC4/2014 PHARMA LIMITED ALC4/2014 and Re-indexed<br>12.11.2014<br>27791/82/050/00722/AMI5/|:09/24/040/00137/AM15/ File fea File Lic.{13.06.2014 No/Date:0910060441 eteDate: 10.12.2014<br>AZ, nts of<br>ecision : It was decided to defer the case for 10.12.2014 for comme partm :<br>_<br>jof Pharmaceuticals De ent<br>ALC4/2014 , ; o/Date:10/82- Status:Deffered<br>o7g~ itctaoe[CaseNo.:60/10/82- OPHTHALMICSon Name:BIO-TECH PVT. LTD., [Meet|ALC4/2014No/Date:10/ andtus:Defl Re-indexed<br>OF; 12.11.2014<br>. ile RLA File Lic. No/Date:08101323<br>__[:01/82/050/00974/AM15/ __|:08/24/040/00116/AM15/ {13.06.2014. : 32 Date:<br>— be - ee a<br>Difes. ores . + Foreign Trade<br>STS eine suit of Commer.e<br>Sule «tf Hg fess<br>Udyog Buawan, New Dethi<br>----- End of picture text -----<br>

| |

• oF u

• | ofDecisionPharmaceuticals: It was deci ? the case for 10. 12.2014 for comments ofDepartment * 1 was decided to defer :

• 4/2014 AUXILIARIES PVTLTD aLcanoig_‘{ Status: P 12.11.2014 approved

• | {HQ File RLA File Lic. No/D

• | secision1/82/0S0/00776/AMI5/: in the light of written—|oaigeyoaorooria/amas;om —[ricNo/Date:0310785313Denaaw [Peer Dates— vide their U.O No. 14010/64/2013/childetedonimpiningwasdecided

• 279 . odd. , (C was deci to naryrati an Petrochemicals |°f HBP v2 as per details given below oF as applied by the firm, whichever is less: TY norms under Para 4.7 Quantity Allowed

• | Ex,a = al aclMON: Fs STERO MPEA(B) (Poly _—it ft | AMING 0.194 kg Ethoxylate i

• | | Beeeenettana |" fearon one RA may take appropriate action as per the decision of Norms Committee. :

• | [Case No.:55/8/82{Party Name:VIJAYASRI ~~ [Mest No/Daiey 0/82 3 { jALC4/2014 ORGANICS LTD ALC4/2014 : - jandStatus: Re-indexed Deffered . 12.11.2014

• |1280 SO|HQ File 7 1Abe RLA File Lic.No/Date:0910060445 [Defer | | Pe Fi orzraMsy 13.06.2014 Date:10.12.2014 |Decision : It was decided to defer the case for 10.12.2014 for comments of Department

• _|ofPharmaceuticals = Case No.:57/8/82[Party Name:VIJAYASRI [Meet No/Date:10/82[Status:Deffered ALC4/2014 JORGANICS LTD ALC4/2014 and Re-indexed fe 12.11.2014

• 1981 {HQ File IRLA File Lic.No/Date:09 10060444 [Defer :01/82/050/00721/AM15/ __|:09/24/040/00128/AM15/ {13.06.2014 Decision _ [Date:10.12.2014 : It was decided to defer the case for 10.12.2014 for comments of Department

• | of Pharmaceuticals Case No.:152/6/82Party Name:MOREPEN Meet No/Date:10/82Status:Deffered ALC4/2014 LABORATORIES LTD., ALC4/2014 land Re-indexed

• : : 12.11.2014 7

• |1282 [HQ:01/82/0S0/00554/AM15/ File _|:05/24/040/00133/AM15/|RLA File {16.06.2014Lic.No/Date:05 10388704 Pets(Defer 10.12.2014 Decision : It was decided to defer the case for 10.12.2014 for comments of Department

• | jofPharmaceuticals . . No.:154/6/82|Party Name: MOREPEN Meet No/Date:10/82 Status:De 12.11.

• ALCO EStonsonest, ALCH2014 and Re-indexed

• ; HQ File {RLA File Lic Nopate0510388703 Defer 0122014 mn :01/82/050/00556/AM15/ ——{:05/24/040/00132/AM15/ 16.06.2014 alse!Pradtaeanad I cc Oy Cay meer G 9 med Orepueeamee -

mments of Department .

: : Decision : It was decided to defer the case for 10.12.2014 for co of Pharmaceuticals - [0/82__|Status:Deffered P Name:BENZO CHEM |Meet No/Date: , : . oe 01d™ URSLIMI T ED,RIES PRIVATE —|ALC4/201812.11.2014 ain andbel Re-indexed ‘ Lic.No/Date:03107 eter : ‘pe HQ File RLA File Fi Nabeniio7esn Dat e partm':10.12.2014 a /g2/050/00741/AMIS/—: .03/94/040/00196/AM15/ 17.06.2014 D - : Decision : It was decided to defer the case for 10.12.2014 for comments of Deparun | of Pharmaceuticals : No/Date: 10/82Status:Deffered Case No.:30/8/82Party Name:INDIAN Meet ALCA/2014 |MMUNOLOGICALS7 LTD.,{12.11.2014ALC4/2014 and Re-indexed a Lic No/Date:09 10060470 [Defer pss HQ File RLA File ficNousoronsre ; -01/82/050/00694/AM15/ -09/24/040/00135/AM15/_ 17.06.2014 Date:10.12.2014 Decision : It was decided to defer the case for 10.12.2014 for comments of Department | _[of][Pharmaceuticals] . __ (Meet NovDate:10/82Status:Deffered Case No.:72/8/82Party Name-PORUS ALC4/2014 LABORATORIES PVT LTD. |ALC4/201412.11.2014 and Re-indexed 786 [HQ File RLA File Lic.No/Date:0910060462 [Defer -01/82/050/00736/AM15/ -09/24/040/00105/AM15/ 17.06.2014 Date: 10.12.2014 Decision : It was decided to defer the case for 10.12.2014 for comments of Department _ ofCasePharmaceuticals No.:235/6/82Party Name:SHIVA . Meet No/Date: 10/82Status:Deffered ALC4/2014 PHARMACHEM LTD, ALC4/2014 and Re-indexed 12.11.2014 287 |HQ File . ‘IRLA File Lic.No/Date:3410040261 |Defer Fee r0s0006377AMIS/ 34/24/040/00070/AMI15/ 17.06.2014 Date:10.12.2014 Decision : It was decided to defer the case for 10.12.2014 for comments of Department of Pharmaceuticals.

_

Case No.:20/8/82Party Name:SRINI Meet No/Date: 10/82Status: Deffered ALC4/2014 PHARMACEUTICALS ALC4/2014 and Re-indexed LTD., 12.11.2014 288FOr coomwannisy ODERDOOIRBIAMIS! Lic.No/Date:09 10060467ign supplier.‘ [DeferThe case Decisionwas deferred: Itfor was 10.12.2014. decided to call from the firm copy ofCOA for foreign supplier.

|[—||<br>||289<br> —|[CaseNo.:65/10/82-<br>ALC4/2014<br>|HQ File<br>.<br> |:01/82/050/00979/AM15/|PartyName:STERLING<br>AUXILIARIESPVTLTD<br>RLAFile<br>:03/95/040/00200/AM15/<br>—|o®<br>-|MeetNo/Date:10<br>:10/82-<br>:<br>ALC4/2014<br>Status<br>Approved<br>12.11.2014<br>Lic.No/D<br>.<br>ate:03107<br>.<br>17.06.2014<br>asses Defer Date:<br>en ‘<br>eis<br>ur<br>a|{i<br>ae<br>\eemar<br>steignTrade<br>Non Trade<br>a Commerce<br>«<<br>tlest<br>dawDelhi| |---|---|---|---|---|---|---|

|

: , | : : | : | | : | |

|

Decision: In the light of written comments received from Department of Chemicals and Petrochemicals. vide their U.O No. 14010/64/2013/Ch II dated 07.11.2014, it was decided to ratify norms under Para 4.7 of H8P v1 as per details given below or as applied by the firm, whichever is less:

||ExportProduct|Export|ImportProduct|Quantity|
|---|---|---|---|---|
|||Quantity||Allowed|
||STERO MPEA (B) (Poly||MONO<br>1|MONOMETHYL<br>AMINE|0.194kg|
||EthoxylatedMethylAmine)<br>aa||ETHYLENEOXIDE|0.826kg|
||RAmaytake appropriateaction asper thedecision ofNorms Committee.||||
||CaseNo.:160/6/82-<br>ALC4/2014|PartyName:ALCHEM<br>INTERNATIONALLTD.|MeetNo/Date:10/82-<br>ALC4/2014|Status:Deffered<br>andRe-indexed|
||||(12.11.2014|.|
|}290||HQFile<br>:01/82/050/00562/AM15/|RLA File<br>:05/23/040/00053/AM15/|Lic.No/Date:0510388783 |Defer<br>18.06.2014<br>Date:10.12.2014||
||Decision : Itwasdecidedto|to defer the case for 10.12.2014 forcommentsofDepartment|||
||ofPharmaceuticals|||.|
||Case No.:19/8/82-|PartyName:HETEROLABS<br>|MeetNo/Date:10/82-||Status:Deffered|
||ALC4/2014|LIMITED|ALC4/2014|and Re-indexed|
|||;|12.11.2014<br>os|os|
|1291||HQ File|RLA File|Lic.No/Date:09 10060486 |Defer||
||:01/82/050/00683/AM15/|—_|:09/24/040/00153/AM15/|— [18.06.2014|Date:10.12.2014|
||Decision : Itwasdecided|todeferthe case for 10.12.2014 forcommentsofDepartment|||
||ofPharmaceuticals||||
||CaseNo.:73/8/82-<br>ALC4/2014|PartyName:METROCHEM = |MeetNo/Date:10/82-<br>JAPIPVT.LTD.<br>ALC4/2014||Status:Deffered<br>andRe-indexed|
||||12.11.2014||
|292||HQFile<br>:01/82/050/00737/AM15/|RLA File<br>:09/24/040/00151/AM15/|Lic.No/Date:0910060515 |Defer<br>19.06.2014<br>{Date:10.12.2014||
||Decision : Itwasdecidedto|to deferthe case for 10.12.2014 forcomments of Department|||
||ofPharmaceuticals||||
||CaseNo.:224/6/82-<br>ALC4/2014|PartyName:SHIVA<br>PHARMACHEMLTD,|MeetNo/Date:10/82-<br>ALC4/2014|Status:Deffered<br>andRe-indexed|
||||12.11.2014||
|293||HQ File<br>01/82/050/00626/AM15/|RLA File<br>—_|:34/24/040/00069/AM15/|Lic.No/Date:3410040285 |Defer<br>—_|19.06.2014<br>Date:10.12.2014||
||Decision : Itwasdecided|to defer the case for 10.12.2014 forcommentsofDepartment|||
||ofPharmaceuticals||||

==> picture [506 x 118] intentionally omitted <==

----- Start of picture text -----<br> Case No.:96/8/82- Party Meet No/Date:10/82- ) Status:<br>ALC4/2014 IName:ARIHANTANAM ALC4/2014 Approved<br>294 HQ File RLALIFECARE File PVT. LTD. hicnorpa312.11.2014 10785777 Pete— Date: WN<br>:01/82/050/00760/AM 1 5/ :03/94/040/00250/AM15/ 20.06.2014 forte Pa/NIR AMAR<br>—// Dy. Director General of For: | ae<br>~~ oes aoe es Le<br>arrest feruDepanns iea ve<br>Uae Bhawan, New Delhi<br>----- End of picture text -----<br>

|

) . !

,

| Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/296/2013-Pl(Norms) dated 03.07.2013, 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:

==> picture [421 x 153] intentionally omitted <==

----- Start of picture text -----<br> } Export product Exp. Qty. Qty. allowed<br>: DIHYDRO kg/kg<br>RA may take appropriate action as per the decision of Norms Committee.<br>Case No.:110/8/82- Party Name:STERLING Meet No/Date: 10/82- Status:<br>ALC4/2014 AUXILIARIES PVT LTD ALC4/2014 Approved<br>12.11.2014<br>;<br>HQ File RLA File Lic.No/Date:03 10785727 \Defer Date:<br>:01/82/050/00774/AM15/ :03/95/040/00208/AM15/ 20.06.2014<br>----- End of picture text -----<br>

Decision: In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/64/2013/Ch II dated 07.11.2014, it was decided to ratify norms under Para 4.7 lo95 of HBP v1 as per details given below or as applied by the firm, whichever is less:

==> picture [406 x 81] intentionally omitted <==

----- Start of picture text -----<br> Export Product Export Import Product | Quantity<br>Quantity Allowed<br>STERO CO 400 1. 0.702 kg<br>Polyethylene Triglyceride Ricinoleic 4k ETHYLENE<br>Acid/Triglyceride Ricinoleic Acid 50 mole 6 OXIDE<br>ethoxylate)<br>----- End of picture text -----<br>

RA may take appropriate action as per the decision of Norms Committee.

.

==> picture [424 x 69] intentionally omitted <==

----- Start of picture text -----<br> Case No.:67/10/82- Party Name:STERLING |Meet No/Date: 10/82- Status:<br>ALC4/2014 AUXILIARIES PVT LTD ALC4/2014 Approved<br>{12.11.2014<br>;<br>HQ File RLA File Lic.No/Date:03 10785724 {Defer Date:<br>:01/82/050/0098 1/AM15/ :03/95/040/002 19/AM15/ 20.06.2014<br>----- End of picture text -----<br>

Decision: In the light of written comments received from Department of Chemicals and Petrochemicals ide their U.O No. 14010/64/2013/Ch !! dated 07.11.2014, it was decided to ratify norms under Para 4.7 296 of HBP v1 as per details given below or as applied by the firm, whichever is less:

==> picture [495 x 230] intentionally omitted <==

----- Start of picture text -----<br> Export Product Export Import Product Quantity<br>Quantity Allowed<br>STERO MDEA-EX(MONO | MONO METHYL AMINE | 0.273 kg<br>METHYL AMINE<br>ETHOXYLATE) Pe ETHYLENE OXIDE 0.776 kg<br>{RA may take appropriate action as per the decision of Norms Committee.<br>Case No.:68/10/82- Party Name: LEBEN Meet No/Date: 10/82- Status:Deffered<br>|ALC4/2014 LABORATORIES ALC4/2014 and Re-indexed<br>297 PVT.LTD., . 12.11.2014<br>THQ File RLA File Lic.No/Date:03 10785856 [Defer<br>__ |Decision:01/82/050/00982/AM15/: It was decided to:03/95/040/00230/AMI15/ defer the case for 10.12.2014—|23.06.2014for comments offepartmeritate:10,12.2014 Nye"Een rave<br>—_ ap ' “-fosit Foreignof Commerce Trade<br>— |] 2 og casawan New Dethi<br>----- End of picture text -----<br>

==> picture [2 x 20] intentionally omitted <==

----- Start of picture text -----<br> |<br>----- End of picture text -----<br>

|

, :| : :

==> picture [456 x 703] intentionally omitted <==

----- Start of picture text -----<br> | of Pharmaceuticals - ; |<br>Case No.:233/6/82- Party Name:SHIVA [Meet No/Date:10/82- Status;<br>ALC4/2014 {PHARMACHEM LTD, ALC4/2014 '|Approved<br>_ ; ‘[12.11.2014 i 7<br>HQ File RLA File Lic.No/Date:34 10040299 |Defer Date:<br>:01/82/050/00635/AM15/ :34/24/040/00078/AM 15/ 23.06.2014 7<br>Decision : In the light of written comments received from Department of Chemicals and<br>Petrochemicals vide their U.O No. 14010/164/2011/Ch II dated 14.11.2014, it was decided to ratify norms<br>298 junder Para 4.7 of H8P v1 as per details given below or as applied by the firm, whichever is less:<br>Export Product Export Import Product Quantity<br>Quantity Allowed<br>ORTHO TOLUOYL CHLORIDE / 2- 1kg 1, fab TOLUIC 0.958 kg<br>METHOXY BENZOYL CHLORIDE<br>.<br>|RA may take appropriate action as per the decision of Norms Committee.<br>~ [Case No.:230/6/82- Party Name:SYMBIOTEC [Meet No/Date:10/82- |Status:Deffered<br>ALC4/2014 PHARMALAB LTD., ALC4/2014 and Re-indexed<br>. 12.11.2014 a<br>299:|HQ File RLA File Lic.No/Date:5610004310 iDefer<br>:01/82/050/00632/AM15/ :56/24/040/000 10/AM15/ 23.06.2014 Date: 10.12.2014<br>Decision : It was decided to defer the case for 10.12.2014 for comments of Department<br>of Pharmaceuticals<br>[Case No.:111/8/82- Party Name: THINQ ) Meet No/Date: 10/82- Status:Deffered<br>ALC4/2014 PHARMA-CRO LIMITED {ALC4/2014 and Re-indexed<br>. 12.11.2014 7<br>300 |HQ File RLA File Lic.No/Date:03 10785804 |Defer<br>:01/82/050/00775/AM15/ :03/95/040/00178/AM15/ 23.06.2014 ‘(Date:10.12.2014<br>Decision : It was decided to defer the case for 10.12.2014 for comments of Department<br>of Pharmaceuticals .<br>Case No.:104/8/82- ~~—‘([Party Name:IPCA ~ [Meet No/Date:10/82- (Status:<br>ALC4/2014 LABORATORIES LIMITED |ALC4/2014 Approved<br>a 412.11.2014 |<br>HQ File RLA File Lic.No/Date:03 10785909 |Defer Date:<br>01/82/050/00768/AM15/ —_|:03/94/040/00219/AM15/ _|24.06.2014 . _<br>Decision : In the light of earlier decision taken in meeting no. 25/82 dated 29.11.2012, it<br>301 |Was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as<br>applied by the firm, whichever is less:<br>allowed<br>PhosphatePrednisolone Sodium TK} BasePrednisolone (Prednisolone | 0.90 kg<br>RA may take appropriate action as per the decision of Norms Committee.<br>. PNIRMAL RG<br>----- End of picture text -----<br>

PNIRMAL RG MAR Dy Director Gene ey Te faa fas alae LPF ego le picectorgte Fe aninent of Cor! a NT aac, ag fe im Udyog Bnawan:

==> picture [448 x 96] intentionally omitted <==

----- Start of picture text -----<br>

||||||||||
|---|---|---|---|---|---|---|---|---|
|Case|No.:107/8/82-|Party Name:LUPIN|Meet No/Date: 10/82-|Status:Deffered|
|ALC4/2014|LIMITED|JALC4/2014|and|Re-indexed|
|||_|(12.11.2014|
|302||HQ File|RLA File|Lic.No/Date:03|10785907||Defer|
|:01/82/050/00771/AM15/|:03/95/040/00244/AMI15/|—s|{24.06.2014|©|Date:10.12.2014|
|Decision|:|It was decided|to|defer the|case|for|10.12.2014|for comments of Department|
|of Pharmaceuticals|

----- End of picture text -----<br>

• Case No.:170/6/82Party Name:SOFTGEL Meet No/Date: 10/82Status:Deffered ALC4/2014 HEALTH CARE PVT. LTD., |ALC4/2014 and Re-indexed . . — ‘|12.11.2014 .

• 303 |HQ File RLA File Lic.No/Date:04 10158822 |Defer 01/82/050/00572/AM15/ —_|:04/24/040/00032/AM15/ [24.06.2014 Date:10.12.2014 Decision : It was decided to defer the case for 10.12.2014 for comments of Department of Pharmaceuticals Case No.:66/10/82Party Name:STERLING Meet No/Date:10/82Status:Deffered ALC4/2014 AUXILIARIES PVT LTD ALC4/2014 and Re-indexed }12,11,2014

• 304 |HQ File RLA File Lic.No/Date:03 10785910 |Defer :01/82/050/00980/AM15/ —_|:03/95/040/00224/AM15/ [24.06.2014 - [Date:10.12.2014 Decision : It was decided to defer the case for 10.12.2014 for comments of Department of Pharmaceuticals . Case No.:231/6/82Party Name: ALEMBIC Meet No/Date:10/82Status:Deffered ALC4/2014 PHARMACEUTICALS LTD |ALC4/2014 and Re-indexed 12.11.2014

• . . .

• 305 |HQ File RLA File Lic.No/Date:34 10040310 |Defer :01/82/050/00633/AM15/ :34/24/040/00055/AM15/ 25.06.2014 Date: 10.12.2014

Decision : It was decided to defer the case for 10.12.2014 for comments of Department of Pharmaceuticals a

• Case No.:87/6/82Party Name:DIVIS Meet No/Date:10/82Status:Deffered ALC4/2014 LABORATORIES LTD., ALC4/2014 and Re-indexed

• | | _ {211.2014 |

• 306 |HQ File RLA File Lic.No/Date:09 10060537 |Defer :01/82/050/00489/AM15/ 4:09/24/040/00149/AM15/ 25.06.2014 Date: 10.12.2014

Decision : It was decided to defer the case for 10.12.2014 for comments of Department of Pharmaceuticals . Case No.:89/6/82Party Name:DIVIS ‘|Meet No/Date:10/82__[Status:Deffered ALC4/2014 LABORATORIES LTD., ALC4/2014 and Re-indexed . 12.11.2014 307 |HQ File RLA File Lic.No/Date:0910060536 |Defer :01/82/050/00491/AM15/ :09/24/040/00150/AM15/ 25.06.2014 Date:10.12.2014 Decision : It was decided to defer the case for 10.12.2014 for comments of Department R of Pharmaceuticals ; a ee7 ayn"ar,eo “7 Dy. Dire ‘ wavs “errerrde ro Y) — arr:pie, oweinSemmeres

==> picture [456 x 324] intentionally omitted <==

----- Start of picture text -----<br>

||||||||||
|---|---|---|---|---|---|---|---|---|
|Case No.:32/8/82-|Party Name:SRIAM LABS|[Meet No/Date:10/82-|Status:Deffered|
|ALC4/2014|PRIVATE LIMITED|ALC4/2014|and Re-indexed|
|..|,|PR|2014|.|
|1308 |HQ|File|RLA File|Lic.No/Date:09 10060539||Defer|
|:01/82/050/00696/AM15/|—_|:09/24/040/00141/AM15/|—_—_|25.06.2014|—|Date:10.12.2014|
|Decision|:|It was decided|to defer the|case|for|10.12.2014|for comments of Department|
|of Pharmaceuticals|.|
|Case No.:108/8/82-|Party Name:SURVIVAL|[Meet No/Date:10/82-|__|Status:Deffered|
|ALC4/2014|TECHNOLOGIES PVT.LTD.||ALC4/2014|and Re-indexed|
|12.11.2014|
|309||HQ File||JRLA|File|Lic.No/Date:03|10786023|(Defer|
|:01/82/050/00772/AM15/|:03/95/040/00214/AMI5/|—_|[25.06.2014|‘{Date:10.12.2014|
|Decision|:|It was|decided|to defer the|case|for|10.12.2014|for comments of Department|
|of|Pharmaceuticals|
|[_|Case No.:52/8/82-|Party Name:LAKE|Meet No/Date: 10/82-|Status:Deffered|
|ALC4/2014|‘(CHEMICALS PRIVATE|ALC4/2014|and|Re-indexed|
|__||LIMITED|—|[12.11.2014|7|
|1310||HQ File|RLA|File|Lic.No/Date:07 10105418||Defer|
|01/82/050/00716/AMI15/|—_|:07/24/040/00096/AMI15/|_|[26.06.2014|_|[Date:10.12.2014|
|Decision|:|It was decided to defer the case|for|10.12.2014|for comments|of Department|
|||jof Pharmaceuticals|

----- End of picture text -----<br>

==> picture [451 x 98] intentionally omitted <==

----- Start of picture text -----<br>

|||||||||||
|---|---|---|---|---|---|---|---|---|---|
|"[Case No.:80/8/82-_|~|[Party Name:PREGNA|Meet No/Date:10/82-|__[Status:Deffered|
|ALC4/2014|INTERNATIONAL|LTD.|ALC4/2014|and Re-indexed|
|.|(12.11.2014|||
|1311|[HQ|File|RLA|File|Lic.No/Date:03 10786143||Defer|
|01/82/050/00744/AM15/|:03/95/040/00250/AM15/|27.06.2014|Date: 10.12.2014|
|Decision|:|It was|decided|to|defer|the case|for|10.12.2014|for comments of Department|
|of Pharmaceuticals|

----- End of picture text -----<br>

• Case No.:63/10/82Party Name:SAVVY CARE & |Meet No/Date: 10/82- 7 Status:Deffered ALC4/2014 COSMETICS PVT LTD ALC4/2014 and Re-indexed 12.11.2014

• | ;

• 312 |HQ File RLA File Lic.No/Date:03 107861 14:|Defer

• | |:01/82/0S0/00977/AM15/ —_|:03/95/040/00254/AM15/ _,|27.06.2014 Date:10.12.2014 Decision : It was decided to defer the case for 10.12.2014 for comments of Department

• | |of Pharmaceuticals

[Case No.:219/6/82Party Name:UNICHEM [Meet No/Date:10/82__[Status:Deffered ALC4/2014 LABORATORIES LIMITED |ALC4/2014 and Re-indexed 12.11.2014 313 [HQ File RLA File Lic.No/Date:03 10786118 (Defer Decision:01/82/050/00621/AM15/: It was decided to:03/95/040/00221/AM15/ defer the case for 10.12.201427.06.2014 for comments ofDepartmentDate: 10.12.2014 ix, of Pharmaceuticals a cig ERE NIRMIAL KUMAR ara1 raPuDeparme' 7 deh Rawan, New vein!

&

:

,

• Case No.:199/6/82Party Name:H.J.AROCHEM [Meet No/Date:10/82Status: Deffered ALC4/2014 PVT. LTD., ALC4/2014 and Re-indexed | | [12.11.2014

• 314.|HQ File RLA File Lic.No/Date:08 10132520 |Defer

• | |:01/82/0$0/00601/AM15/ —_|:08/24/040/00569/AM14/ _{30.06.2014 Date:10.12.2014 Decision : It was decided to call from the firm CA certificate certifying past production and consumption data for the last 3 years. The case is deferred for 10.12.2014. —

• ” [Case No.:210/6/82Party Name:WEXFORD [Meet No/Date:10/82_|Status:Deffered ALC4/2014 LABORATORIES P LTD ALC4/2014 and Re-indexed 12.11.2014

• |

• 315 |HQ File RLA File Lic.No/Date:07 10105465 [Defer :01/82/050/006 12/AM15/ :07/24/040/00105/AM15/ 30.06.2014 Date: 10.12.2014

Decision : It was decided to defer the case for 10.12.2014 for comments of Department of Pharmaceuticals ;

• Case No.:202/6/82Party Name:FORACE Meet No/Date: 10/82Status:Deffered ALC4/2014 POLYMERS (P) LTD. ALC4/2014 and Re-indexed . _ (42.11.2014

• 316 |HQ File RLA File Lic.No/Date:05 10389232 |Defer :01/82/050/00604/AM15/ —|:05/23/040/00139/AM15/ {01.07.2014 =—=————|Daate: 10.12.2014

  • Decision : It was decided to defer the case for 10.12.2014 for comments of Department of Petrochemicals.

==> picture [441 x 71] intentionally omitted <==

----- Start of picture text -----<br> Case No.:62/8/82- Party Name:ADCOCK Meet No/Date:10/82- Status: Deffered<br>ALC4/2014 INGRAM LTD, ALC4/2014 and Re-indexed<br>12.11.2014<br>317 |HQ File RLA File Lic.No/Date:0710105491 |Defer<br>:01/82/050/00726/AM15/ :07/24/040/00111/AM15/ —- [02.07.2014 Date: 10.12.2014<br>----- End of picture text -----<br>

Decision : It was decided to defer the case for 10.12.2014 for comments of Department of Pharmaceuticals. . Z

==> picture [509 x 261] intentionally omitted <==

----- Start of picture text -----<br> Case No.:29/8/82- ” [Party Name:DIVIS Meet No/Date:10/82- (Status:Deffered<br>ALC4/2014 PHARMACEUTICALS ALC4/2014 and Re-indexed<br>|PRIVATE LIMITED 12.11.2014<br>318 /HQ File RLA File Lic.No/Date:09 10060578 [Defer<br>01/82/050/00693/AM15/ —|:09/24/040/00181/AM15/ —|04.07.2014 . _"‘Date:10.12.2014<br>Decision : It was decided to defer the case for 10.12.2014 for comments of Department<br>of Pharmaceuticals<br>. .<br>Case No.:83/8/82- Party Name:-MANGALAM _ /Meet No/Date:10/82- Status:Deffered<br>JALC4/2014 ORGANICS LIMITED ALC4/2014 land Re-indexed<br>(FORMERLY 12.11.2014<br>DUJODWALA I . .<br>39 HQ File RLA File Lic.No/Date:03 10786418 [Defer<br>|:01/82/050/00747/AM15/ |:03/95/040/00109/AM15/ —|04.07.2014 Date:10.12.2014<br>|Decision : It was decided to defer the case for 10.12.2014 for comments of Department <br>of Pharmaceuticals Prfer grrg/NIRME umn<br>so ne of Foren Trade<br>=| L ~ wf men wena7 Qepanment slot Eoin of CommerceTrade<br>----- End of picture text -----<br>

’

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:

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| ) | : |

||CaseNo.:18/8/82-||[PartyName:RACHEM|_|[MeetNo/Date:10/82-|_|[MeetNo/Date:10/82-||_[Status:Deffered|
|---|---|---|---|---|---|---|---|
||ALC4/2014||PHARMALIMITED||ALC4/2014||andRe-indexed|
||;||.||12.11.2014<br>||||
|320||HQFile<br>01/82/0S0/00682/AM15/||RLAFile<br>—_|:09/24/040/00176/AM15/|Lic.No/Date:0910060577 |Defer<br>{04.07.2014<br>___fDate:10.12.2014||||
||Decision : Itwasdecidedtodeferthe case for 10.12.2014 forcommentsof|||||ofDepartment||
||ofPharmaceuticals|||||||
|||||.|||;|
||CaseNo.:64/10/82-<br>ALC4/2014||PartyName:SATYAJIT<br>CHEMICALSPVT.LTD.,||MeetNo/Date:10/82-<br>ALC4/2014||Status:Deffered<br>and Re-indexed|
||||||12.11.2014|||
|321||HQ File<br>:01/82/050/00978/AM15/||RLA File<br>:03/95/040/00303/AM15/||Lic.No/Date:03 10786462 |Defer<br>07.07.2014<br>Date:10.12.2014|||
||Decision : Itwas decided to deferthecase for 10.12.2014 forcomments|||||ofDepartment||
||ofPharmaceuticals|||||||
|[|[CaseNo.:218/6/82-||‘|PartyName:UNICHEM||(MeetNo/Date:10/82-||_(Status:Deffered|
||ALC4/2014||LABORATORIESLIMITED|||ALC4/2014||and Re-indexed|
|||||.||12.11.2014|||;|
|1322|[HQFile<br>:01/82/050/00620/AM15/||RLAFile<br>:03/95/040/00246/AM15/||Lic.No/Date:0310786466 <br>07.07.2014||[Defer<br>Date: 10.12.2014|
||Decision : Itwasdecidedtodeferthecase for 10.12.2014 forcommentsofDepartment|||||ofDepartment||
||ofPharmaceuticals|||||||
||CaseNo.:28/10/82-<br>ALC4/2014|:|PartyName:GLOCHEM<br>INDUSTRIESLIMITED||MeetNo/Date:10/82-<br>ALC4/2014||Status:Deffered<br>andRe-indexed|
|323||HQ File<br>:01/82/050/00942/AM15/||RLA File<br>—_|:09/24/040/00143/AM15/||12.11.2014<br>Lic.No/Date:09 10060609 <br>_—_|08.07.2014<br>.|||Defer<br>Date:10.12.2014|
||Decision : Itwasdecidedtodeferthecase for 10.12.2014 forcommentsof|||||ofDepartment||
||ofPharmaceuticals|_|||.|||
||CaseNo.:84/8/82-|~|[PartyName:NAPRODLIFE||[MeetNo/Date:10/82-|__|Status:Deffered||
||ALC4/2014||SCIENCES PVT. LTD.||ALC4/2014||landRe-indexed|
||||||12.11.2014||_|
|374||HQ File||IRLA File||Lic.No/Date:03 10786556|||Defer|
||:01/82/050/00748/AM15/||—_|:03/95/040/00258/AM15/||_—_|08.07.2014|_|[Date:10.12.2014|

Decision : It was decided to defer the case for 10.12.2014 for comments of Department | lof Pharmaceuticals

Case No.:62/10/82Party Name:STERLING Meet No/Date:10/82Status: Deffered ALC4/2014 AUXILIARIES PVT LTD ALC4/2014 and Re-indexed | 12.11.2014 325 |HQ File RLA File Lic.No/Date:03 10786523 |Defer Decision:01/82/050/00976/AM15/: It was decided—|:03/95/040/00271/AM15/to defer the case for 10.12.2014——_|08.07.2014for comments of|Date:10.12.2014 Department / ( p. C&PC. . . AL KUMAR Dy Director oo Te fo eee 2 ~ 77 ~ Ditettorae tects “ 2 : anfersa frarypesvutiress OF! Udy«.. as

| | | | | :

&

• Case No.:21/8/82Party Name:MYLAN Meet No/Date:10/82__[Status:Deffered ALC4/2014 LABORATORIES ALC4/2014 and Re-indexed a . LIMITED _ (12.11.2014 7

• 326 |HQ File File RLA File Lic.No/Date:09 10060632 |Defer :01/82/050/00685/AM15/ :09/24/040/00134/AM15/ —_ {09.07.2014 Date: 10.12.2014 Decision : It was decided was decided decided to defer the case for 10.12.2014 for comments of Department comments of Department of Department of Pharmaceuticals. . a . Case No.:31/8/82- No.:31/8/82Party Name:MYLAN Name:MYLAN (Meet No/Date:10/82- No/Date:10/82_[Status: ALC4/2014 LABORATORIES LIMITED LIMITED |ALC4/2014 Approved 12.11.2014

• |

• HQ File RLA File Lic.No/Date:0910060631 |Defer Date: Date: :01/82/050/00695/AM15/ :09/24/040/00168/AM15/ 09.07.2014

==> picture [506 x 707] intentionally omitted <==

----- Start of picture text -----<br> a . LIMITED _ (12.11.2014 7 |<br>326 |HQ File File RLA File Lic.No/Date:09 10060632 |Defer<br>:01/82/050/00685/AM15/ :09/24/040/00134/AM15/ —_ {09.07.2014 Date: 10.12.2014<br>Decision : It was decided was decided decided to defer the case for 10.12.2014 for comments of Department comments of Department of Department<br>of Pharmaceuticals. . a .<br>Case No.:31/8/82- No.:31/8/82- Party Name:MYLAN Name:MYLAN (Meet No/Date:10/82- No/Date:10/82- [Status:<br>ALC4/2014 LABORATORIES LIMITED LIMITED |ALC4/2014 Approved<br>12.11.2014<br>|<br>HQ File RLA File Lic.No/Date:0910060631 |Defer Date: Date:<br>:01/82/050/00695/AM15/ :09/24/040/00168/AM15/ 09.07.2014<br>Decision : Committee considered the case as per agenda and in light of written comments<br>received from Department of Pharmaceuticals vide their OM No. 3501 1/786/2013-PI(Norms)<br>dated 02.09.2014 and in consultation with technical authority present in meeting, decided to<br>ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is<br>lower:-<br>327<br>| Qty. Kg/kg<br>| 1 ((S)-5-Chloro-Alpha-(cyclopropylethyny!)- | 0.987<br>| EFAVIRENZ BETA 1kg 2-Amino-Alpha<br>FORM (EFB) (trifluoro methyl)<br>Benzene methanol<br> [2_-[TriPhosgene—s—“[0.448<br>En<br>RA concerned may take further necessary action as per above decision of NC. |<br>[Case No.:53/8/82- Party Name: ALEMBIC Meet No/Date:10/82- Status:<br>ALC4/2014 PHARMACEUTICALS LTD |ALC4/2014 Approved<br>: 12.11.2014<br>jHQ File RLA File Lic.No/Date:34 10040353 |Defer Date:<br>| :01/82/050/007 17/AM15/ :34/24/040/00090/AM15/ 10.07.2014<br>|Decision : Committee considered case as per agenda and in the light of written comments received<br>from Department of Pharmaceuticals vide their OM No. 35011/665/2013-PI(Norms) dated<br>328 22.01.2014, it was decided to ratify norms under para 4.7 of HBP v 1 as per details given below<br>jor as applied by the firm, whichever is less:<br>Export Product IRBESARTAN HEUMANN 75 Mg, 150 Mg and 300 MG FILMTABLETTEN<br>:<br>Import item For 1 No. Tablet<br>~ a ~ - a Poeee ee A AR<br>BU Ae Aepe rates<br>Dy Direct “oners. F v eign Trade<br>——"7 6 ~ aiftreyDitocionan a °:Departinvoteae “asac. CommercenN Trad<br>Uayog Bhawan Wee eon:<br>----- End of picture text -----<br>

| : | | : , | | | 7 ! | | | | | | | | , : |

ALC4/2014 DEEPTHA ALC4/2014 and Re-indexed Re-indexed j oo |PHARMACEUTICALS LTD LTD [12.11.2014 331 [HQ File RLA File Lic.No/Date:09 10060653 |Defer i :01/82/050/00678/AM15/ —|:09/24/040/00191/AM15/ |11.07.2014 _ |Date:10.12.2014 F Decision : It was decided to defer the case was decided to defer the case decided to defer the case to defer the case defer the case the case case for 10.12.2014 for comments of comments of of Department i of Pharmaceuticals ; Case No.:36/8/82- No.:36/8/82Party Name:RA CHEM Name:RA CHEM CHEM Meet No/Date:10/82- No/Date:10/82Status:Deffered : ALC4/2014 PHARMA LIMITED LIMITED ALC4/2014 and Re-indexed Re-indexed A oo 12.11.2014 / | 332 |HQ File File RLA File Lic.No/Date:09 10060661 10060661 |Defer : :01/82/050/00700/AM15/ '|:09/24/040/00198/AM15/ 14.07.2014 Date: 10.12.2014 10.12.2014 . Decision : It was decided to defer the case for 10.12.2014 for comments ofDepartment | of Pharmaceuticals . . Case No.:200/6/82Party Name:PANACEA Meet No/Date:10/82Status:Deffered s ALC4/2014 BIOTEC LTD., ALC4/2014 and Re-indexed . a 333 [HQ File RLA File Lic.No/Date:0510389734 [Defer ) . :01/82/050/00602/AM15/ —|:05/24/040/00168/AM15/ ——‘|16.07.2014 Date:10.12.2014 Decision : It was decided to defer the case for 10.12.2014 for comments of Department of Petrochemicals. _ . | [334 [Case No.:214/6/82Party Name:ALCHYMARS (Meet No/Date:10/82_(Status:Deffered : ALC4/2014 ICM SM PRIVATE ALC4/2014 indexed |< Fj attra AAPVDe, Or ¥ 4 SINT Ae ig Tae - | Udyog Bhawan, New teed q |

==> picture [437 x 59] intentionally omitted <==

----- Start of picture text -----<br>

|||||
|---|---|---|---|
|200|:|
|[a|[MAGNESUMSTEARATE———=d'4.125|p25|[450|
||RA may take appropriate|action as per the decision ofNorms Committee.|a|

----- End of picture text -----<br>

==> picture [455 x 419] intentionally omitted <==

----- Start of picture text -----<br>

|||||||||||
|---|---|---|---|---|---|---|---|---|---|
|Case No.:32/10/82-|Party Name:AUROBINDO|[Meet No/Date:10/82-|__[Status:Deffered|
|ALC4/2014|PHARMA LIMITED|ALC4/2014|and Re-indexed|
|12.11.2014|a|
|329|[HQ File|RLA File|Lic.No/Date:09 10060655||Defer|
|:01/82/050/00946/AM15/|—_|:09/24/040/00182/AM15/|_—j11.07.2014|-|Date:10.12.2014|
|Decision|:|It was|decided|to defer the|case|for|10.12.2014|for comments|of Department|
|of|Pharmaceuticals|_|.|_|
|Case No.:194/6/82-|[Party Name:MOREPEN|[Meet No/Date:10/82-|_[Status:Deffered|
|ALC4/2014|LABORATORIES LTD.,|ALC4/2014|land Re-indexed|
|||12.11.2014|
|330||HQ|File|RLA|File|Lic.No/Date:05 10389654||Defer|
|:01/82/050/00596/AM15/|—_—_|:05/24/040/00147/AM15/|{11.07.2014|———-PDate:10.12.2014|
|Decision|:|It was decided to|defer the case|for|10.12.2014|for comments of Department|
|of Pharmaceuticals|
|Case No.:14/8/82-|Party|Name:SATYA|Meet No/Date:10/82-|Status:|Deffered|
|,|ALC4/2014|DEEPTHA|ALC4/2014|and Re-indexed Re-indexed|
|oo||PHARMACEUTICALS LTD LTD|[12.11.2014|
|331|[HQ|File|RLA|File|Lic.No/Date:09|10060653||Defer|
|:01/82/050/00678/AM15/|—_|:09/24/040/00191/AM15/|_|11.07.2014|_||Date:10.12.2014|
|Decision|:|It was decided to defer the case was decided to defer the case decided to defer the case to defer the case defer the case the case case|for|10.12.2014|for comments of comments of of|Department|
|of|Pharmaceuticals|
|Case No.:36/8/82- No.:36/8/82-|Party Name:RA CHEM Name:RA CHEM CHEM|Meet No/Date:10/82- No/Date:10/82-|Status:Deffered|
|ALC4/2014|PHARMA LIMITED LIMITED|ALC4/2014|and Re-indexed Re-indexed|
|oo|12.11.2014|/|
|332||HQ File File|RLA|File|Lic.No/Date:09 10060661 10060661||Defer|
|:01/82/050/00700/AM15/|'|:09/24/040/00198/AM15/|14.07.2014|Date: 10.12.2014 10.12.2014|

----- End of picture text -----<br>

«

|||||[LIMITED|[12.11.2014<br>||||
|---|---|---|---|---|---|---|---|
||||HQFile|RLA File|Lic.No/Date:0410159026||Defer||
||||:01/82/050/00616/AM15/|—_|:04/24/040/00067/AM15/<br>[18.07.2014||Date:10.12.2014||
|||||Decision : Itwasdecided|todeferthecase for|10.12.2014 forcommentsofDepartment|||
|||||ofPharmaceuticals|||||
||||CaseNo.:31/10/82-|PartyName:EMCURE|MeetNo/Date:10/82-|[Status||
||||ALC4/2014|PHARMACEUTICALS LTD. |ALC4/2014||Approved||
||||.<br>.||12.11.2014|||
||||HQ File|RLA File|Lic.No/Date:3 110064562'|Defer Date:|||
||||01/82/050/00945/AM15/|—_|:31/83/040/00087/AM15/<br>_|18.07.2014||-||
||||Decision : Committeeconsidered thecaseasperagendaand inthe lightofearlierdecisiontaken|||||
||||in meeting no. 6/82 dated 29.08.2014, itwas decided to ratifynorms underPara4.7 ofHBPv1 as|||||
||||perdetails givenbeloworas appliedbythe firm,whichever is less:|||||
|||335||||||
||||DEXKETOPROFEN<br>TROMETAMOL|1.|3{1-CYANOETHYL)<br>BENZOPHENONE|||
||||RELEVANTBULKDRUG||CHEMICAL|||
|||||||N-OCTYL-D-<br>GLUCAMINE<br>CHEMICAL||:|
||||RAmaytake appropriate|actionasperthe decisionofNorms Committee.||||
||||CaseNo.:72/10/82-|PartyName:GLOBAL|\MeetNo/Date:10/82-|Status:Deffered||
||||ALC4/2014|CALCIUMPRIVATE|ALC4/2014|‘land Re-indexed||
|:||||{LIMITED,<br>—|12.11.2014<br>7|||
|||336.||HQ File|RLA File|Lic.No/Date:0710105884||Defer||
||||01/82/050/00986/AM15/|—_|:07/24/040/00112/AM15/<br>{18.07.2014<br>=—_[Date:10.12.2014||||
||||||Decision : Itwas decided|to deferthe case for|10.12.2014 forcommentsofDepartment|||
||||ofC&PC.||a|||

==> picture [498 x 273] intentionally omitted <==

----- Start of picture text -----<br> Case No.:60/8/82- Party Name:R L FINE Meet No/Date: 10/82- Status:<br>ALC4/2014 CHEM ALC4/2014 Approved<br>ee 12.11.2014 .<br>HQ File RLA File Lic.No/Date:07 10105849 |Defer Date:<br>:01/82/050/00724/AM15/ —|:07/24/040/00129/AM15/ {18.07.2014 a<br>Decision: tn the light of earlier decision taken in meeting no. 10/82 dated 22.08.2013, it was decided<br>to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is<br>337 less:<br>| [Export product | Exp. tty. |SI.No. | importitems =| Qty. allowed<br>| Methane Sulfonate of ikg 1 Bromo 3 Chloro 2 Methyl Propane | 0.72 kg<br>f 10,11, Dihydro-N,N ‘<br>| BetatrimethyISH Benzo<br>f (B,F) Azepine-5 :<br>| Propanamine<br>poRA J tminodibency!<br>= may take appropriate action as per the. decision__ ofLeNorms Committee.. - f \.<br>[338 [Case No.:69/8/82- [Party Name:DEEPAK [Meet No/Date:10/82- {siatusspetreredastUMAR<br>; — Tee al at Forel n Trade<br>R 0 ae * _enariment of A eee<br>----- End of picture text -----<br>

| | | 7

|

4%

==> picture [455 x 91] intentionally omitted <==

----- Start of picture text -----<br>

||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
|.|eee|.|wee|—|-|—e|=|_|
|ALC4/2014|NITRITE LIMITED|ALC4/2014|and Re-indexed|
|12.11.2014|
|a|;|
|HQ File|RLA|File|Lic.No/Date:34 10040383|[Defer|
|:01/82/050/00733/AMI15/|—_|:34/24/040/00083/AMI5/|—_—_—|21.07.2014|Date:10.12.2014|
|Decision|:|It was decided|to remind the|firm to|furnish|the|following|technical|details:|—|

----- End of picture text -----<br>

1. Details of manufacturing process from Ortho Xylene, with chemical equations, molecular formula, molecular weights and yield obtained on molecular weight basis. 2. Authentic technical literature in support of yield claimed. 3. Detailed calculations of arriving at the norms applied for.

The case was deferred for 10.12.2014

|

==> picture [456 x 331] intentionally omitted <==

----- Start of picture text -----<br>

||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
|Case No.:70/8/82-|Party|Name:SHANPAR|Meet No/Date:|10/82-|Status:Deffered|.|
|ALC4/2014|INDUSTRIES|PVT. LTD.|ALC4/2014|and Re-indexed|
|12.11.2014|foo|
|339||HQ|File|RLA|File|Lic.No/Date:34 10040385||Defer|
|:01/82/050/00734/AM15/|_|:34/24/040/00097/AM15/|—|21.07.2014|—|fDate:10.12.2014|
|Decision|:|It was|decided|to|defer the|case|for|10.12.2014 for comments|of Department|
|of|C&PC.|os|.|||
|Case No.:103/8/82-|[Party Name:IPCA|Meet No/Date:10/82-|_|Status:Deffered|
|ALC4/2014|LABORATORIES LIMITED|jALC4/2014|and Re-indexed|—|
|12.11.2014|
|a|;|7|
|3409||HQ File|IRLA|File|Lic.No/Date:03 10787202,||Defer|
|:01/82/050/00767/AM15/|—_|:03/94/040/00230/AM15/|—|[22.07.2014|Date:10.12.2014|
|Decision|:|It was decided|to defer the|case|for|10.12.2014|for comments of Department|
|jof Pharmaceuticals|.|;|
|CaseNo.:2/6/82-ALC4/2014|[Party Name:SOFTGEL|Meet No/Date:10/82-|_|Status:Deffered|
|HEALTH CARE PVT. LTD.,||ALC4/2014|and Re-indexed|
|7|«12.11.2014|.|||
|341||HQ|File|IRLA|File|Lic.No/Date:0410159058||Defer|
|||—||:01/82/050/00404/AM15/|—_|:04/24/040/00031/AM15/|—|[22.07.2014|[Date: 10.12.2014|
|Decision|:|It was|decided|to|defer the|case|for|10.12.2014|for comments|of Department|
|of Pharmaceuticals|

----- End of picture text -----<br>

[— [Case No.:71/8/82Party Name:ALEMBIC [Meet No/Date:10/82_[Status:Deffered ALC4/2014 PHARMACEUTICALS ALC4/2014 and Re-indexed |LTD 12.11.2014 . _ 342 |HQ File RLA File Lic.No/Date:34 10040394 |Defer :01/82/050/00735/AM15/ :34/24/040/00099/AM15/ 23.07.2014 Date:10.12.2014 Decision : It was decided to defer the case for 10.12.2014 for comments of Department | of Pharmaceuticals.

Case No.:3/6/82-ALC4/2014 [Party Name:CADILA [Meet No/Date:10/82_[Status:Deffered 343 HEALTHCARE LTD., ALC4/2014 and Re-indexed wa Ti ft Dy. Director Gene. Directorate Ge:

Udyog Bhi... vow Leen

&

.

~

||HQFile|RLAFile|Lic.No/Date:0810132790:|10132790:||Defer|
|---|---|---|---|---|---|
||:01/82/050/00405/AM15/|—_|:08/24/040/00165/AM15/|[23.07.2014|__|[Date:10.12.2014|
|_|Decision : Itwasdecided to defer thecase for 10.12.2014 forcommentsofDepartment<br>lofPharmaceuticals|||||

||CaseNo.:12/10/82-<br>ALC4/2014|PartyName:SHIVA<br>PHARMACHEMLTD,||Meet No/Date:10/82-<br>Status:Deffered<br>ALC4/2014<br>andRe-indexed|
|---|---|---|---|---|
||.||———||12,11.2014<br>.|
|344||HQ File<br>:01/82/050/00926/AM15/|RLA File<br>:34/24/040/00100/AM15/||Lic.No/Date:3410040395 |Defer<br>23.07.2014<br>Date:10.12.2014|
||Decision : Itwasdecided <br>ofPharmaceuticals|to deferthe case for|10.12.2014 forcommentsofDepartment||

Case No.:5/6/82-ALC4/2014 [Party Name:COVALENT [Meet No/Date:10/82(Status: LABORATORIES PRIVATE |ALC4/2014 Approved - LIMITED 12.11.2014 _ . HQ File RLA File Lic.No/Date:09 10060728 |Defer Date: :01/82/050/00407/AM15/ __|:09/24/040/00195/AM15/ [24.07.2014 . . |Decision : Committee consider the case and the case and case and and in the light of earlier decision taken the light of earlier decision taken light of earlier decision taken of earlier decision taken earlier decision taken decision taken taken in its meeting No. meeting No. No. 6/82 dated 29.08.2014, it was decided was decided decided to ratify norms under Para norms under Para under Para Para 4.7 of HBP v1 HBP v1 v1 as per details given per details given details given given below or or applied by the firm, the firm, firm, whichever is less: E | Ceftriaxone Sodium Sterile Ceftriaxone sodium Non1.04 kg Sterile Activated Carbon [ Carbon 51.66 gm/ kg Enoanticromos 13. |dC.Acetone 72 kg Aluminium Canisters with Relevant, as per inner & Outer Lids packing poli RA may take appropriate may take appropriate take appropriate action as per the decision of Norms Committee. as per the decision of Norms Committee. per the decision of Norms Committee. the decision of Norms Committee. decision of Norms Committee. of Norms Committee. Norms Committee. Committee. 7

|Decision : Committee consider the case and the case and case and and in the light of earlier decision taken the light of earlier decision taken light of earlier decision taken of earlier decision taken earlier decision taken decision taken taken in its meeting No. meeting No. No. 6/82 dated 29.08.2014, it was decided was decided decided to ratify norms under Para norms under Para under Para Para 4.7 of HBP v1 HBP v1 v1 as per details given per details given details given given below or or as applied by the firm, the firm, firm, whichever is less:

345 E

; RA may take appropriate may take appropriate take appropriate action as per the decision of Norms Committee. as per the decision of Norms Committee. per the decision of Norms Committee. the decision of Norms Committee. decision of Norms Committee. of Norms Committee. Norms Committee. Committee.

Case No.:122/8/82Party Name-EMCURE [Meet No/Date:10/82_|Status:Deffered ALC4/2014 PHARMACEUTICALS LTD. |ALC4/2014 and Re-indexed 346 |HQ:01/82/050/00786/AM15/File RLA:31/83/040/00101/AM15/File Lic.No/Date:324.07.2014 1 10064607 |DeferDate: 10.12.2014 Decision : It was decided to defer the case for 10.12.2014 for comments of Department of Pharmaceuticals ; . a - Case No.:123/8/82Party Name:EMCURE [Meet No/Date:10/82_[Status: ALC4/2014 PHARMACEUTICALS {ALC4/2014 Approved HQ Filea LTD.RLA File _ {12.11.2014Lic.No/Date:3 110064609 [Defer Date: _ [347 |:01/82/050/00787/AM15/ —_|:31/83/040/00104/AM15/ _ {24.07.2014 ; | |Decision : : Committee considered the case as per agenda and in the light of earlier decision taken in meeting no. 6/82 dated 29.08.2014, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: UMAR : ; . - . pret Wy x 1 ade Dy Oe Fare, TETERTELT 4g

Uayog Bawa

| |

|

a)

|

==> picture [360 x 198] intentionally omitted <==

----- Start of picture text -----<br> DEXKETOPROFEN 3(1-CYANOETHYL) 1.82<br>RELEVANTTROMETAMOL BULK DRUG CHEMICALBENZOPHENONE<br>N-OCTYL-D-<br>GLUCAMINE<br>CHEMICAL<br>RA may take appropriate action as per the decision ofNorms Committee. _<br>Case No.:64/8/82- No.:64/8/82- Party Name:MOREPEN Name:MOREPEN [Meet No/Date:10/82- No/Date:10/82-<br>ALC4/2014 LABORATORIES LTD., ALC4/2014<br>12.11.2014<br>/ |<br>|HQ File File RLA File Lic.No/Date:05 10389956 10389956<br>:01/82/050/00728/AM15/ :05/24/040/00189/AM15/ 25.07.2014<br>Decision : It was decided was decided decided to defer the the case for 10.12.2014 for comments of comments of of<br>of Pharmaceuticals. Pharmaceuticals.<br>.<br>----- End of picture text -----<br>

• Case No.:64/8/82- No.:64/8/82Party Name:MOREPEN Name:MOREPEN [Meet No/Date:10/82- No/Date:10/82__|Status:Deffered ALC4/2014 LABORATORIES LTD., ALC4/2014 and Re-indexed 12.11.2014

• / |

• 348 |HQ File File RLA File Lic.No/Date:05 10389956 10389956 |Defer :01/82/050/00728/AM15/ :05/24/040/00189/AM15/ 25.07.2014 Date: 10.12.2014

Decision : It was decided was decided decided to defer the the case for 10.12.2014 for comments of comments of of Department of Pharmaceuticals. Pharmaceuticals.

• Case No.:73/10/82Party Name: ADCOCK Meet No/Date: 10/82Status: Deffered ALC4/2014 INGRAM LTD, ALC4/2014 and Re-indexed {12.11.2014 ;

• |HQ File RLA File Lic.No/Date:07 10106215 |Defer :01/82/050/00987/AM15/ —_|:07/21/040/00370/AM15/ {28.07.2014 _— [Date:10.12.2014

• 349 |HQ File

Decision : It was decided to defer the case for 10.12.2014 for comments of Department of Pharmaceuticals.

• [Case No.:26/10/82Party NameINDO PHYTO [Meet No/Date:10/82-__[Status:Deffered ALC4/2014 CHEMICALS PVT LTD ALC4/2014 and Re-indexed : 12.11.2014

• . 7

• 350 [HQ File RLA File Lic.No/Date:05 10390068 |Defer :01/82/050/00940/AM15/ :05/23/040/00170/AM15/ {01.08.2014 , Date: 10.12.2014 Decision : It was decided to defer the case for 10.12.2014 for comments of Department lof Pharmaceuticals

==> picture [448 x 129] intentionally omitted <==

----- Start of picture text -----<br> <br>Case No.:66/8/82- Party Name:RECKITT Meet No/Date: 10/82- Status:Deffered<br>ALC4/2014 }BENCKISER ALC4/2014 and Re-indexed<br>HEALTHCARE INDIA 12.11.2014<br>LIMITED .<br>351 [HQ File RLA File Lic.No/Date:05 10390158 [Defer<br>01/82/050/00730/AM15/ —|:05/24/040/00205/AM15/ {06.08.2014 Date: 10.12.2014<br>Decision : It was decided to defer the case for 10.12.2014 for comments of Department<br>of Pharmaceuticals .<br>----- End of picture text -----<br>

==> picture [496 x 101] intentionally omitted <==

----- Start of picture text -----<br> Case No.:87/10/82- Party Name:VEGESNA [Meet No/Date:10/82- [Status:Deffered<br>ALC4/2014 LABORATORIES PRIVATE |ALC4/2014 and Re-indexed<br>LIMITED 12.11.2014<br>352 |HQ File RLA File Lic.No/Date:09 10060837 [Defer<br>:01/82/050/01001/AM15/ —|:09/24/040/00258/AM15/ —‘|11.08.2014 Date: 10.12.2014<br>Decision : It was decided to defer the case for 10.12.2014 for comments ofDepartment a<br>of Pharmaceuticals. ; yNiRMAL KUMAR<br>----- End of picture text -----<br>

,

sary Ha, arg fest " sea Udyog Bhawan, Mer”

&

==> picture [454 x 304] intentionally omitted <==

----- Start of picture text -----<br>

|||||||||
|---|---|---|---|---|---|---|---|
|[Case No.:2/8/82-ALC4/2014|[Party Name:SAURAV|[Meet No/Date:10/82-|_|[Status:Deffered|
|CHEMICALS LTD,|ALC4/2014|and Re-indexed|
|||(42.11.2014|.|
|353||HQ File|RLA|File|Lic.No/Date:22|10015079||Defer|
|:01/82/050/00666/AM15/|_|:22/24/040/00051/AM15/|_|03.09.2014|[Date:10.12.2014|
||||Decision|:|It was decided to|defer the case|for|10.12.2014|for comments of Department|
|_|lof|Pharmaceuticals|.|
|~|[Case No.:16/10/82-|Party Name:GLAND|Meet No/Date:10/82-|_[Status:Deffered|
|ALC4/2014|PHARMA LIMITED|ALC4/2014|and Re-indexed|
|;|(12.11.2014|
|354||HQ|File|RLA|File|JLic.No/Date:09 10060946||Defer|
|:01/82/050/00930/AM15/|—_|:09/24/040/00297/AM15/|_|11.09.2014|Date:10.12.2014|
|Decision|:|It was decided to defer the case|for|10.12.2014|for comments|of|Department|
|of|Pharmaceuticals|||
|Case No.:4/8/82-ALC4/2014||Party Name:HONOUR LAB|[Meet No/Date:10/82-|[Status:Deffered|
|LIMITED|ALC4/2014|and|Re-indexed|
|||a|||12.11.2014|
|355||HQ|File|RLA|File|Lic.No/Date:09 10060963|.|Defer|
|:01/82/050/00668/AM15/|—_|:09/24/040/00318/AM15/|{12.09.2014|==|Date:10.12.2014|

----- End of picture text -----<br>

|

==> picture [456 x 212] intentionally omitted <==

----- Start of picture text -----<br>

|||||||||
|---|---|---|---|---|---|---|---|
|Case|No.:6/8/82-ALC4/2014||Party Name:HONOUR LAB|{Meet|No/Date:10/82-|Status:Deffered|
|LIMITED||ALC4/2014|jand Re-indexed|||
|.|.|{12.11.2014|.|.|
|356|[HQ File|RLA File|Lic.No/Date:09 10060964|[Defer|
|:01/82/050/00670/AM15/|_|:09/24/040/00314/AMI5/|{12.09.2014|=|Date:10.12.2014|
|Decision|:|It was decided to|defer the case|for|10.12.2014|for comments|of Department|
|of|Pharmaceuticals|
||”|[Case No.:7/8/82-ALC4/2014|[Party Name:HONOUR LAB|[Meet No/Date:10/82-|[Status:Deffered|
|LIMITED|ALC4/2014|‘jand|Re-indexed|
|.|12.11.2014|a|
|1357|}HQ|File|RLA|File|Lic.No/Date:09|10060965|:|Defer|
|:01/82/050/00671/AMI15/|—_|:09/24/040/00317/AMI15/|_|12.09.2014|___|[Date:10.12.2014|
|Decision|:|It was decided to|defer the case for|10.12.2014|for comments of Department|
|of Pharmaceuticals|

----- End of picture text -----<br>

[Case No.:8/8/82-ALC4/2014 |Party Name:HONOUR LAB (Meet No/Date:10/82[Status:Deffered LIMITED ALC4/2014 and Re-indexed 358./HQ File RLA File Lic.No/Date:09 10060966 |Defer :01/82/050/00672/AM15/ _|:09/24/040/00315/AM15/ _|12.09.2014 — [Date:10.12.2014 . lofPecisonPharmaceuticals: It was decided to deferthe case. for 10.12.2014 for comments of epastnrestt'*! A ieee . py Director General ene7 Directo ate Cunetal of Foams? — Rog feTVOepartme? — : E y .SEM lant how Bel

x

||;Case|Case|CaseNo.:10/8/82-<br>)<br>ALC4/2014|PartyName:HETERO<br>MeetNo/Date:10/82-<br>DRUGSLIMITED,<br>ALC4/2014|Status:<br>Approved|||
|---|---|---|---|---|---|---|---|
||||-|:<br>12.11.2014|a<br>—|||
||||HQFile<br>:01/82/050/00674/AM15/|RLA File<br>Lic.No/Date:09 10060969 <br>:09/24/040/00293/AMI5/<br>15.09.2014||DeferDate:<br>-|||
||||Decision : In the light ofwritten comments received from Department ofPharmaceuticals vide|||||
||||theirOM No. 35011/286/2014-PI(Norms) dated 11.11.2014, it was decided to||ratify the norms|||
||||under Para4.7 ofHBPv1 as|perdetailsgivenbeloworasappliedbythe firm, whichever is less:||||
||359|| <br>||Lisinopril|Ot;<br>kg pl 2,2,2-Trifluoroaceticacid|kg/ke|||
|||||monohydrochloride|‘|||
|1|||||3.<br>3-Benzoylacrylic acidethyl<br>ester|‘|||
||||||}6. | N,N-Carbony!diimidazole|0.400|||
|||||Taco||||
||||RAmaytake appropriate action asperthedecisionofNormsCommittee.<br>_|||||
||||CaseNo.:9/8/82-ALC4/2014 |PartyName:HETEROLABS<br>[MeetNo/Date:10/82-||(Status:Deffered|||
||||.|LIMITED<br>ALC4/2014|landRe-indexed|||
|||||12.11.2014||||
||360|||HQFile<br>01/82/050/00673/AM15/|RLA File<br>Lic.No/Date:09 10060967 <br>—_|:09/24/040/00320/AM15/<br>_|15.09.2014||Defer<br>Date:10.12.2014|||
||||Decision : Itwas decided|to deferthecase for 10.12.2014 forcomments ofDepartment||||
||||ofPharmaceuticals||a|||
||~||[CaseNo.:13/8/82-<br>ALC4/2014|Party Name:HETERO LABS<br>[MeetNo/Date:10/82-<br>LIMITED<br>ALC4/2014|_[Status:Deffered<br>and Re-indexed|||
|||||12.11.2014||||
||||||-|||
||361|||HQ File<br>01/82/050/00677/AM15/|RLA File<br>Lic.No/Date:0910060989 <br>—_|:09/24/040/00324/AM15/<br>_{17.09.2014|[Defer<br>Date:10.12.2014|||
||||Decision : Itwasdecided|to deferthecase for 10.12.2014 forcomments ofDepartment||||
||||ofPharmaceuticals|||||
|||CaseNo.:125/8/82-<br>ALC4/2014||PartyName:HETERO<br>MeetNo/Date:10/82-<br>DRUGSLIMITED,<br>ALC4/2014|Status:Deffered<br>and Re-indexed|||
||362||,<br> [iQFile|12.11.2014<br>RLAFile<br>Lic.No/Date:09 10061000|-<br> [Defer|||
|;||:01/82/050/00789/AM15/<br>_|:09/24/040/00345/AM15/<br>[19.09.2014<br>Date:10.12.2014<br>[Decision : Itwasdecidedtodeferthecasefor10.12.2014 forcomments,e&Deparpent., <br>Oy. DirectorGenie.|||||.l.,<br>“||
|||||Directorate Ce<br>aiftrey fara.||||
|||||Vem ta fee<br>i<br>Udyog Bia.<br>‘|||;|

&

| lof Pharmaceuticals

• lof Pharmaceuticals ; . en | Case No.:126/8/82Party Name:RELIANCE (Meet No/Date:10/82__(Status:Deffered ALC4/2014 INDUSTRIES LTD. ALC4/2014 and Re-indexed 12.11.2014

• .

• 363 |HQ File RLA File Lic.No/Date:03 10789468.|Defer :01/82/050/00790/AM15/ |:03/95/040/00269/AMI15/ —|19.09.2014 Date:10.12.2014 Decision : It was decided to defer the case for 10.12.2014 for comments of Department ofC&PC. . Case No.:127/8/82Party Name:HETERO LABS [Meet No/Date:10/82Status:Deffered ALC4/2014 LIMITED ALC4/2014 and Re-indexed 12.11.2014

• 364 |HQ File RLA File Lic.No/Date:09 10061002 (Defer 01/82/050/00791/AM15/ —_|:09/24/040/00339/AM15/ {22.09.2014 _ Date:10.12.2014 Decision : It was decided to defer the case for 10.12.2014 for comments of Department ofPharmaceuticals 7

||CaseNo.:128/8/82-<br>ALC4/2014|PartyName:HETEROLABS<br>LIMITED||MeetNo/Date:10/82-<br>ALC4/2014|Status:Deffered<br>landRe-indexed|
|---|---|---|---|---|
|||12.11.2014|||
|365||HQ File<br>:01/82/050/00792/AMI5/|RLA File<br>:09/24/040/00341/AM15/|Lic.No/Date:0910061003 <br>22.09.2014||Defer<br>Date:10.12.2014|

• Decision : It was decided to defer the case for 10.12.2014 for comments of Department of Pharmaceuticals . Case No.:129/8/82Party Name:HETERO LABS |Meet No/Date:10/82Status:Deffered ALC4/2014 LIMITED ALC4/2014 and Re-indexed 12.11.2014

• 1366 |HQ File RLA File Lic.No/Date:09 10061004 |Defer :01/82/050/00793/AM15/ |:09/24/040/00338/AMI15/ —[22.09.2014 _— PDate:10.12.2014 Decision : It was decided to defer the case for 10.12.2014 for comments of Department of Pharmaceuticals Case No.:130/8/82Party Name:HETERO LABS (Meet No/Date:10/82- _ |Status:Deffered ALC4/2014 LIMITED ALC4/2014 and Re-indexed . (12.11.2014 :

• 367 |HQ File RLA File Lic.No/Date:0910061005 |Defer :01/82/050/00794/AM15/ —_|:09/24/040/00332/AM15/ {22.09.2014 =————S—SC—=s(Date: 10.12.2014 Decision : It was decided to defer the case for 10.12.2014 for comments of Department of Pharmaceuticals - . Case No.:131/8/82Party Name:HONOUR LAB [Meet No/Date:10/82Status:Deffered ALC4/2014 LIMITED ALC4/2014 and Re-indexed

• 368 | _ 422.11.2014 HQ File RLA File Lic.No/Date:09 10061007 |Defer . :01/82/050/00795/AM15/ :09/24/040/00353/AM15/ —s 22.09.2014 -JDate: 10.12.2014 /) ro PetaWy restae tvicr NirR ahfe SUTaysMAR

• —~ ge 6 Dy.facesDies ocrcc,i) weee a!creTPreenscrof Foraign Trade Direv: a often of Foreign Trade afte: YoLD ay artment of Commerce Udyog Bead be Coins

‘

|[s] | Decision : It was decided to defer the case for 10.12.2014 for comments of Department | | |of Pharmaceuticals - | Case No.:88/10/82Party Name: VINDHYA Meet No/Date: 10/82Status: ALC4/2014 ORGANICS PVT LTD ALC4/2014 Approved ; . 12.11.2014 . a : : HQ File RLA File Lic.No/Date:09 10061050 |Defer Date: :01/82/050/01002/AM15/ {:09/24/040/00367/AM15/ 30.09.2014 _

| | : | | :

Decision : Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/238/2014-PI(Norms) dated 10.10.2014 and in consultation with technical authority present in meeting, decided to : ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:-

==> picture [395 x 143] intentionally omitted <==

----- Start of picture text -----<br> Qty. Kge/kg<br>AFC : 1kg 1 2-AZABICYCLO (2.2.1) HEPT-5- | 1.41<br> Abacavir (ABV) | EN-3-ONE; (VINCELACTAM)<br>N-(2-AMINO-4, 6-DICHLORO- | 0.764<br>S-PYRIMIDINYL) FORMAMIDE<br>| SODIUM BOROHYDRIDE<br>POWDER<br>Zz—<br>----- End of picture text -----<br>

RA concemed may take further necessary action as per above decision of NC.

Case No.:89/10/82Party Name: VINDHYA Meet No/Date:10/82Status: ALC4/2014 ORGANICS PVT LTD ALC4/2014 Approved . . 12.11.2014 a HQ File RLA File Lic.No/Date:0910061051.|Defer Date: :01/82/050/01003/AM15/ {:09/24/040/00366/AM15/ 30.09.2014

Decision : Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/238/2014-PI(Norms) dated 10.10.2014 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is 370 |lower:-

==> picture [484 x 157] intentionally omitted <==

----- Start of picture text -----<br> Qty. Ke/kg<br>| AFC Abacavir (ABV)<br>EN-3-ONE; (VINCELACTAM)<br>| | 1 2-AZABICYCLO (2.2.1) HEPT-5- | 1.41<br>N-(2-AMINO-4, 6-DICHLORO- | 0.764<br>i 5-PYRIMIDINYL) FORMAMIDE<br>| SODIUMPOWDER BOROHYDRIDE 1 <br>,<br>= 8 7 — PRTDy DirectorsBAIR /NIRMALva oh KUMARTg<br>(faaer wy iy sereerrere<br>Directorate C aeral of Foreign Tr 43<br>aftrsa frvDepanmert are a<br>BINT<br>Udyog Bini wan, New Deihi<br>----- End of picture text -----<br>

==> picture [553 x 232] intentionally omitted <==

----- Start of picture text -----<br> &<br>peOO aeeacid 7<br>| RA concerned may take further necessary action as per above decision of NC. .<br>3 | [Case No.:69/10/82- Party Name:ATLAS FINE [Meet No/Date:10/82- Status:<br>ALC4/2014 CHEMICALS PVT LTD ALC4/2014 Approved<br>; . {12.11.2014 2<br>HQ File RLA File Lic.No/Date:03 10790377 |Defer Date:<br>:01/82/050/00983/AM15/ :03/94/040/00693/AM15/ {20.10.2014 nn<br>Decision : In the light of written comments received from Department of Chemicals and<br>Petrochemicals vide their U.O No. 14010/74/2013-Ch. tl dated 17.01.2014, it was decided to<br>ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm,<br>whichever is less:<br>----- End of picture text -----<br>

==> picture [450 x 317] intentionally omitted <==

----- Start of picture text -----<br> Item of Export |Quantity| S,No | Item of Import Quantity allowed<br>371 COUMARIN<br>Apperance: Crystaline Salicylaldehyde 0.920 kg<br>Powder Freezing Point: .<br>68C os Molecular Weight: 122.12<br> Minimum Molten > Hydroxybenzaldehyd<br>Apperance: Clear Odor: 5 xfeaion A enyde<br>Standard Assay: 99% pecm - Appearance<br>ae Straw color Liquid Colour:<br>Minimum Color of .<br>. . 200 Hazen Maximum<br>Sulphuric and Solution:<br>125 . Assay GLC 95-99%<br> Hazen Maximum Mini Water Content<br>|<br>} Molecular Weight: 146 0 5% Maxim er onten<br>Boiling Point: 310C “ef um<br>|RA may take appropriate action as per the decision of Norms Committee.<br>Case No.:78/10/82- Party Name:HETERO LABS [Meet No/Date:10/82- |Status:Deffered<br>ALC4/2014 LIMITED ALC4/2014 and Re-indexed<br>372 |HQ File RLA File Lic.No/Date:0910061 130:|Defer<br>:01/82/050/00992/AM15/ :09/24/040/00393/AM15/ 22.10.2014 ‘{Date: 10.12.2014<br>Decision : It was decided to defer the case for 10.12.2014 for comments of Department<br> jof Pharmaceuticals .<br>----- End of picture text -----<br>

==> picture [514 x 168] intentionally omitted <==

----- Start of picture text -----<br> (Case No.:79/10/82- Party Name:HETERO LABS [Meet No/Date:10/82- _ [Status:Deffered<br>ALC4/2014 LIMITED ALC4/2014 and Re-indexed<br>os . {12.11.2014 .<br>373 |HQ File RLA File Lic.No/Date:09 10061131 |Defer<br>:01/82/050/00993/AM15/ —|:09/24/040/00391/AM15/ [22.10.2014 Date: 10.12.2014<br>Decision : It was decided to defer the case for 10.12.2014 for comments of Department<br>| jof Pharmaceuticals - .<br><br>[374 [Case No.:80/10/82- Party Name:HETERO LABS [Meet No/Date:10/82- [Stabus:Defferederat garesni KUMARignTrade<br>Direct uate © oneral of Foreign Trade<br>aiftrsy 7-11 17/Denartment of Commerce<br> ge ~ ws Ban Now Delhi<br>----- End of picture text -----<br>

a ]

==> picture [458 x 437] intentionally omitted <==

----- Start of picture text -----<br>

|||||||||||
|---|---|---|---|---|---|---|---|---|---|
|||[ALC472014|LIMITED|ALC4/2014|and Re-indexed|
|HQ|File|IRLA File|Lic.No/Date:09 10061132||Defer|
|:01/82/050/00994/AMI15/|—_|:09/24/040/00394/AM15/|22.10.2014|.|Date:10.12.2014|
|Decision|:|It was|decided|to defer the|case|for|10.12.2014|for comments of Department|
|of|Pharmaceuticals|
|Case No.:81/10/82-|Party Name:HONOUR LAB|[Meet|No/Date:10/82-__[Status:Deffered|
|ALC4/2014|LIMITED|ALC4/2014|and Re-indexed|
|_|{12.11.2014|a|
|375||HQ|File|RLA|File|Lic.No/Date:0910061|133||Defer|
|:01/82/050/00995/AM15/|:09/24/040/00407/AM15/|22.10.2014|Date: 10.12.2014|
|Decision|:|It was|decided|to defer the case|for|10.12.2014|for comments of Department|
|of Pharmaceuticals|
|Case No.:82/10/82-|Party Name:DEEPAK|Meet No/Date:10/82-|_|Status:Deffered|
|.|ALC4/2014|INOVOCHEM|ALC4/2014|and Re-indexed|
||TECHNOLOGIESLTD|{12.11.2014|.|||
|376||HQ File|RLA|File|Lic.No/Date:3 110065004||Defer|
|:0:1/82/050/00996/AM15/|:31/83/040/00151/AM15/|[27.10.2014|Date:10.12.2014|
|Decision|:|It was decided|to|defer the|case|for|10.12.2014|for comments of Department|
|of Pharmaceuticals|.|
|Case No.:84/10/82-|Party Name:HETERO|Meet No/Date: 10/82-|Status:Deffered|
||ALC4/2014|DRUGS LIMITED|ALC4/2014|and Re-indexed|
|1377|[HQ File|RLA File|Lic.No/Date:09 10061 140|[Defer|
|01/82/050/00998/AMI15/|_|:09/24/040/00400/AM15/|—_—_—[27.10.2014|_|[Date:10.12.2014.|
|Decision|:|It was|decided|to|defer the|case|for|10.12.2014|for comments of Department|
|of Pharmaceuticals|

----- End of picture text -----<br>

==> picture [455 x 186] intentionally omitted <==

----- Start of picture text -----<br>

|||||||||||
|---|---|---|---|---|---|---|---|---|---|
|[—|[Case No.:83/10/82-_|[Party Name:HETERO LABS|[Meet No/Date-10/82-|__[Status:Deffered|
|ALC4/2014|LIMITED|(ALC4/2014|and Re-indexed|
|.|12.11.2014|
|378||HQ File|RLA|File|Lic.No/Date:09 10061139||Defer|
|:01/82/050/00997/AM15/|:09/24/040/00402/AM15/|27.10.2014|Date: 10.12.2014|
|Decision|:|It was decided|to|defer|the|case|for|10.12.2014|for comments of Department|
|of|Pharmaceuticals|7|.|
|[Case No.:85/10/82-|~|[Party Name:HETERO LABS|(Meet No/Date:10/82-|__|Status:Deffered|
|ALC4/2014|LIMITED|ALC4/2014|and Re-indexed|
|12.11.2014|
|||
|379||HQ|File|RLA|File|Lic.No/Date:0910061141|[Defer|
|:01/82/050/00999/AM15/|_|:09/24/040/00403/AM15/|[27.10.2014||Date:10.12.2014|

----- End of picture text -----<br>

Decision : It was decided to defer the case for 10.12.2014 for comments of Department | [of Pharmaceuticals —~ &F —

T_T, Dy. Directs; Gonerat = ' faery avai #: Directorate General .. arfersy fPiryvDeparta . WENT Way, Hg Udyog Bhawan, iwew Usihi

| | | |

||CaseNo.:86/10/82-<br>ALC4/2014<br>_<br>7|PartyName:SHIVA<br>PHARMACHEMLTD,<br>.|‘|MeetNo/Date:10/82-<br>ALC4/2014<br>__-<br>[12.11.2014<br>.|—_|Status:Deffered<br>andRe-indexed<br>_|
|---|---|---|---|---|
|380||HQFile<br>:01/82/050/01000/AM15/|RLAFile<br>:34/24/040/00194/AM15/|Lic.No/Date:3410040644 <br>—s_ [30.10.2014<br>_|[Defer<br>[Date:10.12.2014|
||Decision : Itwasdecided|to deferthe case for 10.12.2014 forcommentsof Department|||
||ofPharmaceuticals|.|.<br>.||

Date:07.11.2014 Nirmal Kumar Place:New Delhi Dy. Director General of Foreign Trade

we

4

|

: :

Government of India Ministry of Commerce and Industry Directorate General of Foreign Trade DES - III Section

Subject: Draft Minutes of Norms Committee- III Meeting No. 10/82-ALC4/2014 scheduled to be held on 12.11.2014 but was actually held on 13.11.2014: reg.

Please find enclosed herewith a copy of draft minutes of above meeting for vetting and furnishing comments, if any.

,

2. Technical Authorities are requested to kindly return the vetted draft minutes immediately, suitably incorporating their remarks in the draft minutes, for finalization of minutes at our end. In case the vetted draft minutes are not received within two days, it will be presumed that Technical Authorities agree with the draft minutes and same wil! be finalized . accordingly, Encl: as above Ge (M.V. Singh) Foreign Trade Development Officer Tel. No. 23061562 Ext. 269.

3. Dr. Nitin Jain D/o Biotechnology, CGO Complex, New Delhi Dew 2. Shri O.N. Mathur. Consultant, Department of Pharmaceutical " 3. Shri Jasbir Singh, Consultant, Department of C&PC, Shastry Bhawan; N. Delhi

A Ms. Swak Rirwets » Yor Of/a De Osv&) \ JUNG

DGFT U.O.No. 01/82/50/00164/AM15/DES-IIi Dated D&I}. 2014

~