IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2014-09-25

DGFT Committee Minutes

Document text

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Office of Directorate General of Foreign Trade New Delhi

Para 4.7 Decision(DRAFT)

MEETING NUMBER __ : 8/82-ALC4/2014 MEETING DATE: 25.09.2014

The Meeting No. 8/82 of 2014-15 to consider the cases/issues under Duty Exemptioj ‘ Scheme (Chapter-4) of Foreign Trade Policy, 2009-14 pertaining to Chemical and Alte products and falling under Chapter 29 and 30 was scheduled for 25.09.2014 but actually held on 10.10.2014 erelhi. the Chairmanship of Shri Jaikant Singh, Addi. DGFT in Room No.11, Udyog Bhawan, New Following members were present:-

Dr. Nitin Jain D/o Biotechnology Shri Nirmal Kumar, Deputy Director General of Foreign Trade Shri Mahendra Vikram Singh, Foreign Trade Development Officer 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 -IIl meeting No. 7/82 scheduled for 11.09.2014 but actually heid on 23.09.2014 and approved the same.

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

Case No. A-8 M/s Wockhardt Ltd. Meeting No.08/AM15 dated — 10.10.2014 F.No. 01/82/162/0009/AM 14/DES-I SEEPZ-SEZ/EOU/20/2003-04/V ol. X el Decision: It was decided to remind the firm to furnish a copy of Master-Batch formula for each export product duly authenticated by Quality — Control Incharge. The case was deferred for 12.11.2014.

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----- Start of picture text ----- Case No. A-9 M/s Hikal Ltd. Ref. from CSEZ, Cochin Meeting No.08/AM15 dated ~ 10.10.2014 | F.No. 01/82/162/117/AM14/DES-III Decision: It was decided to remind the firm to furnish following information: Clarification from MSME, Bangalore on waste generated /solvent waste viz: Certification from Central Excise Authority on past production consumption data of the firm for various export items. Complete technical details as per Appendix -33 for each export items. ----- End of picture text -----

The case is deferred for 12.11.2014

Case No. A-10 M/s Emami Biotech Ltd. Meeting No. 08/AM15 dated — 10.10.2014 F.No. 01/82/50/00108 /AM15/DES-III Prete are Oh be tae Dy. Dienst oa et ay Cn “de Directs: at: arse[j] Wha: canis cateeay Commence Uayou Bhawan Nos Soni

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----- Start of picture text ----- y Decision: In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/52/2014-Ch. it dated 10.10.2014, 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: ----- End of picture text -----

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----- Start of picture text ----- Palm Methyl Ester ----- End of picture text -----

|Qty.<br>1ke|RBDPalmOil/Edible |0.968kg<br>Oil|
|---|---|
||Sodium Methylate30<br>0.025kg<br>PercentPuri|

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

CaseNo.B-74	M/sVarunMedimpex Inc.
MeetingNo.08/AM15<br>dated- 10.10.2014	F.No.01/83/050/01147/AM13/DES-Hl
RLA’s File no. 05/24/040/00405/AM13	Adv. Lic.No.0510347194 dt.22.02.2013
Decision: Itwasdecided todiscuss thecaseinnextNCmeetingwithconcernedtechnical authority. Thecase is<br>deferred20.10.2014.

Case No, B-75<br>MeetingNo.08/AM15 dated~ 10.10.2014	M/s Unichem Laboratories Ltd.<br>F.No.01/82/50/00692/AM11/DES-IIl
R.AF,No,09/24/040/00138/AM08	Adv,Lic.No.0310588002dated17.08.2010

Decision: It was decided to defer the case for 20.10.2014 for comments of Department of Pharmaceuticals

Case No. B-76	M/s Vivin Labs Ltd.
MeetingNo.08/AM15 dated~ 10.10.2014	F.No. 01/82/50/0087 1/AM08/DES-II1
R.A F. No. 09/24/040/00138/AM08	Adv. Lic. No, 0910031028 dated 01.08.2007
Decision:<br>It was decided to defer the case for 20.10.2014 for comments of Department of
Pharmaceuticals

M/s Shiva Pharma Ltd. Meeting No.08/AMI15 dated — 10.10.2014 F_No. 01/82/162/000 16/AM 13/DES-III Adv. Lic. No. 3410025487 dated 30.10.2009 Adv. Lic. No. 3410025693 dated 25.11.2009 Adv. Lic. No. 3410026511 dated 03.03.2010 Ady. Lic, No. 3410027522 dated 16.07.2010 Decision: It was decided to defer the case for 20.10.2014 for comments of Department of C&PC. Case No. B-78 M/s Scott-Edil Pharma Ltd. Pref araysNRMAL Ear | Dy Dect rt 2 = : 5 : - : a Directuste Core | . . Sa trode arftrsy arty lopurtrtaes it ui ce mumerce Udyog Brean VE ni

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----- Start of picture text ----- ie | Meeting No.08/AM15 dated — 10.10.2014 | F.No. 01/82/050/00222/AM14/DES-III RA F. No. 22/24/040/00015/AM14 Adv. Lic. No. 2210013866 dt. 17.05.2013 Decision ‘It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals. ----- End of picture text -----

Case No. B-79

M/s Techno Drugs & Intermediates(P)

Meeting No.08/AM15 dated — 10.10.2014 F.No. 01/83/050/00530/AM07/DES-HI RLA’s File no. 03/95/040/00486/AM07 Adv. Lic. No. 0310392619 dt. 02.08.2006

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

Details of manufacturing process of this Phenol with chemical equations, molecular formulae, molecular weights. You have enclosed details of Sodium Picosulphate along with the application.
Technical literature in support of yield claimed. 3. Norms approved in your favor in the past for export of per kg of export item i.e. Bisphenol from Pyridine-2 Aldehyde.
Production of export item — Biphenyl and corresponding consumption of each input in past..

The case was deferred for 12.11.2014.

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----- Start of picture text ----- Case No. B-80 M/s Ecological Chemicals Ltd. Meeting No.08/AM15 dated - 10.10.2014 | F.No. 01/82/050/00932/AM13/DES-IH R.A F. No. 09/24/040/00296/AM13 Adv. Lic. No. 0910053811 dt. 14.09.2012 Decision : Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 3$011/354/2014-PI(Norms) dated +. 02.09.2014 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:- - «.- ome eer Ko/kg 1 Napthyl) propionate acie '2__| Methylene Chloride [2.286 Hydrobromic Acid 0.278 48% |4 | Sodium Sulfite 0.185 [5 [|] [Ethyl] [Lactate] 6| Palladium —S——s«i| 0.010 gm [7 |[Toulene ———is1GT RA concemed may take further necessary action as per above decision of NC. IY Oy. Directes co T soS Pe eye ce Drectaute © amare. of are aR ig ipa. soarnent 7 “Coenonee uayou Bhawanatigeat ----- End of picture text -----

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|||||||
|---|---|---|---|---|---|
|-|Case|No.|B-81|M/s Coral Labs|Ltd.|
|Meeting No.08/AM15 dated ~ 10.10.2014|||F.No.|01/82/162/00275/AM14/DES-III|

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Decision : It was decided to defer the case for 20.0.0 9 ..2014.2.2014 for comments of Department of Pharmaceuticals.

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|||||||
|---|---|---|---|---|---|
|Case No.|B-82|M/s Drof Ketal Chemicals I Pvt. Ltd.|
|Meeting|No.08/AM15 dated —|01/82/171/280/AM14/DES-HI1|
|10.10.2014|
|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|
|Adv.|Lic.|No. 0310594926|dated|04.10.2010|

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Decision : It was decided to defer the case for 20.10.2014.

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||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|Mis|Advy|Chemicals|Pvt|Lid|
|Meeting No.08/AM15 dated ~ 10.10.2014|01/83/050/00035/AM|[1]|[1/DES-III]|
|03/94/040/01124/AM10|Adv.|Lice. No. 0310568188|Dated|06.04.2010|
|Decision:|in|the|light|of written|comments|received|from|Department|of Biotechnology|vide|their OM|No.|
|BT/IL/0S/231/2006-PID|dated|21.07.2014,|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:|

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||||||||
|---|---|---|---|---|---|---|
|fem of pen|Oty alowed|
|CReactive|Protein||1gm||1.||Immobilized|P- Aminophenyl|Phosphoryl|
|Human|Choline.|
|Phenylmethane|Sulfonyl|Fluoride.|
|Calcium|Chloride|-|2- Hydrate|R.G|Reag.|
|A|||6- Aminohexanoic Acid.|0.189 gm|
|5.|Phosphocholine Chloride Calcium|Salt|6.06 gm|
|(79413-250|G).|
|Phosphocholine Chloride Calcium Salt|penta|| 6.06|gm|||\|
|P0378-SPEC).|SE|Saad|ht|
|“avy|wine|yee,|se8|
|Directorate|Gerore:|f_.”|ivf|
|wPree|ENOL, one|ent on|commoree|

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| || |

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----- Start of picture text ----- DE 52 Pre- Swollen AIEC. 0.042 gm ----- End of picture text -----

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----- Start of picture text ----- RA may take appropriate action as per the decision of Norms Committee's. ----- End of picture text -----

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----- Start of picture text ----- Case No. C-7 M/s Gaurav Pharma Ltd., New Dethi Meeting No.08/AM15 dated — 10.10.2014 F.No. 01/82/171/00018/AM13/DES-IH ----- End of picture text -----

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----- Start of picture text ----- Decision: Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/164/2014-PI{Norms) dated 05.09.2014 has mentioned that the Application of the for fixation of SION is for the export of (1) Sodium Ascorbate and (2) 1,2-Benzisothiazol-3(2H)-one 1,1-Dioxide (insoluble). As per the CA certificate endorsed by the firm, it is noted that:- a) The firm's production of these two products are shown as NIL during the last 3 years. And b) The firm has not taken any advance authorization for the above two product during the last 3 years. It was decided to advised the firm to take advance authorization under para 4.7 for the immediate export, Case No.:132/8/82- Party Name:PROVENTUS Meet No/Date:8/82- Status:Case ALC42014 LIFELIMITED, SCIENCES PRIVATE 25.09.2014|ALC4/2014 Deferred 1 |HQ File RLA File Lic.No/Date:04 10094357 |Defer 01/82/050/00796/AM15/ :04/24/040/00395/AM08/ 12.03.2008 Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals. ] Case No.:28/28/82- Party Name: MYLAN ALC4/2012 LABORATORIES LIMITED (ALC4/2014Meet No/Date:8/82- DeferredStatus:Case 2 HQ File RLA File 25.09.2014Lic.No/Date:09 10053660 [Defer . 01/82/050/00995/AM13/ :09/24/040/00270/AM13/ 04.09.2012 Date: 12.11.2014 Decision : It was decided to remind the firm to furnish the details of Past Production vis-a- vis Actual consumption of inputs duly certified by Central Excise Authorities. The case was deferred for 12.11.2014. TT [Case No:40/15/82- Party Name:CALYX Meet No/Date:8/82-____[Status:Case ALC4/2013 CHEMICALS & ALC4/2014 Approved PHARMACEUTICALS LTD. [25.09.2014 HQ File RLA File Lic.No/Date:03 10707994 |Defer Date:; 3 |:01/82/050/00802/AM14/ :03/94/040/00199/AM10/ 06.09.2012 ----- End of picture text -----

Decision : Committee considered the case as per agenda and in light of written comments received from Department ofPharmaceuticals vide their OM No. 35011/31/2014-Pl(Norms) dated Iay 24.09.2014 and in consultation with technical authority present in meeting, rdecided:tonrati

Dy. Director eet ior d anAL KUMARTote

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----- Start of picture text ----- Uayog Bhawan, Nos Lomi ----- End of picture text -----

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----- Start of picture text ----- norms under para 4.7 of HBP as per details given below or as applied by firm whichever is lower:- a Ail1 Pyrazinea2,3 Dicarboxylic Kg/kg Zopiclone BP/EP ikg Acid 1.53 2-Amino 5-Chioro Pyridine | 6 5 [Reis [a] | 7 Pyrazine 2,3 Dicarboxylic Acid 1.53 ----- End of picture text -----

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

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|||||||
|---|---|---|---|---|---|
|Case No.:88/1/82-ALC4/2013||Party|Name: MYLAN|Meet No/Date:8/82-|Status:Case|
|LABORATORIES|LIMITED||ALC42014|Deferred|
|a|25.09.2014|
|HQ File|RLA|File|Lic.No/Date:09|10054034||Defer|
|:01/82/050/01446/AM13/|:09/24/040/00287/AM13/|11.10.2612|Date: 12.11.2014|
|4||Decision|:|It was decided to remind the firm to furnish following technical details:|

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i) Complete technica! details as per Appendix 33. ii) Copy of technical literature in support of yield envisaged in the process past production vis-a-vis Actual consumption of all inputs duly certified by Central Excise Authorities. The case was deferred for 12.11.2014.

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|||||||||
|---|---|---|---|---|---|---|---|
|Case No.:4/27/82-ALC4/2012||Party Name:PORUS|Meet No/Date:8/82-|Status:Case|
|LABORATORIES|PVT LTD.||ALC4/2014|Deferred|
|25.09.2014|
|5||HQ|File|RLA|File|Lic.No/Date:0910054464||Defer|
|:01/82/050/00959/AM13/|:09/24/040/00408/AM13/|07.12.2012|Date:12.11.2014|
|Decision|:|It was decided|to defer the|case|for|12.11.2014|for comments of Department of|
|Pharmaceuticals,|

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|||||||
|---|---|---|---|---|---|
|Case|No.:87/14/82-|Party Name:ASTRIX|Meet No/Date:8/82-|Status:Case|
|ALC4/2013|LABORATORIES|LTD.,|ALC4/2014|Approved|
|25.09.2014|
|HQ|File|RLA File|Lic.No/Date:0910055844|{Defer Date:|
|6||:01/82/050/00672/AM14/|:09/24/040/00009/AM|14/|3,04.2013|;|

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Decision : Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/752/2014-P1(Norms) l\ dated 09.09.2014 and in consultation with technical authority present in meeuine s tecided.te UMAR

Udyog Bhawan eee a,

/ :

ratify norms under para 4.7 of HBP as per details given below or as applied by firm whichever is lower:-

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||||||||
|---|---|---|---|---|---|---|
|}|Export product|EP|||SINe. ||import items|Qty. Allowed|
|||Kg/kg|
|||Lamivudine (Cyclohexyi|1kg|Cyclohexyl Ester|
|||Ester Route)|-|
|:|2|[Satan Boh|
|Dipotassium|Hydrogen|
|Phosphate|1.9849|
|4|[MethanolTTMethanol|0.167|
|eer|
|||6|Triethylamine|0.575|
|Isopropyl|Alcohol|1.427|

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

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|||||||||
|---|---|---|---|---|---|---|---|
|Case No.142/10/82-|Party Name:WOCKHARDT|[Meet No/Date:8/82-_([Status:Case|
|ALC4/2013|LIMITED|ALC4/2014|Deferred|
|.|25.09.2014|
|7|{HQ|File|RLA|File|Lic.No/Date:03|10734494|[Defer|
|:01/82/050/00325/AM14/|703/95/040/00101/AM14/|15.05.2013|Date: 12.11.2014|
|Decision|:|It was decided to remind DCGI to|furnish their comments.|The case was|
|deferred|for|12.11.2014.|

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||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|{Case No.:136/14/82-|Party Name:CALYX|Meet No/Date:8/82-|__(Status:Case|
|ALC4/2013|CHEMICALS &|ALC4/2014|Approved|
|PHARMACEUTICALS|LTD.|(25.09.2014|
|HQ File|RLA|File|Lic.No/Date:0310735110|{Defer Date:|
|:01/82/050/400721/AM14/|:03/94/040/00507/AM13/|21.05.2013|:|
|Decision|:|Committee|considered|the|case|as|per|agenda|and|in|light|of|written|comments|
|received|from|Department|of|Pharmaceuticals|vide|their|OM|No.|35011/734/2013-Pl(Norms)|
||dated|09.09.2014|and|in|consultation|with|technical|authority|present|in|meeting,|decided|to|
|8|ratify norms under para|4.7 of HBP as per details given below or as applied|by firm whichever|is|
|lower:-|
|(al|Ka/k 0|
|||Export product|EXP.|||SLNo.|Import items|Qty. Allowed|
|||2|||3-Amino-1-Adamantanol|0.682|
|RA concerned may take further necessary action as per|above decision of NC.|

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----- Start of picture text ----- AY ----- End of picture text -----

Udyog Bhawan Weare,

| |

	CaseNo.:42/20/82-	PartyName:GLAND	MeetNo/Date:8/82-	Status:Case
	ALC4/2013	PHARMALIMITED	ALC4/2014	Deferred
			25.09.2014	7
9	HQFile<br>:01/82/050/01028/AM14/	RLAFile<br>:09/24/040/00058/AM14/	Lic.No/Date:0910056116 <br>3.05.2013	Pefe<br>Date:12.11.2014

Decision : Reply received from the firm and sent to Department of Pharmaceuticals for their comments. The case was deferred for 24.07.2014 .

Case No.:42/15/82Party Name:IPCA Meet No/Date:8/82Status:Case ALC4/2013 LABORATORIES LIMITED |ALC4/2014 Approved - 25.09.2014 . HQ:01/82/050/00804/AM14/ File RLA:03/94/040/0007 File 1/AM14/ Lic.No/Date:0324.05.2013 10735502 |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. 35011/21/2014-Pi(Norms) dated 22.09.2014 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:-

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----- Start of picture text ----- 10 Export ; product EXP. | Import items Kg/kgQty. Allowed ) Carvedilol 1kg 4-hydroxy carbazole | 106 Dimethyl sulfoxide | 100 | 3 2(2-methoxy phenoxy) ethylamine 1.089 ----- End of picture text -----

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----- Start of picture text ----- RA concerned may take further necessary action as per above decision of NC. . Case No.:225/10/82- Party Name:APEX Meet No/Date:8/82- __|Status:Case ALC42013 HEALTHCARE LTD ALC4/2014 Approved 25.09.2014 HQ File RLA File Lic.No/Date:3410037038 [Defer Date: :01/82/050/00408/AM14/ —:34/24/040/00035/AM14/ [31.05.2013 Decision : Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/90/2014-Pl(Norms) 11 dated 24.09.2014 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:- ----- End of picture text -----

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----- Start of picture text ----- | Export product Be. | SINo. ----- End of picture text -----

Qty.Kg/ka Allowed CEERI TT BRL KUMAR SM eae vetee eee Directorate Generar oti yer Frade aftsaUdyogTPTBran!De pommentFinvi Commerce

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RA concerned may take further necessary action as per above decision of NC. _ Case No.:156/14/82Party Name:EYTAN LABS Meet No/Date:8/82Status:Case ALC4/2013 LIMITED ALC4/2014 Approved 25.09.2014 . HQ File RLA File Lic.No/Date:0910056288 |Defer Date: :01/82/050/00741/AM14/ —_—|:09/24/040/00087/AM14/ —[07.06.2013 oe

Decision : Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/755/2013-PI(Norms) dated .2014 and in consultation with technical authority present in meeting, decided to ratify 12 |norms under para 4.7 of HBP as per details given below or as applied by firm whichever is lower:-

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|||||||
|---|---|---|---|---|---|
|Export product|EXP.|||SINo.|Import items|Qty.Ka/ko Allowed|
|L-Menthyl Glyoxylate|Glyoxylic Acid 50%|0.752|
|Hydrate (MGH)|

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

~~ Case No.:77/14/82[Party Name:GLAND Meet No/Date:8/82_[Status:Case ALC42013 PHARMA LIMITED ALC4/2014 Approved 25.09.2014 i HQ File RLA File Lic.No/Date:09 10056304 |Defer Date: :01/82/050/00662/AM14/ :09/24/040/00106/AM14/ 10.06.2013

Decision : Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/807/2013-PI(Norms) dated 09.10.2014 and in consultation with technical authority present in meeting, decided to 13 |fatify norms under para 4.7 of HBP as per details given below or as applied by firm whichever is lower:Export Product : Amiodarone Hcl Injection Prefilled Syringe 50mg/ml, 3m! PFS

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----- Start of picture text ----- Import Item Norms Applied | As per Central Batch Lowest of (i) (2) Excise Logsheet (2) to (4) Certificate (4) 3 Sey wars, at face ere? Udyog Bhawan Nee in; ----- End of picture text -----

; :

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----- Start of picture text ----- : [4|5____|| NeedlePlungerPlunger StoppersShield Rods || —s1.28Nos.~728Nos.108Nos [L1G| | 121291.2283, |||-Do---Do--|1.22=Do~ || 1.01.2129 8 Nos. Nos. | [6 | Preventis(Rubber) | —*L.0SNos. | =NA. | --Do-- | Netto Net| [8 | Anti Factor Ia Test Kits | 19 | Analytical Columns il||cahims—o MedicalAnalytical Grade PapeGuard Consumable, Net to Net [12 | Tubing [13[14 ||AntiFactorXa [AntiFactorila] 116| Mol. Wt. Standard ----- End of picture text -----

In accordance with the earlier decision of Norms-Committee, present case may be considered specific to USFDA project and Export to USA only.

A concerned may take further necessary action as per above decision ofNC.

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----- Start of picture text ----- Case No.:28/12/82- Party Name:BLISS GVS Meet No/Date:8/82- Status:Case ALC4/2013 PHARMA LTD. ALC4/2014 Deferred . 25.09.2014 HQ File RLA File Lic.No/Date:03 10738193 [Defer 14 |:01/82/050/00452/AM14/ —|:03/94/040/00245/AM14/ —_—| 19.06.2013 Date: 12.11.2014 Decision : It was decided to remind the firm to furnish the following technical details: 1, COA for foreign supplier indicating Potency of Nystatin imported under present A.A 2. Detailed calculation of arriving at the quantity of API applied. The case was deferred for 12.11.2014. ----- End of picture text -----

Case No.:183/10/82Party Name: VIVEK Meet No/Date:8/82Status:Case ALC4/2013 PHARMACHEM (INDIA) ALC4/2014 Deferred 7 LTD, 25.09.2014 15 HQ File RLA File Lic.No/Date:1310043416 [Defer |:01/82/050/00366/AM14/ _—:13/24/040/00032/AM12/ {19.06.2013 ———Ss«Date 12.11.2014 Decision : It was decided to call from the firm Copy of relevant DML for each export product alongwith detailed working on the requirement of AP] in each case.The case was deferred for 09.10.2014, | 7 "(Case No.:172/14/82Party Name:RECKON Meet No/Date:8/82(Status:Case ALC4/2013 DIAGNOSTICS PVT.LTD. jALC4/2014 Deferred 25.09.2014 a HQ File RLA File Lic.No/Date:3410037268 |Defer — 16 Decision201/82/050/00757/AM14/* : It was decided. to:34/24/040/00044/AM14/ remind+ the firm to furnish= the27.06.2013 copy of Manufacturing. processDate:12.11.2014flow 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 | japplication. The case was deferred for 12.11.2014. 7 a atee shan we\WAR WY tee : ‘2 Dy PUIDenonWPLGr eeaBeta coyserGrade Directuiute Gerieral ot Foreign Trade aftrsa frvDepartment of Commerce Udyog Bhawan, New Delhi

Case No.:201/10/82[PartyName:SHASUN Meet No/Date:8/82Status:Case ALC4/2013 PHARMACEUTICALS ALC4/2014 Deferred _ {LIMITED {25.09.2014 17 HQ File RLA File Lic.No/Date:0410147551 |Defer |:01/82/050/00384/AM14/ —:04/24/040/00063/AM14/ —[27.06.2013 Pete 112014 Decision : It was decided to remind the firm to furnish a copy of Master Batch Formula duly certified by Quality Control Incharge. The case was deferred for 12.11.2014. ‘Case No.:24/12/82Party Name: WOCKHARDT Meet No/Date:8/82Status:Case ALC4/2013 LIMITED ALC4/2614 Deferred 25.09.2014 | HQ File RLA File Lic.No/Date:03 10739850 |Defer 8 :01/82/050/00448/AM14/ :03/95/040/00256/AM14/ 02.07.2013 - Date: 12.11.2014 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 12.11.2014. . [ | [Case No.:27/13/82Party Name:ADVY ‘Meet No/Date:8/82Status:Case ALC4/2013 CHEMICAL PVT.LTD. ALC4/2014 Deferred 25.09.2014 OO 19 [HQ File RLA File Lic.No/Date:03 10740927 |Defer :01/82/050/00503/AM14/ :03/94/040/00269/AM14/ 10.07.2013 jDate: 12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Biotechnology. . Case No.2160/14/82Party Name:ALCHYMARS = Meet No/Date-8/82Status:Case ALC4/2013 ICM SM PRIVATE LIMITED |ALC4/2014 Deferred 25.09.2014 | 20 |HQ File RLA File Lic.No/Date:0410147942 iDefer :01/82/050/00745/AM14/ —|:04/24/040/000S0/AM14/ ‘11.07.2013 Date:12.11.2014

Decision : It was decided to defer the case for 12.11.2014 for comments of Department of |Pharmaceuticals. . . Case No.:60/14/82Party Name:GLAND Meet No/Date:8/82__[Status:Case A4LC4/2013 PHARMA LIMITED ALC4/2014 Deferred 25.09.2014 ; 21 |HQ File RLA File Lic.No/Date:0910056772 |Defer 701/82/050/00645/AM14/ :09/24/040/00085/AM14/ 16.07.2013 Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals. . Case No.:21/12/82Party Name:WOCKHARDT [Meet No/Date:8/82-___[Status:Case 22 ALC4/2013 LIMITED ALC4/2014 Deferred [HQ File IRLA File [Lic.No/Date:03107419925,09.2014 [Defer 1,So Oy eer Ge er ». i ian Trade irectorate oneral of. area aren frvosseunen of Corenonce Udyog Bhawan wees Deini

! ) |

|“||
|---|---|
||[:01/82/050/00445/AM14/<br>[:03/95/040/00306/AM14/<br>[18.07.2013<br>[Date:12.11.2014|
||Decision : Committeeconsidered thecaseand ithasbeenobservedthatthe exportof|
||EntacaponeTablets 200mgandthe input isalsoEntacaponeTablets200mgwith2%|
||wastage. Itappearstobeacaseofreferdingonlyandnomanufacturing activity is|
||involved.<br>Itwasdecided toremindDCGI to furnish theircomments. Thecasewas|
||deferred for 12.11.2014.<br>.<br>oe|
||CaseNo.:68/17/82-<br>PartyName:BHARAT<br>MeetNo/Date:8/82-<br>Status:Case<br>ALC4/2013<br>PARENTERALSLTD,<br>ALC4/2014<br>Deferred<br>25.09.2014<br>L|
|23|[HQFile<br>RLA File<br>Lic.No/Date:34 10037475<br>\Defer|
||:01/82/050/00930/AM 14/<br>:34/21/040/00163/AM14/<br>23.07.2013<br>Date:12.11.2014|
||Decision : Itwas decidedtosendacopyofapplication againtoDepartment ofPharmaceuticals|
||fortheircomments.Thecasewasdeferred for 12.11.2014.|
|[|[GaseNo.:52/12/82-<br>PartyName:UNIJULESLIFE<br>[MeetNo/Date:8/82-___|Status:Case|
||ALC4/2013<br>SCIENCESLTD.<br>ALC4/2014<br>Deferred<br>25.09.2014<br>)|
||HQ File<br>RLA File<br>Lic.No/Date:03 10742481<br>(Defer|
|0|01/82/050/00476/AM14/<br>—_—[:03/95/040/00305/AM14/<br>[23.07.2013<br>Date:12.11.2014<br>Decision : Itwasdecidedtoremindthefirm tofurnishthefollowingtechnical details: 1.|
||Technical detailsasperAppendix33 forconversionofGadoliniumtoGadopenteate<br>Dimeglumine. 2.VolumeoftheInjection /Vial tobeexported.Thecasewasdeferredfor|
||12.11.2014|

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----- Start of picture text ----- Case No.:1/10/82-ALC4/2013 |Party Name:MICRO LABS Meet No/Date:8/82- Status:Case 25.09.2014 LTD ALC4/2014 Deferred 25 THQ File RLA File Lic.No/Date:07 10097180 |Defer 01/82/050/00184/AM14/ —:07/24/040/00111/AM14/ [30.07.2013 Date:12,11.2014 Decision : It was decided to call from the firm detailed justification for the import of 1039.076 kg ofAPI against the present advance authorization. The case was deferred for 12.11.2014 Case No.:17/13/82- No.:17/13/82- Party Name:PAB ORGANICS Name:PAB ORGANICS ORGANICS [Meet No/Date:8/82- No/Date:8/82- Status:Case ALC4/2013 PVT.LTD, ALC4/2014 Deferred 25.09.2014 26 |HQ File File - RLA File . Lic.No/Date:34 10037541 10037541 |Defer :01/82/050/00493/AM14/ ——:34/24/040/00085/AM14/ —_—([31.07.2013 — [Date:12.11.2014 Decision : It was decided was decided decided to send a copy of send a copy of a copy of copy of of application again again to Department of Department of of Pharmaceuticals for their comments. The case was deferred their comments. The case was deferred comments. The case was deferred The case was deferred case was deferred was deferred deferred for 12.11.2014 ----- End of picture text -----

| Case No.:17/13/82- No.:17/13/82Party Name:PAB ORGANICS Name:PAB ORGANICS ORGANICS [Meet No/Date:8/82- No/Date:8/82Status:Case | ALC4/2013 PVT.LTD, ALC4/2014 Deferred | 25.09.2014 | 26 |HQ File File - RLA File . Lic.No/Date:34 10037541 10037541 |Defer : :01/82/050/00493/AM14/ ——:34/24/040/00085/AM14/ —_—([31.07.2013 — [Date:12.11.2014 Decision : It was decided was decided decided to send a copy of send a copy of a copy of copy of of application again again to Department of Department of of Pharmaceuticals for their comments. The case was deferred their comments. The case was deferred comments. The case was deferred The case was deferred case was deferred was deferred deferred for 12.11.2014 | Case No.:31/4/82-ALC4/2014 |Party Name: UNIVERSAL Meet No/Date:8/82Status:Case BIOFUELS PRIVATE ALC4/2614 Deferred LIMITED 25.09.2014 | | 27 THQ File RLA File Lic.No/Date:0910056959 [Defer :01/82/050/00279/AM15/ :09/24/040/00 155/AM14/ 31.07.2013 Date:12.11.2014 : 7 [Decision : It was decided to deferthe case for 12.11.2014 for comments of Dy. DirectormoreGenera " re T iya ara RrvDepartment of Commerce | pietorte Goneral ‘of Poregn trade : Udyog 1 er ES Delhi |

ao) | are.

| | : |

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----- Start of picture text ----- Case No.:48/14/82- Party Name:LOUIS Meet No/Date:8/82- __[Status:Case ALC4/2013 PHARMACEUTICALS PVT /ALC4/2014 Approved LTD (25.09.2014 . HQ File RLA File Lic.No/Date:09 10057008 [Defer Date: :01/82/050/00633/AM14/ =—_——§:09/24/040/00200/AM14/ 02.08.2013 ----- End of picture text -----

Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/724/2013-Pi{(Norms) dated 09.09.2014, 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:

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----- Start of picture text -----

|||||||
|---|---|---|---|---|---|
|og|||Item of Export|Quantity|item of import|Quantity|
|allowed|
|ke/kg|
|1.|(2B,|3A,5A,16B,|17B)-2-(4-|
|RCB|Diol|MORPHOLINYL)-16|
|(PYRROLIDINYL)|
|ANDROSTANE-3,|17-DIOL|||!-|
|CRUDE|
|RA may take appropriate action as per the decision of Norms Committee.|
|Case No.:40/14/82-|Party Name:CTX|Meet No/Date:8/82-|Status:Case|
|ALC4/2013|LIFESCIENCES PVT LTD,||ALC4/2014|Deferred|
|.|25.09.2014|;|
|HQ File|RLA File|Lic.|No/Date:03 10744552||Defer|
|9||:01/82/050/00625/AM14/|:03/94/040/00307/AM14/|07.08.2013|Date:12.11.2014|

----- End of picture text -----

Decision : It was decided to call from the firm following information:- (a) Complete technical details as per Appendix 33. (b) Past production vis-d-vis actual consumption of inputs duly certified by Central Excise Authority. The case was deferred for 12.11.2014

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----- Start of picture text -----

|||||||||||
|---|---|---|---|---|---|---|---|---|---|
|Case No.:11/13/82-|Party Name:WANBURY|(Meet No/Date:8/82-___([Status:Case|
|ALC4/2013|LIMITED(FORMERLY|ALC4/2014|Deferred|
|PEARL ORGANICS|LTD)|25.09.2014|
|HQ File|RLA|File|Lic.No/Date:03 10744468||Defer|
|30||:01/82/050/00487/AM14/|:03/95/040/00134/AM|14/|07.08.2013|Date:12.11.2014|
|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-4-vis|actual consumption|
|of input duly|certified by Central|Excise Authorities. The case was deferred|for|12.11.2014|

----- End of picture text -----

| :

Case No.:34/13/82-~ Party Name: WANBURY Meet No/Date:8/82Status:Case ALC42013 LIMITED(PORMERLY ALC4/2014 Deferred 131 PEARL ORGANICS LTD) [25.09.2014 HQ File RLA File Lic.No/Date:03 10744838 |Defer :01/82/050/005 10/AM14/ :03/95/040/00132/AM14/ 12.08.2013 __{Date: 12.11.2014 ov, sperfersras “uf oe y. Diractor General of Foreign Trade Directorate Goneral hes de afiey ParvDepartment of Commerce Udyven Le ag fh ei

| |

|| : : : | | | | :

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 12.1 1.2014

Case No.:73/13/82Party Name: WANBURY Meet No/Date:8/82Status: Case ALC4/2013 LIMITED(XFORMERLY ALC4/2014 Deferred HQ File . PEARL ORGANICSRLA File LTD) _ [25.09.2014Lic.No/Date:03 10744832. |Defer 3p |:01/82/0S0/00549/AM14/ _|:03/95/040/00133/AM14/ {12.08.2013 pete12.11.2014 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 12.11.2014

. Case No.:76/13/82Party Name:WANBURY [Meet No/Date:8/82-‘[Status:Case ALC4/2013 LIMITED(FORMERLY ALC4/2014 Deferred PEARL ORGANICS LTD) [25.09.2014 __ . HQ File RLA File Lic.No/Date:03 10744834 |Defer ; 43 (OL/82/0S0/00S52/AMI4/ —|:03/95/040/0012S/AM14/—|12.08.2013 Date:]2.11.2014 | [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 12.11.2014

Gane NOXTSILSIBD (Party Name: WOCKHARDT [Meet No/Date:8/82__[Status:Case ALC4/2013 LIMITED - |ALC4/2014 Deferred 25.09.2014 | HQ File RLA File Lic.No/Date:03 10744861 |Defer :01/82/050/0055 1/AM14/ :03/95/040/00320/AM14/ 12.08.2013 Date:12.11.2014 34 Mecision : 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% | jwastage. 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 12.11.2014.

Case No.:107/13/82Party Name:DR REDDYS Meet No/Date:8/82Status:Case ALC4/2013 LABORATORIES LIMITED |ALC4/2014 Deferred HQ. File . RLA File 25.09.2014Lic. No/Date:09 10057189 | iDefer 35 |:01/82/050/00583/AM 14/ :09/24/040/00222/AM14/ 14.08.2013 Date: 12.11.2014 Decision : It was decided to remind the firm to furnish the following information : i) Complete details as per Appendix 33. ii) Copy relevant technical literature in support of yields envisaged iii) Past production vis-a-vis actual consumption of input duly certified by Central Excise Authorities. The case was deferred for 12.11.2014.

Case No.:118/14/82Party Name: WANBURY Meet No/Date:8/82Status:Case 36 |ALC4/2013 LIMITED(FORMERLY JALC4/2014 Approved PEARLORGANICS LTD) _[25.09.2014 PotsDy. Director Brae General/NIRMAL Kof Foreign Pi Directoratefaaer eqnGeneralwerPresnrereof Foreign Trade afrsy fPrPvDepartment of Commerce sent was, ag fect Udyog Bhawan, New Delhi

HQ File RLA File [LicNo/Date-0310745568 [Defer Date: 01/82/050/00703/AM14/ —_|:03/95/040/00517/AM13/ 16.08.2013 . . Decision : Committee considered the case as per agenda and in light of written comments | |receiveddated 05.09.2014from Departmentand in consultationof Pharmaceuticalswith technicalvide theirauthority OM presentNo. 35011/767/2013-PI(Norms)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:See | Ka/kg Dicyanodimide 0.567 Metformin Hel 1kg :

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

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----- Start of picture text -----

||||||||
|---|---|---|---|---|---|---|
|Case No.:117/14/82-|Party|Meet No/Date:8/82-|Status:Case|
|ALC4/2013|Name:|MAC CHEM PRODUC||ALC4/2014|Deferred|
|TS (INDIA) PRIVATE LIM!|[25.09.2014|
|TED|
|HQ File|RLA File|Lic.No/Date:03 10745962||Defer|
|5|:01/82/050/00702/AM14/|:03/95/040/00407/AMI14/|20.08.2013||Date:12.11.2014|
|||[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|12.11.2014|

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----- Start of picture text -----

|||||||||||
|---|---|---|---|---|---|---|---|---|---|
|Case No.:20/13/82-|Party|Name:|VARUN|[Meet No/Date:8/82-|_[Status:Case|
|ALC4/2013|MEDIMPEX INC.|ALC422014|Deferred|
|38||HQ File|-|RLA File|25.09.2014Lic.No/Date:05 10363085||Defer-|;|
|:01/82/050/00496/AM14/|—_—:05/24/040/00134/AM14/|21.08.2013|Date:20,10.2014|
|Decision|:|It was|decided|to discuss the comments|received from|Petrochemical|Division|of|Department|
|of|C&PC. The case|is deferred|for 20.10.2014|
|[7|[Case No.:3/12/82-ALC4/2013|[Party Name:ACTAVIS|Meet No/Date:8/82-|__[Status:Case|
|PHARMA|ALC4/2014|Deferred|
|MANUFACTURING|25.09.2014|
|PVT.LTD|.|;|
|39|THQ|File|RLA|File|Lic.No/Date:04 10148864|[Defer|
|:01/82/050/00427/AM14/|—|:04/24/040/0009S/AM14/|—_[22.08.2013|_—|[Date:12.11.2014|
|Decision|:|It was decided|to send|a copy of application again to DCGI|for their comments|
||(solution of import items contains 8% water). The case was deferred|for|12.1 1.2014.|

----- End of picture text -----

ho Case No.:88/13/82-_ Party Name: MAKCUR Meet No/Date:8/82_[Status:Case ALC4/2013 LABORATORIES LTD. —_{ALC4/2014 Dy. Dir e ctorforredinnGeneral of Forel{tenn Wade afreyDirectorate fFArVDepartmentGeneral of Foreignof CommerceTrade Udyog Bnewan Won Dethi

HQ File RLA File Lic.No/Date:0816124120 |Defer Date: :01/82/050/00564/AM14/ ——|:08/24/040/00232/AM14/—[26.08.2013

Decision : in the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/699/2013-Pi(Norms) dated 09.09.2014, 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 [428 x 88] intentionally omitted <==

----- Start of picture text -----

||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
|kg/kg|
|||Item of|Export|oN.|[SNe|||Item of import|Quantity allowed|
|||Cefuroxime|750|mg|Inj.|USP|Vial ||1|vial|Cefuroxime|822.50 mg/vial|
|size|10mt|[each|vial|contains|Sodium|Sterile|
|cefuroxime|sodium|USP|equivalent|
|to Cefuroxime|750mg]-1No.|

----- End of picture text -----

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

~
Case No.:154/14/82[Party Name:CADILA. Meet No/Date:8/82- _ [Status:Case ALC4/2013 PHARMACEUTICALS LTD. [|ALC4/2014 Approved 25.09.2014
| {HQ File RLA File Lic.No/Date:0810124684 |Defer Date: :01/82/050/00739/AM14/ —_—|:08/24/040/00264/AM14/ 11.09.2013

| |Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/810/2013-PI(Norms) dated 02.09.2014, it was decided to ratify norms under 41 |Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

==> picture [422 x 51] intentionally omitted <==

RA may take appropriate action as per the decision of Norms Committee. — - Case No.:47/16/82Party Name:SHASUN Meet No/Date:8/82__|Status:Case ALC4/2013 PHARMACEUTICALS ALC4/2014 Deferred | . LIMITED 25.09.2014 a
42 |HQ File RLA File Lic.No/Date:04 10149741 Defer 01/82/050/00860/AM14/ —_j:04/24/040/00130/AM14/ 11.09.2013 Date: 12.11.2014 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 12.11.2014. | Case No.:10/16/82Party Name:STERICON Meet No/Date:8/82Status:Case ALC4/2013 PHARMA PVT.LTD., ALC4/2014 {Deferred
43 |HQ. File RLA File . (25.09.2014Lic. No/Date:07 10098284 |Defer . :01/82/050/00823/AM14/ :07/24/040/0020 /AM14/ 16.09.2013 Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals.

==> picture [22 x 33] intentionally omitted <==

----- Start of picture text ----- Rt ----- End of picture text -----

Dy. Director General of Foreign Trade airespikefrarvDepartment General of Foreignof Comme: Trace Udyog an Now Delhi

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||||||||
|---|---|---|---|---|---|---|
|A|||
|Case|No.:35/17/82-|Party Name:S M$|Meet No/Date:8/82-|1Status:Case|
|ALC4/2013|PHARMACEUTICALS LTD|/ALC42014||Deferred|
|25.09.2014|fo|
|44||HQ File|RLA|File|Lic.No/Date:0910057602|[Defer|
|01/82/050/00897/AM14/|—_-09/24/040/00083/AM14/|18.09.2013|=||Date: 12.11.2014|
|Decision|:|It was|decided remind the firm to furnish complete technical|details as per Appendix|
|33.|The case was|deferred|for|12.11.2014.|
|Case No.:46/16/82-|Party Name:SHASUN|Meet No/Date:8/82-|Status:Case|
|ALC4/2013|PHARMACEUTICALS|ALC4/2014|Deferred|
|LIMITED|25.09.2014|
|45|[HQ|File|RLA|File|Lic.No/Date:0410149960|[Defer|
|Decision:°01/82/050/00859/AM14/;|It was|decided to cali:04/24/040/00127/AM14/ from the firm a copy of|Master18.09.2013 Batch|Formula dulyDate:12,11.2014certified|by|
|Quality Control|In charge. The case was deferred|for|12.11.2014|

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||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|||Case No.:47/15/82-|Party Name:PI|INDUSTRIES||Meet No/Date:8/82-|Status:Case|
|||ALC4/2013|LTD.,|ALC4/2014|Approved|
|||25.09.2014|.|
|||HQ01/82/050/00809/AM14/ File|RLA—|:13/24/040/00026/AM14/ File|24.09.2013Lic. No/Date: 1310044452.|[Defer Date:|
|7|Decision|:|In the|light of written comments received from|Petrochemical|Division|of Department|
|||of Chemicals and Petrochemicals|vide their U.O No.|14012/4/2011-50|Ch.|Hl dated|24.07.2014,|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:|

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----- Start of picture text ----- | Export product Exp. | Si.No. | Import items Qty. Qty. Allowed }46 | kgs. : Ethyl-5[({[isopropyl(methyl) 4-Chloro-2 Fluoro- 2-ChMethy l oro-4-FluoroIso Propyl Amine Toluene 0.615 amino]sulfonyl} amino) 3 NOBLYST (R) P8086 (P/C 0.008 carbonyl]phenylcarbamate Catalyst (+1%PT +2% V/C, | PT - 0.3% Mo CP 2.274 (S|Toene 0.743 | '6 [_|] [Ethyl][ Chloroformate] 0.370 | Sulfuryl Chloride 0.715 ----- End of picture text -----

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

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----- Start of picture text ----- Case No.:38/15/82- Party Name:FDC LTD Meet No/Date:8/82- Status:Case ALC4/2013 ALC4/2014 Approved 25.09.2014 47 {HQ File RLA File Lic.No/Date:03 10751024 [Defer Date: :01/82/050/00800/AM14/ :03/94/040/00256/AM14/ —[25.09.2013 a theirDecisionOM No.: In 35011/34/2014-PI{Norms) dated the light of written comments received 05.09.2014, from itDepartmentwas decided of to Pharmaceuticals ratify norms under vide { by Breau paN/NIRMALhtbsad fexet caraKUM, R oie General erraera PisafEVOpanment of Commare Udyog Bhawan Wee Eotns ----- End of picture text -----

| |

| | : | |

Para 4.7 ofHBP v1 as per details given below or as applied by the firm, whichever is less:

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

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||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
|)|
|Case No.:34/19/82-|Party Name:ELPPE|Meet No/Date:8/82-|Status:|Case|
||ALC4/2013|CHEMICALS PRIVATE|ALC4/2014|Approved|
|LIMITED|25.09.2014|
|HQ01/82/050/00979/AM14/ File|RLA—_—j:03/94/040/00552/AM14/ File|_[07.10.2013Lic.No/Date:03 10752484;||Defer Date:oo|
|Decision|:|In|the|light|of written comments received|from|Department of Pharmaceuticals vide|
|their OM|No.|35011/84/2014-Pi(Norms)|dated|10.10.2014,|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::-|

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|||||||||||
|---|---|---|---|---|---|---|---|---|---|
|Export|product|Exp.|Qty.|import items|Qty.|
|Allowed|
|ko/kg|
|||Phenyl Thio|Proline|||14|kg|Trans 4|Hydroxy|L-Proline|1.574|
|isobutyl Acetate|a6|||
|0.839|
|4.|__| Methane Sulphonyi Chloride|

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

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||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|||
|[Case No.:171/6/82-|Party Name:ATUL|Meet No/Date:8/82-|Status:Case|
|ALC42014|BIOSCIENCE LIMITED|ALC42014|Deferred|
|25.09.2014|
|49|[HQ File|||RLA File|Lic.No/Date:52 10040265|[Defer|:|
||||:01/82/050/00573/AM15/|152/24/040/00025/AM|14/|10.10.2013|Date: 12.11.2014|
|Decision:|It|was|decided|to|defer|the|case|for|12.11.2014|for|comments|of|Department|of.|
|Pharmaceuticals|

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Case No.:213/3/82Party Name: TATVA Meet No/Date:8/82Status:Case ALC4/2014 CHINTAN PHARMA CHEM |ALC4/2014 Deferred PVT LTD 25.09.2014 HQ File RLA File Lic.No/Date:34 10038266 \Defer :01/82/050/00217/AM15/ 334/24/040/001 84/AMI14/ 21.10.2613 Date: 12.11.2014 50 Decision : It was decided call form the firm following information: i) Details of manufacturing process with chemical equations, molecular formula, molecular weights ii) Yield obtained in each step iii) Authentic technical literature in support of yield obtained iv) pastCA certificate three yearscertifying and correspondingthe production consumption ofof export itemeach input.esa achieved by yougare,forp,, the Lb. zeny Department of Commerce Udyog Bhawan Nee ein,

| : : | |

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----- Start of picture text ----- | | The case is deferred for 12.11.2014 | Case No.:6/20/82-ALC4/2013 Party Name:ZIM Meet No/Date:8/82- Status:Case LABORATORIES LTD. ALC4/2014 Deferred . . 25.09.2014 . 51 [HQ File RLA File Lic.No/Date:03 10754588 |Defer :01/82/050/00992/AM14/ 03/95/040/00591/AM14/ 21.10.2013 Date: 12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of |Pharmaceuticals. . [Case No.:28/4/82- Party Meet No/Date:8/82- __[Status:Case ALC4/2014 IName:S.R.S.PHARMACEUTICALS |ALC4/2014 Deferred PVT. LTD. 25.09.2614 §2 |HQ File RLA File :03/95/040/00575/AMI4/ _Lic.No/Date:03 10754848 |Defer ; :01/82/050/00276/AM15/ 22.10.2013 Date: 12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals. ----- End of picture text -----

Case No,:46/4/82-ALC4/2014 |Party Name:ZIM Meet No/Date:8/82Status:Case LABORATORIES LTD. ALC4/2014 Deferred 25.09.2014 53 [HQ File RLA File Lic.No/Date:03 10754827 |Defer 01 /82/050/00294/AM15/ 203/95/040/00595/AM14/ 22.10.2013 Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals.

Case No.:1/3/82-ALC4/2014 Party Name:EYTAN LABS [Meet No/Date:8/82Status:Case LIMITED ALC4/2014 Deferred 25.09.2014 ; HQ File RLA File Lic.No/Date:0910057999 |Defer *4 :01/82/0S0/00005/AM15/ —|:09/24/040/00354/AM14/ ——|24.10.2013 Date:12.11.2014 Decision : Committee considered the case and it has been observed that both import and export items are same. As per the details given by the firm, purity of import item is Not Less Than 99.0% (w/w) and that of export item is NLT 97.5% and NMT102.0% (w/w). It was decided to take comments of DCGI. The case is deferred for 12.11.2014 .

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----- Start of picture text ----- Case No.:60/17/82- Party Name:SHAMSHREE [Meet No/Date:8/82-[Status:Case ALC4/2013 LIFESCIENCES LTD., ALC4/2014 Approved 25.09.2014 HQ File RLA File Lic.No/Date:2210014319 |Defer Date: 01/82/050/00922/AM14/ —|:22/24/040/00051/AM14/ —_——{24.10.2013 - 55 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/88/2014-PI(Norms) dated 24.09.2014, 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: ----- End of picture text -----

Dy,awDirectorenueGeneralweesof Frain Frade Directorate General of F urexja Trade aftr fuTVDepanment of Commerce . Udyog Be ini

| | | : | ||| | | 7

MEROPENEM ~ FOR| Nos. | 1 597.778 mg /500 mg vial INJECTION MEROPENEM FOR. 500MG INJ. USP RA may take appropriate action as per the decision of Norms Committee. Case No.:100/23/82Party Name:SYMBIOTEC Meet No/Date:8/82Status:Case ALC4/2013 PHARMALAB LTD., ALC4/2014 Approved ; oC 25.09.2014 - HQ File RLA File Lic. No/Date:56 10003085 |Defer Date: :01/82/050/01147/AM14/ 756/24/040/00025/AM14/ 25.10.2013 / |Decision : In the light of written comments received from written comments received from comments received from received from from Department of Pharmaceuticals vide of Pharmaceuticals vide vide [their OM OM No. 35011/179/2014-Pi(Norms) dated 02.09.2014, 02.09.2014, it was decided was decided decided to ratify norms norms |para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever 4.7 of HBP v1 as per details given below or as applied by the firm, whichever of HBP v1 as per details given below or as applied by the firm, whichever HBP v1 as per details given below or as applied by the firm, whichever v1 as per details given below or as applied by the firm, whichever as per details given below or as applied by the firm, whichever per details given below or as applied by the firm, whichever details given below or as applied by the firm, whichever given below or as applied by the firm, whichever below or as applied by the firm, whichever or as applied by the firm, whichever as applied by the firm, whichever by the firm, whichever the firm, whichever firm, whichever whichever is less: less: [item of export |Qty.| S.No | Item of Import Qty. allowed Prednisolone Hemisuccinate | kg [1 . USP Prednisolone IP 0.85 kg/kg RA may take appropriate action as per the decision of Norms Committee. Case No.:51/15/82Party Name:SAURAV Meet No/Date:8/82Status:Case ALC4A2013 CHEMICALS LTD, ALC4/2014 Approved _ [25.09.2014 HQ File RLA File Lic.No/Date:22 10014341 |Defer Date: :01/82/050/00813/AM14/ :22/24/040/00049/AM 14/ 29.10.2013

| |Decision : In the light of written comments received from written comments received from comments received from received from from Department of Pharmaceuticals vide of Pharmaceuticals vide vide {__ [their OM OM No. 35011/179/2014-Pi(Norms) dated 02.09.2014, 02.09.2014, it was decided was decided decided to ratify norms norms under . 56 |para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever 4.7 of HBP v1 as per details given below or as applied by the firm, whichever of HBP v1 as per details given below or as applied by the firm, whichever HBP v1 as per details given below or as applied by the firm, whichever v1 as per details given below or as applied by the firm, whichever as per details given below or as applied by the firm, whichever per details given below or as applied by the firm, whichever details given below or as applied by the firm, whichever given below or as applied by the firm, whichever below or as applied by the firm, whichever or as applied by the firm, whichever as applied by the firm, whichever by the firm, whichever the firm, whichever firm, whichever whichever is less: less: |

Decision ; In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/56/2014-Pi{Norms) dated 02.09.2014, 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:

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----- Start of picture text ----- 157 ----- End of picture text -----

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----- Start of picture text ----- Item of Export |Qty.| S,No_ | Item of import Qty. allowed 2 | N-Octyi-D- N-Octyi-D- glucamine 0.36 RA may take appropriate action as per the decision of Norms Committee. may take appropriate action as per the decision of Norms Committee. take appropriate action as per the decision of Norms Committee. 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.:36/19/82- Party Name:SOHAM Meet No/Date:8/82- Status:Case ALC4/2013 ORGANICS PVT LTD ALC4/2014 Deferred 25.09.2014 5g |HQ File RLA File Lic.No/Date:3110060943 |Defer :01/82/050/0098 1/AM14/ :31/83/046/00124/AM14/ 29.10.2013 Date:12.11..2014 Decision : It was decided to call from the firm the complete technical details as per Appendix 33. The case was deferred for 12.11.2014. a ----- End of picture text -----

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----- Start of picture text ----- | 2 | N-Octyi-D- N-Octyi-D- glucamine RA may take appropriate action as per the decision of Norms Committee. may take appropriate action as per the decision of Norms Committee. take appropriate action as per the decision of Norms Committee. 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. ----- End of picture text -----

[59 [Case No.:4/22/82-ALC4/2013 (Party Name: VINDHYA

1[|] [Meet No/Date:8/82-raa ene Direc’ ae Deparment of Commerce ceudyog BhawanOe

| |

,, | |

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|||||||
|---|---|---|---|---|---|
|ORGANICSPVTLTD|__(ALC4/2014|Approved|
|HQ|File|RLA|File|Lic.No/Date:0910058161||Defer Date:|
|:01/82/050/01047/AM14/|—_—_—|:09/24/040/00279/AM14/|[06.11.2013|a|

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| |Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/246/2014-Pi(Norms) dated 10.10.2014, 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:

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|||||||||
|---|---|---|---|---|---|---|---|
|Item of Export||Qty.||S,No|||Item of import|Qty.|allowed|ke/kg|
|Aminocarbinol|Tartrate|kg|1.337|
|||2-Azabicyclo (2.2.1)|
|hept-5-en-3-one|
|||(VINCELACTAM)|
|7|Sodium Borohydride|0.214|

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| '|RA may take appropriate action as per the decision of Norms Committee. 7

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||||||||
|---|---|---|---|---|---|---|
|[7|[€aseALC42013 No.:18/24/82-|PartyPHARMA Name:RALIMITED CHEM|[MeetALC4/2014 No/Date:8/82-,_[Status:CaseDeferred|
|25.09.2014|
|60||HQ|File|RLA|File|Lic.No/Date:0910058173|[Defer|
|01/82/050/01217/AM14/|—j:09/24/040/00388/AM14/|(08.11.2013.|‘Dates 12.11.2014|
|Decision|:|It was decided to defer the case|for|12.11.2014|for comments of|Department of|
|Pharmaceuticals.|.|;|
|[”|{Case No.:42/24/82-|Party Name:AHLCON|Meet No/Date:8/82-|_([Status:Case|
|ALC4/2013|PARENTERALS INDIA LTD.||ALC4/2014|Deferred|
|25.09.2014|
|_|
|61|{HQ|File|RLA File|Lic.No/Date:05 10371021||Defer|
|01/82/050/01241/AM14/|—|:05/23/040/00330/AM14/|{13.11.2013|fDate:12.11.2014|

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Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals. . _

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||||||||
|---|---|---|---|---|---|---|
|(Case No.:37/4/82-ALC4/2014|(Party Name:EMCURE|Meet No/Date:8/82-|_|Status:Case|
|PHARMACEUTICALS|LTD.||ALC4/2014|Deferred|
|25.09.2014|
|;|7|a|_|
|62||HQ|File|RLA|File|Lic.No/Date:3 110061152 110061152||Defer|
|:01/82/050/00285/AM15/|:31/83/040/00141/AM14/|25.11.2013|Date:12,11.2014|

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: 62 |HQ File RLA File Lic.No/Date:3 110061152 110061152 |Defer :01/82/050/00285/AM15/ :31/83/040/00141/AM14/ 25.11.2013 Date:12,11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals. | Case No.:14/24/82Party Name:DR REDDYS (Meet No/Date:8/82_‘|Status:Case | ALC4/2013 LABORATORIES LIMITED (ALC4/2014 Deferred | 63 25.09.2014 | | HQ File RLA File Lic.No/Date:09 10058344 |Defer | :01/82/050/01213/AM14/ 109/24/640/0038 V/AM14/ 26.11.2013 |Date:12.11.20] R wey Warhrasre SIRT ANI - Dy. Director General of r . pian Made aprsa frpP/Department of Commerce | Oe ee ee eon trade | APP Sues CU De -hi

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----- Start of picture text ----- Decision : It was decided to defer the case for 12.11.2014 for comments of Department of | | [Pharmaceuticals. | | [Case No.:24/24/82- ~+*‘(PartyName:GLAND __—‘([Meet No/Date:8/82- __[Status:Case ALC4/2013 PHARMA LIMITED JALC4/2014 Deferred . . 25.09.2014 fo 64 |HQ File RLA File Lic.No/Date:09 10058352 Defer :01/82/050/01223/AM14/ —|:09/24/040/00419/AMI14/ {26.11.2013 -|Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals. [ [Case No.:8/18/82-ALC4/2013 (Party Name:TITAN Meet No/Date:8/82- (Status:Case LABORATORIES PVT. LTD. |ALC4/2014 Deferred {25.09.2014  65 [HQ File RLA File {Lic.No/Date:03 10761921 [Defer | |:01/82/050/00943/AM14/ ——|:03/95/040/00637/AM14/ 16.12.2013 =———Date:12,11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals ; Case No.:125/23/82- Party Name-EMCURE Meet No/Date:8/82- Status:Case ALC4/2013 PHARMACEUTICALS LTD. |ALC4/2014 Approved 25.09.2014 . HQ File RLA File Lic.No/Date:3 110061658 |Defer Date: :01/82/050/01172/AM14/ :31/83/040/00170/AM14/ 19.12.2013 ; Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/209/2014-Pi{Norms) dated 10.10.2014, 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: Item of Export Qty. Item of Import Norms allowed for 1 No. Vial 66 1000 000 IU/ml, fu/mi, imi iml } Heparin Sodium Injection USP 1000 | vial HEPARIN SODIUM USP | 6.341 31.705 and 5000 USP Heparin Units/mt mg/vial mg/vial 5 [3 NEEDLE SHIELD Relevant as per packing 4 [RUBBERPLUNGER STOPPER ROD | poeyi THREADED) RA may take appropriate action as per the decision of Norms Committee. 7 Case No.:181/3/82- Party Name:AKZO NOBEL [Meet No/Date:8/82-[Status:Case | 67) |ALC4/2014 INDIA LIMITED 4/2014 Deferred | 25.09.2014 ; [HQ File IRLA: File —[Lic.No/Date:0210198392 [Defer LK : wee aT ATS Direct ae Department of Commerce ger Sean Hem Dein ----- End of picture text -----

| |

[:01/82/050/00185/AM15/ [:02/24/040/00053/AM14/ [02.01.2014 ~ [Date:12.112014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals.

Case No.:24/8/82-ALC 4/2014 |Party Name:GLOBAL Meet No/Date:8/82Status:Case CALCIUM PRIVATE ALC4/2014 Deferred LIMITED, 25.09.2014 68 |HQ File RLA File Lic.No/Date:0710101055 |Defer | -:01/82/050/00688/AM15/ —_|:07/24/040/00323/AM14/ —(02.01.2014 Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Chemicals and C&PC

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----- Start of picture text ----- Case No.:117/6/82- Party Name: VIVIMED LABS ~ Meet No/Date:8/82- Status:Case ALC4/2014 LIMITED ALC4/2014 Deferred i . [25.09.2014 - 169 HQ File RLA File Lic.No/Date:09 10058894 |Defer :01/82/050/00519/AM15/ 109/24/040/00517/AM14/ 09.01.2014 Date:12.11.2014 ----- End of picture text -----

Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Chemicals and C&PC

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----- Start of picture text ----- Case No.:198/3/82- Party Name:SATYA Meet No/Date:8/82- Status:Case ALC42014 DEEPTHA ALC4/2014 Deferred PHARMACEUTICALS LTD [25.09.2014 . 70 HQ File RLA File Lic.No/Date:09 10058953 |Defer :01/82/050/00202/AM15/ —_[:09/24/040/00523/AM14/ 16.01.2014 Date:12,11.2014 | |Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals. ----- End of picture text -----

Case No.:43/3/82-ALC4/2014 [Party Name:INDO PHYTO [Meet No/Date:8/82_(Status:Case CHEMICALS PVT LTD ALC4/2014 Approved ; 25.09.2014 HQ File RLA File Lic.No/Date:05 10376464 |Defer Date: :01/82/050/00047/AM15/ :05/23/040/00620/AM14/ 17.01.2014

Decision : In the light of earlier decision taken by NC in its 1/82 meeting dated 10.04.2014, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by 71 |the firm, whichever is less:

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----- Start of picture text ----- : Export product Exp. Import items Qty. Allowed Qty. ke/kg Testosterone Enanthate ikg 4-Androstene-3,17-Dione Bulk Drug RA may take appropriate action as per the decision of Norms Committee. ----- End of picture text -----

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----- Start of picture text ----- Case No.:22/6/82-ALC4/2014 [Party Name:BLUE CIRCLE [Meet No/Date-8/82- _[Status:Case n ORGANICS PVT. LTD. LC4/2014 Deferred [AQ File IRLA File 5.09.2014 . | [Lic.No/Date:03 1076844, PRefEDy ‘Director Coney niiencacbite ttof.)ee AER) eae WeITeereer Directorate General of F oceign Trade afm TVOepartment of Commerce Udyog Bhawan Nes Dethi ----- End of picture text -----

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----- Start of picture text ----- [:01782/050/00424/AM15/ ([03/94/040/00582/AM14/ (21.01.2014 [Date:20. 10.2014 Decision : It was decided to defer the case for 20.10.2014 for comments of Department of Pharmaceuticals. ----- End of picture text -----

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----- Start of picture text ----- Case No.:208/3/82- Party Name:OGENE Meet No/Date:8/82- Status:Case ALC4/2014 SYSTEMS INDIA PVT. LTD. |ALC4/2014 Deferred 25.09.2014 73 [HQ:01/82/050/00212/AM15/ File RLA:09/24/040/005 File 15/AM14/ 22.01.2014Lic.No/Date:0910059017 PeteDate: 12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Chemicals and C&PC ----- End of picture text -----

| Case No.:111/3/82Party Name:SRIAM LABS Meet No/Date:8/82Status:Case |ALC4/2014 PRIVATE LIMITED ALC4/2014 Deferred (25.09.2014 | 7
74 |HQ File RLA File Lic.No/Date:09 10059150 |Defer :01/82/050/001 15/AM15/ :09/24/040/00509/AM14/ 03.02.2014 Date: 12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals.
Case No.:87/3/82-ALC4/2014 |Party Name: VIVIMED LABS |Meet No/Date:8/82Status: Case LIMITED ALC4/2014 Deferred 25.09.2014
. oo
75 |HQ File RLA File Lic.No/Date:0910059155 |Defer 01/82/050/00091/AM15/ —_—|:09/24/040/00544/AM14/ {04.02.2014 Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Chemicals and C&PC
- _

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----- Start of picture text ----- Case No,:117/3/82- Party Name: VIVIMED LABS [Meet No/Date:8/82- Status:Case ALC42014 LIMITED ALC4/2014 Deferred 25.09.2014 ; 76 |HQ File RLA File Lic.No/Date:09 10059156 |Defer 01/82/050/00121/AM15/ —_—|:09/24/040/00543/AM14/ — [04.02.2014 Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Chemicals and C&PC | Case No.:232/3/82- Party Name:CADILA Meet No/Date:8/82- _|[Status:Case ALC4/2014 HEALTHCARE LTD., ALC4/2014 Approved . 25.09.2014 a HQ File RLA File Lic.No/Date:08 10128700 |Defer Date: :01/82/050/00236/AM15/ :08/24/040/00485/AM14/ 05.02.2014 7 |Decision : In the light of earlier decision taken by NC in its 30/82 meeting dated 7 |07.02.2013, 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 -----

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----- Start of picture text ----- Export product Exp. Import items ----- End of picture text -----

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----- Start of picture text ----- Qty. Allowed ----- End of picture text -----

Uayodlyog BnaWin,tray,partmentNoeof Co.Sn,mmMercerade

| Colistimethase ‘for Injection “Ti. | Colistimethate 403.85 mg/vial 150 mg (each vial contains USP | colistimethate sodium USP | equivalent to 150 mg colistine | base activity) RA may take appropriate action as per the decision ofNorms Committee. . Case No.:168/3/82Party Name:CIPLA LIMITED [Meet No/Date:8/82-___{Status:Case ALC4/2014 ALC4/2014 Deferred 25.09.2014 7g |HQ File RLA File Lic.No/Date:03 10769592 |Defer | :01/82/050/00172/AM15/ :03/94/040/01009/AM14/ 06.02.2014 Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals. ; Case No.:211/3/82Party Name:DEEPAK Meet No/Date:8/82Status:Case ALC4/2014 NITRITE LIMITED ALC4/2014 Approved $.09.2014 HQ File RLA File Lic.No/Date:34 10039219 (Defer Date: 01/82/0S0/00215/AM15/ —|:34/24/040/00201/AM14/ (07.02.2014 .

Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/36/2012-Ch. Il dated 28.07.2014, it was decided to 79 |tatify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

| Export product Import items Qty. Allowed Qty. 3,4 NITRO ORTHO XYLENE (4 1 1.63 kg | NOX) ORTHO XYLENE

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

Case No,:54/3/82-ALC4/2014 Party Name: ASTRIX Meet No/Date:8/82Status:Case LABORATORIES LTD., ALC4?2014 Deferred 25.09.2014 80 [HQ File RLA File Lic.No/Date:09 10059230 [Defer :01/82/050/00058/AM15/ :09/24/040/00552/AM14/ 10.02.2014 _{Date: 12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals.

Case No.:167/3/82Party Name:CIPLA LIMITED |Meet No/Date:8/82Status:Case ALC4/2014 ALC4/2014 Deferred . 25.09.2014 ; 81 [HQ File RLA File Lic.No/Date:03 10769983 [Defer :01/82/050/00171/AM15/ 103/94/040/01028/AM 14/ 10.02.2014 Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of| ,. Pharmaceuticals. SAT SUR AZAL \dey D Reyer CAIN, g hgicssvneagy aitse fr Off Sgn Trade SPUCu partment of Commerce Udyog Bn swan hi eTE ,

||CaseNo.164/3/82-ALC4/2014|PartyName:ARENELIFE<br>SCIENCESLIMITED.|MeetNo/Date:8/82-<br>ALC4/2014|Status:Case<br>‘\Deferred|
|---|---|---|---|---|
|||;|25.09.2014|_|
|82||HQFile|RLAFile|Lic.No/Date:0910059247||Defer|
||:01/82/050/00068/AM15/|:09/24/040/00554/AM14/|11.02.2014|Date:12.11.2014|

Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals.

||Pharmaceuticals.|||||
|---|---|---|---|---|---|
||CaseNo.:46/3/82-ALC4/2014|[PartyName:ARENELIFE|[MeetNo/Date:8/82-_(Status:Case|||
|||SCIENCESLIMITED.|ALC4/2014|Deferred||
|||.|{25.09.2014<br>-|||
|83||HQFile<br>:01/82/050/00050/AM15/|RLA File<br>—_—_—|:09/24/040/00555/AM14/|Lic.No/Date:09 10059260<br>‘12.02.2014<br>—|.|Defer<br>[Date:12.11.2014||
||Decision : Itwasdecided|to deferthe case for 12.11.2014 forcommentsofDepartmentof|||of|
||Pharmaceuticals.|.<br>.||-|;|
||CaseNo.:47/3/82-ALC4/2014[Party|[Party Name:ARENE LIFE<br>SCIENCESLIMITED.|[MeetNo/Date:8/82-__[Status:Case<br>ALC4/2014<br>Deferred|||
||_.|.|(25.09.2014||||
|g4||HQ File|RLA File|Lic.No/Date:0910059259|[Defer||
||:01/82/050/00051/AM15/|:09/24/040/00535/AM14/|12.02.2014|Date:12.11.2014||

Decision : It was decided to defer the case for 12.11.2014 for comments ofDepartment of Pharmaceuticals.

||CaseNo.:61/3/82-ALC4/2014|CaseNo.:61/3/82-ALC4/2014|Party Name: INCHEM|MeetNo/Date:8/82-|Status:Case|
|---|---|---|---|---|---|
||||LABORATORIES PRIVATE||ALC4/2014|Deferred|
||||{LIMITED||25.09.2014|.|
|g5|[HQFile<br>:01/82/050/00065/AM15/||RLA File<br>—_|:09/24/040/00568/AM14/|Lic.No/Date:09 10059258 |Defer<br>12.02.2014<br>**—**<br>[Date:42.11.2014||
||Decision : Itwasdecided|decided|to deferthe case for 12.11.2014 forcommentsof||ofDepartmentof|
||Pharmaceuticals.||7|||

||Pharmaceuticals.|7|||
|---|---|---|---|---|
||CaseNo.:113/3/82-<br>ALC42014|PartyName:RANBAXY<br>LABORATORIESLTD|MeetNo/Date:8/82-<br>ALC42014|Status:Case<br>Deferred|
||||25.09.2014||
||.|||'|
|86|[HQFile<br>01/82/0S0/00117/AM15/|RLA File<br>—_|:05/24/040/00332/AM14/|Lic.No/Date:05 10379132 [Defer<br>_—{12.02.2014<br>Date:12.11.2014||
||Decision : Itwasdecided|todefer thecase for 12.11.2014 forcommentsofDepartment of|||
||Pharmaceuticals.|||.|

Case No.:48/3/82-ALC4/2014 [Party Name: VIVIMED LABS [Meet No/Date:8/82__[Status:Case LIMITED ALC4/2014 Deferred 25.09.2014 - 87 |HQ File RLA File Lic.No/Date:0910059263 |Defer :01/82/050/00052/AM15/ :09/24/040/00582/AM14/ 12.02.2014 Date:12.11.2014 ChemicalsDecision and: It wasC&PC decided to defer the case for 12.11.2014 for comments of Department of \y5 Prats Pay Ray oy, PF OF Forgan aR Director se pte Tre fargy SA Trade TRY Roryget Of Foreign vayoe repay neo Of CommereeTe newan, Weethi

io) | Case No.:112/3/82Party Name: VIVIMED LABS |Meet No/Date:8/82Status:Case ALC4/2014 LIMITED ALC4/2014 Deferred 25.09.2014 |:01/82/050/00116/AM15/ :09/24/040/00564/AM 14/ 12.02.2014 Date:12.11.2014 |88 |HQ File RLA File Lic.No/Date:09 10059262 |Defer | Decision : It was decided to defer the case for 12.11.2014 for comments of Department of | | |Chemicals and Petrochemicals = Case No.:2/3/82-ALC 4/2014 Party Name:SCOTT-EDIL [Meet No/Date:8/82(Status:Case | Py ;PHARMACIA LTD., ALC4/2014 Deferred i | [25.09.2014 | g9 |HQ File RLA File Lic.No/Date:2210014609 Defer | :01/82/050/00006/AM I 5/ :22/24/040/00089/AM 14/ 13.02.2014 Date:12.11.2014 | Decision ;: It was decided to defer the case for 12.11.2014 for comments ofDepartment of | | |Pharmaceuticals. |

||} [Case| No.:73/3/82-ALC4/2014 [PartySCIENCES Name:ARENELIMITED. LIFE ALC4/2014{Meet No/Date:8/82-__(Status:CaseDeferred | | 25.09.2014 90 |HQ File RLA File Lic.No/Date:09 10059285 [Defer

:01/82/050/00077/AMI S/ 109/24/040/00536/AM 14/ 14.02.2014 Date: 12.11.2014

| |Decision : It was decided to defer the case for 12.11.2014 for comments of Department of | {Pharmaceuticals.

y. Director General of Fureign Trade Die;: 3SATIS General TerPayof Foreign yrsTrade wre FPrTVDepanment of Commerce Udyog Bhawan Wes Delhi

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,[Case No.:9/3/82-ALC4/2014 [Party [Meet No/Date:8/82Status:Case | 4 Name:SMILAX LABORATORIES = |ALC4/2014 Approved i | LIMITED [25.09.2014 | . ——~—-—| -01782/050/00013/AM15/HQ File RLA File :09/24/040/00584/AM14/ Lic.14.02.2014No/Date:0910059308 |Defer Date: | Decision35011/86/2014-P!(Norms): In the light of writtendated comments02.09.2014, receivedit was decided from Depa to r atifytment norms ofPharmaceuticals under Para 4.7 ofvide HBP theirv1OMas No.per details | ‘given below or as applied by the firm, whichever is less: 2-Ethoxy-1 {[2+1tke 3-Nitro phathalic acid | triphenylmethyl-1H-tetrazol-5benzimidazole-7-carboxylic — a 4-bromomethyl bipheny!-2carbonitrile ! ed | | : fs Methylene chloride 13,260 ! Tea bs | 11 Tetra ethyl ortho carbonate | | (TEOC) 0.793 ! | t | fe [RA may take appropriate action as per the decision of Norms Committee. {Case No.:29/3/82———=«( Party Name:R L FINE CHEM‘Meet No/Date:8/82Status:Case | j jALC4/2014 ALC4/2014 Approved 3 i 25.09.2014 | | HQ File RLA File Lic. No/Date:07 10102208 |Defer Date: | :01/82/050/00033/AM I5/ 07/24/040/00422/AM14/ 17.02.2014 | | Decision : tn the tight of earlier decision taken in meeting no. 5/82 dated 24.07.2014, it was decided to | jratify norms under Para 4.7 of HBP vi as per details given below or as applied by the firm, whichever is 92 Hess: | Export product Exp. | Si.No. | Import items Qty. Allowed | | Qty. kg/kg | | | CHLORPROMAZINE HCL 1 BROMO3CHLORO PROPANE [0.95 | ! | PIP 2—-CHLOROPHENOTHAZINE [090 ‘|: | [3__| ACETONE [3330 | RA may take appropriate action as per the decision of Norms Committee. ; | [Case No.:63/6/82Party Meet No/Date:8/82Status:Case | | |ALC4/2014 Name: ARIHANTANAM ALC4/2014 Deferred | \ 193 | iLIFECARE PVT. LTD. 25.09.2014 Li a | HQ File LA File :[Ve NoDate05107708 6642 eltrenanunwarPrresi Frere KUeT RtHOF Gora ot 819 THA fazer wu wetiasnaa Directorate ora cant of Com[Trace] Udyog nas Ct Deihi

[[01782/050/00465/AM15/ [:03/94/040/01037/AM14/__ [18.02.2014 [Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals. . .

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|||||||||||
|---|---|---|---|---|---|---|---|---|---|
|Pharmaceuticals.|.|.|
|Case No.:130/3/82-|Party Name:AUROBINDO|[Meet No/Date:8/82-|__[Status:Case|
|ALC4/2014|PHARMA LIMITED|ALC4/2014|Approved|
|||25.09.2014|.|
|HQ File|RLA File|Lic.No/Date:0910059321|Defer Date:|
|01/82/050/00134/AM15/|—_|:09/24/040/00587/AM14/|18.02.2014||Oe|
|Decision|:|In the|light|of written|comments received from|Department|of Pharmaceuticals vide|
|their OM|No.|35011/110/2014-PI(Norms)|dated|02.09.2014,|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:|

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|||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|||item of Export|Quantity|||S,No|||item of Import|Quantity|
|allowed kg/kg|
|||Raloxifene Hel|1kg|1.|4-[2-(1-|
|Piperidinylethoxy]benzoicacid|
|||hydrochloride|0.93|
|m4|2(4-methoxy phenyl)6-|
|methoxy benzo(b)thiophene|0.88|
|||}6|||Methanesulfonyl chloride|1.367|
|[r|
|>|Tanti|
|[TRA may take appropriate may take appropriate take appropriate appropriate|action as per the decision of Norms Committee. as per the decision of Norms Committee. per the decision of Norms Committee. decision of Norms Committee. of Norms Committee. Norms Committee. Committee.|
|Case No.:242/3/82-|Party Name:CADILA|Meet No/Date:8/82-|Status: Case|
|ALC4/2014|HEALTHCARE LTD.,|ALC4/2014|Approved|
|25.09.2014|
|HQ|File|RLA|File|Lic.No/Date:0810128924||Defer Date:|
|:01/82/050/00246/AM15/|:08/24/040/00505/AM 14/|18.02.2014|
|Decision:|In|the|light|of earlier|decision|taken|by NC|in|its|5/82|meeting|dated|24.07.2014,|it|
|95|lwas 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|
||Etodolac Extendedimport ItemsRelease Tablets 400 MG,|500 MGFor and export600 of MG 1 Million TAB Tablets|\\|
|mvevariment|of Commerce|
|Udyog Bhawan|Now|Bein|

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----- Start of picture text ----- [TRA may take appropriate may take appropriate take appropriate appropriate action as per the decision of Norms Committee. as per the decision of Norms Committee. per the decision of Norms Committee. decision of Norms Committee. of Norms Committee. Norms Committee. Committee. ----- End of picture text -----

| :

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----- Start of picture text ----- | 1 LACTOSE 35.5kg 44.375 kg 86.850 kg MONOHYDRATE NF/PH |2___ [|] [386.376] 482.970 579.564 aa|MAGNESIUM [7-ETHYL][ TRYPTOPHOL] STEARATE 21.875 [26.2500 | 76% | METHYL-3-OXO 275.400 330.480 VALERATE RA may take appropriate action as per the decision of Norms Committee. ----- End of picture text -----

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----- Start of picture text ----- (Case No.:64/6/82-ALC4/2014 (Party Name:FDC LTD Meet No/Date:8/82-____‘(Status:Case ALC4/2014 Deferred 25.09.2014 196 |HQ File RLA File Lic.No/Date:03 10770862 |Defer :01/82/050/00466/AM15/ :03/94/040/00707/AM 14/ 18.02.2014 Date: 12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals. - Case No.3166/3/82- Party Name: VAY ‘Meet No/Date:8/82- Status:Case ALC4/2014 PERFUMES PVT.LTD. ALC4/2014 Deferred 25.09.2014 7 97 [HQ File RLA File Lic.No/Date:03 10770668 [Defer 201/82/050/00170/AM15/ 203/95/040/009 16/AM14/ 18.02.2014 _ yDate:12.11.2014 | |Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals. | . Case No.:52/3/82-ALC4/2014 [Party Name:ALEMBIC Meet No/Date:8/82- __[Status:Case PHARMACEUTICALS LTD |ALC4/2014 Approved . | . 25.09.2014 : . HQ File RLA File Lic.No/Date:3410039321 [Defer Date: :01/82/050/00056/AM15/ :34/24/040/00282/AM14/ 19.02.2014 Decision : tn the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/800/2013-PI(Norms) dated 09.09.2014, 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: 98 : Export product Er |SiNo. Import items Qty. Allowed 1 Methyl(2S)-2-{[2Cyano- | | Valsartan 1,1-bipehyl-4-yl)methy]] amino}-3-methyl 1.455 kp/kg butanoate ethanedioate (Bi : phenyl valine oxalate) 2.486 litkg 3 12.545 lit/kg Methylene chloride (or vn on ff beast dichloromethane i LT ie vase Sse yt eivans New Deint ----- End of picture text -----

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

Case No.:62/6/82-ALC4/2014 |PartyName:ARIHANTANAM [Meet No/Date:8/82Status:Case : LIFECARE PVT. LTD. ALC4/2014 Approved 25.09.2014 HQ File RLA File Lic.No/Date:03 10770969 iDefer Date: :01/82/050/00464/AM15/ :03/94/040/01036/AM14/ 19.02.2014 ; 99 Decision : In the light of earlier of earlier earlier decision taken in meeting in meeting meeting no. 3/82 dated 08.05.2014, it was decided to ratify norms under Para 4.7 of HBP HBP v1 as per details given below or as applied by the by the the firm, whichever whichever is less: 1.235 kg RA may take appropriate action as per the decision ofNorms Committee. Case No.:65/3/82-ALC4/2014 |Party Name:HETERO LABS Meet No/Date:8/82Status:Case LIMITED LC4/2014 Deferred 5.09.2014 . 100 [HQ File RLA File Lic. No/Date:09 10059337 [Defer 01/82/0S0/00069/AMI5/ —_|:09/24/040/0059S/AM14/ —‘|19.02.2014 [Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department ofPharmaceuticals. a

99 Decision : In the light of earlier of earlier earlier decision taken in meeting in meeting meeting no. 3/82 dated 08.05.2014, it was decided to ratify norms under Para 4.7 of HBP HBP v1 as per details given below or as applied by the by the the firm, whichever whichever is less:

, Case No.:59/6/82-ALC4/2014 Party Name:INDO AMINES Meet No/Date:8/82Status:Case LIMITED ALC4/2014 Approved 5.09.2014 . HQ File . RLA File Lic. No/Date:03 10770990 [Defer Date: 01/82/050/00461/AM15/ ——|:03/94/040/00963/AM14/ ——[19.02.2014 Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/81/2010-Ch. tl dated 23.09.2014, it was decided to 101 ratify norms under Para 4.7 of HBP vi as per details given below or as applied by the firm, whichever is less: Lai lb als ikg 1 0.941 kg | Oleyl Diamine Oleic Acid RA may take appropriate action as per the decision of Norms Committee. Case No.:125/3/82Party Name:MYLAN Meet No/Date:8/82__[Status:Case ALC4/2014 LABORATORIES LIMITED |ALC4/2014 Deferred 25.09.2014 102 FQ File RLA File Lic.No/Date:09 10059353 [Defer :01/82/050/00129/AM15/ 709/24/040/00570/AM14/ 19.02.2014 Date: 12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for commentsGf Department | fr ; famtuDepariment of Gommarce Udyog bnewan hes Dethi

Ny | of Pharmaceuticals. _ . _ Case No.:47/23/82Party Name:PORUS Meet No/Date:8/82__[Status:Case ALC4/2013 LABORATORIES PVT LTD. |.ALC4/2014 Approved 25.09.2014 7 HQ File RLA File Lic. No/Date:09 10059356 |Defer Date: :01/82/050/01094/AM14/ —j:09/24/040/00585/AM14/ —_—[19.02.2014 ; 7

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||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|Decision|:|in|the|light|of|written|comments|received|from|Department|of|Chemicals|and|
|;|Petrochemicals|vide|their|U.O|No.|14010/33/2013-Ch.|il|dated|15.09.2014,|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:|
|103|||[tem of Export|Qty.|Item of import|Quantity|
|||allowed|kg/kg|
|||2-Phenyl-3,3-Bis(4-Hydroxy|1kg|Phthalic|0.927 kg|
|Phenyl)|Phthalimide (PPPBP)|Anhdydride|
|Zinc Chloride|0.546 kg|
|/6.|||Activated Carbon|_||9.400 ke|
|[|[RA may take appropriate action as per the decision of Norms Committee.|
|Case No.:216/3/82-|Party Name:SENTISS|Meet No/Date:8/82-|__[Status:Case|
|ALC4/2014|PHARMA PVT.LTD.|ALC4/2014|Deferred|
|104|[HQ File|.|RLA File|25.09.2014Lic.|No/Date:05|10379833|[Defer|
|:01/82/050/00220/AM15/|—_|:05/24/040/00431/AM14/|_—_—|19.02.2014|Date:12.11.2014|
|Decision|:|It was decided to defer the case for|12.11.2014|for comments of|Department|
|of Pharmaceuticals.|
|Case No.:86/3/82-ALC4/2014|[Party Name:AKZO NOBEL|[Meet No/Date:8/82-|[Status:Case|
|INDIA|LIMITED|ALC4/2014|Deferred|
|;|25.09.2014|Z|
|105||HQ File|RLA File|Lic.No/Date:02 10200380||Defer|
|:01/82/050/00090/A M1|5/|_02/24/040/00197/AM|14/|21.02.2014|Date:|12.11.2014|
|Decision|:|It was decided to defer the case for|12.11.2014|for comments of Department|
|of Pharmaceuticals.|
|(Case No.:241/3/82-|Party Name:ATUL|Meet No/Date:8/82-|_|Status:Case|
|ALC4/2014|LIMITED,||ALC4/2014|Approved|
|25.09.2014|—|
|1106||HQ File|RLA|File|Lic.No/Date:08 10129084|\Defer Date:|
|:01/82/050/00245/AM15/|°08/24/040/00483/AM|14/|(21.02.2014|©|;|
|Decision|:|In|the|light|of|written|comments|received|from|Departmenk|pf, Chemicals|and,|AR|
|Petrochemicals|vide|their|U.O|No.|15022/14/2011-Ch.|II|dated|30.06.20185|jt|Was|‘decided:|toy:|
|EQ|ITYg|a bh|y GAT|
|Udyog Bhoman|tees Delhi|

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----- Start of picture text ----- 9 ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the whichever is less: . Item of Import Quantity | item of Export Qty SNe | allowed kg/kg | 1,3-Cyclohexanedione ike 1.12 kg | 2. Caustic Soda 0.460 kg Flakes | [ RA may take appropriate action as per the decision of Norms Committee. — —F/a/8) ALCA/1014 [Party Name:VIVIMED LABS [Meet No/Date:8/82- _|Status:Case [25.09.2014 ; 107 [HQ File> RLA File; Lic.No/Datei -0910059372 |Defer ° 01/82/050/00019/AMI5/ :09/24/040/00598/AM14/ hi02.2014 7 Perr 1.2014 Decision ; It was decided to defer the case for 12.11.2014 for comments of Department of Chemicals and C&PC . , ----- End of picture text -----

Case No 63/82-ALC4/2014 [Party Name:VIVIMED LABS [Meet No/Date:8/82—_|Status:Case LIMITED ALC4/2614 Deferred
108 |HQ File RLA| File 25.09.2014Lic.No/Date:09 10059375 [Defera :01/82/050/00020/AM15/ —_|:09/24/040/00592/AM14/ [21.02.2014 [Dates12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Chemicals and C&PC , Case No.:237/3/82Party Name:CADILA ] Meet No/Date:8/82Status:Case ALC4/2014 HEALTHCARE LTD., ALC4/2014 Deferred
109:/HQ File RLA File Lic.No/Date:08 10129092 |Defer :01/82/050/00241/AM1S/ —_|:08/24/040/00S23/AM14/ [24.02.2014 ———— fDate:12.11.2014
- |Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Chemicals and Pharmaceuticals
Case No.:105/3/82Party Name:-THINQ [Meet No/Date:8/82_[Status:Case ALC4/2014 PHARMA-CRO LIMITED /ALC4/2014 Deferred
110.|HQ File RLA File Lic.No/Date:031077 1596 |Defer :01/82/050/00109/AM1 5/ 103/95/040/00842/AM14/ 24.02.2014 Date:12.11.2014

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----- Start of picture text ----- Decision : !t was decided to call from the firm the complete technical details as per Appendix 33. The case was deferredfor 12.11.2014 a ) Case No.:161/3/82- Party Name: UNIMAX ALC4/2014 CHEMICALS PVT LTD. ALC4/2014Meet No/Date:8/82- DeferredStatus:Case lit - 25.09.2014 - - . HQ File RLA File Lic.No/Date:03 193745 et Sez so/016s/AMA5/ :03/95/040/00889/AM14/ {24.02.2014 Sa srifated 2YL 26N4 148 weaontaeease 3teisaeiea [EMVDepanment of Commerce Udyog Bhawan Wes oom; ----- End of picture text -----

Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Chemicals and Petrochemicals

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----- Start of picture text ----- Case No.:30/6/82-ALC4/2014 [Party Name:AARTI Meet No/Date:8/82- ‘(Status:Case INDUSTRIES LIMITED ALC4/2014 1 [Deferred] 25.09.2014 ; 1112 |HQ File RLA File Lic.No/Date:031077 1896 |Defer :01/82/050/00432/AM15/ —‘|:03/94/040/00912/AM14/ [25.02.2014 Date: 12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Chemicals and Petrochemicals : Case No.:233/3/82- Party Name:CADILA Meet No/Date:8/82- Status:Case ALC4/2014 HEALTHCARE LTD., ALC4/2014 Deferred : Oo 25.09.2014 1113 |HQ File RLA File Lic.No/Date:08 10129185 (Defer | — |:01/82/050/00237/AM15/ —|:08/24/040/00S26/AM14/ [25.02.2014 |Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department  jof Pharmaceuticals. Case No.:14/3/82-ALC4/2014 Party Name:RA CHEM ~ Meet No/Date:8/82- Status:Case PHARMA LIMITED ALC4/2014 Deferred 114 |HQ File RLA File Lic.No/Date:09 10059417 |Defer 01/82/050/00018/AM15/ —|[:09/24/040/00589/AM14/[25.02.2014 Date:12.11.2014. ----- End of picture text -----

Decision : It was decided to defer the case for 12.11.2014 for comments of Department {of Pharmaceuticals. | .

Case No.:129/3/82Party Name:HETERO LABS [Meet No/Date:8/82Statns:Case ALC4/2014 LIMITED ALC4/2014 Deferred
, ' - 509.2014 - 1145 |HQ File RLA File Lic.No/Date:09 10059425 |Defer 01/82/050/00133/AM15/ ——|:09/24/040/00605/AM14/ —‘[26.02.2014 Date:12.11.2014

Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals. . :

Case No.:7/3/82-ALC4/2014 |Party Name:-MYLAN .|Meet No/Date:8/82Status:Case LABORATORIES LIMITED jALC4/2014 Deferred . |25.09.2014 .
116 |HQ File RLA File Lic.No/Date:09 10059427 |Defer :01/82/050/00011/AMI5/ ———|:09/24/040/00604/AM14/ —_—|26.02.2014 Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals. -

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----- Start of picture text ----- Case No.:52/4/82-ALC4/2014 |Party Name:SWATI Meet No/Date:8/82- Status:Case MENTHOL & ALLIED ALC4/2014 Approved 117 CHEMICALS LTD., 25.09.2014 Oo HQ File RLA File Lic.No/Date:29 10024211 |Defer Date: :01/82/050/00300/AM15/ :29/24/040/0001 1/AM14/ 6.02.2014 at/NIRMAL KUMAR by Director Genera! ot foreign Trade Directorate Ty Te Tn Trade afreg faarvDepanment of Commerce ware apa, eel fo - ----- End of picture text -----

Decision : In the light of written comments received from Department of Chemicals and : Petrochemicals vide their U.O No. 14010/62/2012-Ch. II dated 08.09.2014, 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:

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||||
|---|---|---|
|:|Qty.|
|ae|ieee|_—|
|RA may take appropriate|action as per the decision of Norms Committee.|

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||||||||||
|---|---|---|---|---|---|---|---|---|
|.|
|Case No.:5/3/82-ALC4/2014|(Party Name:INDO PHYTO|(Meet No/Date:8/82-|Status:Case|
|CHEMICALS PVT LTD||ALC4/2614|Deferred|
|25.09.2014|
|118||HQ|File|RLA File|Lic,|No/Date:05|10380433||Defer|
|:01/82/050/00009/AM15/|:05/23/040/00494/AM|14/|27.02.2014|Date:12.11.2014|
|Decision|:|It was decided|to|defer the|case|for|12.11.2014|for comments of Department|
|of Pharmaceuticals.|
|.|

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||||||||
|---|---|---|---|---|---|---|
|Case No.:118/6/82-|PartyName:SPECTRUM|Meet No/Date:8/82-|Status:Case|
|ALC4/2014|LIFE SCIENCES PRIVATE||ALC4/2014|Deferred|
|LIMITED|25.09.2014|
|119|[HQ File|RLA|File|Lic.No/Date:04 10155675|[Defer|
||||:01/82/050/00S20/AM15/|—_—_—[:04/24/040/00214/AM14/|[27.02.2014|Date:12,11.2014|
|Decision|:|It was|decided to defer the case|for|12.11.2014|for comments of Department|
|of Pharmaceuticals.|

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Case No.:162/3/82Party Name:ZIM Meet No/Date:8/82Status:Case ALC42014 LABORATORIES LTD. ALC4/2014 Deferred . 25.09.2014 _
1120 |HQ File RLA File Lic. No/Date:03 10772330 |Defer :01/82/050/00166/AM15/ —|:03/95/040/00967/AM14/ [27.02.2014 — [Date:12.11.2014
- Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals.
Case No.:58/6/82-ALC4/1014 [Party Name:BAYER [Meet No/Date:8/82-__[Status:Case CROPSCIENCE LIMITED /[ALC4/2014 Deferred 25.09.2014 |
12] |HQ File A File ‘|Lic.No/Date:03 10772503 |Defer :01/82/050/00460/AM15/ :03/94/040/00797/AM14/ 28.02.2014 Date: 12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals. ;

Case No.:79/3/82-ALC4/2014 [PartyName:GLAND Meet No/Date:8/82-__[Status:Case 122 PHARMA LIMITED ALC4/2014 Deferred =| { A 25.09.2014 abo. TW, HQFile IRLA File [Lic.No/Date:0910059455 [Defer | is wv im Sey ne lce Dreworn NHOeESekeTe eTme ni gears NOM bein

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----- Start of picture text ----- :01/82/050/00083/AM15/ [:09/24/040/00610/AM14/ [28.02.2014 7 [Date:12.11.20 14 Decision : It was decided to remind the firm to furnish Central Excise Data and also Batch Log Sheet for last 5 batches . The case was deferred for 12.11.2014 . ----- End of picture text -----

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----- Start of picture text ----- Case No.:133/3/82- Party Name:NECTAR Meet No/Date:8/82- {Status:Case ALC4/2014 LIFESCIENCES LIMITED, |ALC4/2014 Deferred 25.09.2014 123 |HQ01/82/050/00137/AM15/File RLA—_—|:22/24/040/00096/AM14/File —*[28.02.2014Lic.No/Date:22 10014646 Pete|Defer 1.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals.  Case No.:106/3/82- Party Name:PERFECT Meet No/Date:8/82- Status;Case ALC4/2014 VITAMINS PVT.LTD. ALC4/2014 Deferred  {25.09.2014 . 124 |HQ File RLA File Lic.No/Date:03 10772411 |Defer :01/82/050/00110/AM15/ ‘[:03/95/040/00960/AM14/ ——|28.02.2014 Pete2.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals. Case No.:184/3/82- Party Name:ARUDAA VIS (Meet No/Date:8/82- __(Status:Case ALC4/2014 LABS PRIVATE LIMITED (|ALC4/2014 Deferred 25.09.2014 125 }HQ File RLA File Lic.No/Date:04 10155776 |Defer . :01/82/050/00188/AM15/ :04/24/040/00266/AM14/ 03.03.2614 Date: 12.11.2014 Decision: It was decided to defer the case for 12.11.2014 for comments of Department of |Pharmaceuticals. . ----- End of picture text -----

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----- Start of picture text ----- Case No.:228/3/82-~—‘[Party Name:GOPINATH [Meet No/Date:8/82- [Status:Case ALC4/2014 (CHEM-TECH LTD., ALC4/2014 Deferred [25.09.2014 126 |HQ File RLA File Lic.No/Date:08 10129315 .|Defera i1/82/050/00232/AM1!5/ —_|:08/24/040/00521/AM14/ {03.03.2014 ————-PDate:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of C&PC. Case No.:122/3/82- Party Name:NANDU Meet No/Date:8/82- Status: Case ALC42014 CHEMICAL INDUSTRIES /ALC4/2014 Deferred . . 25.09.2014 127 fo:01 /82/050/00126/AM File 15/ RRLA:07/24/040/00408/AM14/ File 03.03.2014Lic.No/Date:07 10102530 Date:[Defer 12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of C&PC. ‘remnneeceeneenecmnacesiteanuannantinuasinatiiumunntnueeiibtinteesiettttttatietsstetsteblssttsstintreseetieebitie . e Case No.:25/3/82-ALC4/2014 Party Name:CATAPHARMA [Meet No/Date:8/82- [StatussCase tog CHEMICALS PVT.LTD. |ALC4/2014 Deferred 25.09.2014 Prio Pres NIRMAL KU [HQ File REA File Lic.No/Date:3. 1 10082028BetyeyeDefer «crs.Dist er ar aftreg fa4ryDepanment of Comune Ue ern ee eins ----- End of picture text -----

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----- Start of picture text ----- :01/82/050/00029/AM15S/ _[:31/83/040/00207/AM14/ [04.03.2014 ([Date:12.11.2014 Decision : It was decided to call from the firm COA of import item from the foreign supplier for the relevant consignment . The case was deferred for 12.11.2014. ----- End of picture text -----

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----- Start of picture text ----- Case No.:3/3/82-ALC4/2014 Party Name:SHASUN ‘(Meet No/Date:8/82- Status:Case PHARMACEUTICALS ALC4/2014 Deferred lke LIMITED 25.09.2014 129 File RLA File Lic.No/Date:04 10156078 |Defer :01/82/050/00007/AM 15/ -04/24/040/00258/AM14/ {11.03.2014 Date:12.11.2014 Decision : It was decided to remind the firm to furnish a copy of Master Batch Formula duly certified by Quality Control incharge. The case was deferred for 12.11.2014 Case No.:6/3/82-ALC4/2014 |Party Name-SHASUN Meet No/Date:8/82- _—‘[Status:Case PHARMACEUTICALS ALC4/2014 Deferred HQ File RLALIMITED File (25.09.2014Lic.No/Date:04 10156076 |Defer| 130 :01/82/050/00010/AM15/ :04/24/040/00257/AM14/ 11.03.2614 Date:12.11.2014 Decision : It was decided to remind the firm to furnish a copy of Master Batch Formula duly certified by Quality Control incharge. ----- End of picture text -----

The case was deferred for 12.11.2014

Case No.:62/3/82-ALC4/2014 |Party Name:SHASUN Meet No/Date:8/82Status:Case PHARMACEUTICALS ALC4/2014 Deferred LIMITED {25.09.2014
HQ File RLA File Lic.No/Date:0410156077 /Defer
131 :01/82/050/00066/AM15/ :04/24/040/00259/AM14/ 11.03.2014 Date:12.11.2014 Decision : It was decided to remind the firm to furnish a copy of Master Batch Formula duly certified by Quality Control incharge.

The case was deferred for 12.11.2014

Case No.:231/3/82Party Name:SWISS Meet No/Date:8/82Status:Case ALC4/2014 EXPORTS PVT. LTD. ALC4/2014 Deferred 25.09.2014 .
132 |HQ File RLA File Lic.No/Date:08 10129646 Defer :01/82/050/00235/AM15/ :08/24/040/00537/AM14/ 13.03.2014 Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals .

Case No.:13/3/82-ALC4/2014 [Party Name:IND-SWIFT Meet No/Date:8/82(Status: LABORATORIES LTD., ALC4/2014 Approved 25.09.2014 133 [HQ:01/82/050/00017/AM15/ File RLA:22/24/040/00101/AM14/ File Lic.14.03.2014 No/Date:2210014693 Pete Date: Decision : Committee considered the case as per agenda and in light of festitter: comments MAR

aPrsy fesrUDepartmentof Cormeen ue SMT, wa, Ad Pe * .

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----- Start of picture text ----- a) received from Department of Pharmaceuticals vide their OM No. 35011/262/2014-Pi(Norms) dated 02.09.2014 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:- | Qty. (4R-CIS)-1,1- Kg/kg Atorvastatin Calcium Dimethylethyl-6- 0.708 Cyanomethyl-2,2- | dimethyl-1,3-Dioxane-4- | kg Acetate(ATS-8ms ) | 4-Fluoro-A-(2-Methyl-i-Oxopropyl- 0.994 G-Oxo-N,B- : Diphenylbenzene Butaneamide (DKT- » a 6| Cyclohexane 0.235 ----- End of picture text -----

| Note:It was also decided for revision of SION A -2797 due to technological updation. RA concerned may take further necessary action as per above decision of NC.

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----- Start of picture text ----- , Case No.:179/6/82- Party Name:BEST VALUE = [Meet No/Date:8/82- Status:Case ALC4/2014 CHEM PVT. LTD. ALC4/2014 Deferred 25.09.2014  134 JHQ File RLA File Lic.No/Date:3410039577 |Defer 01/82/0S0/00581/AMI5S/ ——|:34/24/040/00308/AM14/ _—‘|18.03.2014 [Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of C&PC. ----- End of picture text -----

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----- Start of picture text ----- Case No.:1/4/82-ALC4/2014 (Party Name:DORF-KETAL (Meet No/Date:8/82- Status: Case CHEMICALS INDIA ALC4/2014 Deferred PVT.LTD. 25.09.2014 135 {HQ File RLA File Lic.No/Date:03 10774824 |Defer 01/82/050/00249/AMI15/ | :03/94/040/00999/AM14/ [18.03.2014 Date: 12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of . C&PC [136 [Case No.:57/3/82-ALC4/2014 [Party Name:JUBILANT LIFE [Meet No/Date:8/82- _p4¢agupOaateal; akumar Dy Direcior Gonestar at be wean Trade faew waar Weiter Directorate General of Forengn Trade aica fervOepartment of Commerce ----- End of picture text -----

| | 7 |

| | ! | | : |

BeENCES LIMITED ALC4/2014 Deferred
HQ File RLA File Lic.No/Date:05 10382053 |Defer
| |:01/82/050/00061/AM15/ —_—|:05/23/040/00S06/AM14/ {18.03.2014 ‘WDate:12.11.2014.

Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals

Case No.:180/6/82Party Name:BEST VALUE = [Meet No/Date:8/82Status:Case ALC4/2014 CHEM PVT, LTD. ALC4/2014 Deferred 28.09.2014 a
1137 [HQ File RLA File Lic. No/Date:34 10039601 |Defer :01/82/050/00S82/AM15/ ———|:34/24/040/00298/AM14/ —_|19.03.2014 _ fDate:12.11.2014 Decision ; It was decided to defer the case for 12.11.2014 for comments of Department of C&PC. . .
Case No.:38/6/82-ALC4/2014 [Party Name:CROWN ‘(Meet No/Date:8/82__[Status:Case CHEMICALS PVT.LTD., ALC4/2614 IDeferred 25.09.2014 7
138 [HQ File RLA File Lic.No/Date:03 10775042 |Defer :01/82/050/00440/AM15/ :03/94/040/01 135/AM14/ 19.03.2014 Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of

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----- Start of picture text ----- Case No.:120/6/82- Party Name-SOFTGEL Meet No/Date:8/82- (Status: ALC4/2014 HEALTH CARE PVT. LTD., |ALC4/2014 Approved 25.09.2014 . HQ File RLA File \Lic.No/Date:04 10156356 |Defer Date: :01/82/050/00522/AM15/ —_|:04/24/040/00247/AM14/__|19.03.2014 a Decision : Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/131/2014-P1(Norms) dated 09.10.2014 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:- ----- End of picture text -----

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----- Start of picture text ----- 139 | Export product Exp. | SINo.| Import items Qty. Allowed | Koiv : | 1 VITAMIN A | 1kg PALMITATE 30.0 mg/50,000 IU | SOFT GELATIN CAPSULES L7MIU/gm Capsule } VITAMIN A VITAMIN A | LTMIU/gm Capsule | VITAMIN A | PALMITATE 120.0 mg/200,000 IU 1 | 1.7MIU/gm Capsule li RA concemed may take further necessary action as per above decisign of NC. me-ttunaae va yoo Bhawanyee, hi ----- End of picture text -----

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----- Start of picture text ----- Case No.:45/24/82- PartyName:VIVIMED LABS [Meet No/Date:8/82- [Status:Case ALC4/2013 ALATHUR) PRIVATE ALC4/2014 Deferred po LIMITED {25.09.2014 a ; 1140 |HQ File RLA File Lic.No/Date:04 10156358 |Defer :01/82/050/01244/AM14/ ——|:04/24/040/00264/AM14/ —{19.03.2014 — [Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of C&PC. . . Case No.:36/6/82-ALC4/2014 |Party Name:ALKYL AMINES [Meet No/Date-8/82- Status: CHEMICALS LTD ALC4/2014 Approved 25.09.2014 - HQ File RLA File Lic.No/Date:03 10775191 |Defer Date: :01/82/050/00438/AM15/ ———|:03/94/040/01018/AM14/ {20.03.2014 a DecisionPetrochemicals: In thevidelighttheirofU.O writtenNo. 14010/85/2012-Ch.comments receivedII datedfrom Department12.11.2013, ofit wasChemicalsdecidedandto {141 |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 ee [SNe Import items Qty. Allowed | Qty. tonitrile er . RA may take appropriate action as per the decisionofNorms Committee. Case No.:37/6/82- Party Name:IPCA Meet No/Date:8/82- Status:Case ALC4/2014 LABORATORIES LIMITED |ALC4/2014 Deferred . 25.09.2014 ; 142 |HQ:01/82/050/00439/AM15/File RLA:03/94/040/01File 109/AM14/ 20.03.2014Lic.No/Date:0310775. 194 [DeferDate:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of |Pharmaceuticals ----- End of picture text -----

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----- Start of picture text ----- Case No.:123/3/82- "Party Name:JUBILANT LIFE (Meet No/Date:8/82- |Status:Case ALC4/2014 SCIENCES LIMITED ALC42014 Deferred 25.09.2014 143 [HQ File RLA File Lic.No/Date:05 10382292 |Defer :01/82/050/00127/AM15/ :05/23/040/00508/AM14/ 20.03.2014 Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of _ [Pharmaceuticals . (Case No.:133/8/82- ~~ [Party Name:METROCHEM [Meet No/Date:8/82- __|[Status:Case ALC4/2014 API PVT. LTD. ALC4/2014 Deferred 25.09.2014 7 144 |HQ:01/82/050/00797/AM File 1 5/ RLA:09/24/040/00636/AM File 14/ 21.03.2014Lic.No/Date:09 10059597 [DeferDate:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments, of Department of Pharmaceuticals pw reek! MEP aay ----- End of picture text -----

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----- Start of picture text ----- Ww Deini ----- End of picture text -----

| | |

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----- Start of picture text ----- a) = ALC4/2014Case No.:181/6/82- CHEMParty Name:BEST PVT. LTD. VALUE = ALC4/2014(Meet No/Date:8/82- |Status:CaseDeferred . (25.09.2014 Z 145 (HQ File RLA File Lic. No/Date:34 10039647 |Defer :01/82/050/00583/AM15/ :34/24/040/00299/AM 14/ 25.03.2014 _ }Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of | |carc | | ----- End of picture text -----

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----- Start of picture text ----- Case No.:25/5/82-ALC4/2014 [Party Name:GLOBAL Meet No/Date:8/82- (Status: CALCIUM PRIVATE ALC4/2014 Approved LIMITED, 7 25.09.2014 ; HQ File RLA File Lic.No/Date:671010320 {Defer Date: :01/82/050/00342/AM 1 5/ 107/24/040/00340/AM14/ 9 . ; 26.03.2014 . ----- End of picture text -----

Decision : In the fight of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/56/2011-Ch. Il dated 19.07.2014, 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:

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----- Start of picture text ----- 14 No. EANSINSISE [E[oromeacio | OA 1088 P| [POMMOROIAE] [288 [ononcacin [209 0980 P| RAMOUmOnONe [MB [ononcacw | 087K RA may take appropriate action as per the decision of Norms Committee. 2 ----- End of picture text -----

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----- Start of picture text ----- ~ [Case No.:81/5/82- Party Name:KOPRAN Meet No/Date:8/82- [Status:Case ALC4/2014 LIMITED ALC4/2014 Deferred 25.09.2014 . 147 |JHQ File RLA File Lic.No/Date:03 10775960 iDefer 01/82/0S0/00398/AMI5/ —|:03/94/040/01160/AM14/ — [26.03.2014 — Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals ----- End of picture text -----

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----- Start of picture text ----- Case No.:82/5/82-ALC4/2014 |Party Name:KOPRAN Meet No/Date:8/82- Status:Case LIMITED ALC4/2014 Deferred . 25.09.2014 . a 148 |HQ File RLA File Lic.No/Date:03 10775954 |Defer :01/82/050/00399/AM 15/ 103/94/040/01152/AM14/ 26.03.2014 Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals 1149 Case No.:43/5/82-ALC4/2014 |Party Name:FINE ORGANIC |Meet No/Date:8/82).5, tatus: \ INDUSTRIES PVT.LTD. _ |ALC4/2014 poSe a Appruved’( KUMAR oder er we : * 7 . "a rade afasy fami saet aie ‘rade Sent ax “2h Commerce Udyog Bhawan, Nes Ep, ----- End of picture text -----

| | :

| | ~ 25.09.2014 — HQ File RLA File Lic.No/Date:03 10776137 |Defer Date: :01/82/050/00360/AM15/ 703/94/040/01 145/AM14/ 27.03.2014 -

Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/129/2011-Ch. Il dated 10.12.2013, 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 less:

Export product Qty.Exp. SIN | Import items Qty. Allowed CETO STEARYL STEARATE | ALCOHOL RA may take appropriate action as per the decision of Norms Committee.

Case No.:51/5/82-ALC4/2014 |Party Name:JINDAL DRUGS Meet No/Date:8/82Status:Case LIMITED ALC42014 Deferred | 25.09.2014 | 150 [HQ File RLA File Lic.No/Date:03 10776087 [Defer :01/82/050/00368/AM15/ 203/94/040/01098/AM14/ 27.03.2014 Date: 12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals. Case No.:48/5/82-ALC4/2014 |Party Name:KOPRAN Meet No/Date:8/82Status:Case LIMITED ALC422014 Deferred 25.09.2014 151 (HQ File | RLA File | Lic. No/Date:03 10776170 [Defer :01/82/050/00365/AM15/ :03/94/040/01168/AM14/ 27.03.2014 Date:12.11.2014

Decision: It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals.

Case No.:49/S/82-ALC4/2014 [Party Name:KOPRAN [Meet No/Date:8/82___[Status: LIMITED ALC4/2014 Approved | | 25.09.2014 - HQ File RLA File Lic.No/Date:03 10776158 {Defer Date: :01/82/050/00366/AM 1 5/ :03/94/040/01158/AM14/ 27.03.2014 Decision : Committee considered the case as per agenda and in light of earlier decision taken by 152 INC by NC 18/82 dated 19.12.2013 , decided to ratify norms under para 4.7 of HBP as per details below or as applied. by firm whichever. is: lower:-

[Export Product___| Exp. Qty. [S.No [Import Item | Qty. Allowed kg/kg AZITHROMYCIN |1.| AZITHROMYCIN AMINE | 1.007 | DIHYDRATE ACETONE 10.90 ___ 153[Case] {RA may[ No.:110/6/82-] take appropriate actionParty as Name:-NEULANDper thedecision ofNormsMeet Committee. No/Date:8/82SGasé* “SL\ IKUMAR ALC4/2014 LABORATORIES LTD ALC4/2014 Sefetfed fe, Udyog Bhawan'ty ae in i.

| [25.09.2014 HQ File RLA File Lic.No/Date:09 10059642 |Defer :01/82/050/00512/AM15/ —_[:09/24/040/00606/AM14/ [27.03.2014 Date:12.11.2014

| |Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals ;

(Case No.:35/8/82-ALC4/2014 [Party Name:SATYA Meet No/Date:8/82__|Status:Case DEEPTHA ALC4/2014 Deferred PHARMACEUTICALS LTD 25.09.2014 —
1154 |HQ File RLA File Lic.No/Date:0910059643 |Defer :01/82/050/00699/AM15/ :09/24/040/00639/AM14/ 27.03.2014 Date:12.11.2014

Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals

Case No.:112/6/82Party Name:DIVIS Meet No/Date:8/82Status:Case ALC4/2014 LABORATORIES LTD., ALC4/2014 Deferred | 25.09.2014 .
155 |HQ File RLA File Lic.No/Date:09 10059678 [Defer :01/82/050/005 14/AM15/ :09/24/040/00658/AM14/ 28.03.2014 Date: 12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals
Case No.:44/5/82-ALC4/2014 |Party Name:-KOPRAN Meet No/Date:8/82Status:Case LIMITED ALC4/2014 Deferred 25.09.2014
156 [HQ File RLA File Lic.No/Date:03 10776372 |Defer :01/82/050/00361/AM15/ :03/94/040/01 1S7/AM14/ 28.03.2014 Date: 12.11.2014

|Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals

Case No.:45/5/82-ALC4/2014 |Party Name:KOPRAN Meet No/Date:8/82Status: LIMITED ALC4/2014 Approved
. 25.09.2014
HQ File RLA File Lic.No/Date:03 10776360 |Defer Date: :01/82/050/00362/AMI15/ —_—{:03/94/040/01170/AM14/ 28.03.2014
Decision : Committee considered the case as per agenda and in light of earlier decision taken by
157 INC by NC 18/82 dated 19.12.2013 , decided to ratify norms under para 4.7 of HBP as per details below or as applied. by firm whichever: is. lower:-

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

/ Case No.:46/5/82Party Name:KOPRAN Meet No/Date:8/82|Status:Case 158 |ALC4/2014 LIMITED ALC4/2014 Peter Boferred 5.09.2014 OF Dice anMAL 4g Ina Tee Syne Sr ARR

hawk Fe Commence awan, Nowe.

(AQFile 01/82/050/00363/AM15/

|Date:12.11.2014

| |Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals.

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RLA File _|:03/94/040/01172/AM14/ _—‘[28.03.2014No/Date:03 10776367 eter

. ;
(Case No.:47/5/82-ALC4/2014 |Party Name:KOPRAN Meet No/Date:8/82Status:Case LIMITED ALC4/2014 Deferred __|25.09.2014 . a
1159 |HQ01/82/050/00364/AM15/ File RLA—_|:03/94/040/01169/AM14/File LenoreLic.No/Date:03 10776351 — — [Date:12.11.2014|Defer Decision : It was decided to defer the case for 12.11.2014 fosr comments of Department of Pharmaceuticals ;

_Case	CaseNo.:129/6/82-	PartyName:KLJ	MeetNo/Date:8/82-	Status:Case
160	ALC4/2014<br>.<br> [HQFile<br>:01/82/050/00531/AM15/	PLASTICIZERS LTD.,<br>RLAFile<br>:05/23/040/00554/AM14/	ALC4/2014<br>25.09.2014<br>Lic.No/Date:0510383276Pete<br>01.04.2014	Deferred<br>Pete<br>Date:12.11.2014
	Decision; Itwasdecidedtodefer thecasefor 12.11.2014 forcommentsofDepartmentof
	C&PC.

Case No.:52/6/82-ALC4/2014 [Party Name:UPL LTD. Meet No/Date:8/82Status:Case ALC4/2014 Deferred
| 25.09.2014 ;
161 |HQ File RLA File Lic.No/Date:03 10776594 |Defer :01/82/050/00454/AM15/ _ $:03/95/040/01043/AM14/ 01.04.2014 Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of C&PC.

==> picture [451 x 116] intentionally omitted <==

----- Start of picture text ----- a Case No.:83/5/82-ALC4/2014 (Party Name: VEGESNA {Meet No/Date:8/82- Status:Case LABORATORIES PRIVATE |ALC4/2014 Deferred LIMITED 25.09.2014 } 162 |HQ File RLA File Lic.No/Date:09 10059688 |Defer :01/82/050/00400/AMI5/ _|:09/24/040/00666/AM14/ [01.04.2014 __ _|Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Petrochemical Division of Department ofC&PC. ----- End of picture text -----

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----- Start of picture text ----- (Case No.:73/5/82-ALC4/2014 [Party [Meet No/Date:8/82- _‘(Status:Case . Name:ARIHANTANAM ALC4/2014 Deferred LIFECARE PVT.LTD. —([25.09.2014 ; ; 163 |HQ File RLA File Lic.No/Date:03 10776770 |Defer :01/82/050/00390/AM15/ 703/94/040/01 189/AM14/ 04,2014 Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals 164 Case No.:70/5/82-ALC4/2014 ORGANICS|Party Name:ASHU (INDIA) PVT. Meet|ALC4/2014 No/Date:8/82- soFestS F NIRMALfy et] beaden .R LTD., 25.09.2014 aectorRI aeGr Bieteratot Popowyn TradeTrade anferea faTruDepartment of Commerce Udyog 0, ra Ag eee ini ----- End of picture text -----

| |

==> picture [422 x 28] intentionally omitted <==

----- Start of picture text ----- HQ File RLA File Lic.No/Date:03 10776777 |Defer Date: :01/82/050/00387/AM15/ :03/94/040/01138/AMI14/ 2.04.2014 a ----- End of picture text -----

Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/36/2014-Ch. II dated 04.08.2014, 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:

==> picture [457 x 176] intentionally omitted <==

----- Start of picture text ----- . Qty. NITRO DIMETHYL 1 kg 1 DIMETHYL 0.902 kg TEREPHTHALATE(NITRO TEREPHTHALATE RA may take appropriate action as per the decision of Norms Committee. - | {Case No.:130/6/82- ‘Party Name:MOREPEN Meet No/Date:8/82- Status:Case ALC4/2014 LABORATORIES LTD., ALC4/2014 Deferred 1165 |HQ File 7 RLA File 25.09.2014Lic.No/Date:05 10383452- |Defer 7 :01/82/050/00532/AM15/ :05/24/040/00495/AM14/ 02.04.2014 — Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of _ [Pharmaceuticals - . ----- End of picture text -----

==> picture [424 x 70] intentionally omitted <==

----- Start of picture text ----- ~ [Case No.1 1/5/82-ALC4/2014 [Party Name:AROMA [Meet No/Date:8/82-_[Status: AROMATICS& FLAVOURS |ALC4/2014 Approved . 25.09.2014 HQ File RLA File Lic.No/Date:05 10383624 [Defer Date: 01/82/050/00328/AM15/ ———[:05/23/040/00S07/AM14/ —[03.04.2014 fo. ----- End of picture text -----

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----- Start of picture text ----- Decision : tn the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/41/2014-Ch. Il dated 28.08.2014, it was decided to 166 |fatify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exe | SINS. | Import items Qty. Allowed fromrranovesesrons |!" |! [toveuesronmosne [8M RA may take appropriate action as per the decision of Norms Committee. (Case No.:125/6/82- Party Name:CLEAN Meet No/Date:8/82- __|Status: ALC4/2014 SCIENCE AND ALC4/2014 ‘Approved {TECHNOLOGY PVT.LTD. [25.09.2014 HQ File RLA File Lic.No/Date:3 110063375 |Defer Date: :01/82/050/00527/AM15/ 13 1/83/040/00229/AM14/ 03.04.2014 - ----- End of picture text -----

167 |Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/3/2012-Ch. il dated 07.10.2014, 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: Export product |Exp._| SI.No. | Importitems =TUE DEY. AltoWed, 2 AltoWed,I

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----- Start of picture text ----- Lh = |Exp._| SI.No. =| Importitems =TUE in PEDEY. AltoWed, 2 AltoWed,I a Ee | Kurta! AO oe Yen ST eign Trade antersg PAP YCeparsnent a Commerce Udyog Bhawan ee Eoin ----- End of picture text -----

La z

‘

nN > OL 4-Methoxy Acetophenone (4 Anisole 0.900 kg | MAPY Acetyl Anisole 99% MINIMUM

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

Case No.:23/5/82-ALC4/2014 |Party Name:GLOBAL Meet No/Date:8/82Status: CALCIUM PRIVATE ALC4/2014 approved LIMITED, 25.09.2014 - HQ File RLA File Lic.No/Date:07 10103375 Pete :01/82/050/00340/AM15/ :07/24/040/00484/AM14/ 03.04.2014 Date: 12.1 1.2014 Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/56/2011-Ch. II dated 19.07.2014, it was decided to ; ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, 168 lWhichever is less:

==> picture [431 x 62] intentionally omitted <==

----- Start of picture text ----- Export product Exe. | SIN. | Import items Qty. Allowed [PESTA [aeQty. [F [rncciorancnon [FOE ----- End of picture text -----

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

Case No.:201/6/82Party Name:GLOBAL Meet No/Date:8/82(Status: ALC4/2014 (CALCIUM PRIVATE ALC42014 approved LIMITED, 25.09.2014 ) HQ File RLA File Lic.No/Date:07 10103374 [Defer Date: :01/82/050/00603/AM15/ :07/24/040/00454/AM14/ 03.04.2014

Decision : Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/26/2013-Pi{Norms) dated 22.01.2014 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 [485 x 201] intentionally omitted <==

----- Start of picture text ----- 169} Export product Exe |StN0. | Import items Qty. Allowed CARBONATE Qty. [i | CALCIUM | 0.145 «SCS | [2 [tactose | CALCIUM BROMO Tig [1 | CALCUMCARBONATE [0.233 LACTOBIONATE |2—s|kacTosE (RKO > [igprononeree 43% Yowar 1KG }2_{LACTOSE CdS0.187 f2_ [{Lactose] | RA «| 4.305 \ may take appropriate action as per the decision of Norms Committee. Prior Brent ar dds Direct ote or ----- End of picture text -----

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----- Start of picture text ----- . Case No.:62/5/82-ALC4/2014 [Party Name:Y ASHO Meet No/Date:8/82: - Status: INDUSTRIES PVT.LTD. — |ALC4/2014 Approved 25.09.2014 _. HQ File RLA File [ie NoDee.010777048 Pet Date: :01/82/050/00379/AM15/ :03/95/040/00004/AM15/ 04.04.2014 ; ; Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/95/2011-Ch. li dated 21.05.2014, it was decided to 170 ratifywhichevernormsis less:under Para 4.7 of HBP v1 as per details given below or as applied by the firm, |PARESOcrvLATED Qty.Tig [2 | [DiPNENYLAMINE] | O40SKG PONDER [DrISOBUTYLENE[0.620K6 [AcTIVATEDCLAY fs | 0.200KG | RA may take appropriate action as per the decision of Norms Committee. . ----- End of picture text -----

|CaseNo.:75/S/82-|PartyName:GALAXY|MeetNo/Date:8/82-|Status:|
|---|---|---|---|
|ALC4/2014|SURFACTANTSLTD.,<br>7|ALC4/2014<br>25.09.2014|Approved<br>oh|
|HQFile|RLAFile|Lic.No/Date:0310777284 |DeferDate:||
|:01/82/050/00392/AM15/|:03/94/040/01196/AM14/|07.04.2014||

Decision ; In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/148/2014-Ch. li dated 29.09.2014, it was decided to 171 |ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

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----- Start of picture text ----- | Export product Exe.Oty. | No. | import items Qty. Allowed Galaxy 610 Ethylene Glycol ike 1 0.941kg | disterate Stearic Acid RA may take appropriate action as per the decision of Norms Committee. _ ----- End of picture text -----

Case No.:33/5/82Party Meet No/Date:8/82Status: ALC4/2014 ame:JAINEX SPECIALITY CHEMICA j|ALC4/2014 Approve L 25.09.2014 d HQ File RLA File :34/24/040/0032 1/AM14/ Lic.No/Date:341003974 (Defer :01/82/050/00350/AMI5 6 Date:

Decision : In the light of written comments received from Department of Chemicals and 17 |Petrochemicals vide their U.O No. 14010/16/2014-Ch. || dated 07.10.2014, it was decided to 2 |ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

Qty. CALCIUM BUTYRATE 1 0.788 kg |RA may5 take appropriate action as per the- decision of- Norms Committee. —o eIa geoewe KUMARMe Dies ate, i aa . ot Trade ary faery wel we u sary 49, we 91 Commerce dyog Bhawan, NEE

t t

‘

a)

173

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----- Start of picture text ----- Case No.:28/5/82- Party Name:BALAJI Meet No/Date:8/82- |Status: ALC4/2014 AMINES LIMITED ALC4/2014 Approved 25.09.2014 | ; . HQ File RLA File Lena 10063437 eter Date: :01/82/050/00345/AM15/ :31/83/040/002 17/AM14/ 09.04.2014 ae Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/122/2011-Ch. Il 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, whichever is less: Qty. NSETHVL-PPYRROLIDONE [aig [i [[METHANOL] rz [AMMONIA ANHYDROUS‘|[0 0 . 160k370 K g catacyst rs [ostCATALYST | 0.00075 kg RA may take appropriate action as per the decision of Norms Committee. a [Ease No.:29/5/82- " [Party Name:BALAJI Meet No/Date:8/82- (Status: ALC4/2014 AMINES LIMITED ALC4/2014 Approved 25.09.2014 HQ File RLA File Lic.No/Date:3 110063438 |Defer Date: 01/82/050/00346/AM15/ —_—‘{:31/83/040/00216/AM14/ 09.04.2014 ----- End of picture text -----

Decision : tn 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, 174 |whichever is less:

| || DIETHYL AMINO ETHANOL 71 kg

0.154 KG O34 KG

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

Case No.:67/5/82-ALC4/2014 Party Name:FDC LTD Meet No/Date:8/82-___[Status:Case ALC4?22014 Deferred 25.09.2014
1175 |HQ File RLA File Lic.No/Date:03 10777658 |Defer :01/82/050/00384/AM1 5/ 103/94/040/00001/AM15/ 09.04.2014 Date: 12.11.2014

Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals

176 Case No.:72/5/82-ALC4/2014 |PartyTROTTERS PVT LTDName:GLOBE Name:GLOBE

|PartyTROTTERS PVT LTDName:GLOBE 25.09.2014ALC4/2014Meet No/Date:8/82Ay, eenStatus:CaseeferredN anneRM AL\baer UMARen arfeycaDirector Genera/Oepartment otfrn[af][Commerc] in “Trad e Ud arian New Delhi

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----- Start of picture text ----- File RLA File Lic. No/Date:03 4 FOFHO:01/82/050/00389/AM15/ccseams FLA:03/94/040/01isco 100/AM14/ [-] |09.04.2014 ; 1077795 PeterDate: 12.1 1.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals. . Case No.:23/6/82-ALC4/2014 Party Name:KUDOS Meet No/Date:8/82- Status:Case CHEMIE LTD., ALC4/2014 Deferred 25.09.2014 . 177 |HQ File RLA File [Lic No/Date:2210014788 [Defer :01/82/050/00425/AMIS/ —:22/24/040/00098/AMI14/ ——[09.04.2014 Pete 1.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Despartment Despartment of Pharmaceuticals Case No.:24/6/82-ALC4/2014 |Party Name:KUDOS Meet No/Date:8/82- Status:Case CHEMIE LTD., ALC4/2014 Deferred 25.09.2014 178 |HQ:01/82/050/00426/AM15/ File RLA122/24/040/00107/AM14/| File 09.04.2014Lic.No/Date:2210014787 PeteDate:12.11.2014. . Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals ; ----- End of picture text -----

Decision : It was decided to defer the case for 12.11.2014 for comments of Despartment Despartment of Pharmaceuticals

Case No.:79/5/82-ALC4/2014 |Party Name:AARTI “[Meet No/Date:8/82(Status: INDUSTRIES LIMITED ALC4/2014 Approved 25.09.2014 HQ File RLA File Lic.No/Date:03 10777966 |Defer | |:01/82/050/00396/AM15/ —_—:03/94/040/00015/AMI5/ {10.04.2014 . Date:12.11.2014

Decision ; In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/137/2011-Ch. II dated 04.08.2014, it was decided to 179 |ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

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----- Start of picture text ----- ORTHO DICHLORO BENZENE ----- End of picture text -----

==> picture [252 x 32] intentionally omitted <==

----- Start of picture text ----- Qty. i 0.624 kg BENZENE ----- End of picture text -----

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

==> picture [486 x 198] intentionally omitted <==

----- Start of picture text ----- Case No.:65/5/82-ALC4/2014 |Party Name:CROWN Meet No/Date:8/82-__[Status:Case HEMICALS PVT.LTD., ALC4/2014 Deferred 25.09.2014 180 |HQ File RLA File Lic. No/Date:03 16777887 |Defer :01/82/050/00382/AM15/ :03/94/040/00004/AM15/ 10.04.2014 _ |Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of C&PC 18} CHEMICALS PVT.LTD., ALC4/2014 a . bsf No.:66/5/82-ALC4/2014 (|Party Name:CROWN 25.09.2016MeetNo/Date:8/82-[Status:Casesa Har PORTE a. on ih,en uayog Bret an NE Boni ----- End of picture text -----

. |

fae File RLA File Lic. No/Date-03 10777897 [Defer :01/82/050/00383/AM15/ —_—|:03/94/040/00005/AM15/ 10.04.2014 |Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of CRPC. |

|CaseNo.:157/6/82-<br>ALC4/2014|PartyName:GLOBAL<br>~<br>CALCIUMPRIVATE<br>LIMITED,|MeetNo/Date:8/82-<br>ALC4/2014<br>25.09.2014<br>.|Status:<br>Approved<br>.<br>.|
|---|---|---|---|
|HQFile<br>:01/82/050/00S59/AMI5/|RLA File<br>—_|:07/24/040/00473/AM14/|Lic.No/Date:07 10103554 <br>_—‘|10.04.2014<br>-||Defer<br>[Date:12.11.2014|

Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/56/2011-Ch. I! dated 09.10.2014, 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:

| | | | :

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----- Start of picture text ----- 182]| Export product eeQty. [Sie import items Qty. allowed | Calin Cite kg OBI6Kg Mepis Cow ig [2___|CalciumCarbonate | 0.71. 0 801kgkg | 0.730 kg RA may take appropriate action as per the decision of Norms Committee. Case No.:158/6/82- Party Name:GLOBAL Meet No/Date:8/82- Status: ALC4?2014 CALCIUMLIMITED,’ PRIVATE 25.09.2014ALC4/2014 Approved. HQ File RLA File Lic.No/Date:07 10103553 |Defer :01/82/050/00560/AM15/ :07/24/040/00453/AM14/ 10.04.2014 Date: 12.11.2014 Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/56/2011-Ch. II dated 09.10.2014, 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: ----- End of picture text -----

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----- Start of picture text ----- 183 Qty. Magnesium L-Asparate te ft | L-Asparatic Acid 1.02 kg Calcium L-Asparate L-Asparatic Acid 0.976 kg Zinc L-Asparate fee [2 | L-Asparatic Acid 0.896 kg RA may take appropriate action as per the decisionofNorms Committee. ----- End of picture text -----

Case No.:1/2/82-ALC4/2014 Party Name:CADILA Meet No/Date:8/82Status:Case 184 HEALTHCARE LTD., ALC4/2014 Pre 7 > ferred 1. KUNA 25.09.2014 Dy Bmp UST water NAR Oeacument ot Conunores Uayog Bhawan! Non Eoin

HeHQ File y00003/AMIS RLA:08/24/040/00008/AM15/ File Lic.11.04.2014No/Date:08_ 10130534 [DeferDate:12.11.2014: Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals | (Case No.:32/5/82-ALC4/2014 ‘Party Name:EMCURE Meet No/Date:8/82Status:Case PHARMACEUTICALS LTD. |ALC4/2014 Deferred ; 25.09.2014 oe 185 |HQ File RLA File Lic.No/Date:3 110063481 |Defer 01/82/050/00349/AM15/ —|:31/83/040/00008/AM15/ [11.04.2014 Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals _ , ; [Case No.:68/5/82-ALC4/2014 Party Name-FDC LTD Meet No/Date:8/82-__[Status:Case ALC4/2014 Deferred | 25.09.2014 _ 186 |JHQ File RLA File Lic.No/Date:03 10778 140 |Defer 201/82/050/00385/AMI5/ = :03/94/040/01125/AM14/ _—s|11.04.2014 ,|Date:12.11.2014

Decision ; It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals
| [Case No.:27/5/82-ALC4/2014 [Party Name:ALEMBIC [Meet No/Date:8/82_[Status:Case PHARMACEUTICALS LTD |ALC4?2014 Deferred 25.09.2014 | -
187 |HQ File RLA File Lic.No/Date:34 10039801 |Defer :01/82/050/00344/AM15/ ——|:34/24/040/00006/AM15/ _|15,04.2014 Date: 12.11.2014
- Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals

| :

(Case No.:34/5/82-ALC4/2014 [Party Name:ALEMBIC [Meet No/Date:8/82-_[Status:Case PHARMACEUTICALS LTD |ALC42014 Deferred - (25.09.2014 . ; , 188 |HQ File RLA File Lic.No/Date:34 10039800 |Defer | |:01/82/050/00351/AM15/ ——:34/24/040/00003/AM15/ —‘|15.04.2014 Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals 7

Case No.:80/5/82-ALC4/2014 [Party Name:AARTI Meet No/Date:8/82_|Status: INDUSTRIES LIMITED ALC4/2014 Approved 25.09.2014 - HQ File RLA File Lic.No/Date:03 10778437 .|Defer Date: :01/82/050/00397/AM15/ |-03/94/040/00027/AM15/ ——|16.04.2014 189 Decision : Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/189/2014-Pl(Norms) dated 02.09.2014 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

iors faiVDepariment of ae od aan New Detni

| | |

! | | : : | | | |

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----- Start of picture text -----

||||||
|---|---|---|---|---|
|Export|product|Exp.|import items|Qty.|
|Qty.|Allowed|
|alke|
|4-Cyano-3-|
|||N-[4-Cyano-3-|1|kg|Trifluoromethylaniline|
|||(Trifluromethy!)Pheny!}-3-|(Another Name)4 Amino 2-|
|||[(4-Fluropheny!)|Sulfony!}-2|Trifluoromethy! Benzonitrile|0.533|
|||Hydroxy-2-|
|Methylpropanamide|
|||(Bicalutamide).|
|:|Para Fluoro Thiophenol|0.30|
||||RA concerned may take further necessary action as per above decision of NC.|_|

----- End of picture text -----

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----- Start of picture text -----

|||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|Case No.:39/8/82-ALC4/2014|[Party|Name:-MYLAN|Meet No/Date:8/82-|(Status:Case|
|LABORATORIES LIMITED||ALC4/2014|Deferred|
|190||HQ File|RLA File||Lic.No/Date:09 10059757||Defer|
|201/82/050/00703/AM15/|:09/24/040/00009/AM15/|16.04.2014|Date: 12.11.2014|
|Decision|:|It was decided to defer the case for|12.11.2014|for comments of|Department of|
|Pharmaceuticals|;|
|Case No.:30/5/82-ALC4/2014||Party Name:PRECISE|Meet No/Date:8/82-|Status:Case|
|.|25.09.2014|-|
|CHEMIPHARMA PVT.LTD.,||ALC4/2014|Deferred|
|191|[HQ File|RLA|File|Lic.No/Date:3 110063517|[Defer|
|:01/82/050/00347/AM15/|_|:31/83/040/00013/AMI5/|—_|16.04.2014|jDate:12.11.2014|
|Decision|:|It|was|decided|to|defer|the|case|for|12.11.2014|for|comments|of|Department|of|
|Pharmaceuticals|

----- End of picture text -----

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----- Start of picture text -----

|||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|(Case No.:69/5/82-ALC4/2014|[Party Name:FDC LTD|Meet No/Date:8/82-|_(Status:Case|
|ALC4/2014|Deferred|
|192||HQ File|RLA File|Lic.No/Date:03|10778812||Defer|
|01/82/050/00386/AMI5/|| :03/94/040/00041/AMIS/|—_[21.04.2014|—|[Date:12.11.2014|
|Decision|:|It|was|decided|to|defer|the|case|for|12.11.2014|for|comments|‘of|Department|of|
|__|Pharmaceuticals.|

----- End of picture text -----

Case No.:31/5/82-ALC4/2014 |Party Name:GOPINATH Meet No/Date:8/82Status:Case (CHEM-TECH LTD., ALC4/2014 Deferred 25.09.2014 193 [HQ File RLA File Lic.No/Date:0810130717 [Defer :01/82/050/00348/AM1 5/ :08/24/040/00017/AM1 5/ 21.04.2614 Date:1 2.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments.of Departmentof C&PC. Oy Byer cea LTE area urvOcpanment of Commerce uayen ban WESBoni

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----- Start of picture text ----- Case No.:61/5/82-ALC4/2014 Party Name:LITMUS Meet No/Date:8/82- ” Status: ORGANICS P. LTD. ALC4/2014 Approved . 25.09.2014 HQ File RLA File Lic.No/Date:03 10778780 |Defer Date: :01/82/050/00378/AM15/ ——|:03/95/040/00044/AM15/ [21.04.2014 _ . . ----- End of picture text -----

Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/40/2014-Ch. II dated 25.08.2014, it was decided to 194 {ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

Qty. || TRIETHYLACETATELIQUID CHEMICAL PHOSPHONO 1kg 1 TRIETHYLLIQUID CHEMICAL PHOSPHITE 0.823 kg RA may take appropriate action as per the decision of Norms Committee. 7 Case No.:59/5/82-ALC4/2014 [Party Name:SUNSHIELD [Meet No/Date:8/82(Status: CHEMICALS LTD. LC4/2014 Approved 25.09.2014 - HQ File RLA File Lic.No/Date:03 10778745 |Defer Date: :01/82/050/00376/AMIS/ ——_|:03/95/040/00021/AMI5/ [21.04.2014

Decision ; In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/107/2010-Ch. II dated 28.07.2014, it was decided to 195 jratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm,’ whichever is less:

| Export product Be [SNe | Import items Qty. allowed [SUN HQEE (parsing 0.625 kg RAEto) [2 [etiyene Oxide _—*( 0.490ke may take appropriate action as per the decision of Norms Committee. - Case No.:78/5/82-ALC4/2014 (Party Name:IPCA Meet No/Date:8/82[Status:Case LABORATORIES LIMITED |ALC4/2014 Deferred 25.09.2014 196 |JHQ File RLA File Lic.No/Date:03 10779054 |Defer :01/82/050/00395/AM15/ :03/94/040/000 12/AM15/ 22.04.2014 Date: 12.11.2014

Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals.

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----- Start of picture text ----- Case No.:58/5/82- Party Name:MICRO ORGO- [Meet No/Date:8/82-__|Status: ALC4/2014 CHEM ALC4/2014 Approved 25.09.2014 . 197 HQ|:01/82/050/00375/AM15/ File RLA—_|:03/95/040/00003/AMI5/ File _—|22.04.2014Lic.No/Date:03 10778885. 1|Defer Date: Decision : In the light of earlier decision taken in meeting no. 3/82 dated 08.05.2014, 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: ove aonuaeNIRMAL Kut at Udyogwey artmento ‘ommen, bd nC, TE Rasen ce ----- End of picture text -----

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

Case No.:56/5/82Party Name:SHIRDI Meet No/Date:8/82Status: ALC4/2014 CHEMICALS PVT.LTD. |ALC4?2014 Approved a | 25.09.2014 HQ:01/82/050/00373/AMI5/ File RLA:03/95/040/0005 File 1/AM15/ 22.04.2014Lic.No/Date:03 10778879 PeteJo. Date:

Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/105/2011-Ch. it dated 09.10.2014, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, 198 whichever is less:

Export product SI.No. | Import items allowed CAME crude (Methyl-2-amino- | 1 Kg 2-3-dichlorobenzoic acid | 1.318 kg 3-chlorobenzoate) OR 2-AminoMinimum 99% 3-chlorobenzoic acid methyl ester, crude

RA may take appropriate action as per the decision of Norms Committee. . Case No.:60/5/82Party Name:YASHO Meet No/Date:8/82(Status: ALC4/2014 INDUSTRIES PVT.LTD. —_|ALC4/2014 Approved | 25.09.2014 7 HQ File RLA File Lic.No/Date:03 10778874 iDefer Date: :01/82/050/00377/AM15/ :03/95/040/00040/AM15/ 22.04.2014

Decision : In the light of written comments received from Department of Chemicals and |!99 Petrochemicals vide their U.O No. 14010/95/2011-Ch. ti dated 19.08.2014, 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:

Lag lh ln | DIMETHYLDISULFIDE DIPHENYL(MPID THIURAM N METHYL ANILINE 0.651 kg RA may take appropriate action as per the decision ofNorms Committee.

Case No.:77/5/82-ALC4/2014 [Party Name:INDOCO_ Meet No/Date:8/82-__[Status:Case REMEDIES LIMITED ALC4/2014 Deferred . 25.09.2014 . 200 |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:12.11.2014 , Decision : It was decided to defer the case for 12.11.2014 for comments of Department of C&PC. [201 (Case No.:53/5/82-ALC4/2014 [PartyName: UNIMAX [MeetNo/Date:8/82%rt=, gStatys:Case

[MeetNo/Date:8/82%rt=, gStatys:Case i, Udyog Bhawan Wear oan,

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----- Start of picture text ----- —— CHEMICALSPVTLTD. (ALC4/201425.09.2014 aPetervea HQ —File RLA File: Lenoj 5 779156 ||Deferft 782/050/00370/AMLS/ :03/95/040/0001 S/AM15/ 23.04.2014 Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals. . ; Case No.:138/6/82- Party Name-EMCURE Meet No/Date:8/82- Status:Case ALC4/2014 PHARMACEUTICALS LTD. |ALC4/2014 Deferred 202 |HQ:01/82/050/00540/AM15/ File RLA:31/83/040/00015/AM1 File ; S/ Lis25.09.201424.04.2014 110063590. PeteDate: 12.11.201 4 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of {Pharmaceuticals. ----- End of picture text -----

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----- Start of picture text ----- Case No.:140/6/82- Party Name:EMCURE Meet No/Date:8/82- (Status: Approved ALC4/2014 PHARMACEUTICALS ALC4/2014 LTD. 25.09.2014 | HQ File RLA File Lic.No/Date:3 110063592 |Defer 101/82/050/00542/AM15/ 3 1/83/040/0001 VAMIS/ 4,04.2014 Date: 12.11.2014 ----- End of picture text -----

Decision : Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/61/2014-PI(Norms) dated 02.09.2014 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:-

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----- Start of picture text ----- 203 | Export product Exp. Import items Qty. Qty. Allowed Kaka 1 PROCHLORPERAZINE 16.60 mg PROCHLORPERAZINE Number EDISYLATE vial / EDISYLATE INJECTION USP V9239 FM259/0 FLCO 006 | [OMG][ /2ML] | SERUM STOPPER Relevant, as per packing policy ----- End of picture text -----

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

Case No.:6/5/82-ALC4/2014 |Party Name: UNITED Meet No/Date:8/82Status:Case BIOTECH PVT.LTD. ALC4/2014 Deferred 25.09.2014 . 204 [HO:01/82/050/00323/AM15/File 105/24/040/00034/AM15/RLA File Lic.No/Date:05404.2014 10384810 Date:12.11.2014|Defer Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals. oo ¥. Director Gruerai ot Sose.gn Trade anferegoseélaneral pA Mas bltoe fearLOsportmento: Commerce Uae Bre he ET

“

||CaseNo.:74/6/82-ALC4/2014 |PartyName:DIVIS|CaseNo.:74/6/82-ALC4/2014 |PartyName:DIVIS|MeetNo/Date:8/82-|Status:Case|
|---|---|---|---|---|
|||LABORATORIESLTD.,|ALC4/2014|Deferred|
|||oe|_<br>[25.09.2014|7|
|205|HQFile|RLA File|Lic.No/Date:0910059860||Defer|
||:01/82/050/00476/AM15/|_|:09/24/040/00014/AM15/|—_—([25.04.2014|Date:12.11.2014|
||Decision : Itwas decidedtodefer thecase for 12.11.2014 forcomments ofDepartmentof||||
||Pharmaceuticals.||||

Case No.:63/5/82-ALC4/2014 [Party Name:MACLEODS [Meet No/Date:8/82-__[Status:Case PHARMACEUTICALS LTD. |ALC4/2014 Deferred 25.09.2014 '206./HO File RLA File Lic.No/Date:03 10779501 iDefer :01/82/050/00380/AM15/ :03/95/040/00028/AM 15/ 25.04.2014 Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Case No.:8/5/82-ALC4/2014 |Party Name:MOREPEN (Meet No/Date:8/82-_‘[Status:Case LABORATORIES LTD., ALC4/2014 Deferred 25.09.2014 207 HQ File RLA File Lic.No/Date:05 10384943 [Defer :01/82/050/00325/AM15/ :05/24/040/00016/AM 15/ 25.04.2014 Date: 12.11.2014 | [Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals. . Case No.:7/5/82-ALC4/2014 |Party Name:S.M. HERBALS [Meet No/Date:8/82Status: PVT.LTD. ALC4/2014 Approved _ 25.09.2014 . HQ File RLA File Lic.No/Date:05 10385061 [Defer Date: :01/82/050/00324/AM15/ :05/24/040/00007/AM15/ 25.04.2014 ;

Decision : In the light of earlier decision taken by NC in its 07/82 meeting dated 11.09.2014, 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:

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----- Start of picture text ----- || [Item][ of][ Export] Qty. | S,No Item of Import Quantity | allowed kg/kg | 10 Deacetyl Baccatin Il Tkg | 1. 10 Deacetyl Baccatin Il | HPLC Purity NLT 98.5%. HPLC Purity NMT 95% 1.03 ----- End of picture text -----

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

Case No.:64/5/82-ALC4/2014 |Party Name:SURVIVAL Meet No/Date:8/82Status:Case TECHNOLOGIES PVT.LTD. |ALC4/2014 Deferred 25.09.2014 | 209 |HQ File RLA File Lic.No/Date:03 10779504 |Defer :01/82/050/00381/AM15/ :03/95/040/00026/AM15/ 25.04.2014 Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of are _ Rate gery ninwat KUMAR

anftisy fPTVOepartment of Commerce Udyog Bhawan, fess Desini

| |: |

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----- Start of picture text ----- Case No.:55/5/82-ALC4/2014 [Party Name:0 C Meet No/Date:8/82-__‘(Status: SPECIALITIES PVT.LTD. LC4/2614 Approved HQ File RLA File Lic.No/Date:03 10779584 |Defer Date: 01/82/050/00372/AM15/ —_|:03/95/040/00076/AMI5S/ 28.04.2014 a ----- End of picture text -----

Decision ; In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/108/2012-Ch. I! dated 18.05.2014, 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:

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----- Start of picture text ----- 210] Qty. | }CHLORO 2- HYDRAZINE |1kg [a [[3AMINOPYRIDINE] | 4.30kg | 50% | [3 | [SODIUMNITRITE] | 0.950 kg | aaa FLAKESSODIUM HYDROXIDE | [5____| ISOPROPYL ALCOHOL "| 0.210 kg | [6 |N-BUTANOL [0.770 kg % ANHYDROUS 1.10 kg POTASSIUM CARBONATE RA may take appropriate action as per the decision of Norms Committee. . Case No.:43/8/82-ALC4/2014 [PartyName:COVALENT [Meet No/Date:8/82. ~~ IStatussCase LABORATORIES PRIVATE |ALC4/2014 Deferred ; LIMITED (25.09.2014 — jo11 [HO File RLA File Lic.No/Date:09 10059930 [Defer 01/82/050/00707/AM15/ —_|:09/24/040/00012/AM15/ [29.04.2014 - [Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals. ----- End of picture text -----

| [Case No.:46/8/82-ALC4/2014 [Party Name:METROCHEM [Meet No/Dae@/8a. Stam API PVT. LTD. ALC4/2014 Approved 25.09.2014 a HQ File RLA File Lic.No/Date:0910059928 (Defer Date: :01/82/050/00710/AM15/ :09/24/040/00032/AM15/ 29.04.2014 Decision : Committee considered case as per agenda and in light of earlier decision taken in: 19/82 meeting held on 02.01.2014 and in consultation with technical authority present in meeting, 212 |decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:[ Export product [Exp. Qty. [SLNo. [importitems | 2+(Chloro methyl)-3-methyl-4-_| 1g. 2,3-DimethylPyridine| Gy. alowed } (2,2,2-trifluoroethoxy) Pyridine 2,2,2-Trifluoro Ethanol 0.76 kg | Hydrochloride \ RA concemed may take further necessary action as per above decision of NG: SPATE NiP AL char ais Dy. Direc TOF Cae tes 7 : nyt op ee | OrPSS aay frvbepanment of Commerce Udyog Bhawan hes Detni

| FLUORINE ALC4/2014 Approved INTERNATIONAL LIMITED LIMITED [25.09.2014 : | HQ File File RLA File Lic.No/Date:03 10779872 10779872 |Defer Date: Date: | 201/82/050/00369/AM 1 5/ :03/95/040/01033/AM14/ 29.04.2014 | Decision : tn the light of written comments received from Department of Chemicals and | Petrochemicals vide their U.O No. 14010/92/2011-Ch. il dated 05.08.2014, it was decided to : 215 |ratify norms under Para 4.7 of HBP vi as per details given below or as applied by the firm, whichever is less:

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----- Start of picture text ----- | [Case No.:74/8/82-ALC4/2014 [PartyName:METROCHEM (Meet No/Date:8/82- [Status: API PVT. LTD. ALC4/2014 Approved a 25.09.2014 pe HQ File RLA File Lic. No/Date:09 10059929 |Defer Date: | — |:01/82/0S0/00738/AM15/ —_—|:09/24/040/00033/AM15/ _‘{29.04.2014 a ----- End of picture text -----

Decision : Committee considered case as per agenda and in light of earlier decision taken in 19/82 meeting held on 02.01.2014 and in consultation with technical authority present in meeting, 213 |decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:-

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

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----- Start of picture text ----- oo ----- End of picture text -----

Case No.:75/8/82-ALC4/2014 [Party Name:METROCHEM [Meet No/Date:8/82(Status:Case API PVT. LTD. |ALC42014 Deferred 214 |HQ File RLA File Lic.No/Date:09 10059927 |Defer {:01/82/0S0/00739/AM15/ ———|:09/24/040/00034/AMI5/ —_—|29,04.2014 Date:12.11.2014

Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals.

Case No.:52/5/82-ALC4/2014 |Party Name:NAVIN Meet No/Date:8/82Status: FLUORINE ALC4/2014 Approved INTERNATIONAL LIMITED LIMITED [25.09.2014 : HQ File File RLA File Lic.No/Date:03 10779872 10779872 |Defer Date: Date: 201/82/050/00369/AM 1 5/ :03/95/040/01033/AM14/ 29.04.2014

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

: Case No.:74/5/82Party Meet No/Date:8/82[Status:Case ALC4/2014 ame: ARIHANTANAM ALC4/2014 Deferred LIFECARE PVT. LTD. 25.09.2014 216 [HQ File RLA File Lic.No/Date:03 10780141 [Defer :01/82/050/00391/AM15/ :03/94/040/00080/AM15/ 30.04.2014 1Date: 12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals. . a [217 [Case No:3/S/82-ALC420i4 [PartyName:NEW __ [MeetNo/Date: 8/8373, Slatsitaveall Dircons tt as aoe: ‘* 0 Trade Phra Raysgo ea Bey arent Qi Commane wayeg Bhawan fasBoini ,

|||[ALLIANCEDYE-CHEM|[ALLIANCEDYE-CHEM|_[ALC4/2014|Deferred|
|---|---|---|---|---|---|
||.||PVT. LTD.,<br>||25.09.2014|to.|
||HQ File||RLA File|Lic.No/Date:0310780255 |Defer||
||:01/82/050/00320/AM15/||_|-03/95/040/00017/AMI15/|{01.05.2014<br>=———s—[Date:12.11.2014||
||Decision|: Itwasdecidedtodefer thecasefor 12.11.2014 forcommentsofDepartmentof||||
||C&PC.<br>|||.|||
||||||a|
||‘(CaseNo.:9/5/82-ALC4/2014 [PartyName:DHANUKA<br>LABORATORIESLTD.|||[MeetNo/Date:8/82-<br>ALCA2614|Status:Case<br>Deferred|
||.|a||[25.09.2014||
|218|}HQFile<br>01/82/050/00326/AM15/||RLA File<br>—_—_—|[:05/23/040/00041/AMI5/|Lic.No/Date:05 10385706 |Defer<br>{05.05.2014<br>_—<br>[Date:12.11.2014||
||Decision<br>: It was decided <br>Pharmaceuticals.||to defer the case for12.11.2014 for comments||ofDepartment of|

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----- Start of picture text ----- Case No.:12/5/82-ALC4/2014 [Party Name:DHANUKA [Meet No/Date:8/82- [Status:Case LABORATORIES LTD. ALC4/2014 Deferred - 25.09.2014 | 2.19 |HQ File RLA File Lic. No/Date:05 10385707 |Defer | :01/82/050/00329/AM15/ —|:05/23/040/00042/AMI15/ {05.05.2014 Date: 12.11.2014 | Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals’ ; | > . . oe oo Poe Case No.:54/5/82-ALC4/2014 |Party Name:NEW Meet No/Date:8/82- Status:Case ALLIANCE DYE-CHEM J|ALC422014 Deferred |PVT.LTD., (25.09.2014 7 220 |HQ File RLA File Lic.No/Date:03 10780621 |Defer | :01/82/050/00371/AMi5/ ——|:03/95/040/00077/AM15/ _|05.05.2014 Date: 12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of C&PC. ----- End of picture text -----

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----- Start of picture text ----- ~ [Case No.:57/5/82-ALC4/2014 [Party Name:NEW [Meet No/Date:8/82-(Status:Case ALLIANCE DYE-CHEM ALC42014 Deferred PVT. LTD., ——«42509.2014 9271 |HQ File RLA File Lic.No/Date:03 10780627 |Defer :01/82/030/00374/AM15/ :03/95/040/00085/AMI15/ 05.05.2014 Date: 12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of C&PC. ----- End of picture text -----

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----- Start of picture text ----- Case No.:10/5/82-ALC4/2014 |Party Name:JUBILANT LIFE |Meet No/Date:8/82- Status:Case SCIENCES LIMITED ALC4/2014 Deferred {25.09.2014 . : HQ File RLA File Lic.No/Date:05 10385902 |Defer 222 :01/82/050/00327/AM 1 5/ :05/23/040/00015/AM15/ 06.05.2014 Date: 12.11.2014 Decision ; It was decided to call from the firm the following technical details: . export*Copy ofMas produc t .er Batch Formula duly verified by Quality Control Incharge. Befor a1zeachTATRA MALMUMA:.Kap \ Directorate Cron, y ‘he ters tery aftreg fPIMDexatmen “8190 Trace Set Was, = oi Commerce Udyog Bhawan, LEER, ----- End of picture text -----

a)

Past Production vis-a-vis Actual consumption of imported inputs for each export product duly certified by Central Excise Authorities.

|The case was deferred for 24.07.2014. . . ; Case No.7 1/5/82Party Meet No/Date:8/82Status:Case . ALC4/2014 Name: ARIHANTANAM ALC4/2014 Deferred . LIFECARE PVT. LTD. 25.09.2014 | 223 |HQ File RLA File Lic.No/Date:03 10780901 |Defer :01/82/050/00388/AM15/ —|:03/94/040/00076/AM15/ ——|07.05.2014 — [Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of _ |Pharmaceuticals. Case No.:35/5/82-ALC4/2014 [Party Name:ELIXIR Meet No/Date:8/82-__[Status:Case PHARMA ALC4/2014 Deferred {25.09.2014 224 |HQ:01/82/050/00352/AM15/ File RLA:08/24/040/00047/AM15/ File 07.05.2014Lic.No/Date:081013 1142:/Defer |Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals.

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----- Start of picture text ----- Case No.:91/8/82-ALC4/2014 |Party Name:FILTRA Meet No/Date:8/82- : Status: CATALYSTS & CHEMICALS |ALC4/2014 Approved . LTD., 25.09.2014 / HQ File RLA File Lic.No/Date:03 10781174 {Defer Date: :01/82/050/00755/AM15/ 4:03/94/040/00028/AM15/ 09.05.2014 Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/59/2014-Ch. Ii dated 08.10.2014, it was decided to 225 |ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Qty. [33 Xylenal a9 RA may take appropriate action as per the decision of Norms Committee. Case No.:13/5/82-ALC4/2014 |Party Name: PARABOLIC Meet No/Date:8/82- Status:Case DRUGS LTD., ALC4/2014 Deferred : 25.09.2014 226 |HQ File RLA File Lic.No/Date:05 10386137 |Defer :01/82/050/00330/AM15/ —_—|:05/24/040/00049/AM15/ _—[09.05.2014 Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of C&PC. Case No.:15/5/82-ALC4/2014 |PartyName:PARABOLIC Meet No/Date:8/82- Status:Case 227 DRUGS LTD., ALC4/2014 Deferred (25.09.2014 Pofe; ZN Dy. Director foci par. vt STOTT Udyog Bhawan Wee ny ----- End of picture text -----

1 | 1

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----- Start of picture text ----- A HQ File onan Decision01/82/050/00332/AM15/: It was decided :05/24/040/00036/AM15/a 09.0505. 201 0386135 [Deer|Date:12.11.2014 | RLA Fil ; — Icarc. efer the case for 12.11.2014 for comments ofDepartment of (Case No.:21/5/82-ALCanola Party Name: — Party ame:PARABOLIC [Meet No/Date:8/8)- Status:Case UGS LTD., ALC4/201 4 Deferred OT 25.09.2014 Decision01/82/050/00338/AM15/: It was decided _|:05/24/040/00039/AM15/121 09.05.2014a 9986136 Deferseta C&PC. to defer the case for 12. 1.2014 for comments ofDepartment of Case No.:14/5/82- Party Name:PAYAL " ALC42014 Meet No/Date:8/82- : PETROCHEM PRIVATE |4Lc4/2014 i Status:Approved Wor LIMITED 25.09.2014 ‘O1/82/050/00331/AMIS/ile _ [:05/24/040/00293/AMI4/RLA File bie09.05.9014 NofDatea5i03 6 Peter Date7 Decision : in the light of written comments received from Department of Chemicals and Petrochemicals vide their U.0 No. 14010/18/2014-Ch. It dated 28.05.2014, it was decided to 229 [whichever] ratify norms [is] [less:] under Para 4.7 of HBP v1 as per details given below or as applied by the firm, Qty. t| Di-Octiyl Tetraphthiate ikg Pure Tere Phthalic Acid | 0.447 kg | (DOTP) E-Ethyl Hexanol 0.680 kg ----- End of picture text -----

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

;

Case No.:17/5/82-ALC4/2014 [PartyName:RECKITT [Meet No/Date:8/82. [Status Case IBENCKISER ALC42014 Deferred HEALTHCARE INDIA 25.09.2014 [739 THO File RLA File Lic.No/Date:05 10386224 [Defer :01/82/050/00334/AM15/ _|:05/24/040/00053/AM15/ _ {09.05.2014 Date: 12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals. ;

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----- Start of picture text ----- (Case No.:18/5/82-ALC4/2014 [Party Name:RECKITT Meet No/Date:8/82- __|[Status:Case : BENCKISER ALC4/2014 Deferred {HEALTHCARE INDIA 25.09.2014 LIMITED 231 THQ:01/82/050/00335/AM15/ File _ RLA:05/24/040/00021/AM15/ File 09.05.2014Lic.No/Date:0510386223 PeterDate:12.11.2014 Pharmaceuticals.Decision : It was decided to defer the case for 12.11.2014 for commentsFer of Department of Vi dyog Byrd, ae of Commen awan, RB ----- End of picture text -----

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----- Start of picture text ----- { [Case No.:19/5/82-ALCanpig Party Name:-RECK] HEALTHCABENCKISER naeroDate:8/82- IStatas:Cass 639 -— LIMITED RE INDIA 25.09.20144 Deferred‘ [Rie: RLA FilHe : jsee SO00336/AMIS *05/24/040/00020/4M1 5) 09.0 ate:05 10386217pee_ €cision : It was decided to defer the so fi : Sete: 12-11.2014 harmaceuticals, 8¢ for 12.11.2014 for comments of Department of Case No.:104/6/82. |ALC4/2014 Party Name:SUNSHIELD a HO CHEMICALS LTp, AeNo/Date:882- Status: Fic 25.09.2014 Approved :01/82/050/005 eee rile Lic.No/Date:0 , r Dat Decision : in the {j it : ‘0506/AM15/ght of written:03/95/040/00115/4M15/co ; 05.2014 "10781246 [Defer Dae: Petrochemicals vide their u vuments received from Department of Chemicals and . eir U.O No, 14010/107/2010-ch Ni dated 10 . 233 ratify norms under Para 4.7 of HBP vi as per details a 10.2014, it was decided to [whichever is less: aus given below or as applied by the firm, | Export product | Suncon 100 (Octylated 1 ig Di | i-Iso butylene 0.503 Butylated Diphenylamine) A uy Ke RAmay take appropriate action asper the decision of Norms Committee. Case No.:37/5/82-ALC4/2014[Party Name:ATUL [Meet No/Date:8/82- ~~ IStatusCase {BIOSCIENCE LIMITED ALC4/2014 Deferred a oe . [25.09.2014 234 [HQ01/82/050/003S4/AMIS/ File [RLA —_|:52K4/040/00002/AM15/ File [ie[19.05.2014 NosDates1 004105 Date{Date:12,11.2014 | [Decision : It was decided to defer the case for 12.11.2014 for comments of Department of |Pharmaceuticals, _ . a _ OT RT TTT (Party Name:PREGNA [Meet No/Date:8/82- __[Status:Case Case No.:101/6/82- Deferred ALC4/2014 INTERNATIONAL LTD. —|ALC4/2014 25.09.2014 p39 jie : = RLA File———— Lic. No/Date:0310781971 Deter zoe -O1782/050/00503/AMS/ :03/95/040/00122/AM15/ lsasoe ener Date: 12.11.2014 Decision [:] [It][ was][ decided] to defer the case for 12.11.2014 for comments of Petrochemical Division ofDepartment ofC&PC. 7 = Name:SHIVAM— OILS Meet No/Date::8/82- Status:Case a 236| : = ‘561 92\Defer . < File HQ RLA File [isNerDae5 OEE satel , : 15/ :56/24/040/00007/AM15/ 19.05.2 Sl lee ae :01/82/050/00357/AM: — —= pie ee er ot sromn Trade afersa fEATU Department of lacie Udyog Bhawan, New Dein ----- End of picture text -----

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----- Start of picture text ----- . ----- End of picture text -----

_
For 1
|Decision : It was decided t
| carc. o defer the case for 12.11.2014 for comments of Department of E ee
: 0 ‘\Meet No/Date:8/82.
[Case No.:120/8/82Party Name:INDOC — REMEDIES LIMITED ALC4/2014 Deferred
ALC4/2014 25.09.2014 fer
Reta ss Status:Case . ; 782171 \Defer
337 HO Filile RLA. File Lic No/Date:03 107 - Oe .03/94/040/00111/AM15/ {20.05.2014 Pera 2014 Cee > It was decided to deferthe case for 12.11.2014 for comments ofDepartment of Case No.:38/5/82-ALC4/2014 [Party Name:INTAS Wieck No[batei6/82—‘[StatussCase_ PHARMACEUTICALS ALC4/2014 Deferred [Defer
LTD., [25.09.2014 * A 131456 |Defer ;
1238 |HQ File RLA File Tc No/ibate.0810131456 . .01/82/0S0/0035S/AMI5/ _:08/24/040/00076/AM15/ 20.05.2014 | eter 112014
| |Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals. ~ Party Name:ANUH PHARMA[Meet No/Date:8/82- —~CratusCase
Case No.:220/6/82-
239 \HQ File RLA File Lic. No/Date:03 10782487 |Defer "01/82/050/00622/AM15/ _:03/94/040/00122/AM15/ 22.08.2014 © {Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of
| |Pharmaceuticals. . CacNoanen~*«C mY<—aeANUH PHARMA [Meet No/Date:8/82Status:Case ALC4/2014 LTD. ALC4/2014 Deferred AL (25.09.2014 _
—
1240 HQ File IRLA File Lic.No/Date:0310782489 |Defer 1 |.91/82/050/00623/AM15/_ __1}03194/040/00125/AM15/ {22.08.2014 Per a12014 |
;
| [Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals. ne - _ ) {Meet No/Date:8/82‘\Status:Case
a ‘ 182 Canola’ Ps , “Name:BDR [Case No.c797B/82-ALCA2014 TTACEUTICALS —_|ALONZN Deferred \INTERNATIONAL PVT. 25.09.2014
lal Gore ae : ETE pasLic NofDate: 0310782569 [Def ‘12014 ee 1, |72.08.2014 \pate:12.11.2
191 /82/050/00743/AMI5/_ _ .93/94/040/00040/AM15) _122.05.2 ‘ ————— _
ecision : It was decided to defer the case for 12.11.2014 for comments of Departm narmaceuticals. = : ; : . sCase __
2.42. ALc4n2014. LIMITED : USTAN ; : 25Meet~ 09.2014 No/Date:8/82SteStatus:See RLA File Tic No/Date:03 10782590."aired[firmvLepantment] st Ngaio! Foneyn[ oi][Commerce] en trae
HQ File —— ustlYyos Bhawan, Ta, wg facetNew einini

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----- Start of picture text ----- [:01/82/050/00517/AM15/ —_[:03/94/040/00123/AM15/ {22.05.2014 ~— [Date:12.11.2014 ----- End of picture text -----

|Decision : It was decided to call from the firm the following technical details:

Details of manufacturing process with chemical equations, molecular formula, molecular | — |weights.
Yield obtained in each step.
Authentic technical literature in support of yield obtained.
CA certificate certifying the production of export item achieved by firm for the past three years and corresponding consumption of each input. The case was deferred for 12.11.2014.

|Case No.:113/8/82-|PartyName:IPCA<br>_<br>MeetNo/Date:8/82-<br>Status:Approved|
|---|---|
|ALC4/2014|LABORATORIESLIMITED |ALC4/2014<br>5.09.2014<br>;|
|HQ File|RLA File<br>Lic.No/Date:0310782567 |DeferDate:|
|:01/82/050/00777/AM 1 5/|103/94/040/00127/AMI15/<br>22.05.2014<br>:|
|Decision: InthelightofearlierdecisiontakenbyNCin its20/82meetingdated 16.01.2014, it||
|wasdecided to ratify normsunder|underPara4.7ofHBPv1asperdetailsgivenbeloworas applied by|
|thefirm,whicheverisless:||

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----- Start of picture text ----- i Item of Export j{ Quantity | S,No | Item of Import Quantity allowed kg/kg 543 TTumefantrine [ike | 1. | a(Dibutylamine Methyl) 2,7-Dichloro | 0.8693 -4-Fluoren Methanol [ DBA ] / 2,7- Dichloro -A-(Dibutylamino) Methyl- 9H-Fluorene-4-Methanol | P-Chlorobenzyldehyde 0.3477 |: | - RA may take appropriate action as per the decision of Norms Committee. ----- End of picture text -----

Case No.:117/8/82Party Name:IPCA Meet No/Date:8/82Status:Case ALC4/2014 LABORATORIES LIMITED |ALC4/2014 Deferred 25.09.2014 ; 244 {HQ File RLA File Lic.No/Date:03 10782568 [Defer 01/82/050/00781/AM15/ ——:03/94/040/00128/AM15/ ———|22.05.2014 Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals. . Case No.:118/8/82Party Name:KRISHNA Meet No/Date:8/82Status:Case ALC4/2014 ANTIOXIDANTS PVT. LTD. |ALC4/2014 Deferred 25.09.2014 a 1245 |HQ File RLA File Lic.No/Date:03 10782485 |Defer . :01/82/050/00782/AM15/ :03/94/040/00037/AM 15/ 22.05.2014 — fDate:12,11.2014 Peeision : It was decided todefer the case for 12.11.2014 for comments ofDepartment of 1) C&PC.. Prete Prey hrPeectorateCet Mops, ade Roomy tT aASE SET apap WEN of Common : Udyog Bhawsnk,aearece

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||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|Case No.:22/5/82-ALC4/2014||Party Name:STERILE INDIA|[Meet No/Date:8/82-|Status:Case|
|PRIVATE LIMITED|ALC4/2014|Deferred|
|246||HQ File|_.|RLA|File|«25.09.2014Lic.No/Date:05|10387173||Defer—|
|01/82/050/00339/AM15/|——_—|:05/24/040/00040/AM15/|—_—‘[22.05.2014|fDate:12.11.2014|
|Decision|:|It|was|decided|to|defer|the|case|for|12.11.2014|for|comments|of Department|of|
|Pharmaceuticals.|
|.|
|Case No.:41/5/82-ALC4/2014|[Party Name:ALMELO PVT|(Meet No/Date:8/82.Status:Case|
|LTD|ALC4?2014|Deferred|
|.|.|25.09.2014|.|
|247||HQ File|RLA|File||Lic.No/Date:09 10060207||Defer|
|:01/82/050/00358/AM15/|—_—_|:09/24/040/00096/AMI15/|—_—‘{23.05.2014|Date:12.11.2014|

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Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals.

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|||||||
|---|---|---|---|---|---|
|Case No.:174/6/82-_|Party|Name:AMI ORGANICS (Meet No/Date:8/82-|(Status:|_|
|ALC4/2014|PVT LTD.|ALC4/2014|Approved|
|25.09.2014|
|HQ|File|RLA|File|Lic.No/Date:5210041062||Defer Date:|
|:01/82/050/00576/AM15/|—_|:52/24/040/00010/AMI5/|[23.05.2014|;|

----- End of picture text -----

Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/24/2014-Ch. Il dated 27.08.2014, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, 24g |whichever is less:

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----- Start of picture text -----

|||||
|---|---|---|---|
|Export product|import items|Qty.|allowed|
|||Qty.|
|3-4-DI-HYDROXY 5-NITRO|1|1|158|
|||99.5% MIN.|

----- End of picture text -----

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

Case No.:16/8/82-ALC4/2014 |Party Name:GLAND Meet No/Date:8/82Status:Case PHARMA LIMITED ALC4/2014 Deferred . 25.09.2014 - 249 |HQ File RLA File Lic.No/Date:09 10060220 |Defer :01/82/050/00680/AM15/ |:09/24/040/00094/AMI5/ [26.05.2014 Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals. . . Case No.:114/8/82Party Name:INDOCO Meet No/Date:8/82-[Status:Case ALC4/2014 REMEDIES LIMITED ALC4/2014 Deferred 250 Tid File. RLA File 25.09.2014Lic. No/Date:03 10782942 (Defer. :01/82/050/00778/AM1 5/ 103/94/040/00133/AM15/ 26.05.2014 Date:12.11.2014 (Decision : It was decided to defer the case for 12.11.2014 for comments of ent of Dy, Director athe ner ae

Udyog Bhawan Noe omni

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----- Start of picture text ----- |__ [carc Case No.:119/8/82- Party Name:KUSUMA Meet No/Date:8/82- __[Status:Case ALC4/2014 PHARMA ALC4/2014 Deferred a 25.09.2014 © ; 251 |HQ File RLA File Lic. No/Date:03 10782930 |Defer 01/82/050/00783/AM15/ ———|:03/94/040/00115/AM15/ —_|26.05.2014 Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals. ----- End of picture text -----

—

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----- Start of picture text ----- Case No.:90/8/82-ALC4/2014 jParty Name:FINE ORGANIC Meet No/Date:8/82- Status: INDUSTRIES PVT. LTD. ALC4/2014 Approved 7 25.09.2014 HQ File RLA File Lic._No/Date:03 10783330 \Defer Date: 101/82/050/00754/AM15/ :03/94/040/00147/AM15/ 28.05.2614 ----- End of picture text -----

Decision : In the light of written comments received from Department of Chemicals and | Petrochemicals vide their U.O No. 14010/129/2011-Ch. il dated 10.12.2013, it was decided to : ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, 252 lwhichever is less:

Qty. ALCOHOL 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. .

CETO STEARYL STEARATE

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----- Start of picture text ----- RA may take appropriate action 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. ----- End of picture text -----

||CaseNo.:115/8/82-<br>ALC4/2014|PartyName:INDOCO<br>REMEDIESLIMITED|MeetNo/Date:8/82-<br>ALC4/2014<br>25.09.2014|Status:Case<br>Deferred|
|---|---|---|---|---|
|253||HQ File|RLA File|Lic.No/Date:03 10783328||Defer|
||:01/82/050/00779/AM<br>15/|:03/94/040/00151/AM15/|28.05.2014|Date:12.11.2014|

Decision : It was decided to defer the case for 12.11.2014 for comments of Department of C&PC.

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----- Start of picture text ----- [7 [ease No.:145/6/82- Party Name:LAKE Meet No/Date:8/82- _[Status:Case ALC4/2014 CHEMICALS PRIVATE ALC4/2014 Deferred LIMITED 25.09.2014 254 |HQ File RLA File Lic.No/Date:07 10104565 |Defer :01/82/050/00547/AM15/ :07/24/040/00003/AM15/ 28.05.2014 Date: 12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals. ----- End of picture text -----

Case No.:34/8/82-ALC4/2014 |Party Name:MYLAN Meet No/Date:8/82Status:Case LABORATORIES LIMITED |ALC4/2014 Deferred 255 25.09.2014 HQ File RLA File Lic. No/Date:09 10060257 |Defer 01/82/050/00698/AM15/ —|:09/24/040/00103/AM15/ —[28.05.2014 TFepDatect2 41-2014 bh tire Dy © i Te tpg Dir a Do , 8 WMS bo, ce oe. coonee Uayog Bhswan'se

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----- Start of picture text ----- Decision : It was decided to defer the case for 12.11.2014 for comments of Department of ----- End of picture text -----

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----- Start of picture text ----- Case No.:38/8/82-ALC4/2014 [Party Name:MYLAN [Meet No/Date:8/82. ~ [StatussCase LABORATORIES LIMITED |ALC4/2014 Deferred : . 25.09.2014 - 256 jHQ File RLA File Lic.No/Date:09 10060258 |Defer *01/82/050/00702/AMiS/ _|:09/24/040/00108/AM15/ _|28.05,2014 |Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals. ----- End of picture text -----

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----- Start of picture text ----- Case No.:51/8/82-ALC4/2014 Party Name:PVS ~ ~ [Meet No/Date:8/82- Status:Case LABORATORIES LTD LC4/2014 Deferred 25.09.2014 257 |HQ File RLA File Lic.No/Date:09 10060267 [Defer; :01/82/050/00715/AM15/ :09/24/040/00022/AM 15/ 38.05.2014 Date:12.1 1.2014 Decision : It was decided to defer the case for 12.1 1.2014 for comments of Department of _ {Pharmaceuticals. ----- End of picture text -----

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----- Start of picture text ----- Case No.:101/8/82- Party Name:ENCUBE [Meet No/Date:8/82- Status:Case ALC4/2014 ETHICALS PVT LTD ALC4/2014 Deferred | 25.09.2014 258. {HQ File RLA File Lic.No/Date:03 10783435 Defera 01 /82/050/00765/AM 15/ :03/94/040/00154/AM15/ 29.05.2014 Date:12.11 2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals. . ; ----- End of picture text -----

| : |

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----- Start of picture text ----- Case No.:116/8/82-ALC4/2014 [Party Name:GALAXY Meet No/Date:8/82- (Status: SURFACTANTS LTD., ALC4/2014 Approved . 25.09.2014 HQ File RLA File Lic.No/Date:03 10783552 |Defer Date: . :01/82/050/00780/AM15/ :03/94/040/00033/AM15/ 29.05.2014 | |Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/148/2011-Ch. il dated 03.09.2013, it was decided to 959 ratify norms under Para 4.7 of HBP vi as per details given below or as applied by the firm, whichever is less: | Export product aQty. | tN Import items Qty. Allowed | Cocomonothanolamide ike Coconut fatty Acid 0.830 kg RA [2__| Mono Ethanolamine 0.243 kg may take appropriate action as per the decision of Norms Committee. Case No.:42/8/82-ALC4/2014 [Party Name:GRANULES [Meet No/Date:8/82. [StatussCase 260 INDIA LIMITED ALC4/2014 Deferred 25.09.2014 HQ:01/82/050/00706/AM15/___|:09/24/040/00675/AM14/ File RLA File _|29.05.2014Lic.No/Date:091 By Drees00QQ28S1 BeenDALBET2irenra,1120 ic,bay an Direcionne ous itunes WPT fino ann OF oragn Trade ayog Bhawan, NESE, ----- End of picture text -----

| ,

a)

Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals.

; Case No.:114/6/82Party Name: HINDUSTAN Meet No/Date:8/82Status:Case ALC4/2014 POLYAMIDES & FIBRES (ALC4/2014 Deferred
| . LIMITED 509.2014 7
: 261 |JHQ File RLA File Lic.No/Date:03 10783464 (Defer | :01/82/050/00516/AMI5/ ——|:03/94/040/00132/AMI15/ [29.05.2014 Date:12.11.2014 | Decision : It was decided to defer the case for 12.11.2014 for comments of Department of C&PC.
- Case No.:99/8/82-ALC4/2014 [Party Name:IPCA [Meet No/Date:8/82__|[Status:Case LABORATORIES LIMITED |ALC4/2014 Deferred :
- . 25.09.2014 . ;
- 1262 |HQ File RLA File Lic.No/Date:03 10783593 |Defer :01/82/050/00763/AM15/ —_|:03/94/040/00150/AM15/ [29.05.2014 Date:12.11.2014 Decision ; It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals.

|||||~||||
|---|---|---|---|---|---|---|---|
|||Case No.:100/8/82-|PartyName:IPCA||MeetNo/Date:8/82-||Status:Case|
|||ALC4/2014<br>.|LABORATORIES LIMITED<br>|||ALC4/2014<br>25.09.2014||Deferred<br>;|
||263|[HQFile<br>:01/82/050/00764/AM15/|RLA File<br>—_—[:03/94/040/00129/AM15/||Lic.No/Date:03 10783592 <br>_|29.05.2014<br>_—|||Defer<br>[Date:12.11.2014|
|||Decision<br>: It was decided|to defer the case for|12.11.2014 for comments||of|Department of|
|||||Pharmaceuticals.||||||

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----- Start of picture text ----- . Case No.:37/8/82-ALC4/2014 [Party Name: MSN Meet No/Date:8/82- _[Status:Case PHARMACHEM PRIVATE |ALC4/2014 Deferred LIMITED (25.09.2014 264 |HQ File RLA File Lic.No/Date:09 10060282 [Defer :01/82/050/00701/AM15/ | :09/24/040/00113/AMI5/ _[29.05.2014 _— Date:12.11,2014 ----- End of picture text -----

Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals.

Case No.:25/8/82-ALC4/2014 |Party Name: VIVIMED LABS |Meet No/Date:8/82Status:Case LIMITED ALC4/2014 Deferred (25.09.2014 .
265 |HQ File RLA File Lic.No/Date:09 10060289 |Defer :01/82/050/00689/AM15/ :09/24/040/00117/AM15/ 29.05.2014 Date:12.11.2014 Decision ; It was decided to defer the case for 12.11.2014 for comments of Department of C&PC.

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----- Start of picture text ----- Case No.:102/8/82-ALC4/2014 |Party Name:AVA 266 CHEMICALS PVT.LTD., [HQ File [RLA File ----- End of picture text -----

Meet No/Date:8/82Status: ALC4/201425.99.2014 Approved Lic.No/Date:0 365i [Refer e: R ¥ Du ace ¢ ne - , ° : T tag it, Udyag Bhawan,aa sy. Nae ommerceSoin,

(:01/82/0S0/00766/AM15/ __[:03/94/040/00159/AMI15/ [30.05.2014

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||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|Decision|:|In|the|light|of|written|comments|received|from|Department|of|Chemicals|and:|
|Petrochemicals|vide|their|U.O|No.|14010/157/2011-Ch.|If|dated|30.04.2014,|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:|
|Qty.|
|EDTA FERRIC SODIUM Fe|1|ETHYLENE DIAMINE|0.730 kg|
|content 13% (+/- 0.5)|TETRA ACETIC ACID|
|RA may take appropriate action as per the decision of Norms Committee.|_|—|
|Case No.:86/8/82-ALC4/2014|Party Name:GLENMARK|Meet No/Date:8/82-|Status:Case|
|GENERICS LIMITED||ALC4/2014|Deferred|
|.|.|25.09.2014|'|
|267|{HQ File|RLA File|Lic.No/Date:03 10783793||Defer|
|01/82/0S0/00750/AM15/|—_—|:03/94/040/00160/AM15/|{30.05.2014|_—|fDatez12.11.2014|
|Decision|:|It|was|decided|to|defer|the|case|for|12.11.2014|for|comments|of|Department|of|
|Pharmaceuticals.|.|
|Case No.:141/6/82-|Party Name:GLOBAL|Meet No/Date:8/82-|(Status:|
|ALC4/2014|CALCIUM PRIVATE|ALC4/2014|Approved|
|.|
|||LIMITED,|25.09.2014|fo|
|Jo°|HQ File|RLA File|Lic.No/Date:07 10104601|[Defer Date:|
|:01/82/050/00543/AM|15/|:07/24/040/00474/AM|14/|30.05.2014|.|a|
||Decision|:|tn|the|light|of|written|comments|received|from|Department|of|Chemicals|and|
|Petrochemicals|vide|their|U.O|No.|14010/56/2011-Ch.|ti|dated|28.05.2012,|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:|
|Ea|Export product|ee|||import items|Qty. Allowed|
|MAGNESIUMLACTATE|||1 kg|0.755 KG|
|GLUCONATE|GLUCONATE DELTA LACTONE|
|26|
|MAGNESIUM|i kg|0.945 KG|
|GLUCONATE|GLUCONATE DELTA LACTONE|
|5|POTASSIUM|0.930 KG|
|GLUCONATE|GLUCONATE DELTA LACTONE|
|7|| MANGANESE|0.945 KG|||
|GLUCONATE|GLUCONATE DELTA LACTONE|
|CALCIUM|MANGNESIUM|0.831|KG|
|LACTATE|GLUCONATE|GLUCONATE DELTA LACTONE|
|:|PSL|at|een|||-|7|
|arse|frvOepanment of Commerce|
|Udyog Bhawan|No|eon;|

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| | | | : |

| RA may take appropriate action as per the decision of Norms Committee. _ 7 | Case No.:44/8/82-ALC4/2014 Party Name:PERKIN "(Meet No/Date:8/82Status:Case | LABORATORIES ALC4/2014 Deferred 1269 [HQ File RLA; File (25.09Lic . No/Date:09100602982014 [Defer . 01/82/050/00708/AM15/ ——|:09/24/040/00087/AM15/ ——|30.05.2014 fDate:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals. . Case No.:87/8/82-ALC4/2014 [Party Name:GLENMARK [Meet No/Date:8/82[Status:Case GENERICS LIMITED ALC4/2614 Deferred : _ _ (25.09.2014 —— 270 |HQ File RLA File JLic.No/Date:03 10784177 |Defer :01/82/050/00751/AM15/ ———[:03/94/040/00156/AM15/ [03.06.2014 —— fDate:12.11.2014 | |Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals. - Case No.:113/6/82PartyName:HINDUSTAN [Meet No/Date:8/82(Status:Case ALC4/2014 POLYAMIDES & FIBRES /ALC4/2014 Deferred | LIMITED 25.09.2014 — ; 971 |HQ File RLA File Lic.No/Date:03 10784160 |Defer :01/82/050/00515/AM15/ —|:03/94/040/00162/AMI5/ —_|03.06.2014 Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of C&PC, . .

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----- Start of picture text ----- | [Case No.:81/8/82-ALC4/2014 [Party Name-KRISHNA [Meet No/Date:8/82- (Status: ANTIOXIDANTS PVT. LTD. |ALC4/2014 Approved 25.09.2014 HQ File RLA File Lic.No/Date:0310784175 (Defer Date: :01/82/050/00745/AM 1 5/ :03/94/040/00164/AMIS/ (03.06.2014 7 . . Decision : in the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/100/2012-Ch. if dated 12.11.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, 272.\whichever is less: Oty. DI PHENYL ISODECYL | [2S | PHENOL, CL OSSBKG | [3 | YELLOW PHOSPHORUS [0.09KG RA may take appropriate action as per the decision of Norms Committee. 7 ~ [Case No.:68/6/82-ALC4/2014 [Party Name:SUN Meet No/Date:8/82-__[Status:Case PHARMACEUTICAL ALC4/2014 Deferred 273 INDUSTRIES LTD., 25.09.2014 ; HQ File RLA File Lic.No/Date:03 10784098 [Deferie oye :01/82/050/00470/AM15/ :03/95/040/00169/AM15/ 03.06.2014 paris * te: #2,11 2044: te Oy ere ETE Scangn 18S Diihfa rate GoneWDepacm oon of Commerce: uayos © ----- End of picture text -----

Decision : It was decided to defer the case for 12.11.2014 for comments of Department of ‘|Pharmaceuticals.

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----- Start of picture text ----- ‘Case No.:50/8/82-ALC4/2014 [Party Name:RA CHEM Meet No/Date:8/82- (Status: PHARMA LIMITED JALC4/2014 Approved HQ File RLA File Lic.No/Date:0910060357 |Defer Date: :01/82/050/00714/AM15/ 09/24/040/00126/AM15/ [04.06.2014 a Decision : In the light of earlier decision taken in meeting no. 22/82 dated 20.02.2014, it 274], 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 Export SLNo. | Import items Qty. } product Qty. allowed . j Orlistat i kg Orlistat 0.505/kg Pellets 50% RA may take appropriate action as per the decision ofNorms committee. ; Case No.:163/6/82- Party Name:STERICON MeetNo/Date:8/82- Status: ALC4/2014 PHARMA PVT.LTD., ALC4/2014 Approved 25.09.2014 ; HQ File RLA File Lic.No/Date:07 10104771 |Defer Date: :01/82/050/00565/AM15/ :07/24/040/00073/AM15/ 04.06.2014 ; Decision : Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/766/2013-Pl(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:- 275 |Export Product VIZULIZE MOISTURIZING AND COMFORT EYE DROPS ; | For Export of 1 No. Bottle Export Item | Export Item | Export Item [1 [__[SorTBOTTLE] No. 1 No. 2 No. 3 Item No. 4 [2[3 |WHITECAP84170001_—|reeam007 | Relevant as per packing policy [4 |[soonnavanunonaTeprope sno: [001 gm [003 gm _|RA concemed may take further necessary actionas per above decision of NC. : Case No.:47/8/82-ALC4/2014 [Party Name:HETERO LABS (Meet No/Date:8/82- _[Status:Case LIMITED ALC4/2014 Deferred 276 (28.09.2014 : HQ File RLA File Lic. No/Date:09 10060381 Defer :01/82/050/0071 1/AM15/ :09/24/040/00122/AM15/ 05.06.2014 Date: 12.11.2014 rane NIRMAL RUMAI wy nafhene Tet Sse Dy. Dvector General of ign Trade faae wnare waif axes Directurate General of Fureign Trade afta fearyDepartment of Commerce Udyog Ui igs Sink Delhi ----- End of picture text -----

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----- Start of picture text ----- Decision : It was decided to defer the case for 12.11.2014 for comments of Department of _ {Pharmaceuticals. ----- End of picture text -----

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----- Start of picture text ----- - Case No.:49/8/82-ALC4/2014 [Party Name:HETERO LABS [Meet No/Date:8/82-[Status:Case LIMITED ALC4/2014 Deferred 5.09.2014 _ . 277 |HQ File RLA File Lic.No/Date:09 10060380 |Defer :01/82/050/00713/AM15/ ———|:09/24/040/00121/AM15/ ——‘|05.06.2014 Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of {Pharmaceuticals.   Case No.:56/8/82-ALC4/2014 [Party Name:HETERO LABS [Meet No/Date:8/82- (Status:Case LIMITED ALC4/2014 Deferred 25.09.2014 ; 1278 }HQ File RLA File Lic.No/Date:09 10060379 |Defer :01/82/050/00720/AM1 5/ 209/24/040/00120/AM15/ 05.06.2014 Date: 12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of . | {Pharmaceuticals. Case No.:70/6/82-ALC4/2014 [Party Meet No/Date:8/82- (Status: Name:METROPOLITAN ALCA/2014 Approved EXIMCHEM LTD. 5.09.2014 - HQ File RLA File ic.No/Date:03 10784490 |Defer Date: | — |:01/82/050/00472/AM15/ ——[:03/95/040/00186/AM15/ ——[05.06.2014 . ; Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/60/2010-Ch. Il dated 17.09.2014, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, 279 whichever is less: | Export product Exp. SI.No. | Import items Qty. Allowed Qty. TSN HYDROCHLORIDE (3,7- | DIMETHYLDIBENZOTHIOPHENE 8 5,5-DIOXIDE ARBO’ RA may take appropriate action as per the decision of Norms Committee. - Case No.:82/8/82-ALC4/2014 Party Name:DORF-KETAL Meet No/Date:8/82- Status: CHEMICALS INDIA ALC4/2014 Approved 7 PVT.LTD. 25.09.2014 . | HQ File RLA File Lic.No/Date:03 10784666 |Defer :01/82/050/00746/AM15/ :03/94/040/00193/AM15/ 06.06.2014 Date: 12.11.2014 280 |Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/176/2012-Ch. tI dated 10.10.2014, 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: Export product [Exp. | Sl.No. | [Importitems] | tty. Allowed 1 Be be fs MEE ot aes — ot = ZU Bieee 2 of Fwe eniore apr faTTOepanment of Commence Udyog Bhawan, Noe Loin ----- End of picture text -----

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----- Start of picture text ----- EE eee oe 1 Polymer Additives - Bis (N- ikg PAC -2M ( 4,4 - Trade Name : Clearlink 1000 Hexanamine ), Synonym : ||| Alkylaminocycohexy!) methane |2_|MethylenebiBisMethyl(para-aminocycichexy!Ethyl ScycioKetone / MEK | 0.798 KG carbon powder (ondry basis _|RA may take appropriate action as per the decision of Norms Committee. - ----- End of picture text -----

Case No.:15/8/82-ALC4/2014 [Party Name:ALMELO PVT [Meet No/Date:8/82_[Status:Case LTD ALC4/2014 Deferred . 25.09.2014 / 281 |HQ File RLA File ‘|Lic.No/Date:09[10060403][|Defer] :01/82/050/00679/AM15/ | :09/24/040/00119/AM15/ [09.06.2014 Date:12.11.2014 Decision ; It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals. Case No.:48/8/82-ALC4/2014 [Party Name:ALMELO PVT [Meet No/ivate:8/82(Status:Case LTD ALC4/2014 Deferred 25.09.2614 282 |HQ File RLA File . Lic.No/Date:09 10060402 : |Defer ; :01/82/050/00712/AM15/ —_|:09/24/040/00118/AM15/ —[09.06.2014 ‘|Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals.

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----- Start of picture text ----- Case No.:88/8/82-ALC4/2014 Party Name:ENALTEC LABS |Meet No/Date:8/82- Status: PVT.LTD. ALC4/2014 Approved 25.09.2014 7 HQ File IRLA File Lic.No/Date:03 10784856 |Defer Date: :01/82/050/00752/AM15/ :03/94/040/00167/AMI15/ 09.06.2014 - Decision : Committee considered case as per agenda and in light of earlier decision taken in meeting No. 46/82 heid on 14.02.2012 and in consultation with technical authority present in 083 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 Import items | allowed Febuxostat 1. 2-(3-Cyano-4-(2- Methylpropoxy)Pheny!)-4-MethyI-5- Thiazolecarboxylic Acid ethyl Ester ----- End of picture text -----

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

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----- Start of picture text ----- Case No,:92/8/82-ALC4/2014 [Party Name:AVA Meet No/Date:8/82- Status: CHEMICALS PVT.LTD., ALC4/2014 Approved 25.09.2014 284 THQ File RLA File Lic.No/Date:03 10784980 ca[Defer Date: :01/82/050/00756/AM 15/ 103/94/640/00060/AM15/ 10.06.2014 Decision : In the light of written comments received from Department of Chemicals and — AR NIRVAL KUMAR ----- End of picture text -----

AR NIRVAL KUMAR WO waft wreays T eeTUT Dy. Director Generali ot F U-eign Trade Directorate General of Foreign Trade afersa farVDepartment of Commerce UdyogwertBhawan,wa4, arg NewfacetDelhi.

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----- Start of picture text ----- Petrochemicals vide their U.O No. 14010/157/2011-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 less: Qty. | | EDTA Diammonium 1kg 1 ETHYLENE DIAMINE| 0.825 kg [_@ower) TETRA ACETIC ACID RA may take aPpropriate action as per the decision of Norms Committee. . [Case No.:54/8/82-ALC4/2014 [Party Name:GLAND Meet No/Date:8/82- [Status:Case PHARMA LIMITED ALC4/2014 Deferred 1285 (HQ File RLA File 25.09.2014Lic.No/Date:0910060413 |Defer ; :01/82/050/007 18/AM15/ :09/24/040/00123/AM15/ 10.06.2014 — fDate:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals. ; Case No.:40/8/82- Party Name:MYLAN [Meet No/Date:8/82- [Status:Case ALC4/2014 LABORATORIES ALC4/2014 Deferred LIMITED 25.09.2014 . 286 |HQ File IRLA File Lic.No/Date:09 10060411 [Defer :01/82/050/00704/AM1 5/ |:09/24/040/00130/AM15/ 10.06.2014 _ Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals. . Case No.:45/8/82- Party Name:RA CHEM Meet No/Date:8/82- Status: ALC4/2014 PHARMA LIMITED ALC4/2014 Approved HQ File . RLA File | | 25.09.2014Lic.No/Date:09 10060426 |Defer. :01/82/050/00709/AM15/ — |:09/24/040/00144/AM15/ {11.06.2014 Date: — Decision : In the light of earlier decision taken in meeting no. 22/82 dated 20.02.2014, it was 27 |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 Export SLNo. | Import items product Oty. allowed Orlistat Pellets Orlistat 0.505/kg | 50% RA may take appropriate action as per the decision ofNorms committee. - Case No.:106/8/82- Party Name:BAYER Meet No/Date:8/82- Status:Case ALC4/2014 CROPSCIENCE ALC4/2014 Deferred {LIMITED 25.09.2014 288 |HQ File RLA File Lic.No/Date:03 10785223.|Defer :01/82/050/00770/AM15/ |:03/94/040/00131/AM15/ |12.06.2014 Date: 12.11.2014 Pharmaceuticals.Decision : It was decided to defer the case for 12.11.2014 for comments of Department of a ----- End of picture text -----

SE RMAL KUMAR Ditectorate SonalEARSTa arftroy frvOepanment of Commane Layog Bhawan WEE in,

| |

a)

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----- Start of picture text ----- Case No.:89/8/82- Party Name:ENALTEC Meet No/Date:8/82- Status: JALC4/2014 LABS PVT.LTD. ALC4/2014 Approved HQ File RLA File Lic. No/Date:03 10785240 |Defer :01/82/050/00753/AMI1S/ | :03/94/040/00209/AM15/ {12.06.2014 Date: ----- End of picture text -----

Decision : Committee considered case as per agenda and in light of written comments : given by technical authority from Department of Pharmaceuticals, it was decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is 289 lower:-

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----- Start of picture text ----- | Export product Exp. Qty. Qty. allowed TROMETAMOLDEXKETOPROFEN N-OCTYL-D-GLUCAMINE 0.36ke/KC | 3-(1-CYANOETHYL) BENZOIC , ACID ----- End of picture text -----

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

Case No.:121/8/82-ALC4/2014 [Party Name:INDO AMINES [Meet No/Date-8/82(Status: ; LIMITED ALC4/2014 Approved HQ File RLA File Lic.No/Date:03 10785233 |Defer Date: :01/82/050/00785/AM15/ :03/94/040/00138/AM15/ 12.06.2014 . Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/81/2010-Ch. Il dated 23.04.2013, it was decided to 290 |ratify norms under Para 4.7 of HBP vi as per details given below or as applied by the firm, whichever is less:

Qty. RA may take appropriate actionas per the decision of Norms Committee. Case No.:105/8/82Party Name:INDOCO [Meet No/Date:8/82[Status:Case ALC4/2014 REMEDIES LIMITED ALC4/2014 Deferred . - 25.09.2014 ; 291 [HQ File RLA File Lic. No/Date:03 10785225 [Defer 01/82/050/00769/AM15/ ———|:03/94/040/00205/AMI5/ —_—|12.06.2014 Date:12.11.2014

Decision : It was decided to defer the case for 12.11.2014 for comments of Department of C&PC. .

Case No.:58/8/82-ALC4/2014 |Party Name:AUROBINDO [Meet No/Date:8/82[Status:Case PHARMA LIMITED ALC4/2014 Deferred 292 . 25.09.2014 . | HQ File RLA File Lic.No/Date:09 10060441 |Defer 701/82/050/00722/AM15/ :09/24/040/00137/AM15/ 13.06.2014 _ }Date:12.11.2014 fetaog Teter=n Preeme< Diet BE meeresee Wectorate Ceaneral of F orergn Trade arftrsg frrvDepartment of Commerce Udyog Bhawan Now Eoin;

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----- Start of picture text ----- Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals. _ : a 7 [ ~ |Gase No.:93/8/82-ALC4/2014 [Party Name:AVA. Meet No/Date:8/82- (Status: CHEMICALS PVT.LTD., ALC4/2014 Approved . (25.09.2014 . ; HQ File RLA File Lic.No/Date:03 10785324 |Defer Date: :01/82/050/00757/AM15/ :03/94/040/00201/AM15/ 13.06.2014 : Decision : tn the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/157/2011-Ch. II dated 22.04.2014, it was decided to 293 jratify norms under Para 4.7 of HBP vi as per details given below or as applied by the firm, whichever is less: Qty. | | EDTA Tetra Sodium 1kg 1 Ethylene Diamine Tetra 0.750 kg | Acetic Acid |_ [RA may take appropriate action as per the decisionof Norms Committee. — [ [ease No.:94/8/82-ALC4/2014 No.:94/8/82-ALC4/2014 [Party Name-DORF-KETAL Name-DORF-KETAL (Meet No/Date:8/82- No/Date:8/82- (Status: CHEMICALS INDIA INDIA ALC4/2014 Approved : PVT.LTD. | 25.09.2014 : HQ File RLA File Lic.No/Date:03 10785334 10785334 [Defer Date: Date: 01/82/050/00758/AM15/ :03/94/040/00217/AMI5/ {13.06.2014 to. Decision : In the fight of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/176/2011-Ch. [I dated 07.10.2014, 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: |294 | Export product Ere | SIN. | import items Qty. Allowed 1165MS /YSSR SR 116S/SR11650 1102/SR [22 | WitbreakWitbreak DRIDRI90659045 —[ 0.020kg 3023 /SR 1104/SR 1182/YS SR 3 0.180 kg H 1147 Alkyldiphenyloxide Di | Containing 50% of MEG & 18% sulfonate / Calfax DB- 45 / of Alkyldiphenyloxide Dowfax 2A1 1 Disulphonate RA may take appropriate action as per the decision of Norms Committee. a ----- End of picture text -----

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----- Start of picture text ----- [ [ease No.:94/8/82-ALC4/2014 No.:94/8/82-ALC4/2014 [Party Name-DORF-KETAL Name-DORF-KETAL (Meet No/Date:8/82- No/Date:8/82- (Status: CHEMICALS INDIA INDIA ALC4/2014 Approved : PVT.LTD. | 25.09.2014 : HQ File RLA File Lic.No/Date:03 10785334 10785334 [Defer Date: Date: 01/82/050/00758/AM15/ :03/94/040/00217/AMI5/ {13.06.2014 to. ----- End of picture text -----

Case No.:22/8/82-ALC4/2014 |Party Name:HETERO LABS = /|Meet No/Date:8/82Status:Case : LIMITED ALC4/2014 Deferred — 25.09.2014 _ 295 |HQ File RLA File Lic.No/Date:09 10060438 |Defer :01/82/050/00686/AM15/ ——|:09/24/040/00146/AM15/ —|13.06.2014 Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals. [296 [Case No.:112/8/82-: [PartyName:STERLING [Meet No/Date:8/82- mr{StagusCase__ | ) Dy. Dir at we ‘h ay © 7 Mr OR PISS FIUDepariment of Conn ee Udyog Bhawan Were in,

ALC4/2014 AUXILIARIES PVT LTD ALC4/2014 Deferred | 25.09.2014 to. HQ File RLA File Lic.No/Date:03 10785313 |Defer :01/82/050/00776/AM15/ :03/95/040/001 14/AM15/ 13.06.2014 Date: 12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of C&PC.

‘Case No.:55/8/82-ALC 4/2014 iParty Name:VIJAYASRI Meet No/Date:8/82Status:Case ORGANICS LTD ALC4/2014 Deferred 297 |HQ File RLA File Lic.No/Date:09 10060445 |Defer :01/82/050/00719/AMI5/ | :09/24/040/00127/AMIS/ [13.06.2014 Date:12.11.2014 | |Decision : It was decided to defer the case for 12.11.2014 for comments of Department of | |Pharmaceuticals.

(Case No.:57/8/82-ALC4/2014 [Party Name:VIAYASRI [Meet No/Date:8/82Status: Case ORGANICS LTD ALC4/2014 Deferred 25.09.2014 ;
298 [HQ File RLA File {Lic. No/Date:09 10060444 [Defer :01/82/0S0/0072/AMIS/ ——|:09/24040/00128/AMI5/ —[13.06.2014 Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals. -
Case No.:152/6/82Party Name: MOREPEN Meet No/Date:8/82Status:Case ALC4/2014 LABORATORIES LTD., ALC4/2014 Deferred
|299 [HQ File | RLA File 25.09.2014Lic.No/Date:05 10388704 [Defer01/82/050/00554/AMI5/ ——:05/24/040/00133/AM15/ ——|16.06.2014 _ [Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals.
Case No.:154/6/82Party Name:MOREPEN [Meet No/Date:8/82_[Status:Case ALC42014 LABORATORIES LTD., ALC4/2014 Deferred [25.09.2014
| | _ /
300 |HQ File RLA File Lic.No/Date:05 10388703 [Defer :01/82/050/00556/AM15/ 205/24/040/00132/AM15/ 16.06.2014 _ |Date:12.11,2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals. -
Case No.:77/8/82-ALC4/2014 |Party Name:BENZO CHEM [Meet No/Date:8/82Status:Case INDUSTRIES PRIVATE ALC4/2014 Deferred LIMITED, 25.09.2014 . :
301 |HQ File RLA File Lic. No/Date:03 10785501 iDefer 01/82/050/00741/AMI15/ ——|:03/94/040/00196/AM15/ _|17.06.2014 Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of C&PC
[302 Case No.:30/8/82-ALC 4/2014 [Party Name:INDIAN _ [Meet No/Date:8/82 255 [gtatus:Case [gtatus:Case

_ [Meet No/Date:8/82 255 [gtatus:Case [gtatus:Case |iN icecton, au Trerf. exon rade Udyog Bhawan eee in,

TMMUNOLOGICALS LTD., |ALC4/2014 Deferred | HQ File RLA File - 25.09.2014Lic. No/Date:09 10060470; |Defer} | :01/82/050/00694/AM15/ —_—|:09/24/040/0013S/AM15/ _|17.06.2014 Date:12.11.2014 Decision ; It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals.

Case No.:98/8/82-ALC4/2014 (Party Name:IPCA Meet No/Date:8/82Status: LABORATORIES LIMITED (ALC4/2014 Approved 25.99.2014 HQ File RLA File Lic.No/Date:0310785500 |Defer Date: :01/82/050/00762/AM 1 5/ 103/94/040/00198/AM15/ 17.06.2014

Decision : Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/113/2013-Pl(Norms) dated 09.10.2014 and in consultation with technical authority present in meeting, decided to 303 |ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is

lower:-

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----- Start of picture text ----- Export Product Exp. S.No | Import Product Quantity Qty. Allowed kg/ke ----- End of picture text -----

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----- Start of picture text ----- RA may take appropriate action as per the decision of Norms Committee. ----- End of picture text -----

Case No,:72/8/82-ALC4/2014 |Party Name:PORUS Meet No/Date:8/82Status:Case LABORATORIES PVT LTD. |ALC4/2014 Deferred 25.09.2014 ft 304 HQ File RLA File Lic.No/Date:09 10060462 |Defer :01/82/050/00736/AM 15/ :09/24/040/00105/AM15/ 17.06.2014 Date: 12.11.2014

Decision : It was decided to defer the case for 12.11.2014 for comments of Department of _ |Pharmaceuticals.

Case No.:235/6/82Party Name:SHIVA Meet No/Date:8/82__[Status:Case ALC4/2014 PHARMACHEM LTD, ALC4/2014 Deferred 25.09.2014 305 JHQ File RLA File Lic.No/Date:34 10040261 |Defer :01/82/050/00637/AM15/ 134/24/040/00070/AM15/ 17.06.2014 Date: 12.11.2014

Decision : It was decided to defer the case for 12.11.2014 for comments of Department of |c&PC

—

Case No.:20/8/82-ALC4/2014 [Party Name:SRINI Meet No/Date:8/82_(Status:Case_ PHARMACEUTICALS ALC4/2014 Deferred LTD., 8 25.09.2014 7 306 jHQ File RLA File Lic. No/Date:09 10060467 |Defer Decision:01/82/050/00684/AM15/: It was decided to defer the_|:09/24/040/00139/AM15/ case for 12.11.2014{17.06.2014for comments_of Department ofDate:12.11.2014 hy . Decision + 1 . Su nafiaesyon Neraye eee zara re tratewae“e Udyog Bhawan Wess Dethi

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----- Start of picture text ----- Case No.:160/6/82- Party Name:ALCHEM Meet No/Date:8/82- Status:Case ; ALC4/2014 INTERNATIONAL LTD. ALC4/2014 Deferred . Q File RLA File 25.09.2014Lic.No/Date:05 10388783 |Defer. . :01/82/050/00562/AM15/ :05/23/040/00053/AM 15/ 18.06.2014 Date:12.11.2014 Decision : It was decided to remind the firm to furnish following technical details: ----- End of picture text -----

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

ii) Assay of Export Product iii) 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.

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----- Start of picture text ----- Case No.:19/8/82-ALC4/2014 |Party Name: HETERO LABS Meet No/Date:8/82- Status:Case LIMITED ALC4/2014 Deferred 25.09.2014 | 308 |HQ File RLA File Lic.No/Date:09 10060486 Defer | Decision:01/82/050/00683/AM15/: It was decided —|:09/24/040/00153/AM1S/to defer the case for 12.11.2014|18.06.2014for comments of DepartmentDate:12.11.2014of Pharmaceuticals. Case No.:167/6/82- Party Name:CLEAN Meet No/Date:8/82- Status: ] ALC422014 SCIENCE AND ALC4/2014 approved TECHNOLOGY PVT.LTD. 25.09.2014 HQ File RLA File Lic. No/Date:3 110064423 |Defer 01/82/050/00569/AM15/ —_|:31/83/040/0006S/AM15/ {19.06.2014 Date:12.11.2014 Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/3/2012-Ch. Il dated 07.10.2014, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, 309 whichever is less: ----- End of picture text -----

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----- Start of picture text ----- 310 ----- End of picture text -----

|| Export product Ex.Oty. | Sto. | import items Qty. Allowed b 99% PURITY 99% AND ABOVE , PURITY 60% PURITY 99% AND ABOVE RA may take appropriate action as per the decision of Norms Committee. Case No.:73/8/82-ALC4/2014 |Party Name:METROCHEM [Meet No/Date:8/82Status:Case API PVT. LTD. \ALC4/2014 Deferred 25.09.2014 [HQ File . RLA File Lic.No/Date:09 10060515 [Defer :01/82/050/00737/AM15/ :09/24/040/0015 1/AM15/ 19.06.2014 Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals.

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----- Start of picture text ----- | ----- End of picture text -----

||CaseNo.:224/6/82-<br>ALC4/2014|PartyName:SHIVA<br>PHARMACHEMLTD,|MeetNo/Date:8/82-<br>ALC4/2614<br>25.09.2014|Status:Case<br>Deferred<br>_|
|---|---|---|---|---|
|311||HQ File<br>:01/82/050/00626/AM15/|RLA File<br>:34/24/040/00069/AM15/|Lic.No/Date:34 10040285 <br>19.06.2014<br>—||Defer<br>Date:12.11.2014|

Decision : It was decided to defer the case for 12.11.2014 for comments of Department of C&PC.

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----- Start of picture text ----- . ----- End of picture text -----

|CaseNo.:109/8/82-ALC<br>4/2014||Party Name: YASHO|MeetNo/Date:8/82-|:|Status:|
|---|---|---|---|
|HQFile<br>:01/82/050/00773/AM15/|INDUSTRIESPVT.LTD.<br>RLAFile<br>:03/95/040/00229/AM15/|ALC4/2014<br>25.09.2014<br>Lic.No/Date:0310785600 <br>19.06.2014|Approved<br>-<br> :|DeferDate:|

Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/95/2011-Ch. I! dated 27.07.2014, it was decided to 312 jratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

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----- Start of picture text ----- | Export product Ere [SIN | import items Qty. Allowed | AROMATIC DERIVATIVE OF [| bipHenvcaMinE —~[oaa7ig DIPRENYLAMINE |2___factivatepciay ——[0.200kg RA may take appropriate action as per the decision of Norms Committee. ----- End of picture text -----

Case No.:96/8/82-ALC4/2014 iParty Meet No/Date:8/82Status:Case Name: ARIHANTANAM ALC4/2014 Deferred LIFECARE PVT. LTD. 25.09.2014 313 |HQ File RLA File Lic.No/Date:03 10785777 Defer :01/82/050/00760/AM15/ —j:03/94/040/00250/AM15S/ —|20.06.2014 Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals. -

Case No.:110/8/82Party Name:STERLING Meet No/Date:8/82Status:Case ALC42014 AUZXILIARIES PVT LTD ALC4/2014 Deferred ; 25.09.2014 314 |HQ File RLA File Lic. No/Date:03 10785727 |Defer :01/82/050/00774/AM15/ —_|:03/95/040/00208/AM15/ [20.06.2014 Date: 12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of C&PC.

Case No.:65/4/82-ALC4/2014 |Party Name:AUROBINDO Meet No/Date:8/82Status: PHARMA LIMITED ALC4/2014 Approved 25.89.2014 315 HQ File RLA File Lic.No/Date:09 10060521 |Defer Date: :01/82/050/003 13/AM15/ :09/24/040/00162/AM15/ 23.06.2614 - Decision : Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/1 20/26 24-P\Norms)

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----- Start of picture text ----- ;. o) dated 02.09.2014 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:- ----- End of picture text -----

| Export product Qty. Allowed | Kg/kg | Raloxifene Hel 4[24(1. | Piperidiny!)ethoxy]benzoicacid hydrochloride | 2(4-methoxy pheny!)61kg methoxy benzo(b)thiophene 0.88 | S| Dimethylformamide 0.045 aa Methanesulfonyl chloride 1.367 | fe _ [raion Triethylamine 1.206 _|RA concerned may take further necessary action as per above decision of NC. Case No.:85/8/82Party Name:ORION CHEM [Meet No/Date:8/82Status:A pproved ; ALC4/2014 PVT.LTD. ALC42014 HQ 25.09.2014 File RLA File Lic.No/Date:03 10785844 |Defer 01/82/050/00749/AMI5/ _{:03/95/040/00237/AM15/ {23.06.2014 -fDate:12.11.2014 Decision : In the fight of written comments received from Department of Chemicals and [316 Petrochemicals vide their U.O No. 14010/10/2013-Ch. {1 dated 20.05.2013, 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: Qty. 2,3 DIMETHYL 2,3 DINITRO 1 1 1.20 Sere OTTO [ks |S Panamera [20 RA may take appropriate action as per the decision of Norms Committee. Case No.:233/6/82Party Name:SHIVA Meet No/Date:8/82[Status:Case ALC4/2014 PHARMACHEM LTD, ALC4/2014 Deferred 317 25.09.2014 hQ File RLA File Lic.No/Date:34 10040299 [Defer :01/82/050/00635/AM15/ :34/24/040/00078/AM1 Sf 23,06.2014 Date:12.11.2014 [Decision : It was decided to defer the case for 12.11.2014 for comments of OfIRMaL bd Mar i faeer enn of Foreign Te, Crate iv ei. erp Berry ent of Commer, Udyog Bhawan S,Resne

| (capc: | wd Case No.:230/6/82Party Name:SYMBIOTEC [Meet No/Date:8/82_(Status:Case ALC4/2014 PHARMALAB LTD., ALC4/2014 Deferred | 4 . 25.09.2014 318 {HQ File RLA File Lic.No/Date:56 10004310 |Defer 01/82/050/00632/AM15/ ——|:56/24/040/00010/AMIS/ ——|[23.06.2014 ~ {Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals. ; [7 [Case No.:111/8/82-~—~”~*(Party Name: THING Meet No/Date:8/82__[Status:Case ALC4/2014 PHARMA-CRO LIMITED ALC4/2014 Deferred . 25.09.2014 ; 319 |HQ File RLA File Lic.No/Date:03 10785804 |Defer | |:01/82/050/00775/AM15/ —|:03/95/040/00178/AMI5/ ——|23.06.2014 —— [Date:12.11.2014 Decision : it was decided to call from the firm the complete technical details as per Appendix 33. The case was deferred for 12.11.2014 . Case No.:97/8/82-ALC4/2014 jParty Name:ARIHANTANAM Meet No/Date:8/82‘{Status: LIFECARE PVT. LTD. ALC4/2014 |Approved 25.09.2014 . HQ File RLA File Lic.No/Date:03 10785923 ‘|Defer Date: :01/82/050/00761/AM15/ :03/94/040/00262/AM 1S/ 24.06.2014 Decision : in the fight of earlier decision taken in meeting no. 6/82 dated 29.08.2014, and in . 32 ofconsultation HBP v1 as with per details technical given authority below or (O/o as applied Pharmaceuticals) by the firm,it whichever was decidedis less: to ratify norms under Para 4.7 0 A ¢. : =< EE =. Lumefantrine ikg [1. 2,7-Dichloro A- 0.8693 kg (Dibutylamino) Methyl -9 H-fluoren-4- Methanol ; (DBA) RA may take appropriate action as per the decision of Norms Committee. Case No.:104/8/82Party Name:IPCA Meet No/Date:8/82[Status:Case ALC42014 LABORATORIES LIMITED |ALC4/2014 Deferred . . 25.09.2014 7 321 [HQ File RLA File Lic.No/Date:03 10785909 (Defer :01/82/050/00768/AM15/_|:03/94/040/00219/AMI5/ {24.06.2014 Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals.

7 Case No.:107/8/82Party Name:LUPIN LIMITED Meet No/Date:8/82Status:Case ALC4/2014 ALC4/2014 Deferred 322 25.09.2014 : He File RLA File Lic.No/Date:03 10785907 |Defer | :01/82/050/0077 1/AM15/ :03/95/040/00244/AM i5/ 24.06.2014 Date: 12.11.2014 ST FerfeenPa ‘ = AAIyy. TAL EUM‘MAR Udyog Bhawan No Doin

oan Decision : It was decided to defer the case for 12.11.2014 for comments of Department of | [|Pharmaceuticals.] - ; ~ [Case No.:170/6/82- ~ Party Name:SOFTGEL Meet No/Date:8/82_[Status:Case ALC4/2014 HEALTH CARE PVT. LTD., |ALC4/2014 Deferred [25.09.2014 _
1323,/HQ File RLA File Lic.No/Date:04 10158822 |Defer :01/82/050/00572/AM15/ —_|:04/24/040/00032/AM15/ pic Noa pete 1.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals. ; Case No.:231/6/82Party Name:ALEMBIC Meet No/Date:8/82Status:Case ALC4/2014 PHARMACEUTICALS LTD |ALC4/2014 Deferred _ | 25.09.2014 7 .
324:|HQ:01/82/050/00633/AM15/ File RLA:34/24/040/00055/AM15/ File 25.06.2014Lic.No/Date:34— 10040310 Def{Dat e :r 12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of
| |Pharmaceuticals.
- Case No.:87/6/82-ALC4/2014 (Party Name:DIVIS Meet No/Date:8/82|Status:Case LABORATORIES LTD., ALCA2614 Deferred
- 1325 . 25.09.2014 : [HQ File RLA File Lic.No/Date:09 10060537 (Defer :01/82/050/00489/AM15/ _|:09/24/040/00149/AMI5/ _|25.06.2014 _ Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals.

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----- Start of picture text ----- Case No.:89/6/82-ALC4/2014 [Party Name:DIVIS ~ [Meet No/Date:8/82- (Status:Case LABORATORIES LTD., ALC4/2014 Deferred [25.09.2014 1326 |HQ File IRLA File Lic.No/Date:09 10060536 |Defer :01/82/050/00491/AMI15S/ —_|:09/24/040/00150/AM15/ _ [25.06.2014 Date: 12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals. ; Case No.:32/8/82-ALC4/2014 [Party Name:SRIAM LABS {Meet No/Date-B82e ISintuaxCanz PRIVATE LIMITED ALC4/2014 Deferred - ; 25.09.2014 ; 327 (HQ File RLA File Lic.No/Date:09 10060539 |Defer :01/82/050/00696/AM15/ __|:09/24/040/00141/AMI5/ [25.06.2014 Date:12.11.2014 | Decision : It was decided to defer the case for 12.11.2014 for comments of Department of |Pharmaceuticals. ----- End of picture text -----

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----- Start of picture text ----- Case No.:108/8/82- Party Name:SURVIVAL Meet No/Date:8/82- Status:Case 328 ALC4/2014 TECHNOLOGIES PVT.LTD. 25.09.2014|ALC4/2014 Deferred HQ:01/82/050/00772/AM15/ File |:03/95/040/00214/AMI5/RLA File [25Lic . 06.2014No/Date:03 10786023,|Date:12.11.2014|Defer ih R/NIR © irectora saa Terre Trade ser Nt Of Commerce Udyog BhawanRee ----- End of picture text -----

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----- Start of picture text ----- A Decision : It was decided to defer the case for 12.11.2014 for comments ofDepartment of C&PC. ----- End of picture text -----

Case No.:232/6/82Party Meet No/Date:8/82Status: ALC4/2014 (Name:JAINEX SPECIALITY CHEMICA jALC4/2014 approve [HQ File RLAL File :34/24/040/00079/AM15/a Lic.No/Date:3410040315.09.2014 qd[Defer : :01/82/050/00634/AMI5 7 Date: 32 Decision : In the light of written comments received from Department of Chemicals and ? Ipetrochemicals vide their U.O No. 14010/ /2013-Ch. il dated .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: J Qty. [cacctomporyeate Tikg |i [purvricaap =i SS {RA may take appropriate action as per the decision of Norms Committee. . Case No.:52/8/82-ALC4/2014 |Party Name:LAKE Meet No/Date:8/82Status: Case CHEMICALS PRIVATE ALC4/2014 Deferred 330 |HQ File RLA File Lic.No/Date:0710105418:|[Defer 01/82/050/00716/AMIS/ —|:07/24/040/00096/AM15/ [26.06.2014 Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals. .

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----- Start of picture text ----- . 7 Case No.:80/8/82-ALC4/2014 Party Name:PREGNA Meet No/Date:8/82- Status:Case INTERNATIONAL LTD. ALC4/2014 Deferred 331 |HQ File | RLA File | 25.09.2014Lic.No/Date:03 10786143 |Defer; :01/82/050/00744/AMI5/ |03/95/040/00250/AMI 5/ [27.06.2014 Decision —— Date:12.11.2014 Division : It was decided to defer the case for 12.11.2014 for comments of Petrochemical of Department of C&PC _ Case No.:225/6/82- Party Name:SOLARIS- Meet No/Date:8/82- Status: ALC4/2014 CHEMTECH INDUSTRIES /ALC4/2014 Approved . LTD. ; 25.09.2014 HQ File RLA File Lic.No/Date:34 10040320 |Defer. Date: :01/82/050/00627/AM15/ _|:34/24/040/00066/AMI5/ 7,06.2014 7 Decision : In the light of written comments received from Department of Chemicals and 332 [Petrochemicals vide their U.O No. 14022/2/2014-Ch. II dated 10.10.2014, 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: ETHYL-2-BROMOBUTYRATE Qty. Lenvczmromosurnarey | 4 N-BUTYRICACID ['@ |? | NpunyRICAGD” [oi IL Dy, Breck Rene faSet cara® Dire, earaTE 7TETPrevinae WPAUdyog RaDepariment Bree oeDonade ----- End of picture text -----

7 :

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----- Start of picture text ----- [C6H11BrO2] ETHYL [ESTER)] | RAfits TT [TT] : may take appropriate action as per the decision of Norms Committee. Case No.:219/6/82- Party Name: UNICHEM Meet No/Date:8/82- Status:Case ALCA72014 LABORATORIES LIMITED |ALC4/2614 Deferred 333 {HQ:01/82/050/00621/AM15/ File RLA_|:03/95/040/00221/AM15/ File —_([27.06.201425.09.2014Lic.No/Date:03 10786118Pet|Defer7 11.204 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals. Case No.:199/6/82- Party Name:H.J.AROCHEM [Meet No/Date:8/82- (Status:Case ALC4/2014 PVT. LTD., ALC4/2014 Deferred 25.09.2014 334 |HQ File RLA File Lic.No/Date:08 10132520- |Defer| :01/82/050/0060VAMI5/ :08/24/040/00569/AM 14/ 30.06.2014 Date:12.11 2014 C&PC.Decision : It was decided to defer the case for 12.1 1.2014 for comments of Department of ; Case No.:28/8/82-ALC4/2014 Party Name:PORUS Meet No/Date:8/82- Status: LABORATORIES PVT LTD. ALC42014 Apporved HQ ‘25.09.2014 File RLA File Lic.No/Date:0910060554 [Defer 101/82/050/00692/AM15/ :09/24/040/00129/AM15/ 30.06.2014 Date: 12.11.2014 Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/33/2013-Ch. 1) dated 15.09.2014, it was decided to whicheverratify normsis less:under Para 4.7 of HBP v1 as per details given below or as applied by the firm, 335 ||| [tem of Export aty. Item of import Quantity || 2-Phenyl-3,3-Bis(4-Hydroxy ikg | 1. Phthalic 0.927allowed k kg/kg Phenyl) Phthalimide (PPPBP) Anhdydride wet Xs 3. | Zine Chloride 0.546 kg [ RA may take appropriate action as per the decision of Norms Committee. Case No.:212/6/82- Party Name:RAY [Meet No/Date:8/82- [StatassGase 1336 ALC4/2014 CHEMICALS PRIVATE ALC42014 Deferred luo File RLALIMITED, File Lic.No/Date:0725.09.2014 10105469 Defer :01/82/050/00614/AM15/ :07/24/040/00098/AM15/ 30.06.2014 late: : tkJNar wa FET eres PYAR arate Dy. Director Generat ot Fureign Trade feet equre treifaaenend Directorate General of Foreign Trade aifiisa fHrvDepartment of Commerce Sarl was, ag fees Udyog Bhawan, New Dethi ----- End of picture text -----

a) Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals. -

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|||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|Case|[Nou?]|226/8/82-ALC4/2014 (Party|Name:SUVEN|LIFE|_—_[Meet No/Date:8/82|Status:|
|SCIENCES LIMITED|ALC4/2014|Deferred|
|25.09.2014|;|
|»°7|HQ File:|RLA Filei|Lic.No/Date:i|0910060553||Defer|
|:01/82/050/00690/AM15/|Ra|SOO|73/AMLSY|Piety|||: Pete|a 112014|
|Decision|:|It|was|decided|to|defer|the|case|for|12.11.2014|for|comments|of Departments|of|
|Pharmaceuticals.|
|Case No.:210/6/82-|Party|Name:|WEXFORD|Meet No/Date:8/82-|Status:Case|
|ALC4/2014|LABORATORIES P LTD|ALC4/2014|Deferred|
|||25.09.2014|.|
|338||HQ:01/82/050/006 File|12/AM15/|RLA:07/24/040/00105/AM15/ File|Lie30.06.2014NoyDate:0710105465|DefDat|e|:r 12.11.2014|
|Decision|:|It|was|decided|to|defer|the|case|for|12.11.2014|for|comments|of|Department|of|
|Pharmaceuticals.|

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|||||||
|---|---|---|---|---|---|
|Case No.:202/6/82-|Party Name:FORACE|||Meet No/Date:8/82-|Status:Case|
|.|ALC42014|POLYMERS (P) LTD.|ALC4/2014|Deferred|
|||25.09.2014|
|339|HQ File|RLA|File|Lic.No/Date:05 10389232||Defer|
|:01/82/050/00604/AM 1 5/|:05/23/040/00139/AMI15/|01.07.2014|Date:12.11.2014|

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Decision : It was decided to defer the case for 12.11.2014 for comments of Petrochemical ___ [Division of Department of C&PC

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||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|~|[Case No.:95/8/82-ALC4/2014|{Party Name:RIOCARE INDIA|[Meet No/Date:8/82.|(Status:|
|PRIVATE LIMITED.|ALC42014|Approved|
|25.09.2014|
|HQ|File|RLA|File|Lic.No/Date:0310786223||Defer Date:|
|:01/82/050/00759/AM15/|:03/95/040/00228/AM15/|01.07.2014|;|
|Decision|:|Committee|considered|the|case|as|per|agenda|and|in|light|of|written|comments|
|received|from|Department|of|Pharmaceuticals|vide|their OM|No.|35011/635/2013-Pl(Norms)|
|||{dated|02.09.2014|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:-|

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340

Export Product Simethicone (3 Export Item)

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||||||||
|---|---|---|---|---|---|---|
|Export|product|Qty. Allowed|
|1|kg|Export|Product|
|i|r|:|3|
|Simethicone|100% USP or BP|Silicone Fluid / Oil of|0.96 kg/kg|
|relevant Viscosity|
|2|Simethicone Emulsion USP|relevantSilicone Fluid Viscosi / Oily|of|0.288 kg/kg|’|\|
|SAR /NIRMAUIKUMAR|
|Monkrector Tareonora srerpaSererafe)|S Cre|oan|
|aaiftisa fearvOepanmentof emo|
|Udyog Bhawan|hes|Delhi|

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----- Start of picture text ----- * ----- End of picture text -----

, — Dimethicone USP or BP or EP Silicone Fluid / Oi of | 1.01 kg/kg arious Viscosi relevant Viscosi

RA concerned may take further necessary action as per above decisionofNC.

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se No.:62/8/82-ALC4/2014 [Party Name:ADCOCK Meet No/Date:8/82-__[Status:Case Case No. INGRAM LTD, ALC4/2014 Deferred 25.09.2014 341 [HQ:01/82/050/00726/AM15/ File RLA:07/24/040/001 File 11/AM15/02.07.2014Lic.No/Date:07 10105491 PeterDate:12.11.2014: Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals.

Case No.:29/8/82-ALC4/2014 Party Name:DIVIS Meet No/Date:8/82Status:Case PHARMACEUTICALS ALC4/2014 Deferred PRIVATE LIMITED 25.09.2014 Oo 342 }HQ File RLA File JLic.No/Date:09 10060578 |Defer :01/82/050/00693/AM15/ :09/24/040/00181/AM15/ 04.07.2014 Date:12.11.2014

| Decision ; It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals.

Case No.:83/8/82-ALC4/2014 Party Name:MANGALAM __ [Meet No/Date:8/82Status:Case ORGANICS LIMITED ALC42014 Deferred 343 |HQ File (FORMERLYRLA File DUJODWALA {25.09.2014Lic.No/Date:03 107864 18./Defer| 0 1/82/050/00747/AM 15/ :03/95/040/00109/AM 15/ 04.07.2014 Date: 12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals. ; Case No.:61/8/82-ALC4/2014 |Party Name:PAYAL Meet No/Date:8/82Status: PETROCHEM PRIVATE ALC4/2014 approved LIMITED . 25.09.2014 HQ File RLA File Lic.No/Date:0510389377 |Defer Date: :01/82/050/00725/AM15/ :05/24/040/00143/AM15/ 04.07.2014 :

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----- Start of picture text ----- Decision : in the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/18/2011-Ch. Il dated 28.05.2014, it was decided to : ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, 344 |whichever is less: | Export product xe | SINS. | Qty. allowed | Di-Octiyl Tetraphthlate 1kg 1 Pure Tere Phthalic Acid | 0.447 kg 1 (DOTP) RA may take appropriate action as per the decision of Norms Committee. ----- End of picture text -----

[345 [Case No.:18/8/82-ALC4/2014 [Party Name:RA CHEM

_ [Meet No/Date:8/82- By Sa iS Reg aaCUSAL off ereionUhTrad, Directoraty oS enter ye * New Deihi

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||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|i|PHARMA LIMITED|ALC42014|Deferred|
|HQ File|RLA File|_|{25.09.2014Lic.No/Date:09 10060577||Defer|-|
|:01/82/050/00682/AM1S/|__|:09/24/040/00176/AM15/|04.07.2014|—|[Date:12.11.2014|
|Decision|:|It|was|decided|to|defer|the|case|for|12.11.2014|for|comments|of Department|of|
|Pharmaceuticals.|

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----- Start of picture text ----- Case No.:218/6/82- [Party Name:UNICHEM Meet No/Date:8/82-[Status:Case ALC4/2014 LABORATORIES LIMITED |ALC4/2014 Deferred 25.69.2014 346 |HQ File RLA File Lic.No/Date:03 10786466 |Defer- :01/82/050/00620/AM15/ :03/95/040/00246/AM15/ 07.07.2014 Date:12.11 2014 | |Decision : It was decided to defer the case for 12.11.2s014 for comments of Department of Pharmaceuticals. Case No.:23/8/82-ALC4/2014 Party Name:ADCOCK Meet No/Date:8/82- Status: Case INGRAM LTD, ALC4/2014 Deferred . [25.09.2014 347 [HQ File RLA File Lic.No/Date:0710105575 [Defer. 01/82/050/00687/AM 1S/ :07/24/040/00120/AM15/ 08.07.2014 Date:12.] 1.2014 Decision : It was decided to defer the case for 12.11.28014 for comments of Department of Pharmaceuticals. . . Case No.:17/8/82-ALC4/2014 Party Name:GLAND Meet No/Date:8/82- (Status: PHARMA LIMITED ALC42014 Approved HQ 25.09.2014 File RLA File Lic.No/Date:0910060614 [Defer Date: :01/82/050/00681/AM15/ ‘09/24/040/00174/AMI5/ [08.07.2014 Decision : Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/53/2014-PI(Norms) dated .2014 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:- Export Product : Adenosine Injection USP Prefilled Syringe 3mg/ml, 4m! in a PFS 348| [SiNo. Import Item Norms As per Central Batch Lowest of e3) Applied Excise Logsheet (2) to (4) (2) Certificate (4) Adenosine 3 0.0132 N.A. NIL 0.0132 -2[ Barrel Syringes (Glass) | 1.28gm/vial Nos| 1.1095} Nix] 1.1095om/vial Nos. V-OVS 10.6 Tip Caps 1.2942 1.03 Nos. NIL 1.03 Nos. |4___| Plastic Nos. -3___| Plunger Stoppers (Rubber | 1.28Nos. [| Li4st [NIL] 1.1481 Nos) [6 | PlungerFilters (Plastic)Rods (Plastic) [1.08 Nos.[ Consumable,1.03 Nos, on| Net toNIL Net basis| 1.03 Nog [8| [Reference] [Standards] : __ Ste Set) S<UMAR Oy Director Coney ot Learm DiecrenagITe setae ade arg RTYDeparmen ee? Trade Uayod Bia, He pacommerce yog Bhawan tyes Dein ----- End of picture text -----

%

; In accordance with the earlier dicisions of Norms-Committee, present case may be considered specific to USFDA project and Export to USA only.

‘|RA may take appropriate action as per the decision of Norms Committee. — Case No.:76/8/82-ALC4/2014 Party Name:KARNATAKA Meet No/Date:8/82Status:Case ANTIBIOTICS & ALC4/2014 Deferred PHARMACEUTICALS 25.09.2014 LTD., 349 ; THQ01/82/050/00740/AM15/ File RLA—_—|:07/24/040/00119/AM15/ File [eXLic.No/Date:0710105576 Pete[Defer 1.2014 Decision : It was decided to defer the case for 12.11.2s014 for comments of Department of Pharmaceuticals.

;

| [Case No.:84/8/82-ALC4/2014 [Party Name:NAPROD LIFE [Meet No/Date:8/82[Status:Case SCIENCES PVT. LTD. ALC4/2014 Deferred 25.09.2014 350|:01/82/050/00748/AM15/[HQ File RLA—|:03/95/040/00258/AM15/File —|08.07.2014Lic.No/Date:03 10786556dtPet|Defer 1.2014a Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals. . : 7 Case No.:207/6/82Party Name: VARUN ~ [Meet No/Date:8/82Status:Case ALC4/2014 MEDIMPEX INC. ALC4/2014 Deferred (25.09.2014 351 |HQ File RLA File _ Lic.No/Date:05 10389445 |Defer:01/82/050/00609/AMIS/ _|:05/24/040/00136/AM15/ [08.07.2014 _ |Date:20,10.2014

Decision : It was decided to discuss the comments received from Petrochemical Division ofDepartment ofC&PC. The case is deferred for 20.10.2014.

Case No.:78/8/82-ALC4/2014 [Party Name:BALAJI AMINES [Meet No/Date:8/82. [Staras: LIMITED ALC4/2014 Approved HQ 25.09.2014 ae File RLA File Lic.No/Date:3 110064540 Defer Date: | — |:01/82/050/00742/AM15/ 31/83/040/00074/AM15/ [09.07.2014 - Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/122/2011-Ch. It 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, whichever is less:

==> picture [491 x 191] intentionally omitted <==

| [RA may take appropriate action as per the decision of Norms Committee . | Case No.:21/8/82-ALC4/2014 [Party Name: MYLAN Meet No/Date:8/82__[Status:Case ; LABORATORIES LIMITED |ALC4/2014 Deferred . [25.09.2014 353 [HQ File RLA File Lic.No/Date:09 10060632 [Defer 7 :01/82/050/00685/AM15/ :09/24/040/00134/AM15/ 09.07.2014 Date:12.1 1.2014 Decision : It was decided to defer the ease for 12.11.2014 for comments of Department of Pharmaceuticals. . (Case No.:31/8/82-ALC4/2014 Party Name MYLAN” Meet No/Date:8/82[Status:Case LABORATORIES LIMITED ALC4/2014 Deferred 25.09.2014 354 |HQ File RLA File Lic.No/Date:0910060631 [Deferoe | 01/82/050/00695/AM1S/ :09/24/040/00168/AM 15/ 09.07.2014 Date: 12.11.201 4 |Decision ; It was decided to defer the ease for 12.11.2014 for comments of Department of _|Pharmaceuticals. . Case No.:53/8/82-ALC4/2014 Party Name:ALEMBIC Meet No/Date:8/82Status:Case PHARMACEUTICALS LTD ALC4/2014 Deferred 25.09.2014 355 HQ File RLA File Lic.No/Date:34 10040353 [Defer/ OUB2IOSOMOTIT/AMIS/ _|:34/24/040/00090/AM15/ 10.07.2014 Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of ___ |Pharmaceuticals. ;

(Case No.:193/6/82. Party Name:MOREPEN [Meet No/Date:8/82(Status; Case ALC42014. LABORATORIES LTD., ALC4/2014 Deferred . 25.09.2014 ; 356 [HQ File RLA File Lic.No/Date:05 10389651 [Defer 7 *01/82/050/00595/AM15/ __|:05/24/040/00144/AM15/ {11.07.2014 Date: 12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals. ;

Case No.1194/6/82. Party Name: MOREPEN Meet No/Date:8/82[Status:Case ALC4/2014 LABORATORIES LTD., ALC4/2014 Deferred , 25.09.2014 357 |HQ File RLA File Lic.No/Date:05 10389654 [Defer. OUB2/050/00S96/AM15/ __|:05/24/040/00147/AMI5/ {11.07.2014 Date:12.11.2014 Pharmaceuticals.Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Case No.:196/6/82Party Name: MOREPEN eet No/Date:8/82Status: ALC4/2014 LABORATORIES LTD., ALC4/2014 Approved 358 25.09.2014 . [HQ File RLA File Lic.No/Date:05 10389653 [Defer Date: :01/82/050/00598/AM15/ :05/24/040/00146/AM15/ 11.07.2014 [Decision ; Committee considered the case as per agenda and in flight of written commentsTE NIE MAL tha fRrep aque wedaeeiccg Directorate General of Foran trade arr fPTVOepanment of Commerce vert war, ag feo Udyog Bhawan, New Dethi

|received from Department ofPharmaceuticals videtheirOM No. 35011/146/2014-P\(Norms)<br>dated 09.10.2014andinconsultationwith technicalauthoritypresentinmeeting, decidedto<br>ratifynormsunderpara 4.7ofHBPasperdetailsgivenbeloworasappliedbyfirmwhicheveris<br>lower:-|
|---|
|| Exportproduct<br>Ee |StNe-]<br>Qty.Allowed<br>Q<br>Kg/kg<br>|<br>8-Chloro-1I-Hid<br>N<br>1<br>3-chlorobenzyl<br>|<br>Oro-1<br>1-H roxy-N-<br>id<br>1.82<br>| Methy! Piperidino<br>cyanide|
||<br>3<br>N,N-Dimethy!|
|carbomy!chloride<br>2.233<br>!<br>4<br>N,N-Dimethy!<br>|<br>formamide<br>0.05|
|a|
|[eesti|
|RAconcemedmaytakefurthernecessary actionasperabovedecision ofNC.|
|.|
|CaseNo.:198/6/82-<br>PartyName:MOREPEN<br>MeetNo/Datei®/@2. ~~ [StatassGaze<br>ALC42014<br>LABORATORIESLTD.,<br>ALC4/2014<br>Deferred<br>25.09.2014|
|359./HQFile<br>RLAFile<br>Lic.No/Date:05 10389652. |Defer<br>:01/82/050/00600/AM15/<br>:05/24/040/00145/AM15/<br>11.07.2014<br>Date:12.112014<br>Decision : It was decided to defer the case for 12.11.2014 for comments ofDepartment of<br>Pharmaceuticals.|

Case No.:85/5/82Party Name:S M S Meet No/Date:8/82Status: ALC4/2014 PHARMACEUTICALS 12014 Approved HQ . LTD 25.09.2014 | File RLA File Lic.No/Date:09 10060654 [Defer :01/82/050/00402/AM15/ |:09/24/040/00185/AM15/ |1] 07.2014 Date:12.11.2014 Decision : In the light of earlier decision taken by NC in its 3/82 meeting dated 02.05.2013, it 360 [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. [SiNo. | importitems | @iy. allowed] | 1. {5)-5-chloro-alpha-{cyclopropy! 0.987 kg ethylyl)-2-amino-alpha-{trifluoro methyl) benzene methanol RA may take appropriate action as per the decision of Norms Committee. _ BTR NIRN Ve Diraan Gonna oe earare eCtorate Ga Tear Tey Trade ofr FrrD6., ei otMeNtnee oteignOf Comme, Tras'e

Ay

Case No.:14/8/82-ALC4/2014 [Party Name:SATYA Meet No/Date:8/82__[Status:Case DEEPTHA ALC4/2014 Deferred . PHARMACEUTICALS LTD [25.09.2014 361 |HQ File RLA File Lic.No/Date:09 10060653 |Defer :01/82/0S0/00678/AM15/ —_:09/24/040/00191/AMI5/ _[11.07.2014 Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals.

==> picture [452 x 99] intentionally omitted <==

----- Start of picture text ----- ~ [Case No.:36/8/82-ALC4/2014 [Party Name:RA CHEM Meet No/Date:8/82-___[Status:Case PHARMA LIMITED ALC4/2014 Deferred 362 |HQ File RLA File 7 25.09.2014Lic.No/Date:09 10060661 |Defer :01/82/050/00700/AM15/ :09/24/040/00198/AM 15/ 14.07.2014 Date: 12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals. ----- End of picture text -----

Case No.:27/8/82-ALC4/2014 |Party Name:SHILPA Meet No/Date:8/82(Status:Case MEDICARE LTD., ALC4/2014 Deferred 25.09.2014 .
363 [HQ File RLA File Lic.No/Date:07 10105736 [Defer :01/82/050/00691/AMI5/ _|:07/24/040/00144/AM15/ _|15.07.2014 Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals.

==> picture [452 x 101] intentionally omitted <==

----- Start of picture text ----- Case No.:200/6/82- Party Name:PANACEA [Meet No/Date:8/82- [Status:Case ALC42014 BIOTEC LTD., ALC4/2014 Deferred (25.09.2014 364 |HQ File RLA File Lic.No/Date:05 10389734 |Defer| | :01/824050/00602/AM15/ :05/24/040/00168/AM15/ 16.07.2014 Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Petrochemical Division of Department ofC&PC. ----- End of picture text -----

Case No.:214/6/82Party Name:ALCHYMARS [Meet No/Date:8/82. (StatussCase ALC4/2014 ICM SM PRIVATE LIMITED |ALC4/2014 Deferred - 25.09.2014
365 |HQ File IRLA File Lic. No/Date:04 10159026 [Defer . :01/82/050/00616/AM15/ :04/24/040/00067/AM 15/ 18.07.2014 Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals,
Case No.:124/8/82-ALC4/2014 Party Name:BALAJI AMINES [Meet No/Date:8/82Status: LIMITED ALC4/2014 Approved 25.09.2014
366 |HQ File RLA File Lic.No/Date:3 110064568 |Defer Date: :01/82/050/00788/AM1 5/ :31/83/040/00077/AM 15/ 18.07.2014

Decision : in the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/122/2011-Ch. il dated 25.08.2014, it was.decided to

= A AoClorate Generan ti! freer TP rey fomypeDamee ofan Trada

ratify norms under Para 4.7 of HBP vi as per details given below or as applied by the firm, whichever is less:

==> picture [432 x 73] intentionally omitted <==

----- Start of picture text ----- | Export product Exp. Qty. Allowed Qty. RAGANMABUTYROLACTONE Ti kg [i[2 |iaBUTANEDIOL|caLcatatyst| [0.00164g kg may take appropriate action as per the decision of Norms Committee. ----- End of picture text -----

; Case No.:59/8/82-ALC4/2014 [PartyName-GLOBAL Meet No/Date:8/82‘Status: CALCIUM PRIVATE ALC4/2014 Approved _ LIMITED, 25.09.2014 HQ File RLA File Lic.No/Date:0710105911 |Defer Date: :01/82/050/00723/AM15/ :07/24/040/001 13/AM15/ 18.07.2014 Decision : In the light of written comments received from Department of Chemicals and 367 Petrochemicals vide their U.O No. 14010/56/2011-Ch. II dated 22.05.2012, it was decided to lratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

==> picture [338 x 42] intentionally omitted <==

----- Start of picture text ----- | CALCIUM GLUCONATE - 1kg CALCIUM GLUCONATE - POWDER GRANULAR RA may take appropriate action as per the decision of Norms Committee. ----- End of picture text -----

[~ |Case No.:41/8/82-ALC4/2014 [Party Name:R L FINE CHEM [Meet No/Date8/82. [Statues Case ALC4/2014 Deferred 368 [HQ File | RLA File | Lic.No/Date:071010588325.09.2014 |Defer. 0 1/82/050/00705/AM15/ :07/24/040/00130/AM15/ 18.07.2014 Date: 12.11.2014

Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals.

"Case No.:60/8/82-ALC4/2014 [Party Name:R L FINE CHEM [Meat Nolbate/8aISmtansCace ALC4/2014 Deferred . . 25.09.2014 . 1369 |HQ File RLA File Lic.No/Date:0710105849 |Defer 01/82/050/00724/AMI5/ —_|:07/24/040/00129/AMI5/ _|18.07.2014 — — [Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of. Pharmaceuticals.

Case No.:69/8/82-ALC4/2014 |Party Name:DEEPAK Meet No/Date:8/82Status:Case ITRITE LIMITED ALC4/2014 Deferred 25.09.2014 . 370 |HQ File RLA File Lic. No/Date:34 10040383 (Defer :01/82/050/00733/AMI5/ -34/24/040/00083/AM iy/ 21.07.2014 Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of C&PC. Oy Din Eersy PreCKana fae pare Speers a rade aysqDirectorate Genoat ot t Gren tal Prvoepartment of Communes Udyog Bhawan Neer on,

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----- Start of picture text ----- | {Case No.:70/8/82-ALC42014 [Party Name:SHANPAR |Meat NoDasa/Ga— Status:Case | INDUSTRIES PVT. LTD. JALC4/2014 Deferred 371 |JHQ File RLA File Lic.No/Date:34 10040385 [Defer *01/82/050/00734/AM15/ —|:34/24/040/00097/AM15/ 21.07.2014 Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments ofDepartment of C&PC. |  Case No.:103/8/82- [Party NamesIPGA ~ [Meet No/Date:8/82- ~~ (Status:Caso ALC4/2014 . LABORATORIES. LIMITED ALC42014 Deferred 372 : 25.09.2014 | |HQ File RLA File Lic.No/Date:03 10787202 [Defer :01/82/050/00767/AMI15/ :03/94/040/00230/AM 1S/ (22.07.2014 Date:12.11.2014 | _ Decision : It was decided to defer the case for 12.11.2014 for comments of Department of |Pharmaceuticals. . ----- End of picture text -----

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----- Start of picture text ----- . . Case No.:2/6/82-ALC4/2014 [Party Name:SOFTGEL [Meet No/Dale-@/83- Status:Case HEALTH CARE PVT. LTD., |ALC4/2014 Deferred 25.09.2014 373 IHQ File RLA File Lic.No/Date:0410159058 [Defera ON/B2/050/00404/AM1S/ |:04/24/040/00031/AMI5/ 22.07.2014 | Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals.s | | | Case No.:71/8/82-ALC4/2014 [Party NamecALEMBIC Meet No/Date:8/82- [Status:Case PHARMACEUTICALS LTD ALC42014 Deferred 3741HQ File RLA File Lic.No/Date:34 10040394: Defer ‘01/82/050/00735/AMI5/|:34/24/040/00099/AMI5/_ 23.07.2014 Date:12.11.2014 | _ Decision : It was decided to defer the case for 12.11.2014 for comments of Department of |Pharmaceuticals. 7 : [Case No.13/6/82-ALCa/n014 Party Name:CADILA Meet No/Date:8/82- ~~ [Status:Case | HEALTHCARE LTD., ALC42014 Deferred | (25.09.2014 375 |HQ File RLA File Lic.No/Date:0810132790 [Defer | *01/82/050/00405/AM15/ —|:08/24/040/00165/AMI5/ 23.07.2014 Decision | Date:12.11.2014 : It was decided to defer the case for 12.11.2014 for comments of Department of |Pharmaceuticals. ; (Case No.:5/6/82-ALC4/2014 Party Name:COVALENT Meet No/Date:8/82- Status:Case ” LABORATORIES PRIVATE ALC4/2014 Deferred LIMITED 25.09.2014 376 |HQ File RLA File Lic.No/Date:09 10060728 (Defer | FOU/E2/0S0/00407/AMIS/ _|:09/24/040/00195/AM15/ 24.07.2014 Date: 12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals. Prefs; Dy. Directs eer Ror TAR ----- End of picture text -----

| |

! | |

Case No.:122/8/82[PartyName:EMCURE Meet No/Date:8/82Status:Case ALC4/2014 PHARMACEUTICALS LTD. |ALC4/2014 Deferred . | [25.09.2014 - - 1377 |HQ File RLA File Lic.No/Date:3 110064607 [Defer | — [:01/82/050/00786/AM15/ —_|:31/83/040/00101/AM15/ _[24.07.2014 — [Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals.

Case No.:123/8/82[Party Name:EMCURE [Meet No/Date:8/82_[Status:Case ALC4/2014 PHARMACEUTICALS LTD. |ALC4/2014 Deferred 378 [HQ01/82/0S0/00787/AMI5S/File RLA File |Lic.No/Date:3110064609 [Defer —__|:31/83/040/00104/AMI5/ [24.07.2014 Date:12.11.2014. | |Decision : It was decided to defer the case for 12.11.2014 for comments of Department of | |Pharmaceuticals’

;

Case No.:68/8/82-ALC 4/2014 |Party Name:KARNATAKA [Meet No/Date:8/82Status:Case ANTIBIOTICS & ALC4/2614 Deferred PHARMACEUTICALS 25.89.2014
379 HQ File RLA File Lic.No/Date:07 10106124 |Defer :01/82/050/00732/AM15/ |:07/24/040/00146/AM15/ —[24.07.2014 |Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of
{Pharmaceuticals’ . | . .
Case No.:33/8/82-ALC4/2014 [Party Name-PAYAL Meet No/Date:8/82‘Status: PETROCHEM PRIVATE ALC4/2014 Approved
HQ LIMITED 25.09.2014 | ' File RLA File Lic.No/Date:0510389937 ‘Defer Date:
:01/82/050/00697/AM15/ 05/24/040/00496/AM14/ 24.07.2014 -

Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/18/2014-Ch. II dated 28.05.2014, it was decided to 380 |ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

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----- Start of picture text ----- t Export product Qty.Exp. SNe import items Qty. Allowed |Di iso Nonyl Adipate | 1 kg 0754 (DINA kg RA ) }2_ [ Adapic Acid [0.385 kg may take appropriate action as per the decision of Norms Committee. Case No.:67/8/82-ALC4/2014 [Party Name:STERICON [Meet No/Date:8/82- [StatussCase PHARMA PVT.LTD., ALC42614 Deferred [25.09.2014 a 381 |HQ File RLA File Lic. No/Date:07 1010612) |Defer :01/82/050/0073 1/AM15/ :07/24/040/00150/AM15/ 24.07.2014 — (Date:12.11.2014 Decision | Pharmaceuticals’ : It was decided to defer the case for 12.11.2014 for comments of Department of POS cen rae cane Dy. Director Canera + Pweegn 1 cade Di eS alert cogn trade wpa feAarvDepartment of Commerce Udyog brown ow Delni ----- End of picture text -----

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----- Start of picture text ----- Case No.:63/8/82-ALC4/2014 Party Name:ADCOCK Meet No/Date:8/82- Status:Case INGRAM LTD, (2014 Deferred | 25.09.2014 382.|HQ File RLA File Lic.No/Date:0710106181 |Defer- *01/82/050/00727/AM15/ |:07/24/040/00148/AM15/ 25.07.2014 Decision | Date:12.11.2014 : It was decided to defer the case for 12.11.2014 for comments of Department of  [Pharmaceuticals’ Case No.:64/8/82-ALC4/2014 |Party Name: MOREPEN Meet No/Date:8/82- __[Status:Case LABORATORIES LTD., ALCA/2014 Deferred 383 |HQ File RLA File Lic.No/Date:05 10389956 |Defer :01/82/050/00728/AM1 BY 05/24/040/001 89/AM15/ 25.07.2614 Date: 12.11.20 14 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of {Pharmaceuticals. ----- End of picture text -----

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----- Start of picture text ----- Case No.:6/6/82-ALC4/2014 (Party Name:OCEAN Meet No/Date:8/82- (Status: _ PHARMA COAT PVT LTD. [ALC4/2014 Approved HQ File RLA File | Lic.No/Date:0925.09.2014 10060738 (Defer. Date: <ON82/050/00408/AMI5/ __|:09/24/040/00216/AM15/ |25.07.2014 Decision : In the light of earlier decision taken in meeting no. 22/82 dated 20.02.2014, it 384 appliedwas decided by the tofirm, ratify whichever norms underis less: Para 4.7 of HBP v1 as per details given below or as | Export SLNo. | Import items Qty. | product Oty allowed | PelletsOrlistat 50% 1 kg 0.505/kg RA may take appropriate action as per the decision ofNorms committee. Case No.:65/8/82-ALC4/2014 PartyName:OTSUKA Meet No/Date:8/82- Status:Case CHEMICAL ( INDIA ) ALC42014 Deferred 385 PRIVATE LIMITED 25.09.2014 HQ File RLA File Lic.No/Date:05 10390112 (Defer :01/82/050/00729/AM15/ :05/24/040/001 FO/AMIS/ 05.08.2014 Date:12.11 2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of |Pharmaceuticals. ----- End of picture text -----

Case No.:66/8/82-ALC4/2014 |Party Name:RECKITT Meet No/Date:8/82Status:Case IBENCKISER ALC4/2014 Deferred HEALTHCARE INDIA 25.09.2014 386 LIMITED HQ File RLA File [Lic.No/Date:0510390158 [Defer :01/82/050/00730/AM15/ :05/24/040/00205/AMI5/ 06.08.2014 Date:12.11.2014 Pharmaceuticals.Decision : It was decided to defer the case for 12.11.2014 for comments ofPrefs Departmentara, of af Dy. DirectorTHF Gene 54! Franfas QITITSMAR ost eI y “tai on Trade Wrectorate Gerneorg: ofp 7 SET Udyog Binnie

! | | | | | : an

|a|||||iccNo.:215/6/82-<br>ALC4/2014<br>feFile<br>:01/82/050/00617/AM15/|iccNo.:215/6/82-<br>ALC4/2014<br>feFile<br>:01/82/050/00617/AM15/|reName:CADILA<br>icNo/Date:8/82- Doe<br>HEALTHCARELTD.,<br>ALC4/2014<br>approved<br>[RLAFile<br>[bicNorDat:0610152540PeteDate:<br>:08/24/040/00190/AM15/<br>08.08.2014|reName:CADILA<br>icNo/Date:8/82- Doe<br>HEALTHCARELTD.,<br>ALC4/2014<br>approved<br>[RLAFile<br>[bicNorDat:0610152540PeteDate:<br>:08/24/040/00190/AM15/<br>08.08.2014|||
|---|---|---|---|---|---|---|---|---|---|---|
||||||Decision : Inthelightofearlierdecisiontakeninmeetingno. 10/82dated22.08.2013, itwas<br>decidedto ratifynormsunderPara4.7ofHBPv<br>| asperdetailsgivenbeloworasappliedbythe<br>firm, whichever is less:||||the||
||||||Lala <br>| Atenolol25mg||a <br>1,00,000|al<br>allowed<br>[1. | AtenololUSP<br>S«d2SSkg|||
|||||||||Cellulose|||
|||||||||||||
||||||!||||||
|||||||<br>|<br>|||||6.__| Magnesium Stearate<br>«|0.073kg <br>Bottles &Caps(Packing<br>Asper<br>Materials infinishedForm<br>packing<br>60CCWhiteHDPERound<br>policy<br>bottel|__||
|||||||||75CCWhiteHDPE Round|||
|||||||||150CC WhiteHDPERound|||
||387||||||||400CCWhiteHDPERound|||
|||||||||Bottle|||
||||||||||Bottle|||
|||||||||||||
|||||||||||||
||||||||||1.<br>[Atenolol USP<br>«(SOK<br>HD SilicifiedMicrocrystalline<br>[13.74kg<br>Cellulose|||
|||| <br>| <br>|||<br> <br>|<br>|Atenolol50mg<br> Tablet|1,00,000<br>Nos.|||4.___| Citric Acid Anhydrous USP____[0.050kg<br>__<br>(6.<br>|Magnesium Stearate<br>[0.145kg]<br>Bottles&Caps(Packing<br>Asper<br>MaterialsinfinishedForm<br>packing<br>policy<br>bottel<br>75CCWhiteHDPERound|||
||||<br>|||||||bottle<br>150CCWhiteHDPERound<br>Bottle<br>400CCWhiteHDPERound|||
|||||||||Bottle<br>o||\|

Vayog T Areysz men or Commece g Bhawan, aa

==> picture [414 x 334] intentionally omitted <==

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||||||
|---|---|---|---|---|
|ee|
|||HD Silicified|Microcrystalline|
|||Cellulose|
||||6.__||Magnesium|Stearate|«| 0.290kg|
|||Bottles & Caps (Packing|As per|
|||Materials in finished Form|packing|
|1|Atenolol100 mg|1,00,000|bottel|
|||Tablet|Nos.|75 CC White HDPE Round|
|:|150 CC White HDPE Round|
|||Bottle|
|[Botte7d.|400 CC|WhiteVE HDPEMDPERouneRound|
|Bottle|
|||
|,|
|RA may take appropriate action as per the decision ofNorms Committee.|

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, Case No.:1/7/82-ALC4/2014 |Party Name:COVALENT Meet No/Date:8/82Status:Case LABORATORIES PRIVATE /ALC4/2014 Deferred 7 [sdons rae | . 388 fae:01/82/050/00645/AM15/ File LA:09/24/040/00261/AM15/ File Lie26.08.2014 NovDate:09 10060890 PeteDate:12.11.2014 DesisionPharmaceuticals.: It was decided to defer the case for 1s2.11.2014 for comments of Department of

|Case No.:2/8/82-ALC4/2014 PartyCHEMICALS Name:SAURAV LTD, ALC4/2614Meet No/Date:8/82Status:CaseDeferred van . 389 fee:01/82/050/00666/AM File 1 5/ RLA:22/24/040/0005 File 1/AM15/ [ic03.09.2614 NovDate22 10015079 DefDat e r:12.11.2014 DeeisionPharmaceuticals.: It was decided to defer the case for 12.11.2014 for comments of Department of

(Case No,:5/7/82Party Name: THEMIS Meet No/Date:8/82Status:Case ALC4/2014 PHARMACEUTICALS(PROP.CHEM |ALC4/2014 Deferred . | Pie LTD.) | aan | | 39 |HQ File RLA File :08/24/040/00177/AM15/ Lic.No/Date:08 1013321 (Defer 0 eintsoonsnn15/ | 03.09.2014 Duet4 1.201 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Ri Pharmaceuticals.s Refer gare, NIRMALKUMAR Wectoratu Genera: of foc at RPE KaTVOepartinent of commene

| | | | | | :

Case No.:1/8/82-ALC4/2014 [Party Name:OPTIMUS ~ [Mea NombasB/e)Status: DRUGS PRIVATE LIMITED |ALC4/2014 approved HQ File ARLA File 25.09.2014Lic.No/Date:0910060915. [Defer Date: . :01/82/050/00665/AM15/ :09/24/040/00100/AM15/ 04.09.2014 Decisionratify : in the tight of earlier decision taken in meeting no. 2/82 dated 18.04.2013, it wasOo decided to norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: 391 | | Export product ae | SEN] Import items Qty. alle Rosuvastatin 1. (4R-Cis) -6-{(Acetyloxy) Methyl}-2,21.871 ki Calcium Dimethyl-1,3-Dioxane-4-Acetic Acid-1,1Dimethylethyl Ester (DS 4-(4-Fluoropheny!)-6-Isopropyl-2[(N-Methyl1.871 ki: N- Methylsulphoni)Amino] Pyrimidine 5-YLMethanol (27) RA concerned may take further necessary action as per above decision of NC. Case No.:3/8/82-ALC4/2014 |Party Name:CADILA Meet No/Date:8/82|Status: HEALTHCARE LTD., ALC4/2014 approved oe HQ . (25.09.2014 File RLA File Lic.No/Date:0810133319 Defer Date: :01/82/050/00667/AM15/ :08/24/040/0022 I/AM15/ 12.09.2014 Decisionwas : In the light of earlier decision taken in meeting no. 22/82 dated 20.02.2014,in it 392 decided to ratify norms under para 4.7 of HBP v | as per details given below or as applied by ithe firm, whichever is less: H Export product Qty.Export S.No Import items Qty. allowed

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

a Case No.:4/8/82-ALC4/2014 Party Name: HONOUR LAB Meet No/Date:8/82Status:Case LIMITED ALC4/2014 Deferred 1393 25.09.2014 | [HQ File RLA File Lic.No/Date:09 10060963 [Defer | :01/82/050/00668/AMiv/ :09/24/040/003 18/AM15/ 12.09.2014 Date:12.] 1.2014 |Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals. | |Case No.:6/8/82-ALC4/2014 |Party Name:HONOURLAB [Meet Nobacal&a: Status:Case IMITED ALC4/2014 (Deferred 394 25.09.2014 . ; THQ File RLA File Lic.No/Date:0910060964 [Defer :01/82/050/00670/AM15/ :09/24/040/003 14/AM15/ 12.09.2014 Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments Gf,Department af ‘hs Directoraten 2 foncaee. ay ° Uayog)Pane &Bea

==> picture [497 x 708] intentionally omitted <==

----- Start of picture text ----- | [Pharmaceuticals. a ; | Case No.:7/8/82-ALC4/2014 [Party Name:HONOUR LAB [Mest NoDanaie: Status:Case LIMITED JALC4/2014 Deferred . {25.09.2014 395 [HQ File RLA File Lic.No/Date:09 10060965 Defer_ - “O1/82/0S0/00671/AMIS/_|:09/24/040/00317/AM15/ _{12.09.2014 Decision . Date:12.11.2014 : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals. - Case No.:8/8/82-ALC4/2014 {|Party Name: HONOUR LAB 4Meet No/Date:8/82- Status:Case LIMITED ALC4/2014 Deferred (25.09.2014 396 |HQ File RLA File Lic.No/Date:0910060966 Defer | *01/82/050/00672/AM15/ _|:09/24/040/00315/AMIS/ _|12.09.2014 Date:12.11.2014 Decision : It was decided to defer the case for 12.1 1.2014 for comments of Department of [ [Case No.:8/8/82-ALCar2014 [Party Name-SHIVAM OILS "Men No/Date:8/82- {Status:Case & PROTEINS INDUSTRY, |ALC4/2014 Deferred 397 |HQ File RLA File . 25.09.2014Lic,No/Date:5610004402- Defer Decision:01/82/050/00669/AM1 5/ :56/24/040/00030/AMI a 12.09.2014 Date:12.11.2014 : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals. Case No.:12/8/82-ALC4/2014 [Party Name:DISTO Meet No/Date:8/82- [Statusr PHARMACEUTICALS ALC4/2014 japproved . PRIVATE LIMITED 25.09.2014 : | ‘ HQ File RLA File Lic.No/Date:0910060973 Defer Date: :01/82/050/00676/AM15/ :09/24/040/00321/AMI5/ 15.09.2014 leg Decision : In the light of earlier decision taken in meeting no. 22/82 dated 20.02.2014, it 398 |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 Export | SI.No. | Import items Qty. | product Qty. allowed | Orlistat lkg 0.505/kg | Pellets 50% RA may take appropriate action as per the decision ofNorms committee. Case No.:11/8/82-ALC4/2014 [Party Name:DIVIS Meet No/Date:8/82- Status: LABORATORIES LTD., ALC4/2014 Approved 399 25.09.2014 HQ File RLA File Lic.No/Date:09 10060970 fer Date: :01/82/050/00675/AM15/ :09/24/040/00298/AM15/ 15.09.2014 [Decision : In the light of earlier decision taken by NC in its 4/82 meeting dated 03.07.2014, it: | ----- End of picture text -----

| !

Dy. Director Canura ort, eon Trade fare aire teers og ; Directorate Gere ats, ut Teada aifisy faaPYC gastro Commerce SUT Was, HY Tee Udyog Shawan, New Deini

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 [426 x 163] intentionally omitted <==

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|||||||
|---|---|---|---|---|---|
|||Item of Export|| Quantity|Item of|Import|Quantity|
|[IOPAMIDOL|allowed kg/kg|
|TECH)|[2|| 2aceroxy rRoPionvi|cHLORIDE|[044i|
|||[3|[DIMEraviFoRMaMipe_—_—_~([|0702|
|ES|7317|
|[6|a|2|
|A|[NNDIMeTHYL AcETAMIDE|__—*(asi@|
|RA may take appropriate action as per the decision|of Norms Committee.|

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(Case No.:10/8/82-ALC4/2014 [Party Name: HETERO Meet No/Date:8/82__[Status:Case DRUGS LIMITED, ALC4/2014 Deferred 400 |HQ File RLA File 25.09.2014Lic.No/Date:09 10060969 |Defer_ :01/82/050/00674/AM15/ —_|:09/24/040/00293/AMI5/ 15.09.2014 Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals.

. .

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||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|||Case No,:9/8/82-ALC4/2014|[Party|Name:|HETERO LABS|| Meet No/Date:8/82-|Status:Case|
|LIMITED|ALC4/2014|Deferred|
|||25.09.2014||.|.|
|401||HQ File|RLA File|Lic.No/Date:09 10060967||Defer|
|:01/82/050/00673/AM15/|:09/24/040/00320/AM15/|_415.09.2014|Date: 12.11.2014|
|Decision|:|It|was|decided|to|defer|the|case|for|12.11.2014|for comments|of Department|of|
||Pharmaceuticals.|
|Case No.:13/8/82-ALC4/2014||Party|Name:|HETERO LABS|(Meet No/Date:8/82-|Status:Case|
|LIMITED|ALC42014|Deferred|
|.|.|25.09.2014|
|402||HQ File|RLA|File|Lic.No/Date:09|10060989||Defer|
|[:01/82/050/00677/AM15/|_|:09/24/040/00324/AM15/|—_{17.09.2014|Date:12.11.2014|
|Decision|:|It|was|decided|to|defer|the|case|for|12.11.2014|for|comments|of Department|of|
|_|[|Pharmaceuticals.]|

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)
ALC4/2014Case No.:125/8/82Party Name:HETERO Meet No/Date:8/82Status:Case DRUGS LIMITED, ALC4/2014 Deferred 25.09.2014
1403 |HQ File RLA File Lic.No/Date:09 10061000 |Defer :01/82/050/00789/AM15/ __j:09/24/040/00345/AMI5/ _|19.09.2014 Date:12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals.

yy, PreteOSE eneraresN n fees carne

Udyog Bhawan, Ver a

Case No.:126/8/82Party Name:RELIANCE Meet No/Date:8/82Status:Case ALC4/2014 INDUSTRIES LTD. ALC4/2014 Deferred
404 |HQ File RLA File 25.09.2014Lic.No/Date:03 10789468 |Defer; :01/82/050/00790/AM 1 5/ :03/95/040/00269/AM15/ {19.09.2014 |Date: 12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals. Case No.:127/8/82Party Name:HETERO LABS [Meet No/Date:8/82[StatussCane ALC4/2014 LIMITED ALC4/2614 Deferred 25.09.2014 |
405 |HQ File RLA File Lic.No/Date:09 10061002 |Defer , :01/82/050/0079 1/AM15/ . :09/24/040/00339/AM15/ 22.09.2014 Date: 12.11.2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of
|Pharmaceuticals.s

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----- Start of picture text ----- Case No.:128/8/82- Party Name:HETERO LABS (Meet No/Date:8/82- [StatussCase ALC4/2014 LIMITED ALC42014 Deferred (25.09.2014 406 JHQ File RLA File Lic.No/Date:09 10061003 |Defer :01/82/050/00792/AM15/ :09/24/040/00341/AMI S/ 22.09.2014 Date: 12.11 2014 Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals. . Case No.:129/8/82- Party Name:HETERO LABS [Meet No/Date:8/82- (Statue: Case ALC4/2014 LIMITED ALC4/2014 Deferred . | 25.09.2014 407 {HQ File RLA File Lic.No/Date:091006 :01/82/050/00793/AM 1004 |Defer 15/ :09/24/040/00338/AM 15/ ‘(22.09.2014 Date: 12.11.2014 Decision : It was decided to defer the case for 12.1 1.2014 for comments osf Department of Pharmaceuticals.j ----- End of picture text -----

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----- Start of picture text ----- Case No.:130/8/82- PartyName:HETERO LABS [Meet No/Date:8/83- ~~ [StatuazCace ALC42014 LIMITED ALC4/2014 Deferred «25.09.2014 408 |HQ File RLA File Lic. No/Date:09 10061005. IDefer :01/82/050/00794/AMiS/ —_|:09/24/040/00332/AM15/ [22.09.2014 [Date:12.11.2014 | |Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals. ----- End of picture text -----

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----- Start of picture text ----- Case No.:131/8/82- Party Name:HONOUR LAB [Meet No/Date:8/82- [Status:Case ALC4/2014 LIMITED ALC4?2014 Deferred 409 |HQ File RLA File . 25.09.2014Lic.No/Date:09| SODecision yOO79S/AMIS/ :09/24/040/00353/AMI5/ [22.09.20141006 1007 Date:12.11.2014|Defer Pharmaceuticals.: It was decided to defer the case for 12.11.2014 for comments of Department of — EA AL RS ad mere eps ha ade De iis guettoets Ob vommetee Udyog Lt ow Delhi ----- End of picture text -----

Date:25.09.2014 Nirmal kumar Place:New Delhi Dy. Director General of Foreign Trade

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