IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2014-11-26

DGFT Committee Minutes

Document text

MEETING NUMBER ~ : 11/82-ALC4/2014 MEETING DATE: 26.11.2014 But actually held on 01.12.2014 : The Meeting No. 11/82 of 2014-15 to consider the cases/issues under Duty Exemption 7 Scheme (Chapter-4) of Foreign Trade Policy, 2009-14 pertaining to Chemical and Allied products | and falling under Chapter 29 and 30 was scheduled for 26.11.2014 but actually held on 01.12.2014 7 under the Chairmanship of Shri Jaikant Singh, Addi. DGFT in Room No.11, Udyog Bhawan, New | Delhi. | Following members were present:| Dr. Nitin Jain D/o Biotechnology

*

Office of Directorate General of Foreign Trade New Delhi -0

Para 4.7 Decision(DRAFT)

Shri Nirmal Kumar, Deputy Director General of Foreign Trade Ms. Swati Kumari, O/o Dc (MSME)

Shri O.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. 10/82 scheduled for 12.11.2014 but actually held on 13.11.2014 and approved the same.

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

CaseNo. B-102	M/sRohan Exports IndiaLtd.<br>&M/aMahesh Raj
	Chemicals Ltd. .
MeetingNo.11/AM1I5 dated~01.12.2014	F.No.01/83/162/00654/AM12/DES-IIT
Appeals filed	Againstorderofthe Jt.DOFT,Ahmedabad inpursuanceof
	order dated 20.01.2010ofthe Hon’ble HighCourtof
	Gujarat.

Decision: Committee considered case as per agenda and in consultation with technical authority present in the meeting it has been found that despite repeated reminders the Institute of Chemical Technology Mumbai, has not given their opinion as to whether the export product “4, 4 Diamino Sulfanilide “ is manufactured only of purity 93% on commercial scale. Further, whether the product always contained 7% or more of impurities. It was also decided to remind the Department of C&PC to take appropriate action and furnish their comments as the case has been pending for long.

The case is deferred for 22.12.2014

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----- Start of picture text ----- Case No. B-103 M/s. PIRAMAL HEALTHCARE LTD. \ ; {FORMERLY NICHOLAS PIRAMAL) ht Meeting No.11/AM15 dated ~01.12.2014 —_| F. No.01/82/50/00557/AM13/DES-I] ——_oxaPh, Hyer" 3 »> Cok oe ea SeAP Ga mSaceacon [ ae] Sae BPIT vs? ----- End of picture text -----

Ff adv. Lic. No. 0310701405 dated 10.07.2012 Decision: The case was withdrawn as a decision in the matter had already been taken in 5/82 meeting held on 25.07.2014.

		naena
		ORMERLYNICHOLAS PIRAMAL
MeetingNo.11/AM15dated—01.12.2014		F.No.01/82/50/256/AM13/DES-III
		F.No.01/82/50/261/AM13/DES-IHl
		F. No.01/82/50/260/AM 13/DES-Hl
		F. No.01/82/50/255/AM13/DES-IIl
		F.No.01/82/50/928/AM12/DES-Iil
		adv. Lic.No. 0310694731 dated 15.05.2012
		adv. Lic. No.0310694936 dated 16.05.2012
		adv. Lic.No. 0310694925 dated 16.05.2012
		adv. Lic.No. 0310694706dated 15.05.2012
		adv. Lic.No. 0310642739 dated 18.07.2011
Decision:	It was decided to defer the case for 09.10.2014 for comments of Department of
Pharmaceuticals.

Case No. B-105	M/s.PIRAMALHEALTHCARELTD.<br>(FORMERLYNICHOLASPIRAMAL)
Meeting No.11/AM15dated~01.12.2014	F.No.01/82/50/00556/AM13/DES-IIl<br>F.No.01/82/50/00001/AM13/DES-III
	F.No.01/82/50/01173/AM13/DES-Ill
	adv. Lic. No. 0310701402 dated 10.07.2012 adv.
	Lic. No. 0310688849 dated 30.03.2012 adv. Lic.
	No.0310721416dated18.01.2013

Decision: The case was withdrawn as a decision in the matter had alreadybeen taken in 5/82 meeting held on 25.07.2014.

|Case No. B-106<br>M/s. INDIAN IMMUNOLOGICALS LTD|
|---|
|MeetingNo.11/AM15dated—01.12.2014 | F. No.01/82/050/00902/AM14/DES-II|
|RLA F.No. 09/24/040/00345/AM14<br>Adv.lic.No. 0910057931 dated 15.10.2013|
|Decision<br>:it was decided to defer the case for 10.12.2014 for comments of Department of|
|Biotechnology.|

CaseNo. B-107	M/s Aarti Drugs Ltd.
MeetingNo.11/AM15 dated—01.12.2014	F.No.01/82/050/427/AM13/DES-I0
RA.No. 03/81/040/241/AM13	Adv. Lic.No. 0310714511<br>dt. 07.11.2012
RANo. 03/81/040/00072/AM14	Adv. Lic.No.0310737543 dt. 13.06.2013
	a<br>CTE TERECAT<br>;<br>ractorateGeneral ofForo Trade<br>apresfPyrpPepariment oa:Commerce
	UdyogBhawan,Newont

| |

% Decision: It was decided to give last reminder to the firm to furnish relevant portion of British Pharmacopeia to show that 2-Thiophene Ethylamine and Thiophene-2-Ethanol are one and the same. The case was deferred for 22.12.2014.

|Case No. B-108|M/sTechnoDrugs& Intermediates(P)|
|---|---|
|MeetingNo.11/AM15dated-01.12.2014 | F.No.01/83/050/00530/AM07/DES-III||
|RLA’sFileno.03/95/040/00486/AM07|Adv.Lic.No.0310392619dt.02.08.2006|

Decision: It was decided to give last reminder to the firm to furnish the following technical details:

Details of manufacturing process of the Pheno! 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 22.12.2014.

|Case No. B-109<br>M/s Scott-Edil Pharma Ltd.|
|---|
|MeetingNo.11/AM15dated—01.12.2014 | F.No.01/82/050/00222/AM14/DES-IIls|
|R.A F, No. 22/24/040/00015/AMi4<br>Adv. Lic. No. 2210013866 dt. 17.05.2013|
|Decision :Itwasdecidedtodeferthecase for22.12.2014 forcommentsofDepartment of|
|Pharmaceuticals.|

Case No. B-110	M/sChiragEnterprise, Jamnagar, Gujarat
Meeting No.11/AM15dated~01.12.2014	F.No. 01/82/050/00256/AM1 1/DES-Ill
	F.No. 01/82/050/01090/AM1 1/DES-IIl
RLA’s File no.24/24/040/00009/AM1 1	Adv. Lic.No.2410029974dt.27.10.2010
RLA’s File no,24/24/040/00014/AM11	Adv. Lic.No. 2410030871 dt. 27.10.2010
Decision: Itwasdecidedtoremind theDepartmentof	ofPetrochemicals tofurnish theircomments. The case
isdeferred12.06.2014.

Case No. 8-111 M/s Coral Labs Ltd. ee Decision :It was decided to defer the case for 22.12.2014 for comments of Department of Pharmaceuticals. fY\ :, Usrector Meneral c 'g mistbeite General a qitea RapyDepartn:. ze Udyog Bhawan, : val

| | 3

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----- Start of picture text ----- Case No.:4/16/82-ALC4/2011 Party Name:BOSTIK INDIA [Meet No/Date:11/82- Status: Deffered PRIVATE LIMITED ALC4/2014 and Re-indexed 6.11.2014 1 |HQ File RLA File Lic.No/Date:0710079777 |Defer :01/82/050/00462/AM12/ :07/24/040/00073/AM12/ 13.06.2011 Date:22.12.2014 Decision :It was decided to defer the case for 22.12.2014 for comments of Petrochemicals Division of Department ofChemicals and Petrochemicals. Case No.:196/10/82- Party Name:BOSTIK INDIA Meet No/Date:11/82- Status:Deffered ALC4/2013 PRIVATE LIMITED ALC4/2014 and Re-indexed 6.11.2014 HQ File RLA File Lic.No/Date:07 10085024 {Defer :01/82/050/00379/AM 14/ :07/24/040/00380/AM 12/ $.12.2011 Date:22.12.2014 | |Decision :It was decided to remind the firm to furnish the following information: 1. Technical specifications, % composition (by weight), alongwith specific end use/application and the copy of export order for the export product i.e. Polysocyanate Solution-75% solid may be furnished. ----- End of picture text -----

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Oetails and quantity of other indigenous inputs to be used in the manufacture of the export product may be indicated.
Detailed manufacturing process along with balanced chemical reactions Indicating %yield/wastages along with technical justification for wastages at each stage and also on each of the raw material may be furnished.
Complete material balance indicating input and output material at each stage of manufacturing process.
Details of production of export product under reference and corresponding consumption of raw material in the year 2012-13 and 2013-14 duly certified by CA may be furnished. If the production has not commenced in the past, the details from commencement of production may be furnished duly certified by CA.
Any other relevant information.

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----- Start of picture text ----- The case was deferred for 22.12.2014 ----- End of picture text -----

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----- Start of picture text ----- Case No.:44/20/82- Party Name:HIRAN Meet No/Date:11/82- Status:Deffered ALC4/2013 ORGOCHEM LIMITED ALC4/2014 and Re-indexed 26.11.2014 3 |HQ File RLA File Lic.No/Date:03 10692029 |Defer :01/82/050/01030/AM14/ :03/94/040/008 14/AM12/ ‘(25.04.2012 Date:22.12.2014 Decision : It was decided to call from the firm the complete technical details as per Appendix 33. The case was deferred for 22.12.2014. Case No.:30/13/82- Party Name:HALDIA Meet No/Date:1 1/82- Status:Deffered 4 ALC4/2012 PETROCHEMICALS LTD. |ALC4/2014 land Re-indexed 6.112014 ; [HQ File RLA File (Lic.No/Date:02101 77518 [Defer ria QAR /NIRMAL K Sy ABST fast ign Trade Dy. Director General of Foreig airedRicksFAmuDeparinenttoConorai ofPoraagn pSGorpennscTrad e Ud hnawan, New Geihi ----- End of picture text -----

} | : | |

[:01/82/050/00365/AM13/ [-02/24/040/00029/AM13/ __ [14.05.2012 ~ [Date:22.12.2014

Decision : It was decided to defer the case for 22.12.2014 for comments of Petrochemicals Division of Department of Chemicals and Petrochemicals. 7

Case No.:18/20/82Party Name:CADILA Meet No/Date:11/82-__(Status:Deffered ALC4/2013 HEALTHCARE LTD., ALC4/2014 and Re-indexed 26.11.2014 _ |. 1HQ File RLA File Lic.No/Date:0810112511 |Defer 5 |:01/82/050/01004/AM14/ 08/24/040/00090/AM13/ 14.06.2012 ——— (Date:22.12.2014 | |Decision : It was decided to call from the firm copy of relevant DML showing composition of the export product. The case was deferred for 22.12.2014.

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----- Start of picture text ----- Case No.:19/20/82-ALC4/2013 |Party Name:CADILA Meet No/Date:1 1/82- Status: HEALTHCARE LTD., ALC4/2014 Approved 26.11.2014 JHQ File RLA File Lic.No/Date:0810112510 Defer Date: :01/82/050/0 1005/AM 14/ :08/24/040/00095/AM 13/ 14.06.2012 |Decision :in the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/04/2014-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: Export Product Gabapentin, 600 MG and 800MG Tablets : Import Items For export of 1 No. Tablet 6 | {1|GABAPENTIN [2| MANNITOL |3____| COPOVIDONE [3754 S00 |4__| POVIDONE K 30 a EX | HYDROXYPROPYL CELLULOSE |6____| MAGNESIUM STEARATE | 17 18_|| CRC150 WHITE WHITE HDPE CAP 38 BOTTLE MM Relevant, as per packing policy : [9__ 750 CC WHITE HDPE BOTTLE : 110| NCRC WHITE CAP 53 MM { . lu | 225 CC WHITE HDPE CRC BOTTLE 112| CRC WHITE CAP 45 MM ; 113| 950 CC WHITE HDPE BOTTLE a | 14 | DESICANT CANISTER 2 G | RA may take appropriate action as per the decision of Norms Committee. E |Am: o : eects ee | ‘Case No.:4/20/82-ALC4/2012 |Party Name:RANBAXY Meet No/Date:11/82- Status:Deffered VES eo Fe 7) LABORATORIES LTD ALC4/2014 and Re-indexed [sesh 0 [HQ File2 IRLA File [Lic.No/Date:0526.11.2014 10333154 [Defer SayPee CASES ;t % +3Sas . SS se , Of 2P ----- End of picture text -----

| | | | : | |

[:01/82/050/00615/AM13/Decision : It was decided to[:05/24/040/00323/AM defer the case for12/ 22.12.2014(30.08.2012 for comments of_ Department|Date:22.12.2014 of Pharmaceuticals.

Case No.:40/15/82Party Name:CALYX Meet No/Date:11/82Status: ALC4/2013 CHEMICALS & ALC4/2014 Approved _ PHARMACEUTICALS LTD. [26.11.2014 8 . THQ File RLA File Lic. No/Date:03 10707994 [Defer Date: :01/82/050/00802/AM14/ :03/94/040/00199/AM10/ 06.09.2012 [Decision :Withdrawn, as the case is already approved in 8/82 meeting dated 25.09.2014 Case No.:3/23/82-ALC4/2012 |Party Name:TITAN Meet No/Date: 1 1/82Status: LABORATORIES PVT. LTD. |ALC4/2014 Approved a 26.11.2014 HQ File RLA File Lic.No/Date:03 10713360 iDefer Date: :01/82/050/00803/AM13/ :03/95/040/00544/AM13/ 22.10.2012

Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/145/2013-Pl(Norms) dated 01.12.2014, it was decided to ratify the norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

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Case No,:£9/1/82Party Name:CDYMAX Meet No/Date: 1 1/82Status:Deffered ALC42013 (INDIA) PHARMA PVT, ALC42014 and Re-indexed | LTD. 26.11.2014 10 |HQ File RLA File Lic.No/Date:0710091789 |Defer :01/82/050/01377/AM13/ :07/24/040/00317/AM 13/ 06.11.2012 Date:22.12.2014 Decision:It was decided to remind the firm to furnish complete technical details as per Appendix 33. The case was deferred for 22.12.2014.

Case No.:112/33/82Party Name:STERICAT Meet No/Date: 1 1/82Status:Deffered ALC4/2012 GUTSTRINGS PVT. LTD. ALC4/2014 and Re-indexed - 6.112014 11 . __s THQ File RLA File Lic.No/Date:0510340033 [Defer AST °01/82/050/01259/AM13/ :05/24/040/00304/AM13/ 04.12.2012 Date:22.12.20\ tS x“& Decision : It was decided to defer the case for 22.12.2014 for comments of Departmept of4;¢ 3 bd A eSBES ees | eS

| (er.

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12 |Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 3501 1/160/2014-PI(Norms) dated 26.11.2014, mentioned that they have examined the case and noted that the firm has stated that they will be importing Clexane 60 mg injection from their group of company in France and after carrying out certain relabeling and repacking export the injections to Sri Lanka Govt. Agencies. No wastage claimed. Since there is no manufacturing activity involved except certain relabeling and repacking. It was decided to call OC from DCGI. The case was deferred for 22.12.2014.

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|---|---|---|---|---|---|
|Case|No.:165/33/82-|Party Name:CADILA|Meet No/Date:1 1/82-|Status:Deffered|
|ALC4/2012|HEALTHCARE LTD.,|ALC4/2014|and Re-indexed|
|6.11.2014|
|;|
|13|HQ File|RLA|File|Lic.No/Date:0810117317||Defer|
|:01/82/050/01312/AM13/|:08/24/040/002$7/AM 13/|02.01.2013|Date:22.12.2014|

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----- Start of picture text ----- 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 22.12.2014. ----- End of picture text -----

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|---|---|---|---|---|---|---|---|---|---|
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|Case No.:13/12/82-|Party|Name: HETERO DRUGS||Meet No/Date:1|1/82-|Status: Deffered|
|ALC4/2013|LIMITED,|ALC4/2014|and|Re-indexed|
|26.11.2014|
|HQ File|RLA|File|Lic.No/Date:0910054735||Defer|
|14||:01/82/050/00437/AM14/|:09/24/040/00495/AM13/|=|(09.01.2613|Date:22.12.2014|
|Decision|:|It was decided to call the following information from the firm|:|i) Stepwise chemical|
|reactions|showing|correct Molecular weight of|each|reactant & output product, and % yield on|
|molar|basis.|ii)|Justification|for requirement of imported|inputs|in|view ofCA|certificate|furnished|
|by the firm. The case was deferred|for 22.12.2014.|

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|---|---|---|---|---|---|---|
|Case No.:2/30/82-|Party|Name: MOREPEN|Meet No/Date:11/82-|Status: Deffered|
|ALC42012|LABORATORIES LTD.&|ALC4/2014|jand Re-indexed|
|MOREPEN INTERNATION|=|[26.11.2014|;|
|15|[HO|File|RLA|File|Lic.No/Date:0510343975|[Defer|
|:01/82/050/01038/AM13/|:05/24/040/00389/AM 13/|23.01.2013|Date:22.12.2014|

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Decision ;: It was decided to send a copy of application again to department of |Pharma for their comments. The case was deferred for 22.12.2014

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|||||||
|---|---|---|---|---|---|
|. Case No.:9/4/82-ALC4/2013||Party|Name:GOPALDAS|-|Meet No/Date:1 1/82-|Status:Deffered|
|VISRAM & CO.LTD.|ALC4/2014|and|Re-indexed|
|26.11.2014|
|16|[HQ File|RLA|File|Lic.No/Date:03 10722715|iDefer|
|:01/82/050/00050/AM14/|:03/94/040/00945/AM13/|(01.02.2013|Date:22.12.2014|

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|Decision :Reply received from the firm does not relate to the present case under reference, import item Betamethasone Dipropionate USP. it was decided to give last reminder to the fi pmiRy aa ‘ ot Seeeea a oir Dy eI TATE Mot FOLIO” ° oiai oan‘ NOwpe wayos

| ! |

to furnish the following technical details: (a) Net weight of the cream in each tube. (b) Detailed working on arriving at the norms applied by the firm | _ |The case was deferred for 22.12.2014. —

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Case No.151/33/82Party Name:FORACE Meet No/Date:1 1/82Status:Deffered ALC4/2012 POLYMERS (P) LTD. \ALC4/2014 jand Re-indexed . 26.11.2014
17 |HQ File RLA File Lic.No/Date:05 10345208 |Defer
|| [:01/82/050/01298/AM13/ _|:08/23/040/00459/AM13/ 7.02.2013 _ [Date:22.12.2014 |Decision : It was decided to defer the case for 22.12.2014 for comments of Petrochemicals Division of Department of Chemicals and Petrochemicals. .

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|---|---|---|---|---|---|
|Case No.i7/3/82-ALC4/2013|[Party|Name:|WOCKHARDT|(Meet No/Date:1 1/82.|[Staiussbefforca|
|LIMITED|ALC4/2014|and Re-indexed|
|||26.11.2014|
|18||HQ File|RLA File|Lic.No/Date:03 10723636||Defer|
||||:01/82/050/00040/AM14/|:03/95/040/00886/AM 13/|11.02.2013|Date:22.12.2014|
|||TheDecision case was: It was deferred decided for to 22.12.2014 send a|copy ofapplication again to DCGI for their comments.|
|.|.|.|
|||Case No.:4/4/82-ALC4/2013|Party Name:SABERO|Meet No/Date:1 1/82-|Status:Deffered|
|!|
|||ORGANICS GUJARAT|ALC4/2014|and Re-indexed|
|.|LIMITED|26.11.2014|
|19|[HQ File|RLA|File|Lic.No/Date:03 10724136|[Defer|
|:01/82/050/00045/AM14/|:03/95/040/00880/AM13/|
||Decision|.|14.62.2013|Date:22.12.2014|
|||;|It was decided to defer the case for 22.12.2014|for comments of|Department of|
||Chemicals and Petrochemicals.|.|
|Case No.:79/1/82-|Party Name:STERICAT|Meet No/Date:11/82-||Status:Deffered|
|ALC4/2013|GUTSTRINGS PVT. LTD.|ALC422014|and Re-indexed|
|.|26.11.2014|
|120|HQ:01/82/050/01437/AMI13/File|RLA|File||Lic.No/Date:05 10346353|Defer|
|Decision|_{:05/24/040/00420/AM13/|_—_{18.02.2013|Date:22.12.2014|
|IPP.|: It was decided to deferthe case for 22.12.2014 for comments ofDepartment of|

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Case No.:31/8/82Party Name: MYLAN Meet No/Date: * 1! 1/82Status:Deffered 1ALC4/2013 LABORATORIES LIMITED |ALC4/2014 and Re-indexed HQ File RLA File ; 26.11.2014Lic.No/Date:0910055106 |Defer 01/82/050/00162/AM14/ —_|:09/24/040/00537/AM13/ 19.02.2013 | Date:22.12.2014 21 |Decision: it was decided to give last reminder to the firm to furnish the following technical details: * Complete technical details as per Appendix -33 including % Yield on molar basis for each step and solvent Recovery etc. A * Past Production vis-a-vis Actual consumption ofraw materials duly certified by Central: . bog — Excise Authorities. EUx = opt ‘se oFa)SigeooEGOSMeer’ ies BECOaeNOes ReyE,NeeeCe4 oretS an roeae BPO Ayn? Uaye?

| | | | : |

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----- Start of picture text ----- | [The case was deferred for 22.12.2014. ----- End of picture text -----

||[CaseNo.:32/8/82-<br>ALC4/2013|PartyName:BIOLOGICALE<br>LTD|[MeetNo/Date:11/82-<br>LC4/2014|[MeetNo/Date:11/82-<br>LC4/2014||__|Status:Deffered<br>andRe-indexed|
|---|---|---|---|---|---|---|
||.||6.11.2014||.||
||HQFile<br>99 '|:01/82/050/00163/AM14/|RLAFile<br>:09/24/040/00607/AM 13/|Lic.No/Date:0910055421<br>19.03.2013|10055421<br>_—|||Defer<br>[Date:22.12.2014|
||Decision : It was decided to give last reminder to the firm to <br>jproduction<br>record of complete Manufacturing process<br>(up|||furnish <br>stream,||copy ofBatch.<br> down<br>stream,|
||formulation,<br>filling|etc.)<br>showing<br>quantities|and<br>use|of|import<br>inputs”.||
||Thecasewas deferred for22.12.2014.||||||
||CaseNo.:57/10/82-|PartyName:BIOLOGICALE|[MeetNo/Date:11/82-|||Status:Deffered|
||ALC4/2013|LTD|ALC4/2014|||and Re-indexed|
||||26.11.2014||||
||a||||||
|||JHQ File|RLA File|Lic.No/Date:0910055420||||Defer|
|[23 (:01/82/050/00240/AM<br>14/||:09/24/040/00606/AM 13/|19.03.2013|||Date:22.12.2014|
||Decision :It was decided to give last reminder to||the firm to|furnish||copy of Batch|
||production record<br>of|complete Manufacturing process<br>(up||stream,||down<br>stream,|
||formulation,<br>filling|etc.)<br>showing<br>quantities|and<br>use|of|import<br>inputs”.||
||Thecasewasdeferredfor22.12.2014.|||||.|
||)|CaseNo.:6/10/82-<br>JALC42013|PartyName:RANBAXY<br>LABORATORIESLTD|MeetNo/Date:11/82-<br>ALC4/2014|||Status:Deffered<br>and Re-indexed|
||||26.11.2014||||
||.||||||
||24 1HQFile<br>:01/82/050/00189/AM14/|RLA File<br>:05/24/040/00480/AM13/|Lic.No/Date:0510350030<br>2.03.2013|10350030|||Defer<br>Date:22.12.2014|

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 22.12.2014.

|[CaseNo.:33/2/82-<br>ALC4/2013|[Party Name: MOREPEN<br>LABORATORIESLTD.&|MeetNo/Date:11/82- _ <br>ALC4/2014||Status:Deffered<br>andRe-indexed|
|---|---|---|---|
||MOREPEN INTERNATION|26.11.2014||
|25 THQFile<br>:01/82/050/01480/AM13/|RLA File<br>:05/24/040/00481/AM13/|Lic.No/Date:0510350279<br>26.03.2013||Defer<br>Date:22.12.2014|

Decision : Reply received from the firm and sent to Department of Pharmaceuticals for their comments. The case was deferred for 22.12.2014

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----- Start of picture text ----- Case No.:117/10/82- Party Name:PRASOL Meet No/Date:1 1/82- Status: ALC4/2013 CHEMICALS LIMITED ALC4/2014 Reject 26.11.2014 26 |HQ File RLA File Lic.No/Date:03 10729886 |Defer Date: ‘|:01/82/050/00300/AM14/ :03/95/040/0088 1/AM13/ 28.03.2013 ----- End of picture text -----

, |

Decision : It was decided to reject the case as the firm has not furnished information despite repeated reminders. NW |" 7 |Case No.:71/4/82Party Name:CHIRAGMeet No/Date:11/82—_|Status:Deffered egee |ALC4/2013 ENTERPRISE ALC4/2014 an med es ot Oe an OY oc so n xB 1g COME greg (UE io aA, ae APOyav??aLnowe

|||:<br>.||||(26.11.2014|||||
|---|---|---|---|---|---|---|---|
||HQ File||RLA File|Lic.No/Date:2410038645||||Defer|
||:01/82/0S0/00112/AM14/||—|:24/24/040/00001/AM14/|_—[09.04.2013|_—||[Date:22.12.2014|

Decision :It was decided to defer the case for 22.12.2014 for comments of Petrochemicals Division of Department of Chemicals and Petrochemicals.

Case No.:120/10/82Party Name:MEHTA API PVT |Meet No/Date:1 1/82Status:Deffered ALC4/2013 LTD ALC4/2014 and Re-indexed . 6.11.2014 _ HQ File RLA File Lic.No/Date:03 10730905 |Defer :03/95/040/00020/AM14/ 09.04.2013 Date:22.12.2014 98[:0][1/82/050/00303/AM][ 14/] Decision :It was decided to remind the firm to furnish the following information: 1. Stepwise yield on molar basis for each step of manufacturing process. 2. Material balance for each step. 3. Copy of Technical Literature in support of yield claimed 4. Requirement of Cairithromycin Oxime per kg of clarithromycin. (ii) Past production vis-a-vis actual consumption of input duly certified by Central Excise Authorities. The case was deferred for 22.12.2014

CaseNo.:3/3/82-ALC42013	(PartyName:LAKE	MeetNo/Date:11/82-	Status:
	CHEMICALSPRIVATE	ALC4/2014	Apporved
qo	LIMITED	26.11.2014
HQ File	RLA File	Lic.No/Date:0710094921	{Defer Date:
:01/82/050/00036/AM14/	:07/24/040/00003/AM14/	18.04.2013

Decision : In the tight of earlier decision taken by NC in its 03/82 meeting 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:

==> picture [431 x 103] intentionally omitted <==

----- Start of picture text ----- 29 Export product exp. | SIN0.| Import items Qty. | Midazolam 1QtyKg. 2-Aminomethyl-7-Chloro-2,3- allowed2.52 kg | Maleate Dihydro-5(2-Fluropheny])1h-1,4- | Benzodlioazepine Dimaleate triethyl )| orthoTriethylacetateOrtho Acetate 1.18 kp ----- End of picture text -----

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

Case No.:43/10/82Party Name:SRINI Meet No/Date:} 1/82Status:Deffered ALC4/2013 PHARMACEUTICALS LTD., |[ALC4/2014 and Re-indexed : 26.11.2014 30 |HQ File RLA File Lic.No/Date:0910055800 |Defer :01/82/050/00226/AM14/ 109/24/040/00017/AM14/ 19.04.2013 Date:22.12.2014 Decision :It was decided to defer the case for 22.12.2014 for comments of Department of Pharmaceuticals. .

==> picture [487 x 131] intentionally omitted <==

----- Start of picture text ----- Case No.:18/7/82- Party Name: VIVIN Meet No/Date:11/82-__[Status:Deffered ALC4/2014 LABORATORIES PRIVATE |ALC4/2014 and Re-indexed stp LIMITED 26.11.2014 — - pt Q File [RLA File [Lic.No/Date:0910055914 [Defer 4S i> A EK Ee € \ aaa ees ~ OF eee eee,¥ [a0] aeRY [aye?] taal2 ----- End of picture text -----

—_[:09/24/040/00624/AM13/ _{02.05.2013 [Date:22.12.2014

==> picture [465 x 57] intentionally omitted <==

----- Start of picture text ----- Ay. [:01/82/050/00662/AM15/ —_[:09/24/040/00624/AM13/ _{02.05.2013 [Date:22.12.2014 | {Decision :It was decided to defer the case for 22.12.2014 for comments of Department of |__[Pharmaceuticals. | | ----- End of picture text -----

||__[Pharmaceuticals.||__[Pharmaceuticals.|||||||
|---|---|---|---|---|---|
|[7|{CaseNo.:6/7/82-ALC4/2014||PartyName:RACHEM|MeetNo/Date:11/82-||__[Status:Deffered|
|||PHARMALIMITED|ALC4/2014||andRe-indexed|
|.|||26.11.2014|||
||||||||
||32 |HQ File|RLA File|Lic.No/Date:0910055932|||Defer|
||:01/82/050/00650/AM15/|—_|:09/24/040/00043/AM14/|_—{03.05.2013|-||Date:22.12.2014|

Decision : It was decided to defer the case for 22.12.2014 for comments of Department of Pharmaceuticals.

|||||||||
|---|---|---|---|---|---|---|
|||CaseNo.:157/10/82-|PartyName:LUPINLIMITED||[MeetNo/Date:11/82-|Status:Reject|
|||ALC4/2013|||LC4/2014||
|||.|||6.11.2014<br>.||
|33|||HQ File|RLA File||Lic.No/Date:0316733961|(Defer|
|||:01/82/050/00340/AM14/|:03/95/040/00098/AM14/||10.05.2013|Date:22.12.2014|
|||Decision : Itwasdecidedto<br>|Pharmaceuticals.|todef**e**r<br>the cas for|22.12.2014 forcommentsofDepartment of|||
|_|||||||
|~||[CaseNo.:2/5/82-ALC4/2013|(PartyName:MYLAN||MeetNo/Date:11/82-|_|Status:Deffered|
||||LABORATORIES LIMITED||j|ALC4/2014|and Re-indexed|
||||||26.11.2014||
|||HQ File|RLA File||Lic.No/Date:0910055979|‘|Defer|
|||}:01/82/050/00120/AM14/|:09/24/040/00023/AM14/||10.05.2013|Date:22.12.2014|

34 |Decision : It was decided to remind the firm to furnish the following information: 1, Complete technical details as per Appendix 33

Past production vis-a-vis actual consumption of input duly certified by Central Excise Authorities.

|The casewasdeferred for22.12.2014|The casewasdeferred for22.12.2014||.|
|---|---|---|---|
|” (CaseNo.:20/7/82-|PartyName:DRREDDYS|[MeetNo/Date:11/82-|_[Status:Deffered|
|ALC4/2014|LABORATORIESLIMITED||ALC4/2014|andRe-indexed|
|||26.11.2014||
|35/HQFile<br>|:01/82/050/00664/AM15/|RLA File<br>109/24/040/00041/AM14/|Lic.No/Date:0910056000<br>15.05.2013||Defer<br>Date:22,12,.2014|

|Decision : It was decided to defer the case for 22.12.2014 for comments of Department of _|Pharmaceuticals.

||CaseNo.:10/7/82-<br>|ALC4/2014|PartyName:-RACHEM<br>PHARMALIMITED|MeetNo/Date:11/82-<br>Status:Deffered<br>ALC4/2014<br>andRe-indexed|MeetNo/Date:11/82-<br>Status:Deffered<br>ALC4/2014<br>andRe-indexed|
|---|---|---|---|---|
||||6.112014||
||:||||
|36||HQFile<br>:01/82/050/00654/AM15/|RLAFile<br>:09/24/040/00059/AM14/|Lic.No/Date:0910056003<br>16.05.2013|10056003<br>|Defer<br>Date:22.12.2014|
||{Decision : Itwasdecidedto|todeferthecase for22.12.2014 forcommentsofDepartmentof|||
||(Pharmaceuticals.|||.<br>a }MaAr<br>pat!<br>FAS oT rade|
|||||PRTgGanComer<br>Oeeetag 2 Doint<br>yennpBnewer|

||CaseNo.:11/7/82-<br>ALC4/2014|PartyName:SRINI<br>MeetNo/Date: 11/82-<br>PHARMACEUTICALSLTD., |ALC4/2014|PartyName:SRINI<br>MeetNo/Date: 11/82-<br>PHARMACEUTICALSLTD., |ALC4/2014|Status:Deffered<br>and Re-indexed|
|---|---|---|---|---|
||||6.11.2014||
|37||HQFile<br>:01/82/050/00655/AM15/|RLAFile<br>:09/24/040/00062/AM14/_|Lic.No/Date:0910056024 |Defer<br>17.05.2013<br>_|Date:26.11.2014||
||Decision : Itwasdecidedto<br>Pharmaceuticals.|todeferthecase for22.12.2014 forcommentsofDepartment of||ofDepartment of|
|||||.|
||CaseNo.:52/13/82-<br>ALC4/2013|PartyName:STERICON<br>PHARMAPVT.LTD.,|[MeetNo/Date:11/82-<br>ALC4/2014|(Status:Deffered<br>andRe-indexed|
||.||26.11.2014||
|3g|[HQFile<br>01/82/050/00528/AM14/|RLAFile<br>—_—|:07/24/040/00039/AM14/_|Lic.No/Date:0710095454 |Defer<br>_—{17.05.2013<br>_—<br>|Date:22.12.2014||
||Decision : Itwasdecidedto<br>Pharmaceuticals.|todeferthecase for22.12.2014 forcommentsof||ofDepartmentof|

||CaseNo.:8/7/82-ALC4/2014||PartyName:SUVEN LIFE<br>SCIENCESLIMITED|Meet No/Date:<br>11/82-<br>ALC4/2014||Status:Deffered<br>and Re-indexed|
|---|---|---|---|---|---|
||||26.11.2014|:||
||||||||
|139:|}HQ File|RLAFile|Lic.No/Date:0910056039||[Defer|
||:01/82/050/00652/AMI5/|—_|:09/24/040/00049/AM14/|(17.05.2013||Date:22.12.2014|

||CaseNo.:12/7/82-<br>ALC4/2014|Party Name: VIVIMEDLABS<br>LIMITED|MeetNo/Date:<br>11/82-<br>ALC4/2014|Status:Deffered<br>andRe-indexed|
|---|---|---|---|---|
||||(26.11.2014|||
|40||HQFile<br>:01/82/050/00656/AM15/|RLA File<br>:09/24/040/00060/AM14/|Lic.No/Date:0910056017<br>17.05.2013|[Defer<br>_|Date:22.12.2014|

Decision : It was decided to defer the case for 22.12.2014 for comments of Department of C&PC.

Case No.:14/6/82Party Name:GLAND Meet No/Date: 1 1/82Status: Deffered ALC42014 PHARMA LIMITED ALC4/2014 and Re-indexed 26.11.2014 41 |HQ File RLA File Lic.No/Date:0916056109 |Defer :01/82/050/00416/AM15/ :09/24/040/00065/AMI14/ 3.05.2013 Date:22.12.2014 Decision : It was decided to defer the case for 22.12.2014 for comments of Department of Pharmaceuticals.

==> picture [452 x 155] intentionally omitted <==

----- Start of picture text ----- Case No.:12/20/82- Party Name:GLAND Meet No/Date: 1 1/82- Status:Deffered ALC4/2013 PHARMA LIMITED ALCA/2014 and Re-indexed | 26.11.2014 42 |HQ File RLA File Lic.No/Date:09 100561087 [Defer :01/82/050/00998/AM14/ :09/24/040/00061/AM14/ 23.05.2013 Date:22.12.2014 Decision : It was decided to defer the case for 22.12.2014 for comments ofDepartment of Pharmaceuticals. patio SECONE SorC o s, of ees0 Fane AAae ----- End of picture text -----

==> picture [454 x 97] intentionally omitted <==

----- Start of picture text ----- ALC4/2013Case No.:207/10/82- PartyENTERPRISE Name:CHIRAG MeetLC4/2014 No/Date:1 1/82- ‘andStatus:Deffer Re-index ed 1 1. 26.11.2014 . 143 |HQ File RLA File Lic. No/Date:24 10038996 |Defer | i/82/050/00390/AM14/ ———|:24/24/040/00008/AM14/ 27.05.2013 Date:22.12.2014 | Decision : It was decided to defer the case for 22.12.2014 for comments Petrochemical | [Division of Department of C&PC ----- End of picture text -----

Case No.:71/10/82Party Name:SCOTT-EDIL Meet No/Date:1 1/82Status:Deffered ALC4/2013 PHARMACIA LTD., ALC4/2014 and Re-indexed 611.2014 ; HQ File RLA File Lic.No/Date:2210013890 |Defer 101/82/050/00254/AM14/ :22/24/040/00016/AM 14/ 38.05.2013 Date:22. 12.2014 Decision : It was decided to send a copy of application again to department of |Pharma for _ {their comments. The case was deferred for 22.12.2014. | Case No.:133/14/82Party Name:CALYX Meet No/Date:1 1/82Status: Deffered ALC4/2013 CHEMICALS & LC4/2014 and Re-indexed PHARMACEUTICALS LTD. [26.11.2014 . 45 |HQ File RLA File Lic.No/Date:03 10736138 |Defer 01/82/0$0/00718/AM14/ ——|:03/94/040/00537/AM13/ ——[30.05.2013 Date:26.11.2014 Decision ; It was decided to defer the case for 22.12.2014 for comments of Department of _ |Pharmaceuticals. .

==> picture [470 x 382] intentionally omitted <==

----- Start of picture text ----- |Pharmaceuticals. . Case No.:225/10/82- Party Name:APEX Meet No/Date: [1][ 1/82-] Status; ALC4/2013 HEALTHCARE LTD ALC4/2014 Approved 26.11.2014 ; HQ File RLA File Lic.No/Date:3410037038 [Defer Date: :01/82/050/00408/AM 14/ :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-PI(Norms) '\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:- bi i a a; . 1kg | 1 | |2___| Dimethyl Formamide }0.616 | | |3___| tso Propyl Alcohol [1.286 | [4 [Sodiummetal «0.32 : [5 [MethanoldT : [6 [__|] [Propionaldehyde] [7 [Thiourea054 RA concerned may take further necessary action as per above decision ofNC. [ ][ MAR] ----- End of picture text -----

wu Reise feet wax Dy. Director General of Foreign Trade aftrovers {DepartmenCone s t ronof Commerc trad e Da ean Now Delhi

|||||LS|
|---|---|---|---|---|
||CaseNo.:96/10/82-<br>ALC4/2013|PartyName:-TORRENT<br>PHARMACEUTICALSLTD.|MeetNo/Date:<br>11/82-<br>Status:Deffered<br>|ALC4/2014<br>and Re-indexed||
|||||26.11.2014<br>.<br>.||
|47||HQFile<br>:01/82/050/00279/AM14/|RLAFile<br>:08/24/040/00085/AM 14/|Lic.No/Date:0810121573<br>|Defer<br>31.05.2613<br>Date:22.12.2014||
||Decision : Itwasdecided <br>Pharmaceuticals.|todeferthecase for22.12.2014forcommentsofDepartment of|||
|||.|||
||CaseNo.:40/12/82-<br>ALC4/2013|PartyName:SMILAX<br>LABORATORIESLIMITED|[MeetNo/Date:11/82- _ [Status:Deffered<br>|ALC4/2014<br>and Re-indexed||
||||26.11.2014||
|48||HQFile<br>:01/82/050/00464/AM 14/|RLAFile<br>:09/24/040/00113/AM14/|Lic.No/Date:0910056355<br>|Defer<br>17.06.2013<br>‘'|Date:26.11.2014||
||Decision : Itwasdecidedto<br>Pharmaceuticals.|todeferthecasefor22.12.2014 forcommentsofDepartmentof|||
||||.||
||[Case No.:23/12/82-ALC472013 [PartyName:CIRONDRUGS&<br>PHARMACEUTICALS P.<br>LTD.,||& [MeetNo/Date:11/82. ~~ IStatus:<br>ALC4?2014<br>Approved<br>26.11.2014||
||HQFile<br>201/82/050/00447/AM14/|RLAFile<br>:03/94/040/00094/AM14/|Lic.No/Date:0310738255<br>|DeferDate:<br>19.06.2013||

Decision :The Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/648/201 3-PI(Norms) 49 dated 28.11.2014 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 ofHBP as per details below or as applied by firm whichever is lower: ;| Oits4 | CAN-C EYE DROPS [Number] | N-ACETYL-CARNOSINE 0.05) gm / Sml

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

Case No.:22/12/82Party Name:INDOFIL Meet No/Date:11/82(Status: Deffered ALC4/2013 INDUSTRIES LTD. ALC4/2014 and Re-indexed 26.11.2014 50 [HQ File RLA File Lic.No/Date:03 10738404 [Defer |:01/82/050/00446/AM 14/ 703/94/040/00197/AMI14/ 20.06.2013 Date:22.12.2014 ‘Decision :It was decided to defer the case for 22.12.2014 for comments of Department of |C&Pc. |

Case No.:19/13/82Party Name:BOSTIK INDIA Meet No/Date:11/82Status:Deffered . ALC4/2013 PRIVATE LIMITED ALC4?2014 and Re-indexed >! 26.11.2014 . - [HQ File RLA File Lic.No/Date:0710096186 [Defer +:01/82/050/00495/AM14/ :07/24/040/00502/AM13/ {25.06.2013 Date:2 14 [Decision : It was decided to call from the firm the following technical details: Neos oe cSa o“ oe MS BENSeee¢ . ss eo Ot oe", oe Poa heea vt

ae Technical specification % composition (by weight) along with specific end use/application and use/application and the copy of export order for the export product i.e. Hardener for water based | |Polyurethane Adhesive may be furnished. | |2. Details and quantity of other indigenous input to be used in the manufacture of the export | [product may be indicated 3. Detailed manufacturing process along with balanced chemical reaction indicating % yield/wastage along with balanced chemical reaction indicating % yield/wastage along with technical justification for wastage along with technical justification for wastage at each stage and also on each of the raw material may be furnished. 4. Complete material balance indicating input and output material at each stage of manufacturing process. 5. Details of production of export product under reference and corresponding consumption of raw material in the year 2012-13 and 2013-14 duly certified by CA may be furnished. If the production has not commenced in the past, the details from commencement of production may be furnished duly certified by CA. 8. Any other relevant information.

_ [The case was deferred for 22.12.2014

==> picture [454 x 86] intentionally omitted <==

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

|||||||||
|---|---|---|---|---|---|---|---|
|“[€ase No.:111/10/82-|Party Name:STERICAT|(Meet No/Date:11/82-|Status:Deffered|
|ALC4/2013|GUTSTRINGS|PVT. LTD.|ALC4/2014|and Re-indexed|
|26.11.2014|
|.|
|52||HQ File|RLA|File|Lic.No/Date:0510358000||Defer|
|:01/82/050/00294/AM14/|205/24/040/0009|1/AM14/|25.06.2013|Date:22.12.2014|
|Decision|:It was decided|to defer the|case|for 22.12.2014|for comments of|Department of|||

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

==> picture [452 x 70] intentionally omitted <==

----- Start of picture text ----- | Case No.:203/10/82- Party Name:SHASUN Meet No/Date:11/82- Status:Deffered JALC42013 PHARMACEUTICALS ALC4/2014 and Re-indexed i LIMITED 26.11.2014 fo 53) HQ File RLA File Lic.No/Date:0410147556 [Defer ‘1:01/82/050/00386/AM14/ :04/24/040/00064/AM 14/ 27.06.2013 Date:22,12.2014 ----- End of picture text -----

|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 22.12.2014

==> picture [479 x 247] intentionally omitted <==

----- Start of picture text ----- [Case No.:204/10/82- Party Name:SHASUN Meet No/Date: ALC4/2013 PHARMACEUTICALS ALC4/2014 1 1/82- andStatus:Re-indexe Deffere d pe LIMITED 26.11.2014 §4 |HQ File RLA File Lic.No/Date:0410147559 |Defer :01/82/050/00387/AM 14/ 104/24/040/00065/AM 14/ 27.06.2013 Date:22.12.2014 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 22.12.2014 Case No.:64/13/82- Party Name:EAGLE Meet No/Date:11/82- |Status:Deffered ALC4/2013 CHEMICAL WORKS ALC4/2014 and Re-indexed 26.11.2014 — 55 {HQ File RLA File Lic. No/Date:03 10740489 ete Ih :01/82/0S0/00540/AM14/ —_—|:03/94/040/00019/AM14/ [05.07.2013 Date:22.12.2014 |1 Decision :It was decided to remind the firm to furnishthe following technieafgelfke va ex a ua BETS General oF Fore reree aia a, ag eB ini Udyog Bhawan, ----- End of picture text -----

irere

| . Complete technical details as per Appendix 33. 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 22.12.2014.

==> picture [454 x 114] intentionally omitted <==

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

||||||
|---|---|---|---|---|
|Case No.:41/13/82-|Party Name:JJAGSONPAL|Meet No/Date: 1 1/82-|Status:Deffered|
|ALC4/2013|PHARMACEUTICALS LTD.||ALC4/2014|and|Re-indexed|
|26.11.2014|
|||HQ|:01/82/050/00517/AM14/ File|RLA:05/23/040/00056/AM14/ File|09.07.2013Lic.No/Date:05 10359156|PeteDate:22.12.2014|
|Decision|:|It was decided to remind the firm to furnish|the following technical|details:|
|56||1. Copy of valid Drug Manufacturing Licence along with|list of|approved items showing|
|the composition of export product.|

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

The firm has given license for the import of 1000 kg Indomethacin from China. Justification for claiming import of indomethacin Mixed Pellet 53% may be furnished. 3. COA from Foreign Supplier for the import of Indomethacin Mixed Pellet 53%.

The case was deferred for 22.12.2014

==> picture [453 x 333] intentionally omitted <==

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

||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|Case No.:44/12/82-|Party Name:ENCUBE|Meet No/Date:|
|ALC42013|ETHICALS PVT LTD|ALC4/2014|1 1/82-|andStatus: Re-indexedDeffered|
|26.11.2014|
|.|
|57||HQ File|RLA|File|Lic.No/Date:03|10740922||Defer|
|:01/82/050/00468/AM|14/|:03/94/040/00306/AM14/|10.07.2013|Date:22.12.2014|
|Decision|:Reply|received|from|the|firm|and|sent|to|Department|of|Pharma|for|their|
|comments.|The case is deferred|for 22.12.2014.|
|Case No.:28/13/82-|Party Name:RANBAXY|Meet No/Date:1 1/82-|Status:Deffered|
|ALC4/2013|LABORATORIES LTD|ALC4/2014|and Re-indexed|
|58|HQ File|RLA|File|(26.11.2014Lic.No/Date:05 10360180||Defer|
|1:01/82/050/00504/AM14/|:05/24/040/001 14/AM14/|18.07.2013|Date:22.12.2014|
|Decision|:It|was|decided|to|request|the|firm|to|furnish|a|copy|of|Master|Batch|Formula|duly|
|_|certified|by Quality Control|Incharge. The|case was deferred|for 22.12.2014.|
||Case No.:46/14/82-|Party Name:MYLAN|Meet No/Date:11/82-|Status:Deffered|
|ALC4/2013|LABORATORIES LIMITED||ALC4/2014|and Re-indexed|
|26.11.2014|
|.|.|.|
|59 He:01/82/050/0063 File|1/AM14/|RLA:09/24/040/00185/AM14/ File|Lic.No/Date:09§.07.2013|10056909|Date:26.11.2014[Defer|
|Decision|:|It was decided to send a copy of|application again|to department|of |Pharma for|
|_||their comments. The case was deferred for 22.12.2014.|

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

==> picture [477 x 119] intentionally omitted <==

----- Start of picture text ----- CaseNo.:24/17/82-ALC4/2013 ‘Party Name:SMILAX Meet No/Date: LABORATORIES LIMITED /ALC4/2014 Approved la ‘0 1 1/82- Status: 26.11.2014 so _ [HQ File IRLA File [Lic No/Date:0910056902 [peeps — IOS AO ene OF eeexO ost [Aion] onanatoneat) yor? ----- End of picture text -----

==> picture [401 x 18] intentionally omitted <==

----- Start of picture text ----- | [:01/82/050/00886/AM14/ [:09/24/040/00180/AM14/ (25.07.2013 | ----- End of picture text -----

{Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/86/2014-Pi(Norms) dated 24.09.2014, it was decided to ratify norms under Para 4.7 of HBP v1 as per detaiis given below or as applied by the firm, whichever is less:

==> picture [519 x 456] intentionally omitted <==

----- Start of picture text ----- item of Export Quantity Item of import Quantity | allowed ke/kg | 2-Ethoxy-1 {[2-(1- 11.| 3-Nitro phathalic acid 0.978 | triphenylmethyl-1H- [2. | Acetone (0.572 | tetrazol-5-yl)yl] biphenyl-4- |3. |Acetonitrile| 0.835 | methyl} 4-bromomethy] biphenyl- benzimidazoile-7- wan | carboxylic acid (CAN-O) 2-carbonitrile 1.02 oe [S.___| Dimethyl formamide _ | [0.915] ! 6. | Trin-buty! tin chloride | Iso propyl alcohol ! }8 |Methanol 9.915 | | [9 | Methylene chloride 13.260 al | a carbonatea(TEOC 0.793 | Le 3.337 | [ [Ra may take appropriate action as per the decision of Norms Committee. . . ) ; Case No.243/12/82- Party Name:AM] ORGANICS (Meet No/Date:1 1/82- Status:Deffered ALC4/2013 PVT LTD. ALC42014 and Re-indexed 26.11.2014 7 | . . ) 61)|HQ File RLA File Lic.No/Date:52 10040038 [Defer | :01/82/050/00467/AM14/ —:52/24/040/00015/AM14/ 30.07.2013 _ PDate:22,12.2014 ‘Decision :It was decided to defer the case for 22.12.2014 for comments of Department of C&PC. | __. [Case No.:61/14/82- Party Name: HETERO DRUGS [Meet No/Date:11/82- __[Status:Deffered LC42013 LIMITED, ALC4/2014 and Re-indexed 26.11.2014 . HQ File RLA File Lic.No/Date:0910057007 |Defer 62 }01/82/050/00646/AM14/ —09/24/040/00206/AM14/ ——[02.08.2013 Date:22.12.2014 ----- End of picture text -----

| |Decisioneactions showing; It was decided correct Molecular to call the weight following of eachinformation reactantfrom& outputthe firmproduct,: i) Stepwiseand % yieldchemical on molar basis. ii) Justification for requirement of imported inputs in view ofCA certificate furnished by the firm. The case was deferred for 22.12.2014.

==> picture [486 x 161] intentionally omitted <==

----- Start of picture text ----- case No.:22/13/82- Party Name:PROMED Meet No/Date: ALC4/2013 EXPORTS PVT.LTD. ALC4/2014 | 1/82- andStatus:DeffRe-ind e xr ed | 26.11.2014 . 63 [HQ:91/82/050/00498/AMFile 14/ RLA:05/24/040/0017 File 1/AM14/ Lic.No/Date:05708.2013 10362268 [PeteDate:22.12.2014 Jecision :It was decided to cali from the a copy of Drug Manufacturing Licence for the export luct. The case was deferred for 22.12.2014. | Dy Drea ier Re KUMAR | pigteer array of Foreign Trade ! i Coneral of Foran, ! Bethe ape MeNt of Commence Udyog Bhawan,a ----- End of picture text -----

||CaseNo.:10/17/85-<br>PartyName:BELOORBAYIR (MeetNo/Date:11/82-<br>_Status:Deffered|CaseNo.:10/17/85-<br>PartyName:BELOORBAYIR (MeetNo/Date:11/82-<br>_Status:Deffered|
|---|---|---|
||ALC3/2013<br>BIOTECHLTD,|ALC4226014<br>andRe-indexed|
|||26.11.2014|
||.||
|64 |HQ File<br>RLAFile<br>:01/85/050/00113/AM14/<br>:07/24/040/00150/AM14/||Lic.No/Date:0710097664<br>|Defer<br>22.08.2013<br>Date:22.12.2014|
||Decision : Itwasdecidedtocallfromthe acopy ofDrugManufacturingLicencefortheexport<br>product. The casewasdeferredfor22.12.2014.||
||CaseNo.:47/14/82-<br>Party Name: VIVIMEDLABS<br>ALC4/2013<br>LIMITED||MeetNo/Date:11/82-<br>Status:Deffered<br>ALC4/2014<br>andRe-indexed|
||;<br>«(26.11.2014||
|65 |HQ File<br>RLAFile||Lic.No/Date:0910057280<br>|Defer|
||:01/82/050/00632/AM14/<br>109/24/040/0025 1/AM14/|208.2013<br>Date:22.12.2014|
||Decision : Itwasdecidedtodefer thecase for22.12.2014forcommentsofDepartment of<br>Pharmaceuticals.<br>|||
||CaseNo.:4/4/82-ALC4/2014 PartyName:SHASUN<br>PHARMACEUTICALS<br>LIMITED|MeetNo/Date:11/82-<br>Status:Deffered<br>ALC4/2014<br>andRe-indexed<br>26.11.2014|
|66 [HQFile<br>RLA File||Lic.No/Date:0410148932<br>|Defer|
||:01/82/050/00252/AM15/<br>104/24/040/00107/AM14/|3.08.2013<br>Date:22.12.2014|
||Decision : ItwasdecidedtoremindthefirmtofurnishacopyofMaster BatchFormula||
||dulycertifiedby QualityControl Incharge.Thecasewas|wasdeferred for22.12.2014.|
||[Case No.:116/14/82-<br>PartyName:UNIJULESLIFE<br>ALC4/2013<br>SCIENCESLTD.||MeetNo/Date:11/82-<br>Status:Deffered<br>ALC4/2014<br>and Re-indexed|
|||26.11.2014|
|JHQ File<br>RLA File<br>Lic.No/Date:0310747079<br>|Defer<br>6701/82/050/00701/AM14/<br>:03/95/040/00215/AMI14/<br>27.08.2013<br>Date:22.12.2014<br>{Decision: itwasdecidedtocallfromthefirmfollowing information:|||
||1)<br>Completedescription ofexportproductshowingthecontentofAP! intheInjection,and||
|||)<br>CopyofrelevantDMLalong withthe listofapproveditems.|items.|
||_|Thecasewasdeferred for 22.12.2014.||
||”||
||[CaseNo.:53/14/82-<br>PartyName:STERILE INDIA<br>ALC4/2013<br>PRIVATELIMITED|[MeetNo/Date:11/82-<br>(Status:Deffered<br>ALC4/2014<br>andRe-indexed|
|||26.11.2014|
||.||
|68 [HQFile<br>RLAFile<br>:01/82/050/00638/AM 14/<br>:05/24/040/00203/AM14/||Lic.No/Date:05 10364653<br>|Defer<br>5,09.2013<br>Date:22.12.2014|
|_|Decision sitwasdecided tocalifromthefirmthecompletetechnical detailsasperAppendix33.The<br>|casewas deferred for22.12.2014,||
|CaseNo,:2/12/82-<br>Party Name: VIVEK<br>MeetNo/Date:11/82-<br>Status:Deffered<br>.ALC4/2013<br>PHARMACHEM(INDIA)<br>ALC4/2014<br>andRe-indexed<br>69]<br>LTD.,<br>(26.11.2014|||
|HQFile<br>RLA File<br>__(01/82/050/00426/AM14/—_|:13/24/040/00022/AM14/ ._y||ic.No/Date:1310044274<br>|Defer<br> |09,09.2013<br>**,** arnacKU»iate:22.12.2014|
|||FETSof Foreign Trace<br>rectorGenera<br>Dy.DitCHapaTeseegntrade<br>Diroctora eT eparimentofCommerc<br>a<br>aTat,ausaeDelhi<br>UdyogBHAWwe"|

| :

} %

|Decision: it was decided to call from the firm the complete technical details as per Appendix 33. The | | case was deferred for 22.12.2014 :

==> picture [458 x 97] intentionally omitted <==

----- Start of picture text ----- [ [Case No.:56/14/82- Party Name:VIVEK eet No/Date:11/82- __[Status:Deffered ALC4/2013 PHARMACHEM (INDIA) ALC4/2014 and Re-indexed 170JLHe File RLALTD., File 26.11.2014Lic.No/Date:1310044273a iDefer _ , :01/82/050/00641/AM14/ :13/24/040/00021/AM14/ 89.2013 Date:22.12.2014 | Decision: it was decided to call from the firm the complete technical detaits as per Appendix 33. The |case was deferred for 22.12.2014 ----- End of picture text -----

: |

Case No.:11/15/82Party Name:BENZO CHEM [Meet No/Date:11/82Status: ALC4/2013 INDUSTRIES PRIVATE ALC4/2014 Approved LIMITED, 26.11.2014 HQ File RLA File Lic.No/Date:03 10749169 |Defer :01/82/050/00773/AM14/ :03/94/040/00352/AM14/ 11.09.2013 Date:26.11.2014 ' [Decision : Committee considered the case as per agenda and in light of written comments | {received from Department of Pharmaceuticals vide their OM No. 35011/287/2011-PI(Norms) . {dated 05.09.2014 and in consultation with technical authority present in meeting, decided to __ {ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:| 71 | Export product Exp. | SI.No. | import items Qty. i | Qty. Allowed | Kg/kg | | PROPIOPHENONE 240 | | | 2-4N,N-DIMETHYLAMINO)-2METHANOL | | PHENYL-1-BUTANOL 13 __| SODIUM CYANIDE 0.768 f | 1K CAUSTIC SODAFLAKES 11.00| | 9 [5 [DIMETHYL SULPHATE | 1.019 | | |6| FORMALDEHYDE (0.66 SYNHYDRIDE / VITRIDE 242 |

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

[Case No.:33/16/82Party Name: HETERO eet No/Date:11/82_|Status:Deffered HALC4/2013 DRUGS LIMITED, ALC4/2014 and Re-indexed | 6.112014 HQ File RLA File Lic.No/Date:09 10057537 |Defer :0.1/82/050/00846/AM 14/ :09/24/040/00278/AM 14/ 12.09.2013 Date:22.12.2014

47\Decision : It was decided to request the firm to furnish the following information :

i) Stepwise chemical reactions showing correct Molecular weight of each input reactant & output product and % yield on molar basis.

ii) Justification for requirement of imported inputs in view of CA certificate furnished by the firm.

e case was deferred for 22.12.2014.

, |

==> picture [138 x 30] intentionally omitted <==

----- Start of picture text ----- 3 ase No.:55/4/82-ALC4/2014 — ; ----- End of picture text -----

‘Party Name:NECTAR Meet No/Date:11/82Status: ; LIFESCIENCES LIMITED, ALC4/2014 Approved Preis NIRMAL KUMAR

Dy. Director Ganeral of Foreign Trade

Directorate General of Foreign Trade mPreq furyoeparniment of Commerce Lidyog Bhawan, New Delhi

at eal

==> picture [459 x 753] intentionally omitted <==

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

|||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|.|
|[t~<‘“i‘C:;~™~™~™O::””:SYC|(26.1 1.2014|||
|lee:01/82/050/00303/AMFile|15/|Rua:22/24/040/00044/AM14/ File|ic12.09.2013 NovDate-22 10014211|Pefe|Date:|
|[Decision|:|In the|light of written comments|received|from Department|of Pharmaceuticals|vide|their OM|
|0. 3501 1/274/2014-PI(Norms)|dated 30.10.2014,|it was decided to|ratify the norms under Para 4.7 of|HBP|
|v1|as per details given below or as applied by the firm, whichever|is|less:|
|||||Quantity|kg/kg|
|Cefuroxime Axetil|ikg|1.|Desacetyl-7-amino|0.79|
|ACA)|
|[2._[Ethylacetate|13.74|
||||(3.|[Methanol162|
|acetic|acid ammonium|salt|
|eo|Syn-methoxyimino furanyl|
|TS.|||(SMIA)Activated|carbon|0.100|
|pentachioride|
|||a|a|
||||(8.|[Sodium|hydroxide|1.0.43|
|||9.|[Aceticacidacid|0.048|sd|
|Isocyanate|
|||i|
|||[a2|[Acetone|
|||
|||
|[14|||Acetoxyethylbromide|[0.59|
|||f15|||Cyctohexane|0.92|
|||
|.|if|item|
|item|
|||ze [fette|e|e|
||RA may take appropriate action as per the decision of|Norms Committee.|,|
|JALC4/2013|LABORATORIES|LIMITED||ALC4/2014|and|Re-indexed|
|;|26.11.2014|
|"4 fae:01/82/050/00925/AM14/ File|RL:09/24/040/0026 File|1/AM14/|Lic13.09.2013 NoyDate:0910057546|[DeferDate:22,12.2014ota|
|:_|Decjthe|i|No.:63/17/82-rsi c|o|mments.n|:It was The decided case to wasfe send deferredName:DR a|copyf|o|REDDYSrf 22.12.2014.applicationie againNo/Dat to d partment|e|:1|1/82-|ofrn|Pharmaent for|
|fis~{ALC4/2013[Case Nowsstsye2-|PartyLIMITEDName:KOPRAN|DonWgMeetAL48 GARDENS. No/Date:neratof11/82; FORMcarat,,,ar|Status:DefferedJand Re-indexed|
|Director|eyoeparmestpeel|;|
|a|uayoser|[BN]|gaNew OS|

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

[ | (26.11.2014 laa:01/82/050/00797/AM14/ File PLA:03/94/040/00472/AM14/ File Lic.No/Date:0313.09.2013 10749439 |DeferDate:22.12.2014 | Decision : it was decided to call from the firm the complete technical details as per Appendix 33. _ |The case was deferred for 22.12.2014 " [Case No.:26/4/82-ALC4/2014 [PartyName:RANBAXY Meet No/Date:11/82(Status: LABORATORIES LTD ALC4/2614 Approved 26.11.2014 HQ File RLA File Lic.No/Date:0510365650 |Defer Date: HO Fie e02T4/AMIS) :05/24/040/002 12/AM14/ 16.09.2013 | Decision :Committee considered the case as per agenda and in consultation with technical _ jauthority present in the meeting, it was decided to ratify norms as per SION A-1931 as details i jgiven below or as applied by the firm, whichever is less: 176: | Export product Export | SIL.No. | Import items Qty. allowed per " | Qty. unit ofexport | product i Volini Gei 30 gm 1 No. Racementhol 1.53 gm/30 gm | (Each tube contains 1.5 gm tube | 4 Racementhol

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

||CaseNo.:151/14/82-<br>ALC42013|Party Name: THINQ<br>PHARMA-CROLIMITED|Meet No/Date:<br>1 1/82-<br>ALC4/2014<br>26.11.2014|Status:Deffered<br>andRe-indexed|
|---|---|---|---|---|
|77(HQ|(HQ File<br>:01/82/050/00736/AM14/|RLAFile<br>—_—_—[:03/95/040/00432/AM14/|Lic.No/Date:0310749651<br>—_—{16.09.2013||Defer<br>Date:22.12.2014|

ecision : It was decided to cali from the firm the complete technical details as per Appendix 33. The case was deferred for 22.12.2014 was deferred for 22.12.2014 deferred for 22.12.2014 for 22.12.2014 22.12.2014 .

The case was deferred for 22.12.2014 was deferred for 22.12.2014 deferred for 22.12.2014 for 22.12.2014 22.12.2014 . Case No.:18/4/82Party Name:SHASUN Meet No/Date:11/82(Status: Deffered ALC4/2014 PHARMACEUTICALS ALC4/2014 and Re-indexed _ LIMITED 26.11.2014 . 78 [HQ File RLA File Lic.No/Date:0410150092 [Defer :01/82/050/00266/AM15/ 104/24/040/00137/AM14/ 19.09.2013 Date:22.12.2014

Decision : It was decided to remind the firm to furnish a copy of Master Batch Formula duly certified by Quality Control In charge. The case was deferred for 22.12.2014.

||CaseNo.:48/16/82-ALC4/2613 |PartyName:SOFTGEL<br>HEALTH CAREPVT.LTD.|Meet No/Date:11/82-<br>|ALC4/2014||Status:<br>Approved|
|---|---|---|---|---|
|||26.11.2014|||
|79|a<br>HQFile<br>RLA File<br> |:01/82/050/00861/AM14/<br>:04/24/040/00099/AM14/|Lic.No/Date:0410150142<br>20.09.2013|||[DeferDate:<br>.|
||‘Decision<br>: 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-Pl(Norms)|||
||dated09.10.2014andinconsultationwithtechnicalauthoritypresentinmeeting,|||decidedto|

, sNIRMAL KUMAR stsete ras feraS ign Trade O ae aenerel of Foreign iiees atDicectoRrupeperimentga an, Nowoffeectl, Comme Dein i

———————————————————————————nn ———__ Zz,

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

==> picture [454 x 302] intentionally omitted <==

----- Start of picture text ----- : @ | Export product Em | SINO.| import items Qty. Allowed ttsVITAMIN A 30.0 mg/S0,000 IU || SOFT [VITAMIN] GELATIN [A] CAPSULES 1.7MIU/gm Capsule VITAMIN A 1] 1.7MIU/gm Capsule | VITAMIN A PALMITATE 120.0 mg/200,000 TU 1.7MIU/gm Capsule IRA concerned may take further necessary action as per above decision of NC. _ ase No.:48/15/82- Party Name:SHASUN Meet No/Date:11/82- _[Status:Reject ALC4/2013 PHARMACEUTICALS ALC4/2014 LIMITED 26.11.2014 80.|HQ File RLA File Lic.No/Date:0410150198 [Defer Date: :01/82/050/00810/AM14/ :04/24/040/00128/AM14/ 23.09.2013 |Decision : : It was decided to reject the case as the firm has not furnished information despite repeated reminders. . ----- End of picture text -----

3 ase No,:62/17/82-ALC4/2013 |Party Name:SMILAX Meet No/Date:! 1/82Status: LABORATORIES LIMITED |ALC4/2014 Approved 1HQ 26.11.2014 File RLA File Lic.No/Date:0910057671 [Defer Date: }:01/82/050/00924/AM14/ :09/24/040/00292/AM14/ 24.09.2013 Decision : In the light of written comments received from Department of Pharmaceuticals vide {their OM No. 35011/60/2014-PI(Norms) dated 22.09.2014, it was decided to ratify the norms junder Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

==> picture [462 x 261] intentionally omitted <==

----- Start of picture text ----- $1 Pantoprazole sodium sesquihydrate lkgQh kg/ke0.80 2,5 Difluoro Methoxy- 2mercapto-1H- Benzimidazole 2. 2-Chioromethyl-3,4- Dimethoxy pyridine Hcl 0.80 RA may take appropriate action as per the decision ofNorms Committee —~ [82[Case No.:21/19/82- [Party Name:GOPALDAS [Meet No/Date:1 1/82- _ ySeutaaeDesieed So ae Ot ACER at BOA nate” vey? ----- End of picture text -----

==> picture [20 x 14] intentionally omitted <==

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

|A.||
|---|---|
|J||ALC4/2013<br>VISRAM&CO.LTD.<br>ALC4/2014<br>and Re-indexed|
||HQFile<br>RLA File<br>Lic.No/Date:0310751325<br>[Defer|
||||:01/82/050/00966/AM14/<br>—_—:03/94/040/00502/AM14/<br>—26.09.2013<br>__|Date:22.12.2014|
||<br>|||Decision :itwasdecidedtoremindthefirmtofurnish followingtechnicaldetails :<br>1. ExportshouldbeinNo.OfBottlesandnotinkgs.|
||2. Theimportitem shouldmatch thedescriptionandtypegiven inDMLand besupportedby|
||Supplier's Brochure.|
||3. NetcontentofCodLiverOil(TypeB),Bothinquantitativeandvolumeticterm, in each bottle|
|{|lof170m.|

Copy of technical literature in support of density of import item. COA from foreign supplier may be given.

==> picture [452 x 102] intentionally omitted <==

----- Start of picture text ----- | | The case was deferred for 22.12.2014. Case No.:46/17/82- Party Name:INCHEM Meet No/Date: ALC4/2013 LABORATORIES PRIVATE |ALC42014 1 1/82- andStatus:Re-indexed Deffered _ LIMITED 26.11.2014 83 'HQ File RLA File Lic.No/Date:09 10057784 |Defer 01/82/050/00908/AM14/ —_—|:09/24/040/00288/AM14/ 01.10.2013 Date:22.12.2014 ----- End of picture text -----

==> picture [453 x 126] intentionally omitted <==

----- Start of picture text ----- Decision : It was decided to remind the firm to furnish complete technical details as per Appendix 33 and (ii) past production vis-avis actual consumption of inputs duly certified by Central Excise _ |Authority. The case was deferred for 22.12.2014. ~ [Case No.:48/17/82- Party Name:INCHEM Meet No/Date:11/82- _[Status:Deffered JALC4/2013 LABORATORIES PRIVATE |ALC4/2014 and Re-indexed LIMITED 26.11.2014 84 :01/82/050/00910/AM14/HQ File RLA:09/24/040/00287/AM14/ File 01.10.2013Lic.No/Date:0910057785 Date:22.12.2014(Defer ----- End of picture text -----

Decision : It was decided to remind the firm to furnish complete technical details as per Appendix [33 and (ii) past production vis-avis actual consumption of inputs duly certified by Central Excise Authority. The case was deferred for 22.12.2014.

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

----- Start of picture text ----- [Case No.:39/16/82- Party Name:SANMAR Meet No/Date:11/82- [Status:Deffered ALC42013 SPECIALITY CHEMICALS /ALC4/2014 and Re-indexed . LIMITED, 26.11.2014 HQ Fite RLA File Lic.No/Date:0410150519 iDefer :01/82/050/00852/AM14/ :04/24/040/00146/AM 14/ 03.10.2013 Date:22.12.2014 ----- End of picture text -----

_|Decision :It was decided to remind the firm to furnish the following technical details: 1. Complete set of Application

Details of manufacturing process of 4 chlorobutylveratrate 60% solution in Methyl - 85 |Ethyl-Ketone with chemical equations, molecular formula, molecular weights.
Yield obtained in each step.
Authentic technical literature in support of yield obtained.

==> picture [415 x 97] intentionally omitted <==

----- Start of picture text ----- 5. Material balance. — 6. CA certificate certifying the production of export item achieved by firm for the past three years and corresponding consumption of each input. 7. Detailed calculations, arriving at the norms applied for. i, The sNIRMAL KUMAR — cage was deferred for 22.12.2014 pict Ss Ss ree Ae = py. Director e ign ----- End of picture text -----

i, sNIRMAL KUMAR pict Ss Ss ree Ae py. Director e ign Trade red Ors,HE gee 7 wee

==> picture [455 x 495] intentionally omitted <==

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

||||||||
|---|---|---|---|---|---|---|
|;|Case No.:26/17/82-|Party|Name:MYLAN|Meet No/Date:|1 1/82-|Status: Deffered|
|ALC4/2013|LABORATORIES LIMITED||ALC4/2014|and Re-indexed|
|26.11.2014|
|HQ|File|RLA|File|Lic.No/Date:0910057816||Defer|
|:01/82/050/00888/AM14/|:09/24/040/00302/AM14/|{04.10.2013|Date:22.12.2014|
|Decision|:It was decided|remind the firm to furnish|following technical|details|:|
|86|
|i)|Molecular weight of|each reactant and|output product at each step of manufacturing.|
|process.|
|ii)|Yield calimed by the firm appears to be very low.|Copy of|Technical|Litrature /Patent|
|may be|furnished|in support of|yield, claimed.|
|iii)|Past productin|vis-a-vis|actual consumption of inputs duly|certified by Central|Excise|
|Authorities.|
|The case was deferred for 22.12.2014.|
|Case No.137/23/82-|Party Name:MANGALAM|(Meet No/Date:11/82-|__|Status:Deffered|
|ALC4/2013|DRUGS & ORGANICS|ALC4/2014|and Re-indexed|
|LIMITED|26.11.2014|
|HQ|File|RLA File|Lic.No/Date:03 10753231|iDefer|
|87|:01/82/050/01184/AM14/|:03/95/040/00454/AM14/|11.16.2013|Date:22.12.2014|
|Decision|:it was decided to|call from the firm following information:|
|1)|Complete technical details as per Appendix 33.|
|Il)|Past|production|vis-a-vis Actual consumption|of Inputs for last three years duly|certified|by|
|Central|Excise Authorities.|
|The|case was|deferred for 22.12.2024.|.|
|Case No.:37/17/82-|Party Name:MYLAN|Meet No/Date:|1 1/82-|Status:Deffered|
|ALC4/2013|LABORATORIES LIMITED||ALC4/201!4|and Re-indexed|
|:|;|.|26.11.2014|a|
|JHQ|File|RLA|File|Lic.No/Date:0910057908|(Defer|
|| :01/82/050/00899/AM|14/|:09/24/040/00316/AM14/|[11.10.2013|_||Date:22,12.2014|
|88||Decision|:it was decided remind the firm to furnish following information:|
|qt)|Stepwise % yield on molar|basis alongwith copy of technical|literature in support of yield|
|envisaged and molar ratio of Diethanolamine,|and|
|Il)|Past production vis-a-vis Actual consumption of Input duly certified by Central|Excise Authorities|
|in|respect|of another Advance authorization taken by Matrix in|2010-11.|

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

_ |The case was deferred for 22.12.2014.

| [Case No.:17/4/82Party Name:NAPROD LIFE [Meet No/Date:11/82|Status:Deffered ALC4/2014 SCIENCES PVT. LTD. ALC4/2014 ‘and Re-indexed 9 fae|:01/82/050/00265/AM1File 5/ RLA:03/95/040/00563/AM File i4/. 117.18.201326.11.2014Lic.No/Date:03 10754049 |DeferDate:22.12.2014 Decision : It was decided tocall following technical details from the firm viz:(a) Complete technical details as per Appendix-33 (b) % content of Buffering Agent in Export Product. __ |The case is deferred for 22.12.2014.

==> picture [127 x 71] intentionally omitted <==

----- Start of picture text ----- AS pier saad See etrateen0 pieorewarSyepeNy; aAew in ud? ----- End of picture text -----

0 |: | 7 | |

|AR<br>CaseNo.:17/24/82-<br>ALC4/2013|,<br>PartyName:EYTANLABS = [MeetNo/Date:11/82-<br>LIMITED<br>ALC4/2014|,<br>PartyName:EYTANLABS = [MeetNo/Date:11/82-<br>LIMITED<br>ALC4/2014|Status:Deffered<br>andRe-indexed|,|
|---|---|---|---|---|
||||6.11.2014|||
|90 |HQFile|RLA File|Lic.No/Date:0910057998||Defer||
|01/82/050/01216/AM14/|—_—[:09/24/040/00355/AM14/|24.10.2013|_[Date:22.12.2014||
|Decision : Itwasdecidedtodefer thecasefor22.12.2014forcommentsofDepartmentof|||||
|Case No.:48/4/82-|PartyName:MANGALAM|(MeetNo/Date:11/82-|___[Status:Deffered||
|ALG42014|DRUGS&ORGANICS<br>LIMITED|ALC4/2014<br>26.11.2014|andRe-indexed||
|91 |HQ<br>File|RLA File|Lic.No/Date:0310755274||Defer||
|:01/82/050/00296/AM15/|:03/95/040/0057 1/AM14/|410.2013|{Date:22.12.2014||
|Decision : Itwasdecided|todefer thecase for22.12.2014 forcommentsofDepartment of||Department of||
|[Phi<br>euticals.|||||
|Case No.1138/23/82-|PartyName:MIDASCARE|[MeetNo/Date:11/82-|__[Status:Deffered||
|ALC4/2013|PHARMACEUTICALSPVT||ALC4/2014|and Re-indexed||
|a|LTD|26.11.2014|||
|HQFile<br>9211,01/82/050/01185/AM14/|IRLAFile<br>—_—_—|:03/95/040/00S99/AM14/|Lic.No/Date:0310755504 <br>25.10.2013<br>-||Defer<br> [Date:22.12.2014||
|:pangs :Itwasdecidedtocallfrom the firmcop**y**ofDML(DrugManufacturingLic**e**nce),and<br>copy ofMasterBatch Formuladulyauthenticatedb Quality Control Incharge.Thecas was|||||
|def<br>for22.12.2014,|||||
|||||||
|aseNos zais2-<br>ALC4R2013|PartyName:‘SANZYMELTD = |MeetNo/Date:11/82-<br>ALC42014||Status:Deff**e**r**ed**<br>and Re-ind x||
|||26.11.2014|||
|po||||||
|93 |HQFile|RLA File||Lic.No/Date:0910058014|[Defer||
|:01/82/950/01202/AM14/|:09/24/040/00295/AM14/|(25.10.2013|Date:22.12.2014||
|Decision : ItwasdecidedtosendacopyofapplicationtoDepartmentof| Biotechnology.<br>Thecasedeferred for22.12.2014.<br>.|||||
|CaseNo:36/19/82-<br>ALCAOL3<br>a|Party Name:SOHAM<br>ORGANICSPVTLTD|MeetNo/Date:11/82-_|Status:Deffered<br>ALC4/2014<br>andRe-indexed<br>26.11.2014|||
|joq [HQ File|RLA File|Lic.No/Date:3 110060943|[Defer||
|:01/82/050/00981/AM14/|—_—|:31/83/040/00124/AM14/|—[29.10.2013|Date:22,12.2014||

Decision : It was decided to cail from the firm the complete technical details as per Appendix 33. The case was deferred for 22.12.2014.

|95|CaseNo.:78/23/82-<br>ALC4/2013<br>Z<br> [HQFile<br>:01/82/050/01125/AM14/|;|PartyName:AMIORGANICS = |MeetNo/Date:11/82-<br>Status:Reject<br>PVTLTD.<br>ALC4/2014<br>26.11.2014<br>RLAFile<br>Lic.No/Date:5210040368 PeteDate:<br>:52/24/040/0003L/AM14/<br>31.10.2013|
|---|---|---|---|
||Decision : Itwasdecided|torejectthecase asthefirmhasnotfurnished information||
||despiterepeatedreminders.||ferretSar/NIRMAL‘ue<br>Dy. DirectorGeneral of ForeignTrade<br>Pee ATTN AETPreereTs<br>DirectorateGeneral of ForeignTrade|
||||arr frvDepartment ofCommerce|
||||UdyogBhawan,<br>NewDelhi|

2¢

==> picture [457 x 318] intentionally omitted <==

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

|||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
|Case No.:19/24/82-ALC4/2013|[Party NameSMILAX|Meet No/Date:11/82-|_[Status:|
|LABORATORIES LIMITED|/ALC4/2014|{Approved|
|.|6.112014|
|1HQ File|RLA File|Lic.No/Date:0910058170|[Defer Date:||
|}:01/82/050/01218/AM14/|:09/24/040/00382/AM14/|08.11.2013|
|Decision|:|In|the|light|of written comments|received from|Department of Pharmaceuticals|vide|
|their OM|No.|3501 1/240/2014-PI(Norms)|dated|28.10.2014,|it|was|decided|to|ratify|the|norms|
|under Para 4.7 of|HBP v1|as per details given below or as applied by the firm, whichever|is|less:|
|f|Export Product|Export|| S. No.|| Import Item|Qty.|
|.|Qty|Allowed|
|"6|kg/kg|
|Tert-butyl 2-((4R,6R)-|(4R,6R)-Tert-butyl-6-|0.588|
|6-(2-(-(4-fluropheny])-|cyanomethyl-2,2-|
|| See|hy|Sphenyl-|dimethyl-1,3-dioxane-|
|||||4(phenylcarbamy))|-|4-acetate (ATS 8)|
|{|1H-pyrrol-1-yl)|-2,2-|
|||4-yl)|acetate|
|{|Cyclohexane|1.14|
|||(Atorvastatin coupled|y|
||]|compound N-2)|Isopropyl|alcohol|

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

RA may take appropriate action as per the decision ofNorms Committee

Case No.:29/24/82Party Name:ATGC BIOTECH |Meet No/Date: | 1/82Status:Deffered ALC4/2013 PVT LTD ALC4/2014 and Re-indexed 26.11.2014 97 [HO File RLA File Lic.No/Date:09 10058222 [Defer :01/82/050/01228/AM14/ :09/24/040/00275/AM 14/ 13.11.2013 Date:22.12.2014 Decision : It was decided to defer the case for 22.12.2014 for comments of Department of _{Pharmaceuticals.

” [Case No.:16/24/82. Party Name:GLAND [Meet No/Date:11/82. (Status: ALC42013 PHARMA LIMITED ALC4?2014 Approved 26.11.2014 HQ File IRLA File Lic.No/Date:0910058218 (Defer Date: :01/82/050/01215/AM14/ :09/24/040/00385/AM14/ 13.11.2013 Decision : Committee considered the case as per agenda and in light of written comments 98 received from Department of Pharmaceuticals vide their OM No. 35011/222/2014-Pl(Norms) dated 01.12.2014 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 ofHBP as per details below or as applied by firm whichever is lower:-

==> picture [435 x 83] intentionally omitted <==

----- Start of picture text ----- [A] For Export ofRocuronium Bromide Injection 10mg/ml, 5mi Vial USP——__-—__1No. S.No. Import Item Norms As per per Batch Lowest of Applied Central Logsheet | (2) to to (4) ; = Excise== a AIIaehhat — ----- End of picture text -----

==> picture [271 x 56] intentionally omitted <==

----- Start of picture text ----- Norms As per per Batch Lowest of Applied Central Logsheet | (2) to to (4) = Excise== a AIIaehhat — ----- End of picture text -----

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

----- Start of picture text ----- : ----- End of picture text -----

==> picture [93 x 32] intentionally omitted <==

----- Start of picture text ----- pier eat, ~ ew ar ah naw? v ayo? ----- End of picture text -----

| | | | |

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

|||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|wm||lm2||S)3|ww|||wg|||
|||Rubber|||PPinos|
|||
|USP|
||||{_8||||[Hydrochloric]|USP___||0.0000004Iit_|||_Excipients|&|Relevant,|
||||10119|||||Tubing, PlasticFilters,Anti factorPlasticxa test_|_0.00__—_—|_0.kits ||[0.000101nos.]|0|006731it_|181nos.|||||Consumables.|Net to Net|
|columns|
|[eee|ea|
|Note:-|These|norms|are|specific|to|US|FDA|project.|The|higher|norms|for|packing|
|matrials|shall|be|permissible|only|in|respect|of export|to USA and|will|not|be|applicable|
|on repeat basis.|

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

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

||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|[B]|For Export|of Rocuronium|Bromide|Injection|10mg/ml,|10m! Vial|USP----------—|
|1No.|
|S.No.|Import Item|Norms|As per|Batch|Lowest of|
|Applied|Central|Logsheet|||(2) to (4)|
|Excise|
|1|2|3|4|5|
||||[3_[Rubber Stoppers||__1.10nos._ ||1.1067|||1.1053__|_1.10nos_|
|[6||Benzylalcohol||_0.000044lit_||
|[9|P108||[HydrochloricTubing|||(0.0 0.0|00|0004li6731i|t|_|||——-Excipients&|Relevant,|
|||11||[FilAn|t|iers factor|xa|test|kits |0.00018Inos.|[0.000101nos.]||||Consumables.|Net|to|Net|
|columns|
|-|.|,|NIRMA!|r||Baar|
|Die|earuDepartmentwn|
|wert wet,|4|Deihi|
|udyog|phaw|‘|

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

Note:- These norms are specific to US FDA project. The higher norms for packing matrials shall be permissible only in respect of export to USA and will not be applicable on repeat basis.

||CaseNo.:26/24/82-<br>ALC4/2013|PartyName:GLAND<br>PHARMALIMITED|MeetNo/Date:11/82-<br>4/2014|Status:Deffered<br>andRe-indexed|
|---|---|---|---|---|
||||6.11.2014||
|99||HQ File|RLA File|Lic.No/Date:0910058221||Defer|
||:01/82/050/01225/AM14/|:09/24/040/00392/AM14/|13.11.2013|Date:22.12.2014|

Case No.:28/24/82Party Name:PORUS Meet No/Date: 1 1/82Status:Deffered ALC4/2013 LABORATORIES PVT LTD. |ALC4/2014 and Re-indexed . 26.11.2014 J1¢0 JHQ File RLA File Lic. No/Date:09 10058239 [Defer :01/82/050/01227/AM14/ 109/24/040/00396/AM14/ 18.11.2013 _ -fDate:22,12.2014

[Case No.:74/23/82-ALC4/2013 (Party Name:SWISS EXPORTS [Meet No/Date:11/82. Status: PVT. LTD. ALC42014 Approved 26.34.2014 HQ File RLA File Lic.No/Date:0810126591 [Defer Date: :01/82/050/01121/AM14/ 108/24/040/0035 1/AM14/ 2L.1E.2013

==> picture [451 x 216] intentionally omitted <==

----- 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. 35011/236/2014-PI(Norms) dated 30.10.2014 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details given below or as applied by firm whichever is lower:~ 101 | Qty. :| Amoxicillin= anne and 1 PotassiumClavulanate 300.90 mg/625 \ mg tablet Diluted with pavulanate 7 . * ! USP 605 mn abiet Microcrystalline I 8 Cellulose (1:1) ----- End of picture text -----

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

==> picture [501 x 115] intentionally omitted <==

----- Start of picture text ----- Case No.:140/23/82- Party Name:UNITED Meet No/Date: 1 1/82- Status:Deffered 102 ALC4/2013 PHOSPHORUS LTD. ALC4/2014 and Re-indexed ——- (26.11.2014 owt  [HQ File [RLA File [Lic.No/Date:03 10758627 [Defer reOA 00 oiot esepo Ge 08%,eeDE AeCIOAN CoO IO" ----- End of picture text -----

foyszsoorisv/amia’ ——[-03/95/040/00495/AMI4/ [21.11.2013 __——_—~(Date:22.12.2014 | _ Decisionjof\C&PC.: It was decided to defer the case for 22.12.2014 for comments of Department

Cage No.:101/23/82Party Name:ACEBRIGHT (Meet No/Date:11/82_|Status:Deffered 4/2013 ENDIA) PHARMA PVT ALC4/2014 and Re-indexed | LTD, 26.11.2014 {103 |HQ File RLA File Lic.No/Date:07 10099923 |Defer :01/82/050/01 148/AM14/ :07/24/040/00269/AM14/ 25.11.2013 Date:22.12.2014

Decision : It was decided to cal! from the firm the complete technical details as per Appendix _ |33. The case was deferred for 22.12.2014.

==> picture [455 x 103] intentionally omitted <==

----- Start of picture text ----- [~ [CaselNo.:20/24/82- Party Name:GLAND Meet No/Date:11/82- [Status:Deffered ALC#4/2013 PHARMA LIMITED ALC42014 and Re-indexed 4 | 26.11.2014 | 104 HQ File RLA File Lic. No/Date:09 10058310 (Defer |:01/82/050/01219/AM14/ —|:09/24/040/00405/AM14/_([25.11.2013 Date:22.12.2014 |Decision : It was decided to defer the case for 22.12.2014 for comments of Department \jof Pharmaceuticals. ----- End of picture text -----

\Case No.111/24/82-ALC4/2013 [Party Name:GLAND [Meet No/Date:11/82(Status: PHARMA LIMITED ALC4/2014 approved {26.11.2014 a . HQ Fik RLA File Lic.No/Date:0910058351 [Defer Date: :01/8: N$0/01210/AM14/ 709/24/040/00420/AM 14/ — 426.11.2013 Decision : Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 3501 1/218/2014-PIl(Norms) dated 30.10.2014 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:

==> picture [304 x 27] intentionally omitted <==

----- Start of picture text ----- Export|Product Acetyltysteine Solution USP 200mg/ml(20%), 4ml vial USP ----- End of picture text -----

==> picture [482 x 272] intentionally omitted <==

----- Start of picture text ----- 105 Si.No, Norms As per Central Batch Lowest of Applied Excise Logsheet (2) to (4) Certificate ri || | [Acetylcysteine] Z 3 4 : [Vials][ Glass] 1.1137 1.0912 [2 [||] | 880mg/vial | AsperSION | 880mp/vial Rubber =] 1 AluminiumDroppers plastic [—1.05nex, [= 08 3—TT Fitters Plastic | 0.0003n0s. | = | = +71 Tubing Plastic | 0.00067 foot [- | = |. NettoNet| [B]For Export of Acetylcysteine So ion USP, 200mg/ml.(20%), 30m! vial USP oe eta BAe/NIR AL KUMAR geeSu, TETeGerereloral ofof ForeignFOTO"TTS? Liens | Giron fraruDeperment of Commer sere bnawan. New Deln ----- End of picture text -----

| |

==> picture [455 x 198] intentionally omitted <==

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

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

----- Start of picture text ----- _ ----- End of picture text -----

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----- Start of picture text ----- " Case No.:32/24/82- Party Name:GLAND Meet No/Date: ALC4/2013 1 1/82- Status: PHARMA LIMITED ALC42014 approved 26.11.2014 HQ File RLA File Lic.No/Date:09 10058353 |Defer Date: ONB20SO/OI23/AMI4/—:09/24/040/00417/AM14/ [26.11.2013 Decision : Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 3501 1/218/2014-PI(Norms) dated 30.10.2014 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:- Export Product Acetylcysteine Solution USP 200mg/ml(20%), 4ml vial USP 106 SLNo. Import Item Norms As per Batch Lowest of Applied Central Logsheet | (2) to (4) (1) Excise (2) Certificate (4) (5) 11 3 __| Acetyicysteine 880me/vial As per SION 880mp/vial 4 —| Vials Glass {1.064 nos. | —Eins7 | 1.0515} 1os 3 RubberRubber Stoppers | _ 1.076 nos. 1.1292 1.076 Seals Plastic &; 1.064 nos. 1.0795 1.0499 1.0499 ref Aluminium ry} PropoessBites Plastic plate [1080810.0008 mos-[ J]. re SS . Tubing Plastic 0.00067 Net to Net i foot . | : accordance with the earlier. decisions of Norms-Committee» present case ma - 3 [be considered specific to USFDA Project and Export to USA only. oe on ane ex » 8e oF Ae og Soe aoe . oF eter As eo yo ----- End of picture text -----

| :

==> picture [508 x 775] intentionally omitted <==

----- Start of picture text ----- 9 ; eamay takeappropriate action asper the decisionof Norms Committee. | Case No.:54/4/82- Party Name:NECTAR Meet No/Date:11/82- Status: ALC4/2014 LIFESCIENCES LIMITED, |ALC4/2014 approved c - | ca | 1:0fre1/82/050/00302/AM15/File LA:22/24/040/00062/AM14/ File [ieNosae2227.11.2013 10014403 Peter Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 3501 1/274/2014-PI(Norms) dated 30.10.2014, it was decided to ratify the norms under Para 4.7 of {HBP v1 as per details given below or as applied by the firm, whichever is less: | Quantity kg/kg | Cefuroxime Axetil 1 kg 1. Desacetyl-7-amino 0.79 : ACA) ) | [2 | Ethylacetate AC ! (3.] Methanol ——+ijoss | acetic acid ammonium salt | eo Syn-methoxyimino furanyl 107] [5. | Activatedcarbon(SMIA) [0.100 | a pentachloridePhosphorous or0.97 |7.| Methylene chloride [2.29 | [8 | Sodiumhydroxide [0.43 || [9 [00SAceticacid | i | alsocyanate || | |14__|Acetoxyethylbromide [059 )| |15___[Cyclohexane [RCS J item | Bee eee | | | | 20 Hydrochloric acid Not an importable | _.]RA may take appropriate action as per the decision ofNorms Committee. ‘1108 iteALC4/2013 No.:77/23/82- maPHARMACEUTICALSLIMITEDName:SHASUN iteALC4/201426.11.2014No/Date:1 1/82- notsand Re-indexed po :01/82/050/01124/AM14/ :04/24/040/00183/AM14/ 27.11.2013 Date:22.12.2014 “ lke File Rua File ; Lic NowDate4 10152258 pete Hh rie PaR/NiRM care, Oy.eee = of Praer Uasey brSwant New beth ----- End of picture text -----

FE I

, 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 22.12.2014.

==> picture [13 x 13] intentionally omitted <==

----- Start of picture text ----- X ----- End of picture text -----

|[CaseNo.:94/23/82-<br>ALC4/2013|PartyName:DHANUKA<br>LABORATORIESLTD.|[MeetNo/Date:11/82.<br>—_|ALC4/2014|(Status:<br>approved|
|---|---|---|---|
|||26.11.2014||
|HQFile<br>:01/82/050/01141/AM14/|RLA File<br>:05/23/040/00342/AMI14/|Lic.No/Date:0510372219 <br>28.11.2013||DeferDate:|

Decision: In the light of written comments received from Department of Pharmaceuticals vide their OM ©. 35011/349/2014-PI(Norms) dated 28.11.2014, it was decided to ratify the norms under Para 4.7 of HBP vi as per details given below or as applied by the firm, whichever is less:

|109|CEFEXIMEUSP/BP/IP/EP<br>Ee|e/K2<br>7-AVCA(7-Amino-3-Vinyi-<br>0.57<br>he<br>[eisoamesc<br>| OST<br>E[ometseante<br>||
|---|---|---|
||,|a<br>4<br>| EthylAcetate<br>S.<br>MethyleneChloride|
|||3.84|
||RAmay take appropriateaction|ee<br>e<br>actionasperthedecisionofNormsCommittee.|
||CaseNo.:104/23/82-<br>ALCA2OZ|PartyName:PCLOIL&<br>[MeetNo/Date:11/82-<br>(Status:Deffered<br>SOLVENTS LTD.,<br>ALC4/2014<br>andRe-indexed|
|||26.11.2014|
|||.|
|110||HQFile<br>:01/82/050/01151/AM14/|RLAFile<br>Lic.No/Date:05 10372321 |Defer<br>:05/24/040/00201/AM14/<br>29.11.2013<br>Date:22.12.2014|
||Decision : Itwasdecidedtodeferthecasefor22.12.2014 forcommentsofDepartment<br>ofC&PC.||

Case No.:8/24/82Party Name:SUVEN LIFE [Meet No/Date:11/82(Status: ALC42013 SCIENCES LIMITED ALC4/2014 approved 26.11.2014 HQ File RLA File Lic.No/Date:0910058405 Defer Date: :01/82/050/01207/AM14/ :09/24/040/00356/AMI4/ 29.11.2013

Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 3501 1/239/2014-Pl(Norms) dated 28.10.2014, it was decided to ratify the norms 111 [under Para 4.7 of HBP vi as per details given below or as applied by the firm, whichever is less:

==> picture [487 x 170] intentionally omitted <==

----- Start of picture text ----- Export Product SI. Import Item Qty. Allowed | ; Qua No. kg/kg | (2-Chloro-5-Iodo Phenyl). | i kg Ethyl Anthranitrile 0.963 | ¢4-Fluoropheny!)-MethanonePhenyl)- 0 Potassium lodide 0.713 . OFKE ERGO Sete OOOHan ey gern vo? ----- End of picture text -----

==> picture [337 x 64] intentionally omitted <==

----- Start of picture text ----- TT 4]aa [Oxalyl CCC hloride ; IRA may take appropriate action as per the decision ofNorms Committee. ----- End of picture text -----

==> picture [240 x 26] intentionally omitted <==

----- Start of picture text ----- 4]aa [Oxalyl CCC hloride | 0.509 ----- End of picture text -----

: Case No.:112/23/82Party Name:CADILA Meet No/Date:1 1/82Status: Deffered AL€4/2013 HEALTHCARE LTD., ALC4/2014 and Re-indexed 112 [HQ_ File | RLA File 26.11.2014Lic.No/Date:08 10126887 [Defer - _ |:01/82/050/01159/AM14/ —_|:08/24/040/00387/AM14/ [04.12.2013 - |Date:22.12.2014 Decision :Reply received from the firm and sent to Department of Pharmaceuticals on _ |03.12.2014.The case is deferred for 22.12.2014.

~~ [Case No.:18/23/82Party Name:NAPROD LIFE [Meet No/Date:11/82Status:Deffered
Ji |ALC4/2013 SCIENCES PVT. LTD. ALC4/2014 and Re-indexed anHQ File RLA File | Lic,No/Date:036.11.2014 10760768| |Defer 113 1:01/82/050/01065/AM14/ :03/93/040/00712/AM14/ 05.12.2013 Date:22,12.2014
| |Decision : It was decided tocall following technical details from the firm viz:(a) Complete technical details as per Appendix-33 (b) % content of Buffering Agent in Export Product.
___ {The case is deferred for 22.12.2014.

ALC4/2013Case No.:146/23/82PartyENTERPRISE Name:CHIRAG ALC4/2014Meet No/Date:1 1/82Status:Defferedand Re-indexed _ 26.11.2014 114 |HQ File RLA File Lic.No/Date:24 10040396 |Defer :01/82/050/01193/AM14/ :24/24/040/00022/AM14/ 06.12.2013 _ jDate:22.12.2014 Decision : It was decided to defer the case for 22.12.2014 for comments of Petro _ |chemical Division of Department of C&PC.

==> picture [460 x 250] intentionally omitted <==

----- Start of picture text ----- |Case No.:120/3/82- Party Name:INCHEM Meet No/Date:11/82- Status: JALC4/2014 LABORATORIES PRIVATE |ALC4/2014 approved in LIMITED 26.11.2014 i HQ File RLA File Lic.No/Date:09 10058483 |Defer Date: | }:01/82/050/00124/AM15/ :09/24/040/00416/AM14/ 06.12.2013 |Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/256/2014-Pl(Norms) dated 30.10.2014, it was decided to ratify the norms | under Para 4.7 of HBP vi as per details given below or as applied by the firm, whichever is less: 115: } f Export Product Export | SIL. Import Item Qty. Allowed 1 | Quantity | No. ke/ke | ! RACTOPAMINE HCL Lkg (RS)4-(2-amino-1- 0.77 | hydroxy ethyl) phenol hel | | 2. 4(4-hydroxy pheny!)2- I {RA may take appropriate action as per the decision ofNorms Committee. ----- End of picture text -----

a exta Ga/NIRMAL KUMAR Directorate artrnentof Comme

wy & i Case No.:115/3/82Party Name:NECTAR [Meet No/Date:11/82[Status: ALC4/2014 LIFESCIENCES LIMITED, jALC4/2014 approved 26.11.2014 HQ File RLA File Lic.No/Date:22 10014426 |Defer Date: :01/82/050/00119/AM15/ :22/24/040/00068/AM14/ 06.12.2013

==> picture [453 x 437] intentionally omitted <==

----- Start of picture text ----- |Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/271/2014-Pl(Norms) dated 11.1 1.2014, it was decided to ratify the norms under Para 4.7 of HBP vi as per details given below or as applied by the firm, whichever is less: | | Export Product Export S.No. | Import Item Qty. Allowed Quanti kg/kg 5. Hydrochloric acid Not an importable 116 | item | ee 037 fom iT a | ae a | La rn Ce a iS Relevant as per Aluminives Bottle packing policy RA beeuseouserunseunvounseessattueveuvecouurevanduentoutneeerevevoremesneuvmooccceesoonccurccommeecncccc ne cconerneeee ne ccacccetttatancvecanceanccanccicctntmiiiitetl may take appropriate action as per the decision of Norms Committee. ----- End of picture text -----

Case No.:4/5/82-ALC4/2014 ‘Party Name:SHASUN Meet No/Date:11/82Status:Deffered PHARMACEUTICALS ALC4/2014 and Re-indexed LIMITED 26.11.2014
117 [HQ File RLA File Lic.No/Date:04 10152693 [Defer :01/82/050/00321/AM15/ :04/24/040/00198/AM14/ 06.12.2013 Date:22.12.2014 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 22.12.2014.

==> picture [485 x 122] intentionally omitted <==

----- Start of picture text ----- 118 Case No.:47/4/82-ALC4/2014 [Party Name: VISION DRUGS [Meet No/Daie-11/82- Status:Deffered ; PVT LTD ALC4/2014 and Re-indexed_ Ape _ 26.11.2014 Lats oS in ofee 3 es © so ear ec as otecoeant Peuoo9 nae ----- End of picture text -----

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----- Start of picture text ----- | jnoFil:01/82/050/00295/AM15/ ~ IRLA709/24/040/00433/AM14/File 06.12.2013Lic. No/Date:0910058477 etDate:22.12.2014 Decision : It was decided to defer the case for 22.12.2014 for comments of Department of Pharmaceuticals. a . | {Case No.:96/23/82- Party Name:MOREPEN [Meet No/Date:11/82- __[Status: ALC4/2013 LABORATORIES LTD., ALC4/2014 approved i 26.11.2014 JHQ File RLA File Lic.No/Date:05 10372885 |Defer Date: |:01/82/050/01 143/AM14/ :05/24/040/003 13/AM14/ 09.12.2613 | ‘|Decision: In the light of written comments received from Department of Pharmaceuticals vide their OM } No. 35011/146/2014-PI(Norms) dated 09.10.2014, it was decided to ratify the norms under Para 4.7 of \HBP v1 as per details given below or as applied by the firm, whichever is less: ----- End of picture text -----

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----- Start of picture text ----- ‘| Export Product Export S.No. | Import Item Qty. Allowed / Quanti kg/ke | 8-Chloro-11- ph] 3-chloro benzyl cyanide | Hidroxy-N-Methyl : : | Piperidino Sodium methoxide 1.218 |] Azatadine(L8) 3. | N,N-Dimethyl carbomyl | 119 chloride 2.233 | | 4. | N,N-Dimethyl | formamide 0.05 | eet RA may take appropriate action as per the decision ofNorms Committee. It was also decided to call Production and consumption data duly certified by Central Excise Authority __ {through Pharmaexcil for revision of SION A-2409 for Loratiadine. [Case No.:137/3/82- Party Name:SUVEN LIFE [Meet No/Date:11/82- (Status: ALC4/2014 SCIENCES LIMITED ALC4/2014 approved . 26.11.2014 HQ File RLA File Lic.No/Date:09 10058555 |Defer Date: 201/82/050/00141/AM15/ :09/24/040/00427/AM 14/ 11.12.2013 120 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM Wo. 35011/272/2014-PI(Norms) dated 30.11.2014, it was decided to ratify the norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: ----- End of picture text -----

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----- Start of picture text ----- Qua kp/kg ----- End of picture text -----

eata Bart! NIRMAL KUMAR oo HETBr Sein Trade Oy eTearrare TENE Tecan Trade DirectorgteSETTeapartmentlan New of Commence Delhi

| ||

} amino)-phenyl): ; a
RA may take appropriate action as per the decision of Norms Committee. ALC4/2014 LABORATORIES PRIVATE |ALC4/2014 and Re-indexed htc No.:141/3/82aeLIMITEDName:COVALENT ie26.11.2014No/Date:1 1/82Status:Deffered
121 |HQ:01/82/050/00145/AM15/ File uA:09/24/040/004 File 18/AM14/ Lie12.12.2013NosDae-0910058567 DeferDate:22.12.2014 Decision : It was decided to defer the case for 22.12.2014 for comments of Department of Pharmaceuticals.
- Case No.:9/23/82-ALC4/2013 |Party Name:-NAWAL Meet No/Date:1 1/82Status:Deffered PRAKASH AVIKEM ALC4/2014 and Re-indexed
- | . | Pena a 1.2014 ms:01/82/050/01056/AM14/ File LA:03/95/040/00434/AM14/ File LicnopDates12.12.2013 10761637 [DeferDate:22.12.2014

Decision :It was decided to remind the firm to furnish the following information:

Separate weight of DI Ethylene Glycol, Fibres Glass String / Rope and Aluminium can in one number of final one number of export product i.e. AL cans with components may be furnished along with the copy of the export order.
Details and quantity of other indigenous inputs to be used in the manufacture of the export product may be indicated.
Detailed manufacturing process along with justification for wastages at each stage and also on each of the raw material may be furnished.

Complete material balance indicating input and output material at each stage of manufacturing process.
Standard /Authentic technical literature in support of the raw material requirement formulation for the manufacture of export product.
You have applied for the import ofaluminium foil/sheets as 1.30 kg/kg content in the Aluminium can which seems t be on gross weight basis and not on net content basis. The details of production of Aluminium cans and corresponding consumption of Aluminium foil/sheets may be furnished for the year 2012-13 and 2013-14.
The commercial sale value of the aluminium sheets scrap generated in the process may be furnished along with the documentary evidence. In addition, earlier NC decision for the import of Aluminium foil/sheets against the export of Aluminium can for your similar export product may also be furnished.
Details of production of export product under reference and corresponding consumption of raw material in the year 2011-12 and 2012-13 (April to December) duly certified by CA may be furnished. If the production has not commenced in the past, the details from 3 Me
commencement of production may be furnished duly certified by CA. Oe ASG ca Any other relevant information. Rae ec" . AE EES EAS oF oo <2 IGF So

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

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

__ {The case was deferred for 22.12.2014.

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----- Start of picture text ----- [Case No.:115/23/82- ~—~‘[PartyName:ALCHEM [Meet No/Date:11/82- (Status:Deffered JALC4/2013 INTERNATIONAL LTD. ALC4/2014 and Re-indexed 26.11.2014 oo Q File RLA File Lic.No/Date:05 10373480 |Defer :01/82/050/01162/AM14/ :05/23/040/00365/AM14/ 13.12.2013 Date:22.12.2014 ‘Decision : It was decided remind the firm to furnish following technical details from the firm 123)\viz:- | (a) % content ofTabersonine in the imported seeds and its % recovery in each step. (b) Content of other bye-products in the seeds, their % recovery and value. (c) Copy oftechnical literature in support of (a) and (b). (d) Past production of Vinpocetine vis-avis Actual consumption of imported : seeds for last 3 years duly certified by Central Excise Authorities. {The case is deferred for 22.12.2014. ~~“ {Case No.:139/3/82- Party Name:SMILAX Meet No/Date:11/82- |Status:Deffered J|ALC42014 LABORATORIES LIMITED |ALC4/2014 and Re-indexed 26.11.2014 [File] RLA File Lic.No/Date:0910058595 [Defer 124] [HO] | :01/82/050/00143/AMI5/ :09/24/040/00441/AM14/ 13.12.2013 Date:22.12.2014 Decision : It was decided to defer the case for 22.12.2014 for comments of Department _ of Pharmaceuticals. ----- End of picture text -----

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----- Start of picture text ----- Case No.:83/23/82- Party Name:SHIVA ) Meet No/Date:11/82- Status: ALC4/2013 PHARMACHEM LTD, ALC4/2014 approved : 26.11.2014 THQ File RLA File Lic.No/Date:34 10038734 [Defer Date: :01/82/050/01 130/AM14/ :34/24/040/0023 1/AM14/ 16.12.2013 ----- End of picture text -----

Decision :in the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/164/2011-Ch. It dated 27.11.2014, it was decided to lh25 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 Export Import items Qty Allowed { | Quantity | [octave| N-OCTYL CHLORIDEMORPEPCHIORS/ 1-CHLORO Tang [1 [SernaOCTYL ALCOHOLOOS7 N- [0.972 kg ----- End of picture text -----

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

. Case No: 7/18/82-ALC4/2013 Party Name:SWISS Meet No/Date: EXPORTS t 1/82Status: Deffered PVT. LTD. ALC4/2014 and Re-indexed : 26.11.2014 |!26 fig File RLA File Lic.No/Date:0810127123 [Defer | of :01/82/050/00942/AM 14/ :08/24/040/00400/AM 14/ 16.12.2013 Date:22.12.2014 VV ———[Decision : It was decided: to defer the case- for 22.12.2014 for comments of Department ALL. UMAR oe dicey General of Foreign Trade fae TAY TERT Directorate General of Foreign . arftrea RarUDepanment of Commerce ee Lean Now Delhi

3&8

| |

| of Pharmaceuticals.

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----- Start of picture text ----- & ----- End of picture text -----

Case No.:33/3/82Party Name:HETERO Meet No/Date:11/82Status: ALC4/2014 DRUGS LIMITED, ALC4/2014 approved 26.11.2014 )
HQ File RLA File Lic.No/Date:09 10058622 |Defer Date: :01/82/050/00037/AM15/ :09/24/040/00466/AM14/ 17.12.2013

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----- Start of picture text ----- | [Decision : In the light of written comments received from Department of Pharmaceuticals vide |their OM No. 35011/286/2014-Pl(Norms) dated 11.11.2014, it was decided to ratify the norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Ot ke/kg P 127 | Lisinopril pe | 2,2,2-Trifluoro acetic acid | | monohydrochloride3-Benzoylester acrylic acid ethyl Poa | | 4. | Lithium hydroxide 0.184 | 6. | N.N-Carbonyl diimidazole 0.400 ----- End of picture text -----

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

Case No.:119/3/82Party Name:HETERO LABS |Meet No/Date:1 1/82Status: ALC4/2014 LIMITED ALC4/2014 approved 26.11.2014 HQ. File IRLA File Lic.No/Date:09 10058620 |Defer Date: :01/82/050/00123/AM15/ :09/24/040/00470/AM 14/ 17.12.2013

Decision :in the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/282/2014-Pi{Norms) dated 11.11.2014, it was decided to ratify norms under Para 4.7 of HBP Vv Las per details given below or as applied by the firrn whichever is less:

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----- Start of picture text ----- 128 kg/kg Item of Export Quantity SNe | Item of Import Quantity allowed | DARUNAVIR AMORPHOUS 4-phenyl butane 10(3,4-b)furan-2-(3H)-on | >a 3 Tobuptamine | Fa [CdS [NNDisncinimidytewtonne] [0.90 | ----- End of picture text -----

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

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----- Start of picture text ----- ¢ 129 Case|ALC42014 No.:98/3/82- PartyLIMITEDName: VIVIMED LABS [MeetALC4/2014No/Date:11/82- _[Status:approved jE.Ses9 26.11.2014 sgt ot Oc? a PREECEeo i \“f oeESO “S OSS is rascoe ae 9;ee oe EFS09 Ss ----- End of picture text -----

| [HQ:01/82/050/00102/AM15/ File RLA:09/24/040/00448/AM14/ File Lic.17.12.2013 No/Date:0910058626 Pet Date: | | Decision : In the light of written comments received from Department of Chemicals and | ‘Petrochemicals vide their U.O No. 14010/43/2011-Ch. Il dated 13.11.2014, it was decided to ! jratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, | whichever is less:

1 Export product Export import items Qty Allowed | Quantity VIOLET 14D NITRO-P- PHENYLENEDIAMINE

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

~ Case No,:39/23/82Party Name:AARTI Meet No/Date: 1 1/82Status: ALC4/2013 INDUSTRIES LIMITED —|ALC42014 pproved ; 26.11.2014 | |HQ File RLA File Lic.No/Date:03 10762301 |Defer Date: 101/82/050/0 1086/AM 14/ :03/94/040/00760/AM14/ 18.32.2013

Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 3501 1/189/2014-PI(Norms) dated 28.11.2014, it was decided to ratify the norms 130 junder Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

| Export product Export import items Qty Allowed | Quantity ke/kg ferme nanos [ag |?[[NOIRE] 6-AMINO -1,3 DIMETHYL -5fase _ [RA may take appropriate action as per the decision of Norms Committee.

Case No.:85/23/82Party Name:PARENTERAL [Meet No/Date:11/82Status:Deffered ALC42013 DRUGS (INDIA) LTD., ALC4/2014 and Re-indexed 26.11.2014 HQ File RLA File Lic.No/Date:56 10003400 |Defer :01/82/050/01132/AM14/ :56/24/040/00033/AM14/ 20.12.2013 Date:22.12..2014

131 [Decision : It was decided to defer the case for 22.12.2014 for comments of Department of Pharmaceuticals.

[Case No.:11/3/82-ALC4/2014 [Party Name:MICRO LABS [Meet No/Date:11/82|Status:Deffered t LTD ALC4/2014 and Re-indexed 26.11.2014 13270 File RLAFile Lic.No/Date:0710100791 [Defer :01/82/050/000 15/AM15/ :07/24/040/003 18/AM14/ 3.12,2013 Date:22.12.2014 7 : Decision: In the light of written comments received from Department of P aceuticals vide i AL AR 1 rep TEE ao wa ‘or General bs Director TyDepariment HI aeUdyog an NOW beim

| |

Yo

their OM No. 3501 1/261/2014-Pl(Norms) dated 26.11.2014, it was decided to call from the firm the following technical details:

i) Complete set of application

ii) Pack size of oral suspension. iii) DML for export items showing composition of each export

The case was deferred for 22.12.2014.

Case No.:142/3/82Party Name:SRIAM LABS Meet No/Date:[1] 1/82Status:Deffered ALC4/2014 PRIVATE LIMITED ALC4/2014 and Re-indexed 6.11.2014 133 {HQ| File RLA File Lic.No/Date:0910058708 [Defer :01/82/050/00146/AM15/ :09/24/040/00439/AM 14/ 24.12.2013 Date:22.12.2014 Decision : It was decided to defer the case for 22.12.2014 for comments of Department of Pharmaceuticals.

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----- Start of picture text ----- Case No:144/3/82- Party Name:SRINI Meet No/Date:11/82- _[Status:Deffered ALC4/2014 PHARMACEUTICALS C4/2014 and Re-indexed LTD., 26.11.2014 134 [HQ File RLAFile Lic.No/Date:09 10058728 |Defer :01/82/050/00148/AM15/ :09/24/040/0047 1/AM14/ 26.12.2013 Date:22.12.2014 Decision : It was decided to send a copy of application to Department of Pharmaceuticals for their comments. The case is deferred for 22.12.2014 . J cttnuenpammminveiaeesiesanmmeininitttt CNN A NC CA Case No.:38/4/82-ALC4/2014 Party Name:ALTA Meet No/Date: [1][ 1/82-] Status: Deffered LABORATORIES LTD. ALC4/2014 and Re-indexed 26.11.2014 135 |HQ File RLA File Lic.No/Date:03 10763559 |Defer :01/82/050/00286/AM15/ :03/94/040/00796/AM14/ 27.12.2013 Date:22.12.2014 Decision : It was decided to defer the case for 22.12.2014 for comments of Department of Pharmaceuticals. ----- End of picture text -----

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----- Start of picture text ----- Case No.:48/23/82- Party Name:EXCEL Meet No/Date:11/82- Status: Deffered ALC4/2013 INDUSTRIES LIMITED ALC4/2014 and Re-indexed 26.11.2014 136 [HQ File RLA File Lic. No/Date:03 10763628 |Defer :01/82/050/01095/AM14/ :03/94/040/007 19/AM14/ 30.12.2013 Date:22.12.2014 Decision : It was decided to defer the case for 22.12.2014 for comments of Department of C&PC. Case No.:22/3/82-ALC4/2014 |Party Name:GLAND Meet No/Date: [1] 1/82- Status:Deffered PHARMA LIMITED ALC4/2014 and Re-indexed 26.11.2014 137 }HQ File RLA File Lic.No/Date:09 10058787 |Defer :01/82/050/00026/AM 15/ :09/24/040/00485/AMI14/ 31.12.2013 Date:22.12.2014 peDecisionPharmaceuticals.; It was decided to defer the case for 22.12.2014 for comments of Departmentoie ato? ee oe Aid x oeKS seo Ooooore oOetSeote™oe [oe] ver ----- End of picture text -----

Wyo

| | | | |

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

||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|ase No.:96/3/82-ALC4/2014||Party Name:GLAND|Meet No/Date:1|1/82-|Status:|
|PHARMA LIMITED|ALC4/2014|Approved|
|26.11.2014|
|||Q File|RLA File|Lic.No/Date:0910058788|[Defer Date:|
|:01/82/050/00100/AM15/|:09/24/040/0048|1/AM14/|31.12.2013|
|{Decision|:|Committee|considered|the|case|as|per|agenda|and|in|light|of|written|comments|
|| received|from|Department|of|Pharmaceuticals|vide|their|OM|No.|35011/53/2014-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|

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

lower:-

Export Product : Adenosine Injection USP Prefilled Syringe 3mg/ml, 4m! in a PFS

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

||||||||||
|---|---|---|---|---|---|---|---|---|
|Import|Item|Norms|As per Central|Batch|Lowest of|
|Q)|Applied|Excise|Logsheet|(2) to (4)|
|138|(2)|Certificate|(4)|
|3|
|gm/vial|em/vial|
||2|_||Barrel Syringes|(Glass|1.28 Nos.|1.1095|1.1095 Nos.|
|4|_||PlungerPlastic|Stoppers|(Rubber|1.28Nos. Nos.|1.1481|1.1481|Nos.|
|Plunger Rods|(Plastic|1.08 Nos.|1.03|Nos.|1.03|Nos.|
|6_||[Filters]|[(Plastic]|Consumable,|on Net to Net basis|
|Tubing|(Plastic|
||8|||Reference|Standards|

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

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

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

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----- Start of picture text ----- {1 [Case No.:88/3/82- Party Name:MYLAN [Meet No/Date:11/82- _(Status:Deffered | | |ALC42014 LABORATORIES ALC4/2014 and Re-indexed 1° LIMITED 26.11.2014 HQ File RLA File Lic.No/Date:09 10058792 [Defer :01/82/050/00092/AM 15/ |:09/24/040/0045 1/AM14/ |31.12.2013 Date:22.122014 ----- End of picture text -----

Decision :In the light of written comments received from Department of Pharmaceuticals vide 39 their OM No. 3501 1/254/2014-PI(Norms) dated 26.11.2014, it was decided to call from the firm lfollowing information:-

(a) % yield on molar basis for each step of manufacturing process (b) Requirement and Recovery of solvent of each step.

(d) Past production vis-a-vis Actual consumption of Input duly certified by Central Excise Authorities

The case was deferred for 22,12.2014

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----- Start of picture text ----- h40 [Case Nosaren-aLcarord PartyLIFESCIENCESName:SAFECON MeetALC4/2014No/Date:11/82-fy __(Status:Defferedand Re-indexed fy ----- End of picture text -----

Seta gax/NIRMAL KUMAR on aan Sonera of Foreign Trade ex aT ABTA RTT areaDirectorate far ConorDepartment of eecf GO erce udyog borat a SS Delhi

| ! } | | |

ns 510) es HQ File RLA File Lic.No/Date:61 10001120 [Defer :01/82/050/00004/AM15/ 361/24/040/00033/AM14/ 31.12.2013 Date:26.11.2014 Decision : It was decided to defer the case for 22.12.2014 for comments of Department of Pharmaceuticals. Case No.:244/3/82Party Name:SAFECON Meet No/Date:1 1/82Status: Deffered ALC4/2014 LIFESCIENCES ALC4/2014 and Re-indexed 26.11.2014 14] |HQ File RLA File Lic.No/Date:6 110001119 |Defer :01/82/050/00248/AM15/ 161/24/040/00023/AM 14/ 31.12.2013 Date:22.12.2014 Decision : It was decided to defer the case for 22.12.2014 for comments of Department of Pharmaceuticals.

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

Case No.:55/23/82Party Name:;SATY AJIT Meet No/Date:11/82Status: Deffered ALC4/2013 CHEMICALS PVT.LTD., ALC4/2014 and Re-indexed 26.11.2014
142 |HQ File RLA File Lic.No/Date:03 10763764 |Defer :01/82/050/01102/AM14/ :03/95/040/0079 1/AM14/ 31.12.2013 Date:22.12.2014
- Decision : It was decided to defer the case for 22.12.2014 for comments of Department of Pharmaceuticals.
Case No.:53/23/82Party Name:EXCEL Meet No/Date:11/82Status:Deffered ALC4/2013 INDUSTRIES LIMITED ALC4/2014 and Re-indexed . 26.11.2014
143 |HQ File RLA File Lic.No/Date:03 10764365 |Defer :01/82/050/01 100/AM 14/ 03/94/040/00744/AM14/ 02.01.2014 Date:22.12.2014 Decision : It was decided to defer the case for 22.12.2014 for comments of Department of C&PC.

Case No.:38/3/82-ALC4/2014 Party Name:PARENTERAL = |Meet No/Date:11/82Status: Deffered DRUGS (INDIA) LTD., ALC4/2014 and Re-indexed | 6.11.2014 HQ File RLA File Lic. No/Date:56 10003472 |Defer :01/82/050/00042/AM15/ :56/24/040/00036/AM 14/ 02.01.2014 Date:22,12.2014

144 |Decision : It was decided to defer the case for 22.12.2014 for comments of Department of Pharmaceuticals.

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----- Start of picture text ----- Case No.:1 18/3/82- Party Name:PARENTERAL (Meet No/Date:11/82- Status: Deffered ALC4/2014 DRUGS (INDIA) LTD., ALC4/2014 and Re-indexed 145 6.11.2014 aN THQ File RLA File Lic.No/Date:5610003471 [Defer _ . :01/82/050/00122/AM15/ :56/24/040/00035/AM14/ 02.01.2014 Date:22.12 2044 yg Decision : It was decided to defer the case for 22.12.2014 for commenOe “a0 DOA eee, ot For von SgrmotLe eetndwaa tree yayo? ----- End of picture text -----

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----- Start of picture text ----- % | of Pharmaceuticals. ----- End of picture text -----

| IGase No.:186/3/82-_ Party Name: MYLAN Meet No/Date:11/82__|Status:Deffered || AILC4/2014 LABORATORIES LIMITED |ALC4/2014 and Re-indexed 26.11.2014 1146| |HQ File RLA File Lic.No/Date:0910058825 [Defer | |:91/82/050/00190/AM15/ —_—[:09/24/040/00484/AM14/ [06.01.2014 Date:22.12.2014 Decision : It was decided to defer the case for 22.12.2014 for comments of Department | _ \of Pharmaceuticals.

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----- Start of picture text ----- 1 [€ase No.:193/3/82-ALC4/2014 [Party Name:NATCO PHARMA [Meet No/Date:11/82- __|Status: LIMITED ALC4/2014 approved " 26.11.2014 Q File RLA File Lic.No/Date:0910058829 |Defer Date: 101/82/050/00197/AMI5/ :09/24/040/00494/AM14/ 06.01.2014 Decision :in the light of written comments received from Department of Pharmaceuticals vide their OM 147 |No- 35011/317/2014-Pi(Norms) dated 01.12.2014, it was decided to ratify norms under Para 4.7 of HBP 1 as per details given below or as applied by the firm, whichever is less: . os a 121.858 mg/100 [mmm [S| [mee : El | _ | {RA may take appropriateie action as per the decisionimatinib of NormsM4 Committee. mg tabs Case No.:2/22/82-ALC4/2013 |Party Name:METROCHEM [Meet No/Date:11/82- Status:Deffered APE PVT. LTD. ALC4/2014 and Re-indexed | 26.11.2014 | | HHQ File RLA File Lic.No/Date:09 10058842 |Defer , ||:01/82/080/01045/AM14/ —|:09/24/040/00503/AM14/ 7.01.2014 Date:22.12,2014 |Decision : It was decided to remind the firm to furnish the following technical details: | out[put product | ,a i) Complete and balanced chemical reaction showing molecular weight of input and ii) % yield on molar basis | |i) Material balance for entire process | |iv) Bye-products recovered, if any. v) Copy of technical literature in support of yield envisaged in the reaction. vi) Past production vis-a-vis actual consumption of all inputs duly certified by Central Excise Authority | |The case is deferred for 22.12.2014. . Case No.:37/3/82-ALC4/2014 iParty Name:NECTAR Meet No/Date:1 1/82- Status: | LIFESCIENCES LIMITED, ALC4/2014 Approved 26.11.2014 | 149 |HQ File RLA File Lic.No/Date:2210014502 [Defer Date: || | |:01/82/050/00041/AM15/ :22/24/040/00077/AM14/ 07.01.2014 Decision : in the light of written comments received from Department of Pharmaceuticals vide their OM ‘| {No. 35011/274/2014-Pl(Norms) dated 30.10.2014, it was decided to ratify the norms under Para 4.7 of Oy BeeParereParereere MAL KUMa KUMa Oneee arene one,arrarr Pra fee Conergy wee eT eT : SPpartm,et OFSign TraCommence Tra Sign TraCommence Tra ----- End of picture text -----

Oy BeeParereParereere MAL KUMa KUMa Oneee arene one,arrarr Pra fee Conergy wee eT eT ayers ReSPpartm,et OFSign TraCommence Tra

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

.

|:||||Cefuroxime Axetil|Quantity SN<br>kg/kg<br>1.<br>Desacetyl-7-amino<br>0.79|Quantity SN<br>kg/kg<br>1.<br>Desacetyl-7-amino<br>0.79|
|---|---|---|---|---|---|---|
|||||||ACA)|
||||||||(2. | Ethylacetate<br>3.74|
||||||||Syn-methoxyiminofurany!<br>=e<br>(SMIA)|
||||||||pentachloride|
|\||||<br>||||19.___|Aceticacid<br>ss<br>0.048|
|||||||PY [iegente<br>ass<br>Isocyanate|
|||||<br>!|||[14<br>|Acetoxyethylbromide 10.59<br>[15 | Cyclohexane<br>092<br>116 | Sodiumcarbonate<br>[0.125|
|||||||||
|||||||item|
|||||||||
|||||||ie<br>item|
|||||RAmaytake appropriateaction|action|asperthe decisionofNormsCommittee.|
||||||CaseNo.:116/3/82-<br>ALC4/2014<br>.|||Party Name: VIJAYASRI<br>‘(MeetNo/Date:11/82-<br>Status:Deffered<br>ORGANICS LTD<br>ALC4/2014<br>andRe-indexed<br>| ae<br>||
|||150|HQ||HQ||HQFile<br>:01/82/050/00120/AM15/|RuaFile<br>bic NovDate:0910058840pete<br>:09/24/040/00402/AM14/<br>07.01.2014<br>Date:22.12.2014||
|||||Decision : Itwasdecidedtodefer thecase for22.12.2014 forcommentsofDepartment|||
|||||ofPharmaceuticals.||.<br>.|
|||151fee|CaseNo.:180/3/82-<br>ican<br>feeFile<br>:01/82/050/00184/AM15/||arty Name: VISIONDRUGS<br>|MeetNo/Date:11/82-<br>Status: Deffered<br>pveLTD<br>cor<br>andRe-indexed<br>(26.11.2014<br>;<br>_<br>uaFile<br>[bieNefDat:0910058899Pete<br>:09/24/040/00426/AM14/<br>‘07.01.2014<br>;<br>Date:22.12.2014||
|||||[Decision : Itwasdecidedtodeferthecasefor22.12.2014forcommentsofDepartmept"}r|||
|||||||SA red Feat<br>ofrocornet<br>OFFMAye GOPoir Her.<br>pier Ra TEA,ayo<br>aor"sa gna?<br>aye?|

Y s~

==> picture [136 x 24] intentionally omitted <==

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

| _|of/Pharmaceuticals. ----- End of picture text -----

==> picture [22 x 24] intentionally omitted <==

----- Start of picture text ----- — ----- End of picture text -----

||~~|[Case No.:90/3/82-ALC4/2014|[PartyName:SUVENLIFE<br>[MeetNo/Date:11/82-<br>SCIENCESLIMITED<br>ALC4/2014|[PartyName:SUVENLIFE<br>[MeetNo/Date:11/82-<br>SCIENCESLIMITED<br>ALC4/2014|___[Status:<br>Approved|
|---|---|---|---|---|---|
||||6.11.2014|||
|||Pf||ie||
|||IQ File|RLA File<br>Lic.No/Date:0910058858<br>|Defer Date:|||
||||:011/82/050/00094/AM15/|:09/24/040/00468/AM14/<br>08.01.2014||a|
||<br>|||| Jecision: Inthelightofwrittencommentsreceivedfrom DepartmentofPharmaceuticals videtheirOM<br>INo.35011/272/2014-Pi{Norms)dated 30.11.2014, itwasdecidedtoratifythenormsunder Para4.7of<br>BP<br>v1 asperdetailsgivenbeloworas appliedbythefirm, whichever is less:<br>|||||
|1152||(ua||kg/kg<br>g/kg||
|| <br>|<br>|<br>||methoxy-ethoxy)<br> |[phenylamino)<br>| Ppyrimidin-4-yt<br>/ amino)-pheny!)-<br>carbamicacidtert||2<br>2-methoxy ethanol<br>Dimethylsulfoxide<br>.<br>.<br>Di-t-butyldicarbonate||<br>||0.439<br>4845 |<br> 1064|
|||IR<br>\ maytakeappropriateactionas|asperthedecisionofNormsCommittee.|||
||~|CaseNo.:203/3/82-|PartyName:VINS<br>MeetNo/Date:11/82-||_[Status:Deffered|
|||ALC4/2014|BIOPRODUCTS LTD.,<br>ALC42014||landRe-indexed|
||||26.11.2014|||
||153|/HQ File||RLA File<br>Lic.No/Date:0910058863||[Defer|
||||f:01/82/050/00207/AM15/|:09/24/040/00362/AM14/<br>08.01.2014||Date:22.12.2014|

Decision : It was decided to again send a copy of application to Department of __ |[Biotechnology. The case is deferred for 22.12.2014

|||||||
|---|---|---|---|---|
|||||||
||i| |CaseNo.:200/3/82-<br>ijALC4/2014|Party Name: WEXFORD<br>LABORATORIESPLTD|MeetNo/Date:11/82-<br>LC42014|(Status:Deffered<br>andRe-indexed|
||||26.11.2014||
||154HQ File|RLA File|Lic.No/Date:0710101|186 [Defer|
|||:01/82/050/00204/AM15/|:'07/24/040/00333/AM14/|8.01.2014|Date:22.12.2014|

| | Decision : It was decided to defer the case for 22.12.2014 for comments ofDepartment | | lof Pharmaceuticals. {1 (Case No.:134/3/82Party Name:SHASUN Meet No/Date:11/82_[Status:Deffered ALC4/2014 PHARMACEUTICALS ALC4/2014 and Re-indexed 13/5| | luo|:01/82/050/00138/AMI5/ File {LIMITEDRLA°04/24/040/00226/AM File 14/ 26.11.2014Lic.No/Date:0413.01.2014 10154220 Date:22.12.2014|Defer | 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 22.12.2014.

|aN . AL KUMAR | Oy OEsractorwaa Genera’ of Foreign Trade . Directorate eoepariment of Commerce area - ara, ayg Beni | Udyog BHawean-

| ‘|

| ,

==> picture [458 x 73] intentionally omitted <==

----- Start of picture text ----- Case No.:179/3/82-ALC4/2014 Party Name: VENUS Meet No/Date:1 1/82- Status: ~ REMEDIES LTD., ALC4/2014 Approved .. 26.11.2014 HQ File RLA File Lic.No/Date:2210014517 Defer Date: :01/82/050/00183/AM15/ :22/24/040/00079/AM14/ 13.01.2014 . ----- End of picture text -----

==> picture [455 x 115] intentionally omitted <==

----- Start of picture text ----- Decision : tn the light of written comments received from Department of Pharmaceuticals vide 156 |their OM No. 35011/339/2014-P(Norms) dated 28.11.2014, 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: . Export product Exp. Qty. |SI.No.| import items Qty. allowed AZTREONAM FOR 1. AZTREONAM FOR INJECTION USP 1.869 gm/20 INJECTION Number (containing780 mg of L-Argenine per gm of ml vial RA may take appropriate action as per the decision of Norms Committee. ----- End of picture text -----

||CaseNo.:196/3/82-<br>ALC4/2014|PartyName:ARUDAAVIS<br>LABSPRIVATELIMITED|{MeetNo/Date:11/82-<br>|ALC4/2014|{MeetNo/Date:11/82-<br>|ALC4/2014|Status:Deffered<br>andRe-indexed|
|---|---|---|---|---|---|
||.<br>.||{26.11.2014|||
|157||HQ File<br>:01/82/050/00200/AM 1 5/|RLAFile<br>:04/24/040/00219/AM14/|Lic. No/Date:0410154292<br>15.01.2014|10154292 <br>_—||Defer<br>|Date:22.12.2014|

Decision : It was decided to defer the case for 22.12.2014 for comments of Department ofPharmaceuticals. |

Case No.:40/4/82-ALC4/2014 |Party Name:NEW Meet No/Date:1 1/82Status:Deffered ALLIANCE DYE-CHEM ALC422014 and Re-indexed
; PVT. LTD., 26.11.2014
158 |HQ File RLA File Lic.No/Date:03 10766431 [Defer :01/82/050/00288/AM 15/ :03/95/040/00805/AM 14/ 16.01.2014 Date:26.11.2014 Decision : It was decided to defer the case for 22.12.2014 for comments ofDepartment
| jof C&PC,
Case No.:202/3/82Party Name:PARENTERAL Meet No/Date:11/82Status:Deffered ALC42014 DRUGS (INDIA) LTD., ALC4/2014 and Re-indexed ; 26.11.2014
159 [HQ File RLA File Lic.No/Date:56 10003580 [Defer :01/82/050/00206/AM15/ 156/24/040/0004 1/AM14/ 16.01.2014 Date:22.12.2014 |Decision : It was decided to defer the case for 22.12.2014 was decided to defer the case for 22.12.2014 decided to defer the case for 22.12.2014 to defer the case for 22.12.2014 the case for 22.12.2014 case for 22.12.2014 for 22.12.2014 22.12.2014 for comments of comments of of Department of Pharmaceuticals. Pharmaceuticals. |

| |Decision : It was decided to defer the case for 22.12.2014 was decided to defer the case for 22.12.2014 decided to defer the case for 22.12.2014 to defer the case for 22.12.2014 the case for 22.12.2014 case for 22.12.2014 for 22.12.2014 22.12.2014 for comments of comments of of Department of Pharmaceuticals. Pharmaceuticals.

Case No.:198/3/82-ALC4/2014 |Party Name:SATYA Meet No/Date:! 1/82Status: DEEPTHA ALC4/2014 Approved 160 HQ:01/82/050/00202/AM15/ File: PHARMACEUTICALSRLA:09/24/040/00523/AM14/ File LTD jLic.No/Date:09{16.01.201426.11.2014 10058953 [Pete Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/268/2014-Pi(Norms) dated 28.11.2014, it was decided to ratify the norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: . . ; aw het ier enarede oF Tigre te ee ome aot Fore aero* picotE Gene ont . ar era Roni yoyo? sega 8 w

||||||||||||
|---|---|---|---|---|---|---|---|---|---|
|%|:|||[Peper **Pro**duct<br>duct<br>1-43-CHLOROPHENYL)||Export TS.No. Importitemten” <br>Quanti|||| Qt.Allowed|<br>ke/ke||
|||||||||Eaa||||
|||;|A maytake|take appropriateaction|actionas|asperthedecisionofNormsCommittee.|Committee.|||
||||CaseNo.:32/3/82-ALC4/2014|||PartyName:DISTO|MeetNo/Date:11/82-|1/82-|Status:|
|||||||PHARMACEUTICALS|ALC4/2014||Approved|
|||||||PRIVATELIMITED|26.11.2014|||
||||QFile|||RLA File|Lic.No/Date:0910058977||‘\Defer Date:|
||||01/82/050/00036/AM15/|||:09/24/040/00519/AM14/|17.01.2014|||

[Decision :in the light of written comments received from Department of Pharmaceuticals vide |161 their OM No. 35011/303/2014-Pi(Norms) dated 28.11.2014, 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:

|. i] Export product Exp. Qty. Import items * | Qty. allowed | i ke/ke | con “Taig [a [one 0.606 ._ |[|RA may take appropriate action as per the decision of Norms Committee. | Case No.:103/3/82Party Name:BLISS GVS Meet No/Date:1 1/82Status: Deffered . ALC4/2014 PHARMA LTD. ALC4/2014 and Re-indexed |. 26.11.2014 1163 [HQ File RLA File Lic.No/Date:03 10767119 (Defer {1 || [:01/82/050/00107/AM15/ :03/94/040/00942/AM 14/ 21.01.2014 Date:22.12.2014: ! | | [Decision : It was decided to defer the case for 22.12.2014 for comments of Department 1, | _jof Pharmaceuticals.

[T [Case No.:22/6/82-ALC4/2014 [Party Name:BLUE CIRCLE [Meet No/Date:11/82(Status: | ORGANICS PVT. LTD. ALC4/2014 Approved Pp 26.11.2014 a HQ File RLA File Lic.No/Date:03 10767101 Defer Date: | | :01/82/050/00424/AM15/ 103/94/040/00582/AM 14/ 21.01.2014 | | [Decision : Committee considered the case as per agenda and in the light of earlier decision taken 1 | din meeting no. 6/82 dated 29.08.2014, it was decided to ratify norms under Para 4.7 of HBP v1 as 193 Iper details given below or as applied by the firm, whichever is less: i | 5-Nitro tsophthalic Acid | 1kg 1. tsophthalic Acid 0.857 kg } Dimethyl Ester or Dimethyi i | 5-Nitroisophthalate ||| |RA may take appropriate action as per the decision ofNorms Committee. Case No.:51/4/82Party Name:SHILPA Meet No/Date:1 1/82Status: _ {164 |ALC42014 MEDICARE LTD., ALC4/2014 Approved i 26.11.2014 | :. ert SPA/ NIRMAL KUMAR ! =asentra, FET on Trade py. Director Gen TeteTaaTes | faeS ‘General of Foreign vac | Dime BerUDepartenent ofCOM ly|

: | | | ||

HQ File RLA File Lic.No/Date:07 10101518 Defer Date: & :01/82/050/00299/AM15/ 07/24/040/0037S/AMI14/ = 22.01.2014 > ;

Decision :Committee considered case as per agenda and in light of earlier decision taken in 37/82 meeting held on 08.12.2009 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:-

==> picture [434 x 94] intentionally omitted <==

----- Start of picture text ----- QO allowed | Ambroxol 1 kg 1.32 kg HCL Trans Para Amino Cyclohexanol 0.80 kg TetraSodiumHydrofuran Borohydride 10.5832.15 kgkg | 2.58 kg |6. __| Methylene Dichloride 3.225 kg ----- End of picture text -----

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

;

|CaseNo.:21/3/82-|PartyName-KUDOS|MeetNo/Date:11/82-|(Status:|
|---|---|---|---|
|ALC4/2014|CHEMIELTD.,|ALC4/2014<br>26.11.2014|Approved|
||||||
|HQFile|RLA File|Lic.No/Date:2210014543||Defer Date:|
|:01/82/050/00025/AMI15/|——{:22/24/040/00075/AM14/|23.01.2014||

Decision ; In the light of written comments received from Department of Pharmaceuticals vide 165 [their OM No. 35011/263/2014-Pi{(Norms) dated 11.11.2014, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

| Export product Exp. Qty. Import items Qty. allowed [abeNNE ke/kg RA | akg | 1. | RANEYNICKELCATALYST] 0.0325 may take appropriate action as per the decision of Norms Committee.

==> picture [454 x 104] intentionally omitted <==

----- Start of picture text ----- Case No.:12/21/82- Party Name:KUDOS Meet No/Date:11/82- (Status:Deffered ALCA2013 CHEMIE LTD., CA/2014 and Re-indexed 6.11.2014 | 166 |HQ File RLA File Lic.No/Date:22 10014544 |Defer :01/82/050/01042/AM14/ 22/2 1/640/00096/AM14/ 23.01.2014 Date:22.12.2014 Decision :It was decided to send a copy of application to Department of Pharmaceuticals | |for their comments. The case is deferred for 22.12.2014. . ----- End of picture text -----

==> picture [480 x 188] intentionally omitted <==

----- Start of picture text ----- Case No.:187/3/82- Party Name:ALCHEM [Meet No/Date:11/82- [Status:Deffered ALC4/2014 INTERNATIONAL LTD. ALC42014 and Re-indexed 26.11.2014 167 HQ File. RLA File Lic.No/Date:05 10376990. |Defer |:01/82/050/00191/AM15/ —‘|:05/23/040/00413/AM14/ 4.01.2014 Pete 122014 Decision : It was decided to call following technical details from the firm viz:- (a) % content of Tabersonine in the imported seeds and its % recovery in each step. a (b) Content of other bye-products in the seeds, their % recovery and value. = Ww Eso Sa are Ba.Sao Fea,a oeAre eee PM a [new] use? ----- End of picture text -----

? | | | | :

| =: ; | f | j 4 | | |

(c) Copy of technical literature in support of (a) and (b). (d) Past production of Vinpocetine vis-avis Actual consumption of imported seeds for last 3 years duly certified by Central Excise Authorities. ___ [The case is deferred for 22.12.2014.

~ ase No.:108/3/82Party Name:-CROPNOSYS Meet No/Date:1 1/82Status: Deffered
; [ALC4/2014 (INDIA) PRIVATE LIMITED |ALC4/2014 and Re-indexed | 6.11.2014
168 |HQ File RLA File Lic.No/Date:03 10767733.|Defer i 1901/82/050/001 12/AM15/ :03/94/040/00908/AM14/ 24.01.2014 Date:22.12.2014
| |Decision :It was decided to defer the case for 26.11.2014 for comments of Department of | J@aseLC4/2014 No.:230/3/82Party Name:SWISS Meet No/Date:1 1/82Status: Deffered EXPORTS PVT. LTD. ALC422014 and Re-indexed
} oy 6.11.2014 1169 |HQ File RLA File Lic.No/Date:08 10128498 |Defer 0 1/82/030/00234/AM15/ 108/24/040/00474/AMI14/ = 29.01.2014 _|Date:22.12.2014 Decision : It was decided to defer the case for 22.12.2014 for comments of Department
_: {Of Pharmaceuticals. (fase No.:44/4/82-ALC4/2014 |Party Name:CATAPHARMA [Meet No/Date: CHEMICALS PVT.LTD., |ALC4/2014 1 1/82andStatus:DefferedRe-indexed
| | | 26.11.2014 1170 |HQ File RLA File ic.No/Date:3 110062387 |Defer . :91/82/050/00292/AM15/ 13 1/83/040/00199/AM 14/ 30.01.2014 Date:22.12.2014
| |Mecision :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 22.12.2014.

==> picture [457 x 267] intentionally omitted <==

----- Start of picture text ----- ||Case No.:209/3/82-ALC4/2014 Party Name:DR REDDYS Meet No/Date:11/82- Status: Re- LABORATORIES LIMITED ‘ALC4/2014 indexed |. 26.11.2014 Q File RLA File Lic.No/Date:0910059127 |Defer Date: 5 1/82/050/00213/AM15/ (09/24/060/00540/AM14/ 30.01.2014 Becision :In the light of written comments received from Department of Pharmaceuticals vide their OM 71 i.0.P35011/293/2014-PI(Norms) v1 as per details given belowdated oras26.11.2014,applied by theit firm,was decided whicheverto isratify less:the norms under Para 4.7 of i () a k g/kgD D 1 'W Cape 2,3-Di-O-acetyl-5-deoxy-5- | RA may take appropriate action as per the decision ofNorms Committee. e No.:177/3/82- Party Name:INDO AMINES [Meet No/Date:11/82- Status:Deffered 172}; ALC4/2014 IMITED ALC4/2014 and Re-indexed 4 . 26.11.2014 ----- End of picture text -----

rt PAN/NIRMAL KUMAR< oa Dy.[Director][General][of][Foreign][Trade] fae aror werresnaat Directorate General of Foreign Trade afrsa frarvDepartment of Commerce Udyog Bhawan Woe Delhi

| | | |

HQ File RLA File Lic. No/Date:03 10768616 [Defer :01/82/050/00181/AM15/ :03/94/040/00958/AM14/ 30.01.2014 ‘|Date:22.12.2014

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

|||||||||
|---|---|---|---|---|---|---|---|
|Decision|:|It was decided|to defer the|case|for 22.12.2014|for comments of|Department|
|ofPharmaceuticals.|.|
|Case No.:223/3/82-|Party Name:UNIJULES LIFE|[Meet No/Date:1|1/82-|Status:|Deffered|
|ALC4/2014|SCIENCES LTD.|ALC4/2014|and|Re-indexed|
|26.11.2014|
|173||HQ File|RLA|File|Lic.No/Date:03 10768632||Defer|
|:01/82/050/00227/AM15/|—_|:03/95/040/00867/AM14/|30.01.2014|=—————__—{Daate:22.12.2014|

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

==> picture [432 x 71] intentionally omitted <==

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

|||||||
|---|---|---|---|---|---|
|Case No.:206/3/82-|Party|Name:AUROBINDO|[Meet No/Date:11/82-|Status:|Approved|
|ALC4/2014|PHARMA LIMITED|ALC4/2014|
|26.11.2014|
|HQ;|File|RLA File|Lic.No/Date:09 10059129|.|Defer Date:|
|:01/82/050/00210/AM15/|:09/24/040/00556/AM14/|31.01.2014|

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

Decision In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/309/2014-PI(Norms) dated 11.11.2014, it was decided to ratify the norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

==> picture [430 x 111] intentionally omitted <==

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

||||||
|---|---|---|---|---|
|||Oty.|allowed|
|ZIRASIDONE|——“T'ikg|| 1.|||Aaiwaeduten|
|HYDROCHLORIDE|SSChloroxindole OR 6-Chioro-5-(2-chlorocthy!)}-1,3-|—~*(.02|
|||Heino|0916|
|:|4.233|
|||6.736|
|||Piperzine|derivative OR 3-(1-Piperaziny!)-1,2+|1.142|
|——SSS*«|
|||||Tewatydeofron [THF]|

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

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

Case No.:165/3/82Party Name:MANGALAM [Meet No/Date:11/82_|Status:Deffered ALC4/2014 ORGANICS LIMITED. LC4/2014 and Re-indexed 26.11.2014
175 [HQ File RLA File Lic. No/Date:03 10768928 (Defer :01/82/050/00169/AM15/ :03/94/040/00448/AM 14/ 33.02.2014 ‘pDate:22.12.2014 Decision : It was decided to defer the case for 22.12.2014 for comments of Department of C&PC . . . . Case No.:111/3/82Party Name:SRIAM LABS Meet No/Date:[1][1/82-] Status:Deffered ALC4/2014 PRIVATE LIMITED ALC4/2014 and Re-indexed | - (26.11.2014
176 |HQ File , RLA File Lic. No/Date:09 10059150 |/Defer :01/82/050/00115/AM15/ :09/24/040/00509/AM14/ 03.02.2014 Date:22.12.2014 ecision : It was decided to defer the case for 22.12.2014 for comments of Departpent
of Pharmaceuticals. . . So? Seoe SFO
BEESoF AL Beateoe eee<2
IF e aa

\

%

||%||||
|---|---|---|---|---|
|||||.|
||||_[CaseNo.:26/3/82-<br>Party Name: MEDICEF<br>MeetNo/Date:11/82-<br>(Status:<br>|<br>|aLc42014<br>PHARMA,<br>ALC4/2014<br>Approved|||
|||||26.11.2014|
|||||—|QFile<br>RLAFile<br>Lic.No/Date:2210014587 |DeferDate:<br> |:91/82/050/00030/AM15/<br>—_—|:22/24/040/00080/AM14/<br>—{04.02.2014<br>||
|||||Decision : Inthe lightof writtencomments receivedfromDepartmentofPharmaceuticalsvide|
|||||IneirOM No. 35011/259/2014-Pi{Norms) dated October 2014, it wasdecided to ratify norms|
|||.||nderPara4.7ofHBPV1 asperdetailsgivenbeloworasappliedbythefirm,whichever is less:|
|||||f/Exportproduct|Exp.<br>Importitems<br>For<br>export<br>of1|
||||177}<br>Qty.<br>MillionTablet||
|||||| Amoxicillin& = | Number<br>Amoxicillintrihydrate<br>580.0kg<br>! Clavulanate|
|||||:<br>|<br>PotassiumTablet<br>2.<br>PotassiumClavulanate<br>137.86kgA<br>USP625mg<br>Diluted (Pot. Clavulanate|
|||||.<br>with Microcrystalline|
||||||<br>Cellulose 1:1,BulkNon-|
|||||i<br>Sterile)|
||||7RA|RAmaytakeappropriateactionasperthedecisionofNormsCommittee.|
||||~~<br>Case No.27/3/82-<br>Party Name: MEDICEF<br>MeetNo/Date:11/82-<br>(Status:<br>IALC42014<br>PHARMA,<br>ALC42014<br>Approved<br>26.11.2014<br>.<br>|<br>HQFile<br>RLAFile<br>Lic.No/Date:2210014589 |DeferDate:<br>| :01/82/050/00031/AM15/<br>:22/24/040/00081/AM14/<br>04.02.2014<br>Decision : Inthe lightofwrittencommentsreceivedfromDepartmentofPharmaceuticalsvide<br>[theirOM No. 35011/259/2014-Pi(Norms) dated October2014, itwasdecided to ratify norms<br>junderPara4.7ofHBP V1asperdetailsgivenbeloworas applied bythefirm,whichever is less:||
|||||Exportproduct<br>Exp.<br>Importitems<br>r<br>f1<br>Milli<br>|<br>Qty.<br>100ml<br>Each|
||||178|Amoxicillin&<br>Amoxicillin Trihydrate<br>4820.605kg<br>| Clavulanate<br>Potassium<br>Clavulanai<br>| Potassiumfororal<br>otassium<br>Clavulanate<br>660.074kgA<br>SuspensionBP<br>Diluted(Pot.Clavulanate<br>| 228.5mg<br>with Silicondioxide (1:1)<br>BulkNon-Sterile)|
|:|,|.__|||3 | Glassbottle<br>Relevant,Asper<br>ia_<br> [RAmaytakeappropriateactionas per thedecisionofNormsCommittee.<br>\\q<br>;|
||||||eta gra/NIRMALKUMAR<br>ssa, TE Sonerel ofForeignTrade|
|||||in<br>rate<br>soartment<br>commerce<br>caresfensa,agBini<br>Udyog Bhawan,|

S22

, | | || |

CaseNo.:28/3/82-<br>ALC4/2014<br>HQ File<br>HOre00032/AMIS)	_.	Party Name: MEDICEF<br>PHARMA,<br>RLA File<br>122/24/040/00082/AM14/	MeetNo/Date:11/82-<br>ALC4/2014<br>26.11.2014<br>Lic.No/Date:2210014588 <br>04.02.2014	Status:<br>Approved<br> DeferDate:

Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/259/2014-Pi{Norms) dated October 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:

||Exportproduct|Exp.||Importitems|Forexportof | Million|
|---|---|---|---|---|---|
|||Qty.|||bottle,100m]Each|
|179)|Amoxicillin&<br>Clavulanate<br>Potassiumfororal<br>SuspensionBP<br>228.5mg|||AmoxicillinTrihydrate<br>Potussium<br>Clavul<br>otassium<br>Clavulanate<br>Diluted(Pot.<br>.<br>Clavulanate+Silicon<br>dioxide 1:1,BulkNon-|4820.605 kg<br>660.074kgA|
|||||Sterile)||
|||||Glassbottle|Relevant,Asper|
||RA maytakeappropriateaction||[pase<br> asperthedecision ofNormsCommittee.|||

|CaseNo.:221/3/82-<br>ALC422014|PartyName:CIPLA<br>LIMITED|MeetNo/Date:11/82-<br>ALC4/2014<br>26.11.2014|Status:<br>Approved|
|---|---|---|---|
|HQFile<br>:01/82/050/00225/AM15/|RLAFile<br>:03/94/040/00995/AM14/|Lic.No/Date:0310769240 <br>05.02.2014||DeferDate:|

Decision: In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/288/2014-Pi{Norms} dated 11.11 .2014, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export Product

Amoxicillin and Clavunlanate Potassium for Oral Suspension

==> picture [476 x 185] intentionally omitted <==

----- Start of picture text ----- 180 ee ae Amoxycillin Trihydrate 10.080 gm 16.695 gm | 26.145 gm mix P| Clavulanate Potassium Syloid 1.6051 gm 2.6802 4.2883 gm [3_| Silicon Dioxide [1.50gm ss 2.50gm_ 4 4.00gm__ Packing Materials Relevant as per packing policy a 1° 7 Q PN RA concerned may take further necessary action as per above decision of NC ey BS ae , oe Ok EAT it ae cot A SeSCA ----- End of picture text -----

==> picture [14 x 13] intentionally omitted <==

----- Start of picture text ----- % ----- End of picture text -----

|“fi<br>aseNo.:222/3/82-<br>PartyName:CIPLA<br>MeetNo/Date:11/82-<br>Status:<br>ALC4/2014<br>LIMITED<br>ALC4/2014<br>Approved|
|---|
|26.11.2614|
|QFile<br>RLAFile<br>Lic.No/Date:0310769244PeteDate:<br>|01/82/050/00226/AM15/<br>:03/94/040/00985/AM14/<br>05.02.2614|
|Decision<br>: Committee considered the case as per agenda and in light of written comments|
|received from Department of Pharmaceuticals vide their OM No. 35011/290/2014-Pl(Norms)|
||dated 11.11.2014 and in consultation with technical authority present in meeting, decided to|
|||ratifynorms under para 4.7ofHBPasperdetailsgivenbelowor asapplied byfirmwhichever is|
|lower:-|

||181|||||
|---|---|---|---|---|---|
|||Exportproduct|SLNe.|Qty.Allowed||
|||||Ut|Kg/kg||
||}|i<br>) <br>||ENTECAVR<br> MONOHYDRATE||DibenzyloxyGuanine<br>(2-amino-1,9-Dihydro- | 1.928<br>9||
|||||(1S,3R,4S)-4-||
|||||(benzyloxy)-3-||
||;|||(benzyloxymethy!)-2-||
||||||Methylenecyclopentyl]-<br>6H-purin-6-one||
||_|RAconcernedmaytakefurther||furthernecessary|action asperabove decision ofNC.||
||ase No.:224/3/82-<br>ALC4/2014||PartyName:CIPLA<br>LIMITED|MeetNo/Date:11/82-<br>[Status:<br>ALC4/2014<br>26.11.2014|[Status:<br>Approved|
||HQFile<br>:01/82/050/00228/AM15/||RLA File<br>Lic.No/Date:0310769253 (DeferDate:<br>:03/94/040/00979/AM14/<br>05.02.2014|||

Decision ; In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/291/2014-Pi(Norms) dated 11.11.2014, it was decided to ratify norms 182 under Para 4.7 of HBP V1 as per details given below or as applied by the firm, whichever is less: Export product Exp. SLNo. | Import items Qty. kg/kg Qty. | | 2. Dichloro Dicyano 1.70 Benzoquinone (DDQ , __| {RA may take appropriate action as per the decision of Norms Committee. [— Case No.:225/3/82Party Name:CIPLA Meet No/Date:11/82Status: ALC4/2014 LIMITED ALC4/2014 Approved 6.11.2014 1183 HQ File RLA File Lic.No/Date:03 10769247 |Defer Date: | |Decision|:01/82/050/00229/AM15/:Committee considered103/94/040/0099the case 1/AM14/as per agenda05.02.2014and in light of written; comments |' | jreceived from Department of Pharmaceuticals vide their OM No. 35011/292/2014-Pl(Norms) iy Ls | |\dated November 2014 and in consultation with technical authority present in meeting, decidedat Oa 1UMAR . pia FF ‘ feet erat a aera of Foreign Trade : Dy. Director GET BTAag pieaorate Genera Or[sar][enerce] U dy o”g Bhaw 4

~~ “4

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

Tenofovir Disoproxi] Fumarate {6 Export Item)

|||Export Items<br>importrecommended perTablets (Qty|Export Items<br>importrecommended perTablets (Qty|Export Items<br>importrecommended perTablets (Qty|Tablets (Qty in mg)|||
|---|---|---|---|---|---|---|---|
|||Tenofovir|Emtricitabine | Efavirenz |Lamuvdine|||||
|||Disoproxil||||||
|||Fumarate||||||
|||TenofovirDisoproxil Fumarate300mg/<br>Tablets|NIL|NIL|NIL|||
|,|TenofovirDisoproxilFumarate300mg+<br>306.0<br>NIL<br>NIL<br>Emtricitabine200mgTablets<br>EaeG<br>Disoproxil Fumarate300mgTablets<br>Tenofovir Disoproxil Fumarate 300mg,|||||||
|||Tablets||||||
|||Fumarate300mg+Emtricitabine200mg,||||||
|||Tablets||||||
|||+Lamivudine 300mg +Efavirenz<br>600mg||||||
||ee<br>Tenofovir Disproxil Fumrate|||||||
|||||kg/kg||||
||1.|9-{2-Phosphony! Methoxy)Propyl]Adenine(PMPA)||||||
||;|||||||
||5.|||||||
||5|||||||
||(cc)|||||||
||Emtrcitabine|||||||
|||||ke/kg||||
||1.|(2R,5R)-5-(4-amino-5-fluore-2-0x0-2 H-Pyrimidin-l-y}}-<br>[1,3]oxathiolane-2-carboxylic acid,2S-isopropyl-5R-Methyl-1R-||2.50||||
|||cyclohexyl<br>ester. (FCMECompound)||||||
||[D]<br>Lamuvidine<br>SI.No.| Importitems|||.<br>Xe<br>p&<br>Qty recommended<br>atye<br>k<br>ne, HA<br>=<br>oe<br>os<br>oo<br>s<br>|<br>GO<br>SSA<br>OM<br>eae”<br>42ZB 0<br>erea<br>° Chota on<br>OFaie<br>ve||||

==> picture [359 x 133] intentionally omitted <==

----- Start of picture text ----- oan 1. (1 R, 2 S, 5 R}MENTHYL-5S-(CYTOSINE-I -YL}-1,3- 2.19 OXATHIOLANE-2R-CARBOXYLATE/ CME COMPOUND ; ip 0575 6 [enmacerareSOSCSC~«~SI ----- End of picture text -----

TED Efavring

SI.No. | Import items Qty recommended kg/kg 1 . (S)-5-Chloro-alpha-(Cyclopropylethynyl)-2-Amino-alpha0.98 (Trifluoromethy!) Benzenemethanol (EV-] compound)

|,_, IRA concemed may take further necessary action as per above decision of NC

~ CaseALC4/2014 No.:149/3/82Party Name: MOREPEN Meet No/Date:| 1/82Status: Deffered LABORATORIES LTD., ALC4/2014 and Re-indexed 26.11.2014 184 |HO File RLA File Lic.No/Date:05 10378413 Defer | :01/82/050/00153/AM15/ :05/24/040/00420/AM14/ 05.02.2014 Date:22.12.2014 | Decision ; It was decided to defer the case for 22.1 2.2014 for comments of Department |__| jof Pharmaceuticals.

|||||||||
|---|---|---|---|---|---|---|
|||||||||
|.|_|||[CaseNo.:168/3/82-<br> /ALC42014|PartyName:CIPLA<br>LIMITED|MeetNo/Date:11/82-<br>ALC4/2014<br>26.11.2014|(Status:<br>Approved|
|4 <br>|||||THQFile<br>:01/82/050/00172/AM15/|RLA File<br>:03/94/040/01009/AM14/|Lic.No/Date:0310769592 <br>06.02.2014||DeferDate:|

Decision : Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/292/2014-PI(Norms) dated November 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 13 is lower:-

Tenofovir Disoproxil Fumarate (6 Export item)

==> picture [454 x 133] intentionally omitted <==

----- Start of picture text ----- Export items Import recommended per Tablets (Qty in mg) Tenofovir Emtricitabine | Efavirenz | Lamuvdine | Disoproxil Fumarate Tablets . tesH Tenofovir Di if Fumarate 300 mg + Pe ; | perdat Gra Gra ----- End of picture text -----

perdat Gra Gra /NIRMAL KUMAR oH,HEMETTT ot roregn Trade OYDirectorateeT SATATR AARTTHEH 4e se Tas, General ortWE of Commerce Udyog Bhawan,

: | | | ) | ( |

i, | 3 LamivudineDisoproxil Fumarate 300 mg 300+ Tenofovir mg Tablets 306.0 NIL NIL 306.0 | Efavirenz 600 mg+Emtricitabine 200 mg + :| BSSTablets ee >|[eaeeres] TabletsEfavirenz 600 mg+ Tenofovir Disoproxil per fae [om eee,[+Lamivudine][ 300][ mg][ +][ Efavirenz] 600 mg 306.0 Nil 612.0 |306.0 6[|] [6 [oa [e) Tenofovir Disproxil Fumrate SI.No. | Import items Qty recommended — 1. kg/kg 9-[2-(Phosphony! Methoxy) Propy!] Adenine (PMPA) 3

Emtrcitabine

SI.No. | Import items

==> picture [314 x 255] intentionally omitted <==

----- Start of picture text ----- kg/kg 1. QQR,5R)-5-(4-amino-5-fluoro-2-0xo-2H-Pyrimidin- 1 -yl)- {1,3] oxathiotane-2-carboxylic acid, 2S-isopropyl-SR-Methyl-IR- 2.50 [o] Lamuvidine SI.No. | import items ke/kg 1. (LR, 2S, 5 R/MENTHYL-SS4CYTOSINE-I -YL}-1,3- OXATHIOLANE-2R-CARBOXYLATE / CME COMPOUND 2 ; 5 0575 ----- End of picture text -----

[E} Efavring .

5[>] € ae 2 we eeneh eee eeGe. ‘7 te& tals

==> picture [15 x 14] intentionally omitted <==

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

1 Ee - — = eee —— pete I eee kg/kg 1. (S)-5-Chioro-alpha-(Cyclopropylethyny!}-2-Amino-alpha0.987 (Trifluoromethy!} Benzenemethanol (EV-I compound)

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

Case No.:150/3/82Party Name:-MACLEODS Meet No/Date:1 1/82Status:Deffered ALC4/2014 PHARMACEUTICALS LTD. |ALC4/2014 and Re-indexed 26.11.2014 186 |HQ File RLA File Lic.No/Date:03 10769509 |Defer :01/82/050/00154/AM15/ :03/95/040/00879/AM 14/ 06.02.2614 Date:22.12.2014 Decision : It was decided to defer the case for 22.12.2014 for comments of Department __ | jof Pharmaceuticals, . [7] [Case No.:8/3/82-ALC4/2014 [Party Name:ALEKHYA [Meet No/Date:11/82. (Status:Defferea DRUGS PVT LTD. ALC4/2014 and Re-indexed 26.11.2014 187 |HQ File RLA File Lic.No/Date:09 10059218 |Defer i}: | {:01/82/050/00012/AM15/ :09/24/040/00548/AM 14/ 07.82.2014 Date:22.12.2014 | | [Decision : It was decided to defer the case for 22.12.2014 for comments of Department | | jof Pharmaceuticals. Case No.:10/3/82-ALC4/2014 |PartySCIENCES Name:ARENE LIFE Meet No/Date:1 1/82Status:Deffered | LIMITED. ALC4/2014 and Re-indexed |19g (26.11.2014 [HO File RLA File Lic.No/Date:0910059227 [Defer :01/82/050/00014/AM15/ :09/24/040/00534/AM14/ 07.02.2014 Date:22.12.2014 | _ | Decision :It was decided to send a copy of application to Department of pharmaceuticals | | {for thier comments. The case is deferred for 22.12.2014. : Case No.:59/3/82-ALC4/2014 |Party Name:ARENE LIFE Meet No/Date:1 1/82Status:Deffered 26.11.2014 iF SCIENCES LIMITED. ALC4/2014 and Re-indexed 1g [HQ File RLA File Lic. No/Date:09 10059222 [Defer. :01/82/050/00063/AM15/ 109/24/040/00551/AM14/ 07.02.2014 Date:22,12.2014 _ |Decision : It was decided to send a copy of application to Department of _ | |\pharmaceuticals frothier comments. The case is deferred for 22.12.2014 Case No.:49/3/82-ALC4/2014 [Party Name:AUROBINDO Meet No/Date:11/82Status: PHARMA LIMITED ALC4/2014 Approved 26.11.2014 190 |HQ File RLA File Lic.No/Date:0910059197 |Defer Date: | [:01/82/050/00053/AM1 5/ 109/24/040/00562/AM14/ 07.02.2014 - | |Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM |_| JNo. 35011/250/2014-PI(Norms) dated October 2014, it was decided to ratify the norms under Para 4.7 of

frist war /NIRMAL arse Dy. Director General of Foreign Trade (eette General of Foreign Trade Oaen |[prUDepartment][ of][ Commerce]

S7 |

| |

2 |

==> picture [476 x 489] intentionally omitted <==

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

|||||||
|---|---|---|---|---|---|
|||©|
|HBP v1|as per details given below or as applied by the|firm,|whichever|is|less:|
|Quanti|ke/ke|
|SIMVASTATIN|i kg|||Activated carbon|0.035|
|a|
|[e|[Men|pines|06|
|||Tertiary butyldimethylsily!|
|||chloride|0.779|
|Taio|
|RA may take appropriate|action|as per the decision of|Norms Committee.|
|Case No.:1§1/3/82-|Party Name:CIPLA LIMITED|[Meet No/Date:11/82-|Status:|Deffered|
|ALC42014|ALC4/2014|and Re-indexed|
|26.11.2014|
|191|[HQ File||RLA File|Lic. No/Date:03 10769755|[Defer|
|:01/82/050/00155/AM15/|4:03/94/040/01022/AM14/|07.02.2014|Date:22,12.2014|
|Decision|:|It was decided|to defer the case|for 22.12.2014|for comments of Department|
|of Pharmaceuticals.|

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

Case No.:21/4/82-ALC4/2014 |Party Name:KREATIVE Meet No/Date:[1][ 1/82-] Status: Deffered ORGANICS (P) LTD., ALC4/2014 and Re-indexed 26.11.2014 192 |HQ File RLA File Lic.No/Date:09 10059237 [Defer :01/82/050/00269/AM15/ °09/24/040/00577/AM 14/ 11.02.2014 Date:22.12.2014

Decision : It was decided to send a copy of application to Department of pharmaceuticals for their comments. The case is deferred for 22.12.2014

Case No.:166/3/82Party Name: VIJAY Meet No/Date:[1] 1/82Status: Deffered . ALC4/2014 PERFUMES PVT.LTD. ALC4/2014 and Re-indexed 26.11.2014 193 THQ7 File RLA File Lic.No/Date:0310770668 [Defer :01/82/050/00170/AM15/ :03/95/040/009 16/AM14/ 18.02.2014 Date: 10.12.2014 | a Decision : It was decided to defer the case for 10.12.2014 for comments of Departerts ,Ero Ss 5 rege A eee a0 ovSF,aoO! Oe ot Forester a own geeoe tk Set ey Gee

”

| _ {of Pharmaceuticals.

| [€ase No.:65/3/82-ALC4/2014 [Party Name-HETERO LABS [Meet No/Date:11/82- _ [Status:Deffered Jo LIMITED LC4/2014 ‘land Re-indexed yo! 6.11.2014 pf 1194 [HQ File RLA File Lic.No/Date:0910059337 [Defer ‘}301/82/050/00069/AM1 5/ :09/24/040/00595/AM14/ 19.02.2014 Date:22.12.2014

Decision : It was decided to defer the case for 22.12.2014 for comments of Department _, |of Pharmaceuticals.

in ; ase No.:132/3/82Party Name: VENUS Meet No/Date: ALC4/2014 1 1/82Status: Deffered REMEDIES LTD., ALC4/2014 and Re-indexed 195 |HQ File| RLA File 26.11.2014Lic.No/Date:22 10014635 |Defer | (01/82/050/00136/AM15/ —|:22/24/040/00088/AM14/ ——-[26.02,2014 |Date:22.12.2014 Decision : It was decided to defer the case for 22.12.2014 for comments of Department bf Pharmaceuticals.

Ease No.:57/6/82-ALC4/2014 (Party Name:GLENMARK (Meet No/Date:11/82(Status: GENERICS LIMITED ALC4/2014 Approved | 26.11.2014 Q File RLA File Lic.No/Date:0310772498 [Defer Date: 01/82/050/00459/AM15/ :03/94/040/01074/AM14/ 28.02.2014

==> picture [444 x 170] intentionally omitted <==

----- Start of picture text ----- Decision :tn the light of earlier decision taken by NC in its 31/82 meeting dated 01.11.2011 and was decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm ; | hichever is lower:- allowed | Ezetimibe 1 Kg. |2.__|N,N-Dimethy!Dimethyl Amino Pyridine 10.09kqi Formamide 1 [1.52kg] | +) 4-Phenyl-2-Oxazotidinone 10.93kqg 4. __| Borane Dimethyl Suifide 0.424 kg i. fe | (R)-2-Methyl-CBS-OxazaborolidineSolution in Toluene (1 M | 0.057 kg 6. _| N,O-Bis (Trimethyisilyl) Acetamide 1.07 kg Tetrahydrofuran 0.074 ka ----- End of picture text -----

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

| | |

ase No.:34/4/82-ALC4/2014 |Party Name: MOREPEN Meet No/Date:1 1/82Status:Deffered | LABORATORIES LTD., ALC4/2014 and Re-indexed 1 26.11.2014 197(HQ File RLA File Lic.No/Date:0510380668 [Defer :01/82/050/00282/AM15/ :05/24/040/00455/AM14/ 03.03.2014 Date:22.12.2014 [Decision : It was decided to defer the case for 22.12.2014 for comments of Department . | of Pharmaceuticals. ;98 (Case No.:178/6/82-ALC4/2014 |Party Name:CLARION Meet No/Date:1 1/82Status: | 4 . DRUGS LTD., ALC4/2014 Approved pada GAR /NIRMAL eaeMAR area GenerelSi[moreign][ rede] pitta General of er[a][eee] arerea faarvDepa ment o ; ne ST, aa ow Hath

| | [ (26.11.2014 | | HQ File RLA File Lic.No/Date:5010001998 |Defer Date: | :01/82/050/00580/AM15/ :50/24/040/000 12/AM14/ 04.03.2014 | Decision :in the light of written comments received from Department of Chemicals and : Petrochemicals vide their U.O No. 14010/51/2014-Ch. ll dated 13.11.2014, it was decided to | ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

==> picture [14 x 22] intentionally omitted <==

----- Start of picture text ----- “ ----- End of picture text -----

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----- Start of picture text ----- Qty. . |1 3-NITRO(99%0, ASSY. ACETOPHENONEVALUE) Kg 1. ACETOPHENONE(99.50% ASSY. | VALUE 0.765 kg -HYDROXY ACETOPHENONE ACETOPHENONE 199% ASSY. VALUE) (99.50% ASSY. 1.896 kg VALUE ‘ RA may take appropriate action as per the decision of Norms Committee. ----- End of picture text -----

Case No.:46/6/82-ALC4/2014 (Party Name:NAPROD LIFE {Meet No/Date:11/82Status:Deffered SCIENCES PVT. LTD. ALC4/26014 and Re-indexed | ———«|26.11.2014 199 |HQ File RLA File Lic. No/Date:03 10772962 |Defer :01/82/050/00448/AM15/ :03/95/040/00986/AM14/ 04.03.2014 Date:22.12.2014 Decision : It was decided to defer the case for 22.12.2014 for comments of Department of Pharmaceuticals.

||CaseNo.133/6/82-ALC4/2014|PartyName:INDOCO<br>REMEDIESLIMITED|MeetNo/Date:11/82- _ (Status:Deffered<br>ALC4/2014<br>and Re-indexed|
|---|---|---|---|
||||26.11.2014|
||.|||
|200||HQFile<br>201/82/050/00435/AM15/|RLA File<br>:03/94/040/00993/AM14/|Lic.No/Date:0310773117 |Defer<br>05.03.2014<br>Date:22,12.2014|

Decision ; It was decided to send a copy of application to Department of pharmaceuticals for their comments. The case is deferred for 22.12.2014.

Case No.:34/6/82-ALC4/2614 |Party Name:INDOCO Meet No/Date: 1 1/82Status:Deffered REMEDIES LIMITED . JALC42014 and Re-indexed (26.11.2014 201 |HQ:01/82/050/00436/AMI5/ File _-:03/94/040/00973/AM14/RLA File . 05.03.2014Lic.No/Date:0310773 112 Date:22.12.2014|Defer Decision : It was decided to send a copy of application to Department of \pharmaceuticals frothier comments. The case is deferred for 22.12.2014 Case No.:32/6/82-ALC4/2014 iParty Name:INDOCO Meet No/Date:1 1/82Status:Deffered REMEDIES LIMITED ALC4/2014 and Re-indexed 26.11.2014 202 [HQ- File RLA File . Lic. No/Date:03 10774050 [Defer :01/82/050/00434/AM15/ :03/94/040/01104/AM14/ 11.03.2014 Date:22.12.2014 i” Decision : It was decided to send a copy of application to Department off . > on 5 Cee ns ae : oFOSACae TEOe,[year?] ayo Uaye?

==> picture [471 x 262] intentionally omitted <==

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

|||||||
|---|---|---|---|---|---|
|>|..|
|||pharmaceuticals|frothier comments.|The case is deferred for 22.12.2014|
|“fi|
|ase No.:3/3/82-ALC4/2014||PartyPHARMACEUTICALS Name:SHASUN|MeetALC4/2014 No/Date:1 1/82-|Status:and|Re-indexe Deffere|d|
|;|LIMITED|6.11.2014|
|203 |HQ|File|RLA File|Lic.No/Date:04 10156078||Defer|
|01/82/050/00007/AM 1 5/|:04/24/040/00258/AM14/|11.03.2014|Date:12.11.2014|
|D ecision|:|It was decided to remind the firm to furnish a copy ofMaster Batch Formula|
|_|uly certified by Quality|Control|Incharge. The case was deferred|for 22.12.2014.|
|“I|
|ase|No.:30/3/82-ALC 4/2014|[Party Name:BELCO|Meet No/Date: 1 1/82-|Status:Deffered|
|PHARMA|ALC4/2014|and|Re-indexed|
|26.41.2014|
|204||HQ File|RLA|File|Lic.No/Date:05 10381658||Defer|
|_||f01/82/050/00034/AM15/|:05/23/040/00479/AM14/|12.03.2014|Date:22.12.2014|
|'|\ofDecision Pharmaceuticals.: It was decided to defer the case for 22.12.2014 for comments of|Department|

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||||||
|---|---|---|---|---|
|)|
|||ase No.:26/6/82-ALC4/2014|[Party Name:ARIHANTANAM|(Meet No/Date-11/82.|(Status:|
|||LIFECARE PVT. LTD.|26.11.2014ALC4/2014|Approved|
|HQ File|RLA File|Lic.No/Date:0310774412||Defer Date:|
|:01/82/050/00428/AM15/|:03/94/040/01123/AM14/|13.03.2014|

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

_ [Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM 205 INo. 35011/336/2013-PI(Norms) dated 26.09.2014, it was decided to ratify the norms under Para 4.7 of ' JHBP v1 as per details given below or as applied by the firm, whichever is less: i | LARTESUNATE Kg | 1. TARTEMISININ” ———S«~ «BBD Ig | JI RA m ayay taktake appropp ri ateate actionact as perper thethe ddecision off NormsNorms C.Commit t tee. (Case No.:11/9/82-ALC4/2014 iParty Name:SMILAX Meet No/Date:11/82Status: Deffered LABORATORIES LIMITED |ALC4/2014 and Re-indexed | 26.11.2014 206|]HQ Fite RLA File Lic.No/Date:09 10059558 (Defer i 1201/82/4050/00808/AM15/ :09/24/040/006 18/AM14/ 13.03.2014 Date:26.11.2014 | Decision : It was decided to defer the case for 22.12.2014 for comments of Department of Pharmaceuticals.

_ '|Case No.:56/4/82-ALC4/2014 PartyLABORATORIES Name:IND-SWIFT Meet No/Date:1 1/82Status:Deffered LTD., ALC4/2014 and Re-indexed . 26.11.2014 | 207 HQ File RLA File Lic.No/Date:22 10014691 [Defer $:01/82/050/00304/AM15/ :22/24/040/00102/AM14/ 14.03.2014 Date:26.11.2014 | | {Decision : It was decided to defer the case for 22.12.2014 for comments ofDepartment | ,_ Jof Pharmaceuticals. -\ V \ Parte[Bas] NIRMAL KUMA< R | oie General of ror arene aria PTVDepartment of Comm : ude hy nawan Now Delhi

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: | | ; , : | 2 , | | | | ; : |

| Case No.:57/4/82-ALC4/2014 Party Name:IND-SWIFT Meet No/Date:1 1/82Status: Deffered : LABORATORIES LTD., ALC4/2614 and Re-indexed : , 26.11.2014 208 [HQ File RLA File Lic. No/Date:22 10014692 |Defer
| O1/$2/050/00305/AMI5/ :22/24/040/00103/AM14/ 14.03.2014 Date:26,11,2014 | Decision : It was decided to defer the case for 22.12.2014 for comments of Department ofPharmaceuticals.
| Status:Deffered
| Case No.:58/4/82-ALC4/2014 (Party Name:IND-SWIFT Meet No/Date:[1][ 1/82-] LABORATORIESLTD., |ALC4/2014 and Re-indexed 26.11.2014
709 [HQ File RLA File Lic. No/Date:22 10014694 |Defer :0 1/82/050/00306/AM 1 5/ :22/24/040/00100/AM14/ 14.03.2014 Date:26.11.2014 Decision : It was decided to defer the case for 22.12.2014 for comments of Department ofPharmaceuticals.
- Case No.:1/4/82-ALC4/2014 [Party Name:DORF-KETAL Meet No/Date:11/82Status: Approved CHEMICALS INDIA ALC4/2014 PVT.LTD. 26.11.2014
- 210 (HQ File RLA File Lic. No/Date-03 10774824 [Defer Date:
- | _ [Decision:01/82/050/00249/AM15/: Withdrawn as the:03/94/040/00999/AM14/ licence was issued on repeatrepeat18.03.2014 basisbasis pacer under paraPal "04.7.1. _ Case No.:42/4/82-ALC4/2014 'Party Name:RECKITT Meet No/Date:11/82Status; Deffered BENCKISER ALC4/2014 and Re-indexed HEALTHCARE INDIA 26.11.2014 LIMITED
- 511 [HQ File RLA File Lic. No/Date:05 10382032 [Defer O1/82/050/00290/AM[I][ 5/] :05/24/040/00480/AM 14/ 18.03.2014 Date:22.12.2014

Decision : It was decided to cali from the firm copy of DML (Drug Manufacturing Licence), and copy of Master Batch Formula duly authenticated by Quality Control Incharge. The case was deferred for 22.12.2014.

Case No.:43/24/82Party Name: THINQ Meet No/Date: 1 1/82Status:Deffered ALC4/2013 PHARMA-CRO LIMITED j|ALC4/2014 and Re-indexed 26.11.2014
212 |HQ File RLA File Lic.No/Date:03 10774773 \Defer :01/82/050/0 1242/AM14/ 103/95/040/00987/AMI14/ 18.03.2014 Date:22.12.2014

Decision : It was decided to remind the firm to furnish complete technical details as per Appendix 33. The case was deferred for 22.12.2014.

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----- Start of picture text ----- ~TCase No.:42/6/82- Party Name: TITAN [Meet NorDate:11/82- [Status ALC4?2014 LABORATORIES PVT. ALC4/2014 Approved 213 |HQ| File (LTD.RLA File l26.11.2014Lic.No/Date:03 10774745 |Defer Date: :01/82/050/00444/AM15/ :03/95/040/00997/AM9SIOAO/NOSSTIAM IAL 14/ [E80318.03.2014 20N8 Decision :In the light of written comments received from Department of PharmaceuticalerVide ----- End of picture text -----

their OM No, 35011/145/2013-PI(Norms) dated 01.12.2014, it was decided to ratjfysdhe'forihs \ & mc ees SS[Sete] ae[ GE] v eral[OFS] . SoeG ues[oA][ he] eee oF

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|||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|%|
|||Tune er Para4.7 ofHBP|vi|as per details given below or as applied by the firm, whichever is less:|
|i|Export product|Exp.|Qty. allowed|
|:|Qty.|kg/kg|
|||Dmeprazole Pellets 8.5%.|[oe|
|||||Hydroxy Propy! Methyl ||0.055|
||||]|Cellulose ES (HPMC)|
||||{|Methacrylic|Acid|Co-||0.397|
|||||polymer|Dispersion|(L-|
|1|i|30D)|(30%|Dispersion)|
|im|in liquid.|
|||
|||
|||aa Titanium Dioxide|0.011|
|RA|may take appropriate|action|as per the|decision|of Norms|Committee.|
|TT|["l€ase No.:124/6/82-|“(Party Name:UNITED|Meet No/Date:11/82-|_(Status:Deffered|
|ALC4/2014|BIOTECH PVT.LTD.|ALC4/2014|and|Re-indexed|
|26.11.2014|
|214|[HQ|File|RLA|File|Lic.No/Date:05 10382042||Defer|
|01/82/050/00526/AM15/|_|$:05/24/040/00467/AM14/|18.03.2014|Date:22.12.2014|
|Decision|:|It was decided|to|defer the case|for 22.12.2014 for comments of|Department|
|||fof|C&PC.|.|
|TR|ase No.:39/6/82-|)|Party Name:CROWN|Meet No/Date:|
|LC4/2014|CHEMICALS|PVT.LTD.,|ALC4/2014|11/82-|Status: Approved|
|26.11.2014|
|Q File|RLA|File|Lic.No/Date:03|10775043||Defer Date:|
|01/82/050/00441/AM15/|—_|:03/94/040/01136/AM14/|—_—|19.03.2014|_|
|Decision|:|in|the|light|of earlier|decision|taken|by|NC|in|its|3/82|meeting|dated|08.05.2014,|it|was|
|hichever|is|less:|
||Hecided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm,|
|||allowed|
|I|Piperonal|Min.|Purity|11.| Catechol|(Min.|Purity|99%|
|98%|a|||99%Dichloromethane (Min.|Purity|0.703 kg|
|99%|
|14.|| Hexamine|(Min.|Purity 96%)||. 1.000kg|
|15.| Toluene|(Min.|Purity|97%|0.430 kg|
|[6.__||Isopropy!|Alcoho!|(Min.|Puri|0.220|kq_|||
|anPrter|[aR]|/|NIRMAL KUMAR0 &||
|Dy.|Director|General|of Foreign|Trade|
|faeer|cara|Herheenea|
|Directorate|General|of|Foreign|Trade|
|wProg|farvDepanment of Commerce|
|of|Udyog er, SS|Delhi|

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| | | ,

||RAmaytake appropriateactionasperthedecisionofNormsCommittee.|
|---|---|
||CaseNo.:172/6/82-<br>PartyName:ATUL<br>MeetNo/Date:<br>11/82-<br>Status: Approved<br>ALC4/2014<br>BIOSCIENCE LIMITED<br>ALC4/2014|
||26.11.2014|
||HQ File<br>RLAFile<br>Lic.No/Date:5210040850 |DeferDate:|
||:01/82/050/00574/AM 15/<br>$2/24/040/00035/AM 14/<br>25.03.2014|
||Decision; In the light of written comments received from Department of Pharmaceuticals vide their|
|216|[OM No. 38011/523/2013-Pi{Norms} dated 11.09.2013, itwasdecided to ratify norms under Para 4.7 of|
||HBPviasperdetailsgivenbelowor asappliedbythefirm,whichever is less:|
||ItemofExport<br>Quantiy |SNo | ItemofImport<br>Quantityallowed<br>kag/ko<br>carwowrtivane [1p—-E _____ aa—<br>CARBONYL-L-VALINE<br>CBZ-L-VALINE<br>[2<br>merrane<br>OS<br>RAmaytakeappropriateactionasper thedecisionofNormsCommittee.|
||CaseNo.:173/6/82-<br>PartyName:ATUL<br>MeetNo/Date:11/82-<br>Status: Approved<br>ALC42014<br>BIOSCIENCE LIMITED<br>ALC4/2614|
||26.11.2014|
||HQ File<br>RLA File<br>Lic.No/Date:5210040851 [DeferDate:<br>:01/82/050/00575/AM15/<br>:52/24/040/00039/AM14/<br>25.03.2014|

Decision : in the light of written comments received from Department of Pharmaceuticals vide their 217 (OM No. 35011/523/2013-Pi{Norms) dated 11.09.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

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----- Start of picture text ----- Item of Export | Quantity [S.No Item of Import Quantity allowedka/kg ARBO! A ee CBZ-L-VALINE EEee RA may take appropriate action as per the decision of Norms Committee. Case No.:123/6/82- Party Name:KLJ Meet No/Date: ALC4/2014 PLASTICIZERS LTD., ALC4/2014 1 1/82- Status: Approved 26.11.2014 ; HQ File RLA File Lic.No/Date:05 10382641 |Defer Date: :01/82/050/00525/AM15/ :05/23/040/00528/AM14/ 25.03.2014 Decision : Decision ; in the light of written comments received from Department of Chemicals and Petrochemicals vide their U.C No. 14010/36/2011/Ch II dated 26.11.2014, it was decided to ratify 218 norms under Para 4.7 of HBP vi as per details given below or as applied by the firm, whichever is less: : Quanti Allowed PHTHALICAGID KANATOLPACKEDHDPE DRUMSIN20801,277MADE NOS.OF OF HM. HM- ! [2.[a |[TERE 2ETHYLHEXANOL — |0.740kg[0.447 Kg HDPE BLOWING GRADE) HM-HDPE DRUMS As per packing Nn MADE OF HM-HDPE Doli ase ae SteeOe SI eae OF coo peta ook aaeeN a ect? . erate soem iow oe OseaSea a yoy? ----- End of picture text -----

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----- Start of picture text ----- | RA may take appropriate action as per the decision of Norms Committee. - ba e No.:133/6/82- Party Name:PARAMOUNT [Meet No/Date:11/82- __ (Status: Approved 26.11.2014 | 4/2014: AROMACHEM PVT.LTD., {|ALC4/2014 ee IHQ File RLA File Lic.No/Date:05 10382643 |Defer Date: :|}0 1/82/050/00535/AM15/ :05/24/040/00487/AM14/ 25.03.2014 Decision : In the light of written comments received from Department of Chemicals and Petrochemicais de their U.O No. 14010/61/2010/Ch !I dated 28.11.2014, it was decided to ratify norms under Para 4.7 219 r BP vi as per details given below or as applied by the firm, whichever is less: . | Export Product Export Import Product Quantity Quanti Allowed 1. D-LIMONENE (LIMONENE, CITRUS TERPENE, ORANGE “CARVONE 1kg CITRUSTERPENE, BRAZALIAN , TERPENE.STANDARD CITRUS TERPENE ORANGE OIL ----- End of picture text -----

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

|Case No.:134/6/82Party Name:PARAMOUNT = |Meet No/Date:1 1/82Status: Approved ALC4/2014 AROMACHEM PVT.LTD., jALC4/2014 (26.11.2014 FHQ File RLA File Lic.No/Date:05 10382650 |Defer Date: | 01/82/050/00536/AM 15/ :05/24/040/00485/AM 14/ 25.03.2014 Decision : In the light of written comments received from Department of Chemicals and Petrochemicals de their U.O No. 14010/61/2010/Ch II dated 28.11.2014, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

220

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----- Start of picture text ----- Export Product Export S.No | Import Product Quantity Quantity Allowed D-LIMONENE (LIMONENE, CITRUS TERPENE, ORANGE ARVACROL TERPENE,CITRUS BRAZALIAN TERPENE.STANDARD CITRUS TERPENE ORANGE OIL | _ | RA may take appropriate action as per the decision of Norms Committee. ‘ i Case No.:15/6/82-ALC4/2014 |Party Name:KOPRAN Meet No/Date:1 1/82- Status: Deffered LIMITED ALC4/2014 and Re-indexed ; . 26.11.2014 122 Q File RLA File Lic.No/Date:03 10775957 Defer : 291/82/050/00417/AM15/ 703/94/040/01159/AM14/ 26.03.2014 Date:22.12.2014 i ecision : It was decided to defer the case for 22.12.2014 for comments of Department |_| @f Pharmaceuticals. |h Dimee’!Dy rtSeePerey Par [rare] f 2 ofWEE Foreign KUMARWe, ----- End of picture text -----

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| | | |

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Case No.:116/6/82Party Name:PARENTERAL [Meet No/Date:11/82Status:Deffered ALC4/2014 DRUGS (INDIA) LTD., ALC4/2014 and Re-indexed 26.11.2014 222;/HQ File RLA File Lic.No/Date:56 10003946 |Defer | :01/82/050/00518/AM15/ :36/24/040/00053/AM 14/ 26.03.2014 Date:22.12.2014

|Decision : It was decided to defer the case for 22.12.2014 for comments of Department jofPharmaceuticals. . Case No.:127/6/82Party Name:CATAPHARMA [Meet No/Date:1 1/82Status:Deffered ALC4/2014 CHEMICALS PVT. LTD., ALC4/2014 and Re-indexed 26.11.2014 223 {HQ File RLA File Lic.No/Date:3 110063312 [Defer :01/82/050/00529/AM15/ 13 1/83/040/00232/AM14/ 28.03.2014 Date:22.12.2014 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 22.12.2014

Case No.:60/6/82-ALC4/2014 Party Name:UNIMAX Meet No/Date:11/82Status: Deffered CHEMICALS PVT LTD. ALC4/2014 and Re-indexed 26.11.2014 HQ File RLA File Lic.No/Date:03 10776326 [Defer °01/82/050/00462/AM15/ :03/95/040/01035/AM14/ (28.03.2014 Date:22.12.2014

224 Decision :In the light of written comments received from Department of Pharmaceuticals vide Itheir OM No. 3501 1/3 15/2014-Pl(Norms) dated 22.12.2014, it was decided to call from the firm the following technical details: i) Copy of certificate of Analysis of Imported Azithromycin Dihydrate IP grade on Actual content basis vis-avis specifications under Indian Pharmacopia. ii) A similar COA ofthe Export Product vis-avis the specifications laid down in USP -36 iii) Justification / Reasons for Reprocessing. The case was deferred for 22.12.2014.

Case No.:83/5/82-ALC4/2014 Party Name: VEGESNA Meet No/Date: LABORATORIES 1 1/82Status:Deffered PRIVATE |ALC4/2014 and Re-indexed . LIMITED 26.11.2014 225 (HQ File RLA File Lic.No/Date:09 10059688 [Defer. :01/82/050/00400/AM15/ :09/24/040/00666/AM14/ 01.04.2014 Date:22.12.2014 Decision : It was decided to defer the case for 26.1 1.2014 for comments ofDepartment of Pharmaceuticals ;

Case No.:35/6/82-ALC4/2014 Party Name:AGIO ‘|Meet No/Date: 11/82Status:Deffered PHARMACEUTICALS LTD |ALC4/2014 and Re-indexed ; 26.11.2014 226 |HQ File RLA File ic.No/Date:03 10776774 |Defer :01/82/050/00437/AM1 5/ :03/94/040/00914/AM14/ 102.04.2014 Date:22,12.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals

a [Party Name:PERFECT Name:PERFECT Meet No/Date:11/82[Status:Deffere se INDUSTRIES PRIVATE ALC4/2014 and Re-jndiied [50° 4 4 oS =A Co S kA ee nerae oxo tO Sty OY Soeeeea aero Feo ABO yer?

597 [Case° No.:51/6/82-ALC4/2014 [Party Name:PERFECT Name:PERFECT : INDUSTRIES PRIVATE

! ! po ~ (LIMITED. (26.11.2014 | 1Q File RLA File Lic. No/Date:03 10776759 (Defer | :01/82/050/00453/AM15/ :03/95/040/01054/AM14/ 02.04.2014 Date:22.12.2014 | pecision : It was decided to send a copy of application to Department of C&PC The || |@ase is deferred for 22.12.2014 i | taseNo.:50/6/82-ALC4/2014 (Party Name:V & V PHARMA [Meet No/Date:11/82- _ (Status:Deffered A. 26.11.2014 | INDUSTRIES ALC4/2014 and Re-indexed | 228 :)|HIQ1/82/050/00452/AM File 1 5/ 703/05/040/01061/AM14/RLA File 02.04.2014Lic.No/Date:03 10776760 Date:22.12.2014|Defer | |Decision : It was decided to defer the case for 26.11.2014 for comments of Department | | of Pharmaceuticals :[T [aseLC4/2014 No.:147/6/82Party Name:RL FINE CHEM ALC4/2014(Meet No/Date:11/82and|Status:Deffered Re-indexed 26.11.2014 . . - boob THQ File RLA File Lic.No/Date:0710103377 [Defer 0.1/82/050/00549/AM 1 5/ :07/24/040/00489/AM 1 4/ 03.04.2014 Date:22.12.2014 . Decision : It was decided to defer the case for 26.11.2014 for comments of Department | [pf Pharmaceuticals | .

||||aseNo137/6/82-|~~~‘(PartyName:RAY|~ [MeetNo/Date:11/82-<br>_|Status:Deffered|
|---|---|---|---|---|---|
||||LC42014|CHEMICALS PRIVATE|ALC42014<br>and Re-indexed|
|||||LIMITED,|26.11.2014<br>;|
||by]||HQFile<br>01/82/050/00539/AM15/|RLA File<br>—_|:07/24/040/00490/AM14/|Lic.No/Date:0710103378 Defer<br>3.04.2014<br>Date:22.12.2014|
|||<br>_||||(Decision : Itwasdecidedto deferthecasefor26.11.2014 forcommentsofDepartment<br>ljofPharmaceuticals<br>_<br>||||

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(T llCase No.:20/6/82-ALC4/2014 |Party Name:ADISHANK [Meet No/Date:11/82_|[Status:Deffered CHEMICALS PVT.LTD. ALC4/2014 and Re-indexed : 26.11.2014 . . [2p fHQ File RLA File Lic.No/Date:03 10777786 |Defer . :01/82/050/00422/AM15/ :03/94/040/01140/AM14/ 04.2014 |Date:22.12.2014 || (Decision ; It was decided to defer the case for 26.11.2014 for comments of Department | _ | lof Pharmaceuticals [7] l[Gase No.:17/6/82-ALC4/2014 [Party Name:ALTA Meet No/Date:11/82(Status: LABORATORIES LTD. ALC4?2014 Approved 26.11.2014 a . HQ File RLA File Lic.No/Date:0310778781 iDefer Date: :01/82/050/00419/AM15/ :03/94/040/00023/AM15/ 21.04.2014 ) ‘|{Decision : in the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/37/2012/Ch Ii dated 25.05.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per detaits given below or as applied by the firm, whichever is fess: ’ Export Product |[Export|] S.No | Import Product PVR mA

PVR aamA .. aT 30 ets SE vot FOTeiOn Fae Genera > at of come Dicer Fr rmimeranns fain a sa, Gyan: NON yayes

Methyl Paraben Paraben |

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----- Start of picture text ----- Methyl Paraben Paraben 14 kg Acid ydroxy Benzoic | 0.969 kg RA may take appropriate action as per the decision| of Norms|Methanol Committee. | 0.500 kg ----- End of picture text -----

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----- Start of picture text ----- Case No.:19/6/82- Party Name:GLENMARK Meet No/Date:11/82- Status: ALC4/2014 GENERICS LIMITED ALC4/2014 Approved - 26.11.2014 . . HQ File RLA File Lic.No/Date:03 10779059 |Defer Date: :01/82/050/00421/AM15/ —_|:03/94/040/000S1/AM15/ [22.04.2014 . . ----- End of picture text -----

| :01/82/050/00421/AM15/ —_|:03/94/040/000S1/AM15/ [22.04.2014 . . : Decision :Committee considered case as per agenda and in light of earlier decision taken in 42/82 meeting held on 17.01.2012 and in consultation with technical authority present in meeting decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied| 233 by firm whichever is lower:-

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----- Start of picture text ----- i Export product Export Oty. import items Qty. allowed Bupropion 1 kg M-Chioropropiophenone 0.85 kg Hydrochioride BP Methylene Chioride/MDC/Methylene Dichloride }3._ |100g Methanol ----- End of picture text -----

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

Case No.:156/6/82Party Name:P.D. NAVKAR [Meet No/Date:1 1/82Status: Deffered ALCA42014 BIO-CHEM PVT.LTD, ALC4/2014 and Re-indexed : [26.11.2014 734/HQ File RLA File Lic.No/Date:07 10103670 |Defer :01/82/050/00558/AM15/ :07/24/040/00483/AM14/ 3.04,2014 Date:22. 12.2014 | |Decision :It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals .

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----- Start of picture text ----- Case No.:183/6/82- Party Name:TIDE iMeet No/Date: 11/82- Status:Deffered ALC4/2014 INDUSTRIES LC4/2014 and Re-indexed 6.11.2014 235 {HQ File RLA File Lic.No/Date:34 10039854 [Defer :01/82/050/00585/AM15/ 134/24/040/00005/AM15/ 3.04,2014 Date:22.12.2014 | |Decision : It was decided to defer the case for 26.11.2014 for comments of Department jof C&PC. ; ; _ Case No.:10/9/82-ALC4/2014 Party Name:AUROBINDO Meet No/Date:11/82- Status:Deffered PHARMA LIMITED 1ALC4/2014 and Re-indexed 7 26.11.2014 236 |HQ File RLA File Lic.No/Date:09 10059875 |Defer :01/82/050/00807/AM15/ :09/24/040/00047/AM1 s/ 25.04.2014 Date:22.12.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals ----- End of picture text -----

aks WAN/ NIRMAL KUMAR Dy. Director Generat of Forsign Trade Directorate General of Foreign Trade arog frvOepartment of Commerce Udyog Bhawan Wes Detni

| | | |

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||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
|||7|ase No.:237/6/82-|Party|Name:ESTEEM|Meet No/Date:|
|||1 1/82-|Status:Deffered|
|||4/2014|a|INDUSTRIES.|PVT. LTD,|26.11.2014CA/2014|and Re-indexed|
|||(123|HQ|File|RLA File|Lic.No/Date:|17|10005803||Defer|
|101/82/050/00639/AM15/|_|:17/24/040/00002/AM15/|5.05.2014|Date:22.12.2014|
|Decision|:|It was decided to defer the case for 26.11.2014|for comments of|Department|
|||[pf|C&PC.|
|oP|
|ase No.:9/9/82-ALC4/2014|iParty Name:SHREE JAYA|Meet No/Date: 1 1/82-|Status: Deffered|
|LABORATORIES PVT LTD.|j|ALC4/2014|and|Re-indexed|
|_:|pas||HO|.|File|.|RLA File|26.11.2014Lic.|No/Date:09|10060006|[Defer|
|01/82/050/00806/AM15/|:09/24/040/00036/AM15/|07.05.2014|Date:22.12.2014|
|Wecision|:|It was decided|to defer the|case|for 22.12.2014|for comments of|Department|
|_||_||Jof|Pharmaceuticals|.|
|||(7)|WiCase No.:236/6/82-|Party Name:ESTEEM|Meet No/Date:11/82-|__(Status:Deffered|
|||||||}ALC4/2014|INDUSTRIES PVT. LTD,|ALC42014|and Re-indexed|
|||26.11.2014|
|||249//HQ File|RLA File|Lic.|No/Date: 1710005806|[Defer|
|||:01/82/050/00638/AM15/|117/24/040/00007/AM15/|08.05.2014|Date:22.12.2014|
|||"|||Decision|:|It was decided to defer the case for 22.12.2014|for comments of|Department|
|||gof|C&PC|.|
|||:|Case No.:240/6/82-|Party Name:MICRO LABS|Meet No/Date:11/82-|Status:Deffered|
||||:|ALC4?2014|LTD|ALC4/2014|and Re-indexed|
|—|||26.11.2014|.|
|||:|doWallHQ|File|IRLA|File|Lic.No/Date:0710103970|[Defer|
|:|:01/82/050/00642/AM15/|:07/2 1/040/00092/AM15/|08.05.2014|Date:22.12.2014|
|||Decision|:|It was decided to defer the case for 22.12.2014|for comments of|Department|
|||of Pharmaceuticals|
|||.|}iCase No.:238/6/82- No.:238/6/82-|Party Name:ESTEEM Name:ESTEEM|Meet No/Date:1 1/82- No/Date:1 1/82-1 1/82- 1/82-|Status:Deffered|
|||:|||ALC42014|INDUSTRIES PVT. LTD, PVT. LTD, LTD,|ALCA/2014|land Re-indexed Re-indexed|
|||26.11.2014|
|||44||HQ File File|RLA File File|Lic.No/Date:1710005810|[Defer|

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. }iCase No.:238/6/82- No.:238/6/82Party Name:ESTEEM Name:ESTEEM Meet No/Date:1 1/82- No/Date:1 1/82-1 1/82- 1/82Status:Deffered : | ALC42014 INDUSTRIES PVT. LTD, PVT. LTD, LTD, ALCA/2014 land Re-indexed Re-indexed 26.11.2014 44 |HQ File File RLA File File Lic.No/Date:1710005810 [Defer | (:01/82/050/00640/AM 1 5/ 2 17/24/040/00008/AM15/ 09.05.2014 Date:22,12.2014 | | |Decision : It was decided to defer the case for 22.12.2014 for comments ofDepartment || | |of Pharmaceuticals . IT [Case No.:40/5/82-ALC4/2014 (Party Name-SHIVAM OILS & (Meet No/Date:11/82__[Status: PROTEINS INDUSTRY, ALC4/2014 Approved 26.11.2014 IF“ THQ File RLA File Lic.No/Date:5610004192 |Defer Date: ll. | |:01/82/050/00357/AM15/ :56/24/040/00007/AM15/ 19.05.2014 . Decision : Withdraw as the case was already approved in 9/82 meeting dated 20.10.2014 : 243 Case No.:88/6/82-ALC4/2014 [Party Name:UPL Nop [Meet No/Date:11/82__[Status:Deffered

==> picture [1 x 13] intentionally omitted <==

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

Dy.freesDirectoraren Generalweirrasndsof Foreign Trade Directorate General of Foreign Trade afta faryvOspanment of Commerce

| | |

| :

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

|||||||
|---|---|---|---|---|---|
|LTD.(FORMERLY UNITED||ALC4/2614|and Re-indexed|»|
|||PHOSPHORUS|LTD.)|6.11.2014|
|HQ File|RLA|File|Lic.No/Date:03 10782129||Defer|
|0|1/82/050/00490/AM15/|:03/95/040/00033/AM15/|0.05.2014|—|Date:22.12.2014|
|Decision|:|It was decided to defer the|case for 22.12.2014|for comments of|Department|
|ofC&PC.|
|Case No.:169/6/82-|Party|Name:SIDDHI|Meet No/Date:11/82-|(Status:|
|ALC4/2014|VINAYAKA SPECHEM|___|ALC4/2014|Approved|
|[PVTLTD.,|26.11.2014|
|HQ File|RLA|File|Lic.No/Date:07|10104283||Defer Date:|
|:01/82/050/0057 VAMIS/|:07/24/040/00052/AM15/|21.05.2014|
|Decision|:in the|light|of written comments received from|Department of Chemicals and Petrochemicals|
|>|vide their U.O No. 14010/154/2011/Ch|I! dated 02.01.2014,|it was decided to ratify norms under Para|4.7|
|AA|of HBP v1 as per details given below or as applied by the firm, whichever is less:|

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;

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

|||||||||
|---|---|---|---|---|---|---|---|
|Export Product|Export|S.No|||import Product|Quantity|
|Quantity|Allowed|
|DITHIOTHREITOL/DTT|Lkg|3.038|[kg]|
|[[rioacencacw|
|[2.581 kg|||
|RA may take appropriate action|as per the decision of Norms Committee.|
|Case No.:17/9/82-ALC4/2014||Party Name:AUROBINDO|Meet No/Date:11/82-|Status: Deffered|
|PHARMA LIMITED|ALC4/2014|and Re-indexed|
|245||HQ File,|;|RLA|File|‘(26.11.2014Lic.No/Date:09 10060176|[Defer|
|701/82/050/008 14/AM15/|:09/24/040/00093/AM15/|2.05.2014|Date:22.12.2014|
|Decision|:|It was decided|to defer the|case|for 22.12.2014|for comments|of Department|
|of|Pharmaceuticals|.|a|
|Case No.:223/6/82-|Party Name:ANUH|Meet|No/Date:11/82-|_[Status:Deffered|
|ALC4/2014|PHARMA LTD.|ALC4/2014|and Re-indexed|
|246||HQ|.File|RLA File|26.11.2014Lic.No/Date:03|10783471|\Defer.|
|:01/82/050/00625/AM15/|303/94/040/00149/AM15/|29.05.2014||Date:22.12.2014|

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

| |Decision : It was decided to defer the case for 22.12.2014 for comments of Department of Pharmaceuticals

(Case No.:86/8/82-ALC4/2014 |Party Name:GLENMARK Meet No/Date:11/82Status:Deffered GENERICS LIMITED ALC4/2014 and Re-indexed 26.11.2014 [247 |HQ File. RLA File Lic.No/Date:03 10783793 |Defer 01/82/0S0/00750/AM15/ —|:03/94/040/00160/AM15/ [30.05.2014 Date:22.12.2014 Decision : It was decided to defer the case for 22.12.2014 for comments of Department of Pharmaceuticals . . ;48 (Case No.:161/6/82Party Name-JAGSONPAL [Meet No/Date:11/82(Status: — |ALC4/2014 _ |PHARMACEUTICALS LTD. |ALC4/4Q} dar _ jApproved — mf Ars = a Sine FISH Go Trade NS tet Sere HEMET gg Dies ne ent of Corme©ce ose baawen New Deni

TY . pa | |

| |

| (26.11.2014 Q File RLA File Lic.No/Date:05 10388035 [Defer Date: 011 /82/050/00563/AM15/ :05/23/040/00077/AM15/ 03.06.2014 Decision : Committee considered the case as per agenda and in consultation with technical ythority present in meeting decided to ratify norms under para 4.7 of HBP as per SION A-412 tn 2% wastage.

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

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----- Start of picture text ----- i se No.:165/6/82- Party Name:-HALDIA Meet No/Date:1 1/82- Status:Deffered 4/2014 PETROCHEMICALS LTD. (|ALC4/2014 and Re-indexed 26.11.2014 249 |HQ File RLA File Lic.No/Date:02 10203844 |Defer /82/050/00567/AM1 5/ 102/24/040/00037/AM15/ 05.06.2014 Date:22.12.2014 Dt ision : It was decided to defer the case for 22.12.2014for comments of Petrochemicals ___[Division of Department of Chemicals and Petrochemicals. [| Cf se No.:228/6/82- Party Name:NECTAR Meet No/Date:11/82- _[Status:Deffered 26.11.2014 | C4/2014 LIFESCIENCES LIMITED, [ALC42014 and Re-indexed b50 JHQ File RLA File Lic.No/Date:22 10014962 |Defer 01 /82/050/00630/AM1 5/ 322/24/040/000 1 7/AM15/ 05.06.2014 Date:22.12.2014 Decision : It was decided to defer the case for 22.12.2014 for comments of Department of Pharmaceuticals ----- End of picture text -----

: : |

| | :

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----- Start of picture text ----- se No.:69/6/82-ALC4/2014 [Party Name:WANBURY Meet No/Date:11/82- —|Status:Deffered LIMITED(FORMERLY ALC42014 and Re-indexed PEARL ORGANICS LTD) 26.11.2014 bsif i/82/050/00471/AM15/File RLA:03/95/040/0004 File /AM15/ 06.06.2014Lic.No/Date:03 10784601 |Defer22.12.2014. Date: Decision : It was decided to remind the firm to furnish complete technical details as per nr Pp pe Abpendix 33. The case was deferred for 22.12.2014. se No.:90/6/82-ALC4/2014 (Party Name: WANBURY Meet No/Date:1 1/82- Status:Deffered LIMITED(FORMERLY ALC4/2014 and Re-indexed PEARL ORGANICS LTD) 26.11.2014 952 [HO File RLA File Lic.No/Date:03 10784592 |Defer Date: /82/050/00492/AM15/ ——:03/95/040/00075/AMI15/ —_—-|06.06.2014 22.12.2014. Dk ision : It was decided to remind the firm to furnish complete technical details as per Ap pendix 33. The case was deferred for 22.12.2014. ase No.:92/6/82-ALC4/2014 PartyLIMITED(FORMERLYName: WANBURY MeetALC4/2014 No/Date:1 1/82- Status:Deffereand Re-indexe d PEARL ORGANICS LTD) = 26.11.2014 b53 [HQ File RLA File Lic. No/Date:03 10784695 [Defer Date: /82/050/00494/AM15/ :03/95/040/00072/AM15/ 06.06.2014 22.12.2014. Dy ision : It was decided to remind the firm to furnish complete technical details as per Appendix 33. The case was deferred for 22.12.2014. } | TITS RITE RAS CAR | Oy. Director Generat of Foreign Trade | Directorate General of Foreign Trade airsg farvDepartment of Commerce PAELLA Obit Delni ----- End of picture text -----

“F 2

w

Case No.:94/6/82-ALC4/2014 |Party Name: WANBURY Meet No/Date: 1 1/82Status: LIMITED(FORMERLY ALC4/2014 Approved PEARL ORGANICS LTD) = 26.11.2014 HQ File RLA File Lic. No/Date:03 10784605 |Defer :01/82/050/00496/AM15/ 103/95/040/00067/AM15/ 06.06.2014 Date:26.11.2014

Decision : Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/767/2013-PI(Norms) dated 05.09.2014 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details given below or as applied by firm whichever is lower:-

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----- Start of picture text ----- 254 Export product Exp. import items Qty. Qty. Allowed Ka/ka Metformin Hel Dicyanodimide 0.567 RA concerned may take further necessary action as per above decision of NC. Case No.:96/6/82-ALC4/2014 |Party Name: WANBURY Meet No/Date:1 1/82- Status: Deffered LIMITED(FORMERLY ALC4/2014 and Re-indexed PEARL ORGANICS LTD) 26.11.2014 255 [HQ File RLA File Lic.No/Date:03 10784633 [Defer Date: 101/82/050/00498/AM 15/ :03/95/040/0007 L/AM15/ 06.06.2014 22.12.2014. ----- End of picture text -----

Decision : It was decided to remind the firm to furnish complete technical details as per Appendix 33. The case was deferred for 22.12.2014.

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----- Start of picture text ----- Case No.:98/6/82-ALC4/2014 |Party Name: WANBURY Meet No/Date: LIMITED(FORMERLY ALC4/2014 1 1/82- andStatus:Re-index Deffer ed PEARL ORGANICS LTD) 26.11.2014 756 |HQ File RLA File Lic.No/Date:03 10784664 |Defer Date: :01/82/050/00500/AM15/ :03/95/040/00074/AM15/ 06.06.2014 22.12.2014. Decision : It was decided to remind the firm to furnish complete technical details as per Appendix 33. The case was deferred for 22.12.2014. ----- End of picture text -----

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----- Start of picture text ----- Case No.:100/6/82- Party Name: WANBURY Meet No/Date: 1 1/82- Status:Deffered ALC4/2014 LIMITED(FORMERLY ALC4/2014 and Re-indexed 257 [HQ| File PEARLRLA File ORGANICS LTD) 26.11.2014Lic. No/Date:03 10784657 |Defer Date: :01/82/050/00502/AM15/ :03/95/040/00073/AM15/ 06.06.2014 22.12.2014. Decision : It was decided to remind the firm to furnish complete technical defasis.as per Appendix 33. The case was deferred for 22.12.2014. were, Na [32] ‘ Gon, xx FORGONE oe.a cal of ee Etot aw s eo ayo? ----- End of picture text -----

i| 73 | \ | | *) | |[Gase No.:103/6/82-ALC4/2014 [Party Name:WANBURY Meet No/Date:11/82(Status: | LIMITED(FORMERLY ALC4/2014 Approved PEARL ORGANICSLTD) [26.11.2014 . | ie File RLA File Lic.No/Date:03 10784587 |Defer Date: } — |:1/82/050/00S0S/AM15/ :03/95/040/00069/AM15/ 06.06.2014 | . 7 (Decision : Committee considered the case as per agenda and in light of written comments | |réceived from Department of Pharmaceuticals vide their OM No. 35011/767/2013-PI(Norms) | ated 05.09.2014 and in consultation with technical authority present in meeting, decided to ! ify norms under para 4.7 of HBP as per details given below or as applied by firm whichever is | ower:mt || | Sxport product Exp. import items Qty. Qty. Allowed | | etformin Hel 1 kg Dicyanodimide 0.567 | : AA concerned may take further necessary action as per above decision of NC. _ a No.:150/6/82Party Name: DHANUKA Meet No/Date:11/82Status: Deffered r4/2014 LABORATORIES LTD. ALC4/2014 and Re-indexed {| 26.1 L.2014 249 [HQ File RLA File Lic.No/Date:0510388492 [Defer 0 R2/050/00552/AM15/ :05/23/040/00099/AM 1 5/ 09.06.2014 Date:22.12.2014 D eq sion : It was decided to defer the case for 22.12.2014 for comments of Department of Ph armaceuticals — 1 1/82Status: Deffered Cc 8 No.:153/6/82Party Name:DHANUKA Meet No/Date: ALC4/2014 LABORATORIES LTD. ALC4/2014 and Re-indexed ti 26.11.2014 | 26) [HQ Rile RLA File Lic. No/Date:05 10388491 (Defer SOVSP/050/00S5S/AMiS/ ——|:05/23/040/00098/AM15/ —— [09.06.2014 Date:22.12.2014 | D f ion : It was decided to defer the case for 22.12.2014 for comments ofDepartment ofPharmaceuticals

Ce 2 No.:67/9/82-ALC4/2014 Party Name:JUBILANT LIFE Meet No/Date:11/82Status:Deffered SCIENCES LIMITED ALC42014 and Re-indexed i 26.11.2014 261||HQ Fite RLA File Lic.No/Date:05 10388394 |Defer :01482/050/00864/AM 15/ :05/23/040/00101/AM15/ 09.06.2014 Date:22.12.2014 Detision : It was decided to defer the case for 22.12.2014 for comments of Department of Ph aceuticals

262 |C*s 0.:148/6/82Party Name:PARABOLIC Meet No/Date:[1][ 1/82-] Status:Deffered b4j2014 DRUGS LTD., ALC4/2014 KY\ jand Re-indexed = Fay BATT / NIRMAL KUMAR Dy. Director General of Foreign Trade fyaer zara Aeifrewtesa Directorate General of Foreign Trade aftrera fearvDepartment of Commerce : | Udyog Bhawan, New Delhi |

pe

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||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|[|||26.11.2014|||
|le:01/82/050/00550/AM15/ File|Rua205/24/040/00070/AMI15/ File|—_|ic[09.06.2014osmates|10388412 PeteDate:22.12.2014|
|_|ofDecision Pharmaceuticals: It|was decided to defer the case for 22.12.2014 for|comments ofDepartment.|
|LIFESCIENCES LIMITED,|ALC4/2614|approved|
|Case.|No.:226/6/82-ALC4/2014 te|Name:NECTAR|ite26.11.2014No/Date: 11/82-|roe|
|RQ:01/82/050/00628/AM File|1|5/|LA122/24/040/000 File|[1]|8/AM15/|hic12.06.2014NosDae:2210014981|Defer Date:|
|Decision::|In the|light of written comments received of written comments received written comments received comments received received|from Department of Department of of|Pharmaceuticals|vide|their OM OM|
|INo.|3501 1/274/2014-Pl(Norms) 1/274/2014-Pl(Norms)|dated|30.10.2014,|it|was|decided|to|ratify|the|norms|under|Para|4.7|of|
|HBP v! v!|as per details given below or as applied by the per details given below or as applied by the details given below or as applied by the given below or as applied by the below or as applied by the or as applied by the as applied by the by the the|firm,|whichever|is|less:|
|.|Quantity|S.No|kg/kg|
|11 AmorphousCefuroxime Axetil|ike|1.|Desacetyl-7-aminocephalosporanic acid (D-7-|er0.79|
|||}3.||02Methanol|
|i|Syn-methoxyimino furany!|
|‘||acetic acid ammonium|salt|
||||5.|||Activatedcarbon|0.100,|
|pentachloride|
||7.___| Methylene|chloride|12.29)|
||||8.__| Sodium hydroxide|10.43|
|||19.|Aceticacid|=f|0B|
|a|lsocyanate|
|||
|||
||||[15[14 __|| Acetoxyethyl Cyclohexane_ bromide010|.|59|92|
|||
|:|item|
|Hydrochloric acid|Not an|importable|

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

Decision:: In the light of written comments received of written comments received written comments received comments received received from Department of Department of of Pharmaceuticals vide their OM OM INo. 3501 1/274/2014-Pl(Norms) 1/274/2014-Pl(Norms) dated 30.10.2014, it was decided to ratify the norms under Para 4.7 of HBP v! v! as per details given below or as applied by the per details given below or as applied by the details given below or as applied by the given below or as applied by the below or as applied by the or as applied by the as applied by the by the the firm, whichever is less:

RA may take appropriate action as per

a werent of Foreign Ti 2 Sa on Department of Cor ‘ Wage brawler ew OF

; || | | 1S Dy yi LIMITED {ALca2014 {and Re-indexed. | UA 6.11.2014 || | [HQ File RLA File |Lic.No/Date:09 10060438 [Defer Date: || | }301/82/050/00686/AMI5/ ———|:09/24/040/00146/AMI5/ —|13.06.2014 22.12.2014 | | ecision : It was decided to defer the case for 22.12.2014 for comments of Department 7 _ | |@fPharmaceuticals [| [tase No.2149/6/82Party Name:INDO PHYTO [Meet No/Date:11/82[Status:Deffered ‘| |1ALC4/2014 CHEMICALS PVT LTD (2014 and Re-indexed all 26.11.2014 || 26 | [991/82/050/0055Q File 1/AM15/ RLA:05/23/040/00108/AM15/ File Lic.13.06.2014 No/Date:65 10388673 22.12.2014|Defer Date: | ecision : It was decided to defer the case for 22.12.2014 for comments of Department | ||@f Pharmaceuticals ! | ase No.:151/6/82Party Name:INDO PHYTO —— [Meet No/Date:11/82—|Status:Deffered | JALC4/2014 HEMICALS PVT LTD ALC4/2014 and Re-indexed | | 26.11.2014 | "66 i Q File RLA File Lic.No/Date:05 10388672 |Defer Date: | 1/82/0S0/00553/AMI5/ecision : It was decided to—|:08/23/040/00107/AMI5/ defer the case for 22.12.2014—_|13.06.2014for comments of Department22.12.2014 | _ |\4£ Pharmaceuticals

fase No.:166/6/82Party Name:KORES (INDIA) [Meet No/Date:11/82|Status:Deffered | . 26.11.2016 | LC4/2014 LTD. ALC4/2014 and Re-indexed 26 HQ File RLA File Lic.No/Date:3 1/82/050/00568/AM1 5/ 33 1/83/040/00033/AM15/ 13.06.2014 22.12.2014 | 1 10064371 |Defer Date: | | ecision : It was decided to defer the case for 22.12.2014 for comments of Department | _||@f Pharmaceuticals.

[~ ]|ffase No.:61/4/82-ALC4/2014 [Party Name:V & V PHARMA [Meet No/Date:11/82[Status:Deffered | INDUSTRIES ALC4/2014 and Re-indexed | 26.11.2014 |o6s HQ File RLA File Lic.No/Date:03 10785305 [Defer Date: | ) 1/82/050/00309/AM15/ :03/95/040/00190/AM15/ {13.06.2014 22.12.2014 | _||of| ecisionPharmaceuticals.: It was decided to defer the case for 22.12.2014 for comments of Department

| [fase No.2152/6/82~ [Party Name:MOREPEN [Meet No/Date:11/82_|Status:Deffered 1LC4/2014 LABORATORIES LTD., LC4/2014 and Re-indexed | 26.11.2014 1260 |HQ File RLA File Lic.No/Date:05 10388704 [Defer Date: )1/82/050/00554/AM15/ :05/24/040/00133/AM15/ 16.06.2014 22.12.2014 | | ecision : It was decided to defer the case for 22.12.2014 for comments of Department _||@f Pharmaceuticals. a Pieter SAR NIRMAL. j Oy Broa Be, freemar eer apo oreign Trade Directorate General yetaeTere PraUdyog rorDepartment of coma BhawanEtthi

;

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----- Start of picture text ----- Case No.:234/6/82-ALC4/2014 Party Name:GULBRANDSEN [MeetNo/Date:11/82- Status: & CHEMICALS PVT LTD ALC4/2014 approved 26.11.2014 HQ. File RLA File Lic. No/Date:34 10040266 |Defer Date: :01/82/050/00636/AM15/ 734/24/040/0007 1/AM15/ 17.06.2014 Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/49/2011-Ch. It 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, whichever is less: ----- End of picture text -----

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----- Start of picture text ----- H Qty. : pl. | Tin Ingots 0.418 kg 270 DiButyl tin Diacetate (DBTDA) 2 Aluminium: 0.071 kg | Grit/ Granules 60/40 Mix Butyl Tin Chloride (60/40 MBTC) | lkg 2 Aluminium 0.048 kg Grit/ Granules F-200 +00(Blend(Blendofof 40%40% mono-butyl-tinmono-buty! a ee— \Trichloride and 3.5%0, of HF) Grit/ Granules 0.025 kg ----- End of picture text -----

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

==> picture [452 x 110] intentionally omitted <==

----- Start of picture text ----- Case No.:159/6/82- Party Name:JAGSONPAL Meet No/Date:11/82- Status: ALC4/2014 PHARMACEUTICALS LTD. ALC4/2014 Approved 26.11.2014 HQ File RLA File Lic.No/Date:05 10388788 |Defer eel :01/82/050/00561/AM15/ :05/23/040/001 16/AMI5/ 18.06.2014 Date:26.11.2014 Decision: Committee considered the case as per agenda and in consultation with technical authority present in meeting decided to ratify norms under para 4.7 of HBP as per SION A-412 with 2% wastage. ----- End of picture text -----

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

==> picture [452 x 121] intentionally omitted <==

----- Start of picture text ----- Case No.7164/6/82- Party Name:VDH CHEM [Meet No/Date:11/82- _[Status:Deffered ALC4/2014 TECH PVT. LTD. ALC4/2014 and Re-indexed 26.11.2014 HQ; File RLA File Lic.No/Date:05 10388792 (Defer 272 :01/82/050/00566/AM15/ 105/24/040/00085/AMI5/ 18.06.2014 Date:22.12.2014 Decision :in the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/58/2010-Ch II dated 23.09.2014, it was decided to call from the firm the following technical details/clarifications: wt ----- End of picture text -----

==> picture [125 x 115] intentionally omitted <==

----- Start of picture text ----- wt formula, m m and We [EASES] oor RO e* oFCGE Soewoor ----- End of picture text -----

° Details of manufacturing process with chemical reactions, molecular formula, m m

s tf ctural formulae and molecular weights. stage wise percentage Yields . aterial balance : A certificate the regarding past three years production of the export item and corresponding |¢0} sumption of different raw materials. etail of by-products/co-products formed in the above production with quantities and values e ified by CA. Detail of by-products recovered and their sale realizations port. : on technical literature in support of manufacturing process and norms applied for |. [Pile case was deferred for 22.12.2014. | 4lalicas2014 ca 2 No.:142/6/82LABORATORIESParty Name:DHANUKA LTD. —[ALC4/2014[Meet No/Date:11/82__[Status:Deffereand Re-indexe d | {| 26.11.2014 | : |273;[HQ File RLA File Lic.No/Date:05 10388965 |Defer : ‘HOWS2/0S0/00S44/AMIS/ —|:05/23/040/00105/AM15/ —_[20.06.2014 Date:22.12.2014 : [Décision : It was decided to defer the case for 22.12.2014 for comments of Department | 0 | Pharmaceuticals

! : | |

| false No.:64/4/82-ALC4/2014 [Party Name:AUROBINDO [Meet No/Date-11/82_[Status:Deffered : PHARMA LIMITED ALC4/2014 and Re-indexed 26.11.2014
074 [HO File RLA File Lic.No/Date:09 10060520 |Defer H/82/050/003 12/AM15/ :09/24/040/00 154/AM15/ 23.06.2014 Date:22.12.2014
| IP ision : It was decided to defer the case for 22.12.2014 for comments ofDepartment ip | Pharmaceuticals

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----- Start of picture text ----- [case No.:72/9/82-ALC42014 [Party Name:DORF-KETAL [Meet No/Date:11/82- (Status: CHEMICALS INDIA ALC42014 approved PVT.LTD. 26.13.2014 ( File RLA File Lic.No/Date:03 10785815 |Defer Date: ' /82/050/00869/AM15/ :03/94/040/00256/AMI15/ 23.06.2014 Dj ision ; in the light of written comments received from Department of Chemicals and Pa rochemicals vide their U.O No. 14010/176/2011-Ch. Il dated 28.11.2014, it was decided to arity norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, | O75 ‘i‘ ichever is less: 7 | Qty. Peseta, Pee Antioxidant fhenyl -1-napthylamine-PX-3806 Octylated N NaphthylamineDi-isobutylene - HP 0.647 kg 3 Fulcat 22B (Solid | RA may take appropriate action as per the decision of Norms Committee. 4, y \ KUMAR earn oenineai Foren” Cases pitetOTeaUDEPAM'faerate Gener ent *(ASVConini 1 : aera aa pia | yoyo Be ----- End of picture text -----

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

||||||
|---|---|---|---|---|
|(Case No.:71/9/82-ALC4/2014||PartyCHEMICALS Name:AVA|Meet No/Date:1 1/82-|Status:Deffered|&|
|PVT.LTD.,|ALC4/2014|and Re-indexed|
|26.11.2014|
|276|[HQ File|RLA File|Lic.No/Date:03 10785955|[Defer|
|-01/82/050/00868/AM1|3/|:03/94/040/00249/AM15/|24.06.2014|Date:22.122014|
|Decision|:|It was decided to defer the case for 22.12.2014 for comments of|Department|
|lof C&PC|

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||||||||
|---|---|---|---|---|---|---|
|[Case No.:83/9/82-ALC4/2014|[Party Name:IPCA|Meet No/Date:11/82-|_|Status:Deffered|
|LABORATORIES|LIMITED||ALC4/2014|and|Re-indexed|
|.|26.11.2014|
|277||HQ|File|RLA|File|Lic.No/Date:03 10785911|Defer|
|:01/82/050/00880/AM15/|:03/94/040/00223/AM15/|24.06.2014|Date:22.12.2014|
|Decision|:|It was decided to defer the case for 22.12.2014 for comments of|Department|
|of|Pharmaceuticals|
|Case No.:68/4/82-ALC4/2014|LTD|Party|Name:|MICRO|LABS|Meet No/Date:1 1/82-|Status:|
||ALC4/2014|Approved|
|.|(26.11.2014|
|HQ File|RLA|File|Lic.No/Date:0710105379|[Defer Date:|
|201/82/050/003 16/AM15/|:07/24/040/00106/AM15/|25.06.2014|

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

Decision : In line with SION A-54 and as per earlier decision taken by NC in its 20/2 meeting dated 20.09.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as o7g [Pet details given below or as applied by the firm, whichever is less:

==> picture [422 x 66] intentionally omitted <==

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

||||||||
|---|---|---|---|---|---|---|
|Item of|Export|Item of|Import|Quantity allowed|
|Amoxycillin|250|mg|Amoxycillin|Trihydrate|| 292.68 mg|
|tablets|BP/EP/USP|
|Amoxycilling|500|mg|2.|Amoxycilling|Trihydrate|| 585.36 mg|
|t|tablets|BP/EP/USP|

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

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

Case No.:85/9/82-ALC4/2014 |Party Name:BLISS GVS Meet No/Date:11/82Status:Deffered PHARMA LTD. ALC42014 jand Re-indexed 6.11.2014 279 |HQ File RLA File Lic.No/Date:03 10786049 [Defer :01/82/050/00882/AM 15/ 703/94/040/00178/AM15/ 26.06.2014 Date:22.11.2014

Decision : It was decided to defer the case for 22.12.2014 for comments of Department of Pharmaceuticals

Case No.:203/6/82-ALC4/2014 |Party Name:KLJ Meet No/Date:11/82(Status: PLASTICIZERS LTD., ALC4/2014 approved | of. 26.11.2014 280 HQ File RLA File Lic.No/Date:0510389118 [Defer Date: |-01/82/050/00605/AM15/ :05/23/040/00129/AM15/ 26.06.2014 Decision : in the light of written comments received from Department ofChemicals and Petrochemicals vide their U.O No. 14010/36/2011/Ch lt dated 28.11.2014, it was decided to ratify norms ungeseara 4.7 of HBP v1 as per details given below or as applied by the firm, whichever Is less: anes oa weeSoe0 €orni ° OF OO eet ocat Cort xe oi Betigeaoe Ayo! yer?

||%||||<br>||||<br>|||||
|---|---|---|---|---|---|---|
||<br>|||'<br>**|**<br>:<br>||||SANATOL<br>1004 os OFHM<br>HDPEDRUMSMADEOFHM-<br>HDPEBLOWINGGRADE)(EACH<br>DRUM SHALL WEIGHT8.3KG<br>J<br>ANDSTORAGECAPACITY|Quantity<br>}2,__|2-PROPYLHEPTANOL<br>—_—|0.590<br>ISODECANOL||Allowed<br>0.349kg<br>0.590kg<br>0.197 kg|
|:|||225.000KGS.)||||
||<br>|<br>|<br>|<br>|||.<br>;<br>WF|||HM-HDPEDRUMSMADEOF | <br>HM-HDPEBLOWINGGRADE<br>(EACHDRUMSHALL<br>WEIGHT8.5KGAND<br>STORAGECAPACITY225.000|Asper packing<br>ji<br>policy|
|:<br>:||||||KGS.)<br>(TOTALNO.OFDRUMS=||
|||||||NOS.||
|||_||RAmaytakeappropriateactionasperthedecisionofNormsCommittee||||
||**|**||{Case No.:74/9/82-ALC4/2014 [PartyName:BLISSGVS<br>PHARMALTD.||MeetNo/Date:11/82-<br>ALC4/2014|Status:Deffered<br>and Re-indexed|
||||||26.11.2014||
|||||||.|
||<br>||8]||i File<br>RLAFile<br>A/82/050/00871/AM15/<br>:03/94/040/00277/AM 15/||Lic.No/Date:0310786144 |Defer<br>27.06.2014<br>Date:22.12.2014||
||||D<br>ision : Itwas decidedto deferthe case for22.12.2014 forcommentsofDepartment||||
||__|of[Pharmaceuticals||||||

)

lee No.:69/4/82-ALC 4/2014 ‘Party Name:RA CHEM Meet No/Date:11/82Status:Deffered PHARMA LIMITED ALC4/2014 and Re-indexed
a 26.11.2014 - .
p82 FD File RLA File Lic.No/Date:09 10060550 [Defer £08/82/050/003 17/AM15/ :09/24/040/00175/AM15/ 27.06.2014 Date:22,12.2014 Dt ision : It was decided to defer the case for 22.12.2014 for comments of Department of Pharmaceuticals
“tse No.:73/9/82-ALC4/2014 |Party Name:D. R. COATS Meet No/Date:| 1/82Status:Deffered INK & RESINS PVT.LTD. |ALC4/2014 and Re-indexed
| 6.11.2014 283 [HW File RLA File Lic. No/Date:03 10786181 (Defer OF /82/050/00870/AM 15/ 103/94/040/00755/AM 14/ 30.06.2014 Date:22.11.2014
Dp ision : It was decided to send a copy of application to Petrochemicals Division of
_|Dgpartment of Chemicals and Petrochemicals. The case is deferred for 22.12.2014.

"|Chse No.:210/6782Party Name:WEXFORD [Meet No/Date:11/82__|Status:Deffered 26.11.2014 | 4/2014 LABORATORIES P LTD ALC4/2014 and Re-indexed; ba [Hid File RLA File Lic.No/Date:07 10105465 |Defer i /82/050/00612/AM15/ :07/24/040/00105/AM15/ 30.06.2014 Date:22.12.2014 ia Decision : It was decided to defer the case for 22.12.2014 for comments of Department jof Pharmaceuticals || Pris ware ieee eT meen Trade : Uayod! APaka ae Fesemmerce 1 New Dein;

==> picture [455 x 70] intentionally omitted <==

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

|||||||
|---|---|---|---|---|---|
|Case No.:191/6/82-ALC4/2014|PartyHEM-TECH Name:GOPINATH|Meet No/Date:1 1/82-|Status:|&|
|LTD.,|ALC4/2614|approved|
|.|.|26.11.2014|
|HQ|File|RLA|File|Lic.No/Date:0810132551||Defer Date:|
|:01/82/050/00593/AM1I5/|708/24/040/00139/AM15/|01.07.2014|

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

Decision: in the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/30/2014/Ch lt dated 27.11.2014, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

==> picture [427 x 218] intentionally omitted <==

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

|||||||
|---|---|---|---|---|---|
|285}|||Export Product|Export|Import Product|Quantity|
|Quantity|Allowed|
|||2.075|
|t-SULPHO|kg|
|HYDRAZONE (BECA)|0.600|
|3.|CAUSTIC SODA FLAKES OR|||1.500|kg|
|CAUSTIC SODA LYE (100%|
|REAL BASIS}|
|_|
|RA may take appropriate action|as per the decision|of Norms Committee|
|Case No.:68/9/82-|Party Name:HINDUSTAN|[Meet No/Date:11/82-|Status:|
|ALC42014|POLYAMIDES & FIBRES||ALC4/2014|approved|
|LIMITED|.|26.11.2014|
|HQ File|RLA|File|Lic.No/Date:03 10786348:|iDefer Date:|
|:01/82/050/00865/AM15/|703/94/040/00269/AMI5/|03.07.2014|

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

Decision: n the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/90/2011/Ch I dated 10.05.2013, 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:

1286

==> picture [394 x 77] intentionally omitted <==

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

|||||||
|---|---|---|---|---|---|
|Export Product|Export|S.No|||Import Product|Quantity|
|Quantity|Allowed|
|MENTHANOL|(4-Isopropy!|CUMINIQUEALDEHYDE|1.185 kg|
|yclohexyl|Methanol)|5% RUTHENIUM ON|0.0035|kg|
|CARBON CATALYST|

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

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

Case No.:205/6/82Party Name:HPL Meet No/Date:11/82(Status: ALC4/2014 ADDITIVES ALC42014 approved LIMITED(FORMERLY 26.11.2014 KNOWN HIGH POLYMER HQ File RLA File Lic.No/Date:05 10389355.|Defer Date: 287 :01/82/050/00607/AMI5/ —_|:05/23/040/00091/AM15/ [04.07.2014 a Decisionvide : tn the tight of written comments received from Department of Chemicals and Petrochemicals their U.O No. 14010/7/2011/Ch i dated 17.09.2014, it was decided to ratify norms under Para 4.7 of HP v1 as per detaits given below or as applied by the firm, whichever Is jess:

==> picture [483 x 116] intentionally omitted <==

----- Start of picture text ----- . Export Product Export Import Product Quantity . - Quant= Allowed | om an 0? 6 3 Ne we OF aE“ po ----- End of picture text -----

9 | [| |[kzodicarbonamide 1kg 2.| Hydrazodicarbonamide |1.19kg | Crude 92% - al ay take appropriate action as per the decision of Norms Committee ; ke No.:63/9/82-ALC4/2014 Party Name:CORAL Meet No/Date:1 1/82Status:Deffered LABORATORIES LTD., ALC4/2014 nd Re-indexed I | . 26.11.2014 . 88) @) File RLA File Lic.No/Date:03 10786480 |Defer |}01/82/050/00860/AM15/ —_|:03/94/040/00177/AM15/ |07.07.2014 Date:22.12.2014 |Décision : It was decided to defer the case for 22.12.2014 for comments of Department ip [Pharmaceuticals | ' No.:59/9/82-ALC4/2014 |Party Name:INDO GERMAN /Meet No/Date:11/82- — |Status:Deffered ALKALOIDS ALC4/2014 and Re-indexed 26.11.2014 9 |H@ File RLA File Lic.No/Date:03 10786553 |Defer 4/82/050/00856/AM1 5/ 103/94/040/00305/AM15/ 08.07.2014 Date:22,12.2014 | [DD f ision : It was decided to defer the case for 22.12.2014 for comments of Department | _|pfi|Pharmaceuticals

Case No.:70/9/82Party Name:IPCA Meet No/Date:11/82_—([Status: 26.11.2014 | 4/2014 LABORATORIES LIMITED ALC4/2014 Approved iQ File RLA File Lic.No/Date:03 10786550 |Defer Date: y 1/82/050/00867/AM15/ :03/94/040/00306/AM15/ 08.07.2014 ! ecision :In the light of earlier decision taken by NC in its 7/82 meeting dated 11.09.2014 and consultation with technical authority present in meeting, decided to ratify norms under para 7 of HBP as per details below or as applied by firm whichever is lower:-

==> picture [406 x 135] intentionally omitted <==

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

xport product Exp. Import items Qty. Qty. Allowed kg/kg 1 3,20 Dioxopregna- RIAMCINOLONE 1 kg 1,4,9(1 1),16 Tetraen-21- ACETONIDE Ylacetate (3 -TR ) RA concemed may take further necessary action as per above decision of NC. ----- End of picture text -----

==> picture [431 x 70] intentionally omitted <==

----- Start of picture text ----- hse No.:192/6/82- Party Name:KLI Meet No/Date:11/82- (Status: 1LC4/2014 PLASTICIZERS LTD., ALC4/2014 approved | 4] [26.11.2014 I if File RLA File Lic.No/Date:05 10389472 |Defer Date: O /82/050/00594/AM15/ 1:05/23/040/00 144/AM 15/ 08.07.2014 ; ----- End of picture text -----

Mecision : in the light of written comments received from Department of Chemicals and Petrochemicals fle their U.O No. 14010/30/2014/Ch I! dated 27.11.2014, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: | h

o2_

|Quantity<br>fa [PaTALICANNYDRIDE **|**0.560<br>KANATOL - 400<br>|2.__| ISO/NORMALBUTANOL<br>PACKED IN 2,554NOS.OFHM-HDPE<br>DRUMSMADEOFHM-HDPE<br>BLOWINGGRADE)<br>HM-HDPEDRUMSMADEOF|Quantity<br>fa [PaTALICANNYDRIDE **|**0.560<br>KANATOL - 400<br>|2.__| ISO/NORMALBUTANOL<br>PACKED IN 2,554NOS.OFHM-HDPE<br>DRUMSMADEOFHM-HDPE<br>BLOWINGGRADE)<br>HM-HDPEDRUMSMADEOF|Quantity<br>fa [PaTALICANNYDRIDE **|**0.560<br>KANATOL - 400<br>|2.__| ISO/NORMALBUTANOL<br>PACKED IN 2,554NOS.OFHM-HDPE<br>DRUMSMADEOFHM-HDPE<br>BLOWINGGRADE)<br>HM-HDPEDRUMSMADEOF|Allowed<br>0.560kg<br>0.560kg<br>Asperpacking<br>policy|
|---|---|---|---|
|||HM-HDPEBLOWINGGRADE||
|||(TOTALNO.OFDRUMS=||
|||2,554NOS.)||
|RAmaytake appropriateactionas|asperthedecisionofNormsCommittee|||
|CaseNo.:204/6/82-<br>ALC4/2014|PartyName:PAYAL<br>PETROCHEMPRIVATE<br>LIMITED|MeetNo/Date:11/82-<br>LC4/2614<br>26.11.2014|Status:Deffered<br>andRe-indexed|
|HQ File<br>:01/82/050/00606/AM15/|RLA File<br>:05/24/040/00192/AM14/|{Lic.No/Date:05 10389448 <br>08.07.2014||Defer<br>Date:22.12.2014|

Decision :in the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/18/2010-Ch II dated 05.11.2014, it was decided to call n92 from the firm the following technical details/clarifications:

Details of manufacturing process with chemical equations, molecular formula, molecular and structural formulate and molecular weights. « Yield obtained in each stage.
Authentic technical literature in support of yield obtained.
CA certificate certifying the production of export item achieved by you for the past three years and corresponding consumption of each input. The case was deferred for 22.12.2014.

Case No.:211/6/82Party Name:PA Meet No/Date:11/82[Status:Deffered ALC4/2014 YAL PETROCHEM ALC4/2014 and Re-indexed . PRIVATE LIMITED 26.11.2014 293 |HQ File RLA File Lic. No/Date:05 10389447 iDefer :01/82/050/00613/AM15/ —|:05/24/040/00191/AM14/ ——_|08.07.2014 |Date:22.12.2014

Decision : : It was decided to defer the case for 22.12.2014 for comments of Department of C&PC

Case No.:64/9/82-ALC4/2014 |PartyLABORATORIES Name:IPCA LIMITED |ALC4/2014Meet No/Date:1 1/82andStatus:DefferedRe-indexed 6.11.2014 994 1HQ File RLA File Lic.No/Date:03 10786631 o|Defer :01/82/050/0086 1/AM15/ :03/94/040/00199/AM15/ 09.07.2014 Date:22.12.2014 Decision : : It was decided to defer the case for 22.12.2014 for comments of Department of Pharmaceuticals . . a ; . [ {Case No.:80/9/82Party Name:MICRO ORGO- (Meet No/Date:11/82[Status:Approved 295 ALC4/2014 CHEM ALC4/2014 HQ| File _ [RLA File _. [Lic.No/Date:0326.11.2014 10786687 [Defer- Date: ‘| Mrare Pra EeeinteralPedof Fore Custer eeerate Corer ment phe yr Direc!ayersaaeee few Dee eini uayeg

*) | [joljszv0sor00877/amis/ —_[:03/95/040/00292/AM15/ [10.07.2014 | i Df ision : In the light of earlier decision taken in meeting no. 8/82 dated 25.09.2014, it ‘i decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as | ! plied by the firm, whichever is less: Re may take appropriate action as per the decision of Norms Committee Ise No.:26/9/82-ALC4/2014 [Party Name:ALMELO PVT (Meet No/Date:11/82-__|Status:Deffered LTD ALC4/2614 and Re-indexed I 26.11.2014 | b96 |FH} File RLA File . Lic.No/Date:09 10060660 |Defer | f /82/050/00823/AM15/ :09/24/040/00188/AM15/ 11.07.2014 Date:22.12.2014 De ision : : It was decided to defer the case for 22.12.2014 for comments ofDepartment of Pharmaceuticals . . Clise No.:65/9/82-ALC4/2014 [Party Name:AMINES & Meet No/Date:11/82(Status: . PLASTICIZERS LIMITED ALC4/2014 Approved |! A| File RLA 26.11.2014Lic.No/Date:0310786813 |Defer| Date: / 0 | /82/050/00862/AM1S/ File:03/94/040/00298/AMIS5/ = 114.077.2014 | of cision ; In the light ofwritten comments received from Department of Chemicals and Petrochemicals ! 97 |“ je their U.O No. 14010/61/2013/Ch 11 dated 11.11.2014, it was decided to ratify norms under Para 4,7 | JOf/HBP v1 as per details given below or as applied by the firm, whichever is less: | | || Export Product Export import Product | | Quantity Allowed =| Ee ___ {Ria may take appropriate action as per the decision of Norms Committee Case No.:88/9/82-ALC4/2014 |Party Name: MAC CHEM Meet No/Date:1 1/82Status: Deffered PRODUCTS (INDIA) ALC42614 and Re-indexed PRIVATE LIMITED 26.11.2014 IQ; File RLA File Lic.No/Date:03 10786782 |Defer #1/82/050/00885/AM15/ 103/95/040/00302/AM15/ 14.07.2014 Date:22.12.2014 ecision : It was decided to defer the case for 22.12.2014 for comments of Department 1 Pharmaceuticals.

7 ts se No.:108/9/82Party Name:NECTAR Meet No/Date:11/82Status:Deffered yl 4/2014 LIFESCIENCES LIMITED, 26.11.2014|ALC4/2014 and Re-indexeda | 99 |HQ File RLA File Lic.No/Date:2210015019 |Defer | I1 ecision/82/050/00905/AM15/: It was decided to defer322/24/040/00083/AM the case for 14/ 22.12.215. 0 7.261414 for comments ofDatD e :22.12.2014partment A Fz | _||@f Pharmaceuticals. \ . ’ i NIRMAL KON Oy i or ener e | wpectoraoeaGheralgnment of FO”© onhens uayog BHEWN™

Case No.:87/9/82-ALC4/2014 Party Name: UNUULES LIFE |Meet No/Date:11/82Status:Deffered & SCIENCES LTD. ALC4/2014 and Re-indexed 26.11.2014 300 |HQ File RLA File Lic.No/Date:03 10786843 |Defer :01/82/050/00884/AM15/ :03/05/040/00324/AM15/ 15.07.2014 Date:22.12.2014

Decision : It was decided to defer the case for 22.12.2014 for comments of Department jof Pharmaceuticals

. . Case No.:99/9/82Party Name:ALKYL MeetNo/Date: ALC4/2014 AMINES CHEMICALS LTD |ALC4/2014 1 1/82Status:approved ; 26.11.2014 HQ File RLA File Lic.No/Date:03 10786924 |Defer Date: :01/82/050/00896/AM15/ :03/94/040/00155/AM15/ 16.07.2014 Decision : tn the light of written comments received from Department of Chemicals and Petrochemicals 301 vide their U.O No. 14010/85/2012/Ch li dated 01.12.2014, 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 Export import Product Quantity Quantity Allowed a[decision][of][ Norms][ Committee] RA[may][ take][ appropriate][ action][ as][ per][ the] lll cb ALC4/2014Case No.:102/9/82AMINESParty Name:ALKYL CHEMICALS LTD [ALC4/2014Meet No/Date:1 1/82Status:approved ‘ 26.11.2014 HQ File RLA File Lic.No/Date:03 10786926 |Defer Date: :01/82/050/00899/AM15/ :03/944040/00130/AM15/ 16.07.2014

Decision :in the tight of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/85/2012/Ch It dated 01.12.2014, it was decided to ratify norms under Para 4.7 302 jof HBP v1 as per details given below or as applied by the firm, whichever is less:

Export Product Export import Product Quantity Quantity Allowed RA may take appropriate action as per the decision of Norms Committee Case No.:6/9/82-ALC4/2014 |Party Name: VIVIMED LABS [Meet No/Date:1 1/82Status: LIMITED ALC4/2014 approved - 7 |26.11.2014 _ HQ File RLA File Lic.No/Date:09 10060667 |Defer Date: :01/82/050/00803/AM15/ 109/24/040/00208/AMI15/ 17.07.2014 303 |Decision: In the light of written comments received from Department ofChemicals and Petrochemicals vide their U.O No. 14010/64/2013/Ch I! dated 11.11.2014, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

Export Product Export Import Product Quantity wot Quant \\ | Allowed ell OF ete‘ Gen joneser anii) ONO OTA, AS ow o HO paw yayod

| | | | | |

| "” Til ? TE 2- | ll] opium ascorByL pHospHaTe. PKS 1. PHOSPHATE 35% OR 1.94 kg | OR C-VITE CALCIUM ASCORBYL | PHOSPHATE 2[|][suomsconswornesmes] JON EXCHANGE RESIN |400K —| [RA may take appropriate action as per the decision of Norms Committee 7 | ase No.:1/6/82-ALC4/2014 [Party Name:ARJUN Meet No/Date:11/82(Status: Deffered ; CHEMICALS PVT. LTD., |ALC4/2014 and Re-indexed | 26.11.2014 i304 [HQ File RLA File Lic.No/Date:04 10159021 [Defer | P 1/82/050/00403/AM15/ :04/24/040/0006 VAMI15/ 18.07.2014 Date:22.12.2014 | p ecision : It was decided to defer the case for 22.12.2014 for comments of Department | || lefC&PC. | | Pase No.:79/9/82-ALC4/2014 [Party Meet No/Date:11/82[Status:Deffered | ame:METROPOLITAN ALC4/2014 and Re-indexed ; }EXIMCHEM LTD. 6.11.2014 | 305 Q File IRLA File Lic.No/Date:03 10787073 .|Defer D 1/82/050/00876/AM[1][5/] 703/95/040/00337/AM15/ 18.07.2014 Date:22.12.2014 fl b ecision ; It was decided to defer the case for 22.12.2014 for comments of Department LiF CRPC.

. ‘ase No.:90/9/82-ALC4/2014 (Party Name:YASHO ‘Meet No/Date:11/82Status: an. INDUSTRIES PVT.LTD. ALC4/2014 Approved ld | 26.11.2014 | Q File RLA File Lic.No/Date:0310787108 |Defer Date: H0 1/82/050/00887/AM15/ :03/95/040/00348/AM15/ 21.07.2014 | | Decision: In the light ofwritten comments received from Department of Chemicals and Petrochemicals. ide their U.O No. 14010/95/2011/Ch I dated 28.11.2014, it was decided to ratify norms under Para 4.7 ! |306 tpf HBP v1 as per details given below or as applied by the firm, whichever is less:

)_=er==| Quantity Allowed | 50% Sodium sait of kg 1. Tolvtriez0l 0.437 kg | olytriazole olytriazole | ! RA may take appropriate action as per the decision of Norms Committee | gCase No.:98/9/82-ALC4/2014 Party Name:AGIO Meet No/Date:1 1/82Status:Deffered { PHARMACEUTICALS LTD |ALC4/2014 and Re-indexed . _ (26.11.2014 | 1307/1HQ File RLA File Lic.No/Date:03 10787172 |Defer :01/82/050/00895/AM15/ :03/94/040/001 10/AM15/ 22.07.2014 Date:22.12.2014 | | | |Decision : It was decided to defer the case for 22.12.2014 for comments of Department | || lof Pharmaceuticals ry. | h ;MIRMAL KUMAR ' OFfreer ETS,TE rei ae DicectOfa Si Dopartment of Commerce UdyoS Bhawan, +

: | :

||CaseNo.:18/9/82-ALC4/2014||PartyName:BIOLOGICALE <br>LTD|MeetNo/Date:11/82-<br>ALC4/2014|Status:Deffered|<br>andRe-indexed|&|
|---|---|---|---|---|---|
||||6.11.2014|||
|308|7<br> [HQFile<br>:01/82/050/00815/AM15/|RLAFile<br>:09/24/040/00197/AMI5/|Lic.No/Date:0910060702 <br>22.07.2014|[Defer<br>Date:22.12.2014||

Decision : It was decided to defer the case for 22.12.2014 for comments of Department of Biotechnology

||CaseNo.:24/9/82-ALC4/2014||PartyName:BRUNDAVAN<br>LABORATORIESPRIVATE <br>LTD.,|MeetNo/Date:11/82-<br>Status:Deffered<br> ,|ALC4/2014<br>‘and Re-indexed<br>26.11.2014|
|---|---|---|---|
|309||HQFile|RLAFile|Lic.No/Date:09 10060703 |Defer|
||:01/82/050/00821/AMI5/|:09/24/040/00104/AM15/|22.07.2014<br>Date:22.12.2014|
||Decision : Itwasdecided|todefer thecase for22.12.2014 forcommentsofDepartment||
||ofPharmaceuticals|||

|||CaseNo.:25/9/82-ALC4/2014||PartyName:DIVIS|MeetNo/Date:11/82-|Status:Deffered||
|---|---|---|---|---|---|---|
||||PHARMACEUTICALS|ALC4/2614|and Re-indexed||
||||PRIVATE LIMITED|26.11.2014|||
||310|[HQFile<br>:01/82/050/00822/AM15/|RLAFile<br>:09/24/040/00194/AM15/|Lic.No/Date:0910060700 <br>07.2614|[Defer<br>Date:22.12.2014||
|||Decision : Itwasdecidedto|todeferthe casefor22.12.2014 forcommentsofDepartment||Department||
|||ofPharmaceuticals|.||||
|||CaseNo.:78/9/82-ALC4/2014||PartyName:PACE<br>PHARMATECHPVT.LTD.|MeetNo/Date:11/82-<br>jJALC4/2014|Status:Deffered<br>and Re-indexed||
|||||26.11.2014|||
||311|;<br> [HQFile<br>:01/82/050/00875/AM15/|RLAFile<br>103/95/040/00347/AM15/|Lic. No/Date:0310787160. <br>22.07.2014|[Defer<br>Date:22.12.2014||
|||Decision : Itwasdecided|todeferthe case for22.12.2014 forcomments of Department||of Department||
|||ofPharmaceuticals|||||
||)||||||
|||CaseNo.:12/9/82-ALC4/2014|(PartyName:AUROBINDO|MeetNo/Date:11/82-|‘|Status:||
||||PHARMALIMITED|ALC4/2614|Approved||
|||||26.11.2014|||
|||.|||||
|||HQ File|RLA File|Lic.No/Date:0910060711<br>{Defer Date:|||
|||:01/82/050/00809/AM15/|:09/24/040/002 14/AM15/|3.07.2014|||
|||||Decision : TheCommittee considered the case as per||agenda and in light ofwritten comments|||
|||received from Department|of Pharmaceuticals vide their OM No. 35011/285/2014-PI(Norms)||||
|||dated October 2014 and in consultation with technical||authority present in meeting, decided to|||
||312||ratify norms under para 4.7 ofHBP as per details below or as applied by firm whichever is|||||
|||lower:-|||||
|||poser) |<br>| as<br>ACIDMONOAMIDE<br>a<br>ACETONE<br>1.541<br>wae<br>Sr<br>CARBONENOANTICROMOS[<br>[0.014 aSd<br>—=<br>\<br>TBO<br>RES<br>Wecste Sihca<br>ASee Ne<br>OFSee<br>eFSe<br>oF|||||

| e) rT ~ || | ACTIVATED CARBON] OYSSSSC*d 4 [ISOPROPYL ALCOHOL | 1.894 ar RA may take appropriate action as per the decision of Norms Committee. ~ [Chse No.:107/9/82Party Name-IND-SWIFT [Meet No/Date:11/82-|Status:Deffered JAILC4/2014 LABORATORIES LTD., ALC4/2014 and Re-indexed ial 26.11.2014 — . 313]HQ File RLA File Lic.No/Date:22 10015039 [Defer 4 /82/050/00904/AM 1 5/ :22/24/040/00033/AM15/ 23.07.2014 Date:22.12.2014 {Decision : It was decided to defer the case for 22.12.2014 for comments of Department Jot Pharmaceuticals . , Clase No.:66/9/82Party Name:S.M. Meet No/Date:11/82tatus: ALCan2014 CHEMICALS ALC4/2014 Approved , | . 26.11.2014 ie File RLA File Lic.No/Date:03 10787305 (Defer Date: | W1/82/050/00863/AM15/ —|:03/95/040/00304/AMI5/ [24.07.2014 1. : } ecision ; In the light ofwritten comments received from Department of Chemicals and Petrochemicals 314l fie their U.O No. 14010/64/2010/Ch it dated 29.11.2014, it was decided to ratify norms under Para 4.7 ot HBP vi as per details given below or as applied by the firm, whichever is less: Export Product Export import Product Quantity Quanti Allowed RIPHENYL PHOSPHITE ! 0.937 kg | [2 vewowniosmonus [0.108 ___ IRA may take appropriate action as per the decision of Norms Committee — 7 f ase No.:96/9/82Party Name:STERLING Meet No/Date:11/82Status: 26.11.2014 } 1 4/2014 AUXILIARIES PVT LTD ALC4/2014 Approved i HQ File RLA File Lic.No/Date:03 10787290 [Defer Date: || | Epl/82/0so/o0893/AMI5/|:03/95/040/00349/AMIS/___ [24.07.2014 | { ecision : In the light of written comments received from Department of Chemicals and Petrochemicals I 31419 ide their U.O No. 14016/64/2013/Ch Ii dated 07.11.2014, it was decided to ratify norms under Para 4.7 } if HBP v1 as per details given below or as applied by the firm, whichever is less: | Export Product Export Import Product Quantity Quanti Allowed | STERO MDEA-EX (MONO METHYL 0.273 kg | ||] p e ve ersoxveare [2 [emiviecoxme 0.776 kg I. IRA may take appropriate action as per the decision of Norms Committee

) Th “ase No.:100/9/82Party Name:INDOCO Meet No/Date:1 1/82Status:Deffered .| ) 4/2014 REMEDIES LIMITED ALC4/2014 and Re-indexed / 316 ll, 26.11.2014 Q File RLA File Lic.No/Date:03 10787333 |Defer | i 1/82/050/00897/AM15/ :03/94/640/00301/AM of 25.07.2014 Date:22.12.2014 . N UMAR aauipt NIRMAL ore ‘ fristserra[|][ae][teign][ Tra0e] py. Director HEIR ae at wATATS gi of FOSS ere pirectorate Gerppariment of com aes i a, Ge Dein yayos BRAWe™

| |

==> picture [452 x 348] intentionally omitted <==

----- Start of picture text ----- Case No.:7/6/82-ALC4/2014 |Party Name:AARTI DRUGS [Meet No/Date: 1/82- Status:Deffered LIMITED ALC4/2014 and Re-indered 26.11.2014 ; 317 [HQ File RLA File sLic.No/Date:03 10787378 |Defer :01/82/050/00409/AM15/ :03/94/040/00321/AM15/ 28.07.2014 Date:22.12.2014 Decision : It was decided to defer the case for 22.12.2014 for comments of Department of Pharmaceuticals Case No.:48/9/82-ALC4/2014 |Party Name:ALCHYMARS _ |Meet No/Date:1 1/82- Status:Deffered ICM SM PRIVATE LIMITED |ALC4/2014 and Re-indexed 26.11.2014 . | . 318 [HQ File RLA File ‘Lic.No/Date:04 10159110 [Defer :01/82/050/00845/AM1 5/ :04/24/040/00062/AM15/ 28.07.2014 Date:22.12.2014 Decision : It was decided to defer the case for 22.12.2014 for comments of Department of Pharmaceuticals Case No.:32/9/82-ALC4/2014 |Party Name:CHEMCON Meet No/Date:1 1/82- Status: Deffered SPECIALITY CHEMICALS {ALC4/2014 and Re-indexed PLTD 26.11.2014 . HQ File RLA File Lic.No/Date:34 10040406 [Defer :01/82/050/00829/AM15/ :34/24/040/00102/AM15/ 28.07.2014 Date:22.12.2014 Decision : Department of Chemicals and Petrochemicals vide their letter No. 14010/21/2012-Ch. I] dated 09.01.2014 requested the firm to furnish the following information: ----- End of picture text -----

319 |* Details of manufacturing process of Chloromethyl Isopropyl Carbonate with chemical equations, molecular formula, molecular weights. ¢ Yield obtained in each step ¢ Authentic technical literature in support of yield obtained * Material balance * CA certificate the production of export item achieved by you for the past three years and corresponding consumption of each input. ¢ Detailed calculation, arriving at the norms applied.

The case was deferred for 22.12.2014

==> picture [452 x 100] intentionally omitted <==

----- Start of picture text ----- Case No.:8/6/82-ALC4/2014 |Party Name:V & V PHARMA /|Meet No/Date:1 1/82- Status:Deffered INDUSTRIES ALC4/2014 and Re-indexed 26.11.2014 329 [HQ File RLA File Lic.No/Date:03 10787382 [Defer :01/82/050/004 10/AM15/ :03/95/040/0033 1/AM15/ 28.07.2014 Date:22.12.2014 Decision : It was decided to defer the case for 22.12.2014 for comments of Department of Pharmaceuticals ----- End of picture text -----

==> picture [463 x 88] intentionally omitted <==

----- Start of picture text ----- 21 [Case No.:97/9/82-ALC4/2014 [Party Name:YASHQymAR [Meet No/Date:11/82-_([Staras: <, y- iractorpart! Sore etyET igntradeTee wreseie : 40“se oie Roener e ! ofeacorm eres oeOo *yk uayes oa? ----- End of picture text -----

‘

, ” INDUSTRIES PVT.LTD. ALC4/2014 Approved AL 26.11.2014 | ? | y File RLA File Lic.No/Date:03 10787381 |Defer Date: |}0 8/82/050/00894/AM15/ :03/95/040/00366/AM15/ 28.07.2014 ee ’ ision : In the light of written comments received from Department of Chemicals and Petrochemicals , | Ge| BPtheirv1 asU.O perNo.details14010/95/2011/Ch given below orasIi datedapplied21.05.2014, by the firm,it waswhichever decided is less:to ratify norms under Para 4.7 = EeeQuanti Allowed bcrvLATED DrHENYLAMINE( 0.405 kg | |} | pemeasseerowne 0.620[kg] . i ' may take appropriate action as per the decisian of Norms Committee : Case No.:22/9/82-ALC4/2014 [Party Name:NATCO PHARMA |Meet No/Date:1 1/82Status: LIMITED ALC4/2014 Approved | ! 26.11.2014 7 KD File IRLA File Lic.No/Date:0910060757 |Defer Date: d /82/050/008 19/AM15/ :09/24/040/00186/AM[1][5/] 30.07.2014 : i ecision : In the light of written comments received from Department of Pharmaceuticals vide their | OF No. 35011/317/2014-Pi{Norms) dated 01.12.2014, it was decided to ratify norms under Para 4,7 of | | 3001 P vi as per details given below or as applied by the firm, whichever is less:

| Export product__| Export Qty. | SI.No. | importitems == ity. allowed J 2 121.858 mg/100 imatinib 400 mg a 487.431 mg/400

| may take appropriate action as perthe decision of Norms Committee.

th se No.:30/9/82-ALC 4/2014 |Party Name:SOFTGEL Meet No/Date:1 1/82Status: Deffered HEALTH CARE PVT. LTD., |ALC4/2014 and Re-indexed 26.11.2014 1323 iQ File RLA File Lic. No/Date:04 10159122 |Defer ) 1/82/050/00827/AM15/ :04/24/040/00033/AM15/ 30.07.2014 Date:22.12.2014 | | ecision : It was decided to defer the case for 22.12.2014 for comments of Department | |{@f Pharmaceuticals. || | (tase No.:54/9/82-ALC4/2014 [Party Name-RATNAMANI [Meet No/Date:11/82_[Status: | BIO CHEMICALS & ALC4/2014 Approved ; PHARMACEUTICALS PVT. {26.11.2014 F LTD | (324 Q File RLA File Lic.No/Date:3410040420 {Defer Date: | i! 1/82/050/0085 1/AM15/ :34/24/040/00092/AM 15/ 31.07.2014 Hh Petrochemicalsi ecision : In thevide lighttheir ofwrittenU.O. commentsNo. 14010/23/2014-Ch received from Department ofII dated 24.06.2014,Chemicals andit was | \ R RMAL KIUMA : oS ae BoneraTiporeign Trade ; Y rare careyen rade i Diao Ropeament of Commerce : OTUdyodar[BR] at,[wer] FEni

\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 [422 x 115] intentionally omitted <==

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

||||||
|---|---|---|---|---|
|||Export product|Import items|Qty. allowed|
|||Qty.|
|pepeenams net|[ike||!|[2eciciewtowme||9952 ke|
|2,3-Dichloro|Tol|.|
|||0.0t Kg|

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

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

Case No.:20/9/82-ALC4/2014 |Party Name:AUROBINDO [Meet No/Date:11/82Status: Deffered PHARMA LIMITED ALC4/2014 and Re-indexed
; | 26.11.2014
325 |HQ File RLA File Lic, No/Date:09 10060790 [Defer :01/82/050/008 17/AM15/ :09/24/040/00202/AM15/ — 1.08.2014 Date:22.12.2014

Decision :It was decided to defer the case for 22.12.2014 for comments of Department of Pharmaceuticals

Case No.:$8/9/82-ALC4/2014 |Party Name:G AMPHRAY [Meet No/Date:11/82Status: Deffered LABORATORIES, ALC42014 and Re-indexed
. 26.11.2014
326 |HQ File RLA File Lic.No/Date:03 10787536 |Defer :01/82/050/00855/AM15/ :03/94/040/0017 1/AMI15/ 01.08.2014 Date:22.12.2014
Case No.:49/9/82-ALC4/2014 |Party Name:SANMAR Meet No/Date:1 1/82Status:Deffered SPECIALITY CHEMICALS jALC4/2014 and Re-indexed LIMITED, 26.11.2014
397 |HQ File RLA File Lic, No/Date:04 10159125 |Defer :01/82/050/00846/AMI5/ :04/24/040/00106/AM15/ 01.08.2014 Date:22.12.2014 Decision : It was decided to defer the case for 22.12.2014 for comments of Department of Pharmaceuticals.

Case No.:29/9/82-ALC4/2014 Party Name:SHASUN Meet No/Date:11/82_—_‘|Status:Deffered PHARMACEUTICALS LC4/2014 and Re-indexed LIMITED 6.11.2014 328 |HQ Fite RLA File Lic. No/Date:04 10159129 |Defer :01/82/050/00826/AM15/ :04/24/040/00117/AM15/ 01.08.2014 Date:22.12.2014 Decision :It was decided to remind the firm to furnish a copy of Master Batch Formula duly certified by Quality Control In-charge. The case was deferred for 22.12.2014.

[529 [Case No.:31/9/82-ALC4/2014 [Party ,Name:AMBERNATYfaa aK _ [Meet No/Date:11/82-_[Status:Deffered | Weirecior General of Foreign Trade \ FaST General of Foren Trade athLePpvOeparmentvan ewo Deinx

| wo A | ORGANICS PVT. LTD. ALC4/2014 and Re-indexed | ad (26.11.2014 qo! | p File RLA File Lic.No/Date:03 10787610 |Defer t0/82/050/00828/AM1S/ | :03/94/040/00074/AMI15/ — {04.08.2014 [Date:22.12.2014 Dy ision : It was decided to defer the case for 22.12.2014 for comments of Department biicarc. | ! | tcllse No.:10/6/82-ALC4/2014 [Party Name:COVALENT (Meet No/Date:11/82[Status:Deffered LABORATORIES PRIVATE j|ALC4/2014 and Re-indexed 530 [HQ1 File LIMITEDRLA File 26.11.2014Lic.No/Date:09 10060796 [Defer l/82/050/00412/AM15/ _|:09/24/040/00204/AMI5/ [04.08.2014 — [Date:22.12.2014 Decision :It was decided to defer the case for 22.12.2014 for comments of D ent of harmaceuticals.: j : se No.:15/9/82-ALC4/20144 |Party Name:COVALENT Meet No/Date: 1 1/82Status:Deffered | LABORATORIES PRIVATE jALC4/2014 and Re-indexed 1 | - LIMITED | 611.2014 331) File RLA File Lic.No/Date:09 10060793 [Defer | $:Q1/82/050/00812/AM15/ —|:09/24/040/00203/AM15/ _ [04.08.2014 Date:22.12.2014 \ ecision : It was decided to defer the case for 22.12.2014 for comments of Department jot Pharmaceuticals. | Case No.:14/9/82-ALC4/2014 Party Name:GLAND Meet No/Date:1 1/82Status: Deffered PHARMA LIMITED ALC4/2014 and Re-indexed (26.11.2014 . 332 AQ File RLA File Lic.No/Date:09 10060797 |Defer 1/82/050/008 1 1/AMI5S/ 209/24/040/002 19/AM15/ 04.08.2014 Date:22.12.2014 pcision : It was decided to defer the case for 22.12.2014 for comments of Department _{jof Pharmaceuticals. . I[ |[dase No.:44/9/82-ALC4/2014 PHARMACEUTICALS[Party Name:INTAS MeetALC4/2014 No/Date:11/82(Status:and Re-indexed Deffered | LTD., 26.11.2014 . i| 33 HQ1 /82/050/0084 File 1/AM15/ 4:08/24/040/00173/AM15/RLA File Lic.No/Date:08 1013288308.2014 Date:22.12.2014[Defer | | ecision : It was decided to defer the case for 22.12.2014 for comments of Department _||@f Pharmaceuticals. . || | \ttase No.:19/9/82-ALC4/2014 [Party Name:SALICYLATES & [Meet No/Date:11/82(Status: CHEMICALS PRIVATE ALC4/2014 Approved LIMITED 26.11.2014 | Q File RLA File Lic.No/Date:0910060792 [Defer Date: 334 |101/82/050/00816/AM1 5/ 709/24/040/00142/AM15/ 64.08.2014 | im | Decision; in the light of written comments received from Department of Chemicals and Petrochemicals i| hf| ideHBP their v1 U.Oas per No.details 14010/34/2013/Ch given below or asI! dated applied 27.11.2014,by the firm,it was whichever decidedis toless: ratify norms under Para 4.7 | iV : TeeseryeereMee carat : Dy. Director General of Foreign Trade ' fee enor wearer ; Directorate General of Foreign Trade aitrce Burpoeparnment of Commerce went wan, ae feet

| | | |

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

==> picture [481 x 232] intentionally omitted <==

----- Start of picture text ----- 92 fewer eP r akiodu ct |EsperQuantity [SNe [import Pro ductduct |[CuenttyAllowed ~||| & OMOSALATE (3,3,5-Trimetiyt 0.572 kg abe Saiyat) [2_[saticvucaciy _|RA may take appropriate action as per the decision of Norms Committee | 0572; kg - | [Case No.:12/6/82-ALC4/2014 [Party Name:ANUPAM [Meet No/Date:11/82- __[Status:Deffered RASAYAN (INDIA)LTD §ALC4/2614 and Re-indexed ; (26.11.2014 335 |HQ:01/82/050/004File 14/AM15/ RLA:52/24/040/00025/AM15/File Lic.No/Date:5255.08.2014 1004 1180 |DeferDate:22.12.2014 Decision : It was decided to defer the case for 22.12.2014 for comments of Department of C&PC. ----- End of picture text -----

Case No.:13/9/82Party Name:EMCURE Meet No/Date:11/82Status: ALC4/2014 PHARMACEUTICALS LTD. |ALC4/2014 Approved . (26.11.2014 | HQ File RLA File Lic.No/Date:31 10064678 [Defer Date: :01/82/050/008 10/AM15/ :31/83/040/001 10/AM15/ 05.08.2014

==> picture [453 x 156] intentionally omitted <==

----- Start of picture text ----- Decision ; In the light of earlier decision taken by NC in its 3/82 meeting date 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::- |__| Export product SLNo, | Import items Qty. allowed 1336 | Ot | Ciprofloxacin HCL One Ciprofloxacin HCL | 555.0 mg/500 mg Tablets USP 500 MG 500 mg (Relevant Bulk Drug) | Tablets | (Each film coated tablet | tablet | contains Ciprofloxacin Hydrochloride USP | equivalent to | Ciprofloxacin 500 mg ----- End of picture text -----

| !| |}

| | , | | :

==> picture [457 x 280] intentionally omitted <==

----- Start of picture text ----- Case No.:27/9/82-ALC4/2014 |Party Name:GRANULES Meet No/Date:11/82- Status:Deffered. INDIA LIMITED ALC4/2014 and Re-indexed ; ; 26.11.2014 | 337 |HQ File RLA File Lic.No/Date:09 10060816 [Defer :01/82/050/00824/AM1I5/ 209/24/040/00217/AMI5/ 06.08.2014 Date:26.11.2014 Decision : It was decided to defer the case for 22.12.2014 for comments ofDepartment of Pharmaceuticals. . Case No.:94/9/82-ALC4/2014 |Party Name:MANGALAM [Meet No/Date:11/82- _ (Status:Deffered DRUGS & ORGANICS ALC42014 and Re-indexed | LIMITED 26.11.2014 _ ; 338 [HQ File RLA File |Lic.No/Date:03 10787716 [Defer | |:01/82/0S0/00891/AM15/ ——:03/95/040/00344/AM15/ 08.2014 — [Date:22.12.2014 Decision :It was decided to defer the case for 22.12.2014 for comments of Department of Pharmaceuticals. _ MAL BATT Dy.FaAaTDirector HETRTARTTE te Director WATTS oy of Foreign te ae ate rjpeparnentFa ‘af Commerce udyou [Bhaw2] ae,ag BBeini ----- End of picture text -----

) A% | -| be No.:16/9/82-ALC4/2014 |PartyLABORATORIES Name:PORUS PVT LTD Meet|ALC4/2014No/Date:1 1/82|ApprovedStatus: | | Ul 26.11.2014 : | {HO File RLA File Lic.No/Date:09 10060814 |Defer ||? || { ) f82/050/008ision :In the 13/AM15/ light of written109/24/040/00234/AM15/ comments received from Department06.08.2014 of Chemicals andDate:22.12.2014 Petrochemicals tvide their U.O No. 14010/33/2013/Ch ft dated 15.09.2014, it was decided to ratify norms under Para 4.7 : | D | BP v1 as per details given below or as applied by the firm, whichever is less: | = Quanti = Allowed |[0546][Kg] | [3 [zncomone Tt [4 [anmine SL 0.730kg __——=«dr a [3[f°[_scrveremcamoen] METHANOL | O2. 0 Kg0 _ #F ; may take appropriate action as per the decision of Norms Committee | A ,:|7 | Chase1 FileNo.:81/9/82-ALC4/2014. PartyEXIMCHEMRLA File Name:METROPOLITAN LTD. (26.11.2014[MeetLic.No/Date:0310787777ALC4/2014 No/Date:11/82Status:Approved|Defer Date: i 182/050/00878/AM15/ 103/9$/040/00404/AM15/ 07.08.2014 | 1: | , ecision : In the light of written comments received from Department of Chemicals and Petrochemicals | 340/lof fleHBP their v1 U.Oas per No.details 14010/60/2010/Ch given below or llas dated applied 04.03.2013, by the firm,it was whichever decidedis to less: ratify norms under Para 4.7 : | Export Product Export import Product Quantity , Quant Allowed 7 S AMINO 6 METHYL ‘ TOLUENE 1.200 kg 80% BASIS | ent iat : _||RA may take appropriate action as per the decision of Norms Committee | ase No.:105/9/82Party Name:SCOTT-EDIL Meet No/Date:1 1/82Status:Deffered | 1.C4/2014 PHARMACIA LTD., ALC4/2014 and Re-indexed | 1 Ht 26.11.2014 : H He | i| 34 )HQ1/82/050/00902/AM15/ File RLA:22/24/040/00035/AMI5/ File 07.08.2014Lic.No/Date:22 10015058 Date:22.12.2014|Defer | ecision : It was decided to defer the case for 22.12.2014 for comments of Department | ‘| _}@£ Pharmaceuticals. i fase No.:91/9/82-ALC4/2014 Party Name:O C Meet No/Date: 1 1/82Status: i SPECIALITIES PVT.LTD. —|ALC4/2014 Approved | | 26.11.2014 . | ; Q File RLA File Lic.No/Date:03 10787837 |Defer Date: WoT RD 1/82/050/00888/AM 1 5/ 103/95/040/00399/A M is/ 08.08.2014 "oe SOR NIRMAL Uys - OYSeeretirectorate c,Conor of Beri; Udyog Bhawan Wee ip,

Decision : in the light of written comments received from Department of Chemicals and Petrochemicals & vide their U.O No. 14010/108/2012/Ch Il dated 27.11.2014, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given betow or as applied by the firm, whichever is fess:

7 : |

: |

|Export Product|Export|importProduct|
|---|---|---|
||Quantity|Allowed<br>fi [sammorveipne —__*[1.30kg|
|BCHLORO-2-HYDARAZINE<br>“ee|||3_|sopumnrmere|0.950kg<br>(4 |macs<br>[20K<br>FLAKES<br>[S__[1soPRoPYL<br>ALCOHOL |0210 **kg**<br>6 {NBuTANOL [0.770|
|||;<br>HYDARAZINEHYDRATE (80-|
|RAmaytakeappropriateaction|FSill<br>CARBONATE<br> asperthedecisionofNormsCommittee||
|{CaseNo,:40/9/82-ALC4/2014||PartyName:ADCOCK<br>MeetNo/Date:11/82-<br>Status:<br>INGRAMLTD,<br>ALC4/2014<br>Approved||
|||26.11.2014|
|HQ File|RLA File|Lic.No/Date:0710106352<br>[Defer Date:|
|701/82/050/00837/AM15/|:07/24/040/00167/AM15/<br>11.08.2014||

Decision ; In the fight of earlier decision taken by NC in its 3/82 meeting 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:

| Export Product 1. Neulin 125mg tablets - Theophylline 125 Mg +Guar gum 4.375 Mg 343 2. Neulin 200mg tablets - Theophylline 200 Mg + Guar gum 7.00 Mg 3. Neulin 250mg tablets - Theophylline 250 Mg + Guar gum 8.750 Mg , 4. Neulin 300mg tablets - Theophylline 300 Mg + Guar gum 10.5 Mg

For export of 1 No. NeulinTablets (Quantity in mg) Theophyline BP / EP / USP / 127.5mg | 204.0 mg 255.0 mg 306.0 mg PH.EUR Anhydrous powder GuarPH.EUR)Gum tH (BP /EP/uSP/ | 4.375 7.00 8.75 10.5 RA may take appropriate action as per the decision of Norms Committee. - ; [ ~ [Case No.:53/9/82-ALC4/2014 [Party Name:ONEIRO Meet No/Date:11/82- _ [Status:Deffered CHEMICALS LTD ALC4?22014 and Re-indexed 26.11.2014 ; 344 |HQ File RLA File Lic.No/Date:34 10040436 |Defer :01/82/050/00850/AM15/ :34/24/040/0011 1/AMI15/ 11.08.2014 _ |Date:22.12.2014 Decision :It was decided to send a copy of application to Department of Pharmaceuticals. The case is deferred for 22.12.2014. : a PSDy. sere,7 NIP! FTEL on rave Director Ger! FETA RTS Directoratefeet STITTas of Foreign Wade aersa PPvDer@ c arment offac. Sormerce

| |

*) [~ [else No.:8/9/82-ALC42014 [Party Name-RANBAXY (Meet No/Date:11/82|Status:Deffered LABORATORIES LTD ALC4/2014 and Re-indexed PFB45 [HQtiFile RLA File 26.11.2014Lic.No/Date:05 10390250 [Defer 01/82/050/00805/AM15/ —:05/24/040/00202/AM15/ ——{11.08.2014 |Date:22.12.2014 |Decision : It was decided to defer the case for 22.12.2014 for comments ofDepartment ‘! ’ p jof Pharmaceuticals. . ~~ [ise No.:7/9/82-ALC4/2014 [Party Name:SENTISS Meet No/Date:11/82[Status:Deffered PHARMA PVT.LTD. ALC4/2014 and Re-indexed J. 6.11.2014 . 346) 1D File RLA File JLic. No/Date:05 10390257, |Defer d)/82/0S0/00804/AMI5/ —_|-05/24/040/00213/AMI5/ {11.08.2014 ‘{Date:22.12.2014 \ ecision : It was decided to defer the case for 22.12.2014 for comments of Department Case No.:93/9/82-ALC4/2014 |Party Name:Y ASHO Meet No/Date:1 1/82Status:Deffered | INDUSTRIES PVT.LTD. LC4/2014 and Re-indexed 6.11.2014 347 i. File RLA File Lic.No/Date:03 10787910 |Defer 81/82/050/00890/AM 1 5/ :03/95/040/004 12/AM15/ ‘|11.08.2014 Date:22.12.2014 hecision : It was decided to defer the case for 22.12.2014 for comments of Department ; af Pharmaceuticals. . ml dlase No.:23/9/82-ALC4/2014 |Party Name:BIO-TECH Meet No/Date:1 1/82Status:Deffered OPHTHALMICS PVT. LTD., |ALC4/2014 and Re-indexed 26.11.2014 | 348 iQ File RLA File Lic.No/Date:0810132955 [Defer ) 1/82/050/00820/AMI 5/ 08/24/040/00176/AMI5/ = {12.08.2014 Date:22.12.2014 ; | ecision : It was decided to defer the case for 22.12.2014 for comments of Department i _{|¢f Pharmaceuticals. mi '| | (tase No.:50/9/82-ALC4/2014 Party Name:CAPLIN POINT (Meet No/Date:11/82(Status: Deffered (26.11.2014 | LABORATORIES LTD., _ ALCAR2O14 and Re-indexed 349 [HQ File RLA File Lic.No/Date:04 10159215 [Defer N) 1/82/050/00847/AM15/ 04/24/040/00078/AM15/ 12.08.2014 Date:22.12.2014 | : ecision : It was decided to defer the case for 22.12.2014 for comments of Department i] _|:lpf Pharmaceuticals. 1 ~ | ease No.:21/9/82-ALC4/2014 PartyName:PI INDUSTRIES [Meet No/Date:11/82- _ |Status:Deffered 26.11.2014 | | LTD., ALC4/2014 and Re-indexed : 1350 [HQ File RLA File Lic.No/Date:13 10047575 |Defer | | | |#01/82/050/00818/AM15/ :13/24/040/00020/AM15/ 12.08.2014 Date:22.12.2014 wf C&PC. \ - | p ecision : It was decided to defer the case for 22.12.2014 for comments of Department j Pete parsninm !| bsuscegDredionate: RP YDeparmentCoS a oforsignTTCommerceTrade : Udyog BrawanNes Deini

||CaseNo.:28/9/82-ALC4/2014|[PartyName-SHASUN|[MeetNo/Date:11/82-__[Status:Defferea||
|---|---|---|---|
||.|PHARMACEUTICALS<br>LIMITED|ALC4/2014<br>and Re-indexed<br>6.11.2014|
|351||HQFile<br>:01/82/050/00825/AM15/|RLA File<br>:04/24/040/00123/AMI15/|Lic.No/Date:0410159219 [Defer<br>13.08.2014<br>[Date:22.12.2014|
||Decision :ItwasdecidedtoremindthefirmtofurnishacopyofMasterBatchFormula|||
||duly certifiedbyQuality Control Incharge.Thecasewasdeferredfor22.12.2014.<br>_|||
||CaseNo.:81/9/82-ALC4/2014|(PartyName:SHASUN|MeetNo/Date:11/82-<br>Status:Deffered|
|||PHARMACEUTICALS<br>LIMITED|ALC4/2014<br>and Re-indexed<br>26.11.2014|
|352||HQ File|RLAFile|Lic.No/Date:0410159220 |Defer|
||:01/82/050/00848/AM15/|—_—_|:04/24/040/00124/AM15/|_|13.08.2014<br>Date:22.12.2014|

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 26.11.2014.

||[CaseNo.:33/9/82-ALC4/2014|[PartyName:TIDE|[MeetNo/Date:11/82-|__[Status:Deffered|
|---|---|---|---|---|
|||INDUSTRIES|ALC4/2014|andRe-indexed|
||.||26.11.2014||
|353|[HQFile|RLAFile|Lic.No/Date:3410040445 [Defer||
||01/82/050/00830/AM15/|—_|:34/24/040/00106/AM15/|{14.08.2014<br>_|Date:22.12.2014|
||Decision : Itwas decided|todefer thecase for26.11.2014 forcommentsofDepartment|||
||ofC&PC.||||
||CaseNo.:46/9/82-ALC4/2614||PartyName:ADCOCK.<br>INGRAMLTD,|MeetNo/Date:11/82-<br>ALC42014|Status:Deffered<br>andRe-indexed|
||||6.112014||
||.||||
|354|[HO File|RLA File|{Lic.No/Date:0710106458 [Defer||
||:01/82/050/00843/AM15/|—_—_|[:07/24/040/00172/AM15/|{19.08.2014|Date:22.12.2014|

Case No.:239/6/82Party Name:SWISS Meet No/Date: 1 1/82Status: Approved ALC4/2014 EXPORTS PVT. LTD. ALC4/2014 | 26.11.2014 | HQ File RLA File Lic.No/Date:08 10133043 {Defer Date: :01/82/050/0064 1/AM15/ :08/24/040/00180/AM15/ 19.08.2014 Decision :Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/236/2014-PI(Norms)[30.10.2014][and][in][consultation][with][technical][authority][present][in][meeting,][decided][to] 355[dated] ratify norms under para 4.7 of HBP as per details given below or as applied by firm whichever is lower:-

==> picture [422 x 130] intentionally omitted <==

----- Start of picture text ----- | Export product Be. [SINo.| Import items Qty. Allowed | Amoxicillin and = |Number)? | potassium 300.90 mg/625 | Clavulanate ISN Clavulanate mg tablet Pre Say 7 NPA UMA Dy Director General of Foreign Trade arferrtpioctorate CorerDepartmentof ForeignofCommerFrade Uideou noras, a Delhi ----- End of picture text -----

Potassium Tablet Diluted IP with SP 625 mg Microcrystalline Cellulose (1:1) | | RA concerned may take further necessary action as per above decision of NC. || |@ase No.:61/9782-A1.C472014 [Party Name:CONCORD [Meet No/Date:11/82-__[Status:Deffered i BIOTECH LTD ALC42014 and Re-indexed H Ik 6.11.2014 rE 356 HQ File RLA File Lic. No/Date:08 10133062 |Defer | ) 1/82/050/00858/AM15/ :08/24/040/00186/AM15/ 20.08.2014 Date:22.12.2014[Pharmaceuticals.] . . : . |[ti] ; ecision[if] : It was decided to defer the case for 22.12.2014 for comments ofDepartment | ase No.:39/9/82-ALC4/2014 |Party Name:SHREE BANKEY /|Meet No/Date:}1/82‘Status: BEHARI LAL AROMATICS {ALC4/2014 Approved 26.11.2014 ‘ll | [ig File RLA File Lic.No/Date:0510390613 (Defer Date: i h 1/82/050/00836/AM15/ :05/24/040/00192/AM15/ 20.08,2014 Decision : In the light of written comments received from Department of Chemicals and Petrochemicals [- . de their U.O No, 14010/28/2012/Ch if dated 28.07.2014, it was decided to ratify norms under Para 4.7 f 357 pf HBP v1 as per details given below or as applied by the firm, whichever is less: | ' Export Product import Product Quantity Quanti Allowed 1 D-LIMONENE (LIMONENE CITRUS : ‘ARVONE ikg TERPENE, ORANGE TERPENE, BRAZILIAN CITRUS TERPENE, STANDARD CITRUS TERPENE, ORANGE OIL). | | (RA may take appropriate action as per the decision of Norms Committee | [| [ease No.:11679/82Party Name:BEST VALUE [Meet No/Date:11/82(Status: 4/2014 CHEM PVT. LTD. ALC4/2014 Approved ; i 26.11.2014 Q File RLA File Lic.No/Date:34 10040469 [Defer Date: 0 1/82/050/009 13/AM15/ :34/24/040/001 10/AM15/ 21.08.2014 || ar| Decision : in the light of written comments received from Department ofChemicals and Petrochemicals [ . 34 | ofide HBP their v1 U.Oas per No. details 14010/58/2011- given below Ch or aslt dated applied15.09.2014, by the firm,it w hichas d e vercidedIs toless: ratify norms under Para 4.7 | Export Product Import Product Quantity on Quanti Aliowed |! | | f Hexyt Salicylate Lkg |A 4._| anHexanol (LorolC oacol6-99) | OT 0.510kg | {RA may take appropriate action as per the decision of Norms Committee i (Case No.:37/9/82-ALC 4/2014 |Party Name:JAGSONPAL Meet No/Date: 1 1/82Status: Deffered | [3$ PHARMACEUTICALS LTD. |ALC4/2014 and Re-indexed tT . A 26.11.2014 Pais Warts NIRMAL mower . Dy. Director General of Foreign Trade few wr Anew Directorate Gencrai of Foreign Trade afica fryvDepariment of Commerce Udyog Shawan, New Delhi

. || | ,

HQ File RLA File Lic.No/Date-0510390634 [Defer 01/82/050/00834/AM15/ —_:05/23/040/00198/AMIS/ [21.08.2014 _ |Date:22.12.2014 Decision : It was decided to defer the case for 22.12.2014 for comments of Department of Pharmaceuticals.

==> picture [13 x 18] intentionally omitted <==

----- Start of picture text ----- 'S ----- End of picture text -----

Case No.:47/9/82-ALC4/2014 (Party Name:OTSUKA Meet No/Date:11/82Status: (CHEMICAL (INDIA) ALC4/2014 Approved HQ— File RLAPRIVATE File LIMITED 26.11.2014Lic.No/Date:05 10390642 . |Defer Date: :01/82/050/00844/AM15/ 05/24/040/00200/AM15/ 21.08.2014 Decision : Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 3501 1/63/2013-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 below or as applied by firm whichever is lower:-

==> picture [453 x 165] intentionally omitted <==

----- Start of picture text ----- } Export product Exp. Import items Qty. [360 aty. Allowed Kg/kg 7- PHENYLACETAMIDEO- PENICILLIN G-POTASSIUM zor 3-CHLOROMETHYL FIRST CRYSTAL CEPHALOSPORONIC 1kg ISOPROPYL ALCOHOL ACID PARA DIMETHYL FORMAMIDE 14.314 METHOXYBENZYL '4 | METHYLENE CHLORIDE [3.29| | ESTER (GCLE) 2 MERCAPTO BENZO ost | THIAZOLE 1.971 a _— a ----- End of picture text -----

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

Case No.:41/9/82-ALC4/2014 |Party Name:RANBAXY eet No/Date:1 1/82Status:Deffered LABORATORIES LTD ALC4/2014 and Re-indexed: 361 |HQ7 File RLA File Lic.6.11.2014 No/Date:05 10390638 (Defer :01/82/050/00838/AM15/ :05/24/040/00217/AM15/ 1.08.2014 ate:22.12.2014 Decision : It was decided to defer the case for 22.12.2014 for comments of Department of Pharmaceuticals. . Case No.:52/9/82-ALC4/2014 |Party Name: UNILINK ‘(Meet No/Date:1 1/82Status:Deffered PHARMA PVT LTD ALC4/2014 and Re-indexed 26.11.2014 362 |HQ File IRLA File ic.No/Date:04 10159266 |Defer :01/82/050/00849/AM15/ —|:04/24/040/00111/AMI5/ —[21.08.2014 Date:22.12.2014 Decision : It was decided to defer the case for 22.12.2014 for comments ofDepartment of Pharmaceuticals. : [363 [Case No.:38/9/82-ALC4/2014 [Party Name:INDO 1 /__ (Meet No/Date:11/82_[Status:Deffered[|] fia garni MAL ; oa Boneral of Foreign Trade mitts General of roe race Raney faraDepariment of Somme

|TT<br>i UL|PHYTOCHEM<br>PHARMACEUTICALS|ALC4/2014<br>andRe-indexed<br>6.11.2014<br>.<br>||
|---|---|---|
||<br>.File<br>|<br>|:D1}82/050/00835/AM15/|RLAFile<br>——_:05/23/040/00209/AM15/|Lic.No/Date:0510390704 |Defer<br>22.08.2014<br>Date:22.12.2014|
||<br>{Decision : Itwasdecidedto defer the<br>Lt<br>4g Pharmaceuticals.|to defer thecasefor22.12.2014forcommentsofDepartment<br>.||
|’<br>[€dbeNo.:38/9/82-ALC4/2014|[PartyName:CADILA<br>HEALTHCARELTD.,|MeetNo/Date:11/82-<br>__[Status:Deffered<br>ALC4/2014<br>andRe-indexed|
|To<br>Oo||26.11.2014<br>.|
||364\H@ File<br>‘o1y82/050/00832/AM15/|RLAFile<br>—_|:08/24/040/00203/AM15/|Lic. No/Date:0810133097 [Defer<br>5.08.2014<br>——<br>[Date:22.12.2014|

De ision : It was decided to defer the case for 22.12.2014 for comments of Department
- Df Pharmaceuticals.

|- DfDf|De ision : It was decided to defer the case for 22.12.2014 for comments ofwas decided to defer the case for 22.12.2014 for comments ofdecided to defer the case for 22.12.2014 for comments ofto defer the case for 22.12.2014 for comments of<br>- DfDfPharmaceuticals.|It was decided to defer the case for 22.12.2014 for comments ofwas decided to defer the case for 22.12.2014 for comments ofdecided to defer the case for 22.12.2014 for comments ofto defer the case for 22.12.2014 for comments ofdefer the case for 22.12.2014 for comments ofthe case for 22.12.2014 for comments ofcase for 22.12.2014 for comments offor 22.12.2014 for comments of22.12.2014 for comments of|It was decided to defer the case for 22.12.2014 for comments ofwas decided to defer the case for 22.12.2014 for comments ofdecided to defer the case for 22.12.2014 for comments ofto defer the case for 22.12.2014 for comments ofdefer the case for 22.12.2014 for comments ofthe case for 22.12.2014 for comments ofcase for 22.12.2014 for comments offor 22.12.2014 for comments of22.12.2014 for comments offor comments ofcomments ofof|It was decided to defer the case for 22.12.2014 for comments ofwas decided to defer the case for 22.12.2014 for comments ofdecided to defer the case for 22.12.2014 for comments ofto defer the case for 22.12.2014 for comments ofdefer the case for 22.12.2014 for comments ofthe case for 22.12.2014 for comments ofcase for 22.12.2014 for comments offor 22.12.2014 for comments of22.12.2014 for comments offor comments ofcomments ofofDepartment|
|---|---|---|---|---|
|~|[elfse No.:36/9/82-<br>4/2014<br>||PartyName:CADILA<br>HEALTHCARELTD.,|MeetNo/Date:11/82-<br>ALC4/2014<br>26.11.2014|__[Status:Deffered<br>andRe-indexed<br>||
|‘B65|THQ File<br>0/82/050/00833/AM15/|RLA File<br>—_|:08/24/040/00202/AM15/|Lic.No/Date:0810133096 <br>[25.08.2014|[Defer<br>Date:22.12.2014|
|.<br>___fof|) cision : Itwasdecidedto<br>fofPharmaceuticals.|todeferthecasefor22.12.2014forcommentsof<br>.||ofDepartment|
|||thse No.:89/9/82-ALC4/2014|[PartyName:KARNATAKA<br>ANTIBIOTICS&<br>PHARMACEUTICALS|[MeetNo/Date:11/82-<br>ALC42014<br>6.112014|[Status:Deffered<br>and Re-indexed|
|366]HQ|File|RLAFile|{Lic.No/Date:0710106502 [Defer||
||||{:1/82/0S0/00886/AM15/|—_|:07/24/040/00179/AMI5/|—_[25.08.2014|- [Date:22.12.2014|
|Hecision : Itwasdecidedto<br>p<br>atPharmaceuticals.<br>mil||todeferthecasefor22.12.2014 forcommentsof||ofDepartment|

ase No.:109/9/82Party Name: VENUS Meet No/Date:11/82Status: Deffered ILc42014 REMEDIES LTD., JALc42014 and Re-indexed = . (26.11.2014 . {36 AQ File RLA File Lic.No/Date:22 10015065 [Defer i 1/82/050/00906/AM 15/ 122/2.4/040/00048/AM 15/ 25.08.2014 ‘|Date:22.12.2014 | ecision : It was decided to defer the case for 22.12.2014 for comments of Department ‘|| |@f Pharmaceuticals. | "| tase No.:42/9/82-ALC4/2014 [Party Name:CADILA Meet No/Date:11/82|Status:Deffered | PHARMACEUTICALS LTD. |ALC4/2014 and Re-indexed 26.11.2014 36 [HQ File [RLA File Lic. No/Date:08 10133103 [Defer f 1/82/050/00839/AM 1 5/ :08/24/040/00197/AM15/ 26.08.2014 Date:22.12.2014 J b ecision ; It was decided to defer the case for 22.12.2014 for comments of Department : ‘|_| |pf Pharmaceuticals. Pr 7 . Oe eeNi Mattedfree SUMar : , Gayeyp2Ferey,Spar pentFore ofCompe Swan, News.,

joo

} , | | :

||(CaseNo.:45/9/82-ALC4/2014|[PartyName:CONCORD<br>BIOTECHLTD|MeetNo/Date:11/82-<br>ALC4/2014|Status:Deffered v<br>andRe-indexed|
|---|---|---|---|---|
||||6.11.2014||
|369||HQFile<br>:01/82/050/00842/AM15/|RLAFile<br>:08/24/040/00196/AM15/|Lic.No/Date:0810133099 <br>6.08.2014<br>7|[Defer<br>Date:22.12.2014|

ecision : It was decided to defer the case for 22.12.2014 for comments of Department of Pharmaceuticals.

Case No.:1/7/82-ALC4/2014 Party Name:COVALENT Meet No/Date: LABORATORIES PRIVATE |ALC4/2014 1 1/82andStatus:Re-indexed Deffered LIMITED 26.11.2014
370 [HQ File RLA File Lic.No/Date:09 10060890 |Defer :01/82/050/00645/AM15/ :09/24/040/0026 1/AMI15/ 26.08.2014 Date:22.12.2014

Case No.:84/9/82-ALC4/2014 |Party Name: DHANUKA Meet No/Date: 1 1/82Status:Deffered LABORATORIES LTD. ALC4/2014 and Re-indexed 26.11.2014 3°71 JHQ File RLA File Lic.No/Date:05 10390763 |Defer :01/82/050/0088 1/AM15/ :05/23/040/0022 1/AM15/ 26.08.2014 Date:22.12.2014 Decision : It was decided to defer the case for 22.12.2014 for comments of Department of Pharmaceuticals.

Case No.:2/7/82-ALC4/2014 [Party Name:DR REDDYS [Meet No/Date:11/82[Status:Deffered LABORATORIES LIMITED |ALC4/2014 and Re-indexed 26.11.2014 . 3°72 |HQ File RLA File Lic.No/Date:09 10060892 .:|Defer :01/82/050/00646/AM15/ :09/24/040/00263/AMI15/ 26.08.2014 Date:22.12.2014 Decision : It was decided to defer the case for 22.12.2014 for comments of Department of Pharmaceuticals.

Case No.:87/9/82-ALC4/2014 Party Name:R L FINE CHEM Meet No/Date:11/82Status: ALC4/2014 Approved ee , 26.11.2014 HQ File RLA File Lic.No/Date:0710106549 Defer Date: . :01/82/050/00854/AM15/ :07/24/040/00182/AM15/ 26.08.2014 373 Decision: tn 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 vi as per details given below or as applied by the firm, whichever is less: [ Export product [Exp. Qy. | SiNo. | impotitems | ly allowed | [Doxilamine Succinate [TKe [1 | 2AcetyiPyridine __—-‘[058ke | BP/USP Tetrahydrofuran | 1.03 kg **** {RAmay take appropriate[ action][as] per the[ decision] of Norms Committee. Case No.:43/9/82-ALC4/2014 Party Name:SARV BIO : Meet No/Date: 374 1 1/82Status: Deffered LABS PVT.LTD., ALC4/2014 and Re-indexed ; 26.11.2014

5 SATE! RMAL KUMAR Sy ABST Foreign Trade Dy. Director Genera Seer feet Terai of Foreign trade Directorate inert of Commerce wT aT, 7g, feet,

[og

;

osu CfFile _ A File Lic.No/Date:0510390783 [Defer _ _ (:p1482/050/00840/AM15/ __|:05/24/040/00203/AMIS/ [27.08.2014 _ [Date:22.12.2014 | De ision : It was decided to defer the case for 22.12.2014 for comments of Department |! }f Pharmaceuticals

| [Eabe No.:34/9/82-ALC42014 [PartyNameKLJ_—~—~—~«*(Meet No/Date:11/82-__[Status: fl: PLASTICIZERS LTD., ALC4/2014 '|Approved 1, Wh 26.11.2014 | IRQ Fite RLA File Lic.No/Date:0510390804 [Defer Date: || fol/82/0s0/0083 1/AM15/ :05/23/040/00214/AMI5/ [28.08.2014 ; Dp ision ; In the light of written comments received from Department ofChemicals and Petrochemicals fe their U.O No. 14010/36/2011/Ch li dated 23.07.2014, it was decided to ratify norms under Para 4.7 10 | BP v1 as per details given below or as applied by the firm, whichever is less: B75} J export Product Export Import Product Quantity ij Quanti Allowed | | HOPEDrums made of HM: HOPE bien Alcohol)0. 560kg | |] HOPE Drums made of HM-HDPE blowing : ol (Mix ol} oo | {| Sse) HM-HDPE DRUMS MADE | © | OF HM-HDPE BLOWING = [ P8Ckin€ GRADE policy _{|RA may take appropriate action as per the decision of Norms Committee. i dlase No.:60/9/82Party Name:JUBILANT Meet No/Date:[|][ 1/82-] Status: Deffered / ILC4/2014 GENERICS LTD ALC4/2014 and Re-indexed a 26.11.2014 | 376 HQ File RLA File Lic.No/Date:05 10390923 (Defer 9 1/82/050/00857/AM15/ :05/23/040/00217/AM15/ —- 02.09.2014 Date:22.12.2014 i ecision : It was decided to defer the case for 22.12.2014 for comments of Department bf Pharmaceuticals.

ij Case No.:76/9/82-ALC4/2014 |Party Name:KLJ Meet No/Date:11/82Status: Deffered : PLASTICIZERS LTD., ALC4/2014 and Re-indexed ! 26.11.2014 | fs7f HQ Filea RLA File . Lic. No/Date:0510390922 [Defer ! nO 1/82/050/00873/AM15/ :05/23/040/00220/AM15/ 02.09.2014 Date:22.12.2014 Decision : It was decided to defer the case for 22.12.2014 for comments of Department | { jpfC&PC. | CT IifCase No.:3/7782Party Name:S VCHEM [Meet No/Date:11/82_|Status:Deffered 1ALC4/2014 INTERMEDIATES P LTD ALC4/2014 and Re-indexed 26.11.2014 : HQ File RLA File Lic.No/Date:041015932 |Defer i 378}|'-01/82/050/00647/AM15/ 104/24/040/00139/AMI15/ 3 Date:22.12.2014 / . 02.09.2014 fo - Decision : It was decided to defer the case for 22.12.2014 for comments of Department | i | |1 jof C&PC. 7iyq . : = Pas NIRMAL KUMAR : Dy. Director Ganeral of Foreign Trade afterDiseretSfryoepanmentCoal TTof Commercede ua hs A Be

fOL

==> picture [528 x 303] intentionally omitted <==

----- Start of picture text ----- : Case No.:5/7/82- Party Name: THEMIS Meet No/Date:11/82- Status:Deffered ALC4/2014 PHARMACEUTICALS(PR C4/2614 and Re-indexed OP.CHEMOSYN LTD.) (26.11.2014 379 |HQ File A File Lic.No/Date:0810133217 |Defer | :01/82/050/00649/AM15/ 108/24/040/00177/AM15/ (03.09.2014 Date:22.12.2014 Decision :It was decided to defer the case for 22.12.2014 for comments of Department jof Pharmaceuticals. | Case No.:75/9/82-ALC4/2014 |Party Name:NEUTEC Meet No/Date:1 1/82- Status:Deffered : HEALTHCARE (P) C4/2014 and Re-indexed . LIMITED 26.11.2014 380 [HQ File RLA File Lic.No/Date:05 10390973 [Defer :01/82/050/00872/AMI5/ :05/24/040/00235/AM15/ 04.09.2014 Date:22.12.2014 Decision : It was decided to defer the case for 22.12.2014 for comments ofDepartment of Pharmaceuticals. . Case No.:62/9/82- Party Name:SHREE Meet No/Date:1 1/82- Status: Approved ALC4/2014 BANKEY BEHARI LAL ALC422014 ; AROMATICS 26.11.2014 HQ File RLA File Lic. No/Date:05 10390975 [Defer Date: 01/82/050/00859/AMI5/ —|:05/24/040/00229/AM15/ —|04.09.2014 ----- End of picture text -----

Decision ; tn the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/28/2012/Ch il dated 10.11.2014, it was decided to ratify norms under Para 4.7 381 |Of HBP v1 as per details given below or as applied by the firm, whichever is less:

==> picture [452 x 381] intentionally omitted <==

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

||||||||
|---|---|---|---|---|---|---|
|Export Product|Export|Import Product|Quantity|
|Quanti|Allowed|
|MENTHOL|1|RELEVANTCITRUS|TERP!D LIMONENERANGE(LIMONENTERPEN|E|,|
|1kg|BRAZILIAN CITRUS TERPENE, STANDARD|
|CITRUS TERPENE,|
|ORANGE OIL).|
|RA may take appropriate|action as per the decision of Norms Committee|
|Case No.:$5/9/82-ALC4/2014||PartyBIOTECH Name:CONCORD|Meet No/Date:1 1/82-|Status:Deffered|
|LTD|ALC42014|and Re-indexed|
|.|26.11.2014|
|392|[HQ|File|RLA|File|Lic.No/Date:0810133285|[Defer|
|0|1/82/050/00852/AM15/|:08/24/040/002 16/AMI5/|10.09.2014|Date:22.12.2014|
|Decision|:|It was decided to defer the case for 22.12.2014|for comments of Department|
|of|Pharmaceuticals.|.|.|
|Case No.:95/9/82-ALC4/2014|[Party NameJAGSONPAL|[Meet No/Date:11/82-|[Status:Defferea|
|PHARMACEUTICALS|LTD.||ALC4/2014|and Re-indexed|
|7|26.11.2014|
|383||HQ File|RLA|File|Lic.No/Date:05 10391100||Defer|
|:01/82/050/00892/AMI5/|—_—|:05/23/040/00246/AMI5/|[11.09.2014|‘[Date:22.12.2014|
|Decision|:|It was decided to defer the case for 22.12.2014|for comments of Department|
|of|Pharmaceuticals.|
|e|a rar N|OTe|
|aed|FEAST|[ai][ of][ Foreign][ Trade]|
|Dy.|Director GONS|rarer|
|Directoratefeast|SATISat of Foreign Trade|
|afore TED oepariment affeet Gomme;ce|
|aSbrewerew De|

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----- Start of picture text ----- | i| | ese No.:56/9/82-ALC4/2014 Party Name:POSY Meet No/Date:1 1/82- Status: PHARMACHEM PVT.LTD. |ALC4/2014 Approved 26.11.2014 : : | @ File RLA File Lic.No/Date:0810133299 |Defer Date: | |y01/82/050/00853/AM15/ —|:08/24/040/00160/AM15/ 11.09.2014 , | Decision : Decision :in the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/4/2012/Ch Ii dated 05.06.2012, it was decided to ratify. | +: +) finorms under Para 4.7 of HBP vi as per details given below or as applied by the firm, whichever is 3e4 Hless: | ! | Export product Exp. Import items Qty. Allowed | Qty. kglkg 1 | | | | ||| RA concerned may take further necessary action as per above decision of NC. mi No.:1/9/82-ALC4/2014 (Party Name:AUROBINDO [Meet No/Date:11/82- Status: Deffered : | PHARMA LIMITED JALC4/2014 and Re-indexed LE | 16.41.2014 . a [385 [HQ File RLA File Lic.No/Date:09 10061043 [Defer (0442/050/00798/AM15/ —|:09/24/040/00329/AM15/ [29.09.2014 Date:22.12.2014 | ID eq sion : It was decided to defer the case for 22.12.2014 for comments of Department | jo! Ft armaceuticals. C4sqNo.:2/9/82-ALC4/2014 PartyLABORATORIES Name:PERKIN Meet No/Date:11/82- Status: Deffered |. ALC4/2014 and Re-indexed 386 [H@] File RLA File 26.11.2014Lic.No/Date:0910061044 [Defer . |. :0. a (050/00799/AM15/ :09/24/040/00358/AM15/ 29.09.2014 Date:22.12.2014 iD ch ion : It was decided to defer the case for 22.12.2014 for comments of Department of 8 armaceuticals, [7 [ifCabelNo.:4/9/82-ALC4/2014 [Party Name:ONEIRO [Meet No/Date:11/82- |Status:Approved CHEMICALS LTD ALC4/2014 i 26.11.2014 . . | | [Hq Fite RLA File Lic.No/Date:3410040593 [Defer Date: 01{84/050/00801/AMI5/ —:34/24/040/00168/AMI5/ —_[30.09.2014 to. 387|De Bion :In the light of written comments received from Department of Pharmaceuticals vide ithe jom No. 35011/267/2011-Pi{Norms) dated 01.04.2014, it was decided to ratify norms q | Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: kg/kg Preis Sars NIRMAL KUMAR By Emer Paw ao i Dy, Director General of Forsign Trade Directorate General of Foreign Trade aifrey ffarvoepartment of Commerce Laser bean ee [Bains] ----- End of picture text -----

Jou

==> picture [432 x 92] intentionally omitted <==

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

==> picture [451 x 70] intentionally omitted <==

----- Start of picture text ----- Case No.:5/9/82-ALC4/2014 Party Name: HETERO Meet No/Date: [1]] 1/82- Status:Deffered DRUGS LIMITED 4/2014 and Re-indexed 6.11.2014 | 388 |HQ File RLA File Lic.No/Date:09 10061060 [Defer :01/82/050/00802/AM15/ 4:09/24/040/00362/AM15/ 07.10.2014 Date:22.12.2014 ----- End of picture text -----

‘Decision : It was decided to defer the case for 22.12.2014 for comments of Department lof Pharmaceuticals.

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

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|||||||
|---|---|---|---|---|---|
|‘[Case No.:103/9/82-|Party Name:NEULAND|[Meet No/Date:11/82-|_[Status:Deffered|
|ALC4/2014|LABORATORIES LTD|ALC4/2014|and Re-indexed|
|26.11.2014|
|389||HQ|File|RLA File|Lic.No/Date:09 10061074|[Defer|
|:01/82/050/00900/AMI1S/|—_|:09/24/040/00365/AMI5/|{09.10.2014|Date:22.|12.2014|

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. |Decision : It was decided to defer the case for 22.12.2014 for comments of Department _|of Pharmaceuticals.

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||||||
|---|---|---|---|---|
|: Case No.:104/9/82-|Party Name:NEULAND|Meet No/Date:11/82-|Status:|Deffered|
|ALC4/2014|LABORATORIES LTD|ALC422014|and Re-indexed|
|)|26.11.2014|
|390||HQ File|RLA File|Lic.No/Date:09 10061076||Defer|
|:01/82/050/0090 1/AM15/|109/24/040/003|19/AM15/|10.10.2014|Date:22.12.2014|

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Decision : It was decided to defer the case for 22.12.2014 for comments of Department _ |of Pharmaceuticals.

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||||||||||
|---|---|---|---|---|---|---|---|---|
|°|
|Case No.:111/9/82-|Party|Name:|HETERO|LABS|MeetNo/Date:| 1/82-|Status:Deffered|
|ALC42014|LIMITED|ALC42014|and|Re-indexed|
|26.11.2014|
|391|}HQ|File|RLA|File|‘Lic.|No/Date:09|10061084||Defer|
|:01/82/050/00908/AM15/|:09/24/040/00346/AM|15/|‘13.10.2014|Date:22.12.2014|
|Decision|:|It was decided|to defer the case|for 22.12.2014|for comments|of|Department|
||of Pharmaceuticals.|

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||||||||
|---|---|---|---|---|---|---|
|~~|[Case No.:113/9/82-|Party Name:ASTRIX|[Meet No/Date:11/82-|__[Status:Deffered|
|ALC4/2014|LABORATORIES LTD.,|{2014|and Re-indexed|
|392||HQ File|RLA|File|Lic.No/Date:09 10061093|[Defer|
|01/82/050/00910/AM15/|——_:09/24/040/00370/AM15/|—‘|15.10.2014|-‘[Date:22.12.2014|
|Decision|:|It was decided to|defer the case|for 22.12.2014|for comments of|Department|
|_|of|Pharmaceuticals.|We|/NIRMAL KUMAR|
|Snerai|of Foraigh|
|DietoSe Soepartment|Commas|
|ae|ayes. ag|eBomi|
|uayog BRawan|

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| ! | |

{ iss No.:114/9/82Party Name:HONOUR LAB [Meet No/Date:11/82- _ [Status:Deffered 1ANC4/2014 LIMITED ALC4/2014 and Re-indexed | 26.11.2014 |
393 ) File A File Lic.No/Date:09 10061094 |Defer }}01/82/050/0091 1/AM15/ :09/24/040/00386/AM15/ 15.10.2014 Date:22.12.2014 Decision : It was decided to defer the case for 22.12.2014 for comments of Department
_ | F harmaceuticals. .
"(Cathe No.:115/9/82Party Name:NAGARJUNA [Meet No/Date:11/82_‘([Status:Deffered Gi! 4/2014 AGRICHEM LTD LC4/2014 and Re-indexed
mil 6.11.2014
394 . File RLA File Lic.No/Date:09 10061106 [Defer 018 2/050/00912/AM15/ 109/24/040/00376/AM 1 S/ 16.10.2014 Date:22.12.2014 be ision : It was decided to defer the case for 22.12.2014 for comments of Department
i dep harmaceuticals.
dadAL 4/2014No.:117/9/82PartyLABORATORIESName: INCHEMPRIVATE Meet|ALC42014 No/Date:1 1/82Status:and Re-indexed Deffered | LIMITED 26.11.2014
395 |HQ|File RLA File Lic. No/Date:09 10061119 |Defer 201/82/050/009 14/AM15/ 109/24/040/00374/AM15/ 17.10.2014 Date:22.12.2014 D et sion : It was decided to defer the case for 22.12.2014 for comments of Department
jo a armaceuticals.
~ [hs No.:83/10/82Party Name:HETERO LABS [Meet No/Date-11/82(Status: Deffered laLdaro14 LIMITED ALC4/2014 and Re-indexed | 6.11.2014
396 |H@ file RLA File Lic.No/Date:0910061139 [Defer :01/82/050/00997/AM15/ :09/24/040/00402/AM15/ 27.10.2014 Date:22.12.2014
iD * sion : It was decided to defer the case for 22.12.2014 for comments of Department

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----- Start of picture text ----- : - re SaR/NIRMAL KUM : Peer erarz oreign Trade | Directorate Gonear ee eR eTa 1 Prefer arz NIRMAL KUMA wary Purp. at Of Foreign Trade Date:18.11.2014oil - BYeeeetwenweerwe ofPay Foreign TradeR UdyogSei Braman arrepgWeareCommerce Place: i * Difetisrate Gen ; . ein New Delhi “iy precios. GOUELAP Foreign Trade | Udyog Bhawan Wee Eoin | | | l ----- End of picture text -----

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