IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2014-10-20

DGFT Committee Minutes

Document text

Office of Directorate General of Foreign Trade New Delhi -0

Para 4.7 Decision(DRAFT)

MEETING NUMBER_ : 9/82-ALC4/2014 MEETING DATE: 20.10.2014 But actually held on 31.10.2014

The Meeting No. 9/82 of 2014-15 to consider the cases/issues under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy, 2009-14 pertaining to Chemical and Allied products and failing under Chapter 29 and 30 was scheduled for 20.10.2014 but actually held on 31.10.2014 | under the Chairmanship of Shri Jaikant Singh, Addl. DGFT in Room No.11, Udyog Bhawan, New Delhi.

Following members were present:-

Dr. Nitin Jain D/o Biotechnology Shri Nirmal Kumar, Deputy Director General of Foreign Trade Shri D.N. Mathur. Consultant, Department of Pharmaceutical Shri Jasbir Singh, Consultant, Department of C&PC

‘The committee went through the minutes of earlier NC Ill meeting No. 8/82 scheduled for 25.09.2014 but actually held on 10.10.2014 and approved the same.

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

(Case No.:11/20/82[Party Name:NEULAND Meet No/Date:9/82Status: Deffered ALC4/2009 LABORATORIES LTD ALC4/2014 and Re-indexed 20.10.2014 1 HQ File RLA File Lic.No/Date:09 10038818 [Defer 1:01/82/050/00422/AM10/ :09/24/040/00144/AM10/ 06.08.2009 Date: 12.1 1.2014 Decision : Copy ofproduction and consumption data of all inputs has been received from the firm and same has been sent to Department of Pharmaceuticals for their comments. Case is deferred for 12.11.2014. Case No.:4/16/82-ALC4/2011 Party Name:BOSTIK INDIA Meet No/Date:9/82Status:Deffered PRIVATE LIMITED ALC4/2014 and Re-indexed 20.10.2014 2 |HQ File RLA File Lic.No/Date:07 10079777 |Defer :01/82/050/00462/AM 1 2/ :07/24/040/00073/AM 12/ 13.06.2011 Date:26. 11.2014 Decision : It was decided to defer the case for 26.11.2014for comments of Petrochemicals Division of Department of Chemicals and Petrochemicals.

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Case No.:196/10/82. |Party Name:BOSTIK INDIA {Meet No/Date:9/82Status:Deffered ALC4/2013 PRIVATE LIMITED ALC4/2014 and Re-indexed 3 20.10.2014 HQ File RLA File Lic.No/Date:0710085024 [Defer | :01/82/050/00379/AM 14/ :07/24/040/00380/AM 12/ 28.12.2011 Date:26.11.2014.j:. oy | " ‘de . i, 4 New Deni ag Ghewor

Decision : Department of Chemicals and Petrochemicals vide their letter no. 46011/45/2010-PC Ii dated

14.08.2014 has requested the firm to furnish 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.
1. Details and quantity of other indigenous inputs to be used in the manufacture of theexport product may be indicated.
1. 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.
1. Complete material balance indicating input and output material at each stage of manufacturing process.
1. 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.
1. Any other relevant information.
The case was deferred for 26a.11.2014

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----- Start of picture text ----- ALC4/2013 DRUGS LIMITED, ALC4/2014 Approved ;ie No.:21/20/82- bre Name:HETERO ite No/Date:9/82- rome | | { :01/82/050/01007/AM14/ :09/24/040/00668/AM 12/ 20.10.201411.04.2012 fae File BLA File ie Ne dDat:09 100521 13 Peter Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 3501 1/67/2014-PI(Norms) dated 10.10.2014, 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: INDINAVIR Quanti kg/ke SULPHATE a EO 0 (2. | Acetonitrile SS«dBB 4 [3.|SSS«*dtAQOSS Methanol“ | 4. | Methane Suifonic Acid [1.07 | |S.| Methylene chloride —+(i6s6. |7.6.|| 3-Phenyl Propiony! Chloride | [8. |Tetrahydrofuran0.5322. 9. «7.65 10. [2-MethoxyPropene_—_—+(.0.7138—~« [Il [nHexaneSS~=«dGOSCS~*S [14 [D D i -Tert Butylcarbonate_[0.489__~*| is Lia ----- End of picture text -----

ott oS rade & wow[bath]

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

;

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|---|---|---|---|---|---|---|
|Case No.:44/20/82-|Party Name:HIRAN|Meet No/Date:9/82-|Status:Deffered|
|ALC4/2013|CRGOCHEM LIMITED|ALC4/2014|and Re-indexed|
|20.10.2014|
|||5|[HQ:01/82/050/01030/AM14/ File|RLA703/94/040/008 File|14/AM12/|25.04.2012Lic.No/Date:03 10692029|Date:26.11.2014[Defer|
|Decision|:|It was decided to call from the firm the complete technical|details as per Appendix 33. The|
|case was deferred|for|26.11.2014.|

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Case No.:30/13/82Party Name: HALDIA Meet No/Date:9/82Status: Deffered ALC4/2012 PETROCHEMICALS LTD. jALC4/2014 and Re-indexed 20.10.2014 . 6 HQ File RLA File Lic.No/Date:0210177518 Defer :01/82/050/00365/AM13/ :02/24/040/00029/AM13/ 14.05.2012 Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Petrochemicals Division ofDepartment of Chemicals and Petrochemicals.

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|---|---|---|---|---|---|---|---|---|---|---|
|~~|
|Case No.:28/20/82-|[Party Name:HETERO LABS|(Meet No/Date:9/82-|(Status:|
|ALC42013|LIMITED|ALC4/2014|Approved|
|20.10.2014|
|HQ File|RLA File|Lic.|No/Date:09 10052608||iDefer.|Date:|
|(01/82/050/01014/AM14/|:09/24/040/00070/AM|13/|14.05.2612|
|Decision|:|In|the|light of written|comments|received|from|Department of Pharmaceuticals|vide|their OM|
|No.|3501 1/66/2014-Pi(Norms) dated|10.10.2014,|it was decided to ratify the norms under Para 4.7|ofHBP v1|
|as per details given below or as applied by the|firm, whichever|is|less:|
|4|
|Export Product|Export|S.No.|||Import Item|Qty. Allowed|
|;|Quanti|kg/ke|
|(PurityEMTRICITABINE 99.5%)||1,| Emtricitabine|(Purity|94%|1055|
|RA||4.__||Isopropyl|Alcohol|
|may take|appropriate action as per the decision ofNorms|Committee.|

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|---|---|---|---|---|---|---|---|---|---|
|Case No.:38/20/82-|Party Name:HETERO LABS|[Meet No/Date:9/82.|(Status:|
|ALC4/2013|LIMITED|ALC42014|Approved|
|||20.10.2014|
|HQ File|RLA File|Lic.No/Date:0910052665||Defer Date:|
|:01/82/050/01024/AM14/|:09/24/040/00069/AM|13/|17.05.2012|
|Decision|:|In|the|light of written|comments|received from Department|of Pharmaceuticals|vide|their OM:|
|8|No. 3501 1/68/2014-PI(Norms)|dated|10.10.2014,|it was decided to ratify the norms under Para 4.7 of|HBP v]|
|as per details given below or as applied by the firm, whichever|is|less:|

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----- Start of picture text ----- Export S. No. Qty. Allowed CILAZAPRIL Quantt ke/ke |1.[ Malonic Acid 14.88 Tert.Butyl Acetate Ze L-Glutamic Acid 741 SSO«Y i OTe eee L MAR by fie oo a eiean Trade : artreg fo.) mepartinent of Commerce Ucvog Bhawan, New Delhi ----- End of picture text -----

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----- Start of picture text ----- Diiso propyl Alcchol 16.81 Ethyl Chloroformate [6.| Dimethyl Formamide (11.36 Tetrahydrofuran R-2-Hydroxy-4-Phenyi Butonic Acid Ethy! Ester Trifluoromethane Sulfonic 1.27 Anhydride |10.[ Methylene Dichloride 130.94 RA [11 |«itaMethanol *d may take appropriate action as per the decision ofNorms Committee. ----- End of picture text -----

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----- Start of picture text ----- Case No.:39/20/82- Party Name:HETERO LABS [Meet No/Date:9/82- Status: ALC4/2013 LIMITED ALC4/2014 Approved ‘THQ 20.10.2014 :0 File RLA File Lic.No/Date:0910052780 [Defer Date: 1/82/050/01025/AM14/ :09/24/040/00094/AM13/ 25.05.2012 - No.Decision : In the light of written comments received from Department of Pharmaceuticals vide their; OM as 3501 1/70/2014-Pi(Norms) dated 13. 10.2014, it was decided to ratify the norms under Para 4.7 ofHBP v] 9 per details given below or as applied by the firm, whichever is less: Export Product Export S. No. Qty. Allowed CILOSTAZOL Quanti kg/kg | 11.| 4-Amino Phenol 059 3. DimetylSulfoxid 90 5-(4-Chlorobutyl)-1- 0.88 |4.___ Cyclohexyl-1H-tetrazole RA [Dimethyl Formamide }2.46 may take appropriate action as per the decision ofNorms Committee. Case No.:31/20/82- Party Name:HETERO LABS [Meet No/Date:9/82- Status: ALC4/2013 LIMITED ALC4/2014 Approved HQ 20.10.2014 File RLA File Lic.No/Date:09 10052814 [Defer Date: :01/82/050/01017/AM14/ :09/24/040/00108/AM13/ 29.05.2012 Decision : In the tight of written comments received from Department of Pharmaceuticals vide their OM No, 3501 1/67/2014-PI(Norms) dated 10.10.2014, 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: 10! Export Export |S. Qty. Product Quantity | No. Allowed RAMIPRIL kg/kg BENZYL~CIS,ENDO)- OCTAHYDROCYCLOPENTA(B)PYRROLE- 2-(S)\CARBOXYLATE HYDROCHLORIDE 2. N-[1(S)}CARBOETHOXY-3- 0.98 PHENYLPROPYL]1S ALANINE N,N-DICYCLOHEXYLCARBODIIMIDE |0.875 | METHYLENE CHLORIDE [2.353 | DHSOPROPYL ETHER [2.647 Lae By Ferra frre: anane Dy. Direct: scalei Foreign Trade four > our evireray Dire: + 1 * Foreign Trade rm trent of Commerce ' ro New Delhi ----- End of picture text -----

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----- Start of picture text ----- Case No.:20/20/82- Party Name:HETERO LABS [Meet No/Date:9/82- Status: ALC4/2013 LIMITED ALC42014 Approved HQ 20.10.2014 :01/82/050/01006/AM14/File :09/24/040/00127/AM13/RLA File [eorDat-095005250807.06.2012 [Pete Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 3501 1/68/2014-PI(Norms) dated 10.10.2014, it was decided to ratify the norms under Para 4.7 ofHBP v1 as per details given below or as applied by the firm, whichever is less: CAPECITABINE Q kg/kg Ll. [DRibose S=*d 09S 2,2-Dimethoxy propane [355 4. Sodium borohydride [0.58 | Dimethyl! sulfoxide [3.17 ||5.[5-Fluoro Diisopropc y tosinelether ——~=«Oss3—~—~«d296 SS RA n-Pentyichloro formate (0.91 «| may take appropriate action as per the decision ofNorms Committee. Case No.:17/20/82- Party Name:CADILA Meet No/Date:9/82- Status: ALC4/2013 HEALTHCARE LTD., ALC4/2014 Approved HQ 20.10.2014 File RLA File Lic.No/Date:0810112512 [Defer Date: :01/82/050/01003/AM14/ :08/24/040/00088/AM13/ 14.06.2012 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 3501 1/120/2014-PI(Norms) dated 10.10.2014, it was decided to ratify the norms under Para 4.7 ofHBP v1 as per details given below or as applied by the firm, whichever is less: | Export Product Export S. No. Qty. Allowed | Quanti keke AMLODIPINE ETHYL -4-CHLORO ACETO 12 BESYLATE ACETATE 2__[ METHANOL 13397 3. IPA (ISO PROPYL 2.73 ALCOHOL | 5. METHYL 3 AMINO CROTONATE | ORTHO CHLORO BENZYL |7,___[ DEHYDE MONO METHYL AMINE fi80 BENZENE SULPHONIC ACID RA may take appropriate action as per the decision ofNorms Committee. my by! Lie : eaters aie ody bier anunsnt of Commerce ----- End of picture text -----

%

||CaseNo.:18/20/82-|PartyName:CADILA|MeetNo/Date:9/82-<br>Status:Deffered|
|---|---|---|---|
||ALC4/2013|HEALTHCARELTD.,|ALC4/2614<br>andRe-indexed<br>20.10.2014<br>i|
|13|HQFile<br> |:01/82/050/01004/AM14/|RLAFile<br>—_[:08/24/040/00090/AM13/|Lic.No/Date:0810112511 |Defer<br>14.06.2012<br>Peta1.2014|
||Decision : Itwasdecidedto|tocallfromthefirmcopyofrelevantDMLshowing composition ofthe||
||exportproduct.|||

The case was deferred for 26.11.2014.

Case No.:19/20/82Party Name:CADILA Meet No/Date:9/82Status:Deffered ALC4/2013 HEALTHCARE LTD., LC4/2014 and Re-indexed 20.10.2014
14 [HQ:01/82/050/01005/AM14/ File RLA:08/24/040/00095/AM File 13/ Lic.No/Date:0814.06.2012 10112510 eterDate:26.11.2014 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.:34/20/82- Party Name:CADILA Meet No/Date:9/82- Status: ALC4/2013 HEALTHCARE LTD., LC4/2014 Approved 20.10.2014 HQ File RLA File Lic.No/Date:08 10112516 [Defer Date: :01/82/050/01020/AM14/ :08/24/040/00100/AM13/ 14.06.2012 Decision ; In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/74/2014-Pi(Norms) dated 09.10.2014, it was decided to ratify the norms under Para 4,7 ofHBP v1 as per details given below or as applied by the firm, whichever is less: 6-chloro-4-hydroxy- Oty 1, kg/kg 2methyl-N-(2-Pyridiny!)- 2, | 3-AMINOTHIOPHENYL-2-2-AMINOPYRIDINE 0.45 15] 2H-Thieno-[2,3}-1,2- CARBONACIDMETHYL Thiazine-3-carboxamide- ESTER Li-dlotie [ACETONE ‘726 ) DIISOPROPYLETHER [2.40 | GLYCINMETHYL ESTER 0.507 | HYDROCHLORIDE : [6.| METHANOL S=«daaO~*d N-BUTYL LITHIUM (20% IN TOLUENE | aa BUTYLATEPOTASSIUM TERTIARY 0.86 }9._|TETRAHYDROFURAN [6515 | RA | (10. [TOLUENE—«sf ga may take appropriate action as per the decision ofNorms Committee. Case No.:4/20/82- Party Name:-RANBAXY Meet No/Date:9/ \ pecALC4/2012 LABORATORIESLTD; 50 1OooKe :9/82- ennaand Re-indexed HQ File RLA File “ieNo 3 . Lic.No/Date:05 10333154 [Defer :01/82/050/00615/AM13/ shemoooszvamia, — LenaDasisionaise ont, “te Cournsrat Ch baeaa mfr fers] aDepartment of Commerce Udyog Broan es Delhi ----- End of picture text -----

fa)

Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals.

Case No.:40/15/82Party Name:CALYX Meet No/Date:9/82Status: Deffered ALC4/2013 CHEMICALS & ALC42014 and Re-indexed PHARMACEUTICALS LTD. [20.10.2014
17 |HQ:01/82/050/00802/AM1i4/ File RLA:03/94/040/00199/AMi0/ File Lic06.09.2012 Nora 10707994 PeteDate:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals.

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Case No.:3/23/82Party Name: TITAN Meet No/Date:9/82Status: Deffered ALC4/2012 LABORATORIES PVT. LTD. ALC4/2014 and Re-indexed 20.10.2014
18 }HQ:01/82/050/00803/AM13/ File RLA:03/95/040/00544/AM13/ File Lic.No/Date:032.10.2012 10713360. [DefDat e :26.11.20r 14 Decision : Reply received and already sent to D/o Pharmaceuticals for their comments. The case was deferred for 26.11.2014

||||CaseNo.:16/28/82-<br>PartyName:CADILA<br>MeetNo/Date:9/82-<br>Status:<br>ALC4/2012<br>PHARMACEUTICALSLTD. |ALC4/2014<br>Approved<br>20.10.2014<br>|<br>19<br>iQFile<br>RLAFile<br>Lic.No/Date:0810115897 [DeferDate:<br>:01/82/050/00983/AM13/<br>:08/24/040/00259/AM13/<br>25.10.2012<br>[Decision :Withdrawas thecasewasalreadyapprovedin4/82meetingdated03.07.2014.|
|---|---|---|
||CaseNo.:187/6/82-<br>Party Name:VIVIMED LABS |MeetNo/Date-:9/82-<br>Status:<br>ALC42014<br>LIMITED<br>ALC4/2014<br>Approved<br>20.10.2016<br>20<br>HOFile<br>RLAFile<br>Lic.No/Date:0910054181 (DeferDate:<br>01/82/050/00589/AM15/<br>:09/24/040/00380/AM13/<br>29.10.2012<br>|<br>[Decision<br>:Withdrawas thecasewasalreadyapprovedin6/82meeting<br>dated 28.09.2014.||
||CaseNo.:19/1/82-<br>PartyName:-CDYMAX<br>MeetNo/Date:9/82-<br>[Status:Deffered<br>ALC42013<br>(INDIA)PHARMAPVT.<br>ALC4/2014<br>andRe-indexed<br>LTD.<br>20.10.2014<br>|<br>psHieFile<br>[RLFile<br>Lic.No/Date:0710091789 [Defer<br>:01/82/050/01377/AM13/<br>:07/24/040/00317/AM13/<br>06.11.2012<br>;<br>Date:26.11.2014<br>Decision<br>: Itwasdecidedtodeferthecasefor26.11.2014 forcommentsofD<br>‘<br>“AL,<br>epartmentof<br>|<br>Pharmaceuticals.||
|||| <br>69<br>|sisi|iteNo.:112/33/82-<br>urName:STERICAT<br>'|MeetNo/Date:9/82-<br>Status:Deffered<br> ceo<br>GUTSTRINGSPVT.LTD.<br>ALC4/2014<br>andRe-indexed<br>20.10.2014<br>HQ<br>File<br>RLAFile sovamiy<br>ieNo/Date:0510340033 [Dek<br>.<br>.<br>S<br>er<br>sisi<br>:05/24/040/00304/AM13/<br>ig.12,2012<br>pete<br>1.2014<br>ecision :<br>Itwasdecidedtod<br>efer thecasefor26.11.2014forcommentsofDepartmentOf btKumar|
|||pints.<br>:<br>Miera|
|||Ud.<br>oy|

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|---|---|---|---|---|
|a|
|Case No.:85/31/82-|Party Name:SANOFIINDIA|(Meet No/Date:9/82-|Status:|Deffered|
|ALC4/2012|LIMITED|ALC4/2014|and Re-indexed|
|20.10.2014|
|53|HQ:01/82/050/01125/AM13/ File|RLA:03/95/040/00465/AM13/ File|Lic.No/Date:6314.12.2012|10717240 PeteDate:26.11.2014|

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Decision; In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/230/2014-Pl{Norms) dated 16.05.2013, stated that there is no manufacturing activity involved as finished formulated injections are to be imported from France and after relabeling /packaging those injections are to be exported to Sri Lanka. Further, since it is more re-export of finishing formulations. The case was deferred for 26.11.2014 Case No.:165/33/82Party Name:CADILA Meet No/Date:9/82Status: Deffered ALC4/2012 HEALTHCARE LTD., ALC4/2014 and Re-indexed 20.10.2014 24 |HQ File RLA File Lic.No/Date:0810117317 |Defer :01/82/050/013 12/AM13/ :08/24/040/00257/AM13/ 02.01.2013 Date:26.11.2014 Decision : It was decided to call from the firm a copy of Master batch Formula duly certified by Quality ~Control In charge. The case was deferred for 26.11.2014.

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|---|---|---|---|---|---|---|
|Case No.:189/6/82-|Party|Name:|VIVIMED|LABS||Meet No/Date:9/82-|Status:|
|ALC4/2014|LIMITED|ALC42014|approved|
|20.10.2014|
|HQ File|RLA File|Lic.No/Date:0910054690||Defer Date:|
|:01/82/050/00591/AM15/|:09/24/040/00486/AM13/|04.01.2013|

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Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/43/2011-Ch tI dated 03.01.2014, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: 25

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----- Start of picture text ----- Export product Exp. SI.No. | Import items: Qty. allowed Qty. 1g Oa Kg [4 Jasmin mexaor =O [5. JaceronmeneSS=«dt OK ----- End of picture text -----

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

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----- Start of picture text ----- (Case No.:13/12/82- Party Name:HETERO eet No/Date:9/82- [Status:Deffered ALC4/2013 DRUGS LIMITED, ALC4/2014 and Re-indexed 26 20.10.2014 | |HQ File Rua File Lic.No/Date:09 10054735 Pete | Decision:01/82/050/00437/AM14/ : It was decided to:09/24/040/00495/AM13/ call the following information09.01.2013 from the firm :7 i) StepwisDat e :26.1 1.2014chemical reactions showing correct Molecular weight of each reactant & output product, fantheyield.on MAL fan Dy. Direiexox Se tered Of Fores In Tra waP ry feaTyDepartment Of Con Trade Vary waz mmerce Udyog Bhawan NESE, ----- End of picture text -----

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molar basis. ii) Justification for requirement of imported inputs in view ofCA certificate furnished by the firm. The case was deferred for 26.11.2014.

Case No.:203/33/82Party Name:SUBHASH Meet No/Date:9/82Status: approved ALC4/2012 CHEMICAL INDUSTRIES /|ALC4/2014 PVT LTD 20.16.2014 . 27 THQ:01/82/050/01350/AM13/ File RLA131/83/040/00137/AM13/ File Lic.11.61.2013 No/Date:3 1 10056802 [Peter Date: Decision : Withdraw as the case was already approved in 6/82 meeting dated 29.08.2014.

Case No.:16/20/82Party Name: ASTRIX Meet No/Date:9/82Status: approved ALC4/2013 iLABORATORIES LTD., ALC4/2014 20.10.2014 HQ File RLA File Lic.No/Date:0910054794 |Defer Date: :01/82/050/01002/AM 1 4/ :09/24/040/0045 1/AM13/ 17.01.2013 ; Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/224/2014-Pl(Norms) dated 21.10.2014, it was decided to ratify the norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

| Export Product Export |S. | Import Item Qty. | Qty No. Allowed LAMEVUDINE(GLYOXYLIC Ikg |1.|GLYOXYLIC ACID kg/kg1.738 ACID ROUTE) 2,5-DIHYDROXY-1,40.739 DITHIANE | [3. [CYTOSINE «(0955 HEXAMETHYLDISLLAZANE IMDS fe | METHANESULPHONICACIDDIMETHYL FORMAMIDE [052 —| SODIUM BOROHYDRIDE |8.|[CYCLOHEXANE] =| :1.9849 10. [N-HEXANE __]230 J |[11.] }12 | TRIETDICHLOROMET H ANEYLAMINE ISO «di 3.63 = PRPOYL ALCOHOL /2.00 RA [15 |GLYOXYLICACIDsoas may take appropriate action as per the decision ofNorms Committee ALC4/2012 LABORATORIES LTD.& ALC4/2014 and Re indeced ne No.:2/30/82a Name: MOREPEN Meet No/Date:9/82[Status: b9 MOREPEN INTERNATION [20.10.2014 || [Stson@eAetar;HQ File LA:05/24/040/00389/AM13/ File les23.01.2013.No/Date:05; 10343975 |DeferDate:26.11.2014 Decision : It was decided to defer the case for 26.1 1.2014 for commentsany ef:Departmentofi kumar Dy. Coreet3 LaanCreaaa! alotFy? toregnSITTRTrade Fito 9 aerPreyrrerr @PrsyDirect.frHi71:Lepartmentaie wr. -eral of Foreignof Commerc Trad e UdyogwarBhawan,was, AL ©fN e wochtDelhi

| Pharmaceuticals.

fe)

(Case No.:3/30/82Party Name:MOREPEN [Meet No/Date-9/82(Status: ALC4/2012 LABORATORIES LTD.& |ALC4/2014 Approved MOREPEN INTERNATION 20.10.2014
| HQ:01/82/050/01039/AM13/ File RLA:05/24/040/00393/AM13/ File ic23.01.2013NorDaes 10343986 Pete Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/228/2014-Pl(Norms) dated 21.10.2014, it was decided to ratify the norms under Para 4.7 of HBP v! as per details given below or as applied by the firm, whichever is less:

||Exportproduct|Exp.|importitems||
|---|---|---|---|---|
|30||aty.|||
||||‘<br>-CHLOROBENZYL|1.82|
||pIPERIDINYLIDI<br>PIPERIDINYLIDENE)-5H-<br>BENZO(5,6)CY CLOHEPTA(I,2<br>IB)PYRIDINE(LH09)|kg|SODIUMMETHOXIDE<br>13.|TOLUENE<br>4.<br>N,N-DIMETHYL<br>CARBAMOYLCHLORIDE<br>|5._|METHANOL<br>[6[TETRAHYDROFURAN|2233<br>063<br>[3205|

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

CaseN0.:9/4/82-ALC4/2013	PartyName:GOPALDAS	MeetNo/Date:9/82-	Status:Deffered
	VISRAM&CO.LTD.	ALC42014<br>20.10.2014	andRe-indexed<br>)
HQ File<br>:01/82/050/00050/AM<br>14/	RLA File<br>:03/94/040/00945/AM13/	Lic.No/Date:0310722715 <br>01.02.2013	{Defer<br>Date:26.11.2014

{31 |Decision : tt was decided to give last reminder to the firm 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 26.11.2014.

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----- Start of picture text ----- Case No:151/33/82. Party Name:FORACE (Meet No/Date:9/82- (StatussDenferea ALC4/2012 POLYMERS (P) LTD. ALC42014 and Re-indexed 20.10.2014 |32 HQHO Fi File 1298/AM13/ RrRLA FileFi eosSS/AMI9 07.02.2013Lic.No/Date:05 10345208 [Defer Decision : It was decided to defer the case for 26.11.2014 for comments of Petrochemicals | ___ |Date:26.11.2014 Division of Department of Chemicals and Petrochemicals. _ Status:Deffered I,HQCase No.:7/3/82-ALC4/2013 ene| WOCKHARDT AnAte [No/Dae:9/82-] “xe File RLA File Lic No/Date: r 4 and Re-indexed :01/82/050/00040/AM1i RRLA File oessamiy tc.No/Date:03 10723636 (Defer AMi4/ __ |:03/95/040/00886/AM13/ 11.02.2013 Date:26.11.2014 syle 7 Foreign Trade arf eey '4+i-VDepartment of Commas Udyog Bhawan NEE iy ----- End of picture text -----

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

||||||||||
|---|---|---|---|---|---|---|---|---|
|Decision|: It was decided to send a copy of|application again to DCGI for their comments.|
|The case was deferred for 26.11.2014.|.|
|9/82-|.|ed|
|Case|14/4/82-ALC4/2013||P:|Name:SABERO|Meet|No/Date:9/82|Status:|Deffer|
|No|ORGANICS GUJARAT|ALC4/2014|and Re-indexed|
|LIMITED|20.10.2014|
|z|FH|;|Defer|
|:|
|-03/95/040/00880/AM|13/|14.02.2013|Date:26.1|1.2014|
|pb|le|[-01/82/050/00045/AM14/]|File|RS|File|Lem|10724136|||
|Decision|: It was decided to defer the case for 26.11.2014 for comments of|Department of|
|Chemicals and Petrochemicals.|
|Case No.:79/1/82-|Party Name:STERICAT|Meet No/Date:9/82-|Status:Deffered|
|ALC4/2013|GUTSTRINGS PVT. LTD.|ALC4/20.10.|201|44|and Re-indexed|
|35||HQ File|RLA File|Porrrae|10346353|Pete|
|:01/82/050/01437/AM13/|:05/24/040/00420/AM13/|18.02.2013|Date:26.11 2014|
|Decision|: It was decided to defer the case for 26.11.2014 for|comments of|Department of|
|IPP|
|Case No.:31/8/82-|Party|Name:|MYLAN|Meet No/Date:9/82-|Status: Deffered|
|ALC4/2013|LABORATORIES LIMITED|ALC4/2014|and Re-indexed|
|HQ File|RLA File|||20.10.2014Lic.No/Date:0910055106||Defer|
|0|1/82/050/00162/AM14/|:09/24/040/00537/AM13/|19.02.2013|\Date:26.11 2014|
|36 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 ¢tc.|
|+ Past Production vis-a-vis Actual consumption of|raw materials duly certified by Central|
|Excise|Authorities.|
|The case was deferred for 26.11.2014.|

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

||||||||
|---|---|---|---|---|---|---|
|Case No.:32/8/82-|Party Name:BIOLOGICAL E|Meet No/Date:9/82-|Status:Deffered|
|ALCA2013|LTD|ALC4/201420.10.2014.|and Re-indexed|
||37FO[01/82/050/00163/AM14/ Fie|orcaamiar|one—_|:09/24/040/00607/AM13/___yooeoT/AMI3)|Lic19.03.2013No/Date:0910055421_|[||D|eferate:26.11.2014|
|Decision|:|It was decided to give last reminder to|the firm to furnish copy ofBatch|
|production record of|complete|Manufacturing process (up stream, down stream,|
|formulation,|filling etc.) showing quantities and use of|import inputs”.|
|The|case|was|deferred|for 26.11.2014.|

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

|||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|Case No.:57/10/82-|Party Name:BIOLOGICAL E|[Meet No/Date:9/82-|__|Status:Deffered|
|ALC4/2013|LTD|AL|[CA/2014]|‘jand Re-indexed|
|:01|PLA Te|QOSOSIAMIS)|iC.|ate:0910055420||Defer|
|||Decisioecisio|n|rt:|It wawa|s|dd|e|cs|id|eded tt|o|sivegive lastbor remv|i|ndernd|t|o|thi|e|Fees|me=|O.tt|
|firm to furnish|capy.pf Batch|a|
|Dy.|Direc. ee om Prezey|maine|
|fers|oo,|1|Foreign|Trade|
|aatiDirectorateUdyogfE4i|CusOsan,tere|“ETPaoreTS|rereTrade|
|hewn|EP,|

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

® | [production record ofcomplete Manufacturing process (up stream, down stream, formulation, filling etc.) showing quantities and use of import inputs”. The case was deferred for 26.11 2014. ALC4/2013 LABORATORIES LTD A eoold and Re-indexed |ite No.:6/10/82| DartPartyName:RANBAXY: Meet No/Date:9/82-9/82Status:De:Deffered |39 (HQ-01/82/050/00189/AM File 14/ RLAFile-05/24/040/00480/AM 13/ [ieNopaets22.03.2013 10350030 PeiDate:26.1 1.2014 Decision : It was decided to remind the firm to furnish a copy ofMaster batch Formula duly certified by Quality -Control Incharge. The case was deferred for 26.11.2014.

Case No.:33/2/82Party Name: MOREPEN Meet No/Date:9/82Status:Deffered ALC4/2013 LABORATORIES LTD.& ALC4/2014 and Re-indexed MOREPEN INTERNATION 20.10.2014 40 |HQ File RLA File oo Pete :01/82/050/01480/AM13/ -05/24/040/00481/AM13/ 26.03.2013 Date:26.11.2014 Decision : Reply received from the firm and sent to Department of Pharmaceuticals fortheir comments. The case was deferred for 26.11.2014

Case No.:117/10/82Party Name:PRASOL Meet No/Date:9/82__|[Status:Deffered ALC4/2013 (CHEMICALS LIMITED ALC4/2014 and Re-indexed 20.10.2014 . . HQ File RLA File Lic.No/Date:03 10729886 |Defer :01/82/050/00300/AM 14/ :03/95/040/00881/AM 13/ 28.03.2013 Date:26.11 2014 Decision : It was decided to remind the firm to furnish the following technical details: 1. Complete set of application 4 2. Details of Manufacturing process of 3,3,5 Trimethyl Cyclohexanone with Chemical equations, molecular formula, molecular weights.

Yield obtained in each step.
Authentic technical literature in support of yield obtained.
Material balance. 6. CA certificate certifying the production of export item achieved by you for the past three years and corresponding consumption of each input 7. Detailed calculations, arriving at the norms applied for. The case was deferred for 26.11.2014.

Case No.:17/10/82Party Name:RANBAXY Meet No/Date:9/82. 420.10.2014 J ALC4/2013 CABonATOMESETD. ALC4/2014 wa/BLStatus:Approved | PHO:01/82/050/00200/AM14/Fil oo20AMLA) RLA_|:05/24/040/00478/AM13/ File Lic.[08.04.2013No/Date:0510350968_ [PetersDe 42 |Decision. : In the light of written comments received from‘Departm ”ent of Pharmaceuticalssmmeuis vid their OM No. 35011/182/2014-Pl(Norms) dated 21.10.2014, it was decided to ratify the norms under Para 4.7 of HBP v! as per details given below or as applied by the firm, whichever is less: Export product Exp. import itemsP . —— eae STA. KUMAR Fadnaa pide: ps a5 ein Trade amfvisy fiw te seca < Foreign Wade Bend erg uals of Commerce Udyog Bhawan, Ne B oni

y

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

|||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
|ikg|1.|3-Cyclohexene-|-Carboxylic|1.773|
|LTLC|(|18,48,5S)-4-IODO-6-|Acid|
|fOXABICYCLO|Ta|| Todine|Sd|
|(3.2,|JOCTAN-7-ONE|Potassium lodide|fo.4|||
|ra.|[R-#)Phenylethylamine|[1353|
|RA may take appropriate action as per the decision of Norms Committee.|
|.|-9/82-|Status:Deffered|
|fieCase No.:71/4/82-|BeePartyENTERPRISE Name:CHIRAG;|20.10.MeetALC4/ No/Date:9/82|2014|and Re-indexed|
|‘3|fe|[-01/82/050/001]|File:|[ 12/AM14/]|RLA-24/24/040/0000 File|1/AM14/|is09.04.2013j|Neate:|0086386|4|55Date:26.1 1.2014Defer|
|Decision|:|It was decided to defer the case for 26.2014|for comments of|Petrochemicals|
|Division of Department of|Chemicals and Petrochemicals|
|Case No,:120/10/82-|Party|Name:|MEHTA|API PVT|[Meet No/Date:9/82-|Status:Deffered|
|ALC4/2013|LTD|ALC4/2014|and Re-indexed|
|20.10.2014|
|:03/95/040/00020/AM14/|09.04.2013|Date:26.11 2014|
|44|HQ|[:01/82/050/00303/AM14/]|File|RLA File|Lic.No/Date:03|10730905 Pete|
|Decision|:|It was decided to remind the firm to furnish the|following information from the firm|:|
|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|
|Catrithromycin Oxime per kg of|clarithromycin.|(ii) Past production vis-4-vis|actual consumption|
|of input duly|certified|by Central|Excise Authorities. The case was deferred for 26.11.2014|

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----- Start of picture text ----- Case No.:3/3/82-ALC4/2013 |Party Name:LAKE Meet No/Date:9/82- Status: Deffered (CHEMICALS PRIVATE ALC42014 and Re-indexed LIMITED 20.10.2014 |Ks— HQ|:01/82/050/00036/AM File 1 4/ RLA:07/24/040/00003/AM File 14/ |Lic.No/Date:071009492118.04.2013 7 [DeferDate:26.11.2014 | theirDecisi c o mments.n : Reply receivedThe case fromis deferred the f io r m26.11.2014 and sent to department ofPharmaceuticals for ALC4/2013 PHARMACEUTICALS LTD,,. |ALC4/2014 and Re-indexed ;ice No.:43/10/82- Pa Name:SRINI [Meet20.10.2014No/Date:9/82-HBL [Status:tus: Def fefered |46 [HQ File IA File Lic.No/Date:0910055800 [Defer secisionLELESOOE: 2AMIt was decided to09/24/040/00017/AM14/ defer the case for 26.11.2014{19.04.2013for co pete 1.2014 | Pharmaceuticals. ofD ™ ent of ----- End of picture text -----

(Case No.:18/7/82Party Name: VIVIN Meet No/Date:9/82-_ le ALC4/2014 : :9/82Status:Deffered | :01/82/050/00662/AMI5/inre _ IRLA File —SSCLED ic20.10.2014 Novato" 091005591409108 [Defer = [:09/24/040/00624/AM13/ 02.05.2013 Date:26.11.2014 BWI&: *7NIRMALce B KUMAR Dy. © re, :ORT & | f Foreign Trade wt uf Commerce

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----- Start of picture text ----- “) | |Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals. ----- End of picture text -----

Case No.:6/7/82-ALC4/2014No PHARMA(|Party Name:RA LIMITED CHEM MeetALC4/2014 No/Date:9/82andStatus: Re-indexed Deffered 20.10.2014 . :01/82/050/00650/AM15/ :09/24/040/00043/AM14/ 03.05.2013 48 |HQ File RLA File Lic NosDate-0910055952_ eteDate:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals.

Case No.:157/10/82Party Name:LUPIN LIMITED [Meet No/Date:9/82[Status:Defferea ALC4/2013 ALC4/2014 and Re-indexed 20.10.2014 49. |HQ File RLA File Lic.No/Date:03 10733961 |Defer | ‘ONB2/0S0/00340/AMI14/ _|:03/95/040/00098/AM14/ 10.05.2013. Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of | |Pharmaceuticals, | [Case No.:2/5/82-ALC4/2013 [Panty Name-MYLAN Meet No/Date:9/82[Status:Delfered LABORATORIES LIMITED Weanin and Re-indexed | keg File fa File Lic.No/Date:091005597910.2014 [Defer :01/82/050/00120/AM14/ :09/24/040/00023/AM 14/ {10.05.2013 50 . {Date:26.11.2014 |Decision : It was decided to remind the firm to furnish the following information: I. Complete technical details as per Appendix 33 Authorities.2. Past production vis-a-vis actual consumption of input duly certified by Central Excise

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----- Start of picture text ----- The case was deferred for 26.1 1.2014 ALC4/2014 : 9/82. Status:Deff ; © us:Deffered Case No.:20/7/82- Party Name:DR REDDYS [Meet NoDaiso | ws:Deffercd 51ict LABORATORIES LIMITED penea and Re-indexed . [HQ File FRA Fi eau, feiedofDat ae OSS ‘No/Date:09 10056000 [Defer ecision AMS 09/24/040/00041/AM 14/ 15.05.2013 Date:26.11.2014 | : It was decided to defer the case 4forcommnno Pharmaceuticals r the for 26.11.2014 for comments ofDepartment of |eteCase No.:10/7/82. P artyHARMAName TareeRAG |hooMeetpnDate:9/82-ss |Status:Deffered | 52 50 tote jand Re-indexed | ptaRsawocsvany|HQ FileOn RLA:09/24/040/00059) Fil ase16.03 2p 0910056008= [Deter Decision : It was decid YAMI4/ {16.05.2013 (PDate:26.11.2014 | : It was deci ed to defer the c — at eens Pharmaceuticals ase for 26.11.2014 for comments ofDepartment of BTS,UdyogVed i MiLupartoent Brawnare WE,of eonbed eeeCe ----- End of picture text -----

|4|53|CaseNo.:11/7/82-<br>ALC4/2014<br> [HQFile<br>-01/82/050/00655/AM15/<br>Decision : Itwasdecidedto|PartyName:SRINI<br>MeetNo/Date:9/82-<br>Status:Deffered<br>PHARMACEUTICALSLTD., ALC4/2014<br>andRe-indexed<br>20.10.2014<br>RLAFile<br>[ieNerpeontoosern Pete<br>:09/24/040/00062/AM14/<br>17.05.2013<br>Date:26.112014<br>todeferthecasefor26.11.2014forcommentsofDepartment of|
|---|---|---|---|
|||Pharmaceuticals.||
|||CaseNo.:52/13/82-<br>ALC4/2013|PartyName:STERICON<br>MeetNo/Date:9/82-<br>Status:Deffered<br>PHARMAPVT.LTD.,<br>ALC4/2014<br>andRe-indexed<br>20.10.2014<br>,|
||54||HQFile<br>RLAFile<br>Lic.No/Date:0710095454Pete<br>:01/82/050/00528/AM 14/<br>-07/24/040/00039/AM 14/<br>17.05.2013<br>Date:26.1 1.2014<br>Decision : Itwasdecidedtodeferthecasefor26.11.2014forcommentsofDepartment of||
|||Pharmaceuticais.||

Case NoSFIB2ALCA/2014 [Party Name:SUVEN LIFE [Meet No/Date:9/82-—_|Status:Deffered SCIENCES LIMITED ALC4/2014 and Re-indexed 20.10.2014
55 [HQ File | RLA File Lic.No/Date:0910056039° Defer :01/82/050/00652/AM15/ :09/24/040/00049/AM 14/ 17.05.2013 Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments ofDepartment of Pharmaceuticals.
| Case No.:12/7/82Party Name: VIVIMED LABS |Meet No/Date:9/82Status:Deffered ALC4/2014 LIMITED ALC42014 and Re-indexed
56 Ha[HQ File st006S6/AMIS RLA09/24/040/00060/AM File 14/ Lic.No/Date:091005601717.05.2013 [DeferDate:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments ofDepartment of C&PC.

Case No.:13/20/82Party Name:HETERO LABS (Meet No/Date:9/82(Status: ALC42013 LIMITED ALC4/2014 Approved | PHOHQ Fi lel 100995/AM. a LA:09/24/040/00068/AM14/ File 20.10.2014[22 05.2013Lic . No/Date:09 10056096 pet Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No, 35011/186/2014-PI(Norms) dated 21.10.2014, 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: 57 Export Qty. allowed LOPINAVIR _ |1kg |2. |Acrylonitrile (3. | Methyl! Chloroformate 23s | a (28,38,5S}-2-amino-3-hydroxy-5-tert. butyloxycrbonylamino)1,6-diphenyl 1.35 \ \vs —— _.. $retall PR UMAR wa FET sere PRT Cae Dy Director. rural of Foreign Trade yc! atu qttcural of Foreign Trade eth ee tei Department of Commerce Udon ‘bnowan. New Dethi

oan

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----- Start of picture text ----- | 5. | 4-Dimethyl amino pyridine 0.0386 | Se fimidazoleSO RA may take appropriate action as per the decision of Norms Committee. . ofDate:9/82- Status: Case No.:132/14/82- Party Name:BLUE DIP Meet “d cae UNS, 20.10.2014 . | [ALCA/2013] ORGANIC INDUSTRIES, ALCA4/2014 Approv HQ-01/82/050/00717/AM14/ File RLA_[:03/94/040/00067/AM14/ File Lic.No/Date:0323.05.2013 10735418: Defer| Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/157/2011-Ch Il dated 23.69.2014, it was decided to ratify norms under Para 4.7 of HBP vi as per details given below or as applied by the firm, 5 \whichever is less: Export product Exp. Qty. fSLNo. [importitems | Oty. allowed EDTA Ferric Monosodium EDTA Acid 0.750 kg ----- End of picture text -----

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

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----- Start of picture text ----- 7 ----- End of picture text -----

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||||||
|---|---|---|---|---|
|Case No.:14/6/82-|Party Name:GLAND|Meet No/Date:9/82-|Status:Deffered|
|ALC4/2014|PHARMA LIMITED|ALC4/2014|and Re-indexed|
|20.10.2014|.|
|59||HQ File|RLA File|Lic.No/Date:0910056109||Defer|
|01/82/080/00416/AM15/|—_|:09/24/040/00065/AM14/—_—_—([23.05.2013|——_ JDate:26.11.2014|

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Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals. 7

Case No.212/20/82Party Name:GLAND Meet No/Date:9/82__[Status:Deffered ALC42013 PHARMA LIMITED ALC422014 and Re-indexed 20.10.2014 . | iso HQ01/82/050/00998/AM File 14/ RLA:09/24/040/0006 File 1/AM14/ 23.05.2013Lic.No/Date:09 10056108 Date:26.11.2014(Defer Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals.

Case No.:134/14/82Party Name:CALYX Meet No/Date:9/82“| Status:Deffered | | |ALc42013 CHEMICALS & ALC4/2014 land Re-indexed PHARMACEUTICALS LTD. [20.10.2014 | |61 a[HQ Fileae so1007IS/AMIa RLA:03/94/040/00508/AM13/ File KexLic. N o /Date:03e 10735499 p[D e fte 1.2014 | Pharmaceuticals.Decision : It: was decided~ to defer the case for 26.11.2014LL. forcomments ofof DDeepartment of

ST =m er D MAR Dir . ° me ere ate 37 2 yet‘ 2uientt Foreignof CommerceTrade 7 Ehawan, New Delhi

a

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|||||||
|---|---|---|---|---|---|
|Case No.:207/10/82-|Party Name:CHIRAG|Meet No/Date:9/82-|Status:Deffered|
|ALC4/2013|ENTERPRISE|ALC4/2614|and Re-indexed|
|20.10.2014|
|62|[HQ:01/82/050/00390/AM14/ File|RLA:24/24/040/00008/AM14/ File|27.05.2013Lic.No/Date:24|10038996.|{Date:26..11.2014[Pete|
|Decision|:|It was decided|to defer the case for 26.11.2014|for comments|Petrochemical|
|Division of Department of|C&PC.|

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|||||||
|---|---|---|---|---|---|
|Case No.:71/10/82-|Party Name:SCOTT-EDIL|Meet No/Date:9/82-|Status: Deffered|
|ALC4/2013|PHARMACIA LTD.,|ALC4/2014|jand Re-indexed|
|20.10.2014|
|63.{HQ File|RLA File|Lic.No/Date:2210013890|(Defer|
|:01/82/050/00254/AM|14/|22/24/040/00016/AM|14/|28.05.2013|Date:26.11.2014|

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Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals.

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||||||
|---|---|---|---|---|
|Case No.:133/14/82-|Party Name:CALYX|Meet No/Date:9/82-|Status:Deffered|
|ALC4/2013|CHEMICALS &|ALC42014|and Re-indexed|
|PHARMACEUTICALS LTD.|[20.10.2014|
|fie File|RL File|Lic.No/Date:03|10736138;|(Defer|
|:01/82/050/007 18/AM14/|:03/94/040/00537/AM13/|30.05.2013||Date:26,11.2014|
|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.:225/10/82- Party Name:APEX Meet NorDate5/82.WSe~ Be | acta HEALTHCARE LTD JALC4/2014 jandStatus: Re-index Deffer ed 65 (20.10.2014 | [HQ. File RLA File Lic No/Date:341003: 7038 jDefereer .1/82/050/00408/AM14/ :34/24/040/00035/AM14/ 31.05.2013 {Date:26.11.2014 | Pharmaceuticals,ecision : It was decided to defer the case for 26.11 2014, foror commentsents ofof DepartmentDe artm of ‘Case No.:96/10/82- Party Name: TORRENT Meet None = ALC4/2013 ° No/Date:9/82.- : iF Pp; eet Status:Deffered 66 20.10.2014 | ete:01/82/0 [OF] HARMACEUTICALS: LTD. |ALC4/20141¢.No/Date:08 10121573 Deferand Re-indexed SSpaesomnzroania RABI licNaDonan: Decisine DE2UOMOOOOBSIAMI4/ [31.05.2013 Date:26.11.2014 | P ecision tticale: It was decided to defer the case for 26.11.2014 for comments~ ofDepartment——— of Case No.:6/6/82-ALC4/2013 [Party Name: HETERO LABS ~ [Mex No/Date:9/82- IStanas 67 LIMITED tatus: | ee:01/82/050/00129/AM14/ A File . 20.10-ALC4/, 20 — 1414 : approved | :09/24/040/00097/4M 14/ 05.06.2013~ a sees= benDeter =z DateIRMAY~ ForeignKUMAR7 Trade “oreign Trada ----- End of picture text -----

| |

% Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/66/2014-PI(Norms} dated 10.10.2014, 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:

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|||||||||||
|---|---|---|---|---|---|---|---|---|---|
|||Export product|Exp.|Import items|Qty.|
|||Qty.|allowed|
|||ke/kg|
||||Levofloxacin Hemihydrate|1kg|pe|Levofloxacinpurity|: 94.5% Hemihydrate|
|purity|
|: 99%)|[2.|3.|||0.38MethyleneMethanol dichloride|}1.00|||
|Co|
|RA may take appropriate|action|as|per the|decision of Norms Committee.|;|
|Case No.:40/12/82-|Party|Name:SMILAX|Meet No/Date:9/82-|Status: Deffered|
|ALC4/2013|LABORATORIES LIMITED||ALC4/2014|and Re-indexed|
|}|20.10.2014|.|.|
|68:|HQ:01/82/050/00464/AM14/ File|RLA—_|:09/24/040/00113/AM14/_—{17.06.2013File|Lic.No/Date:0910056355|pete|Defer|1.2014,|
|Decision|:|It was decided|to defer the case for 26.11.2014|for comments of Department of|
|Pharmaceuticals.|.|
|Case No.:23/12/82-|Party Name:CIRON DRUGS|[Meet No/Date:9/82-|Status:Deffered|
|ALC4/2013|& PHARMACEUTICALS|P.||ALC4/2014|and Re-indexed|
|69|HQ File||RLALTD.,File|20.10.2014Lic,No/Date:03 10738255||Defer||,|
|:01/82/050/00447/AM14/|:03/94/040/00094/AM14/|‘19.06.2013|Date:26.11.2014|
|Decision|:|It was decided|to defer the case for 26.11.2014 for comments of|Department of|
|Pharmaceuticals.|
|No.:22/12/82-|Party Name:INDOFIL|Meet No/Date:9/82-|(Status:Deffered|
|ALC4/2013|INDUSTRIES LTD.|ALC4/2014|and Re-indexed|
|70||1HQ File|RLA|File|||20.10.2014Lic.No/Date:03|10738404|‘Defer|;|||
|‘01/82/050/00446/AM14/|—_|:03/94/040/00197/AM14/|[20.06.2013|Date:26.11.2014|
|Decision|:|It was decided to defer the case for 26.11.2014|for comments of|Department of|
|C&PC.|
|(Case No.:19/13/82-|Party Name:BOSTIK INDIA|[Meet No/Date:9/82-|_Status:Deffered|
|ALC42O1L3|PRIVATE LIMITED|ALC4/2014|and Re-indexed|
|20.10.2014|
|||He File|RLA File|Lic.No/Date:0710096186a|{Defer|
|Decision|:|It was decided to call from the firm the following technical|details:|
||71 |:01/82/050/00495/AM14/|:07/24/040/00502/AM13/|25.06.2013|{Date:26.11.2014|
|1, Technical specification % composition (by weight) along with specific end use/application and|

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

Prte wares siRMAL KUMAR Wa Ersoy per aap Dy. Direcwor < vat ot Forasgn Trade fe@tm ox seifiewnera Directorate General of Foreign Trade aiftiwy faxiyvDepartment of Commerce A Prla Nawgs Sat Delhi

»a 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 ofother indigenous input to be used in the manufacture of the export roduct may be indicated . oe gt gs 3. Detailed manufacturing process along with balanced chemical reaction indicating % yield/wastage along with balanced chemical reaction indicating % yield/wastage along with F technical justification for wastage along with technical justification for wastage at each stage an 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 ofraw 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 09.10.2014 Case No.:111/10/82Party NameSTERICAT (Meet No/Date:9/82_[Status:Deffered ALC4/2013 GUTSTRINGS PVT.LTD. |ALC4/2014 and Re-indexed 172 |HQ:01/82/050/00294/AM File 14/ RLA:05/24/040/0009 File 1/AM14/ 25.06.2013Lic.No/Date:05 10358000 |DaPe t e:26.11.2014e Decision : It was decided to defer the case for 26.11.2014 for comments of Department of IPP.

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

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

|||||||
|---|---|---|---|---|---|
|Case No.:203/10/82-|Party Name:SHASUN|Meet No/Date:9/82-|[Status:Deffered|_|
|ALC42013|PHARMACEUTICALS|ALC4/2014|and Re-indexed|
|LIMITED|20.10.2014|;|
|73.,/HQ|File|RLA|File|Lic.No/Date:04 10147556||Defer|
|:01/82/050/00386/AM14/|:04/24/040/00064/AM14/|27.06.2013|Date:26.11.2014|
|Decision|:|It was decided to remind|the firm to|furnish a copy of Master Batch Formula|
|duly certified by Quality Control|Incharge. The case was deferred|for 26.11.2014.|

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

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

||||||||||
|---|---|---|---|---|---|---|---|---|
|{~|[Case No.:204/10/82-|Party Name:SHASUN|Meet No/Date-9/82-|___[Status:Deffered|
|JALC4/2013|PHARMACEUTICALS|ALC4/2014|and|Re-indexed|
|HQ|File|RLA|File|Lie.No/Date:0410147559|[Defer|
|Ps|:01/82/050/00387/AM.|LIMITED|20.10.2014|a|
|Decision|:|:|It was decided to remind the firm to furnish a copy of|Master Batch Formula|
|||14/|PRL|Fi|e006S/AMIA|7.06.2013|Date:26.11.2014|
|duly certified by Quality Control Incharge. The case|was|deferred for 26.1 1.2014.|
|.|
|CHEMICAL WORKS|JALC4/2014|and Re-indexed|
|Lice|[ALC4/2013]|No.:64/13/82-|ee|Name:EAGLE|‘Meet20.10.2014No/Date:9/82-Oke|_[Status:De:De|ff|ered|
|HQ|File|RLA|File|Lic.N|;|
||35(|Re|Fi|SOOI/AMIA|||ic.|No/Date-03 10740489|[Defer|
|OU/S2/0S0/00SAO/AMI4/|_|:03/94/040/00019/AM14/|[05.07.2013|;|Date:26.11.2014|
|Decision|:|It was decided to remind the firm to furnish the following technical|details:|
|Complete technical details as per Appendix 33.|
|Copy of|technical literature in support of|yield envisaged in the process|Oar|ee.|[NIRMA]|[KUMAR]|
|iret|EUS terrae|
|Bie FeTuDe|senor|en|race|
|Udyog Bhawan|Wee|Homi|

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

. past production vis-a-vis Actual consumption of all inputs duly certified by Central Excise

==> picture [529 x 196] intentionally omitted <==

----- Start of picture text ----- Authorities. | The case was deferred for 26.11.2014. Case No.:41/13/82- Party Name:JAGSONPAL Meet No/Date:9/82- Status:Deffered ALC4/2013 HARMACEUTICALS LTD. |ALC4/2014 and Re-indexed 20.10.2014 ; ; HQ i : fer | oFFile so00s1W/AM14/ R aeLA FileOMn0ss/AMI4/ PeeteLic.No/Date:05 10359156 p|D e te 1.2014 Decision : It was decided to remind the firm to furnish the following technical details: 76|1. Copy of valid Drug Manufacturing Licence alonwith list of approved items showing the composition of export product. ; 2. 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%. ----- End of picture text -----

{The case was deferred for 26.11.2014

| Case No.:27/13/82Party Name: ADVY ALC42013 CHEMICAL PVT.LTD. ALC4/2014Meet No/Date:9/82andStatus:Deffered Re-indexed 20.10.2014 77 1HQ:01/82/050/00503/AM File 14/ RLA:03/94/040/00269/AM14/ File Lic10.07.2013 NovDate:0310740827 PeteDate: 12.11.2014 Decision : It was decided to sent a copy of application again to department of [Biotechnology for their comments. The case was deferred for 12.11.2014 . Case No.:44/12/82Party Name:ENCUBE Meet No/Date:9/82Status:Deffered ALC42013 ETHICALS PVT LTD ALC4/2014 and Re-indexed 20.10.2014 ; | JHQ File RLA File Lic.No/Date:03 10740922 |Defer 01/82/050/00468/AM14/ —_—|:03/94/040/00306/AM14/ [10.07.2013 Date:26.11.2014

Decision : Department of Pharmaceuticals, vide their OM No. 3501 1/647/2013-PI(Norms) dated 02.09.2014, have informed that they have examined the reply received from the firm wherein it is mentioned that the input appearing at S.No. 1,8,15,22 and 29 is CETOSTEARYL ALCOHOL | |(Brand Kollwas CSA 50 or any other) because this input is utilized in the manufacture of the |7g [export product (Ref: RG:VC:DGFT:6 dt 14.12.2013. It has been also simultaneously mentioned that the input is correctly mentioned in the Master Batch Formula which was furnished by the firm vide their letter dated 14.12.2013. In the above context, it may be stated that in the Master Batch Formula for Myoflex Cream 10% , 15% and 20% strength, the relevant input is mentioned as CETYL ALCOHOL NF (speziol C16 Pharm) whereas in the firm's letter RG:VC:DGFT:6 dt 14.12.2013, it has been emphasized repeatedly that the said input is actually- CETOSTEARYL ALCOHOL (Brand Kollwas CSA 50 or any other) and that the essential amendment be carried-out in the description of the input while fixing the norms . The request is therefore confusing and the firm may be advised to explain such contradictory statements, which cause delay in the fixation of norms. The firm may also be advised to clarify the actual import description of the said input. The case was deferred for 26.11.2014.

79 Case No.:160/14/82Party Name:ALCHYMARS [Meet No/Date:9/82Status:Deffered - |ALC4/2013 ICM SM PRIVATE LIMITED |ALC4/2014 and Re-indexed [20.10.2014 vmaienaan HUMAR wag wafers Prey Ang, Dy. Direx tor Cenetal of Foreign Trade alfredDigcioratf e ar/DGwn e pr a lrimentot Foreignof Commerce Trade Ue ERS an Now Dethi

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

| fori RLA File [ReNeDate4 10147942et -01/82/050/00745/AM14/ -04/24/040/00050/AM 14/ 11.07.2013 Date:26. 11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals. Case No.:28/13/82- PartyName:RANBAXY Meet No/Date:9/82- Status:Deffered g0 [HQALC4/2013 File LABORATORIESRLA File LTD ooALC4/201420.10.2014 . Peteand Re-indexed :01/82/050/00504/AM14/ -05/24/040/001 14/AM14/ 18.07.2013 Date:26.1 1.2014 Decision : It was decided to defer the case for 26.1 1.2014 for comments of Department of Pharmaceuticals. ----- End of picture text -----

No.:46/14/82Party Name: MYLAN Meet No/Date:9/82Status:Deffered
ALC4/2013 LABORATORIES LIMITED {ALC4/2014 and Re-indexed
Po 20.10.2014 ,
$1 [HQ File RLA File Lic.No/Date:09 10056909 {Defer /01/82/050/0063 V/AM14/ :09/24/040/00185/AM14/ 25.07.2013 Date:26. 11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals.
- Case No.:24/17/82Party Name:SMILAX Meet No/Date:9/82__(Status:Deffered ALC4/2013 LABORATORIES LIMITED |ALC4/2014 and Re-indexed 20.10.2014
- :01/82/050/00886/AM14/ :09/24/040/00180/AM14/ 25.07.2013 Date:26.11.2014
- lke File RLA File Lic. No/Date:09 10056902 \Defer Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals.

Case No.:28/19/82Party Name:SMILAX Meet No/Date:9/82(Status: ALC4/2013 LABORATORIES LIMITED |ALC42014 ApprovedPP 20.10.2014 . :01/82/050/00973/AM14/ :09/24/040/00181/AM14/ 29.07.2013 | He File RLA File Lic.No/Date:09 10056940 (Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/116/2014-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: et S-methyl-243 CE2Akg/kg ; ty trazole2. 2-(N-Tripheny! methyl 1.15 | 5yl)Biphenyl-4-yl)Methyl) tetrazoly)-4-Bromo methyl pentanamido)butanoate biphenyl y | (Valsartan N-2) i Ethyl acetate 2.219 \ |6.___| Dimethyl formamide Jake oypirectorGer ey eeex eqrade te Co et of Commerce mt aa, 74 Dein udayos Bhawan.

==> picture [481 x 250] intentionally omitted <==

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|||||||
|---|---|---|---|---|---|
|A|||7.|NN Diisopropy!|ethylamine|| 0.556|
|r8._[Acetone|ss|«d'0.673|
|RA may take appropriate action as per the decision ofNorms Committee|_|
|Case No.:43/12/82-|Party Name:AMI ORGANICS||Meet No/Date:9/82-||Status:Deffered|
|ALC4/2013|PVT LTD.|ALC4/2014|and Re-indexed|
|20.10.2014|
|84||HQ File|RLA File|Lic.No/Date:52 10040038 Pefe|
|:01/82/050/00467/AM14/|:52/24/040/00015/AM14/|30.07.2013|Date:26.11.2014|
|Decision|:|It was decided to defer the case for 26.11.2014 for comments of Department of|
|C&PC|.|
|Case No.:61/14/82-|Party|Name:|HETERO|Meet No/Date:9/82-|Status:Deffered|
|ALC4/2013|DRUGS LIMITED,|ALC4/2014|and Re-indexed|
|20.10.2014|
|HQ File|RLA File|Lic.No/Date:0910057007||Defer|
|g5|:O1/82/0S0/00646/AM14/|—|:09/24/040/00206/AM14/|—_[02.08.2013|Date:26.11.2014|

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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 of CA certificate furnished by the firm. The case was deferred for 26.11.2014. 7

==> picture [447 x 71] intentionally omitted <==

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||||||||
|---|---|---|---|---|---|---|
|Case No.:22/13/82-|Party Name:PROMED|Meet No/Date:9/82-|Status:Deffered|
|ALC4/2013|EXPORTS PVT.LTD.|ALC4/2014|and Re-indexed|
|20.10.2014|||
|$6||HQ|File|IRLA|File|Lic.No/Date:05 10362268||Defer|
|:01/82/050/00498/AM14/|—_|:05/24/040/00171/AM14/|{07.08.2013|—|[Date:26.11.2014|

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Decision : \t was decided to call from the acopy of Drug Manufacturing Licence for the export product. The case was deferred for 09.10.2014.

==> picture [428 x 70] intentionally omitted <==

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

|||||||
|---|---|---|---|---|---|
|Case No.:20/13/82-|Party|Name:|VARUN|Meet No/Date:9/82-|(Status:|
|ALC42013|MEDIMPEX INC.|ALC4/2014|approved|
|20.10.2014|
|:01/82/050/00496/AM14/|(05/24/040/00134/AM14/|21.08.2013|
|||le File|RLA File|Lic.No/Date:05 10363085|(Defer Date:|

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

Decision : in the light of written comments received from Petrochemical Division of Department of Chemicals and Petrochemicals vide their U.O No. 46011/104/2009-PC- Ii dated 21.10.2014, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by 87 the firm, whichever is less:

Export product SLNo. | Import items Qty. allowed Qty. | Dettol Medicated 1 NO. Woven Dyed Fabric of 100% | 0.001320 Sq. Meter Fabric Plaster Size 19 Texturised Polyester mmx65mm Filament, GSM115 + 10% | Non Woven Rolls , GSM 100 | 0.000315 Sq. Meter + 15% \ Bure SPATS CNUR NAL KUMAR ba Series MRT SAT yDirector (cal of Foreign Trade Diroutoraie Coen ETS eTTETa SRR pi: 1, epartment of Commerce Udyog Bho wan WES Delhi

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

= . .
Case «1 =< 7 ed No.:10/17/85Party Name:BELOOR BAYIR |Meet No/Date:9/82 Status:Deffer
ALC3/2013 BIOTECH LTD, ALC4/2014 and Re-indexed 20.10.2014
88 |HQ:01/85/050/001 File 13/AM14/ RLA:07/24/040/00150/AM14/ File ic22.08.2013 NoDae-07 10097664 PeteDate:26.11.2014 Decision : It was decided to defer the case for 26.10.2014 for comments of Department of Pharmaceuticals. . .
Pharmaceuticals. . . Case No.:47/14/82Party Name: VIVIMED LABS |Meet No/Date:9/82Status: Deffered ALC4/2013 LIMITED ALC4/2014 and Re-indexed 20.10.2014
g9 [HQ:01/82/050/00632/AM14/ File RLA:09/24/040/0025 File 1/AM14/ |Lic.No/Date:0922.08.2013 10057280 PeteDate:26.11.2014 Decision : It was decided to defer the case for 26.10.2014 for comments of Department of Pharmaceuticals. .
Pharmaceuticals. . Case No.:4/4/82-ALC4/2014 Party Name:SHASUN ‘Meet No/Date:9/82Status:Deffered PHARMACEUTICALS ALC4/2014 and Re-indexed LIMITED 20.10.2014
90 |HQ File RLA File Lic.No/Date:0410148932 ‘Defer :01/82/050/00252/AM15/ :04/24/040/00107/AM 14/ 23.08.2013 Date:26.11.2014

Decision : It was decided to remind the firm to furnish a copy of Master Batch Formula duly certified by Quality Control Incharge. The case was deferred for 26.11.2014.

==> picture [449 x 213] intentionally omitted <==

----- Start of picture text ----- Case No.:152/14/82- Party Name:MYLAN Meet No/Date:9/82- _[Status: ALC4/2013 LABORATORIES LIMITED |ALC4/2014 Approved 91 20.10.2014 THQ File RLA File Lic.No/Date:09 10057368 (Defer Date: | :01/82/050/00737/AM14/ 09/24/040/0021 V/AM14/ 27.08.2013 - [Decision : Withdraw as the case was already approved in 7/82 meeting dated 11.09.2014. Case No.:116/14/82- Party Name:UNIJULES LIFE /Meet No/Date:9/82- Status:Deffered ALC42013 SCIENCES LTD. ALC4R014 and Re-indexed RLA File Lic.No/Date:03 10747079 |Defer laa [File] 20.10.2014 9 :01/82/050/0070 I/AM14/ :03/95/040/002 15/AM14/ 27,08.2013 _ Decision fDate:26.1 1.2014 ) : , it was decided to call from the firm following information: MN) Complete description of export product showing the content ofAPI in the injection, and Copy of relevant DML along with the list of approved items. ----- End of picture text -----

The case was deferred for 26.11.2014.

==> picture [556 x 117] intentionally omitted <==

----- Start of picture text ----- :| Case No.:43/16/82- Party Name:-SYMBIOTEC Meet No/Date:9/82- Status:Deffered 93 ALC4/2013 PHARMALAB LTD., ALC4/2014 and Re-indexed | 0.10.2014 [HQ File IRLAFile —~—~—~—~—~—~S~S*«WL GeNoDatex56100027,aoe : ; / eX /NIRMALIKUMAR wiTea learvOepanmentol com eee BM n are, of mmerce Udyog Bhawan, New Delhi ----- End of picture text -----

o) | [:01/82/0S0/00856/AMi4/ [:56/24/040/00017/AM14/__[03.09.2013 — — [Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals.

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||||||
|---|---|---|---|---|
|Case No.:53/14/82-|Party Name:STERILE INDIA||Meet No/Date:9/82-|Status: Deffered|
|ALC4/2013|PRIVATE LIMITED|ALC4/2614|and Re-indexed|
|20.10.2014|
|194 |HQ:01/82/050/00638/AM File|1 4/|RLA:05/24/040/00203/AM14/ File|Lic05.09.2613 NowDate0s10364653 Pete:|Date:26.1 1.2014|
|Decision:|it was decided to call from the firm the complete technical details as per Appendix 33. The|
|case was deferred|for 26.11.2014.|

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|||||||||
|---|---|---|---|---|---|---|---|
|Case No.:2/12/82-|Party|Name:|VIVEK|Meet No/Date:9/82-|Status: Deffered|
|ALC4/2013|PHARMACHEM|(INDIA)|ALC4/2014|and Re-indexed|
|195|}HQ:01/82/050/00426/AM14/ File|IRLALTD.,213/24/040/00022/AM14/ File|410920.10.2614Lic|.|No/Date:09.20 13|13 10044274 PefeDate:26.1;|1.2014|
|Decision:|it was decided to call from the firm the complete technical details as per Appendix 33. The|
|||[Case was|deferred|for 26.11.2014.|
|Case No.:56/14/82-|Party|Name: VIVEK|Meet No/Date:9/82-|_[Status:Deffered|
|ALC42013|IPHARMACHEM (INDIA)|ALC4/2014|and Re-indexed|
|96|JHQ File.|LTD.,RLA File|20.10.2014Lic.No/Date: 1310044273|Defer.|
|‘O1/82/050/0064/AM14/—_|:13/24/040/00021/AM14/|{09.09.2013|_[Date:26.11.2014|
|Decision:|it was decided to call from the firm the complete technical details as per Appendix 33.|
|The case|was deferred|for 26.11.2014.|

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Case No.:11/15/82Party Name:BENZO CHEM [Meet No/Date:9/82[Status:Defferea ALC42013 INDUSTRIES PRIVATE ALC4/2014 and Re-indexed . LIMITED, 20.10.2014
97 |HQ File RLA File Lic.No/Date:03 10749169 [Defer . :01/82/050/00773/AM14/ :03/94/040/00352/AMI14/ 11.09.2013 Date:26.1 1.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals. Case No.:33/16/82. Party Name: HETERO Meet No/Date:9/82_[Status:Deffered ALC4/2013 DRUGS LIMITED, ALC4/2014 and Re-indexed
| fae File RLA File Lic.20.10.2014No/Date:0910057537| (Defer *01/82/050/00846/AM14/ —_|:09/24/040/00278/AM14/ ‘12.09.2013 - |Date:26..11.2014
9g |Decision : It was decided to request the firm to furnish the following information :

product1) Stepwise and % chemicalyield on reactionsmolar basis, showing correct Molecular weight ofeach input reactant & output it) Justification for requirement of imported inputs in view ofCA certificate furnished by the firm.

The case was deferred for 26.11.2014

Pete SK NIRMAL KUMAR SO Fae free enor Dy. Direr tor Generel al Foreign Trade Faree ee cone weretsrrery Dew torte General of Foreign Trade FNSY TTY Department of Commerce Udyog Brean hy SPE,

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||||||||
|---|---|---|---|---|---|---|
|a|
|>|
|Case No.:32/15/82-|Party|Name:KOPRAN|Meet No/Date:9/82:9/82-|Status:|
|i|LIMITED|ALC4/2014|Approved|
|99|ae|ee|0.10.2014|
|TH File|RLA File|Lic.No/Date:03 10749296 [Pee Date:|
|:01/82/050/00794/AM|1 4/|-03/94/040/00487/AM14/|12.09.2013|;|
|||[Decision|: Withdraw as|the case was already approved in 7/82 meeting dated 11.09.2014|
|Case No.:55/4/82-|Party Name:NECTAR|Meet No/Date:9/82-|Status:Deffered|
|ALC4/2014|LIFESCIENCES LIMITED,||ALC4/2014|and Re-indexed|
|100||HQ:01/82/050/00303/AMI5/ File|RLA:22/24/040/00044/AM File|14/|eso20.10.201412.09.2013|en PeteDate:26.1:|1.2014|
|Decision|:|It was decided to defer the case for 26.11.2014|for comments ofDepartment|
|of|Pharmaceuticals.|
|Case No.:63/17/82-|Party|Name:DRREDDYS|(Meet|No/Date:9/82-|__[Status:Deffered|
|ALC4/2013|LABORATORIES LIMITED||ALC4/2014|and Re-indexed|
|20.10.2014|:|
|1101|[HQ:01/82/050/00925/AM14/ File|RLA:09/24/040/0026 File|1/AM14/|Lic.No/Date:0913.09.2013|10057546 eteDate:261 1.2014|
|Decision|:|It was decided to defer the|case|for 26.11.2014|for comments ofDepartment|
|of Pharmaceuticals.|.|7|

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|||||||||
|---|---|---|---|---|---|---|---|
|‘Case No.:35/15/82-|Party Name:KOPRAN|Meet No/Date:9/82-|(Status: Deffered|
|ALC4/2013|LIMITED|ALC4/2014|and Re-indexed|
|20.10.2014|;|
|102||HQ|File|RLA|File|Lic. No/Date:03|10749439|[Defer|
|:01/82/050/00797/AM14/|—_‘|:03/94/040/00472/AM14/|{13.09.2013|———-fDate:26.11.2014|

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Decision: : it was decided to call from the firm the complete technical details as per Appendix 33. The case was deferred for 26.11.2014.

==> picture [450 x 93] intentionally omitted <==

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

|||||||
|---|---|---|---|---|---|
|Case No.:26/4/82-|Party Name:RANBAXY|Meet No/Date:9/82-|Status: Deffered|
|ALC4/2014|LABORATORIES LTD|ALC4?2014|and Re-indexed|
|tos fe:01/82/050/00274/AM File|15/|RLA105/24/040/00212/AM14/ File|Lic.No/Date:0516.09.2013|103656507|[DeferDate:26.11.2014|
|Decision|:|It was decided|to defer the case|for 26.11.2014 for comments of Department|
|of Pharmaceuticals.|

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Case No.:151/14/82Party Name:THING Meet No/Date:9/82Status: Deffered ALC4/2013 PHARMA-CRO LIMITED /|ALC4/2014 and Re-indexed 20.10.2014 os luo:01/82/050/00736/AM File 14/ RLA:03/95/040/00432/AM14/ File Lic.No/Date:0316.09.2013 10749651 |DeferDate:26.11.2014. Decision : It was decided to call from the firm the compl i i t | 33. The case was deferred for 26.11.2014 plete technical details as peersper Appendix SAR /NIRMAL KUM. op ae7 3 ad free sare UN Fo Pre-erperey ° . ye celal of Foreign Trade : cna Wepantmant of Commerce Udyog Bhawan Noe eon

|||Case<br>No.:49/16/82-<br>PartyName:SOFTGEL<br>MeetNo/Date:9/82-_—‘[Status:<br>ALC4/2013<br>HEALTHCAREPVT.LTD., |ALC4/2014<br>Approved<br>20.10.2014<br>:|
|---|---|---|
||||HQFile<br>RLAFile<br>Lis NofDate410149961PeterDate:<br>:01/82/050/00862/AM14/<br>‘:04/24/040/00100/AM14/<br>18.09.2013<br>—_|
|||Decision ; Inthe lightofwrittencommentsreceived from DepartmentofPharmaceuticalsvide<br>theirOMNo. 35011/130/2014-Pi(Norms) dated 09.10.2014, itwas decided toratify thenorms<br>underPara4.7ofHBPv1 asperdetailsgivenbeloworasappliedbythefirm, whichever is less:|
||105||

||||||||$i||
|---|---|---|---|---|---|---|---|---|
||||||||1 No.|273.768mg/400IU|
|]|VITAMIN|ECAPSULES|CAPSULESUSP|USP10001U|10001U||1No.|1No. | 2.|VITAMINEACETATE |©84-42mg/10001U<br>Capsule|

RA may take appropriate action as per the decision ofNorms Committee

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----- Start of picture text ----- Case No.:81/23/82- Party Name:RANBAXY Meet No/Date:9/82- Status: ALC42013 LABORATORIES LTD ALC4/2014 Approved 2010204 HQ File RLA File Lic.No/Date:05 10366184| |Defer Date: :01/82/050/01128/AM14/ :05/24/040/00207/AM 14/ 19.09.2013 theirDecision : In the light of written comments received from Department of Pharmaceuticals7 vide OM No. 35011/150/2014-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: | Export Product S. Import Item Qty. Allowed 10| WalaeySvirFyrochlo Oty fiNo . [acerone forseke/ke (2. [activatep carson fois [3.__[acyclovir" [4 |—«dsa.de2a cazivaue —«ido7sa DICYCLOHEXYL (6. [pmenivi rormamibe —[ a338 CE 0.028 [9 [mernanotCO RA [10.— |T7669pautabnumsponce —~Too05 may take appropriate action as per the decision ofNorms Committee. PHARMACEUTICALS ALC42014 land Re-indexed anie [ALC4/2014] No.:18/4/82- JLIMITEDrea Name:SHASUN 20.10.2014Meet No/Date-9/82- [Status:Deffered lo?| Re012NSO/00266/AM File 15/ LAF:04/24/040/00137/AMolsraMia 14/ Lic.19.09.2601No/Date:04101500923 PesDate:26.11 2014 | Decision :It was decided to call from the firm a copyofMaster Batch Formula duly certified by Quality Control In charge. The case was deferred for 26.1 1.2014. Pris: arma og,OTS: TR Tanwa cfReForeign craneTrade wilereg fauMDepanment of Commace Udyog Bhawan hy 8s Delhi ----- End of picture text -----

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|||||||
|---|---|---|---|---|---|
|“|Case No.:48/16/82-|Party|Name:SOFTGEL|Meet No/Date:9/82-|Status: Deffered|
|ALC4/2013|HEALTH CARE PVT. LTD.,||ALC4/2014|and Re-indexed|
|(20.10.2014|
|108 [HQ:01/82/050/0086 File|1/AM14/|RLA04/24/040/00099/AM14/ File|28.09.2013Lic.No/Date:04 10150142_ Pet|Dat|e|:26.11.2014|
|Decision|:|It was decided to defer the case for 26.11.2014|for comments ofDepartment|
|of Pharmaceuticals|

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||||||||
|---|---|---|---|---|---|---|
|Case No.:48/15/82-|Party Name:SHASUN|Meet No/Date:9/82-|Status:|Deffered|
|.|ALC42013|PHARMACEUTICALS|ALC4/2014|and Re-indexed|
|LIMITED|20.10.2014|
|109 |HQ:01/82/050/00810/AM14/ File|RLA:04/24/040/00128/AM14/ File|23.09.2013FOr|50198|Dae|te|: 10.11.2014r|
|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 26.11.2014,|

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----- Start of picture text ----- Case No.:62/17/82- Party Name:SMILAX Meet No/Date:9/82- Status: Deffered ALC4/2013 LABORATORIES LIMITED |ALC4/2014 land Re-indexed 110 He File RLA File Lic.No/Date:0910057671 [Defer 101/82/050/00924/AM 14/ :09/24/040/00292/AM14/ 24.09.2013 Date:26, 11.2014 Decision: It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals VISRAM & CO.LTD. ALC42014 and Re-indexed ,ive [ALC4/2013] No.:21/19/82- rm Name:GOPALDAS [Mest No/Date:9/83-~[Statuasberforca | i. File RLA File Lic.20.10.2014pNo/Date:0310751325: |Defer, sIO SOOORSSIAM 103/94/040/00502/AM14/ —_ [26.09.2013 Date:26.11.11.2014 reision : it was decided to call from the firm the following technical deiails i } ; Export should be in No. Of Bottles and not in kgs. "8 i . The import item should match the descriptio: iven i Supplier's Brochure. prlon and type given in DML and be Supported by boitle fe ofCod Liver Oil (Type B), Both in quantitative and volumetic term, in each 4. Copy of technical ti i : : ‘ iinet afal ical literature in support ofdensity ofimport item. COA from foreign supplier The case was deferred for 26.11.2014, Case No.:46/17/82- Party Name: ; ie LIMITED meena and Re-indexed Leesovosmmannay REAP ———— Lic NofDate.0i05 —~ :01/82/050/00908/AM14/ :09/24/040/00288/AM14/ bis NeDat09 10057764 Decision peter hoe and : It was decided to call from the firm the complete techni i on (ii) past production vis-avis actual consumption of inputs d real details as per Appendix 33 thority. The case was deferred for 26.11.2014 Puts Suly centfied by Central Excise Bq ia \NIRMAL KUMAR OY Core coe OTR) EST earare Udyoyog Bhawan,. New ain, ----- End of picture text -----

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----- Start of picture text ----- 4 :Deffered .248/17/82- Party Name:INCHEM Meet No/Date:9/82- Status:Deffe ALCAO13 LABORATORIES PRIVATE |ALC4/2014 and Re-indexed LIMITED 20.10.2014 r 13 FEOHO F il monroe R LAO FileEDmomasTiAMIA). bie01.10.2013i nfmae09: 10057 85.|Defer|Date:26.11.2014 Decision : It was decided to call from the firm the 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 26.11.2014 ----- End of picture text -----

Case No.:39/16/82Party Name:SANMAR Meet No/Date:9/82Status:Deffered ALC4/2013 SPECIALITY CHEMICALS j|ALC4/2014 and Re-indexed LIMITED, 20.10.2014 HQ:01/82/050/00852/AM File 14/ RLA104/24/040/00146/AM14/ File Lic03.10.2013Nospae-o4101505 19 peteDate:26.11.2014 Decision : It was decided to remind the firm to furnish the following technical details: 1. Complete set of Application . 2. Details of manufacturing process of4 chlorobutylveratrate 60% solution in Methyl — 114 Ethyl-Ketone with chemical equations, molecular formula, molecular weights.

Yield obtained in each step.
Authentic technical literature in support of yield obtained.
Material balance.
CA certificate certifying the production of export item achieved by firm for the past three years and corresponding consumption of each input.
Detailed calculations, arriving at the norms applied for.

The case was deferred for 26.11.2014

Case No.:26/17/82Party Name:MYLAN Meet No/Date:9/82Status:Deffered ALC42013 LABORATORIES LIMITED |ALC42014 land Re-indexed | HQ File RLA File 20.10.2014Lic. No/Date:09 10057816 [Defer 01/82/0S0/00888/AM14/ —_|:09/24/040/00302/AM14/ [04.10.2013 Date:26.11.2014 Decision : It was decided to call from the firm the following technical details :

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----- Start of picture text ----- 115 i) Molecular weight ofeach 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 . iii) may be furnished in support ofyield, claimed. yeuthorities,procuctin vis-a-vis actual consumption of inputs duly certified by Central Excise The case was deferred for 26.11.2014. PVT.LTD. ALC4/2014 Approved 7ic [ALC4/2013] No.:24/16/82- a Name:S.M.7S.M. HERBALS [Meet No/Date:: 9/82- Status: lie 20.10.2014 | 116 |:01/82/0S0/00837/AM14/ File RLA_|-05/24/040/00232/AM14/ File [ie[08.10.2013 Nerpee510367“e Pefe Date:: Decision : In the light of written comments received fro: ent of their OM No. 35011/51/2014-PI(Norms) dated 24.09 f ent [of][ Pharmaceuticals][ vide] under Para 4.7 ofHBP v1 as per details gi sor as applied be eed {0 ratify the norms . as per s given below or as applied by the firm, pybicheuer im Weasar kumar ----- End of picture text -----

OPsc Leg tmentol Cora oe Udyog Bhawan: s a Cana

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

, 10 On No. kg/kg Deacetayl Baccatin Hl i kg . HPLC Purity NLT 98.5% 10 Deacetyl Baccatin Hi HPLC Purity NMT 95% RA may take appropriate action as per the decision ofNorms Committee. ; Case No.:73/14/82Party Name:MSN Meet No/Date-9/82(Status: ALC4/2013 LABORATORIES PRIVATE |ALC4/2014 Approved _ LIMITED 20.10.2014 fee[File] RLA File Lic.No/Date:09 10057878 |Defer Date:Decision:01/82/050/00658/AM14/: In the light of written:09/24/040/00325/AM14/comments received from09.10.2013Department of Pharmaceuticals: vide their OM No. 35011/48/2014-Pl(Norms) dated 24.09.2014, it was decided to ratify the norms W7 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 ----- EPLERENONE Qty l. Methyl hydrogen -}7alpha -hydroxy | keke1.764 -3- oxopregna -4,9(11) -diene -7 . alpha,21-dicarboxylate,gamma- lactone RA may take appropriate action as per the decision ofNorms Committee. a Case No.:36/17/82- Party Name: MYLAN Meet No/Date:9/82- (Status: ALC42013 LABORATORIES LIMITED |ALC4/2014 Approved 20.10.2014 : HQ File RLA File Lic.No/Date:09 10057877 |Defer Date: :01/82/050/00898/AM14/ —|:09/24/040/00300/AM14/ [09.10.2013 oe Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/101/2014-Pl(Norms) dated 24.09.2014, it was decided to ratify the norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: (R}-9-(2-(Phosphono 1kgOty |1.| Adenine(6 Amino Purine) [1.023ke/kg | | 118 | methoxy) propyl] adenine R-(+}-Propylene Carbonate |0.992 | fo2) PMPA hydrate (or) Dimethy! formamide Intermediate of Tenofovir 4 Diethyl p- 2.531 Toluenesulphonyloxy methyl phosphonate Magnesium Tert Butoxide Aq. Hydrobromic Acid 8.175 | 7. Not required | N-Methyi-2-Pyrrolidone in the process |8.| Methylene dichloride 12.00| RA may take appropriate action as per the decision ofNorms Committee _ UMAR wa Hera feet STAT Dy. Director General of Foreign fae carey AeTTeITSTA Directorate General of Foreign arforeet RenrreuDepartment of COTence yA vlan Now Delhi ----- End of picture text -----

| {Case No.:137/23/82Party Name:MANGALAM __ [Meet No/Date:9/82(Status: Deffered ALC4/2013 DRUGS & ORGANICS ALC4/2014 land Re-indexed File RLA File Lic.No/Date:03 10753231 |Defer fe LIMITED {20.10.2014 119 :01/82/050/01184/AM14/ 303/95/040/00454/AM14/ 11.10.2013 Date:26.11.2014 Decision: it was decided to call from the firm following information: 1) Complete technical details as per Appendix 33. it) Past production vis-a-vis Actual consumption of Inputs for last three years duly certified by Central Excise Authorities. The case was deferred for 26.11.2014. Case No.:37/17/82Party Name:MYLAN Meet No/Date:9/82Status:Deffered ALC4/2013. LABORATORIES LIMITED |ALC4/2014 and Re-indexed | {20.10.2014 HQ:01/82/050/00899/AM14/ File RLA:09/24/040/003 File 16/AM14/ Lic.11.10.2013No/Date:0910057908 ‘|Date:26.11.2014[Defer 120 |Decision : it was decided to call from the firm following information: I) Stepwise % yield on molar basis alongwith copy of technical literature in support of yield envisaged and molar ratio of Diethanolamine, and H) 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.

The case was deferred for 26.11.2014.

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----- Start of picture text ----- Case No,:38/17/82- Party Name:MYLAN Meet No/Date:9/82- Status:Deffered ALC4/2013 LABORATORIES LIMITED |ALC4/2014 land Re-indexed 20.10.2014 HQ File RLA File Lic.No/Date:09 10057914 Defer :01/82/050/00900/AM14/ :09/24/040/00322/AMI14/ 14.10.2013 _ pDate:10.11.2014 4121 Decision : It was decided to call from the firm the following technical details : i) Molecular weight of each input and output product. ii) % Yield on molar basis along with copy oftechnical literature in support of yield envisaged. iii) Past productin vis-a-vis actual consumption of inputs duly certified by Central Excise Authorities. The case was deferred for 26.11.2014. . Case No.:39/17/82- Party Name: ASTRIX Meet No/Date:9/82- Status: ALC4/2013 LABORATORIES LTD., ALC4/2014 Approved 20.10.2014 a HQ File RLA File |Lic.No/Date:09 10057944 Defer Date: :01/824050/00901/AM 14/ :09/24/040/003 12/AM14/ 17.10.2013 ; 122 (Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 3501 1/95/2014-Pl(Norms) dated 24.09.2014, it was decided to ratify the norms. under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Or g/kg pane Ee ee Wh NEVIRAPINE aYS| Oy Cedi tor Gunes al of Foreign Trade feast qqriix Aurresnera Directornie General of Foreign Trade afirsg fmvDepartment of Commerce wart wae, ag fans Udyog Bhawan, New Delhi ----- End of picture text -----

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||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
|”~|
|||(MALONONITRILE ROUTE)|2,|Dichloromethane|5.16|
|||[3|[Methanol————SS~wa5|
|[||Potassium|hydrovide fakes|[se|
|[S|son Piperidine|
|ot|||[6|
|||Trietiyl|amine|(TEA)|[sz]|
|||2-Chloro nicotinic acid|0.902|
|[8|Pyridine|—C«*dtT|CSW|
|19.|__| Cyclopropyiamine|[0s7.|id|
|_|RA|10.[ Dimethyl formamide|(DMF)|
|may take appropriate action as per the decision ofNorms Committee|
|Case No.:22/17/82-|Party Name:ATHENA DRUG||Meet No/Date:9/82-|Status:Deffered|
|ALC4/2013|DELIVERY SOLUTIONS|ALC4/2014|and Re-indexed|
|PRIVATE LIMITED|20.10.2014|
|123 fe File|RLA File|Lic.No/Date:03|10753955|[Defer|
|:01/82/050/00884/AM14/|:03/94/040/00458/AM14/|17.10.2013|Date: 10.11.2014|
|Decision|:|It was|decided|to|call from the|firm|copy of relevant|Drug|Manufacturing|Licence.|
|The case was deferred for 26.11.2014.|

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||||||||
|---|---|---|---|---|---|---|
|||
|||;|.|-|-|_|-|
|Case No.:17/4/82-|Party|Name:NAPROD LIFE||Meet No/Date:9/82-|_[Status:Deffered|
|ALC4/2014|SCIENCES PVT. LTD.|ALC4/2014|and Re-indexed|
|||20.10.2014|
|HQ File|RLA|File|Lic.No/Date:03 10754049||Defera|
|124||:01/82/050/00265/AM15/|| :03/95/040/00563/AM14/_‘|17.10.2013|Date:26.11.2014|
|Decision|:|It was decided|to|call following technical details from the firm viz:-|
|(a)|Complete technical|details as per Appendix-33|
|The|(b) % content of|Buffering Agent in Export Product.|
|case|is deferred|for 26.11.2014,|
|-|
|Case No.:19/4/82-|Party Name:SAVLA|Meet No/Date:9/82-|_|{[Status:Deffered|
|ALC4/2014|CHEMICALS LIMITED|ALC4/2014|jand Re-indexed|
|||20.10.2014|
|125|[HQ File|RLA|File|Lic.No/Date:03 10754070|[Defer|
|:01/82/050/00267/AM15/|—_|:03/95/040/00566/AM14/|[17.10.2013|Date:26.11.2014|
|Decision|:|It was decided|to defer the case|for 26.11.2014|for comments of Department|
|of|C&PC|

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7 Case No.:59/17/82Party Name:IND-SWIFT Meet No/Date:9/82Status: ALC42013 LABORATORIES LTD., ALC42014 Approved ——-(20,10.2014 ee HQ File RLA File Lic,No/Date:22 10014300 .|Defer Date: :01/82/050/0092 1/AM14/ 22/24/040/00050/AM 14/ 21.10.2013 - 126 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 3501 1/36/2014-Pl(Norms) dated 24.09.2014, it was decided to ratify the norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Qty No. g/kg - Atorvastatin Calcium |ikg| 1. | MehtylIsobutyryl Acetate es, MAR Dy, Tire tor Coneral of Foreign Trade foes amine Herreenrera Directorate General of Foreign Trade zaPtred fPrirvDepartment of Commerce wera wer, aE Udyog Bhawan, New Delhi

| , a

| : | 2.__| Beta Alanine }0.100 | | 4, Methyl[3-Ethyl-5-(2-Hydroxy Thiazolium Bromide Ethyl)-45. (4R-Cis)-1,1-Dimethylethy!-60.708 Cyanomethy]-2,2-Dimethy!-1 -2|6.._| Dioxane-4-Acetate (ATS-8 RA Tert. Buty! Methyt Ether may take appropriate action as per the decision of Norms Committee. Case No.: 108/23/82Party Name:SYMBIOTEC [Meet No/Date:9/82Status: ALC4/2013 PHARMALAB LTD., ALC4/2014 Approved 20.10.2014 ; HQ File RLA File Lic.No/Date:5610003035 |Defer Date: :01/82/050/01155/AM14/ :56/24/040/00020/AM14/ 21.10.2013 theirDecision ; In the light of written comments received from Department of Pharmaceuticals; vide 127 OM No. 3501 1/205/2014-PI(Norms) dated 10.10.2014, it was decided to ratify the norms |under Para 4.7 ofHBP vi as per details given below or as applied by the firm, whichever is less: | | Qh kg/kg | : Methylprednisolone Methylprednisoione | 0.86 | Hemisuccinate USP BP/EP/USP | IRA may take appropriate action as per the decision ofNorms Committee Case No.:17/24/82Party Name:EYTAN LABS [Meet No/Date:9/82Status: Deffered ALC42013 LIMITED ALC42014 and Re-indexed 20.10.2014 12 |HQ File RLA File Lic.No/Date:0910057998 |Defer :01/82/050/012 16/AM14/ :09/24/040/00355/AM14/ 24, 10.2013 Date:26.11.201 4 Decision : It was decided to defer the case for 26.11.2014 for comments ofDepartment of Pharmaceuticals

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~~ (Case No.:48/4/82Party Name:MANGALAM [Meet No/Date:9/82[Status:Deffered ALC4/2014 DRUGS & ORGANICS ALC42014 land Re-indexed LIMITED 0.10.2014 129 |HQ File RLA File Lic.No/Date:03 10755274 \Defer :01/82/050/00296/AM15/ :03/95/040/0057 1/AM14/ 24.10.2013 ‘{Date:2611.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals

Case No.:138/23/82Party Name:MIDAS CARE [Meet No/Date:9/82Status:Deffered ALC4/2013 PHARMACEUTICALS PVT |ALC42014 nd Re-indexed LTD 20.10.2014 130 [HQ File IRLA File Lic.No/Date:03 10755504 [Defer :01/82/050/01185/AM14/ | 03/95/040100599/AM Lay 25.10.2613 Date:26.1 1.2014 Decision : It was decided to call from the firm copy of DML (Drug Manufacturin Licence), chiar and copy ofMaster Batch Formula duly authenticated by Quality Control Inchadge “EHC Uaee SAT fee wiz menreerrcra Directorate General of Ferran Trade Ae ee ecu aieri ot Commerce Luyog ender WES Dethi

| :

| __ [deferred for 26.11.2014. | Case No.:3/24/82Party Name:SANZYME LTD [Meet No/Date:9/82Status:Deffered ALC4/2013 ALC4/2014 and Re-indexed 20.10.2014 «4431 le File RLA File Lic.No/Date:0910058014 iDefer :01/82/050/01202/AM14/ :09/24/040/00295/AM 14/ 25.10.2013 ‘{Date:2611.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department ofC&PC Case No.:21/24/82Party Name:SIFLON Meet No/Date:9/82Status: ALC4/2013 DRUGS ALC4/2014 Approved 20.10.2014 HQ File RLA File Lic.No/Date:09 10058067 |Defer Date: :01/82/050/01 220/AM14/ :09/24/040/00338/AM14/ 29.10.2013 theirDecision : In the light of written comments received from Department of Pharmaceuticals; vide. 132 OM No. 3501 1/241/2014-PI(Norms) dated 10.10.2014, 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: | Export Product S. Qty. Allowed | Qh No. kg/kg J CSANTELSODIOM "1 kg [1 [ PaRAcHLORO MMW GYANDE _Toa7

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

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----- Start of picture text ----- Case No.:31/24/82- Party Name:SIFLON Meet No/Date:9/82- Status: ALC4/2613 DRUGS ALC4/2014 Approved HQ | {20.10.2014 File RLA File Lic.No/Date:0910058070.[Defer Date: :01/82/050/01230/AM14/ :09/24/040/00335/AM14/ 29.10.2013 | |Decision : In the light of written comments received from Department of Pharmaceuticals vide 133 their OM No. 3501 1/237/2014-PI(Norms) dated 10.10.2014, it was decided to ratify the norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: | Export Product S. Import Item Qty. Allowed a ty No. ke/ke RA lL a may take appropriate action as per the decision ofNorms Committee. Case No.:37/24/82- Party Name:SIFLON Meet No/Date:9/82- Status: ] ALC4/2013 DRUGS ALC4/2014 Approved . 20.10.2014 134 HQ File RLA File Lic.No/Date:09 10058069 |Defer Date: ; |-01/82/050/01236/AM14/ _|:09/24/040/00336/AM14/ [29.10.2013 | theirDecision : In the light of written comments received from Department of Pharmaceuticals; vide OM No. 3501 1/244/2014-PI(Norms) dated 10.10.2014, 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, which ris dass AR afiiay faHruDepanment of Commerce Een ioe Deins ----- End of picture text -----

| | | | |

| | || | :

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----- Start of picture text ----- Export Product Ss. Qty. Allowed covmouny Qty No. kg/kg | NO T'1kg [1 | pata cHtoro neavi cramps [oa RA may take appropriate action as per the decision ofNorms Committee. : ALC4/2013Case No.:36/19/82- ORGANICSParty Name:SOHAM PVT LTD ALC4/2014[Meet No/Date:9/82- [Status:Defferedland Re-indexed 1135 20.10.2014 J |HQ File RLA File Lic.No/Date:3 :01/82/050/0098 1 10060943 [Defer Decision 1/AM14/ 3 1/83/040/00124/AM 14/ 29.10.2013 Date:26.11 2014 33. : It was decided to call from the firm the complete technical details as per Appendix The case was deferred for 26.11.2014. ----- End of picture text -----

[ ~ [Case No.:78/23/82Party Name:AMI Meet No/Date:9/82(Status: Deffered ALC4/2013 ORGANICS PVT LTD. ALC4/2014 and Re-indexed 20.10.2014 136 HQ File RLA File Lic.No/Date:52 10040368 [Defer . FO1/82/0S0/0112S/AM14/ _|:52/24/040/00031/AM14/ [31.10.2013 __[Date:26.11.2014 Decision : It was decided to remind the firm to furnish following technical details: 1. Details of manufacturing process with chemical equations, molecular formula, molecular weight. 2. Yield obtained in each step supported with authentic technical literature. 3. Collaborators guaranteed norms. 4. Detailed calculation of arriving at the norms. The case was deferred for 26.1 1.2014,

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----- Start of picture text ----- Case No.:34/24/82- Party Name:HETERO LABS [Meet No/Date:9/82- Status: ALC4/2013 LIMITED ALC4/2014 Approved ee 20.10.2014 ;: HQ File RLA File Lic.No/Date:0910058148 |Defer Date: :01/82/050/01233/AM14/ :09/24/040/00378/AM14/ 05.11.2013 Decision : In the light of written comments received from Department of Pharmaceuticalsa vide their OM No. 3501 1/226/2014-PI(Norms) dated 21.10.2014, it was decided to ratify the norms under Para 4.7 ofHBP v1 as per details given below or as applied by the firm, whichever is less: 137 | Export Product Ss. Qty. Allowed LOSARTAN Oty No. g/kg POTASSIUM lkg 2-Butyl-4-chloro-5-formyl imidazole | 4-Bromo methyl-2-cyano biphenyl Sodium borohydride a 5.[6.__||«dSMethanol SCSC*S RA N-methyl pyrrolidone [0.769 may take appropriate action as per the decision ofNorms Committee. : Case No.:4/22/82- Party Name: VINDHYA Meet No/Date:9/82- Status: 138 ALC4/2013 ORGANICS PVT LTD JALC4/2014 Approved 20.10.2014 | [HQ File IRLA File [Lic.No/Date:0910058 16h DeferDatesRMal|. KUMAR Dy. Director General of Foreign Trade faea marae wereerera afteruayog [fPUOeparinent] Bhawan esof Commerce Delhi ----- End of picture text -----

| [:01/82/050/01047/AM14/ (:09/24/040/00279/AM14/ (06.1 1.2013 | [Decision : Withdraw as the case was already approved in 7/82 meeting dated: 11.09.2014 Case No.:19/24/82Party Name:SMILAX Meet No/Date:9/82_[Status:Deffered ALC4/2013 LABORATORIES LIMITED |ALC4/2014 and Re-indexed 20.10.2614 139 |HQ File RLA File Lic.No/Date:09 10058170 |Defer :01/82/050/012 18/AM14/ :09/24/040/00382/AM 14/ 08.11.2013 Date:26.11.2014 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.:29/24/82- Party Name:ATGC Meet No/Date:9/82- Status:Deffered | ALC4/2013. BIOTECH PVT LTD ALC4/2014 and Re-indexed | . 20.10.2014 . . ! 1140 |HQ File RLA File Lic.No/Date:09 10058222 iDefer | :01/82/050/01228/AM14/ :09/24/040/00275/AM14/ 13.11.2013 Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department | of Pharmaceuticals ; ; ----- End of picture text -----

Case No.:16/24/82Party Name:GLAND Meet No/Date:9/82Status: Deffered ALC4/2013 PHARMA LIMITED ALC4/2014 and Re-indexed 20.10.2014 . .
141 |HQ File RLA File Lic.No/Date:09 10058218 |Defer :01/82/050/01215/AM14/ :09/24/040/00385/AM 14/ 13.11.2013 Date:26.11.2014
| |Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals
[~ [Case No.:26724/82~ Party Name:GLAND [Meet No/Date-9/82-___|Status:Deffered ALC4/2013 PHARMA LIMITED ALC4/2014 and Re-indexed 20.10.2014
142 [HQ File RLA File Lic. No/Date:09 10058221 [Defer :01/82/050/01225/AM14/ :09/24/040/00392/AM14/ {13.11.2013 Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments ofDepartment of Pharmaceuticals . .

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----- Start of picture text ----- Case No.:25/4/82- Party Name:S VCHEM (Meet No/Date-9/82- (Status: ALC42014 INTERMEDIATES PLTD /ALC4/2014 Approved 20.10.2014 - . HQ File RLA File Lic.No/Date:04 10151914 |Defer Date: :01/82/050/00273/AMIi5/ :04/24/040/00176/AM 14/ 14.11.2013 Decision : In the light of written comments received from Department of Chemicals and 143 |Petrochemicals vide their U.O No. 14010/41/2012-Ch li dated 19.08.2014, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: ----- End of picture text -----

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----- Start of picture text ----- Export product Exp. Qty. |SiNo.|Importitems‘| Qty. allowed ca) Oy Dicey ee re roy SUMAR oye clare er peae Tae Udyog Bnew ee feenmerce New Dethi ----- End of picture text -----

| | | | : | , | : | :

Aa || PURITY a[may][take] > 99%[appropriate][action][ as][ per] es[ the][decision][of][ Norms][Cornmittee.] | [Case No.:28/24/82‘Party Name:PORUS Meet No/Date:9/82-—_‘|Status:Deffered |ALC4/2013 ‘LABORATORIES PVT ALC4/2014 and Re-indexed | LTD. 20.10.2014 14 HO File RLA File Lic.No/Date:09 10058239 |Defer 1:0 1/82/050/01227/AM | 4/ 1:09/24/040/00396/AM 14/ 18.11.2013 Date:26.11.2014

/ 'Case No.:40/19/82‘Party Name:INDO PHYTO [Meet No/Date:9/82_—{Status: |ALC4/2013 (CHEMICALS PVT LTD ALC4/2014 Approved _ 20.10.2014 HQ File IRLA File Lic.No/Date:05 10371304 |Defer Date: — :01/82/050/009835/AM14/ :05/23/040/00334/AM14/ 20.11.2013 | Decision : In the light of written comments received ftom Department of Pharmaceuticals vide their OM No. 35011/166/2014-PI{Norms) dated 09.10.2014, it was decided to ratify the norms under Para 4.7 of 145 HBP v1 as per details given below or as applied by the firm, whichever is less: | | Export Product Export | S. Import Item Qty. Allowed P| ¢, No. ke/ke | [Fesecne Enanthate ikg Etherified AD ums TUE Intermediate _ IRA may take appropriate action as per the decision of Norms Committee. [CaseNo.:13/24/82-—=—=«[PartyNameSATYA [Meet No/Date:9/82-—[Status: - , jALC4/2013 iDEEPTHA ALC4/2014 Approved | PHARMACEUTICALS LTD [20.10.2014 | {HQ File iIRLA File lLic.No/Date:09 10058278 (Defer Date: —- :01/82/050/01212/AM14/ ——|:09/24/040/00408/AM14/ l2 1.11.2013 [Decision : Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/238/2014-Pi(Norms) dated 10.10.2014 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:-

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

||||
|---|---|---|
||5| ISOPROPYL ALCOHOL|
|L(*)TARTARIC ACID|__||[123]]|

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

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

Case No.:74/23/82Party Name:SWISS Meet No/Date:9/82Status: Deffered ALC4/2013 EXPORTS PVT. LTD. ALC4/2014 and Re-indexed 20.10.2014
147 [HQ File RLA File , Lic.No/Date:08 10126591 1[Defer 7 :01/82/050/01121/AM14/ :08/24/040/0035 1/AM14/ 21.11.2013 Date:26.11.2014 Decision : It was decided to call from the firm to furnish the copy of DML (Drug Manufacturing Licence). The case was deferred for 26.11.2014.
Case No.:140/23/82Party Name:UNITED Meet No/Date:9/82(Status: Deffered ALC4/2013 PHOSPHORUS LTD. ALC4/2014 and Re-indexed 20.10.2014
148 |HQ File RLA File Lic.No/Date:03 10758627 [Defer :01/82/050/01187/AM14/ :03/95/040/00495/AM14/ 21.11.2013 |Date:26.11.2014 Decision : It was decided to defer the case for 10.11.2014 for comments of Department of C&PC.
.
Case No.:101/23/82Party Name:ACEBRIGHT _|Meet No/Date:9/82Status:Deffered ALC42013 (INDIA) PHARMA PVT ALC4/2014 and Re-indexed LTD, 20.10.2014
149 [HQ File RLA File Lic.No/Date:07 10099923 [Defer :01/82/050/01148/AM14/ :07/24/040/00269/AM 14/ 25.11.2013 Date:26.11.2014
| Decision : It was decided to call from the firm the complete technical details as per Appendix 33. The case was deferred for 26.11.2014,
Case No.:20/24/82Party Name:GLAND Meet No/Date:9/82_[Status:Deffered ALC42013 PHARMA LIMITED ALC42014 and Re-indexed 20.10.2014
150./HQ File RLA File Lic.No/Date:09 100583 10 [Defer :01/82/050/01219/AM14/ :09/24/040/00405/AM 14/ 25.11.2013 Date:26.11.2014 Decision : It was decided to defer the case for 26.1 1.2014 for comments ofDepartment
jof Pharmaceuticals .
Case No.:11/24/82Party Name:GLAND Meet No/Date:9/82Status:Deffered ALC4/2013 HARMA, LIMITED ALC4/2014 and Re-indexed 20.10.2014
151 [HQ:01/82/050/01210/AM14/ File RLA:09/24/040/00420/AM File 14/ 26.11.2013Lic.No/Date:09 10058351 DeDa te r:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals
[152 [Case No.:32/24/82|Party Name:GLAND [Meet No/Date:9/82- Pra tapaTD[:] he Dy Director General redeof Foren;n Berde for mig werrevirerst
Directorate General of Foreign Trade apr fervDepartment of Commuce Udyog Bnewan Nos Delhi

ALC4/2013 ) PHARMA LIMITED ALC4/2014 and Re-indexed 20.10.2014 HQ File RLA File Lic.No/Date:09 10058353 |Defer :01/82/050/0123 1/AM14/ :09/24/040/00417/AM14/ 26.11.2013 Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals.

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|||||||||
|---|---|---|---|---|---|---|---|
|Case No.:129/23/82-|Party Name:HETERO LABS||Meet No/Date:9/82-|Status:|
|ALC4/2013|LIMITED|ALC4/2014|Approved|
|20.10.2014|
|HQ File|RLA File|Lic.No/Date:0910058346||Defer Date:|
|:01/82/050/01176/AM14/|:09/24/040/0042 1/AM14/|26.11.2013|
|Decision|:|In the|light of written comments received|from|Department of Pharmaceuticals vide|
|their OM No.|3501 1/207/2014-Pl(Norms)|dated|21.10.2014,|it was decided|to|ratify|the norms|
|under Para 4.7 ofHBP v1|as per details given below or as applied by the firm, whichever is less:|
|153|T Export Product|S.|Qty. Allowed|
|||Oty|No.|ke/kg|
|||CILOSTAZOL|lkg||1.| 4-Amino Phenol|0.59|
|3.|Dimety!|Sulfoxide|[1.90|||
|5-(4-Chlorobutyl)-1-Cyclohexy!-|10.88|
|1H-tetrazole|
|||
|||Dimethyl Formamide|[216|||

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

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|||||||
|---|---|---|---|---|---|
|Case No.:54/4/82-|Party|Name:NECTAR|Meet No/Date:9/82-|Status:Deffered|
|ALC42014|LIFESCIENCES LIMITED,||ALC4/2014|and Re-indexed|
|||20.10.2014|
|154|[HQ File|RLA File|Lic.No/Date:2210014403|[Defer|a|
|0|1/82/050/00302/AM|15/|:22/24/040/00062/AM14/|27.11.2013|Date:26.11.2014|

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Decision : It was decided to defer the case for 26.11.2014 for comments ofDepartment of Pharmaceuticals.

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Case No.:77/23/82Party Name:SHASUN Meet No/Date:9/82_|Status:Deffered ALC4/2013 PHARMACEUTICALS ALC4/2014 and Re-indexed LIMITED 20.10.2014
155 [HQ File RLA File |Lic.No/Date:04
:01/82/050/01124/AM14/ 10152258 [Defer Decision :04/24/040/00183/AM14/ 27.11.2013 Date:26.1 1.2014 duly : It was decided to remind the firm to furnish a copy of Master Batch Formula certified by Quality Control Incharge. The case was deferred for 26.1 1.2014.

Case No.:94/23/82Party Name:DHANUKA |Meet No/Date:9/82Status: Deffered ALC4/2013 LABORATORIES LTD. ALC4/2014 and Re-indexed 156 20.10.2014 | . fg File RLA File Lic.No/Date:05 10372219 [Defer | :01/82/050/01141/AM14/ *05/23/040/00342/AM 14/ 28.11.2013 Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments ofDepartment Sae7NIRMAL KUMAR wy seas fee cara Oy. Director General of Foreign Trade freer anor servic Directorate General of Fer.: ; iu aitreg fryvDepenment o! Gominene Udyog iia iad | fe '

| | |

: | )| ,| ,| i |

| of Pharmaceuticals

7 | Case No.:104/23/82Party Name:PCL OIL & Meet No/Date:9/82Status: Deffered ALC4/2013 SOLVENTS LTD., ALC4/2014 and Re-indexed 157 [HQ File RLA File 20.10.2014 a . O1/82/0SO/011SVAM14/ |Lic.No/Date:05 10372321 [Defer —_|:05/24/040/00201/AM14/ {29.11.2013 Decision _— [Date:26.11.2014 of C&PC.: It was decided to defer the case for 26.11.2014 for comments ofDepartment

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----- Start of picture text ----- Case No.:8/24/82- Party Name:SUVEN LIFE Meet No/Date:9/82- Status:Deffered ALC4/2013 SCIENCES LIMITED ALC4/2014 and Re-indexed 20.10.2014 158 |HQ File RLA File Lic.No/Date:0910058405 |Defer :01/82/050/01207/AM14/ :09/24/040/00356/AM14/ 29.11.2013 Date:26.1 1.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals [Case No.:148/23/82- Party Name:CTX Meet No/Date:9/82- (Status: | ALC4/2013a LIFESCIENCES PVT LTD,(20.10.2014jALC4/2014 Approved HQ File RLA File Lic.No/Date:03 10760166 (Defer Date: . 301/82/050/01195/AM14/ :03/94/040/00598/AM14/ 02.12.2013 Decision : Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 3501 1/206/2014-PI(Norms) dated 21.10.2014 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:- 159] Export product Import items Qty. Allowed biphenyl | IRBESARTAN 2-Cyano-4-bromomenthy! Kalka [2 | Potassium Carbonate [2.09 2-n-butyl-1 ,3-diazospiro 0.88 4,4]non-4-ene HCL ! 4 | TriEthylAmineHCL —s«0.89SSCSC~S 5 | Sodium Azide —=~iOACSCSC”’ : (6 | SodiumNitite___———~«~drOaB [8 | EthylActivatedAcetateCarbon «i1289 [.100—S—CS™S] | RA concerned may take further necessary action as per above decision of NC. ----- End of picture text -----

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----- Start of picture text ----- Case No.:113/23/82- [Party Name: MARCK Meet No/Date:9/82- (Status: 160}ALC4/2013 BIOSCIENCES LTD. 20.10.ALC4/ 20 1414 Approved HQ File RLA File Lic.No/Date:08 10126809. [Defer Date:MAL R :01/82/050/01160/AM14/ :08/24/040/00385/AM14/ 02.12.2013 _ verre icrisal |pusinal Directorate General cbse bea de apftreg RAPVDeparinieey ee Udyog Bhawan, New Delt ----- End of picture text -----

| |

Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/1 95/2014-Pl(Norms) dated 21.10.2014, it was decided to Tatify the norms under Para 4.7 ofHBP v1 as per details given below or as applied by the firm, whichever is less: | Export Product Ss. Import Item Qty. Allowed 1 Oty No. kg/kg anSODIUM HYALURONATE oe . RA may take appropriate action as per the decision ofNorms Committee. . Case No.:147/23/82. Party Name:AGIO Meet No/Date:9/82(Status: 1 ALC4/2013|. PHARMACEUTICALS LTD(20.10.2014|ALC4/2014 Approved HQ File RLA File Lic. No/Date:03 10760371 |Defer Date:. ‘O1/82/050/01194/AM14/ _|:03/94/040/0070S/AM14/ [03.12.2013 theirDecision : In the tight of written comments received from Department of Pharmaceuticals. . vide OM No. 35011/1 54/2014-Pl(Norms) dated 09.10.2014, it was decided to ratify the norms 16] under Para 4.7 ofHBP v1 as per details given below or as applied by the firm, whichever is less: | Export Product 8. Import Item Qty. Allowed Qty No. ALS: [Febaz Forte Suspension (1000 mi f 5.10 gm/bottle Bendaz Super 50 Suspension ( ‘ 25.5 gm/bottle RA may take appropriate action as per the decision ofNorms Committee.

Case No.:150/23/82Party Name:AGIO Meet No/Date:9/82(Status: ALC4/2013 PHARMACEUTICALS LTD |ALC4/2014 Approved . ee 20.10.2014 HQ File IRLA File Lic.No/Date:03 10760378 |Defer Date: . {| $01/82/050/01197/AM14/ —|:03/94/040/00706/AM14/—_{03.12.2013 theirDecision : In the light of written comments received from Department of Pharmaceuticals vide. OM No. 35011/ 154/2014-Pl(Norms) dated 09.10.2014, it was decided to ratify the norms 162 under Para 4.7 ofHBP v1 as per details given below or as applied by the firm, whichever is less:

, Export Product 8. Import Item Qty. Allowed | OD No. g/kg pemerraie P| [naoaee [Se Bendaz Super 50 Suspension ( f 25.5 gm/bottle 1000 ml Bottie) ie PRAZIQUANTEL RA may take appropriate action as per the decision ofNorms Committee.

163 Case No.:112/23/82Party Name:CADILA Meet No/Date:9/82Status: Deffered ALC4/2013 HEALTHCARE LTD., ALC4/2614 and Re-indexed Mar wy sesieere fleet eae Dy. Director General of Foreicn Trade feat anra~ werhreaxzirera Directorate General of Foreign Trade afore FETUDepartment af Cres ie Udyog Bhawan. New Deni

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----- Start of picture text ----- [ | [20.10.2014 [ HQ File RLA File Lic.No/Date:08 10126887 [Defer 01/82/050/01159/AM14/ —_|:08/24/040/00387/AM14/ {04.12.2013 Date:10.11.2014 Decision : It was decided to call following technical details from the firm:- ----- End of picture text -----

i) Complete technical details as per Appendix-33 for the manufacture of Duloxetine Hel. it) Past production of API vis-a-vis actual consumption of its raw materials duly certified by Central Excise Authorities . The case is deferred for 26.11.2014.

Case No.:66/3/82Party Name:GLAND Meet No/Date:9/82Status:Deffered | ALC4/2014 PHARMA LIMITED ALC4/2014 ‘jand Re-indexed : 164 [HQ File RLA File 20.10.2014Lic.No/Date:0910058454 [Defer. :01/82/050/00070/AMI5/ —_|:09/24/040/00422/AM14/ {04.12.2013 Date:10.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals

Case No.:116/23/82Party Name:ALCHEM Meet No/Date:9/82_[Status:Deffered ALC4/2013 INTERNATIONAL LTD. ALC42014 and Re-indexed 20.10.2014
165 [HQ File RLA File Lic. No/Date:05 10372635 (Defer . 101/82/050/01163/AM14/ —_—|:05/23/040/00341/AM14/ [05.12.2013 Date:10.11.2014 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.:18/23/82- Party Name:NAPROD LIFE [Meet No/Date:9/82- _[Status:Deffered ALC4/2013 SCIENCES PVT. LTD. ALC4/2014 and Re-indexed HQ File- RLA File 20.10.2014Lic.No/Date:03 10760768 |Defer ; 166 :01/82/050/01065/AM14/ :03/9$/040/007 12/AM14/ 05.12.2013 Date:26.11.2014 ----- End of picture text -----

Decision : It was decided to call following technical details from the firm viz:(c) Complete technical details as per Appendix-33 . (d) % content of Buffering Agent in Export Product. The case is deferred for 26.11.2014.

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----- Start of picture text ----- Case No.:138/3/82- Party Name:AUROBINDO _—sMeet No/Date:9/82- Status:Deffered ALC4/2014 PHARMA LIMITED ALC4/2014 and Re-indexed 20.10.2014 167 |HQ File RLA File Lic.No/Date:09 10058481. [Defer ; :01/82/050/00142/AM15/ :09/24/040/00424/AM 14/ 06.12.2013 Date: 10.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments ofDepartment | |of Pharmaceuticals. 168 Case No.:146/23/82- Party Name:CHIRAG Meet No/Date:9/82- Status:Deffered |ALC4/2013 ENTERPRISE ALC4/2014 and Re-indexed 29.10.2014 Prter gm RATATAT NRA Dy. Cine. oe Trede MPP ties Oeporment of Commerce Layee Brean eee a) ----- End of picture text -----

| |

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HQ File RLA File Lic.No/Date:24 10040396 [Defer :01/82/050/01 193/AM14/ :24/24/040/00022/AM14/ 06.12.2013 Date:26.11.2014 Decision : It was decided to defer the case for 26.1 1.2014 for comments of Petro chemical Division of Department of C&PC. . . .

Case No.:120/3/82|Party Name:INCHEM Meet No/Date:9/82Status:Deffered ALC4/2014 LABORATORIES PRIVATE |ALC4/2014 and Re-indexed LIMITED 00.10.2014
169 |HQ File RLA File Lic.No/Date:09 10058483 |Defer :01/82/050/00 124/AM15/ :09/24/040/00416/AM14/ 06.12.2013 Decision _ fDate:26.11.2014 of Pharmaceuticals: It was decided to defer the case for 26.11.2014 for comments of Department Case No.:115/3/82Party Name:NECTAR Meet No/Date:9/82(Status: Deffered ALC42014 LIFESCIENCES LIMITED, |ALC4/2014 and Re-indexed 0.10.2014
170 |HQ File RLA File Lic.No/Date:22 10014426 |Defer :01/82/050/00119/AM15/ :22/24/040/00068/AM14/ 06.12.2013 Date:260,11.2014 Decision ; It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals
a
” [Case No.:4/5/82-ALC42014 [Panty NameSHASUN Meet No/Date:9/82_[Status:Deffered PHARMACEUTICALS ALC4/2014 and Re-indexed
. LIMITED 20.10.2014 171 |HQ File RUA File Lic.No/Date:04 10152693 |Defer :01/82/050/00321/AM15/ :04/24/040/00198/AM14/ 06.12.2013 Date:26.11 2014 Decision : It was decided to remind the firm to furnish a copy of Master Batch Formula duly certified by Quality Control Incharge. The case was deferred for 26.11.2014.

Case No.:47/4/82Party Name: VISION DRUGS [Meet No/Date:9/82Status: Deffered ALC4/2014 PVT LTD ALC42014 and Re-indexed 20.10.2014 172 [HQ File RLA File Lic.No/Date:0910058477 [Defer . :01/82/050/00295/AM15/ :09/24/040/00433/AM14/ 06.12.2013 Date:26.11.2014

Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals

Case No.:96/23/82Party Name:MOREPEN [Meet No/Date:9/82(Status: Deffered ALC4/2013 LABORATORIES LTD., ALC4/2014 and Re-indexed | 20.10.2014 173 [HQ File RLA File Lic.No/Date:05 10372885 [Defer | :01/82/050/01143/AM1 4/ :05/24/040/003 13/AM14/ 09.12.2013 Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals . 174 Case No.:95/23/82Party Name:JAGSONPAL Meet No/Date:9/82Status: | \ |ALC4/2013 PHARMACEUTICALS LTD. |ALC4/2014 JApproved, an,atl } bens 20.10.2014 eG aratrereren frend VN DyeesDirecto waorrev™aa! : qa RAT UOCPOT eee Uae brewan, New bent

| | :

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HQ File RLA File Lic.No/Date:05 10373220 |Defer Date: :01/82/050/01142/AM14/ :05/23/040/00368/AM14/ 11.12.2013

Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/197/2014-PI(Norms) dated 21.10.2014, it was decided to ratify the norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: | Export Product Qt; Ss.No. Qty. Allowed i a ac Misoprostol Tablets |__|2. | Misoprostol_—_| 204 mcg/200 meg tablet
_{RA may take appropriate action as per the decision of Norms Committee. Case No.:137/3/82Party Name:SUVEN LIFE [Meet No/Date:9/82(Status: Deffered ALC42014 SCIENCES LIMITED ALC4/2014 and Re-indexed 20.10.2014
175 [HQ File RLA File Lic.No/Date:09 10058555 (Defer :01/82/050/00141/AM15/ :09/24/040/00427/AM14/ 11.12.2013 Date:26.11.2014 Decision : : It was decided to defer the case for 26.11.2014 for comments ofDepartment of Pharmaceuticals
Case No.:141/3/82Party Name:COVALENT [Meet No/Date:9/82(Status: Deffered ALC42014 LABORATORIES PRIVATE |ALC4/2014 and Re-indexed LIMITED 20.10.2014
176 }HQ File RLA File Lic.No/Date:09 10058567 [Defer :01/82/050/00145/AM15/ :09/24/040/004 18/AM14/ 12.12.2013 _ fDate:26.11.2014
ofDecisionPharmaceu: I t wasicals decided to defer the case for 26.11.2014 for comments ofDepartment |
Case No.:9/23/82Party Name:NAWAL Meet No/Date:9/82Status: Deffered ALC4/2013 PRAKASH AVIKEM ALC4/2014 and Re-indexed . PVT.LTD., 20.10.2014
HQ File RLA File Lic,No/Date:03 10761637 |Defer :01/82/050/01056/AM14/ :03/95/040/00434/AM 14/ 12.12.2013 Date:26.11.2014 Decision : It was decided to remind the firm to furnish the following information: 1. 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
17 furnished along with the copy of the export order. 2. Details and quantity of other indigenous inputs to be used in the manufacture ofthe export product may be indicated.
1. Detailed manufacturing process along with justification for wastages at each stage and also on each of the raw material may be furnished.
1. Complete material balance indicating input and output material at each stage of manufacturing process.
1. Standard /Authentic technical literature in support of the raw material requirement formulation for the manufacture of export product.
1. You have applied for the import ofaluminium foil/sheets as 1.30 kg/kg- content in,the. wv awe arrerer ; * se ad0
oe on ue caol Commerce aut? a at ag BeBe uayog BRawear

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 ofAluminium foil/sheets may be furnished for the year 2012-13 and 2013-14.
7, 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 commencement of production may be furnished duly certified by CA.
Any other relevant information.

The case was deferred for 26.11.2014.

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----- Start of picture text ----- ~ [Case No.1115/23/82- [Party Name:ALCHEM Meet No/Date:9/82- (Status: Deffered ALC4/2013 INTERNATIONAL LTD. ALC4/2014 and Re-indexed 20.10.2014 7 HQ File RLA File Lic.No/Date:05 10373480 [Defer :01/82/050/01162/AM14/ :05/23/040/00365/AM14/ 13.12.2013 Date:26.11.2014 ----- End of picture text -----

178 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. (b) Content of other bye-products in the seeds, their % recovery and value. (c)(d) CopyPast ofproductiontechnical literatureof Vinpocetine in supportvis-avis of (a)Actual and (b).consumption of imported seeds for last 3 years duly certified by Central Excise Authorities.
The case is deferred for 26.11.2014.

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----- Start of picture text ----- Case No.:139/3/82- Party Name:SMILAX Meet No/Date:9/82- Status:Deffered ALC4/2014 LABORATORIES LIMITED |ALC4/2014 and Re-indexed ; 20.10.2014 fo | 1179 |HQ File RLA File Lic.No/Date:0910058595 Defer | |:01/82/050/00143/AM15/ —_|:09/24/040/00441/AM14/ {13.12.2013 Date:26.11.2014 | |Decision : It was decided to defer the case for 26.11.2014 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:9/82- |Status:Deffered ALC4/2013 PHARMACHEM LTD, ALC4/2014 and Re-indexed 20.10.2014 a - 180 |HQ File RLA File Lic.No/Date:34 10038734 [Defer 01/82/0S0/01130/AM14/ —:34/24/040/00231/AM14/_—([16.12.2013 Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments ofDepartment ofC&PC . ----- End of picture text -----

Case No.:7/18/82Party Name:SWISS Meet No/Date:9/82Status: Deffered 181 ALC4/2013 EXPORTS PVT. LTD. ALC4/2014 and Re-indexed 20.10.2014 | [HQFile IRLA File [Lic.No/Date:08 101274284DeferNinmaL kph» Dy Dr or Gece of Foreign 1 oo. ro Uemeral of Foreign | PH vDepartment of con . Uuyeg Bhan ee Ben

| :

| :01/82/050/00942/AM14/ :08/24/040/00400/AM14/ [16.12.2013 [Date:26.11.2014 | Decision : It was decided to defer the case for 26.1 1.2014 for comments of Department lof Pharmaceuticals

Case No.:33/3/82Party Name: HETERO Meet No/Date:9/82Status:Deffered ALC4/2014 DRUGS LIMITED, ALC4/2014 and Re-indexed . 20.10.2014 182 [HQ File RLA File Lic.No/Date:0910058622to(Defer 01/82/050/00037/AM15/|:09/24/040/00466/AM14/ 17.12.2013 Decision *** |Date:26.11.2014 of : It was decided to defer the case for 26.1 1.2014 for comments of Department Pharmaceuticals ; Case No.:119/3/82Party Name:HETERO LABS {Meet No/Date:9/82Status: Deffered ALC4/2014 LIMITED 4JALC4/2014 and Re-indexed 183 JHQ File RLA File Lic.No/Date:09 10058620 [Defer :01/82/056/00123/AM15/ :09/24/040/00470/AM14/ 17.12.2013 — Decision [Date:26.1 1.2014 of : It was decided to defer the case for 26.11.2014 for comments ofDepartment Pharmaceuticals Case No.:98/3/82Party Name:VIVIMED Meet No/Date:9/82(Status:Deffered ALC426014 LABS LIMITED JALC4/2014 and Re-Indexed 20.10.2014 184 |HQ File RLA File Lic.No/Date:09 10058626 |Defer . :01/82/050/00102/AM15/ —|:09/24/040/00448/AM14/__117.12.2013 |Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals Case No.:39/23/82Party Name:AARTI Meet No/Date:9/82[Status:Deffered ALC4/2013 INDUSTRIES LIMITED ALC4/2014 and Re-indexed 185 [HQ File RLA File (20.10.2014Lic.No/Date:03 10762301| [Defer | 01/82/050/01086/AM14/ —|:03/94/040/00760/AM14/ [18.12.2013 Date:26.11.2014 [Decision : It was decided to defer the case for 26.11.2014 for comments ofDepartment ofPharmaceuticals . . Case No.:87/23/82Party Name:INDO PHYTO [Meet No/Date:9/82[Status: ALC42013 CHEMICALS PVT LTD ALC4/2014 approved 20.10.2014 HQ File RLA File Lic.No/Date:05 10373925 (Defer Date:Z :01/82/050/01134/AM14/ :05/23/040/00385/AM14/ 18.12.2013 1g¢ |Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 3501 1/158/2014-PI(Norms) dated 10.10.2014, it was decided to ratify the norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: | Export Product 8. Qty. Allowed Allowed Qty No. ke/ke

Qty. Allowed Allowed ke/ke dD. 2 \aeneral of Foreign 7 ui. I4 A. Departamentof Comer Ua eee Ere RES Bein

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

;
Case No.:91/23/82Party Name:INTAS Meet No/Date:9/82(Status: Deffered ALC4/2013 PHARMACEUTICALS ALC4/2014 land Re-indexed
187 |HQ File LTD.,RLA File 20.10.2014Lic.No/Date:08 10127281 . |Defer :01/82/050/01138/AM14/ °08/24/040/00408/AM14/ [20.12.2013 Date:26.11.2014
| {Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals

Case No.:85/23/82Party Name:PARENTERAL [Meet No/Daie.9/82. (StatussDeffevca ALC4/2013 DRUGS (INDIA) LTD., ALC4/2014 and Re-indexed 20.10.2014
188 JHQ File RLA File Lic.No/Date:56 10003400 |Defera . O1/82/0S0/01132/AMI4/ —|:56/24/040/00033/AM14/ [20.12.2013 [Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals

Case No.:145/3/82Party Name:AUROBINDO [Meet No/Date:9/82Status: ALC4/2014 PHARMA LIMITED ALC4/2014 Approved ; 189 7 20.10.2014 THQ File REA File [Lic.No/Date:09 10058692 (Defer Date: :01/82/050/00149/AM15/ :09/24/040/00465/AM14/ 23.12.2013 | [Decision + Withdraw | as the case was already approved in 7/82 meeting dated 11.09.2014 Case No.:11/3/82‘Party Name:MICRO LABS [Meet No/Date 9/82. [Status Deford : ALC4/2014 LTD ALC4/2014 and Re-indexed 190 jHQ File RLA File 20.10.2014Lic.No/Date:07 10100791. (Defer 101/82/050/00015/AM15S/ —_j:07/24/040/00318/AM14/ 23.12.2013 Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments ofDepartment of Pharmaceuticals . Case No.:41/23/82Party Name: HEMMO Meet No/Date:9/82-__[Status: ALC4/2013 PHARMACEUTICALS ALC4/2014 Approved 191 PRIVATE LIMITED _ 0.10.2014 . ; TQ File RLA File Lic. No/Date:03 10763218 [Defer Date: :01/82/050/01088/AM14/ :03/94/040/00749/AM14/ —s [24.12.2013 | [Decision ; Withdraw as the case was already approved in 7/82 meeting dated 11.09.2014; 19 ALC4/2013[Case No.:27/23/82PartyPRIVATEName:SANDOZ LIMITED ALC4/2014Meet No/Date:9/82-- —(Status: MAL 1, AR wy Dono TYeret roe Dy. Deon: . crengn Trade &: . 2 oe el cl viper De . i foreign Trade z reat of Commerce Usyeg bnaian Ness Bini

| |

|||“A|||[|<br>|<br>20.10.2014||
|---|---|---|---|---|---|
||||||HQFile<br>RLAFile<br>Lic.No/Date:0310763292 |DeferDate:<br>:01/82/050/01074/AM14/<br>:03/95/040/00758/AM14/<br>(24.12.2613||
|||||os<br>Decision<br>: Committee considered the case as peragenda and in light ofwritten comments<br>received<br>from Department ofPharmaceuticals vide theirOMNo. 35011/147/2014-Pl(Norms)<br>dated<br>09.10.2014 and in consultation with technical authority present in meeting, decided to<br>ratify norms under para 4.7 ofHBP as per details below or as applied by firm whichever is<br>lower:-||
|||||| Exportproduct<br>Exp. |SLNo. | Importitems<br>Qty.<br>|<br>Qty.<br>Allowed||
|||||;<br>p/Ke<br>|<br>N-(4-(4-Flurophenyl)-5-Formyl -6-<br>1.013<br>; RosuvastatinTertiaryOcty!<br>Isopropylpyrimidin -2 -yl)- N -<br>| AmineSalt.<br>(Rosuvastatin<br>Methylmethanesulfonamide(PmdCHO)<br>| TOA)<br>kg<br>Z-8<br>.||
||||||<br>2<br>(R)-Methyl3-((tert-<br>1.543<br>|<br>butyldimethyisilylJoxy) -5 -oxo-6-<br>|<br>(riphenylphosphoranylidene)hexanoate<br>|<br>3<br>Diethylmethoxyborane<br>(4M solutionin<br>|0.346<br>iF)<br>DEMB<br>|<br>|4 | Isobutyl Methyl Ketone<br>i208<br>|S | Tert-Octylamine —SSS~*~*«~d(OSSCSC*d<br>[6__| TetraHydroFuran||
|||||RAconcemedmaytakefurthernecessaryactionasperabovedecision ofNC,||
|||||CaseNo.:142/3/82-<br>PartyName:SRIAMLABS<br>[MeetNo/Date:9/82-<br>|Status:Deffered<br>ALC4/2014<br>PRIVATELIMITED<br>ALC42014<br>andRe-indexed||
|||||20.10.2014||
||<br>|<br>|||||193 [HQFile<br>RLAFile<br>Lic.No/Date:0910058708<br>[Defer<br>:01/82/050/00146/AM15/<br>:09/24/040/00439/AM14/<br>24.12.2013<br>Date:26.11.2014<br>Decision : Itwasdecidedtodefer thecasefor26.11.2014forcommentsofDepartment<br>ofPharmaceuticals||
||<br>|<br>|<br>|<br>|<br>|||[**~**|||[CaseNo.:157/3/82-<br>PartyName:ATLAS FINE<br>[MeetNo/Date:9/82-<br>(Statue:<br>ALC42014<br>CHEMICALS PVTLTD<br>ALC4/2014<br>approved<br>.<br>20.10.2014<br>—<br>194TQFile<br>RLAFile<br>Lic.No/Date:0310763403 [DeferDate:<br>:01/82/050/00161/AM15/<br>:03/94/040/00647/AM14/<br>26.12.2013<br> _[Decision :Withdrawas thecasewasalreadyapprovedin7/82meetingdated 11.09.2014||
||<br>|<br>|||||CaseNo.:97/3/82-<br>PartyName:SATYA<br>MeetNo/Date:9/82-<br>Status:<br>ALC4/2014<br>DEEPTHA<br>ALC4/2014<br>Approved<br>PHARMACEUTICALS LTD<br>[20.10.2014||
||<br>|||||a<br>195 |HQFile<br>RLAFile<br>Lic.No/Date:0910058730 |DeferDate:<br>:01/82/050/00101/AM15/<br>:09/24/040/00482/AM14/<br>26.12.2613||
|||||Decision : Committee considered the case as per agenda and in light of written comments<br>received from Department ofPharmaceuticals vide theirOM No. 35011/238A20 14-PH(Nornt a<br>bybien<br>-<br>eee<br>fa:<br>-<br>unTrade<br>be Sa:<br>,<br>tofCommerce||

oe | ; dated 10.10.2014 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:-

==> picture [452 x 340] intentionally omitted <==

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

||||||
|---|---|---|---|---|
|Export product|Exp.|Import items|Qty.|
|Oty.|Allowed|
|Ka/ka|
|||(18,4R)-4-[(2-AMINO-6-CHLORO-|N-(2-AMINO-4,6-|0.764|
|5-FORMAMIDO-4-|1|kg|DICHLORO-5-|
|PYRIMIDINYL)AMINO}-2-CYCLO|PYRIMIDINYL)|
|||PENTENE-1-METHANOL|5|pe|
|AZABICYCLOJ2.2.|1|JHEPT-|
|ONE(VINCELACTA|
|||5-EN-3-|
||||[3||D(-)TARTARIC ACID|
||||4||SODIUMBOROHYDRIDE|__||0.226|
|:||5[8||METHANOLISOPROPYL|ALCOHOL|423|
|||[L(SYTARTARIC|ACID|||
|RA concermed may take further necessary action as per above decision of NC.|
|Case No.:144/3/82-|Party Name:SRINI|Meet No/Date:9/82-|__[Status:Deffered|
|ALC4/2014|PHARMACEUTICALS|ALC4/2014|and Re-indexed|
|LTD.,|20.10.2014|
|196||HQ File|RLA File|Lic.No/Date:09 10058728||Defer|
|:01/82/0S0/00148/AM15/|—_|:09/24/040/00471/AM14/|[26.12.2013|Date:26.11.2014|
|Decision|:|It was decided to defer the case for 26.11.2014|for comments ofDepartment|
|of Pharmaceuticals|

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

==> picture [450 x 98] intentionally omitted <==

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||||||||
|---|---|---|---|---|---|---|
|Case No.:38/4/82-|Party Name:ALTA|Meet No/Date:9/82-|_[Status:Deffered|
|ALC4/2014|LABORATORIES LTD.|ALC42014|and Re-indexed|
|/|||.|.|20.10.2014|
|197|[HQ File|RLA File|Lic.No/Date:03|10763559|[Defer|
|01/82/050/00286/AM15/|—_|:03/94/040/00796/AM14/|{27.12.2013|Date:26.11.2014|
|Decision|:|It was decided|to defer|the case for 26.11.2014|for comments|of Department|
|of Pharmaceuticals|,|

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

Case No.:71/23/82Party Name:RANBAXY Meet No/Date:9/82Status: ALC4/2013 LABORATORIES LTD ALC4/2014 Approved . 20.10.2014 HQ File RLA File Lic.No/Date:05 10374576 |Defer Date: :01/82/050/01118/AM14/ :05/24/040/003 17/AM14/ 27.12.2013 198 Decision : In the light of written comments received from Department of Pharmaceuticals vide- their OM No. 35011/165/2014-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: Export Product 5S. No. Qty. Allowed Qua kg i iy frie Arey NIRMAL KUMAR ot (+ Uf Foreign Trade a . <aunent of Commerce Udyog Bnawan Nos Eom

||} Meropenem Sterile<br>!|lkg<br>1.<br>2-DimethylAmino-4-MercaptoPnz<br>1.133<br>Pcl|
|---|---|---|
|||<br>:<br>||BUTYL-DIMETHYLSILYLOXY)-<br>ETHYL)-2-AZETIDINONE<br>}3.<br>acetone<br>SC«d OCS<br>[4<br>[asivaedCaton<br>__————~*'0200<br>[5<br>[Disha Chorphospiae<br>|1.0961<br>[6<br>imidazole<br>«128<br>ec<br>[8. | Mages<br>CordeAnindrows<br>[0.432]<br>aLc|
|||BS)|
||,|CsCY<br>}13_ | MethylsoBuytKetone<br>2.30|
|||||
|||||
||a<br>:<br>[19<br>| triethylamine<br>«dC<br>|<br>RAmaytakeappropriateaction asperthedecisionofNormsCommittee.<br>a|||

Case No.:64/23/82Party Name:S.M. HERBALS [Meet No/Date:9/82(Status: ALC4/2013 PVT.LTD. ALC4/2014 Approved 199 7 20.10.2614 THQ File RLA File Lic.No/Date:0510374573 [Defer Date: :01/82/050/01111/AM14/ :05/24/040/0032 1/AM14/ 27.12.2013 | [Decision : Withdraw as the case was already approved in 7/82 meeting dated 11.09.2014

~~ [Case No.:143/3/82Party Name:VIVIMED (Meet No/Date.9/82. (Status: ALC4/2014 LABS LIMITED ALC4/2014 '|Approved . 20.10.2014
200 - . Fd File RLA File Lic.No/Date:0910058745 (Defer Date:
| :01/82/050/00147/AM15/ :09/24/040/0046 1/AM14/ 27.12.2013 _ [Decision : Withdraw as the case was already approved in 7/82 meeting dated 11.09.2014
— Case No.:43/23/82Party Name:ANUH Meet No/Date:9/82Status: ALC42013 PHARMA LTD. ALC4/2014 Approved 20.10.2014
HQ File RLA File Lic.No/Date:03 10763631 |Defer Date:(01/82/050/0L090/AM14/ —_—|:03/94/040/00770/AM14/ _—[30.12.2013

201 ‘Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 3501 1/210/2014-Pl(Norms) dated 21.10.2014, 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: Export Product 8. Import Item . Allowed Lacan Eta A teGenerales . _Departme tee Uayog BhawaaT sini

io |

==> picture [364 x 66] intentionally omitted <==

----- Start of picture text ----- , | ERYTHROMYCIN 1i, 12 ERYTHROMYCIN tke LL FoCRARGN [1-22 keV RA may take appropriate action as per the decision ofNorms Committee. ----- End of picture text -----

Case No.:48/23/82-__—~~—([Party Name-EXCEL [Meet NoDaeS/R0o Status:Deffered ALC4/2013 INDUSTRIES LIMITED ALC4/2014 and Re-indexed 202: . 20.10.2014 too! {HQ File RLA File Lic.No/Date:03 10763628 |Defer :01/82/050/01095/AM 14/ :03/94/040/007 19/AM14/ 30.12.2013 Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals

[ ~ [Case No.:22/3/82Party Name:GLAND Meet No/Date:9/82___[Status:Deffered ALC4/2014 PHARMA LIMITED ALC4/2014 and Re-indexed | (20.10.2014 203 |HQ File RLA File Lic.No/Date:09 10058787 |Defer :01/82/050/00026/AM1 5/ :09/24/040/00485/AM14/ 31.12.2013 Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals . . —_ CaseALC42014 No.:96/3/82Party Name:GLAND " Meet No/Date:9/82Status:Deffered : PHARMA LIMITED ALC4/2014 and Re-indexed 20.10.2014 |204 [HQ File RLA File Lic.No/Date:0910058788 (Defer :01/82/050/00100/AM15/ :09/24/040/0048 L/AM14/ 31.12.2013 Date:26.11 2014 Decision : It was decided to defer the case for 26.11.2014 for comments ofDepartment _jofPharmaceuticals . (Case No.:23/3/82Party Name:MSN Meet No/Date:9/82[Status: Approved ALC4/2014 LABORATORIES ALC4/2014 PRIVATE LIMITED 20.10.2014 HQ File RLA File Lic.No/Date:0910058791 |Defer Date: :01/82/050/00027/AM15/ :09/24/040/00486/AM14/ 31.12.2013 |Decisiontheir : In the light of written comments received from Department of Pharmaceuticals videOM No. 3501 1/48/2014-PI(Norms) dated 24.09.2014, it was decided to ratify the norms 205 (under Para 4.7 of HBP vi as per details given below or as applied by the firm, whichever is less: - | Export Product S. No. | Import Item Qty. Allowed | Ob) ke/kg | EPLERENONE | 1 kg Methyl hydrogen -17alpha -hydroxy | 1.764 | -3- oxopregna -4,9(1 1) -diene -7 alpha,21-dicarboxylate,gammalactone RA may take appropriate action as per the decision ofNorms Committee. _ 206 Case No.:88/3/82Party Name: MYLAN Meet No/Date:9/82Status:Deffered \ |ALC4/2014 LABORATORIES LIMITED |ALC4/2014 eraand Rejndexed, WC. 20.10.2014 A) ecu “oti erate Fass ‘ omens teas De. 1k Uresgve Trade ar et sot Commerce Uayog ‘Bha wan! New Sonn

| | |

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----- Start of picture text ----- Ay ----- End of picture text -----

, HQ File RLA File Lic.No/Date:09 10058792 |Defer :0 1/82/050/00092/AM I 5/ 309/24/040/0045 1/AM14/ 31.12.2613 Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments ofDepartment of Pharmaceuticals . Case No.:2/2/82-ALC4/2014 |Party Name:SAFECON Meet No/Date:9/82Status:Deffered LIFESCIENCES ALC4/2014 and Re-indexed 1207 |HQ File RLA File 20.10.2014Lic.No/Date:61; 10001120 /Defer7 ; :01/82/050/00004/AM 1 5/ :61/24/040/00033/AM14/ 31.12.2013 Date:26.11.2014 | Decisionjof Pharmaceuticals: It was decided to defer the case for 26.11.2014 for comments of Department Case No.:244/3/82Party Name:SAFECON Meet No/Date:9/82Status:Deffered ALC4/2014 LIFESCIENCES ALC4/2014 and Re-indexed 20.10.2014 fo {208 [HQ File RLA File Lic.No/Date:61 10001119 [Defer :01/82/050/00248/AM15/ 61/24/040/00023/AM14/ 31.12.2013 ___ fDate:26.1 1.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals | | . . Case No.:55/23/82Party Name:SATYAJIT Meet No/Date:9/82Status:Deffered ALC4/2013 CHEMICALS PVT.LTD., |ALC4/2014 and Re-indexed . 20.10.2014 209./HQ File RLA File Lic.No/Date:03 10763764 |Defer :01/82/050/01102/AM14/ —|[:03/95/040/00791/AM14/ [31.12.2013 Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments ofDepartment of Pharmaceuticals .

" [Case No.:53/23/82Party Name:EXCEL Meet No/Date:9/82_|Status:Deffered ALC42013 INDUSTRIES LIMITED ALC4/26014 and Re-indexed ‘20.10.2014 .
210 [HQ File RLA File Lic. No/Date:03 10764365 [Defer :01/82/050/01 100/AM14/ :(03/94/040/00744/AM 14/ 02.01.2014 Date:26. 11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals .

Case No.:114/3/82Party Name:HETERO LABS [Meet No/Date:9/82(Status: ALC4/2014 LIMITED ALC4/2014 Approved 20.10.2014 HQ File RLA File Lic.No/Date:09 10058802 |Defer Date: 211 [Decision01/82/0S0/00118/AM15/: In the light of written—|:09/24/040/00497/AM14/ comments received from Department[02.01.2014 ofPharmaceuticals vide their OM; INo. 3501 1/68/2014-PI(Norms) dated 10.10.2014, it was decided to ratify the norms under Para 4.7 of HBP |v1 as per details given below or as applied by the firm, whichever is less: { \ Export Product S.No. | Import Item Qty. Allowed Quanti et KEE IRMAY KUMAR oo ia) Che om we ea Dy wry Poragn Trade Cot relTeaurera D: a Ly » of Foreign Trade Udyog Sngwlan how Delhi

==> picture [477 x 323] intentionally omitted <==

----- Start of picture text ----- % CILAZAPRIL Malonic Acid Tert Butyl Acetate | L-Glutamic Acid | |4.| EthylDiisopropylChloroformate Alcohol [16.81 | : |6.| Dimethyl Formamide (11.360 . Tetrahydrofuran 17.39 | . ButonicR-2-Hydroxy-4-Phenyi Acid Ethyl Ester 1.20 Trifluoromethane Sulfonic 1.27 Anhydride | | [10.] | Methylene Dichloride (30.94 RA [11__[ Methanol «di 7S may take appropriate action as per the decision ofNorms Committee, Case No.:38/3/82- Party Name:PARENTERAL |Meet No/Date:9/82- Status:Deffered ALC4/2014 DRUGS (INDIA) LTD., ALC4/2014 and Re-indexed 20.10.2014 212 |HQ File RLA File Lic.No/Date:56 10003472 [Defer . :01/82/050/00042/AM15/ :56/24/040/00036/AM14/ 02.01.2014 Date:26.11.2014 Decision : It was decided to defer the case for 26.1 1.2014 for comments ofDepartment of Pharmaceuticals ----- End of picture text -----

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----- Start of picture text ----- (Case No.:118/3/82- Party Name:PARENTERAL [Meet No/Date:9/82. ~~ [Statua:Deffecad ALC422014 DRUGS (INDIA) LTD., ALC4/2014 and Re-indexed 20.10.2014 213 |HQ File RLA File Lic.No/Date:56 10003471. (Defer :01/82/050/00122/AM15/ :36/24/040/00035/AMI4/ 02.01.2014 Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments ofDepartment of Pharmaceuticals Case No.:24/3/82- Party Name: VIVIMED LABS (Meet No/Date:9/82. ~ [Status: ALC4/2014 LIMITED ALC4/2014 Approved 214 20.10.2014 fp TQ File RLA File Lic.No/Date:09 10058808 [Defer Date: | :01/82/050/00028/AM15/ :09/24/040/00492/AM14/ 02.01.2014 [Decision Withdraw as the case was already approved in 7/82 meeting dated 11.09.2014 Case No.:45/3/82- Party Name:AKZO NOBEL [Meet No/Date:9/82- Status:Deffered ALC42014 INDIA LIMITED ALC4/2014 and Re-indexed [20.10.2014 215 [HQ File RLA File Lic.No/Date:02 10198458 |Defer : :01/82/050/00049/AM1 5/ :02/24/040/00168/AM13/ 03.01.2014 Date:10. 12,2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals 216 {Case~ No.:89/3/82- Party Name:ASTRIX Meet No/Date:9/82- Status:Deffered ALC4/2014 LABORATORIES LTD. —_|ALC4/2014 ooal [KUMAR] fi Sty irene48 “- P orengs Trade mettre se uf Commerce ----- End of picture text -----

% [| | (20.10.2014 [ HQ File RLA File Lic.No/Date:09 10058826 |Defer :01/82/050/00093/AMi5/ —|:09/24/040/00496/AM14/ 06.01.2014 Date:10.11.2014 | |Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals ; Case No.:186/3/82Party Name:MYLAN Meet No/Date:9/82Status: Deffered ALC4/2014 LABORATORIES LIMITED {|ALC4/2014 and Re-indexed . 20.10.2014 217 |HQ File RLA File Lic.No/Date:09 10058825 (Defer 01/82/050/00190/AM15/ —|:09/24/040/00484/AM14/ _|06.01.2014 Date:26.11.2014 ofDecisionPharmaceuticals: It was decided to defer the case for 26.11.2014 for comments ofDepartment

==> picture [506 x 543] intentionally omitted <==

----- Start of picture text ----- Case No.:193/3/82- Party Name:NATCO Meet No/Date:9/82- [Status:Deffered ALC4/2014 PHARMA LIMITED ALC4/2014 land Re-indexed | 20.10.2014 218 |HQ File RLA File Lic.No/Date:09 10058829 [Defer :01/82/050/00197/AMI5/ :09/24/040/00494/AM14/ 06.01.2014 Date:26,11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals Case No.:2/22/82- Party Name:METROCHEM [Meet No/Date.9/82- ~~ (Status:Defferea ALC42013 API PVT. LTD. ALC4/2014 and Re-indexed a 20.10.2014 HQ File RLA File Lic.No/Date:09 10058842. [Defer :01/82/050/01045/AM14/ :09/24/040/00503/AM14/ 07.01.2014 Decision — (Date:26..11.2014 : It was decided to call from the firm following technical details: a19 i) Complete and balanced chemical reaction showing molecular weight of input and out[put product ii) % yield on molar basis iii) Material balance for entire process iv) Bye-products recovered, ifany. 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 26.11.2014. . . Case No.:37/3/82- Party Name:NECTAR Meet No/Date:9/82-_[Status:Deffered ALC4/2014 LIFESCIENCES LIMITED, |ALC4/2014 and Re-indexed | 20.10.2014 270 [HQ File RLA File Lic.No/Date:2210014502 | [Defer | . 01/82/050/00041/AMI5/ _|:22/24/040/00077/AM14/ [07.01.2014 |Date:26.11.2014 of Pharmaceuticals Decision : It was decided to defer the case for 26.11.2014 for comments ofDepartment. [221 [Case No.:121/3/82- [Party Name:NECTAR [MeetNo/Date:9/82- [praea” OeJNUIR i}ALSNe KUMAR . soe sw partment of Commerce uayegBn TES Dethi ----- End of picture text -----

| | | |

==> picture [91 x 37] intentionally omitted <==

----- Start of picture text ----- . | ALC4/2014 | ----- End of picture text -----

==> picture [492 x 765] intentionally omitted <==

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

|||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|||ALC4/2014|LIFESCIENCES LIMITED,||ALC4/2014|Approved|
|||||[avcaror|.|||
|||-|
|lie:01/82/050/00125/AM15/ File|LA:22/24/040/00078/AM14/ File|fic07.01.2014 NorDate:22 10014501 PeterDate:|
|No.Decision|:|In the tight of|written comments received from Department ofPharmaceuticals videoo their|OM|
|35011/198/2014-PI(Norms)|dated|27.10.2014,|it|was|decided|to|ratify|the|norms|under|Para|4.7|of|
|HBP v1|as per details given below or as applied by the firm, whichever|is|less:|
|Cefixime|Quanti|ke/ke|
|Trihydhrate|jl.|GCLESS~™~=~CSIOD.SSCS|
|||[4.0|DMF|SS~=«dC*SLC«GSSSS|
|||[6|[Formaldehyde|SS«dLLSLIB|CS|
|[9[8|||SSSS=«*d‘3808PhenolButyl Acetate|S=«d0302SC~*Y|
|.10.___[EnoCarbon—SSS~=«*CLOSS|
||i.|[Acetone|SSS~=*«~dC‘OLI|iY|
|||[12|[EDTASSSS~C*«dCONDSY|
|||[15|14[13|||[MICAESTER—SSS=«*'Triethylamine(TEA)AceticAcid|=<[0.2717 0820.030|SSS~*SS—~*@d|
|:||16__[EthylAcetate|S=«dt0376|
|RAmay|take appropriate action as per the decision ofNorms Committee,|
|i Case|ALC4/2014No.:116/3/82-|{PartyORGANICSName: LTDVIJAYASRI|ALC4/2014Meet|No/Date:9/82-|andStatus: Deffer Re-index|ed|
|.|||||ean|—|||
|p22|HO File|LA File|Lic|NovDate-09 10058840 Defer|.|
|:01/82/050/00120/AMiS/|—_|09/24/040/00402/AM14/|_ [07.01.2014|Pete|1.2014|
|Decision|:|It was decided to defer the case for 26.11.2014 for comments ofDepartment|
|of|Pharmaceuticals|
|Case No.:180/3/82-|Party|Name: VISION DRUGS|(Meet No/Date:9/82-|Status: Deffered|
||ALC4/2014.||PVTLTD|tevaALC4/2014||and Re-indexed|
|pas fee01/82/050/00184/AM15/ File|—_|:09/24/040/00426/AMRua|File|14/|tic07.01.2014 NorDate:0910058839 DefDat|e|r:26.11.2014—|
|Decision|:|It was decided to defer the case for 26.1 1.2014|for comments of|Department|
|of|Pharmaceuticals|
|224|ALC4/2014|SCIENCES LIMITED|ALC4/2014|and Re-indexed|
|heite No.:90/3/82-|.|saeName:SUVEN LIFE|ie20.10.2014 No/Date:9/82-|footer-|
|||fae101/82/050/00094/AM15/ File|—_|:09/24/040/00468/AM14/LA File|Lic NovDat:09io0sses808.01.2014|PeteDate:26.11.2014|1|
|5|IRMAL|KUMAR|
|OaGTS|
|.|4. Nepartinent|of Commerce|
|uayog Bhawan|Nee|oi,|

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

| | 7,

of Pharmaceuticals Decision : It was decided to defer the case for 26.11.2014 for comments ofDepartment . | Case No.:203/3/82Party Name:VINS [Meet No/Date:9/82. |StatussDefferea ALC42014 BIOPRODUCTS LTD., ALC4/2014 nd Re-indexed 20.10.2014
225 [HQ File RLA File Lic.No/Date:09 10058863 [Defer. :01/82/050/00207/AM15/ :09/24/040/00362/AM14/ 08.01 2014 Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments ofDepartment of Pharmaceuticals Case No.:200/3/82Party Name: WEXFORD Meet No/Date:9/82tatus:Deffered ALC4/2014 LABORATORIES P LTD ALC4/2014 and Re-indexed 20.10.2014
226 |HQ File RLA File Lic.No/Date:07 10101186 [Defer :01/82/050/00204/AM 15/ :07/24/040/00333/AM14/ 08.01.2014 Date:26.11.2014
| Decision : It was decided to defer the case for 26.11.2014 for comments ofDepartment _ [of Pharmaceuticals . .
Case No.:192/3/82Party Name: VIVIMED LABS (Meet No/Date:9/82[StatassDefforea ALC4/2014 LIMITED ALC4A2014 and Re-indexed
227 jHQ File RLA File . Lic.No/Date:0920.10.2014 10058896 |Defer :01/82/050/00196/AMI5/ :09/24/040/005 13/AM14/ 10.01.2014 Date:26.11 2014
| |Decision : It was decided to defer the case for 26.11.2014 for comments of Department of C&PC.

Case No.:204/3/82Party Name:VIVIMED LABS (Meet No/Date:9/82-. tatus:Deffered ALC4/2014 LIMITED ALC42014 nd Re-indexed 20.10.2014 278 [HQ File RLA File Lic. No/Date:0910058895 [Defer :01/82/050/00208/AM15/ :09/24/040/005 14/AM14/ 10.01.2014 Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of C&PC.

==> picture [495 x 226] intentionally omitted <==

----- Start of picture text ----- Case Nos19/23/82. Party Name:DANOPHARM [Meet NolDate-5/82 tus: ALC4/2013 CHEMICALS PRIVATE ALC4/2014 pproved LTD. 20.10.2014 HQ File RLA File Lic.No/Date:03 10766076; [Defer7 Date: | _ |Decision:01/82/050/01066/AM14/: In the light of written—|:03/94/040/00772/AM14/‘|13.01.2014 comments received from Department of Pharmaceuticals vide- their OM 229.1No. 35011/196/2014-PI(Norms) dated 21.10.2014, 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: Export Product Export S. No. Qty. Allowed Ta Quanti kg/kg Mey Phen [4MatiylAccophenone «dT + re errr broign Trade . . 7 abt roreign Trade aa vee unEnt of Commerce Uayog ‘brawan We eon ----- End of picture text -----

==> picture [13 x 12] intentionally omitted <==

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

|||3.<br>Iso PropylAlcohol<br>0.523<br>CR|||
|---|---|---|---|
||0.346|||
|RAmaytake appropriateactionasperthedecisionofNormsCommittee.||||
||a|||
|CaseNo.:197/3/82-<br>ALC4/2014|PartyName:MALLADI<br>(MeetNo/Date.9/82-<br>|Status:Defferea<br>DRUGS&<br>ALC4/2014<br>andRe-indexed<br>{PHARMACEUTICALS<br>0.10.2014|||
||[LIMITED|||
|230 [HQFile<br>01/82/050/00201/AMI15/|.<br>wh.<br>RLAFile<br>Lic.No/Date:0410154188 [Defer<br>—_|:04/24/040/00218/AM14/<br>13.01.2014<br>—<br>fDate:10.11.2014|||
|Decision : Itwasdecidedtodeferthecasefor26.11.2014 forcommentsofDepartment<br>ofPharmaceuticals||||
||a|||
|(CaseNo.:134/3/82-<br>ALC4/2014<br>||Party Name:SHASUN<br>MeetNo/Date:9/82-<br>_(Status:Deffered<br>PHARMACEUTICALS<br>ALC4/2014<br>landRe-indexed<br>LIMITED<br>20.10.2014||||
|1231 |HQFile<br>RLA File<br>Lic.No/Date:0410154220 |Defer<br>01/82/050/00138/AMI5/<br>—_—[:04/24/040/00226/AM14/<br>—_—‘'13.01.2014<br>Date:26.11.2014<br>Decision : ItwasdecidedtoremindthefirmtofurnishacopyofMasterBatchFormula<br>dulycertifiedbyQuality Control Incharge.Thecasewasdeferredfor26.11.2014.||||
|CaseNo.:179/3/82-<br>ALC42014|Party Name: VENUS<br>MeetNo/Date:9/82-<br>(Status:Deffered<br>REMEDIESLTD.,<br>ALC42014<br>andRe-indexed|||
|.||<br>20.10.2014|||
|.<br>232 [HQFile<br>RLA File<br>Lic.No/Date:2210014517<br>[Defer<br>:01/82/050/00183/AM15/<br>:22/24/040/00079/AM14/<br>13.01.2014<br>‘|Date:26.11.2014<br>Decision : Itwasdecidedtodeferthecasefor26.11.2014forcommentsofDepartment<br>ofC&PC||.|||
||.|||
|CaseNo.:196/3/82-<br>ALC4/2014|PartyName:ARUDAAVIS _ [MeetNo/Date:9/82-<br>[Status:Deffered<br>LABSPRIVATELIMITED<br>|ALC4/2014<br>andRe-indexed|||
||20.10.2014|||
|733 |HQFile<br>01/82/050/00200/AM15/<br>Decision : Itwasdecidedto<br>ofPharmaceuticals|-<br>IRLAFile<br>Lic.No/Date:0410154292 (Defer<br>_|:04/24/040/00219/AM14/<br>15.01.2014<br>Date:26.11.2014<br>todeferthecasefor26.11.2014 forcommentsofDepartment|||
||.|||
|CaseNo.:40/4/82-<br>ALC4/2014|PartyName:NEW<br>MeetNo/Date:9/82-<br>__[Status:Deffered<br>ALLIANCEDYE-CHEM<br>_/ALC4/2014<br>andRe-indexed<br>PVT. LTD.,<br>20.10.2014|||
|234 |HQFile<br>01/82/050/00288/AM15/<br>Decision : Itwasdecidedto<br>ofC&PC|RLAFile<br>Lic.No/Date:03 10766431 (Defer<br>—_|:03/95/040/00805/AM14/<br>16.01.2014<br>Date:26.11.2014<br>todeferthecasefor26.11.2014 forcommentsofDepartment<br>|<br>|||\\;|
|535 [CaseNo.:202/3/82-<br>ALC4/2014|PartyName:PARENTERAL_ [MeetNo/Date:9/82-<br>sae<br>DeMARPA,Iccinaac<br>DRUGS(INDIA)LTD.,<br>ALC4/2014<br>©<br>py jadeRe-indeked~ earare<br>rs es<br>oof vif teeter °<br>:<br>8<br>of<br>kureign Trade|||
||Seal winotCommerce<br>UuyogBhawan,Nowomy|||

[| | [20.10.2014 HQ File RLA File Lic.No/Date:56 10003580 |Defer7 :01/82/050/00206/AM15/ :56/24/040/0004 1/AM14/ 16.01.2014 Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals

Case No.:198/3/82Party Name:SATYA Meet No/Date:9/82|Status:Deffered ALC4/2014 DEEPTHA LC4/2014 and Re-indexed : PHARMACEUTICALS LTD 20.10.2014 236 [HQ File RLA File Lic.No/Date:09 10058953 [Defer. :01/82/050/00202/AM1} 5/ :09/24/040/00523/AM14/ 16.01.2014 Date:26.11.2014 | |Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals

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

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

Case No.:32/3/82Party Name:DISTO [Meet No/Date:9/82(StatusDeffered ALC4/2014 PHARMACEUTICALS ALC4/2014 and Re-indexed
237 |HQ File RLAPRIVATE File LIMITED Lic.No/Date:0960.10.2014 10058977; IDefer OV/S2/0SO/00036/AMI5/ — |:09/24/040/00519/AMI4/ [17.01.2014 Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals
Case No.:103/3/82Party Name:BLISS GVS Meet No/Date:9/82Status:Deffered ALC4/2014 PHARMA LTD. ALC4/2014 and Re-indexed 20.10.2014
93g JHQ File RLA File Lic.No/Date:03 10767119f [Defer :01/82/050/00107/AM15/ :03/94/040/00942/AM14/ 21.01.2014 Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department
| jof Pharmaceuticals
Case No.:22/6/82Party Name:BLUE CIRCLE [Meet No/Date:9/82Status:Deffered ALC4/2014 ORGANICS PVT. LTD. ALC4/2014 and Re-indexed 20.10.2014
239 [HQ File RLA File Lic.No/Date:03 10767101 [Defer - :01/82/050/00424/AM15/ :03/94/040/00582/AM14/ 21.01.2014 Date:26.11.2014 Decision ; It was decided to defer the case for 26.11.2014 for comments of Department of C&PC. ;

(Case No.:51/4/82Party Name:SHILPA [Meet No/Date:9/82[Status:Deffered ALC4/2014 MEDICARE LTD., ALC4/2014 and Re-indexed 20.10.2014 240 [HQ File RLA File Lic.No/Date:0710101518 [Defer:01/82/050/00299/AM15/ :07/24/040/00375/AM14/ 22.01.2014 Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department [241 ofPharmaceuticals\ = [Case No.:55/3/82[Party Name:AUROBINDO [Meet No/Date:9/82rasta i ed ——eee arty Name:AUROBINDO [Meet No/Date:9/82- saltatussReffered | ne a KUMAR pen ory frre on Pe ae rede Co“iUayogeGas mit of10CommerceTrade 8hawan! Nowe, thi

| |

ALC4/2014 PHARMA LIMITED ALC4/2014 and Re-indexed 20.10.2014
HQ File RLA File Lic.No/Date:09 10059025 |Defer. :01/82/050/00059/AM15/ :09/24/040/00529/AM 14/ 23.01.2014 Date: 10.11.2014

|Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals

||[~||[CaseNo.:21/3/82-<br>ALC4/2014|Party Name:KUDOS<br>CHEMIELTD.,|MeetNo/Date:9/82-<br>__(Status:Deffered<br>ALC4/2014<br>andRe-indexed|
|---|---|---|---|---|---|
||||||20.10.2014|
||||242|[HQFile<br>:01/82/050/00025/AM15/<br>|Decision : Itwasdecidedto<br>ofPharmaceuticals|.<br>-<br>RLAFile<br>Lic.No/Date:2210014543 [Defer<br>:22/24/040/00075/AM14/<br>23.01.2014<br>Date:26.11.2014<br>todeferthecasefor26.11.2014forcommentsofDepartment||

||CaseNo.:12/21/82-<br>ALC42013|PartyName:KUDOS<br>CHEMIELTD.,|MeetNo/Date:9/82-<br>Status:Deffered<br>ALC4/2014<br>andRe-indexed|
|---|---|---|---|
||||20.10.2014|
|1243|HQFile<br>:01/82/050/01042/AM14/<br>Decision :Itwasdecidedto<br>Pharmaceuticals||<br>RLAFile<br>Lic.No/Date:2210014544 |Defer<br>22/21/040/00096/AM14/<br>{23.01.2014<br>Date:26.11.2014<br>todeferthecasefor26.11.2014 forcommentsofDepartmentof||

Case No.:187/3/82Party Name:ALCHEM Meet No/Date:9/82[Status:Deffered ALC4/2014 INTERNATIONAL LTD. ALC4/2014 and Re-indexed | 20.10.2014
744 |HQ File RLA File Lic.No/Date:05 10376990 |Defer | :01/82/050/0019 1/AM15/ :05/23/040/00413/AM14/ 24.01.2014 Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals .

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

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

[ ~ {Case No.:108/3/82PartyName:CROPNOSYS [Meet No/Date:9/82. (Status: Deffarad ALC42014 (INDIA) PRIVATE ALC42014 and Re-indexed LIMITED 20.10.2014
245 |HQ File RLA File Lic.No/Date:03 10767733 |Defer 01/82/0S0/00112/AMI15/ _|:03/94/040/00908/AM14/ 24.01.2014 Date:26,11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department
__ lof Pharmaceuticals

[Case No.: 19/3/82Party Name: VARUN Meet No/Date:9/82| Status: approved ALC4/2014 MEDIMPEX INC. ALC4/2014 20.10.2014 246 HQ File RLA File Lic.No/Date:0510377141 |Defer Date: :01/82/050/00023/AM15/ :05/24/040/00374/AM14/ 27.01.2014 Decision : tn the light of written comments received from Petrochemical Division of Department of Chemicals and Petrochemicals vide their U.O No. 46011/104/2009-PC- II dated 21.10.2014, it was decided to ratify norms under Para 4.7 of HBP vi as per details given below 1 AL KUMAR ci: 8 Hee ATH fan Trade Dy. tyDires* ory Peureraa eaign Trade ao uf Commerce Udyog ‘Snawan, New Dethi

| | | |

or as applied by the firm, whichever is less:

==> picture [444 x 287] intentionally omitted <==

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

|||||||||
|---|---|---|---|---|---|---|---|
|Export product|Exp.|||SI.No.|||Import items|Qty.|allowed|
|||Dettol Medicated|1|Woven Dyed Fabric of 100%|| 0.001320|Sq. Meter|
|Fabric Plaster|Size|19|||No.|Texturised|Polyester|
|mmx65mm|Filament, GSM115|+/-|10%|
|2.|Non Woven Rolls|, GSM|100|||0.000315|Sq. Meter|
|+/-|15%|
|3.|Cold glue coated poster paper|| As per packing|
|88MM WIDTH +/-1MM|pollicy|
|Release Film39mm width +/-|| As per packing|
|imm|pollicy|
|RA may|take appropriate action as per the decision of Norms Committee.|:|
|Case No.:230/3/82-|Party Name:SWISS|Meet No/Date:9/82-|__[Status:Deffered|
|ALC4/2014|EXPORTS PVT. LTD.|ALC4/2014|and Re-indexed|
|247||HQ File|RLA File||20.10.2014Lic.No/Date:08 101284987|Defer|
|:01/82/050/00234/AMI5/|—_|:08/24/040/00474/AM14/|[29.01.2014|‘[Date:26.11.2014|
|Decision|:|It was decided to defer the case for 26.11.2014|for comments of|Department|
|of|Pharmaceuticals|

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||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|;|
|Case No.:44/4/82-|Party Name:CATAPHARMA|[Meet No/Date:9/82-|(Status:Deffered|
|ALC4/2014|CHEMICALS PVT. LTD.,|[ALC4/2014|and Re-indexed|
|20.10.2014|ce|
|24%||HQ|File|RLA|File|Lic.No/Date:3|110062387|[Defer|
|01/82/0S0/00292/AM15/|—_|:31/83/040/00199/AM14/|[30.01.2014|_—|[Date:26.11.2014|
|Decision|:|It|was|decided|to|call|from|the|firm COA|of import|item|from|the|foreign|
||supplier|for the relevant consignment|.|The case was deferred|for 26.11.2014.|

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||||||||
|---|---|---|---|---|---|---|
|Case No.:209/3/82-|Party Name:DR REDDYS|[Meet No/Date:9/82-|(Status: Deffered|
|ALC42014|LABORATORIES LIMITED||ALC4/2014|and Re-indexed|.|
|249|[HQ File|RLA File|20.10.2014Lic.No/Date:09 10059127|||[Defer|||
|:01/82/050/00213/AM15/|_|:09/24/040/00540/AM14/_[30.01.2014|Date:26.11.2014|
||||Decision|:|It was decided to defer the case for 26.11.2014|for comments of Department|
|of|Pharmaceuticals|

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

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----- Start of picture text ----- 7 Case No.:177/3/82- Party Name:INDO AMINES [Meet No/Date-9/82- Status:Deffered ALC4/2014 LIMITED ALC4/2014 and Re-indexed {20.10.2014 250 [HQ File RLA File Lic.No/Date:03 10768616 [Defer a :01/82/050/00181/AM15/ :03/94/040/00958/AM14/ 30.01.2014 Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals ----- End of picture text -----

Dy. Moa‘ ' Oe catedpoo ForeignMVSTrade : cing Trade wt so! Cosimerce - aed og Pe Juyvy Bnawan, New Oethi

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

|||||||
|---|---|---|---|---|---|
|:|Case No.:223/3/82-|Party Name:UNIJULES LIFE||Meet No/Date:9/82-|Status:Deffered|
|ALC4/2014|SCIENCES LTD.|ALC42614|and Re-indexed|
|_|20.10.2014|
|251|HQ File|RLA File|Lic.No/Date:03|10768632|[Defer7|
|:01/82/050/00227/AM15/|:03/95/040/00867/AM14/|30.01.2014|Date:26.11.2014|
|Decision|:|It was decided to defer the case for 26.11.2014 for comments of|Department|
|of|Pharmaceuticals|
|.|
|Case No.:206/3/82-|Party Name:AUROBINDO|[Meet No/Date:9/82.|~~ [Status:Deffered|
|ALC4/2014|PHARMA LIMITED|ALC4/2014|and Re-indexed|
|0.10.2014|
|252|[HQ File|RLA|File|Lic.No/Date:0910059129|[Defer|
|:01/82/050/00210/AM15/|_|:09/24/040/00556/AM14/|{31.01.2014|Date:26.11.2014|

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

Decision : It was decided to defer the case for 26.11.2014 for comments ofDepartment of Pharmaceuticals

[7 [easeALC4/2014 No.:165/3/82PartyName:MANGALAM [Meet No/Date:9/82-___[Gtatus:Deffered ORGANICS LIMITED. ALC4/2014 jand Re-indexed 20.10.2014
253 [HQ File RLA File Lic.No/Date:03 10768928i[Defer :01/82/050/00169/AM15/ :03/94/040/00448/AM14/ 3.02.2014 Date:26.11.2014 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.:111/3/82-|Party Name:SRIAM LABS|Meet No/Date:9/82-|Status: Deffered|
|ALC42014|PRIVATE LIMITED|ALC42014|and Re-indexed|
|20.10.2014|
|1254||HQ File|RLA|File|Lic.No/Date:09 10059150||[Defer|.|
|:01/82/050/00115/AM15/|:09/24/040/00509/AM14/|03.02.2014|Date:26.11.2014|
|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.:26/3/82-|Party|Name:|MEDICEF|Meet No/Date:9/82-|(Status: Deffered|
|ALC4/2014|PHARMA,|ALC4?2014|and Re-indexed|
|20.10.2014|
|255|1HQ File|RLA File|Lic.No/Date:22 10014587||DeferoO|
|:01/82/050/00030/AM15/|:22/24/040/00080/AM|14/|04.02.2014|26.11.2014|
|||Decision|:|It was decided to defer the case for 26.11.2014 for comments ofDepartment|
|of Pharmaceuticals|

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----- Start of picture text ----- Case No.:27/3/82- Party Name:MEDICEF [Meet No/Date:9/82- (StatusiDeffered ALC4/2014 PHARMA, ALC42014 and Re-indexed . 20.10.2014 256 |HQ File RLA File Lic.No/Date:22 10014589 |v oo |:01/82/050/0003 1/AM15/ :22/24/040/00081/AM14/ [04.02.2014 | [Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals “ ----- End of picture text -----

"+ + Caoneral of Foreign Trade ral of Foreign Trade ‘eparunent of Commerce

“ Case No.:28/3/82Party Name: MEDICEF Meet No/Date:9/82_|Status:Deffered ALC4/2614 PHARMA, ALC4/2014 land Re-indexed 20.10.2014 | !
1257: [HQ File RLA File Lic.No/Date:2210014588 |Defer :01/82/050/00032/AM15/ :22/24/040/00082/AM 1 4/ 04.02.2014 Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments ofDepartment of Pharmaceuticals . - - Case No.:87/3/82Party Name: VIVIMED LABS Meet No/Date:9/82Status:Deffered ALC4/2014 LIMITED ALC4/2014 jand Re-indexed 20.10.2014 . .
258 [HQ File RLA File Lic.No/Date:09 10059155 |Defer :01/82/050/00091/AM15/ :09/24/040/00544/AM14/ 04.02.2014 Date:26.11.2014
| |Decision : It was decided was decided decided to defer the case for 26.11.2014 defer the case for 26.11.2014 the case for 26.11.2014 case for 26.11.2014 for 26.11.2014 26.11.2014 for comments of comments of of Department of Pharmaceuticals - .
- | |Decision : It was decided was decided decided to defer the case for 26.11.2014 defer the case for 26.11.2014 the case for 26.11.2014 case for 26.11.2014 for 26.11.2014 26.11.2014 for comments of comments of of Department of Pharmaceuticals - .
- [Case No.:117/3/82Party Name:VIVIMED LABS (Meet No/Date:9/82(Status: Deffered ALC4/2014 LIMITED ALC4/2014 and Re-indexed
- . 20.10.2014 259 [HQ File RLA File Lic.No/Date:0910059156 (Defer :01/82/050/00121/AM15/ :09/24/040/00543/AM14/ 04.02.2014 Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals 7 . Case No.:232/3/82Party Name:CADILA Meet No/Date:9/82[Status:Deffered - ALC42014 HEALTHCARE LTD., ALC4/2014 jand Re-indexed 20.10.2014 a
- 260 |HQ File RLA File Lic.No/Date:08 10128700. |Defer :01/82/050/00236/AM15/ :08/24/040/00485/AM14/ 05.02.2014 _ |Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department
- | |of Pharmaceuticals.
- ~~ [Case No.i221/3/82Party Name:CIPLA Meet No/Date:9/82(Status:Deffered ALC4/2014 LIMITED ALC4/2014 and Re-indexed 20.10.2014
- 261 |HQ File RLA File Lic.No/Date:03 10769240: |Defer :01/82/050/00225/AM15/ :03/94/040/00995/AM14/ 05.02.2014 Date:26,.11.2014 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.:222/3/82- Party Name:CIPLA Meet No/Date:9/82- Status:Deffered : ALC4/2014 LIMITED ALC4/2014 and Re-indexed 20.10.2014 od . 262 [HQ File RLA File Lic.No/Date:03 10769244 |Defer :01/82/050/00226/AM15/ :03/94/040/00985/AM14/ [05.02.2014 ‘|Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments ofDepartment i of Pharmaceuticals </NIRMAL KUMA net° AEietsce aog aisptif rioForeigntTETetTa Trade lp. f Piscean Trade ----- End of picture text -----

uuyog Bhawan, New Dethi

| |

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

||||||
|---|---|---|---|---|
|4|Case No.:224/3/82-|Party Name:CIPLA|eetNo/Date:9/82-|_[Status:Deffered|
|ALC4?2014|LIMITED|ALC4/2014|and Re-indexed|
|(20.10.2014|
|263||HQ File|RLA File|Lic.No/Date:03 10769253||Defer|
|:01/82/050/00228/AM15/|:03/94/040/00979/AM14/|05.02.2014|Date:26.11.2014|
|Decision|:|It was decided to defer the case for 26.11.2014 for comments ofDepartment|
|of|Pharmaceuticals|

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==> picture [490 x 632] intentionally omitted <==

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

||||||||
|---|---|---|---|---|---|---|
|Case|No.:225/3/82-|Party Name:CIPLA|Meet No/Date:9/82-|Status:Deffered|
|ALC4/2014|LIMITED|ALC4/2014|and Re-indexed|
|20.10.2014|
|264|{HQ File|RLA|File|Lic.No/Date:03|10769247||Defer.|
|{|||Decision:01/82/050/00229/AM15/:|It was decided to:03/94/040/00991/AM14/ defer the case for 26.11.201405.02.2014 for comments ofDate:26.11.2014Department||;|.|
|of|Pharmaceuticals|
|:|Case No.:149/3/82-|Party|Name:|MOREPEN|Meet No/Date:9/82-|Status:Deffered|
|ALC4/2014|LABORATORIES LTD.,|ALC4/2014|and Re-indexed|
|20.10.2014|
|265.|/HQ File|RLA File|Lic.No/Date:05 10378413||Defer|/|
|:01/82/050/00153/AM15/|:05/24/040/00420/AM14/|05.02.2014|_ Date:26.1 1.2014|
|Decision|:|it was decided to call from the firm the complete technical details as per Appendix|
|33. The case was deferred|for 26.11.2014|
|Case No.:168/3/82-|Party Name:CIPLA|Meet No/Date:9/82-___[Status:Deffered|
|ALC4/2014|LIMITED|ALC4/2014|and Re-indexed|
|266||HQ File|RLA File|.|20.10.2014Lic.No/Date:03|10769592||Defer|
|“01/82/050/00172/AM15/|__|:03/94/040/01009/AM14/|—_|[06.02.2014|Date:26.11.2014|
|Decision|:|It was decided to defer the case for 26.11.2014 for comments ofDepartment|
|of|Pharmaceuticals|
|Case No.:150/3/82-|Party Name:MACLEODS|[Meet No/Date:9/82-|[Status:Defferea|
|ALC4/2014|PHARMACEUTICALS|LTD.||ALC4/2014|and Re-indexed|
|.|20.10.2014|
|967|[HQ File|RLA File|Lic.No/Date:03|10769509|[Defer|;|
|:01/82/050/00154/AM|15/|:03/95/040/00879/AM14/|_|06.02.2014|Date:26.11.2014|
|Decision|:|It was decided to defer the case for 26.11.2014 for comments of|Department|
|of|Pharmaceuticals|
|Case No.:8/3/82-ALC4/2014|Party|Name:ALEKHYA|Meet No/Date:9/82-|Status:Deffered|
|DRUGS PVT LTD.|ALC4/2014|and|Re-indexed|
|||.|
|||10.10.2014|
|268||HQ File|RLA File|Lic.No/Date:09 10059218||Defer|.|
|:01/82/050/00012/AM15/|:09/24/040/00548/AM14/|—_—(07.02.2014|Date:26.11.2014|
|of|Pharmaceuticals|
|Decision|: It was decided todefer the case for|26.11.2014 for|comments ofDepartment|ly)|
|p|
|tps|KUMAR|
|wa we|em|Crys|RAAT|
|vayed brigvan|hoe|beini|

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----- Start of picture text ----- a Case No.:10/3/82- Party Name:ARENE LIFE _|[Meet No/Date:9/82- Status: Deffered ALC42014 SCIENCES LIMITED. ALC4/2614 and Re-indexed | 20.10.2014 269 HQ File RLA File Lic.No/Date:09 10059227 (Defer ‘O1/82/050/00014/AM15/__[:09/24/040/00534/AM14/ [07.02.2014 _ [Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department ofPharmaceuticals oe , ----- End of picture text -----

Case No.:59/3/82Party Name:ARENE LIFE (Meet No/Date:9/82Status: Deffered ALC4/2014 SCIENCES LIMITED. ALC4/2014 and Re-indexed 20.10.2014
270 |HQ File RLA File Lic.No/Date:09 10059222 |Defer :01/82/050/00063/AM15/ 709/24/040/0055 1/AM14/ 07.02.2014 Date:26.} 1.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals
Case No.:49/3/82Party Name:AUROBINDO [Meet No/Date:9/82Status:Deffered ALC42014 PHARMA LIMITED ALC42014 and Re-indexed .
[271 | 20.10.2014 [HQ File RLA File Lic.No/Date:0910059197 [Defer :01/82/050/00053/AM15/ :09/24/040/00562/AM14/ 07.02.2014 ‘|Date:26.1 1.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals .
Case No.:151/3/82Party Name:CIPLA Meet No/Date:9/82(Status: Deffered ALC42014 LIMITED ALC4/2014 and Re-indexed
272 |HQ File RLA File 20.10.2014Lic.No/Date:03 107697557 |Defer , :01/82/0S0/00155/AM15/ —|:03/94/040/01022/AM14/[07.02.2014 Date:26.11.2014 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.:84/3/82- Party Name:STERICON Meet No/Date:9/82- Status: ALC42014 PHARMA PVT.LTD., ALC4/2014 Approved 20.10.2014 HQ File RLA File Lic.No/Date:0710102047 |Defera Date: :01/82/050/00088/AM15/ °07/24/040/004 19/AM 14/ 07.02.2014 Decision : Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 3501 1/180/2014-PI(Norms) b73 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:- | SI. | Export Product No. SOFT SODIUM BOTTLE CAPWHITE | DROPPER | HYALURONATE NaF100 wy wears PYEsyT eae Dy fore . bormign Trade ‘ Sel wi gn Trade . Sensi tunnsin uf Commerce ue) bnawan! Now Betni ----- End of picture text -----

| | || | : | | : , |

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----- Start of picture text ----- | AND COMFORT EYE | VIZULIZEDROPS 0.1% -10ML REWETTING EYE | 2 LUBRICATING AND 90/0- VIZULIZE EYE | DROPS 15ML 3 BRIGHTENER EYE NIL DROPS 10ML RA concerned may take further necessary action as per above decision of NC. ----- End of picture text -----

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----- Start of picture text ----- ; ----- End of picture text -----

ALC4/2014Case No.:21/4/82PartyName:KREATIVE [Meet No/Date:9/82(Status: Deffered ORGANICS (P) LTD., ALC422014 and Re-indexed 20.10.2014 1274 |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:26.11.2014 Decision ; It was decided to defer the case for 26.11.2014 for comments of Department of C&PC . .

CaseALC4/2014 No.:166/3/82- P artyERFUMESName: PVT.LTD.VUAY MeetALC4/2014 No/Date:9/82Status:Deffand Re-ind e xr ed 20.10.2014
275 (HQ File RLA File Lic. No/Date:03 10770668 [Defer:
| 01/82/050/00170/AM15/ —_—|:03/95/040/00916/AM14/ ‘18.02.2014 Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals
Case No.:65/3/82Party Name:HETERO LABS |Meet No/Date:9/82Status:Deffered ALC42014 LIMITED ALC42014 land Re-indexed . 20.10.2014
276 [HQ File RLA File Lic,No/Date:0910059337 [Defer :01/82/050/00069/AM15/ :09/24/040/00595/AM14/ 19.02.2014 Date:26.11.2014 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.:132/3/82- Party Name: VENUS Meet No/Date:9/82- Status:Deffered ALC4/2014 REMEDIES LTD., ALC4/2014 and Re-indexed 277 |HQ File _ RLA File 20.10.2014Lic.No/Date:22 10014635 [Defera O1/82/050/00136/AM15/ —_|:22/24/040/00088/AMI14/ 26.02.2014 |Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments ofDepartment __jof Pharmaceuticals . Case No.:57/6/82- ) Party Name:GLENMARK Meet No/Date:9/82- 7 Status:Deffered ALC4/2014 GENERICS LIMITED ALC4/2014 and Re-indexed | |278) | 20.10.2014 .  [HQ File IRLA File [Lic. No/Date:03 10772498 [Defer — r- -t UMAR ‘ "0 esan Trade ' ot} creignere sitar?Trade| Steeple ete. merce Udyog Bnawan, New Delhi ----- End of picture text -----

[28.02.2014 ~— [Date:26.11.2014

| [01/82/0S0/00459/AMis/__[:03/94/040/01074/AM14/ [28.02.2014 ~— [Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals

a Case No.:34/4/82Party Name:MOREPEN _[Meet No/Date-9/82[Status:Deffered ALC4/2014 LABORATORIES LTD., ALC42614 and Re-indexed . 20.10.2014 279 [HQ File RLA File Lic. No/Date:05 10380668 [Defer :01/82/050/00282/AM15/ :05/24/040/00455/AM14/ 03.03.2014 Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department {of Pharmaceuticals .

Case No.:178/6/82Party Name:CLARION Meet No/Date:9/82-__[Status:Deffered ALC4/2014 DRUGS LTD., ALC4/2014 and Re-indexed 20.10.2014 .
280,{HQ File RLA File Lic.No/Date:5010001998 [Defer :01/82/050/00580/AM15/ :50/24/040/000 12/AM14/ 04.03.2014 Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals
~~ (Case No.:46/6/82Party Name:NAPROD LIFE (Meet No/Date:9/82ALC4/2014 SCIENCES PVT. LTD. ALC4/2014 (Status:and Re-indexed Deffered
281 |HQ File RLA File Lic.No/Date:03 10772962 |Defer :01/82/050/00448/AMI5/ —_|:03/95/040/00986/AM14/ [04.03.2014 _— [Date:26.11.2014

Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals

7 Case No.:56/6/82Party Name:GITANJALI Meet No/Date:9/82Status: . ALC42014 CHEMICALS PVT LTD ALC4/2014 Approved . . 20.10.2014 | HQ File JRLA File Lic.No/Date:03 10773094 [Defer Date: | :01/82/050/00458/AMI5/ —_|:03/94/040/00980/AM14/ [05.03.2014 . Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/41/2011-Ch It dated 01.10.2014, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

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----- Start of picture text ----- 282 Export product Exp. Import items Qty. allowed Qty. 0.520 Ke 1.560 ke ----- End of picture text -----

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

sooner fayeey org . ‘or General of Fore + Ti eI ASTeTe ne General of Fore Ire. “ays5 1 4Mbin[Department] NE.[ of] ¢ a

: ||

;

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----- Start of picture text ----- “ Case No.:33/6/82- Party Name:INDOCO Meet No/Date:9/82- — Status:Deffered ALC4/2014 REMEDIES LIMITED ALC4/2614 Jand Re-indexed 283 |HQ File | RLA File 20.10.2014Lic.No/Date:03 10773117 Defer 7 :01/82/050/00435/AM15/ —_|:03/94/040/00993/AM14/ _—‘[05.03.2014 — [Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department jof C&PC ----- End of picture text -----

. . a Case No.:34/6/82Party Name:INDOCO Meet No/Date:9/82-__|Status:Deffered ALC4/2014 REMEDIES LIMITED C4/2014 and Re-indexed 284 |HQ:01/82/050/00436/AMFile RLA File Lic.No/Date:030.10.2014 107731 12'|Defer I 5/ 03/94/040/00973/AM14/ 05.03.2014 ‘{Date:26.11.2014 | Decision : It was decided to defer the case for 26.11.2014 for comments of Department lof C&PC. a . Case No.:45/6/82Party Name:SHREE Meet No/Date:9/82(Status: |ALC4/2014 RAJESHWARI SPECIALTY |ALC4/2014 Approved CHEM. PRIVATE 20.10.2014 LIMITED., HQ File RLA File Lic.No/Date:03 10773455 |Defer Date: :01/82/050/00447/AM15/ —|:03/95/040/00984/AM14/ [07.03.2014 fe : Decision : in the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/10/2009-Ch It dated 02.09.2014, it was decided to 285 iratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

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----- Start of picture text ----- | Export product Exp. import items Qty. allowed Qty. Tate ----- End of picture text -----

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

RA may take appropriate action as per the decision of Norms Committee. may take appropriate action as per the decision of Norms Committee. take appropriate action as per the decision of Norms Committee. appropriate action as per the decision of Norms Committee. action as per the decision of Norms Committee. as per the decision of Norms Committee. per the decision of Norms Committee. the decision of Norms Committee. decision of Norms Committee. of Norms Committee. Norms Committee. Committee. _ Case No.:119/6/82[Party Name:-EMCURE Meet No/Date:9/82(Status: Deffered ALC4/2014 PHARMACEUTICALS LTD. |ALC42014 land Re-indexed 20.10.2014 286 |HQ File IRLA File Lic.No/Date:3 110063002 :!Defer 01/82/050/00S21/AMI5/ —_|:31/83/040/00235/AM14/ _|10.03.2014 |Date:26.11.2014 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.:32/6/82- Party Name:INDOCO Meet No/Date:9/82- |Status:Deffered ALC4/2014 REMEDIES LIMITED ALC4/2014 and Re-indexed 287 [HQ File RLA File Lic.No/Date:0320.10.2014 10774050 (Defer . :01/82/050/00434/AM15/ :03/94/040/01104/AM14/ 11.03.2014 Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department , of C&PC Perio BN/NIRMAL KUMAR Dy Mire. 1: cea Ct Foegn Trade ae rade oan rai! Commerce Uayag ohn Naw Delni ----- End of picture text -----

| | ,

| : |

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----- Start of picture text ----- “ Case No.:28/6/82- Party Meet No/Date:9/82- Status: ALC4/2014 Name: ARIHANTANAM ALC4/2014 Approved . LIFECARE PVT. LTD. 20.10.2014 : HQ File RLA File Lic.No/Date:03 10774198. |Defer Date: :01/82/050/00430/AM15/ :03/94/040/01115/AM14/ 12.03.2014 Decision: In the light of written comments received from Department of Pharmaceuticals vide OT their OM No. 35011/296/2013-Pl{Norms) dated 03.07.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: : i Export product Exp. Qty. Import items Qty. allowed DIHYDR' kg/kg RA may take appropriate action as per the decision of Norms Committee. Case No.:30/3/82- Party Name:BELCO Meet No/Date:9/82- Status: Deffered ALC4/2014 PHARMA ALC4/2014 and Re-indexed 20.10.2014 - 289 |HQ File RLA File Lic.No/Date:05 10381658 \Defer :01/82/050/00034/AM15/ :05/23/040/00479/AM14/ 12.03.2014 [Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments ofDepartment of Pharmaceuticals ; ----- End of picture text -----

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----- Start of picture text ----- Case No.:26/6/82- Party Meet No/Date:9/82- Status:Deffered ALC42014 Name: ARIHANTANAM ALC4/2014 and Re-indexed 1290,/HQ File RLALIFECAREFile PVT. LTD. 20.10.2014Lic.No/Date:03 10774412 | |Defer ; :01/82/050/00428/AM 1 5/ :03/94/040/01123/AM14/ 13.03.2014 Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments ofDepartment of Pharmaceuticals Case No.:11/9/82-ALC4/2014 |Party Name:SMILAX Meet No/Date:9/82- Status:Deffered LABORATORIES LIMITED /ALC4/2014 and Re-indexed 20.10.2014 29} |HQ File RLA File Lic.No/Date:09 10059558 |Defer :01/82/050/00808/AM15/ :09/24/040/0061 8/AM14/ 13.03.2014 Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals ----- End of picture text -----

, Case No.:182/6/82Party Name:ESTEEM Meet No/Date:9/82Status: ALC4/2014 INDUSTRIES PVT, LTD, ALC4/2014 Approved | 20.10.2014 a ae HQ File RLA File Lic.No/Date: 1710005741 .|Defer Date: 292 |:01/82/050/00584/AM15/ ——|:17/24/040/00133/AM14/ ——s*|14.03.2014 Decision : In the light of written comments received from Department of Chemicalsa and Petrochemicals vide their U.O No. 14010/69/2011-Ch ti dated 28.10.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Pris aare/NIRMAL KU Dy Director General of Foreign Trade forer eer 2 aeiPreeirerd Toate accerat. foreign Trade uayeg GnewanNew Bein

| |

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

|||||.<br>,|
|---|---|---|---|---|
||Exportproduct|Exp.|Importitems|Qty.allowed|
|If||Qty.|||
|1||<br>|PRODUCT-ABT (ALKYL<br>SBENZOATE)<br>Appearance:LightYellow<br>provouriess clearThquid)<br>||1kg Zz <br>2.|LAURYLALCOHOL(C12-C14<br> **A**LCOHOL<br>/LAURYLMYRISTYL<br>LCOHOL)<br>‘Colouriessclear insolubleliquid<br>BENZOICACID<br>(Crystalline solid)|0.648kg<br>0.412kg|
||Amaytakeappropriate actionasperthedecisionofNormsCommittee.||||
||CaseNo.:56/4/82-<br>ALC4/2014|PartyName:IND-SWIFT<br>MeetNo/Date:9/82-<br>LABORATORIES LTD.,<br>ALC4/2014||Status:Deffered<br>andRe-indexed|
||||20.10.2014||
||3 [HQFile<br>01/82/050/00304/AM15/|RLAFile<br>Lic.No/Date:2210014691 (Defer<br>:122/24/040/00102/AM14/<br>14.03.2014<br>Date:26.11.2014|||
||Decision : Itwasdecidedtodeferthecasefor<br>ofPharmaceuticals<br>.||for26.11.2014 forcommentsofDepartment||

||||[CaseNo.:57/4/82~<br>ALC42014|PartyName:IND-SWIFT<br>LABORATORIESLTD.,|PartyName:IND-SWIFT<br>LABORATORIESLTD.,|MeetNo/Date:9/82-<br>Status:Deffered<br>ALC4/**20**14<br>andRe-indexed<br>20.10.<br>14||
|---|---|---|---|---|---|---|---|
||||||||||
|||294||HQFile<br>01/82/050/00305/AM15/|RLAFile<br>—_|:22/24/040/00103/AM14/||Lic.No/Date:2210014692 |Defer<br>—_‘{14.03.2014<br>——-PDate:26.11.2014|||
||||Decision ; Itwasdecidedto<br>ofPharmaceuticals|todefer thecase for26.11.2014forcommentsofDepartment||||
||||Case No.:58/4/82-<br>ALC4/2014|PartyName:IND-SWIFT<br>LABORATORIES LTD.,||[MeetNo/Date:9/82-<br>‘(Status:Deffered<br>_<br>ALC4?22014<br>jandRe-indexed||
||.||.|||20.10.2014<br>|||
|||ngs|[HQ File<br>01/82/050/00306/AM15/|RLA File<br>—_|:22/24/040/00100/AM14/||Lic.No/Date:2210014694 [Defer<br>—‘|14.03.2014<br>Date:26.11.2014||
||||Decision : Itwasdecidedto<br>ofPharmaceuticals|todeferthecasefor26.11.2014forcommentsofDepartment||||
||||||||||
||||CaseNo.:1/4/82-ALC4/2014|[PartyName-DORF-KETAL||[MeetNo/Date.9/82.<br>[Status:Defferea||
|||||CHEMICALSINDIA<br>PVT.LTD.|ALC4/2014<br>andRe-indexed<br>20.10.2014||.|
|‘||296|[HQFile<br>:01/82/050/00249/AM15/|RLA File<br>:03/94/040/00999/AM 14/||Lic.No/Date:03 10774824 [Defer<br>18.03.2014<br>Date:26.11.2014||
||||Decision : It was decided <br>ofPharmaceuticals|to deferthecase for26.11.2014|26.11.2014 for comments ofDepartment|||

Case No.:42/4/82Party Name:RECKITT Meet No/Date:9/82Status:Deffered ALC4/2014 BENCKISER ALC4/2014 and Re-indexed 297 HEALTHCARE INDIA 20.10.2014 | [HQ File [RLALIMITED File [Lic.No/Date:0510382032' 4 \ ars areal Press Det . : cb ean Trade Mees te£* 9 ssn Trade "Loy cit crt of Commerce UdyogSHABhawan,Stier, ag NewReetDelhi

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

:01/82/050/00290/AMi5/ __[-05/24/040/00480/AMI4/ (18.03.2014 [Defer oo [Date:26.11.2014 Decision : It was decided to call 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 26.11.2014.

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||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|[”|
||Case No.:43/24/82-|Party|Name:THINQ|Meet No/Date:9/82-|__|Status:Deffered|
|ALC4/2013|PHARMA-CRO LIMITED|ALC4/2014|and Re-indexed|
|_|Z|20.10.2014|.|
|298||HQ|File|RLA File|Lic.No/Date:03 10774773||Defer|
|01/82/050/01242/AM14/|—|:03/95/040/00987/AM14/|_‘|18.03.2014|Date:26.11.2014|
|Decision|:|it was decided to|call from the firm the complete technical|details|as per Appendix|
|33. The case was deferred|for 26.11.2014.|
|Case No.:42/6/82-|Party|Name:TITAN|Meet No/Date:9/82-|__(Status:Deffered|
|ALC4/2014|LABORATORIES|PVT.|ALC4/2014|jand|Re-indexed|
|LTD.|01020140|
|299|[HQ File|RLA File|Lic.No/Date:03 10774745|[Defer|
|:01/82/050/00444/AMI5/|—_|:03/95/040/00997/AM14/|[18.03.2014||Date:26.11.2014|
|Decision|:|It was decided to defer the case for 26.11.2014|for comments of|Department|
|of|Pharmaceuticals|.|
|Case No.:124/6/82-|Party|Name:|UNITED|Meet No/Date:9/82-|Status:Deffered|
|ALC42014|BIOTECH PVT.LTD.|ALC4/2614|jJand Re-indexed|
|300||HQ|File|RLA File|Lic.No/Date:05 10382042||Defer|
|:01/82/050/00526/AM15/|—_|:05/24/040/00467/AM14/|{18.03.2014|‘|Date:26.11.2014|
|Decision|:|It was decided|to defer the|case for 26.11.2014|for comments ofDepartment|
|||_|lof Pharmaceuticals|.|
|Case No.:39/6/82-|Party Name:CROWN|MeetNo/Date:9/82-|Status:Deffered|
|ALC42014|CHEMICALS PVT.LTD.,|ALC4/2014|nd Re-indexed|
|||20.10.2014|.|
|||301|(HQ File|RLA File|Lic. No/Date:03|10775043|[Defer|
|||01/82/050/00441/AM15/|—_[:03/94/040/01136/AM14/|_—|19.03.2014||Date:26.11.2014|
|Decision|:|It was decided|to defer the case|for 26.11.2014|for comments of|Department|
|of Pharmaceuticals|
|[7|[Case No.:29/6/82-|Party Name:DORF-KETAL|[Meet No/Date:9/82-__[Status:|
|ALC4/2014|CHEMICALS INDIA|ALC4/2014|Approved|
|PVT.LTD.|20.10.2014|_|
|||.|HQ File|RLA|File|Lic.No/Date:03 10775045||Defer Date:|
|:|
|302|701/82/050/0043 1/AM15/|:03/94/040/00899/AMI14/|=||19.03.2014|
|Decision|:|In|the|light|of|written|comments|received|from|Department|of|Chemicals|and|
|Petrochemicals|vide|their|U.O|No.|14010/176/2011-Ch|It|dated|07.10.2014,|it|was|decided|to|
|ratify|norms|under|Para|4.7|of|HBP|v1|as|per|details|given|below|or|as|applied|by|the|firm,|
|||,|whichever|is|less:|
|||oor I|of Foreign Trade|
|foo|corny|AerPrexnesa|
|Our|ae|Coneral|of|Foreign Trade|
|ae|So|eye|miment|of Commutce|
|:|Udyog ‘BnoWwan.|New|Delhi|

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

|Aa||=—<br>" —<br>— —<br>| Exportproduct<br>:<br>|Chemical-Solid Wetting<br>Agent<br>-<br>_|———<br>————<br>————————<br>——<br>-_ —<br>Exp.<br>Importitems<br>Qty.<br>MonoEthylene Glycol /MEG |0.500|—<br>Qty.allowed<br>0.500kg|
|---|---|---|---|---|
|||**2**32/<br>; 1 32/SR 1165/YS SR<br>11165/SR 1102/SR 3023 /<br>R 1104/SR 1182/YSSR|3.<br>.<br>.<br>.<br>Alkyldiphenyloxide Di<br>sulfonate/CalfaxDB-45 /|0.180<br>Ke|
|||| Containing50%ofMEG&|||
|||18%of|||
|||A ikyldiphenyloxide|||
|||Disulfonate|||
|||Amaytake appropriateactionasperthedecisionofNormsCommittee.|||
|||||.|
|||CaseNo.:45/24/82-<br>ALC4/2013|Party Name:VIVIMED LABS [MeetNo/Date-9/82-<br>(ALATHUR)PRIVATE<br>4/2014<br>LIMITED<br>20.10.2014|[Starus:Defferea<br>andRe-indexed|
||303 <br>—||HQFile<br>O1/82/0S0/01244/AM14/<br>Decision : Itwasdecidedto<br>fofC&PC.|—<br>RLA File<br>Lic.No/Date:0410156358 :|Defer<br>—_|:04/24/040/00264/AM14/ _ {19.03.2014<br>Date:26.11.2014<br>todeferthecasefor26.11.2014 forcommentsofDepartment||
|||CaseNo.:172/6/82-<br>ALCd2014|PartyName:ATUL<br>[MeetNo/Date-9/82-<br>BIOSCIENCELIMITED<br>ALC4/2014||Status:Deffered<br>andRe-indexed|
|||.|20.10.2014||
||304||HQFile<br>:01/82/050/00574/AM15/<br>Decision : Itwasdecidedto<br>ofPharmaceuticals|RLA File<br>Lic.No/Date:52 10040850 |Defer<br>:52/24/040/00035/AM14/<br>25.03.2014<br>Date:26.11.2014<br>todefer thecasefor26.11.2014 forcommentsofDepartment||

||||||.|
|---|---|---|---|---|---|
||CaseNo.:45/24/82-<br>ALC4/2013||Party Name:VIVIMED LABS [MeetNo/Date-9/82-<br>(ALATHUR)PRIVATE<br>4/2014<br>LIMITED<br>20.10.2014||[Starus:Defferea<br>andRe-indexed|
|303 <br>—||HQFile<br>O1/82/0S0/01244/AM14/<br>Decision : Itwasdecidedto<br>fofC&PC.||—<br>RLA File<br>Lic.No/Date:0410156358 :|Defer<br>—_|:04/24/040/00264/AM14/ _ {19.03.2014<br>Date:26.11.2014<br>todeferthecasefor26.11.2014 forcommentsofDepartment|||

Case No.:173/6/82[Party Name:ATUL ” [Meet No/Date:5/82(Status:Deffere ALC4/2014 BIOSCIENCE LIMITED ALC4/2014 and Re-indexed . 20.10.2014
305 [HQ File RLA File Lic.No/Date:5210040851 [Defer :01/82/050/00S7S/AM15/ |:52/24/040/00039/AM14/ —[25.03.2014 [Date:26.11.2014

|Decision : It was decided to defer the case for 26.11.2014 for comments ofDepartment of Pharmaceuticals.

Case No.:123/6/82Party Name:KLJ [Meet No/Date:9/82Status: Deffered ALC4/2014 PLASTICIZERS LTD., ALC4/2014 and Re-indexed 20.10.2014 306 [HQ File RLA File Lic.No/Date:05 10382641 |Defer i :01/82/050/00525/AM15/ ——:05/23/040/00528/AM14/ _—=[25.03.2014 Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments ofDepartment of C&PC | > y faext ona Oi. eae General of Foreign Trace Biviig [isVDepaament of Comm

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

a

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||||||
|---|---|---|---|---|
|Case No.:133/6/82-|Party|Name:PARAMOUNT|[Meet No/Date:9/82-|Status:Deffered|
|ALC4/2014|AROMACHEM PVT.LTD.,||/ALC4/2014|jand Re-indexed|
|.por ike File|RLA File|Lic.No/Date:0520.10.2014|10382643 [Defer|;|
|0 1/82/050/00535/AM|15/|:05/24/040/00487/AM14/|25.03.2014|Date:26.11.2014|
|Decision|:|It was decided to defer the case for 26.11.2014 for comments ofDepartment|
|of|C&PC.|

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

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|||||||
|---|---|---|---|---|---|
|Case No.:134/6/82-|Party Name:PARAMOUNT|[Meet No/Date:9/82-|Status:Deffered|
|ALC4/2014|AROMACHEM PVT.LTD.,||ALC4/2014|and Re-indexed|
|.|20.10.2014|po|
|.|308|Ho File|RLA File|Lic.No/Date:05 10382650|[Defer|
|:01/82/050/00536/AM15/|:05/24/040/00485/AM14/|25.03.2014|‘Date:26.11.2014|
|Decision|:|It was decided to defer the case for 26.11.2014 for comments of|Department|
|ofC&PC.|

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|||||||
|---|---|---|---|---|---|
|Case No.:15/6/82-|Party Name:KOPRAN|Meet No/Date:9/82-|Status: Deffered|
|ALC4/2014|LIMITED|ALC4/2014|and Re-indexed|
|{309|[HQ|File|RLA File|Lic.No/Date:03 10775957|[Defer|
|:01/82/050/00417/AM15/|_|:03/94/040/01159/AM14/|26.03.2014|[Date:26.11.2014|
|Decision|:|It was decided to defer the case|for 26.11.2014|for comments ofDepartment|
|of Pharmaceuticals|

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|||||||
|---|---|---|---|---|---|
|~|[Case No.:116/6/82-|[Party Name:PARENTERAL|[Meet No/Date:9/82-|[Status:Deffered|
|ALC4/2014|DRUGS (INDIA) LTD.,|ALC4/2014|and Re-indexed|
|__b0.10.2014|_|
|310.||HQ File|RLA|File|Lic.No/Date:56 10003946|Defer|
|:01/82/050/00518/AM15/|—_|:56/24/040/00053/AM14/|—_—|26.03.2014|Date:26,11.2014|
|Decision|:|It was decided to defer the case|for 26.11.2014|for comments|of Department|
|of Pharmaceuticals|

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|||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|[|(Case No.128/6/82-|Party|Meet|No/Date:9/82-|(Status:|
|ALC4/2014|Name:R.K.INDUSTRIES,|ALC4/2014|Approved|
|||.|(20.10.2014|.|
|HQ File|RLA|File|Lic.No/Date:08 10130056|Defer Date:|
|:01/82/050/00530/AM15/|4:08/24/040/00582/AM14/|26.03.2014|.|
|Decision|:|In|the|light|of|written|comments|received|from|Department|of|Chemicals|and|
|Petrochemicals|vide|their|U.O|No.|14010/11/2010-Ch|II|dated|18.09.2014,|it|was|decided|to|
|31]|ratify|norms|under|Para|4.7|of|HBP|v1|as|per|details|given|below|or|as|applied|by|the|firm,.|
|whichever|is|less:|

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| Export product Exp. import items Qty. allowed Qty. | Ortho Toluidine Sulfonic Ortho Toluidine 0.642 kg | ated LDUR MAL. ks MAR Dy.‘Deion: Careral of Foreign Trade c : Thee Trade a: Joss Depanment of Commerce

| | | | : | | :

A may take appropriate action as per the decision of Norms Committee. [Case No.:12 7/6/82. Party Name:CATAPHARMA [Meet No/Date.9/82[StatuasDefferea ALC4/2014 CHEMICALS PVT. LTD., ALC4/2014 land Re-indexed 20.10.2014 312 [HQ File RLA File Lic. No/Date:3 1 10063312 [Defer :01/82/050/00529/AM1 5/ :31/83/040/00232/AM14/ 28.03.2014 Date:26.11 2014 Decision : It was decided to call from the firm COA of import item from the sforeign supplier for the relevant consignment . The case was deferred for 26.1 1.2014

|CaseNo.:60/6/82-<br>ALC4/2014<br>313 [HQFile<br>:01/82/050/00462/AM15/<br>Decision : Itwasdecidedto<br>_jofPharmaceuticals|Party Name:UNIMAX<br>)<br>MeetNo/Date:9/82-<br>Status:Deffered<br>CHEMICALS PVTLTD.<br>ALC4/2014<br>andRe-indexed<br>0.10.2014<br>RLAFile<br>Lic.No/Date:03 10776326 [Defer<br>:03/95/040/01035/AM14/<br>(28.03.2014<br>Date:26.11.2014<br>todeferthecasefor26.11.2014 forcommentsofDepartment|Party Name:UNIMAX<br>)<br>MeetNo/Date:9/82-<br>Status:Deffered<br>CHEMICALS PVTLTD.<br>ALC4/2014<br>andRe-indexed<br>0.10.2014<br>RLAFile<br>Lic.No/Date:03 10776326 [Defer<br>:03/95/040/01035/AM14/<br>(28.03.2014<br>Date:26.11.2014<br>todeferthecasefor26.11.2014 forcommentsofDepartment|
|---|---|---|
|||.|
|CaseNo.:177/6/82-<br>ALC42014|PartyName:ALEMBIC<br>PHARMACEUTICALSLTD|[MeetNo/Date:9/82.<br>(Status:<br> |ALC4/2014<br>Aspproved<br>20.10.2014|
|HQFile<br>:01/82/050/00579/AM15/|RLAFile<br>334/24/040/00320/AM14/|Lic.No/Date:3410039702 [DeferDate:<br>01.04.2014|

|Decision : Committee considered case as per agenda and in the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/665/2013-Pl(Norms) dated 22.01.2014, it was decided to ratify norms under para 4.7 of HBP v 1 as per details given below . or as applied by the firm, whichever is less: 314 For 1 No. Tablet 200 RA may take appropriate action as per the decision ofNorms Committee. Z . Case No.:33/4/82Party Name:JAGSONPAL Meet No/Date:9/82Status: ALC4/2014 PHARMACEUTICALS LTD. |ALC4/2014 Approved 20.10.2014 . 1315 {HQ File RLA File Lic.No/Date:05 10383280 [Defer Date:— :01/82/050/0028 1/AM15/ °05/23/040/00522/AM14/ 01.04.2014 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/197/2014-Pi(Norms) dated 21.10.2014, it was decided=te ratify the nora: R Oy. Director General of Fore:g” i" ide Directorate General of For. ve aE; ly Depanment ure Ry . Udyog Shean ee ni

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----- Start of picture text ----- “ under Para 4.7 ofHBP vi as per details given below or as applied by the firm, whichever is less: ----- End of picture text -----

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||||||||
|---|---|---|---|---|---|---|
|}|Export Product|S.|Import Item|Qty. Allowed|
|||Qh|No.|
|a|i|atc|
|||Misoprostol Tablets|||_—«[2.|||Misoprostol____||204 meg/200 meg tablet|

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

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||||||
|---|---|---|---|---|
|CaseALC4/2014 No.:83/5/82-|PartyLABORATORIESName:VEGESNA PRIVATE__ [Meet|ALC4/2014No/Date:9/82-_(Status:Defferedand|Re-indexed|
|||||LIMITED|20.10.2014|
|316||HQ File|RLA File|Lic.No/Date:09 10059688|[Defer|
|:01/82/050/00400/AM15/|:09/24/040/00666/AM14/|01.04.2014|Date:12.11.2014|

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Decision : It was decided to defer the case for 26.11.2014 for comments of Department | [of Pharmaceuticals

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||||||||
|---|---|---|---|---|---|---|
|7|
|Case No.:35/6/82-|Party Name:AGIO|Meet No/Date:9/82-|Status: Deffered|
|ALC4/2014|PHARMACEUTICALS LTD||ALC4/2014|‘jand Re-indexed|
|20.10.2014|.|.|
|317|[HQ File|RLA File||Lic.No/Date:03 10776774|[Defer|
|:01/82/050/00437/AM15/|_|:03/94/040/00914/AM14/|[02.04.2014|Date:26.11.2014|
|Decision|:|It was decided to defer the case for 26.11.2014|for comments ofDepartment|
|of|Pharmaceuticals|.|
|-|
|” [Case No.:81/6/82-|Party Name:PERFECT|(Meet No/Date:9/82-|[StatussDeffered|
|ALC42014|INDUSTRIES PRIVATE|ALC4/2014|land Re-indexed|
|LIMITED.|20.10.2014|
|318|[HQ File|RLA|File|Lic.No/Date:03|10776759|IDefer|
|:01/82/050/00453/AM15/|:03/95/040/01054/AM14/|02.04.2014|Date:26.1 1.2014|

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| Decision : It was decided to defer the case for 26.11.2014 for comments ofDepartment jof Pharmaceuticals

Case No.:50/6/82PartyName:V&V [Meet No/Date:9/82[Status:Defferea ALC4/2014 PHARMA INDUSTRIES ALC4/2014 and Re-indexed | 20.10.2014
319 [HQ File RLA File Lic.No/Date:0310776760 [Defer . :01/82/050/00452/AM15/ :03/95/040/01061/AM14/ 02.04.2014 ‘[Date:10.11.2014

Decision : It was decided to defer the case for 26.11.2014 for comments ofDepartment of Pharmaceuticals

Case No.:147/6/82Party Name:R L FINE CHEM |Meet No/Date:9/82Status:Deffered ALC4/2014 ALC4/2014 and Re-indexed 320 . 20.10.2014 7 [iQ File RLA File Lic.No/Date:0710103377 [Defer | :01/82/050/00549/AM15/ :07/24/040/00489/AM14/ 03.04.2014 Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments ofDepartment | Dy Director General of Fore.gn Trade Directorate General of Fores 1.53 anti SaryDepantme~ : Week Ha is Udyog Bhawan, New velli

| | | | | ! :

A | fof Pharmaceuticals

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||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|Case|No.:137/6/82-|Party Name:RAY|~~|[Meet No/Date:9/82-__(Status:Deffered|
|ALC4/2014|CHEMICALS PRIVATE|ALC4/2014|and|Re-indexed|
|pa|H|Qoa File|so00539/AMts/|ARLALIMITED,07/24/040/00490/AM14/ File|Lic[03 04.201420.16.2014|.|No/Date:0710103378|—|[| at :26..11.2014|D|ef|e|r|;|
|Decision|:|It was decided|to defer the case|for 26.11.2014|for comments of Department|
|||jofPharmaceuticals|
|Case No.:20/6/82-|Party Name:ADISHANK|(Meet No/Date:9/82-|__(Status:Deffered|
|ALC4/2014|CHEMICALS PVT.LTD.|ALC4/2014|and Re-indexed|
|327||HQ File|RLA|File|Lic. No/Date:03|10777786||Defer|
||||:01/82/050/00422/AM15/|—_|:03/94/040/01140/AMI4/|_{09.04.2014|Date:26.11.2014|
|Decision|:|It was decided to defer the case|for 26.11.2014|for comments|of Department|
|of|C&PC.|
|Case No.:17/6/82-|Party Name:ALTA|Meet No/Date:9/82-|__|Status:Deffered|
|ALC4/2014|LABORATORIES|LTD.|ALC4/2014|and|Re-indexed|
|a|:|20.10.2014|;|.|
|1323:/HQ File|IRLA|File|Lic.No/Date:03 10778781|[Defer|
|:01/82/050/00419/AMI5/|—_|:03/94/040/00023/AM15/|_[21.04.2014|———|Date:26.11.2014|-|
|Decision|:|It was decided to defer the case|for 26.11.2014|for comments of Department|
|||of|Pharmaceuticals|.|
|Case No.:19/6/82-|Panty|Name:GLENMARK|[Meet No/Date:9/82-|__[Status:Deffered|
|ALC4/2014|GENERICS LIMITED|ALC4/2614|and Re-indexed|
|324||HQ File|;|RLA File|20.10.2014Lic. No/Date:03©|10779059||Defer|2|
|:01/82/050/00421/AM15/|:03/94/040/0005 L/AML5/|22.04.2014|Date:26.11.2014|
|Decision|:|It was decided|to defer the case|for 26.11.2014|for comments|of Department|
|of|Pharmaceuticals|a|
|(Case No.:156/6/82-|Party Name:P.D.NAVKAR|[Meet No/Date:9/82-|__Status:Deffered|
|,|ALC4/2014|BIO-CHEM PVT.LTD,|ALC4/2014|and Re-indexed|
|HQ File|RLA File|Lic.No/Date:07 10103670|[Defer|
|01/82/0S0/00SS8/AMI5/|—_[:07/24/040/00483/AM14/|[23.04.2014|—|—|Date:26.11.2014|||
|Decision|:|It was decided|call|form the|firm|following|information:|
|595|i)|Details of|manufacturing process with chemical equations, molecular formula,|
|molecular weights|
|ii)|Yield obtained|in each step supported with authentic|technical|literature|
|iii)|Material|balance|
|iv)|CA certificate|certifying the production of|export item achieved by you for the|
|past three years and corresponding consumption of|each|input.|
|v)|Specifications and formula of|the export product.|
|The|case|is|deferred|for 26.11.2014|;|
|Dy.|Director|General|of Foreign Trade|
|facet|carne|weIfresrea|
|Directorate|General|of Foreign|Trade|
|after|fArVOepartment|of Commerce|
|t sary|Paabala aE|free|

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----- Start of picture text ----- , Case No.:183/6/82- Party Name:TIDE ALC4/2014 |Meet No/Date:9/82- {Status:Deffered INDUSTRIES ALC4/2014 and Re-indexed 20.10.2014 326 HQ File RLA File Lic.No/Date:34 10039854 IDefer oo | :01/82/050/00585/AM13/ ——-|:34/24/040/00005/AM15/ 23.04.2014 Date:26.11.2014 {Decision : It was decided to defer the case for 26.11.2014 for comments ofDepartment of Pharmaceuticals. - 7 Case No.:10/9/82-ALC4/2014 [Party Name:AUROBINDO [Meet No/Date:9/82-[Status:Deffered PHARMA LIMITED ALC4/2014 and Re-indexed 327 {HQ File RLA File Lic.No/Date:09 10059875 [Defer 01/82/050/00807/AM15/ —|:09/24/040/00047/AM15/ (25.04.2014 Decision _ [Date:26,11,2014 of [Pharmaceuticals.] : It was decided to defer the case for 26.11.2014 for comments ofDepartment _ ~ [Case Noi237/6/82- [Party Name-ESTEEM [Meet No/Date:9/82- ‘StatussDeffered ALC4/2014 INDUSTRIES PVT.LTD, [ALC4/2014 and Re-indexed - 328 [HQ File RLA File . 20.10.2014Lic.No/Date: 1710005803 (Defer. . | :01/82/050/00639/AM15/ :17/24/040/00002/AMI15/ [05.05.2014 [Date:09.10.2014 |Decision : It was decided to defer the case for 26.11.2014 for comments of Department of C&PC. | : Case No.:9/9/82-ALC4/2014 [Party Name:SHREE JAYA [Meet No/Date:9/82- ~~ [Status:Defferea ‘LABORATORIES PVT LTD. |ALC4/2014 and Re-indexed . . 20.10.2014 329 |HQ File RLA File Lic.No/Date:09 10060006 (Defer. :01/82/050/00806/AM15/ 09/24/040/00036/AM15/ {07.05.2014 Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department | {of Pharmaceuticals a | [Case No.:236/6/82- Party Name:ESTEEM Meet No/Date:9/82-[Status:Deffered ALC4/2014 INDUSTRIES PVT. LTD, ALC4/2014 jand Re-indexed . 330/HQ . 20.10.2014 File RLA File Lic.No/Date:1710005806.iDefer :01/82/050/00638/AM 1S/ :17/24/040/00007/AM15/ 08.05.2014 Date:09, 10,2014 Decision : It was decided to defer the case for 26.1 1.2014 for comments of Department | lof C&PC. , [ [Case No.:240/6/82- Party Name:MICRO LABS [Meet No/Date:9/2. ~~ [Statuasbetfored ALC42014 LTD ALC4/2014 jand Re-indexed 331 . 20.10.2014 a: | |HQ File IRLA File Lic.No/Date:07 10103970.|Defer :01/82/0$0/00642/AM15/ 07/21/040/00092/AM15/ [08.05.2014 Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department ofPharmaceuticals Peer PER NIRM sR Dr t ad “eneral of Fg SATE ctorate Gone gMeTPreerare Uayed er, ae pa nmerce ----- End of picture text -----

sy

Case No.:72/6/82Party Name:STERLING (Meet No/Date:9/82-__‘(Status: ALC4/2014 AUXILIARIES PVT LTD ALC4/2014 Approved | 20.10.2014 | 1HQ File RLA File Lic.No/Date:03 10780988 iDefer Date: |:01/82/050/00474/AM15/ —_|:03/95/040/00078/AM15/ [08.05.2014 . Decision : : in the light of written comments received from Department of Chemicals and 332 Petrochemicals vide their U.O No. 14010/64/2013-Ch. fi dated 29.08.2014, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

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|||||||
|---|---|---|---|---|---|
|||STERO DIPA|85|Qty.|1.|DIISOPROPANOLAMINE 99|
|(DIISOPROPANOLAMINE)|
|RA may take|appropriate|action|as|per the decision of Norms Committee,|

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||||||||
|---|---|---|---|---|---|---|
|Case No.:238/6/82-|Party Name:ESTEEM|Meet No/Date:9/82-|Status:Deffered|
|ALC4/2014|INDUSTRIES PVT.|LTD,|ALC4/2014|and Re-indexed|
|20.20.2014|
|||
|1333.|HQ File|RLA|File|Lic.No/Date: 1710005810|[Defer|
|||:01/82/050/00640/AM15/|—_‘[:17/24/040/00008/AM15/|—_[09.05.2014|Date:09.10.2014|
|Decision|:|It was decided to|defer the case|for 26.11.2014|for comments of|Department|
|||jof|C&PC.|

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| [Ease No.:40/5/82Party Name:SHIVAM OILS [Meet No/Date:9/82(Status: . ALC4/2014 & PROTEINS INDUSTRY, |ALC4/2014 Approved 20.10.2014 7 HQ File RLA File Lic.No/Date:5610004 192 [Defer Date: :01/82/050/00357/AM15/ :56/24/040/00007/AM15/ 19.05.2014 Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/17/2014-Ch. II dated 27.05.2014, it was decided to 334 ratify norms under Para 4.7 of HBP vi as per details given below or as applied by the firm, whichever is less:

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----- Start of picture text ----- | Export product Export Qty Allowed Quantity | Feed Grade kg on Edible grade RA may take appropriate action as per the decision of Norms Committee. . Case No.:86/6/82- Party Name:SAMARTH Meet No/Date:9/82-a Status:Deffered ALC42014 PHARMA PVT.LTD. ALC4/2014 and Re-indexed . 20.10.2014 - 335 |HQ File RLA File Lic.No/Date:03 10782139 iDefer :01/82/050/00488/AM15/ —_|:03/95/040/00129/AMI15/ [20.05.2014 _— fDate:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals" : . pria Bae /NIRMAL KUMAR aurea faryDepariment ies Lo weet er Octhi ----- End of picture text -----

_ | |Case No.:88/6/82Party Name:UPL Meet No/Date:9/82_—‘|Status:Deffered ALC4/2014 LTD.(FORMERLY UNITED |ALC4/2014 nd Re-indexed
336 |HQ File RLAPHOSPHORUSFile LTD.) 20.10.2014Lic.No/Date:03 10782129 iDefer : :01/82/050/00490/AM15/ :03/95/040/00033/AM15/ —|20.05.2014 Date: 10.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals Case No.:169/6/82Party Name:SIDDHI Meet No/Date:9/82Status:Deffered
| ALC42014 VINAYAKAPVT.LTD., SPECHEM ALC4/201420.10.2014 land Re-indexed | : 337 [HQ File RLA File Lic.No/Date:0710104283 |Defer , :01/82/050/0057 1/AM15/ :07/24/040/00052/AM15/ {21.05.2014 Date:26.11.2014 : | |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.:105/6/82- [Party Name: YASHO Meet No/Date:9/82- (Status: ALC422014 INDUSTRIES PVT.LTD. ALC4/2014 Approved 20.10.2014 HQ:01/82/050/00507/AM15/ File RLA File Lic.No/Date:03 10782310 (Defer Date: :03/95/040/00 142/AM15/ 21.05.2014 Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/95/2011-Ch II dated 08.09.2014, it was | |decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as 338 lapplied by the firm, whichever is less: ----- End of picture text -----

| Export product Exp. Import items Qty. allowed Qty. I vanrq20sBc2sresouumion}! k@ [1. [Hvproquone [0.352 kg JOF TERTIARY BUTYL 0.260 kg RAPROQUINONE) 0.650 kg may take appropriate action as per the decision of Norms Committee. Case No.:17/9/82-AL(C4/2014 |Party Name:AUROBINDO [Meet No/Date:9/82[Status:Deffered PHARMA LIMITED ALC4/2014 and Re-indexed . 20.10.2014 | 339 [HQ File RLA File Lic.No/Date:0910060176 |Defer 01/82/050/008 14/AM15/ :09/24/040/00093/AM15/ 22.05.2014 — (Date:10.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals -

Case No.:223/6/82Party Name:ANUH Meet No/Date:9/82-__[Status:Deffered ALC4/2014 PHARMA LTD. ALC4/2014 nd Re-indexed 340 20.10.2014 HQ File RLA File Lic.No/Date:03 10783471 |Defer : :01/82/050/00625/AM15/ 03/94/040/00149/AM15/ [29.05.2014 Date:26.11.2014 Pete arse niemar KUMAR Dy.STDire TRLee eres“ta ofttaeoregnfoseteangTrade BO 8. AEA Serre Dies, tats General of Foreign Trade Wie TH yDepartment of Commerce Udyog Shawan Nea Soni

“A”

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----- Start of picture text ----- Decision : It was decided to defer the case for 26.11.2014 for comments of Department ----- End of picture text -----

of Pharmaceuticals

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----- Start of picture text ----- Case No.:161/6/82- ‘|Party Name:JAGSONPAL Meet No/Date:9/82- Status:Deffered ALC4/2014 PHARMACEUTICALS LTD. |ALC4/2014 nd Re-indexed 20.10.2014 - 341 HQ File RLA File Lic.No/Date:05 10388035 iDefer 701/82/050/00563/AM15/ :05/23/040/00077/AM 15/ 03.06.2014 Date:10.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals ----- End of picture text -----

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----- Start of picture text ----- ‘Case No.:165/6/82- |Party Name:HALDIA Meet No/Date:9/82- Status:Deffered ALC4/2014 PETROCHEMICALS LTD. |ALC4/2014 and Re-indexed 20.10.2014 a 342 [HQ File RLA File Lic.No/Date:02 10203844 [Defer :01/82/050/00567/AM15/ 102/24/040/00037/AM15/ 05.06.2014 _ -|Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014for comments of Petrochemicals |Division of Department of Chemicals and Petrochemicals. — ~~ [Case No.:228/6/82- Party Name:NECTAR Meet No/Date:9/82- [Status:Deffered ALC4/2014 LIFESCIENCES LIMITED, jALC4/2014 and Re-indexed ce 29.10.2014 343 JHQ File RLA File Lic.No/Date:22 10014962 Defer :01/82/050/00630/AMI5/ —_[:22/24/040/00017/AM15/ _|05.06.2014 Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals ----- End of picture text -----

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----- Start of picture text ----- Case No.:229/6/82- Party Name:NECTAR [Meet No/Date:9/82- _[Status: ALC4/2014 LIFESCIENCES LIMITED, {ALC4/2014 Approved 20.10.2014 - - . HQ File RLA File Lic.No/Date:22 10014961 iDefer Date: :01/82/050/0063 1/AM15/ 22/24/046/000 19/AM15/ — —- (05.06.2014 Decision : In the the light of written comments received of written comments received written comments received comments received received from Department of Pharmaceuticals vide their OM Pharmaceuticals vide their OM their OM OM No. 35011/198/2014-Pi(Norms) dated 27.10.2014, it was decided to ratify the norms under Para 4.7 HBP v1 as per details details given below below or as as applied by the by the the firm, whichever is less: Quanti keke 344 | Cefixime i kg fi | GCLE 0.3628 Trihydhrate Cid S07 Tri Phenyl Phosphine 0.820 | (400 DMF 869 Methylene Chloride 1.546 || |6.| Formaldehyde cel | [8 |«(0.3Phenol 808 | 19. |AcetateButyl :02.302 [10 |0100 EnoCarbon | |il. [Acetonesd 0.793 ----- End of picture text -----

Decision : In the the light of written comments received of written comments received written comments received comments received received from Department of Pharmaceuticals vide their OM Pharmaceuticals vide their OM their OM OM No. 35011/198/2014-Pi(Norms) dated 27.10.2014, it was decided to ratify the norms under Para 4.7 of HBP v1 as per details details given below below or as as applied by the by the the firm, whichever is less:

Dy batae goer Loge Eoeeegn Trade free fap vrererota giveDire. SopciPlbUepantmentita Poresof CommerceTrace Ud Bho wan New Dethi

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----- Start of picture text ----- " [2|EDTA. 100182 ~—S=«| MICA ESTER 0.820 [14 0.030AceticAcid | Triethylamine (TEA 0.2717 [16 [EthylAcetate} 0.376 RA may take appropriate action as per the decision ofNorms Committee. : ----- End of picture text -----

Case No.:69/6/82PartyName:WANBURY [Meet No/Date:9/82___|Status:Deffered ALC4/2014 LIMITED(FORMERLY ALC4/2014 and Re-indexed PEARL ORGANICS LTD) [20.10.2014
345 [HQ File RLA File Lic.No/Date:03 10784601 [Defer 01/82/050/00471/AMI1S/ —_:03/95/040/00041/AM15/ {06.06.2014 _ [Date:26.11.2014 Decision : It was decided to call from the firm a copy of Master Batch Formula duly certified by Quality Control In charge. The case was deferred for 26.11.2014.

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----- Start of picture text ----- Case No.:90/6/82- Party Name: WANBURY (Meet No/Date:9/82- _|Status:Deffered ALC4/2014 LIMITED(FORMERLY ALC4/2014 and Re-indexed . ; PEARL ORGANICS LTD) 20.10.2014 | 1346 (HQ File RLA File Lic.No/Date:03 10784592 \Defer | -|:01/82/050/00492/AMI5/ —|:03/95/040/00075/AM15/ — [06.06.2014 Date:26.11.2014 | |Decision : It was decided to call from the firm a copy of Master Batch Formula duly | |certified by Quality Control In charge. The case was deferred for 26.11.2014. __ ----- End of picture text -----

Case No.:92/6/82Party[Name:WANBURY] [Meet No/Date:9/82__(Status:Deffered ALC4/2014 LIMITED(FORMERLY ALC42014 and Re-indexed PEARL ORGANICS LTD) [20.10.2014 347 [HQ File RLA File Lic.No/Date:03 10784695 [Defer :01/82/050/00494/AM1 5/ :03/95/040/00072/AM15/ 06.06.2014 Date:26.11.2014 Decision : It was decided to call from the firm a copy of Master Batch Formula duly | |certified by Quality Control In charge. The case was deferred for 09.10.2014.

| :

{ [Case No.:94/6/82Party Name:WANBURY (Meet No/Date:9/82_(Status:Deffered_ ALC42014 LIMITED@FORMERLY ALC4/2014 and Re-indexed
[348 |HQ File. PEARLRLA File ORGANICS LTD) [20.10.2014Lic.No/Date:03 10784605 |Defer ; 5 01/82/050/00496/AM15/ _|:03/95/040/00067/AM15/ [06.06.2014 ‘[Date:26.11.2014 Decision : It was decided to call from the firm a copy of Master Batch Formula duly
__ |certified by Quality Control In charge. The case was deferred for 26.11.2014. _

: Case No.:96/6/82Party Name: WANBURY Meet No/Date:9/82Status:Deffered ALC4/2014 LIMITED(FORMERLY ALC4/2014 and Re-indexed _ [PEARL ORGANICS LTD) = [20.10.2014 a 349 |HQ File RLA File Lic.No/Date:03 10784633 |Defer :01/82/050/00498/AM15/ —_|:03/95/040/00071/AMI15/ [06.06.2014 =————s([Date:26.11.2014 Decision : It was decided to call from the firm a copy of Master Batch Formula duly certified by Quality Control In charge. The case was deferred for 26.11.2014. [350 [Case No.:98/6/82[PartyName:WANBURY [Meet No/Date:9/82- ri 4]Status:Deffoned 4 (. Dy ™ > . ‘ral of Foreign Trade a ; os HOPS eer fo 7 ws nvral of Foreign Trade gue sai iti ‘vOepartmentofCommerce Ud ee or ran ee eons

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|||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|oe|ALC42614|LIMITED(FORMERLY|ALC4/2014|and Re-indexed|
|.|PEARL ORGANICS LTD)|[20.10.2014|.|
|HQ|File|RLA|File|Lic.No/Date:03|10784664.||Defer|
|:01/82/050/00500/AM15/|:03/95/040/00074/AM|15/|_|(06.06.2014|_|‘(Date:26.11.2014|
|Decision|:|It|was|decided|to|call|from|the|firm|a|copy|of Master|Batch|Formula|duly|
|certified by Quality Control|In charge.|The case was deferred for 26.11.2014.|
|Case No.:100/6/82-|Party|Name: WANBURY|Meet No/Date:9/82-|. Status:Deffered|
|ALC4/2014|LIMITED{FORMERLY|ALC4/2014|nd Re-indexed|
|.|PEARL ORGANICS LTD)|[20.10.2014|1|
|351|[HQ|File|RLA|File|Lic.No/Date:03 10784657|Defer|
|:01/82/050/00502/AM15/|:03/95/040/00073/AM15/|06.06.2014|___||Date:26.11.2014|
|Decision|:|It|was|decided|to|call|from|the|firm|a|copy|of Master|Batch|Formula|duly|
|certified by Quality Control|In charge. The case was deferred|for 26.11.2014.|
|Case|No.:103/6/82-|Party|Name:WANBURY|[Meet No/Date:9/82-___|[Status:Deffered|
|ALC42014|LIMITED(FORMERLY|ALC4/2014|and Re-indexed|
|||PEARL ORGANICS LTD)|[20.10.2014|Oo|
|359.,/HQ File|RLA|File|Lic.No/Date:03 10784587|[Defer|
|:01/82/0S0/00505/AM15/|—_|:03/95/040/00069/AM15/|[06.06.2014|Date:26.11.2014|||
|Decision|:|It|was|decided|to|call|from|the|firm|a|copy|of Master|Batch|Formula|duly|
|certified by Quality|Control|In charge. The case was deferred|for 26.11.2014.|

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||||||||
|---|---|---|---|---|---|---|
|Case No.:150/6/82-|Party Name:DHANUKA|[Meet No/Date:9/82-|_(Status:Deffered|
|ALC4/2014|LABORATORIES|LTD.|ALC4/2014|and Re-indexed|
|1353|[HQ|File|RLA|File|Lic.No/Date:05 10388492||Defer|
|||:01/82/050/00852/AM15/|_|:05/23/040/00099/AM15/|—_{09.06.2014||Date:26.11.2014|
||||Deeision|:|It was decided|to defer the case|for 26.11.2014|for comments ofDepartment|
|of|Pharmaceuticals|

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[77 ALC4/2014[ease No.:153/6/82PartyLABORATORIES Name:DHANUKA LTD. [MeetALC4/2014 No/Date:9/82_[Status:Defferedand Re-indexed 20.10.2014 1354 |HQ File RLA File Lic.No/Date:05 10388491 Defer 01/82/050/00555/AM15/ —_|:05/23/040/00098/AMI5/ {09.06.2014 Date:26,11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals

Case No.:67/9/82-ALC4/2014 [Party Name:JUBILANT LIFE [Meet No/Date:9/82Status:Deffered SCIENCES LIMITED ALC4/2014 and Re-indexed . | 20.10.2014 355, |HQ File RLA File Lic.No/Date:05 10388394 (Defer | |:01/82/050/00864/AM15/ :05/23/040/00101/AM15/ 09.06.2014 Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals

Prie ares NIRMAL KUMAR wa ere, teT CTO Dy. ; OGM Trade "7 : -Fora:gn Trade av ' eta rep atu eat of Commerce vas bean how Delhi

| [Case No.:148/6/82[Party Name:PARABOLIC [Meet No/Date:9/82_[Status:Deffered ALC4/2614 DRUGS LTD., ALC4/2014 and Re-indexed 356 [HQ File7 RLA File 20.10.2014Lic.No/Date:05 103884 12'[Defer . :01/82/050/00550/AM15/ :05/24/040/00070/AM 15/ 09.06.2014 _ pDate:26.11.2014

Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals

. . Case No.:162/6/82Party Name:PARAGON Meet No/Date:9/82Status: ALC4/2014 INDUSTRIES ALC4/2014 Approved . 20.10.2014 a HQ File RLA File Lic.No/Date:0810132255 (Defer Date: :01/82/050/00564/AM15/ :08/24/040/001 12/AMI15/ 10.06.2014 ,

Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/124/2011-Ch. II dated 07.10.2014, it was decided to i387 ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

==> picture [399 x 56] intentionally omitted <==

----- Start of picture text ----- | Export product Export import items Quantity Quantity Allowed [Soumosezocacn [ike | * [eawocaco _—+| 4.314 kg ----- End of picture text -----

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

Case No.:82/6/82Party Name: YASHO Meet No/Date:9/82Status: ~ ALC42014 INDUSTRIES PVT.LTD. ALC4/2014 Approved 20.10.2014 HQ File RLA File Lic.No/Date:03 10784906 |Defer Date: | 01/82/050/00484/AM15/ _|:03/9$/040/00209/AM15/ _[10.06.2014 ; oo Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/95/2011-Ch Il dated 08.09.2014, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as 358 applied by the firm, whichever is less:

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----- Start of picture text ----- | Export product Import items Qty. allowed NsurmarepocmaraPIPHENYLAMINE [1 KE 0.405kg (YALUB 0.620 kg RA may take appropriate action as per the decision of Norms Committee. ----- End of picture text -----

. ) Case No.:216/6/82ALC42014 AMINESParty Name:ALKYL CHEMICALS LTD Meetj|ALC4/2014 No/Date:9/82Status:Approved— 359 | 20.10.2014 a . HQ File RLA File Lic.No/Date:03 10785244 |Defer Date: :01/82/050/00618/AM15/ :03/94/040/00019/AM 15/ 12.06.2014 : Pris Se PRP RAL R wy vty arate Dy , “co 9 Trade f- ; HRS Die wt. + wed of Foreign Trade ailvToy tdiityOepariment of Commerce Udyog Bhawan, New Oelhi

“ . Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/85/2012-Ch. It dated 12.11.2013, it was decided to ratify norms under Para 4.7 of HBP vi as per details given below or as applied by the firm, whichever is less:

==> picture [399 x 60] intentionally omitted <==

----- Start of picture text ----- : Export product Export import items Quantity Quantity Allowed 46 Kg ----- End of picture text -----

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

Case No.:217/6/82Party Name:ALKYL Meet No/Date:9/82Status: ALC4/2614 AMINES CHEMICALS LTD |ALC4/2014 Approved HQ. File . RLA. File 20.10.2014Lic.No/Date:03 10785246fo|Defer Date: :01/82/050/00619/AM15/ :03/94/040/01179/AM14/ 12.06.2014

Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/85/2012-Ch. II dated 12.11.2013, it was decided to 360 |Tatify 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 Quantity | Quantity Allowed [acetone [ake [2 [acencacm—SCSC=«*r A RA may take appropriate action as per the decision of Norms Committee. . Case No.:184/6/82- Party Meet No/Date:9/82- (Status: ALC4/2014 ame:GULBRANDSEN ——{ALC4/2014 Approved CHEMICALS PVT LTD 20.10.2014 HQ File RLA File Lic.No/Date:34 10040252 (Defer Date: :01/82/0S0/00586/AM15/ —|:34/24/040/00061/AM15/ _|12.06.2014 Oe ----- End of picture text -----

Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/49/2011-Ch. Il dated 17.09.2014, it was decided to 36) [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 Quantity || Tri Ethyl Aluminum |1kgQuantity[1 _| Aluminium Grits/ Granules | 0.270Allowed kg ----- End of picture text -----

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

362 Case No.:226/6/82Party Name:NECTAR Meet No/Date:9/82Status:Deffered |ALC4/2014 LIFESCIENCES LIMITED, |ALC4/2014 land Re-indexed 20.10.2014 HNIRMaL dub Dy. Director General of Fors “ A Directorate General of Fo: aTfyeg iSAUOepartmen Gee. 4 Udy Breen ue: Be Hive

7 |

| | : !

fa | HQ File RLA File Lic.No/Date:2210014981 [Defer :01/82/050/00628/AM 15/ :22/24/040/00018/AM15/ 12.06.2614 , Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals

Case No.:22/8/82‘[Party Name:HETERO LABS [Meet No/Date-9/82[Status:belferea ALC4/2014 LIMITED ALC4/2014 and Re-indexed .
363 |HQ File| RLA File. 20.10.2014Lic.No/Date:09 10060438 |Defer :01/82/0S0/00686/AMI5/ __|:09/24/040/00146/AM15/ _|13.06.2014 {Date:26,11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals _ Case No.:149/6/82[Party Name:INDO PHYTO Meet No/Date:9/82‘|Status:Deffered : ALC4/2014 CHEMICALS PVT LTD20.10.2014ALC4/2014 jand Re-indexed .
364 [HQ File RLA File Lic.No/Date:05 10388673 (Defer :01/82/050/0055 /AMI5/ :05/23/040/00 108/AM15/ 13.06.2014 / Date:10.1 1.2014
Decision ; It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals Case No.:151/6/82Party Name:INDO PHYTO [Meet No/Date-9/82. [StatussDeffered ALC4/2014 CHEMICALS PVT LTD ALC42014 and Re-indexed
365 |HQ File RLA File 20.10.2014Lic.No/Date:05 10388672| (Defer 01/82/050/00553/AM15/ —|:05/23/040/00107/AM15/ —|13.06.2014 Decision __ fDate:10.11.2014 » of Pharmaceuticals: It was decided to defer the case for 26.11.2014 for comments ofDepartment
[~~ [Case No.:166/6/82Party Name:KORES (INDIA) [Meet No/Date:9/82Status: Deffered ALC42014 LTD. ALC4/2014 and Re-indexed 20.10.2014
|366 [HO File IRLA File Lic.No/Date:31 10064371 [Defer :01/82/050/00S68/AMIS/ —_|:31/83/040/00033/AM15/ {13.06.2014 Date:2611.2014 Decision : It was decided to defer the case for 26.11.2014 for comments ofDepartment of C&PC
| [Case No.:61/4/82Party Name:V & V Meet No/Date:9/82-___[Status:Deffered ALC4/2014 PHARMA INDUSTRIES ALC422014 and Re-indexed 20.10.2014
367 |HQ File RLA File Lic.No/Date:03 10785305 {Defer a
| |:01/82/050/00309/AM15/ :03/95/040/00190/AM15/ 13.06.2014 Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals

368 Case No.:234/6/82Party Meet No/Date:9/82Status:Deffered |ALC4/2014 ame:GULBRANDSEN ALC4/2014 and Re-indexed CHEMICALS PVT LTD 20.10.2014

pect ate General of to: wore: F4i/Departe Gate Udyog Bhawan" s, i , on

A HQ File RLA File ” [Lic.No/Date:3410040266 [Defer :01/82/050/00636/AM15/ _|:34/24/040/00071/AM15/ _|17.06.2014 _—‘[Date:10.11.2014 |Decision : It was decided to defer the case for 26.11.2014 for comments of Department of C&PC

| -

ALC4/2014Case No.:159/6/82PartyPHARMACEUTICALSName:JAGSONPAL LTD. |ALC4/2014[Meet No/Date:9/82_ [Status:Defferedand Re-indexed 20.10.2014 369 |HQ File RLA File Lic.No/Date:05 10388788. [Defera :01/82/0S0/00561/AMIS/ __|:05/23/040/00116/AMI5/ [18.06.2014 === Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments ofDepartment of Pharmaceuticals

Case No.:63/4/82Party Name:SALICYLATES [Meet No/Date:9/82(Status: JALC4/2014 & CHEMICALS PRIVATE |ALC4/2014 Approved HQ File RLA File Lic.No/Date:09 10060484! Defer Date: | 01/82/050/00311/AM15S/ —|:09/24/040/00125/AMI5/ —|18.06.2014 po . Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/34/2011-Ch. Il dated 12.05.2013, 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:

370

| Export product Export Quantity | Quantity Allowed | METHYL HYDROXY BENZOATE BP/ 0.989 kg PROPYLMETHYL PARABEN kg Pz [uemavo.BENZOIC ACID [500k | PROPYL PARABEN HYDROXY BENZOATE BP / i kg BENZOIC ACID 0.835 kg [= [rmoranon____—*( OAT Ig RA may take appropriate action as per the decision of Norms Committee. Case No.:164/6/82. Party Name:VDH CHEM [Meet No/Date:9/82. (Status:Defferea ALC4/2014 TECH PVT. LTD. ALC4/2014 and Re-indexed — 7 20.10.2014 1371 JHO File RLA File Lic.No/Date:05 10388792 [Deferoe - | :01/82/050/00566/AM15/ —_|:05/24/040/00085/AM15/ _{18.06.2014 Date: 10.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments ofDepartment of Pharmaceuticals

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----- Start of picture text ----- Case No.:142/6/82- Party Name:DHANUKA [Meet No/Date:9/82- __|Status:Deffered ALC4/2014 LABORATORIES LTD. ALC4/2014 and Re-indexed |372 20.10.2014 . THQ File IRLA File Lic.No/Date:05 10388965 [Defer | 01/82/0S0/00S44/AM15/ —|:05/23/040/00105/AM15/ —|20.06.2014 -_|Date:26.11.2014 (Decision 3 It was decided to defer the case for 26.11.2014 for comments ofDepartment ST Feficvia feet arae Dy. Director General of Foreign Trade Udyed Brean EE ini ----- End of picture text -----

| | | | ! ; : : | | |

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----- Start of picture text ----- a “* | _ jof Pharmaceuticals ; . | Case No.:64/4/82- Party Name:AUROBINDO Meet No/Date:9/82- Status:Deffered ALC4/2014 PHARMA LIMITED ALC4/2014 jand Re-indexed 20.10.2014 373 [HQ File RLA File Lic.No/Date:09— 10060520 [Defer- :01/82/050/00312/AM15/ 709/24/040/00154/AM15/ 23.06.2014 Date:10.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department | jof Pharmaceuticalsf . ----- End of picture text -----

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----- Start of picture text ----- . Case No.:72/9/82-ALC4/2014 [PartyName:DORF-KETAL [Meet No/Date.9/82- (Status: Deffored CHEMICALS INDIA ALC4/2614 and Re-indexed 374 [HQ File PVT.LTD.RLA File 20.10.2014Lic.No/Date:03 10785815. |Defer Date- :01/82/050/00869/AM15/ :03/94/040/00256/AM15/ 23.06.2014 {26.11.2014 | |Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals . Case No.:71/9/82-ALC4/2014 |Party Name:AVA Meet No/Date:9/82- Status:Deffered CHEMICALS PVT.LTD., ALC42014 ‘jand Re-indexed |375.[HQ File RLA File 20.10.2014Lic.No/Date:03 10785955 (Defer | °01/82/050/00868/AM15/ :03/94/040/00249/AM15/ 24,06.2014 Date: 10.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments ofDepartment of C&PC Case No.:83/9/82-ALC4/2014 Party Name:IPCA Meet No/Date:9/82- Status:Deffered LABORATORIES LIMITED /ALC4/2014 and Re-indexed 20.10.2014 1376 [HQ File RLA File Lic.No/Date:03 10785911 [Defer | [:01/82/0S0/00880/AMI5/ —:03/94/040/00223/AM15/ —|[24.06.2014 |Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments ofDepartment of Pharmaceuticals Case No.:68/4/82- Party Name:MICRO LABS (Meet No/Date:9/82- [Status:Deffered ALC4/2014 LTD ALC4/2014 and Re-indexed - 20.10.2014 a 1377 |HQ File IRLA File Lic.No/Date:07 10105379 |Defer | :01/82/050/00316/AM15/ _|:07/24/040/00106/AM15/ |[25.06.2014 Date: 10.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments ofDepartment of Pharmaceuticals _ a Case No.:85/9/82-ALC4/2014 Party Name:BLISS GVS MeetNo/Date:9/82- Status:Deffered PHARMA LTD. ALC4/2014 and Re-indexed 1378 0.10.2014 HQ File RLA File a Lic.No/Date:03 10786049 |Defer a - :01/82/050/00882/AM15/ :03/94/040/00178/AMI5/ 26.06.2014 Date:26.11.2014 PaR/NIRMAL KUMAR Dy. Director General of Foreign Trade faexr anor amPresiren Directorate General of Fore a: i- 4a anforeg ParvDepane eet. ? Udyog 8.8. Ji, ee tere ----- End of picture text -----

| Decision : It was decided to defer the case for 26.11.2014 for comments ofDepartment of Pharmaceuticals . ; .

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----- Start of picture text ----- Case No.:203/6/82- [Party Name:KLI_ Meet No/Date:9/82- __(Status:Deffered ALC4/2014 PLASTICIZERS LTD., ALC4/2014 and Re-indexed 379 [HQ File . RLA7File 20.10.2014Lic.No/Date:0510389118 [Defer . 01/82/050/00605/AM15/ —_|:05/23/040/00129/AM15/ —|[26.06.2014 [Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals ----- End of picture text -----

Case No.:74/9/82-ALC4/2014 [Party Name:BLISS GVS [Meet No/Date:9/82_|Status:Deffered PHARMA LTD. ALC4/2014 and Re-indexed 20.10.2014
380 HQ File RLA File Lic.No/Date:03 10786144 [Defer :01/82/050/00871/AM15/ ——|:03/94/040/00277/AMI5/ —|27.06.2014 |Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals

Case No.:69/4/82Party Name:RA CHEM MeetNo/Date:9/82Status:Deffered ALC42014 PHARMA LIMITED ALC42014 and Re-indexed . 20.10.2014 .
383 |HQ File RLA File Lic.No/Date:09 10060550 [Defer :01/82/0$0/003 17/AM15/ _ 09/24/040/00175/AM15/ 27.06.2014 Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department
| _ jof Pharmaceuticals — |
~ [Case No.:73/9/82-ALC4/2014 [Party Name:D.R. COATS [Meet No/Date:9/82[Status:Deffered TINK & RESINS PVT.LTD. |ALC4/2014 and Re-indexed
382 [HQ File RLA File Lic.No/Date:03 10786181 [Defer {:01/82/050/00870/AM15/ ——|:03/94/040/00755/AM14/ ——(30.06.2014 Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of C&PC.

[~~ [€ase No.:191/6/82Party Name:GOPINATH [Meet No/Date:9/82(Status:Deffered ALC4/2014 CHEM-TECH LTD., ALC4/2014 nd Re-indexed 383 [HQ File RLA File 20.10.2014Lic.No/Date:08 10132551 [Defer . :01/82/050/00593/AM15/ —_|:08/24/040/00139/AM15/ —‘ {01.07.2014 — — [Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals |

Case No.:227/6/82Party Name:NECTAR Meet No/Date:9/82Status: 384 ALC4/2014 LIFESCIENCES LIMITED, 20.10.2014|ALC4/2014 Approveda HQ File RLA File Lic.No/Date:2210015007 |Defer Date: __(:01/82/050/00629/AMI15/ —|:22/24/040/00027/AMI15/ —|02.07.2014 AL KIPMAR wa HET ee on trade Dy. Director General of Foreign ee ae or renege Tr 9 aPied fayDesatment oe wee Ue et itan New Dvini

4 Decision: in the light of written comments received from Department of Pharmaceuticals vide their OM No. 3501 1/198/2014-PI(Norms) dated 27.10.2014, it was decided to ratify the norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: :| Export Product ey [SN | Import Item Qty. Allowed | Qua kg 9 : | CefiximeTrihydhrate i kg pl. SodiumGCLE TT Bromide S=«diL0.3628S07. Tri Phenyl Phosphine 0.820 |: [400 DMFSS~S=«d‘~ST‘R609 | Methylene Chioride 1546 : |6.| Formaldehyde 1118 | 5.117 110.19.[8 ||PhenolButyl Acetate SS=«*t;SS=«d0302S 0.3808 : [EnoCarbonS=«*t'.100.S~*S | |. [Acetone SS=«*d;«793 [12 EDTAS~«*dt(.0 BD | [13 JMICAESTER———=«+' 0.820 | Acetic Acid 0.030 | Triethylamine (TEA 10.2717 |RA [16_ [EthylAcetateS=«*d;‘3 76 may take appropriate action as per the decision ofNorms Committee. Case No.:68/9/82-ALC4/2014 Party Name:HINDUSTAN '\Meet No/Date:9/82Status:Deffered POLYAMIDES & FIBRES /|ALC4/2014 land Re-indexed LIMITED 20.10.2014 1385 |HQ File RLA File Lic.No/Date:03 10786348 [Defer :01/82/050/00865/AM15/ :03/94/040/00269/AM15/ 03.07.2014 Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department _ of Pharmaceuticals Case No,:69/9/82-ALC4/2014 |Party Name:ARIHANTANAM (Meet No/Date:9/82(Status: LIFECARE PVT. LTD. ALC4/2014 Approved 20.10.2014 HQ File IRLA File Lic.No/Date:03 10786421| iDefer Date: :01/82/050/00866/AM15/ :03/94/040/00290/AM15/ 04.07.2014 ; 386 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM |No. 35011/175/2014-PI(Norms) dated 21.10.2014, 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: Artemether jikg 1. [Artemisinn——SSS~«~C23K’ RA concerned may take further necessary action as per above decision of NC.

387 Case No.:205/6/82Party Name:HPL Meet No/Date:9/82Status: ALC4/2014 ADDITIVES ALC4/2014 Approved LIMITED(FORMERLY 20.10.2014 KNOWN HIGH POLYMER rang /NIRMAL KUMAy 3y Astiln of Foreign de Directorate vyoeparunent ol ‘. “" — Udyog Bhawan.

| |

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

||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|*%|||fHoFie|~|IRLA File|Lic.No/Date:0510389355|[Defer Date:|
|:01/82/050/00607/AM15/|°05/23/040/00091/AM15/|04.07.2014|’|
|Decision|:|In|the|light|of|written|comments|received|from|Department|of|Chemicals|and|
|Petrochemicals|vide|their|U.O|No.|14010/7/2011-Ch.|ll|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:|
|Export product|Export|import items|Quantity|
|Quantity|Allowed|
|.|.|Hydrazodicarbonamide|1.19 kg|
|pesos|
|faue||?|||

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

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

|Case No.:206/6/82Party Name:HPL Meet No/Date:9/82Status: ALC4/2014 ADDITIVES ALC422014 Approved LIMITED(FORMERLY 20.10.2014 KNOWN HIGH POLYMER HQ File RLA File Lic. No/Date:05 10389362 [Defer Date: :01/82/050/00608/AM15/ :05/23/040/00092/AM15/ 04.07.2014 Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/7/2011-Ch Il dated 17.09.2014, it was decided 38g |to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

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|||||||
|---|---|---|---|---|---|
|Export product|Exp.|SI.No.|||Import items|Qty. allowed|
|1,3 Dibromo 5,5 Dimethyl!|Cyano =|0.436|xs|
|Hyaanoin|
|0.680 kg|
|RA may take appropriate|action as per the decision of Norms Committee.|

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

Case No.:197/6/82Party Meet No/Date:9/82Status: ALC42014 ame:R.K. INDUSTRIES, ALC4/2014 Approved HQ0 File RLA| File | 20.10.2014Lic.No/Date:08 10132594| |Defer Date:a 1/82/050/00599/AM 15/ :08/24/040/00132/AMI1/5/ 04.07.2014

Decision : In the light of written comments received from Department of Chemicals and 389 Petrochemicals vide their U.O No. 14010/11/2010-Ch Il dated 18.09.2014, it was decided to [ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

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||||||
|---|---|---|---|---|
|Export product|Exp.|import items|Qty. allowed|
|Qty.|
|Ortho Toluidine|Ortho Toluidine|0.642 kg|
|fsulfonic Acid|Caustic soda|0.282 kg|
|fe|sie|/|NIRMAL|is|
|were|'|
|Udyog|[bhuwaa,]|wesw|Deihi|

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

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

7 Case No.:63/9/82-ALC4/2014 [Party Name:CORAL Meet No/Date:9/82___[Status:Deffered LABORATORIES LTD., ALC4/2014 and Re-indexed 390 [HQ File RLA File ‘}20.10.2014Lic. No/Date:03 10786480 {Defer7 :01/82/050/00860/AM15/ :03/94/040/00177/AM15/ 07.07.2014 Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals

~~ (Case No.:59/9/82-ALC4/2014 [Party Name:INDO GERMAN [Mei No/bateS/82. ~~ (Statuasberiera ALKALOIDS ALC4/2014 jand Re-indexed
39] |JHQ File. RLA File Lic.No/Date:0320.10.2014 10786553 |Defer ; :01/82/050/00856/AM15/ :03/94/040/00305/AM15/ 08.07.2014 Date:26,11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments ofDepartment of Pharmaceuticals

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----- Start of picture text ----- Case No.:70/9/82-ALC4/2014 [Party Name:IPCA [Meet No/Date:9/82- [Status:Deffered LABORATORIES LIMITED |ALC42014 and Re-indexed - 20.10.2014 [392 [HQ File RLA File :01/82/050/00867/AM15/ —|:03/94/040/00306/AM15/ |Lic.No/Date:03|08.07.2014 10786550 [Defer Decision ____ [Date:26,11.2014 : It was decided to defer the case for 26.11.2014 for comments of Department | |of Pharmaceuticals . Case No.: 192/6/82-— Party Name:KLI Meet No/Date:9/82- tatus:Deffered ALC42014 PLASTICIZERS LTD., ALC4/2014 and Re-indexed 20.10.2014 | . 393 |HQ File RLA File Lic.No/Date:05 10389472 |Defer :01/82/050/00594/AM1S/ :05/23/040/00144/AM15/ 08.07.2014 Date:26.11.2014 ofDecision C&PC.: It was decided to defer the case for 26.11.2014 for comments ofDepartment . Case No.:204/6/82- Party Name:PAY ALC4/2014 PETROCHEM PRIVATEAL [MeetALC4/2014 No/Date:9/82- [Status:Defferedand Re-indexed | 394.||HQ File RLALIMITED File Lic.No/Date:0520.10.2014 10389448 | [Defer 7 :01/82/050/00606/AM15/ :05/24/040/00192/AM14/ 08.07.2014 {Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department fof C&PC. 7 395 Case No.:211/6/82- Party Name:PAYAL Meet No/Date:9/82-___[Status:Deffered |ALC4/2014 PETROCHEM PRIVATE _|ALC4/2014 and Re-indexed ; . LIMITED ———- 20.10.2014 ab i R oeeee Gonararerne / i. Prog PRI Deon. : ----- End of picture text -----

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HQ File RLA File Lic.No/Date:0510389447 [Defer *01/82/050/00613/AM15/ __|:05/24/040/00191/AM14/_|08.07.2014 Date:26,11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of C&PC.

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----- Start of picture text ----- a . Case No.:207/6/82- Party Name: VARUN Meet No/Date:9/82- (Status: ALC4/2014 MEDIMPEX INC. ALC4/2014 Approved a HQ . 0.10.2014 File RLA File |Lic.No/Date:05 10389445 \Defer Date: 701/82/050/00609/AMI5/ —|:05/24/040/00136/AM15/ —|08.07.2014 Decision : In the light of written comments received from Petrochemical Division; of. Department of Chemicais and Petrochemicals vide their U.O No. 46011/104/2009-PC- II dated 21.10.2014, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: 396 | Export product Exp. | SINo. | Import items Qty. allowed Qty. | | Dettol Medicated 1 No. Woven Dyed Fabric of 100% | 0.001320 Sq. Meter || Fabric Plaster Size 19 Texturised Polyester | mmx6Smm Filament, GSM115 +/- 10% | 2. +/-Non15% Woven Rolls , GSM 100 | 0.000315 Sq. Meter | ! 3. Cold glue coated poster paper | As per packing 88MM WIDTH +/-IMM _| policy | 4. Release Film39mm width +/- | As per packing RA Imm policy may take appropriate action as per the decision of Norms Committee. . Case No.:64/9/82-ALC4/2014 [Party NameIPCA Meet No/Date:9/82- |Status:Deffered LABORATORIES LIMITED /ALC4/2014 and Re-indexed ‘(20.10.2014 397 |HQ File IRLA File Lic.No/Date:03 1078663 1 |Deferee | :01/82/050/00861/AM15/ |:03/94/040/00199/AM15/ — [09.07.2014 Date:26,11.2014 |Decision : It was decided to defer the case for 26.11.2014 for comments of Department | jof Pharmaceuticals — . Case No.:80/9/82-ALC4/2014 [Party Name:MICRO ORGO. [Mest No/Deie:9/83- Status: Deffered CHEM ALC42014 and Re-indexed 20.10.2014 398:1HQ File RLA File Lic.No/Date:03 10786687 |Defer ) 01/82/050/00877/AMI5/ —|:03/95/040/00292/AM15/ |10.07.2014 Date:26.11.2014 | Decision : It was decided to defer the case for 26.11.2014 for comments ofDepartment |of Pharmaceuticals . Case No.:26/9/82-ALC4/2014 |Party Name:ALMELO PVT Meet No/Date:9/82- Status:Deffered |399 LTD ALC4/20140.10.2014 aland bane Re-indexedi] frayt Pa. \ to [HQ File IRLA File Lic. No/Date:09 10060660 [Defer cre aren aferDirectorateUdyogRe [Bhawan,] aTaa,Oi agmentofRBComme;ceni ----- End of picture text -----

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----- Start of picture text ----- “) | [017e2/050100823/AMis/ _[:09/24/040/00188/AMI5/ [11.07.2014 [Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department jof Pharmaceuticals ----- End of picture text -----

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----- Start of picture text ----- . — Case No.:193/6/82- Party Name:MOREPEN [Meet No/Date:9/82-|Status:Deffered ALC4/2014 LABORATORIES LTD., ALC4/2014 jand Re-indexed 20.10.2014 00 |HQ File {RLA File Lic.No/Date:05 1038965te1:|Defer :01/82/050/00595/AM15/ _|:05/24/040/00144/AM15/ |11.07.2014 — [Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments ofDepartment of Pharmaceuticals _ : a (Case No.:195/6/82- (Party Name:AARTI Meet No/Date:9/82- (Status: ALC4/2014 ORGANIC ALC4/2014 Approved HQa File RLA File 20.10.2014Lic.No/Date:08 10132686 ae|Defer Date: | — :01/82/0S0/00597/AMI5/ —|:08/24/040/00143/AM15/ [14.07.2014 _ | |Decision : in the light of written comments received from Department of Chemicals and |Petrochemicals vide their U.O No. 14010/11/2010-Ch Il dated 18.09.2014, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, 401 |Whichever is less: ----- End of picture text -----

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----- Start of picture text ----- | Export product Exp. Oty. allowed Qty. |] Ortho Toluidine Sulfonic Ortho Toluidine 0.642 kg ----- End of picture text -----

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

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----- Start of picture text ----- (Case No.:65/9/82-ALC4/2014 [Party Name:AMINES & [Meet No/Date:9/82- (Status: Deffered PLASTICIZERS LIMITED /|ALC4/2014 and Re-indexed | 20.10.2014 ; 402 |HQ File RLA File Lic.No/Date:03 10786813 iDefer :01/82/050/00862/AMI5/ —_|:03/94/040/00298/AMI15/ [14.07.2014 Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments ofDepartment of C&PC ----- End of picture text -----

Case No.:88/9/82-ALC4/2014 |Party Name:MAC CHEM [Meet No/Date:9/82- _ |Status:Deffered PRODUCTS (INDIA) ALC4/2014 and Re-indexed: PRIVATE LIMITED 20.10.2014 . . 1403 [HQ File RLA File Lic. No/Date:03 10786782 [Defer Date :01/82/050/00885/AM15/ :03/95/040/00302/AM15/ _ {14.07.2014 26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments ofDepartment of Pharmaceuticals . eqa MIRMAL KURA 404 {Case No.:108/9/82Party Name:NECTAR Meet No/Date:9/82-"""""" (Statam Bpfferedi |<" ALC4/2014 LIFESCIENCES LIMITED, {ALC4/2014 Cy aid Redeye. rad °Dero Senphoto, WEEDSbrewerspepartment NOM8facet Delhiommered

| t | | | S| | ft | | | | = 7 | 7 } : : s j | i a q i i : | j i ’ \ ;

| | | | | | | | : | | || | |

oi | boio2014 Of HQ File RLA File |Lic.No/Date:22 01/82/050/0090S/AM15/ 1001 5019 |Defer —|:22/24/040/00083/AM14/ _—*|15.07.2014 |Date:26.11.2014
Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals .
Case No.:87/9/82-ALC4/2014 [Party Name:UNIJULES LIFE {Meet No/Date-9/82. Status:Deffered SCIENCES LTD. 4/2014 and Re-indexed
. 20.10.2014 . -
405 (HQ File RLA File Lic.No/Date:03 10786843 [Defer :01/82/050/00884/AM15/ :03/95/040/00324/AM15/ {15.07.2014 Date:26.1 1.2014 Decision : It was decided to defer the case for 26.1 1.2014 for comments of Department of Pharmaceuticals |
(Case No.:99/9/82-ALC4/2014 [Party Name-ALKYL Meet No/Date:9/82(Status: Deffered AMINES CHEMICALS LTD |ALC4/2014 and Re-indexed
a [20.10.2014
406 [HQ File RLA File Lic. No/Date:03 10786924 (Defer :01/82/050/00896/AM15/ —_|:03/94/040/00155/AM15/ 116.07.2014 **** Date:26.11.2014
ofDecisionC&PC.: It was decided to defer the case for 26.11.2014 for comments ofDepartment . .
Case No.:102/9/82Party Name:ALKYL Meet No/Date:9/82Status:Deffered ALC4/2014 AMINES CHEMICALS LTD |ALC4/2014 and Re-indexed | 20.10.2014
407 [HQ File RLA File Lic.No/Date:03 10786926 [Defer : :01/82/050/00899/AM15/ :03/94/040/00130/AM15/ 16.07.2014 Date:26. 11.2014 of C&PC Decision : It was decided to defer the case for 26.1 1.2014 for comments of Department Case No.:6/9/82-ALC4/2014 Party Name: VIVIMED LABS [Meet No/Date:9/82Status:Deffered LIMITED ALC4/2014 and Re-indexed
408 0.10.2014 | [HQ File RLA File Lic.No/Date:0910060667 [Defer 0 1/82/050/00803/AM15/ :09/24/040/00208/AM1 3 17.07.2014 Decision _ {Date:26.11.2014 of C&PC : It was decided to defer the case for 26.11.2014 for comments ofDepartment Case No,:1/6/82-ALC4/2014 Party Name: ARJUN Meet No/Date:9/82Status:Deffered CHEMICALS PVT. LTD., ALC42014 nd Re-indexed
1409 20.10.2014 |HQ File RLA File Lic.No/Date:0410159021 [Defer :01/82/050/00403/AM15/ :04/24/040/0006 1/AM15/ 18.07.2014 Date:26. 11.2014 ofDecisionC&PC : It was decided to defer the case for 26.11.2014 for comments of Department

[410[Case No.:79/9/82-ALC4/2014 [Party [Meet NoDate:982Dor.SanusON TG TOTSip) yo =! u4 Foreign Trade Adie, pe eneral of Foreign Trade “AS64 TdMPYDepartment of Crm. Udyng Rt dae, Shon

| ! |

|“|||ame:METROPOLITAN<br>EXIMCHEMLTD.|[ALC4/2014<br>0.10.2014<br>.|~|andRe-indexed<br>.|
|---|---|---|---|---|---|---|
|||HQFile<br>201/82/050/00876/AM1 5/|RLA File<br>:03/95/040/00337/AM15/|Lic.No/Date:03 10787073 <br>18.07.2014|||Defer<br>Date:26.11.2014|
|||Decision : Itwasdecidedto|todefer thecasefor26.11.2014 forcommentsof||ofDepartment||
|||ofC&PC.|||||a|
|||(CaseNo.:86/9/82-ALC4/2014||PartyName:SIRMAXO|MeetNo/Date:9/82-||[Status:|
||||CHEMICALS PVTLTD|ALC4/2014||Approved|
||||||20.10.2014|||
|||||||-|
|||HQ File<br>:01/82/050/00883/AM15/|RLA File<br>:03/95/040/00322/AMI5/|Lic.No/Date:0310787043<br>(DeferDate:<br>18.07.2014<br>_|||

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----- Start of picture text ----- Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM 0. 35011/142/2014-Pi(Norms) dated 10.10.2014, it was decided to ratify the norms under Para 4.7 of 411 |HBP v1 as per details given below or as applied by the firm, whichever is less: = Povidone Qty. _ g/kg USP Iodine Topical Solution 1. Povidone iodine Powder | 0.098kg iP/USP RA concerned may take further necessary action as per above decision of NC. ----- End of picture text -----

Case No.:90/9/82-ALC4/2014 [Party Name: YASHO Meet No/Date:9/82__(Status:Deffered INDUSTRIES PVT.LTD. ALC4/2014 and Re-indexed 20.10.2014 |
File RLA File Lic.No/Date:03 10787108 |Defer
:01/82/050/00887/AM15/ :03/95/040/00348/AM15/ 21.07.2014 Date:26.11.2014

1412./HQ File

Decision : It was decided to defer the case for 26.11.2014 for comments of Department fof C&PC.

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----- Start of picture text ----- [~~ [Case No.:98/9/82-ALC4/2014 [Party Name:AGIO Meet No/Date:9/82- _(Status:Deffered PHARMACEUTICALS LTD j|ALC4/2014 and Re-indexed 20.10.2014 . a 413 |HQ File RLA File Lic.No/Date:03 10787172 |Defer :01/82/050/00895/AM15/ —|:03/94/040/00110/AM15/ [22.07.2014 _{Date:26.11.2014 ----- End of picture text -----

| | |

Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals .

Case No.:18/9/82-ALC4/2614 PartyName:BIOLOGICAL E |Meet No/Date:9/82Status:Deffered LTD ALC4/2014 and Re-indexed 20.10.2014
414 [HQ File RLA File Lic.No/Date:0910060702 [Defer :01/82/050/00815/AM15/ ———|:09/24/040/00197/AM15/ —_[22.07.2014 |Date:26.11.2014

| Decision : It was decided to defer the case for 26.11.2014 for comments of Department : | lof Pharmaceuticals [415 [Case No.:24/9/82-ALC4/2014 [Party Name:BRUNDAVAN __ [MeetNo/Date:9/82-.._== | | . _angral of of Fore

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----- Start of picture text ----- t ----- End of picture text -----

. _angral of of Fore | ; fe uea 7 cneral ofent F o f reCommerce Trae tae ire Udyog Bhawan, N:

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----- Start of picture text ----- " _4 LABORATORIES PRIVATE [ALC4/2014 and Re-indexed HQ LTD., — 20.10.2014 Ce File RLA File Lic.No/Date:09 10060703 |Defer :01/82/050/0082 1/AM15/ :09/24/040/00104/AM15/ 22.07.2014 |Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals oe | (Case No.:25/9/82-ALC4/2014 Party Name:DIVIS. [Meet No/Date:9/82- __|Status:Deffered || PHARMACEUTICALS ALC4/2014 and Re-indexed | 416 }HQ File . PRIVATERLA File LIMITED 20.10.2014Lic.No/Date:09 10060700 |Defer 7 :01/82/050/00822/AM15/ :09/24/040/00194/AM15/ 07.2014 = |Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals | ----- End of picture text -----

Case No.:78/9/82-ALC4/2014 [Party Name:PACE Meet No/Date:9/82_[Status:Deffered
; PHARMATECH PVT.LTD. LC4/2014 and Re-indexed 141'7./HQ File Co RLA File Lic.No/Date:0308.10.2014 © 10787160 |Defer | 01/82/0S0/0087S/AMIS/ —_|-03/95/040/00347/AM15/ 22.07.2014 |Date:26.11.2014 | |Decision : It was decided to defer the case for 26.11.2014 for comments of Department — __ fof Pharmaceuticals . . Case No.:12/9/82-ALC4/2014 [Party Name:AUROBINDO [Meet No/Date:9/82. ~~ Statue:Defferea PHARMA LIMITED ALC422014 and Re-indexed
| | 20.10.2014 1418 |HQ File ‘RLA File -\Lic.No/Date:09 1006071| | |Defer . | :01/82/050/00809/AM15/ —_|:09/24/040/00214/AM15/ [23.07.2014 _— Date:26.11.2014 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.:107/9/82- Party Name:IND-SWIFT [Meet No/Date:9/82- [Status:Deffered ALC42014 LABORATORIES LTD., ALC4/2014 jand Re-indexed 1419.)HQ. File |IRLA File (20.10.2014Lic.No/Date:22 10015039 i[Defer | [:01/82/0S0/00904/AM15/ —_[:22/24/040/00033/AM15/ {23.07.2014 Date:26.11.2014 {Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals ----- End of picture text -----

(Case No.:66/9/82-ALC4/2014 |Party Name:S.M. Meet No/Date:9/82__[Status:Deffered CHEMICALS ALC4/2014 and Re-indexed | 420 |HQ File IRLA File Lic.No/Date:03 10787305 |Defer {:01/82/050/00863/AM15/ :03/95/040/00304/AM15/ 24.07.2014 Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals

ba abs = a nef General of Fore or feted fy8) ara ABTS Bie \ sar tO1 ae Geeta or commerce arfeien e e faa |.

||||CaseNo.:92/9/82-ALC4/2014<br>PartyName:STERLING<br>MeetNo/Date:9/82-<br>Status:<br>AUXILIARIESPVT LTD<br>ALC4/2614<br>Approved<br>(20.10.2014|
|---|---|---|---|
|||.<br>421|_<br>ee<br>;<br>HQ<br>File<br>RLAFile<br>Lic.No/Date:0310787298 |DeferDate:<br>ONS2/0S0/00889/AMI15/<br>__|:03/95/040/0035S/AM15/<br>__|24.07.2014<br>7<br>.<br>Decision<br>:<br>In the tight of written comments received from Department of Chemicals and<br>PetrochemicalsvidetheirU.ONo.14010/64/2011/Ch IIdated31.10.2014, itwasdecided to ratifynorms<br>underPara4.7ofHBPv1asperdetailsgivenbelowor asappliedbythefirm,whichever isless:|
|||'|ExportProduct<br>Export<br>ImportProduct<br>Quantity<br>Quanti<br>Allowed<br>|<br>[i [worpnoune [0.490kg<br>STERONMMO 30(N-Met<br>MorpholOt<br>|2.<br>___| FORMALDEHYDE37<br>0.381kg<br>[3 [Foaacacioas%|0254kg|
||||RAmaytake appropriateactionasper thedecisionofNormsCommittee.|
||[||[CaseNo.:96/0/82-ALC4/2014 [Party Name STERLING ~~ [MeetNofDaie-S/B3-<br>Status:Deffered<br>AUXILIARIESPVT LTD<br>ALC4/2014<br>andRe-indexed|
||||422||HQFile<br>RLAFile<br>‘|Lic.No/Date:0310787290 |Defer<br>701/82/050/00893/AMIS/<br>_|:03/95/040/00349/AM15/<br>4.07.2014<br>‘|Date:26.11.2014<br>|Decision : Itwasdecidedtodeferthecasefor26.11.2014forcommentsofDepartment<br>ofC&PC,|

. Case No.:1009/82[Party NamecINDOGO Meet No/Date:9/82(Status: Deffered ALC42014 REMEDIES LIMITED ALC4/2014 and Re-indexed | 20.10.2014 423 [HQ File RLA File Lic.No/Date:03 10787333 | [Defer 7 | O1/82/050/00897/AM15/ __|:03/94/040/00301/AM15/ _ [25.07.2014 Date:26.11.2014 |Decision : It was decided to defer the case for 26.11.2014 for comments ofDepartment | jof C&PC. . | 7 Case No.:7/6/82-ALC4/2014 [Party Name:AARTIDRUGS [Mest Nolbaso/SStatus:Deffered LIMITED ALC4/2014 and Re-indexed . 20.10.2014 | 424 |HQ File RLA File Lic.No/Date:03 10787378 (Defer _ 01/82/0S0/00409/AM15/ __|:03/94/040/00321/AM15/ {28.07.2014 Date:12.11.2014 |Decision : It was decided to defer the case for 12.11.2014 for comments of Department of Pharmaceuticals.

Case No.:48/9/82-ALC4/2014 [Party Name:ALCHYMARS [Meet No/Date.9/82[Status:Deffevea ICM SM PRIVATE LIMITED |ALC4/2014 and Re-indexed 425 [HQ File . RLA File 20.10.2014Lic.No/Date:04 10159110. [Defer a :01/82/050/00845/AM15/ :04/24/040/00062/AM15/ —_—|28,07.2014 Date:12.11.2014 Decision : It was decided to defer the case for 12.1 1.2014 for comments ofDepartment of Pharmaceuticals. . . geet = mf en og & tee Udyog patie WEEN

| |

”

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

||||||||
|---|---|---|---|---|---|---|
|Case No.:32/9/82-ALC4/2014|[Party Name:CHEMCON|[Meet No/Date:9/82-|[Status:Deffered|
|SPECIALITY CHEMICALS|C4/2614|Jand|Re-indexed.|
|PLTD|20.10.2014|
|426||HQ File|RLA|File|Lic.No/Date:34 10040406||Defer.|oo|
|:01/82/050/00829/AM15/|:34/24/040/00102/AM15/|28.07.2014|Date:26.11.2014|
||||Decision|:|It was decided to defer the case|for 26.11.2014|for comments of Department|
|_jof|Pharmaceuticals|oe|
|Case No.:8/6/82-ALC4/2014|(Party Name:V & V|Meet No/Date:9/82-|_[Status:Deffered|
|PHARMA INDUSTRIES|ALC4/2014|jand|Re-indexed|
|20.10.2014|
|427||HQ File|ARLA|File|Lic.No/Date:03 10787382|.|Defer|_|
|:01/82/050/00410/AM15/|—_—|:03/95/040/00331/AM15/|—_—[28.07.2014|Date:26.11.2014|
|Decision|:|It was decided to defer the case|for 26.11.2014|for comments of Department|
|of Pharmaceuticals|
|.|a|
|||~ [Case No.:97/9/82-ALC4/2014|[Party Name:YASHO|(Meet No/Date-9/82-|IStatus:befforea|
|EPNDUSTRIES PVT.LTD.|ALC4/2014|and|Re-indexed|
|20.10.2014|
|fo|
|[428|[HQ|File|RLA|File|Lic.No/Date:03 10787381|[Defer|
|:01/82/050/00894/AMI15/|—_|:03/95/040/00366/AM15/|[28.07.2014|_|PDate:10.11.2014|
||||Decision|:|It was decided to defer the case for 26.11.2014|for comments of|Department|

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

[Case No.:22/9/82-ALC4/2014 [Party Name'NATCO [Meet No/Date:9/82|Status:Deffered PHARMA LIMITED ALC4/2014 and Re-indexed ; 20.10.2014 os - |429 [HQ File ‘IRLA File Lic. No/Date:09 10060757 [Defer | :01/82/050/00819/AM15/ —_|:09/24/040/00186/AM15/ [30.07.2014 — Date:26.11.2014 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.:30/9/82-ALC4/2014 [Party Name:SOFTGEL Meet No/Date:9/82- Status:Deffered HEALTH CARE PVT. LTD., |ALC4/2014 and Re-indexed . 20.10.2014 430 (HQ File |RLA File Lic.No/Date:04 10159122 [Defer :01/82/050/00827/AM15/ :04/24/040/00033/AM15/ 30.07.2014 __ [Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals Case No.:54/9/82-ALC4/2014 [Party Name:RATNAMANI _ [Meet No/Date:9/82- [Status:Deffered BIO CHEMICALS & ALC4/2014 and Re-indexed PHARMACEUTICALS PVT. [20.10.2014 1431 LTD : HQ File RLA File Lic.No/Date:34 10040420 |Defer :01/82/050/0085 1/AM15/ :34/24/040/00092/AM15/ 31.07.2014 Date:26.11.2014 | [Decision : It was decided to defer the case for 26.11.2014 for comments of= a generalrst! 0 ieAo" ieee Se yarimnentOF =" et, AS era u dyoo Bnaw ----- End of picture text -----

| | 7

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----- Start of picture text ----- | lof Pharmaceuticals . Oo | | [Case No.:20/9/82-ALC4/2014 [Party Name:AUROBINDO [Meet No/Date:9/82. Status:Deffered PHARMA LIMITED ALC4/2014 and Re-indexed — 20.10.2014 |432 |HQ File RLA File Lic.No/Date:0910060790 . [Defer :01/82/050/00817/AM15/ —_|:09/24/040/00202/AM15/ 01.08.2014 Date:26,11.2014 Decision : It was decided to defer the case for 26.1 1.2014 for comments of Department of Pharmaceuticals . Case No.:58/9/82-ALC4/2014 Party Name:G AMPHRAY _ [Meet No/Date:9/82- Status:Deffered LABORATORIES, /2014 and Re-indexed 0.10.2014 1433 |HQ File RLA File Lic.No/Date:03 10787536 (Defer °01/82/050/0085S/AMI5S/ —|:03/94/040/00171/AM15/ _—101.08.2014 ‘[Date:26.11.2014 | of|DecisionC&PC.: It was decided to defer the case for 26.11.2014 for comments of Department | - Case No.:49/9/82-ALC4/2014 Party Name:SANMAR Meet No/Date:9/82- Status: Deffered SPECIALITY CHEMICALS |ALC4/2014 and Re-indexed LIMITED, | 20.10.2014 434./HQ File RLA File Lic.No/Date:04 10159125 |Defer ; :01/82/050/00846/AM15/ :04/24/040/00106/AM1S/ ———- Decision (01.08.2014 Date:26,11.2014 of Pharmaceuticals: It was decided to defer the case for 26.11.2014 for comments ofDepartment Case No.:29/9/82-ALC4/2014 Party Name:SHASUN Meet No/Date:9/82- Status: Deffered PHARMACEUTICALS ALC4/2014 and Re-indexed LIMITED 0.10.2014 435.|HQ File RLA File Lic.No/Date:0410159129 |Defer 7 :01/82/050/00826/AM15/ :04/24/040/00117/AM1 s/ 01.08.2014 Date:26. 11.2014 Decision : It was decided to remind the firm to farnish a copy of Master Batch Formula duly certified by Quality Control Incharge. The case was deferred for 26.11.2014. — ----- End of picture text -----

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----- Start of picture text ----- Case No.:31/9/82-ALC4/2014 [Party Name:AMBERNATH [Mea NoDasSioc Status: Deffered RGANICS PVT. LTD. ALC4/2014 nd Re-indexed 1436 (20.10.2014 i [HQ File RLA File Lic. No/Date:03 10787610 [Defer :01/82/050/00828/AM15/ :03/94/040/00074/AM15/ 08.2014 . Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department jof C&PC . ; (Case No.:10/6/82- [Party Name:COVALENT [Meet No/Date.9/8.~ IBuatassbentevca ALC4/2014 LABORATORIES PRIVATE /2014 and Re-indexed | {HQ File RLA File Lic.No/Date:09 10060796 [Defer *01/82/050/00412/AM1S/ —_—_j:09/24/040/00204/AMI5/ _—(04.08.2014 Date:26.11.2014 AR ert areyey NIETe Tog‘ rade3 meKa aye We A, AR ew Dein vayeshnawan. Kew ----- End of picture text -----

Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals .

: :

A

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----- Start of picture text ----- ~ {Case No.:15/9/82-ALC4/2014 [Party Name:COVALENT {Meet No/Date.9/82. Status Derforca LABORATORIES PRIVATE |ALC4/2014 and Re-indexed . . LIMITED 20.10.2014 438 |HQ File RLA File Lic.No/Date:09 10060793 |Defer :01/82/050/00812/AM15/ :09/24/040/00203/AM15/ 04.08.2014 Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals ----- End of picture text -----

[ ~ Case No.:14/9/82-AL.C4/2014 [Party Name:GLAND Meet No/Date:9/82_{Status:Deffered PHARMA LIMITED ALC4/2014 and Re-indexed
- 20.10.2014
439 |HQ File RLA File Lic.No/Date:09 10060797 |Defer :01/82/050/0081 1/AM15/ 709/24/040/002 19/AM15/ 04.08.2014 Date:26.11.2014
| Decision : It was decided to defer the case for 26.11.2014 for comments of Department |of Pharmaceuticals .
Case No.:44/9/82-ALC4/2014 Party Name:INTAS Meet No/Date:9/82Status: Deffered PHARMACEUTICALS ALC4/2014 and Re-indexed
440 [HQ File RLALTD.,File 20.10.2014Lic.No/Date:08 10132883 |Defer a :01/82/050/0084 1/AM15/ _ $:08/24/040/00173/AM15/ 04.08.2014 Date:26.11.2014
| |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.:19/9/82-ALC4/2014 [Party Name:SALICYLATES [Meet No/Date.9/82- StatussDefferea & CHEMICALS PRIVATE |ALC4/2014 and Re-indexed 44] |HQ. File . LIMITEDRLA File Lic.No/Date:0920.10.2014 10060792 |Defer . :01/82/0S0/00816/AM15/ ——|:09/24/040/00142/AMI5/ _|04.08.2014 Date:10.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of C&PC ----- End of picture text -----

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----- Start of picture text ----- Case No.:12/6/82- Party Name:ANUPAM Meet No/Date:9/82- Status:Deffered ALC42014 RASAYAN (INDIA) LTD ALC4/2014 land Re-indexed 20.10.2014 442 |HQ File IRLA File Lic. No/Date:52 10041180 [Defer :01/82/050/00414/AM15/ :52/24/040/00025/AM15/ —_ [05.08.2014 Date:12.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of C&PC Case No.:13/9/82-ALC4/2014 Party Name:-EMCURE Meet No/Date:9/82- Status:Deffered PHARMACEUTICALS LTD. |ALC4/2014 jand Re-indexed 443 | 0.10.2014 HQ:01/82/050/00810/AMI5/File RLA File Lic.No/Date:3110064678 |Defer —_|:31/83/040/00110/AM15/ 05.08.2014 Date:26, A |i ST TET of Forei ‘Trade Oe eee MET ATTH ----- End of picture text -----

| |

}

| : 7 . ' t : ;i :: | :

Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals

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|||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|Case No.:77/9/82-ALC4/2014|[Party Name-STERLING|Meet No/Date:9/82-____([Status:|
|AUXILIARIES PVTLTD|—_—‘|ALC4/2014|Approved|
|.|20.10.2014|oe|
|HQ|File|RLA|File||Lic.No/Date:03 10787632|iDefer Date:|
|||:01/82/050/00874/AM15/|03/95/040/00382/AMI5/|{05.08.2014|to|
|Decision|:|in|the|light|of|written|comments|received|from|Department|of|Chemicals|and:|
|:|Petrochemicals vide|their|U.O|No.|14010/64/2013/Ch|Il dated|31.10.2014,|it was decided|to|ratify norms|
|444|lunder 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|
|||STERO PEG 200|(Di Ethylene|Glyco! 2|Quanti|0.557Allowed kg|
|_|RA may take appropriate action as per the decision of Norms Committee.|-|oo|
|||[Ease No.:27/9/82-A1.C4/2014|[Party Name:GRANULES|[Meet No/Date:9/82-|[Status:Deffered|
|INDIA LIMITED|ALC4/2014|and|Re-indexed|
|\445||[HQ File|RLA||File|||Lic.0.10.2014No/Date:09 10060816||[Defer|
|:01/82/050/00824/AM15/|—_[:09/24/040/00217/AM15/|[06.08.2014|[Date:26,11.2014|
|Decision|:|It was decided to defer the case for 26.11.2014|for comments of|Department|
|||_|of|Pharmaceuticals|||
|Case No.:94/9/82-ALC4/2014|Party|Name:|MANGALAM|[Meet No/Date:9/82-|(Status: Deffered|
|DRUGS & ORGANICS|ALC4/2014|and|Re-indexed|
|.|LIMITED|20.10.2014|a|
|446|HQ File|RLA|File|Lic.|No/Date:03|10787716||Defer|
|:01/82/050/0089|1/AM1|5/|:03/95/040/00344/AM15/|06.08.2014|Date:10.11.2014|
|Decision|:|It was decided|to defer the case for 26.11.2014|for comments of|Department|
|_{of Pharmaceuticals|||
|||(Case No.:106/9/82-|Party Name:NECT.|
|||ALC4/2014|LIFESCIENCES LIMITED,AR|(ALC4/2014MeetNo/Date:9/82-|Approvedtatus:|~|
|||.|a|20.10.2014|
|||HQ File|RLA|File|Lic.No/Date:22 10015056|[Defer||Date:|
|:01/82/050/00903/AM15/|—_|:22/24/040/00038/AM15/|[06.08.2014|;|.|
|Decision|;|In the|light of written comments|received from Department of Pharmaceuticals|vide|their OM|
|||447|No.|35011/198/2014-PI(Norms)|dated|27.10.2014,|it was|decided|to|ratify|the|norms|under|Para|4.7|of|
|HBP|v1|as per details given below or as applied by the|firm,|whichever|is|less:|

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| Quanti kg/kg j Cefixime fi SEGCLE 507 | Trihydhrate 0.3628 | Se Alte ay TY poeDirech.:stecaretGeneral :of feForeigncttrac:: a mPa fayrvOepartment of Commeice ve Bhan New Dethi

| | | | | | | | | = ; | | | | | | | i z | | | ‘ i ¥ i : ' : ; |

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----- Start of picture text ----- DMF 1.869 Methylene Chloride 1.546 | |6.__| Formaldehyde Ng [8 5.117 19. [Phenol| Butyl Acetate= |—C«0,(0.3023808 | 0.793 EDTA 0.0182 MICA ESTER 0.820 0.030 Triethylamine (TEA 0.2717 | 4 1/16| Ethyl Acetate 0.376 RA may take appropriate action as per the decision ofNorms Committee. ; ----- End of picture text -----

| ~ [Case No.:16/9/82-ALC4/2014 [Party Name:PORUS ~ [Meet No/Date:9/82(Status:Deffered LABORATORIES PVT LTD JALC4/2014 and Re-indexed . 20.10.2014 to. . 1448 |HQ File RLA File Lic.No/Date:09 10060814 (Defer | [Decision:01/82/050/00813/AMI5/: It was decided to09/24/040/00234/AMI defer the case for 26.11.2014+ 06.08.2014for comments ofDepartmentDate:10.11.2014 of Pharmaceuticals [— [Case No.:81/9/82-ALC4/2014 [Party Meet No/Date:9/82[Status:Deffered. ame: METROPOLITAN ALC4/2014 and Re-indexed EXIMCHEM LTD. 20.10.2014 . 449 (HQ File RLA File Lic. No/Date:03 10787777 [Defer 01/82/050/00878/AMI5/ —_|:03/95/040/00404/AM15/ [07.08.2014 Date:2611.2014 Decision : It was decided to deferthe case for 26.11.2014 for comments of Department fof Pharmaceuticals

| [€ase No.:105/9/82[Party Name‘SCOTT-EDIL [Meet No/bate:9/82(Status:Deffered ALC4/2014 PHARMACIA LTD., ALCAR014 and Re-indexed 450 |HQ File RLA File Lic. No/Date:22 10015058 (Defer :01/82/050/00902/AM1S/ |:22/24/040/00035/AM15/ ——_[07.08.2014 Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals . a [ ~ [Case No.:82/9/82-ALC4/2014 [Party Name:STERLING [Meet No/Date:9/82(Status: AUXILIARIES PVT LTD ALC4/2014 Approved 20.10.2014 HQ File RLA File Lic.No/Date:03 10787778 |Defer Date: 451 :01/82/050/00879/AM15/ :03/95/040/00403/AM15/ 07.08.2014 - Decision: In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/64/2013/Ch II dated 31.10.2014, it was decided to ratify norms under Para 4.7 of H8P v1 as per details given below or as applied by the firm, whichever is less:

Dy. Cire Serna Foreign We faq err werner: Direct: ate Ganeral of Foreign Tre. aferer fomvDepartment of Comme. 2 vaseyog Bhawan,was, ag | FeatNew Delhi;

| z| a | : ' | | : 5 f 2 ‘ e 4 ; : :

po uantity | slowed STEROan PEG 200 (Di Ethylene Giycot 2 | [1 |[DIETHYLENE] GLYCOL [0.557 kg
RA [2 [Faneewome __[oaozke may take appropriate action asper the decision of Norms Committee. _ —
| [Case No.:9179/82-ALC4/2014 [Party Name:0 C ~~ [Meet No/Date:9/82__[Status:Deffered SPECIALITIES PVT.LTD. |ALC4/2014 jand Re-indexed
a 20.10.2014 . _
452 |HQ File RLA File Lic.No/Date:03 10787837 |Defer :01/82/050/00888/AM15/ :03/95/040/00399/AM 1 5/ 08.08.2014 . _ {Date:10.11.2014
| _ Decision : It was decided to defer the case for 26.11.2014 for comments of Department lof C&PC. , .
, Case No.:40/9/82-ALC4/2014 [PartyINGRAMName:ADCOCK LTD, ALC4/2014[Meet No/Date-9/82-__|[Status:Deffand Re-ind e rx ed (20.10.2014 -
1453 [HQ File RLA File Lic.No/Date:0710106352 [Defer :01/82/050/00837/AM15/ —_|:07/24/040/00167/AM15/ [11.08.2014 _— fDate:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department
_ jof Pharmaceuticals

Case No.:53/9/82-ALC4/2014 [Party Name:ONEIRO [Meet No/Date:9/82(Status: Deffered CHEMICALS LTD ALC4/2014 and Re-indexed . 20.10.2014 . 454 (HQ File RLA File Lic.No/Date:34 10040436 (Defer :01/82/050/00850/AMI5/ ——:34/24/040/00111/AM15/ {11.08.2014 Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments ofDepartment of C&PC. . . ; [Case No.:8/9/82-ALC4/2014 (Party Name-RANBAXY [Meet No/Date-9/82(Status:Deffered LABORATORIES LTD ALC4/2014 and Re-indexed . . . 20.10.2014 ; | 455 [HQ File RLA File |Lic.No/Date:05 10390250 (Defer |:01/82/050/0080S/AM15/ ——|:05/24/040/00202/AM15/——([11.08.2014 _ {Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department | |of Pharmaceuticals . ; Case No.:7/9/82-ALC4/2014 Party Name:SENTISS Meet No/Date:9/82Status:Deffered PHARMA PVT.LTD. LC4/2014 and Re-indexed . 20.10.2014 a 456 [HQ File RLA File Lic.No/Date:0510390257 (Defer :01/82/050/00804/AM15/ :05/24/040/00213/AM15/ 11.08.2014 Date:26.11.2014 | |Decision : It was decided to defer the case for 26.11.2014 for comments of Department jof Pharmaceuticals 4s7 [Case No.:93/9782-ALC4/2014 [Party Name:¥ ASHO Meet No/Date:9/82__[Status:Deffered INDUSTRIES PVT.LTD. ALCA2014 MS Trig aay! StODAR vr ‘ral of Foreign Trade _ oy3 . I Thee cas Udyog . : reament of Commerce Gnawan, Ne ini

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Case No.:23/9/82-ALC4/2014 |Party Name:BIO-TECH Meet No/Date:9/82Status:Deffered OPHTHALMICS PVT. LTD., |[ALC4/2014 and Re-indexed 20.10.2014 a 458 )HQ File RLA File Lic.No/Date:08 10132955 |Defer :01/82/050/00820/AM15/ —_|:08/24/040/00176/AM15/ _|12.08.2014 —— fDate:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments ofDepartment of Pharmaceuticals

Case No.:50/9/82-ALC4/2014 |Party Name:CAPLIN POINT [Meet No/Date:9/82Status: Deffered | LABORATORIES LTD., ALC42014 and Re-indexed
459 [HQ File . RLA File 20.10.2014Lic.No/Date:04 10159215fo[Defer :01/82/050/00847/AM15/ 204/24/040/00078/AM15/ 12.08.2014 _ _ |Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments ofDepartment of C&PC.
CaseNo.i21/9/82-ALC4/2014 [Party Name:PI INDUSTRIES [Meet No/Date-5/83> Status:Deffered LTD., ALC4/2014 and Re-indexed
7 20.10.2014
460 |HQ201/82/050/008File RLA File |Lic.No/Date: 1310047575 |Defer 18/AM15/ $ 13/24/040/00020/AM 15/ 12.08.2014
Decision _ JDate:12.11 2014 of C&PC.: It was decided to defer the case for 26.11.2014 for comments ofDepartment

Case No.:28/9/82-ALC4/2014 [PartyName:SHASUN Meet No/Date:9/82_(Status:Deffered PHARMACEUTICALS ALC42014 and Re-indexed 461 |HQ7 File LIMITEDRLA File 20.10.2014Lic.No/Date:04 10159219 [Defer; :01/82/050/00825/AM15/ :04/24/040/00123/AM15/ {13.08.2014 Date:26.11.2014 Decision : It was decided to remind the firm to furnish a copy of Master Batch Formula duly certified by Quality Control Incharge. The case was deferred for 26.11.2014.

Case No.:51/9/82-ALC4/2014 |Party Name:SHASUN Meet No/Date:9/82Status:Deffered PHARMACEUTICALS ALC4/2014 and Re-indexed | LIMITED 20.10.2014 462 [HQ File RLA File Lic.No/Date:0410159220 [Defer. :01/82/050/00848/AM15/ 104/24/040/00124/AM15/ 13.08.2014 Date:26.11.2014 Decision : It was decided to remind the firm to furnish a copy of Master Batch Formula duly certified by Quality Control Incharge. The case was deferred for 26.11.2014. [463 [Case No.:33/9/82-ALC4/2614 [Party Name:TIDE [Meet No/Date:9/82Status: Deffered Deffered

[Meet No/Date:9/82Status: Deffered Deffered | Yh) 4> vw General o Of" ’ . f , .., General of Fore, bat 1 sPVOeparment fee ' va bean bw Bein

| |

| | |

|||||INDUSTRIES|ALC4/2014|andRe-indexed|andRe-indexed|
|---|---|---|---|---|---|---|---|
||||.||20.10.2014|||
||||HQFile<br>:01/82/050/00830/AM15/|RLA File<br>—_|:34/24/040/00106/AM15/|-<br>Lic.No/Date:3410040445.iDefer<br>[14.08.2014<br>_<br>-fDate:10.11.2014|||
||||||Decision : Itwasdecidedto<br>ofC&PC|todeferthecasefor26.11.2014forcommentsofDepartment||||
|||||||.||
||||CaseNo.:46/9/82-ALC4/2014 [PartyName:ADCOCK<br>INGRAMLTD,||MeetNo/Date:9/82-<br>ALC4/2014|__|Status:Deffered<br>andRe-indexed||
||||||20.10.2014|||
||||HQFile<br>:01/82/050/00843/AM15/|RLA File<br>:07/24/040/00172/AM15/|Lic.No/Date:0710106458 iDefer<br>|19.08.2014<br>Date:10.11.2014|||
||||||Decision : Itwasdecidedto<br>ofPharmaceuticals|todeferthecasefor26.11.2014forcommentsofDepartment||ofDepartment||
||||CaseNo.:239/6/82-<br>ALC4/2014|PartyName:SWISS<br>EXPORTSPVT.LTD.|MeetNo/Date:9/82-<br>ALC4/2014|__(Status:Deffered<br>andRe-indexed|||
||||a<br>.|.<br>||20.10.2014|||
|||465|a<br> HQFile<br>RLAFile<br>Lic.No/Date:0810133043 [Defer<br>:01/82/050/00641/AMI5/<br>—_|:08/24/040/00180/AMI5/<br>{19.08.2014<br>[Date:26.11.2014<br>Decision : Itwasdecidedtodeferthecasefor26.11.2014 forcommentsofDepartment<br>ofPharmaceuticals|||||

Case No.:61/9/82-ALC4/2014 [Party Name:CONCORD [Meet No/Date:9/82. [Status:Defferea BIOTECH LTD ALC4/2014 and Re-indexed 20.10.2014 466 [HQ File RLA File Lic.No/Date:08 10133062 fo(Defer :01/82/050/00858/AM15/ —|:08/24/040/00186/AM15/ — {20.08.2014 Date:26.11.2014 | |Decision : It was decided to defer the case for 26.11.2014 for comments ofDepartment of Pharmaceuticals

Case No.:39/9/82-ALC4/2014 [Party Name:SHREE Meet No/Date:9/82(Status: Deffered BANKEY BEHARI LAL ALC42014 and Re-indexed . . AROMATICS 0.10.2014 | 1467 HQ File RLA File Lic.No/Date:05 10390613 |Defer :01/82/050/00836/AM15/ :05/24/040/00192/AMI15/ 20.08.2014 Date:10.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments ofDepartment of Pharmaceuticals

[Case No.:116/9/82Party Name:BEST VALUE [Meet No/Date:9/82|Status:Deffered ALC4/2014 CHEM PVT. LTD. ALC4/2014 and Re-indexed 468 (HQ File RLA File Lic.No/Date:340.10.2014 10040469.||Defer ; :01/82/050/009 13/AM15/ :34/24/040/001 10/AM15/ 21.08.2014 © _ [Date:10.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments ofDepartment of Pharmaceuticals aa ain a St sekor Generel oO get . oe brewer. New ©

‘

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|||||||
|---|---|---|---|---|---|
|Case No.:37/9/82-ALC4/2014|Party|Name:|JAGSONPAL|Meet No/Date:9/82-|Status:Deffered|
|PHARMACEUTICALS LTD.||ALC4/2014|and|Re-indexed|
|0.10.2014|
|469||HQ File|RLA File|Lic.No/Date:05|10390634|[Deferen|
|:01/82/050/00834/AM15/|:05/23/040/00198/AMI5/|[21.08.2014|__||Date:26.11.2014|
|Decision|:|It was decided to defer the case for 26.11.2014 for comments of|Department|_|
|of Pharmaceuticals|

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

Case No.:47/9/82-ALC4/2014 [Party Name:OTSUKA Meet No/Date-9/82__[Status:Deffered CHEMICALPRIVATE ( INDIA ) LC4/2614 and Re-indexed 470 |HQ File RLA File LIMITED 20.10.2016Lic.No/Date:05 10390642 |DeferOo 01/82/050/00844/AM15/ —_|:05/24/040/00200/AM15/ 21.08.2014 __-[Date:10.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals . | .

Case No.:41/9/82-ALC4/2014PartyName:RANBAXY [Meet No/Daie:S/83- ~~(Statmanbelienca LABORATORIES LTD ALC4/2014 and Re-indexed | 10.10.2014 . Poo
471 :01/82/050/00838/AM|HQ File RLA File .|Lic.No/Date:05 10390638 [Defer Decision 15/ :05/24/040/00217/AM15/ 21.08.2014 Date:26.1 1.2014,
__lof Pharmaceuticals: It was decided to defer the case for 26.11.2014 for comments of Department

[ [Case No.:52/9/82-ALC4/2014 [Party Name:UNILINK [Meet No/Date:9/82- _ |Status:Deffered PHARMA PVT LTD JALC4/2014 and Re-indexed
. 20.10.2014 ; a
472 [HQ File RLA File Lic.No/Date:04 10159266 [Defer :01/82/050/00849/AM15/ —_|[:04/24/040/00111/AMI5/ [21.08.2014 _ [Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals . _
Case No.:38/9/82-ALC4/2014 [Party Name:INDO [Meet No/Date:9/82_[Status:Deffered PHYTOCHEM ALC42014 and Re-indexed
. PHARMACEUTICALS 0.10.2014 pe .
473 [HQ File RLA File Lic.No/Date:0510390704 [Defer -01/82/050/00835/AMI5/ —_|:05/23/040/00209/AMI5/ [22.08.2014 Date:10.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department
| _ {of Pharmaceuticals a
[Case No.:35/9/82-ALC4/2014 [Party Name:CADILA Meet No/Date:9/82(Status:Deffered ALTHCARE LTD., ALC4/2014 and Re-indexed
474.[HQ| File A File Lic.No/Date:0820.10.2014 10133097 [Defera
| :01/82/050/00832/AM15/ :08/24/040/00203/AM15/ 25.08.2014 Date:26.11.2014 |Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals

wy Hehe Pree on Trade Dy. Director co" v . wera azure pitaniprate General ot Foren rae aR er ot sini Udyog Bnawet!.

;

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

Case No.:36/9/82-ALC4/2014 |Party Name:CADILA Meet No/Date:9/82Status:Deffered HEALTHCARE LTD., ALC4/2014 and Re-indexed {20.10.2014 —
475 |HQ File RLA File Lic.No/Date:08 16133096 |Defer :0:1/82/050/00833/AM15/ 08/24/040/00202/AM15/ §.08.2014 Date:26.11.2014 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.:89/9/82-ALC4/2014 [PartyName:KARNATAKA [Meet No/Date-9/82-[Status:Deffered ANTIBIOTICS & ALC4/2014 and Re-indexed PHARMACEUTICALS 60.10.2014 476 THQ File RLA File |Lic.No/Date:07 10106502 [Defer :01/82/0S0/00886/AM15/ —[:07/24/040/00179/AMIS/ [25.08.2014 |Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department __ {of Pharmaceuticals ae Case No.:101/9/82- Party Name:SOMU ~ Meet No/Date:9/82- Status: ALC4/2014 SOLVENTS PVT. LTD ALC42014 Approved . 20. 10.2014 © HQ File RLA File Lic.No/Date:0710106539 [Defer Date: | :01/82/050/00898/AM15/ :07/24/040/00186/AM15/ {25.08.2014 Decision ; in the tight of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/151/2011/Ch i dated 01.05.2012, it was decided to ratify norms under Para 4.7 [as][ per][ details][ given] [below][ or][ as][ applied][ by][ the][ firm,][ whichever] [is] [less:] an7 [of][ HBP][ v1] ----- End of picture text -----

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----- Start of picture text ----- Export Product Export Import Product Quantity Quantit) Allowed Ethyl 3 Ethoxy Propionate 1. oe gs 0.564 kg 3 Ethoxy Ethy! Ester Ethoxy ikg Propionic Acid ----- End of picture text -----

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----- Start of picture text ----- Propionate ----- End of picture text -----

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

| | |

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----- Start of picture text ----- Case No.:109/9/82- Party Name: VENUS Meet No/Date:9/82- —_|Status:Deffered ALC42014 REMEDIES LTD., ALC4/2014 and Re-indexed . . 20.10.2014 oo 478 |HQ File RLA File Lic.No/Date:22 10015065 \Defer | (:01/82/050/00906/AM15/ _|:22/24/040/00048/AM15/ _{25.08.2014 Date:26.11.2014 |Decision : It was decided to defer the case for 26.11.2014 for comments ofDepartment of Pharmaceuticals . ~ [Case No.:42/9/82-ALC4/2014 Party Name:CADILA Meet No/Date:9/82- __[Status:Deffered PHARMACEUTICALS LTD, |ALC4/2014 and Re-indexed. . . 10.10.2014 479 |HQ File RLA File Lic.No/Date:08 10133103 |Defer :01/82/050/00839/AM15/ :08/24/040/00197/AM15/ —- (26.08.2014 Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals PNIRMAL HUAI by birector General of oreo” | 8 ° Te eeePe “ ai Udyor Bh ----- End of picture text -----

“a

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----- Start of picture text ----- Case No.:45/9/82-ALC4/2014 |Party Name:CONCORD Meet No/Date:9/82- Status:Deffered BIOTECH LTD ALC4/2014 and Re-indexed . 0.10.2014 . . 480 |HQ File RLA File Lic.No/Date:08 10133099 [Defer :01/82/050/00842/AM15/ :08/24/040/00196/AM15/ 6.08.2014 Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals Case No.:1/7/82-ALC4/2014 |Party Name:COVALENT Meet No/Date:9/82- Status: Deffered LABORATORIES PRIVATE |ALC4/2014 and Re-indexed LIMITED | [20.10.2014 fo 48) [HQ:01/82/050/00645/AM15/ File —|:09/24/040/00261/AM15/RLA File Fe6.08.2014 Rao nee Dae te :r 10.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals Case No.:84/9/82-ALC4/2014 [Party Name:DHANUKA {Meet No/Date:9/82. Status: Deffered LABORATORIES LTD. LC4/2014 and Re-indexed a . (20.10.2014 to | 482 [HQ File RLA File Lic.No/Date:05 10390763 [Defer :01/82/050/00881/AM15S/ —:05/23/040/00221/AM15/ [26.08.2014 Date: 10.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department __ lof Pharmaceuticals | | [Case No.:2/7/82-ALC4?2014 [Party Name:DRREDDYS [Meet No/Date5/BX. ~~ tatasDeliarea LABORATORIES LIMITED |ALC4/2014 and Re-indexed 20.10.2014 483 [HQ File RLA File Lic.No/Date:09| 10060892 [Defer' “O1/82/0S0/00646/AM15/ _|:09/24/040/00263/AMI5/ 26.08.2014 Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department ofPharmaceuticals - | [Case No.:87/9/82-ALC4/2014 [Party Name:R L FINE CHEM [Mest No/Daie:9/82. ~~ [Statwssbatiorca ALC4/2014 and Re-indexed 1484 _. 20.10.2016 | HOF nesasaungy RLA File Lic.No/Date:0710106549 [Defer | =1/82/050/00854/AM15/ :07/24/040/00182/AM15/ 26.08.2014 Pete 1.2014 |Decision : It was decided to defer the case for 26.11.2014 for co partment | “Al. muments of Departm fof Pharmaceuticals ent Case No.:43/9/82-ALC4/2014 [Party Name:SARV BIO [Mea NagDas as tatashonn: | |ALC4/2014 and ReAndcaca. i, [(eesesoeeatcvins][LABS][ PVT.LTD.,] | orDate:9/82- _Status:Deffered 01/8 ae RLA File [Lic No/Date-osinve a . 4gEOF ‘120.10.2014 | JRLA File povanig ic.No/Date:05 10390783, | —ORHOIAMIS/__}05/24/040/00203/aM15) Praca eSDate 11.2014 Decision : It was decided to defer the case for 26.11 2014 for — 10.11.201 of C&PC AL. comments ofDepartment I) Ren ay eralOf Foreign Trad Ditectrrs,, f lane ETP Regier hd ET REVDepanmen oemeee Yayog ro | ----- End of picture text -----

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Case No.:34/9/82-ALC4/2014 Party Name:KLJ Meet No/Date:9/82Status:Deffered PLASTICIZERS LTD., ALC4/2014 and Re-indexed 20.10.2014 |
436 [HQ:01/82/050/0083 File 1/AM15/ RLA:05/23/040/002 File 14/AM15/ Lic83 . 08.2014No/Date:05 10390804_ [Defer|Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments ofDepartment of C&PC 7 _
Case No.:60/9/82-ALC4/2014 Party Name:JUBILANT Meet No/Date:9/82Status:Deffered GENERICS LTD ALC42014 and Re-indexed 20.10.2014
487 |HQ:01/82/050/00857/AM File iS/ RLA:05/23/040/00217/AMI5/ File bie02.09.2014 NovDate-0510390523 DeferDate:26.11.2014Decision : It was decided to defer the case for 26.11.2014 for comments ofDepartment of Pharmaceuticals _ .

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----- Start of picture text ----- Case No.:76/9/82-ALC4/2014 [Party Name:KL) Meet No/Date:9/82-[Status:Deffered PLASTICIZERS LTD., ALC4/2014 and Re-indexed 488 [HQ File RLA File Lic.20.10.2014No/Date:05 10390922 [Defer| | /01/82/050/00873/AM15/ |:05/23/040/00220/AM15/ {02.09.2014 Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of C&PC oo a Case No.:110/9/82- Party Name:NECTAR Meet No/Date:9/82- [Status ALC4/2014 LIFESCIENCES LIMITED, [ALC4/2014 Approved HQ . 20.10.2014 File RLA File Lic. No/Date:22 10015077 [Defer Date: Oe osovans :22/24/040/00044/AM15/ (02.09.2014 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM 0. 35011/198/2014-Pi(Norms) dated 27.10.2014, it was decided to ratify the norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: | Quanti Jago1 Cefixime fi. | atia/ko | 3° }OCLE 507 Trihydhrate (2. | Sodium Bromide 0.3628 | CE Dy Ss see 1.869, | |5.| Methylene Chloride ae | |6.___| Formaldehyde Ot | [8 [Phenol | [03808 4] | pea Aeeate F3094 !i a feoTo—fa ia —fear—} —fe01e —¥F Dafc '9 Oe Sareeay waifasa farvDepanmemot Gone: Udyog Bnawan, New wou: ----- End of picture text -----

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----- Start of picture text ----- io) ——— os = ———— ——— — ee ee | }14 | Acetic Acid == 0.27170.030 . Ethyl Acetate 0.376 . RA may take appropriate action as per the decision ofNorms Committee. — Case No.:3/7/82-ALC4/2014 (Party Name:S V CHEM [Meet No/Date:9/82-__[Status:Deffered INTERMEDIATES PLTD |ALC4/2014 and Re-indexed | 7 20.10.2014 1490./HQ File RLA File Lic.No/Date:04 10159328 |Defer :01/82/050/00647/AMIS/ —|:04/24/040/00139/AMI5/ [02.09.2014 Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of C&PC Case No.:5/1/82- [Party Name: THEMIS Meet No/Date:9/82- (Status: Deffer ALC4/2014 PHARMACEUTICALS(PROP.CHEMO |ALC4/2014 ed and Re- . SYN LTD.) 20.10.2014 indexed 49 |HQ File RLA File :08/24/040/00177/AM15/ Lic.No/Date:08101332 [Defer | |:01/82/050/00649/AM 17 Date:26.11.20 Decision15/ : It was decided to defer the case for 26.11.201403.09.2014 for comments ofDepartment14 . of Pharmaceuticals ,|Case No.:75/9/82-ALC4/2014eeHEALTHCARE[Party Name:NEUTECZ (P) ALC4/2014MeetNo/Date:9/82:9/82- andstatus:Deff Rodted red e | 20.10.2014 :01/82/050/00872/AM15/ Re coz3sams 04.00.2014 nenose0e73 Pete 11.201 | ofDecision Pharmaceuticals;: It was decided to defer the casevee for 26.11.2014, for commentsi sa. of DepartmentEEOLL 2014 Case No.:62/9/82-ALC4/2014 [Party Name:SHREF Mect NoDendes- gE BANKEY BEHARILAL —[ALC42014 {Ptatus:Dittered ; AROMATICS {fend exed [3 20.10.2014} . | HQ File LAF eae = a 7 on 05/24/040/00229/AM15/ 0400on 05103 fer 4 : It was decided to deferthe case find a 10.113014 | [ae] -:01/82/0 [MS] . ic. : = Case No.:5 s a = ~ J S/9/82-ALC4/2014 [Party Name:CONCORD Meet No/Date-5 aBorie RLABIOTECH File LTD= ALCAROIG20.10.2014 |_ [PadStatus:Deti Re-inde Decision : It was decided to def. aa 10.0914 yi 06 | :01/82/ i i ~ : L of Pharmacemnts wer the case for 26.11.2014 fr commen HES hss 42614 Party ‘MACEUTICALSName:JAGSONPAL LTD, Mees|; i Date 9783 . i: I mtus:Deffered| Mh ° ; “ U Re-indexeq “f DyAGBeciorSr GenralNR MAL aaha wee ~eeermentof Commer ----- End of picture text -----

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----- Start of picture text ----- 20.10.2014 - oo i RLA File [CiewNofDate:051059) 100 [Defer HO File -01/82/050/00892/AM15/ 0s/23/040/00246/AMI15/ 11.09.2014 Date:26.11.2014 ee |Decision : Tt was decided to defer the case for 26.11.2014 for comments of Department | of Pharmaceuticals a . Cane No156/9782-ALC4/2014 PartyPHARMACHEMumePOSY.‘(Meet PVT. LTD. ALC4/220.10.2 ~cibaie5/82- 01 44 (StatustDefferedand Re-indexed. RLA File Lic No/Date:0810133299 Defer 496 HQ File .01/82/050/00853/AM15/ OB24/040/00160/AM15/ 11.09.2014 Pete6.112014 . Decision : It was decided to deferthe case for 26.11.2014 for comments ofDepartment | lof Pharmaceuticals CaseNouS/6/62-ALCA/2014 Pasty Name:SHIVAM OILS Meet Wo/Date:9/82- Sans PROTEINS INDUSTRY, ALCA4/2014 Approved 20.10.2014 fo JHQ File RLA File Lic. No/Date:5610004402 Defer Date: .0)1/82/050/00669/AM15/ |:56724/040/00030/AM15/ 12.09.2014 : | | Decision : in the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 44010/17/2014-Ch. ii dated 27.05.2014, it was decided to 497 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 ExportQuantity| S.No. Qty Allowed [of] [Norms] [Com] [wrtee.] RA may take appropriate action as per the [decision] [~ ='bo.102d - => Jand Re-indexed a [: [ease No.s1/9782-ALC472014mene PHARMA[Party<aLIMITEDAGROBINDOpe MeatMeet Nogi¢:9/82-° |Status:Deffered %6 g|Date:26.11.2014seen ho RO orStAMS) RiAFile ecision : It was. decided to defer the case for 26.11.2014, . + * Department | lof(8)sinnersPharmaceutical -09/24/040/00329/AM15/ 2909.204 097100610 pet , ‘ase No.:2/9/82-ALC4/2014 (Party Name-PERKIN cet Novi. /82- —— : eos Delicrcd LABORATORIES weLC4/201 Re-indexed .. 499 |HQ File po eee ).10.2014F | HOF oorggamis’ (Konan:09/24/040/00358/AM15/ TE2 No DedeEMP 10061044- io0sic i.IDel ogs.11.2014 ; ——— aS efer the case for 26.19 2014 for of Pharmaceuticals = §f &§ rent ef : es sy Far 4 Seba, Mt Ay Myf, Sea AP ----- End of picture text -----

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----- Start of picture text ----- oe , Case No.:3/9/82-ALC4/2014 = Party Name:CADILA Meet No/Date:9/82- Status: PHARMACEUTICALS LTD. |ALC4/2014 Approved HQ (20.10.2014 |. | HeFile 00800/AMIS) RLA:08/24/040/00242/AM15/ File hicLic. N o/Date:0810133479oe ||Defer. Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM INo. 3501 1/220/2014-Pi(Norms) dated 21.10.2014, 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: 900 Export product Export import items Qty Allowed | | Qty. ke/ke CILOSTAZOL 1kg 1. $-(4~CHLOROBUTYL)-1-CYCLOHEXYL - iH-TETRAZOL | 6-HYDROXY-3, 4-DIHYDRO 2(1H)}- QUINOLINONE RA concerned may take further necessary action as per above decision of NC. . [Case No.:4/9/82-ALC4/2014 [Party Name:ONEIRO [Meet No/Date:9/82- [StatussDefferea CHEMICALS LTD ALC4/2014 jand Re-indexed . [501 - ‘(20.10.2014 01/82/0S0/00801/AMI5/[HQ File IRLA—|:34/24/040/00168/AM15/File [30.09.2014Lic.No/Date:34 10040593 Pete|Defer 112014 Decision ; It was decided to defer the case for 26.11.2014 for comments of Department | fof C&PC, OO ~ [Case No.:5/9/87-ALC4/2014 [Party NamecHETERO [Meet No/Date.9/82. [Starassbetterca DRUGS LIMITED JALC42014 and Re-indexed 502 [HQ:01/82/050/00802/AM15/ File RLA File Lic.No/Date:0910061060 (Defer Decision —|:09/24/040/00362/AM15/ (07.10.2014. Date:26.11.2014 : It was decided to defer the case for 26.11.2014 for comments of Despartment | {of Pharmaceuticals . a Case No.:103/9/82- PartyName:NEULAND ‘(Meet No/Date:9/82- Status: Deffered : ALC42014 rasoeaToR LTD ——_ |ALC4/2014 and Re-indexed |503,{HQ ~ 20.10.2014 | Fil e RUA Fie scsamiy) +N 006105 a e ns :09/24/040/00365/AM15/ {0910.2014 _ Date:26.11.2014 ecision : It was decided to defer the case for 26.11.2014 for co: F Departm ALC4/2014 . 2. Sta: | LABORATORIES No/Date:9/8 flered. 504acts= ORA _. LTD #2014 and Re-indexed | lovEtsoomovannis, BEAR _ NODS(20.10.2014 — | :01/82/050/00901/AM15/ 09/24/040/00319/AM15/ 10.2014 061076Pr enone Decision : It was decided to defer the for 26.11.01 ——__1°626.11.2014 aea YOu 3h) tT, FT. 2Wwan, Ke ein; ----- End of picture text -----

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----- Start of picture text ----- | . lof Pharmaceuticals _ oo. [ [Case No.:111/9/82- ~ |Party Name:HETERO LABS {Meet No/Date:9/82- [Status:Deffered ALC4/2014 LIMITED ALC4/2014 jand Re-indexed . 20.10.2014 | . 505 |HQ:01/82/050/00908/AM1 File 5/ RLA:09/24/040/00346/AM15/File —[13.10.2014Lic.No/Date:09 10061084 ef:|Defer 112014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals . ----- End of picture text -----

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----- Start of picture text ----- Case No.:112/9/82- Party Name:ASTRIX Meet No/Date:9/82- Status: | JALc4n014 |LABORATORIES LTD., — |ALC4/2014 Approved 10.10.2014 . HQ File RLA File Lic.No/Date:09 10061092 (Defer Date: :01/82/050/00909/AMI5/ —|:09/24/040/00363/AM15/ [15.10.2014 - | Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/95/2014-Pl(Norms) dated 24.09.2014, it was decided to ratify the norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: 506 2h) g/kg } NEVIRAPINE tke [1 | Malononitrile | [(MALONONITRILE][ ROUTE)] 084Dichloromethane | [3 |SCSMethanol : Potassium hydroxide flakes | 6. Tr etiyi anine (REA) o5 | — [8 2-Chloro nicotinic acid fo.902 | | }9.| [Cyclopropyiamine] Pyridine Sidst057 «| 10.| Dimethyl formamide (DMI | [RA may take appropriate action as per the decision ofNorms Committee. [Tease No.:113/9/82- Party Name:ASTRIX ~ [Meet No/Date-9/82 Status] LABORATORIES LTD., —|ALC4/2014 jand Re-indexed: a [ALC4/2014] ; SHBL- tatus:Deffered. : :01/82/050/00910/, o/Date:09 10061093 [Defer Ploteaisomraany. —[atRloworeana. Renata(20.10.2014 Tosa rae ae5/- Seaton 15102014 Pet 11201 | of Pharmaceuticals? Itwas decided to defer the case for 1.201426. 1 . for comments ofDepartment:a ;ctsCase No.:114/9/82- LIMITEDParty Name-HONCNOURLAB +[Meet NofDate:9782-— apeae [ered] a 508 ho.10 Q and Re-Sédexed | |HQ File RLA Fil > ee Decision01/82/050/0091: It was 1/AM15/ decided;:09/24/040/00386/AM15/nM . is,15.10.2014iota"910961094_ Pe|Date:26.11.2014sao | , 0 defer the <== ofPharmaceuticals case for 26.11.2014 fer comments of Department °i Acris ----- End of picture text -----

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----- Start of picture text ----- “” Case No.:115/9/82- Party Name: NAGARJUNA [Meet No/Date:9/82- Status:Deffered ALC4/2014 AGRICHEM LTD ALC4/2014 and Re-indexed 20.10.2014 1509 HQ:01/82/050/00912/AM15/File RLA File Lic.No/Date:0910061 106 to.[Defer :09/24/040/00376/AM 15/ 16.10.2014 Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments ofDepartment __ jof Pharmaceuticals. . Case No.:117/9/82- Party Name:INCHEM Meet No/Date:9/82- ) ALC4/2014 LABORATORIES PRIVATE |ALC4/2014 Status:and Re-indexed Deffered LIMITED 20.10.2014 . 510 |HQ File RLA File Lic.No/Date:0910061119:|Defer :01/82/050/009 | 4/AM15/ :09/24/040/00374/AM15/ 17.10.2014 Date:26.11.2014 Decision : It was decided to defer the case for 26.11.2014 for comments of Department of Pharmaceuticals ----- End of picture text -----

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----- Start of picture text ----- Outside Agenda Case No. | M/s. GLENMARK GENERICS LIMITED Norms Committee Meeting No.9/AMI15 | 01/82/50/00393/AM15/DES Il Meeting Date:31.10.2014 RLA File No. 03/94/040/00050/AM15 Ady. Lic. No. & Date Adv. Lic. No.0310779212 dt. 23.04.2014 Decision: The case was earlier approved in Norms Committee meeting no. 5/82 dated 31.10.2012. The firm has requested for amendment in the description ofexport product. There is typographical error in the minutes. The export item recommended as Linezolid whereas it was mistyped as Linezilid. Hence, the export item may be corrected to read as : Without any other change in the earlier decision ofNC. RA may take appropriate action as per the decision ofNorms Committee. Date:24.10.2014 / i} Place:New NIRMAL KUMAR p"- Delhi Dy. Director General of Foreign Trade ----- End of picture text -----

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