IN FORCE 2014-08-29

200 Seventh Meeting of the Expert Committee on 29.08.2014 to examine the matters related to the approval of the safety and efficacy of Fixed Dose Combinations(FDC's) permitted for manufacture for sale

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----- Start of picture text ----- Office of Drugs Controller General (india) (EDC Division) ° Kotla Road.FDA New Bhawan,Delhi beet 19 AUG 2014 To Pe) 1, Dr. Krishna Biswas,Prof, & Head, Deput. Otheridocrinalogy.a, VardhmanMahavir Medical College &Safderjung Hospital, Delhi. 2 Dr. Nikhil Tandon, Professor, Dept. of Endocrinology & Metabolism, AIIMS, New Delhi. 3. Dr, Anil Bansali, Addi. Prof. & Head, Deptt. Of Endocrinology, PGIMER, Chandigarh. 4. Dr, Neeraj Kumar Agrawal, Associate Professor, Dept. of Endocrinology and Metabotisen, Institute of Medical Sciences (1.M.S.}, BHU, Varanasi. . 5, Or. Shantany Tripathi, Department of Clinical & Experimental Pharmacology, Schoal of Tropical Medicine, Chittaranjan Avenue, Kolkats-700012. ----- End of picture text -----

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----- Start of picture text ----- Subject» Sixth Meeting of the Expert Committee on 27.08.2014 at 11:00 a.m. to 6:00 p.m, in the Conference Room, 1* floor, FDA Bhawan, Kotla Road, Near National Bal Bhawan, New Delhi-110002, to : examine the matters related to approval of the safety and efficacy of Fixed Dose Combinations (FDCs) permitted for manufacture for sale in the country without due approval from office of DCG(N — regarding, Sir, Reference is invited to this Directorate’s Office Memorandum No. 4-11/2013-DC (Mise13-PSC) dated 03.02.2014 on the subject cited above. opinion ofThisExpertofficeCommitteein the followingas to whetherproposalsbasedforonapprovalthe dataofsubmitiedFixed Doseby Combinationsthe firm, theseseeksproposals your éxpertcan be approved, eal Recall ae 1 Shield Heatthcare | Benfothiamine 75mg +Metformin HCI 50mg Tablets : 2.safetab life science 2.benfotiamine 75/100 mg + metformin HCI S00 mg tablets 3.Goodman Pharmaceuticals 3.Metformin HCl 500mg +Benfotiamine 75mg Tablets , [East West Phurma TOlivenclamide IP Sm >Meiormin HCl IP 850mp Uncoated Todlets 2.Darwin Formulations 2.Metformin HC] 800mg *Glibenclamide Smg Tablets 3 | Sun Pharma Glibenclamide+Metformin HCi+Pioglitazone HC Smper5dOme+?. Smeg Tablets 4 Lindy drugs pyt itd 1 Gliclazide 80 mg + mettormin hydrochloride 325 mg Tablets — 2.Dr. Reddy's Laboratories 2 Gliclazide 40mg +Metformin HCI Sig Tablets } oad 3.Sun Pharmacecuticlas 3.Kilicluzine Img/2mg +Metformin HC! BSima2/850meg Tablets ' [ 4.Ravian Life Science 4.Metiormin HCI 500mg +Gliclazide 80mg Tablet * ----- End of picture text -----

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----- Start of picture text ----- Lwindlas bavxtech L glimepiride 3mg/4 mg + metformin hydrochloride 100" 1000 rs 2.Swiss Garnier mg tablets 3,Glenmark Pharmaceuticals Coated2.GlimepirideTablets [P 2mg * Metformin HC! (ER) 850mg Film 4.Ordain Heakthcare 3.Glimepiride IP 3mg +Metformin HC! 1 100mg Uncoated ' Bitayered tablet 5.ALCHEMIST Lid, , 6. Windlas Biotech +.Glimepirideretease) S00me/SOlmgIP bng2meTublets+Metformin HC! (as sustuinded « Adore Drugs & | 5.Glimepiride Wie Metformin HC! IP 500mg Uncoated Pharmaceuticals |.td Tablets 8.USV nt 6.Gilimepiride Img/2mg/img +Metformin HCI limited 850mg/8S0eng/S0mp Tabless 7.Glimepiride 4me +Metformin HCI SR 1000mg tabfet S.metiormin hydrochloride mg + glimepiride 0,5 me tablet PharmaceuticalsLAkums Drugs & | |.Glimepiride IP Img/2Img +Piogitazone HC} IP 7.Smgi7.Smg . Ltd +Metformin HCI IP SODmg/500m_g Tablets 2. Windlas Biotech 2.Glimepiride IP Img/2mg +Pioglitazone HCI IP 7.Smp/7.5mg +Metformin HCI IP 1000mp/1000me Tablets 3.windlss biotech 4.Mis, Actne Formulation i.glimepiridemg + metforminImg/2mghydrochloride* pioglitazone850 mg’ 850hydrochloride mg tablets [Smp/ts S.inventia Healthcare 4.Metformin HCL —1000/MKI0/S00/500mg — +Pioglitazone HCLT.S/7.5/7.5/7_Smg + Glimepiride 1/2/1/2mg Tablets Swiss Garnier 3.Metformin HCL 300mg =Pioglitazone HCL 75mg: + 7.Swiss Gamer Gilimepiride Img/2mg Tablets #.US¥' Lid. 6,ImgMetforminTabicis HC? 850mg +Pioglitazone HC! 7.5mg +Glimepiride 5 ue ia 7.Metformin HCI 850mg +Pioglitazone 7.5mg +Glimepride mg Tablets ‘ P §.Piogtitazane HC! 15mg +Metformin HCI Simg +Glimepiride | Imp/2mw Tablets : 9Pioglitazone HCI 7.Smg *Metformin HC! 500mg +Glimepiride Img’2me Tablets Glenwell Pharma Glipizide IP-Metformin HCI IP 2.5mg+4idme Uncoated tablet 1,Safetab Life Science 1.Mecobalamin JP 7Himeg +Metformin HC! IP 500mg/1000me Film Coated Tablets ZiInventin Healtheare ; 2Meiformin HC! IP S00mg/iXiOmg +Methylcobalamin _< 3,Goodman Pharmaceuticals | 750meg/1500meg Tablets ore J.Metformin HC) IP 300mg +Methyleobalamin JP S00meg Uncoated Tablets . 2 ----- End of picture text -----

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----- Start of picture text ----- ra af re 4.Acon Formulations Uncoated Tablets xe isunglow pharma 4.Metformin HCI IP 1000mg +Methytcobalamin JP 7S0meg ‘ Film Coated Tablets H S.methylcobalamin 7 9 HCL 500 mg/1000 mg/1000me750 meg/750tabletsmg/1530 meg + metformin ! |.Savi Pharma 0.2mgMetformin uncoated HCI ERbilayered1MOmg tablet+Gliclazide MR 60mg +Voglibase s CoatedMetformi¥HC!Tablets 1P 1000mg +Atorvastatin Calcium IP 20mg Film A meeting has been convened on 27.08.2014 10 evaluate the above Propesuls, You are requested to kindly make it convenient to attend the said meeting on the said date TAMA for attending the meeting as well as honorarium will be paid as per this Directorate’s Office ‘ Memorandum No, 4-01/2013-DC (Misc?3-PSC) dated 03.02.2014. If travelled by Air, it should be by Indian Airlines only and the air tickets, if purchased through agent, should be Purchased through M/s Balmacr Laurie & Co, who is the authorized Govt. agent for this purpose. to You are requested kindly to make it convenient to attend the said Meeting Oo 27.08.2014 at 17:00 a.m: Delhi-6:001 p.m,10002,in the Conference Room, 1” floor, FDA Bhawan, Kotla Road, Near National BalBhawan, New You are requested to confirm your participation by e-mail at fdedivisiona@gmail,com. Youp4 faithfully, Drugs Controller(Dr. GJenerulGLN. Singh) a , Copy to: | M's. Shield Health Care Put. Lid,, No; 66, Second Cross Street,Pallavan Nagar Extn,Maduravoyal, 2 Chennai - 600095, Tamilnadu, 605107.M's, Safetab Life Sciences, Plot No. A-t? & 68, PIPDIC Electronic Park, Thirubuvanai, Puducherry- % M/s.PondicherryGoodman 605pharmaceuticals,107, PLOT No. 83 To B8, PIPDIC Electronic Park, Thirubhuyanai, 4 Mis,Maravaneri, SalemEase — 636007,WestTamil Nadu,Pharma, Na, 10, 2nd Cross, —_ 5, M/s,Andhry Darwin FormuationsPradesh $2000, Pya | td SHE RST AT AR Catoay, Hens Cirele, lene Cirgle. Viityawada, =e 6. M/s, Sun Pharma Advanced Research Company Ltd, Tandalja, Vadodara, Gujarat, . 7 M/s. InduAndhra Pradesh Drugs Pu500072 Lid,, $-35/278/279. Prasanthi Nagar, | DA, Kakaipally, Kukatpally, Hyderabad, 8. Mrs, Dr. Reddy"s Laborasories Lid. 71-27, Amecerpet, Huderabyd-S00016. AP. | . . eT RATT Mshigee. : 7 . wnt SF ----- End of picture text -----

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----- Start of picture text ----- 4%. Mis. Ravian Life Science Pvt. Lid. Vivek Anand Shahi, Plot No. — 34. Sector 8a. SIDCLIL. THE. Haridwar ~ 249403, Uuarakhand, 10. Mis, Windlas Biotech Limited, 40/1 Mohabewala Induswial Area,S.B.1 Road, Saharanpur Highway, Dehradun- 248002, Uttranchal Nn. Mis. Swiss Garnier Life Sciences, No. 21-23 Industrial Area Mehatpur, Dist. UNA, H.P. 174315. 2. M/s.Glenmark Pharmaceuticals Lid., B’2, Mahalaxmi Chambers, 22, Bhulabhai Desai Road, Mumbai- 400026. LB. M/s, Ordain Health Care Global Private Limited, Sri Devi Temple Towers, No, 6, Second Main Road,, Sembukkam, Chennai, Tamil Nadu 600073. 4, Mis, Alchemist Liu, ow 23, Nehru Place NEW DELHI = 110019. a: 15, ° ye ,! A Want ae eet 16. Mis. Akums Drugs & Pharmaceuticals Lid., 19 t0 21, Sector 6-A, IIE, Ranipur, Haridwar, 17, M/s, USV Limited, Arvind Vithal Gandhi Chowk, BSD Marg. Station Road, Govandi East, Mumbai - 400 088. 1k. Mis. Acme Formulations Pvt. Lid., Ropar Raod, Nalagarh, Distt. Solan, HP.- 174101, “ 1. Mis. Inventin Healthoare Pvt. Lid. FI-FI/1: Additional Ambernath, M.1.D.C. Ambernath (East) 421506, Dist-Thane. 2. Mis. GLENWELL PHARMA, No, 32/7, Ramanathapuram Road. Rarmanathapuram Village. Puduchrry-605502 21, Mis. Aeon Formulations Pvt. Lid, RS. No. S15V2 & $15/2 & StS, no, 1532/7, Vinayagar Koil Stret, Thirubuvanaipalayam, Mannadipel Commune, Puducherry-605 1017, 22, M/s, Sunglow Pharmaceuticals Pvt, Lid, Plot No, 2938, Opposite to Co-operative Milk Diary {Pontait), Kurumbapet, Pondicherry-605009, 23, ' . ----- End of picture text -----

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----- Start of picture text ----- m4, M/s, GKM New Pharma, Spl. Type Plot No, 5 to 8 PIPDIC Electronic Park, Thirubuvanai, Mannadipet Commune, Puducherry-605 107, 28, M/s. Savi Pharrns Limited. Notefor Firms: - Yoo are requested to depute your technics! team for presentation, As application for same FDC have been received from multiple applicants, you are requested to be present at COSCO on 27.08.2014 at 11:00 am. to 6:00 p.m, in the Conference Room, 1" floor, PDA Bhawan, Kotla Road, Near National Bal ; Bhawan, New Dethi- 110 002 to make presentation as considered necessary by the committee. + Also requested to submit the copy of the presentation of the respective proposals before 3 days of the meeting date. : ~ Also requested to bring Drug Samples in original pack as well as package insert while coming for . presentation. ~ Any other manufacturer who have applied abowe FDC's may also present their case before the coenmittee. . Yop? faithfully, —— = —_ (Dr. $5.N. Singh) Drugs Controtley General (1) ----- End of picture text -----

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