206 Postponement of the Seventh Expert Committee Meeting from 29.08.2014 to 05.09.2014 to examine the matters related to the approval of the safety and efficacy of Fixed Dose Combinations(FDC's) permi

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----- Start of picture text -----<br> o<br>7 K ni<br>]<br>:<br>.<br>FDA 1<br>Kotla Bhawan,<br>Road, New Dethj is<br>Te . Dated: 22 AUG 2014<br>1. °<br>Kolkata<br>Dr. Dipankar Bhattacharyya, Prof. & Ge, Dept. of Pharmacology, IPGMER & SSKM,<br>2. Dr, Sudhir Gupta, Professor & Head, Dept, ofGastroenterology, Government Medical College &<br>3, Super Speciality Hospital, Tukdoji Square, Nagpur, Maharashtra.<br>4, Dr, Goswami, Prof, &Head, Deptt.Of Hepatology, Guwhati Medical College, Guwhati<br>S. Dr. Sanjeey Sachdeva, Deptt. ofGastroenteralogy, G.B, Pant Hospital, New Delhi<br>GD e .neral K, Narayan, Council Prof. Hospital, & Head, Chennai. Dept. of Hepatology, Madras Medical College and Rajiv Gandhi<br>Subject:- Postponement of the seventh Expert Committee Meeting from 29.08.2014 to 05.09.2014 at<br>11:06 a.m, to 6:00 p.m. in the Conference Room, I" floor, FDA Bhawan, Kotla Road, Near<br>National Bal Bhawan, New Dethi-110002, to examine the matters related 10 approval of the<br>safety and efficacy of Fixed Dose Combinations(FDCs) permitted for manufacture for sale in<br>Sie, the country without due “approval from officeof DCG(I)}-regarding.<br>Reference is invited to this Directorate's Office letter<br>dated: no, 4-01/2013-DC (Mise. 13-PSC -Pt-Meeting)<br>under, 12.08.2014 requesting you to Participate in aforesaid Meeting which was scheduled to be held an<br>29.08.2014. Now, the said meeting has been Postponed to 05.09.2014. The detailed agenda for the meeting is as<br>Te ig<br>1.Vivimed labs 1. Magnesium hydroxide 98 mg + alminium hydroxide 0 251 gr<br>oxetacaine 10 mg oral liquid<br>2.Restech 2.Dried afuminium hydroxide gel 400 mg + magnesium '<br>Pharma hydroxide 100 mg + Oxetacaine 10 mg Liquid Suspension<br>3.Acron Pharmaceutical JOxctacaine 10mg = +Aluminium Hydroxide 0,298mg<br>+Magnesium Hydroxide 98mg Oral Suspension<br>4.Skan 4.Dried slumialuetae 3 |hydroxide gel 150 mg + magnesium<br>research lab hydroxide 150 mg + oxetacaine S mg suspension<br>5-Seivok Pharmaceuticals: 5.Oxetacaine BP 10mg +Aluminium Hydroxide eg. to dried<br>Aluminium Hydroxide Gel IP 0291gm eq, tc 0.380gm<br>LFDC +Magnesiurn Hydroxide IP 98mg Suspension<br>Lid Aluminium hydroxide gel 250mg +Magnesium hydroxide om<br>250mg +Simethicone SOing +Oxetacaine f0mg Oral suspension sien<br>2.Livin 2.Aluminium hydroxide — paste+ Magnesium — hydroxide<br>Formulations : PaSu s tp e +Sns i onmethicone+Oxetacaine 1.57g+1.25gm+50mge+10mg<br>:<br>i '<br>“<br>. |<br>----- End of picture text -----<br>

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----- Start of picture text -----<br> P LEspi Industries 1Alginic Acid 200mg +Sodiam Bicarbonate 70mg +Drled in<br>Aluminium Hydroxide 300mg *Magnesium Hydroxide Somg 1<br>2.Espi Chewable Tablets |,<br>1.Pharma= Industries ChewableAluminium2.Alginic TabletsAcidHydroxide200mg 150mg+Sodium+MapnesiumBicarbonateHydroxide70mg +Dried75mg H!!<br>Synth Formulauons Oil|Activated Dimethicone 0.0007m! Oral Liquid IP 40mg +Dil Ol BP 0.005ml +Fennel .<br>2.Abaris 2Dill Oi Roosm +Fennet oil 0.000%! +Simethicone<br>3ulndoco Healthcare or 40mg Ora! Liquid<br>Remedies 0.0007m!ommethicone Syrup LP 40mg +Dill oil BP 0.00Smi +Ferne! oi usp<br>4unibiotech 4.Simethicone emulsion 40 mg + fennel oi! Dilt oft O07 imal +<br> formulations 1.008 ml drog suspension<br>‘ndoco Remedies: 5.Simethicone Emulsion USP eg. to Simethicone USP 40mg<br>*Dil Oil BP 0.00Sm! +Fennel oi! USP 0.0007! Oral Drops<br>6.Degon Pharmaceuticlas 6.Simethiconewt Collgnemulsiondoy 40mg +Dill oi! 0.005m) +Fennel oil<br>7.Next Wave omen dmg +Dill Oil 0,00Smi Fennel oi! 0.0007%m!<br>1.Pharma ty s<br>Synth Formulations lActivated Dimethicone IP 50mg Magnesium Hydroxide IP<br>Solution250mg +Dried1.252m Suspension Aluminium Hydroxide Gel IP 250mg +Sorbital<br>2.EspiBey Industries +Dried2.ActivatedAluminium Dimethicone Hydroxide Sdmg++Magnesium250mg +Sarbitaol Hydroxide Solution 250mg (70%)<br>Non-Crystallizing 0.650gm Oral Liquid<br>3.Galpha Laboratories. 3Aluminium Hydroxide Paste 1p 300mg +Magnesium<br>Hydroxide Paste [p 200mg +Activated Dimethicone IP 125mg<br>*Sorbitol Solution 750mg Syrup<br>4-Waltsce Pharmaceuticals1 oral+activated4.Aluminium dimethiconeHydroxide¢ 40mg 300mg+sorbitol +Magnesiumsolutionhydroxide1000mg 250mgliquid -<br>LShivalik Remedies 1,Activated Simethicone IP 40mg ‘Magnesium Hydroxide IP<br>400mg +DRIED Alluminiym Hydroxide Gel 1P400mg<br>_<br>—<br>2.Rexer pharma 2almunim hydroxide 250mg + magnesium hydroxide 250mg +<br>es -<br>Livin Formulations Bet3.Aluminium1.57gm eg.hydroxideto 250mg Paste +Magnesium eg. to Driedhydroxide AluminumPaste Hydroxideeq. lo<br>Magnesium Hydroxide {P 1.14gm eq. to 250mg +Simethicane IP |<br>2<br>: .<br>3<br>ne<br>----- End of picture text -----<br>

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||-||50mg Oral Suspension|||
|||4.RPG<br>Lifesciences<br>5,Cartel lnboratories|‘Dried Aluminium Hydroxide BP 300mg +Magnesium<br>Hydroxide BP150mg +Simethicone BP 40mg UncoatedTablets||‘4<br>ie|
||||S.Simethicone<br>50 mg+ magnesium hydroxide pel 250 <br>aluminium<br>hydroxidegel 250Mgsuspension|mg +|a<br>‘|<br>i|
|||6.HemaLaboratories<br>1.Hippo<br>Labs|6.Simethicone SO.mg +Dried Aluminium Hydroxide Get<br>250.0mg +ygagnesium<br>© Hydroxide 250.0mg Monorin-MPS<br>LAipha<br>ase (12000)10mg+Papain20mgSyrup||#<br>a|
|||2.UnibiotechFormulations|2.AlphaAmylaseIP100mg+PapainIPSOmgSyrup|||
|||3.ShreyaLifeSciences|4.AlphaAmylaseIP 125mg+PapainIP40mgSyrup|||
|||4.CartelLaboratories|4.PungalDiastaseIP50mg+PapainIP10mgSyrup|||
|||5.NoelPharma|5.FungalDiastase [P12.5mg+PapainIP 7.SingSyrup|||
|||6.LaboratePharmaceuticals|6.PungalDiastase IP50mg+PapainIP60mgSyrup|||
|||7.ElanPharma|7.DiastuseIP100mg+PapainIPGOrngTablets|||
|||8.Sain Medicarnents<br>1,Datwin Formulations|&.Fungal Diastase<br>(1:1200) IP<br>50<br>B *Papain<br>iP60mg<br>Syrup<br>[Alpha Amylase(1:2000 )50mg+PepsinIP10mgSyrup|||
|||2.ShreyaLifeSciences|2A-Amylase(FangatDiastase1:800fromAspergillusoryzae) IP<br>62.5mg+PepsinIP20mgSolutionforOraladministration|||
|||d.parnax lab itd|3alpha-amylase62.5mg*pepsin20mgoralsyrup|||
|||4.SuntiseIntemationalLabs|4.Diastase IP (Fungal Diastase derived fram aspergillusoryzae<br>digestsnotJessthan60emsofcoockedstrach)50mg+PepsinIP<br>(OmgSyrup|||
|||S.ElderPharmaceutical Lid|5.Diastase<br>IP $Omg + Pepsin 10mg OralLiquid||7|
|||6.Noel<br>re<br>7,GKM Nirare|6.Diastase33.33mg+Pepsin Smg Drops<br>es<br>7.DinstaseS0mg+Pepsin10mgSyrup|||
|||8.Versatile Pharma|8.Fungal Diastase (1:1200)IP50mg+Pepsin(1:3000)IP 10mg<br>Syrup|||
|||9.P&BPhameaceuticals|9.FungalDiastase(1-2500)62.5mg+Pepsin IP20mgOralLiquid|||
|.||10,Cartel<br>laboratories<br>L1.BHC Lab|"0-fangal diastase$0mg+pepsin10mgsyrup<br>11.FungalDiastaseIP(1:1200) IP50mg+PepsinIP(1:2000)<br>lOmgHardGeletinCapsules||_<br>sa|
||||||.|
||||12.Fungal Diastase IP(1:1200)IP50mg+Pepsin IP(123000)|||
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----- Start of picture text -----<br> 2 ~. 12.Dr. Sain's Laboratories 10mgSyrup ¥ :<br>13.Hippo Labs 13.Fungal Diatase (1:1200) SOmg *+Pepsin(1:3000) 10mg Syrup<br>,<br>'<br>7<br>1<br>toDelhi-1 10002.va requested Kindly 10 make it convenient to atend the suid meeting on 05.09.2014 af 11:00 am. .<br> 60) p.m. in the Conference Room, Ist floor, FDA Bhawan, Kotla Road, Near National Bal Bhawan, New<br>s<br>TA/DA for sttending the meeting as well aspres Mpeg Will be paid as per this Directorate's Office .<br>Memorandum No, 4-01/2013-DC (Mise13-PSC) 3.02.2014. If travelled by Alr, it should be by Indian<br>Airlines only and the air tickets, if purchased through agent, should be purchased through M/s Balmaer<br>Laurie & Co. who is the authorized Govt. agent for thisPurpose,<br>You are requested to confirm your participation by e-mail at fdedivision@gmail.com.<br>Yours faithfully,<br>Drugs (Dr. GN, Singh)<br>apt (1)<br>----- End of picture text -----<br>

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lf Mis, Vivimed Labs Lad, D9, Industrial Area, Haridwar, Uttarakhand, 2 M/s. Restech Pharma, B-1 84/183, PIPDIC Industrial Estate, Mettupetlayam, Pondicherry, P.C. 3. 605(9.Pondicherey, 4., Mis. Acton Pharmaceuticals, 38/2, Main Road, G.1_D.C., Estate, Nazoda, Ahmedabad-382330, Gujarat, M/s, Skan Research Lab Pvt, Lid, # WW7-b, Thirubuvunai, Munnadipet Commune, Viflianur, Pondicherry. PC, 605107. Pondicherry, Pondicherry i 3./ Mis. Selvok Phartaaceuticals, 147, G.LD.C,, Antatia, Bilimora - 396 321, Dist. Navsari, Gujarat. 6. / Mis. FDC Limited, 142-48, S.V_ Road, Jogeshwari (W), Mumbai-400102. 7, (East),M/s, Wallace Mumbai Pharmaceuticals- 400 093, Ltd. 8-307/312, Floral Deck Plaza, Off. Central MIDC Road, Andheri 8y Mis. Espé Industries & Chemicals Pvt. Lid, Plot No, M-7/2, Kakatiya Nagar, Habsiguda, Hyderabad” v4 500007. Mis, Pharmasynith gt Formulations Limited, 10y A-10/15, Jhilenit Industrial Area, Dethi- 110095, AhmedabadM/s. ABARIS- 380 006,HEALTHCARE PRIVATE LIMITED, 46, Saffron, Panchvati, Ambavadi, 1k M/s.160030.Unibiotech Formulations, Mr. JK. Gulati, $CO-272, Ist Floor, Sector-32- D, Chandigarh — 12 Swarghat Ré,Mis. Dagon Pharmaceuticals Baddi, Himachal Pvt Pradesh Ltd, Opp174102.Gurudwara, Baddi - Nalagarh Road, Manpara P.O, Pinjore— 13, i 14,[Mls,] M/s.[ Next] Indoco[Wave] Remedies[(India),] Limited, Indoce House. 166, CST Road, Santacruz (Bast), Mumbai 400 098, —_— - CORPORATE OFFICE, C 980 Sushant Lok, Phase I if Gurgaon « (Haryana}- 122002, 16/ Mit Galpha Laboratories LigG Babu Sokpal Marg, Worll, Mumbai, Maharsshire 400018. bd M/s. NOEL Pharma, 24-85/7, Laxmninarayana Nagar Colony, New 1.D.A,, Uppal, Hyderabad - 17, 039. ‘ a M/s, Pro Laboratories Pvt, Pvt Ltd, 190-14], Mskkanpur, Bhagwanpur, Roorkee Dist, Hari 4 . . i.

• . P=. 7 Uttrakhand, Haridwar + ‘* 1 DF ~ 249401, 1 atean ni Remedics Pvt. Lid. Khaaru No, 309/12 & $20, Village Bhagwanpur Mus, Ro 4 19,, Dehradun Road, Bhagwanapur. P,C. 247667. Roorkee, ‘5 20, M/s. Rexer Pharma PytLid,Phase-IL, Ida,Cheriapally, Cherlupally, 114/2/B, Telangana $0051, ’ 21, Mis.M's, CartelRPG LifesciencesLaboratories, 24-112/4,Lid, 25, MIDC Ln Colony,Land, thane Belapur Road, Navi Mumbal-40070s, \y 22, Near Gvi Bio, IDA, Uppal, Hyderabad- 500039 it Mis,Dehradun-248Hema197,Laboratories Uttarakhand. Put. Lid, Selaqui Industrial Area Pharma 33, SOOTMis. Hippo1. Labs PVT LTD., Goutham Nagar,> & 273 Old Air Port Road, Hyderabad, Hyderal s 24..Mis, Shreya Life Sciences Private Limg Shreya Mouse MHA, Parera Gill Road, Andheri 7” 25, Andheri East, Mumbai, Mahurashéry woe 26, M/s. Laborite Pharmaceutical india Limited, E-11, Ind. Area, Panipat-132103, M aharashtrais. Elan Pharma 400088India Pvt. Lid. SOL. Raikar Chamber, Govandi, Deonur E. Govandi, Mu 28, 29.M/s. Sain Medicements Pyt. Ltd, 10, HVES Building, Sultan Bazar, Hyderabad-$00095, 23, AndhraM/s. Darwin Pradesh Formulations320008. Put Lad, 54-18-3744, AIR Colony, Benz Circle, Benz Circle, Vijayawada, 30 Mis. Parnax Lab Private Limited, 104-107, Building, No-8, Jogani Industrial Estate, Chunabhatti Sly Station, Sion, Sion, Mumbai, Maharashtra 400022. 32, Mis, Sunrise International Labs, Plot No 100, Phase-II IDA, Cherlapally, Hyderabad 500051 AP. Mis, Elder Pharmaceuticals Py, Ud, Elder House, Plot no. C-9, Dalia Industrial Estate, OF Veera 33., Desai Road, Andheri (W), Mumbai-400053. * Mis.GKM New Pharma, Spl, Type Plot No, $ t 8 PIPDIC Electronic Park, Thirubuvanai, 34, Manadipet Commune, Puducherry-605107. Mis.HyderabadVersatil ~ 500007.Pharmaceuticals Pvt, Ltd, #5-62, Street No, 8, Habasigude 36.35. Mis.Mumbai-400 P & B Pharmaceuticals 053, Limited, 4/09, Ashfrwad,11a) Lokhandwala Complex, Andheri (W), 37, M/s. BHC Lab Private Lid, Factory: Unit [1 91/2, DLC, Baddi, Distt. Solan (H.P,) M's. Dr Sains Laboratories, 1054 N § RoadHariharpur,South Twenty Four Parganas, West Bengal. Notefor Firms: - rceveda ay dite your technica eam for presentation. As application for same FOC have ben received@m. to 6200 fromp.m. multiplein the applicants,Conference you Room, are requested1floor, toFDAbe presentBhawan,at CDSCOKotla Road,on 05.09.2014Near Nationalat 11-00Bal ‘ - Bhawan, New Delhi . 110 002 to make presentation as considered necessary by the commie. Alsomeetingrequested date to submit the copy of the presentation of the respective proposals before 3 days of the ‘ i > pesemaion, |" 8 Drve Samples in original pack as wel ss package insert while coming for ~ committer,Any other manufacturer who have applied above” FG's may also peesent their case before the Y faithfully, (Dr. —_ Drugs G.N. Singh) “« C eneral (1) ~ | . | J ae