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Subject:- Se ( DeRv F Cxo Oe a Go Cn m (m St i ish , n )) e M ~I pe * t ee r h r et f e m gi l i aon m t rog a t dr t, ieo t ndf eF g r ,t tD sh o e A rr E e mx lB aap h nte a uer w d tt aa tC cn oo t, um a rm K p ei po rt t folt ovae ra e lR s o o aoa ln f ed 2 , t9 i h n. N e0 e t8 a s h. ar e2 f 0 e cN1 t aa y4 ut na i a tt o n rn d1 ya1 l e2 wf0 B if0 a ti l ha c o. a um cB t, yh at o do w f u a6 eFn: i,0 ax0 pe N pp d re. om w D v. o a D si ln e e l f t h rh Cie ao- mmC 1 bo i1 on f0 nf f0 ae i0 tr c2 ie e, o n n oc t s fe o
Sir,
03.02.201R 4e f oe nr e tn hc ee S ui bs ji en cv ti t ce id t et do s t hh oi vs e D .i rectorates Office Memora en jdum No, 4-01/2013-DC (Misct3-PSC) dated
o opp pi rn ei vo en d o .T fh i Es x po ef rf ti c Ce oi mn m it the t ef eo l al so w ti on g w hP er to hp eo rs a bl es s el do r o a np p tr ho ev da al t ao f s uF bi mx ie td t eD do s be y C tho em b fi in rma ,t i to hn es se s pe re ok ps o sy ao lu sr ce ax np e br et
S.No. | Name of firm/ Institute
Drug
I 1, Vivimed labs oI x. M eta ag cn ae is nei u 1m
0
mhy gd r oo rax li d
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e
i
q9 u8
i
dmg + aiminium hydroxide 0 291 g +
2.Restech pharma h2 y.D dr ri oe xd i dea l 1u 0m 0i mn giu +m oxf ey td ar co ax ii nd ee 1 6 g mel g L3 i0 q0 u" i dm sg us pe+ n sim oa ngnesiuen
3_Acron Pharmaceutical +J. MO ax ge nt eac sa ii un mg Hyde rn og x ' -+ATurninium Hydroxide — 6.29%my
-_——~s-<
de 98mg Oral Suspension
4.Skan h tab h4 y.D dr ri oe xd i dea l 1u 5m 0i n mi gu m + oxh ey td ar co ax ii nd ee § g Mel g S1 u5 s0 p enm sg io n+ magnesium
5,Selvok Pharmaceuticals A *5 l MO ux ae m gt i na n ec i sa u ii m un me H HB y yd dP r
r
o ox xl i iO d dm e eg IP+ G A e 9ll
8
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ox ei gd ,e tey o. 0to 3 8d 0ri ge md
2 LEDC Lid 2A 5l 0u mm gi +n Si iu mm
et
hh iy cd or no ex i Sd ie
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ge e +l
O
xe2 t5 a0 cm ag
in
e+ 1M 0a mgn ge Os ri alu m
S
USh Py Ed Nr so ix oi rde ist
2.Livin Formulations P S2 u u. s sA t pl e eu + nm S si i in m oi e nu tm hi c— o nh ey +d Or xox ei td ae c ainP ea use 1s . S 7gM ma >g n fe .s 2i 5u gm m +SOh my gdr +o |x Oi md ye
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|*% .
|.Espi Industries LAlginic Acid 200mg +Sadium Bicarbonate Timg +Dried
CA hl eu wm ai bn li eu m
T
abH ly ed tr soxide 300mg +Magnesium Hydroxide 50mg
2.Espi Industries 2.Alginic Acid 200mg +Sodium Bicarbonate Omg +Dried
CA hl eu wm ai bn li eu m
T
aH by ld er soxide 150mg +Magnesium Hydroxide 75mg
|.Pharma Synth Formulations | Activated Dimethicone IP 40mg +Dil Off BP 0.003ml +Feanel
Ol! 0,.0007m! Oral Liquid
o
_ 2. Aberis Healthcare E2, mD ui ll fl i_ oO si l U SP0 . 40 05 mm gi O ra+ lF e Ln in qe uil d Oil 0,0007m! +Simethicone
3.1ndece Remedies 3,Dimethicone IP 40mg +Dill of) BP 0,005! +Fennel oi] USP
1.0007ml Syrup
4.Simethicone emulsion 40 mg + fennel oil Dill oi! 0.007 mi +
4.unibiotech formulations 0.005 ml drop suspension
S.indoco Remedies *S5 D. iS li Om ie |t h Bic Po n 0e
.
0E 0m 5u ml !s i +o Fen
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nU eS !P
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ile q U, St Po 0S ,i 0m 0e 0t 7h mi !c o On re
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6.Dagon Pharmaceuticlas
06. .S 0i 0m 0e 7t mh lic Ca on le
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ge om u dl rs oi po sn 40mg +Dill ofl 0.00Smi +Fenne! oil
7.Next Wave O7 v. aS li m Le it qh ui ic done 40mg +Dill Oil 0.00Sm! +Fennel oil 0.0007m!
1.Pharma Synth Formulations 2 S| o5. lA 0 uc tmt ii g ov na + t D !e r .d i 2e 5D d gi m mAe Slt uuh si m pc i eo n nn i se u
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m oI
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P H y3 d0 rm oxg i d+ eM a Gg eln e Is Pi u 2m 5 0H my gd r +o Sx oi rd be i toI lP
ZEspi Industries 2.Activated Dimethicone SOmg++Magnesium Hydroxide 250mg
N* oD nr -i Ce rd
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sA tb au lm lii zn ii nu gm
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l2 5 Lim qug
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d+ S -orbitaol Solution (70%)
3.Galpha Laboratories H3 y. dA rl ou xm ii dn ei u Pm
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*Sorbitol Solution 750mg Syrup ;
4. Wallace Pharmaceuticals o4 + ra. acA ltl iu vm ai ten di u Jm i mH e ‘y td hr io cx oi ned e 4 3 00 m0 gm g +s o+ rM ba itg en le ss oi lu utm i oh ny d 1r 0ox 0i 0d me g 2 l5 i0 qum ig d
LShivalik Remedies
|-Activated Simethicone
2.Rexer phurma
3. Livin Formulations
400mg +DRIED AlluI miP n i4 u0 mm g H> yM da rog xn ie ds ei um G eH ly dro 1x Pi 4d 0e 0 mI gP
Suspension
2.almunim hydroxide 250mg + magnesium hydroxide 250mg +
simethioone $0 mg suspension
3.Aluminium hydroxide Paste 4. to Dried Aluminum Hydroxide
gel 1.57
—_—
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—50mg Ora! Suspension
34 .. CR arP tG el L li at be os rc ai te on rc ie es s 4 H. yD dr ri oe xd i deA Blu Pm i | 5n 0iu mm g +SH iy md er to hx ii cd oe n e BB PP 403 m0 g0 Um ng c oa+ tM ea d g Tn ae bls ei tu sm
a5 l. uS mim ie nt ih ui mc o hn ye
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e+ magnesium hydroxide gel 250 mg +
gel 250 Mg Suspension
6.Hema Laboratories S26 u5. s0S p.i e0m ne e st nh igi
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c no *n Me a g5 n0 e, s0 im ug m + HD yr di re od x idA el um 2i 5n 0i .u 0m m g Hy Md ar no ox ri ide n -MG Pe Sl
|.Hippo Labs LAlpha t- flase (1:2000) 10mg +Papain 20mg Syrup
2.Unibiotech Formulations 2 Alpha Amylase IP 100mg +Papain iP 50mg Syrup
J.Shreya Life Sciences J.Alpha Amylase IP 125mg +Papain (P 40mg Syrup
4.Cartel Laboratories 4.Fungal Diastase iP 50mg +Papain IP }Omg Syrup
5.Noe! Pharma 5.Fungal Diastase IP 12.Smg +Papain IP 7.img Syrup
6.Laborate Pharmaceuticals 6.Fungal Diastase iP 50mg +Papain IP img Syrup
7.Elan Pharma 7.Diastase IP 100mg +Papain IP (mg Tablets
§ |..Sain Medicaments 8.Fungal Diastase (11200) IP SOemg +Papain IP 60mg Syrup Darwin Formalations L.Aipha Amylase (12000 ) 50mg *Pepsin [P 10mg Syrup
2.Shreya Life Sciences 62 2. .A 5-A mm gy +l Pa es pe s i( nF u In Pg a 2l 0 D mi ga s St oa ls ue t i1 o- n8 0 fo0 r f Or ro am l A as dp me ir ng ii sl tl ru ats i o or nyzae) [P
3. parnax lab itd 3.alpha-amylase 62.5 mg + pepsin 20 mg oral syrup
4_Sunrise International Labs d4 i. gD ei sa ts st a ns oe t lI eP s s( F tu hn ag na 6l O D gi ma ss t oa fse derived from aspergillus oryzae
5.Elder Pharmaceutical Lid
6.Noel Pharma
7.GKM New Pharma
8. Versatile Pharma
9.P & B Phameaceuticals
10.Cartel laboratories
IL.BHC Lab
10mg Syrup coocked strach) Sng + Pepsin IP
:
5.Diastase IP 50mg + Pepsin 10mg Oral Liquid
6.Diastase 33, 33mg Pepsin Smy Drops
7.Diastase 50mg +Pepsin \Omg Syrup
S8 y.F ru un pgal Diastase (121200) IP Sdmg +Pepsin (1:3000) IP 10mg
9.Fungal Diastase (1:2500) 62.Smg +Pepsin IP 20mg Oral Liquid
10.fungel diastase $0 mg * pepsin 10 mg syrup rst
111 0_ mP gu n Hg aa rl dD Gi ea ls et ta is ne C( aP
p
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( u: l1 e2 s00) 1P 30mg +Pepsin [P C1200)
12.Fungal Diastase IP (1 1200) IP SOmg +Pepsin IP (13000)TM
12.Dr, Sain’s Laboratories 10mg Syrup
13.Hippo Labs 13.Fungal Diatase (1:1200) SOmg +Pepsin( 1:3000) 10mg Syrup
A meeting has been convened on 29.08.2014 to evaluate the ubove proposals
You are requested to kindly make it convenief# to attend the said meeting on the said date.
T MA e/ mD oA r f ao nr d ua mtt Ne on .d i 4n -g 0 1t /h 2e 0 m 1e 3e -t Di Cng as weil as um will be paid as per this Directorate’s Office LAl arl ui rne is e only and the air tickets,( M ii fs pc u r1 c3 h- aPS sC e) d d ta ht re od u 0 g3 h. 0 a2 g. e2 n0 t1 ,4 , s hoIf u lt dra bve el l pe ud r cb hy a A si er d, tit h s rh oo uu gl hd Mb /e s b By a I ln md ai ea rn & Co. who is the authorized Gove, agent for this purpose.
sal are requested Kindly to make it convenient to attend the said meeting on 29.08.2014
3
to 6:00 p.m. in the Conference Room, I" floor, FDA Bhawan, Kotla Road, Near National BalBa ht a w1 a1 n:0 ,0 Na e.m w.
You are requested to confirm your participation by e-mail at f{dedivision@gmail.com.
Yours faithfully,
Copy to:
2. MMM Ii/ Sss I.. O V SRi .ev s Pi t om e nce dh id c hL P ea h rb a rs r y m ,L at ,d , B D E- S9 4, / I Tn Rd Sus ,t r Pia Il P A Dr Ie Ca , IH na dr usi td rw ia ar l , EU st tt aa tr e,a kh Ma en id t; upalayum, Pondicherry. P.C,
3. GM ul js a, r aA t,eron Pharmaceuticals, 38/2. Main Road, G.L.D.C., Estate; Naroda, Almedabad-382330,
4. M Pol ns d. i vS hk era rn y . R Pe .s Ce .a 6rc 0h 4 10L 7a b P oP nr dii c hL ei rd r. y.. , P# o ndA i/ cF he, r ryThirubuvanai, Mannatipst Commune, Villignur,
765 ... (MM M Eliy asss s,., t ) F WS , e aD Ml l uCv l mo a Lk c bi e umP ih iPta h er -a dm r 4,a m 0 c a 01e c4u e 02t u 9-i t 34c i .8a c,l a s $ l, . s V { L.4 t 7 d, R . o G Ba1 -d 3D . 0 J. 7oC /g 3_ e 1 s 2A h ,m w a Fal lri oia r a, ( l WB ) Di , el i cMm u ko m r Pba la a - i z a-3 ,49 06 Of0 3 f12 .01 2 C, e. D ni ts rt a. l N Mav Is Dar Ci , R G ou aj da ,r a At n, dheri
§. HM/ ys d. e rE as bp ai d -I Sn 0d 0u 0st 0r ?i .es & Chemicals Pvt. Lid. Plot No, M-7/2, Kakatiya Nagar, Habsiguda,
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Formulations :
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1. AMl hs m. e dA abB aA dR -I 3S 8 0 H 60E 6A .LTHCARE PRIVATE LIMITED, 40%, Saffron. Panchvati, Ambavadi. I"t
Hl. M 1/ 6s 0. 0 30U .nibiotech Formulations, Mr. J.K, Gulati, SCO-272, Ist Floor, Sector-32- D, Chandigarh —
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17, HM a/s r. i dP wr ao r L Ua tb to rr aa kt ho ar ni de ,s HP ar rva i, dP wv at r. —L a 2d 4, 9 401 }4 ,0-141, Makkanpur, Bhagwanpur, Roorkee Dist Haridy
{8. DM e/s h. r aS dh uiv na Rli ok a dR ,e m Bhe ad gi we as n P av pt u, r L .i d P. ., C ,K h 2a 4s 7r 6a 6 7N .o R, o $ o0 r9 k/ e1 e- .2 & 520. Village Bhagwanpur Mus, Rooe
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23. 3M 0/ 0s 0. 1 H 1i ,ppo Labs PVT LTD., Goutham Nagar, § 273 Old Air Port Road, Hyderabad, Hyderaba
24, AM/ ns d, h eS rh ir Ee ay sa t ,L i Mf ue m S bc ai ie ,n c Me as h aP rr ai sva ht te r aL i 4m 0i 0t 0e 9d 3, , Shreya House JOI/A, Parera Gill Road, Andheri E
22 65 ., MMM / a/ s hs , a. r L E aa l sb a ho n tr ra P at h 4e a 0P r 0h m 0a a 8r m 8Ia nc de iu a t Pi vc ta .l LI tn ddi ,a 5L 0i 1m ,i t Re ad i. k E a- r1 C1 h, aI mn bd. e rA ,re Ga o, v P aa nn di ip ,a t D- e1 o32 n1 a0 r3 . E, Govandi, Mum!
29.M/s, Sain Medicaments Pvt, Lid.. 10, HVES Building, Sultan Bazar, Hyderabad-S0U095,
28. AM/ ns d. h rD aa r Pw ri an de F so hr 5mu 2l 0a 0t 0i 8o .ns Pvt Lad. 54-18-374, ALR Colony, Benz Circle. Benz Circle, Vijayawadt,
29, SM t/ as t. i oP na , r Sn ia ox n ,L Sa ib o nP ,r Miv ua mt be aL ii ,m i Mt ae hd a, r a1 s0 h4 t- r10 a7 4, 0 B 0u 0i 2l 2d ,ing, No-8, Jogani Industrial Estate, Chunabhatti
33 t0 .. DMM e/' sss a,, i S E Ru l on ds aei drs ,e P AhI nan drt m he a er cn ra e it u i (to 'in Wca )al ,l L Msu u b P rvs nt, b. a P iLl to -dt 4. 0N , 0 o E 0l 5 1 d 30 e .0 r, HP oh ua sse e* ,l l P lI oD t A n. o ,C h Ce -r 9l ,a p Dal al ly i, a H Iy ndd ue sr ta rib aa ld E 5 s0 ta0 t0 e5 ,1 O A FP F. Veera
32 MM a/s n. n aG diK peM t CN oe mw m uP nh ea ,r m Pa u, d uS cp hl e. r rT yy -p 6e 0 5P 1l 0o 7t , No, 3 to %, PIPDIC Electronic Park, Thirubuvanai,
33. HM y/s d. e rabV ae dr s —a t $i 0l 0 007P ,harmaceuticals Pvt, Lid. 5-62, Street No, 8 Habasiguda
34, MM u/s m. m baP i& -4 0B 0 P 0h 5a 3r ,maceuticals Limited, A/O9, Ashirwad,11 Lokhandwala Complex, Andheri (W),
33 65 ,. MM ll ss ., DB rH SC a iL na sb L aP br oi rv aa tt oe r L ii ed s. , F 1a 0c 5to 4r Ny: SU $ n Ri ot a I dt, H 9 a1 r/ i2 h, a D rp. uC r,. S oB uu td hd Ti, w eDi ns tt yt, FS oo ul ra n P a( rH g_ aP n. a) s, Wes Bengal. .
Note for Firms;
~* ABarY le hmo sc a.u e @w i aa rv tr n eoee , q d 6 u r N: efe s0r eq t0ou w e e m dp s D .t m teme u ol,d l h s t t i ui io p bn - d t mee t i hp 1 ta 1eu p 0 tt p 0C he l 0o ei y n 2c co a f otu n e pt or rs y e mt , ne a oyc c k fh eo e n t u i hR p c ere oa erl po se rm et enre . stea e aq nm I tu t * ie af o s to N nt ir o e o2op d n5e r e , octs o o fe F n n tb st D he ia e A dt Pi e r ro r eBen ses h, pde a e A n n cwts e ta c i a na e vtp , s e p sC l paKi O rroc oyS ta p lt obCi a syo O a n R t l ho sof ea o n b dr c e , os f2 ma o9 N m rm . ie ee 0 t a8 3trF . e d2D eN a0 .C a y1 t s4 ih oa oa n fv t a e l1 b 1e B: ae 0 ln 0 meting date. the
* pA el cs so e nr te atq iu oe ns .ted to bring Drug Samples in original pack a5 well as package insert while coming for
* Any other manufacturer who have applied above FDC's may also present their case before the
oe
Yours faithfully,
(Dr. GN. Singh)
5 Drugs Control eneral (f} i
- -
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