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FDA Bhawan,
Kotla Road, New Delhi
Te N22 AUG 2014
C4
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Subject:- tsN1 haa1 f eP t: e o i c0 ts o o0 yt n u a aap n. l no tm n d r, Be y a em t l f we o f in iB t6 ct h h: a oa0 co uw0 yf t a o t dnp fh u,. e F em iN. s ax e e peiv pw dne r n Dt oDt h o veh e s at eh lCE i ox fC-p n ro1e f m o1r e 0 b mt r 0 i o e 0 n fC 2n a fo ,c it m e citm e o oR oi no et fso xt ( Dame CFm,e GDi (M CI n 1"e e s ) e ) -f tt l rh pi o ee eon g rrg am, m r a if F dt tr itD t no e eA gm r d .s 2 B f r9 oh e. ra l 0 mw a8 ata. e nn2 d u0 , 1 f t4 K ao o ct at to pl u pa r0 r 5 eR o. o fv0 oa a9 r. ld 2 , so0 a f1 N l4 ee t a iha nr et
Sir,
Reference is invited to this Directorate's Office letter u2d n9a dt . ee 0 rd 8 ,: . 201 12 4. .0 8 N. o2 w01 ,4 t hr ee q su ae is dt mi eng e ty io ngu ht ao s P ba er et ni c Pi opa st te p oi nn e da f to or e 0s 5a .i 0d 9 .M 21 e0 0, 1e 4t4 .i- n0 Tg1 h / ew2 h d0 ei1 tc3 ah- i lD w eC da ( s aM g i s es c ne h d. e a d 1 fu3 ol r- e P d tS heC t o m - eP b et e t- iM h ne e ge lt d ii s n o ag n s)
S.No. | Name of firm/ Institute
1 1. Vivimed labs oi x. eM ta ag can ie ns ei u 1m 0 mhy gd r oo rx ali d le i q9 u8 id mgD r +u ag lminium hydroxide 0 251 g
2.Restech Pharma 2 v. adroxide Dried at 1u 0m 0i mn gi u +m oxh ey td ar co ax ii nd ee 10g mef
g
L3 i0 q0
ui d
m sg
us
pe+
n
sim oa ngnesium
3.Acron Pharmaceutical +3_ MO ax ge nt ea sca ii un me Hyd1 r0 oxm ig
d e
2+ 8A ml gu Om ri an li Su um
s
penH sy id or noxide 0,298mg
4.Dried alumniniun’ ,hydroxide gel 130 mg + magnesium
4.Skan research lab hydroxide 150 mg + oxetacaine 5 mg suspension
*-Seivok Pharmaceuti=c als A5.lOuxmeitnaicuaimn e HBydPr ox1i0dmeg +GeAll umIiPn i0um2 9H1ygdmr oxeiqd,e tego. 0t.o 3d8r0igemd
+Magnesiurn Hydroxide IP 98mg Suspension
2 TifbeLa
2j 5s 0al mu gm i +n Si iu mm e th‘ ih cy od nr eox Sid Oe m gg e +l O xe2 t3 a0 cm aig n e7 fM 0a mg gn e Os ri ala m su st py ed nsr io oa nde
2.Livin Formulations : SP2 ua. ssA ptl eeu n+m sSi iin omi neu tm h icoh ny ed +r Oo xx ei td ae c ai— n p ea ste 1+ . 57 gM ma +g 1n .e 2s 5i gu mm + 50h my gd +r 1ox 0i md ge-
CA1 hl. eA u wl mg aii bnn li i ec u m TA ac bHi ly ed d
t
r so2 x0 i0 dm eg 3+ 0S 0o gdi u +m Bicar jb uo mn at He
y
d7 ro0 xm ig
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4 12 ..E Ps hp ai r mIn ad Su yst nr ti he s Formulstions OCA |2 ih .l. ?AeA u cl w 0m tg .ai ii 0b vnn 0l ai i 0tec u
e 7
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F
+ eD 7 nr 5 ni m ee lgd
2.Abaris Healthcare E2 rD uit l! s loO ni g 3B P o 4o 0s mm gi O+ rF e Lin qn ue it d oii 0.0007! +Simethicone
3.Indooo Remedies 03 .. 0D 0im 0e 7t mh !i Sc yo rn ue p IP 40mg +Dill oil BP 0.005mi *+Fennel oil USP
4.unibiotech formulations 04 .. 0S 0i 5m e mt ih i dc ro on pe S e um su pl es ni so ion n 40 mg + fennel oi! Dill oit 0.007 mi +
S.Indooo Remedies *5 D. iS li m Oe it lh Bic Po n 0e . 0E 0m Su ml ls +i Fo en n nU eS lP o i!e q U. S t Po 0S .i 0m 0e 0t 7h mi !c o On re a lU DS rP op s40mg
6.Dagon Pharmaceuticlas 96 .. 0S 0i 0m 7et mh li c Co on le i ge om du rls oi po sn 40mg +Dill oi! 0.005m) +Fennel oil
7.Next Wave O7 r. aS li m Le it qh ui ic done mg +Dill Oil 0.00mi *Fennel oi 0.0007m)
$ 1.Pharma Synth Formulations
2.Espi Industries
3.Galpha Laboratories
4. Wallace
*H3 Sy oA d rl r bu o im x tii oldn ei S ou P lm a u s tt ie aH ny [ d 7pr 5o 2 0x 0 mi 0 gd m e Sg y r+P uAa pcs tt ie v atJ ep d Di3 m0 e0 tm hg ic on+ eM a [Pg p n 1e 2s 5iu mm g
Pharmaceuticals o+4 ra. acA ltl iu vm ai ten di u Cm i mH ey td ir jo ox éoi nd ee 4 3 00 m0 gm +g s o+ rM ba itg on le ss oi lu utm i oh ny d 1r 0ox 0i 0d me g 2 l5 i0 qum ig d
6 1Shivalik Remedies
2.Rexer pharma
3.Livin Formulations g3 e. tA l 1u .mi 5n 7ium hydroxide Paste eg. to Dried Aluminum Hydroxide
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Magnesig um m Heg y. d rt oo x 2 id5 e0 Im Pg 1 + .M 14a gg mn e egs .i u tom 2h 5y 0d mro gx +i Sd ie
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P ea ts ht ie
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oe nq e. It Po
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ee ee
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.
I
Re50mg Oral Suspension
54 ,. CR arP tG el L li af be os rc ai te on rc ie es s H4. yD dr ri oe xd i deA l Bu Pm 1i 5n 0i mu gm +SH iy md er to hx ii cd oe n e BB PP 403 m0 g0 Um ng c oa+ tM eda g Tn ae bs lei tu sm
aS l. uSi mm ie nt ih ui mc o hn ye
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2m 5a 0g n Me gs i su um
sp
eh ny sd ir oo nxide pel 250 mg +
6.Hema Laboratories 6 2. 5S 0i .m 0e mt gh ic to yn ge eg5 n0 e. s0 im ug m + HD yr di re od x idA el um 2i 5n 0i .u 0m m g Hy Md or no ox rid ie n -MG Pe Sl
l,Hippo Labs 1 Alpha (12000) 10mg +Papain 20mg Syrup
2.Unibiotech Formulations 2.Alpha Amylase IP 100mg +Papain IP 50mg Syrup
3.Shreya Life Sciences 3.Alpha Amylase IP 125mg +Papain IP 40mg Syrup
4.Cactel Laboratories 4Pungal Diagtase IP Sémg +Pupain IP 10mg Syrup
S.Noel Pharma 5.Fungal Diastase [P 12.5mg +Papain IP 7.Sing Syrup
6.Laborate Pharmaceuticals 6.Fungal Diastase IP S0mg +Papain IP 60mg Syrup
7.Elan Pharma 7-Diastase IP 100mg +Papain IP Gmg Tablets
8 1. .S Da ai rn w iM ne d Foi rc ma um le an tt is o ns |8. -Fu An iga pl hs AD mi ya lst aa ss ee (1:(1 2: 01 020 00 ) ) SIP O mS gO m +p P e+ ps in IPn 1i 0P m6 g0m Sg y r§ up
2.Shreya Life Sciences 62 2. .A 5-A mm gy +l Pa es pe s i( nF u In Pg 2al 0 D mi ga s St oa ls ue t i1 o: n8 f0 o0 r f Or ro am l aA ds mp ie nr ig si tll ru as t io or nyzae) IP
3.pernax lab itd 3.alpha-amylase 62.5 mg * pepsin 20 mg oral Syrup
4.Sunrise International Labs d4 Oi. g mD ei s ga ts s St a yns roe t u pI JeP s s( F tu hn ang a 6l 0 D gi ma ss t oa fs e c oG oe cr ki ev de d s tf rr ao chm ) a Ss Ope mr gg i +ll u Ps e po sr iy nz Ia Pe
5-Diastase IP SOmg + Pepsin 10mg Oral Liquid
S.Elder Pharmaceutical Lid
6.Noel 6.Diastase 33.33mg +Pepsin Smg Drops
a 7.Dinstase 50mg +Pé e' psin 10mg Syrup
7,GKM Nrere 8.Pungal Diastase (1:1200) IP 50mg +Pepsin (1:3000) IP 10mg
8. Versatile Pharma Syrup
9.P & B Phameaceuticals 9.Fungal Diastase (1:2500) 62.5mg +Pepsin IP 20mg Oral Liquid
10,Cartel laboestories 10.fungal diastase $0 mg + pepsin 10 mg syrup
L1 R. BHC Lab 11 .Fungal Diastase IP (1:1200) 1P $0mg +Pepsin IP (1:2000)
Omg eneus Hard Geletin
12.Pungal Diastase [P (1:1200)
It
IP 50mg +Pepsin IP (1:3000)
.
3
oe- -
12.Dr. Sain's Laboratories | 10mg Syrup ”
13.Hippo Labs '3.Pungal Diatase (1:1200) Smg +Pepsin(1:3000) 10mg Syrup
veut are requested kindly to make it convenient to attend the said meting on 05.09.2014 to 6:00) p.m. in the Conference Room, Ist floor, FDA Bhawan, Kotla Road, Near National Bal Ba ht a 1 w1 a: n0 ,0 a N. em w.
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10y AM/ hs. m A eBA dR aIS b aHE dALTHCARE PRIVATE LIMITED, 406, Saffron, Panchvatl, Ambsvadi, - 380 006,
1k. M 1/ 6s 0. 0 30U .nibiotech Formulations, Mr. J-K. Gulati, SCO-272, 1st Floor, Sector-32- D, Chandigarh -
12 SM/ ws a. rDa gg ho an t Pharmaceuticals Pvt Ltd, Opp Gurudwara, Baddi - Nalagarh Road, Manpara P.O, Pinjore- Rd, Baddi, Himachal Pradesh 174102.
13, M/s. Indoco Remedies Limited, Indoco House, 166, CST Road, Santacruz (Fast), I" 11 4, G MM ui irs sg, .a N Goe anx l t p« h(W Ha a Lv r ae by oa( rnI aan t}d o-i ra i1) e, 2 s C 2 0 LO 0 iR 2 g, GP O BR abA uT SE ak O pF aF lI C ME ar, g ,C W9 o8 r0 l ,S us Mh ua mn bt a L io ,k M, a P hh aa rse e tI irecM ou gm ob ia ei 400 098,
16y 0M/ 3s 9. NOEL Pharma, 24-85/7, Laxminaraysna Nagar Colony, New 1.D.A,, Uppal, Hyderabad -
17 ~, Mis, Pro Laboratories Pvt, Pvt. Led, 140-14), Mskkanpur, Bhagwanpur, Roorkee Dist, Han
4Uttrakhand, Haridwar — 249401.
221F 109 ,.,a M MD Mt ii ie ss she . ..r Rs a CR ad Pe r u x tGn e ev r lLRa Lio Pi f aa h e bd a s o,R r c r e m iB mem a oh ne ra cd P ig evi ew st se a L ,s Ln t t 2a ddP 4p ,,v -u Pt 12h. r 15 a. 2L ,s / i eP M 4-d . ,I I, C 1 . LD, K n2 I Ch 4 d C a 7 a Ls 6 , a or 6 nCa 7 dh. l,eN r R to io oh. aa ap rS na nk0 l ele9 yBy/ s e,1 , l- , C a2 h p e ur& rl a5 Rp2 oa0 al, l d y ,V , i N1l a1l 4 va / ig 2e / M B uB , mh T ba e ag l iw a -a n 4n g 0p a 0u n 7r a 0 5 SM 0 ,u 0 s 0, 5 1R .o 7’‘ ‘ Near Gvi Bio, IDA, Uppal, Hyderabad 22, DM ei hs r, adunH -e 2m 48a 1 9— 7, L Ua tb to ar ra at ko hr ai ne ds , Pvt. Lid. Selaqui Industrial Area Ph- a 5 r0 m0 a039 1
23, SM O/s D. D HH 1i .ppo Labs PVT LTD., Go utham Nagar, 8 273 Old Air Port Road, Hyderabad, Hyderal s
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24,. AM n/ ds h. e S rh ir Be ay sa t ,L Mi ufe m bS ac iie ,n Mc ae hs u P rr ai sv ha ét re a L sim oi eShreya House M/A, Parera Gill Road, Andheri
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22 38 ,, AM2 n/9 s. d.M h / rDs aa. r PS w ra i ai n dn e FM soe hr d 3mi 2uc 0la 0am 0te i 8n o .nt ss P P vv tt . L L ii dd ,, , $ 41 -0, 1 8A -V 37E /S 4, Bui Al Id Ri n Cg o, l S ou nl yt ,a n B B ea nz za r Ci, r H cly ed ,e Bra eb na zd C- i$ r0 c0 l0 e,9 5 V, ijayawada,
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Note for Firms:
N ao ac ee m v te ed . ie am sn wulti pld ee b aa pt pe l iy co au ntr s ,t ec yh on ui c aa rl e t re ea qm u ef sr te p dr e ts oe n bt ea t pi ro en s. e nA ts ua fp pl Ci Dca st tio nn ofo nr s 05a .m 0e 9 .F 2D 6C 1 4b aa tv e 1 b 1e -0e 0s $ mmB eh o ea tw n iat ngno g, 6 dd 2 aaN0 tne0 e w p D 1. em ?l. h S ii i n - b1t i1h 0e t 0 hC 0 eo 2 n c f ote o pr ye m n a oc k fe e t hpR ero e pso rem en s, t ea nt1 ti" a o tnf i l oo s no s r o, c f o F n tsD hi eA d e r r eB e sh pd ea cnw tea icn ve, es s pK a rro y ot l b pa y e ltR sho e a tcd oo, t m eN m e ia tr t n eN esa yt io on fa tl h eBal
cApp or n mer ys me ie n tots tta ehte e ei r ,on n mt an a uf” a cS ti urM ee r P wr ho og hS aam vp el e as p pi ln i eo dr ag bi ona vl e ’p a Fc Pk G ’a ss w me al yl as l sp oa c pk ra eg see n i t. n s te hr et i rw h ci al se e c bo efm oi rn eg tf ho er
Yours faithfully,
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Drugs C (Dr. G. eN n. e S ri an lg (h 1) ) ad