1. ONDANSETRON 8 MG/4 ML SOL. FOR INJ. [INJ] d5u1m 36,830 AMP

2. ONDANSETRON 8 MG FILM COATED TAB. FOIL DAB] d?uim 202,950 TAB

3. FUROSEMIDE 10 MG/ML * 2 ML SOL. FOR INJ. [INJ] d%im 41,400 AMP

4. DOPAMINE 250 MG SOL. FOR INJ. [INJ] IN 14,200 AMP

5. MAGNESIUM SULPHATE 50% 2 ML SIL. FOR INJ. [INJ] d h i ~ 46,600 AMP

6. SODIUM BICARBONATE 7.5 % SOL. FOR INJ. [INJ] d?~1161d 11,900 AMP

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1. ONDANSETRON 8 MG/4 ML SOL. FOR INJ. [INJ] d?~761d 36,830 AMP

2. ONDANSETRON 8 MG FILM COATED TAB. FOIL FA01 d ? u ~ m 202,950 TAB

3. FUROSEMIDE 10 MG/ML * 2 ML SOL. FOR INJ. [INJI e]?uim 41,400 AMP

4. DOPAMINE 250 MG SOL. FOR INJ. [INJ] d5u7m 14,200 AMP

5. MAGNESIUM SULPHATE 50% 2 ML SIL. FOR INJ. [INJ] ~%IIN 46,600 AMP

6. SODIUM BICARBONATE 7.5 % SOL. FOR INJ. [INJ] d%lm 11,900 AMP

5. ~~n~nrnw"~~a~3w5lun~~Gil~am151mi Y Y

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aod~aussiair iud ~iurair5uu"o~nwain ~ioijnvarriu~dnCEla v i a i i nwa in l~ i nndou~vva~~ona i~aou~~mi Y Y

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cqPiiolelC

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(2) Wn. ion~n~i~nna v'iowa1uiioio(rauo41~1o~i1~Imoeii~~d~ ~ ~ u b m d l u ~ a u s z i n ?

(3) ~auoriuaar~umr~mnPiii~ldoindoulv~~iesumlu~onaisao~~i~i~~~uai~zi~6~ vi?oiiwasjii

l ~ ~ i i m m a i d K r ~ u u r ~ u ~ d i u u ~ ~ ~ i ~ r a u ~ r i ~ ~ r i u ~ u

(4) r i~ idmuoi in i r~nau mn l u ufiv ad$uuudna Fmu~muo~i rn5 l6ra iuZa~0w?ou

elszw"sJmri Rin"ul5

5.4 ~ u n i ~ m " m ~ u n i r a o ~ r i m i ~ ~ o l u n i ~ w ' i ~ ~ s \ ? i n ~ z n r r ~ l n i r ~ 3 m ~ s ~ a o ~ r i m i v ~ o

u~iwuiziua~uaium?uw~ii~w-jagj;(rauorimi~a~~~u"o~gii~i]~~~ni~ ~ i u z ~' ia~oaf ioa?adauln~~~uau"a~n"u~~au~

sin116 u v i ? w u i a " u a ~ u a i u n 3 u w ~ ~ ~ ~ ~ d o ~ ~ G ? u r 1 n 1 ~ i o ~ ~ ~ ' i ~ ~ q i vinvCn~iu Gqn6ia~8iCinai%a~ui~au

violiq"oa "d - q d

5.5 uwi?nui~ua~uaium5uwin~~la~~aw~~o::2i?~rimi~i~m ~ ? o ~ i n i ~ ~ s ~ i n i I m ~ 3 o ~ i ~ i $ a a u o

Avumn%X r ~ a z o i o ~ o i s m i ~ i o n d o ~ u ~ i u a u M;O"UI~ ~ ~ o r a ~ i ~ ~ i u n i r v ~ ~ s i u n i ~ ~ m v?noio~zunrGnni%aou

r imi lmul i%aimi im&~u~X qnurioarioiron $dud r $ o ~ ~ z l u 9 n i a ~ ~ m a m n i ~ ~ 9 u d i ~ ~ ~azlG?iiiii$jini~OiPlilu

u~.ruvi?wuia"ua~aaiun5u~1~r~ur~mvim $ausnn iezdun%di r iu~ iu lnq~~6 s a u k ~ v i ? w ~ i ~ u a ~ v a i u ~ ~ u ~ i

a : ~ i n ~ m i u n ~ 8 n n i m a ~ r i n i ~ r a ~ a ~ ~ w 9 ~ ( r a u o r i ~ i ~ ~ u @%~iu l i 4 i o z a 9 u ~ r a u o n n i ~ 6 ~ 9 ~ n i s ~ m ~ ~ o n ~ i j L i R

mu ~ i n i i r ~ ~ ~ d a l i i i i n i r ~ a u o r i ~ i n s - v i i n i r l i q ~ 5 a rsiu nis~auonniEur9urvlv ~ i d d n ~ n n a w s n n i m i o ~ ?

vnna8uuiaaunnmarwu r g u ~

5 . 6 ~ u n r ~ i e l r i n ~ ~ d o o ~ a n i ~ ~ a " ~ o i n n i r ~ 0 m ' 1 1 i ) ~ a o u s i m i i [ r nuos ia i~ i i 3n~ l65 "~~n i~n "m~~sn

miudI61~rzninmdo miudo 4.7 ~ ~ u ~ ~ u o ~ i ~ i b ; ~ ~ a ~ c j z ~ u v ~ ~ a u n " u n " u e ~ : r a u o ~ i ~ i ~ i u ~ u m 'jUd5zfIlfl~OU

r i n i v i o r ~ u ~ r a u o r i n i i n ~ z i i n i ~ ~ ~ ~ ~ u n i ~ . u " n ' ~ a i ~ n i 5 b ~ i d ~ u ~ i m i a d i d r ~ u s s ~ u niuGa 1.5

u~i?nui&aauaiumkMi ~ d i u i ~ ~ o ~ ~ ~ i u ~ o ~ ~ a u o ~ i ~ i ~ ~ 3 w ' i ' b ~ ~ ~ n i ~ n r o n n i oonoindxnifi>iu&

m i u ~ 4.7 ~ L ~ ~ ~ ~ l ? ~ ~ l & ~ 4 ~ ~ l ~ ~ ? ~ ~ ~ ~ ~ % i l i ~ ~ i a J b W 9 3 ~ ~ ~ ~ ~ 3 i ~ i 4 i ~ d ~ ~ ~ ~ ~ ~ 4 ~ i ~

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~ s z I u u u ~ u w i ~ r i u n i r o ~ i i ~ 6 ~ d ~ n r a w r a d ~ d 1 u i o 0 n a 8 n n i r ~ ~ m " t l o ~ ~ ~ ~ a u 0 r i m i ~ ~ n ~ i a ~ ~

8. ni~?ulJs=n"9fiaiu~i~munwi~~ d; ~vu:ni~aousini4aI6ii.U"omna~t8uvii~~o w~o i iZ~q iaau iu rn iu~auu~~~z~~u .O"o 1.3 L L ~ ~ L L ~

n~r i i o:k.r~udr:nirnnu.iii~munwio~vo~~~vo~~~av~u~~~m~uniuluszuz~aa~I8isd"ouni~ .~Zou 3 liu ~~iniu~(~o~uuouuazmiuu"omna~lunisd~zn"u~aiuu"i~munwio~vo~m~~mw' luSa 1.7 bu@iub.r<uSnn7cj

s i o u w u u ~ v l 4 ~ n i l 6 ~ m " a ~ ~ u n i u l u ...-..... TuGu~m~in~u~6Tu~~<~naiuu"i~nunw<oa

9. ~oasau3w51uniar~uosif i i~~a~~u q

9.1 f i u 6 i ~ ~ d i v % n i i & n f ~Cuiilinb'4u~udszuiw ds:~~i loindiGniud~zui~

n ~ ~ a a u i d u a i y ~ i o ~ n s z i i I C p i o a ~ o u~ i3nu7~unsva iu~5u~i 16YueyGSuiiW"a~~in

~udsauislddsz<ig oind19a"nsud%zuiwa~a"aa~ifiu

9.2 adsuvi~nui~nauaiun5uni ~ d i n m ~ ~ o n ~ ~ a u o n n i ~ i u ~ m ~ ~ a ~ u ~ v ~ u u a z ~ ~ m n a a d o d a u o ~ m i u

nrmnni$oaaa"a i i i { v i u ~ z ~ & v ~ o i i ~ ~ v o ~ ~ ~ n ~ i a a C i u i u i n p i i a d ~ z a n n ~ a ~ v o a $ ~ ~ l j i ~ ~ i u i ~ m ~ n i ~ 6 o l u

aiiuvlidii~dnurlusd uazaiuirnlCu~niziuvu~m'miu~f~uum~dini~n~zw~a~nuu~~ud~zn~n~ium @,nus d w z s ~ m d a ~ ~ u ~ v ~ u o d ~ a d ~ ~ r n i u n ~ ~ u i u i i 6 a u n i ~ d d a ' ~ ~ 8 1 n i s ~ i ~ v u u i a oau

(1) a a 9 ~ n i ~ ~ ~ ~ ~ o i i ~ ~ v 0 ~ d $ o v i u m " ~ n ~ i a ~ C ~ u i u ~ n ~ i a d ~ ~ a ~ n ~ o ~ ~ G n ~ i ~ ~ m z n r j ~ u n i ~ d a a a ~ 8 1

wifiauui?niulu 7 'iu rju~~udiu~$iu&vio<aussoindi~d5z~~n riuit8uuoadYiuurn7~nisnszw4a~ nuuinud~aninunaa"ulw"u~r~n~muZo~ul~

(2) ~ n i r l ~ ~ ~ v ~ ~ d & v i u m " a n ~ i a u ~ ~ ~ n l m u a ? ~ I w u v i o L f o d i j ~ ~ ~ ~ 9 i u ~ ~ u a n " u G o I ~ u n i n Piidds:mnuiGad5zmdInu ~~uioziiuo~~imoindi~ndiun~zn~~uni~ddbn~uw1~"11uu7~99"u55yn~dvodw"~

'imudo4uiijtdLfdlnu dailz&o;njl~~uo~~ima~uEufiouussynvoaa~~aiu ~?o~5uusd~~uum~iini~ns:wrjaa

rnuuinudszninunaa"ulCu~~ynlmuZo~u

(3) b n ~ ~ & a i d j ~ m i u (I) v jo (2) ~ v i u u z ~ o ~ i u f i m m i u n ~ ~ u i u . d i 6 a u n i ~ ~ ~ a a ~ u wiivuui?

9.3 @ n u o s i ~ i d . ~ u ~ i ~ w u ~ ~ a a u a i u m ? u w ~ ~ ~ m ~ ~ o n a a a ' a I u ~ d ~ i ~ ~ q ~ v ~ s . i i s m n a ~ n ~ u l u ~ a a ~ d ~ i a

nvnisriivumi;aszyZnuCa 6. uvi~nui~iunaoaiun~uwi o i a ~ o i ~ o r i ~ u n ~ ~ ~ ~ " ~ ~ m ~ . i i n a i u t ~ u ~ i u ~ u ~ (61ii) s ~ u b ~ r r i o i r ~ i l i i r 4 u ~ ~ ~ a i u m i u ~ : a ~ u u ' 1 ] o a w i ~ ~ i v n i ~

9.4 usrli~wuia"unavaium?uw5 asau~w56ozun"but~ua?ub"9ouIv miun~iua~uuo~diPdUn~iu6uni~~aqm (6iii)

& . : ( u i ~ ~ ~ ~ ~ % ' l b $ f i m )

1 t i 8 ' ~ t i i ?~2557

A. ao~l~ans~nzelazrm I. ~mqdszas6nisl.iiqiu Igjie?nis?n"n~~iiIlrau 2. drzlnw ~8u iaq~a 'uKmiu i 6 s iun i r

1. ONDANSETRON 8 MG/4 ML SOL. FOR INJ.

2. ONDANSETRON 8 MG FILM COATED TAB. FOIL

3. FUROSEMIDE 10 MG/ML * 2 ML SOL. FOR INJ.

4. DOPAMINE 250 MG SOL. FOR INJ.

5. MAGNESIUM SULPHATE 50% 2 ML SIL. FOR INJ.

6. SODIUM BICARBONATE 7.5 % SOL. FOR INJ.

u1 Y

3) d i~u i lu~ i6~n is~uwz~~uu i i~uu i (LLUU ~ u . 2 Mia wu.3 M%I ~ u . 4 u.2 u<3ba@inri) ~ ~ 6 i u v l j i k a % ria ns[ i i i in is~d~uu~das~~n"b~~?9~o~~iwabazaniud~~m I ~ u u u i i ~ ~ u ~ d ~ u ~ u ~ ~ ~ e l ~ u u ~ ~ d a ~ ~ i u n i ~ l u waaduu~1'7?uui~8uan"u~?uo~~101~~n~nniudwl~1 (MUU u.4) ui~~ounuPd6-~u

4) h ~ u i ~ ~ s ~ o ? ~ s ~ ~ u i m ~ ~ i u n i r ~ ~ m u i ~ 1 i u ~ a " n b n ~ ~ ~ " 5 n i r i m % u n i r ~ ~ m i (Good Manufacturinq a w . 4

Practicer) 1uvuamj /~8u~$o~bu i$~auo (aGuaiqmmiurounirmrailaoubmu~~anir?uso~n~~u~~~u~ ~ ~ i ~ l ~ ~ ~ ~ $ ~ ~ i ~ ~ l ~ ~ b ~ ~ ~ n " ~ d 7 b ~ i ~ s a " ~ d ~ ? ~ ~ ~ ~ n i 9 ~ ~ R 4 i ~ 9 / i ~ t ~ u i l i i ~ G o u ) I n u i o ~ d 3 z n i l ~ 6 a u

4.1) Certificate of GMP Raw Material / Active Pharmaceutical Inyedient (API) w%6?unis?usos GMP

m l ~ ~ I m 5 ~ 1 ~ GMP-PIC/S 0 in PIC/S participatins authorities M% WHO-GMP aosdsabwH{w2m aLaa

4.2) Certificate of GMP Finished Product i?uso~miuuims2iu GMP-PIC/S w?o WHO-GMP

- n ~ d u i ~ ~ ~ d u d r a a ~ f l ~ ~ 1 u 6 o ~ ~ ~ ? u n i s ? u s o ~ GMP miuuimsyu GMP-PIC/S o in i i i i nq iu nasnssuniraiwisuaztn v ~ o l 6 ? u n i s ? u ~ o ~ GMP miuuimr~iu GMP-PIC/S o in PIC/S

participatin2 authorities

- nsiuiPa"i~u"7i l~ni i~dsa~~p160~l6?unis?uso GMP ( ~ ~ I U U I C ~ ~ ~ ~ I U GMP-PIC/S mn PIC/S

participatinq authorities dl

5) dlrrndiuauuv)a!uuii?uu7 (uuu mu.1 G o u.1) ~ ~ ; j t i i u ~ l l i i u a a ~ & wTaus7uar8unqm~nnwwz~awi: voau1di~~il~d~~na.u"on"i~9umuims~iu"~o~?~n1sS~~siadui (Finished Product Specification and

Analytical Procedures) d~unr~iiuuliInurnr~~u1~~7u~s:n7fin~a~sa~a7sism~u ~ 1 1 q s a ~ i i s i u 7 W.H.

2556 n s ~ ~ n i s ~ d ~ u u ~ d a q ~ ~ f % u l~b~uud1~u161u~~~~v~d~uu~~da~s1un~slunzbduui1?uui (bauu wu.9)

'~1% dibu i~ iuo~~v~e l~uu~~da~c j iun is~una~~uu~i?u~ i ( L L ~ U u.5) uiwiau5u62u

6) ~ILUI~I~IUI [Pharmacopoeial i ?L~un i r<un r~ i i uuu i $aa"mq?uhu~iii6Q imt.wAnriol4u181dg:d

a5uaiqn wiamiuC~n"iwumuims,siu"~o~ui~~a:~"sn~s?~~s~aG %udszni~nszws?sai57smq'u a";osszyi~si

U l W.A. 2556

7) dibuiw~d~o?usosni5"abnsi~d (Certificate of Analysis) w~a81m7si~b~uu~!uu~u811ms~i~d~i?uui [Pharmacopoeial ~ f l u n i s < u n a i i i u u u i ~ ~ u ~ ~ a : b a u m i u d ~ z n ~ ~ n s z ~ s a ~ a i ~ i s ~ ~ " ~ ~ ~$84 I~I$IIIUI

Y

w.m. 2556 ~ ~ T m q ~ u ~ a u i d i & - g ~azwGmKmdn'uidi~ta1d Inu6aadaanau62iau

7.1) dibuiw$~~o?~~o~nis?b~sia99 'a"mq?u~auia f i~~ (Certificate of Analysis of Raw Material / Active

Pharmaceutical Inyredient) ~mu6aadsanou6au

7.1.1) i i b u i w $ ~ ~ o % ~ s a ~ "11~g~Ema"mq?u$~uiAi6su_ (Supplier)

7.1.2) dibu19/1C~io?uso~ " U D ~ Q W ~ ~ W : ~ K W ~ ~ ' U ~ ~ I L $ B ~ ~ I (Manufacturer)

7.2) d i b u i ~ ~ ~ ~ a ? u ~ n ~ n i ~ ~ ~ n ~ ~ a ~ w ~ m ~ ~ ~ u i d i ~ ~ i l ~ d (Certificate of Analysis of Finished Product)

Inunasdsanou63iau

7.2.1) h ~ u m C ~ J o ? u s o a slo~~~'ulmwflmriot4uidi~ii l~el (Manufacturer) ~ ~ j u n i s w ~ m d d s ~ ~ a d i ~

bba:~u"a"mq?u~auidi~~~u~~uan"ud1~uiw$~~a?usa~nis?bns1zda"mq~u~auidi6~ (P91nkifiva"nqiu

u a n ~ ~ u n i s w G m % q ? u ~ a u i d 1 ~ ~ % u d i ~ u i ~ C a ~ o ? u s a ~ n i ~ ~ ~ n s i ~ 9 9 ' ~ E m ~ ~ ~ u ~ d i ~ ~ 0 ~ d f i a a ~ u u

wC~3o?usoo;lain~wSp1w~mfim4uidi~f iladijuu"u)

7.2..2) d i ~ u i ~ C d 3 ~ ? u s o a ~ o d a u s i v n i s 6 u ~ ~ a a n i ~ u ~ u ~ n i ~ ~ a a n ~ u ($du~&~f & [Rz~u I~L '~P~~

5 -1~7 ) ih%unis<u"er%o~ Good Laboratory Practices (Certificate of GLP) M%I ISO/IEC 17025

(ws"ouuuud1auiw$q3a?usa4 GLP w:o ISO/IEC 17025 v a ~ ~ a i ~ u ~ Y u ~ ) d iwanis~ains iz~?i i i iu 5 3 e w

uunsaubC1'7rauo5ini [;15]

8) dibu ibona isuan~n is~n~~ ina iun~~~ (Stability data) ~mu6asdsanouKau 8.1) Lon? term stability (n96

i<uwra~uuuiu ius iauinni i 2 g) 8.2) Accelerated stability ~ raa 8.3) In - use stability

9) ~ I L U I M G ~ ~ ~ ~ Y ~ ~ ~ ~ ~ W G W K ~ U G ~ I ~ I L ~ F ~ ~ ~ (Certificate of Pharmaceutical Product / Certificate of Free

Sale) [ n s i ~ ~ ~ u i W ' i ~ ' u " i u i ~ u d ~ ~ ~ ~ ~ ~ ~ ~ ] 10) di~ui~anais~am~~o~anisI~Tunis~ss~Iu Green Book vaq nsu?wu7~11aminisbaWMd [61iil

11) di~ui~onais~~anSEo~nis'b6?unisuss~lu n u n 1 s w E n i i r u v i u ~ a 1 ~ ~ I 9 ~ i ~ ~ ~ ~ 1 u i ~ i ~ ! u u ~ ~ d n i s 615n?n"nsr1in"eruifiu~~uu mi diCn~iunmanssunisoi~~s~~azui [KIZI

12) h~uiw~n,siunaium;a"~~o~w~mKm~u~ (Bioequivalence) m i ~ m m d n ' ~ d i ~ n i i u ~ ~ ~ n s ~ u n ~ ~ a i ' ~ ~ i ~ ~ a a ~ 81 i iwum n s ~ ~ 3 u u i i a a i ~ c g [~IGI

13) ~ i b u i u a m ~ n i s ? u s o ~ ~ ~ u u ~ ~ n i w b ~ ~ ~ i u w ~ m w ~ m ~ ~ d u ~ d ~ ~ f i l ~ d m i u u i ~ s ~ i u 810n.9001 M%I 810n.9002

lu"nnisb~aaaoui iu i l indi$n~iuuims~iuw~mK6~~qm~~~nssu ~ ~ a a l n ~ 5 u ? u s a ~ u i m ~ ~ i u IS0 9/1%

wliau~iudnsamsaagmaiwn~su~~ni~~usa~s~uu~iu nsi$uuiwRmIu~samfiIwu [o'iiii

14) hodi~uiio~aiu~s~luvuimuss~~ilai l"iwGiuod~aod"au 5 ~ G a u u s s ~ f l m d ~ ~ ~ ~ u $ a ~ ~ n ~ ~ a n ~ ~ i u a x ~ ~ u m 16ni~x~~umiu~~1~umIu~au"0~maufiw"~ld.~"i~~u I n u u ~ i ? n u i b n . r ~ a i u ~ ~ u ~ ~ vonqadw~~i? iu

~aor i i~ l i r j inst i l ' lm~

nw8a4o ~ ~ i u ~ ~ d i o a r j p i i ~ u i m i u ~ " i k ~ ~ ~ i l i n ~ m ~ ~ ~ ~ w u ~ i a m ~9ur2m7 i lu iuqn~cyq i

niadwauui 1) [viun?s~szuuil~mi~ui~n"?unis?uso Good Distribution Practices (Certificate of GDP) bmuaawizuid

6o~~misImusauuiasbsic"1aiua6u (Cotd chain system) aaaz6os;mdsuiTw"d dlu~navn5-d~ b-sswuiuia asvaiun5uwi wiubiuaudn"iwun n i u h 30 5u ~eroinTuw%6?u~i$dk

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