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ACYCLOVIR 800 MG COMPRESSED TAB. FOlL
AMOXYClLLlN 500 MG CAP. FOlL
CEFlXlME 100 MG CAP. FOlL
CEFUROXIME 500 MG FlLM COATED TAB. FOlL
CLARITHROMYCIN 500 MG FlLM COATED TAB. FOlL
CLlNDAMYClN 300 MG CAP. FOlL
DlCLOXAClLLlN 500 MG CAP. FOlL
CIPROFLOXACIN 500 MG FlLM COATED TAB. FOlL
LEVOFLOXACIN 500 MG FlLM COATED TAB. FOlL
TAB
CAP
CAP
TAB
TAB
CAP
CAP
TAB
TAB
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3 u~ i iwu iBa . rumumiun i i inaiudrznaAoznsusini~o Ta406miNPi mi~siunl=&d 1. ACYCLOVIR 800 MG COMPRESSED TAB. FOIL [TAB] d~u7m 39,655 TAB
2. AMOXYClLLlN 500 MG CAP. FOIL [CAP] d?u7m 528,000 CAP
3. CEFlXlME 100 MG CAP. FOIL [CAP] d h i ~ 42,600 CAP
4. CEFUROXIME 500 MG FILM COATED TAB. FOIL FAB] ~]?UIN 19,580 TAB
5. CLARITHROMYCIN 500 MG FILM COATED TAB. FOIL [TAB] d?uim 17,010 TAB
6. CLlNDAMYClN 300 MG CAP. FOIL [CAP] d%~lm 100,100 CAP
7. DlCLOXAClLLlN 500 MG CAP. FOIL [CAP] ~?UIN 338,000 CAP
8. CIPROFLOXACIN 500 MG FILM COATED TAB. FOIL FAB] d ? ~ l m 152,300 TAB
9. LEVOFLOXACIN 500 MG FILM COATED TAB. FOIL [TAB] d?u7616 21,600 TAB 3 2" % a ~ a ~ ~ o ~ . a a u m o 4 ~ S u u a ~ ~ ~ w " ua41wi WLRU~~~IUUIT;~~ WL~UUO~L~~ILRU oU~unni*lt/ilzli~iu~m"w"u~ ~a.5
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1. ACYCLOVIR 800 MG COMPRESSED TAB. FOlL
2. AMOXYClLLlN 500 MG CAP. FOlL
3. CEFlXlME 100 MG CAP. FOlL
4. CEFUROXIME 500 MG FlLM COATED TAB. FOlL
5. CLARITHROMYCIN 500 MG FlLM COATED TAB. FOlL
6. CLINDAMYCIN 300 MG CAP. FOlL
7. DlCLOXAClLLlN 500 MG CAP. FOlL
8. CIPROFLOXACIN 500 MG FlLM COATED TAB. FOlL
9. LEVOFLOXACIN 500 MG FlLM COATED TAB. FOlL
4) d i ~ u i ~ ~ d ~ ~ ? ~ s o d u i m s ~ i u n i s ~ ~ m u i m i u ~ ~ n b n ~ ~ " a " s n i s ~ ~ u n i ~ w ~ m u i (Good Manufacturing - a u d
Practices) lunuacild~$ua~osn"uuid~auo (aGuiiqnmiusoun~~msaaaauImu~wan~~?usaan~auw~aua
4.1) Certificate of GMP Raw Materia\ / Active Pharmaceutical Inqredient (API) %Gi~uni=i?uSnas GMP
~7uu7W5~lu GMP-PIC/S i1in PIC/S participating authorities 14% WHO-GMP nasdszbwpI(w~n LLaz
4.2) Certificate of GMP Finished Product d?usodmiuuims~u GMP-PIC/S 14% WHO-GMP
- nsriiuidwinlu~sz~naIwum"osI6?unis?ersos GMP n iuu insa iu GMP-PICIS i i i nd iCnnu
nmznssunisoiuisLLazui u'%l6?unis?usos GMP nia~uimsziu GMP-PIC/S o i n PIC/S
participatin9 authorities
- n s ~ u i G i ~ $ i o i n ~ i ~ d s ~ ~ ~ ~ ~ o s l 6 ? ~ n i s ? e r s o s GMP PII~~UIFIS~~IU GMP-PIC/S 0 i n PIC/S
participatin9 authorities Y
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uosuidibfo~db~a~~on"i99um%]ims~1uuo~"a"5nis?bnsi~6ui (Finished Product Specification and
Analytical Procedures) d $ u n z i ~ u u l i bnunas~6u'bdmiudsznimnszwsa~aisism~v ~a(szy61-11~1 w.m. 2556 n s r i i i n i s ~ d ~ u u r r d a 4 ~ ~ ~ u ~ ~ ~ ; L L U ~ ~ I L ~ I R I ' U ~ L L ~ ~ " I I L ~ $ U ~ L L ~ ~ ~ ~ I U ~ I ~ ~ U ~ ~ L ~ U ~ ~ I ? U ~ I (LLUU ~ u . 9 )
99% ~ I ~ ~ I ~ I " u E I I L ~ ~ ~ L ~ $ u u L L ~ ~ ~ ~ I U ~ I ~ I ~ S / ~ ~ L ~ U ~ ~ I ? U ~ I (LLUU u.5) ui~<oun"u;au
6) d i r u i i i s i u i [Pharmacopoeia] a 8 u n i s $ u ~ : ~ ~ u u u i &a"nqWuKauidi6~ uazwln5miuduididsld
acudi!m ~~o~iu$odiuumuims~iuuosui~~az4"5nis"a~nsiz9/i !udsznionrzwsaaaisismqu da4szuaiisi
81 w.fl. 2556
7) dibuiu~s~o?uso~nis"abnsiz9/i (Certificate of Analysis) w~oumisi~~fiuer~~uun"eraIins~~ud~?eru~ [Pharmacopoeia] a8un is :unz~~uuu i ~~~bazbduniudsznimnszwsa~aisism~v $0.1 Z%~~IZIUI
W.R. 2556 ~sa"nqFiuK~uid16~~ ~ b a ~ ~ ~ ~ f l ~ d ~ i d l b f 9 ~ d kum"osdsznoerEi?~
7.1) di~uiwGs3o?usasnis"a~nsiz6a"mqiuKauidi6~ (Certificate of Analysis of Raw Material / Active
Pharmaceutical Ingredient) bnum"osdsznou6-d~
7.1.1) d i b ~ i u ~ 4 ~ o ? u s o s ms[w~w~mq~u$au1a"16~ (Supplier)
7.1.2) dibui~~s~o?er"er4s u o ~ ( ~ i m w i n f l m d u i d i b i o ~ d (Manufacturer)
7.2) dibui~sa"s~o?uso~nis"a~nsi%6winflmdsiuidib$o~d (Certificate of Analysis of Finished Product)
bmunasdsznou6au
7.2.1) d i ~ u i ~ G s ~ ~ ? ~ ~ ~ s u ~ s ( w i n ~ i n f l m $ u ~ d ~ ~ $ o ~ d (Manufacturer) l u j u n i s w i n d d ~ h o t i i ~
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5 in i ) ~m"?Uni7?~'erso4 Good Laboratory Practices (Certificate of GLP) w?o ISO/IEC 17025
(w~ouuuudibuirGsao?uso~ GLP u?o ISO/IEC 17025 u o ~ a r n i u 6 u ~ ) d i i w a n i s ? ~ n s i z ~ ~ i ~ ~ u 5 8 sd"er8sa"Pd~fi~auorjini [Eli71
8) dibuiLonaisuamsnis~nwi~aiuns~a (Stability data) fimu6oadsznou6au 8.1) Lon? term stability ( n s i
i~uwzbiuuuiu iba~au7nni7 2 8) 8.2) Accelerated stability uaz 8.3) In - use stability
9) d ib~ iu~s~o?u~os~~n f lmds iu id i~~o~d (Certificate of Pharmaceutical Product / Certificate of Free
Sale) [nsri i~~uui~i~"uYuia'ddsz~~~I~u] 10) d i ~ u l ~ o n a i s b l ~ m s ~ o ~ a n i s ~ 6 ? ~ n i s u ~ 5 ~ ~ u Green Book uos nsu"awuiRianinisbL~w~ [t?i:l
11) h ~ l n ~ o n a i s ~ ~ a m ~ L ~ a n i s l 6 ? u n i s u s s ~ l u siunisw~nriordu1a1G~l~9id3naiu~sii~~uulunis sJ'i.J"n?nwin"uui~u~~uu uos diGnsiunmznssun~so~~~s~~azui [:I!]
12) dibuiw~n~iun3iuauua91oswimfl~dsiui (Bioequivalence) miu~nruiudd h~n~iunolrnsrunisoi~isbbaz Y
u i diuum nsGb6uu i ioa iG~ [t?iiil
13) dibuiuamsnis?uso~sz~uqmni~bsssiuw~~~~mflmdsiuidi~~o~d n iuu imsyu uon.9001 M%I uon.9002
luiiilnisuaz.uau4-w oindiGnsiu~ins~iuwimflm$qnaiunssu u~oani9Ju?usasui(sls~iu 180 99%
uliausiu~ns;~sw~mai~nss81lgj;nis?usos~zuusiu nsG~9uuiwiPiludsz~nfilwu [iiiiil 14) a i ? ~ ~ l ~ ~ i ~ ~ ~ ? i ~ b L ~ ~ ~ ~ ~ ~ i ~ ~ ~ ~ ~ ~ ~ z ~ i ~ ~ i ~ ~ ~ i i ~ ~ ~ 5 uliauun?iiruri & ~ 4 u . ' ? ~ ~ ~ u u a n . r ~ i u a z ~ ~ u w
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1. ACYCLOVIR 800 MG COMPRESSED TAB. FOlL
2 . AMOXYClLLlN 500 MG CAP. FOlL
3. CEFlXlME 100 MG CAP. FOlL
4. CEFUROXIME 500 MG FlLM COATED TAB. FOlL
5. CLARITHROMYCIN 500 MG FlLM COATED TAB. FOlL
6. CLlNDAMYClN 300 MG CAP. FOlL
7. DlCLOXAClLLlN 500 MG CAP. FOlL
8. CIPROFLOXACIN 500 MG FlLM COATED TAB. FOlL
9. LEVOFLOXACIN 500 MG FlLM COATED TAB. FOlL
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1) ACYCLOVIR 800 MG COMPRESSED TAB. FOlL
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adubsu .......................... 272,769.75 ...... UIW cjiniia~Ga~ 240.75 UIW [35 TAB]
2) AMOXYClLLlN 500 MG CAP. FOlL
r: s
bdubdu ..................... 898,286.40 ....... UIVI 9ifliia~6au 850.65 UIW [500 CAP1
3) CEFlXlME 100 MG CAP. FOlL
c: 0
rdubdu .......................... 501,402.00 ...... UIW 'di~iia~9dau 1,177.00 UIW [I00 CAP1
4) CEFUROXIME 500 MG FlLM COATED TAB. FOlL
r: s
belub9u ............ .. ..... 391,600.00 ...... UIW ~iniiavsdaer 200.00 UIW [lo TAB1
5) CLARITHROMYCIN 500 MG FlLM COATED TAB. FOlL
a5ub'su ....................... 228,548.79 ...... UIW 9imiia~4au 940.53 UIW [70 TAB1
6) CLlNDAMYClN 300 MG CAP. FOlL
d a
bdubsu .................. 260,270.01 ...... U ~ W ~iflida~9dau 260.01 UIVI [I00 CAP1
7) DlCLOXAClLLlN 500 MG CAP. FOlL
d s ae1ubdu ....................... 676,304.20 ...... UIW T I R I ~ ~ M P ~ ~ U 1,000.45 UIW [500 CAP1
8) CIPROFLOXACIN 500 MG FlLM COATED TAB. FOlL
c: s
bdu~du ...................... 366,662.25 ...... UIW %imiia~sdau 240.75 UIW [I00 TAB]
9) LEVOFLOXACIN 500 MG FlLM COATED TAB. FOlL
d P
...... ...................... bdu~u 388,800.00 UIW =jimiia~4au 1,800.00 UIW [I00 TAB1
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