I !':iL'::1III. I...1 1S2flJ1 1Y4J fl1 41 -nim u3i lu5i •iri nfl-i It i1j4tiif'flU1Th iji...

19
I !':iL'::1III. I I vr .=j• 1 ~ . ................. afl .... I .? 7 15 OG)JPJ/ b IT LWsII mcafoo LJ tfli'1 1 .t1fl1 111111 '11 ULJLJ flnpJ ID(WO i lUflU t Q11J 11 fflJl1 UM1Jfl ttit (tiiJ n ninn irssj MIJ14 ns (iTu ) *) U'A119i ('ii.) nilbiti Ufl1fl1 flJlLL fl1?1uqJ'rnnhJh1J uti Q2JLJ fV5flJ1J t'*, rt4Tt4 I, v G)6) 4iTU LU tJkW 51 UL 1fl13J1WTh 3n ni ww.bb.gath rn1in1s 11 flWJflM3J11flU%1'V 5'1fl1 1uiU 1U1 13J1 (l41 nJ'hJ Qi nnpu r'* nWn15 , - 11W10U5fl1fli1fJbI ii - a g, a 1JJnEJ ( l) tuj .4.l 1 flvfl1%4 tflh1fl$ 4 P 1Ufl11flJ'1fl1 /yL &v1 1eD Le 0 I1Dtt )CO LL 0 I!*3O Imuni 0 bbvicn e dbel i1U) r

Transcript of I !':iL'::1III. I...1 1S2flJ1 1Y4J fl1 41 -nim u3i lu5i •iri nfl-i It i1j4tiif'flU1Th iji...

Page 1: I !':iL'::1III. I...1 1S2flJ1 1Y4J fl1 41 -nim u3i lu5i •iri nfl-i It i1j4tiif'flU1Th iji UflUflW1tJfl1J1) Jfl094 Ono uatr4SAiTcu-~a9iiiii (Good Aquaculture Practice: GAP) nwJrn

I !':iL'::1III. I I vr .=j•

1 ~ . ................. afl .... I .?

7 15 OG)JPJ/

b IT LWsII mcafoo

LJ tfli'1 1 .t1fl1 111111 '11

ULJLJ flnpJ ID(WO i lUflU t Q11J

11 fflJl1 UM1Jfl

ttit (tiiJ n ninn irssj

MIJ14 ns (iTu ) *)

U'A119i ('ii.)

nilbiti

Ufl1fl1 flJlLL fl1?1uqJ'rnnhJh1J uti

Q2JLJ fV5flJ1J t'*, rt4Tt4 I, v

G)6) 4iTU LU tJkW 51 UL 1fl13J1WTh

3n ni ww.bb.gath rn1in1s 11 flWJflM3J11flU%1'V

5'1fl1 1uiU

1U1 13J1 (l41 nJ'hJ Qi nnpu r'* nWn15 , -

11W10U5fl1fli1fJbI ii

- a

g, a 1JJnEJ

(

l) tuj .4.l 1

flvfl1%4 tflh1fl$

4 P 1Ufl11flJ'1fl1

/yL &v1

1eD Le 0 I1Dtt )CO LL 0 I!*3O

Imuni 0 bbvicn edbel i1U) r

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S

'ygu g1j

jtç,i

n aJ1LII

Thu fliumuiJumicu

of a QUUWI2JL$J

fltflQlPl$J 2562

Page 3: I !':iL'::1III. I...1 1S2flJ1 1Y4J fl1 41 -nim u3i lu5i •iri nfl-i It i1j4tiif'flU1Th iji UflUflW1tJfl1J1) Jfl094 Ono uatr4SAiTcu-~a9iiiii (Good Aquaculture Practice: GAP) nwJrn

II LV1J

11ieM1j'i r? (TWLIJ)

02 Wfl1WP1

0201 iuq1Jn16h1UTw!.1

1 02010015 aTniJtn (NILe titapla Blo-extract)

1) vuI14 250 EnShl Inp 194.00

2) -vUlm 500 naffffil 1010 366.00

3) rxwi 1,000 ina imi Intl 672.00

2 02010016 (Plant Blo-extract)

1) -du-M 250 j)gi,i, 194.00

2) 14'Wl 500 ilaiivn Inm 366.00

3) wwi 1,000 EaRMI Intl 672.00

0301*n

3 03010059 eaisiiivmc tirnj (Montetukast Sodium)

wi 5 gainfu (28 ui) 4v 400.00

q$J1VIM,: u W1flL1J 3

LOU 8 t 1LLMOU1U th:fl11.L

iTtVMpnii3jI-AvnIv'Wn (€iiaujiv 2561) LICA8411milldvill

ISO/1EC 17025

ni,u.ii,i t%JiJeuu1u hit (Montelukast

Sodium) uii

4 03010110 eitei,,ni ggenlIft (Otmesartan medoxomiL) 1) &njJ 1It4WI 20 DaAnfu (30 m) nk4 340.00

2) ¶rirwi 40 WnN (30 ) n6w 590.00

1eiu: miunmii*u 1) irw 20 eni

5 03010142 allawV140 ffej.r,ii'tid (Donepezit Hydrochloride)

(tMWVM: DORACEPT)

1) vulit 5 SaMtj (30 iim) nti 450.00

2) ,,mu1.i ww 10 Wnfi (30 ui) nthN 600.00

6 03010143 wminwilu (PreabatIn)

(uu8ffli: NERVJCA)

1) vulm 25 Boanfu (56 I&fJl) nte9 530.00

2) nrm 75 DaAnfm (56 i,iJi) 4w 663.00

3) 'mu'nJje tuin 150 (56 LMINM nfm4 1,060.00

QU .JIi1J flfl1fl3.J 2562 rhtTnuth3i1cu

Page 4: I !':iL'::1III. I...1 1S2flJ1 1Y4J fl1 41 -nim u3i lu5i •iri nfl-i It i1j4tiif'flU1Th iji UflUflW1tJfl1J1) Jfl094 Ono uatr4SAiTcu-~a9iiiii (Good Aquaculture Practice: GAP) nwJrn

1l18Y1i18 ilk

Th Unqsflivni nvuu (umfnJ)

(uii)

7 03010144 ui1eueiirThj (Otanzapine)

Ot.APIN)

n-im 10 nij (30 ii) ndo4 1,750.00

0303 'TtIW4n11WPn1J

8 03030013 trnldfuWfl4Bi'tutlfl (Tuberculosis test kit)

*ii -.vwi (TB D-tect) vulpi 96 test nds4 70,900.00

9 03030014 tuiiuiem (Tube for blood collection)

iut.a (Innomed) a11J1flfl4 uAm 300,00

13 EaRmon V4 75 naSwom (100 e,/un)

1302 nii'oi,ti ilfm$i$TUM

10 13020006 'en,i n nnThui i:iu 3A (Ba(Ustk Vest

Lightweight Level 3A)

ju 2813 23,540.00

11 14000025 (A CLEANSING PRODUCT)

1) W1011mro4a., 6 Lim 170.00

(1 nuu iim 1 &th4 i&

iJ*eon 1 iithi)

2) worniremit 2 ve9i U4 66.00

(1 ma th:nu*w u.thni iii:eim I uu unt

IL;uI0n 1 iu)

1L: 8W4fl1'Al

'11, n11

n,jbiu aiTuAmh fl1flO1fJ 2562 17fl4J1U

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3

0J

q flQ3N1fl1flTJ 1%1J

V

1unLnr

02010015

iw irrc (NiLe titapia Blo-extract)

11fl14W n12fLMJ

Jr1 TJi I (Natural extract SPEED 1)

MV1)1flfl:

S

w

1,J64 ilf~04

1. lUTM1h flfl

2. uvi lur)4 1

3. u

4. Lwi -1

5.

tjpi Muunn11JbnJ

1U')1LUU

ii I'm 411TOI

IrflJj1Pl)J 2562 nnj1j 2570 (8 )

1 1S2flJ1 1Y4J fl1 41

-nim u3i lu5i •iri nfl -i It i1j4tiif'flU1Th iji

UflUflW1tJfl1J1) Jfl094 Ono uatr4SAiTcu-~ a9iiiii

(Good Aquaculture Practice: GAP) nwJrn ni

in' 5 ii di niiin riu nuniisiln iJnuu

wur~ Afj .51 Thi mlni .iuw th nuteilti tth

AP 1 eJn ru'i LIri nu (Auxin) (Gibberellin)

lu (Cytokinin) nn (Humic acid) Jicui t Tiinnii'J inTh "Lkr

iwj (Arsenic: As) iwi (Cadmium: Cd) tua (Chromium: Cr) momw (Copper: Cu) (Lead: Pb)

th€w (Mercury: H) unhnO (Zinc: Zn) uiiJ (Sodium: Na) lOuiotin I tim-ul-IV17,1 -1 -1244

n€luJe.3 - wv'n !JJ Jfl tn fl11Z

W1fl LfTh1' %JflJ1Th fl fl5 fl i%ifl5O fl fltYl

n1ju lrlarllWl5 oThu'ii ii'j'

flL11ULlJ

flULQW

1. i n-]vwJgnti vuwiljll c 250, 500 uat 1,000

UN1 1fl1UI1.

fl3JTh UL3.Ji1J rrnwij 2562 Jv'wicu

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4

2. flotJ%qp uJ nggi lijin

(Good Aquaculture Practice: GAP) nth

3. flu in 11 inr11

_fl

4. cu?lun 1i1i1y 1%1r11flTh n

5. nhli Lobi m I L@i QLAIAORIMA-61-Ult: ni uLLahJ l,iui 1JLJT1

ihli L 1TI t'l -JI-Api L4J Wt1114 nijr..gi LU LJ ti LLbJ iJ

La11a u 'u njI'nlu flL UULJ

* ui 0 5448 3030

JhIU Q'JLYI3JLU nn1i 2562

Page 7: I !':iL'::1III. I...1 1S2flJ1 1Y4J fl1 41 -nim u3i lu5i •iri nfl-i It i1j4tiif'flU1Th iji UflUflW1tJfl1J1) Jfl094 Ono uatr4SAiTcu-~a9iiiii (Good Aquaculture Practice: GAP) nwJrn

5

*1Ufl1LflWM flfl'Lfl

02010016

nfpiv: iinii (Plant Bio-extract)

aviniii'uun 'hiu: i3i1 2 (Natural extract SPEED 2)

%11J1l%J141:

UThfl1)1W: V

-

i 'L,ji 3c

1Mti - J 1. 'J'i L1 J'(Wf flfl1

2. 's if

3. iJ1V: UnIUM TU LMIMMI 1

4.

5. fl 11Lflf1

Un 1404 MIDIMIJ: -LjWffl 1J

flflQ19W 2562 - nniJ 2570 (8 I)

i1 2 (uii LOT)IO

-

1J1) i14U

nn_1.J ¶JE1 1J11 I.J54 416% ffl1 fl 1tfl%13Jfl

inm ilq JTIn!i 3 (ri -rmi 1J) flu mJnu%1r1

iniinnum nii'n1' Lfl iVLJflII (Good Agricultural Practice: GAP) n iini' n

ur it J%'1 5 di un - ii'n itu

UflThiUfl h njiri 1J1LtJ 'fl LwzU OA fl1JS

f1tu'trLf Ithh

11 3J 2 n rj lri uniu (Auxin) hojaoiah (GibbereUin)

11lsti (Cytokinin) n'r (Humic acid) WUN WV5%'

(Arsenic: As) LLmZFnj (Cadmium: Cd) iu3.i (Chromium: Cr) mimuoi (Copper: Cu) (Lead: Pb) thi

(Mercury: Hg) (Zinc: Zn) tiu (Sodium: Na) LU 1 ¶J1Wu'fl

fl 15'fl l.'Lit 'J 'd i.JJ %1!J0 Thfl 41tJ fl1

iirvn th ¶1ninrn' nit nn wn

1. LVQl niolil5l 250, 500 miz. 1,000 ij

2. '1n i ninr, in 3 (n)e iii Js)

iinini Th1 %T14fl ni j'i (Good

Agricultural Practice: GAP) ninmn

3. lu nli 1 - %43Thnm jni,U

4. n -) jii -Ili iniiii nJ.fl1J

, f.iL1j i1J'ULYI1J2J fl1Q1flJ 2562 nann

Page 8: I !':iL'::1III. I...1 1S2flJ1 1Y4J fl1 41 -nim u3i lu5i •iri nfl-i It i1j4tiif'flU1Th iji UflUflW1tJfl1J1) Jfl094 Ono uatr4SAiTcu-~a9iiiii (Good Aquaculture Practice: GAP) nwJrn

5. miHiJulmul liKud J Lfl1

illi Lt1J 411 fl -AMPI LJ1J ITh 14 n4ijiltAur4p IthJ unisti api4lu

....................

* 1Jn tJti ch 0 5448 3030

U ini QJkJLJ flflfl1J 2562

Page 9: I !':iL'::1III. I...1 1S2flJ1 1Y4J fl1 41 -nim u3i lu5i •iri nfl-i It i1j4tiif'flU1Th iji UflUflW1tJfl1J1) Jfl094 Ono uatr4SAiTcu-~a9iiiii (Good Aquaculture Practice: GAP) nwJrn

V of flthflc1LWV1J

03010059.

141U'gflflh1J:

'.11.nh1 1fvflJ'1U

1?Jtfl:

U1Jfl1flU1B:

f7i-wile

NtIY1WA1J: 'I

umi unibii -

I111JU1

iriv (Mon teukast Sodium)

"DOU94 ¶LL1J 5 jr(ASTAIR CHEWABLE 5 MG)

tJy) 1t

U1 Lfl

U1 L UJ

tJ1 Si

ujtnuu 2561 - whnwu 2569 (8 T)

flfl,J:

U1k%1fY1 tLJ3J fl1T ASTAIR CHEWABLE 5 MG

Iin -diN V4 LL L fl1.Lk fl

flB1J 6 LUtJ t1JT I flIBflf1L flt1l fl1Ui 14 flfli1J1

2 TJti

IflY1EJ 6 J t1UtBfl11 Singulair S m lIfl L1Jfl?Y1 Ui5.1

flW1J fl 1)J1W€3J1 J'v14fl1 flW

'JIU LJ1J UJJ'1 LLULL14 1IJ MO-MI Y14 U 1J2Jfl

JY1YI 11€UJ tf LI

nYfl

1. mtjuii

2. fl tA9flfl1 lU

nn1J

3. tL n1an'flL ifl flflLJ

inIn1ni

& I UiL LJ L

flilLQ hUIfl

5. Ii 191b1u (Bioequivaent study) ULtJUJ

iiIIJ1J '49UflTh 1Jl111( UUi4IIUJ i)flfl'1

1JI: 'Jfl .flflJ'L)1J J1JL1JL1J u.rniij 2561

- ni - n,ilLiu 3 J LN 8 MI LLgR Log au-4

(1 rniuti 2561) 0Y1fl1JW1 i'1JiUB4

¶n-v ISO/IEC 17025 inn ui

(Monteljkast Sodium) i'.fl3Jh1J 17UL?UJLi f1flihJ 2562

*- ..L.. 'j-. i 4,A 0 2420 1632 - 5

V J.JIJ nniu 2562 itnthiicu

Page 10: I !':iL'::1III. I...1 1S2flJ1 1Y4J fl1 41 -nim u3i lu5i •iri nfl-i It i1j4tiif'flU1Th iji UflUflW1tJfl1J1) Jfl094 Ono uatr4SAiTcu-~a9iiiii (Good Aquaculture Practice: GAP) nwJrn

8

I : fjl

03010110

1W4fl1J11tJ: ulla (Olmesartan medoxomR)

1n iWfl3JW: 1LiI 20 (ESATEC 20), N ILIAM 40 (ESATEC 40)

ijS1 chfr

flhiJ1 : -

ifrflj1J: 13 cnn

rU1Ui%qflJ: J1 ajollii~ 4161

- .# .-,

%ilJlU4l'U ¶J1 JD1flfl3J1U: 1JS9 FAxu il6o

'1.fl1f1J 2561 - 73J 2564 (3 ) 1flflJ:

1.

2. Fr ESATEC 40 34j1Juu UU 1 4WIJ'U ' 'JJ

UJn mninJa

U U Ui U1J1J1

3. Ic'i 'hIU

Alijm i w ~ oui Pharmaceutical Inspection

Co-operation Scheme (PIC/s)

1. ui ESATEC 20 n.Jnj tiu CM n hr 20

2. .n ESATEC 40 L J LJ1J1m iain CM flULJ 40

3. Fr ESATFC 40 UULUflUUiLJ1J niU1jLflJLfli'ifThr1R

Lfl

4. Package 14 fl1Ufl1 ItJi

inui

5. til ESATEC 20, ESATEC 40 LN I,J ClU1uUienJ

1J1U

Y1J1JL%i: nihiu Q L'JLJ .flflj 2561

iUnh1J 1) %U-IM 20 anJ tu nihitj Qi'unnymi 2562

....................

* ui ciri q 0 3856 4930 - 2

4Jl%1tJ L'i1JW nnjiPJ 2562

Page 11: I !':iL'::1III. I...1 1S2flJ1 1Y4J fl1 41 -nim u3i lu5i •iri nfl-i It i1j4tiif'flU1Th iji UflUflW1tJfl1J1) Jfl094 Ono uatr4SAiTcu-~a9iiiii (Good Aquaculture Practice: GAP) nwJrn

03010142

14fl114W1Wfl'U1bUJ:

MII'JIJ4-IUM'jiTOUU-1

A simin uwr

4I 1LJ1J:

flWflTh:

1uflh1LM)11j" : J1

tic$ (Donepezil Hydrochloride)

ILJ (DORACEPT)

044mimAdmu

8fl1flJ

8fl1?ifl2J

flflflh1J 2562 - nfuJ1n1J 2565 (3 J)

1. Fr DORACEPT 6NtjlvOmumn9,Awijin

n DORACEPT (5 MG) flvJ1?1'nJ Av Donepezil. hydrochloride 5 fitiSnTij

FJ1 DORACEPT (10 MG) 'thn ui*i'nj 0 Donepezil hydrochloride 10 ni3J

2. Fji Donepezit 1Juiinu1 nit UJ€J{

choUnergic uni r acetylcholine inn1'ii nii t

acetylcholine esterase tjw'trn'u ilini acetylcholine qn6wID4

n Donepezil

2.1 1 fl11 Iu 1Prn3Ju.4

5 mia 10 ni'2J 'U1 1

2.2 U fl1fl13JJL lO 1.LL 10 Ini2J

1

ji DORACEPT

3. tii DORACEPT (10 MG) fl1fl iL UiJt1JU1ULWU (Aricept Evess 10 mg)

1n1nmYnU11$ 2 vionli (Therapeutic

equivalence) Tt vi DORACEPT (5 mg) flUn1 i12J%1'fl dose

proportionality tuui DORACEPT (10 mg) Lumin

3.1 Ui DORACEPT (5 mg)

01 DORACEPT (10 mg)

3.2 1jtji DORACEPT MillwJ4 5 M'3i at. 10 1Jfl

3.3 u l DOPACEPT (5 mg) then n4 (un.) wn'u

til DORACEPT (10 mg) IM 11flhl41U Oil 3J1fl I

(<5%)

3.4 niaiv (Dissolution profile) iui DORACEPT (5 mg) nr1.afh pH 1.2, pH 4.5

u.a pH 6.8 n1nEj1rnu1 DORACEPT (10 mg) (similarity factor (f2)>

50%)

* @4AMIW&T-dn513J 'e 0 2203 8600 - 3

• QU1JLJ flfflJ13J 2562 nithiw

Page 12: I !':iL'::1III. I...1 1S2flJ1 1Y4J fl1 41 -nim u3i lu5i •iri nfl-i It i1j4tiif'flU1Th iji UflUflW1tJfl1J1) Jfl094 Ono uatr4SAiTcu-~a9iiiii (Good Aquaculture Practice: GAP) nwJrn

10

Q33Oi4',

4'1U4'flilbTh:

Jfl'fllLfl:

uiniju (Pregabalin)

ij{n1 25 (NERVICA 25), u€rirn 75 (NERVICA 75),

150 (NERVCA 150)

'J1 !ii'u cJII

lci

tJLk1UiMU1): J1 LvvllalJ

UT1

nnpj 2562 -. flflh1fi1.i 2565 (3 0)

UJfl3J:

nrnj'u (PregabaUn) fll 1fl1'51 Ll3n1 25 (NEF'IC.A 25), €iirr 75 (NERVICA 75),

ni 150 (NERVICA 150) iJu 1Ct%l2J l.twi I 011JTO th nuu PregabaUn25 mg, Pregabalin 75 r,

Pregabalin 150 mg

Fjq*Aif) -Ilj')Slu (Pregaba(in) 4 1EJ GABA UmMjfll GABA vi5€) benzodiazepine

receptors Vzlxkj aLDha2-deLta subunit voltage-gated ca(cium channes

(ertatory neurotransmitter)

iJaiui 1'1 L4 glutamate, noradrenaline, serotonin, dopamine Min ' tJii

nin ni 1rJ'

fl1flJfl .LUU partiat seizures 11fl*1flfl1fl

jinrut (Pregabalin) L 1LLal b1J

U1 LJ3J ITUM iNn f11

llUf)T5Wflfjl Pharmaceutical Inspection Co-operation Scheme (PIC/S) fl1fl LLtJUfJ

U1LJU niniji eiynnji,j (Pregabatm)

1. U JtJ1 LU 1JUi' 25 nj 75 LasnTlj ti

150 n'1J

2. nJThj

- NERVICA 25 aL1J 4 AwAiNum 25 PRE iJa

L LJi1 : 1A 70/60 (NG)

- NERVICA 75 W€Y 4 -LAJ 75 PRE iu

4NU"'dja fl NJ1 flLP1 L1J'1L1JUJ1: 1A 68/60 (NG)

- NERVIC.A 150 2 nii 150 ivTn PRE iJa

fl1UU flOfliiO' tLJI1U'l : 1A 69/60 (NG)

* tithi OIN 1t 0 3856 4930 - 2

M'nj'Lm nn,p?i 2562

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11

11Jfl1LLW1U: Iii

03010144

1441IJ145flT2Jb1B: uitti'viu (Oanzapine)

I0fl1J-10 (OLAPIN-10)

U111JLU1: 1J1 ç*14 1(

1J1Jfl11tflW: -

1J1 T1fW

L1141Wii1V: J1't1

hi41ts 1J1

l.x 1I1IJ1J: nn1YW 2562 - nnQ'Wi2J 2565 (3 ti)

U'fl2J:

UIt 4i1lJ LI14 it thienoenzodiazepine dopamine uary

serotonin ttit8u il1tpi monoaminergic 4LQNiicH 11 i fJ serotonin

5-I-fT2A uau. 5-HT2Cdopamine 01-4, muscarinic M1-5, histamine HI- L&v aiphal-adrenergic receptor u

' fu GABA-A BZD uarw beta-adrenergic receptors

CLQ1

1. OLAPIN-10 1LOiJT Jni 1414 )i14MlJ2JL?i'U 10

2. tn O(anzapine fl U1J0U1Jfl1Jfl11LLiJU

n,niiji Wu.)

3. Package )aflJ TnAwah liJwleiq.mnuim

* 1J1 fliU ifI Q 0 3856 4930 - 2

lriu QiTuA64h nniywi 2562 iflflu

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12

*Ufl1I'fl1I: 1flh1UVflUJ

3O3OO13

(Tuberculosis test kit)

nhis1nJi'Pn1,2JlIui: i -L (TB D-tect)

U11Jfl41: JW)1 %1Th9uJ

ui 'Lui.a

ijii utti Sit

-

1thu4114 1J1 U1&lJfl2JbftJ: J1 4it'i

flfl11J 2562 - flfli13i 2570 (8 )

UJ'flTh:

TB D-tect LflaU 1IJ (Lyophilize) 81KInvim0finil

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