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/ wen/la o.mioo Vial <o Vial ©ls.tooo Cap ^^.ooo Vial ls^^.doo Tab u. m @)b.eno u. isvn'n-3i,nan ;. a (e-Govemment Procurement: g-GP) a. mi. m^. nnvtu^ mjnmw^TU' u :. tjJi^^' uwl^f' uianfivisviiapnnsjpijjn' u b. ^n. nruvi inaana tu inanman s>. Albumin human 20% Injection Is. Alteplase 50 img for Injection en. Atazanavir 300 mg Capsule c^. Biphasic Insulin Aspart 100 lU/ml Injection ^n^ penfill (^. Ticagrelor 90 mg Tablet e-bidding) "Ui^m^^iofmiaana^n' UTU -tm -

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^^.ooo Vial

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s>. Albumin human 20% Injection

Is. Alteplase 50 img for Injection

en. Atazanavir 300 mg Capsule

c^. Biphasic Insulin Aspart 100 lU/ml Injection ^n^ penfill

(^. Ticagrelor 90 mg Tablet

e-bidding)"Ui^m^^iofmiaana^n'UTU

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Vj1avn-aai.ua [email protected]

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g). Albumin human 20% Injection^^gtIoo Vial

Is. Alteplase 50 mg for Injections^^ Vial

on. Atazanavir 300 mg Capsule^is.boo Cap

<sL. Biphasic Insulin Aspart 100 ILJ/ml Injection m^ penfill^,ooo Vial

&. Ticagrelor 90 mg Tabletls^,doo Tab

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Ticagrelor 90 mg Tablet

Biphasic Insulin Aspart 100 ILJ/ml Injection "iri^^ penfill

Atazanavir 300 mg Capsule

Alteplase 50 mg for Injection

Albumin human 20% Injection

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- atlsaniu albumin laaaanm 95% t)a*Tvlswu

- 94.0 -106.0% ^ja*'iJsanai'l<iJs^iaviaanns^a

- wrsawiu^naviss^^^lu finished product specification

- <^m^NTu ^i^tj^spin* *\ anvi wa

- Immunoelectrophoresis

- Ouchterlony test (Double immunodiffusion)

5. Heme content

4. Albumin

3. Total protein

2. pH

1. Identification

^^niaaijliYn*iviFiaflt)a* Finished product

^mails*

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^saa administration set mi membrane filter

1.itluem colloid ihipmn^a laa?ia*mvma* via^^naau

2.tbsnau^^a Albumin human 20 /100 ml imJiai^is 50 ml

3.

4.

Albumin human 20% Injection

Albumin human^20%/Injection•' y/

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finished product specification

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(vm.2 via.3 via.4 Vila a.2

via.2 Vila a.2

na.3 Vila a.2

via.4 Vila a.2

l.l.l

1.1.

1.1.

l.l

8 ua^ ^ia 9vuneuvi^j fl

- Wa^aNTUFnuvbs'ulu finished product specification

- Ki!ft^^^i^s<^uiuviH<^hEJ

- -^vrsstm Um Vila Mei heat stabilizer

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- ^n^fhu^nuYi'ssnjiu finished product specification

- ^^^^wnu^numsnjt'U finished product specification

- ^r^aw'VUiimajvb^'ul'U finished product specification

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12. Heat stabilizers aivi wu

N-acetyl-DL-tryptophan,

Caprylic acid/ caprylateniriM heat stabilizer ^^^au

niafluH heat stabilizer

11. Potassium content

10. Aluminium content

(iQnnslum^um^^w^AU.fh)

9. Bacterial endotoxins

8. Pyrogen test

7. Sterility test

6. Sodium content

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2 vnbau^/^^im4.1 wiaua^nm

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3.2wam^wria^ifm:n^^fl4fnyiTVm^iii (Raw material)

3.32^v^ifl?n!^Q^0^^iJ^ia^u1iyYiww^(i^^Anti-

HIV-l, Anti-HIV-2, Hepatitis B Surface antigen, Anti-HCV (Antibody against hepatitis C

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3.

product

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Long Term Stability

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in 2 tl

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7.2

6.

7.

mvmw

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l tl 6 w^u5.1

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5.

- ^'aTawTu^nsjvii^'ui'U finished product specification

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- Imfru 5.0%

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- ^Ti^WTUonuvtazi/lu finished product specification

- ^^^^wTu^nuv^^n/lu finished product specification

- Not more than 1 lU/ml

- 45.0-60.0 Unit/vial

- 95.0-105.0% of the labeled amount of Alteplase

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12. Particulate matter

11. rt-PA monomer determination

10. Single-chain rt-PA determination

9. Reconstitution time

8. Water content

7. pH

6. Uniformity of dosage units

5. Sterility test

4. Bacterial endotoxins

3. Clot lysis

2. "J^*najpnntviflnj

1. Identification

Finished product

pmuui-a

50 ml 1Alteplase 50 mg ^i^n^t vi^

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Alteplase 50 mg for Injection ^<Hl^^A

Alte^^^te 50i.mg for/Injection

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productCertificate of pharmaceutical

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2.2

2.1

2.

specification

(finished product specification)

finished product

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1.1.3

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- 90.0-110.0 % of the labeled amount of atazanavir

- Complied with finished product specification

Specifications

Uniformity of dosage units*

Dissolution test*

Assay

Identification

Test items

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specification

3.1 Finished product specification:

TufhiaisjTuw^w T

2.3

2.4 Qfnn

2.1ijiJuimiil^Ejnitfi\Jei

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d1. ^JBEn Atazanavir 300 mg Capsule

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- Complied with drug substance specification

Specifications

Sulfuric acid

Residue on ignition

Water

ImpurityIndividual impurity

Total impurities

Assay

Identification

Test items

6

54

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l

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3.2 Drug substance specification :

fl.W. b^bo

(sn^an^ti'^ntuvi^ {jaitwrin) *

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4.3.2wam^^^^if!i^ns'Mflai/nw^Wi\j^ia-3^'5a'ianmy (Certification of analysis of drug

substance)

4.3.

viani,ntu<iiaa^5fn<5vilTifn'5wawai PIC/S (Pharmaceutical Inspection Co

operation Scheme) I^aviiba'nu PIC/S participating authorities Q\j\jsin?|Pisnjj

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j ua^awn-soi ^iadianaii Certificate of pharmaceutical product

4.2.2

PIC/S Tuvm^^^tnvhauainEj amja

PiC/S (Pharmaceutical Inspection Co-operation Scheme)

PIC/S participating authorities Vila?

4.2.1

4.2

viej.1 ^a a.l ^ja- tnvkecuanpn

iliJEj'u (finished product specification)

n^j (drug substance specification)

-muuan?mfm<uaunhi (a.5) jnvi^aaj finished product specification

drug substance specification I^o<aaunlunBUTru\J'5Sfnpiil^sm^nfin

a uaslmnu 2 il tu ^i

4.1.2

n.w.

(original drugs)4.6.1

4.6.

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j4.5.1 anvi^-5jja<UTO-3^^anEj1^l^liJ'uaan'in l tl m

4.5.2

4.5.3

4.4.1 wi?cua^fn

4.5.

4.4.

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to 4.3.1

4.3.4w^fm^^ntn long term stability

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4.7.3

4.7.2

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fcof

a-

- Uknu 1.3%

- B28isoAsp insulin aspart: Lknt! 1.0%

- Imnu 0.9%

- 7.20-7.44

- 96.3-105.0% of the labeled amount of Insulin aspart

- ^^'nawt'ufinjjvbs'ul'u finished product specification

product

6. Total Impurities

5. Related proteins

4. Limit of high molecular weight

proteins

3. pH

2. iliincu^nmchpiaj

1. Identification test

^^euajJ'U^vn-^ivifi'Ufitia'3 Finished

2-8 a-a^n^a^aa uasvianiaa-afn^uiiu,^ (avoid freezing)

Tuviwa^i Tuauata ta^iviwain^^tn

ua-a3 mlmultiple doses

3 ml100 lU/ml

Insulin aspart fa^^^ 30 w^^ Protaminated Insulin aspart ^a^as 70

1.

2.

3.

4.

Biphasic Insulin Aspart 100 lU/ml Inje^tion mj^^ penfill

(unofciHtfimnJiu)

^ (inaaa^aiu n^amwu^nv^)

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Certificate of pharmaceutical

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(finished product specification) n<auvia^<5^vrin

finished

3.1

3.

product

2.2

2.1 n^^^vianw^pi1iu'iJ'3t!tvi?ilv)a

2.

product specification

1.1 luaiflVym^^vi^iiia'uw^fuan (via. 2, via.3, via.4 via a.2

1.1.1lun^oiviiil'UEnviwaflluibsivfllvia v^jn^n-^ via. 2 via a.2

1.1.2Tun^uvii^^<uaiTJimi'wamm\j'Jii^^a vinad-a via. 3 via a.2

1.1.3^^n^^viiil^an^h^^nntisi'^ihsivif'f vtinan^ via. 4 via a.2

1.2 lafh^ja^uviKiiia'ua^ via. 1 via a.lif

- lu'inu 80 endotoxin units/100 IU of Insulin aspart

- ^n^wTuenjJvb^'ul'U finished product specification

- ^^WTUW'iiJvta^'ijTu finished product specification

- 16.4-22.9 p/ml j

10. Bacterial endotoxins

9. Sterility test

8. Preservative

7. Zinc content

3J.fi. MR'

60^ l ai^^

prospective randomized controlled trial (RCT)

8.

7.3 l'un'3^^ljjl'lUEj^^i<uu<uiJ^^^ia-^flw^rn^^n'wni,\JiEJ'u^EJUVii-3Fi^^n (comparative clinical trial)

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1.1.21uniuvii^uaith^^iani<3U'U^im^ viuna^ via. 3 vila a.2

1.1.3 ^'um^vii^liiaTuomainwn^iJ^sivif'i vi^ia^-a via. 4 vila a.2

1.

- ^naw'iwiiiY^^nj'Uj finished product specification

- ^T^awTUdnuvi'j^ulu finished product specification

- Pinawnwiuv^^stjlu finished product specification

- 95.0-105.0% of the labeled amount of Ticagrelor

- wii^wiuw'iijvi'sstj'tu finished product specification

5. Degradation products

4. Dissolution Test

3. Uniformity of dosage units

2. vJiuini^nanaimu

1. Identification

Finished product

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Ticagrelor 90 mg

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4.

Ticagrelor 90 mg Tablet^faa

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(Raw materia

(Certification of analysis) tutnfuvid-nil'u

Certificate of pharmaceutical

3.2

3.1

3.

product

2.2

tauaino

(GMP Vila GMP/PlCs) luvunwtnvi

2.1

2.

product specificationfinished

(finished product specification)

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Ticagrelor 90 mg Tablet (sCis)

Biphasic Insulin Aspart 100 lU/mlInjection ^^ penfill (s:.^)

Atazanavir 300 m Capsule (s^.lo)

Alteplase 50 mg for Injection (sl.h)

Albumin human 20% Injection (sCte)

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