Alteplase <o m for Injection antnu oo Vial ^ (e-bidding) J minsjibs?^mis<ij'3^fn<r<nf!n^a&n Alteplase ^o mg for Injection

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1 Alteplase <o m for Injection antnu oo Vial ^ (e-bidding) J minsjibs?^mis<ij'3^fn<r<nf!n^a&n Alteplase ^o mg for Injection Vial ^^itnsib^rn^mfnfh^nyi'aa'un^ (e-bidding) io,odb,(t:oo.oo unvij 1/ alteplase dto mg powder and^iutu oobiaa solvent for solution for injection/infusion, vial. an. ^^m-j wuivni a. ^u tu

2 8>o. wyu^9ifiij WB^a^visi\itJ^tij^^\i\j^^a^^^in^fiiPi!<g(fiQji^nvi^0t3na (Electronic Government Procurement: e - ailnvi^acn^ (Electronic Government Procurement: e - GP) \JaJ.u. mvruw \J.\J.tj. nnviuw Clfnil/IIWUB to^^j '^SVl^n^n^i od.cno M. M ^b.cno "U. Vila vila^iadmuvii^iviipfvivi'viuitilfi'u o-d^en^^-^^^oo ^a tu tuvi ^ n^/nwus n.pi. e-gp

3 (e-bidding) I^IIVl fits^aen Alteplase <o mg for Injection aiinu oo Vial si^^uvi ^ mimnu^ alteplase ^^o mg powder and^ilitu oo solvent for solution for injection/infusion, vial iaapaian.on.b ( ) 'UjymanaiifiTU'vi (to) ^^tai

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12 Alteplase 50 mg for Injection l Alteplase 50 mg 50 ml 1 4. tiatn Finished product 1. Identification - ^n^iwtu^ijjvi^^ijl'u finished product specification 2. tj?jjiai^nynaoi^aj % of the labeled amount of Alteplase 3. Clot lysis Unit/vial 4. Bacterial endotoxins - Not more than 1 lu/ml 5. Sterility test - ^r^wi'u^ntjvb^tjt'u finished product specification 6. Uniformity of dosage units - ^^'n^ifhwisjvta^tjtu finished product specification 7. ph Water content - llhnt! 5.0% 9. Reconstitution time 10. Single-chain rt-pa determination 11. rt-pa monomer determination 12. Particulate matter - a^aofj/notu 2 invi % - Tmraarm 95.0% - ^o^w'i'u^jjvii^'ul'u finished product specification ana.. ana..u..^^frnurra (i^mbww ^n^a^s) - r hi

13 1. l.l (via. 2, vi^.3, via.4 vila a.2 uaiu^'n^dl) l.l.l mno^-j via. 2 visa o vmnao^j via. 3 visa a mra^^ via. 4 Vila a twtuawmi(]at!ai via. l Vila ^.l (finished product specification) specification finished product t^cua^na (GMP Vila GMP/PICs) Certificate of pharmaceutical product /iividiai. ^ wam'3^i^iaqi^i'5is;'m^a!/iiviwa/tai'^t)a-3w^a^ (Certification of analysis) 3.2 (Raw material) 4. JJ.fl. to

14 l li i 3 i^au vi1ailjain^rn^iaauaai^^i^i]'3t;nt5l^i i ria^ tana^at! <\ 7.1 ^ Long Term Stability tl 7.3 trial) prospective randomized controlled trial (RCT) (comparative clinical 7.4

15 s>. Alteplase 50 m for Injection ^tutu oo Vial vona-mi : : los: Alteplase 50 m for Injection s) Vial mfm^^avribh ( unvi) bo,^^bd:.oo UiVl/Vial is &. b ^^n^ vi.pi. en. S'uviwuvi'f niium^

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