Biofactor GmbH

Streptofactor ® Streptokinase


Origin of the Raw Material: Germany

Range of Application: Thrombolytic Agent

Dosage Form: Injection vials (lyophilisate)

Strengths:
100,000 I.U./vial
250,000 I.U./vial
750,000 I.U./vial
1,500,000 I.U./vial

Validated Production Process

Registration file / Dossier: UK, Argentinia, Serbia

Documentation 
Full CTD dossier available
Certificate of Analysis
Batch Documentation
Drug Master File - according to European Guidelines




Doxofactor ®, API Doxorubicin Hydrochloride


Origin of the Raw Material: Germany

Range of Application: Anti Cancer

Dosage Form: Injection vials (lyophilisate)

Strengths:
10 mg
50 mg
150 mg

Validated Production Process

Registration file / Dossier: Germany

Documentation: 
Full CTD dossier available
Certificate of Analysis
Batch Documentation
Drug Master File - according to European Guidelines


Contract manufacturing / Outsourcing





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