Pentapharm AG sell "Batroxobin - Defibrase®"
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Product Name
Batroxobin - Defibrase®
Details
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Specifications
- Indication: Thrombin-like serine protease enzyme used clinically for treatment of thrombotic diseases via selective defibrinogenation
- Storage Conditions: Store concentrated liquid API at 2-8°C, protected from light, per cGMP cold-chain requirements (Article No. 102-02)
- Shelf Life: 24 months from date of manufacture when stored under recommended refrigerated conditions
- Regulatory Approval Status: Manufactured under cGMP conditions with regulatory support documentation including DMF for snake-venom-derived enzyme API
Documents
OtherCEGMPISO
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