Pan Am Farma

Fibrogen-I 0.5g

Product Overview
Generic NameFibrogen-I 0.5g
Brand Name(s)Freeze Dried Powder Human Fibrinogen EP
FormInjection (vial)
Strength0.5 g human fibrinogen
Therapeutic ClassFibrinogen concentrate for congenital fibrinogen deficiency
ATC CodeB02BD03
Manufacturing & Regulatory
ManufacturerIntas Pharmaceuticals Ltd
CountryIndia
GMP ComplianceWHO-GMP certified facility
DMF/CEPNot publicly available
COFEPRISClave pending
Free Sale CertificateYes
Logistics & Export
MOQ10 Vials
Shelf Life24 Months
Storage2–8 °C, do not freeze
IncotermsFOB Mumbai/Bangalore
Lead Time2–4 weeks after PO
Documentation
Certificate of Analysis (COA)Provided by manufacturer
SDSAvailable on request
CTD SummaryAvailable upon paid request (NDA or PO)

Description

Indications & Usage: Indicated for treatment of congenital fibrinogen deficiency (afibrinogenemia/hypofibrinogenemia), acute bleeding support, surgical prophylaxis

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