WHO-GMP Certified Biological / Recombinant Protein API Supplier
| Parameter | Specification |
|---|---|
| Appearance | White to off-white lyophilized powder / sterile solution |
| Identification | SDS-PAGE / Western Blot / Peptide Mapping |
| Purity (SEC-HPLC) | ≥ 98.0% |
| Protein Content | As per validated assay (Lowry / UV280) |
| Potency (Bioassay) | 80% – 125% of label claim |
| Endotoxin | < 1.0 EU/mg |
| Bioburden | NMT 10 CFU/g |
| Moisture Content | NMT 2.0% (lyophilized form) |
Alprolix (Eftrenonacog Alfa) is a biological active ingredient classified as a recombinant factor ix fc fusion protein, used in the treatment and prophylaxis of bleeding episodes in Hemophilia B. As a trusted Alprolix (Eftrenonacog Alfa) sourcing partner in India, Swapnroop Drugs & Pharmaceuticals connects pharmaceutical formulators and research organizations to consistent supply with complete batch documentation for regulated and semi-regulated markets.
Organizations sourcing Alprolix (Eftrenonacog Alfa) evaluate SEC-HPLC purity (≥98.0%), confirmed identity by SDS-PAGE / Western blot / peptide mapping, validated potency by bioassay, and tightly controlled endotoxin and bioburden limits. Cold-chain integrity and batch-to-batch consistency in glycosylation and aggregation profile are critical for downstream formulation performance.
Swapnroop Drugs and Pharmaceuticals coordinates Alprolix (Eftrenonacog Alfa) supply through our Aurangabad, Maharashtra base with full cold-chain handling and batch-specific quality documentation. We support regulatory dossier compilation, provide validated stability data where available, and serve formulation and research organizations across 25+ countries.
Alprolix (Eftrenonacog Alfa) is supplied in validated cold-chain packaging with insulated containers, temperature data loggers, and tamper-evident sealing to preserve product integrity during storage and international transit.
Get Bulk QuoteAlprolix (Eftrenonacog Alfa) is a complex biological product and the applicable CAS / registry reference is available on request along with full batch documentation. Please contact our regulatory team to confirm the reference applicable to your required form.
Alprolix (Eftrenonacog Alfa) is supplied to in-house validated specifications with SEC-HPLC purity ≥98.0%, controlled endotoxin and bioburden limits, and potency confirmed by validated bioassay, with full batch-specific documentation.
Minimum order quantities and lead time for Alprolix (Eftrenonacog Alfa) depend on batch size and cold-chain logistics requirements; please contact our team for current availability. Standard lead time is 3–6 weeks from confirmation of order, with expedited supply available on request.
Yes, Swapnroop provides batch-specific Certificate of Analysis, MSDS, and available regulatory support documentation for Alprolix (Eftrenonacog Alfa) to assist with import, formulation, and dossier requirements in your target market.
Swapnroop Drugs and Pharmaceuticals is a trusted Alprolix (Eftrenonacog Alfa) supplier serving pharmaceutical formulation and research organizations across India and international markets. Our Aurangabad, Maharashtra based team provides consistent Alprolix (Eftrenonacog Alfa) sourcing with batch-specific documentation, competitive pricing, and support for domestic and export programs.
As a Alprolix (Eftrenonacog Alfa) exporter from Maharashtra, India, Swapnroop supports organizations worldwide with available Certificate of Analysis, MSDS, and regulatory filing assistance documentation. Contact us for Alprolix (Eftrenonacog Alfa) pricing, samples, and sourcing support.