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) |
Andexanet Alfa is a biological active ingredient classified as a recombinant modified factor xa decoy protein, used in the reversal agent for Factor Xa inhibitor anticoagulants. As a trusted Andexanet 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 Andexanet 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 Andexanet 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.
Andexanet 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 QuoteAndexanet 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.
Andexanet 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 Andexanet 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 Andexanet Alfa to assist with import, formulation, and dossier requirements in your target market.
Swapnroop Drugs and Pharmaceuticals is a trusted Andexanet Alfa supplier serving pharmaceutical formulation and research organizations across India and international markets. Our Aurangabad, Maharashtra based team provides consistent Andexanet Alfa sourcing with batch-specific documentation, competitive pricing, and support for domestic and export programs.
As a Andexanet Alfa exporter from Maharashtra, India, Swapnroop supports organizations worldwide with available Certificate of Analysis, MSDS, and regulatory filing assistance documentation. Contact us for Andexanet Alfa pricing, samples, and sourcing support.