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) |
Amivantamab is a biological active ingredient classified as a bispecific egfr-met monoclonal antibody, used in the treatment of non-small cell lung cancer with EGFR exon 20 insertion mutations. As a trusted Amivantamab 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 Amivantamab 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 Amivantamab 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.
Amivantamab 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 QuoteAmivantamab 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.
Amivantamab 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 Amivantamab 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 Amivantamab to assist with import, formulation, and dossier requirements in your target market.
Swapnroop Drugs and Pharmaceuticals is a trusted Amivantamab supplier serving pharmaceutical formulation and research organizations across India and international markets. Our Aurangabad, Maharashtra based team provides consistent Amivantamab sourcing with batch-specific documentation, competitive pricing, and support for domestic and export programs.
As a Amivantamab exporter from Maharashtra, India, Swapnroop supports organizations worldwide with available Certificate of Analysis, MSDS, and regulatory filing assistance documentation. Contact us for Amivantamab pricing, samples, and sourcing support.