Biologic Active Ingredient for Specialty and Immunology Formulations
| Parameter | Specification |
|---|---|
| Appearance | Lyophilized powder / solution, biologic origin |
| Identification | Peptide mapping / ELISA compliant |
| Purity (SEC-HPLC) | ≥ 98.0% |
| Protein Content | As per certificate of analysis |
| Endotoxin | Within pharmacopoeial limits |
| Host Cell Protein | Within qualified limits |
| Storage | 2–8°C, protect from light |
Get Bulk Quote for Sintilimab API
WHO-GMP certified · CoA + MSDS included · Ships to 40+ countries
Our Sintilimab supply program is built around repeatable batch quality, responsive communication, and practical support for formulation teams and procurement teams alike.
Our manufacturing and supply approach for Sintilimab emphasizes dependable commercial support, efficient order management, and pharma-focused service for long-term buyers.
Before approving a new source, most formulation teams review Sintilimab for assay consistency, impurity profile, and the completeness of supporting documentation — all of which we prioritise.
Sintilimab is packed in HDPE drums or fiber drums with double poly-lined inner bags, chosen to protect product integrity through transit, warehousing, and routine handling.
Get Bulk QuoteOther APIs available from Swapnroop Pharma
The CAS number for Sintilimab API is Available on Request (biologic). It is a biologic active ingredient manufactured by Swapnroop Drugs and Pharmaceuticals in Maharashtra, India.
Sintilimab API is available in IP, BP, EP, and USP pharmacopeial grades where applicable with quality testing per pharmacopoeial and in-house specifications. All batches come with full CoA and MSDS.
Minimum order is 1 kg for sampling and 25 kg for commercial bulk supply. Standard lead time is 2–4 weeks from our Aurangabad, Maharashtra facility. Expedited supply is available for larger volumes.
Yes, Swapnroop provides full DMF-grade documentation for Sintilimab API including CoA, MSDS, Genotoxic Impurity Report, Stability Data, and regulatory dossier support for USFDA, EMA, and CDSCO market submissions.
Yes, Swapnroop exports Sintilimab API to 40+ countries including the USA, UK, UAE, Germany, Australia, South Africa, Nigeria, Kenya, Brazil, and Southeast Asian markets. We provide full export documentation and regulatory support.
For companies evaluating Sintilimab API manufacturer options in India, this page offers a clear overview of the product profile, quality approach, and supply readiness.
Our team works with buyers who need Sintilimab API backed by practical documentation support, organized batch handling, and efficient supply communication for ongoing business.