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 Ustekinumab API
WHO-GMP certified · CoA + MSDS included · Ships to 40+ countries
Ustekinumab API is positioned for companies seeking a dependable active pharmaceutical ingredient source backed by organized quality systems and scalable supply support.
We work closely with customers on Ustekinumab to align batch documentation, packaging preferences, and delivery schedules with their internal qualification timelines.
Procurement teams typically evaluate Ustekinumab suppliers on regulatory documentation, packaging integrity, and reliability of repeat supply, which shapes how we manage this product line.
Ustekinumab 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 Ustekinumab API is Available on Request (biologic). It is a biologic active ingredient manufactured by Swapnroop Drugs and Pharmaceuticals in Maharashtra, India.
Ustekinumab 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 Ustekinumab API including CoA, MSDS, Genotoxic Impurity Report, Stability Data, and regulatory dossier support for USFDA, EMA, and CDSCO market submissions.
Yes, Swapnroop exports Ustekinumab 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 Ustekinumab 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 Ustekinumab API backed by practical documentation support, organized batch handling, and efficient supply communication for ongoing business.