High-Purity Active Pharmaceutical Ingredient for Oncology Therapeutics
Osimertinib API (CAS 1421373-65-0) is an active pharmaceutical ingredient in the Oncology-Segment API category, manufactured by Swapnroop Drugs and Pharmaceuticals, a WHO-GMP certified facility in Chhatrapati Sambhaji Nagar (Aurangabad), Maharashtra, India. It is supplied in IP/BP/EP/USP pharmacopeial grades, with MOQ starting at 1 kg for sampling and 25 kg for commercial bulk orders, full CoA/MSDS documentation, and export support to USA, UK, Germany, UAE, Saudi Arabia, Brazil, South Africa, Nigeria, Kenya, Australia, and Southeast Asian markets.
| Parameter | Specification |
|---|---|
| Appearance | Brown to yellow-brown crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.2% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 2.0 – 4.0 |
| Individual Impurity | ≤ 0.5% |
| Total Impurities | ≤ 1.5% |
Get Bulk Quote for Osimertinib API
WHO-GMP certified · CoA + MSDS included · Ships to 40+ countries
Osimertinib API is positioned for companies seeking a dependable active pharmaceutical ingredient source backed by organized quality systems and scalable supply support.
Our manufacturing and supply approach for Osimertinib emphasizes dependable commercial support, efficient order management, and pharma-focused service for long-term buyers.
Osimertinib is commonly assessed on quality consistency, handling profile, packaging suitability, and documentation readiness before it is approved for downstream formulation use.
Osimertinib API is manufactured under WHO-GMP certified processes with in-house quality control covering identification, assay, related substances, and heavy-metal testing for every batch. Each shipment is released against a Certificate of Analysis (CoA) and Material Safety Data Sheet (MSDS), with DMF-grade dossier support (stability data and Genotoxic Impurity Report) available for USFDA, EMA, and CDSCO regulatory submissions.
Swapnroop exports Osimertinib API to pharmaceutical buyers across USA, UK, Germany, UAE, Saudi Arabia, Brazil, South Africa, Nigeria, Kenya, Australia, and Southeast Asian markets, with export documentation, phytosanitary/regulatory paperwork, and logistics coordination handled for both sea and air freight consignments.
We offer Osimertinib in pharma-oriented packaging formats including HDPE or fiber drum options with inner protection layers, helping maintain handling quality during storage, shipping, and routine supply movement.
Get Bulk QuoteShare your required quantity and pharmacopeial grade via WhatsApp or email.
We share CoA, MSDS, and applicable DMF-grade documents for evaluation.
Confirm a 1 kg sample or place a commercial bulk order (25 kg+).
Standard lead time is 2–4 weeks with full export documentation handled.
“Batch-to-batch consistency for Osimertinib API has been dependable across multiple commercial orders.”
— Pharmaceutical Procurement Team
“Smooth procurement experience for Osimertinib API — responsive communication and well-organized documentation.”
— Quality Assurance Head
Other APIs available from Swapnroop Pharma
The CAS number for Osimertinib API is 1421373-65-0. It is an Active Pharmaceutical Ingredient manufactured by Swapnroop Drugs and Pharmaceuticals in Maharashtra, India.
Osimertinib API is available in IP, BP, EP, and USP pharmacopeial grades with HPLC-verified purity. All batches include full CoA, MSDS, and pharmacopeial identification testing.
Minimum order is 1 kg for sampling and 25 kg for commercial bulk supply of Osimertinib API. Standard lead time is 2–4 weeks from our Aurangabad, Maharashtra facility.
Yes, Swapnroop provides full DMF-grade documentation for Osimertinib API including CoA, MSDS, Genotoxic Impurity Report, Stability Data, and regulatory dossier support for USFDA, EMA, and CDSCO.
Osimertinib is supplied with a batch-specific Safety Data Sheet outlining recommended handling precautions for oncology-segment actives. Buyers should review the MSDS before commercial handling or formulation work.
For companies evaluating Osimertinib 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 Osimertinib API backed by practical documentation support, organized batch handling, and efficient supply communication for ongoing business.