High-Quality Active Pharmaceutical Ingredient for Oncology (Targeted Therapy) Formulations
| Parameter | Specification |
|---|---|
| Appearance | White to off-white 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 Simotinib API
WHO-GMP certified · CoA + MSDS included · Ships to 40+ countries
For buyers evaluating Simotinib sourcing options, this page outlines our product profile, quality approach, and readiness to support ongoing procurement.
The Simotinib supply chain at Swapnroop is structured to minimise lead-time variability while keeping quality documentation available at every stage.
Consistent analytical performance and complete batch documentation are central to how we manage Simotinib from production through dispatch.
Packaging for Simotinib is selected to balance protection and practicality — HDPE/fiber drum options with inner liners are available depending on order size and destination.
Get Bulk QuoteOther APIs available from Swapnroop Pharma
The CAS number for Simotinib API is Available on Request. It is an Active Pharmaceutical Ingredient manufactured by Swapnroop Drugs and Pharmaceuticals in Maharashtra, India.
Simotinib API is available in IP, BP, EP, and USP pharmacopeial grades 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 Simotinib API including CoA, MSDS, Genotoxic Impurity Report, Stability Data, and regulatory dossier support for USFDA, EMA, and CDSCO market submissions.
Yes, Swapnroop exports Simotinib 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 Simotinib 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 Simotinib API backed by practical documentation support, organized batch handling, and efficient supply communication for ongoing business.