High-Quality Active Pharmaceutical Ingredient for CFTR Modulator / Cystic Fibrosis 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 Deutivacaftor API
WHO-GMP certified · CoA + MSDS included · Ships to 40+ countries
Deutivacaftor 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 Deutivacaftor emphasizes dependable commercial support, efficient order management, and pharma-focused service for long-term buyers.
Deutivacaftor is commonly assessed on quality consistency, handling profile, packaging suitability, and documentation readiness before it is approved for downstream formulation use.
We offer Deutivacaftor API 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.
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The CAS number for Deutivacaftor API is 2642441-97-0. It is an Active Pharmaceutical Ingredient (API) manufactured by Swapnroop Drugs and Pharmaceuticals, a WHO-GMP certified company in Maharashtra, India.
Deutivacaftor API is available in IP, BP, EP, and USP pharmacopeial grades with HPLC purity ≥98.0–102.0%. All batches come with full CoA, MSDS, and pharmacopeial identification testing.
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 Deutivacaftor API including CoA, MSDS, Genotoxic Impurity Report, Stability Data, and regulatory dossier support for USFDA, EMA, and CDSCO market submissions.
Yes, Swapnroop exports Deutivacaftor 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 Deutivacaftor 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 Deutivacaftor API backed by practical documentation support, organized batch handling, and efficient supply communication for ongoing business.