High-Quality Active Pharmaceutical Ingredient for Anticoagulant / Direct Thrombin Inhibitor 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 Dabigatran Etexilate Base API
WHO-GMP certified · CoA + MSDS included · Ships to 40+ countries
Dabigatran Etexilate Base 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 Dabigatran Etexilate Base emphasizes dependable commercial support, efficient order management, and pharma-focused service for long-term buyers.
Dabigatran Etexilate Base is commonly assessed on quality consistency, handling profile, packaging suitability, and documentation readiness before it is approved for downstream formulation use.
We offer Dabigatran Etexilate Base 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 Dabigatran Etexilate Base API is 211914-51-1. It is an Active Pharmaceutical Ingredient (API) manufactured by Swapnroop Drugs and Pharmaceuticals, a WHO-GMP certified company in Maharashtra, India.
Dabigatran Etexilate Base 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 Dabigatran Etexilate Base API including CoA, MSDS, Genotoxic Impurity Report, Stability Data, and regulatory dossier support for USFDA, EMA, and CDSCO market submissions.
Yes, Swapnroop exports Dabigatran Etexilate Base 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 Dabigatran Etexilate Base 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 Dabigatran Etexilate Base API backed by practical documentation support, organized batch handling, and efficient supply communication for ongoing business.