High-Quality Active Pharmaceutical Ingredient for Active Pharmaceutical Ingredient 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 Trofinetide API
WHO-GMP certified · CoA + MSDS included · Ships to 40+ countries
Trofinetide is supplied by Swapnroop with a focus on consistent quality control, transparent documentation, and dependable order fulfilment for pharmaceutical buyers.
Buyers sourcing Trofinetide from Swapnroop benefit from a straightforward quotation process, consistent batch-to-batch quality, and responsive technical coordination.
Trofinetide is commonly assessed on quality consistency, handling profile, packaging suitability, and documentation readiness before it is approved for downstream formulation use.
We offer Trofinetide 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 QuoteOther APIs available from Swapnroop Pharma
The CAS number for Trofinetide API is Available on Request. It is an Active Pharmaceutical Ingredient manufactured by Swapnroop Drugs and Pharmaceuticals in Maharashtra, India.
Trofinetide 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 Trofinetide API including CoA, MSDS, Genotoxic Impurity Report, Stability Data, and regulatory dossier support for USFDA, EMA, and CDSCO market submissions.
Yes, Swapnroop exports Trofinetide 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 Trofinetide 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 Trofinetide API backed by practical documentation support, organized batch handling, and efficient supply communication for ongoing business.