High-Quality Active Pharmaceutical Ingredient for Respiratory Formulations
Pirfenidone API (CAS 53179-13-8) is an active pharmaceutical ingredient in the Respiratory 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 | 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 Pirfenidone API
WHO-GMP certified · CoA + MSDS included · Ships to 40+ countries
Pirfenidone 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 Pirfenidone emphasizes dependable commercial support, efficient order management, and pharma-focused service for long-term buyers.
Pirfenidone is commonly assessed on quality consistency, handling profile, packaging suitability, and documentation readiness before it is approved for downstream formulation use.
Pirfenidone 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 Pirfenidone 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 Pirfenidone 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 Pirfenidone API has been dependable across multiple commercial orders.”
— Verified B2B Customer
“WHO-GMP certified quality with excellent technical support. Pirfenidone API meets all pharmacopoeial specifications.”
— Regulatory Affairs Manager
Other APIs available from Swapnroop Pharma
The CAS number for Pirfenidone API is 53179-13-8. It is an Active Pharmaceutical Ingredient manufactured by Swapnroop Drugs and Pharmaceuticals in Maharashtra, India.
Pirfenidone 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 Pirfenidone API. Standard lead time is 2–4 weeks from our Aurangabad, Maharashtra facility.
Yes, Swapnroop provides full DMF-grade documentation for Pirfenidone API including CoA, MSDS, Genotoxic Impurity Report, Stability Data, and regulatory dossier support for USFDA, EMA, and CDSCO.
Particle-size and micronization requirements for Pirfenidone can be discussed based on the buyer's inhalation or nebulisation formulation needs. Please share your specification when requesting a quote.
For companies evaluating Pirfenidone 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 Pirfenidone API backed by practical documentation support, organized batch handling, and efficient supply communication for ongoing business.