High-Quality Active Pharmaceutical Ingredient for Anti-Allergic Formulations
Epinastine API (CAS 80012-43-7) is an active pharmaceutical ingredient in the Anti-Allergic 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 Epinastine API
WHO-GMP certified · CoA + MSDS included · Ships to 40+ countries
Epinastine 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 Epinastine emphasizes dependable commercial support, efficient order management, and pharma-focused service for long-term buyers.
Epinastine is commonly assessed on quality consistency, handling profile, packaging suitability, and documentation readiness before it is approved for downstream formulation use.
Epinastine 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 Epinastine 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 Epinastine 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.
“Reliable supplier of Epinastine API. Consistent quality with full CoA documentation and on-time delivery.”
— Quality Assurance Head
“Batch-to-batch consistency for Epinastine API has been dependable across multiple commercial orders.”
— Pharmaceutical Procurement Team
Other APIs available from Swapnroop Pharma
The CAS number for Epinastine API is 80012-43-7. It is an Active Pharmaceutical Ingredient manufactured by Swapnroop Drugs and Pharmaceuticals in Maharashtra, India.
Epinastine 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 Epinastine API. Standard lead time is 2–4 weeks from our Aurangabad, Maharashtra facility.
Yes, Swapnroop provides full DMF-grade documentation for Epinastine API including CoA, MSDS, Genotoxic Impurity Report, Stability Data, and regulatory dossier support for USFDA, EMA, and CDSCO.
Epinastine is supplied as a raw material suitable for a range of oral dosage form development, subject to the buyer's own formulation and compatibility studies.
For companies evaluating Epinastine 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 Epinastine API backed by practical documentation support, organized batch handling, and efficient supply communication for ongoing business.