High-Purity Monoclonal Antibody-Class Active Pharmaceutical Ingredient for Neurodegenerative Therapeutics
Lecanemab API (CAS 1935694-88-4) is an active pharmaceutical ingredient in the Anti-Amyloid Monoclonal Antibody-Class 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 lyophilized 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 Lecanemab API
WHO-GMP certified · CoA + MSDS included · Ships to 40+ countries
Lecanemab 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 Lecanemab emphasizes dependable commercial support, efficient order management, and pharma-focused service for long-term buyers.
Lecanemab is commonly assessed on quality consistency, handling profile, packaging suitability, and documentation readiness before it is approved for downstream formulation use.
Lecanemab 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 Lecanemab 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 Lecanemab in pharma-oriented packaging formats with cold-chain-compatible containers and inner protection layers, helping maintain biologic integrity 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.
“Smooth procurement experience for Lecanemab API — responsive communication and well-organized documentation.”
— Verified B2B Customer
“Reliable supplier of Lecanemab API. Consistent quality with full CoA documentation and on-time delivery.”
— Verified B2B Customer
Other APIs available from Swapnroop Pharma
The CAS number for Lecanemab API is 1935694-88-4. It is an Active Pharmaceutical Ingredient manufactured by Swapnroop Drugs and Pharmaceuticals in Maharashtra, India.
Lecanemab 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 Lecanemab API. Standard lead time is 2–4 weeks from our Aurangabad, Maharashtra facility.
Yes, Swapnroop provides full DMF-grade documentation for Lecanemab API including CoA, MSDS, Genotoxic Impurity Report, Stability Data, and regulatory dossier support for USFDA, EMA, and CDSCO.
Yes, Lecanemab is supplied with batch-specific documentation appropriate for biologic-class materials, including CoA and handling guidance. Buyers should confirm specific dossier requirements with our regulatory support team.
For companies evaluating Lecanemab 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 Lecanemab API backed by practical documentation support, organized batch handling, and efficient supply communication for ongoing business.