High-Purity CGRP-Pathway Active Pharmaceutical Ingredient for Migraine Therapeutics
Galcanezumab API (CAS 1524609-22-0) is an active pharmaceutical ingredient in the CGRP Receptor Antagonist / Anti-Migraine 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 Galcanezumab API
WHO-GMP certified · CoA + MSDS included · Ships to 40+ countries
Galcanezumab 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 Galcanezumab emphasizes dependable commercial support, efficient order management, and pharma-focused service for long-term buyers.
Galcanezumab is commonly assessed on quality consistency, handling profile, packaging suitability, and documentation readiness before it is approved for downstream formulation use.
Galcanezumab 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 Galcanezumab 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 Galcanezumab in pharma-oriented packaging formats including HDPE or fiber drum options with inner protection and light-barrier layers, helping preserve stability 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 Galcanezumab API. Consistent quality with full CoA documentation and on-time delivery.”
— Pharmaceutical Procurement Team
“Batch-to-batch consistency for Galcanezumab API has been dependable across multiple commercial orders.”
— Regulatory Affairs Manager
Other APIs available from Swapnroop Pharma
The CAS number for Galcanezumab API is 1524609-22-0. It is an Active Pharmaceutical Ingredient manufactured by Swapnroop Drugs and Pharmaceuticals in Maharashtra, India.
Galcanezumab 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 Galcanezumab API. Standard lead time is 2–4 weeks from our Aurangabad, Maharashtra facility.
Yes, Swapnroop provides full DMF-grade documentation for Galcanezumab API including CoA, MSDS, Genotoxic Impurity Report, Stability Data, and regulatory dossier support for USFDA, EMA, and CDSCO.
Galcanezumab is supplied for formulation development and commercial sourcing in the CGRP-pathway therapeutic segment. Buyers should confirm applicability to their specific dosage form through their own qualification process.
For companies evaluating Galcanezumab 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 Galcanezumab API backed by practical documentation support, organized batch handling, and efficient supply communication for ongoing business.