Pomalidomide Capsules Suppliers & Bulk Manufacturers
Available Forms: capsules.
Available Strengths: 2 mg, 4 mg, 3 mg, and 4 mg
Reference Brands: Talquetamide(US), Pomalyst(EU)
Category: Orphan Drugs
Pomalidomide Capsules is available in capsules. and strengths such as 2 mg, 4 mg, 3 mg, and 4 mg. Sourced from GMP-certified and ISO-compliant manufacturers, this API meets global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical formulation and commercial manufacturing, Pomalidomide Capsules is supplied in bulk quantities with complete regulatory support including DMF, COA, and MSDS.
| Technical Specifications & Supply Details | |
|---|---|
| Lead Time | 7 to 60 days (depending on batch size & schedule) |
| MOQ | As per manufacturer’s batch size |
| COA | Available with every batch |
| Regulatory Dossier / DMF | Available upon request |
| Export Documentation | FSC, COA, Manufacturing License, Product Permission |
| Standards | IP, BP, USP |
| Certifications | WHO-GMP, EU-GMP, USFDA (as applicable) |
Pomalidomide Capsules can be exported to over 30 countries across Asia, Africa, Europe, and Latin America. Flexible packaging, competitive pricing, and a verified supplier network make Pharmatradz a trusted sourcing partner for pharmaceutical companies and contract manufacturers worldwide.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
Product Description: Pomalidomide capsules, marketed as Pomalyst, are approved in the US by the FDA and in the EU via EMA for relapsed and refractory multiple myeloma. Regulatory approval requires a comprehensive dossier including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. The FDA reviews clinical trial and quality data to ensure safety and effectiveness, while the EMA evaluates compliance with regional safety and manufacturing standards. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper adherence to regional requirements supports timely approval, safe use, and widespread availability, helping improve long-term outcomes for multiple myeloma patients worldwide.
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