Lumacaftor + Ivacaftor Tablets Suppliers & Bulk Manufacturers
Available Forms: Tablets
Available Strengths: 200 mg lumacaftor + 125 mg ivacaftor
Reference Brands: Orkambi®(US & EU)
Category: Orphan Drugs
Lumacaftor + Ivacaftor tablets is available in Tablets and strengths such as 200 mg lumacaftor + 125 mg ivacaftor. 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, Lumacaftor + Ivacaftor tablets 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) |
Lumacaftor + Ivacaftor tablets 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: Lumacaftor + Ivacaftor tablets, marketed as Orkambi®, are approved by the FDA and EMA for cystic fibrosis treatment. Regulatory dossiers include comprehensive clinical trial data, manufacturing details, and safety profiles, supporting approval and market access. These dossiers demonstrate the therapy's efficacy in improving lung function and reducing CF symptoms. Orkambi® is available as a fixed-dose combination tablet, with 200 mg lumacaftor and 125 mg ivacaftor. For detailed insights on regulatory processes, dossier submissions, and market approvals, visit PharmaTradz, your trusted source for pharmaceutical regulatory updates and industry analysis.
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