Linagliptin Tablets Suppliers & Bulk Manufacturers
Available Forms: Tablets
Available Strengths: 5 mg
Reference Brands: Tradjenta®(EU & US)
Category: Diabetes
Linagliptin Tablets is available in Tablets and strengths such as 5 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, Linagliptin 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) |
Linagliptin 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: Linagliptin tablets are approved for the treatment of type 2 diabetes in both the USA and EU. In the USA, they are marketed as Tradjenta®, approved via a New Drug Application (NDA) and regulated under 21 CFR, with labeling for risks like pancreatitis and joint pain. Manufacturers must ensure GMP compliance and implement post-marketing surveillance. In the EU, Linagliptin is authorized as Trajenta® via the centralized procedure, requiring CTD-format submission, a Risk Management Plan (RMP), PSURs, and full pharmacovigilance. For regulatory support, dossier preparation, or B2B sourcing, visit PharmaTradz.com.
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