Linagliptin + Metformin IR & XR Tablets bulk supplier for pharma manufacturers

Linagliptin + Metformin Ir & Xr Tablets Suppliers & Bulk Manufacturers

Available Forms: Tablets(IR & XR)

Available Strengths: 2.5 mg / 1000 mg, 2.5 mg / 850 mg, 2.5 mg / 500 mg

Reference Brands: Jentadueto® / Jentadueto XR®

Category: Diabetes

Linagliptin boosts insulin and lowers glucagon via DPP-4 inhibition, while Metformin reduces liver glucose output and improves insulin sensitivity. Together, they offer effective glycemic control with low hypoglycemia risk, weight neutrality, and flexible IR/ER dosing—ideal for managing type 2 diabetes in monotherapy or combination therapy.

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Product Description:

Linagliptin + Metformin (IR/ER) tablets are approved for type 2 diabetes management in both the USA and EU. In the USA, they are marketed as Jentadueto® (IR) and Jentadueto XR® (ER), approved via NDA under 21 CFR, with labeling for lactic acidosis and pancreatitis risks. GMP compliance and post-marketing surveillance are required. In the EU, the same formulations are marketed under Jentadueto®, authorized through the centralized procedure. Regulatory requirements include CTD submission, RMP, PSURs, and strict pharmacovigilance. For regulatory guidance, dossier support, or global B2B sourcing, visit PharmaTradz.com.

Linagliptin + Metformin Ir & Xr Tablets — third party manufacturing & bulk supply

Linagliptin + Metformin Ir & Xr Tablets is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:

Wholesale / bulk supply Stock or scheduled supply from an existing manufacturer. The fastest route where the product is already registered in your market.

Third party manufacturing Manufactured to your specification and packed under your own brand and label — suits distributors and brand owners building a portfolio in their market.

Dossier licensing Where a CTD, EU-CTD or ACTD dossier exists it can often be licensed for filing in your name, compressing market entry from years to months.

Indicative minimum order quantity

Linagliptin + Metformin Ir & Xr Tablets is supplied as Tablets(IR & XR) — supplied in more than one dosage form, each with its own manufacturing economics, so the indicative MOQ is a minimum order value of USD 5,000 per product. Actual MOQ is confirmed by the allocated manufacturer against your pack presentation and destination market. See full supply terms for dossier formats, market availability and shelf life.

Manufacturers of Linagliptin + Metformin Ir & Xr Tablets listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding.

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Frequently Asked Questions

Linagliptin + Metformin IR & XR Tablets is listed as Tablets(IR & XR) in 2.5 mg / 1000 mg, 2.5 mg / 850 mg, 2.5 mg / 500 mg. Further strengths and pack presentations are confirmed with the manufacturer at RFQ stage.

Linagliptin + Metformin IR & XR Tablets is referenced against Jentadueto® / Jentadueto XR®. Reference brands are shown for identification only and remain the property of their respective trademark owners.