Metformin Hcl Ir Tablets

Form: IR Tablets

Strength: 500 mg, 850 mg, 1000 mg

Reference Brands: Glucophage®, Riomet®, Sandoz Metformin®(US & EU)

Category: Diabetes

Metformin Immediate-Release (IR) Tablets are widely approved in the USA (ANDA pathway) and EU (generic via Article 10) for type 2 diabetes management. Regulatory submissions must include full bioequivalence studies, stability data, and impurity profiling per ICH guidelines. EU submissions may also require environmental risk assessments. In the US, products must comply with USP standards and be supported by Drug Master Files (DMFs). EU dossiers may follow ASMF or CEP formats. Metformin IR is also listed under the WHO Essential Medicines List. To source compliant dossiers or manufacturing partners, visit Pharmatradz.com for global B2B pharma solutions.