Product/Composition:- | Metformin Hcl IR tablets |
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Strength:- | 500 mg, 850 mg, 1000 mg |
Form:- | IR Tablets |
Reference Brands:- | Glucophage®, Riomet®, Sandoz Metformin®(US & EU) |
MOQ | As per the manufacturer batch size |
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Metformin IR reduces hepatic glucose production and improves insulin sensitivity by activating AMP-activated protein kinase (AMPK). It does not stimulate insulin secretion, reducing the risk of hypoglycemia. Benefits include effective blood glucose control, weight neutrality, and cardiovascular protection, making it a first-line therapy for type 2 diabetes management.
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.