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Metformin
HCl

To guarantee the highest purity and efficacy, we adhere to strict global standards

HUMAN API

Metformin HCL Powder

Metformin Hydrochloride is the First-line Active Pharmaceutical Ingredient (API) for the treatment of Type 2 Diabetes Mellitus. It belongs to the Biguanides class. It is highly valued for its efficacy in improving insulin sensitivity without causing weight gain or severe hypoglycemia. We supply Metformin HCl as a white crystalline powder, suitable for manufacturing both immediate-release and extended-release tablets.

The product conforms to the specified requirements of the United States Pharmacopeia (USP), European Pharmacopoeia (EP), and/or British Pharmacopoeia (BP).
A detailed CoA is issued with every batch, outlining potency, purity profile, and microbiological testing verification.
A comprehensive Drug Master File is available to support registration submissions to regulatory authorities worldwide.
Production takes place in certified facilities that strictly adhere to current Good Manufacturing Practices (cGMP).
Therapeutic Class:
Oral Hypoglycemic Agent (Antidiabetic).
Mechanism of Action:
Primarily reduces hepatic glucose production (Gluconeogenesis), improves muscle and tissue sensitivity to insulin, and enhances peripheral glucose uptake.
Clinical Application:
Long-term management of Type 2 Diabetes, often used as monotherapy or in combination with other antidiabetic agents.
Competitive Advantage:
A historically proven, safe, and effective API that forms the foundation of global diabetes treatment protocols.
Immediate-Release (IR) Tablets

Standard tablets taken two or three times daily.

High powder quality ensures rapid dissolution and good bioavailability.

Extended-Release (ER/XR) Tablets

Controlled/Sustained Release tablets for once-daily dosing.

API powder supplied with uniform flow and compressibility characteristics, essential for granulation and compression processes used in ER formulations.

Fixed-Dose Combinations (FDCs)

Tablets combining Metformin with other antidiabetic drugs (e.g., DPP-4 inhibitors).

Excellent compatibility with a wide range of excipients and other APIs in co-formulated tablets.

Regulatory Compliance

The product conforms to the specified requirements of the United States Pharmacopeia (USP), European Pharmacopoeia (EP), and/or British Pharmacopoeia (BP).

Certificate of Analysis (CoA)

A detailed CoA is issued with every batch, outlining potency, purity profile, and microbiological testing verification.

Drug Master File (DMF)

A comprehensive Drug Master File is available to support registration submissions to regulatory authorities worldwide.

Manufacturing Operations

Production takes place in certified facilities that strictly adhere to current Good Manufacturing Practices (cGMP).

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