Metformin Hydrochloride

Metformin Hydrochloride is manufactured in BP, EP, USP and IP grades and is supported by comprehensive regulatory documentation, including EDMF/CTD and CEP.

The product is manufactured under WHO-GMP compliant quality systems, supported by ISO certification and valid manufacturing licenses, enabling supply to customers across multiple regulated markets.

With a manufacturing capacity of 1,400 MT/month (16,800 MT/year), Metformin Hydrochloride is one of our high-volume products, offering strong supply security and the ability to support large and long-term customer requirements.

Our manufacturing process is designed to provide robust control of critical quality attributes. NDMA is not detected in the product based on our established testing and process controls. Impurity F is stringently controlled through defined process parameters and in-process monitoring.

Known and unknown impurities are monitored at relevant stages of manufacturing using advanced analytical techniques, including HPLC and UPLC, supporting consistent quality and batch-to-batch reproducibility.

Flexible batch sizes of 2 MT, 4 MT and 6 MT provide additional flexibility for production planning and customer-specific requirements.