Sigachi Industries receives CEP for Metformin Hydrochloride from EDQM

The CEP certification for Metformin Hydrochloride aligns with the company's strategy to penetrate stringently regulated markets

Sigachi Industries Limited has announced that that Trimax Biosciences, a Sigachi Group Company has successfully achieved the Certificate of Suitability (CEP) for "Metformin Hydrochloride" from European Directorate for the Quality of Medicines & Health Care ("EDQM"). This milestone paves the way for Trimax to export this crucial Active Pharmaceutical Ingredient (API) to Europe and other CEP-accepting markets, further strengthening Sigachi's presence in highly regulated pharmaceutical markets

Metformin Hydrochloride, a widely used first-line therapy for type 2 diabetes management, is expected to grow to USD 386.91 million by 2030, with a compound annual growth rate (CAGR) of roughly 4.7% over the forecast period.

The U.S. Food and Drug Administration (USFDA) has approved multiple Metforminbased FDCs, including Glucovance (glibenclamide + metformin), Actoplus Met (pioglitazone + metformin), Janumet (sitagliptin + metformin), Kombiglyze XR (saxagliptin + metformin), Jentadueto (linagliptin + metformin), Oseni (alogliptin + pioglitazone), Invokamet (canagliflozin + metformin), and Xigduo XR (dapagliflozin + metformin). These approvals highlight the widespread acceptance and significance of Metformin-based therapies in diabetes treatment.

The CEP certification for Metformin Hydrochloride aligns with the company's strategy to penetrate stringently regulated markets, reinforcing Sigachi's capability to meet EU standards for safety, efficacy, and GMP compliance.

Commenting on this development, Amit Raj Sinha, Managing Director and CEO of Sigachi Industries Limited stated "This achievement aligns perfectly with our vision of expanding into highly regulated markets and strengthen our position in the global pharmaceutical industry. With the rising demand for Metformin-based therapies, Sigachi is committed to leveraging its R&D expertise and state-of-the-art facilities to deliver pharmaceutical solutions that meet international standards and address the dynamic needs of the healthcare sector."