Sigachi Industries Limited has informed the Exchange regarding a press release dated May 07, 2025, titled "Trimax Biosciences Pvt Ltd, A Sigachi Group Company has successfully achieved the Certificate of Suitability (CEP) for Metformin Hydrochloride from European Directorate".
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Sigachi Industries announced that its group company Trimax Biosciences has received the Certificate of Suitability (CEP) for Metformin Hydrochloride from the European Directorate for the Quality of Medicines & Health Care (EDQM) on May 5, 2025. This certification allows Trimax to export this active pharmaceutical ingredient (API) to European markets and other CEP-accepting regions. Metformin Hydrochloride is a widely used first-line treatment for type 2 diabetes, with the global market projected to reach USD 386.91 million by 2030 at a CAGR of around 4.7%. The certification strengthens Sigachi's presence in highly regulated pharmaceutical markets and aligns with its strategy to meet EU standards for safety, efficacy, and GMP compliance. Trimax's Raichur, Karnataka facility is already USFDA-approved and complies with cGMP, EMEA, and WHO-GMP guidelines.
This is a positive development for Sigachi shareholders as it opens up new revenue opportunities in Europe and other regulated markets for a high-demand diabetes drug, potentially boosting export earnings and supporting the company's growth in the pharmaceutical API segment. Investors should monitor actual order inflow and revenue contribution from European markets in upcoming quarters.