Sigachi Industries announced that its subsidiary, Trimax Biosciences, has successfully obtained a Certificate of Suitability (CEP) for metformin hydrochloride from the European Directorate for Quality of Medicines & Health Care (EDQM). This regulatory milestone enables the company to export this widely-used active pharmaceutical ingredient (API) to European markets and other regions that recognize the certification.
The achievement represents a significant advancement in Sigachi's global market strategy, particularly for penetrating highly regulated pharmaceutical markets where quality and compliance standards are stringent.
Strategic Market Expansion
Metformin hydrochloride serves as a first-line therapy for type 2 diabetes management worldwide. Market projections indicate the API will grow to USD 386.91 million by 2030, with a compound annual growth rate (CAGR) of approximately 4.7% over the forecast period.
"This achievement aligns perfectly with our vision of expanding into highly regulated markets and strengthening our position in the global pharmaceutical industry," said Amit Raj Sinha, Managing Director and CEO of Sigachi Industries Limited. "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."
Clinical Significance and Applications
The importance of metformin in diabetes treatment is underscored by numerous FDA-approved fixed-dose combinations (FDCs) incorporating the drug. These include Glucovance (glibenclamide + metformin), Janumet (sitagliptin + metformin), Kombiglyze XR (saxagliptin + metformin), and Invokamet (canagliflozin + metformin), among others.
These combination therapies highlight metformin's versatility and central role in diabetes management protocols across different patient populations and treatment approaches.
Regulatory Implications
The CEP certification confirms that Trimax's manufacturing process for metformin hydrochloride meets European Pharmacopoeia standards. This certification serves as evidence of the company's compliance with Good Manufacturing Practices (GMP) and demonstrates the safety and efficacy of their API production methods.
For pharmaceutical manufacturers in Europe, this certification provides assurance that Sigachi's metformin hydrochloride meets the quality requirements necessary for inclusion in medicinal products intended for human use within the European market.
Manufacturing Capabilities
The certification reinforces Sigachi's technical capabilities in producing high-quality pharmaceutical ingredients that meet international standards. The company's investment in quality control systems and manufacturing infrastructure has positioned it to serve markets with the most demanding regulatory requirements.
This development is expected to strengthen Sigachi's competitive position in the global API market, particularly as healthcare systems worldwide continue to address the growing prevalence of type 2 diabetes and related metabolic disorders.
