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Sigachi Industries' Trimax Biosciences Becomes CEP for Metformin, Seeks Europe Exports as Global Market to Reach $386.91 Million by 2030


Updated: May 07, 2025 12:53

Image Source: PharmaCompass.com
Sigachi Industries Ltd has made a huge stride in the international pharmaceutical industry with its affiliate, Trimax Biosciences, obtaining the Certificate of Suitability (CEP) for Metformin Hydrochloride. This regulatory achievement lays the groundwork for Trimax to market its Active Pharmaceutical Ingredient (API) to Europe and other CEP-accepting regions, setting the company up for strong global expansion as the international metformin market is set to hit $386.91 million by 2030.
 
CEP Approval for Metformin Hydrochloride:
Trimax Biosciences, a part of Sigachi Industries, has attained the highly coveted Certificate of Suitability (CEP) from the European Directorate for the Quality of Medicines & Health Care (EDQM) for its Metformin Hydrochloride API. This approval is an essential prerequisite for supplying APIs to regulated markets in Europe and a number of other nations, guaranteeing compliance with the highest standards of quality and safety.
 
Access to Lucrative European and CEP Markets:
With the CEP in hand, Trimax can now export Metformin Hydrochloride to Europe and all countries that recognize the CEP, opening up significant business opportunities in highly regulated and high-value markets. This aligns with Sigachi’s strategy to expand its global footprint and strengthen its presence in the pharmaceutical supply chain.
 
Global Metformin Market Growth:
The worldwide metformin hydrochloride market is anticipated to increase from $268.95 million in 2022 to $386.91 million by 2030, growing at a CAGR of 4.7%. The growth is fueled by the increasing rate of type 2 diabetes, rising healthcare spending, and increasing use of metformin as a first-line drug for diabetes.
 
Adherence to Quality and Innovation
Sigachi Industries stands out in its pursuit of product development, research, and development alongside adhering to international standards. The CEP success of Metformin Hydrochloride reinforces the company even more in having the capability of supplying high-quality APIs and excipients to over 62 international nations.
 
Commentary from a leader
Amit Raj Sinha, Managing Director and CEO of Sigachi Industries, called the CEP approval “a testament to Trimax Biosciences’ commitment to quality, compliance, and innovation in the API domain,” adding that it strengthens Sigachi’s position as a reliable global pharmaceutical partner.
 
Market Outlook
With the global metformin market trending steadily upwards and regulatory entry points open for Europe, Sigachi Industries and Trimax Biosciences are poised to grab new diabetes care segment opportunities. The firm's ongoing focus on innovation, compliance, and quality will ensure long-term growth and value creation for stakeholders.
 
Source: Zion Market Research, Data Bridge Market Research, DSIJ, Sigachi Industries Annual Reports

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