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Sigachi Industries Ltd arm receives CEP from EDQM for Propafenone Hydrochloride

Posted On: 2024-12-01 18:54:35 (Time Zone: IST)


Sigachi Industries Limited is pleased to announced that Trimax Biosciences Pvt Ltd, A Sigachi Group Company has received a communication from European Directorate for the Quality of Medicines & Health Care ("EDQM") on its latest CEP Filing submission of "Propafenone Hydrochloride". Achieving the Certificate of Suitability for this API will enable the company to export this product in Europe and other CEP accepting countries. This is a significant step towards ensuring European regulatory standards and highest levels of product quality and safety. It will also strategically diversify Sigachi's revenue channels to enhance greater value for all stakeholders involved.

- Propafenone Hydrochlride, widely used in the treatment of cardiac arrhythmias, is a highdemand API with a current global market size of USD 1.2 billion.

- The market is poised for robust growth, with projections reaching USD 2.1 billion by 2032, reflecting a CAGR of 7% over the forecast period. This growth is driven by the increasing prevalence of cardiovascular diseases, growing adoption of generic medications, and rising healthcare expenditure globally.

- The company is committed in delivering excellence though advanced manufacturing capabilities and catering needs of highly regulated markets, including the EU ensuring compliance and highest quality standards.

Commenting on this development, Amit Raj Sinha, Managing Director and CEO of Sigachi Industries Limited stated "The submission of our first CEP filing is a testament to Trimax Biosciences' commitment to quality, compliance, and innovation in the API domain. This achievement not only strengthens our position in the pharmaceutical supply chain but also aligns with our vision of providing reliable and sustainable pharmaceutical solutions on a global scale."


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