C2 Pharma gains CEP approval and invests in Digoxin manufacturing

C2 Pharma (formerly Centroflora CMS) is announcing major expansions of its service offering in the run up to the CPhI Worldwide exhibition in Frankfurt, Germany, on 24–26 October 2017, stand 110B40

C2 Pharma is a Luxembourg-based pharmaceutical group which manufactures and distributes its active pharmaceutical ingredients (API) and complex chemical compounds from phytochemical and chemical origins.

Atropine sulfate and homatropine methylbromide

C2 Pharma has recently received from EDQM the Certificate of Suitability (CEP) for the production of atropine sulfate at its CMO, Laurus Labs, one of the best known API manufacturers in India.

The approval was received within 12 months. The US-DMF for atropine sulfate has been available since January 2017. For homatropine methylbromide, CEP approval is expected by year-end and the US-DMF has been available since May 2017. Samples and a full set of reference standards for both atropine sulfate and homatropine methylbromide are available upon request.

Digoxin

C2 Pharma has invested in a state-of-the art, dedicated production facility for the manufacturing of digoxin at the Laurus Labs site in Vizag. Laurus Labs will run the facility and C2 Pharma will market the API.

The total investment from both parties exceeds $5 million, and the facility, which covers an area of more than 1800 m2, will have an annual production output of more than 1000 kg, well in excess of the global demand for digoxin. The building was erected in May 2017 and the manufacturing equipment has been installed. Equipment qualification and validation is currently under way and should be wrapped up by the end of Q4, 2017.

Andrew Badrot, CEO of C2 Pharma, said:

This investment marks a major development in our global API offering and underline our uncompromising approach to product quality and reliability

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C2 Pharma (more information, website)