CPhI 2017: Centroflora CMS gains CEP approvals and invests in Digoxin manufacturing facility in India
- CEP approval for atropine sulfate; availability of US-DMFs for reference for both atropine sulfate and homatropine methylbromide.
- Investment in a dedicated digoxin manufacturing facility at CMO Laurus Labs, India.
Luxembourg, October 2, 2017 – Centroflora CMS (booth Hall 11, Level 0, B40) is announcing major expansions of its service offering in the run-up to the CPhI Worldwide exhibition in Frankfurt am Main, Germany on 24 – 26 October 2017.
- Atropine sulfate and homatropine methylbromide:
Centroflora CMS 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 (active pharmaceutical ingredients) manufacturers in India. The approval was received in just 12 months. The US-DMF for atropine sulfate has been available for reference since January 2017. For homatropine methylbromide, CEP approval is expected by year-end and the US-DMF has been available for reference since May 2017. Samples and a full set of reference standards for both atropine sulfate and homatropine methylbromide are available upon request
Centroflora CMS 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 Centroflora CMS will market the API. The total investment from both parties exceeds USD 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 manufacturing building was erected in May 2017 and the manufacturing equipment has been installed. Equipment qualification and validation is currently under way and should be concluded by the end of Q4, 2017. “This investment marks a major development in our global API offering and underline our uncompromising approach to product quality and reliability,” said Andrew Badrot, CEO of Centroflora CMS.