C2 Pharma Validates Manufacturing Process for Two APIs and Enters Strategic Partnership with Theracule

Luxembourg-based pharmaceutical group, C² Pharma (formerly known as Centroflora CMS) has announced the successful validation of its manufacturing process for two APIs-digoxin and digoxin micron.

In May 2017, C² Pharma invested in a dedicated production facility at the contract manufacturing organization’s, Laurus Labs site located in Vizag, India, for the manufacture of digoxin. Overall investment in the facility has reached nearly $10 million (EUR 8.7 million) and is expected to have an annual production output that will be able to cover the global demand for digoxin.

“Within 24 months, C² Pharma and Laurus Labs have been able to complete the construction of the civil works, install and validate the manufacturing equipment, design and validate the manufacturing process, and prepare the filing for the regulatory dossier for the two APIs,” said Andrew Badrot, CEO of C² Pharma, in a press release. “This is an astonishing performance and a testament to the partnership that exists between the two companies.”

Additionally, the company has revealed that it is entering into a strategic partnership with Theracule that will focus on supporting Theracule’s new drug development programs, aimed at rare neurodevelopmental disorders. These drug development programs are based on a plant-derived API and a botanical extract, which has been specifically manufactured for Theracule by C² Pharma. 

Further to this, C² Pharma will lead the seed funding that will finance Theracule’s operations for the next 12–18 months. “The partnership with C²Pharma goes beyond the financial support that a typical seed round investor would deliver,” said Dr Ana Mingorance, co-founder of Theracule, in a press release. “We also get best GMP-compliant botanical extracts and APIs, regulatory support, analytical sciences support through ASM Research Chemicals, and the backing of one of the leading API companies in the phytochemical field.”

Andrew Badrot, CEO of C² Pharma, added, “We are excited to work with Theracule and help them develop a new botanical extract and plant-derived APIs to treat rare diseases. Theracule’s funding team have a wealth of expertise in new drug development for rare neurological disorders. With C² Pharma’s manufacturing and technical capabilities, we have a ‘dream team’ that will deliver outstanding results.”

C² Pharma will be available at CPhI Worldwide in Madrid, Spain, in Hall 6, Booth F40.

Source: C2 Pharma