C2 Pharma validates the manufacturing process of two APIs and enters into a strategic partnership with Theracule

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The Luxembourg pharmaceutical group C2 Pharma (formerly known as Centroflora CMS) has successfully validated the manufacturing process for two APIs, digoxin and digoxin micron.

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

In May 2017, C2 Pharma has invested in a dedicated production facility at the site of contract manufacturing organization, Laurus Labs, located in Vizag, India, for the manufacture of digoxin. The overall investment in the facility has reached almost 10 million dollars (8.7 million euros) and should have an annual production that will be able to cover the worldwide demand for digoxin.

“Within 24 months, C2 Pharma and Laurus Labs were able to complete construction of civil works, install and validate manufacturing equipment, design and validate the manufacturing process, and prepare for regulatory filing for both APIs,” said Andrew Badrot, CEO of VS2 Pharma, in a statement. “It’s an amazing performance and a testament to the partnership that exists between the two companies.”

Additionally, the company disclosed that it is entering into a strategic partnership with Theracule that will focus on supporting Theracule’s novel drug development programs for rare neurodevelopmental disorders. These drug development programs are based on a plant-derived API and botanical extract, which was specifically manufactured for Theracule by C2 Pharmacy.

Following this, C2 Pharma will lead the seed funding that will fund Theracule’s operations for the next 12 to 18 months. “The partnership with C2Pharma goes beyond the financial backing that a typical seed investor would provide,” said Dr. Ana Mingorance, co-founder of Theracule, in a press release. “We also get the best botanical extracts and GMP-compliant APIs, regulatory support, analytical science support through ASM Research Chemicals, and backing from 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 novel botanical extract and plant-derived APIs to treat rare diseases. Theracule’s funding team has extensive expertise in the development of novel drugs for rare neurological disorders. With C2 With Pharma’s manufacturing and technical capabilities, we have a “dream team” that will deliver exceptional results. »

VS2 Pharma will be available at CPhI Worldwide in Madrid, Spain, Hall 6, Stand F40.

Source: C2 Pharmacy

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