C2 Pharma (C2P), a Luxembourg-based phytochemical and chemical pharmaceutical manufacturing and distribution group, has continued to build its active pharmaceutical ingredient (API) and botanical extracts product portfolio. The most recent addition enhances the previously announced Digoxin API product offer with the inclusion of a micronised grade for Digoxin from two different manufacturing sites.
Multiple niche APIs and botanical extract products are also currently in technical transfer or under development, including Cannabidiol (CBD) and Tetrahydrocannabinol (THC).
Filings
C2P has followed through on plans to file for the US drug master file (US-DMF) of Digoxin (Micron) manufactured at its partner and contract manufacturing organization (CMO) site Laurus labs in India at the end of October. Plans are further confirmed for filing the CEP (Certificate of Suitability to the monographs of the European Pharmacopoeia) by the end of November 2019.
Digoxin (Micron 10), the cardiac glycoside extracted from the leaves of the foxglove plant Digitalis lanata, is being manufactured at a CMO site Nobilus in Poland, the validation campaign has been successfully completed and the US-DMF and the CEP fillings are planned for the first half of 2020. Samples for micronised Digoxin from both sites are currently available.
"The micronised grade of digoxin API has been developed to meet stringent specifications for particle size distribution less than 10 μm. These two APIs will integrate C2P's existing portfolio of four different grades of Digoxin API, including our injectable one." said Andrew Badrot, C2P's CEO.
Securing supply
Badrot explained that this extension is part of the company's long-term plan to act as responsible stewards of the Digoxin API and secure the supply chain for this complex and essential API by offering a redundant and fully independent supply chain via two CMO manufacturing sites, one at Nobilus in Poland and one at Laurus Labs in India.
As the team works to continuously expand the API product portfolio, C2P has confirmed the successful validation campaign of Homatropine Hydrobromide. Samples are available and regulatory fillings will follow in mid-2020.
Future work
C2P has also revamped its R&D product pipeline and is actively working on six tech transfers, an additional five APIs in various phases of development and 19 APIs are in early feasibility.
"In addition to the Digoxin and Homatropine expansion, we have a full portfolio of API and botanical extracts that are coming to market with our high-quality virtual manufacturing approach, which is currently unmatched in the industry. Our CBD franchise is progressing, and we are ramping up for commercial production of CBD as an API," added Badrot.
