C2 Pharma Expands API Portfolio
Adds Digoxin micronized grade, Homatropine Hydrobromide and multiple products under tech transfer and development.
C2P has followed through on plans to file for the U.S. 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. For the Digoxin (Micron 10), manufactured at 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 micronized Digoxin from both sites are currently available.
“The micronized 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, chief executive officer, C2P. “This extension is part of our 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 our customers 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.
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.
Mr. Bardot added, “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.”