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Luxembourg-based company, C2 Pharma (C2P), has expanded its API and botanical extracts product portfolio with digoxin micronized grade and homatropine hydrobromide, and has multiple products under tech transfer and in development.
According to a Nov 4, 2019 press release, Luxembourg-based company, C2 Pharma (C2P), has expanded its API and botanical extracts product portfolio with digoxin micronized grade and homatropine hydrobromide, and has multiple products under tech transfer and in development.
The company’s 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, were achieved at the end of October 2019. By the end of November 2019, the company also has plans to complete filing the CEP (Certificate of Suitability to the monographs of the European Pharmacopoeia). In Poland, the company’s Nobilus site, where digoxin (micron 10) is manufactured, has successfully completed its validation campaign, and the company will be filing for US-DMF and CEP in the first half of 2020.
“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, C2P’s CEO in the press release. “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.”
Additionally, C2P has announced the successful validation campaign of homatropine hydrobromide, samples of which are now available and regulatory filings anticipated to follow in 2020. The company is also working on six tech transfers, a further five APIs in various phases of development, and 19 APIs in early development.
“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 cannabidiol (CBD) franchise is progressing, and we are ramping up for commercial production of CBD as an API,” added Badrot.