API manufacturer C2 PHARMA has announced the approval of a C-DMF for Digoxin, an API by the company's Polish manufacturing partner Nobilus Ent.
This milestone comes after a challenging three-year journey, due to global disruptions caused by the Covid pandemic.
The approval covers both Digoxin and Digoxin micronised. It supports different dosage forms i.e. oral and injectable drug product formulations. Digoxin is derived from the leaves of the Digitalis lanata plant and as a cardiac glycoside, it is commonly used in clinical practice for the treatment of mild to moderate heart failure.
“As a result of this approval, we can now commercialise Digoxin in China. The Chinese customers that have received samples or quantities for exhibit batches of Digoxin can now apply using the API for their finished dosage form,” said Katrien Oosterom, Vice President of Regulatory Affairs.
The Chinese customers that have received samples or quantities for exhibit batches of Digoxin can now apply using the API for their finished dosage form
- Katrien Oosterom, Vice President of Regulatory Affairs
This filing approval process required rigorous stages of reviews and constant communication with the local Chinese authorities and demonstrates full compliance with Chinese quality standards. The support of manufacturing partner and our local Chinese agent were critical to our success. “Made in EU- sold in China is now a reality," said Regulatory Manager Anastasia Motorina.
Oosterom continued: “For China, this implies that another international source of Digoxin will now enter the market and C2 PHARMA now holds the registration of the only European manufactured Digoxin, an achievement that not only expands our global reach, but also marks a stride towards providing access to high-quality medication for local patients.”
The news arrives at an opportune moment on the eve of CPHI Shanghai from the 19-21 June 2023. Mitch Denny, Senior Vice President of Business Development, Asia Pacific, will be representing C2 PHARMA at this year’s event.
