C2 PHARMA, a company that manufactures and supplies ophthalmic and niche active pharmaceutical ingredients (APIs), reported the approval of a C-Drug Master Filing (DMF) for Digoxin, an API manufactured by its Polish manufacturing partner Nobilus Ent. The milestone comes after what the company calls, a challenging three-year journey, due to global disruptions caused by the Covid pandemic.

The approval covers both Digoxin and Digoxin micronized. 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 commercialize 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.  “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 filing approval process required rigorous stages of reviews and constant communication with the local Chinese authorities and demonstrates we are fully compliant with Chinese quality standards. The support of our 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.