Jinyao Pharmaceutical (SHA:600488) has obtained a DMF or drug master files letter from the US Food and Drug Administration for its Deflazacort API, according to a Wednesday filing on the Shanghai Stock Exchange.
Deflazacort is an active pharmaceutical ingredient widely used to treat Duchenne muscular dystrophy. The global market for Deflazacort preparations is estimated to have reached $106 million in 2023, Jinyao said.
The FDA's approval of Jinyao Pharmaceuticals' DMF indicates that the company's Deflazacort API meets the quality standards required for use in the US.
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