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Manufacturing
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Qilu Makes NDA Breakthrough in the U.S. Market
Release time：
2026-06-30
In June, Fosaprepitant Dimeglumine for Injection was shipped to the U.S., which is Qilu’s first FDA-approved product through the NDA pathway. Filed as an NDA for a new formulation, this antiemetic expands Qilu’s global strategy from ANDA to NDA. Earlier this year, the fifth-generation cephalosporin, Ceftaroline Fosamil for Injection, was debuted as the first U.S. generic. Through patent challenge, it launched five years prior to patent expiration.
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