Defining the steps involved in a successful technology transfer process would benefit biopharma, say the researchers behind a “generic” blueprint intended to help drug makers move more easily from ...

President Trump wants pharmaceutical production to return to the United States. A shuttered factory in Louisiana shows how hard that will be for generic medicines. Dr. Reddy’s, an Indian generic ...

Stakeholders offered a wide range of applications for AI technology in the pharmaceutical manufacturing regulatory framework, including Chemistry, Manufacturing, and Controls (CMC) development, ...

The U.S. Food and Drug Administration has awarded the National Institute for Pharmaceutical Technology and Education a grant worth up to $35 million over the next five years to improve drug ...

BOCA RATON, Fla.--(BUSINESS WIRE)--LGM Pharma, a leading provider of tailored API and CDMO services for the full drug product lifecycle, today announced an investment of over $6 million to expand its ...

Can the quality of generic drug applications to the US Food and Drug Administration (FDA) be improved, and if so, what can regulators do to improve it? So asks FDA in a new Federal Register notice ...

From its 17-year development cycle through to its commercial launch, production has always been in Yeztugo’s DNA. And, for the twice-yearly pre-exposure prophylaxis (PrEP) medication—which Gilead ...