A push to reshore some drug production and progress in advanced manufacturing technologies have been prominent trends this year, industry leaders say.

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 ...

Drug Substance manufacturing is a critical component of pharmaceutical production, requiring precise processes, rigorous quality control, and innovative solutions to overcome various challenges. 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 ...

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 ...

While much of the conversation around the Trump administration’s potential pharmaceutical import tariffs has leaned heavily toward branded drugmakers, generic medicines and the companies that ...

An international team of researchers led by the University of California San Diego has developed a new strategy to enhance ...

Representatives of companies including AbbVie, Eli Lilly, Johnson & Johnson and Merck have voiced concerns about the FDA’s ...

Learn how an Abbreviated New Drug Application (ANDA) helps generic drugs get FDA approval without clinical trials, ensuring safety and bioequivalence with brand-name drugs.

Developing high-quality, safe, and effective drugs is a complex process that requires varied scientific skills and stringent regulatory assessments. Drug development is a process that spans many years ...