Big pharmaceutical companies are boosting their production capacity of branded medications with billions of dollars in new U.S. manufacturing plant construction, but generic drug production still ...

India’s Hikal Limited has been hit with an FDA warning letter chiding the drug ingredients manufacturer for failing to uncover the cause of dozens of complaints of metal contamination in its products.

The same company whose infant formula is now under recall in relation to an outbreak of botulism poisoning cases recalled its product in 2022 because of contamination with cronobacter. And, in 2023, ...

A U.S. representative is pressing the FDA for information about ByHeart Inc., the company linked to an outbreak of infant botulism poisonings. In a letter to FDA Administrator Marty Makary, Rep. Rosa ...

“Our customers, in partnership with federal and state agencies, are reshoring drug manufacturing in the U.S., the world’s largest pharmaceutical market. Local API production is vital for supply chain ...