News - Page 3

The FDA slammed a pair of India-based API manufacturers in separate warning letters outlining poor record-keeping, problems maintaining sanitation and licensing issues, among other observations.

Aerospace technology company Redwire—which has partnered with BMS and Eli Lilly to test drug development and manufacturing in space—has opened a new 30,000-square-foot research and microgravity payload development facility in Indiana.

South Korean contract manufacturer Samsung Biologics has tapped into the booming peptide production and weight loss market with plans to buy out Switzerland-based CDMO PolyPeptide for 1.46 billion Swiss francs ($1.8 billion).

Zhejiang Huahai Pharmaceutical has hired a former FDA staffer as its new chief quality officer, as the company struggles to resolve compliance issues with the FDA at a key manufacturing facility.

A bipartisan bill reintroduced by three senators aims to increase transparency around foreign influence on the United States’ drug supplies, marking a potential first step to imposing restrictions.

The FDA has proposed a streamlined pathway for registering production facilities that operate under a “hub-and-spoke” model. The agency has also proposed clarifying the registration requirements for foreign manufacturers, especially those who

Lupin Pharmaceuticals, the U.S. unit of India’s Lupin Limited, issued a voluntary recall of more than 2.5 million bottles of prednisolone acetate ophthalmic suspension after an undisclosed contaminant was discovered.

When launching a drug as big as semaglutide, even as a generic, expectations are immense. Any fumble by a manufacturer can take a toll.

Catalent is shedding one of its U.K. manufacturing facilities as it inks a separate partnership deal to advance a new gene therapy, expanding in certain areas while scaling back in others.

While not on the same scale of some of Big Pharma’s major carveouts in recent years, the deal follows a noticeable pattern in which diversified drugmakers have simplified their structures to focus