News

Eli Lilly has doubled down on its partnership with CDMO Resilience as the companies plan to invest $750 million to increase production of Lilly’s KwikPen injectable device for its diabetes and obesity

Baxter issued a voluntary recall of one lot of cefazolin in dextrose injection after a report that cardboard was found in an IV infusion bag.

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.