Here's your pharma manufacturing news of note.
Biocon has resolved FDA concerns about a plant in India, setting it and Mylan up to potentially win FDA approval for the first Herceptin biosimilar.
Three major regulatory bodies – FDA, EMA and Health Canada – changed their guidelines to drug naming. How could these changes impact drug launch timelines?
With a U.S. saline shortage intensifying, the FDA is getting Baxter preferential treatment in having power restored to saline plants in Puerto Rico.
B. Braun, one of three main saline suppliers, is closing a plant for maintenance, a move it acknowledges will make a bad supply situation worse.
Lupin has been trying for two years to bring its plant in Goa, India, up to FDA standards, but a new warning letter says more improvements are needed.
Pfizer bowed out of a troubled joint venture with China's Hisun Pharma, which sells branded generic drugs in China.
The FDA has slapped a warning letter on a Chinese company that shipped multiple lots of an OTC product to the U.S. that contained the wrong API.
A Danish medicines repackager has again had its manufacturing certificate yanked by regulators just months after it said it had resolved its problems.
India’s Lupin has received a warning letter for two of its plants in India, one which it is key to launching new drugs in the U.S.
AmerisourceBergen's costs to resolve federal litigation tied to syringe sold from an unregistered facility may reach $835 million