Growth in the generic sterile manufacturing industry has spawned a series of big buyouts in the last few years, and Germany’s Fresenius is looking to M&A…

The FDA has nailed India's Indoco with a warning letter for a sterile and solid dose plant in Goa because of its concerns over an injected drug.

London-based private equity firm Permira is buying out Lyophilization Services of New England (LSNE).

Just as the furor over pricing had died down, the EpiPen is back in the spotlight with Mylan recalling more than 80,000 of the injectors.

With expanded capacity in the U.S., the CEO of Patheon says the CDMO is in good position if the Trump administration were to impose a border tax on drugs.

The FDA last month issued a warning letter to Pfizer for a sterile injectables plant in Kansas. Now the FDA has posted details of the inspection that led to…

The FDA has sent Pfizer a warning letter for a former Hospira plant in McPherson, Kansas, for repeating some of the mistakes noted in earlier warning letters.

The Pfizer fill-finish plant whose manufacturing problems have gut-punched the expected approval of a generic of Teva’s long-acting Copaxone is a former…

The FDA has banned products from an Australian company's plant in Guangzhou, China, and cited it with “significant violations” of cGMP regulations saying…

Outsourcing