A Glenmark plant in Baddi has been cited by the FDA for a variety of problems including questions on the unauthorized destruction of quality records.
The public advocacy group Public Citizen has petitioned the FDA to ban an API that it says agency reviewers determined posed safety risks to patients.
Three major regulatory bodies – FDA, EMA and Health Canada – changed their guidelines to drug naming. How could these changes impact drug launch timelines?
CSL has opened the first phase of a $170 million plasma products plant in Australia that will add 200 jobs to the 1,000 already at the site.
China’s WuXi Biologics says its new $150 million, 30,000-liter capacity biologics plant is up and running, a feat it accomplished in less than three years.
Contractor ADC Biotechnology is moving quickly to get a manufacturing facility built in Wales to produce its new ADCs.
CDMO Albany Molecular Research Inc., which was recently acquired by private investors, has bulked up its aseptic API capacity.
A U.S. unit of Japan’s Daiichi Sankyo that makes sterile injectable drugs will invest $145 million to expand facilities in Ohio, adding 80 jobs in the process…
Already dealing with a saline shortage, the FDA now says IV feeding products are scarce after the hurricane damaged plants in Puerto Rico.
Mylan and Biocon today became the first drugmakers to win an FDA approval of a biosimilar of Roche's blockbuster cancer drug Herceptin.
German regulators have signed off on a corrective and preventive action plan for one of Dr. Reddy’s formulation production facilities in India.