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China’s Food and Drug Administration (CFDA) is renewing its push to have all manufacturers of blood products, vaccines and sterile injectables obtain a revised good manufacturing practices (GMP) certificate. Read More
Japan’s national drug regulator has asked drugmakers to submit information on stability monitoring and water purity, in addition to existing requirements, when they apply for mandatory post-approval GMP inspections. Read More
Ranbaxy’s regulatory woes deepened last month as the FDA prohibited the drugmaker’s Toansa, India, plant from manufacturing and distributing active pharmaceutical ingredients (APIs) for U.S. products after a poor inspection. Read More
The FDA has hit two compounding pharmacies with warning letters for quality violations and failure to have prescriptions for products they were compounding. Read More
With only 14 compounding facilities having volunteered for FDA oversight in two months, the agency is now asking hospitals and state authorities to get behind the registration effort. Read More
Novartis is recalling more than 200 lots of OTC cold and flu drugs distributed in seven countries — a massive market correction by the company beset with quality problems at its OTC plants since 2012. Read More
Ranbaxy’s regulatory woes deepened Jan. 23 as the FDA prohibited the drugmaker’s Toansa, India, plant from manufacturing and distributing active pharmaceutical ingredients (APIs) for U.S. products after a poor inspection. Read More