Topic: Form 483

As the Chinese valsartan maker's shares tumble, the FDA fixed its import alert announcement to show that it applies to only one of its two sites in China.

The newest FDA Form 483 says Zhejiang Huahai Pharmaceutical made production changes to valsartan API without thoroughly testing them.

India’s Sun Pharmaceuticals, which is working to shift its focus to novel and specialty drugs, has won FDA approval of a new treatment for glaucoma.

A Takeda founder descendant blasts the Shire deal, as the company moves its U.S. HQ closer to Shire; Sanofi revamps two global units.

Cook Pharmica, a biologics manufacturing company Catalent bought last year, was hit with a Form 483 by the FDA.

Cadila's Liva subsidiary was hit with a Form 483 by the FDA following an inspection of its plant in Vadodara, India.

Analysts are handicapping Teva's chance of getting its migraine drug candidate approved next week given issues at the plant that will produce it.

Former China FDA chief resigns over vaccine scandal; Astellas buys gene therapy specialist Quethera; FDA found problems at valsartan maker Huahai.

An FDA inspection of the Zhejiang Huahai Pharmaceutical plant a year ahead of its global recall of tainted valsartan found big problems.

Lenvima's quarterly sales grow to $106 million; China makes 48-drug list for streamlined review; Samsung commits further investment in biologics.