Wednesday, 14 October 2015

Cipla gets Form 483 for US Invagen plant.
Cipla's new U.S. plant received Form 483 just ahead of Deal

Last month India's Cipla announced it had struck a $550 million deal to buy its first U.S. property, InvaGen Pharmaceuticals, getting a 350,000-square-foot manufacturing facility and portfolio of drugs. What it left out of the announcement is that its first U.S. manufacturing operation came with some FDA concerns. The company received a Form 483 this spring for that plant, which the FDA did not post until two weeks after the deal was disclosed.

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