Alembic Pharmaceuticals Gains After U.S. FDA Issues Form 483 – Shares of the Vadodara-based drug maker rose as much as 4.2 percent, the most in over a month, to Rs 557.85 after the U.S. drug regulator issued Form 483 for its Panelav facility.
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The U.S. FDA inspection was conducted between March 12-20 and at the end of the inspection the regulator issued Form 483 with three observations. None of the observations are related to data integrity or repetitive in nature, Alembic Pharmaceuticals said in an exchange filing.
Meanwhile, the company is preparing the response to the observations, which will be submitted to the U.S. FDA shortly.
