Tuesday, 24 April 2018

Alembic Pharma gains 5% on successful USFDA inspection of Panelav facility

Alembic Pharmaceuticals ups its US game plan, acquires Orit

Shares of Alembic Pharmaceuticals were up 5% at Rs 527 per share on the market in early morning trade after the company informed about the successful United States Food and Drug Administration (US FDA) inspection at its API facility at Panelav with zero 483s.
“The USFDA has conducted an inspection at Alembic Pharmaceuticals API Facility located at Panelav from 16th April, 2018 to 23rd April, 2018. This was a scheduled inspection and at the end of the inspection, there were zero 483s,” the pharmaceutical company said in a regulatory filing.

As per the USFDA, Form 483 notifies the company’s management of objectionable conditions based on observations made by its investigators about the conditions or practices which would “indicate that any food, drug, device or cosmetic has been adulterated or is being prepared, packed, or held under conditions whereby it may become adulterated or rendered injurious to health’’.

At 09:21 am; the stock was trading 4% higher at Rs 524 on the BSE, as compared to 0.39% rise in the S&P BSE Sensex. A combined 29,775 shares changed hands on the counter on the NSE and BSE so far.

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