Shares of pharmaceutical company Alembic Pharma declined over 1 percent as the company notified that the United States Food and Drug Administration (USFDA) has conducted an inspection at its Oncology Injectable Formulation Facility located at Panelav from 4, October 2022 to 14, October 2022.

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At 11:58 am shares of Alembic Pharmaceuticals were trading at Rs 550, down by 1.05 percent from the previous close on the BSE.

Alembic Pharmaceuticals said in a regulatory filing that the USFDA has issued a Form 483 with four procedural observations. None of the observations is related to data integrity and management believes that they are addressable.

“The Company is preparing the response to the observations, which will be submitted to the USFDA within the stipulated period. The Company is committed to maintaining the highest quality standards and compliance at all times,” said the regulatory filing.

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Last month the U.S. drug regulator flagged quality and procedural lapses at Alembic Pharmaceuticals' injectable facility in Vadodara, Gujarat.

“The U.S. Food and Drug Administration has conducted an inspection at Alembic Pharmaceuticals’ injectable facility located at Karkhadi from Aug. 18-30. The U.S. FDA issued a Form 483 with two observations,” the company said in an exchange filing.

Shares of Alembic Pharmaceuticals have declined over 6 percent in one month while the S&P BSE Healthcare index has climbed nearly 3 percent in the same period.

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