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Alembic Pharma Slips as USFDA Issues Form 483

The Diltiazem Hydrochloride Extended-Release capsules are used for managing hypertension.

After the firm received Form 483, the shares of Alembic Pharmaceuticals declined 1.26 per cent to Rs 562.35 with four procedural observations for an inspection conducted by the United States Food and Drug Administration (USFDA)at its Panelav formulation facility. Between 4 October and 14 October 2022, the oncology injectable formulation facility at Panelav USFDA was inspected.

In the end, the pharmaceutical company was issued with four procedural observations by the US drug regulator. The company said that none of the observations is related to data integrity and management believes that they are addressable.

Also, it is preparing the response to the observations, which will be submitted to the USFDA during the specified period. Also, to maintain the highest quality standards and compliance at all times. This pharmaceutical company has integrated research and development pharmaceutical companies. It also manufactures and markets generic pharmaceutical products around the globe.

On a consolidated basis, the net loss of Alembic Pharmaceuticals was Rs 65.88 crore in the first quarter of FY23, compared with a net profit of Rs 164.52 crore posted in the first quarter of FY22. At the end of the June quarter, net sales went down by 4.8 per cent YoY to Rs 1,262.14 crore.

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