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Alembic Pharma slips as USFDA issues 4 observations to Panelav facility

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Alembic Pharmaceuticals fell 3.54% to Rs 554.65 after the company said the US drug regulator has issued a Form 483 with four observations post inspection at Panelav facility in Gujarat.

In an exchange filing made before market hours today, the US Food and Drug Administration (USFDA) has conducted an inspection at Alembic Pharmaceuticals general oral solid formulation facility located at Panelav (Gujarat) from 9th to 13th March 2020. This was a scheduled inspection. At the end of the inspection, the USFDA issued a Form 483 with four procedural observations.

None of the observations are related to data integrity or repetitive in nature. The company will provide comprehensive corrective action report to address each observation. The company said it is committed to maintaining highest quality standards that meet USFDA standards.

 

On a consolidated basis, Alembic Pharma's net profit rose 37.9% to Rs 234.19 crore on a 18.8% rise in the net sales to Rs 1209.13 crore in Q3 December 2019 over Q3 December 2018.

Alembic Pharmaceuticals is engaged developing formulations and active pharmaceutical ingredients (API).

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First Published: Mar 16 2020 | 11:10 AM IST

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