Bliss GVS Pharma declines after Palghar units gets Form 483 with 3 observations from US FDA

Bliss GVS Pharma slipped 1.54% to Rs 74.03 after the company informed that the US FDA issued a Form 483 with 3 minor observations post the inspection conducted at its Palghar-based manufacturing facility.

In an exchange filing made on Saturday, the company said that the United States Food and Drug Administration (US FDA) conducted a pre-approval inspection (PAI) and good manufacturing practice (GMP) inspection at the company's manufacturing unit located at Palghar, Maharashtra, from 13 to 17 March 2023.

After the inspection, the US FDA issued a Form 483 with 3 minor observations. The observations are procedural in nature. None of the observations relate to data integrity, the pharmaceutical company stated. The company shall prepare detailed response to the observations, which will be submitted to the US FDA within the stipulated timelines.

"The company remains committed to maintain the highest standards of compliance and will work closely with the agency to comprehensively address all the observations," Bliss GVS Pharma said in a statement.

Bliss GVS Pharma develops and manufactures pharmaceutical formulations mainly for sale in Africa. The company sells formulations in the form of suppositories, pessaries, capsules, tablets, and syrups. It manufactures more than 250 branded formulations in the anti-malarial, anti-fungal, anti-bacterial, anti-biotic, anti-inflammatory, contraceptive, and anti-diabetic segments.

The company reported a consolidated net profit of Rs 27.94 crore in the quarter ended December 2022 as against net loss of Rs 50.11 crore during the previous quarter ended December 2021. Sales declined 4.87% to Rs 205.72 crore in Q3 FY23 over Q3 FY22.

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