Bliss GVS Pharma share price falls on observations from USFDA

The company shall prepare detailed response to the observations, which will be submitted to the USFDA within the stipulated timelines.

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Shares of Bliss GVS Pharma declined in early trade on March 20 after the company received three observations from the United States Food and Drug Administration (USFDA).

The USFDA had conducted a pre-approval inspection (PAI) and good manufacturing practice (GMP) inspection at Bliss GVS Pharma‘s manufacturing unit at Palghar, Maharashtra, during March 13 to 17, according to a press release.

After the inspection, the USFDA issued Form 483 with three minor observations, which are procedural in nature and none of the observations relate to data integrity, the company said.

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The company shall prepare detailed response to the observations, which will be submitted to the USFDA within the stipulated timelines, it added.

The company remains committed to maintain the highest standards of compliance and will work closely with the agency to comprehensively address all the observations, the company said.

At 9:22am, Bliss GVS Pharma was quoting at Rs 75.08, down Rs 0.11, or 0.15 percent, on the BSE.