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Bliss GVS Pharma Ltd gets 3 minor observations from USFDA for Palghar unit

Posted On : 2023-03-18 18:14:32( TIMEZONE : IST )

Bliss GVS Pharma Ltd gets 3 minor observations from USFDA for Palghar unit

Bliss GVS Pharma Limited has announced 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 at Plot No. 11, Survey No. 38/1, Dewan Udyog Nagar, Aliyali Village, Palghar, 401404, Maharashtra from Monday, March 13, 2023 to Friday, March 17, 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 Company shall prepare detailed response to the observations, which will be submitted to theUS 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.

Shares of Bliss GVS Pharma Limited was last trading in BSE at Rs. 75.19 as compared to the previous close of Rs. 76.48. The total number of shares traded during the day was 4876 in over 113 trades.

The stock hit an intraday high of Rs. 77.20 and intraday low of 74.67. The net turnover during the day was Rs. 369505.00.

Source : Equity Bulls


BlissGVSPharma INE416D01022 Form483 USFDA PreApprovalInspection GMP PalgharUnit