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In a regulatory filing, Gland Pharma said, “…the United States Food and Drug Administration (USFDA) has conducted a pre-approval inspection (PAI) for Sterile APIs at the company’s Facility at [Jawaharlal Nehru Pharmacy City, or JNPC] Visakhapatnam between February 19, 2025, and February 25, 2025,” Gland Pharma said in a regulatory filing.
The inspection resulted in three Form 483 observations, which the company stated are procedural. “The said inspection was concluded with THREE (3) Form 483 Observations [sic]. These observations are procedural in nature,” the company said.
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Gland Pharma explained that the observations are neither repeated from previous inspections nor related to data integrity concerns.
“The corrective and preventive actions for these observations will be submitted to the USFDA within the stipulated period,” it added.
What is pre-approval inspection (PAI)?
Under America’s Food, Drug, and Cosmetic Act, the FDA is empowered to approve a new drug application (NDA) or an abbreviated NDA (ANDA) only if the methods and facilities used to manufacture, process, pack, and test the drug meet certain standards.
What is a Form 483?
Form 483 is a list of observations issued by USFDA inspectors after completing the inspection, as well as explain them to the supplier. A form 483 does not represent a final FDA determination.
Also Read: Gland Pharma shares fall 5% to November 2023 lows after downgrades, target cuts
Once Form 483 is issued, the company is given 15 days to submit its response to the USFDA explaining what steps it will take to resolve the observations.
Shares of Gland Pharma Ltd ended at ₹1,576.20, up by ₹51.15, or 3.35%, on the BSE.
