Last Updated on October 11, 2024 by The Health Master
Hyderabad: Suven Pharmaceuticals Ltd has announced that the US Food and Drug Administration (USFDA) has completed a pre-approval inspection at the Casper Pharma Private Limited formulations manufacturing facility situated at GMR Hyderabad SEZ, a wholly owned subsidiary of Suven Pharmaceuticals Limited in Hyderabad, India.
The inspection was conducted from July 25th through July 29th, 2022.
The audit is part of the agency’s inspection of three product applications filed and slated to be manufactured at this site.
According to Venkat Jasti, Managing Director of Suven Pharmaceuticals Limited, “We are happy to have completed the audit successfully with Zero observations and at the end of the inspection, no form 483 was issued by USFDA which signifies compliance and conformance to applicable cGMP regulations.”
When an investigator(s) has(have) observed any conditions that, in their opinion, may constitute violations of the Food, Drug, and Cosmetic (FD&C) Act and related Acts, a USFDA Form 483 is issued to firm management at the conclusion of an inspection.
Seven Pharmaceuticals Limited, a company incorporated in November 2018, has become a Wholly Owned Subsidiary of Suven Life Sciences Limited, effective February 2019.
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