- Clearing the USFDA audit with nil 483 observations means Cadila Pharmaceuticals can continue to export its high-quality medicines made at the Dholka manufacturing facility to the US
NE BUSINESS BUREAU
AHMEDABAD, APR 20
The Dholka manufacturing facility of Cadila Pharmaceuticals, one of the oldest and largest privately-held pharmaceutical companies in the country, on Thursday announced it has successfully cleared the US Food and Drug Administration (USFDA) audit yet again.
The Dholka manufacturing facility passed the USFDA audit with nil 483 observations, which signifies compliance and conformance to applicable Current Good Manufacturing Practice (cGMP) regulations enforced by the USFDA. USFDA Inspector Vivin George conducted the facility’s audit from April 3 to 7.
USFDA Inspector Vivin George with Cadila Pharmaceuticals team at Dholka.-NE photo
“We are pleased that our Dholka manufacturing facility has cleared the USFDA inspection with nil 483 observations. In all our facilities, quality control is inbuilt at every step in the design and manufacturing process. The successful completion of the USFDA audit is a strong validation of our commitment to ensure the availability of medicines that meet the most stringent global quality standards. I also take this opportunity to congratulate our team at the Dholka facility,” said Dr Rajiv I. Modi, Chairman & Managing Director of Cadila Pharmaceuticals.
Clearing the USFDA audit with nil 483 observations means Cadila Pharmaceuticals can continue to export its high-quality medicines made at the Dholka manufacturing facility to the US, the world’s largest and most stringent drug market.
