Wockhardt’s bioequivalence centre at Aurangabad receives zero observations from US FDA

During the inspection, bioanalytical and quality systems of bioequivalence studies of Tamsulosin 0.4 mg capsules and Metoprolol ER tablets were audited

Drug firm Wockhardt announced that it has received zero observations from the US health regulator after inspection of its bioequivalence centre at Aurangabad in Maharashtra.

The United States Food and Drug Administration (US FDA) carried out inspection of the bioequivalence centre located at R&D centre, Aurangabad from June 10 to June 12, 2019, Wockhardt said in a BSE filing.

During the inspection, bioanalytical and quality systems of bioequivalence studies of Tamsulosin 0.4 mg capsules and Metoprolol ER tablets were audited, it added.

"At the end of the inspection, there were nil observations (i.e. zero 483 observation), signifying that best practices were followed, in compliance to regulations," Wockhardt said.

This outcome would lead approvals of abbreviated new drug applications (ANDAs) in pipeline for which bioequivalence studies are being or will be done in the said centre, it added.

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