Wockhardt gets zero observations from USFDA for bioequivalence centre at Aurangabad

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

New Delhi: Drug firm Wockhardt Thursday said 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 (USFDA) carried out an inspection of the bioequivalence centre located at R&D centre, Aurangabad from June 10 to June 12, 2019, Wockhardt said in a BSE filing.

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

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

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