USFDA completes inspection of Wockhardt’s Bioequivalence Centre

13 Jun 2019 Evaluate

US Food and Drug Administration (USFDA) has carried out inspection of Wockhardt’s Bioequivalence Centre located at R&D Centre in Aurangabad from June 10 to 12 2019. During the inspection Bioanalytical and Quality systems of Bioequivalence studies of Tamsulosin 0.4mg capsules and Metoprolol ER tablets were audited.

At the end of inspection, there was nil observation (i.e. zero 483 observation), signifying that best practices were followed, in compliance to regulations. This outcome would lead approvals of ANDAs in pipeline for which Bioequivalence studies are being or will be done in the said centre.

Wockhardt is one of the few companies with end to end integrated capabilities for its products, starting with the manufacture of the oral and sterile API’s, the dose forms and marketing through wholly owned subsidiary in the US, enabling the company to capture maximum value.

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