The United States Food & Drug Administration (USFDA) has carried out inspection of Wockhardt’s Bioequivalence Centre located at R&D Centre, Aurangabad in the state of Maharashtra. During which Bioequivalence studies of Tamsulosin 0.4mg capsules and Metoprolol Tartrate 200mg 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 applicable 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.