Bioanalytical and quality systems of bioequivalence studies of Tamsulosin 0.4mg capsules and Metoprolol ER tablets were audited, Wockhardt said.
Wockhardt shares rallied 3.7 percent intraday on June 14 after the US health regulator issued zero 483 observations for bioequivalence centre in Maharashtra.
The pharma company informed exchanges that the US Food and Drug Administration has carried out an inspection of its bioequivalence centre located at R&D Centre, Aurangabad in Maharashtra during June 10-12.
Bioanalytical and quality systems of bioequivalence studies of Tamsulosin 0.4mg capsules and Metoprolol ER tablets were audited, it added.
"At the end of inspection, there was zero 483 observations, signifying that best practices were followed, in compliance to regulations," Wockhardt said.
This outcome would lead approvals of ANDAs in pipeline for which bioequivalence studies are being or will be done in the said centre, it added.The stock was quoting at Rs 385.90, up Rs 2.80, or 0.73 percent on the BSE at 10:06 hours IST. It was one of the biggest losers in last one year, losing 45 percent.The Great Diwali Discount!
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