Shares of Aurobindo Pharma Ltd dropped over 5% on Friday after the US Food and Drug Administration (USFDA) pointed out data integrity lapses at the company’s finished dosages plant at Bachupally in Telangana. Meanwhile, shares of Wockhardt jumped as much as 3.7% after the company’s bioequivalence center in Maharashtra successfully cleared inspection by the US health regulator.
The US FDA issued Form 483 with 10 observations to Aurobindo Pharma on the plant which was audited by the US drug regulator between 13 May and 24 May.
FDA said laboratory records at the plant do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.
“Specifically, there is no adequate data integrity programme in place to include an adequate review of all electronic raw data by the quality unit to ensure completeness, consistency, and accuracy of all chromatographic raw data generated by the quality control laboratory,” FDA said as one of the observation.
Meanwhile, Wockhardt on Thursday said it has received zero observations from the US Food and Drug Administration (FDA) after inspection of its bioequivalence center at Aurangabad. The USFDA carried out the inspection on 10 and 12 June, the company said.
During the inspection, bioanalytical and quality systems of bioequivalence studies of Tamsulosin 0.4 mg capsules and Metoprolol ER tablets were audited, Wockhardt said. “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 to approvals of ANDAs (abbreviated new drug applications) in pipeline, for which bioequivalence studies are being done or will be done at the said centre, added Wockhardt. ANDA refers to a written request to the US FDA to manufacture and market a generic drug in the US.
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