Aurobindo Pharma falls 5% after USFDA points out data integrity lapses in Bachupally unit

Aurobindo Pharma shares fell 5 percent intraday on June 14 after the US health regulator pointed out data integrity lapses at finished dosages plant in Bachupally, Telangana.

The US Food and Drug Administration issued Form 483 with 10 observations on the plant which was audited by the US drug regulator between May 13 and May 24.

Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards, the FDA said.

Specifically, there is no adequate data integrity program 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 (QC)laboratory, it said as one of the observation.

Reacting to the FDA observations, Aurobindo Pharma on June 4 said the company has received a 'Form 483' with 10 observations. None of the observations are repetitive and are procedural in nature.

"The company will be responding to the US FDA within the stipulated time. Form 483 will not have an impact on existing business of this facility,"the drug-maker had said.

While having a buy call on the stock with a target price at Rs 930 (implying 46 percent potential upside), Phillip Capital said management believes Bachupally observations do not raise data integrity concerns and are for process upgradation.

"Out of 10 observations, one raises data integrity concerns. Company expects to address observations in the near term," the brokerage added.

The stock was quoting at Rs 616.95, down Rs 19.70, or 3.09 percent on the BSE at 12:32 hours IST.