The US Food and Drug Administration (USFDA) made seven observations for Aurobindo Pharma unit-VII at Polepally in Telangana.
The US Food and Drug Administration (USFDA) made seven observations for Aurobindo Pharma unit-VII at Polepally in Telangana. The drug regulator issued a note after inspecting the facility during September 19-27, 2019, indicating procedural lapses along with poor quality control. Following this, shares of Aurobindo Pharma on Monday tanked 19.16% to end at a five-year low of Rs 458.50 on BSE.
“Pursuant to Regulation 30 of the Sebi (Listing Obligations and Disclosure Requirements) Regulations, 2015, the United States Food and Drug Administration (USFDA) conducted a cGMP inspection at our Unit VII manufacturing facility from September 19-27, 2019. The inspection ended with seven observations,” the company informed stock exchanges.
“We believe none of the observations are related to data integrity. The company is confident of addressing these issues within the stipulated timeline,” the company said. Aurobindo Pharma’s unit VII manufactures non-penicillins, non-cephalosporins and anti-retroviral medicines.
The USFDA observations include failure to review any unexplained discrepancy; failure to consider failure of batch or components; control procedures not established; no written procedures for production and process controls; equipment and utensils not cleaned at appropriate levels; procedures applicable to quality control not thoroughly followed; and written production and process controls not developed in execution of production, process controls.
Meanwhile, the promoters of Aurobindo Pharma, in their personal capacities, are in the process of funding Dr T Gurunath Reddy, founder of Hyderabad-based Continental Hospitals, for buying stake held by IHH Healthcare-backed Parkway Pantai for Rs 600 crore. While Continental Hospitals and Aurobindo did not confirm the development, sources in the know said that it is still in the process. Continental Hospitals is at present majority-owned and controlled by Gleneagles Development (GDPL), a subsidiary of Parkway Pantai, a Singapore and Kuala Lumpur-based healthcare provider owned by the IHH.