USFDA flags several issues at Aurobindo Pharma’s Anakapalli plant

30 Jun 2023 , 10:14 AM

Authorities from the US Food and Drug Administration discovered numerous issues at a facility owned by one of India’s largest pharmaceutical companies.

According to a USFDA report, auditors discovered ‘deficient’ manufacturing equipment cleaning and storage controls during a visit to an Aurobindo Pharma Ltd. plant in Anakapalli, Southern India, last month. At the facility that manufactures specific active pharmaceutical ingredients, the essential raw materials for creating pharmaceuticals, sampling equipment wasn’t kept clean and maintained to prevent contamination.

The report stated that the creation of adequate and scientifically sound specifications, intended to ensure that drug products comply to acceptable standards of identity, quality, and purity, was also left out of laboratory controls. The report added that the auditors also noticed raw materials being kept in extremely hot and humid circumstances and not in accordance with label storage standards during a warehouse walk-through.

The FDA normally waits to make a decision until it has received a company’s plan to resolve problems. According to a presentation made to investors in August, the Anakapalli factory creates APIs for cardiovascular and anti-fungal medicines.

Aurobindo, a manufacturer of semi-synthetic penicillin, was established in 1986 by P.V. Ramprasad Reddy and K. Nityananda Reddy and has its headquarters in Hyderabad, India’s pharmaceutical capital. Since then, it has grown to export medicines to more than 150 nations, with international markets accounting for 90% of its yearly sales of almost $3 billion. APIs account for 15% of its total sales. 

The company has already been ordered to fix problems. Its Doultabad factory received a warning letter in January of last year, one of the agency’s most severe enforcement actions that can result in import restrictions and delays in product approvals. According to the FDA, the plant produced contaminated API, and repeated failures ‘demonstrate that executive management oversight and control over the manufacture of drugs is inadequate.’

On a call with business analysts last month, Aurobindo’s chief financial officer Santhanam Subramanian stated that the organization is working to have the warning letter ‘cleared.’

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