Aurobindo injectables plant receives Form 483 with nine observations

By Dan Stanton

- Last updated on GMT

The US FDA has issued a Form 483 to a manufacturing plant in Hyderabad, India but Aurobindo says none of the observations relate to data integrity.

The US Food and Drug Administration (FDA) visited Aurobindo’s Unit IV facility in Pashamylaram, Hyderabad from February 12 to 20.

“This is a scheduled inspection and at the end of the inspection, we were issued a Form 483 with 9 observations,”​ the firm said in a filing to the Bombay Stock Exchange.

It added: “None of the observations are related to data integrity or repetitive in nature and we are in the midst of providing a comprehensive response to the observations and would be replying to the FDA within 15 working days from the date of closure (20th February, 2018) of audit.”

According to the generics drugmaker, Unit IV is a dedicated manufacturing facility for generic sterile injectables – including lyophilized and powder injections prefilled syringes – along with opthalmics and low volume parenterals.

Aurobindo’s share price dropped by about 5% on the back of the announcement.

The facility in Hyderabad is one of several units in India, which makes active pharmaceutical ingredients (APIs) and finished formulations for the global market.

The Unit VI facility in in Chitkul Village, Andhra Pradesh received a Form 483 detailing two issues last September​. The plant makes oral and liquid formulations of cephalosporin antibiotics.

Meanwhile, Aurobindo’s Unit III facility in Bachupally, Hyderabad which makes a variety of oral solid dosage forms, including anti-retroviral drugs, received a Form 483 with six observations in April 2017​.

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