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DRL’s Vizag facility faces US FDA non-compliance issues
The US Food and Drug Administration has inspected Dr Reddy’s Vizag manufacturing site, reports CNBC-TV18. It points out compliance issues in Form 483 for DRL’s Vizag manufacturing site, sources said.
The US Food and Drug Administration has inspected Dr Reddy's Vizag manufacturing site, reports CNBC-TV18. It points out compliance issues in Form 483 for DRL's Vizag manufacturing site, sources said. Form 483 commonly refers to non-compliance with US FDA's manufacturing norms. Dr Reddy's Vizag plant manufactures cytotoxic or anti-cancer drugs.
This could be a regular pre-ANDA approval inspection that FDA normally conducts for all companies, where the entire manufacturing site is audited; or it could also point out glaring lapses in the manufacturing standards. The manufacturing site actually deals with anti-cancer injectable drugs for which the US FDA is very concerned. The regulator is also very attentive to the care and manufacturing standards for that particular category of products.
The company said it is complying and will respond to the US FDA shortly. Dr Reddy's said it expect intimation of approval for the Vizag site based on the review.
A couple of weeks ago, a similar exercise was taken up by the US FDA for Ranbaxy's plant in Madhya Pradesh. The US FDA is looking at these manufacturing sites very carefully. It may be to do with their own assumptions of what is going on in Indian companies, so they want to really take a re-look at how manufacturing is done by Indian companies.
A response from the US FDA can be expected in a short time. Oncology is a big segment in the US. To attack that market will be a definite ambition for DRL. The US FDA for their part will ensure that quality standards are adhered to.
