Lupin's Mandideep plant OKed by US FDA

By Gareth Macdonald

- Last updated on GMT

Related tags: Pharmaceutical drug, Food and drug administration

Indian drugmaker Lupin can start seeking US approval for new drugs made at its API plant in Mandideep, Bhopal after resolving the cGMP deficiencies that earned the facility a US FDA warning last year.

The US drug watchdog issued Lupin with a warning letter in May last year after uncovering a number of good manufacturing practice (cGMP) deficiencies during an inspection the previous winter.

The agency said that it would not review any new products made at the facility until the problems were fixed, meaning that, for the last seven months, Lupin has only been able to sell established products in the world’s largest pharmaceutical market.

The facility, which was also recently approved by regulators in the UK and Australia, joins other Lupin plants in Aurangabad and Indore in gaining Food and Drug Administration (FDA) clearance to make drugs for the US.

While sanction did not impact on revenues, according to comments made by Lupin CFO S Ramesh during a CNBC-TV18 interview, its removal and the chance to make new drugs for such a lucrative market is surely good news.

This contention is further supported by comments made by Lupin group president Nilesh Gupta during an interview with the Economic Times earlier today.

Gupta told that paper that FDA criticism of the Mandideep plant had been a concern, particularly because Lupin plans to seek approval to market between 30 and 35 new drugs in the US in the next few years.

We are very proud that our people have been able to make this happen. This achievement is even more commendable in the current heightened regulatory environment and is strong testimony of how we are moving up the regulatory curve​.”

In wider terms, Lupin’s news is likely to be welcomed by the rest of India’s drug manufacturing industry, particularly rival Ranbaxy Laboratories, because it shows that such cGMP problems can be successfully resolved.

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