Dr Reddy's Laboratories today said that up to $30 million in annual revenues could be impacted due to import ban by US Food and Drug Administration on some products from its Mexican facility.
According to DR Reddy’s Vice-Chairman and CEO GV Prasad, the issue with the USFDA is expected to be settled by October this year.
"The total revenues from the facility are $60 million, of which half is from Naproxen family which was not affected by the ban. So, $30 million will be affected by the part of the year. October is the earliest we believe that the issue will be resolved," Prasad said at a press conference to announce the first quarter results.
The US health regulator had recently imposed an import ban on products made at the company's Mexican plant for violation of current good manufacturing practices (CGMP).
The plant, which produces intermediates and active pharmaceutical ingredients, had received a warning a letter from the USFDA last month.
Prasad said the company responded to FDA on the action plan and has voluntarily given an undertaking not to release the products until the issue is resolved.
On the accidents at some of the facilities here, Prasad said the company is taking steps to invest and improve safety standards and the R&D work on its ambitious anti-diabetic drug program – Balaglitazone - has been stopped.
"I think [it] will be tough to get a partner. We have already written off as R&D. We have that as an asset but given all the bad news on glitazones and the class of products, I don’t see that," Prasad said.
Dr Reddy’s chairman Anji Reddy said earlier that it may not be able to launch anti-diabetes drug - Balaglitazone after a similar drug - Avandia - was banned in Europe as the company is finding it difficult to get partners to launch it.
The company is believed to have spent considerable time and money on developing the drug.
