The Telegraph
Tuesday , January 14 , 2014
CIMA Gallary

Ranbaxy in a spot

Mumbai, Jan. 13: Ranbaxy Laboratories has run into more trouble with the US regulator.

The US Food and Drug Administration (FDA) has now raised concerns about the manufacturing practices at its plant at Toansa in Punjab that makes active pharmaceutical ingredients (APIs).

Also known as bulk pharmaceuticals, APIs make prescription and over-t he-counter drugs work.

The Ranbaxy stock today sank to a near one-month low of Rs 421.10 before clawing back at the close to Rs 438.35 on the BSE.

All of Ranbaxy’s plants in India are currently banned from exporting medicines to the US after investigators found glaring shortcomings in its manufacturing practices.

The company has received a Form 483 from the FDA which is used to document and communicate concerns dis covered during inspections.

The company said it was assessing the observations and would respond to the US FDA at the earliest.

Last September, the FDA imposed an import ban on Ranbaxy’s factory in Mohali, saying it had not met “good manufacturing practices”. The ban came after the company pleaded guilty in May to US felony charges related to drug safety and agreed to a record $500 million in fine.

The payout came after the US FDA had banned the import of 30 drugs from its two plants in Dewas and Paonta Sahib in 2008 for deviating from manufacturing practices.

Ranbaxy is understood to have made 36 filings for generic drugs from the Mohali plant. It is looking to move some of the products to its Ohm facility in the US.