MUMBAI -- The US Food and Drug Administration (FDA) has said it is satisfied with the manufacturing practices at Ranbaxy's US facility, Ohm Laboratories Inc, in a move that should bring some relief to the drugmaker that was pulled out for irregularities in three of its manufacturing facilities in India.
The clearance will also allow Ranbaxy, now owned by Japan's Daiichi Sankyo Co. Ltd, to file applications for approvals for generics (or off patent drugs) from Ohm.
"Ohm Laboratories Inc of New Brunswick, has said that the company has received a copy from the US Food and Drug Administration of its Establishment Inspection Report (EIR) for its December 2012 inspection," stated a note on the website of Ranbaxy Laboratories Ltd on Thursday.
An EIR signals satisfactory resolution of issues related to good manufacturing practices raised by FDA.
Ohm's manufacturing plant located at New Jersey in the US is the only manufacturing facility of Ranbaxy that supplies products to the US market, after the company's three export-oriented manufacturing plants in India were pulled up by the regulator for violations in good manufacturing practices. The US is an important market for Ranbaxy as it contributed about $1billion in sales to the company in 2010.
"The EIR for Ohm Lab's plant should now pave the way for Ranbaxy for receiving fresh approvals from this facility, particularly the bigger first-to-file products including the generic versions of Diovan (anti-blood pressure) and Valcyte (anti-HIV)," said Hitesh Mahida, a pharma analyst with brokerage Fortune Equity Brokers (India) Ltd.
Ranbaxy's factories located at Paonta Sahib in Himachal Pradesh and Dewas in Madhya Pradesh were banned by US regulator in 2009, and its plant in Mohali in Punjab also received an import alert in September. Ranbaxy paid a fine of $500 million to US department of justice for alleged malpractices in documentation on manufacturing process, and has signed a consent decree (CD) with the US FDA to become compliant with the manufacturing regulations.
"We will continue to work closely with the US FDA on remediating the issues at our Mohali facility and will take all necessary measures to keep our facilities in full compliance to all global regulations. We are focusing on resuming submissions and supplies to the USA from our Mohali plant once we satisfy the US FDA stipulations," said Ranbaxy managing director and chief executive officer Arun Sawhney, in an email on 26 September. "In terms of the CD with the US FDA for its Paonta Sahib and Dewas plants, we are committed to further strengthen procedures and policies to ensure data integrity and to comply with current good manufacturing practices (cGMP). So far we have met all obligations under the CD and are making good progress in its implementation," he added.
Ranbaxy shares rose 3.28% to close at Rs.393.15 a unit on BSE on Thursday, while the exchange's benchmark index, Sensex was up 0. 12% to 20,272.91 points. ___