Trouble for Ranbaxy Laboratories seems to multiply. US-based Ohm Laboratories,
currently its only facility making medicines for the American market,
is also learnt to be under surveillance of the US Food and Drug
Administration (FDA).
According to a source, Ohm Laboratories (in the state of New Jersey) was inspected by FDA towards the end of 2012. After this, a 'Form 483' was issued to the company - this is done to notify of conditions which seem to breach the US Food, Drug and Cosmetic (FD&C) Act and related laws.
After the recent FDA red-flagging ('import alert') on Ranbaxy's Mohali (Punjab) facility, the Ohm one was the only FDA-approved facility of Ranbaxy supplying medicines to the US market. The other two key facilities in India, at Paonta Sahib (Himachal) and Dewas (MP), have been under US import alert since 2008. "As it appears, the company has not yet been able to resolve the issues raised by the FDA at Ohm Laboratories," the source said.
Source: Business Standard
According to a source, Ohm Laboratories (in the state of New Jersey) was inspected by FDA towards the end of 2012. After this, a 'Form 483' was issued to the company - this is done to notify of conditions which seem to breach the US Food, Drug and Cosmetic (FD&C) Act and related laws.
After the recent FDA red-flagging ('import alert') on Ranbaxy's Mohali (Punjab) facility, the Ohm one was the only FDA-approved facility of Ranbaxy supplying medicines to the US market. The other two key facilities in India, at Paonta Sahib (Himachal) and Dewas (MP), have been under US import alert since 2008. "As it appears, the company has not yet been able to resolve the issues raised by the FDA at Ohm Laboratories," the source said.
Source: Business Standard
