Indian drug major Ranbaxy Laboratories Ltd has announced that it has temporarily suspended shipment from its two active pharmaceutical ingredients (API) plants in the country to examine process and controls of manufacturing at these two units.
“This voluntary decision was taken as a precautionary measure and out of abundant caution to better allow the company to assess and review the processes and controls. The company will resume shipments after reassuring them about the processes and controls at these facilities,” Ranbaxy disclosed on Tuesday.
Last month US FDA prohibited Ranbaxy from producing and selling APIs for the American market from its Toansa facility in Punjab, citing manufacturing violations.
The move followed an FDA inspection of the facility which identified significant violations of good manufacturing practices. Following this, the pharmaceutical firm voluntarily suspended API shipments from the facility to the US.
With this, all Indian plants of the company have been banned from shipping products for sale in the US, the world’s largest drug market and key revenue generator for Indian generic pharma companies.
Previously, US FDA had banned Ranbaxy from selling products made at its factories in Paonta Sahib, (Himachal Pradesh), Dewas (Madhya Pradesh) and Mohali (Punjab) over irregularities.
The development followed a visit of Margaret Hamburg, commissioner of US FDA in India. The regulatory body has penalised a number of big Indian pharma companies recently due to quality issues, including Wockhardt, RPG Life Sciences and Agila Specialities.
US FDA swung into action and started active monitoring of pharma labs in the country after Ranbaxy pleaded guilty to felony charges related to drug safety and agreed to pay a fine of $500 million in civil and criminal fine.
This came as a blow to Japanese pharmaceutical company Daiichi-Sankyo, which bought Ranbaxy from previous promoters Malvinder and Shivinder Singh in 2008 for around $4.6 billion.
(Edited by Joby Puthuparampil Johnson)