Ranbaxy Laboratories announced in early April that the company has begun exporting its generic version of Lipitor (atorvastatin calcium) oral tablets to the US market from its new “Mohali” manufacturing facility located in Punjab, India.
In the first quarter of 2012, the company received approval from FDA to manufacture and market atorvastatin 10mg, 20mg, 40mg and 80mg tablets. The first batch of atorvastatin tablets was shipped from the Indian plant to the US market in March and supplements Ranbaxy’s current production from Ohm Laboratories located in the US.
Commenting on the development in a company press release, Ranbaxy CEO & Managing Director Arun Sawhney said, “the resumption of supplies from India into the US market is a significant milestone for Ranbaxy…. Going forward, our Mohali facility will cater to the US and other geographies, improving access to medicines in these regions.”
Clearance to ship atorvastatin from the Indian site follows on the heels of a consent decree signed between Ranbaxy and the US Department of Justice (DoJ) based on FDA inspection findings of data integrity and GMP issues (IPQ “The News in Depth” Jan. 30, 2012).
The “consent decree of permanent injunction” was signed by Ranbaxy and FDA in late December, at which time the generic drug manufacturer announced that it had put aside $500 million to cover potential costs of civil and criminal liability. The decree was filed with the federal court in Maryland in late January.
“This action against Ranbaxy is groundbreaking in its international reach,” emphasized DoJ Civil Division Assistant Attorney General Tony West in a justice department press release. It is “unprecedented in its scope,” and will require the firm to make “fundamental changes to its plants in both the United States and India,” he said.
Ranbaxy’s dosage form facility at Mohali received inspection clearance from FDA in October 2011 and was not named in the consent decree.
International regulatory authorities including WHO, the Romanian National Medicine and Medical Devices Agency (NMMDA), Brazil’s ANVISA, Australia’s TGA and Health Canada have also approved the company’s Mohali facility.
The new facility at Mohali will manufacture oral solid products for export to US, EU and other countries. It is equipped with “the latest state-of-the-art technology, designed to meet global and local regulatory requirement and conforms to cGMP standards,” according to the Ranbaxy press release.[/membership]