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Four years after being banned by the USFDA,Ranbaxy Laboratories today said it has resumed exports of finished drugs to the US with the commencement of shipping of cholesterol lowering drug,atorvastatin calcium oral tablets.
The firm,however,said the anti-cholesterol tablets meant for the US market will be produced at its Mohali SEZ plant in Punjab and not at the three units banned by the US health regulator.
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“The resumption of supplies from India into the US market is a significant milestone for Ranbaxy. This is a testimony to our commitment to provide quality affordable medicines to the US healthcare system,” Ranbaxy CEO and Managing Director Arun Sawhney said in a statement.
In 2008,Ranbaxy had to suspend export of medicines in dosage forms to the US following ban imposed on 30 generic generic drugs produced at its Dewas (Madhya Pradesh),and
Paonta Sahib and Batamandi units in Himachal Pradesh by the US Food and Drug Administration (USFDA) citing gross violation of manufacturing norms.
“The supply of atorvastatin tablets from India supplements the company’s current production from Ohm Laboratories Inc,USA,” the company added.
The first consignment of atorvastatin tablets has been dispatched to the US market in March 2012,the company said.
“Going forward,our Mohali facility will cater to the US and other geographies,improving access to medicines in these regions,” Sawhney added.
In January,the US Justice Department sought a permanent injunction against Ranbaxy,a move that required the Indian pharmaceutical major to make fundamental changes to its plants both in the US and India.
In December,Ranbaxy had filed a consent decree with a US court as part of its settlement with the American authorities and said it had earmarked up to USD 500 million for settlement with the US authorities.
Ranbaxy’s dosage forms facility at Mohali was approved by the US Food and Drug Administration (FDA) in October 2011.
In the first quarter of 2012,the company received approval from the USFDA to manufacture and market atorvastatin in strengths of 10 mg,20 mg,40 mg and 80 mg tablets,the company said.
Shares of Ranbaxy Laboratories were trading at Rs 459.15 on the BSE in afternoon trade,down 2.10 per cent from its previous close.
Earlier,various regulatory authorities such as WHO- Geneva,National Medicine and Medical Devices Agency (NMMDA)- Romania,ANVISA- Brazil,TGA- Australia,Canada Health-Canada had also approved Ranbaxy’s Mohali facility,Ranbaxy said.
“The new facility at Mohali will manufacture oral solid products for export to US,EU and other countries based on filings and after receiving the necessary approvals,” it said.
Ranbaxy had launched its generic version of blockbuster cholesterol-lowering drug Lipitor in the US market in December,2011.
The launch came after final approval from the US health regulator to manufacture the generic version of Lipitor at Ranbaxy’s wholly owned Ohm Laboratories facility in New Brunswick,New Jersey,as well as market the product.