Ranbaxy Laboratories, on Monday, said it had commenced exports of finished drugs to the U.S. market.
“The first consignment of Atorvastatin (cholesterol lowering) tablets has been dispatched from the state-of-the-art Mohali facility in Punjab to the U.S. market in March.
The supply of Atorvastatin tablets from India supplements the company's current production from Ohm Laboratories Inc, USA,” the company said in a statement.
The move comes four years after the U.S Food and Drug Administration (USFDA) banned 30 generic drugs produced by Ranbaxy Laboratories at its Dewas (Madhya Pradesh) and Paonta Sahib and Batamandi units in Himachal Pradesh, citing gross violation of approved manufacturing norms.
However, in December last, Ranbaxy Laboratories signed a consent decree with the USFDA to lift a ban on import of drugs from certain manufacturing plants in India. This was followed by the U.S. Justice Department seeking a permanent injunction against Ranbaxy, a move that required the Indian pharmaceutical major to make fundamental changes to its plants both in the U.S. and India.
The company said Ranbaxy's drug had been approved by the USFDA in October last. 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, it added.
“The resumption of supplies from India into the U.S. market is a significant milestone for Ranbaxy. This is a testimony to our commitment to provide quality affordable medicines to the U.S. healthcare system. Going forward, our Mohali facility will cater to the U.S. and other geographies, improving access to medicines, in these regions,” said Ranbaxy CEO and Managing Director Arun Sawhney.
Mohali facility
The new facility at Mohali will manufacture oral solid products for export to the U.S., the European Union and other countries based on the filings and after receiving the necessary approvals. It is equipped with the latest state-of-the-art technology, designed to meet global and local regulatory requirement and conforms to good manufacturing practice standards.
