Express Pharma

Ranbaxy’s Mohali SEZ facility begins Atorvastatin export in US

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Our News BureauMumbai 

Ranbaxy Laboratories has commenced exports of Atorvastatin calcium oral tablets to the US market, from its state-of-the-art Mohali SEZ manufacturing facility, located in Punjab. The first consignment of Atorvastatin tablets has been dispatched to the US market in March 2012. The supply of Atorvastatin tablets from India supplements the company’s current production from Ohm  Laboratories, US.

Commenting on the development, Arun Sawhney, Chief Executive Officer and Managing Director, Ranbaxy said, “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. Going forward, our Mohali facility will cater to the US and other geographies, improving access to medicines, in these regions.”

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 is equipped with the latest state-of-the-art technology, designed to meet global and local regulatory requirement and conforms to cGMP standards.

Also the company’s German subsidiary Basics located in Leverkusen, has launched Atorvastatin Basics (10/20/40/80 mg), a generic version of the cholesterol lowering drug Sortis, in the German market. It had also obtained, pursuant to a settlement agreement with Pfizer, the rights to an early entry of Atorvastatin in the German market. Pfizer’s patent for Sortis expires in Germany on May 7, 2012.

Basics’ affiliate in Germany, Daiichi Sankyo Deutschland will assist in the launch. Daiichi Sankyo has a substantial reach among cardiologists and physicians, in the German market. “Atorvastatin is the gold standard in the area of cholesterol lowering therapy, helping millions of people worldwide to reduce their cholesterol levels,” said Heike Streu, Managing Director, Basics. “We are delighted to be able to provide a safe, effective and affordable alternative to the German patients. The involvement of Daiichi Sankyo will ensure that the physicians are informed about the early entry of Ranbaxy’s Atorvastatin in Germany”, said Streu.

Ralf Göddertz, Managing Director, Daiichi Sankyo Deutschland emphasised that this is the first collaboration between Daiichi Sankyo and Basics in Germany. Göddertz said, “This launch follows hard on the heels of the partnership established last November between Ranbaxy’s Italian subsidiary, Ranbaxy Italia, and Daiichi Sankyo Italia to distribute two of Daiichi Sankyo’s long established brands. It is a true pilot project by which we will kick-off the hybrid business model between the two companies in Germany. At the same time this project is important for both companies and is a step for further expansion in this country.”

Apart from Germany, Daiichi Sankyo and Ranbaxy are working on synergies in other countries, such as India, Romania, Italy and Mexico, among others. In another development, Ranbaxy Pharmaceuticals Canada Inc (RPCI), a wholly-owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced that RPCI has received approval from Health Canada to manufacture and market RAN Rosuvastatin tablets to the Canadian healthcare system. Rosuvastatin is a HMG-COA Reductase Inhibitor (cholesterol-lowering medication). Brand sales of Crestor in Canada were $742.2 million.

“The finished dosage form was developed, and will be manufactured within RLL’s Health Canada approved facilities located in India. We anticipate making Rosuvastatin tablets available to all classes of trade after April 2 when sufficient supplies are available to meet market demand,” said Paul Drake, President and General Manager, RPCI, Canada.

He further added, “We are pleased to have gained approval for this molecule that will provide an affordable alternative to the brand. Such a generic formulation is anticipated to have positive economic benefits to the healthcare system of Canada, as well as to all Canadian patients that require Rosuvastatin therapy.”

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