The Hindu Business Line : Ranbaxy gets US FDA approval for hypertension drug

Ranbaxy Laboratories Ltd has received approval from the US Food and Drug Administration (FDA) to manufacture and market Atenolol, a hypertension drug.

In a statement, the company said that the approval was for tablets in three strengths: 25 mg, 50 mg and 100 mg.

The US FDA has determined the formulation to be bioequivalent, with the same therapeutic effect as that of AstraZeneca's registered drug, Tenormin.

Mr Jim Meehan, Vice-President (Sales and Marketing) of Ranbaxy Pharmaceuticals Inc (RPI) - a wholly owned subsidiary - said: "This will further expand our product portfolio of affordable generic alternatives to the brand in the treatment of cardiovascular disorders."

He added: "This approval is the result of a strategic alliance with Ipca Laboratories of Mumbai, who will develop a number of generic prescription pharmaceutical products that will be marketed by RPI in the US.

This is the second drug approved through RPI's strategic alliance with Ipca Laboratories, formalised in September.

Atenolol, which is currently being produced by Ranbaxy, will shift to Ipca's units later.

The total annual market sales for Atenolol is estimated at $133.6 million, according to Ranbaxy.

Though the company did not disclose Atenolol's share in its portfolio, a spokesperson said that Ranbaxy would be one among other manufacturers of the generic drug.

On Tuesday on the BSE, the Ranbaxy scrip closed at Rs 398.40, up 1.67 per cent from Rs 391.85 earlier.

Shares of Ipca closed at Rs 581.35, down 2.09 per cent from the previous close of Rs 593.75.

More Stories on : Pharmaceuticals | Announcements | Ranbaxy Laboratories Ltd

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