Ranbaxy gets USFDA nod

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Posted: Tuesday, Mar 10, 2009 at 0007 hrs IST
Updated: Tuesday, Mar 10, 2009 at 0007 hrs IST

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New Delhi: Even as Ranbaxy’s share price continued to tumble on Monday, the pharma company obtained it’s third abbreviated new drug approval (ANDA) from US (Food and Drug Administration) FDA since the start of the year, to manufacture and market cardio-vascular drug Ramipril.

The other two drugs to be approved this year are migraine drug, Imitrex and blood pressure drug Quinapril Hydrochloride and Hydrochlorothiazide. Ranbaxy announced on Monday, that it has received an approval from USFDA to market and manufacture Ramipril capsules 5 mg and 10 mg. Pharma analysts peg the US market size for Ramipril at $380 to $400 million but analysts point out that the market for the drug is already fragmented as the drug has gone off-patent and marketing approvals have been granted to other players including Lupin. “The Office of generic drugs, USFDA, had determined the Ranbaxy formulations to be bioequivalent and as having the same therapeutic effect as that of the reference listed drug, Altace by King Pharmaceuticals Inc,” Ranbaxy said in a statement. The application for all the three drugs were submitted by Ranbaxy from Ohm Laboratories, the company’s manufacturing facility, located in North Brunswick, New Jersey, USA. The BP drug Quinapril + HCTZ tablets, generic equivalent of Pfizer’s Accuretic tablets for which Ranbaxy, was granted permission to market drugs of strength 10mg/12.5mg, 20mg /12.5mg and 20mg/25mg, records an estimated annual market sales of $29 million in the US market. Early this year, Ranbaxy received nod to market anti-migraine drug of Imitrex, 100mg. The annual sales of Glaxo SmithKline’s Imitrex tablets, available in three strengths, 25mg, 50mg and 100 mg stand at roughly $1 billion in the United States market according to IMS sales data. However, the downslide of Ranbaxy continued as it closed at Rs 135, marginally higher than the 52 weeks low, down 4.4% since previous closing.

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