The Hindu : Ranbaxy gets U.S. FDA nod to manufacture Lisinopril

Online edition of India's National Newspaper
Thursday, Jul 04, 2002

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Ranbaxy gets U.S. FDA nod to manufacture Lisinopril

NEW DELHI JULY 3. Ranbaxy Laboratories today (RLL) said it has got final approval from the U.S. FDA to manufacture and market Lisinopril single entity and combination tablets.

"RLL has received final approval from the U.S. FDA to manufacture and market Lisinopril+ Hydrochlorothiazide tablets in 10/12.5 mg, 20/12.5 mg and 20/25 mg,'' a company release said here.

The company has also received final approval from the U.S. FDA to manufacture and market Lisinopril tablets in 2.5 mg, 5 mg, 10 mg, 20 mg and 40 mg.

Based on this approval, all strengths of this combination product will be available along with Lisinopril as single entity formulations.

Under the circumstances, Ranbaxy will be one of the four companies that will have approval for both the single entity and combination product of Lisinopril.

Lisinopril+ Hydrochlorothiazide is indicated for the treatment of hypertension while Lisiopril as a single entity is used for hypertension either alone as initial therapy or concomitantly with other classes of anti-hypertension agents.

— PTI

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