FDA approves two generics from Glochem Industries

WASHINGTON Glochem Industries, an Indian active pharmaceutical ingredients manufacturer, announced Food and Drug Administration approval for its products amlodipine besilate and cetirizine dihydrochloride, according to Pharmabiz, an Indian pharmaceutical news portal.

According to the company, amlodipine besilate, the generic form of Pfizer’s Norvasc) is used as an antihypertensive and cetirizine dihydrochloride (Pfizer’s Zyrtec) is an antihistamine.

The product patent for amlodipine besilate and cetirizine dihydrochloride in the U.S. will expire in September and January 2008, respectively, Pharmabiz reported.