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ePT--the Electronic Newsletter of Pharmaceutical Technology
Ranbaxy Gains FDA Approvals
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Ranbaxy Laboratories has gained approvals from the US Food and Drug Administation to manufacture and market galantamine hydrobromide tablets and carvedilol tablets.
Gurgaon, Hayana, India (Sept. 6)-Ranbaxy Laboratories has gained approvals from the US Food and Drug Administation to manufacture and market galantamine hydrobromide tablets (4, 8, and 12 mg), for the treatment of dementia caused by Alzheimer’s disease, and carvedilol tablets (3.125, 6.25, 12.5, and 25 mg), the bioequivalent of the cardiovascular health drug “Coreg” (GlaxoSmithKline).
Approval for galantamine is tentative and grants the Ranbaxy Pharmaceuticals (Jacsonville, FL) a 180-day market exclusivity period. Upon final approval, Ranbaxy will launch the galantamine tablets in mid-December.
The carvedilol tablets will be manufactured at the company’s Ohm Laboratories facilities in New Brunswick, New Jersey.
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