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news.Glenmark Generics Limited (GGL) has reported that its US subsidiary Glenmark Generics (GGI) has received final ANDA approval for Moexipril Hydrocholoride 7.5mg and 15 mg tablets from the FDA and is expected to initiate marketing and distribution of the product immediately.
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Moexipril HCl is the generic equivalent of Univasc tablets, marketed by Schwarz. The product is indicated for the treatment of patients with hypertension.
Reportedly, in March 2010, Glenmark has also received ANDA approval for Moexipril Hydrochloride and Hydrochlorothiazide tablets, the generic version of Schwarz Pharmaceuticals’ Uniretic.
Terrance Coughlin, CEO of GGL, said: “Today’s approval signifies Glenmark’s fourth ANDA approval in the final quarter of the fiscal year. We are happy to see our diligence in R&D, the tenacity of our pipeline and filing schedule realised giving us the opportunity to continue to bring quality affordable generic products to our customers.”
GGL said that within the previous six weeks, it has received final ANDA approvals for Ropinirole HCl tablets, Moexipril HCl & Hydrochlorothiazide tablets and Calcipotriene Ointment 0.005%.