Glenmark Generics Ltd (GGL), a subsidiary of Glenmark Pharmaceuticals Ltd. (Glenmark), has received ANDA approvals for mometasone furoate ointment USP, 0.1 per cent.
Mometasone furoate cream USP, 0.1 per cent and metformin hydrochloride tablets USP 500 mg, 850 mg and 1000 mg and will soon commence marketing and distribution of these products in the US market.
Mometasone furoate is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Like other topical corticosteroids, mometasone furoate has anti-inflammatory, anti-pruritic, and vasoconstrictive properties. The total sales for the two mometasone furoate products in the 12 month period ending March 2008 were in excess of US $29 million, as per IMS Health.
Mometasone will be manufactured at Glenmark's Baddi facility in India. Glenmark has recently received US FDA approval for its state of the art semi-solids manufacturing plant at Baddi, Himachal Pradesh. The Baddi plant also received GMP approval from UK MHRA UK, and from TPD, Canada. The US FDA approval will now enable Glenmark to enter the niche segment of semi-solid dosages in most of the regulated markets of the world.
Glenmark is a leader in the dermatology segment in India with brands like Candid, Candid TV, Candiderma and has over 30 brands in the domestic market.
GGL had earlier acquired the US marketing rights for a line of Clobetasol Propionate dermatology products that include - cream, E cream, ointment, gel and topical solution through a US based pharmaceutical development company. The company commenced marketing and distribution of these products in March.
Metformin hydrochloride tablets as monotherapy are indicated as an adjunct to diet and exercise to improve glycaemia control in patients with type 2 diabetes.