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Company Watch
Glenmark Generics receives ANDA approvals
Our News Bureau - Mumbai
 Glenmark
Generics Limited (GGL), a subsidiary of Glenmark has received ANDA approvals
for mometasone furoate ointment USP, 0.1 percent, mometasone furoate cream USP,
0.1 percent and metformin hydrochloride tablets USP 500 mg, 850 mg and 1,000
mg and will soon commence marketing and distribution of these products in 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,
antipruritic, and vasoconstrictive properties. The total sales for the two mometasone
furoate products in the 12 month period ending March 2008 were in excess of
$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 MHRA of 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
glycemic control in patients with type II diabetes.
As of 2007, it is one of only two oral anti-diabetics in the World Health Organisation
model list of essential medicines (the other being Glibenclamide). The total
sales for metformin hydrochloride tablets in the 12 month period ending March
2008 were in excess of $158 million as per IMS Health.
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