Glenmark Pharmaceuticals on Tuesday announced that it has received final approval from the US Food & Drug Administration (USFDA) for Apremilast Tablets, used in the treatment plaque psoriasis and oral ulcers.
The approval has been received for Apremilast Tablets in strengths of 10 mg, 20 mg and 30 mg. The tablets are the generic version of Amgen Inc’s Otezla tablets, 10 mg, 20 mg and 30 mg, Glenmark said in a filing to the exchanges.
The Otezla tablets had annual sales of around USD 3.7 billion in the 12 months to August 2023, according to IQVIA sales data.
The tablets are used in the treatment of psoriasis arthritis and moderate to severe plaque psoriasis, a certain type of skin condition.
Glenmark Pharma’s portfolio comprises 188 products that are authorised for distribution in the US market. It has 50 ANDA’s pending approval with the USFDA, according to the company.
Glenmark Pharmaceuticals has a presence across branded, generic and OTC segments with a focus on respiratory, dermatology and oncology products.
It has 10 manufacturing facilities spread across four continents, and operations in over 80 countries.
The pharma company last month announced that its subsidiary Glenmark Specialty S.A. had entered into a distribution and license agreement with Cosmo Pharmaceuticals N.V. for Winlevi (Clascoterone cream 1%) in Europe and South Africa.
Glenmark would have the exclusive right to commercialise Winlevi in 15 EU countries, South Africa and the UK.
Winlevbi is suggested for the topical treatment of acne in patients aged 12 years and older.
Glenmark shares are trading 0.63 percent higher at Rs 802.50 on BSE at 9.43 AM, extending their winning run to a third day in a row.
(Edited by : Asmita Pant)
First Published: Oct 17, 2023 10:46 AM IST
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