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New Delhi: Drug important Glenmark Pharma on Thursday said it has received final approval from the US health regulator for Tadalafil tablets, used to treat erectile dysfunction and enlarged prostate. The business also received two tentative approvals in the US health regulator.
Glenmark Pharmaceuticals Ltd has received final approval from the United States Food and Drug Administration (USFDA) for Tadalafil pills USP from the strengths of 2.5 mg, 5 mg, 10 mg and 20 mg, the company said in a regulatory filing.
The approved product is a generic version of Cialis tablets of Eli Lilly and Company.
Quoting IQVIA sales data for the 12 months ending November 2020, Glenmark stated Cialis pills achieved annual sales of approximately USD 125.5 million.
Glenmark has also received tentative approval from the USFDA for Gabapentin Enacarbil extended release tablets, used to treat moderate-to-severe primary Restless Legs Syndrome (RLS), the company said.
The tentatively approved product is a generic version of Horizant extended-release tablets in the advantages of 300 mg and 600 mg, of Arbor Pharmaceuticals, LLC.
Glenmark said it also received tentative approval for Apremilast tablets in the strengths of 10 mg, 20 mg and 30 mg. Apremilast pills are used for the treatment of specific types of psoriasis and psoriatic arthritis and is the generic version of Otezla pills of Amgen, Inc..
Glenmark’s current portfolio consists of 167 products authorised for distribution in the US marketplace and 44 ANDA’s pending approval with the USFDA.
Besides these internal filings, Glenmark continues to identify and explore outside development partnerships to supplement and accelerate the growth of its current pipeline and portfolio.
Shares of Glenmark Pharma were trading 0.48 percent higher at Rs 501.15 apiece on BSE. SVK MR MR