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Glenmark Pharmaceuticals

Glenmark receives ANDA approval for metformin hydrochloride extended-release tablets

Glenmark receives ANDA approval for metformin hydrochloride extended-release tablets

MUMBAI, India — Glenmark Pharmaceuticals has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for metformin hydrochloride extended-release tablets USP, 500 mg and 1000 mg, the generic version of Glumetza Extended-Release Tablets, 500 mg and 1000 mg, of Salix Pharmaceuticals Inc. According to IQVIA sales data for the 12-month

Glenmark receives ANDA approval for adapalene and benzoyl peroxide gel

Glenmark receives ANDA approval for adapalene and benzoyl peroxide gel

MUMBAI, India —  Glenmark Pharmaceuticals has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for adapalene and benzoyl peroxide gel, 0.1% 2.5%, the generic version of Epiduo Gel, 0.1% 2.5%, of Galderma Laboratories. According to IQVIA sales data for the 12 month period ending September 2019, the Epiduo Gel,  0.1%|2.5%

Glenmark receives ANDA approval for clobetasol propionate foam

Glenmark receives ANDA approval for clobetasol propionate foam

MUMBAI — Glenmark  Pharmaceuticals has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for clobetasol propionate foam, 0.05% (Emulsion Formulation), a generic version of Olux 1-E Foam, 0.05%, from Mylan. According to IQVIATM sales data for the 12 month period ending July 2019, the Olux-E Foam, 0.05% market achieved

Glenmark gets FDA’s nod for generic Vesicare

Glenmark gets FDA’s nod for generic Vesicare

BALTIMORE — Glenmark Pharmaceuticals has gotten the okay from the Food and Drug Administration for solifenacin succinate tablets, in 5 mg and 10 mg dosages strengths. Solifenacin succinate tablets are the generic of Astellas Pharma’s Vesicare tablets, 5 mg and 10 mg. The product had a market value of roughly $942.7 million for the 12

Glenmark gets okay for generic acne solution

Glenmark gets okay for generic acne solution

PARAMUS, N.J. – Glenmark Pharmaceuticals has received the Food and Drug Administration’s approval for generic BenzaClin (clindamycin and benzoyl peroxide gel, 1%/5%). The product, which is an acne treatment, is a generic of Valeant Bermuda’s branded product. BenzaClin gel, 1%/5% had a market value of approximately $99.4 million for the 12 month period ended January

Glenmark to spin off its innovation business into a new company in the U.S.

Glenmark to spin off its innovation business into a new company in the U.S.

PARAMUS, N.J. — Glenmark Pharmaceuticals announced that its board of directors has given an in-principle approval to spin off the innovation business into a new company in the U.S. Setting up of the new company will provide an enhanced focus to the innovation business and help accelerate the pipeline towards commercialization. The new innovation company will

Glenmark opens U.S. manufacturing plant in Monroe, N.C.

Glenmark opens U.S. manufacturing plant in Monroe, N.C.

PARAMUS, N.J. – Glenmark Pharmaceuticals, a global pharmaceutical company, announced the official inauguration of its manufacturing site in Monroe, N.C. The Monroe facility will serve as the first manufacturing site for Glenmark in the United States, and the company anticipates the site will grow well beyond its current 168 employees. The Glenmark site is the

FDA approves sANDA for Glenmark Pharmaceuticals’ Monroe facility

FDA approves sANDA for Glenmark Pharmaceuticals’ Monroe facility

PARAMUS, N.J. — Glenmark Pharmaceuticals announced that the U.S. Food & Drug Administration provided its first supplemental Abbreviated New Drug Application (sANDA) approval for the company’s manufacturing facility in Monroe, N.C. The approval covers: atovaquone and proguanil hydrochloride tablets, 250 mg/100 mg and 62.5 mg/25 mg, a generic version of GlaxoSmithKline’s Malarone (atovaquone and proguanil hydrochloride)

Glenmark cleared to market Nitrostat generic

Glenmark cleared to market Nitrostat generic

MUMBAI, India — Glenmark Pharmaceuticals Inc. USA has received final approval from the Food and Drug Administration for nitroglycerin sublingual tablets in strengths of 0.3 mg, 0.4 mg and 0.6 mg. Glenmark said Wednesday that its nitroglycerin product, which is placed under the tongue, is a generic version of Nitrostat sublingual tablets (0.3 mg, 0.4

Glenmark cleared to market Evista generic

Glenmark cleared to market Evista generic

MUMBAI, India — Glenmark Pharmaceuticals Inc. USA has received final approval from the Food & Drug Administration for raloxifene hydrochloride tablet. Glenmark said Wednesday that its raloxifene product is a generic equivalent of Evista tablets (60 mg) from Eli Lilly and Co. Raloxifene, which reduces the loss of bone tissue, is indicated for the treatment

FDA approves Zyvox generic from Glenmark

FDA approves Zyvox generic from Glenmark

MUMBAI, India — Glenmark Pharmaceuticals Inc. USA has been granted approval from the Food and Drug Administration for linezolid tablets 600 mg, an antibiotic. Glenmark said its linezolid product is a therapeutic equivalent of Zyvox tablets 600 mg from Pfizer Inc. Linezolid is indicated for the treatment of various types of bacterial infections, including pneumonia,

Glenmark cleared to market Lotrisone generic

Glenmark cleared to market Lotrisone generic

MUMBAI, India — Glenmark Pharmaceuticals Inc. USA has received approval from the Food & Drug Administration for clotrimazole and betamethasone dipropionate cream 1%/0.05%, a topical antifungal medication. Glenmark said Monday that its  clotrimazole and betamethasone dipropionate cream product is a generic version of Lotrisone cream 1%/0.05% from Merck, Sharp and Dohme Corp. Lotrisone is indicated

Glenmark ships Dovonex generic

Glenmark ships Dovonex generic

MUMBAI, India — Glenmark Pharmaceuticals Inc. USA has been granted final approval by the Food and Drug Administration for calcipotriene cream, a psoriasis medication. Glenmark said Thursday that it plans to begin shipping of its calcipotriene cream product, a generic version of Dovonex Cream 0.005% from Leo Pharma A/S, immediately. A form of vitamin D,