PP_1170x120_10-25-21

Glenmark Pharmaceuticals

Glenmark inks agreement with AstraZeneca to commercialize its product Pulmicort Respules in Colombia

Glenmark inks agreement with AstraZeneca to commercialize its product Pulmicort Respules in Colombia

BOGOTA, Colombia —  Glenmark Pharmaceuticals announced that its subsidiary Glenmark Pharmaceuticals Colombia S.A.S. and AstraZeneca Colombia S.A.S. have entered into an exclusive licensing agreement for the commercialization of AstraZeneca’s drug Pulmicort Respules. Under the terms of the agreement, AstraZeneca remains the holder of the registration for Pulmicort Respules and will be responsible for manufacturing and supplying

Glenmark receives ANDA approval for arformoterol tartrate inhalation solution

Glenmark receives ANDA approval for arformoterol tartrate inhalation solution

MUMBAI, India — Glenmark Pharmaceuticals has received final approval by the United States Food & Drug Administration (U.S. FDA) for arformoterol tartrate inhalation solution, 15 mcg/2 mL, Unit-Dose Vials, the generic version of Brovana Inhalation Solution, 15 mcg/2 mL, of Sunovion Pharmaceuticals. Arformoterol tartrate inhalation solution, 15 mcg/2 mL, Unit-Dose Vials will be manufactured in

Glenmark gets ANDA approval for dimethyl fumarate delayed-release capsules

Glenmark gets ANDA approval for dimethyl fumarate delayed-release capsules

MUMBAI, India — Glenmark Pharmaceuticals has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for dimethyl fumarate delayed-release capsules, 120 mg and 240 mg, the generic version of Tecfidera1 Delayed-Release Capsules, 120 mg and 240 mg, of Biogen. According to IQVIATM sales data for the 12 month period ending

Glenmark to commence new phase 3 clinical trial for COVID-19 in India

Glenmark to commence new phase 3 clinical trial for COVID-19 in India

MUMBAI, India — Glenmark Pharmaceuticals announced a new randomized, open-label study to test the combined efficacy of two antiviral drugs Favipiravir and Umifenovir as a potential COVID-19 treatment strategy. Favipiravir is an oral antiviral drug approved in Japan since 2014. It has a unique mechanism of action by which it inhibits viral replication: Umifenovir is another oral

Glenmark pledges meals for undernourished children, pregnant women and daily wage earners amidst COVID-19 pandemic

Glenmark pledges meals for undernourished children, pregnant women and daily wage earners amidst COVID-19 pandemic

MUMBAI, India — As millions across the country grapple with the COVID-19 pandemic, Glenmark Foundation, the CSR arm of Glenmark Pharmaceuticals along with its NGO partners, is working closely in alignment with government directives and state health authorities to extend its support – through a combination of on-ground and remote health initiatives. Glenmark’s community outreach

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