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breast cancer: Gland Pharma gets USFDA nod for generic breast cancer drug

Gland Pharma has received approval from the USFDA to market a generic medication for breast cancer treatment, Eribulin Mesylate Injection. It's expected to be the first generic approval in the market, with sales of around USD 92 million in the US.

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India News | Alembic Pharma Gets Final USFDA Nod for Generic Version of Arformoterol Tartrate Inhalation Solution

Get latest articles and stories on India at LatestLY. Alembic Pharmaceuticals Ltd on Wednesday said it has received final approval from the US health regulator for its generic version of Arformoterol Tartrate inhalation solution indicated for long-term treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease.
India News | Alembic Pharma Gets Final USFDA Nod for Generic Version of Arformoterol Tartrate Inhalation Solution.

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Alembic Pharma gets final USFDA nod for generic - Jammu Kashmir Latest News | Tourism

version of Arformoterol Tartrate inhalation solutionNew Delhi, May 11: Alembic Pharmaceuticals Ltd on Wednesday said it has received final approval from the US health regulator for its generic version of Arformoterol Tartrate inhalation solution indicated for long-term treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease. The approval by the US Food & Drug Administration (USFDA) for the abbreviated new drug application (ANDA) for Arformoterol Tartrate inhalation solution is for strength of 15 mcg (base)/2 mL unit-dose vial, the […]

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Alembic Pharmaceuticals acquires 100% stake in Aleor Dermaceuticals

Aleor has product offerings across cream, gel, ointment, shampoo, lotion, solutions, sprays, foams, microsponge and nanoparticulate platform-based products.

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Alembic Pharma JV Aleor Dermaceuticals gets USFDA nod for testosterone topical solution

Alembic Pharma JV Aleor Dermaceuticals gets USFDA nod for testosterone topical solution
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Aleor's ANDA for treatment of cutaneous candidiasis gets USFDA nod

Aleor’s ANDA for treatment of cutaneous candidiasis gets USFDA nod
April 01, 2021
ANDA is for Nystatin and Triamcinolone Acetonide Cream USP to be marketed in US
Alembic Pharmaceuticals Limited’s joint venture Aleor Dermaceuticals Limited (Aleor) has received final approval from the US drug regulator, US Food & Drug Administration (USFDA), for an Abbreviated New Drug Application (ANDA) for Nystatin and Triamcinolone Acetonide Cream USP, the company informed.
Aleor is a 60:40 joint venture between Alembic Pharmaceuticals Limited and Orbicular Pharmaceutical Technologies Pvt Ltd (Orbicular) focused on commercialising dermatology products globally.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Nystatin and Triamcinolone Acetonide Cream USP, 100,000 units/gram and 1 mg/gram, of Taro Pharmaceuticals U.S.A. Inc, an official statement said here.

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