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PharmaDr Reddy's Laboratories, Drug recall, USFDA, Zydus pharma

Dr. Reddy’s Laboratories & Zydus Pharma recalls drugs from U.S.

Leading drug makers Dr Reddy's Laboratories and Zydus Pharma are recalling bottles of a product each, in the US market, for different reasons, according to the latest report of the US health regulator. Dr Reddy's Laboratories, Inc, the US arm of Dr Reddy's Laboratories, is recalling 37,560 bottles of Tizanidine HCl tablets, USP 4 mg, the latest enforcement report by the US Food and Drug Administration (USFDA) said. The tablets are manufactured by Dr Reddy's Laboratories Ltd at its Srikakulam facility, it added. The product is used…

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

Aleor Dermaceuticals has received final approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Testosterone Topical Solution USP, 30 mg per pump actuation, Alembic Pharmaceuticals said in a regulatory filing. Aleor Dermaceuticals has received final approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Testosterone Topical Solution USP, 30 mg per pump actuation, Alembic Pharmaceuticals said in a regulatory filing. Testosterone Topical Solution actuation is indicated for replacement therapy in males for conditions…

Alembic Pharmaceuticals recieves USFDA approval for bipolar depression.

Drug firm Alembic Pharmaceuticals on Friday said it has received final approval from the US health regulator for Lurasidone Hydrochloride tablets, used to treat bipolar depression. The approved product is therapeutically equivalent to the reference listed drug product (RLD) Latuda tablets of Sunovion Pharmaceuticals Inc. The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Lurasidone Hydrochloride tablets in the strengths of 20 mg, 40 mg, 60 mg, 80 mg, and 120 mg, Alembic Pharmaceuticals said in a regulatory filing.Quoting IQVIA data, Alembic Pharma said Lurasidone Hydrochloride…