Zydus Cadila gets USFDA’s nod for Vardenafil Hydrochloride tablets, Ursodiol tablets

Zydus Cadila has launched Vardenafil Hydrochloride Tablets (US RLD – LEVITRA Tablets), 2.5 mg, 5 mg, 10 mg and 20 mg in the US market upon receiving the final approval from the US Food and Drug Administration (USFDA). Manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad, the medication is indicated for the treatment … Read more

Glenmark receives USFDA’s final approval for Fluocinolone Acetonide Topical Oil

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (USFDA) for Fluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil), a generic version of Derma-Smoothe/FS Topical Oil, 0.01% (Scalp Oil), of Hill Dermaceuticals, Inc. According to IQVIA sales data for the 12 month period ending September 2018, the … Read more

USFDA inspects Alembic Pharmaceuticals’ general oral solid formulation facility

The US Food and Drug Administration (USFDA) has completed an inspection at Alembic Pharmaceuticals’ general oral solid formulation facility at Panelav, Gujarat, India. The facility was inspected from October 22, 2018 to October 26, 2018. At the end of the inspection, the US FDA issued a Form 483 with four procedural observations. The company will … Read more

Zydus Cadila gets final approval from USFDA for Clobazam Tablets

Zydus Cadila has received the final approval from the US Food and Drug Administration (USFDA) to market Clobazam Tablets, (US RLD-ONFI Tablet), 10 mg and 20 mg. It will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad. Clobazam is used in combination with other medications to treat seizures caused by a paediatric … Read more

Lupin receives USFDA’s approval for generic Triamcinolone Acetonide Ointment

Lupin has received approval for its Triamcinolone Acetonide Ointment USP, 0.1% from the United States Food and Drug Administration (FDA) to market a generic version of Mylan Pharmaceuticals, Inc.’s (Mylan) Triamcinolone Acetonide Ointment, 0.1%. Lupin’s Triamcinolone Acetonide Ointment USP, 0.1% is the generic version of Mylan’s Triamcinolone Acetonide Ointment, 0.1%. It is indicated for the … Read more

Alembic Pharmaceuticals rises on its JV clearing first USFDA inspection at its Gujarat facility

Alembic Pharmaceuticals is currently trading at Rs. 616.05, up by 7.95 points or 1.31% from its previous closing of Rs. 608.10 on the BSE. The scrip opened at Rs. 619.35 and has touched a high and low of Rs. 621.00 and Rs. 614.00 respectively. So far 992 shares were traded on the counter. The BSE … Read more

Alembic Pharmaceuticals’ JV clears first USFDA inspection at its Gujarat facility

Alembic Pharmaceuticals and Orbicular Pharmaceutical Technologies’ Joint Venture (JV) Company — Aleor Dermaceuticals has successfully cleared its first United States Food and Drugs Administration (USFDA) inspection of its new formulation manufacturing facility located at Karakhadi in the state of Gujarat; without any observations. The scheduled inspection was carried out between October 15, 2018 and October … Read more

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