USFDA

Unichem Laboratories Limited is an international, integrated, specialty pharmaceutical company. It manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in several markets across the world. In India, The Company has strong skills in product development, process chemistry and manufacturing complex API as well as dosage forms.

Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) to market Prochlorperazine Maleate tablets, USP 5 mg and 10 mg.

Prochlorperazine tablets are used to treat nervous, emotional, and mental conditions (eg. schizophrenia) and non-psychotic anxiety. It is also used to control severe nausea and vomiting. The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India.

The U.S. Food and Drug Administration prioritizes the health and safety of American consumers and patients as well as animals and uses a variety of tools for the appropriate oversight of FDA-regulated products and establishments. With manufacturers and supply chains dispersed around the world, the FDA works to help ensure that only products that meet our rigorous standards reach the U.S. marketplace.

Natco Pharma Limitedannounces that the U.S. Food and Drug Administration has granted approval to its partner Breckenridge Pharmaceutical Inc’s Abbreviated New Drug Application for Cabazitaxel Intravenous Powder (generic for Jevtana Kit) for the 60mg/1.5mL (40mg/mL) strength.

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products and APIs in over 100 markets in the U.S., India, South Africa and across Asia Pacific (APAC), Latin America (LATAM), Europe and Middle-East regions.

U.S. FDA has issued Form 483 with six observations after an inspection at Glenmark Pharma's formulation manufacturing facility based out of Baddi, India between June 13, 2022 and June 22, 2022.

Harish Kuber, Company Secretary & Compliance Officer, Glenmark Pharma said, The Company is committed to undertake all necessary steps required to address their observations at the earliest. The Company is committed to maintaining the highest quality manufacturing standards at all of its facilities across the globe.

Eli Lilly and Company and Incyte announced that the U.S. Food and Drug Administration (FDA) has approved OLUMIANT (baricitinib), a once-daily pill, as a first-in-disease systemic treatment for adults with severe alopecia areata (AA), available as 4-mg, 2-mg and 1-mg tablets.  The recommended dose is OLUMIANT 2-mg/day, with an increase to 4-mg/day if treatment response is inadequate. For patients with nearly complete or complete scalp hair loss, with or without substantial eyelash or eyebrow hair loss, consider treating with 4-mg/day.

Alembic Pharmaceuticals Limited announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dasatinib Tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Sprycel Tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg, of Bristol Myers Squibb Company (BMS).

Amneal Pharmaceuticals, Inc.announced that the U.S. Food and Drug Administration has approved the Company’s Biologics License Applicationfor pegfilgrastim-pbbk, a biosimilar referencing Neulasta. The product will be marketed under the proprietary name FYLNETRA.