USFDA

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.

Zydus Lifesciences Ltd has received final approval from the United States Food and Drug Administration (USFDA) to market Pemetrexed for Injection, in the strengths of 100 mg/vial,500 mg/vial, and 1000 mg/vial Single-Dose Vials (USRLD: Alimta). Pemetrexed is used to treat certain types of cancers such as lung cancer, mesothelioma.

Aurobindo Pharma receives 6 observations after inspection of Aurobindo Pharma Jedcherla plant.

The United States Food and Drug Administration (US FDA) inspected Aurobindo Pharma's Unit VII, an oral manufacturing facility situated at Jedcherla, Hyderabad, from 2nd to 10th May 2022.

Gesynta Pharma AB announces that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to the company's drug candidate GS-248 for the treatment of systemic sclerosis. GS-248 is currently being evaluated in a Phase II clinical trial as a treatment for Raynaud’s phenomenon secondary to systemic sclerosis.

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 the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.