USFDA

The Food and Drug Administration (FDA) is the regulatory, scientific, public health and consumer protection agency responsible for ensuring all human and animal drugs, medical devices, cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, tobacco and radiation emitting devices are safe, and effective. The mission of the Center for Drug Evaluation and Research (CDER) is to perform an essential public health task by making sure that safe and effective drugs are available to improve the 2 health of people in the United States.

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.

Glenmark Pharmaceuticals Limited (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) for Clindamycin Hydrochloride Capsules USP, 75 mg, 150 mg, and 300 mg, the generic version of Cleocin®1 Hydrochloride Capsules, 75 mg, 150 mg, and 300 mg, of Pfizer Inc. Glenmark’s Clindamycin Hydrochloride Capsules USP, 75 mg, 150 mg, and 300 mg, will be distributed in the U.S. by Glenmark Pharmaceuticals Inc., USA.

Global pharma major Lupin Limited announced that the United States Food and Drug Administration (U.S. FDA) has completed a Pre-Approval and GMP Inspection of its API manufacturing facility located in Visakhapatnam (Vizag), India. The inspection was conducted from March 6 to March 10, 2023 and concluded with no observations.

Marksans Pharma Limited hereby announces that it has received final approval from US Food & Drugs Administration for its Abbreviated New Drug Application (ANDA) of Famotidine Tablets USP, 10 mg and 20 mg for over-the-counter (OTC) use.

The product is bioequivalent to the reference listed drug (RLD), Pepcid AC® tablets, a registered trademark of Johnson & Johnson Consumer Inc. which has sales of over $ 200 million in the US market.

Amneal Pharmaceuticals, Inc. announced the U.S. Food and Drug Administration (FDA) has accepted for review the Abbreviated New Drug Application (ANDA) for naloxone hydrochloride nasal spray, USP, 4mg, which is the generic version of Narcan® and is used in the treatment of a known or suspected opioid overdose emergency.

Alembic Pharmaceuticals Limited announced it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Fluorouracil Injection USP, 2.5 g/50 mL (50 mg/mL) Pharmacy Bulk Vial. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Fluorouracil Injection, 2.5 g/50 mL (50 mg/mL), of Spectrum Pharmaceuticals, Inc. (Spectrum).

Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as “Zydus”) has received final approval from the United States Food and Drug Administration (USFDA) for Apixaban Tablets, 2.5 mg and 5 mg (USRLD: Eliquis® Tablets).

Granules India Limited announced that the US Food & Drug Administration (US FDA) has approved its Abbreviated New Drug Application (ANDA) for Losartan Potassium Tablets USP, 25 mg, 50 mg, and 100 mg.

It is bioequivalent to the reference listed drug product (RLD), Cozaar Tablets of Organon LLC. Granules now has a total of 54 ANDA approvals from US FDA (52 Final approvals and 2 tentative approvals).