Global pharmaceutical company Lupin Limited has announced its receipt of approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Allopurinol Tablets USP, 100 mg and 300 mg. This approval enables Lupin to market a generic equivalent to Zyloprim Tablets, 100 mg and 300 mg, of […]
Rusan Pharma, a global leader in healthcare and addiction treatment solutions, has recently achieved a groundbreaking milestone with the launch of its state-of-the-art Active Pharmaceutical Ingredients (API) facility in Pithampur, Special Economic Zone (SEZ), Madhya Pradesh. This strategic move underscores Rusan Pharma’s commitment to combating the increasing challenges in pain management and addiction, while significantly […]
Global pharmaceutical giant Lupin Limited announced its receipt of approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Pitavastatin Tablets in 1 mg, 2 mg, and 4 mg dosages. These tablets are set to be a generic equivalent of Livalo Tablets by Kowa Company Limited, […]
Lupin Limited, a recognized global pharmaceutical powerhouse, proudly announced its receipt of the much-anticipated approval from the US Food and Drug Administration (FDA). This authorization paves the way for its Abbreviated New Drug Application concerning Fluconazole Tablets USP in varying strengths: 50 mg, 100 mg, 150 mg, and 200 mg. These tablets are designed to […]
In a significant stride for global pharmaceuticals, Lupin Limited has garnered tentative approval from the United States Food and Drug Administration (U.S. FDA) to introduce its generic version of Apalutamide Tablets, 60 mg, echoing the renowned Erleada Tablets by Janssen Biotech, Inc. With an aim to tap into the vast US market, Lupin’s Abbreviated New […]
Lupin Limited announced today that it has secured approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Pirfenidone Tablets, 267 mg and 801 mg. These tablets are the generic equivalent of Esbriet Tablets, a product of Hoffmann La Roche Inc. The tablets will be manufactured […]
Global pharmaceutical titan, Lupin Limited, has officially declared its success in securing the esteemed approval from the United States Food and Drug Administration (FDA). This sanction is specific to Lupin’s Abbreviated New Drug Application (ANDA) for Bromfenac Ophthalmic Solution at a concentration of 0.09%. With this, Lupin is now green-lighted to market its version as […]
Lupin Limited, a dominant player in the global pharmaceutical landscape, announced its triumph in obtaining the coveted approval from the United States Food and Drug Administration (FDA). This authorization is for Lupin’s Abbreviated New Drug Application (ANDA) for Metoprolol Succinate Extended-Release Tablets USP in the concentrations of 25 mg, 50 mg, 100 mg, and 200 […]
Global pharmaceutical corporation, Lupin Limited has received the Establishment Inspection Report (EIR) from the US Food and Drug Administration (FDA) for its Pithampur Unit-2 facility in Madhya Pradesh. This manufacturing unit, which produces oral solids and ophthalmic dosage forms, underwent its last inspection from March 21 to March 29, 2023. The US FDA classified the […]
Indian pharma titan Lupin has announced receiving approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application for Tiotropium Bromide Inhalation Powder, 18 mcg/capsule. This medication is a generic equivalent of Spiriva HandiHaler (Tiotropium Bromide Inhalation Powder), an 18 mcg/capsule product of Boehringer Ingelheim Pharmaceuticals, Inc. Lupin will manufacture this […]