Lupin's Efinaconazole Topical Solution gets USFDA nod

Lupin today announced that it has received approval from the USFDA for its ANDA, Efinaconazole Topical Solution, 10%to market a generic equivalent of Jublia Topical Solution, 10%, of Bausch Health Americas, Inc..;

Published On 2022-03-04 06:39 GMT | Update On 2022-03-05 04:51 GMT

Mumbai: Global pharma major Lupin Limited (Lupin) today announced that it has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), Efinaconazole Topical Solution, 10%to market a generic equivalent of Jublia® Topical Solution, 10%, of Bausch Health Americas, Inc. The product will be manufactured at Lupin's facility in Pithampur, India.

Efinaconazole Topical Solution, 10%(RLD: Jublia® Topical Solution, 10%) had estimated annual sales of USD 274million in the U.S. (IQVIA MAT December 2021).

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.Lupin's R&D effort is aligned with our enterprise goal — to bring affordable, quality medicines to market in order to address unmet patient needs.

The Company enjoys a leadership position in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women's health areas. Lupin commenced operations as a manufacturer of vitamins, and soon started producing drugs to combat tuberculosis (TB). Over the years, Lupin has grown and expanded into new areas and regions, manufacturing drugs that extend the promise of good health to communities across the globe. Beginning with two employees — a peon-cum-packer and a part-time typist — Lupin's current global footprint spans 11 countries, across six continents. The Intellectual Property Management Group (IPMG) at Lupin is responsible for creating, securing and leveraging advanced research to build a high-value portfolio of patents, products and research pipeline products.

Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.

NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.

MD Bureau

Medical Dialogues Bureau consists of a team of passionate medical/scientific writers, led by doctors and healthcare researchers. Our team efforts to bring you updated and timely news about the important happenings of the medical and healthcare sector. Our editorial team can be reached at editorial@medicaldialogues.in.

Comments Policy

Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .

Lupin's Efinaconazole Topical Solution gets USFDA nod

Lupin today announced that it has received approval from the USFDA for its ANDA, Efinaconazole Topical Solution, 10%to market a generic equivalent of Jublia Topical Solution, 10%, of Bausch Health Americas, Inc..;

Similar News

Lupin bags USFDA approval for Multiple myeloma treatment

Biocon Biologics wins USFDA nod for Bosaya and Aukelso, Denosumab Biosimilars

Cocrystals of Approved APIs to Be Treated as New Drugs, Clarifies CDSCO

India ranks among top global contributors in adverse event reporting: DCGI

Marketers Linked to Defaulting Pharma Units Under DCGI Lens

Intas Pharma Secures CDSCO Panel Approval for Post-Marketing Study of Tacrolimus Enema

Health Authorities Crack Down on OTC Sale of Antibiotics, NRx Drugs in Visakhapatnam

Merck gets USFDA Breakthrough Therapy Designation for Raludotatug deruxtecan for Platinum-Resistant Ovarian Cancer