Lupin bags USFDA nod for Doxycycline Hyclate Delayed Release Tablets

Published On 2023-08-14 11:00 GMT   |   Update On 2023-08-14 11:00 GMT
Advertisement

Mumbai: Global pharma major Lupin Limited today announced that the company has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Doxycycline Hyclate Delayed-Release Tablets USP, 50 mg, 60 mg, 75 mg, 80 mg, 100 mg, 120 mg, 150 mg, and 200 mg.

The product is a generic equivalent of Doryx Delayed-Release Tablets, 50 mg, 75 mg, 80 mg, 100 mg, 150 mg, and 200 mg and Doryx MPC Delayed-Release Tablets, 60 mg and 120 mg, of Mayne Pharma International Pty. Ltd.

This product will be manufactured at Lupin’s Pithampur facility in India.

Doxycycline Hyclate Delayed-Release Tablets USP (RLD Doryx) had estimated annual sales of USD 9 million in the U.S. (IQVIA MAT June 2023).

Read also: ­Lupin Digital Health unveils Digital Heart Failure Clinic in India

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.

The Company specializes 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. The company invested 7.9% of its revenue in research and development in FY23. Lupin has 15 manufacturing sites, 7 research centers.

Read also: Lupin bags USFDA nod for Fluocinolone Acetonide Body Oil



Tags:    

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.

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 .

Similar News