Medical Dialogues
  • Dermatology
Login Register
This site is intended for healthcare professionals only
Login Register
  • Medical Jobs
  • Medical Matrimony
  • MD Brand Connect
  • MDTV
    • Breaking News
    • Medical News Today
    • Health News Today
    • Latest
    • Journal Club
    • Medico Legal Update
    • Latest Webinars
    • MD Shorts
    • Health Dialogues
Medical Dialogues
  • Medical News & Guidelines
      • Anesthesiology
      • Cardiology and CTVS
      • Critical Care
      • Dentistry
      • Dermatology
      • Diabetes and Endocrinology
      • ENT
      • Gastroenterology
      • Medicine
      • Nephrology
      • Neurology
      • Obstretics-Gynaecology
      • Oncology
      • Ophthalmology
      • Orthopaedics
      • Pediatrics-Neonatology
      • Psychiatry
      • Pulmonology
      • Radiology
      • Surgery
      • Urology
      • Laboratory Medicine
      • Diet
      • Nursing
      • Paramedical
      • Physiotherapy
  • Health news
      • Doctor News
      • Government Policies
      • Hospital & Diagnostics
      • International Health News
      • MCI News
      • Medical Organization News
      • Medico Legal News
      • NBE News
      • NMC News
  • AYUSH
    • Ayurveda
    • Homeopathy
    • Siddha
    • Unani
    • Yoga
  • State News
      • Andaman and Nicobar Islands
      • Andhra Pradesh
      • Arunachal Pradesh
      • Assam
      • Bihar
      • Chandigarh
      • Chattisgarh
      • Dadra and Nagar Haveli
      • Daman and Diu
      • Delhi
      • Goa
      • Gujarat
      • Haryana
      • Himachal Pradesh
      • Jammu & Kashmir
      • Jharkhand
      • Karnataka
      • Kerala
      • Ladakh
      • Lakshadweep
      • Madhya Pradesh
      • Maharashtra
      • Manipur
      • Meghalaya
      • Mizoram
      • Nagaland
      • Odisha
      • Puducherry
      • Punjab
      • Rajasthan
      • Sikkim
      • Tamil Nadu
      • Telangana
      • Tripura
      • Uttar Pradesh
      • Uttrakhand
      • West Bengal
  • Medical Education
      • Ayush Education News
      • Dentistry Education News
      • Medical Admission News
      • Medical Colleges News
      • Medical Courses News
      • Medical Universities News
      • Nursing education News
      • Paramedical Education News
      • Study Aborad
  • Industry
      • Health Investment News
      • Health Startup News
      • Medical Devices News
      • Pharma News
      • Pharmacy Education News
      • Industry Perspective
  • MDTV
      • Health Dialogues MDTV
      • Health News today MDTV
      • Latest Videos MDTV
      • Latest Webinars MDTV
      • MD shorts MDTV
      • Medical News Today MDTV
      • Medico Legal Update MDTV
      • Top Videos MDTV
      • Health Perspectives MDTV
      • Journal Club MDTV
This site is intended for healthcare professionals only
LoginRegister
Medical Dialogues
LoginRegister
  • Home
  • Medical news & Guidelines
    • Anesthesiology
    • Cardiology and CTVS
    • Critical Care
    • Dentistry
    • Dermatology
    • Diabetes and Endocrinology
    • ENT
    • Gastroenterology
    • Medicine
    • Nephrology
    • Neurology
    • Obstretics-Gynaecology
    • Oncology
    • Ophthalmology
    • Orthopaedics
    • Pediatrics-Neonatology
    • Psychiatry
    • Pulmonology
    • Radiology
    • Surgery
    • Urology
    • Laboratory Medicine
    • Diet
    • Nursing
    • Paramedical
    • Physiotherapy
  • Health news
    • Doctor News
    • Government Policies
    • Hospital & Diagnostics
    • International Health News
    • MCI News
    • Medical Organization News
    • Medico Legal News
    • NBE News
    • NMC News
  • AYUSH
    • Ayurveda
      • Ayurveda Giuidelines
      • Ayurveda News
    • Homeopathy
      • Homeopathy Guidelines
      • Homeopathy News
    • Siddha
      • Siddha Guidelines
      • Siddha News
    • Unani
      • Unani Guidelines
      • Unani News
    • Yoga
      • Yoga Guidelines
      • Yoga News
  • State News
    • Andaman and Nicobar Islands
    • Andhra Pradesh
    • Arunachal Pradesh
    • Assam
    • Bihar
    • Chandigarh
    • Chattisgarh
    • Dadra and Nagar Haveli
    • Daman and Diu
    • Delhi
    • Goa
    • Gujarat
    • Haryana
    • Himachal Pradesh
    • Jammu & Kashmir
    • Jharkhand
    • Karnataka
    • Kerala
    • Ladakh
    • Lakshadweep
    • Madhya Pradesh
    • Maharashtra
    • Manipur
    • Meghalaya
    • Mizoram
    • Nagaland
    • Odisha
    • Puducherry
    • Punjab
    • Rajasthan
    • Sikkim
    • Tamil Nadu
    • Telangana
    • Tripura
    • Uttar Pradesh
    • Uttrakhand
    • West Bengal
  • Medical Education
    • Ayush Education News
    • Dentistry Education News
    • Medical Admission News
    • Medical Colleges News
    • Medical Courses News
    • Medical Universities News
    • Nursing education News
    • Paramedical Education News
    • Study Aborad
  • Industry
    • Health Investment News
    • Health Startup News
    • Medical Devices News
    • Pharma News
      • CDSCO (Central Drugs Standard Control Organisation) News
    • Pharmacy Education News
    • Industry Perspective
  • Home
  • News
  • Industry
  • Pharma News
  • Aurobindo Pharma...

Aurobindo Pharma subsidiary bags USFDA nod to manufacture, market Diclofenac Sodium Topical Solution

Ruchika SharmaWritten by Ruchika Sharma Published On 2023-02-08T11:15:39+05:30  |  Updated On 8 Feb 2023 10:02 AM GMT
Aurobindo Pharma subsidiary bags USFDA nod to manufacture, market Diclofenac Sodium Topical Solution
  • facebook
  • twitter
  • linkedin
  • whatsapp
  • Telegram
  • koo
  • Email

Diclofenac Sodium Topical Solution USP, 2 % w/w is indicated for the treatment of the pain of osteoarthritis of the knee(s).

Hyderabad: Aurobindo Pharma Limited has announced that its step-down subsidiary company, Aurolife Pharma LLC., has received a final approval from the US Food & Drug Administration (USFDA) to manufacture and market Diclofenac Sodium Topical Solution USP, 2% w/w, which is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Pennsaid Topical Solution, 2%...

Hyderabad: Aurobindo Pharma Limited has announced that its step-down subsidiary company, Aurolife Pharma LLC., has received a final approval from the US Food & Drug Administration (USFDA) to manufacture and market Diclofenac Sodium Topical Solution USP, 2% w/w, which is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Pennsaid Topical Solution, 2% w/w of Horizon Therapeutics Ireland DAC.

The product is expected to be launched in Q1FY24. The approved product has an estimated market size of around US$ 487 million for the twelve months ending December 2022, according to IQVIA.

This is the first ANDA to be approved out of the Aurolife Unit-II, North Carolina, USA, used for manufacturing topical products.

Aurobindo now has a total of 430 ANDA approvals (404 Final approvals and 26 tentative approvals) from USFDA.

Diclofenac Sodium Topical Solution USP, 2% w/w is Indicated for the treatment of the pain of osteoarthritis of the knee(s).

Read also: Aurobindo Pharma arm gets USFDA nod for Azacitidine for Injection to treat myelodysplastic syndrome

Aurobindo Pharma Limited is an integrated global pharmaceutical company headquartered in Hyderabad, India. The Company develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients globally in over 150 countries. The company has 24 manufacturing and packaging facilities that are approved by leading regulatory agencies including USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, Brazil ANVISA. The company’s product portfolio is spread over 7 major therapeutic/product areas encompassing CNS, AntiRetroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics and Anti-Allergic.

Read also: Aurobindo Pharma JV Tergene gets CDSCO panel recommendation for 15-valent Pneumococcal Polysaccharide Conjugate Vaccine

Aurobindo PharmaAurobindo Pharma newsAurolife PharmaUSFDADiclofenac Sodium Topical SolutionPennsaid Topical SolutionHorizon Therapeutics Irelandosteoarthritis
Ruchika Sharma
Ruchika Sharma

    M.Com

    Ruchika joined Medical Dialogue as an Desk Editor for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

    Show Full Article
    Next Story
    Similar Posts
    NO DATA FOUND

    Editorial

    Journal Club Today

    Health News Today

    © 2022 All Rights Reserved.
    Powered By: Hocalwire
    X
    X