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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 3:32 PM IST
Aurobindo Pharma arm CuraTeQ Biologics completes successful Phase 1 Pharmacokinetics study of bone drug
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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% 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

    Ruchika Sharma joined Medical Dialogue as an Correspondent 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

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