Alembic Pharma JV Aleor Derma gets USFDA nod for Mupirocin Cream

Written by Ruchika Sharma Published On 2021-11-17T15:39:43+05:30 | Updated On 17 Nov 2021 3:39 PM IST

Alembic Pharma JV Aleor Derma gets USFDA nod for Mupirocin Cream

Mumbai: Alembic Pharmaceuticals Limited today announced that its joint venture Aleor Dermaceuticals Limited has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Mupirocin Cream USP, 2%.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Bactroban Cream, 2%, of SmithKline Beecham(Cork) Ltd, Ireland (SmithKline).

Mupirocin Cream USP, 2% is indicated for the treatment of secondarily infected traumatic skin lesions (up to 10 cm in length or 100 cm2 in area) due to susceptible strains of S. aureus and S. pyogenes.

Aleor has been granted a Competitive Generic Therapies (CGT) designation for this ANDA and it is eligible for 180 days of CGT exclusivity as it is the first approved applicant.

Mupirocin Cream USP, 2% has an estimated market size of US$ 28 million for twelve months ending Jun 2021 according to IQVIA.

Alembic has received year to date (YTD) 13 approvals (10 final approvals and 3 tentative approvals) and a cumulative total of 152 ANDA approvals (133 final approvals and 19 tentative approvals) from USFDA.

Aleor Dermaceuticals Limited had earlier received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Nystatin and Triamcinolone Acetonide Cream USP, 100,000 units/gram and 1 mg/gram.

Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company headquartered in Gujarat.

Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world.

Read also: Alembic Pharma bags USFDA nod for Clomipramine Hydrochloride Capsules to treat OCD

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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