Two Alembic Pharma drugs get USFDA approval; estimated market size is USD 4 million

Alembic Pharmaceuticals joint venture Aleor Dermaceuticals received the final nod from USFDA for Nystatin and Triamcinolone Acetonide Ointment USP, 100,000 units/gram.

Alembic Pharmaceuticals today announced that its joint venture Aleor Dermaceuticals Limited (Aleor) has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Nystatin and Triamcinolone Acetonide Ointment USP, 100,000 units/gram.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Nystatin and Triamcinolone Acetonide Ointment USP, 100,000 U/g/0.1%, of Taro Pharmaceuticals U.S.A. Inc. Nystatin and Triamcinolone Acetonide Ointment is indicated for the treatment of cutaneous candidiasis; it has been demonstrated that the nystatin-steroid combination provides greater benefit than the nystatin component alone during the first few days of treatment.

Nystatin and Triamcinolone Acetonide Ointment has an estimated market size of US$ 4 million for twelve months ending December 2021 according to IQVIA.

Alembic has received year to date (YTD) 21 approvals (15 final approvals and 6 tentative approvals) and· a cumulative total of 160 ANDA approvals (138 final approvals and 22 tentative approvals) from USFDA.

Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company that has been at the forefront of healthcare since 1907. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. Alembic's state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA. Alembic is one of the leaders in branded generics in India. Alembic's brands, marketed through a marketing team of over 5000 are well recognized by doctors and patients.

Aleor is a 60:40 joint venture between Alembic and Orbicular Pharmaceutical Technologies Pvt Ltd (Orbicular) formed in Apr'16 focusing on commercialising dermatology products globally.

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