Alembic Pharma receives final approval for anti fungal drug

Alembic Pharmaceuticals on Tuesday informed that company's joint venture, Aleor Dermaceuticals has received final approval from US Food and Drug Administration (USFDA) for nystatin and triamcinolone acetonide ointment.

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. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) nystatin and triamcinolone acetonide ointment of Taro Pharmaceuticals U.S.A. Inc.

According to IQVIA, nystatin and triamcinolone acetonide ointment has an estimated market size of $4 million for twelve months ending December 2021. Alembic said it has received year to date 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.

Shares of Alembic Pharma were trading 0.58% higher at Rs 714.85 on BSE. Meanwhile, the barometer index, the S&P BSE Sensex declined 192.13 points or 0.36% to 52,650.62 amid soaring crude oil prices and ongoing Russia-Ukraine crisis.

Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world. On a consolidated basis, the company reported a 39.7% fall in net profit to Rs 176.42 crore on a 3.2% fall in net sales to Rs 1,271.7 crore in Q3 FY22 over Q3 FY21.

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