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USFDA inspection at Karakhadi unit completed without any observations: Alembic

Vadodara: Alembic Pharmaceuticals on Monday said the United States Food and Drug Administration (USFDA) successfully completed the inspection of its derma facility located at Karakhadi in Vadodara, Gujarat, without any observations.

According to a company statement released on Monday, the inspection was done between March 6 and March 10 this year.

Alembic had posted a 29 per cent decline in its net profit to Rs 121.92 crore for the third quarter despite 18.7 per cent surge in net sales to Rs 1,509.02 crore in Q3FY23 over Q3FY22.

The shares of the company dropped 2.09 per cent to Rs 61 apiece on BSE. In a span of five days, the shares dropped 2.70 per cent.

In December last year, Alembic announced that it received final approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Desonide Cream, 0.05 per cent, an ointment used for the treatment of skin conditions.

According to a statement from the Vadodara-headquartered pharma firm, the ANDA was filed by Aleor Dermaceuticals (Aleor) which was amalgamated with Alembic. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Desonide Cream, 0.05 per cent, of Padagis US. Desonide Cream, 0.05 per cent, is a low-potency corticosteroid indicated for the relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Desonide Cream, 0.05 per cent, has an estimated market size of USD 12 million for twelve months ending September 2022, according to pharma firm IQVIA.

Alembic said it received a cumulative total of 178 ANDA approvals (155 final approvals and 23 tentative approvals) from USFDA.

An abbreviated new drug application (ANDA) is an application for a US generic drug approval for an existing licensed medication or approved drug.

Alembic Pharmaceuticals, established in 1907, is an Indian multinational pharmaceutical company headquartered in Vadodara. It is involved in manufacture of pharmaceutical products, pharmaceutical substances and intermediates. It is also termed to be one of the market leaders in macrolides segment of anti-infective drugs in India.

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