FDC gets USFDA approval for Cefixime 400 mg tablets to treat bacterial infections

FDC gets USFDA approval for Cefixime 400 mg tablets to treat bacterial infections

FDC Limited announced on Wednesday, December 18, 2024, that it has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Cefixime 400 mg Tablets.

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Cefixime is used to treat bacterial infections in many different parts of the body. It belongs to the class of medicines known as cephalosporin antibiotics. It works by killing bacteria or preventing their growth.

This approval follows an earlier update on November 13, 2024, regarding a US FDA inspection at the company’s manufacturing facility in Baddi, Himachal Pradesh. The approval marks a significant step in FDC’s efforts to expand its product offerings in the U.S. market.

For the first quarter of the current financial year, the company reported healthy revenue and profitability growth backed by robust performance in the domestic formulation business growing by 23.6% year-on-year.

With no regulatory price revision permitted on the scheduled products, the company has been able to sustain the overall revenue and profitability growth with optimisation of the operating expenses.

Export formulation business although reported de growth by 6.8% year-on-year due to lower sales in certain regulated markets. Active Pharmaceutical Ingredient (API) business continues to show steady-state growth of 6.2% year-on-year during the first quarter.

With more focus on cost optimisation, efficiency improvement and other income from treasury surplus, the company has been able to report healthy growth in profit before tax at 15.6% year-on-year.

Shares of FDC were closed prior to the announcement, gaining 2% to close at 516 on Wednesday.

Also Read : Gandhar Oil Refinery says USFDA closed inspection on co’s Taloja facility

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