FDC Limited has recently informed exchanges that the company has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Cefixime 400 mg Tablets. This approval follows the inspection of the company’s manufacturing facility in Baddi, Himachal Pradesh, as previously communicated on November 13, 2024.
In the exchange filing, FDC Limited shared, “We are pleased to announce that the Company has received final approval from US FDA for the Company’s Abbreviated New Drug Application (ANDA) for Cefixime 400 mg Tablets.”
This marks a significant milestone for FDC Limited, further strengthening its position in the global pharmaceutical market. The approval of Cefixime 400 mg Tablets opens new avenues for the company in providing high-quality generic medicines to patients.
