FDC Limited has received an Abbreviated New Drug Application (ANDA) approval from the United States Food and Drug Administration (USFDA) for Cefixime for Oral Suspension USP, available in two strengths — 100 mg/5 mL and 200 mg/5 mL. The development was disclosed to stock exchanges on 18 May 2026 under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, and adds to the company's growing product portfolio in the U.S. pharmaceutical market.

ANDA Approval Details

The approval covers Cefixime for Oral Suspension USP in both available strengths, as outlined below:

Expanding U.S. Market Presence

The USFDA ANDA approval for Cefixime for Oral Suspension USP in both 100 mg/5 mL and 200 mg/5 mL strengths represents a notable development for FDC Limited as it continues to build its regulated market portfolio. Cefixime is a broad-spectrum antibiotic commonly used in the treatment of bacterial infections, and its oral suspension form is particularly relevant for pediatric and adult patients requiring liquid dosage formulations. The approval reflects the company's ongoing commitment to meeting U.S. regulatory standards and broadening its therapeutic offerings in one of the world's most competitive pharmaceutical markets. The intimation was signed by Varsharani Katre, Company Secretary & Legal Head (Membership No. F-8948), on behalf of FDC Limited.

FDC Limited has notified the stock exchanges of a forthcoming Board of Directors meeting, scheduled in accordance with Regulation 29 of the Securities and Exchange Board of India (Listing Obligations and Disclosure Requirements) Regulations, 2015. The meeting is set to take place on Wednesday, May 27, 2026, and will focus on the approval of the company's audited financial results for the quarter and year ended March 31, 2026.

Board Meeting Details

The following table summarises the key details of the scheduled board meeting as disclosed by the company:

Trading Window Closure

In line with the company's Code of Conduct for Prevention of Insider Trading and SEBI (Prohibition of Insider Trading) Regulations, 2015, FDC Limited had previously intimated the closure of its trading window vide communication dated March 26, 2026. The trading window has been closed for all Directors, Designated Persons, Connected Persons, and their Relatives effective from Tuesday, April 01, 2026. The closure will remain in effect until 48 hours after the declaration of the audited financial results for the quarter and year ended March 31, 2026.

The intimation was signed by Varsharani Katre, Company Secretary & Legal Head (Membership No.: FCS-8948), on behalf of FDC Limited, and was submitted to both BSE Limited and the National Stock Exchange of India Ltd. on May 16, 2026.