Announcement under Regulation 30 - ANDA approval

Regulatory Product ApprovalBusiness Updates View source PDF

FDC · price

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-0.6%1-day move

₹364.10

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₹358.25

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AI summary

FDC Ltd has received Abbreviated New Drug Application (ANDA) approval from the United States Food and Drug Administration (USFDA) for Cefixime for Oral Suspension USP. The approval covers two dosage strengths: 100 mg/5 mL and 200 mg/5 mL. This regulatory approval allows FDC to manufacture and sell this antibiotic product in the United States market. Cefixime is a commonly used cephalosporin antibiotic for oral suspension. The company informed BSE and NSE on May 18, 2026, under SEBI Listing Regulations.

Likely market impact

Positive for shareholders as ANDA approval opens the US market for this product, potentially generating export revenue in US dollars. The actual revenue impact will depend on market penetration and sales execution.