FDC Limited has informed the Exchange about General Updates
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FDC Limited has received ANDA (Abbreviated New Drug Application) approval from the US FDA for Cefixime for Oral Suspension USP in two dosage strengths - 100 mg/5 mL and 200 mg/5 mL. The approval was disclosed under SEBI Listing Regulations, specifically Regulation 30. This generic antibiotic drug can now be manufactured and marketed in the United States. No specific revenue projections or order values were disclosed in the filing.
The US FDA approval opens the US generic pharmaceutical market to FDC for this antibiotic product, potentially boosting export revenue in USD. The actual commercial impact will depend on market penetration and pricing.