Lupin Ltd said on Friday it has received USFDA approval for its Abbreviated New Drug Application for Cefdinir Suspension 125mg/5ml.
Cefdinir is a third generation cephalosporin administered orally to treat a wide variety of bacterial infections, Lupin informed the Bombay Stock Exchange.
Lupin is the first company to receive ANDA approval for Cefdinir, both capsule and suspension forms. With this approval, the company now has 12 ANDAs approved by the USFDA.
"The approval of our Cefdinir Suspension and the recent approval for the capsule form by the USFDA reinforces Lupin's ability on submitting high-quality dossiers and gaining approvals in time. This approval further strengthens our position in the Cephalosporins business in the US", company MD Kamal Sharma said.
Cefdinir is being marketed by Abbott under the Omnicef brand name.
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