Lupin Ltd announced that the US Food and Drug Administration (USFDA) has approved the company's Abbreviated New Drug Application (ANDA) for Cefixime Tablet 400 mg. Lupin has also filed an ANDA for Cefixime Suspension and believes that it will receive the approval for the Suspension soon.
Lupin is the first company with an ANDA approval for Cefixime Tablets. Earlier in this financial year Lupin received FDA approval for Cefuroxime Axetil Tablets, Cefotaxime vials for injection and Ceftriaxone vials for injection, all of which are in the cephalosporin family of products, which provide the company with a niche presence in this segment.
Headquartered in Mumbai, Lupin develops, manufactures and markets generic intermediates, active pharmaceutical ingredients and finished dosages. Lupin's revenue in FY2002-03 was Rs.11.2 billion on an equity base of Rs.401 million. Nine of Lupin's plants have been approved by the USFDA and two plants have been approved by the UKMCA.