06 June 2012 | Regulatory | By BioSpectrum Bureau
US FDA approves Suprax 400 mg by Lupin
Lupin is expected to start shipping of the product soon
Mumbai: Lupin Pharmaceuticals, a subsidiary of India-based Lupin, has received approval for Suprax (Cefixime) Capsules 400 mg from the US Food and Drugs Administration (FDA). A statement released by Lupin said it expected to commence shipping of the product in the near future.
The approval will expand Lupin's range of Suprax dosage forms available to treat the approved indications in appropriate patients. Suprax is currently available as 100 mg/5ml and 200 mg/5ml suspensions as well as 400 mg tablets.
Commenting on the approval, Mr Nilesh Gupta, group president & executive director, Lupin, said: "We are happy to receive this approval. The new dosage form will add to our growing SUPRAX franchise and gives health care providers and patients a new formulation to treat the indicated infections. The approval of SUPRAX capsules is one more example of our ongoing commitment to serving our customers and addressing their needs."
Headquartered in Mumbai, Lupin is an innovation-led transnational pharmaceutical company producing a wide range of generic and branded formulations and APIs. It is the fifth largest and fastest growing generics player in the US.