Orchid receives US FDA approval for its Cefepime ANDA

Orchid Chemicals & Pharmaceuticals Ltd has announced that it has received approval from the US FDA for its ANDA (Abbreviated New Drug Application) for Cefepime injection. The product is available in three dosage strengths, 500 mg/vial, 1 gram/vial, and 2 grams/vial. Cefepime injection is a life saving cephalosporin antibiotic drug used in hospital setting. The brand product has a recorded sale of USD 190 mn over a 12-month period.

Commenting on the approval, the Company"s Managing Director, Mr. K Raghavendra Rao, said "Orchid"s Cefepime approval for the US generic market is prestigious given that it is the first ANDA approval received for this product from the US FDA. The product has been supplied to Apotex for distribution by them in the Us".

The Company has till date filed 40 ANDAs (comprising 29 antibiotic and 11 non-antibiotic products). Including the Cefepime approval just received, the Company has received approvals for 19 ANDAs from the US FDA.

The stock was trading at Rs.263.40, up by Rs.4.20 or 1.62%. The stock hit an intraday high of Rs.264.50 and low of Rs.259.50. The total traded quantity was 137684 compared to 2 week average of 135152.

Source : Equity Bulls

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