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Corporate - Regulatory Bodies & Rulings
FDA nod for Aurobindo drug

Our Bureau

Hyderabad, Jan. 29

Aurobindo Pharma Ltd (APL) has received one more approval from the US Food and Drug Administration (USFDA) for Cefadroxil capsules of 500 mg.

Cefadroxil is a first generation Cephalosporin antibiotic. It is used in a wide variety of bacterial infections, especially concerning respiratory, skin & soft tissue, and urinary tract. According to a press release from APL, the Cefadroxil 500 mg capsules commands a market of over $21 million in the US alone. For APL, a leading manufacturer of generic pharmaceuticals and active pharmaceutical ingredients, Cefadroxil is the third approval from the USFDA in the cephalosporin range. It is also the company's 37th overall approval from the regulator, the press release added. The company has filed over 75 abbreviated new drug applications for the US alone and over 100 drug master files.

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