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Hyderabad March 29 Aurobindo Pharma Ltd (APL) has announced that its joint venture, Cephazone Pharma, at California in the US, has received the first Abbreviated New Drug Application (ANDA) approval for Cefriaxone.

The California facility is dedicated to cephalosporin injectable drugs. The company has received approval for Ceftriaxone injectable, a third generation cephalosporin antibiotic, from the US Food and Drug Administration.

Ceftriaxone is the research innovation of Hoffmann-La Roche and is used in respiratory infections and as a choice antibiotic in bacterial meningitis. Besides, its use is also well documented in paediatrics and in preventing possible Septicemias, according to a press release from APL.

The injectable in 250 mg, 500 mg, single use vials for intra-muscular, intra-venous use and in bottles (popularly known as piggy pack) for intravenous use, has been approved by the FDA.

Cephazone has filed several ANDAs with the USFDA. Aurobindo has already received the facility approval for sterile Cephalosporin APIs (active pharmaceutical ingredients).

More Stories on : Regulatory Bodies & Rulings | Pharmaceuticals

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