Hikma announces FDA approval for Cephalexin, Saudi Arabia facility

By Lisa Kerner

Erie, Pa., Jan. 25 - Hikma Pharmaceuticals plc said the Food and Drug Administration has approved its abbreviated New Drug Application filings for the oral cephalosporin, Cephalexin, in 250 mg and 500 mg capsule form.

These products will be manufactured by Jazeera Pharmaceutical Industries, Hikma's associate company in Riyadh, Saudi Arabia, for sale in the U.S. market, according to a company news release.

Jazeera Pharmaceutical Industries has received FDA approval for the manufacture of oral Cephalosporin products. It is the first company in the Gulf area with FDA-approved facilities, the company said.

Hikma Pharmaceuticals is a multinational pharmaceutical group focused on developing, manufacturing and marketing a broad range of both branded and non-branded generic and in-licensed pharmaceutical products.

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