20 December 2022 - - US-based ANI Pharmaceuticals, Inc (NASDAQ: ANIP) has received US Food and Drug Administration approval for the Abbreviated New Drug Application for Levocarnitine Tablets USP, 330 mg, the company said.

ANI's Levocarnitine Tablets are the generic version of the Reference Listed Drug Carnitor.

The current annual US market for Levocarnitine Tablets is approximately USD 10m, according to IQVIA/IMS Health, a leading healthcare data and analytics provider.

ANI Pharmaceuticals, Inc. is a diversified bio-pharmaceutical company serving patients in need by developing, manufacturing, and marketing high quality branded and generic prescription pharmaceutical products, including for diseases with high unmet medical need.

Its team is focused on delivering sustainable growth by building a successful Purified Cortrophin Gel franchise, strengthening its generics business with enhanced development capability, innovation in established brands and leveraging our North American manufacturing capabilities.