Wockhardt Bio AG, a subsidiary of Wockhardt, has reportedly received approval from US FDA for its abbreviated new drug application (ANDA) for Oxycodone Hydrochloride Oral Solution USP, 5 mg/5 mL. The Oxycodone Hydrochloride Oral Solution USP, 5 mg/5 mL, is bioequivalent and, therefore, therapeutically equivalent to the reference listed drug product (RLD), Oxycodone Hydrocodone Oral Solution, USP 5 mg/5 mL, of VistaPharm, Inc.
Wockhardt is one of the few companies with end to end integrated capabilities for its products, starting with the manufacture of the oral and sterile API’s, the dose forms and marketing through wholly owned subsidiary in the US, enabling the company to capture maximum value.
