The company said India’s Central Drugs Standard Control Organisation (CDSCO) approved the intravenous (IV) formulation, while Taiwan’s Food and Drug Administration (TFDA) approved both Hunterase IV and Hunterase ICV.
The acquisition includes MacroGenics’ biologics drug substance manufacturing facility in Rockville, Maryland, as well as a warehousing center in Frederick, Maryland, located about 30 miles away.
The venture aims to deliver comprehensive active pharmaceutical ingredient (API) services, covering everything from initial development stages through full-scale commercial production.