Over the past 8 months, says API developer and manufacturer Hovione, its facilities have undergone a total of 6 inspections by the US FDA, the Japanese PMDA, and the Portuguese authorities. Pre-approval inspections for 2 new products for customer synthesis, and for existing molecules used in new formulations, took place at the company’s facilities in New Jersey, China, and Loures, Portugal.
Hovione attributes the amount of inspection activity to a “constant flow of submissions” from its customers. “Successful outcomes at inspections is not an unusual event at Hovione,” commented Hovione CEO Guy Villax, “but to continue with this kind of stellar record in the current climate is something that makes us all really proud. “
In addition to manufacturing APIs, Hovione offers inhalation particle engineering, formulation, analysis, and dry powder inhalers. Hovione offers licensing of its capsule-based DPIs and it also provides capsule filling.
Read the company’s press release.
