Suven’s Pashamylaram OKed for APIs by US FDA
Suven Life Sciences’ facility in Pashamylaram, India has been cleared for the production active pharmaceutical ingredients (APIs) and intermediates by the US FDA.
The decision, which follows a renewal inspection by the US regulator, means the facility is compliant with current good manufacturing practice (cGMP) requirements. To date Suven has filed 16 drug master files (DMFs) and one abbreviated new drug application (ANDA) from the plant.
In a press statement the firm said that: “With partner ANDA approvals Suven can supply the active pharmaceutical ingredients in future thus generating new revenues in due course of time.”
The renewal will be welcome news for US drugmaker Eli Lilly, which has collaborated on a number of central nervous system disorder (CNS) focused projects with the contract research and manufacturing services (CRAMS) firm since 2006.
