Lyophilization Services of New England (LSNE) reported on Monday the receipt of the US Food and Drug Administration (FDA) approval for an Abbreviated New Drug Application (ANDA) for its sterile injectable product manufactured at its aseptic fill finish facility in León, Spain.

Acquired in June 2019, the Spanish facility is approved for US commercial distribution and is now the company's fourth facility to gain commercial approval.

The LSNE-León site is an integral part of the company's overall growth strategy of increasing services, capacity and the footprint of its global network, added VP of Quality and Regulatory, Tom McGrath.

Since 1997, the company has been providing contract lyophilization services to the pharmaceutical, biotechnology and medical device industries, specializing in a wide range of services including process development, cGMP fill finish and lyophilization (for vials, pre-filled syringes and dropper bottles for ophthalmics), analytical testing services and regulatory support.