EMEA approves Patheon’s Puerto Rico facility

Patheon acquired its Puerto Rican facilities in 2004 but the contract manufacturing organisation’s (CMO) financial results were negatively impacted by the operations until it restructured.

Some facilities were sold or downsized but Patheon chose to expand the Manati site to handle high-potency compounds.

The European Medicines Agency (EMEA) has now approved the Manati facility, following an earlier inspection by the Medical Products Agency of Sweden, and it can begin exporting.

Patheon believes the site will provide benefits and flexibility to clients. Furthermore, the CMO regards the approval, and the 19 successful inspections its facilities have had in 2009, as evidence of its commitment to quality and compliance.

High potency expansion​

In June 2008 Patheon gave details of a $2.8m (€2m) investment in the Manati facility. The expansion added a 3,386 sq ft dedicated high potency and controlled substance production area.

This includes three manufacturing suites, air lock containment areas and humidity controlled air systems. By adding three manufacturing suites Patheon is able to perform technology transfer, bulk production and packaging and storage in one area.

Included in the expansion is capacity for high potency compounds, with containment down to 1µg per m3 occupational exposure limits (OEL), and humidity controlled solid dosage forms.

The market for high potency manufacturing services has become increasingly competitive in recent years. Approval of the Patheon site comes months after SafeBridge Consultants granted Lonza’s facility in Visp, Switzerland with its “Potent Compound Safety Certification”.

Lonza was the first in continental Europe to receive the award but plenty of other CMOs are moving into high potency compounds, including Norwich, Penn Pharma and Metrics.