We own and operate an FDA approved manufacturing facility in Zofingen, Switzerland
which produces the active pharmaceutical ingredient (API) for REVLIMID®
and THALOMID® and have contracted with FDA approved third-party contract
manufacturers to provide backup API manufacturing services for these products.
Manufacturing services for REVLIMID® and THALOMID®, which consist of
formulation, encapsulation, packaging, warehousing and distribution, are performed
at our FDA approved drug product manufacturing facility in Boudry, Switzerland.
We have contracted with a number of third-party drug product manufacturing service
providers and packaging service providers to provide backup manufacturing and
packaging services. All of our third-party service providers are approved by
the regulatory authorities for the geographies that they serve.
The API for ABRAXANE® is generally available from multiple sources and
is normally available in quantities adequate to meet our needs. Manufacturing
services for ABRAXANE® are performed at our manufacturing facility in Arizona
and by an approved third party contract manufacturing facility.
The API for VIDAZA® is supplied by three suppliers. Manufacturing and
packaging services are provided by a number of third-party service providers.
The API for the azacitidine for injection (generic version of VIDAZA®) is
supplied by a single -source supplier. Manufacturing and packaging services
are provided by a single manufacturer.
The API for POMALYST®/IMNOVID® is supplied by a single-source supplier
with primary manufacturing services being performed at our Boudry manufacturing
facility.We have contracted with a number of third-party drug product manufacturing
service providers and packaging service providers to provide backup manufacturing
and packaging services for this product.
The API for ISTODAX® is supplied by a single-source supplier. Manufacturing
and packaging services are provided by a number of third-party service providers.
The API for OTEZLA® (apremilast) is supplied by two suppliers with manufacturing
services being performed at our Boudry manufacturing facility. We expect to
utilize third-party service providers for backup manufacturing and packaging
services for this product.
The API for FOCALIN® and FOCALIN XR® is currently obtained from two
suppliers, and we rely on a single manufacturer for the tableting and packaging
of FOCALIN® finished product.