UCB SA - BNP Paribas Fortis

(d) Manufacturing and supply of raw materials
The products of the UCB Group are manufactured by a combination of internal manufacturing and
outsourced manufacturing. Like all pharmaceutical companies, the UCB Group is always examining
ways of furthering the outsourcing capabilities of manufacturing and/or supply. Both the active
pharmaceutical ingredient (“API”) manufacturing and pharmaceutical manufacturing have been
outsourced in part. Internal API manufacturing is located in Braine l’Alleud (Belgium), Shannon
(Ireland), and Bulle (Switzerland). Pharmaceutical operations and packaging for most of the products
of the UCB Group takes place in various manufacturing sites located in Braine l’Alleud (Belgium),
Monheim (Germany), Zwickau (Germany), Rochester (United States), Bulle (Switzerland), Pianezza
(Italy) and Vapi (India). The manufacturing sites in Rochester, Bulle and Pianezza, most of the site in
Braine l’Alleud and the site in Vapi are owned by the UCB Group; two buildings for research and
development purposes in Braine l’Alleud are leased, together with the UCB headquarters in Brussels.
UCB regularly reviews the sourcing of its products and will continue to do so in the foreseeable future.
The manufacturing of Cimzia® has been entirely outsourced to toll manufacturers. Currently, Cimzia®
is manufactured by Sandoz GmbH pursuant to the terms of a development and manufacturing
agreement between Celltech Group plc and Sandoz GmbH, formerly Biochemie GmbH, with Vetter
Pharma-Fertigung GmbH & Co.KG manufacturing and supplying Cimzia® pre-filled syringes. In the
future, the manufacturing of Cimzia® will also be outsourced to Lonza Limited. For a more detailed
description of the manufacturing agreements with Sandoz GmbH and Lonza Limited. see Section 14
“Key Contracts” of this Part VI.
The API for Neupro® is manufactured by Cambrex Karlskoga AB, which has recently expanded
capacity. LTS Lohmann Therapie-Systeme AG supplies the patches, and a second manufacturing site is
under construction. The packaging of the product takes place within the UCB Group. The API for
Vimpat® is manufactured at Chemtech Leuna GmbH (Germany) and PCAS SA (France) and is finished
in-house. Keppra® is manufactured at three different locations, one of which is outsourced. Products
licensed to the UCB Group by its commercial partners, such as Xyrem® from Jazz Pharmaceuticals, are
manufactured by the respective licensor and subsequently supplied to the UCB Group.
Within the UCB Group, a dedicated function manages the strategic relationships with all product supply
and manufacturing counterparties.
Manufacturing processes are strictly controlled and approved in the framework of the relevant product
approval and related marketing authorizations, and all sites are approved and regularly inspected by
various regulatory authorities. Regulatory authorities require that drugs are manufactured, packaged
and labelled in conformity with current good manufacturing practices (“GMP”). The GMP
requirements govern quality control of the manufacturing process and documentation policies and
procedures. The UCB Group has established an internal quality control and quality assurance program,
including a set of standard operating procedures and specifications. For more detailed information see
Section 12, “Governmental Regulation” of this Part VI.
With respect to its supply chain, the UCB Group relies on forecasts from its commercial operations
which are converted into supply, manufacturing and purchasing plans. The UCB Group uses various
suppliers for the raw materials required to manufacture its products. These raw materials are mainly
solvents or other readily available raw materials. The UCB Group does not depend on a single supplier
or site for any of its key raw materials, except with respect to Cimzia® for which the PEG component is
produced and supplied by Nektar AL Corporation. For a more detailed description of the supply
agreements of the UCB Group see Section 14 “Key Contracts” of this Part VI.
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