LLY » Topics » Raw Materials and Product Supply

This excerpt taken from the LLY 10-K filed Feb 22, 2010.
Raw Materials and Product Supply
Most of the principal materials we use in our manufacturing operations are available from more than one source. However, we obtain certain raw materials principally from only one source. In addition, Byetta is manufactured by third-party suppliers to Amylin. In the event one of these suppliers was unable to provide the materials or product, we generally have sufficient inventory to supply the market until an alternative
 
 
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source of supply can be implemented. However, in the event of an extended failure of a supplier, it is possible that we could experience an interruption in supply until we established new sources or, in some cases, implemented alternative processes.
 
Our primary bulk manufacturing occurs at five sites in the United States as well as locations in Ireland, Puerto Rico, and the United Kingdom. Finishing operations, including labeling and packaging, take place at a number of sites throughout the world. Effective in January 2010, we sold one of our U.S. sites, Tippecanoe Laboratories in West Lafayette, Indiana, to an affiliate of Evonik Industries AG, and entered into a nine-year supply and services agreement whereby Evonik will manufacture final and intermediate step active pharmaceutical ingredients for certain Lilly human and animal health products.
 
We manage our supply chain (including our own facilities, contracted arrangements, and inventory) in a way that should allow us to meet all expected product demand while maintaining flexibility to reallocate manufacturing capacity to improve efficiency and respond to changes in supply and demand. However, pharmaceutical production processes are complex, highly regulated, and vary widely from product to product. Shifting or adding manufacturing capacity can be a very lengthy process requiring significant capital expenditures and regulatory approvals. Accordingly, if we were to experience extended plant shutdowns at one of our own facilities, extended failure of a contract supplier, or extraordinary unplanned increases in demand, we could experience an interruption in supply of certain products or product shortages until production could be resumed or expanded.
 
These excerpts taken from the LLY 10-K filed Feb 27, 2009.
Raw Materials and Product Supply
 
Most of the principal materials we use in our manufacturing operations are available from more than one source. We obtain certain raw materials principally from only one source. In addition, Byetta is manufactured by third-party suppliers to Amylin. In the event one of these suppliers was unable to provide the materials or product, we generally have sufficient inventory to supply the market until an alternative source of supply can be implemented. However, in the event of an extended failure of a supplier, it is possible that we could experience an interruption in supply until we established new sources or, in some cases, implemented alternative processes.
 
Our primary bulk manufacturing occurs at three sites in Indiana as well as locations in Ireland, Puerto Rico, and the United Kingdom. Finishing operations, including labeling and packaging, take place at a number of sites throughout the world.
 
We seek to design and operate our manufacturing facilities and maintain inventory in a way that will allow us to meet all expected product demand while maintaining flexibility to reallocate manufacturing capacity to improve efficiency and respond to changes in supply and demand. However, pharmaceutical production processes are complex, highly regulated, and vary widely from product to product. Shifting or adding manufacturing capacity can be a very lengthy process requiring significant capital expenditures and regulatory approvals. Accordingly, if we were to experience extended plant shutdowns or extraordinary unplanned increases in demand, we could experience an interruption in supply of certain products or product shortages until production could be resumed or expanded.
 
Raw
Materials and Product Supply



 



Most of the principal materials we use in our manufacturing
operations are available from more than one source. We obtain
certain raw materials principally from only one source. In
addition, Byetta is manufactured by third-party suppliers to
Amylin. In the event one of these suppliers was unable to
provide the materials or product, we generally have sufficient
inventory to supply the market until an alternative source of
supply can be implemented. However, in the event of an extended
failure of a supplier, it is possible that we could experience
an interruption in supply until we established new sources or,
in some cases, implemented alternative processes.


 



Our primary bulk manufacturing occurs at three sites in Indiana
as well as locations in Ireland, Puerto Rico, and the United
Kingdom. Finishing operations, including labeling and packaging,
take place at a number of sites throughout the world.


 



We seek to design and operate our manufacturing facilities and
maintain inventory in a way that will allow us to meet all
expected product demand while maintaining flexibility to
reallocate manufacturing capacity to improve efficiency and
respond to changes in supply and demand. However, pharmaceutical
production processes are complex, highly regulated, and vary
widely from product to product. Shifting or adding manufacturing
capacity can be a very lengthy process requiring significant
capital expenditures and regulatory approvals. Accordingly, if
we were to experience extended plant shutdowns or extraordinary
unplanned increases in demand, we could experience an
interruption in supply of certain products or product shortages
until production could be resumed or expanded.


 




These excerpts taken from the LLY 10-K filed Oct 21, 2008.
Raw Materials and Product Supply
 
Most of the principal materials we use in our manufacturing operations are available from more than one source. We obtain certain raw materials principally from only one source. In addition, four of our significant products are manufactured by others: Actos by Takeda; ReoPro by Centocor; Xigris by Lonza Biologics (bulk product) and DSM, N.V. (finished product); and Byetta by third-party suppliers to Amylin. If we were unable to obtain certain materials from present sources, we could experience an interruption in supply until we established new sources or, in some cases, implemented alternative processes.
 
Our primary bulk manufacturing occurs at three sites in Indiana as well as locations in Ireland, Puerto Rico, and the United Kingdom. Finishing operations, including labeling and packaging, take place at a number of sites throughout the world.
 
We seek to design and operate our manufacturing facilities and maintain inventory in a way that will allow us to meet all expected product demand while maintaining flexibility to reallocate manufacturing capacity to improve efficiency and respond to changes in supply and demand. However, pharmaceutical production processes are complex, highly regulated, and vary widely from product to product. Shifting or adding manufacturing capacity can be a very lengthy process requiring significant capital expenditures and regulatory approvals. Accordingly, if we were to experience extended plant shutdowns or extraordinary unplanned increases in demand, we could experience an interruption in supply of certain products or product shortages until production could be resumed or expanded.
 
Raw
Materials and Product Supply



 



Most of the principal materials we use in our manufacturing
operations are available from more than one source. We obtain
certain raw materials principally from only one source. In
addition, four of our significant products are manufactured by
others: Actos by Takeda; ReoPro by Centocor; Xigris by Lonza
Biologics (bulk product) and DSM, N.V. (finished product); and
Byetta by third-party suppliers to Amylin. If we were unable to
obtain certain materials from present sources, we could
experience an interruption in supply until we established new
sources or, in some cases, implemented alternative processes.


 



Our primary bulk manufacturing occurs at three sites in Indiana
as well as locations in Ireland, Puerto Rico, and the United
Kingdom. Finishing operations, including labeling and packaging,
take place at a number of sites throughout the world.


 



We seek to design and operate our manufacturing facilities and
maintain inventory in a way that will allow us to meet all
expected product demand while maintaining flexibility to
reallocate manufacturing capacity to improve efficiency and
respond to changes in supply and demand. However, pharmaceutical
production processes are complex, highly regulated, and vary
widely from product to product. Shifting or adding manufacturing
capacity can be a very lengthy process requiring significant
capital expenditures and regulatory approvals. Accordingly, if
we were to experience extended plant shutdowns or extraordinary
unplanned increases in demand, we could experience an
interruption in supply of certain products or product shortages
until production could be resumed or expanded.


 




These excerpts taken from the LLY 10-K filed Feb 29, 2008.
Raw Materials and Product Supply
 
Most of the principal materials we use in our manufacturing operations are available from more than one source. We obtain certain raw materials principally from only one source. In addition, four of our significant products are manufactured by others: Actos by Takeda; ReoPro by Centocor; Xigris by Lonza Biologics (bulk product) and DSM, N.V. (finished product); and Byetta by third-party suppliers to Amylin. If we were unable to obtain certain materials from present sources, we could experience an interruption in supply until we established new sources or, in some cases, implemented alternative processes.
 
Our primary bulk manufacturing occurs at three sites in Indiana as well as locations in Ireland, Puerto Rico, and the United Kingdom. Finishing operations, including labeling and packaging, take place at a number of sites throughout the world.
 
We seek to design and operate our manufacturing facilities and maintain inventory in a way that will allow us to meet all expected product demand while maintaining flexibility to reallocate manufacturing capacity to improve efficiency and respond to changes in supply and demand. However, pharmaceutical production processes are complex, highly regulated, and vary widely from product to product. Shifting or adding manufacturing capacity can be a very lengthy process requiring significant capital expenditures and regulatory approvals. Accordingly, if we were to experience extended plant shutdowns or extraordinary unplanned increases in demand, we could experience an interruption in supply of certain products or product shortages until production could be resumed or expanded.
 
Raw
Materials and Product Supply



 



Most of the principal materials we use in our manufacturing
operations are available from more than one source. We obtain
certain raw materials principally from only one source. In
addition, four of our significant products are manufactured by
others: Actos by Takeda; ReoPro by Centocor; Xigris by Lonza
Biologics (bulk product) and DSM, N.V. (finished product); and
Byetta by third-party suppliers to Amylin. If we were unable to
obtain certain materials from present sources, we could
experience an interruption in supply until we established new
sources or, in some cases, implemented alternative processes.


 



Our primary bulk manufacturing occurs at three sites in Indiana
as well as locations in Ireland, Puerto Rico, and the United
Kingdom. Finishing operations, including labeling and packaging,
take place at a number of sites throughout the world.


 



We seek to design and operate our manufacturing facilities and
maintain inventory in a way that will allow us to meet all
expected product demand while maintaining flexibility to
reallocate manufacturing capacity to improve efficiency and
respond to changes in supply and demand. However, pharmaceutical
production processes are complex, highly regulated, and vary
widely from product to product. Shifting or adding manufacturing
capacity can be a very lengthy process requiring significant
capital expenditures and regulatory approvals. Accordingly, if
we were to experience extended plant shutdowns or extraordinary
unplanned increases in demand, we could experience an
interruption in supply of certain products or product shortages
until production could be resumed or expanded.


 




This excerpt taken from the LLY 10-K filed Feb 28, 2007.
Raw Materials and Product Supply
 
Most of the principal materials we use in our manufacturing operations are available from more than one source. We obtain certain raw materials principally from only one source. In addition, four of our significant products are manufactured by others: Actos by Takeda; ReoPro by Centocor; Xigris by Lonza Biologics (bulk product) and DSM, N.V. (finished product); and Byetta by third-party suppliers to Amylin. If we were unable to obtain certain materials from present sources, we could experience an interruption in supply until we established new sources or, in some cases, implemented alternative processes.
 
Our primary bulk manufacturing occurs at three sites in Indiana as well as locations in Ireland, Puerto Rico, and the United Kingdom. Finishing operations, including labeling and packaging, take place at a number of sites throughout the world.
 
We seek to design and operate our manufacturing facilities and maintain inventory in a way that will allow us to meet all expected product demand while maintaining flexibility to reallocate manufacturing capacity to improve efficiency and respond to changes in supply and demand. However, pharmaceutical production processes are complex, highly regulated, and vary widely from product to product. Shifting or adding manufacturing capacity can be a very lengthy process requiring significant capital expenditures and regulatory approvals. Accordingly, if we were to experience extended plant shutdowns or extraordinary unplanned increases in demand, we could experience an interruption in supply of certain products or product shortages until production could be resumed or expanded.
 
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