WPI » Topics » Manufacturing, Suppliers and Materials

These excerpts taken from the WPI 10-K filed Feb 23, 2009.
Manufacturing, Suppliers and Materials
 
During 2008, we manufactured many of our own finished products at our plants in Corona, California; Davie, Florida; Goa, India; Carmel, New York; Copiague, New York and Salt Lake City, Utah. As part of an ongoing effort to optimize our manufacturing operations, we implemented several cost reduction initiatives in 2008, which included the transfer of several solid dosage products from our Carmel, New York facility to our


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Goa, India facility, and the ongoing implementation of our operational excellence program at certain of our U.S. manufacturing facilities.
 
We have development and manufacturing capabilities for raw material and active pharmaceutical ingredients (“API”) and intermediate ingredients to support our internal product development efforts in our Goa and Ambernath, India and Changzhou, China facilities. Our Ambernath, India facility also develops and manufactures API for third parties. We also have an equity investment in Scinopharm Taiwan, Ltd., a company that specializes in the development and manufacture of API.
 
Our manufacturing operations are subject to extensive regulatory oversight and could be interrupted at any time. Our Corona, California facility is currently subject to a consent decree of permanent injunction. See “Item 1A. Risk Factors — Risks Related to Our Business — Extensive industry regulation has had, and will continue to have, a significant impact on our business, especially our product development, manufacturing and distribution capabilities.” Also refer to Legal Matters in “NOTE 15 — Commitments and Contingencies” in the accompanying “Notes to Consolidated Financial Statements” in this Annual Report.
 
We contract with third parties for the manufacture of certain of our products, some of which are currently available only from sole or limited suppliers. These third-party manufactured products include products that have historically accounted for a significant portion of our revenues, such as Ferrlecit ®, bupropion hydrochloride sustained-release tablets and a number of our oral contraceptive products. Third-party manufactured products accounted for approximately 58%, 57% and 58% of our product net revenues in 2008, 2007 and 2006, respectively, and 56%, 56% and 64% of our gross profit in 2008, 2007 and 2006, respectively.
 
We are dependent on third parties for the supply of the raw materials necessary to develop and manufacture our products, including the API and inactive pharmaceutical ingredients used in our products. We are required to identify the supplier(s) of all the raw materials for our products in the drug applications that we file with the FDA. If raw materials for a particular product become unavailable from an approved supplier specified in a drug application, we would be required to qualify a substitute supplier with the FDA, which would likely interrupt manufacturing of the affected product. To the extent practicable, we attempt to identify more than one supplier in each drug application. However, some raw materials are available only from a single source and, in some of our drug applications, only one supplier of raw materials has been identified, even in instances where multiple sources exist.
 
In addition, we obtain a significant portion of our raw materials from foreign suppliers. Arrangements with international raw material suppliers are subject to, among other things, FDA regulation, customs clearance, various import duties, foreign currency risk and other government clearances. Acts of governments outside the U.S. may affect the price or availability of raw materials needed for the development or manufacture of our products. In addition, any changes in patent laws in jurisdictions outside the U.S. may make it increasingly difficult to obtain raw materials for R&D prior to the expiration of the applicable U.S. or foreign patents. See “Item 1A. Risk Factors — Risks Related to Our Business — If we are unable to obtain sufficient supplies from key suppliers that in some cases may be the only source of finished products or raw materials, our ability to deliver our products to the market may be impeded.” in this Annual Report.
 
Manufacturing,
Suppliers and Materials



 



During 2008, we manufactured many of our own finished products
at our plants in Corona, California; Davie, Florida; Goa, India;
Carmel, New York; Copiague, New York and Salt Lake City, Utah.
As part of an ongoing effort to optimize our manufacturing
operations, we implemented several cost reduction initiatives in
2008, which included the transfer of several solid dosage
products from our Carmel, New York facility to our





10





Table of Contents






Goa, India facility, and the ongoing implementation of our
operational excellence program at certain of our
U.S. manufacturing facilities.


 



We have development and manufacturing capabilities for raw
material and active pharmaceutical ingredients (“API”)
and intermediate ingredients to support our internal product
development efforts in our Goa and Ambernath, India and
Changzhou, China facilities. Our Ambernath, India facility also
develops and manufactures API for third parties. We also have an
equity investment in Scinopharm Taiwan, Ltd., a company that
specializes in the development and manufacture of API.


 



Our manufacturing operations are subject to extensive regulatory
oversight and could be interrupted at any time. Our Corona,
California facility is currently subject to a consent decree of
permanent injunction. See “Item 1A. Risk
Factors — Risks Related to Our Business —
Extensive industry regulation has had, and will continue to
have, a significant impact on our business, especially our
product development, manufacturing and distribution
capabilities.” Also refer to Legal Matters in
“NOTE 15 — Commitments and
Contingencies” in the accompanying “Notes to
Consolidated Financial Statements” in this Annual Report.


 



We contract with third parties for the manufacture of certain of
our products, some of which are currently available only from
sole or limited suppliers. These third-party manufactured
products include products that have historically accounted for a
significant portion of our revenues, such as Ferrlecit
®,

bupropion hydrochloride sustained-release tablets and a number
of our oral contraceptive products. Third-party manufactured
products accounted for approximately 58%, 57% and 58% of our
product net revenues in 2008, 2007 and 2006, respectively, and
56%, 56% and 64% of our gross profit in 2008, 2007 and 2006,
respectively.


 



We are dependent on third parties for the supply of the raw
materials necessary to develop and manufacture our products,
including the API and inactive pharmaceutical ingredients used
in our products. We are required to identify the supplier(s) of
all the raw materials for our products in the drug applications
that we file with the FDA. If raw materials for a particular
product become unavailable from an approved supplier specified
in a drug application, we would be required to qualify a
substitute supplier with the FDA, which would likely interrupt
manufacturing of the affected product. To the extent
practicable, we attempt to identify more than one supplier in
each drug application. However, some raw materials are available
only from a single source and, in some of our drug applications,
only one supplier of raw materials has been identified, even in
instances where multiple sources exist.


 



In addition, we obtain a significant portion of our raw
materials from foreign suppliers. Arrangements with
international raw material suppliers are subject to, among other
things, FDA regulation, customs clearance, various import
duties, foreign currency risk and other government clearances.
Acts of governments outside the U.S. may affect the price
or availability of raw materials needed for the development or
manufacture of our products. In addition, any changes in patent
laws in jurisdictions outside the U.S. may make it
increasingly difficult to obtain raw materials for R&D
prior to the expiration of the applicable U.S. or foreign
patents. See “Item 1A. Risk Factors — Risks
Related to Our Business — If we are unable to obtain
sufficient supplies from key suppliers that in some cases may be
the only source of finished products or raw materials, our
ability to deliver our products to the market may be
impeded.” in this Annual Report.


 




These excerpts taken from the WPI 10-K filed Feb 25, 2008.
Manufacturing, Suppliers and Materials
 
During 2007, we manufactured many of our own finished products at our plants in Corona, California; Davie, Florida; Carmel, New York; Copiague, New York and Salt Lake City, Utah. As part of an ongoing effort to optimize our manufacturing operations, we implemented several cost reduction initiatives in 2007,


9


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which included the divestiture of our Phoenix, Arizona injectable product manufacturing facility and the closure of our Puerto Rico manufacturing facility. In August 2007 we received our first FDA approval to manufacture product at our solid dosage manufacturing facility in Goa, India.
 
We have development and manufacturing capabilities for raw material, active pharmaceutical ingredients (“API”) and intermediate ingredients to support our internal product development efforts in our Goa, Ambernath and Dombivli, India and Changzhou, China facilities. Our Ambernath and Dombivli, India facilities also develop and manufacture API for third parties. We also have an equity investment in Scinopharm Taiwan, Ltd., a company that specializes in the development and manufacture of API.
 
Our manufacturing operations are subject to extensive regulatory oversight and could be interrupted at any time. Our Corona, California facility is currently subject to a consent decree of permanent injunction. In September 2005, the FDA placed our Davie, Florida manufacturing facility in OAI status relating to the FDA’s May 2005 current Good Manufacturing Practices (“cGMP”) inspection of the facility and the related issuance of a Form 483 List of Inspectional Observations. The effect of the OAI designation is that until the FDA is satisfied with (i) the Company’s responses to the inspectional observations and (ii) the results of their inspections of the Davie, Florida facility, FDA approval of product candidates to be manufactured at that facility will be withheld. During the OAI status, ANDAs continue to be submitted from the Davie, Florida facility and the FDA continues to review new product applications. The OAI status does not affect Watson’s other locations. See “Item 1A. Risk Factors — Risks Related to Our Business — Extensive industry regulation has had, and will continue to have, a significant impact on our business, especially our product development, manufacturing and distribution capabilities.” Also refer to Legal Matters in “NOTE 13 — Commitments and Contingencies” in the accompanying “Notes to Consolidated Financial Statements” in this Annual Report.
 
For certain of our products, we contract with third parties for the manufacture of products, some of which are currently available only from sole or limited suppliers. These third-party manufactured products include products that have historically accounted for a significant portion of our revenues, such as Ferrlecit®, bupropion hydrochloride sustained-release tablets and a number of our oral contraceptive products. Third-party manufactured products accounted for approximately 57%, 58% and 51% of our product net revenues in 2007, 2006 and 2005, respectively, and 56%, 64% and 58% of our gross profit in 2007, 2006 and 2005, respectively.
 
We are dependent on third parties for the supply of the raw materials necessary to develop and manufacture our products, including the API and inactive pharmaceutical ingredients used in our products. We are required to identify the supplier(s) of all the raw materials for our products in the drug applications that we file with the FDA. If raw materials for a particular product become unavailable from an approved supplier specified in a drug application, we would be required to qualify a substitute supplier with the FDA, which would likely interrupt manufacturing of the affected product. To the extent practicable, we attempt to identify more than one supplier in each drug application. However, some raw materials are available only from a single source and, in some of our drug applications, only one supplier of raw materials has been identified, even in instances where multiple sources exist.
 
In addition, we obtain a significant portion of our raw materials from foreign suppliers. Arrangements with international raw material suppliers are subject to, among other things, FDA regulation, customs clearance, various import duties, foreign currency risk and other government clearances. Acts of governments outside the U.S. may affect the price or availability of raw materials needed for the development or manufacture of our products. In addition, any changes in patent laws in jurisdictions outside the U.S. may make it increasingly difficult to obtain raw materials for R&D prior to the expiration of the applicable U.S. or foreign patents. See “Item 1A. Risk Factors — Risks Related to Our Business — If we are unable to obtain sufficient supplies from key suppliers that in some cases may be the only source of finished products or raw materials, our ability to deliver our products to the market may be impeded.” in this Annual Report.
 
Manufacturing,
Suppliers and Materials



 



During 2007, we manufactured many of our own finished products
at our plants in Corona, California; Davie, Florida; Carmel, New
York; Copiague, New York and Salt Lake City, Utah. As part of an
ongoing effort to optimize our manufacturing operations, we
implemented several cost reduction initiatives in 2007,





9





Table of Contents






which included the divestiture of our Phoenix, Arizona
injectable product manufacturing facility and the closure of our
Puerto Rico manufacturing facility. In August 2007 we received
our first FDA approval to manufacture product at our solid
dosage manufacturing facility in Goa, India.


 



We have development and manufacturing capabilities for raw
material, active pharmaceutical ingredients (“API”)
and intermediate ingredients to support our internal product
development efforts in our Goa, Ambernath and Dombivli, India
and Changzhou, China facilities. Our Ambernath and Dombivli,
India facilities also develop and manufacture API for third
parties. We also have an equity investment in Scinopharm Taiwan,
Ltd., a company that specializes in the development and
manufacture of API.


 



Our manufacturing operations are subject to extensive regulatory
oversight and could be interrupted at any time. Our Corona,
California facility is currently subject to a consent decree of
permanent injunction. In September 2005, the FDA placed our
Davie, Florida manufacturing facility in OAI status relating to
the FDA’s May 2005 current Good Manufacturing Practices
(“cGMP”) inspection of the facility and the related
issuance of a Form 483 List of Inspectional Observations.
The effect of the OAI designation is that until the FDA is
satisfied with (i) the Company’s responses to the
inspectional observations and (ii) the results of their
inspections of the Davie, Florida facility, FDA approval of
product candidates to be manufactured at that facility will be
withheld. During the OAI status, ANDAs continue to be submitted
from the Davie, Florida facility and the FDA continues to review
new product applications. The OAI status does not affect
Watson’s other locations. See “Item 1A. Risk
Factors — Risks Related to Our Business —
Extensive industry regulation has had, and will continue to
have, a significant impact on our business, especially our
product development, manufacturing and distribution
capabilities.” Also refer to Legal Matters in
“NOTE 13 — Commitments and
Contingencies” in the accompanying “Notes to
Consolidated Financial Statements” in this Annual Report.


 



For certain of our products, we contract with third parties for
the manufacture of products, some of which are currently
available only from sole or limited suppliers. These third-party
manufactured products include products that have historically
accounted for a significant portion of our revenues, such as
Ferrlecit®,
bupropion hydrochloride sustained-release tablets and a number
of our oral contraceptive products. Third-party manufactured
products accounted for approximately 57%, 58% and 51% of our
product net revenues in 2007, 2006 and 2005, respectively, and
56%, 64% and 58% of our gross profit in 2007, 2006 and 2005,
respectively.


 



We are dependent on third parties for the supply of the raw
materials necessary to develop and manufacture our products,
including the API and inactive pharmaceutical ingredients used
in our products. We are required to identify the supplier(s) of
all the raw materials for our products in the drug applications
that we file with the FDA. If raw materials for a particular
product become unavailable from an approved supplier specified
in a drug application, we would be required to qualify a
substitute supplier with the FDA, which would likely interrupt
manufacturing of the affected product. To the extent
practicable, we attempt to identify more than one supplier in
each drug application. However, some raw materials are available
only from a single source and, in some of our drug applications,
only one supplier of raw materials has been identified, even in
instances where multiple sources exist.


 



In addition, we obtain a significant portion of our raw
materials from foreign suppliers. Arrangements with
international raw material suppliers are subject to, among other
things, FDA regulation, customs clearance, various import
duties, foreign currency risk and other government clearances.
Acts of governments outside the U.S. may affect the price
or availability of raw materials needed for the development or
manufacture of our products. In addition, any changes in patent
laws in jurisdictions outside the U.S. may make it
increasingly difficult to obtain raw materials for R&D
prior to the expiration of the applicable U.S. or foreign
patents. See “Item 1A. Risk Factors — Risks
Related to Our Business — If we are unable to obtain
sufficient supplies from key suppliers that in some cases may be
the only source of finished products or raw materials, our
ability to deliver our products to the market may be
impeded.” in this Annual Report.


 




This excerpt taken from the WPI 10-K filed Mar 1, 2007.

Manufacturing, Suppliers and Materials

We manufacture many of our own finished products at our plants in Corona, California; Davie, Florida; Carmel, New York; Copiague, New York; and Salt Lake City, Utah. As part of an ongoing effort to optimize our manufacturing operations, we announced several cost reduction initiatives that will take place by mid 2007, including the planned divestiture or closure of our Phoenix, Arizona injectable manufacturing facility and the closure of our Puerto Rico manufacturing facility in order to consolidate certain of our solid dosage manufacturing operations. In December 2005 we acquired a solid dosage manufacturing facility in Goa, India. The Goa facility is in the final stages of preparations to ensure that it will comply with the requirements of the current Good Manufacturing Practices (“cGMP”) for it to be approved by the FDA to supply product to the U.S. market.

Our manufacturing operations are subject to extensive regulatory oversight and could be interrupted at any time. Our Corona, California facility is currently subject to a consent decree of permanent injunction. In September 2005, the FDA placed our Davie, Florida manufacturing facility in Official Action Indicated (“OAI”) status relating to the FDA’s May 2005 cGMP inspection of the facility and the related issuance of a Form 483 List of Inspectional Observations. The effect of the OAI designation is that until the FDA is satisfied with (i) the Company’s responses to the inspectional observations and (ii) the results of their inspections of the Davie, Florida facility, FDA approval of product candidates to be manufactured at that facility will be withheld. During the OAI status, ANDAs continue to be submitted from the Davie, Florida facility and the FDA continues to review new product applications. The OAI status does not affect Watson’s other locations. See “Risks Related to Our Business—Extensive industry regulation has had, and will continue to have, a significant impact on our business, especially our product development, manufacturing and distribution capabilities.” Also refer to Legal Matters in “Note 14—Commitments and Contingencies” in the accompanying “Notes to Consolidated Financial Statements” in this Annual Report

For certain of our products, we contract with third parties for the manufacture of the products, some of which are currently available only from sole or limited suppliers. These third-party manufactured products include products that have historically accounted for a significant portion of our revenues, such as Ferrlecit®, bupropion hydrochloride sustained-release tablets and a number of our oral contraceptive products. Third-party manufactured products accounted for approximately 58%, 51% and 48% of our Generic and Brand product net revenues in 2006, 2005 and 2004 respectively, and 64%, 58% and 50% of our gross profit in 2006, 2005, and 2004 respectively.

We are dependent on third parties for the supply of the raw materials necessary to develop and manufacture our products, including the active and inactive pharmaceutical ingredients used in our products. We are required to identify the supplier(s) of all the raw materials for our products in the drug applications that we file with the FDA. If raw materials for a particular product become unavailable from an approved supplier specified in a drug application, we would be required to qualify a substitute supplier with the FDA, which would likely interrupt manufacturing of the affected product. To the extent practicable, we attempt to identify more than one supplier in each drug application. However, some raw

12




materials are available only from a single source and, in some of our drug applications, only one supplier of raw materials has been identified, even in instances where multiple sources exist.

In addition, we obtain a significant portion of our raw materials from foreign suppliers. Arrangements with international raw material suppliers are subject to, among other things, FDA regulation, customs clearance, various import duties, foreign currency risk and other government clearances. Acts of governments outside the U.S. may affect the price or availability of raw materials needed for the development or manufacture of our products. In addition, any changes in patent laws in jurisdictions outside the U.S. may make it increasingly difficult to obtain raw materials for research and development prior to the expiration of the applicable U.S. or foreign patents. To assist in addressing our reliance of third party raw material and active and inactive pharmaceutical ingredient suppliers, in March 2006, we completed the acquisition of Mumbai, India-based Sekhsaria Chemicals, Ltd. that provides active pharmaceutical ingredients (“API”) and finished dosage formulation expertise to the global pharmaceutical industry, and in January 2006, we increased our investment in Scinopharm Taiwan, Ltd., a company that specializes in the development and manufacture of API. See “Risks Related to Our Business—If we are unable to obtain sufficient supplies from key suppliers that in some cases may be the only source of finished products or raw materials, our ability to deliver our products to the market may be impeded.”

This excerpt taken from the WPI 10-K filed Mar 10, 2006.
Manufacturing, Suppliers and Materials

We manufacture many of our own finished products at our plants in Corona, California; Carmel, New York; Copiague, New York; Salt Lake City, Utah; Phoenix, Arizona; and Humacao, Puerto Rico. As part of an ongoing effort to optimize our manufacturing operations, we announced plans in October 2005 to consolidate certain of our solid dosage manufacturing operations. As a result, we have begun the transfer of products from our Humacao, Puerto Rico facility to our Carmel, New York and Corona, California sites and plan to discontinue operations at our Puerto Rico facility within the next 15 to 21 months.

In December 2005, we acquired a solid dosage manufacturing facility in Goa, India. This facility is currently undergoing FDA qualification upgrades to ultimately produce current Good Manufacturing Practices (“cGMP”) compliant products for the U.S. market.

Our manufacturing operations are subject to extensive regulatory oversight and could be interrupted at any time. Our Corona, California facility is currently subject to a consent decree of permanent injunction. See “Risks Related to Our Business—Extensive industry regulation has had, and will continue to have, a significant impact on our business, especially our product development, manufacturing and distribution capabilities.” See also “Item 3. Legal Proceedings—FDA Matters.”

For certain of our products, we contract with third parties for the manufacture of the products, some of which are currently available only from sole or limited suppliers. These third-party manufactured products include products that have historically accounted for a significant portion of our revenues, such as Ferrlecit®, bupropion hydrochloride sustained-release tablets and a number of our oral contraceptive products. Third-party manufactured products accounted for approximately 51%, 48% and 41% of our product net revenues in 2005, 2004 and 2003, respectively, and 58%, 50% and 48% of our gross profit in 2005, 2004 and 2003, respectively.

We are dependent on third parties for the supply of the raw materials necessary to develop and manufacture our products, including the active and inactive pharmaceutical ingredients used in our products. We are required to identify the supplier(s) of all the raw materials for our products in the drug applications that we file with the FDA. If raw materials for a particular product become unavailable from an approved supplier specified in a drug application, we would be required to qualify a substitute supplier with the FDA, which would likely interrupt manufacturing of the affected product. To the extent practicable, we attempt to identify more than one supplier in each drug application. However, some raw materials are available only from a single source and, in some of our drug applications, only one supplier of raw materials has been identified, even in instances where multiple sources exist.

In addition, we obtain a significant portion of our raw materials from foreign suppliers. Arrangements with international raw material suppliers are subject to, among other things, FDA regulation, customs clearance, various import duties, foreign currency risk and other government clearances. Acts of governments outside the U.S. may affect the price or availability of raw materials needed for the development or manufacture of our products. In addition, any changes in patent laws in jurisdictions outside the U.S. may make it increasingly difficult to obtain raw materials for research and development prior to the expiration of the applicable U.S. or foreign patents. See “Risks Related to Our Business—If

9




we are unable to obtain sufficient supplies from key suppliers that in some cases may be the only source of finished products or raw materials, our ability to deliver our products to the market may be impeded.”

This excerpt taken from the WPI 10-K filed Mar 15, 2005.

Manufacturing, Suppliers and Materials

        We manufacture many of our own finished products at our plants in Corona, California; Carmel, New York; Copiague, New York; Salt Lake City, Utah; Phoenix, Arizona; and Humacao, Puerto Rico. Our manufacturing operations are subject to extensive regulatory oversight and could be interrupted at any time. Our Corona, California facility received a Form 483 notice from the FDA in May 2004 and is currently subject to a consent decree of permanent injunction. See "Risks Related to Our Business—Extensive industry regulation has had, and will continue to have, a significant impact on our business, especially our product development, manufacturing and distribution capabilities." See also "Item 3. Legal Proceedings—FDA Matters."

        For certain of our products, we contract with third parties for the manufacture of the products, some of which are currently available only from sole or limited suppliers. These third-party manufactured products include products that have historically accounted for a significant portion of our revenues, such as Ferrlecit®, bupropion hydrochloride sustained-release tablets and a number of our

9



oral contraceptive products. Third-party manufactured products accounted for approximately 48%, 41% and 47% of our product net revenues in 2004, 2003 and 2002, respectively, and 50%, 48% and 41% of our gross profit in 2004, 2003 and 2002, respectively.

        We are dependent on third parties for the supply of the raw materials necessary to develop and manufacture our products, including the active and inactive pharmaceutical ingredients used in our products. We are required to identify the supplier(s) of all the raw materials for our products in the drug applications that we file with the FDA. If raw materials for a particular product become unavailable from an approved supplier specified in a drug application, we would be required to qualify a substitute supplier with the FDA, which would likely interrupt manufacturing of the affected product. To the extent practicable, we attempt to identify more than one supplier in each drug application. However, some raw materials are available only from a single source and, in some of our drug applications, only one supplier of raw materials has been identified, even in instances where multiple sources exist.

        In addition, we obtain a significant portion of our raw materials from foreign suppliers. Arrangements with international raw material suppliers are subject to, among other things, FDA regulation, customs clearance, various import duties, foreign currency risk and other government clearances. Acts of governments outside the U.S. may affect the price or availability of raw materials needed for the development or manufacture of our products. In addition, any changes in patent laws in jurisdictions outside the U.S. may make it increasingly difficult to obtain raw materials for research and development prior to the expiration of the applicable U.S. or foreign patents. See "Risks Related to Our Business—If we are unable to obtain sufficient supplies from key suppliers that in some cases may be the only source of finished products or raw materials, our ability to deliver our products to the market may be impeded."

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