Waters, ACQUITY UPLC, and UPLC are registered trademarks of Waters Corporation. Empower and The Science of What’s Possible are trademarks of Waters Corporation. All other trademarks are the property of their respective owners.

©2006-2007 Waters Corporation. Printed in the U.S.A.July 2007 720001980EN LB-CP

“Because we use Waters hardware and software in our analytical R&D, quality control and stability labs, we ensure that each batch of product has accurate release data attached to it. This helps us have our products available for shipment, faster. That’s the bottom line.” – Clay-Park Labs, Inc.

www.waters.com/generics

GENERIC PHARMACEUTICAL COMPANIES NEED MORE THAN GENERIC SOLUTIONS.

SaleS OfficeS:

Austria 43 1 877 18 07

Australia 61 2 9933 1777

Belgium and Luxembourg 32 2 726 1000

Brazil 55 11 5094 3788

Canada 1 800 252 4752

China 86 10 8586 8899

Czech Republic 420 2 617 11384

Denmark 45 46 59 8080

Finland 358 9 5659 6288

France 33 1 30 48 72 00

Germany 49 6196 400 600

Hong Kong 852 2964 1800

Hungary 36 1 350 5086

India 91 80 2837 1900

Ireland 353 1 448 1500

Italy 39 02 265 0983

Japan 81 3 3471 7191

Korea 82 2 820 2700

Mexico 52 55 52 00 1860

The Netherlands 31 76 508 7200

Norway 47 6 384 6050

Poland 48 22 833 4400

Puerto Rico 787 747 8445

Russia/CIS 495 727 4490 / 290 9737

Singapore 65 6273 1221

Spain 34 93 600 9300

Sweden 46 8 555 115 00

Switzerland 41 62 889 2030

Taiwan 886 2 2543 1898

UK 44 208 238 6100

US 1 800 252 4752

Waters Corporation 34 Maple StreetMilford, MA 01757 U.S.A.T: 508 478 2000F: 508 872 1990www.waters.com

WATERS SOLUTIONS

A generics manufacturer that

specializes in over-the-counter

topical pharmaceuticals relies

on Waters. “Waters Empower™

Software is simply second

to none. It provides far more

reliable data. It’s key to helping

us maintain compliance. There

are fewer problems with our

client/server thanks to Empower.

It supports 3D products like

photodiode array detectors. Plus,

it supports other manufacturer’s

instrumentation, maximizing

our investment in it. All of which

helps us release our products

faster,” says the company’s

technical services director.

Another global generics

pharmaceutical firm implemented

Empower 2 Method Validation

Manager, which automated

and significantly streamlined

their chromatographic method

validation process – resulting

in a dramatic increase in

productivity. One R&D scientist

reported that, for non-sample

prep activities, the Waters

solution provided a 50 percent

overall time savings in a

method validation study. Just as

importantly, the scientist said he

is more confident that his method

validation data is accurate

and traceable.

Time To decide.

Time To develop.

Time To deliver.

Time for Waters.

For generic pharmaceutical companies, there is an expansive – and expensive

– gap between testing for variability in production and verifying product

quality. The key to end-product profitability is found in the confidence that

your formulations are of high quality and are consistent throughout the

entire commercialization process. Every tick of the clock between regulatory

filing and shipment holds an opportunity for generic pharmaceutical

companies to address the laboratory demands that ensure maximized

returns. ■ Reliability. ■ Consistency. ■ Quality. ■ Efficiency. ■ Productivity.

■ Cost efficiency. ■ Transparency for compliance. ■ And, above all, sustainable

profitability. Waters has the expertise to help you optimize your operation and

produce the right formulation, at the right time and at the right price point.

Regulatory

Qualification tools and a data management strategy enable you to compile and retrieve

information that you can rely on during regulatory filings or reviews – as quickly as you

need it. Equally important are trained and certified operators, and software that prevents

those operators from operating out of specification. From staffing to instrumentation

to data management, Waters solutions encompass the tools that you need to achieve

compliance.

■ Waters’ advanced column technology records system operational conditions for

easy documentation.

■ With a variety of thorough courses that address all the operational needs of a

laboratory, Waters courses provide the certified training your staff needs.

■ Waters data management strategies enable you to automate how you capture,

process, save, report, store and retrieve information of any type – facilitating

compliance through pervasive electronic documentation.

HOW CAN WAT ERS HELP yOU DRIv E P ROFITABIL IT y?

Quality

To decrease costs – and increase margins – your lab needs to

maintain consistent quality. Whether this means fewer scrapped

or reworked batches, minimizing waste to reduce disposal costs,

or even reducing overtime caused by adverse out-of-specification

events that require samples to be re-analyzed, Waters® technolo-

gies can help you address quality manufacturing processes.

■ With UPLC® technology, you get faster and better information

about the samples you analyze, enabling you to address

challenges earlier in your manufacturing process.

■ Waters offers the application expertise and services that support

your labs, enabling you to resolve questions more completely.

■ Our compliant-ready software and qualification tools help you

maintain a quality-based operational environment.

Productivity

To increase revenues, you must address productivity. To introduce

new products – or even produce more of the same product – com-

panies must maximize every moment: the time it takes to develop,

manufacture and deliver a new product; the window of opportunity

to capitalize on a drug coming off patent; the time required to cap-

ture market share; or time needed to become a valued supplier to

distributors or wholesalers by maintaining a positive history of prod-

uct delivery. Whether it’s variability, reproducibility or reliability,

Waters solves the productivity challenges in your labs.

■ The speed, sensitivity and resolution of Waters chromatographic

innovations help you achieve the highest levels of laboratory

productivity possible. With UPLC technology, you can increase

productivity by a factor of 10.

■ Waters services ensure that both your staff and your instru-

ments perform at their best – whether this means certified

training for analysts or intelligent instrument diagnostics

services that ensure uptime.

■ Software solutions enable you to automate time-consuming

chromatographic method validation processes, from protocol

planning to final reporting – potentially reducing validation

time and costs by as much as 50 percent.

Efficiency

There are diverging paths to increase the operational efficiency

and asset utilization that impacts margins. Addressing laboratory

throughput by instrumentation that either multi-tasks or simply pro-

duces better results faster. Decreasing the development time for a new

product. Decreasing the manufacturing time for an existing product

that takes better advantage of fixed assets. Or you can achieve gains

by implementing just-in-time manufacturing, which reduces the hold-

ing costs of raw materials and the storage costs of finished goods.

■ The ACQUITY UPLC® system provides substantial opportunity

in improving throughput, proven to reduce analysis time by

factors of 5 of 10 times.

■ Waters data management solutions apply new informatics

technologies that increase the efficiency of acquiring, analyzing,

reporting and archiving data – and provide time-savings in

product development and commercialization.

■ With better training, analysts can work more efficiently or

multi-task by cross-training among laboratory functions.

■ Ease-of-use, an important attribute in all Waters instruments

and software, substantially contributes to an efficient lab

environment.

Time to Market

A missed ship date means increased facilities costs – and lost

revenues. With a comprehensive strategy for laboratory solutions

that encompass all operational needs from instrumentation to

chemistries to software to support services; to understanding the

needs of a laboratory environment that includes third-party vendor

instrumentation, you can be confident that you meet target delivery

timeframes.

■ Custom calculations are simplified with Waters chromatography

data software.

■ Faster, consistent and more accurate analyses available with the

ACQUITY UPLC system provide confidence in your production

cycle, end-to-end.

[ Generic pharmaceutical solutions ]

Waters, ACQUITY UPLC, and UPLC are registered trademarks of Waters Corporation. Empower and The Science of What’s Possible are trademarks of Waters Corporation. All other trademarks are the property of their respective owners.

©2006-2007 Waters Corporation. Printed in the U.S.A.July 2007 720001980EN LB-CP

“Because we use Waters hardware and software in our analytical R&D, quality control and stability labs, we ensure that each batch of product has accurate release data attached to it. This helps us have our products available for shipment, faster. That’s the bottom line.” – Clay-Park Labs, Inc.

www.waters.com/generics

GENERIC PHARMACEUTICAL COMPANIES NEED MORE THAN GENERIC SOLUTIONS.

SaleS OfficeS:

Austria 43 1 877 18 07

Australia 61 2 9933 1777

Belgium and Luxembourg 32 2 726 1000

Brazil 55 11 5094 3788

Canada 1 800 252 4752

China 86 10 8586 8899

Czech Republic 420 2 617 11384

Denmark 45 46 59 8080

Finland 358 9 5659 6288

France 33 1 30 48 72 00

Germany 49 6196 400 600

Hong Kong 852 2964 1800

Hungary 36 1 350 5086

India 91 80 2837 1900

Ireland 353 1 448 1500

Italy 39 02 265 0983

Japan 81 3 3471 7191

Korea 82 2 820 2700

Mexico 52 55 52 00 1860

The Netherlands 31 76 508 7200

Norway 47 6 384 6050

Poland 48 22 833 4400

Puerto Rico 787 747 8445

Russia/CIS 495 727 4490 / 290 9737

Singapore 65 6273 1221

Spain 34 93 600 9300

Sweden 46 8 555 115 00

Switzerland 41 62 889 2030

Taiwan 886 2 2543 1898

UK 44 208 238 6100

US 1 800 252 4752

Waters Corporation 34 Maple StreetMilford, MA 01757 U.S.A.T: 508 478 2000F: 508 872 1990www.waters.com

WATERS SOLUTIONS

A generics manufacturer that

specializes in over-the-counter

topical pharmaceuticals relies

on Waters. “Waters Empower™

Software is simply second

to none. It provides far more

reliable data. It’s key to helping

us maintain compliance. There

are fewer problems with our

client/server thanks to Empower.

It supports 3D products like

photodiode array detectors. Plus,

it supports other manufacturer’s

instrumentation, maximizing

our investment in it. All of which

helps us release our products

faster,” says the company’s

technical services director.

Another global generics

pharmaceutical firm implemented

Empower 2 Method Validation

Manager, which automated

and significantly streamlined

their chromatographic method

validation process – resulting

in a dramatic increase in

productivity. One R&D scientist

reported that, for non-sample

prep activities, the Waters

solution provided a 50 percent

overall time savings in a

method validation study. Just as

importantly, the scientist said he

is more confident that his method

validation data is accurate

and traceable.

Time To decide.

Time To develop.

Time To deliver.

Time for Waters.

For generic pharmaceutical companies, there is an expansive – and expensive

– gap between testing for variability in production and verifying product

quality. The key to end-product profitability is found in the confidence that

your formulations are of high quality and are consistent throughout the

entire commercialization process. Every tick of the clock between regulatory

filing and shipment holds an opportunity for generic pharmaceutical

companies to address the laboratory demands that ensure maximized

returns. ■ Reliability. ■ Consistency. ■ Quality. ■ Efficiency. ■ Productivity.

■ Cost efficiency. ■ Transparency for compliance. ■ And, above all, sustainable

profitability. Waters has the expertise to help you optimize your operation and

produce the right formulation, at the right time and at the right price point.

Regulatory

Qualification tools and a data management strategy enable you to compile and retrieve

information that you can rely on during regulatory filings or reviews – as quickly as you

need it. Equally important are trained and certified operators, and software that prevents

those operators from operating out of specification. From staffing to instrumentation

to data management, Waters solutions encompass the tools that you need to achieve

compliance.

■ Waters’ advanced column technology records system operational conditions for

easy documentation.

■ With a variety of thorough courses that address all the operational needs of a

laboratory, Waters courses provide the certified training your staff needs.

■ Waters data management strategies enable you to automate how you capture,

process, save, report, store and retrieve information of any type – facilitating

compliance through pervasive electronic documentation.

HOW CAN WAT ERS HELP yOU DRIv E P ROFITABIL IT y?

Quality

To decrease costs – and increase margins – your lab needs to

maintain consistent quality. Whether this means fewer scrapped

or reworked batches, minimizing waste to reduce disposal costs,

or even reducing overtime caused by adverse out-of-specification

events that require samples to be re-analyzed, Waters® technolo-

gies can help you address quality manufacturing processes.

■ With UPLC® technology, you get faster and better information

about the samples you analyze, enabling you to address

challenges earlier in your manufacturing process.

■ Waters offers the application expertise and services that support

your labs, enabling you to resolve questions more completely.

■ Our compliant-ready software and qualification tools help you

maintain a quality-based operational environment.

Productivity

To increase revenues, you must address productivity. To introduce

new products – or even produce more of the same product – com-

panies must maximize every moment: the time it takes to develop,

manufacture and deliver a new product; the window of opportunity

to capitalize on a drug coming off patent; the time required to cap-

ture market share; or time needed to become a valued supplier to

distributors or wholesalers by maintaining a positive history of prod-

uct delivery. Whether it’s variability, reproducibility or reliability,

Waters solves the productivity challenges in your labs.

■ The speed, sensitivity and resolution of Waters chromatographic

innovations help you achieve the highest levels of laboratory

productivity possible. With UPLC technology, you can increase

productivity by a factor of 10.

■ Waters services ensure that both your staff and your instru-

ments perform at their best – whether this means certified

training for analysts or intelligent instrument diagnostics

services that ensure uptime.

■ Software solutions enable you to automate time-consuming

chromatographic method validation processes, from protocol

planning to final reporting – potentially reducing validation

time and costs by as much as 50 percent.

Efficiency

There are diverging paths to increase the operational efficiency

and asset utilization that impacts margins. Addressing laboratory

throughput by instrumentation that either multi-tasks or simply pro-

duces better results faster. Decreasing the development time for a new

product. Decreasing the manufacturing time for an existing product

that takes better advantage of fixed assets. Or you can achieve gains

by implementing just-in-time manufacturing, which reduces the hold-

ing costs of raw materials and the storage costs of finished goods.

■ The ACQUITY UPLC® system provides substantial opportunity

in improving throughput, proven to reduce analysis time by

factors of 5 of 10 times.

■ Waters data management solutions apply new informatics

technologies that increase the efficiency of acquiring, analyzing,

reporting and archiving data – and provide time-savings in

product development and commercialization.

■ With better training, analysts can work more efficiently or

multi-task by cross-training among laboratory functions.

■ Ease-of-use, an important attribute in all Waters instruments

and software, substantially contributes to an efficient lab

environment.

Time to Market

A missed ship date means increased facilities costs – and lost

revenues. With a comprehensive strategy for laboratory solutions

that encompass all operational needs from instrumentation to

chemistries to software to support services; to understanding the

needs of a laboratory environment that includes third-party vendor

instrumentation, you can be confident that you meet target delivery

timeframes.

■ Custom calculations are simplified with Waters chromatography

data software.

■ Faster, consistent and more accurate analyses available with the

ACQUITY UPLC system provide confidence in your production

cycle, end-to-end.

[ Generic pharmaceutical solutions ]

WATERS SOLUTIONS

A generics manufacturer that

specializes in over-the-counter

topical pharmaceuticals relies

on Waters. “Waters Empower™

Software is simply second

to none. It provides far more

reliable data. It’s key to helping

us maintain compliance. There

are fewer problems with our

client/server thanks to Empower.

It supports 3D products like

photodiode array detectors. Plus,

it supports other manufacturer’s

instrumentation, maximizing

our investment in it. All of which

helps us release our products

faster,” says the company’s

technical services director.

Another global generics

pharmaceutical firm implemented

Empower 2 Method Validation

Manager, which automated

and significantly streamlined

their chromatographic method

validation process – resulting

in a dramatic increase in

productivity. One R&D scientist

reported that, for non-sample

prep activities, the Waters

solution provided a 50 percent

overall time savings in a

method validation study. Just as

importantly, the scientist said he

is more confident that his method

validation data is accurate

and traceable.

Time To decide.

Time To develop.

Time To deliver.

Time for Waters.

For generic pharmaceutical companies, there is an expansive – and expensive

– gap between testing for variability in production and verifying product

quality. The key to end-product profitability is found in the confidence that

your formulations are of high quality and are consistent throughout the

entire commercialization process. Every tick of the clock between regulatory

filing and shipment holds an opportunity for generic pharmaceutical

companies to address the laboratory demands that ensure maximized

returns. ■ Reliability. ■ Consistency. ■ Quality. ■ Efficiency. ■ Productivity.

■ Cost efficiency. ■ Transparency for compliance. ■ And, above all, sustainable

profitability. Waters has the expertise to help you optimize your operation and

produce the right formulation, at the right time and at the right price point.

Regulatory

Qualification tools and a data management strategy enable you to compile and retrieve

information that you can rely on during regulatory filings or reviews – as quickly as you

need it. Equally important are trained and certified operators, and software that prevents

those operators from operating out of specification. From staffing to instrumentation

to data management, Waters solutions encompass the tools that you need to achieve

compliance.

■ Waters’ advanced column technology records system operational conditions for

easy documentation.

■ With a variety of thorough courses that address all the operational needs of a

laboratory, Waters courses provide the certified training your staff needs.

■ Waters data management strategies enable you to automate how you capture,

process, save, report, store and retrieve information of any type – facilitating

compliance through pervasive electronic documentation.

HOW CAN WAT ERS HELP yOU DRIv E P ROFITABIL IT y?

Quality

To decrease costs – and increase margins – your lab needs to

maintain consistent quality. Whether this means fewer scrapped

or reworked batches, minimizing waste to reduce disposal costs,

or even reducing overtime caused by adverse out-of-specification

events that require samples to be re-analyzed, Waters® technolo-

gies can help you address quality manufacturing processes.

■ With UPLC® technology, you get faster and better information

about the samples you analyze, enabling you to address

challenges earlier in your manufacturing process.

■ Waters offers the application expertise and services that support

your labs, enabling you to resolve questions more completely.

■ Our compliant-ready software and qualification tools help you

maintain a quality-based operational environment.

Productivity

To increase revenues, you must address productivity. To introduce

new products – or even produce more of the same product – com-

panies must maximize every moment: the time it takes to develop,

manufacture and deliver a new product; the window of opportunity

to capitalize on a drug coming off patent; the time required to cap-

ture market share; or time needed to become a valued supplier to

distributors or wholesalers by maintaining a positive history of prod-

uct delivery. Whether it’s variability, reproducibility or reliability,

Waters solves the productivity challenges in your labs.

■ The speed, sensitivity and resolution of Waters chromatographic

innovations help you achieve the highest levels of laboratory

productivity possible. With UPLC technology, you can increase

productivity by a factor of 10.

■ Waters services ensure that both your staff and your instru-

ments perform at their best – whether this means certified

training for analysts or intelligent instrument diagnostics

services that ensure uptime.

■ Software solutions enable you to automate time-consuming

chromatographic method validation processes, from protocol

planning to final reporting – potentially reducing validation

time and costs by as much as 50 percent.

Efficiency

There are diverging paths to increase the operational efficiency

and asset utilization that impacts margins. Addressing laboratory

throughput by instrumentation that either multi-tasks or simply pro-

duces better results faster. Decreasing the development time for a new

product. Decreasing the manufacturing time for an existing product

that takes better advantage of fixed assets. Or you can achieve gains

by implementing just-in-time manufacturing, which reduces the hold-

ing costs of raw materials and the storage costs of finished goods.

■ The ACQUITY UPLC® system provides substantial opportunity

in improving throughput, proven to reduce analysis time by

factors of 5 of 10 times.

■ Waters data management solutions apply new informatics

technologies that increase the efficiency of acquiring, analyzing,

reporting and archiving data – and provide time-savings in

product development and commercialization.

■ With better training, analysts can work more efficiently or

multi-task by cross-training among laboratory functions.

■ Ease-of-use, an important attribute in all Waters instruments

and software, substantially contributes to an efficient lab

environment.

Time to Market

A missed ship date means increased facilities costs – and lost

revenues. With a comprehensive strategy for laboratory solutions

that encompass all operational needs from instrumentation to

chemistries to software to support services; to understanding the

needs of a laboratory environment that includes third-party vendor

instrumentation, you can be confident that you meet target delivery

timeframes.

■ Custom calculations are simplified with Waters chromatography

data software.

■ Faster, consistent and more accurate analyses available with the

ACQUITY UPLC system provide confidence in your production

cycle, end-to-end.

[ Generic pharmaceutical solutions ]

Waters, ACQUITY UPLC, and UPLC are registered trademarks of Waters Corporation. Empower and The Science of What’s Possible are trademarks of Waters Corporation. All other trademarks are the property of their respective owners.

©2006-2007 Waters Corporation. Printed in the U.S.A.July 2007 720001980EN LB-CP

“Because we use Waters hardware and software in our analytical R&D, quality control and stability labs, we ensure that each batch of product has accurate release data attached to it. This helps us have our products available for shipment, faster. That’s the bottom line.” – Clay-Park Labs, Inc.

www.waters.com/generics

GENERIC PHARMACEUTICAL COMPANIES NEED MORE THAN GENERIC SOLUTIONS.

SaleS OfficeS:

Austria 43 1 877 18 07

Australia 61 2 9933 1777

Belgium and Luxembourg 32 2 726 1000

Brazil 55 11 5094 3788

Canada 1 800 252 4752

China 86 10 8586 8899

Czech Republic 420 2 617 11384

Denmark 45 46 59 8080

Finland 358 9 5659 6288

France 33 1 30 48 72 00

Germany 49 6196 400 600

Hong Kong 852 2964 1800

Hungary 36 1 350 5086

India 91 80 2837 1900

Ireland 353 1 448 1500

Italy 39 02 265 0983

Japan 81 3 3471 7191

Korea 82 2 820 2700

Mexico 52 55 52 00 1860

The Netherlands 31 76 508 7200

Norway 47 6 384 6050

Poland 48 22 833 4400

Puerto Rico 787 747 8445

Russia/CIS 495 727 4490 / 290 9737

Singapore 65 6273 1221

Spain 34 93 600 9300

Sweden 46 8 555 115 00

Switzerland 41 62 889 2030

Taiwan 886 2 2543 1898

UK 44 208 238 6100

US 1 800 252 4752

Waters Corporation 34 Maple StreetMilford, MA 01757 U.S.A.T: 508 478 2000F: 508 872 1990www.waters.com