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OUR BUSINESS

OUR BUSINESS

GEOGRAPHICAL FOOTPRINT

GEOGRAPHICAL FOOTPRINT

Polpharma Group International Markets

Our core markets are Poland, Russia, and Kazakhstan. Polpharma Group developed its geographic footprint by focusing on a selection of high-growth markets in Central and Eastern Europe, CIS countries, Ukraine, and SE Asia. Our Group operates via direct presence and strategic partnerships in many countries. Polpharma Group plays a key role in certain therapeutic areas like paediatrics, cardiology, and ophthalmology, as well as consumer healthcare. Our Vitamin D products enjoy a leading position in the region. The Polpharma Group portfolio makes high-quality treatment available to a wider population in less developed countries and provides affordable quality in other countries.

Bulgaria
Czech
Slowakia
Baltics (Estonia,
Latvia, Lithuania)
Hungary

CEE

UA

Ukraine

Belarus
Uzbekistan
Kirgizstan

CIS

SE

Asia

Vietnam

Polpharma B2B is a world-class provider of high-quality products
and services with customised support as well as an international and
professional sales team. We offer finished dosage forms (FDF) &
licensing-out as well as customised contract manufacturing services with
full analytical support in our GMP-compliant production plants. We also
provide CDMO services. Thanks to strong R&D centres, we are able to
provide our partners with tailor-made solutions addressing all of their
business needs. Polpharma offers high-quality dossiers. We boast almost
20 years of experience in supplying FDF to 3rd parties with successful
launch of products on day zero of patent expiry.

POLPHARMA B2B SEGMENT

Polpharma API is a European producer of Active Pharmaceutical
Ingredients (since 1951) and provider of CDMO services. Recognised as
a long-term partner of choice for many business customers worldwide,
Polpharma is present in 60+ countries. At Polpharma, Quality,
Compliance and EHS come first. Our manufacturing processes and
facilities are in line with the stringent requirements of customers and
healthcare authorities, including Polish authorities, US FDA, EMA,
EDQM, SKFDA, PMDA and ANVISA. Polpharma API is transforming to
be a leading European API player and the first choice for our partners.
We are providing a one-stop shop solution for your API needs, from
process development scale-up capabilities based on in-house or
external customised technologies, to regulatory support. Our generic
APIs are well-recognised thanks to state-of-the-art documentation,
competitiveness and excellent customer service.

POLPHARMA API SEGMENT

POLPHARMA B2B SEGMENT

Polpharma B2B is a world-class provider of high-quality products
and services with customised support as well as an international and
professional sales team. We offer finished dosage forms (FDF) &
licensing-out as well as customised contract manufacturing services with
full analytical support in our GMP-compliant production plants. We also
provide CDMO services. Thanks to strong R&D centres, we are able to
provide our partners with tailor-made solutions addressing all of their
business needs. Polpharma offers high-quality dossiers. We boast almost
20 years of experience in supplying FDF to 3rd parties with successful
launch of products on day zero of patent expiry.

POLPHARMA API SEGMENT

Polpharma API is a European producer of Active Pharmaceutical
Ingredients (since 1951) and provider of CDMO services. Recognised as
a long-term partner of choice for many business customers worldwide,
Polpharma is present in 60+ countries. At Polpharma, Quality,
Compliance and EHS come first. Our manufacturing processes and
facilities are in line with the stringent requirements of customers and
healthcare authorities, including Polish authorities, US FDA, EMA,
EDQM, SKFDA, PMDA and ANVISA. Polpharma API is transforming to
be a leading European API player and the first choice for our partners.
We are providing a one-stop shop solution for your API needs, from
process development scale-up capabilities based on in-house or
external customised technologies, to regulatory support. Our generic
APIs are well-recognised thanks to state-of-the-art documentation,
competitiveness and excellent customer service.

The foundation for our future growth is Polpharma
Group’s strong portfolio of high-quality medicine. The
Group continuously expands its portfolio of more than
4,000 SKUs in prescription medicine (incl. Hard-to-Make
Generics and Novel Combinations) and non-prescription
consumer healthcare products with several category
leading brands in CEE and CIS markets. In addition, the
companies focused API business currently operates a
portfolio of >30 APIs. Worldwide, Polpharma Group sells
its products in more than 40 countries.

PRODUCTS

PRODUCTS

The foundation for our future growth is Polpharma Group’s strong portfolio of high-quality medicine. The Group continuously expands its portfolio of more than 4,000 SKUs in prescription medicine (incl. Hard-to-Make Generics and Novel Combinations) and non-prescription consumer healthcare products with several category leading brands in CEE and CIS markets. In addition, the companies focused API business currently operates a portfolio of >30 APIs. Worldwide, Polpharma Group sells its products in more than 40 countries.

NET SALES PER THERAPEUTIC AREA RX VS CHC (2020)

Prescription Medicine

What is prescription medicine (generics)?

Prescription medicine are medical products that are dispensed by retail
or hospital pharmacies requiring a prescription from a healthcare
professional. One of Polpharma Group’s important business areas is the
development, production and sales of affordable prescription medicines
that are generally known as generics. Generics are pharmaceutical
products that contain the exact active pharmaceutical ingredient as the
original patented product of the initial supplier. Despite their high quality,
generics are substantially substantially less expensive than the original
patented product. Following its purpose to help people to life a healthy
life in a healthy world, Polpharma Group offers a wide range of more than 200 active pharmaceutical ingredients and more than 2,000 articles to
people.

Prescription Medicine

What is prescription medicine (generics)?

Prescription medicine are medical products that are dispensed by retail
or hospital pharmacies requiring a prescription from a healthcare
professional. One of Polpharma’s important business areas is the
development, production and sales of affordable prescription medicines
that are generally known as generics. Generics are pharmaceutical
products that contain the exact active pharmaceutical ingredient as the
original patented product of the initial supplier. Despite their high quality,
generics are substantially substantially less expensive than the original
patented product. Following its purpose to help people to life a healthy
life in a healthy world, Polpharma offers a wide range of more than 200
active pharmaceutical ingredients and more than 2,000 articles to
people.

POLPHARMA GROUP CAPABILITIES

Polpharma Group’s prescription medicine
portfolio is based on strong internal
development capabilities. The Group
has proven capabilities and continues
to invest in a series of differentiated
capabilities – combined with a growing
network of partners.

POLPHARMA GROUP CAPABILITIES

Polpharma’s prescription medicine portfolio is based on strong internal development capabilities. The Group has proven capabilities and continues to invest in a series of differentiated capabilities – combined with a growing network of partners.

PRESCRIPTION MEDICINE (RX) R&D CAPABILITIES

PRESCRIPTION MEDICINE (RX) R&D CAPABILITIES

LONG ACTING INJECTABLES

  • Complex technologies available (e.g. lyophilization, nano milling)
  • Performing clinical efficacy studies beyond usual bioequivalence studies

ECO EYE
DROPS

  • Innovative preservative-free
    formulation innovation
  • Multi-dose packaging

INNOVATIVE
COMBOS

  • Innovative multi-compound
    formulations
  • New fix dose combos of known generics for hypertension treatment
  • Clinical trials needed for EU
    Market registration, incl. efficacy studies for European
    registrations

H2M GX

  • Innovative formulation work
    going much beyond typical level of complexity
  • Strong track record of patented formulations and technologies

LONG ACTING INJECTABLES

  • Complex technologies available (e.g. lyophilization, nano milling)
  • Performing clinical efficacy studies beyond usual bioequivalence studies

ECO EYE
DROPS

  • Innovative preservative-free
    formulation innovation
  • Multi-dose packaging

INNOVATIVE
COMBOS

  • Innovative multi-compound
    formulations
  • New fix dose combos of known generics for hypertension treatment
  • Clinical trials needed for EU
    Market registration, incl. efficacy studies for European
    registrations

H2M GX

  • Innovative formulation work
    going much beyond typical level of complexity
  • Strong track record of patented formulations and technologies

Consumer Healthcare

Polpharma Group is a fast-growing Consumer Healthcare (CHC)
Company in CEE and CIS. The Group offers a wide range of high-quality
products across various health categories available without a prescription
that help to heal, relieve, and prevent a variety of conditions. The group
works closely with stakeholders across the full healthcare landscape to
fulfill its purpose: In line with its purpose to help people to live a healthy life
in a healthy world.

Consumer Healthcare

Polpharma Group is a fast-growing Consumer Healthcare (CHC) Company in CEE and CIS. The Group offers a wide range of high-quality products across various health categories available without a prescription that help to heal, relieve, and prevent a variety of conditions. The group works closely with stakeholders across the full healthcare landscape to fulfill its purpose: In line with its purpose to help people to live a healthy life in a healthy world.

Polpharma Group relies on a
proven expertise to deliver first
to market Rx → CHC switches
in selected countries in a wide
variety of therapeutical areas and
across various technology types.

Examples

KEY SWITCHES
Momentasone
Famotidine
Sildenafil
Fexofenadine
Carbocysteine

Aciclovir
Pyrantelum
Olopatadine
Clotrimazole
Doxylamine

Polpharma Group relies on a
proven expertise to deliver first
to market Rx → CHC switches
in selected countries in a wide
variety of therapeutical areas and
across various technology types.

Examples

KEY SWITCHES
Momentasone
Famotidine
Sildenafil
Fexofenadine
Carbocysteine

Aciclovir
Pyrantelum
Olopatadine
Clotrimazole
Doxylamine

PHARMACOVIGILANCE

Go to our local pharmacovigilance pages:

PHARMACOVIGILANCE

APPROACH

APPROACH

At Polpharma Group, we create innovations that translate into earlier and increased availability and higher product safety, greater ease of
drug use and improvement of patient compliance with therapeutic
recommendations, as well as higher therapy effectiveness. We are
one of the most innovative companies on our core markets, which is
confirmed by national rankings.

RESEARCH & DEVELOPMENT

We invest significant resources into the development of new products.
Our domain is generic drugs, thanks to which we facilitate access
to modern therapies for a wide group of patients and respond to
customers’ needs. We conduct our own research and development
activities, and we cooperate with universities and research institutes,
both locally and abroad. Collaboration is crucial to agile action,
being successful and creating higher value.

RESEARCH & DEVELOPMENT

At Polpharma, we create innovations that translate into earlier and
increased availability and higher product safety, greater ease of
drug use and improvement of patient compliance with therapeutic
recommendations, as well as higher therapy effectiveness. We are
one of the most innovative companies on our core markets, which is
confirmed by national rankings.

We invest significant resources into the development of new products.
Our domain is generic drugs, thanks to which we facilitate access
to modern therapies for a wide group of patients and respond to
customers’ needs. We conduct our own research and development
activities, and we cooperate with universities and research institutes,
both locally and abroad. Collaboration is crucial to agile action,
being successful and creating higher value.

Our specialisations

We have five R&D
centres located in
the vicinity of our
manufacturing sites.
Have a look at the
projects and forms
we specialise in

PL

STAROGARD GDANSKI

Oral solid forms

Immediete and Modified Release Tabletes,
multi-layer tablets, hard capsules, granules,
pellets
Fixed dose combinations

Infusion blow-fill-seal

Sterile forms

Active Pharmaceutical ingredients

Variety of advanced technologies in organic
synthesis, Solid State Chemistry, contract
development services (CDMO)

PL

SIERADZ

Oral solid forms

oft gelatin capsules, including gastroresistance

Suspensions, lacquer, syrups, solutions, drops,
nasal-solid forms

Non-sterile liquids

Dry powder inhalers and devices

Respiratory DPI (Dry Powder Inhalers) mono
and combo-products

Our specialisations

We have five R&D centres located in the vicinity of our manufacturing sites. Have a look at the projects and forms we specialise in

STAROGARD GDANSKI

PL

Oral solid forms

Immediete and Modified Release Tabletes, multi-layer tablets, hard capsules, granules, pellets Fixed dose combinations

Sterile forms

Infusion blow-fill-seal

Active Pharmaceutical ingredients

Variety of advanced technologies in organic synthesis, Solid State Chemistry, contract development services (CDMO)

SIERADZ

PL

Oral solid forms

oft gelatin capsules, including gastroresistance

Non-sterile liquids

Suspensions, lacquer, syrups, solutions, drops, nasal-solid forms

Dry powder inhalers and devices

Respiratory DPI (Dry Powder Inhalers) mono and combo-products

PL

WARSAW

Sterile injectables and infusions

Solutions, emulsions, lyophilisates
Long Acting Injectables

Ophthalmic solutions and suspensions,
including ECO (preservative-free)

Nasal

Aerosol and drops
Sterile tablets for implantation

KZ

SHYMKENT

Liquids and Injectives

Non-sterile liquids

Parental forms, SVP/LVP, sterile antibiotics

Solide dosage forms

RU

STARAYA KUPAVNA

Tablets in different FDF

Tablets, soluble tablets/ODT, vaginal tablets

Capsules (hard gelatin)

Ointments & Creams & Gels
& Emulsions

WARSAW

PL

Sterile injectables and infusions

Solutions, emulsions, lyophilisates
Long Acting Injectables

Ophthalmic solutions and suspensions,
including ECO (preservative-free)

Nasal

Aerosol and drops
Sterile tablets for implantation

SHYMKENT

KZ

Liquids and Injectives

Non-sterile liquids

Solide dosage forms

Parental forms, SVP/LVP, sterile antibiotics

STARAYA KUPAVNA

RU

Tablets in different FDF

Tablets, soluble tablets/ODT, vaginal tablets

Capsules (hard gelatin)

Ointments & Creams & Gels & Emulsions

R&D for Polpharma Group supports our intensive
growth with a long-term perspective focused
around key therapeutic areas and targeted
competence centres. Owing to a broad range
of forms and our specialisation in hard-to-make
products, we are able to deliver added-value
products to patients.

R&D for Polpharma Group supports our intensive  growth with a long-term perspective focused around key therapeutic areas and targeted competence centres. Owing to a broad range of forms and our specialisation in hard-to-make products, we are able to deliver added-value  products to patients.

INNOVATIVE CAPABILITIES

INNOVATIVE CAPABILITIES

LONG ACTING INJECTABLES

  • Nano formulation
  • Patients Human Clinical Studies

ECO EYE
DROPS

  • Preservative-free formulation
    innovation
  • Multi-dose packaging of
    ophthalmics

INNOVATIVE
COMBOS

  • Innovative multi-compound
    formulations
  • New single pill fix dose combos for hypertension treatment up to triple combinations
  • Phase 3 clinical trials

HARD TO MAKE PRODUCTS

  • Innovative formulation work going much beyond typical level of complexity

LONG ACTING INJECTABLES

  • Nano formulation
  • Patients Human Clinical Studies

ECO EYE DROPS

  • Preservative-free formulation
    innovation
  • Multi-dose packaging of
    ophthalmics

INNOVATIVE COMBOS

  • Innovative multi-compound
    formulations
  • New single pill fix dose combos for hypertension treatment up to triple combinations
  • Phase 3 clinical trials

HARD TO MAKE PRODUCTS

  • Innovative formulation work going much beyond typical level of complexity
0

R&D
centers

with the latest
available technology
and the highest
quality standards

> 0

Products in development

0

R&D
employees

incl. 91 with a
doctorate

0

Patent applications*

0

Patents obtained in last five years*

* Polish organization

Another of our distinguishing features on the
market is vertical integration that allows us
to operate agilely and efficiently, as well as to
consistently pursue our long-term R&D strategy.
By managing the entire process of medicine life
cycles, we are able to be the first producer of
generics on the market. The combination of our
in-house resources, the latest technologies and
state-of-the-art equipment also allows us to
support our business partners around the world.

Another of our distinguishing features on the  market is vertical integration that allows us  to operate agilely and efficiently, as well as to consistently pursue our long-term R&D strategy. By managing the entire process of medicine life cycles, we are able to be the first producer of generics on the market. The combination of our in-house resources, the latest technologies and state-of-the-art equipment also allows us to support our business partners around the world.

DIGITAL TRANSFORMATION

DIGITAL TRANSFORMATION

At Polpharma Group, we believe that patient-centric digital
transformation of the healthcare industry can create real value for all
of us. Thanks to our unique knowledge of patient journeys and system
requirements, we play an important role in reshaping the future.

A couple of years ago, we decided to concentrate our efforts on two key
areas. First of all, we exploit the digital development of our company
internally. Secondly, thanks to active collaboration with external
stakeholders, we explore possibilities to provide systematic solutions
supporting patients in living healthy lives in a healthy world.

At Polpharma Group, we believe that patient-centric digital transformation of the healthcare industry can create real value for all of us. Thanks to our unique knowledge of patient journeys and system requirements, we play an important role in reshaping the future.

A couple of years ago, we decided to concentrate our efforts on two key areas. First of all, we exploit the digital development of our company  internally. Secondly, thanks to active collaboration with external stakeholders, we explore possibilities to provide systematic solutions supporting patients in living healthy lives in a healthy world.

Our employees are the foundation of all our changes (Digital Culture
& Organization). It all starts with the organisational culture and
people’s mind-set – tools and technologies are necessary but secondary
in importance. We are proud to respond proactively and quickly and
thereby operate successfully in uncertain times (COVID-19 pandemic),
continuously serving our patients. All of this is possible thanks to the
major investments we have made in digital initiatives and digital employee
development over the last few years.

At the heart of our activities are Digital Operations, Digital Market
and Digital Products based on leading-edge technologies, i.e. Internet
of Things (IoT), Cloud Computing, Artificial Intelligence (AI) and
Augmented Reality (AR). We use the latter to build a digital machine
model (digital twin) to train new employees, monitor the operating status
of devices or retool production lines (Factory of the Future). We want
to meet the growing expectations of consumers within the e-commerce
area, as well as assist doctors with a hybrid-commercial model in making
accurate and effective decisions in patient care.

We work intensively with a wide range of partners (Digital Ecosystem) to
explore new business opportunities (New Digital Business) and enhance
areas such as patient compliance, patient outcome improvements,
Digital Transformation Model
telemedicine and diagnostics.

Our employees are the foundation of all our changes (Digital Culture & Organization). It all starts with the organisational culture and  people’s mind-set – tools and technologies are necessary but secondary in importance. We are proud to respond proactively and quickly and  thereby operate successfully in uncertain times (COVID-19 pandemic), continuously serving our patients. All of this is possible thanks to the  major investments we have made in digital initiatives and digital employee development over the last few years.

At the heart of our activities are Digital Operations, Digital Market  and Digital Products based on leading-edge technologies, i.e. Internet of Things (IoT), Cloud Computing, Artificial Intelligence (AI) and Augmented Reality (AR). We use the latter to build a digital machine model (digital twin) to train new employees, monitor the operating status of devices or retool production lines (Factory of the Future). We want to meet the growing expectations of consumers within the e-commerce area, as well as assist doctors with a hybrid-commercial model in making accurate and effective decisions in patient care.

We work intensively with a wide range of partners (Digital Ecosystem) to explore new business opportunities (New Digital Business) and enhance areas such as patient compliance, patient outcome improvements, Digital Transformation Model telemedicine and diagnostics.

INDUSTRIAL OPERATIONS

& QUALITY

Our annual production

8

billion
tablets

Each Polpharma Group plant specialises in particular drugs and medical products.
Together, they form a network of eight competence centres.

730

million
capsules

215

million
ampoules

INDUSTRIAL OPERATIONS

& QUALITY

Our annual production

7.3

billion tablets

2

billion capsules

150

million ampoules

Each Polpharma Group plant specialises in particular drugs and medical products. Together, they form a network of eight competence centres.

The quality, effectiveness and safety of our products are the highest priority for the Polpharma Group.

We ensure the quality of a product at every stage of its development, production, testing, storage, distribution and sales through standardisation of
quality processes and implementation of continuous improvement mechanisms and process controls.

Our adopted standards and practices are in line with legal requirements and current guidelines. All sites are GMP-certified, including Polish factories
with EU cGMP certification, and API plant with FDA certification. In addition, we have obtained all the other certificates needed for our distribution
markets.

The quality, effectiveness and safety of our products are the highest priority for the Polpharma Group.

We ensure the quality of a product at every stage of its development, production, testing, storage, distribution and sales through standardisation of  quality processes and implementation of continuous improvement mechanisms and process controls.

Our adopted standards and practices are in line with legal requirements and current guidelines. All sites are GMP-certified, including Polish factories  with EU cGMP certification, and API plant with FDA certification. In addition, we have obtained all the other certificates needed for our distribution markets.

POLPHARMA GROUP COMPETENCE CENTRES

Main competencies

Solid dosage forms and food
supplements such as tablets
and hard capsules

PL

Polpharma S.A.
Production Department

New competencies

High-active solid forms,
probiotics

API

CORNERSTONES

1

Partner of choice within a
therapy area

2

Clarity of communication to
customers on role of each brand

3

Defined growth strategies for
each brand

4

Optimized pricing

5

Complimented with additional
services, e.g. compliance,
education

COVERAGE OF SPECIALISTS PER SPECIALITY

COVERAGE OF SPECIALISTS PER SPECIALITY

POLAND

KAZAKHSTAN

RUSSIA

POLAND

KAZAKHSTAN

RUSSIA

STAROGARD GDANSKI

Solutions and emulsions in glass ampoules

Tablets

Hard capsules

DPE Large Volumes Parenteral (BFS)

LDPE Small Volumes Parenteral (BFS)

NOWA DEBA

Tablets

Hard capsules

DUCHNICE

Solutions and emulsions in glass vials

Tablets

SIERADZ

Nasal drops and gel

Topical products and cosmetics

Soft gelatin capsules

Non-sterile liquid forms

Oral liquids

WARSAW

Nasal drops and gel

Eye drops

Pre-filled syringes

Solutions and emulsions in glass ampoules

Solutions and emulsions in glass vials

SHYMKENT

Tablets

Hard capsules

STARAYA KUPAVNA

Solutions and emulsions in glass ampoules

Tablets