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:
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
R&D
centers
with the latest
available technology
and the highest
quality standards
Products in development
R&D
employees
incl. 91 with a
doctorate
Patent applications*
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,
parenteral forms SVP/LVP
PL
Finished dosage
New competencies
Ophthalmic forms, pfs,
LVP/SVP in PE/PP
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
Main competencies
Cephalosporin antibiotics,
injectable and oral dosage forms
PL
Polpharma S.A.
Production Department
Main competencies
Soft gelatin capsules, Nasal Drops
Oral Liquids
PL
Polpharma S.A.
Medana Branch
New competencies
Dry Powder Inhalors brathing
Main competencies
Small molecules; wide
range of organic chemical
reactions; R&D Lab, pilotGMP and non-GMP; new
product development,
scale-up and production
(generics and CDMO)
New competencies
Kilo Lab, High containment
APIs
Main competencies
Ophthalmic drugs and parenteral
forms
PL
Warsaw Pharmaceutical Works Polfa S.A.
Main competencies
Parenteral forms, SVP/LVP,
antibiotics, solid forms
KZ
SANTO Plant
(JSC Chimpharm)
New competencies
Non-sterile liquid forms
Main competencies
Solid-form, semi-solids forms
RU
JSC Akrihin Plant
New competencies
Hormonal semi-solids
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
