54
COMPANY OVERVIEW
80 years of experience in pharma business
Within top 20 generic drug manufacturers
Leader in the Polish pharmaceutical market
The largest pharmaceutical manufacturer in Kazakhstan
One of the leading pharmaceutical companies in Russia
A significant European Fine Chemicals producer
Commitment to excellence
in providing high quality pharmaceuticals
_____________
MISSION
R&D centres
manufacturing sites
in Poland, Russia and Kazakhstan
products
employees
6
7
650
7500
LOCATION
WORLDWIDE PRESENCE
Total area 94 ha
PLANT VIEW
R&D CAPABILITIES
The facility using state-of-the-art equipment will consist of six sections:
• Analytical
• General R&D
• Process Development
• Purification Methods Development
• Formulation
• Pilot Plant
We work in collaboration with major Academic Institutions in Gdansk
and leading Institutions from Poland and around the World.
Following the increasingly better solutions for patients, we have created a special
business unit Polpharma Biologics and built a state-of-the-art research and
development center in Gdansk Science and Technology Park.
The laboratory is the largest of its kind in Poland. It is equipped with the most modern
equipment enabling efficient work with complex monoclonal antibodies and other
therapeutic proteins.
http://www.polpharmabiologics.com/en
World class R&D laboratory
BIOLOGICS
ACTIVE PHARMACEUTICAL INGREDIENTS
European manufacturing site
cGMP-compliant and FDA-approved
World class regulatory service
Registration documentation eCTD (ASMF, CEP, US DMF, Japanese DMF, Chinese DMF)
In-house product development by dedicated R&D resources
Worldwide presence
Extended production capacity
LICENSING OUT
In-house development
Intellectual property expertise
4 R/D centers
Regulatory support
Dossiers in a CTD format according to EU standards
2x2 for blockbuster products
CONTRACT MANUFACTURING
Customized contract manufacturing services
The highest confidentiality and IP protection standards
5 European cGMP-compliant manufacturing sites
Excellent product quality at competitive manufacturing cost
Solid dosage forms, oral liquids, sterile infusions and injections, eye and nasal drops, topical products
FINISHED DOSAGE FORMS
Wide experience in FDF supply to third parties worldwide
Vertically integrated API
Constant price optimization in API and manufacturing
Fulfillment of clients requirements for specific markets
API
FDF
CM
LO
A significant European API producer: development and production of generic API to 6 continents and +60 countries
Superior quality of products and customer service
World-class regulatory service and intellectual property guidance
Development of new salts and polyphormic forms of API, adjusted particle size distribution (PSD)
cGMP compliant and FDA-approved multipurpose facilities
Non-infringing process development
We offer solutions tailored
to your needs:
The description of the facilities• 5 multipurpose production lines
• Pilot Plant
• R&D Laboratories 330
employees
Sales 2015
€ 41 M
US$ 52 M
Presence in
6 continents
60+ countries
FDA approvedEuropean API
producer
Location - Starogard Gdański
• 50 km from Gdańsk international airport
• 70 km from a major Polish seaports in Gdańsk and Gdynia
• 11 km from a major highway
Accreditation from
Japanese Health Authority
(PMD)
Successful cooperation
with Indian companies
launched
Innovation award
(Sildenafil Citrate)
First CEP(Sodium Alendronate)
FDA audit (with
no 483 observations)
Pilot Plant
upgrade API developed for
Customer for Para 4
ANDA filing strategy in US
Expansion
of Pilot Plant
2nd FDA audit (with
no 483 observations)
KEY MILSTONES
New Process
Development Labs
1st successful
Korean FDA inspection
Japanese Customer
Audit
Green Chemistry
Innovative R&D
Technology Labs
ANVISA audit
(Brasilian MOH agent)
Completion of
the Restructuring
Hydrogenation
Small scale
unit set-up
3rd FDA audit (with no
483 observations)2nd successful
Korean FDA inspection
Award from the President
of Poland in the
"Innovation" category for
the development of
osteoporosis products
KEY MILSTONES
Expansion in Asia
and Latin America
First registration
in China
First European monograph for Tolterodine L-tartrate
developed by Polpharma.
Published in Pharmeuropa in
2014
Laboratory for conducting
high pressure processes
start up
Positive customer
audits
Scientific
Advisory Board
established
4 CEPs received• Sildenafil citrate,
• Sodium Risedronate
• Etodolac
• Tadalafil
Funding for
2 projects from:
FDA audit
4th in a row with no
483 observations
30+
KEY MILSTONES
Positive customer
audits
38
SALES PERFORMANCE
2016 API sales is estimated
$52m
Captive use 24%
2015 EXTERNAL SALES
TERRITORY SPLIT
28 30 35
40 39 41 42
9 10
9
10 14 11 10
-
10
20
30
40
50
60
2010 2011 2012 2013 2014 2015 2016
External Transfer
We are present in 6 continents
We supply to 60+ countries
Our key export regions are: Europe, Asia and NA
We are a trustworthy partner to 300 customers worldwide
WORLDWIDE PRESENCE
USA
Canada
LATAM
Brazil
Mexico
Argentina
Germany Malta Ireland
France Poland Spain
Slovenia Turkey Hungary
Switzerland Greece
Belgium Croatia Great
Britain Italy Netherlands
Denmark Romania
Slovakia Bulgaria
Portugal Austria Cyprus
Czech Republic
Israel
Morocco
Jordan Syria
Egypt Tunis
Iran UAE
Saudi Arabia
Japan
South Korea
Thailand India
Taiwan
Bangladesh
China Vietnam
Indonesia
47%
23%
2%5%MENA
ASIA
EUROPE
AUSTRALIA
NORTH AM. 23%
API WORLDWIDE CONSUMPTION
2014 [kg]
INNIMS 2014
PPH 2014
2014 MS%
BACLOFEN 21 075 17 271 82%
ALENDRONATE 28 374 13 502 48%
ACETAZOLAMIDE 75 765 28 939 38%
RISEDRONIC ACID 4 608 989 21%
OPIPRAMOL 18 449 3 833 21%
PENTOXIFYLLINE 432 678 75 018 17%
SALICYLAMIDE 156 592 26 816 17%
ANIRACETAM 18 141 2 837 16%
HCTZ 506 335 63 441 13%
ETODOLAC 242 746 28 825 12%
TOLTERODINE 1 274 142 11%
ZOLEDRONIC ACID 22 2 8%
REPAGLINIDE 2 930 205 7%
MARKET SHARES
API WORLDWIDE CONSUMPTION
2014 [kg]
We are aadopting our structures
to meet the challenges of the future
Quality
Time to market
Highest standards
Innovative and cost
competitive process
Analytical standards
Development
Production
Storage
Sale
New technologies
Polymorphs
New crystals
Particle engineering
ADVANTAGES
23
MultipurposeMultipurpose from
Q3 2015
Glass lined340 m³
167 reactors
360 m³
175 reactors
Stainless steel15 m³
9 reactors
30 m³
14 reactors
Auxiliary tanks 150 m³ 200 m³
Tank Farm 1040 m³ 1040 m³
ACTIVE PHARMACEUTICAL INGREDIENTS
CAPACITY
Plant 17
max capacity (MT) 50
batch size 50 - 100 Kg
reactors scale 1,2 - 1,6 m3
glass lined reactors (45) capacity 53,88 m3
SS reactor (1) capacity 0,15 m3
Plant 27
max capacity (MT) 110
batch size 1 50-1200 Kg
reactors scale 4,0 – 6,0 m3
glass lined reactors (14) capacity 58,5 m3
SS reactor (1) capacity 4 m3
Plant 28 max capacity (MT) 330 batch size 30 - 960 Kg reactors scale 3,0 m3
glass lined reactors (27) capacity 64,25 m3
SS reactors (3) capacity 4 m3
Plant 26 (after investment) max capacity (MT) 500 batch size 34-1170 Kg reactors scale 1,0 – 4,0 m³
glass lined reactors (8) capacity 19m³ SS reactors (5) capacity 15,5 m³
Plant 10/11
max capacity (MT) 110
batch size 100 – 550 Kg
reactors capacity range 1,6 - 2,6 m3
glass lined reactors (44) capacity 83,5 m3
SS reactors (2) capacity 2 m3
Small Scale Facility
(Pilot Plant)
• batch size 1 – 15 Kg
• reactors scale 60 – 500 L
• glass lined reactors (24) capacity 5,38 m3
• SS reactors (2) capacity 0,58 m3
Plant 22 /intermediates/
• batch size 100 - 300 Kg
• reactors scale 1,2 - 4 m3
• glass lined reactors (46) capacity 91,15 m3
• SS reactor (8) capacity 15 m3M
ultip
urp
ose
pla
nts
CAPACITY PER BUILDING
Comprehensive list of basic processes
PROCESSES
From R&D to Market
34
a continuous innovation approach
in product life cycle management
ProcessChemistry
FacilitiesCrystal Morphology
Quality Standards
…………………. ……………......
……………......……………......
• Process Development
• QbD• Green Chemistry
• Process Engineering• Regulatory
Support• Continuous improvement
• FDA Approved facilities
• ISO 14001 and 18001• Scale-up capabilities
• ime to market• Agile supply
chain
• Controlled crystallization• Particle
morphology• Micronization• Jet milling
• Impurities Profile
• Outstanding Quality
Compliance• Quality
Management System
• Process Development
• QbD
• GreenChemistry
• Process Engineering
• RegulatorySupport
• Continuous improvement
• Particle size engineering
• Controlled crystallization
• In-process particle sizedistribution measurement
• Micronization/jet milling
• Impurities Profile
• Outstanding Quality Compliance
• Quality Management System
• FDA approved facilities
• ISO 14001
and 18001• Scale-up
capabilities• Time to market• Agile supply
chain
Facilities
Development process
From Lab Scale to GMP batch
Synthesis route optimization
Synthesis route verification
2-3 months
12-19 months
Time
TOTAL
Pilot Plant scale-up
3-4 months
6-12
months
First laboratory samples available after 6-8 months
Laboratory samples from validated process available after 9-16 months
GMP batches available after 12-19 months (depends on project complexity)
DMF ready after additional 6 months stability tests
R&D Structure
35
Polpharma API Plant take advantage of their own R&D function and facilities
as well as from cooperation with external institutions
R&D Management
(including Planning)
4
Project Management
3
Analytical
Development
Laboratory
20
New Process
Development
10
Process Improvement
Laboratory
4
Regulatory Service
Dept. & Prod.Doc.
9
PhD13 Post Graduate and University degree 35 Secondary technical education 2
World class Regulatory Service
Full support from the beginning of cooperation to the marketing authorization.
Registration documentation for API (ASMF, CEP, US DMF, Japanese DMF) is prepared in eCTD format
using the software DocuBridge.
The registration documentation for APIs has been submitted and evaluated by authorities from
Europe, USA, Canada, Australia, Japan, Korea, Indonesia, New Zealand, Singapore, Brazil,
Israel, Mexico, Malaysia, Sudan, Vietnam, Philippines, China and many others.
We work in a close cooperation with the most important authorities, for example: EMA and EDQM
Europe), FDA and USP (USA) and TPD (Canada).
Our APIs are manufactured with the most stringent requirements: USFDA, EMA, EDQM, SKFDA,
PMDA, ANVISA, Polish Main Pharmaceutical Inspectorate.
We do not only follow the requirements and guidelines but we are ahead of them
Our Value Proposition
• Customer centric marketing and sales model
• Focus and commitment in finding innovative solutions for the use ofour APIs in breakthrough finished dosage forms for the genericpharma industry
• Diverse and broad based product portfolio and pipeline, along withinnovative non infringing solutions applied in the processdevelopment stages, at minimum risk exposure for all of ourcustomers
• Competitive prices for our products and services that are ofsuperior quality and meet unparalleled customer servicerequirements
• Sustainable development, product stewardship and efficientsupply chain
14 years of experience in FDF supply to third parties in 40 countries, more than 25 dossiers a year developed by 4 R&D Centers
Successful launch of products at day zero of patent expiry and registration in Latin America, Australia, Africa and Russia
Minimum risk in supply: API and manufacturer 2x2 strategy for blockbuster products
Constant price improvement to enhance our customers’ competitiveness
Change Management control to improve the competitiveness and quality of products
Customers satisfaction & loyalty: most of our customers renew supply agreement and our top 10 clients have on average 4 molecules in supply
Both in-house and external manufacturing capabilities
2001 2002 2008 2009 2011 2012 2013 2014
First worldwide
supply to third
parties of
injectable forms
Launches of the first
oral forms:
Simvastatin,
Citalopram and
Gabapentin
Expansion of
injectable portfolio
with the launches of
Pantoprazole and
Clarithromycin
First supply to
third parties
from in-house
production
Launch of
Metoprolol
succinate in
Europe,
LATAM and
Asia
Launch of Orlistat in
Europe with the
biggest
multinational
generic companies
30 different
molecules in
supply with 500
SKUs (counting
units)
Orlistat:
Ongoing supply in 12
countries where our
clients have 46% of
market share
In-house
production
transfer of
Simvastatin
41 different
molecules in
supply with
571 SKUs
(counting
units)
KEY MILSTONES
5 continents
40 countries
110
customers
41 molecules
571 SKUs (counting
units)
Scenario FDF supply in 2015
Actual 2014 Budget 2015 Expected 2015
Turnover (millions of Euros)
OVERVIEW
ASIA 10%
UK 22%Germany 18%Spain 8% Poland 6%France 5%Others 22,3%
EUROPE 83%
1 %SOUTH AFRICA
RUSSIA 5%
1%OTHERS
Countries with FDF supply in 2015
Next countries where we will supply FDF
Orlistat hard capsules:
• Anti-obesity molecule approved by FDA and EMA with more than 50 million users
worldwide
• Both RX (120mg) and OTC (60mg) strengths available
• Polpharma’s Orlistat is nowadays the only EU generic in the market
• Developed and produced in-house
• With 2 sources of API in the dossier
Metoprolol succinate XR tablets:
• The extended release formulation of Metoprolol, beta-blocker used in several
cardiovascular diseases
• Very few competitors in the market due to its difficult formulation
• Successfully launched in EU and some non-EU markets
• Possibility of embossed tablets
Our Top Products
Simvastatin tablets:
• Most experienced statin in the market and still in continuous growth
• Recently transferred production in-house with 2x2 strategy to minimize risks (2 API suppliers
and 2 approved manufacturers)
• Possibility of scored or scored-non film-coated tablets
• European quality at most competitive price
Injectable lyophilized products portfolio: Pantoprazole, Omeprazole, Esomeprazole,
Clarithromycin:
• Recognition of importance in stabilizing medical products is increasing
• Expected to strongly grow in the next years
• EU manufacturers
• Reliable and short lead-times allow our customers supply in tenders
Our Top Products
• Staff with high qualified education and experience
• Structure covering all the aspects related to the
development of a generic dosage form
• Facilities with the highest international standards,
including cGMP pilot plant for solid dosage forms
• Procedures in accordance to international guidelines
• Flexible organization based on team work and
assigned project management, able to shorten the
development calendars
• Possibility to make vertically integrated key projects
with API
We have in-house R&D resources to be competitive in the
development of finished dosage forms for generics, but we
also cooperate with academic institutions and partners to
get the most innovative dosage forms
R&D Competetive Competences
Highest international
standards including cGMP
High qualified
team of professionals
Vertically integrated
development
• Wide spectrum of processes and technologies in-
house and partners covering different dosage
forms
• Wide network of R&D cooperating institutions
(universities, institutes, private development labs)
permitting the solution of all the potential
problems which can appear during development
• High experience in scale-up transfers and process
improvements
• Good connection with Manufacturing
Departments, internal and external, cooperating
in the manufacturing of first commercial batches
• Tight cooperation with Regulatory Affairs to obtain
a dossier according to the international standards
of quality and to answer the subsequent potential
deficiency letters
R&D Competetive Competences
Scale-up transfers and
process improvements
Cooperation with R&D
institutions
Close collaboration with
Regulatory Affairs
• Audit report availability of suppliers
• QA consultancy service: audits conducted on behalf of our customers
• QP release: Finished Product ready to be marketed in EU
• Additional batch documentation• Product Quality Reviews• Dossier Compliance• Release site
• Periodic Safety Update Report (PSUR)
• Risk Management Plan (RMP)• Addendum to the clinical
overview
• ICH & On going stability studies
• Storage of stability samples on request
• Batch analysis for finished products
• Finished product analysis• Analytical method transfers
• Transport according to customer needs
• Import/Export services• Artwork management
Quality services Pharmacovigilance
Quality Control Logistics
Value-added Services
Contract manufacturing services
European cGMP compliant manufacturing sites
Transfer process management – analytical and technology
Highly skilled and experienced transfer teams
Superior quality of products and customer service at competitive manufacturing costs
Individual approach to every enquiry
Relevant manufacturing costs
Contract Manufacturing Services
In addition to manufacturing our own products,
we provide a wide range of contract manufacturing services.
We accept orders for the manufacture of medicinal
products (Rx and OTC), dietary supplements and
cosmetics.
We ensure professional order processing in
accordance with the highest manufacturingstandards (cGMP).
We treat each order individually.
We supply top quality products while maintaining low
production costs.
Our team of process engineers provides support with
process modifications expected by customers.
Contract Service Department offers full customer service in the following areas:
management of transfer projects / transfer of
technology and analytical methods for raw
materials and products;
manufacturing process validation;
manufacture of bulk and contract packaging
service
quality control / quality assurance / product release;
stability testing during shelf life;
development of new products in collaboration with our in-house R&D unit or external teams;
Contract Manufacturing Services
Non-sterile liquids
Syrups
Suspensions
Oral solutions
Oral drops
Nasal drops/gels
Solid dosage forms
Tablets
Multilayer tablets
Coated tablets
Effervescent tablets
Hard capsules
Soft capsules
Multiform hard capsules
Parenterals
Solutions for injection in glass
ampoules
LDPE Small Volumes
Parenterals
LDPE Large Volumes
Parenterals
Emulsion for injection
Solution in Vials
Eye drops
Single-dosage eye drops
Multi-dosage eye drops
Solution eye drops
Suspension eye drop
Topical
Gels
Emulsions
Antifungal nail polish
Ointments
Shampoos
Scope of product forms offered for Contract Manufacturing
Contract Manufacturing Services
Process phase Unit Total Capacity
Tablets M tabs./ year5 625incl. 26
cephalosporines
Hard capsules M caps./ year 393
Soft gel capsules M caps./ year 541
Non-sterile liquids M bottles/ year 45
SVP - PE M units/ year 154,9
LVP-PE M bags/ year 19,4
Glass ampoules M ampoules/ year 135,9
Nasal drops M units/ year 28,5
Opthalmics M units/ year 26,3
Vials M units/ year27,1
incl. 10,5 cephalosporines
Prefilled syringes M units/ year 2,4
Contract Manufacturing Services
We provide Quality Control services in the scope of:
validation and re-validation of analytical methods
carrying out analytical, microbiological tests
analytical development
stability testing in different climatic conditions (ICH, ongoing)
storage of product samples for stability testing
release to the market
We ensure:
Individual approach to each enquiry and precise calculation of product costs and Tech Transfer
The highest confidentiality and IP protection standards
Highly skilled and experience Tech Transfer Team dedicated to your project
Professional Customer Service
Excellent product quality at competitive manufacturing costs
Quality assurance system compliant with cGMP requirements
Access to a global pool of trusted suppliers and a guarantee of competitive price for APIs, raw and
packaging materials
Thoroughly equipped high tech laboratories: Analytical, Microbiological In-Process Control laboratory
Contract Manufacturing Services
Manufacturing Sites located in Poland
25.000 m² total area3.500 m² class Dmanufacturing
8.150 m² total production area
We are among the largest and most modern pharmaceutical factories
in Europe. The annual production capacity of the works is 3.9 billion
solid-form drug units (tablets, capsules) and 230 million liquid-form drug
units (injectables in polyethylene containers and glass ampoules and infusion solutions and
solutions for topical use).
cGMP unique technological solutions
Manufacturing Sites – Starogard Gdański
The manufacturing works is among the leaders in the manufacture of
pediatric medicines, vitamin products and food supplements.
We offer a number of products to be
manufactured with our already developed
technology:
• Shark liver oil + Vitamin E caps.
• Shark liver oil + garlic macerated oil caps.
• Primrose seed oil caps.
• Flax oil caps.
• Omega 3 caps.
• Omega 3-6-9 caps.
• Vitamin D3 caps.
• Vitamin D3 + Vitamin K caps. (twist - off)
• Vitamin E caps.
• Cranberry extract + Vitamin C caps.
Wide range of capsules’ sizes and shapes
Manufacturing Sites – Sieradz
High-bay storage warehouse
• Administration & QC
• Formulation Unit
• Packaging Unit
Manufacturing Division in Nowa Dęba is providing services:
• pilot batch production (starting from 10 kg)
• trial batches manufacturing
• manufacturing bulk product (tablets, dragees, hard caps)
• packaging
• validation and re-validation of analytical methods
• carrying out analytical, microbiological tests
• analytical development
• stability testing in different climatic conditions (ICH, ongoing)
• storage of product samples for stability testing
• Storing and release to the market
We specialize in solid dosage forms and food supplements such as tablets and hardcapsules. Highly efficient modern machines and manufacturing equipment and well-fitted
laboratories with experienced highly-qualified staff guarantee an effective management
and the implementation of difficult projects.
Manufacturing Sites – Nowa Dęba
Polpharma’s Manufacturing Branch in Duchnice near
Warsaw is specialized in the manufacture of antibiotics.
We manufacture first-, second- and third-generation
cephalosporins (both injectable and oral dosage forms)
in pediatric and adult doses.
Manufacturing Sites – Duchnice
Licensing-Out
New products are key factor for corporate growth when product life
cycles are getting shorter all the time.
Our interdisciplinary, experienced teams cover all the core
competences required for:
Market research Patent evaluation Product specification Clinical studies
Development process
Manufacturing process
right to the out- licensing process
We developed many new, first generic medicinal products
Licensing-Out
Flexibility in License Models:• License + Supply(different possibilities)
• License + Tech Transfer + Supply of API (if vertically integrated)
• License + Tech Transfer
Different Models of Partnership
Attractive groups of the products• Ophthalmologic products without preservatives
• First generics
• „Generic+” (added value products in modern form)
• Modern combo products
Perspective therapeutic groups• Oncology products
• Ophthalmology
• Niche products: ADHD treatment, Pulmonary arterial hypertension
Adaptation to new markets• New products are tested in IV climatic zone conditions
• Dossier adaptation to different non-EU market requirements
Production safety• Risk management – 2 API suppliers in dossier
• Production for domestic markets (Polish market leader) guarantees production continuity
Competitive Cogs level• API cost control – API manufactured internally
• Constant improvement of manufacturing costs
Strengths
Regulatory• Regulatory knowledge and expertise: our regulatory affairs activity is world widely
extended. So far our dossiers were successfully registered all over the Europe and
out of it
• Full support in developing registration strategies
• Execution and support of registration procedures
• Full regulatory support is provided to our customers for the authorization of our
Medicinal products
• Registration documentation (dossiers) are provide in eCTD format using Exedo’s
software
• Registration documentation (dossiers) can be also in Nees format;
• Our dossiers are prepared using European guidelines and may be also adapted
according to local Non-EU requirements
• Nowadays our dossiers are submitted to the competent Health Authorities at
almost all continents, mostly in MENA region, Latin American countries and several
Asiatic countries
Value-Added Services
Intellectual Property• Intellectual property knowledge and expertise
• Support in assessment of patent situation of offered products in the territory of
client’s interest
• Experienced IP team of specialists including lawyers and European, Polish and
Russian patent attorneys
• IP’s primary mandate is to search for, and strategically develop, opportunities for
API, R&D Pharma and Biotechnology
• Find early entry opportunities in markets of interest
• Following critical patents in order to be on the market as soon as possible: Third
party Observations, Oppositions and Appeals at EPO; Litigations (country by
country)
Value-Added Services
Thank you for your attention
