cm presentation 2020

CM presentation 2020

Orion today — year 2018 in figures

Net sales 977 MEUROperating profit 253 MEUR

Personnel ~ 3 200

R&D investments104 MEUR

6 production sites in Finland

Own sales unit in26 European countries

34%

50%

7%5% 4%

Sales by business

32%

16%31%

6%

15%

Sales by market area

You can rely on us - Orion Contract Manufacturing

Our businesses

Contract Manufacturing

Manufacturing and packaging services for other pharmaceutical companies

Animal Health

Medicine and well-being products for animals

Fermion

Active pharmaceutical ingredients (APIs)

Proprietary Products

In-house developed drugs and other drugs with valid product protection

Specialty Products

Generic prescription drugs, OTC and non-medicinal products, biosimilars


Orion has operations in 27 countries

Finland

• HQ• Research & development• Six production sites• Sales unit• Support functions

UK • Sales unit• Research & development

Europe • Sales unit in 26 countries

India • Support functions

ROW • Global partner network for sales



Orion Manufacturing Operations in Finland

Espoo Plant | ~730 SC and QM employees

Dosage forms

Liquid small-volume parenterals

(vials & ampoules)

Tablets & capsules

Inhalations

Dosage forms

Non-sterile liquids, suspensions

Nasal & topical sprays, drops

Rectal enemas

Kuopio Plant | ~50 SC and QM employees

Dosage forms

Hormone gels & solutions

Tablets & capsules

Potent & cytotoxic tablets & capsules

Creams & ointments

Turku Plant | ~500 SC and QM employees

Salo Plant | ~110 SC and QM employees

Centralized warehouse

Tablet packaging

Serialization

Hanko Fermion plant | ~160 employees

API synthesis development & production

Oulu Fermion plant | ~100 employees

API synthesis development & production

Oulu

Kuopio

EspooTurku

Salo

Hanko

We know the importance of keeping a promise. It is the reason why we have been over 100 years in the business.

You can rely on us.


If you are looking for a partner who...

Helpsyou to get your product

from development to the market

WE OFFER• Upscaling product to commercial stage

• Wide expertise throughout the whole value chain

• Diverse production and process capability as your needs grow

• Tailor-made complex solutions

• Our established processes to Customers

Delivers with high reliability

throughout product life cycle

WE OFFER• Established and highly developed processes

and technologies

• Approvals of global regulatory bodies and long track record of inspections

• On-time delivery reliability

• Sustainability, CSR and EHS practices well in place

• Our experience to Customers


You can rely on us.

99,5 %On-time delivery

performance FDA, EMA, JP, ANVISA,

TGA, Korean FDA, Russia etc.

Compliance

Prepare while others are daydreaming.

Finnish airports run throughout year despite the hard weather conditions in winter. That constant performance is not a matter of luck,

it is a matter of high standards and good preparation.

That is in our heritage as well. We prepare to maintain good service level.



Secure your supply chain

Finland is like this bedrock

• No hurricanes, floods or earthquakes

• Stable politics and currency

• Well-established legislation and infrastructure

Protect your IP

Protect your product

Protect your reputation

Ensure your supply chain ethics

• One of the least corrupted countries

• The best adult literacy skills in EU


Our main approvals (FDA & EMA) track record

KUOPIO

TURKU

ESPOO

SALO(EST. 2014)

1990 2000 20202010

Our latest GMP inspections and audits

Authority Espoo plant Turku plant Kuopio plant* Salo plant

FDA 2018, 2016, 2014 2016, 2014, 2013 2015

EMA 2018, 2017, 2015 2017, 2014, 2011 2019, 2013, 2010 2019, 2018, 2015

ANVISA 2017, 2014, 2008 2018, 2012, 2007 2016

MOH, Russia 2017,2020 2018, 2017, 2020 2017, 2020

Korean FDA 2009 2013

MOH, Turkey 2018, 2012 2012 2018, 2016

Taiwan 2013

Belarus 2018 2018

PMDA Accredited Accredited Accredited


13

Material themes of Orion’s sustainability

LTIF 1 (6.3)

5.5

Injury rate

1,074

Energysavings

MWh (3,725)238

Audits undertakenby Orion

(314)40%

Energy savings target set for 2025

achieved

(31%)

56

Customer complaints

(Pharmaceuticals)

Ppm (64)

• Patient safety• Ensuring reliable supply of medications• Manufacturing medications in an

environmentally sustainable way: efficient use of materials, energy efficiency, wastewater management


2016 2017

GxP and EHSaudits, partnersand customers

GxP and EHSaudits, authorities

● No critical observations in audits carried out by authorities, customers and partners.

● Slightly less critical observations than in the previous year in audits carried out by Orion on partners.

● No product recalls related to critical defects (Class 1).

In 2017 there were fewer product recalls than in the year before, number of audits increased

55

81

2016 2017

GxP audits

EHS audits

29 26

Critical observations

14

1

4

6

4

3

2016 2017

Non-medicinal product

Class 3 (minor)

Class 2 (major)

Class 1 (critical)

13

10269

314

Audits by 3rdparties

Product recalls

Auditsby Orion



Production capabilities and expertise


Orion Contract Manufacturing

Hormonal Gels and Solutions

Semisolids Cytotoxics Packaging and Serialization

APIs and IntermediatesLiquid

Forms

Special Capabilites High potent Veterinary

products

Sterile Solutions Solid Oral Dosage Forms


Hormone production

PROCESSING

• Mixing• Homogenisation• OEL-5

DOSAGE FORMS

• Solutions• Gels• Creams

BATCH SIZES

• 120-2000 Liters

EQUIPMENT

• Becomix• Krieger• Fryma

• Alu/Laminate Sachets• Pump Bottles• Sprays• Tailor-made

PACKAGING PRODUCTION FACILITY• 8000 m² of new manufacturing, packaging, technical and supporting

areas• Dedicated area for storing, weighing and dispensing of potent APIs• Suitable for handling of large volumes of flammable liquids• Closed processes, isolators and glove boxes • Controlled removal of wastes


Sterile production

• Aseptic Manufacturing & Filling

• Terminal Sterilization• OEL-4/5

• Injectable• Solutions

• 20-580 Liters

• Bosch• Bausch & Ströbel• Eisai (Inspection)• Nikka (Inspection)

• Glass Vials 5-50 ml• Ampoules 1-20 ml• Blister Packaging

PROCESSINGDOSAGE FORMS BATCH SIZES

EQUIPMENT PACKAGING


Semi-solid forms

• Mixing• Homogenisation• OEL-4/5

• Ointments• Creams & Gels• Solutions

• 80/300 -1000 kg

• Fryma• Krieger• Nordenmatic• Groninger• King

• Alu/Plastic/Polyfoil Tubes Plastic PumpBottles

• Oral Syringes• Rectal Tubes• Nasal & Topical Sprays


EQUIPMENT PACKAGING


Cytotoxics production

• Fielder• Lödige• Fette• Accela Cota

• Plastic Jars

• 15/70 -140 Kg• Tablets Film- & Uncoated• Capsules Hard Gelatin

• Dry Mixing• Isolators• OEL-5


EQUIPMENT PACKAGING


Liquid forms production

• Glass Bottles• Plastic Bottles• Nasal Spray Bottles

• 80-6000 kg• Solutions• Drops• Suspensions• Nasal & Topical Sprays

• Mixing• Homogenisation• Filtering• Isolators

(Telstar)


EQUIPMENT PACKAGING

• Bausch & Ströbel• Uhlmann• Bosch• FrymaKoruma• IKA


Solid oral dosage forms

• Fielder• Glatt• GEA

• Lödige• Fette• Manesty

• Blisters• Glass Jars• Plastic Jars• Square and round bottles

• 100-1700 Kg

• Tablets filmcoated/uncoated/modifiedrelease

• Capsules, hard gelatin

• High shear & fluid bedgranulation, FB drying

• SpheronizationDry mixing

• OEL-4


EQUIPMENT PACKAGING


Tablet Packaging in Salo

SERIALIZATION

PACKAGES

• Plastic round/square jars• Glass jars • Blister packages• Tailor-made

EQUIPMENT

• Uhlmann

• Systech software • TraceLink repository• Aggregation• Tamper evidence• Semi-manual for special packages• Experience since 2015

FACILITY AND PROCESS

• Site established in 2013 • Each line in in its own dedicated area• Primary & secondary packaging separated in own

cleanliness classes• Humidity & temperature controlled as needed

SERVICESWAREHOUSING

• 14 000 pallet locations • 120 cold storage pallet locations

• QA release • EU reanalyzing • Regulatory support• Logistics management• VMI• Serialization data

management• Launch support• Fluent artwork process


Special capabilities

• Medical devices

• EU re-analyses & QA release

• Logistics & launch management

• FDA compliant free space

SERVICES VETERINARY PRODUCTS

CONTROLLED SUBSTANCES POTENTS

• License for manufacturing

• All dosage forms

• Oral prefilled syringes

• Schedules I-V

• Fast and easy licensing procedures

• Secure production and logistics

• Potent products up to OEL-5

• Corticosteroids

• Isolators & employee protection


Fermion – APIs ● One partner for api & drug products

Contract Manufacturing• Production from laboratory scale to

commercial scale

• 3 manufacturing sites in Finland

• Total volume of reactors 320 m3

• GMP reactor sizes vary from 10 l to 6300 l

• Annual API capacity >400 metric tons

• High-potency APIs (OEB5) (cytotoxic and

non-cytotoxic) from grams to tens of tons

Contract Development• Synthesis development and process

engineering

• Analytical development and testing

• Particle engineering

• Scale-up

• Validation

• Lifecycle management

Regulatory and ComplianceDMF compilation, maintenance and

consultancy services

Experience in regulatory filings in e.g.

USA, Canada, EU DMF/CEP, Japan,

Taiwan, China, Brazil, Australia

FDA approved since 1979 and EMA

approved since 1971

Equipment

• Highly automated facilities

• Reactor sizes from 10-30 l (R&D) to 60 – 6300 l, total volume of reactors 320 m3

• Hastelloy, stainless steel, glass-lined

• Glove boxes for HAPI handling

• Buss loop of 500 l for hydrogenations

Inspection history Espoo Hanko Oulu

FDA 20032011

2011201420162018

2010201320162017

FIMEA (Finland) 201020132017

201120142017

201120142017

PMDA (Japan) 2006*

KFDA (South Korea) 2010

ANVISA (Brazil) 20112016


Packaging and serialization – We are ready!

2010 2012

2011 2013

2014

2015

2016

2017

2018

2019

2020

2021

2022

2023

2024

Serialization and aggregation2010-2012

Serialization and aggregationstarted in 2011, all medicines in 2016

Serialization- aggregation for special products 2011-2014

Serialization + aggregation of all exported medicines 2014

Serialization in 2015 and aggregation at latest 2017

Serialization2016-2017

Serialization in 2017 and aggregation at latest 2023

Serialization for all EU countries 2019 (except Belgium, Italy & Greece at latest 2024)

On hold

We make your product serialized, tamper proof and child resistant so that you can sell in all your target markets

REGULATORY TIMELINE


CONTACT US FOR MORE INFORMATION

TEEMU KORHONENHead of Region Europe and ROWContract [email protected]. +358 50 966 5307

TIMO SUOKONAUTIOHead of Region North AmericaMarketing & SalesGeneric APIs and CM [email protected]. +358 50 966 5800

MARIA MOUKOLA Business Manager Contract [email protected]. +358 50 966 7162

Visit our web page: www.orion-cmo.fi

Contact us via email: [email protected]

Follow us in LinkedIn Orion Contract Manufacturing

http://www.orion-cmo.fi/

mailto:[email protected]

cm presentation 2020

Documents