cm presentation 2019 · on-time delivery reliability ... fermion –apis one partner for api &...

CM presentation 2019

Orion today — year 2018 in figures

Net sales 977 MEUROperating profit 253 MEUR

Personnell ~ 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 2018, 2017 2017

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

1

4

1

4

6

4

3

2016 2017

Non-medicinal product

Class 3 (minor)

Class 2 (major)

Class 1 (critical)

13

10269

314

Audits by 3rd

parties

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 Pump

Bottles

• 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/modified

release

• Capsules, hard gelatin

• High shear & fluid bed

granulation, FB drying

• Spheronization

Dry 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 2003

2011

2011

2014

2016

2018

2010

2013

2016

2017

FIMEA (Finland) 2010

2013

2017

2011

2014

2017

2011

2014

2017

PMDA (Japan) 2006*

KFDA (South Korea) 2010

ANVISA (Brazil) 2011

2016


Packaging and serialization – We are ready!

2010 2012

2011 2013

2014

2015

2016

2017

2018

2019

2020

2021

2022

2023

2024

Serialization

and aggregation

2010-2012

Serialization and aggregation

started 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

Serialization

2016-2017

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

Jari Kaunisto

Director Sales and Marketing


[email protected]

Tel. +358 50 966 3543

Maria Moukola

Business Manager


[email protected]

Tel. +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 2019 · on-time delivery reliability ... fermion –apis one partner for api &...

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