CM presentation 2018
Orion today —year 2017 in figures (adjusted) S ales by business Net sales 1,034 MEUR Operating profit 284 MEUR 5% 4% 7% 34% Personnell ~ 3 200 R&D investments 99 MEUR 50% 6 production sites in Finland Own sales unit in 26 European countries On 21 April 2018, Orion signed an agreement on t he sale of all shares in Orion Diagnost ica Oy (i.e. t he Orion Diagnost ica business division). Following t he t ransact ion, Orion Diagnost ica business is report ed as discont inued operat ion. The f igures f or 2017 are adj ust ed, and do not include Orion Diagnost ica. You can rely on us - Orion Contract Manufacturing
Our businesses Proprietary Products Specialty Products In-house developed drugs and Generic prescript ion drugs, OTC and ot her drugs wit h valid product non-medicinal products, biosimilars prot ect ion Animal Health Fermion Medicine and well-being Act ive pharmaceut ical product s for animals ingredients (APIs) Contract Manufacturing Manufacturing and packaging services for ot her pharmaceutical companies You can rely on us - Orion Contract Manufacturing
Orion has operations in 27 countries • HQ • Research & development • S Finland ix production sites • S ales unit • S upport functions • S ales unit UK • Research & development • S Europe ales unit in 26 countries • S India upport functions • Global partner network ROW for sales You can rely on us - Orion Contract Manufacturing
Orion Manufacturing Operations in Finland Oulu Fermion plant | ~100 employees Turku Plant | ~500 S C and QM employees API synt hesis development & product ion Dosage forms Hormone gels & solut ions Kuopio Plant | ~50 S C and QM employees Tablet s & capsules Dosage forms Pot ent & cyt ot oxic t ablet s & capsules Non-st erile liquids, suspensions Creams & oint ment s Nasal & t opical sprays, drops Rect al enemas Oulu S alo Plant | ~110 S C and QM employees Espoo Plant | ~730 S C and QM employees Cent ralized warehouse Dosage forms Tablet packaging Liquid small-volume parent erals Kuopio S erializat ion (vials & ampoules) Tablet s & capsules Hanko Fermion plant | ~160 employees Turku Inhalat ions Salo Espoo API synt hesis development & product ion Hanko You can rely on us - Orion Contract Manufacturing
We know the importance of keeping a promise. It is the reason why we have been 100 years in the business. You can rely on us.
If you are looking for a partner who... Delivers Helps wit h high reliabilit y you t o get your product t hroughout product life cycle from development t o t he market WE OFFER WE OFFER • • Est ablished and highly developed processes Upscaling product t o commercial st age and t echnologies • Wide expert ise t hroughout t he whole value • Approvals of global regulat ory bodies and chain long t rack record of inspect ions • Diverse product ion and process capabilit y • On-t ime delivery reliabilit y as your needs grow • • S ust ainabilit y, CS R and EHS pract ices well Tailor-made complex solut ions in place You can rely on us - Orion Contract Manufacturing
You can rely on us. Compliance 99,5 % On-time delivery FDA, EMA, JP , ANVIS A, performance in TGA, Korean FDA, 2017 Russia etc. You can rely on us - Orion Contract Manufacturing
Prepare while others are daydreaming. Finnish airport s run t hroughout year despit e t he hard weat her condit ions in wint er. That const ant performance is not a mat t er of luck, it is a mat t er of high st andards and good preparat ion. That is in our heritage as well. We prepare to maintain good service level. You can rely on us - Orion Contract Manufacturing
Secure your supply chain Protect your IP Protect your product Protect your reputation Ensure your supply chain ethics Finland is like this • One of the least corrupted countries bedrock • The best adult literacy skills in EU • No hurricanes, floods or earthquakes • S table politics and currency • Well-established legislation and infrastructure You can rely on us - Orion Contract Manufacturing
Our main approvals (FDA & EMA) track record 2000 2010 1990 2020 ESPOO TURKU KUOPIO SALO (EST. 2014) You can rely on us - Orion Contract Manufacturing
Our latest GMP inspections and audits You can rely on us - Orion Contract Manufacturing
Production capabilities and expertise You can rely on us - Orion Contract Manufacturing
Orion Contract Manufacturing Hormonal Gels Semisolids Cytotoxics Packaging and and Solutions Serialization APIs and Liquid Intermediates Forms Special Capabilites Sterile Solutions Solid Oral High potent Dosage Forms Veterinary products You can rely on us - Orion Contract Manufacturing
Hormone production EQUIPMENT PROCESSING BATCH SIZES DOSAGE FORMS • Becomix • S olutions • Mixing • 120-2000 Liters • Krieger • Gels • Homogenisation • Fryma • • OEL-5 Creams PACKAGING PRODUCTION FACILITY • 8000 m² of new manufacturing, packaging, technical and supporting • Alu/ Laminate S achets areas • Pump Bottles • Dedicated area for storing, weighing and dispensing of potent APIs • S prays • S uitable for handling of large volumes of flammable liquids • Tailor-made • Closed processes, isolators and glove boxes • Controlled removal of wastes You can rely on us - Orion Contract Manufacturing
Sterile production PROCESSING BATCH SIZES DOSAGE FORMS • Aseptic Manufacturing & • Inj ectable • 20-580 Liters Filling • S olutions • Terminal S terilization • OEL-4/ 5 EQUIPMENT PACKAGING • Bosch • Glass Vials 5-50 ml • Bausch & S tröbel • Ampoules 1-20 ml • Eisai (Inspection) • Blister Packaging • Nikka (Inspection) You can rely on us - Orion Contract Manufacturing
Semi-solid forms DOSAGE FORMS PROCESSING BATCH SIZES • Mixing • Ointments • 80/ 300 -1000 kg • Homogenisation • Creams & Gels • OEL-4/ 5 • S olutions PACKAGING EQUIPMENT • Fryma • Alu/ Plastic/ Polyfoil Tubes Plastic Pump • Krieger Bottles • Nordenmatic • Oral S yringes • Groninger • Rectal Tubes • King • Nasal & Topical S prays You can rely on us - Orion Contract Manufacturing
Cytotoxics production DOSAGE FORMS PROCESSING BATCH SIZES • • 15/ 70 -140 Kg • Tablets Film- & Uncoated Dry Mixing • • Capsules Hard Gelatin Isolators • OEL-5 EQUIPMENT PACKAGING • Fielder • Plastic Jars • Lödige • Fette • Accela Cota You can rely on us - Orion Contract Manufacturing
Liquid forms production DOSAGE FORMS PROCESSING BATCH SIZES • Mixing • S olutions • 80-6000 kg • Homogenisation • Drops • Filtering • S uspensions • Isolators • Nasal & Topical S prays (Telstar) EQUIPMENT PACKAGING • Bausch & S tröbel • Glass Bottles • Uhlmann • Plastic Bottles • • Bosch Nasal S pray Bottles • FrymaKoruma • IKA You can rely on us - Orion Contract Manufacturing
Solid oral dosage forms DOSAGE FORMS PROCESSING BATCH SIZES • High shear & fluid bed • Tablets filmcoated/ • 100-1700 granulation, FB drying uncoated/ modified Kg • Extrusion and spheronization release Dry mixing • Capsules, hard gelatin • OEL-4 EQUIPMENT PACKAGING • Blisters • • Fielder Lödige • Glass Jars • Glatt • Fette • Plastic Jars • GEA • Manesty • S quare and round bottles You can rely on us - Orion Contract Manufacturing
Tablet Packaging in Salo EQUIPMENT PACKAGES WAREHOUSING SERVICES • Plastic round/ square j ars • Uhlmann • • QA release 14 000 pallet locations • Glass j ars • • EU reanalyzing 120 cold storage pallet locations • Blister packages • Regulatory support • Tailor-made • Logistics management • VMI • S erialization data management FACILITY AND PROCESS SERIALIZATION • Launch support • Fluent artwork process • S ite established in 2013 • S ystech software • Each line in in its own dedicated area • TraceLink repository • Primary & secondary packaging separated in own • Aggregation cleanliness classes • Tamper evidence • Humidity & temperature controlled as needed • S emi-manual for special packages • Experience since 2015 You can rely on us - Orion Contract Manufacturing
Special capabilities SERVICES VETERINARY PRODUCTS • Medical devices • License for manufacturing • EU re-analyses & QA release • All dosage forms • Logistics & launch management • Oral prefilled syringes • FDA compliant free space POTENTS CONTROLLED SUBSTANCES • Potent products up to OEL-5 • S chedules I-V • Corticosteroids • Fast and easy licensing procedures • Isolators & employee protection • S ecure production and logistics You can rely on us - Orion Contract Manufacturing
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