Acino Contract Manufacturing Overview Introduction to Acino Contract Manufacturing Services July 2019
Acino at a Glance Headquartered in Zurich, Switzerland, Acino Key Figures Acino develops, manufactures and commercializes high quality pharmaceuticals for the benefit of patients 311 m€ ~1’950 Acino takes leadership through commercial excellence in selected emerging markets with own Acino brand Sales in 2018 Employees globally Sales in Emerging Markets 400 >75% Middle East, Africa, CIS, Russia and LATAM Employees in Switzerland Swiss manufacturing sites serve a variety of B2B customers 75% : 25% 3 Out-Licensing Acino products sold in European and other markets by a Sales split B2C : B2B Manufacturing sites (CH, EE, UA) broad range of leading pharmaceutical companies 183 Years 100% Contract Manufacturing Of Swiss company Privately owned by Avista Capital & Customers’ products are manufactured and packaged by history Nordic Capital Acino, often with a full-service business model 2
Where we deliver our products to Corporate Headquarters Regional Offices Production and Packaging Market Authorization office, Germany Commercial operations English-speaking Africa Commercial operations Middle East, North/French-speaking Africa Commercial operations Latin America Commercial operations Ukraine/CIS Commercial operations Russia Out-licensing and contract manufacturing 3
Technology we’re proud of We have the know-how, the technology and the infrastructure to support you achieving your needs. Our in-house engineering team has the experience and know-how to be able to adapt or bring in technology solutions quickly. We continue to invest in a range of technologies, capabilities and company structures to stay competitive. >50 >60 Years experience Countries being supplied in pharm. manuf. with our products 10 27 multi-national small-medium sized pharma pharma customers customers 5
Quality in all we do Our Quality Mindset is rooted in our Swiss heritage. We meet and exceed the highest standards for our products, as well as using our own quality culture to continually improve our offer. 100% 99.6% Our global Quality strategy that covers all aspects of our business, from the relationships we develop to the products Passed audits & Batch acceptance in we deliver. HA inspections 2018 Our Quality Policy greets every visitor and employee in 10+2 224 every site entrance in Acino. Customer + Quality employees in Health Authority 2018 audits in 2018
Our global CMO presence Liesberg, Switzerland Põlva, Estonia AL AE Packaging, Logistics, Manufacturing Warehouse Aesch, Kiev, Ukraine Dornacherstrasse, Switzerland AD AU Manufacturing Manufacturing Packaging Packaging Aesch, Pfeffingerring, Switzerland Zurich, Switzerland AP HQ Packaging, Logistics, Headquarters Warehouse CH EE UA 7
Our OSD Center of Excellence Since many decades Acino has been manufacturing pharmaceuticals. With many successful in-house developments, we have gained in-depth knowledge in bringing products from development to commercialization and expertise in solid dosage forms by constantly optimizing and improving our processes. ~130 ~55 Employees Employees in production 3’400 m 2 10’500 m 2 Production area Total site area 33 km 3 bn Distance to Basel Bulk unit capacity
Overview Health Authority Audits: Liesberg, Switzerland Regulatory Authority Date of inspection Country / Region Ministry of Health of the Republic of Belarus May 2019 Belarus Ministry of Industry and Trade of the Russian January 2019 Russia Federation RHI /Swissmedic February 2017 Switzerland RHI /Swissmedic March 2014 Switzerland RHI /Swissmedic December 2011 Switzerland Executive Board of the Health Ministers’ Council January 2011 Gulf Cooperation Council • The Liesberg facility is routinely inspected by both its international clients and its local Health Authority – Swissmedic • The facility is approved for all European countries, Canada, New Zealand and Australia through mutual recognition and ships to multiple destinations such as, Europe, Asia, MEA, South America etc. • The facilities have received accreditation by the Japanese Ministry of Health, Labour and Welfare. • Russian audit (GISK) in January 2019 – approval outstanding 9
Our Packaging and Logistic Site in Estonia Our Estonian packaging site in Põlva offers our customers packaging services for OSD’s at the highest flexibility in terms of order volumes, costs and delivery performance, while applying highest Acino quality standards. From large scale down to small manual packaging order volumes, our Estonian team is capable to transform their flexibility to a customer’s benefit. ~62 42% Employees Employees with higher education 1’176 m 2 5’100 m 2 Packaging site area Total site area with technical area and warehouse 228 km 15 mio Distance Tallinn to Polva Packs packaging capacity
Health authority inspections, customer & internal audits, Põlva, Estonia Competent authority/ corporate audits Date of inspection Country / Region Veterinary and Food Board December 2013 Estonia Veterinary and Food Board November 2014 Estonia State Agency of Medicines January 2015 Estonia Veterinary and Food Board November 2015 Estonia Veterinary and Food Board September 2016 Estonia State Agency of Medicines February 2018 Estonia Veterinary and Food Board March 2018 Estonia Customer audit Date of inspection Comments MNC Company 1 – external audit: initial qualification September 2017 Acceptable Acino (AL) – initial assessment audit April 2018 Acceptable MNC Company 2 – qualification audit June 2018 Acceptable MNC Company 3 – qualification audit October 2018 Acceptable MNC Company 4 – qualification audit February 2019 Approved 11
GMP-certified manufacturing and QC and R&D in Ukraine Our modern production site in Kyiv, was planned and built in accordance with GMP ЕU guidelines; applying the highest Acino quality standards. We manufacture and package products for the Ukrainian market as well as export to CIS countries: 105 MA’s in Ukraine, 86 MA’s in CIS. Our plant is equipped with state-of-art technology and our warehouse complex has a capacity ~2,700 pallets. 2’150m² 317 Employees Total production site area 1 bn 1 bn Tablet capacity Capsule capacity 30 mio June 2019 Packs capacity EU GMP Audit planned
Acino CMO Offering - Overview Granulation/Pelletization Finished Dosage Form Primary Packaging Secondary Packaging • Wet (aqueous & • Modified-release • PVC//Alu • Standard secondary organic), dry and melt tablets (MUPS & • PVC/PVDC//Alu packaging (for packs & granulation Matrix tablets) • PVC/PE/PVDC//Alu • bottles) • Fluid-bed & high shear • Film coated- or • Alu//Alu • PIL-packages granulation dispersible-tablets • Controlled substances • Artwork management • Direct compression • Printed tablets packaging (AP & AE) • Serialization & • Extrusion / • Modified release • Packaging of potent aggregation Spheronization capsules OSDs • Warehousing & • Pellet layering in fluid • Micro-tablets in • Bottles (glass, plastic, logistics bed process capsules aluminium) with • Coating of pellets • Controlled substance different Caps (push- • Fluid-bed and tray & broad-spectrum on, screw, snap safe, drying antibiotics desiccant capsules) • Sieving / blending • Unit dose blister 13
Our flexibility – your choice AL AL Due to our flexibility, our customer can choose the right set-up for their supply chain. Our team will assist our customers to choose the perfect solution. 14
Our flexibility – your choice AL AE Due to our flexibility, our customer can choose the right set-up for their supply chain. Our team will assist our customers to choose the perfect solution. 15
Our flexibility – your choice AP Due to our flexibility, our customer can choose the right set-up for their supply chain. Our team will assist our customers to choose the perfect solution. 16
Granulation / Pellet manufacture • Pellet manufacture and coating • By extrusion & spheronization • Pellets layering on starter cores • Pellets coatings with functional and/or non-functional films • Wet granulation: • Fluid Bed and High Shear Granulation • Aqueous & organic granulation (Isopropanol & Ethanol) • Dry granulation / Roller compaction • Melt granulation / Cooling with dry ice 10 350 t available at fluidized bed of pellets & granulate AL AP AE AU granulators in CH produced in 2018 (CH)
Bulk Production • Focus on hard-to-make generics & niche-technologies • Focus on suspension layering & modified-release dosage forms • Strong expertise in narcotics & broad-spectrum antibiotics production • Our offerings: • Modified-release Tablets (MUPS & Matrix Tablets) • Film- or Dispersible- Tablets • Printed Tablets • Modified-release Capsules (MUPS) • Capsules • Micro-tablets in Capsules 3 bn up to 900 k available at bulk units capacity tablets / hr AL AP AE AU in CH 18
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