Our vision APL

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2 Our vision We want be the most attractive partner and workplace for development and manufacturing of extemporaneous drug formulations and pharmaceuticals. APL

3 Our task Our task is to develop and manufacture individually adapted medicines for patients with special needs, such as children who need specific strengths or flavours, and persons suffering from various over-sensitivities. APL

4 Our values APL will act for a sustainable society, good health and a healthy environment. APLs operation shall be characterized by good ethics. APL shall be an attractive employer and workplace. APL

5 APL at a glance One of Europe s largest manufacturers of extemporaneous drug formulations. Leading contract manufacturer within Life Science. More than 30 years of experience of development and manufacturing of pharmaceuticals. Turnover of about 140 M (2017). 591 employees. Contributes to pharmaceuticals that improve and save lives. APL

6 APL s manufacturing sites are located in Sweden Göteborg Supply Chain & Logistics Non-sterile manufacturing Oral solutions Umeå Sterile and aseptic filling Clinical trial materials Malmö Non-sterile manufacturing Semi solids Stockholm Solid preparations Clinical trial materials Analytical development Extempore Customer service APL

7 APL offers services and products in two business areas Healthcare & Pharmacies Extemporaneous pharmaceuticals Cytotoxic preparation Preparation of pharmaceuticals for clinical trials Life science Contract manufacturing Formulation development and manufacturing of clinical trial material (CTM) Analytical services Development and manufacturing of OTC and branded products APL branded products APL

8 Business area Healthcare & Pharmacies Develops and manufactures extemporaneous pharmaceuticals Offers extemporaneous pharmaceuticals in all dosage forms Compounding of cytostatics pharmaceauticals Focus on patients with special needs APL

9 Definition: Extemporaneous pharmaceuticals A pharmaceutical which is not commercially available by the pharmaceutical industry, but for which there is a medical need Specially manufactured according to the prescriber s assessment of the patient s needs Divided into individually adapted and stock preparations 1-2% of the prescribed pharmaceuticals in Sweden are unregistered pharmaceuticals that meet the individual patients need. APL receives about 500 extemporaneous pharmaceuticals orders per day. APL

10 Many of APL s extemporaneous pharmaceuticals are manufactured for children with special needs. APL

11 Our extemporaneous pharmaceuticals are needed in the Swedish health care When: desired substance is not available desired dose is not available desired dose form is not available longer durability is needed avalible drugs causes allergic reactions approved drugs are not available approved drugs and/or licensed medicines are temporary not available APL

12 APLs extemporaneous pharmaceuticals products 280 products manufactured batch wise For many therapeutic areas: - Pediatrics - Pain - Dermatology - Dental care - Cardiovascular - Stomach/intestine - Ophthalmology - Gynecology - Veterinary APL

13 Extemporaneous pharmaceuticals in many dosage forms Aseptic/Sterile: Parenteral preparations Vials Bottles Ampoules Eye/Ear preparations Drops Ointment Gels Ambulatory systems Infusion bags Non-sterile: Semi-solids Ointments Creams Gels Lotions Liquids Oral solutions Emulsions Suspensions Solid preparations Capsules APL

14 APL supports Swedish pharmacies with products and services Development and manufacturing of pharmaceutical products and OTC drugs APL branded products Dose dispensing aids Sales and calibration of thermometers APL

15 We produce merchandise with high quality Skin and hair care Wound care Dose dispensing aids Animal care Health care Other products APL

16 Business area Life science We offer services from preclinical development to commercial manufacturing through close dialogue with our customers. APL

17 We offer CDMO* services that cover the entire development chain Product development Manufacture of clinical trial manterials Commercial manufacture *CDMO = Contract development & manufacturing organisation APL

18 Product development Development of formulations for medicines and medical devices Development of analytical methods Stability studies APL

19 Manufacture of clinical trial materials Project management and project planning Manufacture of trial medicines and placebo QP release Randomising, labelling and packaging APL

20 Commercial manufacture Upscaling to commercial level Tech transfer from development laboratory or from other manufacturing unit Purchase of raw materials and packaging and labelling materials Manufacture of pharmaceutical and medical devices QP release APL

21 We adapt our preparations to customer needs Pre-filled syringes Injection vials Infusion bottles & bags Ampoules Semi-solids Oral and topical liquids Solid preparations APL

22 Our customers are spread globally APL

23 Products manufactured at APL are sold in 35 countries APL

24 Sustainability - an integrated part of the business Ongoing audits identify improvement areas Sustainability work is reported according to GRI Activities to reduce waste Efforts to reduce energy consumption Efforts to reduce carbon dioxide emissions Good ethics in everything we do - Ethical guidelines - Code of Conduct - Minimize the number of risk providers APL

25 Social responsibility Engagement that strengthens our sustainability efforts : - Save the Children, Young Cancer and Swedish Childhood Cancer Foundation - NMC, The Swedish Association for Sustainable Business - SwedenBIO - SWE-life - FN Global Compact - Fossilfree Sweden APL

26 All production at APL follows GMP All of APLs facilities meet GMP in accordance with the quality system. The quality system covers all activities in the development process. Extemporaneous preparations are manufactured in accordance with MPA s requirements. APL is regularly inspected by MPA and FDA. Over 30 customer audits annually. APL

27 High quality is a prerequisite for safe and effective pharmaceuticals The management system is certified in compliance with - ISO (environment) - OHSAS (occupational health and safety) - ISO13485 (medical devices) We have sustainability committees at all sites Certification ensures safe and effective pharmaceuticals APL

28 We work according to Lean in order to increase customer benefit We have implemented a common model for Lean work for all businesses Lean work is part of APLs sustainability work The goal is to increase efficiency and customer benefit28s APL

29 Employee involvement is crucial The healthy APL - promote health - prevent and rehabilitate ill health Occupational health Overall wellness group Local wellness groups Zero tolerance to harassment and offensive treatment APL

30 Together we contribute to pharmaceuticals that improve and save lives APL