Our role in the society APL's task is a responsibility to develop - PowerPoint PPT Presentation

Our role in the society APL's task is a responsibility to develop and provide a medically effective and quality assured assortment of individually adapted medicines. The purpose is for patients with special needs who cannot use the medicines available on the market to be able to access the right treatment. This is done in close collaboration with specialist physicians, prescribers and authorities. At APL we are continuously working on measures that aim to reduce environmental impact and increase the effect in the value chain. Read more at: www.apl.se

Our vision We want to be the most attractive partner and workplace for development and manufacturing of extemporaneous drug formulations and pharmaceuticals. APL 2019 2

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 2019 3

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 2019 4

APL at a glance • One of Europe’s largest manufacturers of extemporaneous drug formulations. • Leading contract manufacturer within Life Science. • Turnover of about 140 M € (2018). • 489 employees. • Contributes to pharmaceuticals that improve and save lives. APL 2019 5

APL’s manufacturing sites are located in Sweden Umeå Sterile and aseptic filling Göteborg Clinical trial materials Supply Chain & Logistics Non-sterile manufacturing Oral solutions Stockholm Solid preparations Clinical trial materials Malmö Analytical development Non-sterile manufacturing Extempore Semi solids Customer service APL 2019 6

APL offers services and products in two business areas Healthcare & Pharmacies Life science • • Extemporaneous Contract manufacturing pharmaceuticals • Formulation development • and manufacturing of Cytotoxic preparation clinical trial material (CTM) • Preparation of pharmaceuticals • for clinical trials Analytical services • Development and manufacturing of OTC and branded products • APL branded products APL 2019 7

Business area Healthcare & Pharmacies • Develops and manufactures extemporaneous pharmaceuticals • Offers all kinds of extemporaneous manufacturing, emergency boxes and one dose treatments • Compounding of cytostatics pharmaceauticals • Focus on patients with special needs APL 2019 8

Definition: Extemporaneous pharmaceuticals • A pharmaceutical which is not 1-2% of the prescribed pharmaceuticals in commercially available by the Sweden are unregistered pharmaceuticals that meet the individual patients need. pharmaceutical industry, but for which there is a medical need APL receives about 500 extemporaneous pharmaceuticals orders per day. • Specially manufactured according to the prescriber’s assessment of the patient’s needs • Divided into individually adapted and stock preparations APL 2019 9

Many of APL’s extemporaneous pharmaceuticals are manufactured for children with special needs. APL 2019 10

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 2019 11

APLs extemporaneous pharmaceuticals • 2 000 products • 280 products manufactured batch wise • For many therapeutic areas: - Pediatrics - Pain - Dermatology - Dental care - Cardiovascular - Stomach/intestine - Ophthalmology - Gynecology - Veterinary APL 2019 12

Extemporaneous pharmaceuticals in many dosage forms Aseptic/Sterile: Non-sterile: Parenteral preparations Semi-solids • • Ointments Vials • Creams • Bottles • Gels • Ampoules • Lotions Eye/Ear preparations Liquids • Drops • Oral solutions • Ointment • Emulsions • Gels • Suspensions Ambulatory systems Solid preparations • Infusion bags • Capsules APL 2019 13

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 2019 14

We produce merchandise with high quality Dose dispensing aids Skin and hair care Wound care Animal care Health care Other products APL 2019 15

Business area Life science We offer services from preclinical development to commercial manufacturing through close dialogue with our customers. APL 2019 16

We offer CDMO* services that cover the entire development chain Manufacture of clinical Commercial Product trial manterials development manufacture *CDMO = Contract development & manufacturing organisation APL 2019 17

Product development • Development of formulations for medicines and medical devices • Development of analytical methods • Stability studies APL 2019 18

Manufacture of clinical trial materials • Project management and project planning • Manufacture of trial medicines and placebo • QP release • Randomising, labelling and packaging APL 2019 19

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 2019 20

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 2019 21

Our customers are spread globally APL 2019 22

Products manufactured at APL are sold in 35 countries APL 2019 23

Sustainability - an integrated part of the business • Ongoing audits identify improvement areas • We have sustainability committees at all sites • 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 2019 24

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 2019 25

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 2019 26

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 benefits APL 2019 28

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 2019 28

Together we contribute to pharmaceuticals that improve and save lives www.apl.se APL 2019 29