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

• n 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

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We want to be the most attractive partner and workplace for development and manufacturing

• f extemporaneous drug

formulations and pharmaceuticals.

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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.

Our task

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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.

• 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.

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APL at a glance

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APL’s manufacturing sites are located in Sweden

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Göteborg Supply Chain & Logistics Non-sterile manufacturing Oral solutions Malmö Non-sterile manufacturing Semi solids Umeå Sterile and aseptic filling Clinical trial materials Stockholm Solid preparations Clinical trial materials Analytical development Extempore Customer service

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APL offers services and products in two business areas

Healthcare & Pharmacies

Life science

• Contract manufacturing
• Formulation development

and manufacturing of clinical trial material (CTM)

• Analytical services
• Extemporaneous

pharmaceuticals

• Cytotoxic preparation
• Preparation of pharmaceuticals

for clinical trials

• Development and

manufacturing of OTC and branded products

• APL branded products

• 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

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Business area Healthcare & Pharmacies

• 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

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Definition: Extemporaneous pharmaceuticals

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.

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

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

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Our extemporaneous pharmaceuticals are needed in the Swedish health care

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• 2 000 products
• 280 products manufactured batch

wise

• For many therapeutic areas:
• Pediatrics
• Pain
• Dermatology
• Dental care
• Cardiovascular
• Stomach/intestine
• Ophthalmology
• Gynecology
• Veterinary

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APLs extemporaneous pharmaceuticals

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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

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APL supports Swedish pharmacies with products and services

• Development and manufacturing
• f pharmaceutical products and

OTC drugs

• APL branded products
• Dose dispensing aids
• Sales and calibration of

thermometers

Wound care Health care Animal care Skin and hair care Other products Dose dispensing aids

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We produce merchandise with high quality

We offer services from preclinical development to commercial manufacturing through close dialogue with our customers.

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Business area Life science

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Product development Commercial manufacture Manufacture of clinical trial manterials

We offer CDMO* services that cover the entire development chain

*CDMO = Contract development & manufacturing organisation

Product development

• Development of formulations

for medicines and medical devices

• Development of analytical

methods

• Stability studies

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Manufacture of clinical trial materials

• Project management and

project planning

• Manufacture of trial medicines

and placebo

• QP release
• Randomising, labelling and

packaging

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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

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• Pre-filled syringes
• Injection vials
• Infusion bottles & bags
• Ampoules
• Semi-solids
• Oral and topical liquids
• Solid preparations

We adapt our preparations to customer needs

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Our customers are spread globally

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Products manufactured at APL are sold in 35 countries

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

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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

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• 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.

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All production at APL follows GMP

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

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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
• ffensive treatment

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Together we contribute to pharmaceuticals that improve and save lives

www.apl.se