Regulatory framework for the manufacture of medicines

Good quality is a prerequisite for safe and effective medicines, and we work with a long-term view to ensure our products are of good quality.

  • We comply with international standards for medicine manufacture on an industrial scale.
  • As we manufacture medicines for various markets within and outside Europe, our production units are regularly inspected by the Swedish Medical Products Agency and the USA’s Food and Drugs Administration.
  • Our customers also carry out regular inspections, which provides us with continuous feedback on our quality work.
  • The manufacture of materials for trials follows the same regulatory framework.
  • Our manufacture of extemporaneous medicines for individual patients complies with the Swedish medicine standards, SLS, and the Medical Product Agency’s enactment LVFS 2010:4.
  • We also manufacture medical devices. All our activities are inspected by accredited bodies, which certify the operation.

Quality system

We work with constant improvements and follow up our quality work through annual quality audits in order to safeguard even and good quality in all units.

APL’s quality manager leads and coordinates the quality work together with the production units’ quality managers to create a common and well-established quality system. The local quality managers lead the quality work locally and, in their roles as QP, are responsible for the release of medicines.

Read more in Certificates External link.


Extemporeläkemedel och lagerberedningar

Beställ online via EbEx


Telefon: 010-447 97 00
e-post: kundservice@apl.se


Ordinarie öppettider:
Helgfria vardagar 08:00-17:00



Reservrutinen används endast för akuta medicinskt viktiga beställningar av extemporeläkemedel under tiden EbEx ordersystem inte kan nås. För att kunna använda dig av rutinen så krävs det att du redan är befintlig kund hos APL och har ett kundnummer.

Beställningar görs på för ändamålet avsedd blankett och får inte innehålla några patientuppgifter.

Beställningen skickas via e-post till kundservice@apl.se.



Visiting adress:

Prismavägen 2, Kungens Kurva

+46 10 447 96 00

Other contact information

About APL

Apotek Produktion & Laboratorier (APL) is one of Europe’s leading companies manufacturing extemporaneous drugs and stock preparations. We have a social mission from the Swedish government, but also work together with other pharmaceutical companies to create the greatest possible patient benefit. Our vision is that we will make a difference for patients with special needs. We are also an established contract manufacturer within Life Science in Scandinavia, where we deliver services within development and analysis. With more than 500 employees and five manufacturing units in Malmö, Gothenburg, Stockholm and Umeå, we develop drugs that improve and save lives.

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