Regulatory framework for the manufacture of medicines

Good quality is a prerequisite for safe and effective medicines. We work with a long-term view to ensure our products are of the highest quality.

We follow international standards for industrial-scale medicine production.

As we manufacture medicines for various markets within and outside of Europe, our production facilities are regularly inspected by the Swedish Medical Products Agency and the U.S. Food and Drug Administration (FDA).

Our customers also conduct regular inspections, giving us continuous feedback on the quality of our work. Manufacturing clinical trial material 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 certifying our operations.

Quality system

We continuously improve our operations and undergo annual quality audits following regulatory requirements to safeguard consistently high quality in all our facilities. We are also regularly audited by our customers and follow their procedures and guidelines.

APL’s corporate quality management leads and coordinates quality control together with production facility quality managers to create a common and well-established quality safeguarding system. Local quality managers lead quality control in their facilities and are responsible for releasing medicines in their roles as Qualified Persons (QP).


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.


Öppettider sommar:
Helgfria vardagar 08:00-16:00.

Gäller 24 juni-16 augusti 2024.



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 public policy assignment from the Swedish government, but also work together with other pharmaceutical companies to create the greatest possible patient benefit. The assignment also comprises preparedness to maintain operations in times of crisis and ultimately war.

Our vision is that we will make a difference for patients with additional 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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