Commercial manufacture

Manufacture of aseptic, sterile and non-sterile medicines and medical devices on a small and medium scale




When upscaling, we either adapt the product formulation, the manufacturing process, or both, to manufacture a larger batch.


In some cases, the formulations need to be adjusted in terms of compatibility between the active substance and excipients, pH levels in the finished product, viscosity and other characteristics.

The manufacturing process is adapted to allow for the critical process parameters, such as mixing, homogenising and filling the products. 


Tech transfer

Knowledge transfer

We transfer knowledge on production formulation, manufacturing processes and QC (Quality Control) analyses and also on raw materials and primary packaging materials. This information may come from another manufacturing unit or from a development laboratory. In some cases, further development and supplementing of the various steps are necessary to adapt them to new manufacturing conditions. A close dialogue between specialists within the various areas is often needed to ensure all details agree.

Tech transfer


Approved suppliers

Our special purchasing team manages the purchase, analysis and release of raw materials and packaging materials for GMP manufacturing. We work exclusively
with approved suppliers to safeguard quick deliveries of necessary materials of GMP quality.


All raw materials and packaging materials undergo analysis according to both official pharmacopeias (Ph Eur, USP, BP, etc.) and according to adapted
specifications. The methods are developed and validated according to applicable ICH guidelines.



Batch protocols

All our medicines and medical devices are manufactured on GMP-classed premises. Ahead of manufacture, we produce and approve a batch protocol, which describes step by step how the manufacture is done. The batch protocol is supplemented during the manufacturing process.

Mixing and filling

Manufacture usually consists of two steps:

1) mixing, where the active substance and excipients are melded together into a finished product mix, and

2) filling, where the finished mix is filled into the primary packaging selected, such as bottles, vials or tubes, and then sealed.

We label and pack the filled units for onwards transport.


QP release

QC laboratory

Every product manufactured goes through a pre-defined list of analyses to safeguard the product’s quality and identity. These analyses are carried out at a QC (Quality Control) laboratory that is independent from the manufacturing unit. By far the most analyses are carried out at APL. In some cases, we outsource analyses to approved suppliers.


When the analysis is completed, our certified QPs (Qualified Person) carry out a detailed review of all documentation associated with the reception of raw
materials, manufacture and analysis of the product. If all has been done according to GMP and corresponds to our SOPs (Standard Operating Procedures) and instructions, the product is released for a clinical trial. We release products to be used in clinical trials approved by EMA (European Medicines Agency) or other recognised Health Authorities globally.

We have one or more QPs at each manufacturing unit.

QP frisläppning

Preparation forms

Sterile and non-sterile manufacture of medicines and medical devices.

QC analysis

Microbiological and chemical analyses as a quality control of raw materials, water and finished products are carried out daily by QC. The methods used comply with Swedish medicine standards and the European pharmacopeia (Ph Eur).

Labelling and packaging

We label and package on both a small and a large scale, everything from hand packaging to fully automated packaging lines.


Extemporeläkemedel och lagerberedningar

Beställ online via EbEx


Telefon: 010-447 97 00


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



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 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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