APL - Contract Development and Manufacturing Services

APL offers a broad range of contract development and contract manufacturing services. Our expertise covers every aspect in drug process development and manufacturing, including prototype formulation, development, documentation, process scale-up, validation, cGMP production and quality control.

PREFORMULATION, DESIGN, PROTOTYPE FORMULATION AND PROCESS DEVELOPMENT

APL offers a complete development program or a single analysis, depending on your needs. Our pharmaceutical specialists involved in formulation development can assist you in preformulation, dosage form design, prototype formulation and process development.

We assist a wide range of emerging as well as established pharmaceutical companies in the development of new pharmaceutical products for the world market.

APL's experienced pharmaceutical staff offer support in compiling CMC parts in your preclinical, clinical or marketing authorization dossier, in compliance with EU and FDA regulations.

Our experience covers a wide range of formulations, including oral solids, solutions, suspensions, powders, creams, lotions and sticks as well as sterile products.

CHEMICAL, CHEMICOPHYSICAL AND MICROBIOLOGICAL QUALITY CONTROL

Our analytical chemists handle both chemicophysical quality control of drug substances and quality control of finished products. They can take care of your needs for method development and validation. We also conduct single stability studies in accordance with ICH guidelines.

We provide chemical and microbiological quality control as well as quality control of medical devices and consumer products.

CLINICAL TRIALS

APL has particular strength in small-scale cGMP production and the manufacture of clinical trial material and placebo can be supplied for a wide range of formulation types. With the aim of being a full service provider, APL provides assistance with planning, randomisation, coding, labelling and packaging as well as distribution of clinical trial material. When conducting a clinical trial in Sweden, we can also assist with a full range of services at each clinical trial centre through our hospital pharmacies.

cGMP MANUFACTURING

Our four manufacturing sites are equipped for large-scale cGMP manufacturing. Our services include process scale-up and the sourcing of drug substances or packaging material.

Other manufacturing capabilities include capsules, creams, ointments, suppositories, sticks, powders, sachets, solutions, suspensions as well as most types of sterile products.

APL has experience from working with leading pharmaceutical companies as well as emerging, virtual entities. Our pharmaceutical production facilities have been cleared by the FDA to provide contract manufacturing services for the US market.

APIs, EXCIPIENTS AND PACKAGING PROCUREMENT

APL purchasing unit procures a wide range of starting materials, APIs, excipients and packaging material, with complete quality control. We can source as part of a manufacturing service or supply quality controlled materials for you own needs.

QC, QA, PROJECT MANAGEMENT AND CONSULTANCY

APL performs all aspects of Quality Control (QC), on starting materials, IPCs, final control of finished products and their release.

We also supply Quality Assurance (QA), project management and consultancy services.

OUR PHARMACEUTICAL FACILITIES AND PERSONNEL

APL has four manufacturing sites in Sweden, each specialized on different types of products and with their own QC/QP function.

APL has a history of pharmaceutical manufacturing since the beginning of the 1900s. With 510 employees, of which about 80 are highly qualified scientists engaged in analytical and development work, APL has served more than 400 companies during the last years.

APOTEKET AB

APL is part of Apoteket AB which is the leading supplier of pharmaceuticals to Swedish healthcare, through its pharmacy chain and hospital pharmacies. APL is the nationwide supplier of named-patient pharmaceuticals and special products and regularly manufactures more than 2000 pharmaceutical products.

Apoteket AB also offers market research services for the Swedish pharmaceutical market.