Licensing & Distribution

Expanding into new markets

To make our products available to patients worldwide, we offer licensing and distribution models for qualified commercial partners.

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Global reach

Partnering models

AMW is already a trusted partner of leading international pharmaceutical companies and offers comprehensive licensing and regulatory support packages for the commercialization of products manufactured at its own production facilities.

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Licensing

Out-licensing of products and pipeline candidates
Sustainable lifecycle management through continuous regulatory maintenance and support
Manufacturing of pharmaceutical products on state-of-the-art production lines

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Regulatory Approval

AMW's experienced Regulatory Affairs team provides efficient and reliable support in planning, obtaining and maintaining approvals.

Regulatory strategy consulting
Scientific advice procedures (preparation, coordination and execution)
Preparation of regulatory submissions (CTD Modules 2–5 and, where required, the complete Module 1)
Approval process: support including responses to regulatory questions and deficiency letters, or, if desired, preparation and full management of the submission process
Product lifecycle management:
- Preparation of variation documentation for submission
- Support during variation procedures, including responses to regulatory questions and deficiency letters, or complete management of the process

Marketing

Provision of market research insights on relevant markets and industry trends
Marketing support, including positioning concepts, key messaging and templates for promotional materials

Already available

Products for licensing partners and distributors

Our biodegradable drug delivery systems for controlled drug release can help support treatment adherence and enable cost-effective therapies. We currently have three products on the market: implants, which are distributed in numerous markets through local and global pharmaceutical partners.

To our products

Currently in development

Our pipeline

Our pipeline comprises projects for innovative drug delivery systems at various development stages.

Go to pipeline

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Selection of partners

Our existing licensing and distribution partnerships with leading pharmaceutical companies demonstrate our successful collaboration with partners across a wide range of markets and our ability to translate different partnership models into effective commercial solutions. In addition, we offer partnership opportunities for the development of new products.

Co-development

Are you interested not only in licensing or distributing our existing products, but also in the joint development of additional long-acting pipeline candidates from AMW across various therapeutic areas? Our product candidates typically have already reached the level of maturity required for clinical development and offer partnership opportunities in the final stages of development as well as for global commercialization.

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CDMO+

Are you interested in the joint development of new long-acting formulations for your APIs? With CDMO+, AMW offers the full spectrum of services - from research and development to GMP-compliant manufacturing of clinical samples and commercial products. Through efficient and sustainable project management, we deliver tailored solutions across all stages of development, from formulation design and process development to scale-up for commercial manufacturing.

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Your contacts

You can reach our Licensing Team at

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FAQs about AMW’s Licensing & Distribution

Does AMW support its partners with obtaining market access and in regulatory matters?

Yes. AMW has a dedicated Regulatory Affairs team with specialized expertise in the approval and lifecycle management of pharmaceutical combination products.

What partnering models does AMW?

Depending on the market and product, AMW offers either licensing arrangements or direct distribution through local distribution partners.

What is the difference between licensing and direct distribution at AMW?

In a licensing model, typically broader product and market rights are transferred to the partner. Under a direct distribution model, the product remains under the AMW brand while being distributed through a local commercial partner.

Which companies may benefit from partnering with AMW?

Partnerships are of interest particularly for pharmaceutical companies, regional and local distributors, and business development teams seeking innovative and differentiated products.

Can new markets be developed together with AMW?

Yes. Specifically for markets where AMW is not yet represented, we actively seek new partnerships worldwide, while identifying the most suitable commercialization model.