AMW GmbH develops and manufactures innovative drugs that optimize the success of therapies and improve patients’ well-being. A drug comprises two components: an active ingredient or a mixture of active ingredients and a drug delivery system, which plays a decisive role in the efficacy of a drug.
In the slow-release dosage forms, the active ingredients are released over a long period of time. These have advantages over conventional dosage forms with regard to the active ingredient’s effectiveness and its tolerability for patients. Greater effectiveness also reduces the cost of therapy.
The drug delivery systems developed at AMW are parenteral modified-release formulations. This means that the active ingredients “bypass” the intestine and remain chemically unchanged by avoiding the gastrointestinal tract. This causes less strain on the body, because important organs such as the stomach, liver, kidney, and intestines do not have to break down an active ingredient.
AMW GmbH’s drug delivery systems contain various active ingredients. These may be generic, already approved, or completely novel drugs. Hormones, monoclonal antibodies, and nucleic acids can also be applied with AMW technology.
AMW technologies are used worldwide in the following rapidly expanding fields:
- Pain management
Our core products
International business and licensing
To enable you to access international markets quickly and easily, we provide licensing models for high-quality drug patches and biodegradable implants developed by us in-house.
We partner with renowned pharmaceutical companies and offer our customers and international marketing and sales partners a complete package comprising licensing and support for our products, which we manufacture on site in Warngau. We grant licenses for the marketing of our products in all global markets.
We develop and license only products that we manufacture in our modern production facilities. Furthermore, as the rights holder, we take care of patent and regulatory matters.
In addition to developing our own pipeline, we are in constant contact with innovative pharmaceutical and medtech companies regarding transdermal and/or parenteral delivery systems, and we collaborate by contributing our expertise as a CDMO.
Our range of services in the licensing business:
- Outlicensing of our existing products and pipeline products for worldwide submissions based on the EU dossier
- Contract development and contract manufacturing for implants and patches (CDMO)
- Sustainable lifecycle management through continuous regulatory support and constant improvements to processes
- Production of high quality pharmaceuticals on state-of-the-art production lines
- Market-friendly packaging of products thanks to high-performance packaging lines
Quality control and batch release
We perform quality control/batch release according to EU-GMP Guidelines within the framework of a manufacturing authorization for medicinal products using state-of-the-art analytical equipment.
- Implementation of the EU-GMP Guidelines Part I
- Raw material testing in accordance with Ph. Eur/USP (APIs/excipients/packaging)
- Stability tests according to ICH Q1
- Test method transfer, development, and validation according to ICH Q2R
- All drug testing according to EU-GMP Guidelines (pharmaceutical, chemical, technical)
- Microbiological testing methods in-house and at qualified partner laboratories
- Process and cleaning validation according to EU-GMP Annex 15
- Batch release/GMP certifications according to EU-GMP Annex 16 of transdermal systems, implants, and vaginal rings for clinical trials and market goods
- Supplier qualification and auditing, issuing of QP declarations
- Technical agreements (TA) to define the scope of responsibility for GMP-compliant customer safety
- FTIR spectroscopy, ATR
- UV-VIS spectroscopy
- Microscopic image analysis
- Coulometric water determination
- Potentiometric titration
- HPLC/UPLC with UV/RI/fluorescence and MS detection
- GPC analytics
- HS-GC analytics
- In-vitro-release tests according to Ph. Eur. and our own modern methods
- Material testing, for example, adhesive strength tests, tensile strength
- Skin permeation testing
- All climate ranges for ICH stability studies
- 10 highly qualified analysts
- In a team led by two experts in raw material and pharmaceutical analytics
- Many years’ experience in all areas of GMP quality control in accordance with Chapter Six of the EU-GMP Guidelines
Quality management and certificates
The range of services offered by AMW GmbH covers the entire value chain, from development to manufacturing/testing/certification to the sale of transdermal systems (TDS, medicated patches), subcutaneous systems (implants), and medical devices.
AMW GmbH holds a manufacturing permit in accordance with Section 13 of the German Medicinal Products Act (AMG) and a corresponding GMP certificate, and is certified in accordance with DIN EN ISO 13485 for medical devices. A quality management system that meets EU-GMP and ISO requirements has been implemented.
AMW GmbH’s quality management system meets high international standards. AMW GmbH has passed routine inspections by the administrative district of Upper Bavaria and other bodies, and has performed very well in customer audits. It has also passed inspections by the following state authorities:
Our innovative dosage forms and high quality standards make us an excellent partner for realizing your ideas in the field of pharmaceuticals and medical devices.
AMW GmbH holds the following certificates:
- Manufacturing permit in accordance with Section 13 of the German Medicinal Products Act (AMG) for transdermal systems, implants, and vaginal rings for clinical trials and market-grade products, with confirmation of production according to GMP (“GMP certificate”)
- DIN EN ISO 13485 for the production, quality control, quality assurance, and sale of medical devices
AMW GmbH’s experienced RA team provides efficient and reliable support to customers in planning, obtaining, and retaining marketing authorizations:
- Conception of regulatory strategies
- Scientific advice procedures (as meetings or in writing):
- Preparation (consultation, briefing document)
- Organization and procedure management
- Preparation of product registration dossier (CTD modules 2-5; and also complete module 1, if required)
- Product registration procedure: support including replying to deficiency letters; if necessary, also preparing and carrying out the complete procedure
- Product lifecycle management:
- Preparation of variation documentation for submission
- Support during variation procedures, including replying to deficiency letters; if necessary, also preparing and carrying out the complete procedure
So far, marketing authorizations for the following drug products developed by AMW GmbH have been obtained via European DCPs or national procedures in the European or Asian region respectively:
- Goserelin 3.6 mg implant in a pre-filled syringe
- Goserelin 10.8 mg implant in a pre-filled syringe
- Leuprorelin 11.25 mg implant in a pre-filled syringe
- Buprenorphine 35 microgram/hour transdermal patch
- Buprenorphine 52.2 microgram/hour transdermal patch
- Buprenorphine 70 microgram/hour transdermal patch
- Rivastigmine 4.6 mg/24 hours transdermal patch
- Rivastigmine 9.5 mg/24 hours trandermal patch
- Rivastigmine 13,3 mg/24 hours transdermal patch