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mibe GmbH Arzneimittel Sandersdorf-Brehna Address & Contact
mibe GmbH Arzneimittel Sandersdorf-Brehna Overview
mibe GmbH Arzneimittel is a powerful medium-sized pharmaceutical manufacturer and GMP-certified contract manufacturer in Sandersdorf-Brehna, located in the Anhalt-Bitterfeld district of Saxony-Anhalt. The company belongs to Dermapharm AG and plays a crucial role in the German pharmaceutical landscape. With a strong focus on quality and innovation, mibe GmbH Arzneimittel produces pharmaceuticals, cosmetics, and dietary supplements for external clients. In accordance with the highest industrial standards, the company adapts to the constantly evolving demands of the healthcare market.
Services and Production Areas
The contract manufacturing of mibe GmbH includes a variety of dosage forms offered in solid and semi-solid formats. These include tablets, capsules, ointments, and creams, all produced under strict GMP conditions and according to the manufacturing license in accordance with § 13 AMG. The company specializes in providing tailored solutions for pharmaceutical companies, including:
- Formulation Development: mibe GmbH offers comprehensive support in formulation development to create products that are not only effective but also marketable.
- Process Development: To maximize manufacturing efficiency and quality, all processes are thoroughly analyzed and optimized.
- Stability Studies: Conducting extensive stability studies ensures the longevity and safety of the products.
- Packaging Development: mibe GmbH also provides innovative packaging solutions that meet the specific requirements of the pharmaceutical and cosmetics industries.
- Regulatory Affairs: Experienced experts support customers upon request in complying with legal regulations and guide them through the approval procedures.
Regulatory Classification and Quality Assurance
mibe GmbH operates in a highly regulated environment as it manufactures and distributes pharmaceuticals. Compliance with Good Manufacturing Practice (GMP) is not only a legal requirement but also a commitment the company takes very seriously. Regular internal and external audits, as well as employee training, help ensure high-quality standards. The certifications and approvals extend to numerous product categories, including highly sensitive therapeutic agents.
Regional Importance and Economic Influence
The production site in Sandersdorf-Brehna has strategic significance within the Chemical Triangle of Central Germany, a region known for its dense cluster of chemical and pharmaceutical companies. mibe GmbH actively contributes to the economic development of the region by creating jobs and integrating into local networks. The interplay with other companies in this region promotes innovation and creates synergies that benefit the entire industry.
Furthermore, mibe GmbH plays an important role in training young professionals, which ensures the long-term competitiveness of not only the company but also the entire region.
Special Features of the Company
A standout feature of mibe GmbH is its flexibility and adaptability to evolving market demands. The ability to execute both small and large production runs allows for comprehensive adjustments to meet specific customer needs. Additionally, the company continuously invests in technological innovations to make the production process more efficient while minimizing environmental impact.
Commitment to sustainability is also reflected in the choice of eco-friendly raw materials and sustainable packaging solutions. These initiatives not only meet societal expectations but also position mibe GmbH as a responsible player in the healthcare sector.
Find more Contract Manufacturers in Germany in our overview.
Contract Manufacturers in Germany
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About Contract Manufacturers
A contract manufacturer, often referred to internationally as a Contract Manufacturing Organisation (CMO), produces medicines or medical products on behalf of another company (the marketing authorisation holder) without itself holding the marketing authorisation for the finished product. Contract manufacturing is a well-established and growing model in the pharmaceutical industry, allowing brand holders, biotech startups and generic companies to outsource manufacturing capacity while focusing on research, regulatory affairs and commercial activities. In Germany, operating as a pharmaceutical contract manufacturer requires a manufacturing authorisation (Herstellungserlaubnis) issued under Section 13 of the AMG (German Medicinal Products Act). Without this authorisation it is not permitted to manufacture, fill, package or release medicinal products for commercial use. Alongside the manufacturing authorisation, CMOs must produce in full compliance with Good Manufacturing Practice (GMP) standards, as defined in Annex I of Directive 2003/94/EC and the EU GMP Guidelines (EudraLex Volume 4). GMP compliance is verified through regular announced and unannounced inspections carried out by the competent pharmaceutical supervisory authority of the relevant German state (Landesbehörde). Services offered by German CMOs span the entire production chain: active pharmaceutical ingredient (API) synthesis, formulation development, solid dosage forms (tablets, capsules, granules), semi-solid and liquid forms, sterile manufacturing (injectables, infusions, eye drops), biological products, packaging (primary and secondary) and quality control and release testing. This directory lists all GMP-certified contract manufacturers in Germany with their manufacturing authorisation under Section 13 AMG and full contact details.
Contract Manufacturing in the German Pharmaceutical Industry
Contract pharmaceutical manufacturing in Germany has grown significantly over recent decades as global pharmaceutical companies seek to optimise their manufacturing footprints and reduce capital expenditure on production capacity. German CMOs benefit from the country's engineering expertise, well-trained workforce, strong regulatory standing and proximity to European clients. The German CMO market serves a diverse client base: established pharmaceutical companies outsourcing non-core production, generic manufacturers seeking additional capacity, biotech startups without their own manufacturing facilities, and international companies seeking a European manufacturing base with GMP certification recognised by the EMA and FDA. The services offered by German CMOs span the full development-to-commercial lifecycle, from formulation and process development in the lab through pilot-scale production and technology transfer to full commercial manufacturing and distribution. Germany's high GMP standards mean that products manufactured by German CMOs are accepted in regulatory submissions worldwide.
GMP Requirements and State Inspections for German CMOs
All pharmaceutical contract manufacturers in Germany must operate in compliance with EU GMP guidelines (EudraLex Volume 4) as a condition of holding a manufacturing authorisation under Section 13 of the AMG. GMP covers every aspect of pharmaceutical manufacturing: facility design and qualification, equipment qualification and calibration, cleaning validation, process validation, personnel training and hygiene, starting material and finished product testing, batch record documentation, stability studies, and management of deviations, out-of-specification results and change controls. GMP compliance is verified through inspections conducted by the pharmaceutical supervisory authority of the relevant German federal state (Landesbehörde). Inspections may be routine, announced or unannounced. Inspection findings are classified by severity (critical, major, minor) and manufacturers must respond with corrective and preventive action plans (CAPAs). GMP inspection results are entered into the EudraGMDP database. Foreign regulatory authorities such as the FDA, PMDA (Japan) and TGA (Australia) also conduct inspections of German CMOs that supply their markets.
Sterile Manufacturing and Specialised CMO Capabilities in Germany
Germany has a particularly strong track record in sterile pharmaceutical manufacturing, a technically demanding and heavily regulated segment of the CMO market. Sterile manufacturing encompasses injectable products (vials, ampoules, pre-filled syringes, cartridges), ophthalmic preparations (eye drops, eye ointments), inhalation solutions and infusion bags. These products must be manufactured in controlled cleanroom environments classified according to EU GMP Annex 1, which underwent a major revision in 2022 introducing the concept of contamination control strategy (CCS). Germany's engineering and cleanroom construction companies are world leaders in pharmaceutical facility design, making the country an attractive location for state-of-the-art sterile manufacturing investments. Beyond sterile manufacturing, German CMOs offer specialised capabilities in highly potent APIs (HPAPIs) and cytotoxic products requiring containment, modified-release oral dosage forms, transdermal drug delivery systems, biologics fill-and-finish, and clinical trial material manufacturing (CTMS).
Specialisations and the Growing Contract Manufacturing Market
The global market for pharmaceutical contract manufacturing is growing at approximately eight percent annually and is projected to exceed 300 billion US dollars by 2030. Growth drivers include the outsourcing strategy of large pharmaceutical companies, the growth of small biotech startups without their own production capacities and increasing demand for biologics and Advanced Therapy Medicinal Products (ATMPs). German contract manufacturers have established themselves in several niches: sterile manufacturing (injection solutions, lyophilisates) requires ultra-clean cleanrooms to ISO classifications; HPAPI containment (highly potent active pharmaceutical ingredients) requires specialist fume cupboards and personal protection measures; biologics CMOs require bioreactors and cell culture technology. CDMOs (Contract Development and Manufacturing Organizations) additionally offer formulation development and clinical trial materials. Important players in the German CMO market include Rentschler, Boehringer Ingelheim Biopharmaceuticals, Siegfried and Corden Pharma.
What is a pharmaceutical contract manufacturer?
A contract manufacturer (CMO) produces medicines or medical products on behalf of other companies. In Germany, CMOs require a manufacturing authorisation under Section 13 of the AMG (German Medicinal Products Act) and must comply with GMP (Good Manufacturing Practice) standards. They offer services across the entire production chain.
What requirements must contract manufacturers meet?
Contract manufacturers for medicines must hold a manufacturing authorisation under the AMG, produce in compliance with GMP standards and submit to regular inspections by the responsible state authorities. Qualification and validation of all manufacturing processes is mandatory.
How do I choose the right contract manufacturer?
When selecting a CMO, key criteria include GMP certification status, proven expertise in the desired dosage form (tablets, injectables, biologics, sterile products), production capacity, cleanroom classification, containment capabilities for HPAPIs and reference projects in the relevant product class. A structured supplier qualification process in line with GMP requirements is mandatory. All German CMOs with manufacturing authorisation under Section 13 AMG are listed on Sanoliste.
How many pharmaceutical contract manufacturers are there in Germany?
Germany is home to a significant number of GMP-certified contract manufacturers operating across a wide range of dosage forms and therapeutic areas. They range from large, multi-product contract manufacturing sites with hundreds of employees to smaller specialist CMOs focused on specific forms such as sterile injectables, biotechnology-derived products or controlled-release oral dosage forms. All those holding a manufacturing authorisation under Section 13 AMG are listed on Sanoliste.
What is the role of the Qualified Person (QP) at a German CMO?
The Qualified Person (Sachkundige Person, QP) is a legally required role under Section 14 of the AMG and EU Directive 2003/94/EC. The QP is personally responsible for certifying each batch of medicinal product before it is released onto the market, confirming that it has been manufactured and tested in accordance with GMP and the relevant marketing authorisation. Without a QP on site, a manufacturing authorisation under Section 13 AMG cannot be granted.
What types of dosage forms do German CMOs typically produce?
German CMOs cover a very broad range of dosage forms including conventional oral solid forms (tablets, capsules, granules, powders), liquid oral forms (solutions, suspensions, syrups), semi-solids (creams, ointments, gels), sterile injectables and infusions, eye drops, inhalation products, transdermal patches, biologics and biosimilars, APIs and active ingredient intermediates, and specialised forms such as modified-release or taste-masked products.
What is the difference between a CMO and a CDMO in Germany?
A CMO (Contract Manufacturing Organisation) focuses purely on manufacturing services. A CDMO (Contract Development and Manufacturing Organisation) additionally offers pharmaceutical development services such as formulation development, process development, analytical method development and scale-up support. Many German contract manufacturers have evolved into CDMOs, offering clients an integrated service from early development through to commercial manufacturing under one roof.