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Pharmadrug Production GmbH Address & Contact
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Pharmadrug Production GmbH Overview
Pharmadrug Production GmbH was founded in 2017 and has since developed into a leading contract manufacturer in the field of medical cannabis. The company is based in Rostock, Mecklenburg-Vorpommern, a location distinguished by its excellent logistical connections and infrastructural conditions. Pharmadrug focuses on the production and processing of cannabis products intended for medical use and offers a variety of contract manufacturing services specially tailored to the requirements of cannabis pharmacy.
Medical Cannabis: Production and Processing
Pharmadrug Production is considered one of the few German companies that holds a GMP certification (Good Manufacturing Practice) for the production of cannabis medicines. This is a crucial factor for quality assurance and compliance with international standards in drug manufacturing. The company produces standardized cannabis flowers, which are carefully cultivated and harvested, as well as high-quality cannabis extracts used for a variety of therapeutic applications. These products are intended for both the German market and the European pharmacy market.
In addition to its own product portfolio, Pharmadrug also offers contract manufacturing services for other companies in the cannabis industry. This supports other producers in the GMP-compliant processing of their harvests. The collaboration spans all production steps, from plant cultivation to the bottling of end products. Pharmadrug is also involved in research and development of new cannabis formulations and actively contributes to the advancement of cannabis therapy.
To meet strict regulatory requirements, Pharmadrug holds the necessary licenses from the Federal Institute for Drugs and Medical Devices (BfArM) for the trade and manufacture of narcotics. This ensures a legally secure and high-quality processing of all products. The focus on safety and quality runs through all company processes, from raw material procurement to the final inspection of products.
Location Rostock
The location in Rostock, Mecklenburg-Vorpommern offers special advantages for cannabis production. The production areas are generously sized and allow for flexible design of production processes. Additionally, an optimal climate system ensures that the growth conditions for the cannabis plants are ideal. Another strategic advantage is the proximity to the Rostock port, which ensures efficient import and export of high-quality raw materials and products. This logistical advantage is particularly important for a company active in both the national and international markets.
Furthermore, Pharmadrug Production has also established itself as an important employer in the region. By creating jobs and promoting regional economic cycles, the company contributes to the economic stability in Mecklenburg-Vorpommern. The close collaboration with local partners and support for educational and research initiatives in the region underscore the company’s commitment to the local community.
Another aspect that distinguishes Pharmadrug Production from other contract manufacturers is its continuous commitment to developing innovative solutions and product technological advancements. Therefore, the company invests not only in modern technologies but also in training and further education of its employees to ensure the highest quality standards in production.
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Frequently asked questions about Pharmadrug Production GmbH
Was ist Pharmadrug Production GmbH?
Pharmadrug Production GmbH ist ein GMP-zertifizierter Lohnhersteller (CMO/CDMO) in Rostock, Mecklenburg-Vorpommern, der pharmazeutische Produkte im Auftrag für andere Unternehmen produziert.
Was produziert Pharmadrug Production GmbH?
Pharmadrug Production GmbH fertigt als Lohnhersteller Arzneimittel, Wirkstoffe oder Medizinprodukte nach GMP-Standards für Auftraggeber aus der Pharmaindustrie und angrenzenden Branchen.
Wie kann ich Pharmadrug Production GmbH als Auftragnehmer anfragen?
Kontaktdaten und Adresse von Pharmadrug Production GmbH in Rostock, Mecklenburg-Vorpommern finden Sie auf dieser Sanoliste-Seite. Dort finden Sie alle relevanten Informationen für eine Kontaktaufnahme.
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.