List of Contract Manufacturing Companies in Germany - 17

Contract Manufacturing & Analytical

BIOTYPE is an innovative German solution provider for molecular precision diagnostics. We are committed to advancing precision medicine through our products & services for reliable analysis and interpretation of clinical biomarkers. BIOTYPE offers a strong portfolio in molecular cancer diagnostics for applications in hemato-oncology, liquid biopsy, and molecular profiling of solid tumors. The portfolio includes IVD assays for clinical diagnostics and RUO assays for translational and clinical research. In addition, BIOTYPE offers high-quality and IVD-compliant contract development and manufacturing services. Our proprietary MODAPLEX platform is a benchtop system for automated molecular profiling and multi-biomarker testing. MODAPLEX addresses the growing need to simplify and accelerate precision testing by reliably delivering actionable molecular information required for biomarker-guided care in precision medicine. The MODAPLEX consolidates multi-gene testing into one workflow with same-day results. BIOTYPE‘s quality management system is certified according to ISO 9001:2015 & ISO 13485:2016.

Celonic is a "Pure Play" Biologics Contract Development Manufacturing Organization (CDMO). Celonic's mission is to help its customers, primarily small to large Biotech Companies, bring life-saving and improving drugs effectively to the market using innovative, "next generation" bioprocessing technologies such as, process intensification and full-perfusion. Celonic has a state-of-the-art Development and Innovation Center in Basel, Switzerland (headquarters), and clinical and commercial GMP manufacturing facilities in Heidelberg, Germany. At present, more than 500 highly qualified employees work at Celonic. Due to the expansion of the company, Celonic is looking for committed and qualified employees. Our job is to make a difference!

ChemCon GmbH - Your Good Manufacturing Partner! ChemCon is a contract development and manufacturing organization (CDMO) located in Freiburg, Germany. We manufacture drug substances (injectable, ophthalmic, oral, topic grade) and ultra-pure chemicals to your specifications. With multidisciplinary expertise we can meet your individual demands for small-molecule organic APIs, inorganic compounds, polymers, and highly potent or controlled substances. ChemCon’s facilities are optimized for the production of small to medium quantities (g to multi 100 kg per year). This is particularly interesting if you are sourcing APIs for clinical trials or commercial applications (i.e., orphan diseases, oncology, or emergency care) with a low annual demand. We also manufacture excipients, provocation substances, dietary trace elements, diagnostics, delivery agents, or reference standards. Your project will be under one roof from synthesis & process development/establishment all the way to commercial cGMP manufacturing, including full documentation, quality control and regulatory support. We also offer external analytical services, independent from production services. ChemCon looks back on an outstanding inspection history by both the FDA and European health authorities. Impressum: ChemCon GmbH, Engesserstr. 4b, 79108 Freiburg i.Br. Phone.: +49 (0)761-5597-0; E-Mail: Info@chemcon.com CEO/President: Dr. Raphael Vogler Commercial register: HRB 5973 Court of registration: Freiburg VAT Reg. No: DE812753447

CPL Sachse produces APIs for human and veterinary use. We manufacture APIs under cGMP for (pre-)clinical development and market supply up to ≤ 50 kg scale. The company has been successfully inspected multiple times by EMA (LaGeSo) and FDA. The following compounds are available from us under a GMP certificate from our local authority: - Anagrelide, - Atipamezole, - Clenbuterol (CEP), - Detomidine (CEP), - Medetomidine, - Methacetin(13C), - Nabilone - Phenoxybenzamine. Further APIs as well as reference standards for APIs and impurities are available on request. Moreover, we carry our route scouting for NCEs and develop and validate processes as well as analytical methods required to test the APIs and the subsequent drug products. Furthermore, we offer stability tests according to ICH guidelines. The company introduced and offers Maximator® HPE. This continuous high pressure extruder (HPE) allows rapid and reproducible large-scale production of unilamellar liposomes. Finally, we offer all regulatory services required for the preparation and submission of a pharmaceutical dossier (for APIs and drug products).

c-LEcta is a global biotechnology company specializing in the development, production and distribution of enzyme products. The company uses world-class enzyme engineering and production technologies to provide its partners in the food and pharmaceutical industries with superior biotechnological solutions for innovative industrial applications. c-LEcta is part of the Kerry Group.

CordenPharma is your full-service partner in the Contract Development & Manufacturing (CDMO) of APIs, Lipid Excipients, Drug Products and Packaging. Through a network of cGMP facilities across Europe and the US organized under six technology platforms – Peptides, Lipids & Carbohydrates, Oligonucleotides, Injectables, Highly Potent & Oncology, Small Molecules - CordenPharma experts translate complex ideas, processes and projects at any stage of development into high-value pharmaceutical products. Visit to learn more > cordenpharma.com

As a family-owned and operated business, Erbe develops, manufactures,and markets systems for professional use in various medical disciplines all over the world. Since the company's foundation, Erbe has continuously reshaped and adapted its business to an ever-changing reality in several key disciplines such as gastroenterology, general surgery, gynecology, pulmonology and urology. The portfolio comprises devices and instruments for electrosurgery, vessel sealing, plasma surgery, cryosurgery, hydrosurgery, and imaging. Over the last ten years, sales have increased by 75% with an 85% increase in employees to over 1.800 colleagues worldwide. Today, the international group of companies is represented in 110 countries around the world with sales and service units, sales and production units and an international distributor network. A dedicated team of around 260 employees works intensively in research and development. Close cooperation with renowned physicians from medical faculties and hospitals is a key success factor that helps Erbe to successfully drive medical development forward Imprint: https://de.erbe-med.com/de-en/meta-navigation/imprint/ Disclaimer: https://erbe-med.com/fileadmin/pdf/company/Terms_of_use_EN.pdf

Evotec is a biotechnology company that is committed to advancing drug discovery and development. Through flexible business models, we collaborate with pharmaceutical companies, biotechs, foundations, and government agencies on a substantial scale. We believe that by working together, we can make a difference in the lives of patients. Our Pipeline Co-Creation model represents our adaptable, multi-modality, fully integrated end-to-end approach to drive collaborations and services across all phases of drug discovery and development – from discovery of novel targets to achieving Proof of Concept in the clinic and into commercial manufacturing. We aspire to contribute data-driven disease understanding and early disease relevance in humans to bring the probability of success up. We select the right modality, which is then propelled forward on our platforms by our passionate people striving for the fastest and most effective ways towards patient impact. This is enabled by convergence of human ingenuity with data and AI. We also offer specific solutions, products, and CRO/CDMO-like services, always in support of the Biopharma R&D innovator. Our more than 4,000 scientists work closely with numerous partners concurrently, delivering fully integrated research and development portfolios or individual projects with the highest quality standards and efficiency, coupled with great science, passion, engagement, and communication.

IDT Biologika is your full-service CDMO for viral vaccines, cell & gene therapeutics and other biologics protecting humans worldwide! We are committed to your development and manufacturing needs from the early stages of process development to clinical trial materials and commercial manufacturing: • Process Development • Clinical & Commercial Scale Drug Substance (e.g. Viral Vaccines, Viral Vectors for Cell and Gene Therapeutics) • Aseptic Liquid Filling & Lyophilization (Biologics) • Labeling, Packaging & Storage • Quality Control and Analytical Services With the expertise and capacity to handle large-scale campaign production of human vaccines and biopharmaceuticals, IDT Biologika brings development, testing and regulatory excellence along with state-of-the-art manufacturing lines required to advance projects with the highest level of quality, efficiency and consistency of supply: • FDA, EMA, ANVISA standards European and North American Footprint IDT Biologika is headquartered in Germany (Dessau-Rosslau and Magdeburg in Saxony-Anhalt). Here we operate one of Europe's premier integrated biopharmaceutical facilities for end-to-end services: • Process Development • Clinical Phases I-III • Commercial Scale Drug Substance (e.g. Viral Vaccines, Viral Vectors for Cell and Gene Therapeutics) • Commercial Manufacturing • Aseptic Liquid Filling & Lyophilization (Biologics) • Labeling, Packaging & Storage • Quality Control and Analytical Services Our North American facility is in Rockville, Maryland. The site has a long history of contract manufacturing and state-of-the-art technologies used to develop and manufacture clinical trial materials for phases I–II: • Process Development • Clinical-Scale Drug Substance (Viral Vaccines, Viral Vectors for Cell & Gene Therapeutics) • Aseptic Liquid Filling & Lyophilization • Packaging & Storage • Analytical Service

ProBioGen is a renowned contract development and manufacturing organization (CDMO) and technology provider. We perform cell line engineering, process development, and GMP manufacturing of biopharmaceuticals for clients in biotech and pharma. We offer proprietary innovative technologies for optimized biopharmaceutical manufacturing and analysis. ProBioGen also provides process development services and manufacturing technologies for viral vaccines. Our additional new building houses 1000 L single-use bioreactor capacity to keep up with the ever-increasing demand from our clients. A second 1000 L single-use bioreactor is coming soon. With 30 years of experience in animal cell culture, combined with innovative scientific excellence and a strong intellectual property base, we cover the entire drug development value chain end-to-end. Watch & learn more: https://youtu.be/vtEgrEVfj70

Transforming proteins into pioneering drugs ProJect Pharmaceutics, based in Martinsried/Munich, Germany, transforms proteins, peptides and delicate small molecules into pioneering drugs. ProJect Pharmaceutics adds value to client´s bio-pharmaceutical products by applying an innovative concept of development called Advaceutics. Based on the Advaceutics concept, ProJect Pharmaceutics designs optimized formulations and delivery systems for biologics that are stable, convenient and safe. Tailored to these optimized systems the company develops cost-effective manufacturing processes and transfers those from its own pilot labs to large-scale manufacturing. ProJect Pharmaceutics makes sure that investigational products, biosimilars as well as "bio-betters" are developed effectively and will run smoothly in clinical and commercial scale GMP manufacturing. We offer: • predictive formulation analytics • formulation development including in-depth protein analytics • lyophilization process development and optimization • lyophilization in dual chamber prefilled syringe • development of liposomal formulations, producible by simple stirring • manufacturing of preclinical study material • technology-transfer including scale-up to GMP-manufacturer We deliver: • optimized formulations for biopharmaceuticals • tailored manufacturing processes and transfer to GMP manufacturing • development reports ready for submission to the authorities for registration

Rentschler Biopharma is a leading contract development and manufacturing organization (CDMO) focused exclusively on client projects. The company offers process development and manufacturing of biopharmaceuticals, including advanced therapies, as well as related consulting activities, project management and regulatory support. Rentschler Biopharma's high quality is proven by its long-standing experience and excellence as a solution partner for its clients. A high-level quality management system, a well-established operational excellence philosophy and advanced technologies ensure product quality and productivity at each development and manufacturing step. Rentschler Biopharma is a family-owned company with about 1,400 employees, headquartered in Laupheim, Germany, with operations in Milford, MA, USA and Stevenage, UK. In 2024, the company joined the United Nations Global Compact, emphasizing Rentschler Biopharma’s focus on sustainability.

Rommelag is the inventor of blow-fill-seal technology (BFS) and the global market leader in the aseptic filling of liquids and semisolids with its bottelpack machines. Our machines are primarily used in the pharmaceutical, chemical, and food industries. Together with our customers, we develop innovative packaging solutions tailored precisely to the specific packaging task at hand. We built the first prototype bottelpack machine in 1962. Since then, we have continued gathering and sharpening our expertise in packaging solutions using BFS. We are delighted to say we now have customers in over 80 countries worldwide and more than 2,000 dedicated employees.

ROTOP Pharmaka is a leading German pharmaceutical company that produces cGMP compliant radiopharmaceuticals for diagnostics and therapy in Nuclear Medicine and Molecular Imaging and distributes them in more than 30 countries worldwide. With almost 20 years of experience in the development, production, authorization and distribution of sterile kits for radiolabeled pharmaceuticals ROTOP continuously expands its product portfolio by developing new products and entering new strategic partnerships.

We turn active ingredients into medicine. As one of the leading pharmaceutical service providers for the aseptic manufacture of injectable medicines, we are a global player – and a family business. Together with our 6,000 employees, we help improve the lives of people around the world. We combine tradition and innovation in a job that has meaning. Ravensburg is where our roots are. We make a significant contribution to reliably supplying patients with medicines from our state-of-the-art production sites in Europe and the United States. We work hand in hand with pharmaceutical and biotechnology companies of all sizes, accompanying them on their journey to help those who are affected with their treatment of cancer, multiple sclerosis, and other diseases – from active ingredient development all the way to its delivery in people. With success comes responsibility. Teamwork, openness, and commitment: These qualities are important to us. At Vetter, we are sustainably helping to shape the future. We fully support personal and professional development – to build a strong team in which everyone can develop their skills, and in which every contribution counts. And for those who rely on us. Find out more about our company at www.vetter-pharma.com/ Privacy Notice: https://www.vetter-pharma.com/en/privacy-notice Imprint: https://www.vetter-pharma.com/en/imprint