Medac Group

What Medac Group does

medac Group is a privately-held German pharmaceutical company founded in 1970 and headquartered in Wedel, near Hamburg. The company develops, manufactures, and distributes specialty pharmaceutical products across four therapeutic areas: rheumatology, urology, hematology, and oncology. Its portfolio of 34+ products includes the metoject/metex PEN methotrexate autoinjector (launched 2013 as the world's first MTX-filled autoinjector), BCG-medac for non-muscle invasive bladder cancer, Trecondi (Treosulfan) for HSCT conditioning therapy, and a broad cytostatic portfolio including 5-FU, bendamustine, irinotecan, doxorubicin, carboplatin, and lomustine. Products are manufactured at three European sites in Wedel, Dessau-Roßlau (Germany), and Brno (Czech Republic) with capabilities spanning pre-filled syringes, vials, cartridges, aseptic filling, terminal sterilisation, lyophilisation, and high-potent API handling down to OEL = 10 ng/m³.

The business operates on a dual model combining proprietary product sales with contract development and manufacturing (CDMO) services for third-party pharmaceutical clients. Proprietary products are sold B2B through owned subsidiaries in 14+ European markets plus Japan, supplemented by distribution partnerships (Clinigen for APAC, Hyphens for Southeast Asia) and the newly established Dubai entity serving MEA. CDMO services provide injectable manufacturing from clinical supply (1-50L) to large-scale commercial campaigns (up to 11,000L), including small molecules, biologics (mAbs, proteins, peptides, oligonucleotides), and antibody-drug conjugates. Manufacturing facilities are approved by US FDA, EU EMA, ANVISA Brazil, PMDA Japan, Health Canada, MFDS South Korea, and other major health authorities, enabling distribution across 90+ countries.

medac serves hospitals, oncology wards, rheumatology practices, urology departments, and transplant centers, engaging healthcare professionals through field sales teams, medical congress presence (EULAR, EADV, EBMT, PreS), an Investigator Initiated Trials program, and dedicated medical education. The company employs over 2,000 people globally and remains privately owned under managing directors Frank Lucaßen, Dr. Christian Matschke, and Dr. Christoph Willers, with recent expansion into the Middle East via the October 2025 Biotech Pharma acquisition.

Name

Medac Group

Legal name

medac Gesellschaft für klinische Spezialpräparate m.b.H.

Website

https://medac-group.com

Company type

Private

Founded year

1970

Operating status

Operating

Headcount range

1,001–5,000 employees

Short description

medac Group is a privately-held German pharmaceutical company founded in 1970 that develops, manufactures, and distributes specialty drugs in rheumatology, urology, hematology, and oncology across 90+ countries, serving hospitals and transplant centers from European manufacturing sites.

Ownership category

akta.pro rank

Product category

Specialty Pharmaceuticals

NAICS

Pharmaceutical and Medicine Manufacturing (3254), Pharmaceutical Preparation Manufacturing (325412)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Small-Molecule Drug Product (Solid/Oral/Parenteral) CDMO (HLAGABAB)

akta.pro secondary industries

Biologics (mAbs/Recombinant Proteins) CDMO (HLAGABAC), Contract Development & Manufacturing for Generics (CDMO/CMO) (HLAIABAI), Clinical Trial Material (CTM) Manufacturing & Supply CDMO (HLAGABAK), Drug Substance–Drug Product Integrated CDMO (HLAGABAG)

Keywords

• Sterile injectable manufacturing
• Rheumatology pharmaceuticals
• Oncology injectable drugs
• CDMO injectable services
• Hematology pharmaceuticals

Headquarters

HQ city

Wedel

HQ country

Germany

HQ region

Europe

Offices16 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Operations, Personnel, Marketing or Sales, Technology or R&D, Supply Chain, Infrastructure

Revenue model

1. Pharmaceutical Product Sales: Revenue from sales of proprietary and generic pharmaceutical products across four therapeutic areas: Rheumatology, Urology, Hematology, and Oncology. Products distributed globally to hospitals, clinics, and pharmacies.
2. CDMO Contract Manufacturing: Contract development and manufacturing services for injectables for third-party pharmaceutical clients. Services include commercial solutions, clinical solutions, development, technology transfer, regulatory support, and packaging/storage.

Go-to-market motion3 records

Distribution channels4 records

Marketing channels6 records

Core offering

Medac Group develops, manufactures, and distributes pharmaceutical products with focus on four therapeutic areas: rheumatology, urology, hematology, and oncology. The portfolio spans 34+ sterile injectable products (including methotrexate autoinjectors, Treosulfan/Trecondi for HSCT conditioning, BCG immunotherapy for non-muscle invasive bladder cancer, and a broad range of cytostatic agents) manufactured in Germany and the Czech Republic and distributed across more than 90 countries. The company additionally operates a Contract Development and Manufacturing Organization (CDMO) segment providing injectable development, manufacturing, technology transfer, and regulatory support services to third-party pharmaceutical clients.

Product overview

Medac Group is a privately-owned pharmaceutical company founded in Germany in 1970, specializing in the development, manufacturing, and distribution of pharmaceutical products and diagnostics. The company's core portfolio spans four therapeutic areas: Rheumatology (including metoject/metex PEN, Leflunomide medac, Methotrexate formulations), Urology (BCG-medac), Hematology (Trecondi/Treosulfan, Hydroxyurea medac), and Oncology (including 5-FU medac, Bendamustin medac, Carmustine medac, Irinotecan medac, and numerous other cytostatic agents). The company also operates a Contract Development and Manufacturing Organization (CDMO) segment offering injectable manufacturing services including commercial bulk manufacturing, clinical supply, development, technology transfer, regulatory support, analytical capabilities, and packaging. Products are manufactured in Germany and Europe with distribution to over 90 countries worldwide.

Differentiator

Problem solved

Functional benefit

Brands

• medac CDMO: Contract Development and Manufacturing Organization offering services from clinical supply to large-scale commercial manufacturing of injectables, including aseptic filling, lyophilisation, and high potent API handling.
• metoject/metex PEN
• BCG-medac
• Trecondi

Products and services

• 5-FU medac 5-Fluorouracil is a pyrimidine analogue antimetabolite that disrupts cell division and metabolism by incorporating into DNA/RNA, leading to apoptosis. Used for various cancer treatments including colorectal, breast, and head/neck cancers.
• Abiraterone medac Abiraterone acetate selectively inhibits the CYP17 enzyme required for androgen biosynthesis, reducing serum testosterone levels. Used for metastatic hormone-sensitive and castration-resistant prostate cancer.
• Arsenic trioxide medac Arsenic trioxide induces morphological changes and DNA fragmentation characteristic of apoptosis in promyelocytic leukemia cells. Used for newly diagnosed and relapsed/refractory acute promyelocytic leukemia (APL) in combination with tretinoin or ATRA.
• BCG-medac BCG-medac is an intravesical immunotherapy for non-muscle invasive bladder cancer (NMIBC) that triggers local immune activation to recognize and fight tumor cells. Contains 2×10^8 to 3×10^9 viable units of Bacillus Calmette-Guérin.
• Bendamustin medac Bendamustine hydrochloride is an alkylating agent that cross-links DNA strands and impairs DNA synthesis and repair. Used for chronic lymphocytic leukemia, indolent non-Hodgkin's lymphoma, and multiple myeloma.
• Bleomedac Bleomycin sulfate is a glycopeptide antibiotic that causes DNA strand breaks in cancer cells. Used for squamous cell carcinomas, Hodgkin's and non-Hodgkin's lymphoma, testicular carcinoma, and malignant pleural effusion.
• Bortezomib medac Bortezomib is a reversible proteasome inhibitor that prevents ubiquitin-bound protein degradation, causing cancer cell death. Used for progressive multiple myeloma and mantle cell lymphoma as monotherapy or combination therapy.
• Capecitabine medac Capecitabine is an orally administered prodrug of 5-fluorouracil that converts preferentially in tumor tissue. Used for adjuvant colon cancer treatment, metastatic colorectal cancer, advanced gastric cancer, and breast cancer.
• Carbomedac Carboplatin is a platinum derivative that cross-links DNA strands through platinization, impairing transcription and replication. Used for advanced ovarian cancer and small cell lung carcinoma.
• Carmustine medac Carmustine (BCNU) is a nitrosourea alkylating agent that crosses the blood-brain barrier. Used for brain tumors, lymphomas, gastrointestinal tumors, melanoma, and as conditioning treatment prior to hematopoietic stem cell transplantation.
• Dacarbazine medac Dacarbazine is an alkylating agent that causes DNA strand breaks and inhibits nucleic acid and protein synthesis. Used for metastasized malignant melanoma, advanced Hodgkin's disease, and soft tissue sarcomas.
• Doxorubicin medac Doxorubicin is a cytotoxic anthracycline antibiotic that causes DNA strand breaks through intercalation and topoisomerase II inhibition. Used for SCLC, ovarian carcinoma, bladder carcinoma, osteosarcoma, soft tissue sarcoma, Hodgkin's disease, various leukemias, and multiple myeloma.
• Gliolan Gliolan (5-aminolevulinic acid hydrochloride/5-ALA HCl) is a prodrug used in fluorescence-guided tumor resection. Metabolized to protoporphyrin IX which emits red-violet fluorescence under blue light, enabling visualization of malignant glioma tissue during neurosurgery.
• Hydroxyurea medac Hydroxycarbamide inhibits ribonucleotide reductase, disrupting DNA synthesis and cell division. Used for chronic myeloid leukemia, essential thrombocythaemia, and polycythaemia vera with high thromboembolic risk.
• Irinotecan medac Irinotecan is a camptothecin derivative that inhibits topoisomerase I, causing DNA single-strand breaks. Used for advanced colorectal cancer in combination with 5-FU/folinic acid, and with cetuximab for KRAS wild-type metastatic colorectal cancer.
• Leflunomide medac Leflunomide inhibits dihydroorotate dehydrogenase (DHODH), reducing lymphocyte proliferation and inflammation. Used as a disease-modifying antirheumatic drug (DMARD) for active rheumatoid arthritis and psoriatic arthritis.
• Levofolinic acid (Oncofolic) Levofolinic acid is the active l-isomer of folinic acid used as an antidote for methotrexate toxicity and combined with 5-fluorouracil in colorectal cancer therapy. Bypasses DHFR blockage to provide reduced folate coenzymes.
• Lomustine medac Lomustine is a nitrosourea that penetrates the blood-brain barrier and alkylates DNA guanine. Used for brain tumors, small cell lung cancer, Hodgkin's disease, melanoma, and as standard of care in WHO grade II-III gliomas with IDH mutation.
• Methotrexate 15 solution for injection medac Methotrexate is a folic acid antagonist inhibiting dihydrofolate reductase, disrupting DNA synthesis. Used in low/medium doses for trophoblastic tumors, breast cancer, head/neck cancer, lymphomas, and ALL; high doses for osteosarcoma.
• Methotrexate 25 mg/ml and 100 mg/ml solution for injection High-dose methotrexate for injection with antimetabolite and immunosuppressive effects. Used for various leukemias, lymphomas, head/neck cancer, breast cancer, choriocarcinoma, osteosarcoma, and bladder cancer. Also used intrathecally for meningeal leukemia prophylaxis/treatment.
• metoject/metex PEN Methotrexate-filled autoinjector for subcutaneous administration. Since 2013, the worldwide first methotrexate-filled autoinjector making RA treatment easier for patients in Germany and Europe.
• Trecondi (Treosulfan) Treosulfan is the only product approved since 2019 as conditioning therapy in combination with Fludarabine prior to allogeneic HSCT in adult and pediatric patients older than one month with malignant and non-malignant diseases. Manufactured by medac subsidiary Oncotec Pharma Production GmbH.
• medac CDMO Services Contract Development and Manufacturing Organization (CDMO) services providing tailored injectable solutions from clinical supply to large-scale commercial manufacturing. Services include commercial solutions, clinical solutions, development, technology transfer, global regulatory support, analytical capabilities and stability, and packaging and storage.

Quantifiable outcome

• 32% of U.S. transplant centers ordering GRAFAPEX with 77% reorder rate
• +2 more outcomes

Named customers2 records

Segments6 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Four partnerships are on record, tiered core and minor.

• Biotech PharmacoreStrategic or Co-development Partner · 14 October 2025Acquisition of Dubai-based Biotech Pharma, marking medac's establishment of its own entity (medac pharma LLC) in the Middle East, Africa, and Turkey region. The experienced Biotech Pharma team will manage and operate the new entity, combining local expertise with medac's international standards to expand impact and improve patient care in the MEA region.
• Clinigen GroupcoreChannel Partner/ Reseller/ Distributor · 16 June 2025medac and Clinigen expanded their existing cooperation with an exclusive marketing and distribution agreement for six key drugs produced by medac in oncology, hematology and immune-mediated diseases. Clinigen has exclusive rights to distribute these products in Australia, parts of Southeast Asia and China (APAC region). The partnership leverages Clinigen's established global distribution network, regional regulatory expertise, and market access strategies to accelerate patient access in these dynamic and growing markets.
• MedscapeminorGTM or Marketing Partner · 12 June 2025Medac provided an independent educational grant to Medscape for the production and release of an on-demand symposium recording on HSCT conditioning regimens for AML/MDS. The symposium was presented at the EBMT 2025 Annual Meeting and attracted around 500 physicians onsite. Medscape organized and accredited the educational content.
• Hyphens PharmaminorChannel Partner/ Reseller/ DistributorDistribution partnership for one of medac's key autoimmune products in Southeast Asia markets. This partnership complements the broader Clinigen agreement for the APAC region.

Scale indicators5 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Hikma Pharmaceuticals: Jordan-headquartered specialty and injectable generics pharmaceutical company with comparable portfolio in oncology injectables and hospital-focused specialty products. Both operate CDMO-adjacent injectable manufacturing capabilities and compete in similar hospital procurement channels across Europe and MEA.
• Stada Arzneimittel: German-headquartered specialty and generics pharmaceutical company with a similar product portfolio across multiple therapeutic areas and strong European manufacturing footprint. Both companies target the same hospital and specialty pharmacy channels with mature molecules in oncology, rheumatology, and adjacent indications.
• Recipharm: European-headquartered CDMO offering sterile injectable manufacturing, fill-finish services, and pharmaceutical development across multiple dosage forms. Directly comparable to medac's CDMO division serving third-party pharma clients with injectable contract manufacturing.
• Aspen Pharmacare: South African-headquartered specialty and generics pharmaceutical group with significant oncology and injectable manufacturing operations. Comparable focus on hospital-channel specialty generics across emerging markets including MEA, where medac recently entered via Biotech Pharma acquisition.
• Almirall: Spanish specialty pharmaceutical company with dermatology and rheumatology focus and European commercial footprint. Comparable business model targeting specialty prescribers with branded formulations of mature molecules across European markets.
• Aenova Group: German-headquartered CDMO with capabilities in sterile injectables, solid dosage forms, and contract development services for pharmaceutical clients. Closely comparable to medac CDMO on injectable contract manufacturing services in the European market.
• Recordati: Italian specialty pharmaceutical company with established presence in oncology, rheumatology, and rare disease therapeutic areas across Europe and global markets. Similar business model combining proprietary specialty products with manufacturing scale in Europe.

Broad incumbents

• Aurobindo Pharma: Indian-headquartered global pharmaceutical manufacturer with extensive generic injectables and oncology portfolio. Competes with medac in hospital-channel generics across Europe and global markets, often on price-led positioning.
• Teva Pharmaceutical Industries: Global pharmaceutical company with one of the largest specialty and generics portfolios including oncology and injectable products. Overlaps with medac on multiple generic molecules while operating at significantly larger scale across global markets.
• Sandoz (Novartis): Global generics and biosimilars leader spun out from Novartis, with broad portfolio including oncology injectables and hospital specialty generics. Much larger scale than medac but competes directly on the same oncology generic molecules across global markets.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xtwitter.com/medac_gmbh
• LinkedInlinkedin.com/company/medac-gmbh

Revenue estimate

Valuation estimate

Number of profiles

Profiles10 records

Subsidiaries5 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Medac Group