Medac DMF, CEP, Written Confirmations, FDF, Prices, Patents, Patents & Exclusivities, Dossier, Manufacturer, Licensing, Distributer, Suppliers, News, GMP

medac CDMO Supports UGN-103 Ph3 UTOPIA Trial for LG-IR-NMIBC

21 Jul 2025

// PRESS RELEASE

A New Chapter for medac CDMO: One Brand, One Vision

14 Jul 2025

// PRESS RELEASE

Medac Unveils New Methotrexate Data For Arthritis At EULAR 2025

30 Jun 2025

// PRESS RELEASE

DATA COMPILATION
#PharmaFlow

Contact Supplier

Website

CPhI WW Frankfurt

Booth #5.0B92

Book a meeting

envelop Contact Supplier

DIGITAL CONTENT

2 Corporate Content #SupplierSpotlight, 1 Data Compilation #PharmaFlow, 14 News #PharmaBuzz

media
2 Corporate Content #SupplierSpotlight
1 Data Compilation #PharmaFlow
14 News #PharmaBuzz

DEVELOPMENTS

32 Drugs in Development

32 Drugs in Development

FINISHED DOSAGE FORMULATIONS

170 FDF Dossiers, 170 Europe

170 FDF Dossiers
170 Europe

SERVICES

API & Drug Product Development, Drug Product Manufacturing

pharmaServices
API & Drug Product Development
- 2 Formulation Development
Drug Product Manufacturing
- 4 Injectable / Parenteral

KEY SERVICES

Contract Manufacturing of Injectables, Clinical Supply of Injectables, Highly Potent Injectables, CDMO for Pre-Filled Syringes, CDMO for Injectables

Contract Manufacturing of Injectables
Clinical Supply of Injectables
Highly Potent Injectables
CDMO for Pre-Filled Syringes
CDMO for Injectables

INSPECTIONS & REGISTRATIONS

2 FDA, 4 EDQM

inspections
2 FDA
4 EDQM

medac CDMO: Tailored CDMO services for injectables in syringes, cartridges & vials – aseptic, reliable, flexible and a solution ahead.

About

At medac CDMO, we offer tailored fill & finish services for sterile injectables in pre-filled syringes and cartridges and liquid and lyophilized drugs in vials. We are specialized in complex formulations including biologics and ADCs with over 25 years of aseptic expertise. From clinical to commercial scale, our two European sites deliver flexibility and speed. Our unwavering commitment to foresight, progress, reliability and creative solution thinking makes us - a solution ahead.

CPhI WW FrankfurtCPhI WW Frankfurt

Industry Trade Show

Booth #5.0B92

28-30 October, 2025

Frankfurt
World ADC USAWorld ADC USA

Industry Trade Show

Attending

03-06 November, 2025

San Diego
AusBiotechAusBiotech

Industry Trade Show

Not Confirmed

21-24 October, 2025

Melbourne Convention & Exhibition Centre

CONTACT DETAILS

Click the arrow to open the dropdown

Country

Germany

Address

Theaterstraße 6 22880 Wedel

Telephone

+49 0410380060

CDMO@medac.de

Website

https://www.medac-cdmo.com/

https://www.linkedin.com/company/medac-cdmo/

YouTube

https://www.youtube.com/@medacglobal7218

Digital content

Explore the latest content creation from this company

CORPORATE CONTENT #SupplierSpotlight

GMP Certificate 2024

CDMO Service Book

DATA COMPILATION #PharmaFlow

CDMO Activity Tracker: Veranova, ChemExpress invest in ADC facilities; Cohance to set up oligonucleotide facility in India

The contract development and manufacturing organization (CDMO) sector has emerged as a key partner in new drug development. This was evident from the strategic investments, partnerships, and expansions witnessed in the third quarter (Q3) of 2025. Several CDMOs, such as Cohance Lifesciences, Fermion Oy, Axplora, AGC Pharma Chemicals invested in new projects. Others, including Veranova, Aenova, and Biosynth, expanded capacities, while Ofichem strengthened its footprint with the acquisition of Avivia BV. CDMOs like Fareva, Evonik, and Samsung Biologics forged strategic partnerships for growth. During Q3, the sector continued to adopt artificial intelligence (AI). This prompted the US Food and Drug Administration (FDA) to issue guidance that recognizes the increasing use of AI and data analytics in drug development. View CDMO Activity Tracker for Q3 2025 (Free Excel Available) Cohance, Veranova invest in bioconjugation suites in US; ChemExpress inks ADC deal Earlier this year, Indian drugmaker Suven Pharmaceuticals Limited merged with leading CDMO Cohance Lifesciences Limited. The merged entity — Cohance Lifesciences — has invested US$ 10 million in a current Good Manufacturing Practice (cGMP) bioconjugation suite at its subsidiary NJ Bio in Princeton, New Jersey. NJ Bio is executing a major program for an existing innovator client with multiple antibody-drug conjugate (ADC) candidates. Cohance also announced an INR 230 million (approximately US$ 2.58 million) investment in a cGMP oligonucleotide facility at its Hyderabad (India) site. Veranova’s Devens (Massachusetts) site successfully passed a routine FDA cGMP surveillance inspection with a “No Action Indicated” (NAI) classification. Earlier, the company had initiated a US$ 50 million investment to expand its ADC and bioconjugate capabilities at its Devens site. This includes a 9,000-square-foot facility expansion with a new process development lab, two additional cGMP suites, and state-of-the-art bioconjugation development and manufacturing capabilities. These initiatives strengthen the site’s highly potent API (HPAPI) and ADC development and manufacturing capabilities. Biosynth has expanded its Berlin facility with a new GMP bioconjugation suite. The expansion supports the company’s manufacturing capabilities in conjugate vaccines, conjugate drugs, activated polyethylene glycol (PEGs), and polymer-based drug delivery excipients. ChemExpress, Mabwell Bioscience, and Insilico Medicine have entered into a strategic partnership to jointly develop a large ADC compound library and advance next-generation ADC candidates. The collaboration combines Mabwell’s antibody and ADC technology, Insilico’s AI-powered drug design platform, and ChemExpress’s expertise in linker-payload chemistry. Together, they aim to build a complete, AI-driven ADC development model that accelerates discovery, optimization, and commercialization. This partnership is expected to enhance R&D efficiency and deliver safer, more effective cancer treatments. View CDMO Activity Tracker for Q3 2025 (Free Excel Available) Fermion, Axplora, Aenova increase API manufacturing capacities; ICE Pharma expands India facility Finnish CDMO Fermion Oy has launched a renovation project at its Hanko (Finland) production site to modernize its API manufacturing capabilities. This expansion is part of Fermion's broader strategy to increase production, enhance flexibility in the manufacturing of both existing and future pharmaceutical products, and enable potential contract manufacturing opportunities. German CDMO Axplora has announced a €6.5 million (approximately US$ 7.5 million) investment to expand its API manufacturing capacity at its Vizag site in India. This expansion aims to strengthen both production capabilities and supply chain resilience. India-based Aarti Pharmalabs has inaugurated the first phase of its greenfield manufacturing facility in Gujarat (India). This expansion aims to bolster Aarti's CDMO and contract manufacturing organization (CMO) services, targeting a revenue goal of INR 10 billion (approximately US$ 112 million). Snapdragon Chemistry, which was acquired by Cambrex in 2023, has expanded its Massachusetts facility to better support peptide drug development and manufacturing. With this upgrade, the company can now handle peptide projects from early development through full-scale manufacturing. Italy-headquartered ICE Pharma has expanded its Raichem facility in India. The new facility will enhance the production of ursodeoxycholic acid (UDCA), an API it derives from chicken bile. This expansion increases the site’s raw UDCA output by 120 metric tons annually. Spain-headquartered AGC Pharma Chemicals inaugurated a new advanced manufacturing plant in Barcelona, with an investment of €110 million (approximately US$ 128.3 million). The plant spans 7,500 square meters and integrates cutting-edge technologies to support the entire drug development lifecycle — from R&D to commercial manufacturing. This represents a 30 percent increase in the company’s production capacity and introduces a segment dedicated to HPAPIs. Germany-headquartered Aenova has launched a new hot melt extrusion platform at its Regensburg (Germany) site. This new equipment enables the production of advanced drug formulations, while handling all testing and quality checks in-house. The move strengthens Aenova’s capabilities in developing and manufacturing complex medications. US-based Cytovance Biologics has introduced in-house formulation development services, enhancing its role as a comprehensive partner for biologic drug developers. These services utilize quality-by-design principles to ensure speed, safety, and precision in current and future client programs. View CDMO Activity Tracker for Q3 2025 (Free Excel Available) Ofichem acquires Avivia BV; Evonik, Samsung Biologics form strategic collaborations Europe-based CDMO Ofichem Group announced the acquisition of Avivia BV, a formulation development company in the Netherlands. This acquisition is part of Ofichem’s strategy to become a fully integrated provider of development solutions across both drug substance and drug product, with a focus on complex formulations. Ofichem has also acquired Meribel Pharma Solutions’ site in Uppsala (Sweden) to strengthen its support for biotech innovators and expand its presence in the Nordic region. Simtra BioPharma Solutions has acquired a 65-acre property near its Bloomington, Indiana (US) facility, adding over 300,000 square feet of potential expansion space. With this site, Simtra now has the flexibility to rapidly expand in the US. German specialty chemicals company Evonik is partnering with German biotech Ethris to develop and commercialize a next-generation lipid nanoparticle (LNP) platform for delivering nucleic acid therapies. Evonik will assist in formulation using Ethris’ SNaP LNP technology. The LNP market alone is projected to grow to US$2.3 billion by 2032. Luxembourg-headquartered Fareva has partnered with Zhaoke Ophthalmology to expand its footprint in China’s pharma market. Zhaoke will act as Fareva’s go-to partner for customers seeking pharmaceutical manufacturing in China. Samsung Biologics has signed a 1.8 trillion won (US$ 1.3 billion) manufacturing agreement with an undisclosed US-based drugmaker. And UK-based eXmoor Pharma has partnered with Anthony Nolan to provide end-to-end services for cell therapy developers. View CDMO Activity Tracker for Q3 2025 (Free Excel Available) Our view The global CDMO market, valued at around US$ 255 billion in 2025, is projected to grow to over US$ 465 billion by 2032. Significantly, about 60 percent of new drug approvals in the US and over 65 percent in Europe now involve CDMO support. The developments outlined above underscore the increasing role CDMOs are playing today in bringing about growth and innovation in the pharmaceutical industry.