Name

CUP Contract Labs

Legal name

CUP Laboratorien Dr. Freitag GmbH

Website

https://cup-contract-labs.com

Company type

Private

Founded year

2008

Operating status

Operating

Headcount range

11–50 employees

Ownership category

akta.pro rank

Product category

Pharmaceutical Contract Laboratory Services

NAICS

Scientific Research and Development Services (5417)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Release Testing & Batch Certification (QC) (HLAGADAC)

akta.pro secondary industries

GMP Scale-Up, Tech Transfer & Process Validation (PPQ) (HLAGAHAL), Laboratory Quality & GLP/GCLP Compliance (HLAGAKAK)

Keywords

• Contract laboratory services
• Pharmaceutical analytical testing
• Radiopharmaceutical analysis
• GMP quality control
• Sterility testing services

Headquarters

HQ city

Radeberg

HQ country

Germany

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Analytical Testing Services: Contract laboratory providing GMP-compliant pharmaceutical analysis services including sterility testing, particle analysis, radiolabeling development, extractables/leachables studies, nitrosamine analysis, and stability testing. Revenue generated through service contracts and project-based testing.
2. Method Development and Validation: Product-specific analytical and process validations including sterility testing validation for automated systems. Supports regulatory compliance and dossier submissions across development stages.
3. GMP Quality Control and Release Testing: Quality control services for batch release of sterile products including in-process control and release analysis for radioactive and classical products.

Pricing tiers

Go-to-market motion2 records

Distribution channels1 record

Marketing channels4 records

Core offering

CUP Contract Labs is a contract laboratory providing GMP/FDA-compliant pharmaceutical analytical services from development through quality control and release testing. The company specializes in complex pharmaceuticals including radiopharmaceuticals, biologics, vaccines, high-potency drugs, orphan drugs, and targeted therapeutics, offering sterility testing, radiolabeling development, extractables/leachables studies, nitrosamines analysis, and stability testing under a one-stop-shop model.

Product overview

CUP Contract Labs is a contract laboratory and strategic partner providing comprehensive pharmaceutical analysis services from development through quality control and regulatory approval. Their portfolio includes RADIOSTER (their branded radiopharmaceutical analysis service), sterility testing, radiolabeling development, nitrosamines analysis, extractables and leachables studies, stability testing, and analytical services for biologics, vaccines, radiopharmaceuticals, high potent drugs, targeted therapeutics, orphan drugs, and other complex pharmaceuticals. They operate analytical methods including HPLC, LC-MS/MS, GC/GC-MS, ICP-MS, and Radio-TLC, all performed under GMP/FDA standards. The company offers these services as an integrated one-stop-shop concept, supporting clients from initial analysis through final product release.

Differentiator

Problem solved

Functional benefit

Brands

• RADIOSTER: Specialized radioactive analysis service for radiopharmaceuticals, including microbiology and analytical chemistry services.

Products and services

• RADIOSTER - Radioactive Analysis Specific analysis in the field of microbiology and analytical chemistry for radiopharmaceuticals, including GMP quality control and release testing services, designed for pharmaceutical manufacturers of radioactive products.
• Sterility Testing & Validation for Radiopharmaceuticals Sterility testing using membrane filtration in compliance with Ph. Eur. 2.6.1 and USP <71>, suitable for products with short half-lives and high activity levels under GMP conditions, including sterility testing validation for automated systems such as SteriNow (TRASIS).
• MAT for Radiopharmaceuticals Monocyte Activation Test specifically adapted for radiopharmaceutical products, supporting pyrogen testing under GMP conditions.
• Radiolabeling Development Development of radiolabelling for active substances (small molecules, peptides, antibodies) with analytical control of radiochemical purity (RCP), radiochemical yield (RCY), and potential by-products, including full chemical and microbiological quality control to support GMP-compliant product release.
• Hygiene Monitoring Operational hygiene monitoring services for pharmaceutical manufacturing environments, supporting GMP compliance for cleanroom and production facilities.
• Nitrosamines Analysis Highly sensitive screening and validated quantification of nitrosamines in APIs, formulations, and materials, with methods that support regulatory risk assessments including challenging matrices.
• Dissolution Testing Dissolution testing services for pharmaceutical quality control of solid dosage forms.
• Visible & Subvisible Particles Analysis Determination of visible and sub-visible particles to ensure compliance with particle-related quality requirements and support batch release of sterile products.
• Extractables and Leachables (E&L) Studies Assessment of extractables and leachables from packaging and process contact materials, including impurity profiling and evaluation of potential impact on product safety and stability.
• Stability Testing & Storage Stability studies under defined storage conditions, providing scientific basis for shelf life, storage instructions, and transport conditions under GMP storage requirements.
• Method Development and Validation Services Product-specific analytical and process validations, including sterility testing validation for automated systems such as SteriNow (TRASIS), and tailored method development to support regulatory compliance and dossier submissions across development stages.

Named customers4 records

Segments4 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Six partnerships are on record, tiered core and minor.

• Helmholtz Zentrum Dresden Rossendorf (HZDR)coreStrategic or Co-development PartnerCUP Contract Labs participates in research projects with HZDR including the RUBIN Alliance SNRT project (Saxon Network for Radionuclide Theranostics) and EU-funded UroNec project. HZDR provides cyclotron facilities and develops radiopharmaceutical candidates such as NECT-224 for bladder cancer imaging. CUP serves as industrial partner contributing analytical expertise to bring radiopharmaceutical research to application.
• TRASIScoreTechnology or IntegrationPartnership for automated sterility testing using SteriNow system. CUP performs sterility testing validation for TRASIS automated systems, which supports regulatory compliance for radiopharmaceutical products. Gauthier Philippart, President & CEO of TRASIS, has publicly discussed the collaboration for innovative solutions in nuclear medicine.
• Eckert & Ziegler Radiopharma GmbHcoreStrategic or Co-development PartnerKey customer relationship for radiopharmaceutical analytics. Dr. Michael Pröhl, CDMO Manager, has publicly praised CUP as a reliable partner for radiopharmaceutical analytics. The partnership supports release testing and quality control for Eckert & Ziegler radiopharmaceutical products.
• Telix Pharmaceuticals LimitedcoreStrategic or Co-development PartnerKey customer relationship for radiopharmaceutical analysis services. Caroline Defraiteur, COO EMEA, has identified CUP as her key contract lab for radiopharmaceutical analyses. The partnership involves ongoing analytical testing and quality control services for Telix radiopharmaceutical products.
• GlaxoSmithKline (GSK)coreStrategic or Co-development PartnerQuality control and vaccine analytics partnership. Steffen Schewitzer, Value Creation Implementation Lead at GSK, has praised CUP as a reliable partner for quality control and vaccine analytics, indicating ongoing service relationship for GSK pharmaceutical products.
• LinkedIn Ireland Unlimited CompanyminorGTM or Marketing PartnerLinkedIn platform used for promoting webinars and events. CUP receives aggregated anonymized information about content interactions. LinkedIn processes personal data per their own privacy policy when users interact with CUP content.

Scale indicators2 records

Recent moves5 records

Expansion highlights5 records

Broad incumbents

• Eurofins Scientific: Global leader in testing services with a large pharmaceutical/analytical division that offers release testing, stability, and radiopharmaceutical-adjacent analytical services. Comparable as a major incumbent CRO/lab services competitor against which CUP's specialized radiopharma offering competes for analytical outsourcing spend.
• Piramal Pharma Solutions: CDMO with integrated analytical services including radiolabeling, stability, and release testing. Comparable as a CDMO that bundles analytical services with development and manufacturing, competing for the same radiopharma and complex pharma outsourcing wallet.
• Intertek Pharmaceutical Services: Pharmaceutical services division of Intertek providing GMP analytical testing, stability, extractables/leachables, and method validation. Directly comparable service portfolio overlap with CUP's QC and validation offerings.
• Charles River Laboratories: Large CRO offering pharmaceutical analytics, biologics testing, and quality control services. Directly comparable as a broad incumbent in GMP analytical testing where CUP competes for outsourced pharma QC projects.
• Labcorp Drug Development (Fortrea): Major CRO providing bioanalytical, central lab, and pharmaceutical development services including QC release testing. Comparable broad incumbent competing for outsourced pharma analytical work.
• SGS Life Sciences: Global testing, inspection and certification company with a dedicated Life Sciences division offering GMP analytical services, stability, and release testing for pharma and biologics. Comparable broad incumbent peer in pharma analytical testing.

Direct peers

• Curium Pharma: Global radiopharmaceutical company with manufacturing and analytical capabilities. Comparable as a radiopharma specialist whose QC outsourcing and method-development needs overlap directly with CUP's RADIOSTER service line.
• ITM Isotope Technologies Munich: Radiopharmaceutical developer and manufacturer with in-house and partner analytical capabilities. Comparable as a radiopharma-focused specialist operating in the same therapeutic/diagnostic modality, representing both a potential partner and competitor for CUP's radiopharma QC services.

Emerging players

• Bionova Scientific (part of Asahi Kasei): Specialized analytical and GMP testing services for biologics and complex therapeutics. Comparable emerging specialized peer for biologics/vaccines testing, where CUP also offers services beyond radiopharmaceuticals.
• Sartorius Lab Products & Services: Provides bioprocess and laboratory products/services to pharma and biologics manufacturers, with growing emphasis on integrated analytical and QC solutions. Comparable as a vendor/partner in the GMP analytical ecosystem where CUP operates.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/cup-contract-labs

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 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 CUP Contract Labs