Why ROTOP?
We support your radiopharmaeutical journey with:
What we do
We provide end-to-end CDMO services for radiopharmaceuticals — from early-stage development to commercial supply — all under one roof.
Our Services
Radiopharmaceutical Development
cGMP Manufacturing
Quality Assurance
Quality Control
Packaging & Labeling
Qualified Person Services
Regulatory Affairs
Medical Affairs
Global Distribution
Our facilities and capabilities
Our facilities are purpose-built for radiopharmaceutical development and manufacturing, offering:
- ■ Hot cells: Safe handling of alpha, beta and gamma emitters
- ■ Cleanrooms: Modular GMP suites for clinical and commercial batches
- ■ QC Labs: Radiochemical, microbiological and method validation
- ■ Precursor labs: Custom synthesis and scale-up optimization
- ■ Non-GMP areas: Early feasibility and process development
19,000
sqft lab & clean room space
5,000
vials per batch possible
10+
CDMO projects successfully completed
CDMO Services in focus
Hot Cell Manufacturing
GMP Manufacturing
Precursor Laboratories
-
- ■ Clinical & commercial batch manufacturing
- ■ Multiple isotope support (e.g. Ac-225, Cu-64, Ga-68, I-123, Lu-177, Pb-212)
- ■ I-123 Iodide solution supply for radioactive compound development
- ■ Just-in-time global logistics
- ■ Early market access of clinical products under special national programs
-
-
- ■ Formulation & lyo cycle development
- ■ Radiolabeling and QC method validation
-
- ■ Transfer to GMP suite for clinical manufacturing
- ■ In-process control definition (e.g. CCIT)
- ■
- ■ 100% visual inspection and GDP stability testing
-
- ■ Synthesis of peptides and small molecules
- ■ GMP Manufacturing and aliquotation services
- ■ Process optimization using Quality by Design (QbD) principles
- ■ Stability studies and scale-up support
Hot Cell Manufacturing
-
- ■ Clinical & commercial batch manufacturing
- ■ Multiple isotope support (e.g. Ac-225, Cu-64, Ga-68, I-123, Lu-177, Pb-212)
- ■ I-123 Iodide solution supply for radioactive compound development
- ■ Just-in-time global logistics
- ■ Early market access of clinical products under special national programs
GMP Manufacturing
-
-
- ■ Formulation & lyo cycle development
- ■ Radiolabeling and QC method validation
-
- ■ Transfer to GMP suite for clinical manufacturing
- ■ In-process control definition (e.g. CCIT)
- ■
- ■ 100% visual inspection and GDP stability testing
-
Precursor Laboratories
- ■ Synthesis of peptides and small molecules
- ■ GMP Manufacturing and aliquotation services
- ■ Process optimization using Quality by Design (QbD) principles
- ■ Stability studies and scale-up support
Strategic Location
Headquartered in Dresden, Germany, with reliable worldwide logistics via Berlin and Prague International Airports and Leipzig DHL Hub (3rd largest hub in Europe) for temperature-sensitive, just-in-time shipments.
Sie sehen gerade einen Platzhalterinhalt von Google Maps. Um auf den eigentlichen Inhalt zuzugreifen, klicken Sie auf die Schaltfläche unten. Bitte beachten Sie, dass dabei Daten an Drittanbieter weitergegeben werden.
Mehr InformationenOur Team
At ROTOP, people drive innovation. Our multidisciplinary CDMO team blends radiopharmaceutical expertise, regulatory insight and global development experience.
Meet the leadership:
- Dr. Thomas Gottlieb – Chief Business Officer
- Andrew Varghese – President, ROTOP US & CDMO Services
- Dr. Tanmaya Joshi – Executive VP (CDMO)
Together they bring decades of experience in theranostics, CDMO strategy and global pharma leadership – ensuring that your project is in expert hands.
We're more than a manufacturer – we're your development partner. From concept to commercialization, we're here to accelerate your success.
We believe in long-term, transparent collaboration built on trust and shared goals. With every CDMO project, we aim to drive sustainable innovation that advances patient care and creates lasting value — for you, and for those who depend on your therapies.
Let’s collaborate
