What ROTOP does

ROTOP Pharmaka GmbH is a privately held German pharmaceutical company headquartered in Dresden-Rossendorf that manufactures radiopharmaceutical diagnostics and therapy products for nuclear medicine. The company develops and produces under GMP standards and international certification a portfolio that includes SPECT products (RoTecPSMA, Tetrofosmin, MAG-3, DMSA, NanoHSA-ROTOP/NANOTOP, Ioflupan I-123), PET products (NaFRos F-18 Fluoride, DopaRos F-18 DOPA, FDG), the GalliAd 68Ge/68Ga generator, and cold kits and ready-to-use patient doses for radioligand therapy. Its customer base is primarily composed of nuclear medicine practices and clinics across Germany with selected international exports, served via a direct B2B sales motion through phone, fax, email, and written orders.

ROTOP generates revenue through two streams: sale of branded radiopharmaceutical products to medical practices and clinics, and CDMO services covering precursor synthesis, API synthesis, theranostic and cold kit development, process scaling, cGMP manufacturing of clinical and commercial batches, quality control, stability testing, QP services, and regulatory support for EU, USA, and worldwide markets, plus global logistics for radioactive products. The company originated from the Zentralinstitut für Kernforschung Rossendorf, now HZDR, providing inherited nuclear research expertise. In January 2025, ROTOP secured a private equity investment from SHS Capital and Genui and became the anchor company of the nukliD Radiopharmacy Cluster Dresden. It received a building permit in April 2026 for the ROTOP CMO Center, a new production facility intended to materially expand capacity and reinforce its European radiopharmaceutical position. Jens Junker serves as Managing Director.

Name

ROTOP

Legal name

ROTOP Pharmaka GmbH

Website

https://rotop-pharmaka.de

Company type

Private

Founded year

2000

Operating status

Operating

Headcount range

101–250 employees

Short description

ROTOP Pharmaka GmbH is a GMP-certified German manufacturer of radiopharmaceutical diagnostics and therapy products for nuclear medicine practices, clinics, and pharmaceutical CDMO customers, with roots in the Dresden-Rossendorf nuclear research institute.

Ownership category

akta.pro rank

Product category

Radiopharmaceutical Manufacturing

NAICS

Pharmaceutical Preparation Manufacturing (325412), Pharmaceutical and Medicine Manufacturing (3254), Scientific Research and Development Services (5417), Drugs and Druggists' Sundries Merchant Wholesalers (424210)

SIC

Pharmaceutical Preparations (2834), Wholesale-Drugs, Proprietaries & Druggists' Sundries (5122), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Radiopharmaceutical CDMO & Manufacturing (GMP Fill-Finish) (HLAIAGAF)

akta.pro secondary industries

Radiopharmaceutical Manufacturing & CDMO (Synthesis, GMP, Packaging, QA/QC) (EUAKAIAC), Clinical Trial Material (CTM) Manufacturing & Supply CDMO (HLAGABAK), Small-Molecule API & Intermediates CDMO (HLAGABAA)

Keywords

• Radiopharmaceutical manufacturing
• Nuclear medicine diagnostics
• CDMO services
• PET imaging agents
• Radioligand therapy

Headquarters

HQ city

Dresden

HQ country

Germany

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Radiopharmaceutical Product Sales: Sale of SPECT and PET radiopharmaceutical products and cold kits to medical practices and clinics. Products include RoTecPSMA, Tetrofosmin, NaFRos, DopaRos, and other nuclear medicine diagnostic agents. Delivery of non-radioactive products typically next day for orders before 12:00, radioactive products by arrangement.
2. CDMO Contract Manufacturing Services: Contract development and manufacturing services for radiopharmaceuticals, including precursor synthesis, API synthesis, theranostic development, process scaling, cGMP manufacturing, quality control, regulatory support, and global logistics for pharmaceutical companies and research partners.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels3 records

Core offering

ROTOP Pharmaka GmbH develops and manufactures radiopharmaceuticals for nuclear medicine diagnostics (SPECT and PET imaging agents) and therapy under GMP standards. Its portfolio includes cold kits (e.g., Tetrofosmin, MAG-3, DMSA, NanoHSA), ready-to-use PET and SPECT patient doses (RoTecPSMA, NaFRos, DopaRos), and radioligand therapy doses. The company also provides CDMO services covering precursor/API synthesis, theranostic and cold kit development, process scaling, cGMP manufacturing, quality control, regulatory support, QP services, and global logistics for pharmaceutical companies and research partners.

Differentiator

Problem solved

Functional benefit

Brands

• DopaRos®: DopaRos® Injektionslösung [18F]DOPA - PET diagnostic product for neuroimaging applications
• RoTecPSMA®
• NaFRos®
• GalliAd®
• Tetrofosmin ROTOP
• NanoHSA-ROTOP/NANOTOP
• ROTOP-MAG-3
• ROTOP-DMSA
• ROTOP-Adenosin

Products and services

• RoTecPSMA® SPECT radiopharmaceutical product for prostate cancer diagnostics. For nuclear medicine practices and clinics.
• Tetrofosmin ROTOP Cold kit for radioactive pharmaceutical for cardiac imaging, labeled with Tc-99m. For nuclear medicine practices and clinics.
• NaFRos® Injektionslösung [18F]Fluorid NaFRos® ready-to-use PET diagnostic injection solution containing [18F]Fluoride. For nuclear medicine practices and clinics.
• DopaRos® Injektionslösung [18F]DOPA DopaRos® PET diagnostic injection solution containing [18F]DOPA for neuroimaging applications. For nuclear medicine practices and clinics.
• ROTOP-Adenosin ROTOP-Adenosin pharmaceutical solution used in cardiac stress testing. For nuclear medicine practices and clinics.
• Ioflupan (I-123) ROTOP Ioflupan (I-123) ROTOP SPECT radiopharmaceutical product, available to order from ROTOP's production site in Dresden-Rossendorf. For nuclear medicine practices and clinics.
• NanoHSA-ROTOP / NANOTOP Cold kit for radioactive pharmaceutical used in imaging with Tc-99m. For nuclear medicine practices and clinics.
• ROTOP-MAG-3 Cold kit for radioactive pharmaceutical used in renal imaging with Tc-99m. For nuclear medicine practices and clinics.
• ROTOP-DMSA Cold kit for radioactive pharmaceutical used in tumor and renal imaging with Tc-99m. For nuclear medicine practices and clinics.
• GalliAd® 68Ge/68Ga Radionuclide Generator 68Ge/68Ga radionuclide generator used as a source of Gallium-68 for theranostic radiolabeling. For nuclear medicine practices and clinics.
• CDMO Services Contract Development and Manufacturing Organization (CDMO) services covering the full radiopharmaceutical lifecycle: precursor and API synthesis, theranostic and cold kit development, process scaling, cGMP manufacturing for clinical trial materials and commercial products, quality control, stability testing, regulatory support (EU, USA, worldwide), QP services, and global logistics. For pharmaceutical companies and research partners.

Quantifiable outcome

• Building permit received for new radiopharmaceutical production facility

Named customers1 record

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature2 records

Partnerships

Two partnerships are on record, tiered core.

• nukliD Radiopharmacy Cluster DresdencoreStrategic or Co-development Partner · 16 January 2025ROTOP Pharmaka serves as the anchor company of the nukliD Radiopharmacy Cluster Dresden, officially founded on January 16, 2025. The cluster combines research institutions (HZDR), industry partners, and contract manufacturers to advance theranostics using radioactive isotopes for targeted tumor diagnosis and treatment.
• HZDR (Helmholtz-Zentrum Dresden-Rossendorf)coreStrategic or Co-development PartnerHZDR is the research institution that ROTOP originated from (Zentralinstitut für Kernforschung Rossendorf). It is a key research partner in the nukliD Radiopharmacy Cluster, contributing to theranostics research and development.

Scale indicators3 records

Recent moves8 records

Expansion highlights6 records

Direct peers

• Curium Pharma: One of the largest global radiopharmaceutical manufacturers, producing SPECT and PET diagnostics and offering CDMO services. Directly comparable to ROTOP across product portfolio, customer base (nuclear medicine practices), and GMP manufacturing model.
• Eckert & Ziegler: Berlin-based radiopharmaceutical and isotope technology group with CDMO services for radiopharmaceuticals, comparable to ROTOP's GMP manufacturing and CDMO stack, particularly for SPECT/PET isotopes and contract manufacturing.
• ITM Isotope Technologies Munich: Munich-based radiopharmaceutical company developing targeted radionuclide therapies and offering manufacturing capabilities. Comparable as a European-focused radiopharma peer with CDMO and proprietary therapeutic assets.
• Lantheus Holdings: US-listed radiopharmaceutical company with a portfolio of SPECT, PET, and radioligand therapy products (e.g., PNT2002, Pylarify). Comparable in target market and product category to ROTOP, though at substantially greater scale.

Broad incumbents

• GE HealthCare: Global incumbent with a major radiopharma segment (including PETNET Solutions) producing PET/SPECT tracers. Overlaps with ROTOP in nuclear medicine diagnostics but operates a much broader imaging and equipment portfolio.
• Bayer (Radiology / Radiopharmaceuticals): Bayer operates a radiopharmaceuticals franchise including Xofigo (Ra-223) and is investing in targeted radionuclide therapies. Comparable therapeutic/clinical overlap with ROTOP's therapy products, though within a much larger pharma portfolio.
• Bracco Imaging: Italian-headquartered imaging diagnostics company with contrast agents and growing radiopharmaceutical exposure. Comparable in nuclear medicine diagnostics and European footprint, broader imaging portfolio than ROTOP.
• Siemens Healthineers (PETNET Solutions): Through PETNET Solutions, operates a global network of PET radiopharmaceutical manufacturing sites. Directly comparable to ROTOP's PET production activities, scaled through Siemens' broader imaging and diagnostics business.
• Norgine / AAA (Advanced Accelerator Applications, a Novartis company): AAA, owned by Novartis, is a leader in radioligand therapy (Lutathera, Pluvicto) and PET diagnostics. Comparable in nuclear medicine manufacturing and theranostic positioning, though substantially larger and vertically integrated with Novartis.

Emerging players

• Telix Pharmaceuticals: Commercial-stage radiopharmaceutical company focused on PSMA-targeted imaging and therapy (Illuccix). Comparable theranostic and PSMA positioning to ROTOP's RoTecPSMA, though Telix is more commercially advanced and US-listed.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/rotop-pharmaka-gmbh

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds1 record

Investors2 records

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 ROTOP