F Fuzkk Atlas of the EU, Switzerland, the United Kingdom and Israel
#111FUZKK selection 101–300

ITM Isotope Technologies Munich

Germany · European Union

RadiopharmaceuticalsFinished dosage forms and small molecules

Manufacturing profile

Country
Germany
Regulatory region
European Union
ISO
DEU

Selection basis

The company is placed in positions 101–300 as a manufacturer, biotechnology company, generics player or CDMO with practical relevance to the FUZKK utility catalog.

The Top 300 is a FUZKK atlas priority rather than a single official revenue table. The mapping does not claim actual use of FUZKK, a specific installed equipment model or a product not confirmed by the public company profile.

Representative manufacturing and QC chain

  1. 1Radionuclide production or generator handling
  2. 2Shielded synthesis and hot-cell operations
  3. 3Sterile filtration and aseptic dispensing
  4. 4Activity, identity and radionuclidic/radiochemical purity
  5. 5Rapid release, sterility/endotoxin evidence and timed distribution
  6. 6Raw-material receipt and identification
  7. 7Dispensing, blending and granulation
  8. 8Tableting, encapsulation or solution preparation
  9. 9Packaging and labelling

Relevant FUZKK packages

Germany: national essential medicines QC packageRPH: combined radiopharmaceutical QC packageRadioligand & Theranostics Expansion QC SuiteGlobal API & Biosimilars QC SuiteLumex QC SuiteLabEx QC Suite

Product/API utilities

Radionuclidic Purity CheckerCold Chain Shipping Temperature And MKT Quality CheckerAssay & Impurities Result Reviewer

Lumex — instrumental QC

System Suitability Parameters Checker

LabEx — laboratory QC

Bacterial Endotoxins LAL Quality CheckerSterility Test Membrane Filtration Quality CheckerParticle Count Injection USP <788> Quality CheckerAssay & Impurity HPLC Quality CheckerResidual Solvents GC Quality CheckerWater Content KF Quality CheckerElemental Impurities ICP Quality CheckerContent Uniformity Quality CheckerDissolution Apparatus 1 & 2 Quality CheckerStability Condition Monitoring Quality Checker

Medical Devices — equipment and software lifecycle

Process Validation CheckerData Integrity Security CheckerSupplier Evaluation CheckerCalibration Status CheckerChange Control Impact CheckerRequirement Traceability Checker

Suggested first pilot

  1. Confirm one real product, method or recurring QC review.
  2. Record the instrument, export format and current specification.
  3. Select 3–7 utilities from the map above.
  4. Run a PASS/FAIL sample and agree the expected output.
  5. After user validation, expand to other products and sites.

Mapping boundary

The Top 300 is a FUZKK atlas priority rather than a single official revenue table. The mapping does not claim actual use of FUZKK, a specific installed equipment model or a product not confirmed by the public company profile.

Methodology