Manufacture of active substance. Names of substances subject to inspection:

[15]SWISSMEDIC LIST OF APIS, SEE 4 ACTIVE SUBSTANCES(en)

3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES
Active Substance:SWISSMEDIC LIST OF APIS, SEE 4 ACTIVE SUBSTANCES
3.1	Manufacture of Active Substance by Chemical Synthesis
	3.1.1  Manufacture of active substance intermediates 3.1.2  Manufacture of crude active substance 3.1.3  Salt formation / Purification steps: crystallisation 3.1.4  Other: All steps from API starting material to finished non-sterile API
3.5	General Finishing Steps
	3.5.1  Physical processing steps: drying, milling, filling 3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance) 3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance) 3.5.4  Other: All steps from API starting material to finished non-sterile API
3.6	Quality Control Testing
	3.6.1  Physical / Chemical testing 3.6.2  Microbiological testing excluding sterility testing

4. Other Activities - Active Substances:
Other activities: Quality control of medicinal products as an external analytical laboratory. Zinc Histidine Dihydrate, Vernakalant HCL, Calcium Folinate Hydrate, Calcium Levofolinate Hydrate, Levomefolate Calcium, Morphine HCL, Tepotinib nicht mikronisiert.