cGMP API Manufacture

At Ubichem Pharma Services, we have regulatory approval for cGMP manufacture of APIs and intermediates for clinical trials. Clients regularly visit our facilities for formal or informal audits, and we are happy to provide detailed information in relation to our quality systems. Our facilities include a class 100,000 Laboratory, a Kilo Laboratory and a Pilot Plant.

Class 100,000 cGMP API Laboratory

• 15L jacketed vessel with Huber thermostats (dedicated single-use glassware)
• Temperature range -50°C to 150°C
• Tray drier, capacity to 1.5kg

Kilo Laboratory

• 63L reactors
• 50L crystallisation vessel
• 35L Hastelloy C reactor
• Mobile glass reactors to 100L
• 20L and 50L Rotary evaporators
• 400mm ss Centrifuge (Class 100,000 HEPA environment)

Pilot Plant

• 250L, 500L, 1600L gl reactors
• 1000L crystallisation vessel
• 1000L Hastelloy C reactor, operable down to -80°C
• 600mm and 1000mm (Class 100,000 HEPA environment) ss Centrifuges
• 4.6m² warm water heated tray drier