cGMP Manufacture of APIs

Ubichem Pharma Services have the regulatory approval and expertise to manufacture APIs and intermediates under cGMP on lab to pilot plant scale. We have expertise from the preclinical stage through to commercial supply. We have the knowledge and ability to help our clients achieve their development program objectives.

The equipment at our disposal enables us to meet and exceed the necessary standards in the manufacturing process for our clients. Our equipment is housed in a Class 100,000 cGMP API laboratory, kilo laboratory and pilot plant.

Our cGMP Laboratory has 15-25L jacketed vessels (dedicated single-use glassware), with Huber thermostats, temperature range -50°C to 150°C and a tray drier with a capacity of 1.5kg. Our kilo laboratory contains 63L reactors, 35L Hastelloy C reactor, 50L crystallisation vessel, Mobile glass reactors to 100L, 400mm ss Centrifuge (Class 100,000 HEPA environment) and 20L and 50L Rotary evaporators. Our pilot plant has 250L, 500L, 1600L gl reactors, 1000L Hastelloy C reactor, operable down to -80°C, 1000L crystallisation vessel, 4.6m2 warm water heated tray drier and 600mm and 1000mm (Class 100,000 HEPA environment) ss Centrifuges.

For more information or to discuss cGMP Manufacture of APIs please contact us directly.