Contract Manufacturing (API, fluorination, etc.)

Building on an R&D organization with many years of experience in inorganic and organic chemistry and our own fluorination technology, Central Glass has worked with pharmaceutical companies around the world in joint development projects for active pharmaceutical ingredients. We began globally supplying fluorine-containing drug substance in 1990 and non-fluorine containing drug substance in 2000. We have built a system for GMP-compliant quality assurance and we have the ability to maintain DMF registration.
With the systems in place, we are able to provide contract manufacturing services that support your development and commercialization activities. For example, we can use our facilities where our people are highly skilled in the handling of processes for fluorination or elimination of fluorine. Or Central Glass can work with customers to replace processes that use costly fluorinating agents as in the initial early development phase with economical substitutes developed with a view to commercial production.

Click here to find out about other compounds.

*Contact Central Glass directly for more information.

Production facilities

Central Glass (Ube Plant)

  • The production and quality assurance of Central Glass pharmaceutical products is based on GMP. We have set up a GMP system to ensure that we can at all times maintain high levels of production quality control.
  • The company undergoes periodic inspections by the US FDA and other regulatory authorities. Our production facilities and quality assurance system have been recognized for their ability to produce high-quality pharmaceutical products.
Recent FDA inspection results
July, 2009
February, 2012
September 2014

Central Glass Germany GmbH(Germany)

  • The production and quality assurance of Central Glass Germany pharmaceutical products is based on GMP. We have set up a GMP system to ensure that we can at all times maintain high levels of production quality control.
  • Central Glass Germany undergoes periodic inspections by the US FDA and other regulatory authorities. Its production facilities and quality assurance system have been recognized for their ability to produce high-quality pharmaceutical products.
Recent FDA inspection results
June, 2009
May, 2013

Facilities of Central Glass Germany

  Capacity Material
Reactor 100~5,000L SUS, GL, Hastelloy
Distillation equipment   SUS
Dryer Tray, multi-function filter, conical SUS
Centrifuge   Hastelloy

http://www.cg-germany.com/

Flow of contract services

Fluorination technology
Selective halogen exchange reaction using hydrofluoric acid (HF)
Electrolytic fluorination
Deoxyfluorination (-OH→-F)
Direct fluorination using F2 gas

For Product Inquiries

Links

Research and Development
View our R&D activities.

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