A DRUG
SUBSTANCE
CDMO
Good manufacturing practices
SERATEC complies
with the top
Good Manufacturing
Practices
(cGMP)
quality level.
API development
& production
SERATEC specializes in fine
organic chemistry and is dedicated
to API development & production
for the pharmaceutical industry.
SERATEC operates in highly
regulated markets and where
high quality products
are critical.
DMF-driven
services
SERATEC offers a complete
range of custom
development and
DMF-driven services,
incl. exclusive
collaborations.
SERATEC is dedicated
to low volume and complex
APIs in a context of quality
excellence.
CORE SKILLS
Custom development
and manufacturing
(CDMO)
  • Route scouting
  • Risk management
  • Safety and toxicology assessments
  • Identification of Impurities
  • Proof of API Structure
  • Process development, optimization
    and Process scale-up
    (small to medium scale)
  • Synthesis and purification
    of analytical reference standards
    and impurities
  • Clinical batch supply
  • cGMP (FDA) and GMP routine
    production
  • Supply chain
API support
services
  • Process Validation
  • Cleaning Validation
  • Batch Release
  • Analytical Method Development
    & Validation
  • Characterization of Solid-state
    Properties, e.g. Particle Size
    Distribution & Polymorphism
  • Execution of ICH Stability Studies
  • Regulatory Filing Support (CMC
    information on CTD format)
“For API Chemistry
and Filing”
OUR PRODUCTS AND THOSE THAT YOU CAN IMAGINE
CTD
GMP
2-Chloropropionic acid, sodium salt
3,4-Diaminopyridine phosphate
4-Methylpyrazole free base
4-Methylpyrazole sulfate
Amsacrine
Anthrarobin
Avizafone
Bethanechol chloride
Carbachol
Dichloroacetic acid, sodium salt
Dithranol (Anthralin)
Isoprenaline
CTD
GMP
Meso-2,3-dimercaptosuccinic acid [succimer]
Methacholine
Methyldopate
Proguanil
Pralidoxime
Pyridostigmine
Mepacrine (Quinacrine)
Sodium sulfide nonahydrate
Tacrine
Thalidomide
Thiobutabarbital
Triethylenetetramine tetrahydrochloride
We have other APIs available or in development.
Please contact us.