+420 602 554 176
Opava, Czech Republic

The Services

R&D – Custom
organic synthesis

The R&D laboratory specializes in the isolation techniques of natural products and their conversion to semi-synthetic derivatives. Mihulka’s staff has extensive experience with ergot and morphinan alkaloids isolated from natural sources. Starting materials are produced by extraction from plant or fungal materials and used for subsequent custom syntheses. We specialize in the discovery and development of novel value-added synthetic routes and in the process scale up to pilot plant and production scales.

Mihulka s.r.o.

GMP manufacturing
and commercial production

Mihulka has the capabilities to manufacture clinical supplies and commercially marketed compounds in compliance with cGMP. The facility is equipped with glass, stainless steel, Hastelloy, or glass-lined reaction vessels with size range from 10 L to 250 L and corresponding accessories, including filters, dryers, and evaporators.

Mihulka s.r.o.
Mihulka s.r.o.

QC Services

In-house testing includes the following QC services

  • IR, UV, HPLC, GC, GC-HS, Flash/Prep. chromatography
  • Quantitative analyses by titration, melting point determinations, moisture content (loss on drying)
  • Stability studies – long term and accelerated
  • All analytical instrumentation and stability chambers are GMP compliant. Additional testing is procured using qualified analytical laboratories.

QA Services

Mihulka has the systems in place for cGMP compliant production. The QA department implements GMP enabling activities, including

  • GMP documentation for production of APIs
  • GMP documentation for products intended for clinical testing
  • DMFs

Biotechnology – R&D
and feedstock production

Biotechnological services are provided by a partner company, Mycotech, LLC. Its main focus is on the development of new source of feedstock for ergot alkaloids synthesis using Mycotech’s proprietary cell cultures.

Mihulka s.r.o.