+420 602 554 176
lubos.markovic@mihulka.cz
Opava, Czech Republic

About Us

Our Company

Mihulka*, s.r.o. was founded in 2016 by Luboš Markovič.

The company is housed in a fully renovated building in the industrial zone Opava-Jaktař located in the North-East part of the Czech Republic. The building features brand new analytical, organic synthesis and biotechnological laboratories, as well as a pilot plant and a manufacturing facility.

The company offers custom synthesis of small molecules for pharmaceutical industry, including cGMP synthesis of active pharmaceutical ingredients (APIs), intermediates and raw materials. Output quantities range from few grams discovery/non-GMP laboratory scale batches to 100 kg batches manufactured under cGMP process controls for late-stage clinical studies and marketed products. In summary, Mihulka offers a full-service custom synthesis development, process scale-up, and technology transfer from laboratory to pilot and commercial production scales.

*Mihulka – named after a tower in Prague Castle, which was used as an alchemy laboratory in the late 16th century, the first one in Europe, for Rudolf II, Holy Roman Emperor.

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

Our Goals

We strive to be recognized as a preferred contract manufacturing organization (CMO) specializing in the development of value-added novel and innovative syntheses for generic APIs and intermediates and subsequent technology transfers to our cGMP facility.

This goal is achieved by

  • Optimizing current synthetic routes to improve quality and/or reduce cost.
  • Establishing new sources of natural raw materials and its products by biotechnological processes.
  • Managing projects internally from start to finish, from initial laboratory trials, through a pilot plant verification to a final GMP production.
  • Offering full services cGMP production, including test method development and validation, release and stability testing.
  • Generating corresponding GMP-compliant documentation for clinical materials supporting all phases of clinical development.

The Visions

Visions

Be an innovative, flexible and reliable CMO for custom syntheses of challenging compounds, including API’s and intermediates.

Visions

Become a preferred full service CMO for clients from pharmaceutical, biotech and related industries for synthesis development, clinical supplies and commercial production.

Visions

Work diligently and tirelessly to deliver the finest quality products in the most efficient way to benefit our customers and patients.