History
MiraxBioPharma is not only a laboratory and production complex, but also part of a holding company with diverse specialized divisions essential for the development, promotion, and distribution of our products.
History
- 2005 MiraxBioPharma was founded.
- 2007 The company’s research and production site developed its own pharmaceutical substance manufacturing technology. Patents for production methods were registered.
- 2008 A reconstruction project was developed and approved to transform MiraxBioPharma into a full-cycle facility for manufacturing pharmaceutical substances and finished dosage forms.
- 2009 Reconstruction of the pharmaceutical production facility began.
- 2010 Reconstruction and equipment installation were completed. The facility received a compliance certificate for GOST R 5249-2009 (GMP). Two original pharmaceutical substances were registered. Clinical trials began for the drug Indinol Forto® to assess its safety and efficacy.
- 2011 A license was obtained for the production of medicinal products, including pharmaceutical substances. Technology and analytical method transfer processes were implemented for contract manufacturing.
- 2012 A new original drug, Indinol Forto®, developed by MiraxBioPharma, was registered.
- 2014 The manufacturing facility was reconstructed and expanded.
- 2015 The facility successfully passed a re-certification audit for compliance with the requirements of Order No. 916 of the Russian Ministry of Industry and Trade (June 14, 2013) "On Approval of the Rules for the Organization of Manufacturing and Quality Control of Medicinal Products" and received a GMP compliance certificate.
- 2016 A new original drug, Cervicon®-DIM, developed by MiraxBioPharma, was registered.
- 2018 The dietary supplements production line and R&D area were reconstructed and modernized.
- 2019 The production facility underwent a repeat licensing inspection for compliance with the requirements of Order No. 916 of the Ministry of Industry and Trade of the Russian Federation dated June 14, 2013, "On Approval of the Rules for the Organization of Manufacturing and Quality Control of Medicinal Products".
- 2020 More than 90 new pieces of equipment were commissioned between 2016 and 2020. Fire suppression systems were installed in production areas. HVAC systems were repaired and upgraded. The facility passed a repeat inspection and received an updated GMP certificate.
- 2021 Swiss company Acino Pharma AG acquired a portfolio of products developed by MiraxBioPharma.
- 2023 The facility passed another licensing inspection and received an updated GMP certificate.
- 2024 New equipment for sachet manufacturing and liquid filling was commissioned.
- 2025 The company underwent rebranding — introducing a new logo and the brand MBP.