For three active pharmaceutical ingredients (Atracurium Besylate, Biperiden HCl, Cisatracurium Besylate) we plan to develop a manufacturing technology first on laboratory scale followed by pilot plant and finally on production scale. The quality of the pharmaceutical ingredients manufactured with this technology shall meet both the quality standards of the European Pharmacopoeia {Atracurium Besylate: Ph.Eur 10.0 Vol.II. p.1894 (2020); Biperiden HCl: Ph.Eur 10.0 Vol.II. p.1980 (2020) and Cisatracurium Besylate: Ph.Eur 10.0 Vol.II. p.2226 (2020)}, and the especially high customer requirements of developed countries (regulated market). The methods known from the literature do not meet the above requirements, therefore by modifying these syntheses, partly by developing new syntheses and intermediate purification methods, we plan to manufacture the above pharmaceutical ingredients in production scale in such a manner that we check the purity of intermediates, and if necessary before use we apply further purification. As a result, it will be possible to manufacture these pharmaceutical ingredients in such quality which meets the increasing purity requirements of the customers in developed countries. To meet these needs of our customers, we develop new, modern analytical quality control methods that are suitable for the detection of even small amounts of contaminants (50-100 ppm). When modifying the production technology of the active pharmaceutical ingredients, we consider it an important aspect that the manufacturing process complies with the environmental regulations as much as possible, the fewer by-products are produced, and the used solvents are regenerated. The project will create a new marketable technology of international importance.

INFORMATIONS

NAME OF THE BENEFICIARY: CF Pharma Kft.
GRANT AMOUNT: HUF 455,191,287
GRANT INTENSITY: 58,36%
YEAR OF THE GRANT: 2019
PROJECT IDENTIFICATION NUMBER: 2019-1.1.1-PIACI-KFI-2019-00269
BEGINNING OF THE PROJECT: 01.08.2019
COMPLETION OF THE PROJECT: 31.07.2022