API – Procaine HCl is used in numerous pharmaceutical formulations and medical devices as a local anesthetic, which finds its application in different medical fields.
In 2016 the only European manufacturer discontinued the production of the active ingredient – Procaine HCl for human use.
The pharmaceutical market was likely to be uncovered by 2021, as the last produced batches of Procaine HCl guarantee a validity (shelf life) of only five years.
Pharmaceutical Companies, holders of the marketing of such Procaine HCl-based drugs, could no longer source from a qualified and authorized manufacturer, as the few existing global manufacturers were not in compliance with the regulatory and quality requirements necessary and demanded by the European Medicines Authority.
This situation would lead to the inevitable divestment and unavailability of Procaine HCl-based drugs.
Flarer SA’s goal was to succeed in structuring and scheduling the production of the API – Procaine HCl within a tight timeframe, elaborating and developing high-quality technical and documentary support, which will be accepted and approved by the European Medicines Authority for use in the European market, with the final release of the Certification of Suitability (CEP) by EDQM.
This had to be concluded within the five-year validity period of the last batches of API – Procaine HCl produced by the European manufacturer, in order to avoid the stock breakage of the numerous European MAHs, resulting in the forfeiture of marketing authorizations for the various drugs.
Flarer SA completed a structured market analysis, involving some of its customers which are users of API – Procaine HCl and also identifying other MAHs, determining the medicinal formulations involved, and specifying the quantities of API potentially required.
A study was thus conducted to assess the economic impact of the active ingredient, both for those products at risk of being discontinued and for possible new formulations, quantifying and defining the scope of interest of the project.
The manufacturing partner with the most suitable and qualified know-how and production asset was identified in order to better support the entire project of synthetic development and production of the molecule – Procaine HCl.
In collaboration with the manufacturing partner, the process of realization of the project was structured by setting up a time schedule that would allow defining the entire process for obtaining the product and the quality certifications, taking into account the necessary chemical/synthetic and documentary development.
Flarer SA involved a group of end-user customers, who immediately showed the greatest interest in the project and the strongest need for the supply of API – Procaine HCl, generating a production synergy, which would allow the complete and smooth achievement of the project.
The production process was started, following the chemical refinement of the molecule’s synthetic route, to obtain four validation batches of the API, progressively developing the entire technical compartment and documentary support, in order to comply with regulatory and quality requirements.
It was thus possible to finalize the development and structuring of the Eu-DMF of the API – Procaine HCl, thus proceeding to the filing of the letter with the European Authority EDQM, a necessary and preparatory condition for obtaining the Certificate of Conformity to the European Pharmacopoeia (CEP), issued on 14/11/2022.
The synthetic process has been completed and the analytical method of the molecule – Procaine HCl – has been improved.
In just 36 months from the start of the project, industrial production was completed and the GMP release of the four API validation batches took place.
The solid structure and the high-quality profile of the documentation package and the Eu-DMF, supporting API – Procaine HCl, enabled CEP to be obtained within 18 months of its submission to EDQM.
Flarer SA nullified the risk of stock breakage of manufacturers’ finished formulations and avoided incurring the forfeiture of marketing authorizations of drugs, both owned by its clients and by all European MAHs. Thus, Flarer SA ensured the supply of API – Procaine HCl, with a high level of quality, throughout the European and, potentially, the world market.