Specially EU API manufacturers are confronted with a strong competition coming from third party countries. In order to reduce production costs companies often look for more competitive sources of starting materials.
As per our experience the qualification of alternative sources of starting materials is normally not enough to become more competitive in the market. Instead the qualification of alternative sources for intermediates better fulfill this purpose.
In fact, this process is much more complex, especially due to the regulatory hurdles often linked to necessary upgrades of the regulatory documentation and internal capacities. However, mid to long term this is an important tool to reduce internal production costs and remain competitive in the market.
Midas has been supporting our partners with the identification of suitable manufacturers for the concerned intermediates, compilation of requested documents levelled to current regulatory requirements, carrying out audits, taking care of questions raised by authorities related to the intermediate etc.
In addition, Midas reduces the complexity of such qualification process and at the same time, as consequence of these activities, upgrades the concerned regulatory documents to the current requirements. By reducing the cost level of the involved API our partners are not only able to remain competitive but shall be even in the position to increase their market shares.
We have been successfully working on this approach for more than one decade combining our technical, regulatory and marketing expertise.
We will be glad to also support you!