Our company has a policy of continuous improvement of products and process. The commitment to quality lead this Neuland policy to focus on the European and United States market. Consequently, Neuland started working with the EDQM and other regulatory authorities (TGA, MHRA etc) as well as the USFDA. This also gave us a clear understanding of the possible direction of regulations and standards so that they could be put in place sooner, rather than later.
The site manufactures API,s for the US, EU and other regulated markets and complies with the cGMP guidelines established by ICH (Q7A). The relevance of new requirements from the FDA, ICH, EMEA and EDQM is continuously monitored.Stringent controls are built in to ensure that every single product meets the specification of most known pharmacopeias and our customer requirements.