We constantly aim to provide our clients with APIs coupled with complete technical and regulatory documentation
(TDP / CTD / E-DMF / CEP / US-DMF etc…). Our APIs originate from EU-GMP certified and US-FDA approved production facilities.
Our supported Therapeutic Classifications include:
We constantly aim to provide top technical support and full regulatory documentation (TDP / CTD / E-DMF / CEP / US-DMF etc…) even for the most recently approved APIs, originating from EU-GMP certified and US-FDA approved production facilities. Many of the above APIs are manufactured via non-infringing routes of synthesis and would be suitable for Paragraph IV challenges / early launch in regulated markets.