The APIs listed below are the main Monoclonal Antibody (mAbs) ingredients that are presently available from LGM Pharma:
- Brentuximab vedotin
- Certolizumab pegol
- Ibritumomab Tiuxetan
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.
Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e)+A13(1).
Any patent infringement and resulting liability is solely at buyer risk.