Frontage’s formulation development and CTM manufacturing team designs formulations for targeted delivery of a therapeutic and then develops GMP manufacturing processes to ensure a high quality product is produced for clinical trials.
We develop finished products supporting IND, NDA filings and generic ANDA filings. Our facilities have been designed for flexibility, as we offer a variety of dosage forms and the ability to handle highly potent compounds and DEA-controlled substances.
FACT: Work with > 200 clients for > 200 compounds and > 380 GMP batches
- IND: Formulation development and CTM manufacturing of oral solid, semi-solid (topical), liquid and sterile dosage forms
- ANDA: Reverse engineering, formulation development and tech transfer
- Consumer products: OTC reformulation
- High potency suite for CTM manufacturing
- Sterile suite for CTM manufacturing (Phase I)
- DEA manufacturing license for controlled substances (CI-V)
- Proof of Concept studies in animals
- Integrated services with Frontage clinical center