Once FDF early development work is completed, our partners will tech-transfer & scale up the FDF on an exclusive basis under full cGMP and in compliance with regulatory requirements and highest quality standards.
PHC helps you to find one-stop-shop and cost-effective “solutions” and offers you with a comprehensive management at different project phases. Our network will support our client from evaluation on the feasibility of product candidate, product development management, registration, as well as commercial supply of the finished product.
Our FDF CDMO partner’s capabilities:
- General liquid and lyophilized SVP (vial, ampoules or PFS) injectable
- General oral solid (tablet, capsule, wet granulation pellets) and Ointment
- High potency & oncology liquid and lyophilized SVP (vial, ampoules or PFS) injectable
- β-lactam Aseptic powder filling
Our FDF CDMO partner’s GMP status and locations:
- Taiwan, Korea, Germany, EU & US
- Compliance with US FDA, EU GMP, JP PMDA, KFDA and PIC/s GMP requirements