GMP API development aims to create Active Pharmaceutical Ingredients (APIs) in compliance with Good Manufacturing Practices (GMP).
The objective is to ensure the quality, safety, and efficacy of the APIs. The process typically starts with route scouting or technology transfer and progresses through process development steps to culminate with the production ready technology for GMP-compliant batches of the required size. Once a compliant API is developed then regulatory approvals are secured by submitting ASMF/DMF documentations to appropriate agencies. When market-ready then the API advances to commercial production.
TBD’s in-house team offers a comprehensive end-to-end API technology development service, optimized for cost-effectiveness.