SERATEC

Seratec is a pharmaceutical company that specializes in the production of active pharmaceutical ingredients (APIs) for the treatment of rare and orphan diseases. The company registers drug master files (DMFs) of innovative or generic APIs with the US-FDA or EMEA on behalf of pharmaceutical laboratories, primarily based in the US. With extensive expertise in managing highly potent APIs in accordance with current Good Manufacturing Practices (cGMP), Seratec is regularly inspected by the US-FDA. The company excels in complex organic synthesis, handling processes ranging from gram to ton scales, particularly within niche markets. Notably, Seratec has been appointed as the main manufacturer for a significant hospital organization in Europe, reflecting the talent of its multidisciplinary team that efficiently manages business operations.

Services include:
- Contract Development and Manufacturing (CDMO)
- Regulatory Services
- Containment
- Active Pharmaceutical Ingredients (APIs)
- Analytical Services

Seratec is dedicated to providing high-quality pharmaceutical solutions tailored to meet the needs of its clients. For more information, please visit serateclab.com.