Tergus has a 2,000 sq. foot state-of-the-art GLP and cGMP compliant manufacturing facility based on-site in Research Triangle Park, NC. This facility is ISO 8 (Class 100K) compliant clean rooms, equipped to handle high-potent compounds ranging from steroids and sexual hormones to cytotoxic. Our highly-equipped lab is capable of manufacturing batches up to 150 Kg.
Tergus Pharma manufacturing services include:
- Analytical methods transfer and validation
- Sourcing of raw materials
- Process scale-up and optimization
- Manufacture of GLP supplies for toxicology studies
- Manufacture of GMP supplies Phase I to Phase III
- Technology transfer
- CMC support for proof-of-concept studies, 505(b)(2), IND, NDA or ANDA
- Logistics services
Tergus is committed to providing topical drug product development services from Concept to Commercialization. As part of our manufacturing and logistics services, Tergus provides project management support to oversee and coordinate raw material release testing, microbiology testing, labeling and distribution of clinical supplies with 3rd party vendors. Tergus has manufacturing capability for semi-solids, aerosols, and solutions. The company ensures clinical-ready drug product supply distribution to clinical sites around the globe in accordance with Sponsor clinical protocols.