Hubei SeaGate Pharma Science Ltd.
Dalian Yongda-Suli Pharma Co., LTD
Scale Up and cost effective China manufacturing operations, summarized as follows:
- Two RSM approved China manufacturing facilities for late stage development and commercial production
- Highly flexible, multi-purpose production capacity
- Staff of 100, including highly skilled chemists, production operators, QA and QC teams.
- cGMP-like Kilolabs for Early Phase Delivery
- Pilot and commercial production vessels from 50L to 5000L
- Operating Temperature Range – 80°C To + 250°C
- Highly skilled in lengthy multi-step chemistry, hazardous reactions, sensitive processes
- Experienced Quality Assurance professionals team following Q7A principles
- Well trained QC analytical chemists to release in-coming raw materials, perform in-process assays and to release intermediates and API as well as develop and validate methods used during production.
- Batch records are prepared specifically for each individual project and provided upon request.
- Two new commercial factory production sites currently under construction. Upon completion, they will add a total of 650m3 new RSM & cGMP production volume capacity and an additional supporting staff of 300.