Dalian Production

Accelerating, transforming challenge into success

Location:

109 Dengta Road, Changxiang Island Economic Development District, Dalian, Liaoning, China116433
Newly built, operations formally started in December 2023
Total area of 176m2, that includes 64 buildings
Total Lab Space: 2786m2

Dedicated GMP production area

11,800m2, twolarge GMP production buildings

Total of 85 reactors (including 6 hydrogenators, 10MPa max pressure), with a total volume of 125m3
Production capacity: 100MT annually
Management system build-up to strictly follow cGMP/FDA/EMA standards
Successfully obtained China Gov API Drug production permit

Dedicated non-GMP production area:

22,800m2, five large production buildings, including:
4 intermediates buildings, total 163 reactors with a total volume of 450m3
1 hydrogenation building, total 16 hydrogenation reactors: SS, Hastelloy,
pressure up to 8MPa Production capacity: 1000MT annually
Multifunctional workshop: Low temperature(to -80DegC) & Hastelloy reactors

Warehouse facilities: Total storage area of 13,900m2 including:

7 class A warehouses, 4 class C warehouses, 1 gas storage warehouse, 1 Haz waste warehouse
Temperature and humility controlled at ≤ 20oC and 2-8oC.

Waste disposal facilities including

Wastewater bio-disposal system, with designed 600ton/day capacity
Waste gas RTO disposal facility
Waste solid treated by Gov approved Haz waste disposal company

On-site QC facilities including

15 HPLCs, Agilent & Waters
5 GCs
GCMS
IR
KF, Titration, AA, UV
Stability chambers

EHS management system

Strictly following local & international standards. Successful audit (Gov & customer) record
Process safety evaluation performed for every process step
DSC, Sedex, RC1 and Hazop analysis
Production temperature and pressure monitored by DSC. Flow fully automated under digital control
High standard gas detectors and fire-fighting system installed
Suitable PPEs defined and well equipped
Waste-gas treatment and WWTP under control & fully meeting local & international standards
Training and emergency drills performed on regular basis