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Drug Product CDMO Service API & Intermediates CDMO Service Analytical Service Support
Drug Product CDMO Service

Drug Product Manufacturing

Our oral product manufacturing suits meet the global GMP compliances and standards. The total area of these GMP suits is around 1000 m^2. Each suit has specific functions to meet the manufacturing requirement of various oral solid dosage forms including tablet, capsule, particulate and others. This ensures timely and high quality clinical product delivery, commercial formulation and manufacturing process development, technology transfer, process characterization, process control strategy definition, process performance qualification, and commercial manufacturing.

The main services include followings; they can be either a single unit operation service or combination thereof.
(1) Micronization——Air-assisted milling (5 g/hr to 20 kg/hr) or mechanical milling (10 g-10 kg/hr);
(2) Blending——Tumbling (0.2 L to 100 L) or high shear mixing (1 L to 120 L);
(3) Granulating——High shear wet (1 L to 120 L), dry (5 g/hr to 40 kg/hr), and fluid bed granulation (2 L to 100 L);
(4) Drying——Fluid bed (2 L to 100 L) or Oven drying;
(5) Milling——Comil U5 (50 g/hr to 1 kg/hr) and ZLJ-125 (up to 150 kg/hr); 
(6) Compressing——Fully instrumented single (single station) and bilayer rotary tablet presses (6 and 8 stations, B and D tooling options);
(7) Encapsulating——Fully instrumented encapsulators (5,000 to 40,000 caps/hr), capable of encapsulating particulates, powder, and liquid;
(8) Coating——Fully instrumented coaters (0.5 L to 70 L);
(9) Packaging——Bottle and blister packaging;