As a cGMP manufacturer for APIs and pharmaceutical intermediates, we have successfully manufactured in cGMP of different APIs and intermediates for a number of pharmaceutical companies from US, Hong Kong, France and China. Our services can support the new drug discovery through all the stages including clinical trials and commercial sales on market.
Our cGMP capacity enables us to manufacture APIs and pharmaceutical intermediates from grams, kilograms to metric tons. Currently our cGMP manufacturing facility in Guilin, a plant with an area of 26,000 M2, has an extracting capacity of more than 3,000 tons of medicinal herb annually. The facility is well equipped and validated for extraction, concentration, partition, column chromatography purification, spray drying, vacuum drying and low temperature workshops and storages. Our QC laboratories are validated and well equipped with all necessary analytical methods and equipment.
1. Contracted manufacturing of APIs, dietary supplement raw materials, and biologically active polysaccharides and glycoproteins.
2. Process development, scale-up or pilot manufacturing.
3. Formulation development for oral and injectable drugs.
4. Synthesis of small molecules including APIs, intermediates, drug analogs and impurities.
Facility and Major Equipment:
1. Clean rooms (class 10,000 with partial class 100)
2. Clean workshop (class 300,000)
3. Explosion-proof workshop I, workshop II, workshop III, workshop IV
4. Cold room
5. Chemistry laboratory I, chemistry laboratory II
6. Analytical chemistry lab I, and II
7. Warehouse I, II, III, IV, V
8. De-ionized/UF water supply system
9. Column chromatography systems (30 x 500, 30 x 1200, 75 x 500, 75 x 1200, 150 x 500, 220 x 500, 150 x 1500, 220 x 1500, 300 x 2500)
10. Extraction systems (100L, 500L, 1000L, 3000L)
11. Concentration systems
12. All-purpose reactor
13. Centrifuges (high-speed 500ml x 6, 250ml x 6, 1L x 6, continuous)
14. Freeze dryer (Virtis, 25EL)
15. UF systems (Millipore, Pall, 1 - 10M2)
16. Analytical lab: HPLC, GC, Plate Reader, etc.)
For detail, please contact us at:
Address: Beijing Medicass Biotech. Co. Ltd.
1-E18 Yard III, N. Yongchang Rd.
Beijing Eco-Tech Dev. Area, Beijing 100176