The API & intermediates manufacturing base has a building area of 4,000 square meters, equipped with advanced equipment and complete functions. It can meet the requirements of filing in China, the U.S. and Europe, with comprehensive chemical reaction processing capacity. It can flexibly carry out the manufacturing of APIs and intermediates with different manufacturing processes and different batch sizes in 2-100 kg/batch, and carry out pilot, scale-up and validation batch manufacturing of APIs and intermediates under cGMP conditions, with an annual manufacturing capacity of up to 200,000 tons.
The workshop is equipped with manufacturing equipment of different specifications and has experienced manufacturing technicians to meet requirements of different process manufacturing. It has 14 reaction kettles, which can carry out low-temperature reaction (temperature as low as -10℃), high- temperature reaction (temperature as high as 200℃), asymmetric catalytic hydrogenation, metal catalytic and oxidation reaction which is sensitive to air and water, and so on.
Workshop Address: No.8 API Plant, Binjiang API Platform, Taizhou City, Jiangsu Province, China
API
Advanced pharmaceutical intermediates
The highly flexible solid dosage manufacturing base has a floor area of 6,600 m2, with several manufacturing lines for different dosages. The annual manufacturing capacity of oral solid tablets (including double-layer tablets) is up to 150 million tablets, that of oral films is up to 30 million tablets, and that of capsules is up to 150 million capsules. The manufacturing line of nasal spray formulation is under construction, which is expected to have an annual manufacturing capacity of up to 10 million vials upon completion. The workshop is equipped with advanced equipment and complete functions. It can meet the requirements of filing in China, the U.S. and Europe and GMP manufacturing quality requirements. It can carry out Pilot, scale-up, validation batches, and commercial production of multiple dosage forms.
The workshop has a number of modular formulation units. including facilities such as wet granulator, boiling dryer, tablet press, coating machine, roller plate high-speed blister packaging machine, multi-functional cartoning machine, orally dissolving film machine and supporting post- packaging equipment and auxiliary equipment, such as purified water system, supporting clean and general air conditioning system, air compressor and so on. Meanwhile, we have an experienced QA/QC team to meet the customer's requirements of high quality and high activity of the preparation and ensure the smooth manufacturing.
Workshop Address: Building G56, Phase IV, China Pharmaceutical Town, Taizhou, Jiangsu Province, China.
Oral solid tablets (including double-layer tablets)
Oral film
capsule
nasal spray