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We has a full spectrum of manufacturing capabilities spanning from active pharmaceutical ingredients (APIs) to finished products with a variety of dosage forms. The manufacturing and quality management system meets global regulatory requirements. The newly built biologics facility can be used for manufacturing of clinical test articles as well as commercial products.

Manufacturing Bases

NANJING LARGE-MOLECULE DRUG MANUFACTURING FACILITY

As Simcere’s development and manufacturing center for biologics, the facility has a total capacity of 4 x 2000L upstream production lines, dedicating to in-house innovative biologics development as well as co-development with leading companies around the world.

NANJING SMALL-MOLECULE MANUFACTURING FACILITY

Located in Jianbei New Area and with a total area of 146,000 square meters, the facility is capable of manufacturing injectables, oral solids, oral liquids, and inhalation products. The facility was among the first group of GMP certified companies in Jiangsu Province. The Oral Solid Unit and the quality system had passed U.S. FDA inspection.

YANTAI

Located in Yantai Economic & Technological Development Area and with an area of 48,000 square meters, the facility serves as a manufacturing base for genetically engineered drugs and recombinant proteins.

HAINAN(HAIKOU/CHENGMAI)

HAIKOU is situated in the Pharma Valley of Haikou National High-Tech Zone, the facility occupies an area of 166,000 square meters and is capable of manufacturing injectables, oral solids, and topical gels. The quality system has passed the U.S. FDA inspection and the diosmectite production unit has been certified by EU regulatory authority. The diosmectite products are exported to Europe and have been included in French National Health Insurance.
CHENGMAI is located in Chengmai County, Hainan Province and with an area of 261,000 square meters, the facility is dedicated to manufacturing of antibiotic products.

WUHU

Located in Wuhu Sanshan Economic Development Area, the facility is dedicated to the manufacturing of long-acting controlled release implants for intraoperative application. Total area of the facility is about 20,000 square meters.

We have obtained GMP certifications for all of our workshops and production lines. We have also received EU GMP certification for the production of our Biqi-branded diosmectite powder in our Yaogu facility. In addition, we have passed the U.S. FDA inspection for our solid dosage form production workshop in our Nanjing facility. Our Yaogu facility and Nanjing facility have been granted ISO9001 certifications for their quality management systems.

We have established comprehensive quality control procedures and protocols that span across the entire production lifecycle. Our senior management team is actively involved in formulating internal quality control policies and monitoring our overall quality control process. Our quality control personnel are independent from our production team and are responsible for the implementation of such procedures and protocols. In addition, we utilize equipment and devices to inspect, test and ensure the quality of our raw materials, production-in-progress and final products.

  • Environment

  • Health

  • Safety

EHS

We adhere to an EHS management policy and are committed to sustainable development through using operational mode that protect the environment and human health and safety.