| EN
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, dedicated to in-house development of innovative biologics as well as co-development with leading companies around the world.

NANJING SMALL-MOLECULE MANUFACTURING FACILITY

Located in Nanjing Biotech and Pharmacetical Valley in Jianbei New Area, occupying a total area of 146,000 square meters, the facility is capable of manufacturing injectables, oral solids, oral liquids, and inhalation products. The facility is one of the first group of GMP certified companies in Jiangsu Province. The solid preparation workshop has passed the on-site inspection of the U.S. FDA with zero defects.

YANTAI

Located in Yantai Economic & Technological Development Area,, occupying an area of 48,000 square meters, the facility serves as a manufacturing base for enetically modified veterinary biologics and protein drugs.

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, occupying an area of 261,000 square meters, the facility is dedicated to the manufacturing of oral antibiotic products and so on.

WUHU

Located in Wuhu Sanshan Economic Development Area, occupying an area of 20,000 square meters, the facility is dedicated to the manufacturing of exclusive sustained release implants for intraoperative application.

We have obtained China GMP certifications for all of our workshops and production lines. Hainan Simcere has passed the EU GMP certification for several times consecutively. Simcere Pharmaceutical's solid preparation workshop has passed the on-site inspection of the U.S. FDA with zero defects. We have established the quality management system covering the entire production cycle, from raw material procurement to delivery of finished products to customers. Our quality control personnel are independent from our production team, who 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, intermediates and final products.

  • Environment

  • Health

  • Safety

EHS

We insist on EHS in all processes of manufacturing. we are committed to sustainable development, and shall operate the business in a manner that protects the well-being and safety for both environment and humans.