Established in 1943 as the national largest manufacturing and exporting base in the chemical synthetic pharmaceuticals field, Shandong Xinhua Pharmaceutical Company Limited (the “Company”) is in an leading position in the manufacturing technology and capacity for antipyretics and analgesics in China and is an important manufacturer in China for the drugs for central nervous system, steroids, cardio cerebrovascular system as well as finished dosage forms, pharmaceutical intermediates and pharmaceutical equipment.
With implementing the global market development strategy and adopting the international advanced standards in quality management, the Company has been granted the certifications of GMP, ISO9001, ISO14001, and ISO 10012. The main products of the Company have been granted the COS Certificate from EDQM and passed the site inspection from USA FDA.
By taking the advantages of its solid scientific research strength, well-established quality system, high market reputation as well as being a listing company of H shares and A shares with sound capital structure and product mix. "XINHUA" brand was honored with the title of "Chinese Famous Brand" in China. With the high commitment to the product quality and development of the international markets, the Company has established the strategic partnership with dozens of MNCs, the products of the Company has been distributed to more than 60 countries and regions.
Since 1943
Plant size: 460,000 square meters (not including planned future
development area)
Location: Total three manufacturing sites in Zibo with headquarter in Zhangdian, Zibo city, Shandong Province, P.R.China, with convenient traffic linked by railway, expressway and sea transport;, and API Manufacturing site in East Area, and Finished Product Manufacturing area in west area.
Employees on site: 4800, among them 30% are personnel in the specific field with junior and senior titles.
Production capacity: Annual output of bulk pharmaceuticals 20,000 tons, and
pharmaceutical intermediates of 40,000 tons, the largest manufacturer of
antipyretics and analgesics bulk pharmaceuticals in China and Asia. 6
categories of preparations with more than 300 varieties, among which annual
output for tablets is 6 billions and the capacity reach 8 billions, for injections
is 200 million and for capsules is 300 million.
Warehouse: 10,000 m2 of GMP standards gantry warehouse with the capacity 300,000 tons, and the dedicated airway line is available.
Domestic status: one of king-sized pharmaceutical enterprises in China; one of the largest 500 industrial enterprisesin China appointed by Chinese government.
Company System: Public company with H shares in Hong Kong (stock code: 0719, Shandong Xinhua) and A sharin shenzhen(stock code: 0756 新华制药).
Enterprises management
Granted the ISO 9001 certificate in 1999
GMP certified by SDA (counterpart of FDA) for formulations and 5 API in 2000
Granted the ISO 10012 certificate in 1998
1st pharmaceutical enterprise in China to be granted the ISO 14001 certificate
6 products have been approved by FDA as of June 2005
9 products have been granted COS as of Dec.31 2005
25 products filed the FDA/EDQM DMF/EDMF as of Dec.31,2008.