Boehringer Ingelheim Pharmaceutical Production Plant, Shanghai, China

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key facts
Key Data
Order year
July 1998
Location
Pudong Zangjiang High Tech Plant, Shanghai, China
Estimated investment
$41 million (€45.7 million)
Completion
March 2002
Sponsor
Boehringer Ingelheim International GmbH, Shanghai Sine Pharmaceutical Co Ltd
Lead engineer/designer
Holzmann, CEL International, Siebel Systems, Scala Business Systems
Validation
CEL International, National Pharmaceutical Supervision Bureau

In March 2002 Boehringer Ingelheim opened their new manufacturing facility in Pudong, Zhangjiang High Tech Park in Shanghai. The new facility enables Boehringer Ingelheim to produce pharmaceutical products to supply an expanding Chinese market. The new plant covers an area of 34,500m³. The plant conducts secondary manufacturing and 'fill and finish' activities, producing tablets, vials, inhalers and bottled liquid products. The annual production capacity is 150 million tablets, 6.2 million metered dose inhalers, 10 million bottles of liquid products and 11.7 million unit dose vials (UDV).

PARTNERS AND INVESTMENT

Boehringer Ingelheim has invested $41 million (€45.7 million) in this new plant. The plant is actually owned by a Chinese subsidiary of the main company. The subsidiary is called Boehringer Ingelheim Shanghai Pharmaceuticals Co Ltd. This is a joint venture between Boehringer Ingelheim International GMBH and Shanghai Sine Pharmaceutical Co Ltd. Boehringer Ingelheim has provided the majority of the investment and hence holds a 95% stake in the company.

CONTRACTORS AND CONSTRUCTION

The National Pharmaceutical Supervision Bureau gave approval for the plant in July 1998. Plans were drawn up and passed by July 1999 and construction began in November 1999. The general construction contract was awarded to Holzmann, a German construction company. In 2001 CEL International, a project management and engineering company based in Coventry, which specialises in Chinese engineering projects, was awarded the contract for the outfitting of the plant with mills, ovens, packaging equipment, spray dryers, tablet presses, waste treatment systems, water purification systems and class 10,000 and 100,000 clean rooms. CEL International also outfitted a UDV production plant at the site that was not on the original plan. The company responsible for validation of the plant to Chinese GMP was CEL International.

COMPUTER SYSTEMS AND INFORMATION TECHNOLOGY

Boehringer Ingelheim has implemented Scala Pharma in the Shanghai plant. This is an Enterprise Requirements Planning (ERP) system designed for small- to mid-scale companies produced by Scala Business Solutions. ERP is a suite of applications linked to a control system allowing the logistics of supply, demand, manufacturing and stock-control to be synchronised. Siebel Systems of San Mateo, California, also provided software for the plant as part of the 'Siebel Pharma' suite of applications developed specially for the pharmaceutical industry.

PRODUCTS AND DISTRIBUTION

Boehringer Ingelheim will produce their most popular products at the Shanghai plant, aimed at the Chinese market. The products will include Mucosolvan (a potent decongestant and expectorant), Mobic (a non-steroidal anti-inflammatory drug for the treatment of osteoarthritis) and Actilyse (a thrombolytic treatment for use in acute myocardial infarction). The new Shanghai production facility forms the basis for the expansion of Boehringer Ingelheim's operations in south-east Asia. The plant allows the production network in Japan, Indonesia, South Korea and Taiwan to be much strengthened.



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Boehringer Ingelheim's new pharmaceutical manufacturing facility in Shanghai was opened in March 2002.



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Tablets manufactured in Shanghai undergoing dissolution tests.



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Range of tablets manufactured in Shanghai.



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Boehringer's newly designed metered dose inhaler will be manufactured at the Shanghai plant.



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Boehringer Ingelheim will produce their most popular products at the Shanghai plant, aimed at the Chinese market.



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