Company’s Profile

Jiangsu WestPoint Pharmaceutical Excipients Co., Ltd.

I. Company business

Jiangsu WestPoint Pharmaceutical Excipients Co., Ltd., cooperated `with technical team from US, is a research, development, manufacture and sales enterprise of pharmaceutical excipients that meets EP and USP standards. The main products are microcrystalline cellulose (MCC) series, pretreatment accessories series and aseptic accessories series. All of them have the same quality as American ’s excipients which represent the highest quality standards in the global excipient market.

Based on the continuous development of Chinese drug industry and the comprehensive integration with global regulations and standards, especially the campaign of “generic drug consistency evaluation”, domestic pharmaceutical companies are improving their technology and drug product quality.

Currently the high-quality excipients used by domestic pharmaceutical companies are fully imported from FMC or other global suppliers.  Based on our experience of CMO business over past 10 years and the profound knowledge of European and American R&D standards, our company has carried out excipient R&D for eight years. From 2016, our domestic made pharmaceutical excipients are commercialized to gradually replace the imported excipients and realize the integration of our excipients with global technology and quality standards

Ⅱ. Professional team

Our company's core team members are senior professionals in pharmaceutical product development, technology management, customer service. They have many years technical and management experiences when working for giant European and American pharmaceutical companies.

Ⅲ. Advantages of Jiangsu WestPoint Pharmaceutical excipients 

1. Compliance with GMP requirements

Different from the traditional domestic excipient manufacturers, our staffs in excipient business have pharmaceutical industry knowledge/background and have experiences in EU and US GMP compliance. Our excipient production line is based on deep understanding and assessment of excipient manufacture process. Our excipient facility is designed and built following the requirements of pharmaceutical manufacture, the principle of QbD and risk assessment. These efforts can fully avoid the error which may be caused by hardware problem in production, possible pollution, and out of process control etc.

WestPoint pharmaceutical builds up the excipient quality management system in accordance with the standards of EU and US GMP and completely meet the CMC regulation of drug production in the material control, manufacture process control, laboratory management, validation, production deviation analysis and modification. It provids a perfect systematic guarantee for the stability and uniformity of excipients quality.

2. Reliability of product performance

Based on the experience in pharmaceutical industry, we are well aware of the importance of the pharmaceutical excipients in keeping consistent quality between product batches. We analyze the possible factors which may impact to the quality of excipient which could in turn lead to a number of drug quality problems. Factors, including raw materials, key process parameters and product batch traceability, have been specially controlled. The excipient manufacture process and test procedures have been validated to minimize the quality difference between excipient batches.

3. Strong technical support capability

Based on our CRO service and GMP consultation protocol, we can provide technical services to our clients not only in excipient application, drug registration, regulations and drug GMP compliance, but also can help them to solve relevant problems quickly, so that our clients can experience their potential value.