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Second successful FDA inspection for HumanWell PuraCap Pharmaceutical LLC’s China manufacturing faci

2017-09-21

PuraCap Pharmaceutical LLC has announced that the US Food and Drug Administration (FDA) has completed another successful general inspection of its affiliated soft gelatin capsule manufacturing facility, Humanwell PuraCap Pharmaceutical (Wuhan) Co, Ltd ,  located in Wuhan, Hubei Province China.  In addition, a pending Abbreviated New Drug Application (ANDA) was also recommended for approval as a result of this successful inspection.  The inspection also confirmed that the site is compliant with Current Good Manufacturing Practices, and no Form 483 observations were issued. This FDA inspection took place from September 11 through September 15.

PuraCap Pharmaceutical LLC CEO Dahai Guo commented, “This is our second successful FDA inspection within two years, and the continuation of the planning, development and training necessary to achieve our goal of building a world class pharmaceutical manufacturing facility in China. I am grateful for the tireless work of the Humanwell PuraCap team of manufacturing and quality professionals.”

Xiaofeng Meng, general manager of Humanwell PuraCap Pharmaceutical (Wuhan) Co., added, “We have always measured our cGMP and quality performance and have consistently achieved the highest potential scores on outside audits from global customers and third party authorities. A second FDA inspection without observations as well as the pending ANDA pre-approval is a testimony to our commitment to world-class quality”

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