HumanWell PuraCap Pharmaceutical Announces Second Successful FDA Inspection Of China Manufacturing Facility
Published: Sep 18, 2017
PISCATAWAY, N.J., Sept. 18, 2017 /PRNewswire/ -- PuraCap Pharmaceutical LLC is pleased to announce 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 ANDA was also recommended for approval as a result of this successful inspection. The inspection confirmed that the site is compliant with Current Good Manufacturing Practices, and no Form 483 observations were issued. This FDA inspection took place on September 11 through September 15.
Dahai Guo, Chief Executive Officer 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, Ph.D/MBA 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."
About PuraCap Pharmaceutical LLC
PuraCap Pharmaceutical LLC is an emerging, fully integrated pharmaceutical company with expertise in product development, manufacturing, and bringing affordable, world-class quality products to their customers. The PuraCap corporate structure supports a two-pronged approach for global growth with dedicated companies in the areas of prescription brands (PuraCap Pharmaceutical) as well as prescription generics and OTC drugs (PuraCap International). PuraCap Pharmaceutical continues to innovate using our soft gel expertise and developing other oral solid options. Go to www.puracap.com for more information.
SOURCE PuraCap Pharmaceutical LLC