Humanwell PuraCap Pharmaceutical LLC Announces Successful FDA Inspection
SOUTH PLAINFIELD, N.J., Nov. 12, 2015 /PRNewswire/ -- PuraCap Pharmaceutical LLC is pleased to announce that the US Food and Drug Administration (FDA) has completed a successful inspection of its affiliated soft gelatin capsule manufacturing facility, Humanwell PuraCap Pharmaceutical (Wuhan) Co, Ltd, located in Wuhan, Hubei Province China. 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 May 18 through May 22, 2015.
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Dahai Guo, Chief Executive Officer commented, " This successful inspection is the culmination of years of planning, development and training to achieve our goal of building a world class pharmaceutical manufacturing facility in China. It reflects the tireless work of the Humanwell PuraCap team of manufacturing and quality professionals."
Xiaofeng Meng, VP of Global Regulatory and Quality added, "We have always measured our cGMP and Quality performance and have consistently achieved the highest potential scores on outside audits from global customers as well as 3rd-party authority, such as UL-STR, Intertek etc. An FDA inspection without observations is a testimony to our commitment to world-class quality and continuous improvement."
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 Pharmaceutical continues to innovate using our soft gel expertise and developing other oral solid options. Go to www.puracap.com for more information.
Forward-Looking Statement
All of the statements contained in this news release, other than statements of fact that are independently verifiable at the date hereof, are forward-looking statements. Such statements, based as they are on the current expectations of management, inherently involve numerous risks and uncertainties, known and unknown. Some examples of known risks are: the impact of general economic conditions, general conditions in the pharmaceutical industry, changes in the regulatory environment in the jurisdictions in which PuraCap Pharmaceutical LLC does business, fluctuations in costs, and changes to the competitive environment due to consolidation or otherwise. Consequently, actual future results may differ materially from the anticipated results expressed in the forward-looking statements.
Media Contact:
Elise Klein
Vice President and General Manager
Branded Rx Products
Email
908-941-5456 ext. 640
SOURCE PuraCap Pharmaceutical LLC
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