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PuraCap facility gets thumbs-up from FDA

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PISCATAWAY, N.J. — PuraCap Pharmaceutical LLC said the Food and Drug Administration has completed successful general inspection of its affiliated soft gelatin capsule manufacturing facility, Humanwell PuraCap Pharmaceutical (Wuhan) Co. Ltd., in Wuhan, Hubei Province, China.

In addition, a pending Abbreviated New Drug Application (ANDA) for Dutasteride was recommended for approval following the successful inspection, PuraCap noted.

“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,” stated Dahai Guo, chief executive officer of PuraCap. “I am grateful for the tireless work of the Humanwell PuraCap team of manufacturing and quality professionals.”

The company said the inspection, conducted last week, confirmed that the site is compliant with Current Good Manufacturing Practices (cGMP), and no Form 483 observations were issued.

“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,” commented Xiaofeng Meng, general manager of Humanwell PuraCap Pharmaceutical (Wuhan) Co. “A second FDA inspection without observations as well as the Dutasteride ANDA preapproval is a testimony to our commitment to world-class quality.”

With expertise in product development and manufacturing, PuraCap encompasses dedicated companies in the areas of prescription brands (PuraCap Pharmaceutical) as well as prescription generics and over-the-counter drugs (PuraCap International).


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