Puracap's Wuhan site passes US FDA inspection prompted by ANDA

By Staff reporter

- Last updated on GMT

Puracap's Wuhan site passes US FDA inspection prompted by ANDA

Related tags Food and drug administration

US regulators are satisfied a soft gelatin capsule plant in Wuhan, China is up to code according to Puracap Pharmaceutical LLC.

The New Jersey, US headquartered capsule maker announced the facility – which is run by its China-based subsidiary Humanwell Puracap Pharmaceutical Co Ltd - had passed the inspection on Monday.

According to Puracap, the US Food and Drug Administration (FDA) inspectors also recommended that a pending abbreviated new drug application (ANDA) that lists the Wuhan plant as the manufacturing site is approved.

Puracap spokeswoman Lisa Atkinson told us "the inspection was a routine cGMP and ANDA inspection.​" She declined to provide details of the ANDA.

The Wuhan facility makes more than25 over-the-counter (OTC) pharmaceutical products for the US market.

The inspection and approval recommendation comes a little over a year after Puracap bought Puerto Rico-based Blu Pharmaceuticals. At the time the firm said the idea was to add oral tablet and capsule dosage forms production capabilities to its offering.

Access to the US marker was also a motivation. Buying Blu alos gave Puracap a facility housing 185,000 sq ft of warehouse and distribution space in Franklin, Kentucky.

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