Successful FDA Inspection at PharmaBlock Shangyu Manufacturing Site

On July 16th, 2019, PharmaBlock Sciences (Nanjing), Inc. announced its intermediates and APIs manufacturing site at Shangyu (Zhejiang, China) successfully completed an FDA general GMP inspection conducted from July 1st to July 5th. No 483 forms were issued. This is the first time PharmaBlock’s Shangyu facility has been inspected by the FDA. 

PharmaBlock’s Shangyu site is located in a national level chemical industry park in Zhejiang Province, with an area of 1,436,000ft2. The facility is well equipped with over 90 reactors ranging from 300L to 6300L, with cutting-edge technology platforms including flow chemistry, bio catalysis etc. Last month, two micro-packed bed catalytic reactors were put into use, with over 100kg output per day. 

“PharmaBlock has long been recognized for our ability to tackle challenging chemistry problems. In recent years, we have been improving the manufacturing capabilities and capacity, along with quality system enhancements. The result of the inspection reaffirms our commitment to quality and reassures our partners about our ability to meet the highest quality standards in the manufacturing of GMP products,” said Dr. Shijie Zhang, CTO of PharmaBlock.

PharmaBlock recently initiated a site expansion project at the Shangyu site, adding a GMP kilo-scale workshop, and strengthening the chemistry and engineering technologies platform, with a focus on flow chemistry and microreactor technology. Additional workshops for pilot and commercial manufacturing are expected to be operational in next few years.