Daewoong Pharmaceutical said it got the U.S. Food and Drug Administration’s cGMP approval for its three-story, 7,284-square meter manufacturing plant that produces Nabota, its botulinum toxin product.
The plant, which can produce up to 4.5 million vials of Nabota a year, is equipped with state-of-the-art production facilities and an advanced quality control system, Daewoong said.
|Daewoong’s Botox manufacturing plant in Hwaseong, Gyeonggi Province, has recently won the cGMP certification from the U.S. FDA.|
The latest approval marks the third for the company following the ones it got in Europe and Korea. The plant received a QP certification from Europe in May 2017 and a KGMP certification from Korea’s Ministry of Food and Drug Safety in October last year.
With the FDA approval, Daewoong Pharma said it is one step closer to getting U.S. approval for its botulinum toxin product used to remove wrinkles.
According to Daewoong, FDA officials visited its Nabota plant, located in Hwaseong-si, Gyeonggi Province, last November to examine the manufacturing facility and quality maintenance system, and approved it in a final Establishment Inspection Report (EIR) report Tuesday.
“The FDA approval of the Nabota plant is an important first step toward success in our full-scale global business project,” said Park Sung-soo, manager of the Nabota Business Division at Daewoong Pharmaceutical. “We plan to complete getting the approval of regulatory agencies in major countries around the world such as Europe, Canada, and Australia.”
The FDA also finished examining its biologics license application (BLA), Daewoong said. Evolus, Daewoong’s U.S. partner, received a Complete Response Letter from the FDA requesting supplemental data for the therapy approval, the firm added.
Daewoong and Evolus said that they would prepare the supplementary data and apply for the resumption of approval examination soon.
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