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合一生技股份有限公司 / 2022 / Oneness Nanchou manufacturing site received GMP certificate from the FDA Philippines

Oneness Nanchou manufacturing site received GMP certificate from the FDA Philippines

2022-03-15

Published Date:2022-03-15

Original Link:https://www.onenessbio.com/en/news_detail152_3.htm

No 3 Date of announcement 2022/03/15 Time of announcement 18:47:21
Subject Oneness Nanchou manufacturing site received GMP certificate from the FDA Philippines
To which item it meets paragraph 53 Date of events 2022/03/15
Statement
  1. Date of occurrence of the event: 2022/03/15
  2. Company name: Oneness Biotech Co., Ltd.
  3. Relationship to the Company (please enter “head office” or “subsidiaries”):head office
  4. Reciprocal shareholding ratios: NA
  5. Cause of occurrence: The company has been notified by the consulting company that Oneness Nanchou manufacturing site has been granted GMP compliance certificate under certificate number CDDR-CGMP-4358.
  6. Countermeasures: None
  7. Any other matters that need to be specified: The Company received PA-F4 API license on December 13th of 2019. The Nanchou manufacturing site received PA-F4 API GMP certification on December 16th of 2020. The drug license for the new drug “Fespixon cream” has been issued on March 26th of 2021. The Company received GMP with GDP certification on the finished product (Fespixon cream) on April 12th 2021. The Company has received the GMP certificate issued by the FDA Philippines today and will submit the NDA application later this month.