Oneness Nanchou manufacturing site received GMP
certificate from the FDA Philippines
Date of events
2022/03/15
To which item it meets
paragraph 53
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.
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Disclaimer
Oneness Biotech Co Ltd. published this content on 15 March 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 15 March 2022 11:11:03 UTC.
ONENESS BIOTECH CO., LTD. is a Taiwan-based company principally engaged in the research, development, production and sales of health products. The Company's main products include health supplies, health food and healthy food. The Company is also involved in the development of new drugs for the treatment of wound healing in chronic diabetic foot ulcers, as well as the development of new anticancer drugs. The Company distributes its products in domestic market.