Published Date:2021-04-12
Original Link:https://www.onenessbio.com/en/news_detail37_3.htm
| No | 1 | Date of announcement | 2021/04/12 | Time of announcement | 20:52:15 |
|---|---|---|---|---|---|
| Subject | Oneness announces that Nanchou manufacturing site has been GMP and GDP certified by MOHW | ||||
| To which item it meets |
paragraph 53 | Date of events | 2021/04/12 | ||
| Statement | |||||
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1.Date of occurrence of the event:2021/04/12
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 Ministry of Health and Welfare by writing that the Nanchou manufacturing site has been in compliance of Good Manufacturing Practice under Guide to Good Manufacturing Practice for Medicinal Products. The letter confirming GMP Compliance of a Manufacturer has been issued with certificate number (AP)0465156. 6.Countermeasures:None 7.Any other matters that need to be specified:The Company has 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 today received GMP with GDP certification on the finished product. |
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