Published Date:2020-12-16
Original Link:https://www.onenessbio.com/en/news_detail74_1.htm
| No | 1 | Date of announcement | 2020/12/16 | Time of announcement | 17:20:11 |
|---|---|---|---|---|---|
| Subject | Announcement by Oneness on Nanchou Manufacturing Site Receiving GMP Certification from TFDA on Manufacturing Active Pharmaceutical Ingredient | ||||
| To which item it meets |
paragraph 53 | Date of events | 2020/12/16 | ||
| Statement | |||||
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1.Date of occurrence of the event:2020/12/16
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 GMP audit on manufacturing active pharmaceutical ingredient Plectranthus amboinicusextract-F4 at Nanchou site was completed and the certification on Good Manufacturing Practice for Medicinal Products according to Pharmaceutical Good Manufacturing Practice Regulations was granted to Oneness by Taiwan Food and Drug Administration(TFDA) today. The approval number is (C) 0047035. 6.Countermeasures:None 7.Any other matters that need to be specified:Active pharmaceutical ingredient license of PA-F4 (Plectranthus amboinicusextract-F4) was granted by TFDA in 2019. |
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