Announced details
Antidepressant
Daito Group's fifth in-house generic drug formulation to receive manufacturing and marketing approval in China
The regulatory authority granting approval. Manufacturing will be handled by the consolidated Chinese subsidiary 大桐製薬（中国）有限責任公司, while the active pharmaceutical ingredient is scheduled to be manufactured by 安徽鼎旺医薬有限公司.
China's pharmaceutical regulatory authority
China's National Medical Products Administration (NMPA)
大桐製薬（中国）有限責任公司: Hefei, Anhui, China / 安徽鼎旺医薬有限公司: Anqing, Anhui, China
The approval has already been incorporated into the earnings forecast, and there will be no revision to the consolidated earnings forecast.
The company does not address Contract Value / Offering price.
| Item | Details |
|---|---|
| Names of Products / Services Covered | Fluvoxamine Maleate Tablets 100 mg |
| Counterparty | China's National Medical Products Administration (NMPA) |
| Counterparty overview | China's pharmaceutical regulatory authority |
| Relationship with the Company | The regulatory authority granting approval. Manufacturing will be handled by the consolidated Chinese subsidiary 大桐製薬（中国）有限責任公司, while the active pharmaceutical ingredient is scheduled to be manufactured by 安徽鼎旺医薬有限公司. |
| Applicable area | Antidepressant |
| Awarding / certifying body | China's National Medical Products Administration (NMPA) |
| Location | 大桐製薬（中国）有限責任公司: Hefei, Anhui, China / 安徽鼎旺医薬有限公司: Anqing, Anhui, China |
| Quantitative Effects | Daito Group's fifth in-house generic drug formulation to receive manufacturing and marketing approval in China |
| Impact on Business Performance | The approval has already been incorporated into the earnings forecast, and there will be no revision to the consolidated earnings forecast. |
Items this document does not state (9)
These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.
The reasons the company gives
The company's own explanation, not something inferred from the numbers.Following changes to the regulatory system in China, it was agreed that having 大桐製薬, which operates a manufacturing facility, hold the manufacturing and marketing rights would provide a competitive advantage in terms of sales strategy.