Otsuka Pharmaceutical Co., Ltd, Saga Plant - B001203
ブラジル保健規制当局（ANVISA）の認証を受けた工場
ブラジルの保健規制当局である ANVISA は、この工場に対して有効な医薬品有効成分を含む適正製造基準証明書を保持しており、有効期限は 2027 年 10 月 30 日までです。証明書は工場自体の検査後に発行されるため、外国の規制当局はこのサイトを名前に挙げています。ここで製造された商品はブラジル市場での販売が許可されています。プロセス番号 25351568266202309。
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer
- Location
- Japan
- Categories
- 医薬品製造
- Markets
- 日本, ブラジル
Listed in a source registry
What is established and what is not
No facet of this company has been investigated yet. The facts below are collected records, not an assessment: nothing here confirms manufacturing, ownership or trading status beyond what each record literally says.
Verified facts
- gmp-certified (green), checked 2026-08-21 ANVISA (Brazilian Health Regulatory Agency), public register of Good Manufacturing Practice certificates (CBPF)
- debarment-clear (green), checked 2026-09-02 - screened by name only: no legal entity is established for this record, so this is not a clearance OpenSanctions
- sanctions-clear (green), checked 2026-09-02 - screened by name only: no legal entity is established for this record, so this is not a clearance OpenSanctions
Import rules for these goods
- Medicines imported into the EU must come from a site holding an EU GMP certificate, and the importer needs a manufacturing/import authorisation. European Medicines Agency (GMP)