Octapharma Ab
Company-provided description, not an official-source fact. Certifications, capacities, years and market positions stated in it are the company's own claims until a record below confirms them.
브라질 보건 규제 기관인 ANVISA는 2027년 11월 20일까지 유효한 생물학적 활성 제약 성분을 다루는 이 식물에 대한 유효한 우수 제조 관리 기준 인증서를 보유하고 있습니다. 인증서는 공장 자체를 검사한 후에 발급되므로 외국 규제 기관에서 이 사이트를 명명합니다. 여기서 생산된 제품은 브라질 시장에서 허용됩니다. 프로세스 번호 25351544837201689.
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer (official record)
- Location
- Sweden
- Categories
- 의약품 제조
- Markets
- 스웨덴, 브라질
Listed in a source registry
What is established and what is not
No researcher review has been written for this company yet. 10 official records from 10 official sources are on file. 2 other entries are not official records: our own technical checks and searches, open directory listings, our inferences or the company's own statements. Everything is listed below with its evidence type: each entry confirms only what it literally says; none of them is a review. The manufacturing role above rests on the official records listed below, and only as far as each literally goes: a facility registration or licence is not an observation of current production. Nothing here confirms ownership or trading status beyond what each record literally says.
Facts on file, each with its evidence type
- No match found in the debarment registers we checked (record type: debarment-clear) [our own observation, not an official record; name search, no matching candidate] We searched the public debarment datasets and found no matching candidate. Absence from these lists is a search result, not a certificate. checked 2026-08-24. OpenSanctions
- No match found on the sanctions lists we checked (record type: sanctions-clear) [our own observation, not an official record; name search, no matching candidate] We searched the public sanctions datasets and found no matching candidate. A name search is not full compliance screening. checked 2026-08-24. OpenSanctions
- Places goods on the market (national producer register) (record type: places-goods-on-market; this record does not by itself establish manufacturing) [official record; status green] A state register lists this company as placing these goods on the market, as their maker or importer. By itself it does not show who makes them. checked 2026-08-23. Finnish Medicines Agency (Fimea), basic register of medicinal products
- Active legal entity ID (LEI) (record type: lei-active) [official record; status green] A global identifier used in finance; an active one is renewed yearly. checked 2026-09-07. GLEIF global LEI register (golden copy)
- Market access approved: European Union (record type: market-access-eu) [official record; status green] Shows the establishment is approved for the listed activities under the EU food-hygiene rules and appears in the EU list of approved establishments. It is not an import check and not an observation of current production. checked 2026-08-22. TRACES NT, European Commission register of approved establishments (DG SANTE)
- Operating permit for the production site (record type: operating-permit; this record does not by itself establish manufacturing) [official record; status green] Shows an authority issued a permit for an installation at this site for the activity named in the record. A permit is not an inspection report and not an observation that production is running today. effective since 2026-08-08. EEA Industrial Emissions Portal (IED), EU-wide permit register
- Street address on file in the state register (record type: registered-address) [official record; status green] Registered address: STOCKHOLM, 11275, SE-LAND. The address the company itself gave the register, so post and inspectors reach it there. checked 2026-09-23. Bolagsverket, vardefulla datamangder (bulkfil)
- GMP certificate from a medicines agency (record type: gmp-certified) [official record; status green] A medicines regulator inspected the site and confirmed it may manufacture medicines. checked 2026-10-03. ANVISA (Brazilian Health Regulatory Agency), public register of Good Manufacturing Practice certificates (CBPF)
- Medicines manufacturing or import authorisation (MIA) (record type: medicines-mia-holder) [official record; status green] A medicines regulator authorises this company to manufacture and/or import medicinal products at the named site. The register lists the authorisation itself, not which products it covers, and it is not a record of trading. effective since 2026-08-15. EudraGMDP manufacturing and importation authorisation register (EMA)
- Site address listed in a government regulator's register (record type: facility-registered) [official record; status green] Shows the regulator records a site of this company at a named address. A registration is not an observation of current production. checked 2026-09-07. European Industrial Emissions Portal (E-PRTR / IED), European Environment Agency
- Registered as a manufacturer (record type: registered-manufacturer) [official record; status green] Its own declared activity in the register covers making these goods. checked 2026-08-21. Jordan Food and Drug Administration (JFDA), approved manufacturing sites (open data portal of Jordan)
- Registry ID checks out with the state register (record type: registry-id-verified) [official record; status green] Helps confirm the company on this page is the same legal entity as in the register. checked 2026-09-10. GLEIF Global LEI record
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)