Agc Biologics A/S
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.
ブラジルの保健規制当局である ANVISA は、生物学的有効医薬品成分を対象としたこの工場の有効な製造基準証明書を 2028 年 7 月 1 日まで有効に保持しています。証明書は工場自体の検査後に発行されるため、外国の規制当局が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 25351791288202362。
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer (official record)
- Location
- Denmark
- Categories
- 医薬品製造
- Markets
- デンマーク, ブラジル
Listed in a source registry
What is established and what is not
No researcher review has been written for this company yet. 5 official records from 5 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
- 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)
- 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)
- 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)
- Listed in a source registry (record type: listed-in-registry) [official record; status amber] Listed in Erhvervsstyrelsen; entry number 25950941. Matched to this company by name only; no second anchor confirms it is the same legal entity.. Found in a named public register, not only on its own website. checked 2026-08-31. BRIS, EU business registers interconnection (e-justice.europa.eu)
- 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. Screened by name only: no legal entity is established for this record, so this is not a clearance. checked 2026-08-31. OpenSanctions
- 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. Screened by name only: no legal entity is established for this record, so this is not a clearance. checked 2026-08-31. OpenSanctions
- 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
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)