APOTEK PRODUKTION & LABORATORIER AB
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer (official record)
- Location
- Umea Vasterbotten, Sweden
- Categories
- Tıbbi ve Sağlık Malzemeleri
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 8 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
- Site address listed in a government regulator's register (record type: facility-registered; this record does not by itself establish manufacturing) [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. effective since 2026-08-17. US FDA device establishment registration (openFDA)
- 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. effective since 2026-02-12. EudraGMDP, EU register of GMP certificates (EMA)
- 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 2026-08-15. 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 2026-08-15. OpenSanctions
- Registered with the U.S. FDA (active, renewed for the current year) (record type: fda-registered) [official record; status green] Registered with the US food and drug regulator, renewed for the current year. checked 2026-08-15. FDA
- Registered with the U.S. FDA as a Contract Manufacturer (record type: fda-contract-manufacturer) [official record; status green] Registered as making goods for other brands. checked 2026-08-15. FDA
- 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)
- registry-activity (record type: registry-activity) [official record; status green] Shows what the state itself says the company does, which you can compare with what it promises you. checked 2026-09-23. Statistikmyndigheten SCB via Bolagsverket, vardefulla datamangder
- 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 2026-09-23. Bolagsverket, vardefulla datamangder (bulkfil)
- 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. checked 2026-08-15. EudraGMDP manufacturing and importation authorisation register (EMA)
- Street address on file in the state register (record type: registered-address) [official record; status green] Registered address: Box 5071, KUNGENS KURVA, 14105. The address the company itself gave the register, so post and inspectors reach it there. checked 2026-09-23. Bolagsverket, vardefulla datamangder (bulkfil)
Relationships
2 relationship(s) on file. Each line names the other party, the relationship as its source records it, and the source. A record of a relationship is not a finding about control beyond what it literally says.
Recorded in a source
- Celsiusgatan 43, 20120, Malmö: Holds the site's permit, registry number SE1108025. TRACES NT, European Commission register of approved establishments (DG SANTE)
- Umea: Manufactures at the site. EudraGMDP, EU register of GMP certificates (EMA)
Import rules for these goods
Product-specific import rules not established for the catalog category Tıbbi ve Sağlık Malzemeleri: neither the company's own description nor an official activity code shows that its own goods are of this kind. A catalog category alone is our classification, not proof of what the company makes or sells.