EMA API Registration Certificates of Non-EEA Sites

$179 / year

The European Medicines Agency (EMA) API Registration Certificates of Non-EEA Sites dataset includes API sites registration certificates delivered by EMA or national competent authorities to European Economic Area countries API manufacturers.

Complexity

Manufacturers of active substances intended for the manufacture of human medicines for the EU market must register with the national competent authority of the Member State where API will be imported.
Active substance manufacturers must comply with good manufacturing practices (GMP). In addition, the manufacturer of the finished product is obliged to ensure that the active substances they use have been manufactured in compliance with GMP.
Importers are responsible to ensure that the third country manufacturer they are importing from comply with GMP.
For active substance manufacturing sites located in countries outside the EEA, a Member State which is the supervisory authority for a medicinal product has also the responsibility for supervision and inspection of the active substance manufacturers associated with the medicinal product.

Date Created

2011

Last Modified

2019-11-19

Version

2019-11-19

Update Frequency

Daily

Temporal Coverage

N/A

Spatial Coverage

European Economic Area Countries

Source

John Snow Labs; European Medicines Agency (EMA), EudraGMP;

Source License URL

Source License Requirements

N/A

Source Citation

N/A

Keywords

Non-EEA Active Substance GMP, EMA Active Substance GMP, Active Substance Inspection, European Medicines Agency Registration, European Medicines Agency API Certificates

Other Titles

EMA API GMP Certificates of Non-EEA Countries, API Sites Certificates of Non-EEA Countries

NameDescriptionTypeConstraints
API_Registration_NumberAPI site registration numberstringrequired : 1
EudraGMDP_Document_Reference_NumberThe EudraGMDP document reference numberintegerlevel : Nominal required : 1
EEA_SiteEuropean economic area site.stringrequired : 1
EEA_Site_CountryEuropean economic area country.stringrequired : 1
EudraGMDP_Site_Reference_NumberThe EudraGMDP site reference numberintegerlevel : Nominal
Third_Country_SiteNon-EEA sitestringrequired : 1
Third_Country_Site_AddressNon-EEA site addressstringrequired : 1
Third_Country_Site_CountryNon-EEA site countrystringrequired : 1
Last_Updated_ByLast updated submitterstringrequired : 1
Competent_AuthorityCompetent authority namestringrequired : 1
API Registration NumberEudraGMDP Document Reference NumberEEA SiteEEA Site CountryEudraGMDP Site Reference NumberThird Country SiteThird Country Site AddressThird Country Site CountryLast Updated ByCompetent Authority
AMA - 56/201914555FARMAKA S.R.L.Italy (IT)54976API CORPORATION, Yoshitomi Plant955, Oaza-Koiwai, Yoshitomi-cho, Chikujo-gunItaly (IT)54976IT_AIFA
AMA - 56/201914555FARMAKA S.R.L.Italy (IT)54976AMANO ENZYME INC.27, Hanno, KunotsuboItaly (IT)54976IT_AIFA
AMA - 56/201914555FARMAKA S.R.L.Italy (IT)54976CENTAUR PHARMACEUTICALS PVT LTDPlot No 75, 76, 76/1, Chikhloli, MIDC, Ambernath (west)Italy (IT)54976IT_AIFA
API - 86/20169348OLON S.P.A.Italy (IT)37136DISHMAN PHARMACEUTICAL AND CHEMICALS LTDBavla, Survey No. 47, Paiki sub plot No. 1, Lodariyal Taluka, AhmedabadItaly (IT)37136IT_AIFA
API - 86/20169348OLON S.P.A.Italy (IT)37136YUIL PHARM TECH CO. LTD365-1 Sinwol-ri, Jincheon-gunItaly (IT)37136IT_AIFA
API - 86/20169348OLON S.P.A.Italy (IT)37136IPCA LABORATORIES LTDNo. 48, Kandivli Industrial Estate, Kandivli (West)Italy (IT)37136IT_AIFA
API - 123/20155827SANOFI S.P.A.Italy (IT)34053HENAN TOPFOND PHARMACEUTICAL CO. LTDNo. 1199 Jiaotong Road (West), Yicheng DistrictItaly (IT)34053IT_AIFA
API - 123/20155827SANOFI S.P.A.Italy (IT)34053CKD Bio Corporation292, Sinwon-ro, Danwon-guItaly (IT)34053IT_AIFA
140/WTC0539/API/165846Cornelius Polska Sp. z.o.o.Poland (PL)41096Bloomage Freda Biopharm Co. Ltd.High - Tech Development ZonePoland (PL)41096PL_GIF
806-1/2018-1614735MGC PHARMACEUTICALS pridelovanje rastlin in trgovina d.o.o.Slovenia (SI)52275Linnea SAVia Cantonale,Slovenia (SI)52275SI_ARSZMP