Indian and Chinese API Manufacturers in the Focus of European Authorities

Indian and Chinese API Manufacturers in the Focus of European Authorities

The EudraGMP database was originally launched in April 2007 and is used to exchange information on compliance with the Good Manufacturing Practices (GMP) between the relevant regulatory authorities of the EU Member States – including Iceland, Liechtenstein and Norway. Since January 2011 the data of all national authorities can be accessed. Further, since April 2013 the database also contains information about GDP, why it is referred to as Eudra GMDP database now.

The database comprising the reports about deficiencies found in inspections by the European authorities – the “non-compliance reports” or, officially, “statement of non-compliance with GMP” – was extended by three reports last week: two of these reports related to Chinese firms, one report to a company in India. The inspections were conducted by inspectors of the Italian authority.

The inspection of the Indian site (antibiotic…