CEP Suspensions and Withdrawal due to GMP Deviations

The EDQM, the European Directorate for the Quality of Medicines and Healthcare, has suspended and withdrawn a number of Certificates of Suitability (CEP) between September and November 2011. When the EDQM withdraws or suspends a CEP, the marketing authorisation holder must take the necessary measures to ensure that active substances from the concerned active substance manufacturer are not used, either permanently or for a defined period. The Danish Medicines Agency in addition requires that if any medicines on the market contain this active substance from the concerned active substance manufacturer, the marketing authorisation holder must report the product defect to the Danish Medicines Agency.

The following CEP has been suspended due to a failure to comply with a declaration of willingness to be inspected and/or to operate according to EU GMP (e.g. refusal, of inspection, reconstruction/restoration of site(s), to achieve GMP level, and temporary closure):

Substance Name CEP Number
Theophylline CEP RI-1998-094-Rev 01

The manufacturer concerned is: Bakul Aromatics And Chemicals Ltd, A/6 Mide Patalganga Ind Area, Raigad District, India-410 220 Kaire

The following CEPs have been suspended following an inspection of the manufacturing site:

Substance Name CEP Number
Oxytetracycline dihydrate CEP 2002-211-Rev 00
Oxytetracycline Hydrochloride CEP 2002-070-Rev 01
Oxytetracycline Hydrochloride CEP 2001-125-Rev 00

 The manufacturer concerned is: Huashu Pharmaceutical Corporation , 29 Gaoying Street, China-050 031 Shijiazhuang, Hebei

Substance Name CEP Number
Protamine Sulphate CEP 2000-162-Rev 00

The manufacturers concerned are:

  • Biochem Corporation, Tamagawa Plant, 2146-3 Tamagawa, Tokigawa-machi, Japan-355-0342 Hiki-Gun, Saitama and
  • Biochem Corporation, Kawagoe Plant, 84-2 Hiratsuka Kawagoe, Japan-350 0814 Saitama

Substance Name CEP Number
Isosorbide mononitrate, diluted CEP 2002-104-Rev 01

The manufacturer concerned is: J P Laboratories Private Ltd, India 413801 Daund

Substance Name CEP Number
Protamine sulfate CEP 2000-162-Rev 00

The manufacturer concerned is Biochem Corporation, Japan, 350-0814 Saitama

The following CEP has been withdrawn as a result of an inspection of the manufacturing site:

Substance Name CEP Number
Paclitaxel Isolated from natural sources CEP 2008-005-Rev 00

The manufacturer concerned is: TAIHUA NATURAL PLANT PHARMACEUTICAL CO., LTD. China, 726 100 Shangzhou

The following CEPs have been withdrawn due to a failure to fulfill the requirements of the CEP procedure with regard to updating the application and complying with GMP:

Substance Name CEP Number
Ribavirin CEP 2009-257

The manufacturer concerned is: ERREDUE S.P.A., 24040 Isso, Italy

Substance Name CEP Number
Tiamulin Hydrogen for veterinary use CEP 2007-008

The manufacturer concerned is: Erredue S.P.A., Via Cascina Secchi 217, 24040 Isso, Bergamo, Italy

Source Press Release EDQM and Danish Medicines Agency

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