EDQM, the European Directorate for the Quality of Medicines and Healthcare, has suspended the following Certificates of Suitability (CEP):
- CEP 2000-055 Diclofenac NA
- CEP 2005-072 Metformin HCL.
The manufacturer concerned is:
Aaarti Drugs Limited
Plot No. G-60
M.I.D.C, Tarapur
Tal. Palghar, District Thane
India-401 506 Tarapur, Maharashtra.
The EDQM has moreover removed the manufacturer concerned from the following Certificates of Suitability (CEPs), but the CEPs are still valid for alternative manufacturing sites:
- CEP 2005-119 Ciprofloxacin HCL
- CEP 2002-082 Zolpidem Tartrate.
If 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.
If any medicines on the market contain these active substances from the concerned active substance manufacturers, the marketing authorisation holder must report the product defect to the Danish Health and Medicines Authority at rapidalert@dkma.dk.
Please find additional information on EDQM's website.
