European drug regulator suspends CEP certificate for Anuh Pharma's 3 products

The ad hoc committee of the European Directorate for the Quality of Medicines & HealthCare (EDQM) has suspended the Certificate of Suitability (CEP) of Anuh Pharma’s three APIs - erythromycin ethyl succinate, erythromycin and pyrazinamide – following the inspection of the company’s manufacturing site at Boisar, near Mumbai. The committee has also decided to close the application for a certificate of suitability of erythromycin stearate.
 
“Following the inspection of manufacturing site of Anuh Pharma Ltd at Boisar, the EDQM ad hoc committee has taken the decision to suspend the Certificate of Suitability of erythromycin ethyl succinate, erythromycin & pyrazinamide, and to close the application for a certificate of suitability of erythromycin stearate,” said Anuh Pharma in a BSE filing.
   
A Certificate of Suitability (CEP) confirms that pharmaceutical substances or active pharmaceutical ingredients (APIs) are produced according to the monographs of the EP and is must for marketing products in the European countries.
 
According to Anuh Pharma, the company can request a hearing in order to ask the EDQM ad hoc committee to review its decision. “The company appreciate the efforts of EDQM to ensure GMP compliance through the CEP programme and the company wish to work in the spirit of partnership with EDQM. The company is fully committed in resolving this issue at the earliest,” said Anuh Pharma.
 
Anuh Pharma Ltd, a manufacturer of APIs, is one of the largest producers of macrolides in the country.