European drug regulator suspends Anuh Pharma's three drugs
New Delhi : Drug firm Anuh Pharma said that following the inspection of it's manufacturing site at Boisar in Maharashtra, European Directorate for the Quality of Medicines and Healthcare (EQDM) has suspended certificate of suitability for it's three drugs.
"The EDQM Ad Hoc Committee has taken the decision to suspend the certificate of suitability for Erythromycin Ethyl Succinate, Erythromycin and Pyrazinamide," Anuh Pharma said in a regulatory filing.
The committee has also decide to close the application for a certificate of suitability of Erythromycin Stearate, it said.
"According to the resolution, they have given us the possibility to request a hearing in order to ask the EDQM Ad Hoc Committee to review its decision," the drug firm said.
The company is fully and wholly committed to GMP compliance and is fully committed in resolving this issue at the earliest, it added.
In another filing, Anuh Pharma said "the company does not expects significant effect on its top and bottom line since the company have very good presence in Indian and rest of world's market".
"The EDQM Ad Hoc Committee has taken the decision to suspend the certificate of suitability for Erythromycin Ethyl Succinate, Erythromycin and Pyrazinamide," Anuh Pharma said in a regulatory filing.
The committee has also decide to close the application for a certificate of suitability of Erythromycin Stearate, it said.
"According to the resolution, they have given us the possibility to request a hearing in order to ask the EDQM Ad Hoc Committee to review its decision," the drug firm said.
The company is fully and wholly committed to GMP compliance and is fully committed in resolving this issue at the earliest, it added.
In another filing, Anuh Pharma said "the company does not expects significant effect on its top and bottom line since the company have very good presence in Indian and rest of world's market".
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