Anuh Pharma Ltd. recently said that after the inspection of it's manufacturing site at Boisar in Maharashtra, the European Directorate for the Quality of Medicines and Healthcare (EQDM) has suspended the certificate of suitability for the company'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 stated in a regulatory filing to the BSE Tuesday. It also said that the committee had decided to close the application for a certificate of suitability of Erythromycin Stearate.
According to the EDQM, the role of a certificate of suitability (CEP) is to certify the compliance of a material with the requirements laid down in the relevant monograph of the European Pharmacopoeia. The active pharmaceutical ingredients (API) for which a CEP has been granted are suitable for use in medicinal products.
According to the company's website, Erythromycin Ethyl Succinate and Erythromycin are anti-bacterial drugs, while Pyrazinamide is an anti-tuberculous drug.
"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 company stated in the filing.
In another filing, Anuh Pharma stated, "...The company does not expect significant effect on its top and bottom line since the company have very good presence in Indian and rest of world's market."
The shares of Anuh Pharma Ltd. Tuesday closed at Rs 215.20 at the BSE, down Rs 23.50 or 9.84 percent.
Anuh Pharma is one of the leading manufacturers of API and one of the largest producers of macrolide antibiotics in the country.