SeQuent Scientific gets CEP for its generic API Diclazuril in EU
Diclazuril is an antiprotozoal drug to treat coccidiosis in livestock and equine protozoal myeloencephalitis caused by Sarcocystis neurona in horses
SeQuent Scientific announced that it has received ‘Certificate of Suitability’ (CEP) for its generic active pharma ingredient (API) Diclazuril in the EU.
Diclazuril is an antiprotozoal drug and is a preferred drug of choice for treating coccidiosis in livestock due to zero-day withdrawal period. It is also used in horses to treat equine protozoal myeloencephalitis caused by Sarcocystis neurona.
Sequent/Alivira is the second company in the world to receive approval for Diclazuril from the European Directorate for the Quality of Medicines (EDQM). The product was also recently commercialised in the US with supplies to the innovator. This is Alivira’s 11th CEP approval from the EDQM.
Further, the company also has 21 filings for veterinary APIs in the US, making it the largest portfolio for the regulated markets in the animal health Industry.
Diclazuril is manufactured at Alivira’s Vizag facility, the only US FDA approved veterinary API site in India.