SeQuent receives CEP approval for Diclazuril API in the EU

Diclazuril is an antiprotozoal drug and is a preferred drug of choice for treating coccidiosis in livestock due to a zero-day withdrawal period.

Jan 28, 2021 05:01 IST India Infoline News Service

Sequent Scientific announced on Thursday that the company has received ‘Certificate of Suitability’ (CEP) for its generic active pharmaceutical 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 a zero-day withdrawal period. It is also used in horses to treat equine protozoal myeloencephalitis caused by Sarcocystis neurona.

According to the filing, 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

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