Aurobindo Pharma arm gets European Commission authorization to market Dyrupeg in EU
Telangana: Aurobindo Pharma has announced that the European Commission (EC) has granted marketing authorization in the European Union (EU) for Dyrupeg, a pegylated filgrastim biosimilar, to CuraTeQ Biologics s.r.o., a wholly owned step-down subsidiary of the Company.
Earlier in January 2025, the Committee for Medicinal Products (CHMP) of European Medicines Agency had adopted positive opinion recommending the approval of Dyrupeg.
Read also: Aurobindo Pharma arm gets marketing authorisation for Zefylti in EU
Dyrupeg will be available as 6 mg solution for injection in prefilled syringe and is intended for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).
Read also: Aurobindo Pharma arm gets positive opinion for biosimilar Dyrupeg from EMA
CuraTeQ Biologics Private Limited (CuraTeQ), a subsidiary of Aurobindo Pharma Limited, is a global biopharmaceutical company headquartered in Hyderabad, India. It is focused on developing biosimilars for the treatment of various cancers and autoimmune diseases. CuraTeQ's pipeline consists of fourteen biosimilars, primarily targeting the immunology and oncology segments. It has end-to-end capabilities in producing a full range of products from bulk drug substance to fill finish and packaged drug products.
Its parent company, Aurobindo Pharma Limited is an integrated global pharmaceutical company headquartered in Hyderabad, India. The Company develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients globally in over 150 countries.
The company has 29 manufacturing and packaging facilities that are approved by regulatory agencies including USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, Brazil ANVISA. The Company’s product portfolio is spread over seven major therapeutic/product areas encompassing CNS, Anti-Retroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics and Anti-Allergic.
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