BDR Pharma gets CDSCO panel nod to market antineoplastic drug Azacitidine
New Delhi: The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) has shown a green flag to BDR Pharmaceuticals for the manufacturing and marketing of the antineoplastic drug Azacitidine.
This approval came after BDR Pharmaceuticals presented their proposal for manufacturing and marketing Azacitidine tablets 200mg, requesting a bioavailability/bioequivalence study (BA/BE) and clinical trial (CT) study waiver.
The firm further presented their proposal along with the dissolution profile and BCS data of the applied drug products, i.e., Azacitidine Tablets 200mg, before the committee.
Azacitidine is a pyrimidine nucleoside analogue used to treat certain subtypes of myelodysplastic syndrome. Myelodysplastic syndrome (MDS) is a type of malignancy in which immature blood cells in the bone marrow do not mature and do not become healthy blood cells.
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