At the end of the current inspection, a 'Form 483' was issued with 5 observations which are procedural in nature and no data integrity issues were reported
Earlier in July 2025, Dazublys has received the marketing authorisation in the European Union from the European Commission
The transaction aligns with Aurobindo’s strategic objective to expand its U.S. manufacturing footprint by enhancing its existing domestic capabilities
CuraTeQ Biologics receives approval for biosimilar Zefylti from UK’s MHRA
Trastuzumab specifically binds and inhibits the human epidermal growth factor receptor 2 (HER2) protein
Dasatinib Tablets is indicated for the treatment of (i) newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia
The product will be launched in Q1FY26
The company does not expect this development to have any material impact on the current business operations
This study enrolled a total of 204 healthy volunteers into three groups to compare BP16 with the reference products, Prolia, obtained from both the EU and US markets
Prior to joining Neuland, Deshmukh held several key positions at Cipla
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