Fresenius Kabi Oncology has immediately taken steps to implement remedial measures at company’s API plant located at Kalyani, Nadia district in West Bengal and has voluntarily put the production on hold. The company’s dosage form plants in Himachal Pradesh continue normal production.
The company has taken this step after a recent routine USFDA inspection at the said plant whereby USFDA made certain observations relating to GMP non-conformities in respect of manufacturing, documentation practices and product testing. However, all finished products conform to approved standards and specifications.
Dabur Pharma, a leading company for cancer research and oncology drugs, was renamed Fresenius Kabi Oncology after its acquisition by Fresenius Kabi, the leader in infusion therapy and clinical nutrition in Europe, Latin America, Asia Pacific as well as in the US, where it is a leading supplier of IV generic drugs.