01 1Fresenius Kabi Oncology Limited
01 1BELINOSTAT
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2018-03-01
Pay. Date : 2017-12-05
DMF Number : 32260
Submission : 2018-01-05
Status : Active
Type : II
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Fresenius Kabi Oncology Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA and WHO-GMP.
One of their notable products is BELINOSTAT, with a corresponding US DMF Number 32260.
Remarkably, this DMF maintains an Active status since its submission on January 05, 2018, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 01, 2018, and payment made on December 05, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II
