01 1Wockhardt
01 1PALONOSETRON HYDROCHLORIDE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2017-01-05
Pay. Date : 2016-10-24
DMF Number : 30955
Submission : 2016-10-19
Status : Active
Type : II
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Wockhardt Bio Ag, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.
One of their notable products is PALONOSETRON HYDROCHLORIDE USP, with a corresponding US DMF Number 30955.
Remarkably, this DMF maintains an Active status since its submission on October 19, 2016, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 05, 2017, and payment made on October 24, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II
