01 1Lupin Ltd
01 1TIOTROPIUM BROMIDE MONOHYDRATE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2016-04-20
Pay. Date : 2015-11-19
DMF Number : 29726
Submission : 2016-01-20
Status : Active
Type : II
20
Lupin Ltd, 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 TIOTROPIUM BROMIDE MONOHYDRATE, with a corresponding US DMF Number 29726.
Remarkably, this DMF maintains an Active status since its submission on January 20, 2016, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of April 20, 2016, and payment made on November 19, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II
