01 1Cipla
01 1BOSENTAN MONOHYDRATE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2017-02-03
Pay. Date : 2016-09-28
DMF Number : 29029
Submission : 2015-03-13
Status : Active
Type : II
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Cipla 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 BOSENTAN MONOHYDRATE, with a corresponding US DMF Number 29029.
Remarkably, this DMF maintains an Active status since its submission on March 13, 2015, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 03, 2017, and payment made on September 28, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II
