01 1Zydus Lifesciences
01 1ROFLUMILAST USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2015-01-05
Pay. Date : 2014-10-14
DMF Number : 28657
Submission : 2014-10-31
Status : Active
Type : II
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Zydus Lifesciences 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 ROFLUMILAST USP, with a corresponding US DMF Number 28657.
Remarkably, this DMF maintains an Active status since its submission on October 31, 2014, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 05, 2015, and payment made on October 14, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
