01 1Micro Labs Limited
01 1APIXABAN
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2016-10-06
Pay. Date : 2016-08-16
DMF Number : 30619
Submission : 2016-08-12
Status : Active
Type : II
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Micro Labs 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 APIXABAN, with a corresponding US DMF Number 30619.
Remarkably, this DMF maintains an Active status since its submission on August 12, 2016, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 06, 2016, and payment made on August 16, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II
