01 1Aurobindo Pharma Limited
01 1ROFLUMILAST
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2018-06-29
Pay. Date : 2018-06-04
DMF Number : 32851
Submission : 2018-06-01
Status : Active
Type : II
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Apitoria Pharma Private 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, with a corresponding US DMF Number 32851.
Remarkably, this DMF maintains an Active status since its submission on June 01, 2018, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of June 29, 2018, and payment made on June 04, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II
