01 1Aurobindo Pharma Limited
01 1MODAFINIL USP (NON-STERILE DRUG SUBSTANCE)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-29
Pay. Date : 2013-09-23
DMF Number : 23898
Submission : 2010-06-29
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 MODAFINIL USP (NON-STERILE DRUG SUBSTANCE), with a corresponding US DMF Number 23898.
Remarkably, this DMF maintains an Active status since its submission on June 29, 2010, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 29, 2013, and payment made on September 23, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
