01 1Aurobindo Pharma Limited
01 1PRASUGREL HYDROCHLORIDE USP (NON-STERILE DRUG SUBSTANCE)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-05
Pay. Date : 2013-03-18
DMF Number : 26951
Submission : 2013-03-30
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 PRASUGREL HYDROCHLORIDE USP (NON-STERILE DRUG SUBSTANCE), with a corresponding US DMF Number 26951.
Remarkably, this DMF maintains an Active status since its submission on March 30, 2013, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 05, 2013, and payment made on March 18, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
