01 1Aurobindo Pharma Limited
01 1PALONOSETRON HYDROCHLORIDE (NON-STERILE DRUG SUBSTANCE)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-03-20
Pay. Date : 2013-03-04
DMF Number : 25976
Submission : 2012-04-23
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 PALONOSETRON HYDROCHLORIDE (NON-STERILE DRUG SUBSTANCE), with a corresponding US DMF Number 25976.
Remarkably, this DMF maintains an Active status since its submission on April 23, 2012, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 20, 2013, and payment made on March 04, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
