01 1Aurobindo Pharma Limited
01 1MELPHALAN HYDROCHLORIDE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2022-06-15
Pay. Date : 2022-06-03
DMF Number : 37179
Submission : 2022-06-04
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 MELPHALAN HYDROCHLORIDE, with a corresponding US DMF Number 37179.
Remarkably, this DMF maintains an Active status since its submission on June 04, 2022, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of June 15, 2022, and payment made on June 03, 2022, indicating their dedication to facilitating drug approvals, Categorized as Type II
