01 1Aurobindo Pharma Limited
01 1MONTELUKAST SODIUM USP (NON-STERILE DRUG SUBSTANCE)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-28
Pay. Date : 2013-07-02
DMF Number : 27234
Submission : 2013-07-09
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 MONTELUKAST SODIUM USP (NON-STERILE DRUG SUBSTANCE), with a corresponding US DMF Number 27234.
Remarkably, this DMF maintains an Active status since its submission on July 09, 2013, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 28, 2013, and payment made on July 02, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
