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01 1Aurobindo Pharma Limited
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01 1ISOSULFAN BLUE
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01 1India
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01 1Active
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01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-24
Pay. Date : 2013-12-23
DMF Number : 27795
Submission : 2013-12-21
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 ISOSULFAN BLUE, with a corresponding US DMF Number 27795.
Remarkably, this DMF maintains an Active status since its submission on December 21, 2013, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 24, 2014, and payment made on December 23, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II