01 1Bal Pharma
01 1BEPOTASTINE BESILATE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-06
Pay. Date : 2013-08-16
DMF Number : 27350
Submission : 2013-08-14
Status : Active
Type : II
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Bal Pharma Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.
They are recognized for Bal Pharma, leading manufacturer of niche & specialty API, Intermediates and Finished Formulations.
One of their notable products is BEPOTASTINE BESILATE, with a corresponding US DMF Number 27350.
Remarkably, this DMF maintains an Active status since its submission on August 14, 2013, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 06, 2014, and payment made on August 16, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
