01 1Megafine Pharma (P) Limited
01 1MIRABEGRON DRUG SUBSTANCE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2016-02-05
Pay. Date : 2015-09-30
DMF Number : 29773
Submission : 2015-09-25
Status : Active
Type : II
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Megafine Pharma P Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.
They are recognized for Megafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.
One of their notable products is MIRABEGRON DRUG SUBSTANCE, with a corresponding US DMF Number 29773.
Remarkably, this DMF maintains an Active status since its submission on September 25, 2015, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 05, 2016, and payment made on September 30, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II
