01 1Macleods Pharmaceuticals Limited
01 1IBANDRONATE SODIUM MONOHYDRATE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-04-10
Pay. Date : 2013-09-23
DMF Number : 25793
Submission : 2012-04-09
Status : Active
Type : II
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Macleods Pharmaceuticals 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 IBANDRONATE SODIUM MONOHYDRATE, with a corresponding US DMF Number 25793.
Remarkably, this DMF maintains an Active status since its submission on April 09, 2012, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of April 10, 2014, and payment made on September 23, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
