01 1Ipca Laboratories
01 1RISEDRONATE SODIUM HEMI-PENTAHYDRATE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-22
Pay. Date : 2013-08-08
DMF Number : 27252
Submission : 2013-07-17
Status : Active
Type : II
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Ipca Laboratories 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 RISEDRONATE SODIUM HEMI-PENTAHYDRATE USP, with a corresponding US DMF Number 27252.
Remarkably, this DMF maintains an Active status since its submission on July 17, 2013, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 22, 2014, and payment made on August 08, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
