01 1Ipca Laboratories
01 1ALENDRONATE SODIUM USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-11-14
Pay. Date : 2013-07-30
DMF Number : 21008
Submission : 2007-12-03
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 ALENDRONATE SODIUM USP, with a corresponding US DMF Number 21008.
Remarkably, this DMF maintains an Active status since its submission on December 03, 2007, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 14, 2013, and payment made on July 30, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
