01 1Ipca Laboratories
01 1RISPERIDONE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-19
Pay. Date : 2012-12-10
DMF Number : 22911
Submission : 2009-07-15
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 RISPERIDONE USP, with a corresponding US DMF Number 22911.
Remarkably, this DMF maintains an Active status since its submission on July 15, 2009, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 19, 2013, and payment made on December 10, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II
