01 1Ipca Laboratories
01 1PROGUANIL HYDROCHLORIDE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-12-05
Pay. Date : 2013-07-30
DMF Number : 21475
Submission : 2008-06-16
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 PROGUANIL HYDROCHLORIDE USP, with a corresponding US DMF Number 21475.
Remarkably, this DMF maintains an Active status since its submission on June 16, 2008, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 05, 2013, and payment made on July 30, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
