01 1Ipca Laboratories
01 1MESALAMINE USP (PROCESS II)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-11-14
Pay. Date : 2013-06-06
DMF Number : 22617
Submission : 2010-04-03
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 MESALAMINE USP (PROCESS II), with a corresponding US DMF Number 22617.
Remarkably, this DMF maintains an Active status since its submission on April 03, 2010, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 14, 2013, and payment made on June 06, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
