01 1Cipla
01 1LEFLUNOMIDE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2016-02-18
Pay. Date : 2015-08-21
DMF Number : 16109
Submission : 2002-08-23
Status : Active
Type : II
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Cipla 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 LEFLUNOMIDE USP, with a corresponding US DMF Number 16109.
Remarkably, this DMF maintains an Active status since its submission on August 23, 2002, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 18, 2016, and payment made on August 21, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II
