01 1Shilpa Medicare
01 1PIRFENIDONE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2017-01-13
Pay. Date : 2016-09-20
DMF Number : 30952
Submission : 2016-09-20
Status : Active
Type : II
20
Shilpa Pharma Lifesciences 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 PIRFENIDONE, with a corresponding US DMF Number 30952.
Remarkably, this DMF maintains an Active status since its submission on September 20, 2016, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 13, 2017, and payment made on September 20, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II
