01 1Alembic Pharmaceuticals Limited
01 1PIRFENIDONE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2018-09-03
Pay. Date : 2018-06-05
DMF Number : 32772
Submission : 2018-06-28
Status : Active
Type : II
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Alembic Pharmaceuticals 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 32772.
Remarkably, this DMF maintains an Active status since its submission on June 28, 2018, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 03, 2018, and payment made on June 05, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II
