01 1Sun Pharmaceutical Industries Limited
01 1BUPROPION HYDROCHLORIDE USP (PROCESS-II)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2024-05-29
Pay. Date : 2024-04-30
DMF Number : 39414
Submission : 2024-05-06
Status : Active
Type : II
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Sun Pharmaceutical Industries 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 BUPROPION HYDROCHLORIDE USP (PROCESS-II), with a corresponding US DMF Number 39414.
Remarkably, this DMF maintains an Active status since its submission on May 06, 2024, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 29, 2024, and payment made on April 30, 2024, indicating their dedication to facilitating drug approvals, Categorized as Type II
