01 1Sun Pharmaceutical Industries Limited
01 1NALTREXONE HYDROCHLORIDE USP (DIHYDRATE FORM) (PROCESS-II)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2022-04-22
Pay. Date : 2021-12-03
DMF Number : 36560
Submission : 2022-03-17
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 NALTREXONE HYDROCHLORIDE USP (DIHYDRATE FORM) (PROCESS-II), with a corresponding US DMF Number 36560.
Remarkably, this DMF maintains an Active status since its submission on March 17, 2022, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of April 22, 2022, and payment made on December 03, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II
