01 1Sun Pharmaceutical Industries Limited
01 1NALOXONE HYDROCHLORIDE DIHYDRATE USP (PROCESS II)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2021-12-16
Pay. Date : 2021-11-22
DMF Number : 36432
Submission : 2021-11-19
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 NALOXONE HYDROCHLORIDE DIHYDRATE USP (PROCESS II), with a corresponding US DMF Number 36432.
Remarkably, this DMF maintains an Active status since its submission on November 19, 2021, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 16, 2021, and payment made on November 22, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II
