01 1Saneca Pharmaceuticals
01 1NALTREXONE HYDROCHLORIDE
01 1Slovakia
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2025-11-17
Pay. Date : 2025-09-30
DMF Number : 41264
Submission : 2025-06-20
Status : Active
Type : II
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Saneca Pharmaceuticals As, based in Slovakia, is a pharmaceutical company that stands out with its certifications from EDQM.
One of their notable products is NALTREXONE HYDROCHLORIDE, with a corresponding US DMF Number 41264.
Remarkably, this DMF maintains an Active status since its submission on June 20, 2025, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 17, 2025, and payment made on September 30, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II
