01 1R L Fine Chem
01 1DOXEPIN HYDROCHLORIDE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2023-04-03
Pay. Date : 2023-02-23
DMF Number : 34438
Submission : 2020-01-20
Status : Active
Type : II
20
R L Fine Chem Pvt Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA and WHO-GMP.
They are recognized for > 30 Yrs of Experience in Quality APIs & Intermediates Manufacturing
One of their notable products is DOXEPIN HYDROCHLORIDE, with a corresponding US DMF Number 34438.
Remarkably, this DMF maintains an Active status since its submission on January 20, 2020, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of April 03, 2023, and payment made on February 23, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II
