01 1R L Fine Chem
01 1AMITRIPTYLINE HYDROCHLORIDE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2017-03-22
Pay. Date : 2016-09-26
DMF Number : 18111
Submission : 2005-02-10
Status : Active
Type : II
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Rl 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 AMITRIPTYLINE HYDROCHLORIDE, with a corresponding US DMF Number 18111.
Remarkably, this DMF maintains an Active status since its submission on February 10, 2005, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 22, 2017, and payment made on September 26, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II
