01 1Fareva
01 1METHOTREXATE SODIUM
01 1Luxembourg
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2018-11-26
Pay. Date : 2018-11-16
DMF Number : 12472
Submission : 1997-04-11
Status : Active
Type : II
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Excella Gmbh And Co Kg, based in Luxembourg, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
They are recognized for Fareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.
One of their notable products is METHOTREXATE SODIUM, with a corresponding US DMF Number 12472.
Remarkably, this DMF maintains an Active status since its submission on April 11, 1997, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 26, 2018, and payment made on November 16, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II
