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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 BACLOFEN, with a corresponding US DMF Number 7311.
Remarkably, this DMF maintains an Active status since its submission on February 02, 1988, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 23, 2013, and payment made on July 10, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II