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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 BUSULFAN, with a corresponding US DMF Number 27006.
Remarkably, this DMF maintains an Active status since its submission on June 06, 2013, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 03, 2015, and payment made on July 10, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II