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List of Drug Master Files (DMF) for 20338 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Fareva (1)

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01 ANASTROZOLE (1)

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01 Luxembourg (1)

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01 Active (1)

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01 Complete (1)

Looking for Drug Master Files (DMF) for 20338 of Excella Gmbh And Co Kg

Looking for Drug Master Files (DMF) for 20338 of Excella Gmbh And Co Kg 1

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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 ANASTROZOLE, with a corresponding US DMF Number 20338.

Remarkably, this DMF maintains an Active status since its submission on March 09, 2007, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of April 21, 2017, and payment made on August 10, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II

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