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List of Drug Master Files (DMF) for 16992 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 GANCICLOVIR SODIUM (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 16992 of Excella Gmbh And Co Kg

Looking for Drug Master Files (DMF) for 16992 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 GANCICLOVIR SODIUM, with a corresponding US DMF Number 16992.

Remarkably, this DMF maintains an Active status since its submission on November 17, 2003, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of October 05, 2013, and payment made on September 26, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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