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List of Drug Master Files (DMF) for 28120 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Chemische Fabrik Berg (1)

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01 METHENAMINE HIPPURATE (1)

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01 Germany (1)

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01 Active (1)

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01 Complete (1)

URL Supplier Web Content
28120
Active
2014-04-04
Complete
2014-10-27
2014-03-28
II
Moehs Chemische Fabrik Berg

2024 ACI Convention

Not Confirmed

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Looking for Drug Master Files (DMF) for 28120 of Chemische Fabrik Berg Gmbh

Looking for Drug Master Files (DMF) for 28120 of Chemische Fabrik Berg Gmbh 1

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Chemische Fabrik Berg Gmbh, based in Germany, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is METHENAMINE HIPPURATE, with a corresponding US DMF Number 28120.

Remarkably, this DMF maintains an Active status since its submission on April 04, 2014, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of October 27, 2014, and payment made on March 28, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II

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