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List of Drug Master Files (DMF) for 31558 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Ajinomoto Company (1)

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01 L-LYSINE ACETATE (1)

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01 Japan (1)

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01 Active (1)

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01 Complete (1)

URL Supplier Web Content
31558
Active
2017-03-21
Complete
2021-08-27
2020-11-30
II
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Looking for Drug Master Files (DMF) for 31558 of Ajinomoto Health And Nutrition North America Inc

Looking for Drug Master Files (DMF) for 31558 of Ajinomoto Health And Nutrition North America Inc 1

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Ajinomoto Health And Nutrition North America Inc, based in Japan, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is L-LYSINE ACETATE, with a corresponding US DMF Number 31558.

Remarkably, this DMF maintains an Active status since its submission on March 21, 2017, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of August 27, 2021, and payment made on November 30, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II

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