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List of Drug Master Files (DMF) for 26280 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 MONOHYDROCHLORIDE (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
26280
Active
2012-08-02
Complete
2021-02-26
2021-02-23
II
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Looking for Drug Master Files (DMF) for 26280 of Shanghai Ajinomoto Amino Acid Co Ltd

Looking for Drug Master Files (DMF) for 26280 of Shanghai Ajinomoto Amino Acid Co Ltd 1

20

Shanghai Ajinomoto Amino Acid Co Ltd, 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 MONOHYDROCHLORIDE, with a corresponding US DMF Number 26280.

Remarkably, this DMF maintains an Active status since its submission on August 02, 2012, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of February 26, 2021, and payment made on February 23, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II

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