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List of Drug Master Files (DMF) for 6215 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Asahi Kasei Finechem (1)

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01 CYTARABINE (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
6215
Active
1986-01-23
Complete
2017-06-30
2017-06-08
II
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Looking for Drug Master Files (DMF) for 6215 of Asahi Kasei Finechem Co Ltd

Looking for Drug Master Files (DMF) for 6215 of Asahi Kasei Finechem Co Ltd 1

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Asahi Kasei Finechem 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 CYTARABINE, with a corresponding US DMF Number 6215.

Remarkably, this DMF maintains an Active status since its submission on January 23, 1986, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of June 30, 2017, and payment made on June 08, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II

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