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List of Drug Master Files (DMF) for 25054 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Acebright India Pharma Private Limited (1)

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01 CAPECITABINE USP [DRUG SUBSTANCE (NON-STERILE)] (1)

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01 India (1)

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01 Active (1)

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01 Complete (1)

URL Supplier Web Content
25054
Active
2011-06-14
Complete
2017-02-06
2016-09-09
II
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Looking for Drug Master Files (DMF) for 25054 of Cdymax India Pharma Private Ltd

Looking for Drug Master Files (DMF) for 25054 of Cdymax India Pharma Private Ltd 1

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Cdymax India Pharma Private Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is CAPECITABINE USP [DRUG SUBSTANCE (NON-STERILE)], with a corresponding US DMF Number 25054.

Remarkably, this DMF maintains an Active status since its submission on June 14, 2011, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of February 06, 2017, and payment made on September 09, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II

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