01 1Acebright India Pharma Private Limited
01 1CAPECITABINE USP [DRUG SUBSTANCE (NON-STERILE)]
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2017-02-06
Pay. Date : 2016-09-09
DMF Number : 25054
Submission : 2011-06-14
Status : Active
Type : II
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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
