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List of Drug Master Files (DMF) for 24997 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Aurobindo Pharma Limited (1)

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01 ARIPIPRAZOLE USP (NON-STERILE DRUG SUBSTANCE) (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
24997
Active
2011-06-07
Complete
2013-11-08
2013-09-04
II
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Looking for Drug Master Files (DMF) for 24997 of Aurobindo Pharma Ltd

Looking for Drug Master Files (DMF) for 24997 of Aurobindo Pharma Ltd 1

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Aurobindo Pharma 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 ARIPIPRAZOLE USP (NON-STERILE DRUG SUBSTANCE), with a corresponding US DMF Number 24997.

Remarkably, this DMF maintains an Active status since its submission on June 07, 2011, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of November 08, 2013, and payment made on September 04, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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