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List of Drug Master Files (DMF) for 25517 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 ATAZANAVIR SULFATE 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
25517
Active
2011-12-06
Complete
2015-10-07
2015-09-24
II
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Looking for Drug Master Files (DMF) for 25517 of Apitoria Pharma Private Ltd

Looking for Drug Master Files (DMF) for 25517 of Apitoria Pharma Private Ltd 1

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Apitoria 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 ATAZANAVIR SULFATE USP (NON-STERILE DRUG SUBSTANCE), with a corresponding US DMF Number 25517.

Remarkably, this DMF maintains an Active status since its submission on December 06, 2011, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of October 07, 2015, and payment made on September 24, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II

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