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List of Drug Master Files (DMF) for 24847 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 EFAVIRENZ [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
24847
Active
2011-04-08
Complete
2013-12-17
2013-05-08
II
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Looking for Drug Master Files (DMF) for 24847 of Acebright India Pharma Private Ltd

Looking for Drug Master Files (DMF) for 24847 of Acebright India Pharma Private Ltd 1

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Acebright 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 EFAVIRENZ [DRUG SUBSTANCE (NON-STERILE)], with a corresponding US DMF Number 24847.

Remarkably, this DMF maintains an Active status since its submission on April 08, 2011, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of December 17, 2013, and payment made on May 08, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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