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List of Drug Master Files (DMF) for 18816 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 AMOXICILLIN USP (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
18816
Active
2005-08-31
Complete
2013-07-31
2013-07-19
II
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Looking for Drug Master Files (DMF) for 18816 of Apitoria Pharma Private Ltd

Looking for Drug Master Files (DMF) for 18816 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 AMOXICILLIN USP, with a corresponding US DMF Number 18816.

Remarkably, this DMF maintains an Active status since its submission on August 31, 2005, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of July 31, 2013, and payment made on July 19, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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