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List of Drug Master Files (DMF) for 20211 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 AMPICILLIN SODIUM USP (STERILE) BULK (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
20211
Active
2007-01-16
Complete
2014-05-26
2014-05-19
II
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Looking for Drug Master Files (DMF) for 20211 of Aurobindo Pharma Ltd

Looking for Drug Master Files (DMF) for 20211 of Aurobindo Pharma Ltd 1

20

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 AMPICILLIN SODIUM USP (STERILE) BULK, with a corresponding US DMF Number 20211.

Remarkably, this DMF maintains an Active status since its submission on January 16, 2007, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of May 26, 2014, and payment made on May 19, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II

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