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List of Drug Master Files (DMF) for 32343 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 CARMUSTINE 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
32343
Active
2017-12-26
Complete
2018-01-25
2017-12-22
II
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Looking for Drug Master Files (DMF) for 32343 of Aurobindo Pharma Ltd

Looking for Drug Master Files (DMF) for 32343 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 CARMUSTINE USP, with a corresponding US DMF Number 32343.

Remarkably, this DMF maintains an Active status since its submission on December 26, 2017, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of January 25, 2018, and payment made on December 22, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II

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