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List of Drug Master Files (DMF) for 32377 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Zydus Lifesciences (1)

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01 AZATHIOPRINE 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
32377
Active
2017-12-31
Complete
2019-04-22
2019-02-22
II
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Looking for Drug Master Files (DMF) for 32377 of Zydus Lifesciences Ltd

Looking for Drug Master Files (DMF) for 32377 of Zydus Lifesciences Ltd 1

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Zydus Lifesciences 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 AZATHIOPRINE USP, with a corresponding US DMF Number 32377.

Remarkably, this DMF maintains an Active status since its submission on December 31, 2017, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of April 22, 2019, and payment made on February 22, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II

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