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List of Drug Master Files (DMF) for 33431 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 BUSPIRONE HYDROCHLORIDE 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
33431
Active
2018-12-28
Complete
2019-02-25
2018-12-20
II
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Looking for Drug Master Files (DMF) for 33431 of Zydus Lifesciences Ltd

Looking for Drug Master Files (DMF) for 33431 of Zydus Lifesciences Ltd 1

20

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 BUSPIRONE HYDROCHLORIDE USP, with a corresponding US DMF Number 33431.

Remarkably, this DMF maintains an Active status since its submission on December 28, 2018, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of February 25, 2019, and payment made on December 20, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II

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