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List of Drug Master Files (DMF) for 21439 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Amoli Organics (1)

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01 VENLAFAXINE 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
21439
Active
2008-03-14
Complete
2019-11-14
2019-11-08
II
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Looking for Drug Master Files (DMF) for 21439 of Amoli Organics Private Ltd

Looking for Drug Master Files (DMF) for 21439 of Amoli Organics Private Ltd 1

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Amoli Organics 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 VENLAFAXINE HYDROCHLORIDE USP, with a corresponding US DMF Number 21439.

Remarkably, this DMF maintains an Active status since its submission on March 14, 2008, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of November 14, 2019, and payment made on November 08, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II

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