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List of Drug Master Files (DMF) for 25849 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 HYDROCHLOROTHIAZIDE 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
25849
Active
2012-03-13
Complete
2016-05-09
2015-11-20
II
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Looking for Drug Master Files (DMF) for 25849 of Amoli Organics Private Ltd

Looking for Drug Master Files (DMF) for 25849 of Amoli Organics Private Ltd 1

20

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 HYDROCHLOROTHIAZIDE USP, with a corresponding US DMF Number 25849.

Remarkably, this DMF maintains an Active status since its submission on March 13, 2012, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of May 09, 2016, and payment made on November 20, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II

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