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List of Drug Master Files (DMF) for 26483 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 CLOTRIMAZOLE 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
26483
Active
2012-10-12
Complete
2020-09-17
2016-03-16
II
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Looking for Drug Master Files (DMF) for 26483 of Amoli Organics Pvt Ltd

Looking for Drug Master Files (DMF) for 26483 of Amoli Organics Pvt Ltd 1

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Amoli Organics Pvt 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 CLOTRIMAZOLE USP, with a corresponding US DMF Number 26483.

Remarkably, this DMF maintains an Active status since its submission on October 12, 2012, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of September 17, 2020, and payment made on March 16, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II

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