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List of Drug Master Files (DMF) for 30551 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 CHLORTHALIDONE 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
30551
Active
2016-05-24
Complete
2017-03-22
2016-08-19
II
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Looking for Drug Master Files (DMF) for 30551 of Amoli Organics Private Ltd

Looking for Drug Master Files (DMF) for 30551 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 CHLORTHALIDONE USP, with a corresponding US DMF Number 30551.

Remarkably, this DMF maintains an Active status since its submission on May 24, 2016, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of March 22, 2017, and payment made on August 19, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II

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