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List of Drug Master Files (DMF) for 33001 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 RANOLAZINE (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
33001
Active
2018-07-30
Complete
2019-09-23
2019-09-11
II
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Looking for Drug Master Files (DMF) for 33001 of Amoli Organics Private Ltd

Looking for Drug Master Files (DMF) for 33001 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 RANOLAZINE, with a corresponding US DMF Number 33001.

Remarkably, this DMF maintains an Active status since its submission on July 30, 2018, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of September 23, 2019, and payment made on September 11, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II

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