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List of Drug Master Files (DMF) for 28208 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 DICLOFENAC (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
28208
Active
2014-04-18
Complete
2014-09-12
2014-05-19
II
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Looking for Drug Master Files (DMF) for 28208 of Amoli Organics Pvt Ltd

Looking for Drug Master Files (DMF) for 28208 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 DICLOFENAC, with a corresponding US DMF Number 28208.

Remarkably, this DMF maintains an Active status since its submission on April 18, 2014, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of September 12, 2014, and payment made on May 19, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II

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