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List of Drug Master Files (DMF) for 31451 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Alembic Pharmaceuticals Limited (1)

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01 ERYTHROMYCIN ETHYLSUCCINATE 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
31451
Active
2017-02-28
Complete
2017-03-23
2017-02-22
II
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Looking for Drug Master Files (DMF) for 31451 of Alembic Pharmaceuticals Ltd

Looking for Drug Master Files (DMF) for 31451 of Alembic Pharmaceuticals Ltd 1

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Alembic Pharmaceuticals 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 ERYTHROMYCIN ETHYLSUCCINATE USP, with a corresponding US DMF Number 31451.

Remarkably, this DMF maintains an Active status since its submission on February 28, 2017, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of March 23, 2017, and payment made on February 22, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II

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