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List of Drug Master Files (DMF) for 18719 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 AZITHROMYCIN MONOHYDRATE USP (1)

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01 India (1)

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01 Active (1)

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01 Blank (1)

URL Supplier Web Content
18719
Active
2005-08-31
N/A
II
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Looking for Drug Master Files (DMF) for 18719 of Alembic Pharmaceuticals Ltd

Looking for Drug Master Files (DMF) for 18719 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 AZITHROMYCIN MONOHYDRATE USP, with a corresponding US DMF Number 18719.

Remarkably, this DMF maintains an Active status since its submission on August 31, 2005, highlighting commitment to regulatory compliance.

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