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List of Drug Master Files (DMF) for 20137 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Calyx Chemicals & Pharmaceuticals Limited (1)

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01 ERYTHROMYCIN (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
20137
Active
2006-12-14
Complete
2016-11-10
2016-09-27
II
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Looking for Drug Master Files (DMF) for 20137 of Calyx Chemicals And Pharmaceuticals Ltd

Looking for Drug Master Files (DMF) for 20137 of Calyx Chemicals And Pharmaceuticals Ltd 1

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Calyx Chemicals And Pharmaceuticals Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA and WHO-GMP.

One of their notable products is ERYTHROMYCIN, with a corresponding US DMF Number 20137.

Remarkably, this DMF maintains an Active status since its submission on December 14, 2006, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of November 10, 2016, and payment made on September 27, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II

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