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List of Drug Master Files (DMF) for 27121 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Covalent Laboratories Private Limited (1)

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01 CEFIXIME 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
27121
Active
2013-04-29
Complete
2017-03-28
2016-10-19
II
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Looking for Drug Master Files (DMF) for 27121 of Covalent Laboratories Private Ltd

Looking for Drug Master Files (DMF) for 27121 of Covalent Laboratories Private Ltd 1

20

Covalent Laboratories Private Ltd, based in India, is a pharmaceutical company.

One of their notable products is CEFIXIME USP, with a corresponding US DMF Number 27121.

Remarkably, this DMF maintains an Active status since its submission on April 29, 2013, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of March 28, 2017, and payment made on October 19, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II

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