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List of Drug Master Files (DMF) for 18065 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Divis Laboratories (1)

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01 PROGUANIL HYDROCHLORIDE (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
18065
Active
2005-02-06
Complete
2014-12-16
2014-12-08
II
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Looking for Drug Master Files (DMF) for 18065 of Divi's Labotatories Ltd

Looking for Drug Master Files (DMF) for 18065 of Divi's Labotatories Ltd 1

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Divi's Labotatories 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 PROGUANIL HYDROCHLORIDE, with a corresponding US DMF Number 18065.

Remarkably, this DMF maintains an Active status since its submission on February 06, 2005, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of December 16, 2014, and payment made on December 08, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II

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