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List of Drug Master Files (DMF) for 24601 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Chongqing Carelife Pharmaceutical Co., Ltd. (1)

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01 ENTECAVIR HYDRATE USP, NON-STERILE BULK DRUG SUBSTANCE (1)

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01 China (1)

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01 Active (1)

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01 Complete (1)

URL Supplier Web Content
24601
Active
2011-01-28
Complete
2014-05-12
2013-05-21
II
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Looking for Drug Master Files (DMF) for 24601 of Chongqing Carelife Pharmaceutical Co Ltd

Looking for Drug Master Files (DMF) for 24601 of Chongqing Carelife Pharmaceutical Co Ltd 1

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Chongqing Carelife Pharmaceutical Co Ltd, based in China, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is ENTECAVIR HYDRATE USP, NON-STERILE BULK DRUG SUBSTANCE, with a corresponding US DMF Number 24601.

Remarkably, this DMF maintains an Active status since its submission on January 28, 2011, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of May 12, 2014, and payment made on May 21, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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