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List of Drug Master Files (DMF) for 29057 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Changzhou Pharmaceutical Factory (1)

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01 ATORVASTATIN CALCIUM (TRIHYDRATE) (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
29057
Active
2015-02-03
Complete
2015-07-13
2015-02-11
II
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Looking for Drug Master Files (DMF) for 29057 of Changzhou Pharmaceutical Factory

Looking for Drug Master Files (DMF) for 29057 of Changzhou Pharmaceutical Factory 1

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Changzhou Pharmaceutical Factory, based in China, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is ATORVASTATIN CALCIUM (TRIHYDRATE), with a corresponding US DMF Number 29057.

Remarkably, this DMF maintains an Active status since its submission on February 03, 2015, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of July 13, 2015, and payment made on February 11, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II

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