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List of Drug Master Files (DMF) for 28984 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 TICAGRELOR (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
28984
Active
2015-01-14
Complete
2015-06-29
2015-01-16
II
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Looking for Drug Master Files (DMF) for 28984 of Changzhou Pharmaceutical Factory

Looking for Drug Master Files (DMF) for 28984 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 TICAGRELOR, with a corresponding US DMF Number 28984.

Remarkably, this DMF maintains an Active status since its submission on January 14, 2015, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of June 29, 2015, and payment made on January 16, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II

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