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List of Drug Master Files (DMF) for 21805 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 CSPC Pharmaceutical Group (1)

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01 TRAMADOL HYDROCHLORIDE (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
21805
Active
2008-07-15
Complete
2018-07-13
2018-06-11
II
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Looking for Drug Master Files (DMF) for 21805 of Cspc Ouyi Pharmaceutical Co Ltd

Looking for Drug Master Files (DMF) for 21805 of Cspc Ouyi Pharmaceutical Co Ltd 1

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Cspc Ouyi 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 TRAMADOL HYDROCHLORIDE, with a corresponding US DMF Number 21805.

Remarkably, this DMF maintains an Active status since its submission on July 15, 2008, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of July 13, 2018, and payment made on June 11, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II

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