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List of Drug Master Files (DMF) for 19056 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Anhui Wanbei Pharmaceutical Co.Ltd. (1)

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01 LINCOMYCIN HYDROCHLORIDE USP (1)

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01 China (1)

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01 Active (1)

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01 Complete (1)

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Digital Content Digital Content
URL Supplier Web Content
19056
Active
2005-12-08
Complete
2018-08-14
2018-07-19
II
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Looking for Drug Master Files (DMF) for 19056 of Xinyu Pharmaceutical Co Ltd

Looking for Drug Master Files (DMF) for 19056 of Xinyu Pharmaceutical Co Ltd 1

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Xinyu 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 LINCOMYCIN HYDROCHLORIDE USP, with a corresponding US DMF Number 19056.

Remarkably, this DMF maintains an Active status since its submission on December 08, 2005, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of August 14, 2018, and payment made on July 19, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II

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