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01 1Synthetics China Company, Ltd.

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PharmaCompass

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GDUFA

DMF Review : Complete

Rev. Date : 2017-08-01

Pay. Date : 2017-07-19

DMF Number : 31800

Submission : 2017-05-18

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 31800 of Synthetics China Co Ltd

Looking for Drug Master Files (DMF) for 31800 of Synthetics China Co Ltd 1

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Synthetics China Co Ltd, based in China, is a pharmaceutical company that stands out with its certifications from FDA.

One of their notable products is SAXAGLIPTIN, with a corresponding US DMF Number 31800.

Remarkably, this DMF maintains an Active status since its submission on May 18, 2017, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of August 01, 2017, and payment made on July 19, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II