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01 1Chengdu Shengnuo Biopharm

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PharmaCompass

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BePharma
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BePharma
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GDUFA

DMF Review : Complete

Rev. Date : 2023-10-30

Pay. Date : 2023-09-19

DMF Number : 35812

Submission : 2021-04-06

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 35812 of Chengdu Shengnuo Biopharm Co Ltd

Looking for Drug Master Files (DMF) for 35812 of Chengdu Shengnuo Biopharm Co Ltd 1

20

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

One of their notable products is LINACLOTIDE, with a corresponding US DMF Number 35812.

Remarkably, this DMF maintains an Active status since its submission on April 06, 2021, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of October 30, 2023, and payment made on September 19, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II