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01 1Shivalik Rasayan

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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 : 2021-11-18

Pay. Date : 2021-08-27

DMF Number : 36171

Submission : 2021-08-19

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 36171 of Shivalik Rasayan Ltd

Looking for Drug Master Files (DMF) for 36171 of Shivalik Rasayan Ltd 1

20

Shivalik Rasayan Ltd, based in India, is a pharmaceutical company.

One of their notable products is BORTEZOMIB, with a corresponding US DMF Number 36171.

Remarkably, this DMF maintains an Active status since its submission on August 19, 2021, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of November 18, 2021, and payment made on August 27, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II