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01 1Hangzhou APIChem Technology

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PharmaCompass

Looking for Drug Master Files (DMF) for 36773 of Apichem Laboratories Private Ltd

Looking for Drug Master Files (DMF) for 36773 of Apichem Laboratories Private Ltd 1

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Apichem Laboratories Private Ltd, based in China, is a pharmaceutical company.

One of their notable products is BEMPEDOIC ACID, with a corresponding US DMF Number 36773.

Remarkably, this DMF maintains an Active status since its submission on February 28, 2022, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of September 18, 2023, and payment made on August 18, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II