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01 1Azico Biophore India Pvt. Ltd

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PharmaCompass

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GDUFA

DMF Review : Complete

Rev. Date : 2021-03-24

Pay. Date : 2021-03-17

DMF Number : 35592

Submission : 2021-02-16

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 35592 of Azico Biophore India Pvt Ltd

Looking for Drug Master Files (DMF) for 35592 of Azico Biophore India Pvt Ltd 1

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Azico Biophore India Pvt Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA.

One of their notable products is FAMOTIDINE, with a corresponding US DMF Number 35592.

Remarkably, this DMF maintains an Active status since its submission on February 16, 2021, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of March 24, 2021, and payment made on March 17, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II