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01 1Archimica

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PharmaCompass

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  • fda
  • EDQM
  • WHO-GMP

Virtual BoothArchimica: Excellence in complex chemical technologies, regulatory-approved manufacturing, and API innovation.

GDUFA

DMF Review : Complete

Rev. Date : 2013-07-31

Pay. Date : 2013-07-18

DMF Number : 23704

Submission : 2010-04-12

Status : Active

Type : II

CB

Looking for Drug Master Files (DMF) for 23704 of Archimica Spa

Looking for Drug Master Files (DMF) for 23704 of Archimica Spa 1

20

Archimica Spa, based in Italy, is a pharmaceutical company that stands out with its certifications from FDA.

They are recognized for Archimica: Excellence in complex chemical technologies, regulatory-approved manufacturing, and API innovation.

One of their notable products is BROMFENAC SODIUM, with a corresponding US DMF Number 23704.

Remarkably, this DMF maintains an Active status since its submission on April 12, 2010, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of July 31, 2013, and payment made on July 18, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II