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01 1Axplora

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAxplora is your partner of choice for complex APIs.

GDUFA

DMF Review : Complete

Rev. Date : 2013-05-09

Pay. Date : 2012-12-05

DMF Number : 25593

Submission : 2011-12-15

Status : Active

Type : II

Axplora CB

Looking for Drug Master Files (DMF) for 25593 of Farmabios Spa

Looking for Drug Master Files (DMF) for 25593 of Farmabios Spa 1

20

Farmabios Spa, based in Germany, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

They are recognized for Axplora is your partner of choice for complex APIs.

One of their notable products is METHYLTESTOSTERONE (MICRONIZED), with a corresponding US DMF Number 25593.

Remarkably, this DMF maintains an Active status since its submission on December 15, 2011, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of May 09, 2013, and payment made on December 05, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II