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01 1Axplora

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PharmaCompass

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  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAxplora is your partner of choice for complex APIs.

GDUFA

DMF Review : Complete

Rev. Date : 2014-02-21

Pay. Date : 2013-09-05

DMF Number : 25791

Submission : 2012-02-14

Status : Active

Type : II

Axplora CB

Looking for Drug Master Files (DMF) for 25791 of Farmabios Spa

Looking for Drug Master Files (DMF) for 25791 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 MELPHALAN HYDROCHLORIDE, with a corresponding US DMF Number 25791.

Remarkably, this DMF maintains an Active status since its submission on February 14, 2012, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of February 21, 2014, and payment made on September 05, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II