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01 1ZACH System SA

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothZach System is committed to providing Highly Customized Solutions for all your Development Programs.

GDUFA

DMF Review : Complete

Rev. Date : 2024-10-16

Pay. Date : 2024-10-08

DMF Number : 11105

Submission : 1994-09-26

Status : Active

Type : II

Zach System VB Company banner

Looking for Drug Master Files (DMF) for 11105 of Zach System Sa

Looking for Drug Master Files (DMF) for 11105 of Zach System Sa 1

20

Zach System Sa, based in France, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

They are recognized for Zach System is committed to providing Highly Customized Solutions for all your Development Programs.

One of their notable products is LOTEPREDNOL ETABONATE, with a corresponding US DMF Number 11105.

Remarkably, this DMF maintains an Active status since its submission on September 26, 1994, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of October 16, 2024, and payment made on October 08, 2024, indicating their dedication to facilitating drug approvals, Categorized as Type II