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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSeqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.

GDUFA

DMF Review : Complete

Rev. Date : 2020-12-12

Pay. Date : 2020-12-08

DMF Number : 9716

Submission : 1992-06-08

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 9716 of Cu Chemie Uetikon Gmbh

Looking for Drug Master Files (DMF) for 9716 of Cu Chemie Uetikon Gmbh 1

20

Cu Chemie Uetikon Gmbh, based in France, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

They are recognized for Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.

One of their notable products is 4-PHENYLBUTYRIC ACID SODIUM SALT, with a corresponding US DMF Number 9716.

Remarkably, this DMF maintains an Active status since its submission on June 08, 1992, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of December 12, 2020, and payment made on December 08, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II