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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 : 2017-03-03

Pay. Date : 2017-02-08

DMF Number : 16244

Submission : 2002-11-14

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 16244 of Wavelength Enterprises Ltd

Looking for Drug Master Files (DMF) for 16244 of Wavelength Enterprises Ltd 1

20

Wavelength Enterprises Ltd, 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 CETIRIZINE DIHYDROCHLORIDE, with a corresponding US DMF Number 16244.

Remarkably, this DMF maintains an Active status since its submission on November 14, 2002, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of March 03, 2017, and payment made on February 08, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II