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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 : 2015-01-05

Pay. Date : 2013-05-22

DMF Number : 12553

Submission : 1997-06-18

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 12553 of Wavelength Enterprises Ltd

Looking for Drug Master Files (DMF) for 12553 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 MIDAZOLAM, with a corresponding US DMF Number 12553.

Remarkably, this DMF maintains an Active status since its submission on June 18, 1997, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of January 05, 2015, and payment made on May 22, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II