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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 : 2015-01-16

Pay. Date : 2013-12-31

DMF Number : 28161

Submission : 2013-12-26

Status : Active

Type : II

Seqens Company Banner

Looking for Drug Master Files (DMF) for 28161 of Wavelength Enterprises Ltd

Looking for Drug Master Files (DMF) for 28161 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 TIOTROPIUM BROMIDE MONOHYDRATE, with a corresponding US DMF Number 28161.

Remarkably, this DMF maintains an Active status since its submission on December 26, 2013, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of January 16, 2015, and payment made on December 31, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II