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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 : 2013-09-04

Pay. Date : 2013-08-21

DMF Number : 13084

Submission : 1998-07-22

Status : Active

Type : II

Seqens Company Banner

Looking for Drug Master Files (DMF) for 13084 of Pcas

Looking for Drug Master Files (DMF) for 13084 of Pcas 1

20

Pcas, 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 OXYBUTYNIN BASE, with a corresponding US DMF Number 13084.

Remarkably, this DMF maintains an Active status since its submission on July 22, 1998, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of September 04, 2013, and payment made on August 21, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II