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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 : 2013-10-04

Pay. Date : 2013-09-30

DMF Number : 7077

Submission : 1987-07-14

Status : Active

Type : II

Seqens Company Banner

Looking for Drug Master Files (DMF) for 7077 of Pcas

Looking for Drug Master Files (DMF) for 7077 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 BACLOFEN, with a corresponding US DMF Number 7077.

Remarkably, this DMF maintains an Active status since its submission on July 14, 1987, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of October 04, 2013, and payment made on September 30, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II