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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 : 2015-01-29

Pay. Date : 2015-01-16

DMF Number : 4778

Submission : 1983-01-21

Status : Active

Type : II

Seqens Company Banner

Looking for Drug Master Files (DMF) for 4778 of Pcas

Looking for Drug Master Files (DMF) for 4778 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 CLONIDINE HYDROCHLORIDE, with a corresponding US DMF Number 4778.

Remarkably, this DMF maintains an Active status since its submission on January 21, 1983, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of January 29, 2015, and payment made on January 16, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II