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01 1Pfizer CentreOne

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothPfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.

GDUFA

DMF Review : Complete

Rev. Date : 2013-10-18

Pay. Date : 2013-02-14

DMF Number : 5498

Submission : 1984-06-11

Status : Active

Type : II

Pfizer centreOne

Looking for Drug Master Files (DMF) for 5498 of Pharmacia And Upjohn Co Wholly Owned Sub Pfizer Inc

Looking for Drug Master Files (DMF) for 5498 of Pharmacia And Upjohn Co Wholly Owned Sub Pfizer Inc 1

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Pharmacia And Upjohn Co Wholly Owned Sub Pfizer Inc, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

They are recognized for Pfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.

One of their notable products is HYDROCORTISONE ACETATE USP, MICRO & NON-MICRO, with a corresponding US DMF Number 5498.

Remarkably, this DMF maintains an Active status since its submission on June 11, 1984, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of October 18, 2013, and payment made on February 14, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II