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01 1Minakem (formerly Delmar Chemicals)

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMinakem is manufacturing small molecules APIs including corticosteroids

GDUFA

DMF Review : Complete

Rev. Date : 2020-05-21

Pay. Date : 2020-05-15

DMF Number : 4475

Submission : 1982-03-12

Status : Active

Type : II

Minakem Delmar

Looking for Drug Master Files (DMF) for 4475 of Delmar Chemicals Inc

Looking for Drug Master Files (DMF) for 4475 of Delmar Chemicals Inc 1

20

Delmar Chemicals Inc, based in Canada, is a pharmaceutical company.

They are recognized for Minakem is manufacturing small molecules APIs including corticosteroids

One of their notable products is ESMOLOL HYDROCHLORIDE, with a corresponding US DMF Number 4475.

Remarkably, this DMF maintains an Active status since its submission on March 12, 1982, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of May 21, 2020, and payment made on May 15, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II