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List of Drug Master Files (DMF) for 30336 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 1Minakem (formerly Delmar Chemicals)

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01

Boulder Peptide 2024
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMinakem is manufacturing small molecules APIs including corticosteroids

GDUFA

DMF Review : Complete

Rev. Date : 2016-08-15

Pay. Date : 2016-03-28

DMF Number : 30336

Submission : 2016-03-14

Status : Active

Type : II

Minakem Delmar

Looking for Drug Master Files (DMF) for 30336 of Delmar Chemicals Inc

Looking for Drug Master Files (DMF) for 30336 of Delmar Chemicals Inc 1

20

Delmar Chemicals Inc, based in Canada, is a pharmaceutical company that stands out with its certifications from FDA.

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

One of their notable products is APIXABAN, with a corresponding US DMF Number 30336.

Remarkably, this DMF maintains an Active status since its submission on March 14, 2016, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of August 15, 2016, and payment made on March 28, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II