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List of Drug Master Files (DMF) for 16243 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Minakem (formerly Delmar Chemicals) (1)

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01 MONTELUKAST SODIUM THIOL ACID (1)

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01 Canada (1)

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01 Active (1)

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01 Blank (1)

16243
Active
2002-11-15
N/A
II
Minakem Delmar

Interphex 2024

Not Confirmed

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Looking for Drug Master Files (DMF) for 16243 of Delmar Chemicals Inc

Looking for Drug Master Files (DMF) for 16243 of Delmar Chemicals Inc 1

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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 MONTELUKAST SODIUM THIOL ACID, with a corresponding US DMF Number 16243.

Remarkably, this DMF maintains an Active status since its submission on November 15, 2002, highlighting commitment to regulatory compliance.

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