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Last Updated: December 15, 2025

List of Excipients in API MIGALASTAT HYDROCHLORIDE

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Excipients in NDA-approved (novel) drugs containing MIGALASTAT HYDROCHLORIDE

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Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Amicus Therapeutics US LLC	GALAFOLD	migalastat hydrochloride	71904-100	FD&C BLUE NO. 2	2025-08-10
Amicus Therapeutics US LLC	GALAFOLD	migalastat hydrochloride	71904-100	FERROSOFERRIC OXIDE	2025-08-10
Amicus Therapeutics US LLC	GALAFOLD	migalastat hydrochloride	71904-100	GELATIN	2025-08-10
Amicus Therapeutics US LLC	GALAFOLD	migalastat hydrochloride	71904-100	MAGNESIUM STEARATE	2025-08-10
Amicus Therapeutics US LLC	GALAFOLD	migalastat hydrochloride	71904-100	POTASSIUM HYDROXIDE	2025-08-10
>Company	>Tradename	>Ingredient	>NDC	>Excipient	>Potential Generic Entry

Detailed excipient profiles for MIGALASTAT HYDROCHLORIDE

Excipient focus: FD&C BLUE NO. 2

MIGALASTAT HYDROCHLORIDE drug variants containing FD&C BLUE NO. 2

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Company	Ingredient	NDC
Amicus Therapeutics US LLC	migalastat hydrochloride	71904-100
>Company	>Ingredient	>NDC

MIGALASTAT HYDROCHLORIDE drug variants not containing FD&C BLUE NO. 2

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Company	Ingredient	NDC
>Company	>Ingredient	>NDC

Excipient focus: FERROSOFERRIC OXIDE

MIGALASTAT HYDROCHLORIDE drug variants containing FERROSOFERRIC OXIDE

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Company	Ingredient	NDC
Amicus Therapeutics US LLC	migalastat hydrochloride	71904-100
>Company	>Ingredient	>NDC

MIGALASTAT HYDROCHLORIDE drug variants not containing FERROSOFERRIC OXIDE

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Company	Ingredient	NDC
>Company	>Ingredient	>NDC

Excipient focus: GELATIN

MIGALASTAT HYDROCHLORIDE drug variants containing GELATIN

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Company	Ingredient	NDC
Amicus Therapeutics US LLC	migalastat hydrochloride	71904-100
>Company	>Ingredient	>NDC

MIGALASTAT HYDROCHLORIDE drug variants not containing GELATIN

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Company	Ingredient	NDC
>Company	>Ingredient	>NDC

Excipient focus: MAGNESIUM STEARATE

MIGALASTAT HYDROCHLORIDE drug variants containing MAGNESIUM STEARATE

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Company	Ingredient	NDC
Amicus Therapeutics US LLC	migalastat hydrochloride	71904-100
>Company	>Ingredient	>NDC

MIGALASTAT HYDROCHLORIDE drug variants not containing MAGNESIUM STEARATE

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Company	Ingredient	NDC
>Company	>Ingredient	>NDC

Excipient focus: POTASSIUM HYDROXIDE

MIGALASTAT HYDROCHLORIDE drug variants containing POTASSIUM HYDROXIDE

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Company	Ingredient	NDC
Amicus Therapeutics US LLC	migalastat hydrochloride	71904-100
>Company	>Ingredient	>NDC

MIGALASTAT HYDROCHLORIDE drug variants not containing POTASSIUM HYDROXIDE

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Company	Ingredient	NDC
>Company	>Ingredient	>NDC

Excipient focus: SHELLAC

MIGALASTAT HYDROCHLORIDE drug variants containing SHELLAC

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Company	Ingredient	NDC
Amicus Therapeutics US LLC	migalastat hydrochloride	71904-100
>Company	>Ingredient	>NDC

MIGALASTAT HYDROCHLORIDE drug variants not containing SHELLAC

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Company	Ingredient	NDC
>Company	>Ingredient	>NDC

Excipient focus: STARCH, CORN

MIGALASTAT HYDROCHLORIDE drug variants containing STARCH, CORN

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Company	Ingredient	NDC
Amicus Therapeutics US LLC	migalastat hydrochloride	71904-100
>Company	>Ingredient	>NDC

MIGALASTAT HYDROCHLORIDE drug variants not containing STARCH, CORN

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Company	Ingredient	NDC
>Company	>Ingredient	>NDC

Excipient focus: TITANIUM DIOXIDE

MIGALASTAT HYDROCHLORIDE drug variants containing TITANIUM DIOXIDE

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Company	Ingredient	NDC
Amicus Therapeutics US LLC	migalastat hydrochloride	71904-100
>Company	>Ingredient	>NDC

MIGALASTAT HYDROCHLORIDE drug variants not containing TITANIUM DIOXIDE

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Company	Ingredient	NDC
>Company	>Ingredient	>NDC

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