Is Amino Chemicals Ltd. FDA approved?

Amino Chemicals Ltd. holds 1 FDA-registered establishment in Malta. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.

Where are Amino Chemicals Ltd.'s drugs manufactured?

The FDA register lists Marsa. Registered operations: analytical testing, active ingredient (API) manufacture.

What drugs does Amino Chemicals Ltd. make?

9 products are listed under Amino Chemicals Ltd. in the openFDA NDC Directory, most often as powder. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Amino Chemicals Ltd.

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 1
Active NDC listings: 9
Labeller names: 2
Live patents: 0
Countries: 1
Base: Malta

Authorisation

Registered operations

Analytical testing1Active ingredient (API) manufacture1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Amino Chemicals LtdRegistrant: Amino Chemicals Ltd.	MRA 050X,Industrial Estate, Marsa, - MRS 3000, Malta (MLT)	Analytical testing, Active ingredient (API) manufacture	3003118161644619934

Catalogue

Drug listings by form and route

9 active NDC listings: 9 bulk ingredient. By marketing category: BULK INGREDIENT 9.

Dosage form	NDCs
powder	9

Route	NDCs

Labeller name on the listing	NDCs
amino chemicals ltd	8
amino chemicals ltd.	1

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	Dexlansoprazole	powder	66005-0031BULK INGREDIENT
-	Fesoterodine Fumarate	powder	66005-0035BULK INGREDIENT
-	Lifitegrast	powder	66005-0049BULK INGREDIENT
-	Miglustat	powder	66005-0045BULK INGREDIENT
-	Nitisinone	powder	66005-0046BULK INGREDIENT
-	Paliperidone	powder	66005-0050BULK INGREDIENT
-	Rasagiline Mesylate	powder	66005-0029BULK INGREDIENT
-	Rufinamide	powder	66005-0037BULK INGREDIENT
-	Ziprasidone Hydrochloride	powder	66005-0027BULK INGREDIENT

Compare

Comparable companies in Malta

Sterling Chemical Malta Ltd1 site · 20 NDC

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Common questions

Is Amino Chemicals Ltd. FDA approved?: Amino Chemicals Ltd. holds 1 FDA-registered establishment in Malta. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
Where are Amino Chemicals Ltd.'s drugs manufactured?: The FDA register lists Marsa. Registered operations: analytical testing, active ingredient (API) manufacture.
What drugs does Amino Chemicals Ltd. make?: 9 products are listed under Amino Chemicals Ltd. in the openFDA NDC Directory, most often as powder. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.