Is INKE SA FDA approved?

INKE SA holds 1 FDA-registered establishment in Spain. 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 INKE SA's drugs manufactured?

The FDA register lists Castellbisbal. Registered operations: active ingredient (API) manufacture.

What drugs does INKE SA make?

26 products are listed under INKE SA 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.

INKE SA

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

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Registered sites: 1
Active NDC listings: 26
Labeller names: 4
Live patents: 0
Countries: 1
Base: Spain

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
INKE SA	Calle Argent (AREA INDUSTRIAL DEL LLOBREGAT) 1, Castellbisbal, 08755, Spain (ESP)	Active ingredient (API) manufacture	3003663245460094139

Catalogue

Drug listings by form and route

26 active NDC listings: 26 bulk ingredient. By marketing category: BULK INGREDIENT 26.

Dosage form	NDCs
powder	26

Route	NDCs

Labeller name on the listing	NDCs
inke sa	14
inke sa	6
inke s.a.	3
inke, s.a.	3

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	APREPITANT	powder	64567-0021BULK INGREDIENT
-	ARFORMOTEROL TARTRATE	powder	64567-0022BULK INGREDIENT
-	Aclidinium Bromide	powder	64567-0028BULK INGREDIENT
-	Arformoterol Tartrate Form D	powder	64567-0020BULK INGREDIENT
-	CLEVIDIPINE BUTYRATE	powder	64567-0023BULK INGREDIENT
-	Ensifentrine	powder	64567-0033BULK INGREDIENT
-	Fluconazole	powder	64567-0002BULK INGREDIENT
-	Formoterol Fumarate Dihydrate	powder	64567-0006BULK INGREDIENT
-	GRANISETRON BASE	powder	64567-0010BULK INGREDIENT
-	GRANISETRON HYDROCHLORIDE	powder	64567-0009BULK INGREDIENT
-	Glycopyrrolate	powder	64567-0018BULK INGREDIENT
-	INDACATEROL MALEATE	powder	64567-0024BULK INGREDIENT
-	ONDANSETRON BASE	powder	64567-0008BULK INGREDIENT
-	ONDANSETRON HYDROCHLORIDE	powder	64567-0005BULK INGREDIENT
-	Olanzapine	powder	64567-0017BULK INGREDIENT
-	Olodaterol Hydrochloride	powder	64567-0031BULK INGREDIENT
-	Revefenacin Trihydrate	powder	64567-0029BULK INGREDIENT
-	Risperidone	powder	64567-0003BULK INGREDIENT
-	Rizatriptan Benzoate	powder	64567-0013BULK INGREDIENT
-	Salmeterol Xinafoate	powder	64567-0007BULK INGREDIENT
-	TETRABENAZINE	powder	64567-0025BULK INGREDIENT
-	TIOTROPIUM BROMIDE MONOHYDRATE	powder	64567-0026BULK INGREDIENT
-	Tafamidis Meglumine	powder	64567-0032BULK INGREDIENT
-	Umeclidinium Bromide	powder	64567-0030BULK INGREDIENT
-	VILANTEROL TRIFENATATE	powder	64567-0027BULK INGREDIENT
-	Zolmitriptan	powder	64567-0016BULK INGREDIENT

Neighbours

Registered in the same town

MOEHS BCN SL.CASTELLBISBAL, ESP

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Enquiry

Common questions

Is INKE SA FDA approved?: INKE SA holds 1 FDA-registered establishment in Spain. 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 INKE SA's drugs manufactured?: The FDA register lists Castellbisbal. Registered operations: active ingredient (API) manufacture.
What drugs does INKE SA make?: 26 products are listed under INKE SA 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.