Is Ajinomoto OmniChem N.V. FDA approved?

Ajinomoto OmniChem N.V. holds 4 FDA-registered establishments across 2 countries. 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 Ajinomoto OmniChem N.V.'s drugs manufactured?

At registered sites in Belgium, India. The FDA register lists Balen; Leuven; Wetteren; Anakapalli. Registered operations: analytical testing, active ingredient (API) manufacture.

What drugs does Ajinomoto OmniChem N.V. make?

14 products are listed under Ajinomoto OmniChem N.V. 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.

Ajinomoto OmniChem N.V.

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

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Registered sites: 4
Active NDC listings: 14
Labeller names: 6
Live patents: 0
Countries: 2
Base: Belgium

Authorisation

Registered operations

Analytical testing4Active ingredient (API) manufacture3

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Ajinomoto OmnichemRegistrant: Ajinomoto OmniChem N.V.	Japanse-Kerselarenlaan 1, Balen, 2490, Belgium (BEL)	Analytical testing, Active ingredient (API) manufacture	3003677791400344442
KU Leuven Research & DevelopmentRegistrant: Ajinomoto Omnichem	Waaistraat 6 - box 5105, Leuven, 3000, Belgium (BEL)	Analytical testing	3008520055370983364
Ajinomoto OmnichemRegistrant: Ajinomoto OmniChem N.V.	Cooppallaan 91, Wetteren, 9230, Belgium (BEL)	Analytical testing, Active ingredient (API) manufacture	3002807802400344443
Ajinomoto Bio-Pharma Services India Private LimitedRegistrant: Ajinomoto OmniChem N.V.	Plot No.121 (Part) & 122, Visakha Pharmacity Limited SEZ, Parawada, Anakapalli, Andhra Pradesh 531019, India (IND)	Analytical testing, Active ingredient (API) manufacture	3012806860871290025

Catalogue

Drug listings by form and route

14 active NDC listings: 14 bulk ingredient. By marketing category: BULK INGREDIENT 14.

Dosage form	NDCs
powder	14

Route	NDCs

Labeller name on the listing	NDCs
n.v. ajinomoto omnichem s.a.	6
ajinomoto omnichem	3
n.v. ajinomoto omnichem s.a.	2
ajinomoto omnichem n.v.	1
n.v. ajinomoto omnichem s.a.	1
n.v. ajinomoto omnichem s.a.	1

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	FULVESTRANT	powder	50923-0416BULK INGREDIENT
-	Finafloxacin	powder	50923-0217BULK INGREDIENT
-	GPO-6	powder	50923-0325BULK INGREDIENT
-	Maraviroc	powder	50923-0414BULK INGREDIENT
-	Miconazole nitrate	powder	50923-1213BULK INGREDIENT
-	Not Applicable	powder	50923-0119BULK INGREDIENT
-	Prazosin Hydrochloride	powder	50923-0462BULK INGREDIENT
-	Quetiapine fumarate	powder	50923-0483BULK INGREDIENT
-	ROSUVASTATIN CALCIUM	powder	50923-0490BULK INGREDIENT
-	Rufinamide	powder	50923-0614BULK INGREDIENT
-	TMC-120	powder	50923-0486BULK INGREDIENT
-	Ticagrelor	powder	50923-0314BULK INGREDIENT
-	not applicable	powder	50923-1118BULK INGREDIENT
-	not applicable	powder	50923-1218BULK INGREDIENT

Neighbours

Registered in the same town

LAURUS LABS LIMITEDAnakapalli, IND · 4 sites
Biocon Biologics LimitedAnakapalli, IND · 2 sites
Granules Pharmaceuticals Inc.Anakapalli, IND · 2 sites
LAURUS SYNTHESIS PRIVATE LIMITEDAnakapalli, IND · 2 sites
Viyash Scientific LimitedAnakapalli, IND
Apitoria Pharma Private LimitedAnakapalli, IND
Hospira, Inc.Anakapalli, IND
EUGIA Pharma Specialities LimitedAnakapalli, IND
NATCO PHARMA LIMITEDAnakapalli, IND
Apicore US LLCAnakapalli, IND
Analys Lab Private LimitedAnakapalli, IND
Lee Pharma LimitedAnakapalli, IND

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Enquiry

Common questions

Is Ajinomoto OmniChem N.V. FDA approved?: Ajinomoto OmniChem N.V. holds 4 FDA-registered establishments across 2 countries. 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 Ajinomoto OmniChem N.V.'s drugs manufactured?: At registered sites in Belgium, India. The FDA register lists Balen; Leuven; Wetteren; Anakapalli. Registered operations: analytical testing, active ingredient (API) manufacture.
What drugs does Ajinomoto OmniChem N.V. make?: 14 products are listed under Ajinomoto OmniChem N.V. 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.