Is CMIC CMO USA CORPORATION FDA approved?

CMIC CMO USA CORPORATION holds 2 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 CMIC CMO USA CORPORATION's drugs manufactured?

At registered sites in Japan, the United States. The FDA register lists HACHIMANTAI; Cranbury, NJ. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.

What drugs does CMIC CMO USA CORPORATION make?

2 products are listed under CMIC CMO USA CORPORATION in the openFDA NDC Directory, most often as granule, for suspension. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

CMIC CMO USA CORPORATION

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

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Registered sites: 2
Active NDC listings: 2
Live patents: 0
Countries: 2
Base: United States

Authorisation

Registered operations

Analytical testing2Labelling1Finished drug manufacture2Packaging2

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
CMIC CMO CO., LTD.	DAI2CHIWARI154-13, OBUKE, HACHIMANTAI, IWATE 028-7111, Japan (JPN)	Analytical testing, Labelling, Finished drug manufacture, Packaging	3030612875718618009
CMIC CMO USA CORPORATION	270 Prospect Plains Rd, Cranbury, New Jersey (NJ) 08512-3605, United States (USA)	Analytical testing, Finished drug manufacture, Packaging	3001237056129364723

Catalogue

Drug listings by form and route

2 active NDC listings: 2 drug for further processing. By marketing category: DRUG FOR FURTHER PROCESSING 2.

Dosage form	NDCs
granule, for suspension	2

Route	NDCs

Labeller name on the listing	NDCs
cmic cmo co., ltd.	2

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	Tacrolimus	granule, for suspension	51434-1230DRUG FOR FURTHER PROCESSING
-	Tacrolimus	granule, for suspension	51434-1330DRUG FOR FURTHER PROCESSING

Neighbours

Registered in the same town

WuXi Biologics Co., Ltd.Cranbury, NJ · 2 sites
Taikun Pharmaceutical Technology IncCranbury, NJ
Endo USA, Inc.Cranbury, NJ
SciSafe, Inc.Cranbury, NJ
David WoodCranbury, NJ
E-BEAM Services, Inc.Cranbury, NJ
J-star Research Inc.Cranbury, NJ
Primera Analytical Solutions CorporationCranbury, NJ
Tris Pharma, Inc.Cranbury, NJ
Amerise Pharmaceuticals LLCCranbury, NJ
INVAHEALTH INC.CRANBURY, NJ
Sekisui Medical Co., Ltd.Hachimantai, JPN

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Enquiry

Common questions

Is CMIC CMO USA CORPORATION FDA approved?: CMIC CMO USA CORPORATION holds 2 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 CMIC CMO USA CORPORATION's drugs manufactured?: At registered sites in Japan, the United States. The FDA register lists HACHIMANTAI; Cranbury, NJ. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.
What drugs does CMIC CMO USA CORPORATION make?: 2 products are listed under CMIC CMO USA CORPORATION in the openFDA NDC Directory, most often as granule, for suspension. 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.