Is Merck KGaA FDA approved?

Merck KGaA 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 Merck KGaA's drugs manufactured?

At registered sites in China, Germany. The FDA register lists Nantong; Darmstadt. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging, particle size reduction, repackaging.

What drugs does Merck KGaA make?

14 products are listed under Merck KGaA in the openFDA NDC Directory, most often as powder; crystal. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Merck KGaA

Data as of 28 Sept 2026 · How to read this entry

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Registered sites: 2
Active NDC listings: 14
Live patents: 0
Countries: 2
Base: Germany

Authorisation

Registered operations

Analytical testing2Active ingredient (API) manufacture2Labelling2Finished drug manufacture1Packaging2particle size reduction1Repackaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Merck Life Science Technologies (Nantong) Co., Ltd.Registrant: Merck KGaA	No. 39 Jianggang Road, NETDA, Nantong, Jiangsu 226017, China (CHN)	Analytical testing, Active ingredient (API) manufacture, Labelling, Packaging	3018262809560047465
Merck Kommanditgesellschaft auf AktienRegistrant: Merck KGaA	Frankfurter Str. 250, Darmstadt, 64293, Germany (DEU)	Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging, particle size reduction, Repackaging	3002806906342249299

Catalogue

Drug listings by form and route

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

Dosage form	NDCs
powder	10
crystal	4

Route	NDCs

Labeller name on the listing	NDCs
merck kgaa	14

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	Boric acid	powder	14639-0164BULK INGREDIENT
-	Calcium chloride dihydrate	crystal	14639-2465BULK INGREDIENT
-	Cocarboxylase chloride	powder	14639-0112BULK INGREDIENT
-	Cocarboxylase tetrahydrate	powder	14639-0111BULK INGREDIENT
-	Magnesium chloride hexahydrate	crystal	14639-2367BULK INGREDIENT
-	Meglumine	powder	14639-6143BULK INGREDIENT
-	Potassium iodide	crystal	14639-5040BULK INGREDIENT
-	Sodium chloride	crystal	14639-6444BULK INGREDIENT
-	Sodium citrate	powder	14639-6666BULK INGREDIENT
-	Sodium fluoride	powder	14639-6441BULK INGREDIENT
-	TL-895	powder	14639-4700BULK INGREDIENT
-	Thiamine phosphoric acid ester chloride dihydrate	powder	14639-0667BULK INGREDIENT
-	Urea	powder	14639-8432BULK INGREDIENT
-	di-Potassium hydrogen phosphate	powder	14639-9828BULK INGREDIENT

Neighbours

Registered in the same town

EMD Serono, Inc.Darmstadt, DEU
Siegfried USA, LLCNantong, CHN
Zhejiang Hisun Pharmaceutical Co., Ltd.Nantong, CHN
Sinotherapeutics Inc.Nantong, CHN
Haian Kangrui Textile Co LtdNantong, CHN
Jiangsu Senwo Medical Technology Co., Ltd.Nantong, CHN
Jiangsu Weiqida Pharmaceutical Co., Ltd.Nantong, CHN
Nantong Chanyoo Pharmatech Co., LtdNantong, CHN
Nantong Haiyiwei Textile Co., Ltd.Nantong, CHN
Nantong Jinghua Pharmaceutical Co., LtdNantong, CHN
Novast Laboratories Ltd.Nantong, CHN

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Enquiry

Common questions

Is Merck KGaA FDA approved?: Merck KGaA 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 Merck KGaA's drugs manufactured?: At registered sites in China, Germany. The FDA register lists Nantong; Darmstadt. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging, particle size reduction, repackaging.
What drugs does Merck KGaA make?: 14 products are listed under Merck KGaA in the openFDA NDC Directory, most often as powder; crystal. 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.