Is Amphastar Nanjing Pharmaceuticals, Inc. FDA approved?

Amphastar Nanjing Pharmaceuticals, Inc. holds 1 FDA-registered establishment in China. 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 Amphastar Nanjing Pharmaceuticals, Inc.'s drugs manufactured?

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

What drugs does Amphastar Nanjing Pharmaceuticals, Inc. make?

24 products are listed under Amphastar Nanjing Pharmaceuticals, Inc. in the openFDA NDC Directory, most often as powder; powder, for suspension; injection, powder, for suspension. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Amphastar Nanjing Pharmaceuticals, Inc.

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

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Registered sites: 1
Active NDC listings: 24
Labeller names: 3
Live patents: 0
Countries: 1
Base: China

Authorisation

Registered operations

Analytical testing1Active ingredient (API) manufacture1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Amphastar Nanjing PharmaceuticalsRegistrant: Amphastar Nanjing Pharmaceuticals, Inc.	No.5 Xinghe Road, Nanjing Economic and Technological Development Zone, Nanjing, Jiangsu 210038, China (CHN)	Analytical testing, Active ingredient (API) manufacture	3009805706421255686

Catalogue

Drug listings by form and route

24 active NDC listings: 24 bulk ingredient. By marketing category: BULK INGREDIENT 24.

Dosage form	NDCs
powder	19
powder, for suspension	3
injection, powder, for suspension	1
oil	1

Route	NDCs

Labeller name on the listing	NDCs
amphastar nanjing pharmaceuticals, inc.	22
amphastar nanjing pharmaceuticals	1
amphastar nanjing pharmaceuticals,inc.	1

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	Atropine Sulfate	powder	52221-107BULK INGREDIENT
-	Beclomethasone Dipropionate	powder, for suspension	52221-105BULK INGREDIENT
-	Budesonide	powder	52221-117BULK INGREDIENT
-	Epinephrine	powder	52221-114BULK INGREDIENT
-	Fluticasone Propionate	injection, powder, for suspension	52221-106BULK INGREDIENT
-	Formoterol Fumarate	powder	52221-116BULK INGREDIENT
-	Heparin Sodium	powder	52221-123BULK INGREDIENT
-	Huperzine A	powder, for suspension	52221-104BULK INGREDIENT
-	Hyaluronidase	powder	52221-201BULK INGREDIENT
-	Idraparinux sodium	powder, for suspension	52221-103BULK INGREDIENT
-	Insulin Aspart	powder	52221-115BULK INGREDIENT
-	Insulin Degludec	powder	52221-127BULK INGREDIENT
-	Insulin Glargine	powder	52221-125BULK INGREDIENT
-	Ipratropium Bromide	powder	52221-108BULK INGREDIENT
-	Isoproterenol Hydrochloride	powder	52221-112BULK INGREDIENT
-	Phytonadione	oil	52221-124BULK INGREDIENT
-	Protamine sulfate	powder	52221-110BULK INGREDIENT
-	Salmeterol Xinafoate	powder	52221-109BULK INGREDIENT
-	Sodium Nitroprusside	powder	52221-111BULK INGREDIENT
-	Sodium Taurocholate	powder	52221-120BULK INGREDIENT
-	Sodium Taurocholate Hydrate	powder	52221-121BULK INGREDIENT
-	Teriparatide	powder	52221-119BULK INGREDIENT
-	heparin sodium	powder	52221-101BULK INGREDIENT
-	medroxyprogesterone acetate	powder	52221-118BULK INGREDIENT

Neighbours

Registered in the same town

Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd.Nanjing, CHN · 2 sites
YolTech (Nanjing) Therapeutics Co., Ltd.Nanjing, CHN
Nanjing 3H Medical Products Co., LtdNanjing, CHN
Nanjing Anxing Medical Technology Co., Ltd.Nanjing, CHN
Nanjing Chengong Pharmaceutical Co.,Ltd.Nanjing, CHN
Nanjing Jitaxing Technology Co., LTDNanjing, CHN
Nanjing Ludejin Corporation Management Co., Ltd.Nanjing, CHN
Nanjing Qiaotun Technology Co LtdNanjing, CHN
Nanjing Xingyin Pharmaceutical Group Co. Ltd.Nanjing, CHN

Compare

Comparable companies in China

Qingdao Biopeptek Co Ltd1 site · 110 NDC
Jianerkang Medical Co Ltd1 site · 56 NDC
Zhejiang Ausun Pharmaceutical Co., Ltd.1 site · 55 NDC
Hubei Gedian Humanwell Pharmaceutical Co., Ltd1 site · 31 NDC
Shandong New Time Pharmaceutical Co., Ltd.1 site · 29 NDC
Anqiu Lu'an Pharmaceutical Co., Ltd.1 site · 27 NDC
Hainan Poly Pharm. Co., Ltd.1 site · 27 NDC
Qingdao Qinzeyuan Biotechnology Co Ltd1 site · 27 NDC
Shenzhen Alvantis Pharma Co., Ltd.1 site · 27 NDC
El-Peptido (Shanghai) Biopharmaceutical Co., Ltd1 site · 25 NDC

Enquiry

Common questions

Is Amphastar Nanjing Pharmaceuticals, Inc. FDA approved?: Amphastar Nanjing Pharmaceuticals, Inc. holds 1 FDA-registered establishment in China. 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 Amphastar Nanjing Pharmaceuticals, Inc.'s drugs manufactured?: The FDA register lists Nanjing. Registered operations: analytical testing, active ingredient (API) manufacture.
What drugs does Amphastar Nanjing Pharmaceuticals, Inc. make?: 24 products are listed under Amphastar Nanjing Pharmaceuticals, Inc. in the openFDA NDC Directory, most often as powder; powder, for suspension; injection, powder, 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.