Is Hefei Xinzhu Biological Technology Co Ltd. FDA approved?

Hefei Xinzhu Biological Technology Co Ltd. 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 Hefei Xinzhu Biological Technology Co Ltd.'s drugs manufactured?

The FDA register lists Hefei. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging, repackaging.

What drugs does Hefei Xinzhu Biological Technology Co Ltd. make?

5 products are listed under Hefei Xinzhu Biological Technology Co Ltd. in the openFDA NDC Directory, most often as powder; liquid. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Hefei Xinzhu Biological Technology Co Ltd.

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

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Registered sites: 1
Active NDC listings: 5
Live patents: 0
Countries: 1
Base: China

Authorisation

Registered operations

Analytical testing1Active ingredient (API) manufacture1Labelling1Finished drug manufacture1Packaging1Repackaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Hefei Xinzhu Biological Technology Co., Ltd.Registrant: Hefei Xinzhu Biological Technology Co Ltd.	Building G, Yifan Factory, 200m west of the intersection of Fanhua Avenue and Wenshan Road, Hefei, Anhui 231200, China (CHN)	Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging, Repackaging	3037651207843825160

Catalogue

Drug listings by form and route

5 active NDC listings: 5 bulk ingredient. By marketing category: BULK INGREDIENT 5.

Dosage form	NDCs
powder	3
liquid	2

Route	NDCs

Labeller name on the listing	NDCs
hefei xinzhu biological technology co., ltd.	5

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	Insulin Aspart	powder	85893-009BULK INGREDIENT
-	Insulin Degludec	powder	85893-003BULK INGREDIENT
-	Insulin glargine	powder	85893-002BULK INGREDIENT
-	Teriparatide	liquid	85893-007BULK INGREDIENT
-	somatropin	liquid	85893-006BULK INGREDIENT

Neighbours

Registered in the same town

Anhui Fengle Perfume Co., Ltd.Hefei, CHN
Hefei Lifeon Pharmaceutical Co., Ltd. (API branch)Hefei, CHN
Hefei TianRui Pharmaceutical Chemical Co LtdHefei, CHN

Compare

Comparable companies in China

Kingkey MBC Life Technology Group co., LTD.1 site · 158 NDC
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Changzhou Maokang Medical Products Co., Ltd1 site · 59 NDC
Jianerkang Medical Co Ltd1 site · 56 NDC
Zhejiang Ausun Pharmaceutical Co., Ltd.1 site · 55 NDC
Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd1 site · 40 NDC
Guangdong Aimu Biological Technology Co Ltd1 site · 39 NDC

Enquiry

Common questions

Is Hefei Xinzhu Biological Technology Co Ltd. FDA approved?: Hefei Xinzhu Biological Technology Co Ltd. 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 Hefei Xinzhu Biological Technology Co Ltd.'s drugs manufactured?: The FDA register lists Hefei. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging, repackaging.
What drugs does Hefei Xinzhu Biological Technology Co Ltd. make?: 5 products are listed under Hefei Xinzhu Biological Technology Co Ltd. in the openFDA NDC Directory, most often as powder; liquid. 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.