Is Qilu Pharmaceutical Co., Ltd. FDA approved?

Qilu Pharmaceutical Co., Ltd. holds 5 FDA-registered establishments 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 Qilu Pharmaceutical Co., Ltd.'s drugs manufactured?

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

What drugs does Qilu Pharmaceutical Co., Ltd. make?

57 products are listed under Qilu Pharmaceutical Co., Ltd. in the openFDA NDC Directory, most often as injection, solution; injection, powder, lyophilized, for solution; injection, powder, for solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Qilu Pharmaceutical Co., Ltd.

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

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Registered sites: 5
Active NDC listings: 57
Labeller names: 3
Live patents: 0
Countries: 1
Base: China

Authorisation

Registered operations

Analytical testing5Active ingredient (API) manufacture3Labelling4Finished drug manufacture2Packaging4

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Qilu Pharmaceutical Co., Ltd. (Laoling Site)Registrant: Qilu Pharmaceutical Co., Ltd.	Circular Economy Demonstration Park, Laoling County, Dezhou, Shandong 253600, China (CHN)	Analytical testing, Active ingredient (API) manufacture	3026771716699440617
Qilu Pharmaceutical Co., Ltd.	No.23999, Gong Ye Bei Road, Jinan, Shandong 250100, China (CHN)	Analytical testing, Active ingredient (API) manufacture, Labelling, Packaging	3003674637653878256
Qilu Pharmaceutical Co., Ltd. (Biological Industrial Park)Registrant: Qilu Pharmaceutical Co., Ltd.	8888 Lvyou Road, High-tech Zone, Jinan, Shandong 250104, China (CHN)	Analytical testing, Labelling, Finished drug manufacture, Packaging	3014576629544532200
Qilu Pharmaceutical Co., Ltd. (Dongjia Site)Registrant: Qilu Pharmaceutical Co., Ltd.	No. 849, Dongjia Town, Licheng District, Jinan, Shandong 250105, China (CHN)	Analytical testing, Active ingredient (API) manufacture, Labelling, Packaging	3021324493699432206
Qilu Pharmaceutical Co., Ltd.(High Tech Zone Site)Registrant: Qilu Pharmaceutical Co., Ltd.	No.317, Xinluo Road, High-tech Zone, Jinan, Shandong 250101, China (CHN)	Analytical testing, Labelling, Finished drug manufacture, Packaging	3003802432421279342

Catalogue

Drug listings by form and route

57 active NDC listings: 54 human prescription drug, 3 bulk ingredient. By marketing category: ANDA 54, BULK INGREDIENT 3.

Dosage form	NDCs
injection, solution	11
injection, powder, lyophilized, for solution	10
injection, powder, for solution	9
tablet	8
tablet, film coated	5
injection	4
powder	3
capsule	2
kit	2
tablet, film coated, extended release	2
tablet, coated	1

Route	NDCs
intravenous	33
oral	18
intramuscular	13
subcutaneous	3

Labeller name on the listing	NDCs
qilu pharmaceutical co., ltd.	52
qilu pharmaceutical co. ltd.	3
qilu pharmaceutical co., ltd	2

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Amikacin Sulfate	Amikacin Sulfate	injection, solution, intramuscular, intravenous	67184-0569ANDA
Amikacin Sulfate	Amikacin Sulfate	injection, solution, intramuscular, intravenous	67184-0570ANDA
-	Bortezomib	powder	67184-0026BULK INGREDIENT
Bortezomib	Bortezomib	injection, powder, lyophilized, for solution, intravenous, subcutaneous	67184-0530ANDA
Bumetanide	Bumetanide	injection, intramuscular, intravenous	67184-0593ANDA
Bumetanide	Bumetanide	injection, intramuscular, intravenous	67184-0594ANDA
Cefazolin	Cefazolin	injection, powder, for solution, intramuscular, intravenous	67184-1001ANDA
Cefepime	CEFEPIME HYDROCHLORIDE	injection, powder, for solution, intramuscular, intravenous	67184-1002ANDA
Cefepime	CEFEPIME HYDROCHLORIDE	injection, powder, for solution, intramuscular, intravenous	67184-1003ANDA
Cefepime	CEFEPIME HYDROCHLORIDE	injection, powder, for solution, intravenous	67184-1004ANDA
Ceftriaxone Sodium	Ceftriaxone Sodium	injection, powder, for solution, intramuscular, intravenous	67184-1005ANDA
Ceftriaxone Sodium	Ceftriaxone Sodium	injection, powder, for solution, intramuscular, intravenous	67184-1006ANDA
Ceftriaxone Sodium	Ceftriaxone Sodium	injection, powder, for solution, intramuscular, intravenous	67184-1007ANDA
Ceftriaxone Sodium	Ceftriaxone Sodium	injection, powder, for solution, intramuscular, intravenous	67184-1008ANDA
Cetrorelix acetate	Cetrorelix Acetate for Injection	kit, subcutaneous	67184-0605ANDA
Daptomycin	Daptomycin	injection, powder, lyophilized, for solution, intravenous	67184-0549ANDA
Decitabine	decitabine	injection, powder, lyophilized, for solution, intravenous	67184-0535ANDA
FOSAPREPITANT DIMEGLUMINE	FOSAPREPITANT DIMEGLUMINE	injection, powder, lyophilized, for solution, intravenous	67184-0540ANDA
Ganirelix Acetate	Ganirelix Acetate	injection, solution, subcutaneous	67184-0574ANDA
Gefitinib	Gefitinib	tablet, coated, oral	67184-0531ANDA
HYDROXYUREA	HYDROXYUREA	capsule, oral	67184-0607ANDA
Icosapent Ethyl	Icosapent Ethyl	capsule, oral	67184-0582ANDA
Irinotecan Hydrochloride	Irinotecan Hydrochloride	injection, solution, intravenous	67184-0511ANDA
Irinotecan Hydrochloride	Irinotecan Hydrochloride	injection, solution, intravenous	67184-0512ANDA
Irinotecan Hydrochloride	Irinotecan Hydrochloride	injection, solution, intravenous	67184-0513ANDA
MICAFUNGIN	Micafungin	injection, powder, lyophilized, for solution, intravenous	67184-0589ANDA
MICAFUNGIN	Micafungin	injection, powder, lyophilized, for solution, intravenous	67184-0590ANDA
Melphalan Hydrochloride	melphalan hydrochloride	kit, intravenous	67184-0618ANDA
Mirabegron	mirabegron	tablet, film coated, extended release, oral	67184-0571ANDA
Mirabgeorn	mirabegron	tablet, film coated, extended release, oral	67184-0572ANDA
Nicardipine Hydrochloride	Nicardipine Hydrochloride	injection, solution, intravenous	67184-0611ANDA
ONDANSETRON	ONDANSETRON	injection, solution, intramuscular, intravenous	67184-0507ANDA
Olanzapine	Olanzapine	tablet, oral	67184-0561ANDA
Olanzapine	Olanzapine	tablet, oral	67184-0562ANDA
Olanzapine	Olanzapine	tablet, oral	67184-0563ANDA
Olanzapine	Olanzapine	tablet, oral	67184-0564ANDA
Olanzapine	Olanzapine	tablet, oral	67184-0565ANDA
Olanzapine	Olanzapine	tablet, oral	67184-0566ANDA
Olanzapine	Olanzapine	injection, powder, for solution, intramuscular	67184-0573ANDA
-	Oxaliplatin	powder	67184-0007BULK INGREDIENT
Oxaliplatin	Oxaliplatin	injection, powder, lyophilized, for solution, intravenous	67184-0501ANDA
Oxaliplatin	Oxaliplatin	injection, powder, lyophilized, for solution, intravenous	67184-0502ANDA
Oxaliplatin	oxaliplatin	injection, solution, intravenous	67184-0508ANDA
Oxaliplatin	oxaliplatin	injection, solution, intravenous	67184-0509ANDA
Oxaliplatin	Oxaliplatin	injection, solution, intravenous	67184-0510ANDA
Palonosetron	Palonosetron Hydrochloride	injection, intravenous	67184-0514ANDA
Palonosetron	Palonosetron Hydrochloride	injection, intravenous	67184-0515ANDA
-	Palonosetron Hydrochloride	powder	67184-0013BULK INGREDIENT
Pemetrexed	Pemetrexed disodium	injection, powder, lyophilized, for solution, intravenous	67184-0503ANDA
Pemetrexed	Pemetrexed disodium	injection, powder, lyophilized, for solution, intravenous	67184-0504ANDA
Solifenacin Succinate	Solifenacin Succinate Tablets	tablet, film coated, oral	67184-0517ANDA
Tadalafil	Tadalafil	tablet, film coated, oral	67184-0523ANDA
Tadalafil	Tadalafil	tablet, film coated, oral	67184-0524ANDA
Tadalafil	Tadalafil	tablet, film coated, oral	67184-0525ANDA
Tadalafil	Tadalafil	tablet, film coated, oral	67184-0526ANDA
imatinib mesylate	imatinib mesylate	tablet, oral	67184-0532ANDA
imatinib mesylate	imatinib mesylate	tablet, oral	67184-0533ANDA

Neighbours

Registered in the same town

Shandong Anxin Pharmaceutical Co., Ltd.Dezhou, CHN; Jinan, CHN · 2 sites
Bloomage Biotechnology corp LtdJinan, CHN
Qilu Antibiotics Pharmaceutical Co., Ltd.Jinan, CHN
Shandong Anhong Pharmaceutical Co., Ltd.Dezhou, CHN
Shandong Chenghui Shuangda Pharmaceutical Co., Ltd.Dezhou, CHN
Shandong Keyuan Pharmaceutical Co.,Ltd.Jinan, CHN
Shandong Lianfa Medical Plastic Products CO,. LTDJinan, CHN

Compare

Comparable companies in China

Jiangsu Hengrui Pharmaceuticals Co., Ltd.4 sites · 28 NDC
BrightGene Bio-Medical Technology Co., Ltd.4 sites · 19 NDC
Asymchem Inc6 sites · 0 NDC
Bimeda, Inc.4 sites · 0 NDC
Zhejiang Huahai Pharmaceutical Technology Co Ltd3 sites · 76 NDC
Zhejiang Xianju Pharmaceutical Co., Ltd.3 sites · 38 NDC
Zhejiang Hisun Pharmaceutical Co., Ltd.3 sites · 27 NDC
Viwit Pharmaceutical Co., Ltd.3 sites · 5 NDC
Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd.3 sites · 4 NDC
Akeso Biopharma Co., Ltd3 sites · 1 NDC

Enquiry

Common questions

Is Qilu Pharmaceutical Co., Ltd. FDA approved?: Qilu Pharmaceutical Co., Ltd. holds 5 FDA-registered establishments 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 Qilu Pharmaceutical Co., Ltd.'s drugs manufactured?: The FDA register lists Dezhou; Jinan. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.
What drugs does Qilu Pharmaceutical Co., Ltd. make?: 57 products are listed under Qilu Pharmaceutical Co., Ltd. in the openFDA NDC Directory, most often as injection, solution; injection, powder, lyophilized, for solution; injection, powder, for solution. 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.