Jiangsu Hengrui Medicine Co., Ltd., Established in 1970, Having Over 13,000 Employees Globally, Is the Largest Manufacturer of Antineoplastics in China
Company Profile
Jiangsu Hengrui Medicine Co., Ltd., established in 1970, having over 13,000 employees globally, is the largest manufacturer of antineoplastics in China. Its operating income was over USD 1.7 billion in 2015. The company stock was officially listed on the Shanghai Stock
Exchange in 2000. All APIs and finish dosage forms have passed national
GMP authentication. For APIs, we got approvals from US-FDA, EDQM,
PMDA and TGA. For FDFs, we got approvals from US-FDA, EU and
PMDA.
API List
APIs
Atracurium Besylate US-DMF Gadoteric Acid Meglumine
Butorphanol Tartrate Ifosfamide FDA, CEP
Capecitabine US-DMF Iodixanol US-DMF
Caspofungin Acetate US-DMF, EDMF* Ioversol
Celecoxib Irinotecan HCl FDA, PMDA
Cisatracurium Besylate US-DMF, EDMF* Ketamine HCl
Clopidogrel Bisulfate Letrozole FDA , CEP, PMDA
Daptomycin Mesna US-DMF, EDMF*
Desflurane US-DMF Olmesartan Medoxomil
Dexmedetomidine HCl US-DMF Oxaliplatin FDA, CEP, TGA
Docetaxel Trihydrate US-DMF Sevoflurane FDA, EDMF
Ethiodized Poppyseed Oil Tegafur
Etoposide FDA, CEP Temozolomide
*: Submission in schedule
APIs in Development (R&D Status) Dutasteride Iohexol
Gadobutrol Tolvaptan (US-DMF*) *: Submission in schedule
Disclaimer: If a product shown on this poster is still under patent in a specific market, the information has to be considered for information purpose only.
No.7, Kunlunshan Rd., ETDZ, Lianyungang, Jiangsu, China 222047 Fax: (86)-518-85465746 Tel: (86)-518-85475919; 85473511 http: //www.hrs.com.cn/ E-mail: [email protected]
Finished Dosage Form List
Antineoplastic
No. Name Strength RA Status 1 Apatinib Mesylate Tablets 0.25g; 0.375g; 0.425g 2 Calcium Folinate for Injection 5mg; 25mg; 50mg; 0.1g 3 Calcium Folinate Injection 5ml:50mg; 10ml:0.1g 4 Calcium Levofolinate for Injection 25mg 5 Capecitabine Tablets 0.15g, 0.50g MA issued from US FDA, German 6 Cyclophosphamide for Injection 500mg; 1g; 2g BfArm, Netherlands CBG 7 Docetaxel Injection 20mg/0.5ml; 20mg/1ml; 60mg/1.5ml; 80mg/2.0ml US ANDA 8 Etoposide Injection 5ml:0.1g; 9 Etoposide Soft Capsules 50mg 10 Ifosfamide for Injection 0.5g; 1.0g MA issued from US FDA, Japan 11 Irinotecan HCl Injection 40mg/2ml; 100mg/5ml PMDA 12 Irinotecan HCl for Injection 40mg; 100mg MA issued from US FDA, Japan 13 Letrozole Tablets 2.5mg PMDA, Spain, Netherlands CBG 14 Mesna Injection 2ml:0.2g; 4ml:0.4g
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15 Methotrexate for Injection 5mg; 0.1g; 1g MA issued from Spain, Netherlands 16 Oxaliplatin for Injection 50mg/vial; 0.1g/vial CBG, UK MHRA 17 Oxaliplatin Injection 100ml:0.1g MA issued from US FDA 18 Pegaspargase Injection 5ml:3750IU; 2ml:1500IU Tegafur:20mg, Gimeracil:5.8mg, Oteracil potassium:19.6mg; 19 Tegafur, Gimeracil, Oteracil Potassium Capsules Tegafur:25mg, Gimeracil:7.25mg, Oteracil potassium:24.5mg 20 Temozolomide for Injection 100mg
Contrast Media
1 Gadoteric Acid Meglumine Salt Injection 15ml:5.654g 2 Iodixanol Injection 100ml:65.2g (100ml: 32g I) 3 Iodized Oil Ethyl Esters Injection 10ml 4 Ioversol Injection 20ml:13.56g; 50ml:33.9g; 100ml:67.8g; 100ml:74.1g
Anaesthetic
1 Atracurium Besylate for Injection 10mg; 25mg 2 Butorphanol Tartrate Injection 1ml:1mg; 2ml:4mg 3 Butorphanol Tartrate Nasal Spray 10mg/ml 4 Cisatracurium Besylate for Injection 10mg/5ml US ANDA Submitted 5 Dexmedetomidine HCl Injection 2ml:200μg; 1ml:100μg US ANDA Submitted
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MA issued from US FDA, Germany 6 Sevoflurane Inhalation Anesthetic 250ml BfArm, Spain, and Netherlands CBG Others
1 Ambroxol HCl Oral Solution 100ml:0.3g; 100ml:0.6g 2 Ambroxol HCl Tablets 30mg 3 Aspirin Dipyridamole Sustained-release Capsules Dipyridamole:200mg, Aspirin:25mg 4 Azelastine HCl Nasal Spray 10ml:10mg US ANDA Submitted 5 Caspofungin Acetate for Injection 50mg/vial; 70mg/vial Netherlands GMP Certificated Cetirizine HCl and Pseudoephedrine HCl 6 Cetirizine HCl: 5mg; Pseudoephedrine HCl: 120mg Sustained Release Capsules 7 Daptomycin for Injection 0.5g 8 Enalapriline Maleate Tablets 10mg 9 Febuxostat Tablets 40mg; 80mg 10 Fexofenadine HCl Tablets 60mg 11 Fondaparinux Injection 0.5ml:2.5mg; 0.4ml:5mg; 0.6ml:7.5mg; 0.8ml:10mg Pass US FDA Preapproval Inspection 12 Gabapentin Capsules 0.1g; 0.3g; 0.4g Pass US FDA Preapproval Inspection 13 Gadoteric Acid Meglumine Salt Injection 15ml:5.652g 14 Imrecoxib Tablets 0.1g 15 IrbesartanTablets 0.15g; 0.3g 16 Omeprazole Enteric-coated Capsules 20mg
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17 Palonosetron HCl Injection 5ml:0.25mg 18 Papaverine HCl Injection 1ml:30mg 19 Raloxifene HCl Tablets 60mg 20 Sodium Valproate Sustained-release Tablets 0.2g 21 Tamsulosin HCl Sustained-release Capsules 0.2mg 22 Terfenadine Tablets 60mg 23 Tropisetron HCl Capsules 5mg 24 Tropisetron HCl Injection 5ml:5mg 25 Zoledronic Acid for Injection 4mg
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Product Pipeline
Antineoplastic
1 Abiraterone Acetate Tablets 0.25g 醋酸阿比特龙片
Contrast Media
1 Gadavist Injection 7.5ml:4.5354g 钆布醇注射液 Others
1 Bimatoprost Ophthalmic Solution 3ml:0.9mg; 5ml:1.5mg 贝美前列素滴眼液 2 Clopidogrel Bisulfate Tablets 75mg 硫酸氢氯吡格雷片 3 Desflurane, Liquid for Inhalation 240ml 吸入用地氟烷 4 Landiolol Hydrochloride for Injection 12.5mg 注射用盐酸兰地洛尔 5 Limaprost Tablets 5μg 利马前列素片 5mg:20mg; 5mg:40mg; 6 Olmesartan Medoxomil/Amlodipine Tablets 奥美沙坦氨氯地平片 10mg:20mg; 10mg:40mg 7 Paclitaxel Protein-Bound Particles for Injection Suspension 100mg 紫杉醇注射液 8 Propofol Injectable Emulsion 10mg/ml; 20mg/ml 丙泊酚脂肪乳 9 Tacrolimus, Capsule, Extended Release 0.5mg; 1mg; 5mg 他克莫司缓释胶囊
Disclaimer: If a product shown on this poster is still under patent in a specific market, the information has to be considered for information purpose only.
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Jiangsu Hengrui Medicine Co., Ltd. No.7, Kunlunshan Rd., ETDZ, Lianyungang, Jiangsu, China 222047. Fax: (86)-518-85465746 Tel: (86)-518-85475919; 85473511 Http://www.hrs.com.cn E-mail: [email protected]
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