API
API
Approval result: A已上市
抗凝药
  • Apixaban
    阿哌沙班
    Anticoagulants, venous thrombosis CDE
    Y20170002323(A)
    GMP
    NO
  • Clopidogrel Bisulfate
    硫酸氢氯吡格雷
    Prevent atherosclerotic thrombosis formation CDE
    Y20180000992(A)
    GMP
    YES
  • Ticagrelor
    替格瑞洛
    Inhibit platelet aggregation, acute coronary syndrome CDE
    Y20170002354 (A)
    GMP
    YES
  • Rivaroxaban
    利伐沙班
    Anticoagulants, thrombosis CDE
    Y20180000881(A)
    GMP
    NO
肝病系列
  • Sofosbuvir
    索磷布韦
    Hepatitis C CDE
    Y20180001300 (A)
    GMP
    NO
  • Tenofovir Alafenamide
    富马酸丙酚替诺福韦
    Chronic hepatitis B CDE
    Y20200000794(A)
    GMP
    NO
血液病
  • Lanthanum Carbonate
    碳酸镧
    Chronic kidney failure patients with hyperphosphatemia CDE
    Y20200001500 (A)
    GMP
    YES
  • Avatrombopag Maleate
    马来酸阿伐曲泊帕
    Chronic liver disease-related thrombocytopenia CDE
    Y20220000133(A)
    GMP
    YES
  • Idarubicin Hydrochloride
    盐酸伊达比星
    Leukemia CDE
    Y20190000054 (A)
    GMP
    YES
心脑血管与老年用药
  • Tolvaptan
    托伐普坦
    Hyponatremia CDE
    Y20190000614 (A)
    GMP
    YES
  • Olmesartan Medoxmil
    奥美沙坦酯
    High blood pressure CDE
    Y20170002347 (A)
    GMP
    YES
  • Sitagliptin Phosphate
    磷酸西格列汀
    Type 2 diabetes and chronic kidney disease CDE
    Y20180001214 (A)
    GMP
    YES
  • Macitentan
    马昔腾坦
    Pulmonary arterial hypertension CDE
    Y20190000404 (A)
    GMP
    NO
  • Mirabegron
    米拉贝隆
    Urinary urgency, frequency, and incontinence caused by overactive bladder. CDE
    Y20200000941 (A)
    GMP
    NO
  • Tadalafil
    他达拉非
    Erectile dysfunction CDE
    Y20170002353(A)
    GMP
    NO
  • Roxadustat
    罗沙司他
    Patients undergoing dialysis treatment due to anemia caused by chronic kidney disease (CKD) CDE
    Y20200000901 (A)
    GMP
    NO
  • Dapagliflozin
    达格列净
    Improve blood sugar control CDE
    Y20210001011 (A)
    GMP
    NO
  • Tofacitinib Citrate
    枸橼酸托法替布
    Rheumatoid arthritis CDE
    Y20190000296 (A)
    GMP
    NO
抗肿瘤系列
  • Aprepitant
    阿瑞匹坦
    Highly emetogenic antitumor chemotherapy CDE
    Y20200000395(A)
    GMP
    YES
  • Lenvatinib Mesilate
    甲磺酸仑伐替尼
    Hepatocellular carcinoma CDE
    Y20190001094(A)
    GMP
    YES
  • Raltiturexed
    雷替曲塞
    Colorectal cancer CDE
    Y20170002348(A)
    GMP
    YES
  • Regorafenib
    瑞戈非尼
    Colorectal cancer CDE
    Y20210000583(A)
    GMP
    NO
  • Pazopanib Hydrochloride
    盐酸培唑帕尼
    Renal cell carcinoma CDE
    Y20190021299 (A)
    GMP
    YES
  • Bortezomib
    硼替佐米
    Mantle cell lymphoma CDE
    Y20170000624(A)
    GMP
    NO
麻醉镇静用药
  • Parecoxib Sodium
    帕瑞昔布钠
    Pain reliever CDE
    Y20170001121 (A)
    GMP
    NO
  • Dexmedetomidine Hydrochloride
    盐酸右美托咪定
    Calm CDE
    Y20190000503 (A)
    GMP
    NO
其它
  • Lubiprostone
    芦比前列酮
    Laxatives CDE
    Y20200001305 (A)
    GMP
    YES
  • Sugammadex Sodium
    舒更葡糖钠
    Antagonize rocuronium or vecuronium-induced neuromuscular blockade CDE
    Y20220000787 (A)
    GMP
    NO
Approval result:I
在审
  • Ruxolitinib Phosphate
    磷酸芦可替尼
    Myelofibrosis CDE
    Y20220000415 (I)
    GMP
    NO
  • Obeticholic acid
    奥贝胆酸
    Primary Biliary Cholangitis (PBC) CDE
    Y20240000466 (I)
    GMP
    NO
  • Pemafibrate
    佩玛贝特
    Hyperlipidemia (including familial) CDE
    Y20250000181(I)
    GMP
    NO
  • Rosuvastatin Calcium
    瑞舒伐他汀钙
    Primary hypercholesterolemia (Type IIa) or mixed dyslipidemia (Type IIb) CDE
    Y20240001404 (I)
    GMP
    NO
  • Methylene blue
    亚甲蓝
    Diagnostic agents for enhancing visualization of colonic lesions CDE
    Y20240001514(I)
    GMP
    NO
  • Indocyanine Green
    吲哚菁绿
    contrast agent CDE
    在研
    GMP
    NO
  • Nalfurafine Hydrochloride
    盐酸纳呋拉啡
    Nalfurafine Hydrochloride CDE
    在研
    GMP
    NO
  • Ferric Derisomaltose
    异麦芽糖酐铁
    Ferric Derisomaltose CDE
    在研
    GMP
    NO
In development
在研
  • Ivocase,Evocalcet
    依伏卡塞
    Hypercalcemia caused by hyperparathyroidism CDE
    在研
    GMP
    NO
  • Dotinurad
    多替诺雷
    Gout with hyperuricemia CDE
    在研
    GMP
    NO
  • Chidamide,Tucidinostat
    西达本胺
    T-cell lymphoma CDE
    Y20250000162(I)
    GMP
    NO
  • Axitinib
    阿昔替尼
    Hyperlipidemia (including familial) CDE
    在研
    GMP
    NO
  • Tepotinib
    特泊替尼
    non-small cell lung cancer CDE
    在研
    GMP
    NO
  • Ibrutinib
    伊布替尼
    Mantle cell lymphoma CDE
    在研
    GMP
    NO
  • Etrasimod
    伊曲莫德
    Ulcerative colitis CDE
    在研
    GMP
    NO
  • Ribociclib
    瑞波西利
    breast cancer CDE
    在研
    GMP
    NO
  • Dexrazoxane
    右雷佐生
    Reduce the cardiotoxicity of anthracycline chemotherapy drugs CDE
    在研
    GMP
    NO
  • Elagolix Sodium
    艾拉戈克钠
    Endometriosis pain CDE
    在研
    GMP
    NO
  • Melitracen
    美利曲辛
    Depression and anxiety disorders CDE
    在研
    GMP
    NO
  • Ramelteon
    雷美替胺
    Insomnia with difficulty falling asleep CDE
    在研
    GMP
    NO
  • Ziprasidone mesilate
    甲磺酸齐拉西酮
    Acute agitation symptoms in patients with schizophrenia CDE
    在研
    GMP
    NO
  • Tafamidis Meglumine
    氯苯唑酸葡胺
    Transthyroid hormone protein amyloidosis polyneuropathy CDE
    在研
    GMP
    NO
  • Opicapone
    奥匹卡朋
    parkinsonism CDE
    在研
    GMP
    NO
  • Safinamide mesylate
    甲磺酸沙非胺
    parkinsonism CDE
    在研
    GMP
    NO
  • Tetrabenazine-d6
    氘代丁苯那嗪
    Huntington’s disease CDE
    在研
    GMP
    NO
  • Letermovir
    来特莫韦
    Anti Cytomegalovirus Infection CDE
    在研
    GMP
    NO
  • Tedizolid Phosphate
    磷酸特地唑胺
    Acute skin and skin tissue infections in adults caused by Gram positive bacteria CDE
    在研
    GMP
    NO
TRSDITIONAL CHINESE MEDICINE EXTRACTION
TRSDITIONAL CHINESE MEDICINE EXTRACTION

W06 workshop is PURE's traditional Chinese medicine extraction workshop. The overall design adopts a gravity flow concept to transfer materials and selects currently advanced industry equipment, which greatly improves and enhances the working environment and efficiency.

The pretreatment equipment choose slitting and crushing equipment with built-in dust collection devices, and the workshop is equipped with additional dust collection devices to minimize the dust generated during the pretreatment of Chinese medicinal materials.

The slag removal equipment adopts the most advanced automatic slag squeezing equipment in China, which realizes automated operation through buttons, reducing work intensity, shortening slag removal time, and improving work efficiency.


CMO/CDMO SERVES
CMO/CDMO SERVES

Pilot and commercial production: For time-sensitive customers such as CRO and clinical batch products, the workshop's excellent multifunctionality, flexible production capacity quick switching, and project-based management model ensure that the production operation system can deliver high-quality products and services to meet customer needs quickly. Relying on internationally standard quality systems and extensive experience in large-scale commercial GMP product manufacturing, we can provide customers with high-quality commercial API and intermediate products at the best cost, along with a series of additional services including secondary process development and optimization for our customers.