Shandong Xinhua Pharmaceutical Co., Ltd

Products

Product List for Finished Drug

#	Products submitted to China Authoriyfor Registration are marked as #
*	Psychocontrol drugs are marked as *
UPDTED ON 250528
Higly recmended	TABLET/CAPSULE	NAME	STRENGTH	FILE	GMP	API	PACK	TREATMENT	REMARK
1	Ibuprofen tablet	布洛芬片	200mg;300mg;400mg; 600mg;800mg	US ANDA	EUGMP/FDA	Own API	Bottle&Blister	NSAIDs 非甾体抗炎药
2	Ibuprofen soft gel	布洛芬软胶囊	200mg		EUGMP/FDA	Own API	Bottle		Pipeline （Pilot ）
3	Ibuprofen suspension	布洛芬混悬液#	100ml:2g; 30ml:0.6g#	NMPA consistency evaluation	GMP	Own API	Bottle		Pipeline
4	Ibuprofen sustained release capsule	布洛芬缓释胶囊	300mg	NMPA consistency evaluation	GMP	Own API	Blister
5	Ibuprofen Suspension Drops	布洛芬混悬滴剂#	15ml:0.6g ;30ml:1.2g	NMPA consistency evaluation	GMP	Own API	Bottle
6	Ibuprofen Suspension Drops	布洛芬混悬滴剂	20ml			Own API	Bottle		Pipeline （Trial）
7	Arginine Ibuprofen Granules	精氨酸布洛芬颗粒	0.4mg			Own API	sachet		Pipeline （Pilot ）
8	Ibuprofen granules	布洛芬颗粒#	0.2g	NMPA consistency evaluation	GMP	Own API	Sachet		Pipeline
9	Sevelamer carbonate tablet	碳酸司维拉姆片	800mg	US ANDA	EUGMP/FDA	Own API	Bottle	Chronic kidney disease(CKD)
10	Sevelamer carbonate dry suspension	碳酸司维拉姆干混悬剂#	2.4g; 400mg	US ANDA(drafting)	EUGMP/FDA	Own API	Sachet	Chronic kidney disease(CKD)	Pipeline （Stability test study）
11	Colesevelam hydrochloride tablets	盐酸考来维仑片	625mg		EUGMP/FDA	Own API	Sachet	Cardiovascular medication 心血管用药	Pipeline （Trial）
12	Ethyl Eicosapentaenoate soft gels 98%	二十碳五烯酸乙酯软胶囊	0.5g; 1.0g;		EUGMP/FDA	Own API	Bottle		Pipeline
13	Ethyl Eicosapentaenoate soft gels 98%	二十碳五烯酸乙酯软胶囊	0.3g;0.6g; 0.5g;1.0g; #		GMP	Own API	Bottle		Pipeline
14	Atorvastatin calcium Tablets	阿托伐他汀钙片	10mg; 20mg; 40mg; 80mg	US ANDA & NMPA	EUGMP/FDA		Bottle
15	Rosuvastatin calcium Tablets	瑞舒伐他汀钙片	10mg 20mg	NMPA consistency evaluation	GMP		Bottle
16	Empagliflozin tablets	恩格列净片	10mg	NMPA consistency evaluation	GMP		Blister
17	Dapagliflozin Tablets	达格列净片#	5mg,10mg	NMPA consistency evaluation	GMP		Blister		Pipeline
18	Carbidopa and levodopa sustained release tablets	卡左双多巴缓释片	200mg+50mg		GMP	Own API	Alu-Alu	Anti-parkinson's disease medication 抗帕金森症用药	Pipeline （Trial）

Recommended	TABLET/CAPSULE	NAME	STRENGTH	FILE	GMP	API	PACK	TREATMENT	REMARK
1	Phenobarbital tablet	苯巴比妥片#*	30mg; 100mg	NMPA consistency evaluation	GMP	Own API	Blister&Bottle	Medication for the nervous system 神经系统用药	Pipeline
2	Tramadol HCL Sustained Release tablet	盐酸曲马多缓释片*	0.1g	NMPA consistency evaluation	GMP	Own API	Blister
4	Pregabalin capsules	普瑞巴林胶囊	150mg;75mg	NMPA consistency evaluation	GMP		Blister
10	Mecobalamin tablets	甲钴胺片	0.5mg	NMPA consistency evaluation	GMP		Blister
11	Escitalopram oxalate tablets	草酸艾司西酞普兰片*	5mg	NMPA consistency evaluation	GMP	Own API	Blister
12	Donepezil Hydrochloride disintegrating tablets	盐酸多奈哌齐口崩片#	5mg	NMPA consistency evaluation	GMP		Blister	Medications for Alzheimer's disease	Pipeline
13	Memantine Hydrochloride tablets	盐酸美金刚片	10mg	NMPA consistency evaluation	GMP		Blister	Medications for Alzheimer's disease
14	Captopril tablet	卡托普利片	25mg	NMPA consistency evaluation	GMP		Bottle	Cardiovascular medication 心血管用药
15	Diltiazem Hydrochloride tablet	盐酸地尔硫卓片	30mg	NMPA consistency evaluation	GMP		Blister
16	Clopidogrel Bisulfate Tablets	硫酸氢氯吡格雷片	75mg	NMPA consistency evaluation	GMP		Blister
17	Nimodipine tablet	尼莫地平片#	30mg	NMPA consistency evaluation	GMP	Own API	Bottle		Pipeline
18	Valsartan capsule	缬沙坦胶囊#	80mg	NMPA consistency evaluation	GMP		Blister		Pipeline
19	Irbesartan tablet	厄贝沙坦片	0.15g	NMPA consistency evaluation	GMP		Blister
20	Irbesartan Hydrochlorothiazide Tablets	厄贝沙坦氢氯噻嗪片	150mg/12.5mg	NMPA consistency evaluation	GMP		Blister
21	Clopidogrel hydrogen sulphate tablet	硫酸氢氯吡格雷片#	75mg	NMPA consistency evaluation	GMP		Alu-Alu		Pipeline
22	Amlodipine besylate tablet	苯磺酸氨氯地平片#	5mg	NMPA consistency evaluation	GMP		Blister		Pipeline
23	Lisinopril Benzenesulfonate Tablets	苯磺酸左氨氯地平片#	2.5mg	NMPA consistency evaluation	GMP		Blister		Pipeline
24	Ivabradine Hydrochloride tablets	盐酸伊伐布雷定片#	5mg	NMPA consistency evaluation	GMP		Blister		Pipeline
25	Bisoprolol fumarate tablet	富马酸比索洛尔片#	0.2g	NMPA consistency evaluation	GMP		blister		Pipeline
26	Sacubitril-valsartan sodium tablet	沙库巴曲缬沙坦钠片#	50mg	NMPA consistency evaluation	GMP	Own API	blister		Pipeline
27	Glimepiride tablet	格列美脲片	1mg;2mg	NMPA consistency evaluation	GMP	Own API	Blister
28	Pioglitazone hydrochloride capsules	盐酸吡格列酮胶囊	15mg	NMPA consistency evaluation	GMP		Blister
29	Rabeprazole sodium enteric-coated tablet	雷贝拉唑钠肠溶片	10mg;20mg	NMPA consistency evaluation	GMP	Own API	Alu-Alu；bottle; blister	Medication for the digestive system 消化系统用药
31	Ursodeoxycholic Acid capsule	熊去氧胆酸胶囊	250mg	NMPA consistency evaluation	GMP		Blister
32	Vornosulfonate Tablets	富马酸伏诺拉生片	20mg	NMPA consistency evaluation	GMP				Pipeline
33	Sodium bicarbonate tablet	碳酸氢钠片	0.3g;0.5g	NMPA consistency evaluation	GMP/EU GMP/FDA		Blister
34	Clindamycin Phosphate tablet	克拉霉素片	0.25g	NMPA consistency evaluation	GMP		Blister	Anti-infective drugs 抗感染类用药
35	Clindamycin Phosphate dry suspension	克拉霉素干混悬剂#	60ml:0.15g	NMPA consistency evaluation	GMP		sachet		Pipeline
36	Clindamycin Phosphate granules	克拉霉素颗粒	0.1g/50mg; 1.5g/瓶(0.125g/5ml)	NMPA consistency evaluation	GMP		bottle
37	Compound sulfamethoxazole tablets	复方磺胺甲噁唑片	0.4g;80mg	NMPA consistency evaluation	GMP		bottle/blister
38	Azithromycin dry suspension	阿奇霉素干混悬剂	0.1g	NMPA consistency evaluation	GMP		sachet
39	Dapoxetine Hydrochloride Tablets	盐酸达泊西汀片#	30mg	NMPA consistency evaluation	GMP		Blister	Medications for the urinary system/andrology 泌尿系统用药/男科用药	Pipeline
40	Finasteride tablet	非那雄胺片	5mg	NMPA consistency evaluation	GMP		Blister
41	Citrate Sildenafil Sublingual Tablets	枸橼酸西地那非口崩片#	50mg	NMPA consistency evaluation	GMP				Pipeline
42	Tadalafil tablets	他达拉非片	20mg	NMPA consistency evaluation	GMP		Blister
43	Cetirizine HCL tablet	盐酸西替利嗪片	10mg	NMPA consistency evaluation	GMP		Blister	Antiallergic agent 抗过敏药
44	Diphenhydramine Hydrochloride tablet	盐酸苯海拉明片	25mg	NMPA consistency evaluation	GMP		Alu-Alu	Antiallergic agent 抗过敏药
45	Aminophylline tablet	氨茶碱片	0.1g	NMPA consistency evaluation	GMP	Own API	Bottle	Respiratory system durgs 呼吸系统用药
47	Meloxicam Capsules	美洛昔康胶囊	7.5mg	NMPA consistency evaluation	GMP	Own API	Blister	NSAIDs 非甾体抗炎药
48	Tofacitinib Citrate Tablets	枸橼酸托法替布片	5mg	NMPA consistency evaluation	GMP		Blister	Immunomodulatory drugs 免疫调节药物
49	Oseltamivir Phosphate Granule Suspension	磷酸奥司他韦干混悬剂#	60ml:0.36g	NMPA consistency evaluation	GMP		sachet	Antiviral medication 抗病毒用药	Pipeline
51	Febuxostat tablet	非布司他片	20mg	NMPA consistency evaluation	GMP	Own API	Blister	Anti-gout medication 抗痛风用药
52	Glucosamine sulfate capsule	硫酸氨基葡萄糖胶囊#	0.25g	NMPA consistency evaluation	GMP			Cartilage protectant 软骨保护剂	Pipeline

Oral Liquid	ORAL LIQUID	NAME	STRENGTH	FILE	GMP	API	PACK	TREATMENT	REMARK
1	Lactulose Oral Liquid	乳果糖口服液	100ml:66.7g; 15ml/袋	NMPA consistency evaluation	GMP		Bottle/Sachet	Medication for the digestive system 消化系统用药
2	Magnesium Sulfate, Sodium and Potassium Oral Concentrated Solution	硫酸镁钠钾口服用浓溶液#	177ml:1.6g,17.5g,3.13g	NMPA consistency evaluation	GMP		Bottle	Medication for the digestive system 消化系统用药	Pipeline
3	Ambroxol Hydrochloride Oral Solution	盐酸氨溴索口服溶液	100mL:0.3g;10ml:30mg	NMPA consistency evaluation	GMP		Bottle/Sachet	Respiratory system Medicine 呼吸系统用药
4	Ambroxol Oral Solution	氨溴特罗口服溶液#	100ml (150+0.1mg)	NMPA consistency evaluation	GMP		Bottle	Respiratory system Medicine 呼吸系统用药	Pipeline
5	Memantine Hydrochloride Oral solution	盐酸美金刚口服溶液	360ml:0.72g	NMPA consistency evaluation	GMP		Bottle	Medications for Alzheimer's disease
6	Pregabalin oral solution	普瑞巴林口服溶液	473ml:9.46g	NMPA consistency evaluation	GMP		bottle	Medication for the nervous system 神经系统用药
8	Alendronate Sodium Oral Solution	阿伦磷酸钠口服溶液#	75ml:70mg	NMPA consistency evaluation	GMP		Bottle	骨质疏松用药Osteoporosis medications	Pipeline
9	Levocarnitine Oral Solution	左卡尼汀口服溶液#	10ml:1g	NMPA consistency evaluation	GMP		Bottle	代谢类药物 Metabolic drugs	Pipeline

Injections	INJECTIONS	NAME	STRENGTH	FILE	GMP	API	PACK	TREATMENT	REMARK
	Clindamycin Phosphate Injection	克林霉素磷酸酯注射液	2ml:0.3g;4ml:0.6g	NMPA consistency evaluation	GMP		Ampole	Anti-infective drugs 抗感染类用药
	Aminophylline Injection	氨茶碱注射液	10ml:0.25g	NMPA consistency evaluation	GMP	Own API	Ampole	Respiratory system durgs 呼吸系统用药
	Adrenaline hydrochloride injection	盐酸肾上腺素注射液#	1ml:1mg	NMPA consistency evaluation	GMP		Ampole	Cardiovascular and cerebrovascular drugs 心脑血管药物	Pipeline
1	Pentoxifylline Injection	己酮可可碱注射液	5ml:0.1g	NMPA consistency evaluation	GMP		Ampole
2	Dobutamine hydrochloride injection	盐酸多巴酚丁胺注射液	2ml: 20mg;5ml:100mg	NMPA consistency evaluation	GMP		Ampole
3	Fasudil Hydrochloride Injection	盐酸法舒地尔注射液	2ml:30mg	NMPA consistency evaluation	GMP		Ampole
4	Edaravone injection	依达拉奉注射液	10ml:15mg	NMPA consistency evaluation	GMP		Ampole
6	Norepinephrine Bitartrate Injection	重酒石酸去甲肾上腺素注射液	1ml:1mg;4ml:4mg				Ampole		Pipeline （Pilot）
10	Citicoline Sodium Injection	胞磷胆碱钠注射液	4ml:0.5g	NMPA consistency evaluation	GMP		Ampole	Medication for the nervous system 神经系统用药
11	Piracetam Injection	吡拉西坦注射液	5ml:1g/10ml:2g	NMPA consistency evaluation	GMP		Ampole	Medication for the nervous system 神经系统用药
15	Analgin injection	安乃近注射液	2ml:1g; 1ml:0.5g		GMP	Own API	Ampole	Antipyretic，analgesic and anti-inflammatory drug 解热镇痛抗炎药
17	Ketorolac Tromethamine Injection	酮咯酸氨丁三醇注射液#	1ml:30mg	NMPA consistency evaluation	GMP		Ampole	NSAIDs 非甾体抗炎药	Pipeline
18	Dexketoprofen Trometamol Injection	右酮洛芬氨丁三醇注射液#	2ml:50mg	NMPA consistency evaluation	GMP		Ampole		pipeline
19	Ibuprofen Injection	布洛芬注射液	4ml0.4g;8ml0.8g			Own API	Ampole		pipeline (Clinical study)
20	Famotidine and Sodium Chloride Injection	法莫替丁氯化钠注射液	2ml:20mg	NMPA consistency evaluation	GMP		Ampole	Medication for the digestive system 消化系统用药
22	Calcium Gluconate Injection	葡萄糖酸钙注射液	10ml:1g	NMPA consistency evaluation	GMP	Own API	Ampole	酸碱平衡调节药物
23	Sodium bicarbonate injection	碳酸氢钠注射液	10ml:0.5g； 10ml:0.84g；	NMPA consistency evaluation	GMP		Ampole	酸碱平衡调节药物
25	Pentazocine Injection	喷他佐辛注射液*	1ml:30mg	NMPA consistency evaluation	GMP	Own API	Ampole	Medication for the nervous system 神经系统用药
27	Acetamide injection	乙酰胺注射液	5ml:2.5g		GMP	Own API	Ampole	解毒药 Aantidote
28	Naloxone Hydrochloride Injection	盐酸纳洛酮注射液	1ml:1mg，2ml:2mg，1ml:0.4mg	NMPA consistency evaluation	GMP		Ampole	解毒药 Aantidote
30	Furosemide injection	呋塞米注射液	2ml:20mg	NMPA consistency evaluation	GMP		Ampole	Hydragogue 利尿剂
32	Sodium Stibogluconate Injection	葡萄糖酸锑钠注射液	6ml:0.6g		GMP	Own API	Ampole	抗寄生虫药 Antiparasitic agent
33	Dexamethasone Sodium Phosphate Injection	地塞米松磷酸钠注射液	1ml:5mg;1ml:1mg; 1ml:2mg		GMP		Ampole	激素类药物 Hormonal Drugs
34	Gentamicin Sulfate Injection	硫酸庆大霉素注射液	2ml: 80000 U; 1ml: 40000 U; 1ml: 20000 U		GMP		Ampole	抗生素 Antibiotics

OTCs	US OTC Monograph	NAME	STRENGTH	FILE	GMP	API	PACK	TREATMENT	REMARK
1	Caffeine tablets	咖啡因片	200mg	US OTC Monograph	GMP/EU GMP/FDA	Own API	Bottle	N/A
2	Polycarbophil calcium tablet	聚卡波非钙片	500mg;625mg		GMP/EU GMP/FDA	Own API	Bottle	N/A
3	Aspirin tablet	阿司匹林片	75mg; 325mg;		GMP/EU GMP/FDA	Own API	Bottle	N/A
4	Aspirin enteric-coated tablet	阿司匹林肠溶片	81mg;100mg;		GMP/EU GMP/FDA	Own API	Bottle	N/A
5	Bismuth subsalicylate tablet	次水杨酸铋片	262mg		GMP/EU GMP/FDA	Own API	Alu-Alu	N/A	pipeline （PV）
6	Diphenhydramine hcl tablet	盐酸苯海拉明片	25mg		GMP/EU GMP/FDA		Alu-Alu	N/A
7	Sodium bicarbonate tablet	碳酸氢钠片	300mg;500mg		GMP/EU GMP/FDA		Blister	N/A
8	Acetaminophen tablet	对乙酰氨基酚片	500mg		GMP/EU GMP/FDA		Bottle	N/A

Healthcare products	Health Products	NAME	STRENGTH	FILE	GMP	API	PACK	TREATMENT	REMARK
1	EPA90 Fish Oil Softgel	EPA90鱼油软胶囊	0.5g	N/A	GMP	Own API	Bottle	N/A
2	EPA65 Fish Oil Softgel	EPA65鱼油软胶囊	0.5g	N/A	GMP	Own API	Bottle	N/A
3	Ω-3 Fish Oil Softgel	Ω-3鱼油软胶囊	0.5g	N/A	GMP	Own API	Bottle	N/A
4	DHA Fish Oil Softgel	DHA软胶囊	0.5g	N/A	GMP	Own API	Bottle	N/A
5	Fish Oil Health Product	加优可牌鱼油保健品	25%EPA+35%DHA (750mg)			Own API	Bottle	N/A	pipeline （Trial）
6	Fish Oil Health Product	畅悦欣牌鱼油保健品	36%EPA+24%DHA (750mg)			Own API	Bottle	N/A	pipeline （Trial）
27	Coenzyme Q10 Soft Capsules	辅酶Q10软胶囊	100g:10g 0.4g	N/A	GMP		Bottle	N/A
8	Vitamin C Chewable Tablets	维生素C咀嚼片	213mg				Bottle	N/A	pipeline （Trial）
9	Melatonin tablets	美立宁（褪黑素）片	3mg	N/A	GMP		Alu-Alu	N/A