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Contact Us The eleventh batch
List of Reference Preparations for Generic Drugs (11th & 12th batch)
List of Reference Preparations for Generic Drugs (11th batch)
No.Generic Name English Name/Proprietary NameStrengthDosage FormApplicant HolderNote 1Note 2
11-1苯磺酸氨氯地平片Amlodipine BesilateTablets5mgTABLETPfizer Pharmaceuticals LtdProduced in China by original enterprises
11-2苯磺酸氨氯地平片Amlodipine BesilateTablets10mgTABLETPfizer Pharmaceuticals LtdProduced in China by original enterprises
11-3蒙脱石散Montmorillonite Powder3gpowderBeaufort - Ipson (Tianjin) 
Pharmaceutical Company Limited
Produced in China by original enterprises
11-4左氧氟沙星片Levofloxacin Tablets0.5gTABLETDaiichi Sankyo Pharmaceutical (Beijing) 
Co., LTD.
Produced in China by original enterprises
11-5盐酸氟桂利嗪胶囊Flunarizine Hydrochloride Capsules5mgCapsuleXian-Janssen Pharmaceutical LtdProduced in China by original enterprises
11-6尼莫地平片Nimodipine Tablets30mgTABLETBayer HealthCare AGProduced in China by original enterprises
11-7阿卡波糖片Acarbose Tablets50mgTABLETBayer HealthCare AGProduced in China by original enterprises
11-8阿卡波糖片Acarbose Tablets100mgTABLETBayer HealthCare AGProduced in China by original enterprises
11-9多潘立酮片Domperidone Tablets10mgTABLETXian-Janssen Pharmaceutical LtdProduced in China by original enterprises
11-10利培酮片Risperidone Tablets1mgTABLETXian-Janssen Pharmaceutical LtdProduced in China by original enterprises
11-11利培酮片Risperidone Tablets2mgTABLETXian-Janssen Pharmaceutical LtdProduced in China by original enterprises
11-12盐酸贝那普利片Benazepril Hydrochloride Tablets5mgTABLETBeijing Novartis Pharma LtdProduced in China by original enterprises
11-13盐酸贝那普利片Benazepril Hydrochloride Tablets10mgTABLETBeijing Novartis Pharma LtdProduced in China by original enterprises
11-14盐酸特拉唑嗪片Terazosin Hydrochloride Tablets2mgTABLETShanghai Abbott Pharmaceutical Co. LTDProduced in China by original enterprises
11-15克拉霉素片Clarithromycin Tablets   250mgTABLETShanghai Abbott Pharmaceutical Co. LTDProduced in China by original enterprises
11-16酒石酸美托洛尔片Metoprolol Tartrate Tablets25mgTABLETAstraZeneca Pharmaceutical Co LtdProduced in China by original enterprises
11-17酒石酸美托洛尔片Metoprolol Tartrate Tablets50mgTABLETAstraZeneca Pharmaceutical Co LtdProduced in China by original enterprises
11-18酒石酸美托洛尔片Metoprolol Tartrate Tablets100mgTABLETAstraZeneca Pharmaceutical Co LtdProduced in China by original enterprises
11-19依卡倍特钠颗粒Ecabet Sodium Granules1.0ggranulesTianjin Tanabe Seiyaku Co. LTDProduced in China by original enterprises
11-20培哚普利叔丁胺片Perindopril tert-Butylamine Tablets4mgTABLETSchviya (Tianjin) Pharmaceuticals 
Co., LTD.
Produced in China by original enterprises
11-21培哚普利叔丁胺片Perindopril tert-Butylamine Tablets8mgTABLETSchviya (Tianjin) Pharmaceuticals
Co., LTD.
Produced in China by original enterprises
11-22吲达帕胺Indapamide Sustained-release Tablets1.5mgTABLETSchviya (Tianjin) Pharmaceuticals 
Co., LTD.
Produced in China by original enterprises
11-23盐酸曲美他嗪片Trimetazidine Dihydrochloride Tablets20mgTABLETSchviya (Tianjin) Pharmaceuticals 
Co., LTD.
Produced in China by original enterprises
11-24盐酸多奈哌齐片Trimetazidine Dihydrochloride Tablets5mgTABLETisai (China) Pharmaceutical Co. LTDProduced in China by original enterprises

11-25盐酸多奈哌齐片Trimetazidine Dihydrochloride Tablets10mgTABLETisai (China) Pharmaceutical Co. LTDProduced in China by original enterprises

11-26甲钴胺片Mecobalamin Tablets0.5mg
(film-coating)
TABLETisai (China) Pharmaceutical Co. LTDProduced in China by original enterprises
11-27坎地沙坦酯片Candesartan Cilexetil Tablets8mgTABLETtianjin takeda pharmaceuticals co., ltdProduced in China by original enterprises
11-28伏格列波糖片Voglibose Tablets0.2mgTABLETtianjin takeda pharmaceuticals co., ltdProduced in China by original enterprises
11-29伏格列波糖片Voglibose Tablets0.3mgTABLETtianjin takeda pharmaceuticals co., ltdProduced in China by original enterprises
11-30美洛昔康片Meloxicam Tablets7.5mgTABLETShanghai Boehringer Ingelheim Pharmaceutical Co. LTDProduced in China by original enterprises
11-31奥美沙坦酯片Olmesartan Medoxomil Tablets20mgTABLETDaiichi Sankyo Pharmaceutical (Shanghai) 
Co., LTD.
Produced in China by original enterprises
11-32头孢克洛胶囊Cefaclor Capsules0.25gCapsuleEli Lilly Suzhou Pharmaceutical Co. LTDProduced in China by original enterprises
11-33盐酸雷尼替丁胶囊Ranitidine Hydrochloride Capsules0.15g(On C13H22N4O3S base)CapsuleDR REDDY’S Laboratories LimitiedOrange Book-USAsupplement
Proprietary Name :RANITIDINE HYDROCHLORIDE








List of Reference Preparations for Generic Drugs (11th batch)








No.Generic Name English Name/Proprietary NameStrengthDosage FormApplicant HolderNote 1Note 2
12月1日拉莫三嗪片Lamotrigine Tablets/LAMICTAL25mgTABLETThe Wellcome Foundation LimitedOriginal Import 
12月2日拉莫三嗪片Lamotrigine Tablets/LAMICTAL50mgTABLETThe Wellcome Foundation LimitedOriginal Import 
12月3日琥珀酸索利那新片Solifenacin Succinate Tablets/Vesicare5mgTABLETAstellas Pharma Europe B.V.Original Import 
12月4日交沙霉素片Josamycin Tablets/--50mgTABLETAstellas Pharma Inc.Orange Book-Japan
12月5日交沙霉素片Josamycin Tablets/--200mgTABLETAstellas Pharma Inc.Orange Book-Japan
12月6日阿莫西林胶囊Amoxicillin Capsules/Sawacillin125mgCapsuleAstellas Pharma Inc.Orange Book-Japan
12月7日尼麦角林片Nicergoline Tablets/SERMION5mgTABLETPfizer Italia S.r.l.EU-listed(origin:Italy)
12月8日尼麦角林片Nicergoline Tablets/SERMION10mgTABLETPfizer Italia S.r.l.EU-listed(origin:Italy)
12月9日尼麦角林片Nicergoline Tablets/SERMION30mgTABLETPfizer Italia S.r.l.EU-listed(origin:Italy)
12月10日雷米普利片Ramipril tablets/Tritace2.5mgTABLETSanofi-Aventis Deutschland GmbHOriginal Import 
12月11日雷米普利片Ramipril tablets/Tritace5mgTABLETSanofi-Aventis Deutschland GmbHOriginal Import 
12月12日磷霉素钙片Fosfomycin Calcium Tablets/FOSMICIN250mgTABLETMeiji Seika Pharma Co., LtdOrange Book-Japan
12月13日磷霉素钙片Fosfomycin Calcium Tablets/FOSMICIN500mgTABLETMeiji Seika Pharma Co., LtdOrange Book-Japan
12月14日L-谷氨酰胺呱仑酸钠颗粒L-Glutamine and Sodium Gualenate Granules/Marzulene-S0.67g:L-Glutamine663.3mg,Sodium Gualenate Granules 2.0mggranulesKotobuki Pharmaceutical Co., Ltd.Original Import 
12月15日二甲双胍格列本Glyburide and Metformin Hydrochloride Tablets /GlucovanceMetformin Hydrochloride 500mg Glyburide 2.5mgTABLETMerk SANTE S.A.SEU-listed(Listed country: France)
脲片
12月16日二甲双胍格列本Glyburide and Metformin Hydrochloride Tablets /GlucovanceMetformin Hydrochloride 500mg Glyburide 5 mgTABLETMerk SANTE S.A.SEU-listed(Listed country: France)
脲片
12月17日二甲双胍格列本
脲片
Glyburide and Metformin Hydrochloride Tablets /GlucovanceMetformin Hydrochloride 250mg Glyburide 1.25 mgTABLETMerk(Schweiz)AG,ZugEU-listed(Listed country: Switzerland)
12月18日硫糖铝片Sucralfate Tablet/CARAFATE1gTABLETAllergan USA. IncOrange Book-USA
12月19日硫糖铝Sucralfate Oral Suspension/CARAFATE10ml:1gsuspensionAllergan USA. IncOrange Book-USA
12月20日氯霉素片Chloromycetin Tablets/CHLOROMYCETIN50mgTABLETDaiichi Sankyo Co.,Ltd.Orange Book-Japan
12月21日氯霉素片Chloromycetin Tablets/CHLOROMYCETIN250mgTABLETDaiichi Sankyo Co.,Ltd.Orange Book-Japan
12月22日甲磺司特Suplatast Tosilate Dry Syrup/IPD Dry Syrup 5%5%1gDry SyrupTAIHO PHARMACEUTICAL CO., LTD.Orange Book-Japan
12月23日富马酸喹硫平缓Quetiapine Fumarate Extended-Release Tablets/--50mgSustained release tabletsAstraZeneca Pharmaceuticals LPOriginal Import 
释片on the Quetiapine base
12月24日富马酸喹硫平缓
释片
Quetiapine Fumarate Extended-Release Tablets/--200mgSustained release tabletsAstraZeneca Pharmaceuticals LPOriginal Import 
on the Quetiapine base
12月25日富马酸喹硫平缓Quetiapine Fumarate Extended-Release Tablets/--300mgSustained release tabletsAstraZeneca Pharmaceuticals LPOriginal Import 
释片on the Quetiapine base
12月26日富马酸喹硫平缓Quetiapine Fumarate Extended-Release Tablets/--400mgSustained release tabletsAstraZeneca Pharmaceuticals LPOriginal Import 
释片on the Quetiapine base
12月27日硫辛酸片Thioctic Acid Tablets/Thioctacid0.6gTABLETMEDA Pharma GmbH & Co. KGEU-listed(Listed country:Germany,origin:Germany)
12月28日左炔诺孕酮炔雌醇(三相)片Levonorgestrel and Ethinylestradiol Tablets(Triphasic)/TriquilarcompoundsTABLETJenapharm GmbH & Co. KGEU-listed
(origin:Germany)
12月29日甲巯咪唑片Thiamazole Tablets/Thyrozol10mgTABLETMerck Serono GmbHEU-listed
(origin:Germany)
12月30日甲巯咪唑片Thiamazole Tablets/Thyrozol20mgTABLETMerck Serono GmbHEU-listed
(origin:Germany)
12月31日华法林钠片Warfarin Sodium Tablets/Coumadin3mgTABLETBristol Myers Squibb Pharma CoOrange Book-USA
12-32头孢克洛干混悬剂Cefaclor for Suspension/0.125gOral SuspensionEli Lilly  Suzhou Pharmaceutical Co. LTDProduced in China by original enterprises


12-33氯雷他定片Loratadine Tablets /开瑞坦10mgTABLETBayer Pharmaceutical (Shanghai) Co., LTDProduced in China by original enterprises
12-34培哚普利吲达帕Perindopril and Indapamide Tablets/百普乐Perindopril 4mg,indapamide 1.25mgTABLETSchviya (Tianjin) Pharmaceuticals
Co., LTD.
Produced in China by original enterprises
胺片
12-35盐酸曲美他嗪缓Trimetazidine Dihydrochloride Modified Release Tablets35mgTABLETSchviya (Tianjin) Pharmaceuticals
Co., LTD.
Produced in China by original enterprises
释片
12-36格列齐特Gliclazide Modified Release Tablets/30mgTABLETSchviya (Tianjin) Pharmaceuticals
Co., LTD.
Produced in China by original enterprises
12-37阿立哌唑片Aripiprazole Tablets5mgTABLETZhejiang Otsuka Pharmaceutical Co. LTDProduced in China by original enterprises

12-38阿立哌唑片Aripiprazole Tablets10mgTABLETZhejiang Otsuka Pharmaceutical Co. LTDProduced in China by original enterprises

12-39格列美脲片Glimepiride Tablets/亚莫利2mgTABLETSanofi (Beijing) Pharmaceutical Co. LTDProduced in China by original enterprises
12-40洛索洛芬钠片Loxoprofen Sodium Tablets/乐松60mgTABLETDaiichi Sankyo Pharmaceutical (Shanghai) Co., LTDProduced in China by original enterprises
12-41富马酸替诺福韦二吡呋酯片Tenofovir Disoproxil Fumarate Tablets0.3gTABLETGlaxosmithkline (Tianjin) LTDProduced in China by original enterprises
12-42阿托伐他汀钙片Atorvastatin Calcium Tablets/立普妥10mgTABLETPfizer Pharmaceuticals LtdProduced in China by original enterprises
12-43阿托伐他汀钙片Atorvastatin Calcium Tablets/立普妥20mgTABLETPfizer Pharmaceuticals LtdProduced in China by original enterprises
12-44阿托伐他汀钙片Atorvastatin Calcium Tablets/立普妥40mgTABLETPfizer Pharmaceuticals LtdProduced in China by original enterprises
12-45枸橼酸西地那非片Sildenafil Citrate Tablets/25mgTABLETPfizer Pharmaceuticals LtdProduced in China by original enterprises
万艾可
12-46枸橼酸西地那非片Sildenafil Citrate Tablets/50mgTABLETPfizer Pharmaceuticals LtdProduced in China by original enterprises
万艾可
12-47枸橼酸西地那非片Sildenafil Citrate Tablets/100mgTABLETPfizer Pharmaceuticals LtdProduced in China by original enterprises
万艾可
12-48艾司奥美拉唑镁肠溶片Esomeprazole Magnesium Enteric-coated Tablets/耐信20mgTABLETAstraZeneca Pharmaceutical Co LtdProduced in China by original enterprises

12-49艾司奥美拉唑镁肠溶片Esomeprazole Magnesium Enteric-coated Tablets/耐信40mgTABLETAstraZeneca Pharmaceutical Co LtdProduced in China by original enterprises

12-50多巴丝肼片Levodopa and Benserazide Hydrochloride Tablets /0.25gTABLETShanghai Roche Pharmaceuticals Co. LTDProduced in China by original enterprises
美多芭
12-51卡培他滨片Capecitabine Tablets /希罗达0.5gTABLETShanghai Roche Pharmaceuticals Co. LTDProduced in China by original enterprises
12-52盐酸二甲双胍缓Metformin Hydrochloride Extended-release Tablets/Glucophage XR0.5gcontrolled-release TABLETMerck Serono LimitedOriginal Import supplement
释片
12-53阿托伐他汀钙片Atorvastatin Calcium Tablets/Lipitor20mgTABLETPfizer Inc.Orange Book-USAsupplement
12-54氢氯噻嗪片Hydrochlorothiazide Tablets/Esidrix25mgTABLETLaboratoires Juvise PharmaceuticalsEU-listed,Listed country:Germany,origin:Francesupplement
12-55单硝酸异山梨酯片Isosorbide Mononitrate Tablets10mgTABLETKREMERS URBAN PHARMACEUTICALS INC/LANNETT CO INCOrange Book-USA/authorized genericssupplement
12-56阿苯达唑片Albendazole Tablets/ Eskazole Tab. 200mg0.2gTABLETGlaxo Smithkline K.K.Orange Book-Japansupplement


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