Registered substances
| Name of substance: | Azithromycin dihydrate |
| Name of manufacturer: | Jubilant Organosys Limited, India |
| Reg.Cert. №: | № ЛС-001961 dtd 01.09.2006 |
| ND №: | 42-14016-06 |
| Reg.Cert. validity: | until 01.09.2011 |
Registered substances
| № | Name of substance | Name of manufacturer | Reg.Cert. № | ND № | Reg.Cert. validity |
| 1 | Azithromycin dihydrate | Jubilant Organosys Limited, India | № ЛС-001961 dtd 01.09.2006 | 42-14016-06 | until 01.09.2011 |
| 2 | Amitriptyline-Hcl | R.L.Fine Chem, India | № П N013525/01-2001 dtd 19.05.2008 (renewal of RU) | 42-11904-01 42-15224-08 (renewal of registration) |
valid until RU for an unlimited period is obtained |
| 3 | Amlodipine besylate | Glochem Industries Ltd, India | № ЛС-001777 dtd 14.07.2006 | 42-14070-06 | until 14.07.2011 |
| 4 | Aminophylline | Shandong Xinhua Pharmaceutical Co., Ltd, China | № ЛС-002181 dtd 03.11.2006 | 42-14303-06 | until 03.11.2011 |
| 5 | Amoxicillin trihydrate | Zakaria Tabriz Pharm.CO.,Iran | № П№015779/01 dtd 21.06.2004 | 42-13114-04 | until 21.06.2009 |
| 6 | Amoxicillin trihydrate | Zhuhai United Laboratories Co.,Ltd, China | № ЛС-000827 dtd 07.10.2005 | 42-13766-05 | until 07.10.2010 |
| 7 | Ampicillin sodium sterile | I.C.I.International Chemical Industry S.p.A., Italy | № П№015741/01 dtd 15.06.2004 | 42-13060-04 | until 15.06.2009 |
| 8 | Ampicillin trihydrate | Zakaria Tabriz Pharm.CO.,Iran | № П№015769/01 dtd 21.06.2004 | 42-13113-04 | until 21.06.2009 |
| 9 | Ampicillin trihydrate | Tine Pharma Limited, India | № П№015478/01 dtd 26.01.2004 | 42-12923-03 | until 26.01.2009 |
| 10 | Ampicillin trihydrate | Zhuhai United Laboratories Co.,Ltd, China | № ЛС-000972 dtd 02.12.2005 | 42-13899-05 | until 02.12.2010 |
| 11 | Articaine-Hcl | SINTECO S.p.A, Italy | № ЛС-000797 dtd 30.09.2005 | 42-13624-05 | until 30.09.2010 |
| 12 | Ascorbic acid | Northeast General Pharmaceutical Factory, China | № ЛСР-001570/08 dtd 14.03.2008 | 14691-07 | unlimited |
| 13 | Atorvastatin calcium | Chanzghou Pharmaceutical Factory, China | № ЛСР-004522/08 dtd 10.06.2008 | 42-14619-06 | unlimited |
| 14 | Acyclovir | Zhejiang Zhebei Pharmaceutical Co., Ltd, China | № ЛСР-002130/08 dtd 27.03.2008 | 14921-07 | unlimited |
| 15 | Bendazole | Second Pharma Co., Ltd, China | № ЛСР-003071/07 dtd 09.10.2007 | 42-14504-06 | until 09.10.2012 |
| 16 | Bisacodyl | Dishman Pharmaceuticals and Chemicals Limited, India | № ЛСР-004193/08 dtd 30.05.2008 | 42-14687-07 | unlimited |
| 17 | Haloperidol | Lake Chemicals Pvt., Ltd, India | № N013361/01 dtd 03.04.2008 | 42-14676-07 | unlimited |
| 18 | Gamma-aminobutyric acid | Northeast General Pharmaceutical Factory, China | № П№014240/01-2002 dtd 16.05.2008 (renewal of RU) | 42-12250-02 | valid until RU for an unlimited period is obtained |
| 19 | Gentamycin sulphate sterile | Yantai Justaware Pharmaceutical Co.,Ltd, China | № П№015595/01 dtd 21.04.2004 | 42-13035-04 | until 21.04.2009 |
| 20 | Heparin sodium salt | Hebei Changshan Biochemical Pharmaceutical Co, Ltd, China | № П№015882/01 dtd 10.08.2004 | 42-13181-04 | until 10.08.2009 |
| 21 | Dexamethasone | Zhejiang Xianju Pharmaceutical Co., Ltd, China | № ЛСР-002453/08 dtd 03.04.08 | 42-14604-06 | unlimited |
| 22 | Diclofenac sodium | Henan Dongtai Pharm Co., Ltd., China | № ЛС-002109 dtd 20.10.2006 | 42-14252-06 | until 20.10.2011 |
| 23 | Diphenhydramine-Hcl | Beijing Taiyang Pharmaceutical Industry Co., Ltd, China | № ЛС-001326 dtd 26.02.2006 | 42-13960-05 | until 26.02.2011 |
| 24 | Doxasozine mesylate | Precise Chemipharma Pvt. Ltd, India | № ЛС-000674 dtd 26.08.2005 | 42-13620-05 | until 26.08.2010 |
| 25 | Doxycycline-Hcl | Yangzhou Pharmaceutical Co. Ltd, China | № ЛС-001962 dtd 01.09.2006 | 42-14115-06 | until 01.09.2011 |
| 26 | Doxycycline-Hcl | Shanghai International Pharmaceutical Co.Ltd, China | № П№016078/01 dtd 25.11.2004 | 42-13308-04 | until 25.11.2009 |
| 27 | Drotaverine-Hcl | Five Coop Cooperative of fine chemicals, Hungary | № П N012329/01 dtd 29.12.2006 | 42-14354-06 | until 29.12.2011 |
| 28 | Drotaverine-Hcl | Zhejiang Apeloa Pharmaceutical Co., Ltd, China | № П N015182/01-2003 dtd 18.09.2008 | 42-12678-02 | valid until RU for an unlimited period is obtained |
| 29 | Ibuprofen | Juhua Group Corp. Pharmaceutical Factory, China | № ЛС-000204 dtd 22.04.2005 | 42-13488-05 | until 22.04.2010 |
| 30 | Indapamide | Shandong Yinfeida Pharmaceutical Co., Ltd, China | № ЛСР-003466/08 dtd 04.05.08 | 42-15067-07 | unlimited |
| 31 | Inosine | Guangdong Zhaoqing Starlake Bio-Chemical Pharmaceutical Factory, China | № П№015885/01 dtd 10.08.2004 | 42-13182-04 | until 10.08.2009 |
| 32 | Isoniazide | Amsal Chem Pvt Ltd, India | № П№012702/01 dtd 26.05.2008 | 42-11319-06 | unlimited |
| 33 | Calcium gluconate | Zhejiang Ruibang Laboratories, China | № П№015240/01 dtd 29.08.2008 | 42-12699-02 | valid until RU for an unlimited period is obtained |
| 34 | Camphor synthetic | Jianyang Qingsong Green Pine Chemical Co., Ltd, China | № ЛСР-002178/08 dtd 28.03.2008 | 15003-07 | unlimited |
| 35 | Kanamycin monosulphate | Fuzhou Fuxing Pharmaceutical Co., Ltd, China | № ЛС-001327 dtd 26.02.2006 | 42-13970-05 | until 26.02.2011 |
| 36 | Captopril | Changzhou Pharmaceutical Factory, China | № ЛСР-003133/08 dtd 25.04.08 | 42-15066-07 | unlimited |
| 37 | Carbamazepine | Zhejiang Jiuzhou Pharmaceutical Co.,Ltd, China | № ЛС-000678 dtd 26.08.2005 | 42-13625-05 | until 26.08.2010 |
| 38 | Carbamazepine | Jubilant Organosys Limited, India | № ЛС-002503 dtd 29.12.2006 | 42-14347-06 | until 29.12.2011 |
| 39 | Ketoconazole | Nanjing Baijingyu Pharmaceutical Co.,Ltd, China | № ЛС-001508 dtd 14.04.2006 | 42-14072-06 | until 14.04.2011 |
| 40 | Clarithromycin | Zhejiang Huayi Pharmaceutical Co., Ltd, China | № ЛСР-003346/08 dtd 30.04.08 | 42-14967-07 | unlimited |
| 41 | Clindamycin phosphate | Suzhou Tianma Pharma Group Tianji Bio-Pharmaceutical Co., Ltd., China | № ЛС-002546 dtd 29.12.2006 | 42-14457-06 | until 29.12.2011 |
| 42 | Clotrimazole | Jintan Zhongxing Medical and Pharmaceutical Material Factory, China | № ЛС-001699 dtd 23.06.2006 | 42-14171-06 | until 23.06.2011 |
| 43 | Caffeine | Shandong Xinhua Pharmaceutical CO. Ltd, China | № П№015241/01 dtd 06.05.2008 | 42-12622-02 | valid until RU for an unlimited period is obtained |
| 44 | Lamotrigine | Jubilant Organosys Limited, India | № ЛС-002190 dtd 03.11.2006 | 42-14295-06 | until 03.11.2011 |
| 45 | Levonorgestrel | Beijing Zizhu Pharmaceutical Co., Ltd, China | № ЛС-002189 dtd 03.11.2006 | 42-14279-06 | until 03.11.2011 |
| 46 | Lansoprazole pellets | Precise Chemipharma Pvt. Ltd, India | № ЛС-001723 dtd 30.06.2006 | 42-14017-06 | until 30.06.2011 |
| 47 | Lidocaine-Hcl | Dishman Pharmaceuticals and Chemicals Limited, India | № ЛС-002017 dtd 22.09.2006 | 42-14192-06 | until 22.09.2011 |
| 48 | Lisinopril dihydrate | Unimark Remedies Ltd, India | № ЛС-001435 dtd 24.03.2006 | 42-14030-07 | until 24.03.2011 |
| 49 | Lincomycin-Hcl | North China Pharmaceutical Group Hualuan Co., Ltd, China | № ЛС-004409 dtd 07.06.2008 | 42-14488-06 | unlimited |
| 50 | Lovastatine | Artemis Biotech (A Division of Themis Medicare Limited), India | № ЛСР-003487/08 dtd 05.05.2008 | 42-14668-07 | unlimited |
| 51 | Loperamide-Hcl | Fleming Laboratories Limited, India | № ЛС-000798 dtd 30.09.2005 | 42-13676-05 | until 30.09.2010 |
| 52 | Loratadine | Tonira Pharma Limited, India | № ЛС-000579 dtd 29.07.2005 | 42-13577-05 | until 29.07.2010 |
| 53 | Metoclopramide | Beijing Taiyang Pharmaceutical Industry Co., Ltd, China | № ЛС-001509 dtd 14.04.2006 | 42-14084-06 | until 14.04.2011 |
| 54 | Metronidazole | Wuhan Wuyao Pharmaceutical Co.Ltd, China | № ЛС-001743 dtd 07.07.2006 | 42-14054-06 | until 07.07.2011 |
| 55 | Metformin-Hcl | Harman Finochem Ltd, India | № П№015717/01 dtd 02.06.2004 | 42-13067-04 | until 02.06.2009 |
| 56 | Naproxen | Zhejiang Charioteer Pharmaceutical Co.,Ltd, China | № ЛС-000665 dtd 26.08.2005 | 42-13602-05 | until 26.08.2010 |
| 57 | Neomycin sulphate | Yichang Sanxia Pharmaceutical Co. Ltd, China | № ЛС-000796 dtd 30.09.2005 | 42-13680-05 | until 30.09.2010 |
| 58 | Nicotinamide | Aarti Drugs Ltd., India | № П№015883/01 dtd 24.03.2006 | 42-13176-04 | until 24.03.2011 |
| 59 | Oxacillin | I.C.I. International Chemical Industry SpA., Italy | № П№016115/01 dtd 21.12.2004 | 42-13325-04 | until 21.12.2009 |
| 60 | Oxytetracycline-Hcl | Jiangxi Guoyao Pharmaceutical Limited-Liability Company, China | № П№015831/01 dtd 12.07.2004 | 42-13141-04 | until 12.07.2009 |
| 61 | Omeprazole pellets | Precise Chemipharma Pvt.Ltd., India | № ЛС-000494 dtd 15.07.2005 | 42-13515-05 | until 15.07.2010 |
| 62 | Ondansetrone-Hcl | Sun Pharmaceutical Industries Ltd., India | № ЛС-000677 dtd 26.08.2005 | 42-13644-05 | until 26.08.2010 |
| 63 | Pancreatin | ABC Farmaceutici S.p.A.-Unibios Division, Italy | № ЛС-001328 dtd 26.02.2006 | 42-13958-05 | until 26.02.2011 |
| 64 | Paracetamol | Mallinckrodt Chemical Ltd, USA | № П№015593/01 dtd 20.04.2004 | 42-12744-03 | until 20.04.2009 |
| 65 | Pioglitazone-Hcl | Aarti Drugs Limited, India | № ЛСР-006077/08 dtd 31.07.2008 | 15210-08 | unlimited |
| 66 | Pyrazinamide | Linaria Chemicals (Thailand) Ltd., Thailand | № П№013873/01 dtd 21.07.2008 | 14955-07 | unlimited |
| 67 | Piracetam | Northeast General Pharmaceutical Factory, China | № П№015884/01 dtd 10.08.2004 | 42-13203-04 | until 10.08.2009 |
| 68 | Piroxicam | Nantong Jinghua Pharmaceutical Co.,Ltd, China | № П№011314/01 dtd 13.01.2006 | 42-13824-05 | until 13.01.2011 |
| 69 | Primidone | Nantong Jinghua Pharmaceutical Co.,Ltd, China | № ЛСР-009660/08 dtd 04.12.2008 | 15451-08 | unlimited |
| 70 | Procain-Hcl | Sanmen Huali Medical Chemical Co., Ltd., China | № ЛС-002468 dtd 29.12.2006 | 42-14377-06 | until 29.12.2011 |
| 71 | Propranolol-Hcl | Changzhou Yabang Pharmaceutical Co., Ltd., China | № ЛС-002547 dtd 29.12.200 | 42-14479-06 | until 29.12.2011 |
| 72 | Ranitidine-Hcl | Saraca Laboratories Limited, India | № ЛС-000670 dtd 26.08.2005 | 42-13621-05 | until 26.08.2010 |
| 73 | Ranitidine-Hcl | SMS Pharmaceuticals Limited, India | № ЛС-002582 dtd 29.12.2006 | 42-14387-06 | until 29.12.2011 |
| 74 | Ribavirin | Guilin Hwasun Pharmaceutical Co., Ltd., China | № ЛСР-002195/08 dtd 28.03.2008 | 15023-07 | unlimited |
| 75 | Riboflavin sodium phosphate | Danashmand Organic Private Limited, India | № ЛС-002018 dtd 22.09.2006 | 42-14222-06 | until 22.09.2011 |
| 76 | Rimantadine-Hcl | Zhejiang Kangyu Pharmaceutical Co., Ltd, China | № П N014012/01-2002 dtd 21.07.2008 (renewal of RU) | 42-12125-02 42-15445-08 (renewal of registration) |
valid until RU for an unlimited period is obtained |
| 77 | Rifampicin | Zhengzhou Minzhong Pharmaceutical Co. Ltd, China | № П№016077/01 dtd 25.11.2004 | 42-13307-04 | until 25.11.2009 |
| 78 | Rutin | Sichuan Xieli Pharmaceutical Co., Ltd, China | № П №013343/01-040408 dtd 04.04.2008 | 11781-07 | unlimited |
| 79 | Simvastatin | Zhejiang Hisun Pharmaceutical Co.Ltd, China | № ЛС-001638 dtd 09.06.2006 | 42-14087-06 | until 09.06.2011 |
| 80 | Streptomycin sulphate | North China Pharmaceutical Huasheng Co.,Ltd, China | № ЛС-000808 dtd 07.10.2005 | 42-13717-05 | until 07.10.2010 |
| 81 | Sulfadimethoxine | Zhejiang Jiuzhou Pharmaceutical Co., Ltd, China | № ЛС-000675 dtd 26.08.2005 | 42-13651-05 | until 26.08.2010 |
| 82 | Sulfamethoxazole | Virchow Laboratories Limited, India | № П015246/01 dtd 09.10.2008 (renewal of RU) | 42-12828-03 | valid until RU for an unlimited period is obtained |
| 83 | Sumatriptane succinate | SMS Pharmaceuticals Limited, India | № ЛС-002545 dtd 29.12.2006 | 42-14421-06 | until 29.12.2011 |
| 84 | Tamsulosine-Hcl | Boryung Pharmaceutical Co.,Ltd, Korea | № ЛС-001174 dtd 19.01.2006 | 42-13855-05 | until 19.01.2011 |
| 85 | Theophylline | Shandong Xinhua Pharmaceutical CO.Ltd, China | № П№015242/01 dtd 12.05.2008 | 42-12385-02 | valid until RU for an unlimited period is obtained |
| 86 | Thymol | Kanta Chemical Co., India | № ЛСР-006132/08 dtd 01.08.2008 | 15215-08 | unlimited |
| 87 | Tinidazole | Aarti Drugs Limited, India | № ЛС-000187 dtd 22.04.2005 | 42-11870-04 | until 22.04.2010 |
| 88 | Tramadol-Hcl | Sun Pharmaceutical Industries Ltd., India | № ЛС-000971 dtd 02.12.2005 | 42-13799-05 | until 02.12.2010 |
| 89 | Trimethoprim | № ЛС-000203 dtd 22.04.2005 | 42-13489-05 | until 22.04.2010 | |
| 90 | Troxerutin | Sichuan Xieli Pharmaceutical Co. Ltd, China | № ЛС-002188 dtd 03.11.2006 | 42-14260-06 | until 03.11.2011 |
| 91 | Phenyephrine-Hcl | Shenzhen Oriental Pharmaceutical Co. Ltd, China | № ЛС-001171 dtd 19.01.2006 | 42-13814-05 | until 19.01.2011 |
| 92 | Phenobarbital | Nantong Jinghua Pharmaceutical Co., Ltd, China | № ЛС-000202 dtd 22.04.2005 | 42-13487-05 | until 22.04.2010 |
| 93 | Fluconazole | Mantena Laboratories Limited, India | № ЛСР-000472/09 dtd 27.01.2009 | 15365-08 | unlimited |
| 94 | Microcrystalline cellulose | JRS Pharma GmbH & Co.KG, Germany | № ЛС-002380 dtd 22.12.2006 | 42-14414-06 | until 22.12.2011 |
| 95 | Cefazoline sodium sterile | I.C.I. International Chemical Industry SpA., Italy | № ЛС-000425 dtd 01.07.2005 | 42-13563-05 | until 01.07.2010 |
| 96 | Cefotaxime sodium | Zhuhai United Laboratories Co., Ltd, China | № ЛС-001264 dtd 17.02.2006 | 42-13962-05 | until 17.02.2011 |
| 97 | Cefotaxime sodium sterile | Daewoong Chemical Co., Ltd, Republic of Korea | № П №016175/01 dtd 27.01.2005 | 42-13331-04 | until 27.01.2005 |
| 98 | Ceftazidime and sodium carbonate | Harbin Pharmaceutical Group Co., Ltd. General Pharm Factory, China | № ЛС-002548 dtd 29.12.2006 | 42-14468-06 | until 29.12.2011 |
| 99 | Ceftriaxone sodium | Zhuhai United Laboratories Co., Ltd, China | № ЛС-001265 dtd 17.02.2006 | 42-13989-05 | until 17.02.2011 |
| 100 | Cinnarizine | Fleming Laboratories Limited, India | № П N013279/01 dtd 29.12.2006 | 42-11672-06 | until 29.12.2011 |
| 101 | Ciprofloxacin-Hcl | Zhejiang Xinhua Pharmaceutical Co., Ltd, China | № ЛСР-002448/08 dtd 03.04.2008 | 14855-07 | unlimited |
| 102 | Citalopram hydrobromide | Jubilant Ortganosys Ltd, India | № ЛС-000826 dtd 07.10.2005 | 42-13762-05 | until 07.10.2010 |