Levodopa
CAS number： 59-92-7
Molecular formula： C9H11NO4
molecular weight： 197.188
Chemical structure：
Producers shown on SFDA
(Record date:06/09/2021）
Producer | Documents | GMP Valid till(based on SFDA) |
Guangxi Bang'er Pharmaceutical Co., Ltd. | GMP | Valid till January 2020 |
Guangxi Lingyun Pharmaceutical Co., Ltd. | GMP | Valid till January 2020 |
Guangxi Hefeng Pharmaceutical Co., Ltd. | GMP | Valid till January 2021 |
| Guangzhou Hanfang Pharmaceutical Co., Ltd. | GMP | / |
| Shandong Xinhua Pharmaceutical Co., Ltd. | GMP | Valid till July 2022 |
Producers shown on EP
(Quoted from EP website；record date:06/09/2021）
| Substance | Certificate Holder | Certificate Number | Issue Date | Status | End date | Type |
| Levodopa | Ajinomoto Co., Inc. JP 104-8315 Tokyo | R1-CEP 1999-001-Rev 01 | 19/10/2007 | VALID | / | Chemistr |
| Levodopa Enzymatic process | TEVA PHARMACEUTICAL INDUSTRIES LTD. IL 4951033 Petach Tikva | R1-CEP 2013-293-Rev 00 | 26/05/2020 | VALID | / | Chemistry |
| Levodopa | SHANDONG XINHUA PHARMACEUTICAL CO., LTD. CN 255 086 Zibo | R1-CEP 2009-174-Rev 01 | 13/11/2018 | VALID | / | Chemistry |
| Levodopa | DAIICHI SANKYO CHEMICAL PHARMA CO., LTD. JP 254-0073 Kanagawa | R1-CEP 1999-091-Rev 03 | 14/05/2008 | WITHDRAWN BY HOLDER | 30/08/2013 | Chemistry |
| Levodopa | EGIS Pharmaceuticals PLC HU 1106 Budapest | R1-CEP 1998-071-Rev 01 | 13/02/2009 | WITHDRAWN BY HOLDER | 07/01/2019 | Chemistry |
| Levodopa | GUANGXI BONGER PHARMACEUTICAL CO., LTD. CN 531 500 Tiandong Town | R0-CEP 2014-348-Rev 00 | 06/10/2016 | VALID | / | Chemistry |
| Levodopa | ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. CN 317 024 Linhai | R0-CEP 2017-090-Rev 02 | 30/07/2020 | VALID | / | Chemistry |
| Levodopa | TORRENT PHARMACEUTICALS LIMITED IN 382 428 Village Bhat | R1-CEP 2011-253-Rev 00 | 15/05/2018 | VALID | / | Chemistry |
| Levodopa | DIVI'S LABORATORIES LIMITED IN 500 032 Hyderabad | R1-CEP 2005-161-Rev 04 | 25/01/2018 | VALID | / | Chemistry |
| Levodopa | TEVA PHARMACEUTICAL INDUSTRIES LTD. IL 4951033 Petach Tikva | R1-CEP 1999-187-Rev 07 | 28/06/2017 | VALID | / | Chemistry |
| Levodopa | ZHEJIANG WILD WIND PHARMACEUTICAL CO., LTD. CN 322 105 Geshan Town | R1-CEP 2012-377-Rev 00 | 28/02/2019 | VALID | / | Chemistry |
Producer:Guangxi Bang'er Pharmaceutical Co., Ltd. has API: levodopa (extracted from agricultural products cat beans) extraction workshop, comprehensive plant extraction workshop and raw material planting base under construction. The API: levodopa (gyzz h45020127) extraction workshop has passed GMP certification, and the product quality meets the latest version of BP \ EP \ CP.
Staff size:About 50 persons
Registered capital:RMB 2 million
Producer:Guangxi Lingyun Pharmaceutical Co., Ltd. was established in 1990. The company is mainly engaged in tablets, granules, API, star anise oil and traditional Chinese medicine extract.
Staff size:About 50 persons
Registered capital:RMB 18 million
Producer:Guangxi Hefeng Pharmaceutical Co., Ltd., founded in 1970, covers an area of 55000 square meters and has fixed assets of more than 50 million yuan.
The company has APIs, small volume injections, tablets, capsules, granules, tea and other dosage forms, all of which have passed the national GMP certification.
Staff size:100-199 persons
Registered capital:RMB 5.5 million
Producer:Guangzhou Hanfang Pharmaceutical Co., Ltd.is one of nearly 30 member enterprises of Guangzhou Baiyunshan Pharmaceutical Group Co., Ltd. under Guangzhou Pharmaceutical Group. It is a high-tech enterprise engaged in the production of characteristic APIs, high-end raw and auxiliary materials of medicinal lipids, natural drugs, health products and preparations and formula foods for special medical purposes. At present, the company has 40 drug production approvals, 3 pharmaceutical excipients approvals and 4 health food approvals, and its products have passed the EU CEP certification.
Staff size:300-399 persons
Registered capital:RMB 252 million 564 thousand and 300
Producer:Shandong Xinhua Pharmaceutical Co., Ltd., established in Jiaodong Anti Japanese base in 1943, is the first chemical synthetic pharmaceutical enterprise in China, an important global production and export base of antipyretic and analgesic drugs, and an important domestic manufacturer of cardio cerebrovascular, anti infection and central nervous system. It has three pillar industries of chemical raw materials, pharmaceutical preparations and pharmaceutical intermediates, five industrial parks and 13 subsidiaries. The annual production capacity of chemical APIs is 40000 tons, pharmaceutical intermediates is 500000 tons, solid preparations are 28 billion tablets (tablets), and injections are 1 billion.
At present, all the drugs in production of Xinhua Pharmaceutical have passed the new national GMP certification, 18 products have passed the FDA inspection, 10 products have obtained the EU cos certificate, and the tablets have passed the MHRA audit of the UK drug and health products administration. More than 3 billion tablets have been exported to the EU high-end market, It has become one of the first 15 leading enterprises implementing the internationalization strategy of preparations in China and one of the top ten enterprises in the export of preparations in China.
Staff size:About 7000 persons
Registered capital:RMB 627 million 400 thousand
For supply and market information, please feel free to contact Mr. Paul, paulzhang@yinuopharmchem.com, WhatsApp: +86 18402846978
Tel: Cell/WhatsApp/WeChat: +86 18402846978
Email: paulzhang@yinuopharmchem.com
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