
Phenobarbital
CAS number: 50-06-6
Molecular formula: C12H12N2O3
molecular weight: 232.235
Chemical structure:
Producers shown on SFDA
(Record date:21/10/2021)
Producer | Documents | GMP Valid till(based on SFDA) |
Shandong Xinhua Pharmaceutical Co., Ltd. | GMP | Valid till March 2023 |
Producers shown on EP
(Quoted from EP website;record date:21/10/2021)
Substance | Certificate Holder | Certificate Number | Issue Date | Status | End date | Type |
Phenobarbital | HARMAN FINOCHEM LIMITED Mumbai IN | R1-CEP 2003-017 - Rev 03 | 21/07/2015 | Valid | / | Chemical |
Phenobarbital | ALKALOIDA CHEMICAL COMPANY ZRT. Tiszavasvari HU | R1-CEP 2009-132 - Rev 01 | 09/10/2015 | Valid | / | Chemical |
Phenobarbital | NANTONG JINGHUA PHARMACEUTICAL CO., LTD. Nantong CN | R1-CEP 2005-118 - Rev 02 | 04/10/2016 | Valid | / | Chemical |
Phenobarbital | SHANDONG XINHUA PHARMACEUTICAL CO., LTD. Zibo CN | R0-CEP 2017-269 - Rev 00 | 31/10/2018 | Valid | / | Chemical |
Methylphenobarbital | HARMAN FINOCHEM LIMITED Mumbai IN | R1-CEP 2005-202 - Rev 02 | 01/10/2020 | Valid | / | Chemical |
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 people
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