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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 tilMarch 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