Guaifenesin
CAS number： 93-14-1
Molecular formula： C10H14O4
molecular weight： 198.22
Chemical structure：
Producers shown on SFDA
(Record date:18/10/2021）
Producer | Documents | GMP Valid till(based on SFDA) |
Zhejiang Haizhou Pharmaceutical Co., Ltd. | GMP | Valid till September 2023 |
Ningbo Smart Pharmaceutical Co., Ltd. | GMP | Valid till December 2020 |
Producers shown on EP
(Quoted from EP website；record date:18/10/2021）
| Substance | Certificate Holder | Certificate Number | Issue Date | Status | End date | Type |
| Guaifenesin | M/s Stellar Chemical Laboratories PVT Limited Mumbai IN | R0-CEP 2002-223 - Rev 01 | 22/11/2004 | Expired | 12/03/2009 | Chemical |
| Guaifenesin | Rhodia Opérations S.A.S. Aubervilliers FR | R2-CEP 1994-008 - Rev 02 | 31/08/2006 | Withdrawn by Holder | 09/11/2011 | Chemical |
| Guaifenesin | BIESTERFELD SPEZIALCHEMIE GMBH Hamburg DE | R1-CEP 2002-194 - Rev 03 | 22/06/2018 | Valid | / | Chemical |
| Guaifenesin | SYNTHOKEM LABS PRIVATE LIMITED Hyderabad IN | R1-CEP 1999-088 - Rev 05 | 26/06/2018 | Valid | / | Chemical |
| Guaifenesin | GRANULES INDIA LIMITED Hyderabad IN | R1-CEP 2009-201 - Rev 03 | 27/11/2018 | Valid | / | Chemical |
| Guaifenesin Unit-II | SYNTHOKEM LABS PRIVATE LIMITED Hyderabad IN | R0-CEP 2019-065 - Rev 00 | 27/11/2019 | Valid | / | Chemical |
| Guaifenesin Regular, milled | DELTA SYNTHETIC CO., LTD. New Taipei City TW | R1-CEP 2009-351 - Rev 02 | 18/06/2020 | Valid | / | Chemical |
| Guaifenesin | SEVEN STAR PHARMACEUTICAL COMPANY, LTD. New Taipei City TW | R1-CEP 2008-275 - Rev 04 | 09/04/2021 | Valid | / | Chemical |
Producer:Zhejiang Haizhou Pharmaceutical Co., Ltd. was established in 1997. At present, two APIs (potassium guaiacol sulfonate and guaiacol glycerol ether) have passed GMP certification, among which guaiacol glycerol ether has passed cos certification in Europe and FDA certification in the United States.
Staff size:400-499 persons
Registered capital:RMB 30.8 million
Producer:Ningbo Smart Pharmaceutical Co., Ltd.(NINGBO SMART),founded in 1991 with a building area of 20,000m2 ,is a bulk pharmaceutical manufacturers in Ningbo, China. NINGBO SMART strictly follows the Chinese GMP and ICHQ7 regulations in both production and quality management .We obtained GMP certificate for Mefenamic Acid and Diclofenac Sodium in Oct.2003, and obtained GMP Certificate for Methocarbamol in Feb,2007. In Jun,2015, we successfully became the first Diclofenac Sodium manufacturer in China who obtained COS Certificate. Staff size:RMB 26 million 943 thousand and 769 Registered capital:RMB 26 million 943 thousand and 769
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Email: paulzhang@yinuopharmchem.com
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