Fenbendazole
CAS number： 43210-67-9
Molecular formula： C15H13N3O2S
molecular weight： 299.348
Chemical structure：
Producers shown on SFDA
(Record date:22/10/2021）
Producer | Documents | GMP Valid till(based on SFDA) |
| Henan Houyi Pharmaceutical Co., Ltd. | GMP | Valid tillJuly 2026 |
| Changzhou Yabang-QH Pharmachem Co., Ltd. | GMP | Valid till June 2026 |
| Henan Huijin Pharmaceutical Co., Ltd. | GMP | Valid till July 2025 |
| Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | GMP | Valid till December 2024 |
| Lianyungang City Yahui Pharmachem Co., Ltd. | GMP | Valid till June 2024 |
| Shaanxi Hanjiang Pharmaceutical Group Co., Ltd. | GMP | Valid till June 2023 |
| Jiangsu Baozong & Baoda Pharmachem Co., Ltd. | GMP | Valid tillJuly 2021 |
Producers shown on EP
(Quoted from EP website；record date:22/10/2021）
| Substance | Certificate Holder | Certificate Number | Issue Date | Status | End date | Type |
| Fenbendazole for veterinary use | JIANGSU BAOZONG & BAODA PHARMACHEM CO., LTD. Changjiang CN | R1-CEP 2002-205 - Rev 00 | 11/05/2012 | Valid | / | Chemical |
| Fenbendazole for veterinary use | SEQUENT SCIENTIFIC LIMITED Thane IN | R1-CEP 2002-205 - Rev 00 | 11/05/2012 | Valid | / | Chemical |
| Fenbendazole for veterinary use | Shaanxi Hanjiang Pharmaceutical Group Co., Ltd. Hanzhong City CN | R1-CEP 2001-271 - Rev 03 | 11/01/2017 | Valid | / | Chemical |
| Fenbendazole for veterinary use Process 2 | Shaanxi Hanjiang Pharmaceutical Group Co., Ltd. Hanzhong City CN | R0-CEP 2018-250 - Rev 00 | 05/03/2019 | Valid | / | Chemical |
| Fenbendazole for veterinary use | LASA SUPERGENERICS LIMITED Mahad IN | R1-CEP 2013-184 - Rev 00 | 16/01/2020 | Valid | / | Chemical |
Producer:Henan Houyi Pharmaceutical Co., Ltd. is subordinate to Henan Houyi industrial group. The company covers an area of 800 mu, with a fermentation tonnage of 4000 tons and a synthesis capacity of 13800 tons. After completion, it will be a large production base of veterinary API in the Central Plains.
The company's main product production line has passed GMP acceptance, and the annual sales of sulfamethoxam and Cyclopropylamine are 500 tons and 1000 tons respectively; After tylosin and acetylisovaleryl tylosin are launched, the annual output can reach 500 tons and 200 tons.
Staff size:50-99 people
Registered capital:RMB 128 million
Producer:Changzhou Yabang-QH Pharmachem Co., Ltd.is subordinate to Jiangsu Qihui Pharmaceutical Technology Co., Ltd. the company's quality system has passed who certification, EU EDQM certification and US FDA certification, and obtained eu-gmp certificate. Most products have been registered with asmfs and CEPS in Europe, and some products vmfs have passed US FDA certification. EHS system has obtained the effective certification of ISO14001 environmental management system and OHSAS18001 occupational safety and health management system since 2007.
Staff size:200-299 people
Registered capital:RMB 50 million
Producer:Henan Huijin Pharmaceutical Co., Ltd., established in 2013, covers an area of 200 mu with a total investment of 100 million yuan. The company has an engineering technology research center and more than a dozen API synthesis workshops with an annual production capacity of 1000 tons. The company has passed ISO9001, ISO14001, OHSAS18001, "cleaner production" and other certifications.
Staff size:/
Registered capital:RMB 10 million
Producer:Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. is subordinate to Apeloa Pharmaceutical Co., Ltd. Apeloa Pharmaceutical Co., Ltd. is a state-level key high-tech enterprise and key enterprise in pharmaceutical industry in Zhejiang Province .The company is engaged in the research and development, production and sales of pharmaceutical products. The main business is in crude drug (API), contract R & D, production service (CDMO) and preparation (FDF) business.
In order to improve market competition, our company build core competitiveness continuesly in quality, EHS and technology . Five of the API plants were certified by GMP, four by FDA, three by PMDA, three by CE in EU, one by WHO, one by KFDA, one by Germany GMP, and all of preparation factory were certified by GMP. In addition to the safety and occupational health management system certification, API plants continue to be audited by EHS audits from international pharmaceutical companies or third parties.
Staff size:1000-1999 people
Registered capital:RMB 83.75 million
Producer:Lianyungang City Yahui Pharmachem Co., Ltd. is subordinate to Jiangsu Qihui Pharmaceutical Technology Co., Ltd. the company's quality system has passed who certification, EU EDQM certification and US FDA certification, and obtained eu-gmp certificate. Most products have been registered with asmfs and CEPS in Europe, and some products vmfs have passed US FDA certification. EHS system has obtained the effective certification of ISO14001 environmental management system and OHSAS18001 occupational safety and health management system since 2007, and has passed the safety, environmental protection and social responsibility audit of well-known pharmaceutical enterprises and third-party institutions at home and abroad for many times.
Staff size:About 50 people
Registered capital:RMB 20 million
Producer:Shaanxi Hanjiang Pharmaceutical Group Co., Ltd. currently has four API production workshops and two pharmaceutical intermediate workshops that meet GMP specifications. In recent years, the company has successively passed the new GMP audit of CFDA, the GMP audit of the Ministry of agriculture of the people's Republic of China, the FDA of the United States, the EDQM of the European Union (EU) and the official GMP audit of Mexico. All raw materials have obtained the written GMP confirmation letter for export to the EU issued by China CFDA. In terms of quality management and EHS, the company has successively passed the certification of ISO9001, ISO14001 and OHSMS18001 systems.
Staff size:600-699 people
Registered capital:RMB139 million
Producer:Jiangsu Baozong & Baoda Pharmachem Co., Ltd., established in 2006, covers an area of 195000 square meters and has modern production workshops and facilities. Mainly engaged in the production of medicine, veterinary drugs, pesticides and other related intermediates and APIs.
Staff size:600-699 people
Registered capital:USD 55.90503779 million
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