
Bromhexine Hydrochloride
CAS number: 611-75-6
Molecular formula: C14H21Br2ClN2
molecular weight: 412.59
Chemical structure:
Producers shown on SFDA
(Record date:11/10/2021)
Producer | Documents | GMP Valid till(based on SFDA) |
Hunan Erkang Pharmaceutical Co., Ltd. | GMP | Valid till August 2020 |
Jiangxi Yiyou Pharmaceutical Co., Ltd. | GMP | Valid till June 2021 |
Taicang Pharmaceutical Factory Co., Ltd. | GMP | Valid till February 2024 |
Zhejiang Lepu Pharmaceutical Co., Ltd. | GMP | Valid till June 2019 |
Wanbond Pharmaceutical Group Co., Ltd. | GMP | Valid till December 2020 |
Renhe Yikang Pharmaceutical Co., Ltd. | GMP | Valid till November 2023 |
Producers shown on EP
(Quoted from EP website;record date:11/10/2021)
Substance | Certificate Holder | Certificate Number | Issue Date | Status | End date | Type |
Bromhexine hydrochloride | Ven PetroChem & Pharma (India) Pvt Ltd Mumbai IN | R1-CEP 2003-021 - Rev 01 | 23/11/2015 | Valid | / | Chemical |
Bromhexine hydrochloride | Bidachem S.p.A. Fornovo San Giovanni IT | R1-CEP 2002-025 - Rev 02 | 14/12/2015 | Valid | / | Chemical |
Bromhexine hydrochloride | FDC Limited Mumbai IN | R1-CEP 2007-032 - Rev 02 | 15/03/2019 | Valid | / | Chemical |
Producer:Hunan Erkang Pharmaceutical Co., Ltd., established in October 2003, is a leading enterprise of pharmaceutical excipients with the largest scale and the most complete varieties in China; It is also one of the few enterprises in China that have the registration approval documents of new penicillin antibiotics - sulbacillin sodium API and finished products 。 In 2014, the company successfully broke through the technical bottleneck of the industrialization of starch plant capsules, a new high-end excipient variety, and became the world's first enterprise in the industrialization of starch capsules 。 The company was listed on Shenzhen Stock Exchange on September 27, 2011. It is the first listed company in China's pharmaceutical excipients industry.
Staff size:About 1700 persons
Registered capital:RMB 2 billion 63 million
Producer:Jiangxi Yiyou Pharmaceutical Co., Ltd. was established in 2015. The business scope of the company includes the production and sales of chemical raw materials, pharmaceutical and chemical intermediates, pharmaceutical excipients, granules, tablets, hard capsules and powders.
Staff size:About 50 persons
Registered capital:RMB 100 million
Producer:Taicang Pharmaceutical Factory Co., Ltd. was established in 1958. It mainly produces food additives, synthetic drugs, preparations and chemical APIs. The enterprise has a GMP workshop for the production of APIs and preparations. The production management and facilities meet the requirements of GMP and iso900214000 ISO and 18000. The enterprise covers a total area of 11.8 Mu and a construction area of 12840 square meters.
Staff size:50-99 persons
Registered capital:RMB 500 thousand
Producer:Zhejiang Lepu Pharmaceutical Co., Ltd., established in 2001, is located in Jiaojiang block, Taizhou chemical API Industrial Park, Zhejiang Province. Covering an area of nearly 300 mu, the company is a core subsidiary of Lepu (Beijing) medical device company.
The company attaches great importance to product quality and has successively passed GMP certification and registration such as China nm-pa, US FDA, EU EDQM, Japan PMDA and Korea KFDA. Many varieties occupy a leading position in the world.
The company's marketing network covers five continents and has established partnerships with nearly 600 customers at home and abroad in more than 70 countries and regions. Many products lead the sales in the international market, among which the sales of main varieties of atorvastatin calcium account for more than 50% of the world.
Staff size:700-799 persons
Registered capital:RMB 160 million
Producer:Wanbond Pharmaceutical Group was founded in 1970 with a registered capital of 360 million yuan. It now has 6 subsidiaries, 192 drug production approval numbers and 16 dosage forms.
At present, wanbond Pharmaceutical Group has formed a product pattern of "taking natural botanical drugs as the characteristics, focusing on drugs for cardio cerebrovascular and nervous system, supplemented by drugs for respiratory system and other fields". Its products cover many treatment fields such as cardio cerebrovascular diseases, nervous system diseases, respiratory system diseases and digestive system diseases.
Registered capital:RMB 360 million
Producer:Renhe Yikang Pharmaceutical Co., Ltd., a subsidiary of Renhe Yikang group, was established in 2016, with API workshop, oral solution workshop, small volume injection workshop and oral solid preparation workshop. Oral solution workshop and small volume injection workshop have obtained GMP certificate.
Staff size:300-399 persons
Registered capital:RMB 20 million
For supply and market information, please feel free to contact Mr. Paul, paulzhang@yinuopharmchem.com, WhatsApp: +86 18402846978