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Fexofenadine Hydrochloride

CAS number: 138452-21-8

Molecular formula: C32H40ClNO4

molecular weight: 538.117

Chemical structure:

Producers shown on SFDA

(Record date:12/10/2021)

Producer

Documents

GMP Valid till(based on SFDA)

Zhejiang Lepu Pharmaceutical Co., Ltd.

GMPValid till 

June 2019

Zhejiang Huahai Pharmaceutical Co., Ltd.

GMP
Valid till 

September 2022

Hainan Sha Ting Ning Pharmaceutical Co., Ltd.

GMP
Valid till July 2023

Venturepharm (Hainan) Co., Ltd.

GMP
Valid till 

April 2019

Sichuan Xuhui Pharmaceutical Co., Ltd.

GMP
Valid till 

March 2023

Chizhou Dongsheng Pharmaceutical Co., Ltd. 

GMP
Valid till 

January 2024

Jiangsu Tasly Diyi Pharmaceutical Co., Ltd.

GMP
Valid till August 2023
Jiangsu Hengrui Medicine Co.,Ltd.
GMP
Valid till 

January 2020




Producers shown on EP

(Quoted from EP website;record date:12/10/2021)

Substance
Certificate Holder
Certificate Number
Issue Date
Status
End date
Type
Fexofenadine hydrochloride
CIPLA LIMITED Mumbai IN
  R0-CEP 2010-218 - Rev 01
03/07/2014
Withdrawn by Holder
06/11/2018
Chemical
Fexofenadine hydrochloride
SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN
  R1-CEP 2008-247 - Rev 01
09/06/2015
Valid
/Chemical
Fexofenadine hydrochloride
VASUDHA PHARMA CHEM LIMITED Hyderabad IN
  R0-CEP 2015-234 - Rev 00
26/04/2017
Valid
/Chemical
Fexofenadine hydrochloride
AUROBINDO PHARMA LIMITED Hyderabad IN
  R0-CEP 2018-101 - Rev 00
11/02/2019
Valid
/Chemical
Fexofenadine hydrochloride
Ind-Swift Laboratories Limited Chandigarh IN
  R1-CEP 2008-226 - Rev 02
09/08/2019
Valid
/Chemical
Fexofenadine hydrochloride
SANOFI-AVENTIS DEUTSCHLAND GMBH Frankfurt am Main DE
  R1-CEP 2009-297 - Rev 02
20/12/2019
Valid
/Chemical
Fexofenadine hydrochloride
VIRUPAKSHA ORGANICS LIMITED Hyderabad IN
  R1-CEP 2009-160 - Rev 02
19/06/2020
Valid
/Chemical
Fexofenadine hydrochloride
HETERO DRUGS LIMITED Hyderabad IN
  R1-CEP 2012-278 - Rev 01
23/03/2021
Valid
/Chemical
Fexofenadine hydrochloride
MOREPEN LABORATORIES LIMITED New Delhi IN
  R1-CEP 2015-256 - Rev 00
16/09/2021
Valid
/Chemical

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:Zhejiang Huahai Pharmaceutical Co., Ltd.was founded in 1989 and headquartered in Zhejiang, China. The company has nearly 7000 employees and more than 40 subsidiaries around the world (including China, the United States, Japan, Germany, etc.As a leading enterprise in the internationalization of Chinese medicine, Huahai pharmaceutical is the first pharmaceutical company in China to pass the FDA preparation quality certification and independently own the Anda document number. It is also the first Chinese pharmaceutical company to realize large-scale preparation sales in the United States. It has established China's pharmaceutical quality image in the world's high-end pharmaceutical market.

Staff size:About 7000 persons

Registered capital:RMB 1 billion 492 million


Producer:Hainan Sha Ting Ning Pharmaceutical Co., Ltd., founded in 2015, has four workshops that meet the requirements of drug production and pass GMP certification. All production raw materials of the company have obtained and passed the GMP certification of the State Food and drug administration.

Staff size:50-99 persons

Registered capital:RMB 10 million


Producer:Venturepharm (Hainan) Co., Ltd.,is a group providing outsourced production service management for global pharmaceutical enterprises, which is authorized and managed by venturepharm Group Inc.

With 7 advanced API and preparation production bases in Asia, the company provides comprehensive production outsourcing services for global pharmaceutical enterprises. Customers can obtain professional support and services from the early stage of product development to large-scale production. All production bases of vante have passed GMP certification, and two API production bases have passed FDA certification.

Staff size:100-199 persons

Registered capital:RMB 194 million 870 thousand and 600


Producer:Sichuan Xuhui Pharmaceutical Co., Ltd. was established in 2011, covering an area of 25346 square meters. The company has passed the new GMP certification of the State Food and Drug Administration on March 18, 2013. There are 10 approvals for API and chemical agents, including national class II new drugs fexofenadine hydrochloride tablets and amlexanol paste, National medical insurance new drugs cilostazol tablets and zomitriptan tablets.

Staff size:About 50 persons

Registered capital:RMB 30 million


Producer:Chizhou Dongsheng Pharmaceutical Co., Ltd. is a high-tech enterprise specializing in pharmaceutical and chemical research and production. It mainly produces chemical raw materials and pharmaceutical intermediates such as cephalosporin side chain, citalopram, pantoprazole sodium and zopiclone. Its products are well-known in domestic and foreign markets. In 2010, the company built a new GMP production plant to produce API such as fexofenadine hydrochloride, diammonium glycyrrhizinate and tiopronin.

Staff size:About 50 persons

Registered capital:RMB 6 million


Producer:Jiangsu Tasly Diyi Pharmaceutical Co., Ltd. is a wholly-owned subsidiary of Tianshili Pharmaceutical Group Co., Ltd. the company covers an area of 323 Mu and a construction area of about 87700 square meters. The company mainly produces chemical raw materials and oral solid preparations (tablets and capsules). The products mainly involve anti-tumor, cardiovascular, psychiatric and liver protecting drugs.

The company has a chemical API manufacturing platform (anti-tumor API and ordinary API) with an annual output of 300t, and a common solid preparation and anti-tumor solid preparation manufacturing platform with an annual output of 2.2 billion tablets (tablets). All dosage forms of the company have passed the new Chinese GMP certification, and the API has successively passed the EU GMP certification, South Korea GMP certification and Japan GMP certification. The company has also passed ISO14001 environmental management system certification, ISO9001 quality management system and OHSAS18001 occupational health and safety evaluation system certification.

Staff size:800-899 persons

Registered capital:RMB 66.86 million


Producer:Jiangsu Hengrui Medicine Co.,Ltd. is a pharmaceutical company engaged in the development and commercialization of innovative and high-quality drugs. 

The company has 28000 employees globally, fifth R & D centers were built around the globe and several subsidiaries were established in the US, EU, and Japan.

The company has 10 manufacturing facilities and most of them maintain USP, EUP, and JP. We are the first Chinese company that exported injections on a large scale to the US, EU, and Japan markets. All dosage forms of the company have passed the national GMP certification, and ifosfamide, etoposide, mesilar and tiotepa have passed the verification of FDA.

Staff size:About 30000 persons

Registered capital:RMB 6 billion 397 million


For supply and market information, please feel free to contact Mr. Paul, paulzhang@yinuopharmchem.com, WhatsApp: +86 18402846978