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Loratadine

CAS number: 79794-75-5

Molecular formula: C22H23ClN2O2

molecular weight: 382.88

Chemical structure:

Producers shown on SFDA

(Record date:08/10/2021)

Producer

Documents

GMP Valid till(based on SFDA)

Changzhou Yabang Pharmaceutical Co., Ltd.

GMP
Valid till May 2023

Zhejiang East-Asia Pharmaceutical Co., Ltd.

GMP
Valid till May 2017

Weiao Pharmaceutical (Sichuan) Co., Ltd.

GMP
Valid till March 2023

Venturepharm (Hainan) Co., Ltd.

GMP
Valid till September 2023

Hunan Jiudian Hongyang Pharmaceutical Co., Ltd.

GMP
Valid till November 2024

Kunming Jida Pharmaceutical Co., Ltd.

GMP
Valid till October 2018

Shenzhen Salubris Pharmaceuticals Co., Ltd.

GMP
Valid till June 2019

Henan Jiushi Pharmaceutical Co., Ltd.

GMP
Valid till March 2019

Shandong Luoxin Pharmaceutical Group Hengxin Pharmaceutical Co., Ltd.

GMP
Valid till August 2020

Guangdong Jiuming Pharmaceutical Co., Ltd.

GMP
Valid till February 2024



Producers shown on EP

(Quoted from EP website;record date:08/10/2021)

Substance
Certificate Holder
Certificate Number
Issue Date
Status
End date
Type
Loratadine
ROLABO OUTSOURCING, S.L. ES 50016 Zaragoza
  R1-CEP 2007-283-Rev 01
01/03/2017
VALID

Chemistry
Loratadine
SUN PHARMACEUTICAL INDUSTRIES LIMITED IN 400 063 Mumbai
  R1-CEP 2008-282-Rev 02
26/06/2019
VALID

Chemistry
Loratadine
CADILA PHARMACEUTICALS LIMITED IN 393 002 Ankleshwar
  R1-CEP 2007-284-Rev 01
09/03/2015
VALID

Chemistry
Loratadine
MYLAN LABORATORIES LIMITED IN 500 096 Hyderabad
  R1-CEP 2007-171-Rev 02
22/09/2017
VALID

Chemistry
Loratadine
CADILA HEALTHCARE LIMITED IN 393 002 Ankleshwar
  R1-CEP 2007-254-Rev 02
21/04/2020
VALID

Chemistry
Loratadine
VASUDHA PHARMA CHEM LIMITED IN 500 038 Hyderabad
  R1-CEP 2009-009-Rev 02
12/10/2020
VALID

Chemistry

Producer:Changzhou Yabang Pharmaceutical Co., Ltd., established in October 2002, is located at No. 6, Liangchang East Road, Jintan Economic Development Zone, Changzhou City, Jiangsu Province, with a registered capital of 70 million yuan. Its business scope is the production and sales of chemical APIs. It is a subsidiary controlled by Jiangsu Yabang Pharmaceutical Group Co., Ltd.

The company covers an area of 80000 square meters, a construction area of 14000 square meters and a total investment of more than 100 million. It has 6 fine baking bag production lines, 5 synthesis workshops, 1 hydrogenation workshop, 1 testing center and 1 R & D center that meet the requirements of GMP, a set of sewage treatment devices and environmental protection facilities. The greening area is more than 40%, forming a professional company of 500 t / a API and pharmaceutical intermediates.

Staff size:200-299 persons   

Registered capital:RMB 70 million


Producer:Zhejiang East-Asia Pharmaceutical Co., Ltd., founded in 1998 and headquartered in Taizhou City, Zhejiang Province, has more than 1000 employees and a total assets of 1.3 billion yuan. It has successively won the titles of "national high-tech enterprise", "Zhejiang Patent Demonstration Enterprise" and "Taizhou top ten enterprises in management innovation".

Many products of the company have passed the new version of cGMP certification, European Union (EDQM) certification and Japan's Ministry of health and welfare (PMDA) certification. It has established long-term cooperative relations with customers in Europe, America, Southeast Asia and other more than ten countries and regions, and its product sales network covers more than 50 countries and regions around the world.

Staff size:About 1000 persons

Registered capital:RMB 113.6 million


Producer:Weiao Pharmaceutical (Sichuan) Co., Ltd.is a wholly-owned subsidiary of Tibet Aim Pharm.Inc. It has 13000 square meters of solid preparation workshop, traditional Chinese medicine extraction workshop and API production workshop of tablets, capsules and powders that have passed the national GMP certification.

Staff size:200-299 persons

Registered capital:RMB 26 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:Hunan Jiudian Hongyang Pharmaceutical Co., Ltd. is a wholly-owned subsidiary of Hunan Jiudian Pharmaceutical Co., Ltd.

Hunan Jiudian Pharmaceutical Co., Ltd. has completed the all-round layout of pharmaceutical preparations, traditional Chinese medicine, APIs, pharmaceutical accessories, pharmaceutical commerce and other industries, established a perfect R & D, marketing and production system, and continuously improved the level of operation and management; R & D resources and market resources are increasingly abundant. It has modern production lines including raw material medicine, oral solid preparation, oral liquid preparation, gel paste, pharmaceutical excipient and so on. Preparations and traditional Chinese medicine are produced in Liuyang Economic Development Zone, APIs and excipients are produced in Wangcheng Economic Development Zone, and R & D and commercial sales are in Changsha high tech Zone.

The company is a R & D driven enterprise with sound R & D system and advanced instruments and equipment. It has more than 10000 square meters of research and development sites, forming a complete test platform from small-scale research to pilot test to industrialization. A 400 person R & D team with doctors, masters and returned overseas talents as the main body has been established, with the strongest R & D level in the province. The company's leading products are self-developed. There are nearly 100 products under research and declared products, which will greatly enrich the company's product pipeline. After the new drugs under research are listed, they will become a heavy variety of existing advantageous products.

Staff size:About 1500 persons

Registered capital:RMB 234 million 700 thousand


Producer:Kunming Jida Pharmaceutical Co., Ltd. was established in 1993. There are 13 workshops and 16 production lines in the preparation production base, all of which have passed the national GMP certification, and some of which have passed the drug certification qualification in the international market. It has more than 40 varieties of powder injection, water injection, tablet, capsule, granule, suspension, pre perfusion and other series.
Staff size:1100-1199 persons

Registered capital:RMB 370 million


Producer:Shenzhen Salubris Pharmaceuticals Co., Ltd., established in 1998 and listed on Shenzhen Stock Exchange in 2009, is a comprehensive pharmaceutical listed company integrating pharmaceutical product R & D, production and sales. The company accurately distributes the global industrial chain, covering more than 30 countries and regions such as China, the United States, Germany, France and Japan. All products and production workshops of the company have passed the domestic GMP certification, Daya Bay production base has passed the EU GMP certification, and the key product Taijia has obtained the listing license of 12 EU countries. All kinds of products enjoy a good reputation in the industry.
Staff size:About 3500 persons

Registered capital:RMB 1 billion 115 million


Producer:Henan Jiushi Pharmaceutical Co., Ltd., founded in 1993, covers an area of 120000 square meters. At present, it has five dosage forms: API, tablet, large infusion, capsule and granule. Among them, chlorphenamine maleate API accounts for more than 85% of the national market share. The annual production capacity of the group company: 1 billion tablets, 50 million bottles of large infusion, 500 million capsules, 50 million bags of granules and 200 tons of API.
Staff size:About 50 persons

Registered capital:RMB 48 million


Producer:Shandong Luoxin Pharmaceutical Group Hengxin Pharmaceutical Co., Ltd. is a wholly-owned subsidiary of Luoxin Pharmaceutical Group Co., Ltd.

Luoxin Pharmaceutical Group Co., Ltd. is a large pharmaceutical enterprise group integrating drug R & D, production, trade and medical and health services.

At present, the company has four manufacturing bases, including more than 50 production lines, including powder injection, lyophilized powder injection, solid preparation (including cephalosporins), spray, aerosol, pre encapsulation, large capacity injections, small volume injections, chemical raw materials, cephalosporins, and so on. There are more than ten dosage forms and more than 300 product specifications on the market. There are 48 national new drugs. The company can produce 1 billion powder injections, 500 million freeze-dried powder injections, 400 million large bottles of injections (bags), 500 million small volume injections, 7 billion tablets, 2 billion capsules, 300 million capsules, 80 million dry suspensions, 300 tons of micro pills, 1000 tons of raw materials, 30 million aerosol cans, spray ingredients, and pre encapsulated branches.
Staff size:RMB 50 million

Registered capital:700-799 persons


Producer:Guangdong Jiuming Pharmaceutical Co., Ltd. is subordinate to Shenzhen Jiuming Pharmaceutical Group, covering an area of more than 42700 square meters, with 15000 square meters of modern GMP workshop and more than 3000 square meters of quality inspection laboratory. The company's existing API workshop, solid preparation workshop and cephalosporin workshop have passed the new national GMP certification. At present, the company mainly produces tablets, hard capsules, cephalosporin capsules and other preparations, with a total of 45 quality regulated drugs and API sodium salicylate and desloratadine.
Staff size:50-99 persons

Registered capital:RMB 42 million 173 thousand and 913


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