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Desloratadine

CAS number: 100643-71-8

Molecular formula: C19H19N2Cl

molecular weight: 310.82

Chemical structure:

Producers shown on SFDA

(Record date:15/10/2021)

Producer

Documents

GMP Valid till(based on SFDA)

Hainan Poly Pharmaceutical Co., Ltd.

GMP
Valid till October 2023

Zhejiang Huahai Pharmaceutical Co., Ltd.

GMP
Valid till August 2020

Taiji Group Chongqing Fuling Pharmaceutical Factory Co., Ltd.

GMP
Valid till February 2021

Guangdong Jiuming Pharmaceutical Co., Ltd.

GMP
Valid till February 2024

Chengdu Minri Pharmaceutical Co., Ltd. 

GMP
Valid till December 2021

Huizhou Salubris pharmaceuticals Co, Ltd.

GMP
Valid till May 2021

Shenzhen Haibin Pharmaceutical Co., Ltd.

GMP
Valid till January 2024

Zhejiang RC Sanjiu Zhongyi Pharmaceutical Co., Ltd.

GMP
Valid till May 2019

Venturepharm (Hainan) Co., Ltd.

GMP
Valid till December 2023

Hefei Enruite Pharmaceutical Co., Ltd. 

GMP
Valid till December 2023


Producers shown on EP

(Quoted from EP website;record date:15/10/2021)

Substance
Certificate Holder
Certificate Number
Issue Date
Status
End date
Type
Desloratadine
HETERO LABS LIMITED Hyderabad IN
  R0-CEP 2016-065 - Rev 00
21/04/2017
Valid
/Chemical
Desloratadine
ROLABO OUTSOURCING, S.L. Zaragoza ES
  R0-CEP 2017-303 - Rev 00
07/09/2018
Valid
/
Chemical
Desloratadine
HAINAN POLY PHARMACEUTICAL COMPANY LIMITED Haikou CN
  R0-CEP 2018-174 - Rev 00
09/05/2019
Valid
/
Chemical
Desloratadine D304
GLENMARK LIFE SCIENCES LIMITED Mumbai IN
  R0-CEP 2017-072 - Rev 02
27/09/2019
Valid
/
Chemical
Desloratadine
GLENMARK LIFE SCIENCES LIMITED Mumbai IN
  R1-CEP 2014-047 - Rev 00
11/09/2020
Valid
/
Chemical
Desloratadine
VASUDHA PHARMA CHEM LIMITED Hyderabad IN
  R1-CEP 2014-310 - Rev 00
17/09/2020
Valid
/
Chemical
Desloratadine
CADILA PHARMACEUTICALS LIMITED Ankleshwar IN
  R1-CEP 2014-173 - Rev 00
16/10/2020
Valid
/
Chemical
Desloratadine Milled, micronised
MOREPEN LABORATORIES LIMITED New Delhi IN
  R1-CEP 2014-302 - Rev 00
19/10/2020
Valid
/
Chemical
Desloratadine
SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN
  R1-CEP 2013-231 - Rev 01
12/11/2020
Valid
/
Chemical
Desloratadine
CIPLA LIMITED Mumbai IN
  R1-CEP 2014-359 - Rev 00
08/02/2021
Valid
/
Chemical
Desloratadine
DR. REDDY'S LABORATORIES LIMITED Hyderabad IN
  R1-CEP 2014-321 - Rev 00
11/02/2021
Valid
/
Chemical
Desloratadine
MYLAN LABORATORIES LIMITED Hyderabad IN
  R1-CEP 2013-319 - Rev 01
28/05/2021
Valid
/
Chemical

Producer:Founded in 1992, Hainan Poly Pharmaceutical Co., Ltd. is mainly engaged in the research, development and production of drugs in the fields of slow and controlled release, taste masking, dry mixing, freeze-drying and liquid capsules. The company has passed the EU and who certification, cGMP certification of FDA, FDA injection inspection, who GMP injection certification and EU GMP injection certification. All dosage forms and main raw materials have passed the new version of GMP certification in China.

Staff size:800-899 persons

Registered capital:RMB 437 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:Taiji Group Chongqing Fuling Pharmaceutical Factory Co., Ltd., established in 1972, is the birthplace and core pharmaceutical enterprise of Taiji group,

It mainly produces and sells more than 80 varieties in 6 categories, including syrup, mixture (including oral liquid), hard capsule, soft capsule, tablet, dropping pill and granule, as well as health food, cosmetics, medical devices, disinfection products and drug packaging materials, including 15 exclusive product specifications and 38 invention patents.

Staff size:3000-3999 persons

Registered capital:RMB 90 million


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


Producer:Chengdu Minri Pharmaceutical Co., Ltd. covers an area of 43 mu, with a construction area of 10000m2, a road area of 5200m2, a greening area of 5998m2 and a greening coefficient of 35%.

The company has 48 varieties, including 4 APIs, 25 oral drugs and 19 external drugs. Annual production capacity: 5 million ointment, 350 tons of solution, 200 million tablets, 100 million capsules, 50 tons of tincture, 100 tons of liniment, 2.5 tons of API and 350 tons of lotion.

Staff size:50-99 persons

Registered capital:RMB 35 million


Producer:Huizhou Salubris pharmaceuticals Co, Ltd. is a subsidiary of Shenzhen salubris Pharmaceuticals Co., Ltd.It is a high-end biopharmaceutical manufacturer integrating R & D, production and sales. It is committed to the research, development and production of cardiovascular, anti diabetic, anti-tumor, anti infective materials, and product groups around cardiovascular and cerebrovascular diseases.
Staff size:100-199 persons

Registered capital:RMB 45 million


Producer:Shenzhen Haibin Pharmaceutical Co., Ltd. is a wholly-owned subsidiary of Health Yuan Pharmaceutical Group Co., Ltd. It was established in 1989 and officially put into operation in 1992 with a registered capital of 700 million RMB. The factory covers an area of 16,000 square meters. 26,800 m2. The company is located in the national eco-environmental demonstration zone.The container port of the class --- Yantian Port, the route reaches more than 80 countries and regions.

The production capacity of powder injection injection is 80 million bottles, 100 million tablets, 100 million capsules and 30 tons of raw materials.

"Based on the domestic and the world" is a major strategic goal of Shenzhen Haibin Pharmaceutical Co., Ltd. Through unremitting efforts, the export of Meropenem raw materials in 2003 began, and in 2006, the export volume reached 1.3 tons. In just a few years, the drug product was ranked first in the world in terms of sales volume, and the products were exported. Southeast Asia, Africa, the Middle East, South America and other places. In 2006, imipenem cilastatin sodium API has also begun to export to countries such as India and Brazil. In December 2006, we signed a cooperation agreement with a German company on COS certification, which opened the curtain for entering the European and American market.

Staff size:500-599 persons

Registered capital:RMB 70 million


Producer:Zhejiang RC Sanjiu Zhongyi Pharmaceutical Co., Ltd. was established in January 2006, covering an area of 84 mu. The company has established GMP certified solid preparation production workshops such as tablets, capsules and granules, freeze-dried powder injection, small volume injection, powder injection and other injection workshops, as well as chemical raw material drug production workshops.

Staff size:300-399 persons

Registered capital:RMB 40 million 500 thousand


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:Hefei Enruite Pharmaceutical Co., Ltd. is a wholly-owned subsidiary of Hefei medical industry pharmaceutical Co., Ltd. At present, the company has two production bases in Hefei and Anqing, Anqing API production base, covering an area of 133 mu. The production scale of the enterprise can reach: 2.5 tons of loratadine, 10 tons of piragramine sodium, 8 tons of sinacase hydrochloride, 1 ton of Tadanafil and 265 tons of calcium hydroxybenzene sulfonate.
Staff size:50-99 persons

Registered capital:RMB 20 million


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