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Capecitabine

CAS number: 154361-50-9

Molecular formula: C15H22FN3O6

molecular weight: 359.35

Chemical structure:

Producers shown on SFDA

(Record date:06/09/2021)

Producer

Documents

GMP Valid till(based on SFDA)

Lianyungang Guike Pharmaceutical Co., Ltd.

GMP, USDMF, DMF
Valid till January 2024

Jiangsu Shengdi Pharmaceutical Co., Ltd.

GMPValid till May 2018

Lianyungang Runzhong Pharmaceutical Co., Ltd.

GMP
Valid till April 2023

Qilu Tianhe Huishi Pharmaceutical Co., Ltd. 

GMP
Valid till February 2023

Jiangsu Hengrui Medicine Co.,Ltd.

GMP
Valid till February 2023


Producers shown on EP

(Quoted from EP website;record date:06/09/2021)

Substance
Certificate Holder
Certificate Number
Issue Date
Status
End date
Type
Capecitabine
DR. REDDY'S LABORATORIES LIMITED IN 500 034 Hyderabad
  R1-CEP 2014-203-Rev 00
07/05/2020
VALID
/Chemistry
Capecitabine
EXCELLA GMBH & CO. KG DE 90537 Feucht
  R0-CEP 2014-055-Rev 01
15/12/2016
EXPIRED
07/07/2021
Chemistry
Capecitabine
DR. REDDY'S LABORATORIES LIMITED IN 500 034 Hyderabad
  R1-CEP 2014-109-Rev 00
24/07/2020
VALID
/
Chemistry
Capecitabine
TEVA PHARMACEUTICAL INDUSTRIES LTD. IL 4951033 Petach Tikva
  R0-CEP 2015-078-Rev 00
19/01/2017
VALID
/
Chemistry
Capecitabine
MSN LABORATORIES PRIVATE LIMITED IN 502 300 Kardanur Village
  R0-CEP 2015-391-Rev 03
06/01/2021
VALID
/
Chemistry
Capecitabine
DIVI'S LABORATORIES LIMITED IN 500 032 Hyderabad
  R1-CEP 2015-111-Rev 00
16/04/2021
VALID
/
Chemistry
Capecitabine
INTAS PHARMACEUTICALS LIMITED GB HA1 4HF North Harrow
  R1-CEP 2015-325-Rev 00
03/05/2021
VALID
/
Chemistry
Capecitabine
CIPLA LIMITED IN 400 013 Mumbai
  R1-CEP 2014-136-Rev 00
30/04/2020
VALID
/
Chemistry
Capecitabine
ACEBRIGHT (INDIA) PHARMA PRIVATE LIMITED IN 560 105 Bangalore
  R1-CEP 2013-309-Rev 02
27/07/2021
VALID
/
Chemistry
Capecitabine
MYLAN LABORATORIES LIMITED IN 500 096 Hyderabad
  R0-CEP 2013-359-Rev 01
27/09/2017
WITHDRAWN BY HOLDER
15/09/2020
Chemistry
Capecitabine
Zhejiang Hisun Pharmaceutical Co., Ltd. CN 318 000 Taizhou City
  R0-CEP 2015-009-Rev 00
11/12/2015
WITHDRAWN BY HOLDER
02/04/2019
Chemistry
Capecitabine
SUN PHARMACEUTICAL INDUSTRIES LIMITED IN 400 063 Mumbai
  R0-CEP 2016-140-Rev 00
03/07/2017
VALID
/
Chemistry
Capecitabine
SHILPA MEDICARE LIMITED IN 584 135 Raichur
  R0-CEP 2014-332-Rev 01
06/12/2018
VALID
/
Chemistry
Capecitabine
SCINOPHARM TAIWAN, LTD. TW 74144 Shan-Hua
  R0-CEP 2018-015-Rev 00
22/05/2019
VALID
/
Chemistry
Capecitabine
SHANDONG BOYUAN PHARMACEUTICAL CO., LTD. CN 251 400 Jinan City
  R1-CEP 2014-343-Rev 00
11/12/2020
VALID
/
Chemistry
Capecitabine
GRANULES INDIA LIMITED IN 500 081 Hyderabad
  R0-CEP 2019-091-Rev 00
13/05/2020
VALID
/
Chemistry
Capecitabine
HETERO LABS LIMITED IN 500 018 Hyderabad
  R0-CEP 2014-355-Rev 05
24/07/2020
VALID
/
Chemistry
Capecitabine
SHANDONG ANXIN PHARMACEUTICAL CO., LTD. CN 250 105 Dongjia Town
  R1-CEP 2014-189-Rev 00
26/04/2021
VALID
/
Chemistry
Capecitabine Process II
INTAS PHARMACEUTICALS LIMITED GB HA1 4HF North Harrow
  R0-CEP 2019-143-Rev 00
05/11/2020
VALID
/
Chemistry



Producer:Lianyungang Guike Pharmaceutical Co., Ltd., established in 2006, is a high-tech integrated pharmaceutical manufacturer focuses on research, development, production and sales of pharmaceutical raw material. Located at No. 1 Xianfeng Road, Dapu Industrial Park, Lianyungang Economic and technological development zone,  and covers a total area of around 31148.9m2   with all facilities built strictly according to the GMP standard. The factory owns many internationally leading equipment imported from Europe and the United States. The products are popular for high quality and have customers in Japan, Korea, Russia, Belarus, Turkey, Pakistan, Indonesia, etc.

Staff size:50-99 persons

Registered capital:RMB 43 million 23 thousand and 566


Producer:Founded in 2005, Jiangsu Shengdi Pharmaceutical Co., Ltd. is mainly engaged in the R & D and production of pharmaceutical raw materials, formerly known as the API branch of Jiangsu Hengrui Pharmaceutical Co., Ltd.

The company is now deregistered

Staff size:/

Registered capital:RMB 50 million


Producer:Lianyungang Runzhong Pharmaceutical Co., Ltd., a wholly-owned subsidiary and API production base of Zhengda Tianqing Pharmaceutical Group, was established in 2010, covering an area of 206 mu. In 2012, it was recognized as a high-tech enterprise, mainly engaged in the R & D, production and sales of various chemical APIs.

At present, the company has 7 product production workshops, 4 pilot workshops for new products, 1 product development center, and 2 drug inspection centers, power workshops and warehouses. There are 52 products approved for listing in China, of which 16 are listed as high-tech products in Jiangsu Province, involving liver disease, tumor, cardiovascular, respiratory and other fields, with an annual production capacity of more than 100 tons.

With the continuous increase of product types and production scale, the economic benefits of the company have also increased year by year. In 2020, the sales revenue will reach 3.5 billion yuan, including 10 API products such as arotinib hydrochloride, magnesium isoglycyrrhizinate and Diammonium Glycyrrhizinate, forming a "product group with sales of more than 100 million". The company has passed FDA certification for "zero defect" twice, and 14 products passed GMP on-site inspection in 2020, indicating that the company's quality management is at a high level in the industry.

Staff size:1000-1999 persons

Registered capital:RMB 103 million 528 thousand and 805


Producer:Qilu Tianhe Huishi Pharmaceutical Co., Ltd. is a Sino foreign joint venture jointly invested and established by Qilu Pharmaceutical Co., Ltd. and anty Hong Kong International Co., Ltd. in 2006.

The company is now deregistered.

Staff size:2000-2999 persons

Registered capital:RMB 612.5 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