
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. | GMP | Valid 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Capecitabine | MYLAN LABORATORIES LIMITED IN 500 096 Hyderabad | R0-CEP 2013-359-Rev 01 | 27/09/2017 | WITHDRAWN BY HOLDER | 15/09/2020 | Chemistry |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 CN 318 000 Taizhou City | R0-CEP 2015-009-Rev 00 | 11/12/2015 | WITHDRAWN BY HOLDER | 02/04/2019 | Chemistry |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