Home>APIs>

Cyclophosphamide

CAS number: 50-18-0

Molecular formula: C7H15Cl2N2O2P

molecular weight: 261.09

Chemical structure:

Producers shown on SFDA

(Record date:06/09/2021)

Producer

Documents

GMP Valid till(based on SFDA)

Qilu Pharmaceutical Co., Ltd.

GMP
Valid till May 2023

Guangdong Xiangxue Pharmaceutical Co., Ltd. 

GMP
Valid till August 2014

Hainan Quanxing Pharmaceutical Co., Ltd. 

GMP
Valid till November 2021

Nanjing Pharmaceutical Factory Co. Ltd.  

GMP
Valid till September 2024

Jiangsu Shengdi Pharmaceutical Co., Ltd.

GMP
Valid till August 2018

Guangdong Lingnan Pharmaceutical Co., Ltd. 

GMP
Valid till March 2023

Zhejiang Hisun Pharmaceutical Co., Ltd.

GMP
Valid till  February 2021

Shanxi Pude pharmaceutical Co., Ltd.

GMP
Valid till March 2020

Jiangsu Hengrui Medicine Co.,Ltd. 

GMP
Valid till April 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
Cyclophosphamide
EMCURE PHARMACEUTICALS LIMITED IN 411 026 Pune
  R1-CEP 2010-329-Rev 01
18/11/2020
VALID
/Chemistry
Cyclophosphamide
HETERO LABS LIMITED IN 500 018 Hyderabad
  R1-CEP 2014-342-Rev 00
05/07/2021
VALID
/Chemistry
Cyclophosphamide
Zhejiang Hisun Pharmaceutical Co., Ltd. CN 318 000 Taizhou City
  R1-CEP 2005-279-Rev 01
30/06/2016
WITHDRAWN BY HOLDER
02/11/2020
Chemistry
CyclophosphamideSHILPA MEDICARE LIMITED IN 584 135 Raichur
  R0-CEP 2020-083-Rev 00
27/08/2021
VALID
/Chemistry
Cyclophosphamide
MSN LABORATORIES PRIVATE LIMITED IN 502 300 Kardanur Village
  R0-CEP 2018-092-Rev 00
31/10/2019
VALID
/Chemistry


Producer:Qilu Pharmaceutical Co., Ltd. is one of the first batch of GMP certified enterprises by the State Food and drug administration. Among them, non sterile APIs (fermentation, chemical synthesis), sterile APIs and various preparations have passed the certification of the US Food and Drug Administration (USFDA), the European Drug Quality Council (EDQM), the UK MHRA, the South African pharmaceutical Regulatory Commission (MCC) and other national drug regulatory agencies.

Qilu pharmaceutical has seven production bases including preparation, chemical synthesis and biotechnology and antibiotic fermentation, covering an area of 1.9 million square meters. The company's automatic production line and other main production equipment and testing instruments are purchased from major professional pharmaceutical equipment manufacturers in the world.

Staff size:7000-7999 persons

Registered capital:RMB 60 million


Producer:Guangdong Xiangxue Pharmaceutical Co., Ltd. is subordinate to Guangzhou Xiangxue Pharmaceutical Co., Ltd.

The company has become a modern leading enterprise and high-tech enterprise of traditional Chinese medicine with independent intellectual property rights, independent brands and independent innovation ability, focusing on the large health industry in the fields of new traditional Chinese medicine decoction pieces, Chinese patent medicines, functional health products, biomedical engineering, life science research and so on.

Staff size:/

Registered capital:RMB 70 million


Producer:Hainan Quanxing Pharmaceutical Co., Ltd. is a national high-tech enterprise integrating scientific research, production and sales. The factory covers an area of nearly 50 mu, with a registered capital of 47.38 million yuan and nearly 300 employees,

The factory mainly processes and produces drugs. With advanced production equipment, it has 12 modern production lines, including oral solid preparations (including cephalosporin and anti-tumor), external drug preparations, ordinary freeze-dried powder injection, ordinary sterile powder injection, anti-tumor drug sterile preparations (including freeze-dried preparations and non final sterilization and final sterilization small volume injection), ordinary small volume injection and cephalosporin powder injection, with a production line area of about 60000 square meters, All have passed the new GMP certification organized by the State Food and drug administration.

Staff size:200-299 persons

Registered capital:RMB 47.38 million


Producer:Nanjing Pharmaceutical Factory Co., Ltd., formerly known as Nanjing Pharmaceutical Factory, was established in 1935. The preparation production base is located in Nanjing Xingang economic and Technological Development Zone, covering an area of 70 mu and the whole plant area of more than 26000 m2,

There are injection workshops for powder water injection dominated by antitumor drugs and solid preparation workshops for tablets, capsules and granules.

The company's API and preparation products have passed the acceptance and approval of national SFDA GMP. Sucralfate API has passed FDA inspection. Praziquantel API has passed FDA inspection and obtained EU CEP certificate.

Staff size:400-499 persons

Registered capital:RMB 200.8 million


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:Guangdong Lingnan Pharmaceutical Co., Ltd. is a high-tech enterprise dedicated to the research, production and sales of antitumor drugs and digestive system drugs.

It has several production workshops for APIs, solid preparations (tablets, capsules, granules) and injections (freeze-dried powder injection and water injection), and its production scope covers general drugs and antitumor drugs. All production workshops have successively passed the GMP certification of the State Food and drug administration.

Staff size:50-99 persons

Registered capital:RMB 11.38 million


Producer:Zhejiang Hisun Pharmaceutical Co., Ltd. was founded in 1956. In 2000, Hisun issued A-shares in Shanghai stock exchange, but it continues to remain a state-owned enterprise. Hisun is one of the largest antibiotics and anti-tumor drug production bases in the country. It has won several titles, including first batch of innovative enterprises, national technology innovation demonstration enterprises, and "National Industrial Brand Demonstration Enterprise” of the Chinese Ministry of Industry and Information Technology. 

Hisun began as a small chemical factory and entered the pharmaceutical field in the early 1970s. Since its founding over 60 years ago in 1956, Hisun has amassed a total asset worth of 21.8 billion RMB. While Hisun is primarily engaged in the R&D, manufacturing, and sales and marking of API and final dosage forms of chemical and biological drugs, its core business has extended to include branded generic drugs, biosimilarst and other innovative drugs. 

Staff size:About 9000 persns

Registered capital:RMB 1 billion 169 million


Producer:Shanxi Pude pharmaceutical Co., Ltd., founded on September 13, 1995, is a wholly-owned subsidiary of Harbin Yuheng Pharmaceutical Co., Ltd.

The company now has 35 national new drugs and 31 invention patents. It has 22 production lines for freeze-dried powder injection, small volume injection, powder injection, oral preparation, chemical synthesis, traditional Chinese medicine extraction, biochemical pretreatment and 7 production workshops. The existing production line can produce 60 million powder injections / year; 80 million small volume injections / year; 100 million lyophilized powder injections / year; Sterile API 60 t / year.

Staff size:About 600 persons

Registered capital:RMB 138.8 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