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Paracetamol

CAS number: 103-90-2

Molecular formula: C8H9NO2

molecular weight: 151.16

Chemical structure:

Producers shown on SFDA

(Record date:31/08/2021)

Producer

Documents

GMP Valid till(based on SFDA)

Shenzhou branch of Hebei Jiheng (Group) Pharmaceutical Co., Ltd.

GMP
Valid till July 2023

Novartis (Wuxi) Pharmaceutical Co., Ltd. 

GMP
Valid till December 2024

Tianjin Bofa Pharmaceutical Co., Ltd. 

GMP
Valid till July 2019

Anqiu Luan Pharmaceutical Co., Ltd.

GMP, DMF
Valid till May 2022

Lianyungang Kangle Pharmaceutical Co., Ltd.

GMP
Valid till October 2020

Hebei Jiheng (Group) Pharmaceutical Co.,  Ltd.

GMP
Valid till December 2020

Anhui BBAC Likang Pharmaceutical Co., Ltd.

GMP, DMF
Valid till December 2020

Jiuquan Dadeli Pharmaceutical Co.,  Ltd.

GMP
Valid till February 2025

Shantou Jinshi Pharmaceutical General Factory

GMP
/

Liaoyuan Baikang Pharmaceutical Co., Ltd.

GMP
Valid till July 2020

Huazhong Pharmaceutical Co., Ltd.

GMP
Valid till February 2021

Changshu Huagang Pharmaceutical Co., Ltd.

GMP
Valid till September 2019



Producers shown on EP

(Quoted from EP website;record date:31/08/2021)

Substance
Certificate Holder
Certificate Number
Issue Date
Status
End date
Type
Paracetamol
Rhodia Organique SAS FR 69006 Lyon
  R1-CEP 1996-004-Rev 02
14/02/2005
WITHDRAWN BY HOLDER
21/06/2006
Chemistry
Paracetamol
LIAOYUAN CITY BAIKANG PHARMACEUTICAL CO. LTD CN 136 200 Liaoyuan
  R1-CEP 2007-054-Rev 03
06/11/2019
VALID
/Chemistry
Paracetamol
Bristol Laboratories Ltd GB HA1 2EN Harrow
  R0-CEP 2001-092-Rev 02
13/10/2004
WITHDRAWN BY HOLDER
25/10/2005
Chemistry
Paracetamol
FARMSON PHARMACEUTICAL GUJARAT PRIVATE LIMITED IN 391 340 Nandesari
  R1-CEP 2002-020-Rev 08
15/10/2020
VALID
/Chemistry
Paracetamol
SRI KRISHNA PHARMACEUTICALS LIMITED IN 500 039 Hyderabad
  R1-CEP 2000-144-Rev 05
24/07/2018
VALID
/Chemistry
Paracetamol
Weistar Industry Limited CN 313 000 Huzhou
  R0-CEP 2006-156-Rev 00
17/04/2008
WITHDRAWN BY EDQM
16/04/2013
Chemistry
Paracetamol
Rhodia Opérations S.A.S. FR 93306 Aubervilliers
  R2-CEP 1992-010-Rev 02
31/08/2006
WITHDRAWN BY HOLDER
09/11/2011
Chemistry
Paracetamol
NOVACYL FR 69130 Ecully
  R1-CEP 2002-214-Rev 04
29/04/2021
VALID
/Chemistry
Paracetamol
Indukern Chemie AG CH 8952 Schlieren
  R0-CEP 2000-002-Rev 00
22/10/2001
WITHDRAWN BY EDQM
09/10/2002
Chemistry
Paracetamol
Atabay Kimya Sanayi Ve Ticaret A.S. TR 34718 Kadiköy, Istanbul
  R1-CEP 1995-050-Rev 04
17/10/2018
VALID
/Chemistry
Paracetamol
GRANULES INDIA LIMITED IN 500 081 Hyderabad
  R1-CEP 1998-047-Rev 06
19/01/2018
VALID
/Chemistry
Paracetamol
Anqiu Lu'an Pharmaceutical Co., Ltd. CN 262 100 Anqiu City
  R1-CEP 2000-124-Rev 08
20/09/2018
VALID
/Chemistry
Paracetamol
HEBEI JIHENG PHARMACEUTICAL CO., LTD. CN 053 000 Hengshui City
  R1-CEP 2012-148-Rev 03
01/03/2021
VALID
/Chemistry
Paracetamol
ANHUI BBCA LIKANG PHARMACEUTICAL CO., LTD. CN 233 010 Bengbu
  R0-CEP 2011-278-Rev 00
30/03/2012
EXPIRED
31/03/2017
Chemistry
Paracetamol
HEBEI JIHENG PHARMACEUTICAL CO., LTD. CN 053 000 Hengshui City
  R1-CEP 2005-032-Rev 04
15/02/2021
VALID
/Chemistry
Paracetamol
ZHEJIANG KANGLE PHARMACEUTICAL CO., LTD. CN 325 011 Wenzhou
  R1-CEP 2004-309-Rev 02
18/03/2020
VALID
/Chemistry
Paracetamol
MEGHMANI LLP IN 380 006 Ahmedabad
  R0-CEP 2015-377-Rev 0107/11/2018
VALID
/Chemistry
Paracetamol
SPECGX LLC US 63119 Webster Groves
  R1-CEP 1996-039-Rev 04
25/04/2018
VALID
/Chemistry

Producer:Shenzhou branch of Hebei Jiheng (Group) Pharmaceutical Co., Ltd. has been cancelled.

Hebei Jiheng (Group) Pharmaceutical Co., Ltd., established in 1996, is a wholly-owned subsidiary of Hebei Jiheng group.

The company strictly implements GMP standards. Its leading products paracetamol, analgin and folic acid have obtained national GMP certificate, kosher certificate, Indian registration certificate and American DMF registration number. Now they are being certified by American FDA. The pillar product paracetamol has obtained the EU cos certificate; Folic acid has obtained halal certificate. The company has the right to import and export products. Its products are sold to 30 provinces, cities and autonomous regions in China and more than 40 countries and regions such as the Middle East, Southeast Asia, South America, Eastern Europe and Africa, and enjoy a good reputation at home and abroad.

Staff size:/

Registered capital:/


Producer:Novartis (Wuxi) Pharmaceutical Co., Ltd. (formerly Rodia Wuxi Pharmaceutical Co., Ltd.) is a wholly-owned subsidiary of novacyl, France. It was established in 2001 and mainly produces powder, particles and other pharmaceutical intermediates of raw drug p-acetaminophen. The company is located at No. 8, Guangshi West Road, Wuxi City, covering an area of about 40000 square meters and a construction area of about 14000 square meters. The plant is reasonably arranged according to GMP requirements. The company is a cooperative supplier of raw material drug p-aminophenol powder, particles and other pharmaceutical intermediates for many top pharmaceutical companies in the world.

Staff size:100-199 persons

Registered capital:USD 16.8 million


Producer:Tianjin Bofa Pharmaceutical Co., Ltd. is a manufacturer of paracetamol API. It was established in April 2004, formerly known as Hongfa branch of Xinxin Pharmaceutical Factory of Tianjin Zhongxin Pharmaceutical Group Co., Ltd.

In July 2004, it passed the GMP certification of Tianjin drug administration. The registered capital is 3 million yuan. The annual output reaches 9000 tons. In 2009, it created brilliance again, and passed the GMP certification again by Tianjin drug administration on June 18, 2009, with an annual output of 10000 tons. It has become a leading enterprise with high quality, high standard and high output value.

Staff size:About 50 people

Registered capital:RMB 10 million


Producer:Anqiu Lu'an Pharmaceutical Co., Ltd. (formerly Weifang No. 4 pharmaceutical factory) is a manufacturer of Western medicine raw materials. The company mainly produces and exports western medicine raw material paracetamol, with an annual production capacity of 40000 tons  、 The annual production capacity of DC grade paracetamol is 12000 tons  ; Paracetamol solid preparation is 8 billion tablets / capsule, and the products sell well in more than 100 countries and regions around the world   。 Become the world's largest paracetamol production base.   The company's products have passed the US FDA quality certification, EU EDQM certification and the quality audit of the Canadian government for five consecutive times. The product paracetamol has obtained the applicability certificate of European Pharmacopoeia issued by the European Medical Quality Council.

Staff size:1000-1999 people

Registered capital:RMB 60 million


Producer:Lianyungang Kangle Pharmaceutical Co., Ltd. is a newly completed and put into operation API production enterprise. The company is located in Ganyu District Economic Development Zone, Lianyungang City, covering an area of more than 80000 square meters, a construction area of nearly 20000 square meters, with a total investment of 80 million yuan. The selected production equipment has reached the international and domestic advanced level, with first-class laboratory instruments and testing equipment and a team with high education High quality management team and staff were officially put into production in November 2004. The company's main products are acetaminophen (paracetamol), the raw material drug. The products are mainly exported to Nigeria, Indonesia, South Korea, Taiwan, Singapore, Hong Kong and many other countries and regions. As a newly-built drug manufacturer, it has a production line established in full accordance with cGMP standards and advanced testing equipment, with an annual production of 6000 tons of acetaminophen (paracetamol).

Staff size:200-299 people

Registered capital:RMB 20 million


Producer:Hebei Jiheng (Group) Pharmaceutical Co., Ltd., established in 1996, is a wholly-owned subsidiary of Hebei Jiheng group.

The company strictly implements GMP standards. Its leading products paracetamol, analgin and folic acid have obtained national GMP certificate, kosher certificate, Indian registration certificate and American DMF registration number. Now they are being certified by American FDA. The pillar product paracetamol has obtained the EU cos certificate; Folic acid has obtained halal certificate. The company has the right to import and export products. Its products are sold to 30 provinces, cities and autonomous regions in China and more than 40 countries and regions such as the Middle East, Southeast Asia, South America, Eastern Europe and Africa, and enjoy a good reputation at home and abroad.

Staff size:900-999 people

Registered capital:RMB 90 million

Producer:Anhui BBAC Likang Pharmaceutical Co., Ltd., a wholly-owned subsidiary of BBCA Pharmaceutical , was established in November 2010 with a registered capital of 66 million yuan. It is mainly engaged in the production and sales of APIs and the import and export of its products and technologies. The company is located in Bengbu high tech Development Zone, covering an area of about 135 mu.

At present, the company has an annual production capacity of 8000 tons of paracetamol and 2000 tons of dc90. The product quality meets the requirements of Chinese Pharmacopoeia (cp2010), European Pharmacopoeia (EP7) and American Pharmacopoeia (usp36), and has been highly praised by customers in domestic and foreign markets.

 Staff size:200-299 people

Registered capital:RMB 138 million


Producer:Jiuquan Dadeli Pharmaceutical Co., Ltd., a holding subsidiary of Lanzhou Dadeli Pharmaceutical Group, is a high-tech enterprise specializing in drug R & D, production and sales. There are 146 drug approval numbers, including 32 API approvals. The company has more than ten production lines for solid preparations, small volume injections, lyophilized powder injections, biochemical APIs, chemical APIs, traditional Chinese medicine extraction, traditional Chinese medicine decoction pieces, etc., all of which have passed the national GMP certification.

Staff size:100-199 people

Registered capital:RMB 59.43 million


Producer:Sinopharm Shantou Jinshi Pharmaceutical Co., Ltd. (formerly Shantou Jinshi Pharmaceutical General Factory) is now a wholly-owned subsidiary of Shanghai Modern Pharmaceutical Co., Ltd.

The enterprise covers an area of more than 36 Mu and a construction area of more than 20000 square meters. Its production scope includes chemical APIs, sterile APIs, tablets, hard capsules, powder injections, granules, dry suspensions, oral liquids and oral solutions. It has independently developed, developed and produced 154 approvals, including 142 preparations and 12 APIs; The Department and all its production lines (nine dosage forms and seven workshops in total) have passed the new version of GMP certification.

Staff size:400-499 people

Registered capital:RMB 83.98 million


Producer:Liaoyuan Baikang Pharmaceutical Co., Ltd. is a wholly-owned subsidiary of Chongqing Sansheng Industrial Co., Ltd. Its predecessor, Liaoyuan No. 1 pharmaceutical factory, was founded in 1958.

After more than 50 years of accumulation and development, the company now has 104 drug production approval numbers, including 20 APIs and 84 preparations. The leading varieties of API are acetaminophen, chlorpipetin hydrochloride, nefopam hydrochloride, procaine hydrochloride, diphenhydramine hydrochloride, famotidine, dioxpromazine hydrochloride and levofloxacin mesylate. The annual output of preparations is more than 2 billion tablets, mainly including chlorpipetin hydrochloride tablets and compound paracetamol diphenhydramine tablets. The company has import and export rights, and its products are mainly exported to India, Hong Kong, Macao, Taiwan and other countries and regions. The company has passed GMP certification and COS certification, and is applying for FDA certification to obtain a pass for products to enter the European and American markets.

Staff size:About 400 people

Registered capital:RMB 50 million 


Producer:Huazhong Pharmaceutical Co., Ltd. is subordinate to China Ordnance Equipment Group Corporation. It is located in Xiangyang City, an important town in Northwest Hubei Province with beautiful scenery and rich resources. It covers an area of 700000 square meters. It is a modern comprehensive pharmaceutical enterprise integrating R & D, production and sales of pharmaceutical products. The company has strong technical force, complete quality testing equipment and quality assurance system, advanced production technology and equipment, and has passed GMP, fami-qs, HACCP, ISO9001, ISO22000, kosher, halal and other certifications.

Subsidiaries of Huazhong Pharmaceutical Co., Ltd.: Hubei 295 Technology Co., Ltd. and Xiangfan 295 Pharmaceutical Trading Co., Ltd. We are the earliest manufacturer of vitamin B1 raw materials in China and the largest in the world. The product quality meets the quality standards of CP, BP, USP, EP and JP. At the same time, we have also developed VB1 Granule Series and VB1 derivative series products.

Staff size:600-699 people

Registered capital:RMB 245 million 148 thousand and 515


Producer:Changshu Huagang Pharmaceutical Co., Ltd., founded in 1991, is a manufacturer of Western medicine raw materials, covering an area of more than 100000 square meters. It has been renamed Changshu Huayu Trading Co., Ltd.

The company mainly produces and exports paracetamol (paracetamol), the raw material of Western medicine, with an annual output of 8000 tons; Paracetamol dc90%. In 2004, it passed the national GMP certification and obtained the GMP certificate. In 2007, it passed the EDQM European GMP on-site verification. In 2008, he obtained the cos certificate and carried out DMF registration and FDA certification in the United States. The product paracetamol obtained the cos certificate issued by EDQM in 2008. The products are exported all over the world with good reputation and class a quality. At present, the company has completed DMF registration in the United States and FDA certification is in progress.

Staff size:About 50 people

Registered capital:USD 1 million 889 thousand and 100


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