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Meropenem

CAS number: 96036-03-2

Molecular formula: C17H25N3O5S

molecular weight: 383.46300

Chemical structure:

Producers shown on SFDA

(Record date:27/08/2021)

Producer

Documents

GMP Valid till(based on SFDA)

Shenzhen Haibin Pharmaceutical Co., Ltd.

GMP

Valid till June 2024

Chongqing Shenghuaxi Pharmaceutical Co., Ltd.

GMP
Valid till May 2021

Zhuhai United Laboratories Co., Ltd.

GMP
Valid till December 2023

CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

GMP
Valid till August 2023

Chongqing Tiandi Pharmaceutical Co., Ltd.

GMP
Valid till June 2024

Zhejiang Hisun Pharmaceutical Co., Ltd.

GMP
Valid till November 2017

PKU HealthCare Corp., Ltd.

GMP

Valid till May 2019

Producers shown on EP

(Quoted from EP website;record date:27/08/2021)

Substance
Certificate Holder
Certificate Number
Issue Date
Status
End date
Type
Meropenem trihydrate Sterile, synthetic origin
UNIMARK REMEDIES LIMITED IN 400 099 Mumbai
R0-CEP 2015-148-Rev 00
23/08/2017
WITHDRAWN BY EDQM
12/04/2021
Chemistry
Meropenem trihydrate Sterile, synthetic origin
SUN PHARMACEUTICAL INDUSTRIES LIMITED IN 400 063 Mumbai
R0-CEP 2015-241-Rev 01
12/01/2018
VALID
/Chemistry
Meropenem trihydrate Sterile, synthetic origin, process I
SHANDONG ANHONG PHARMACEUTICAL CO., LTD. CN 251 500 Dezhou City
R0-CEP 2020-020-Rev 01
18/06/2021
VALID
/Chemistry
Meropenem trihydrate Synthetic origin, sterile
Kyongbo Pharmaceutical Co., Ltd. KR 336-020 Asan-Si
R0-CEP 2012-089-Rev 00
07/04/2014
WITHDRAWN BY EDQM
22/10/2018
Chemistry
Meropenem trihydrate Synthetic origin, sterile
SHENZHEN HAIBIN PHARMACEUTICAL CO., LTD. CN 518 081 Shenzhen City
 R1-CEP 2012-133-Rev 01
29/11/2019
VALID
/Chemistry
Meropenem trihydrate Sterile and synthetic origin
SHANDONG ANHONG PHARMACEUTICAL CO., LTD. CN 251 500 Dezhou City
R0-CEP 2015-362-Rev 03
23/01/2020
VALID
/Chemistry
Meropenem trihydrate
DAEWOONG BIO INC. KR 445-938 Hwaseong-Si
R0-CEP 2011-361-Rev 00
20/05/2014
WITHDRAWN BY EDQM
31/10/2018
Chemistry
Meropenem trihydrate Sterile, synthetic origin, for parenteral preparations
ACS DOBFAR S.P.A. IT 20067 Tribiano
R1-CEP 2011-238-Rev 00
09/07/2019
VALID
/Chemistry
Meropenem trihydrate Sterile, synthetic origin, process II
SUN PHARMACEUTICAL INDUSTRIES LIMITED IN 400 063 Mumbai
 R0-CEP 2018-268-Rev 00
15/05/2020
VALID
/Chemistry

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:Chongqing Shenghuaxi Pharmaceutical Co., Ltd. was established in 1998 and officially restructured into a joint stock limited company in 2010; At present, the company has more than 900 employees. After more than ten years of development, it has been established   Jingjing is a high-tech API and pharmaceutical preparation enterprise integrating R & D, production and sales.

Taking new drug R & D as the core competitiveness of the enterprise, the company has built a large-scale scientific research system, with more than 200 full-time scientific and technological developers; The company invests more than 12% of its sales revenue into new drug research and development every year. The company has three production bases, with more than ten fully sterile API and non sterile API production workshops, fine, drying and charter workshops, as well as a number of pharmaceutical preparation workshops; It has an annual production capacity of more than one billion yuan for APIs and pharmaceutical preparations.

Staff size:About 800 persons

Registered capital:RMB 66 million


Producer:Zhuhai United Laboratories Co., Ltd. is a subsidiary of The United Laboratories International Holdings Limited (United Lab). United Lab now has 11 major series of preparation products, more than 60 varieties, more than 120 product specifications, and nearly 50 varieties of 5 major series of API and intermediate products. All workshops of UL have passed the new version of GMP certification in China, and many products have successively obtained EU GMP certification and US FDA certification. With advanced enzymatic production technology, UL has become the first enterprise in China to obtain the EU CEP certificate of enzymatic amoxicillin, and a number of scientific and technological achievements have obtained national patents.

United Labowns advanced production equipment and adequate production capacity. Every year, it can produce 1.8 billion capsules, 1 billion tablets, 134 million sachets of granules, 86 million sachets of suspension, 20 million vials of oral solution, 117 million vials of powder injections, 37.8 million tubes of ointments, 28 million vials of lyophilized powder for injection, 24 million tubes of eye drops and about 300 million tubes of insulin preparation.

Staff size:2000-2999 persons

Registered capital:RMB 1 billion 678 million 396 thousand


Producer:CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.is a joint venture invested and established by CSPC Pharmaceutical Group Co., Ltd. in the mainland. It is a professional production base of antibiotic raw materials and preparations in China and a major supplier of non patented drugs in China. The market share of amoxicillin dispersible tablets and Amoxicillin Capsules produced by the company ranks first in the industry.

The "zero defect items" of cephalosporin powder injection, tablet and capsule passed the FDA certification for the first time; The annual output is 1.2 billion powder injections, 4.4 billion capsules and 800 million tablets; It is divided into four dosage forms: powder injection, capsule, tablet and granule; More than 150 specifications of antibiotics were produced. All kinds of products have passed GMP certification and meet the latest national standards.

Staff size:2000-2999 persons
Registered capital:RMB 678 million 555 thousand and 900


Producer:Chongqing Tiandi Pharmaceutical Co., Ltd., established in December 2003, is a holding subsidiary of the listed company Hainan sea Co., Ltd., with total assets of 230 million yuan. All products have passed GMP certification of the State Food and Drug Administration and ISO9001 certification of China Quality Certification Center. After 8 years of continuous development, the company has established a strategic partnership for sustainable development with many well-known pharmaceutical enterprises in China.

Staff size:500-599 persons

Registered capital:RMB 532 million 916 thousand and 370


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:PKU HealthCare Corp., Ltd.is a core member enterprise of Founder group medical and pharmaceutical industry - Peking University medical industry group. It has more than 50 years of pharmaceutical manufacturing history and a national technology center. It is a key backbone enterprise of Chinese medicine, a national innovative pilot enterprise and a key high-tech enterprise of the national torch plan.

Peking University Pharmaceutical has a pharmaceutical manufacturing base built according to international cGMP in Liangjiang New Area, Chongqing. Its products cover more than 10 categories and more than 100 varieties, such as anti-tumor, psychoneurological, cardiovascular, immunosuppressive, anti microbial, antipyretic and analgesic. The company has a perfect quality assurance system, which has passed the FDA and EU GMP certification.

Staff size:About 800 persons

Registered capital:RMB 596 million


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