01 1(주)엔지케명과학@Jingdezhen Fuxiang Pharmaceuticla Co., Ltd., (Raw product manufacturer)
02 1Laboratorios Bago SA@[Starting Material Manufactory]Jiangsu Huaxu Pharmaceutical co.,Ltd_x000D_
03 2Zhuhai United Laboratories Co., Ltd.@JiangXi Fushine Pharmaceutical Co., Ltd.[Starting material (sulbactam) manufacturer]
01 1Alvogen Korea Co., Ltd.
02 1Boryeong Co., Ltd.
03 1Engichem Life Sciences Co., Ltd.
04 1Seongi Bio Co., Ltd.
01 4Sulbaktampiboksil
01 1Argentina
02 2China
03 1Blank
Registrant Name : Engichem Life Sciences Co., Ltd.
Registration Date : 2012-09-19
Registration Number : 20120919-150-I-218-02
Manufacturer Name : (주)엔지케명과학@Jing...
Manufacturer Address : 59 Biovalley-ro, Jecheon-si, Chungcheongbuk-do @No. 2 Yuli Industrial Zone, Changjian...
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Product Web Link
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Corporate PDF
Registrant Name : Alvogen Korea Co., Ltd.
Registration Date : 2014-10-06
Registration Number : 20141006-150-I-383-08
Manufacturer Name : Laboratorios Bago SA@[Starti...
Manufacturer Address : St.455, between St.24 and St.27, City Bell of the Province of Buenos Aires, of the Ar...
Registrant Name : Seongi Bio Co., Ltd.
Registration Date : 2013-09-27
Registration Number : 20130927-150-I-284-07
Manufacturer Name : Zhuhai United Laboratories C...
Manufacturer Address : No.2428, Anji Road, Sanzao Town, Jinwan District, Zhuhai, Guangdong, 519040, PR China...
Registrant Name : Boryeong Co., Ltd.
Registration Date : 2014-01-08
Registration Number : 20130927-150-I-284-07(1)
Manufacturer Name : Zhuhai United Laboratories C...
Manufacturer Address : No.2428, Anji Road, Sanzao Town, Jinwan District, Zhuhai, Guangdong, 519040, PR China...
A Sulbactam manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sulbactam, including repackagers and relabelers. The FDA regulates Sulbactam manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sulbactam API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Sulbactam manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sulbactam supplier is an individual or a company that provides Sulbactam active pharmaceutical ingredient (API) or Sulbactam finished formulations upon request. The Sulbactam suppliers may include Sulbactam API manufacturers, exporters, distributors and traders.
click here to find a list of Sulbactam suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Sulbactam Drug Master File in Korea (Sulbactam KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Sulbactam. The MFDS reviews the Sulbactam KDMF as part of the drug registration process and uses the information provided in the Sulbactam KDMF to evaluate the safety and efficacy of the drug.
After submitting a Sulbactam KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Sulbactam API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Sulbactam suppliers with KDMF on PharmaCompass.
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