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01 1Farmabios SPA
02 1ICE SPA@Raichem Medicare Pvt. Ltd
03 1Daewoong Bio Co., Ltd.@Zhejiang Warrant Pharmaceutical Co., Ltd@Hunan Jiudian Hongyang Pharmaceutical.Co.,Ltd
04 1Korea Biochem Pharmaceutical Co., Ltd@Zhongshan Belling Biotechnology Co., Ltd
05 1Shilpa Pharma Lifesciences Limited (unit-2)
06 2Suzhou Tianlu Bio-Pharmaceuticals Co.,Ltd.
07 6Suzhou Tianlu Bio-pharmaceutical Co., Ltd
08 1Zhongshan Belling Biotechnology Co.,Ltd.
01 1Ace Biopharm Co., Ltd.
02 1Daeshin Pharmaceutical Co., Ltd.
03 1Daewoong Bio Co., Ltd.
04 1Eltek Pharmachem Co., Ltd.
05 1Hwain Farm Co., Ltd.
06 1JSP Co., Ltd.
07 1Korea Biochem Pharmaceutical Co., Ltd.
08 1Kukjeon Pharmaceutical Co., Ltd.
09 1Otran Pharm Korea Co., Ltd.
10 1Pampia Co., Ltd.
11 1SG Biochem Co., Ltd.
12 1Samoh Pharmaceutical Co., Ltd.
13 1Sanil Pharmaceutical Co., Ltd.
14 1Sechang International Co., Ltd.
01 14Ursodeoxycholic acid
01 9China
02 1Germany
03 1India
04 1Italy
05 2South Korea
Registrant Name : Eltek Pharmachem Co., Ltd.
Registration Date : 2020-08-13
Registration Number : 20200813-211-J-501
Manufacturer Name : Farmabios SPA
Manufacturer Address : Via Pavia 1-27027, GROPELLO CAIROLI (PV), Italy
ICE Pharma offers a unique range of bile acid products and best-in-class services for the pharmaceutical industry.
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2020-07-16
Registration Number : 20200716-211-J-434
Manufacturer Name : ICE SPA@Raichem Medicare Pvt...
Manufacturer Address : Via Sicilia, 8-10-42122 Reggio Nell' Emilia (RE) Italy@Plot No. 24, 25 & 26, Raichur ...
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2023-08-08
Registration Number : 20230808-211-J-1475
Manufacturer Name : Shilpa Pharma Lifesciences L...
Manufacturer Address : Plot No. 33, 33A, 40 to 47, Block C,D,E,H,I & AM, Raichur Industrial Growth Centre, C...
Registrant Name : Hwain Farm Co., Ltd.
Registration Date : 2022-08-05
Registration Number : 20210723-211-J-885(5)
Manufacturer Name : Suzhou Tianlu Bio-Pharmaceut...
Manufacturer Address : 1128 Yinzhong South Road Wuzhong Economic Development Zone,Suzhou Jiangsu 215214 Chin...
Registrant Name : Ace Biopharm Co., Ltd.
Registration Date : 2022-08-04
Registration Number : 20210723-211-J-885(4)
Manufacturer Name : Suzhou Tianlu Bio-pharmaceut...
Manufacturer Address : 1128 Yin Zhong South Road, Wuzhong Economy Development Zone, Suzhou Jiangsu China-215...
Registrant Name : JSP Co., Ltd.
Registration Date : 2022-08-04
Registration Number : 20210723-211-J-885(3)
Manufacturer Name : Suzhou Tianlu Bio-Pharmaceut...
Manufacturer Address : 1128 Yin Zhong South Road, Wuzhong Economy Development Zone, Suzhou Jiangsu China-215...
Registrant Name : Sanil Pharmaceutical Co., Ltd.
Registration Date : 2022-08-04
Registration Number : 20210723-211-J-885(2)
Manufacturer Name : Suzhou Tianlu Bio-pharmaceut...
Manufacturer Address : 1128 Yin Zhong South Road, Wuzhong Economy Development Zone, Suzhou Jiangsu China-215...
Registrant Name : SG Biochem Co., Ltd.
Registration Date : 2023-12-07
Registration Number : 20210723-211-J-885(7)
Manufacturer Name : Suzhou Tianlu Bio-pharmaceut...
Manufacturer Address : 1128 Yin Zhong South Road, Wuzhong Economy Development Zone, Suzhou Jiangsu China-215...
Registrant Name : Daeshin Pharmaceutical Co., Ltd.
Registration Date : 2023-01-10
Registration Number : 20210723-211-J-885(6)
Manufacturer Name : Suzhou Tianlu Bio-pharmaceut...
Manufacturer Address : 1128 Yin Zhong South Road, Wuzhong Economy Development Zone, Suzhou Jiangsu China-215...
Registrant Name : Pampia Co., Ltd.
Registration Date : 2023-03-07
Registration Number : 20230307-211-J-1457
Manufacturer Name : Zhongshan Belling Biotechnol...
Manufacturer Address : No.28 Jiuzhou Road, Torch Development Zone, Zhongshan City, Guangdong Province, PRChi...
A Ursodiol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ursodiol, including repackagers and relabelers. The FDA regulates Ursodiol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ursodiol 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 Ursodiol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ursodiol supplier is an individual or a company that provides Ursodiol active pharmaceutical ingredient (API) or Ursodiol finished formulations upon request. The Ursodiol suppliers may include Ursodiol API manufacturers, exporters, distributors and traders.
click here to find a list of Ursodiol 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 Ursodiol Drug Master File in Korea (Ursodiol KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ursodiol. The MFDS reviews the Ursodiol KDMF as part of the drug registration process and uses the information provided in the Ursodiol KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ursodiol 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 Ursodiol API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Ursodiol suppliers with KDMF on PharmaCompass.
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