Axplora- The partner of choice for complex APIs.
01 1Farmabios S. p. A.
02 2ICE S.p.A.
03 5DAEWOONG BIO INC.
04 1International Chemical Entity Japan Co., Ltd.
05 2MARENIS Pharma GmbH
06 1Zhongshan Belling Biotechnology Co. , Ltd.
Axplora- The partner of choice for complex APIs.
Registration Number : 303MF10073
Registrant's Address : Via Pavia, 1-27027 Gropello Cairoli, Pavia, Italy
Initial Date of Registration : 2021-04-27
Latest Date of Registration : 2022-06-28
ICE Pharma offers a unique range of bile acid products and best-in-class services for the pharmaceutical industry.
Japanese Pharmacopoeia Ursodeoxycholic Acid (for manufacturing only)
Registration Number : 218MF10319
Registrant's Address : Via Sicilia, 8/10 42122 Reggio Emilia, ITALY
Initial Date of Registration : 2006-03-09
Latest Date of Registration : 2024-04-03
ICE Pharma offers a unique range of bile acid products and best-in-class services for the pharmaceutical industry.
Ursodeoxycholic Acid (JP) (for manufacturing purposes only)
Registration Number : 218MF10320
Registrant's Address : Via Sicilia, 8/10 42122 Reggio Emilia, ITALY
Initial Date of Registration : 2006-03-09
Latest Date of Registration : 2011-12-05
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.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Ursodiol Drug Master File in Japan (Ursodiol JDMF) empowers Ursodiol API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Ursodiol JDMF during the approval evaluation for pharmaceutical products. At the time of Ursodiol JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Ursodiol suppliers with JDMF on PharmaCompass.
We have 6 companies offering Ursodiol
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