ICE Pharma offers a unique range of bile acid products and best-in-class services for the pharmaceutical industry.
01 1ICE Pharma
02 1Sichuan Elixir Pharmaceuticals
03 1ALP Pharm
04 1Adare Pharma Solutions
05 1Arch Pharmalabs
06 3Daewoong Pharmaceutical
07 1Dipharma
08 1Erregierre SpA
09 1F. Hoffmann-La Roche
10 1FALK & Co
11 1Giuliani
12 1Glenmark Life Sciences
13 1Mitsubishi Tanabe Pharma
14 2Sichuan Xieli Pharmaceutical
15 1Solara Active Pharma Sciences
16 1Solvay Chemicals International S.A
17 1Zhongshan Belling Biotechnology
18 3Blank
ICE Pharma offers a unique range of bile acid products and best-in-class services for the pharmaceutical industry.
GDUFA
DMF Review : Complete
Rev. Date : 2019-03-25
Pay. Date : 2019-02-14
DMF Number : 16803
Submission : 2003-09-03
Status :
Type : II
Sichuan Elixir Pharmaceutical, a manufacturer of small molecule APIs & a CMO/CDMO service provider for anti-tumor characteristic APIs..
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39647
Submission : 2024-03-27
Status :
Type : II
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.
A Ursodiol DMF (Drug Master File) is a document detailing the whole manufacturing process of Ursodiol active pharmaceutical ingredient (API) in detail. Different forms of Ursodiol DMFs exist exist since differing nations have different regulations, such as Ursodiol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ursodiol DMF submitted to regulatory agencies in the US is known as a USDMF. Ursodiol USDMF includes data on Ursodiol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ursodiol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ursodiol suppliers with USDMF on PharmaCompass.
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