ICE Pharma offers a unique range of bile acid products and best-in-class services for the pharmaceutical industry.
01 1ICE Pharma
01 1TAUROURSODEOXYCHOLIC ACID
01 1Italy
01 1Active
01 1Blank
ICE Pharma offers a unique range of bile acid products and best-in-class services for the pharmaceutical industry.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31049
Submission : 2016-09-30
Status : Active
Type : II
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PharmaCompass offers a list of Tauroursodeoxycholic Acid API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Tauroursodeoxycholic Acid manufacturer or Tauroursodeoxycholic Acid supplier for your needs.
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PharmaCompass also assists you with knowing the Tauroursodeoxycholic Acid API Price utilized in the formulation of products. Tauroursodeoxycholic Acid API Price is not always fixed or binding as the Tauroursodeoxycholic Acid Price is obtained through a variety of data sources. The Tauroursodeoxycholic Acid Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Ursodoxicoltaurine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ursodoxicoltaurine, including repackagers and relabelers. The FDA regulates Ursodoxicoltaurine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ursodoxicoltaurine API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Ursodoxicoltaurine supplier is an individual or a company that provides Ursodoxicoltaurine active pharmaceutical ingredient (API) or Ursodoxicoltaurine finished formulations upon request. The Ursodoxicoltaurine suppliers may include Ursodoxicoltaurine API manufacturers, exporters, distributors and traders.
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A Ursodoxicoltaurine DMF (Drug Master File) is a document detailing the whole manufacturing process of Ursodoxicoltaurine active pharmaceutical ingredient (API) in detail. Different forms of Ursodoxicoltaurine DMFs exist exist since differing nations have different regulations, such as Ursodoxicoltaurine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ursodoxicoltaurine DMF submitted to regulatory agencies in the US is known as a USDMF. Ursodoxicoltaurine USDMF includes data on Ursodoxicoltaurine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ursodoxicoltaurine USDMF is kept confidential to protect the manufacturer’s intellectual property.
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