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PharmaCompass

01

PharmScience R&D
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothICE 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 : Active

Type : II

ICE S.p.A

03

PharmScience R&D
Not Confirmed

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PharmScience R&D
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Looking for 128-13-2 / Ursodeoxycholic Acid API manufacturers, exporters & distributors?

Ursodeoxycholic Acid manufacturers, exporters & distributors 1

19

PharmaCompass offers a list of Ursodeoxycholic 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 Ursodeoxycholic Acid manufacturer or Ursodeoxycholic Acid supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ursodeoxycholic Acid manufacturer or Ursodeoxycholic Acid supplier.

PharmaCompass also assists you with knowing the Ursodeoxycholic Acid API Price utilized in the formulation of products. Ursodeoxycholic Acid API Price is not always fixed or binding as the Ursodeoxycholic Acid Price is obtained through a variety of data sources. The Ursodeoxycholic Acid Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Ursodeoxycholic Acid

Synonyms

Ursodiol, 128-13-2, Actigall, Ursodeoxycholate, Udca, Ursofalk

Cas Number

128-13-2

Unique Ingredient Identifier (UNII)

724L30Y2QR

About Ursodeoxycholic Acid

An epimer of chenodeoxycholic acid. It is a mammalian bile acid found first in the bear and is apparently either a precursor or a product of chenodeoxycholate. Its administration changes the composition of bile and may dissolve gallstones. It is used as a cholagogue and choleretic.

Ursodiol Manufacturers

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.

Ursodiol Suppliers

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.

Ursodiol USDMF

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.

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.