Curia - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.
01 1Curia
02 1Alivus Life Sciences
01 1DEOXYCHOLIC ACID
02 1DEOXYCHOLIC ACID USP
01 1India
02 1U.S.A
01 2Active
01 1Complete
02 1Blank
Curia - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33526
Submission : 2019-01-16
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-02-08
Pay. Date : 2018-01-03
DMF Number : 32305
Submission : 2017-12-29
Status : Active
Type : II
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A Degalol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Degalol, including repackagers and relabelers. The FDA regulates Degalol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Degalol 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 Degalol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Degalol supplier is an individual or a company that provides Degalol active pharmaceutical ingredient (API) or Degalol finished formulations upon request. The Degalol suppliers may include Degalol API manufacturers, exporters, distributors and traders.
click here to find a list of Degalol suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Degalol DMF (Drug Master File) is a document detailing the whole manufacturing process of Degalol active pharmaceutical ingredient (API) in detail. Different forms of Degalol DMFs exist exist since differing nations have different regulations, such as Degalol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Degalol DMF submitted to regulatory agencies in the US is known as a USDMF. Degalol USDMF includes data on Degalol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Degalol USDMF is kept confidential to protect the manufacturer’s intellectual property.
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