01 1Dipharma
01 17-KETOLITHOCHOLIC ACID
01 1Italy
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32475
Submission : 2018-02-27
Status : Active
Type : II
A Nutriacholic Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nutriacholic Acid, including repackagers and relabelers. The FDA regulates Nutriacholic Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nutriacholic Acid API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Nutriacholic Acid supplier is an individual or a company that provides Nutriacholic Acid active pharmaceutical ingredient (API) or Nutriacholic Acid finished formulations upon request. The Nutriacholic Acid suppliers may include Nutriacholic Acid API manufacturers, exporters, distributors and traders.
click here to find a list of Nutriacholic Acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nutriacholic Acid DMF (Drug Master File) is a document detailing the whole manufacturing process of Nutriacholic Acid active pharmaceutical ingredient (API) in detail. Different forms of Nutriacholic Acid DMFs exist exist since differing nations have different regulations, such as Nutriacholic Acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nutriacholic Acid DMF submitted to regulatory agencies in the US is known as a USDMF. Nutriacholic Acid USDMF includes data on Nutriacholic Acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nutriacholic Acid USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nutriacholic Acid suppliers with USDMF on PharmaCompass.
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