Axplora- The partner of choice for complex APIs.
01 1Axplora
01 1DELTA-1-CORTIENIC ACID
01 1Germany
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27008
Submission : 2013-03-21
Status : Active
Type : II
A Cortienic Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cortienic Acid, including repackagers and relabelers. The FDA regulates Cortienic Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cortienic 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 Cortienic Acid supplier is an individual or a company that provides Cortienic Acid active pharmaceutical ingredient (API) or Cortienic Acid finished formulations upon request. The Cortienic Acid suppliers may include Cortienic Acid API manufacturers, exporters, distributors and traders.
click here to find a list of Cortienic Acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cortienic Acid DMF (Drug Master File) is a document detailing the whole manufacturing process of Cortienic Acid active pharmaceutical ingredient (API) in detail. Different forms of Cortienic Acid DMFs exist exist since differing nations have different regulations, such as Cortienic Acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cortienic Acid DMF submitted to regulatory agencies in the US is known as a USDMF. Cortienic Acid USDMF includes data on Cortienic Acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cortienic Acid USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cortienic Acid suppliers with USDMF on PharmaCompass.
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