01 1Fujifilm Diosynth Biotechnologies
02 1Merck & Co
03 1SIGMA TAU
01 2CORTICOSTERONE
02 1PREPARATION OF CORTICOSTERONE FROM HYDROCORTISONE
01 2U.S.A
02 1United Kingdom
01 3Inactive
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5294
Submission : 1983-12-28
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 695
Submission : 1963-10-11
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7165
Submission : 1987-09-25
Status : Inactive
Type : II
A Corticosterone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Corticosterone, including repackagers and relabelers. The FDA regulates Corticosterone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Corticosterone 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 Corticosterone supplier is an individual or a company that provides Corticosterone active pharmaceutical ingredient (API) or Corticosterone finished formulations upon request. The Corticosterone suppliers may include Corticosterone API manufacturers, exporters, distributors and traders.
click here to find a list of Corticosterone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Corticosterone DMF (Drug Master File) is a document detailing the whole manufacturing process of Corticosterone active pharmaceutical ingredient (API) in detail. Different forms of Corticosterone DMFs exist exist since differing nations have different regulations, such as Corticosterone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Corticosterone DMF submitted to regulatory agencies in the US is known as a USDMF. Corticosterone USDMF includes data on Corticosterone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Corticosterone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Corticosterone suppliers with USDMF on PharmaCompass.
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