01 1ACS DOBFAR SPA
02 1Bayer AG
03 2Fujifilm Diosynth Biotechnologies
04 1Quimica Sintetica
05 1SIMS Srl
01 1HYDROCORTISONE 21-HYDROGEN, SUCCINATE, BULK, NON-STERILE
02 3HYDROCORTISONE HEMISUCCINATE
03 1HYDROCORTISONE HEMISUCCINATE MICRO
04 1HYDROCORTISONE SODIUM SUCCINATE
01 1Germany
02 2Italy
03 1Spain
04 2United Kingdom
01 6Inactive
01 6Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3097
Submission : 1978-01-09
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2889
Submission : 1977-03-21
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3961
Submission : 1980-10-06
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4122
Submission : 1981-04-07
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6753
Submission : 1986-11-26
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6185
Submission : 1986-01-30
Status : Inactive
Type : II
53
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A Flebocortid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Flebocortid, including repackagers and relabelers. The FDA regulates Flebocortid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Flebocortid API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Flebocortid supplier is an individual or a company that provides Flebocortid active pharmaceutical ingredient (API) or Flebocortid finished formulations upon request. The Flebocortid suppliers may include Flebocortid API manufacturers, exporters, distributors and traders.
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A Flebocortid DMF (Drug Master File) is a document detailing the whole manufacturing process of Flebocortid active pharmaceutical ingredient (API) in detail. Different forms of Flebocortid DMFs exist exist since differing nations have different regulations, such as Flebocortid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Flebocortid DMF submitted to regulatory agencies in the US is known as a USDMF. Flebocortid USDMF includes data on Flebocortid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Flebocortid USDMF is kept confidential to protect the manufacturer’s intellectual property.
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