Aspen API. More than just an API.
01 1Aspen API
01 1RIMEXOLONE
01 1Netherlands
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8112
Submission : 1989-06-20
Status : Inactive
Type : II
A Rimexolone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rimexolone, including repackagers and relabelers. The FDA regulates Rimexolone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rimexolone 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 Rimexolone supplier is an individual or a company that provides Rimexolone active pharmaceutical ingredient (API) or Rimexolone finished formulations upon request. The Rimexolone suppliers may include Rimexolone API manufacturers, exporters, distributors and traders.
click here to find a list of Rimexolone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Rimexolone DMF (Drug Master File) is a document detailing the whole manufacturing process of Rimexolone active pharmaceutical ingredient (API) in detail. Different forms of Rimexolone DMFs exist exist since differing nations have different regulations, such as Rimexolone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Rimexolone DMF submitted to regulatory agencies in the US is known as a USDMF. Rimexolone USDMF includes data on Rimexolone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Rimexolone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Rimexolone suppliers with USDMF on PharmaCompass.
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