01 2Bio-Rad Laboratories
01 1MACRO-PREP 50 EPOXIDE, DISTILLED SIZED SUPPORT
02 1MP50 EPOXIDE, UNDISTILLED, SIZED
01 2India
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10876
Submission : 1994-04-07
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9804
Submission : 1992-08-06
Status : Inactive
Type : II
A Oxirane manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Oxirane, including repackagers and relabelers. The FDA regulates Oxirane manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Oxirane 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 Oxirane supplier is an individual or a company that provides Oxirane active pharmaceutical ingredient (API) or Oxirane finished formulations upon request. The Oxirane suppliers may include Oxirane API manufacturers, exporters, distributors and traders.
click here to find a list of Oxirane suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Oxirane DMF (Drug Master File) is a document detailing the whole manufacturing process of Oxirane active pharmaceutical ingredient (API) in detail. Different forms of Oxirane DMFs exist exist since differing nations have different regulations, such as Oxirane USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Oxirane DMF submitted to regulatory agencies in the US is known as a USDMF. Oxirane USDMF includes data on Oxirane's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Oxirane USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Oxirane suppliers with USDMF on PharmaCompass.
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