01 1Alcami
01 1PILOCARPINE (FP-039)
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16936
Submission : 2003-10-30
Status : Inactive
Type : II
A Ferrocene manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ferrocene, including repackagers and relabelers. The FDA regulates Ferrocene manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ferrocene 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 Ferrocene supplier is an individual or a company that provides Ferrocene active pharmaceutical ingredient (API) or Ferrocene finished formulations upon request. The Ferrocene suppliers may include Ferrocene API manufacturers, exporters, distributors and traders.
click here to find a list of Ferrocene suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ferrocene DMF (Drug Master File) is a document detailing the whole manufacturing process of Ferrocene active pharmaceutical ingredient (API) in detail. Different forms of Ferrocene DMFs exist exist since differing nations have different regulations, such as Ferrocene USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ferrocene DMF submitted to regulatory agencies in the US is known as a USDMF. Ferrocene USDMF includes data on Ferrocene's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ferrocene USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ferrocene suppliers with USDMF on PharmaCompass.
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