01 1Blank
01 1ERGOTAMINE IN HUMAN PLASMA
01 1Blank
01 1Inactive
01 1Blank
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6422
Submission : 1986-06-11
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
A Ergotamine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ergotamine, including repackagers and relabelers. The FDA regulates Ergotamine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ergotamine 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 Ergotamine supplier is an individual or a company that provides Ergotamine active pharmaceutical ingredient (API) or Ergotamine finished formulations upon request. The Ergotamine suppliers may include Ergotamine API manufacturers, exporters, distributors and traders.
click here to find a list of Ergotamine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ergotamine DMF (Drug Master File) is a document detailing the whole manufacturing process of Ergotamine active pharmaceutical ingredient (API) in detail. Different forms of Ergotamine DMFs exist exist since differing nations have different regulations, such as Ergotamine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ergotamine DMF submitted to regulatory agencies in the US is known as a USDMF. Ergotamine USDMF includes data on Ergotamine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ergotamine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ergotamine suppliers with USDMF on PharmaCompass.
LOOKING FOR A SUPPLIER?