01 1Curia
01 1MECAMYLAMINE BASE
01 1U.S.A
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13019
Submission : 1998-06-12
Status : Active
Type : II
A Mecamylamine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mecamylamine, including repackagers and relabelers. The FDA regulates Mecamylamine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mecamylamine 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 Mecamylamine supplier is an individual or a company that provides Mecamylamine active pharmaceutical ingredient (API) or Mecamylamine finished formulations upon request. The Mecamylamine suppliers may include Mecamylamine API manufacturers, exporters, distributors and traders.
click here to find a list of Mecamylamine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Mecamylamine DMF (Drug Master File) is a document detailing the whole manufacturing process of Mecamylamine active pharmaceutical ingredient (API) in detail. Different forms of Mecamylamine DMFs exist exist since differing nations have different regulations, such as Mecamylamine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mecamylamine DMF submitted to regulatory agencies in the US is known as a USDMF. Mecamylamine USDMF includes data on Mecamylamine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mecamylamine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Mecamylamine suppliers with USDMF on PharmaCompass.
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