01 1POLI INDUSTRIA CHIMICA SPA
01 1S(+)Mecamylamine Hydrochloride
01 1Italy
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21157
Submission : 2007-12-17
Status : Inactive
Type : II
18
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A Mecamylamine HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mecamylamine HCl, including repackagers and relabelers. The FDA regulates Mecamylamine HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mecamylamine HCl 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 HCl supplier is an individual or a company that provides Mecamylamine HCl active pharmaceutical ingredient (API) or Mecamylamine HCl finished formulations upon request. The Mecamylamine HCl suppliers may include Mecamylamine HCl API manufacturers, exporters, distributors and traders.
click here to find a list of Mecamylamine HCl suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Mecamylamine HCl DMF (Drug Master File) is a document detailing the whole manufacturing process of Mecamylamine HCl active pharmaceutical ingredient (API) in detail. Different forms of Mecamylamine HCl DMFs exist exist since differing nations have different regulations, such as Mecamylamine HCl USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mecamylamine HCl DMF submitted to regulatory agencies in the US is known as a USDMF. Mecamylamine HCl USDMF includes data on Mecamylamine HCl's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mecamylamine HCl USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Mecamylamine HCl suppliers with USDMF on PharmaCompass.
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