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