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