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