01 1SIGMA TAU
01 1ACETYLCHOLINE CHLORIDE
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7221
Submission : 1987-10-13
Status : Inactive
Type : II
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A MIOCHOL-E manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of MIOCHOL-E, including repackagers and relabelers. The FDA regulates MIOCHOL-E manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. MIOCHOL-E API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of MIOCHOL-E manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A MIOCHOL-E supplier is an individual or a company that provides MIOCHOL-E active pharmaceutical ingredient (API) or MIOCHOL-E finished formulations upon request. The MIOCHOL-E suppliers may include MIOCHOL-E API manufacturers, exporters, distributors and traders.
click here to find a list of MIOCHOL-E suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A MIOCHOL-E DMF (Drug Master File) is a document detailing the whole manufacturing process of MIOCHOL-E active pharmaceutical ingredient (API) in detail. Different forms of MIOCHOL-E DMFs exist exist since differing nations have different regulations, such as MIOCHOL-E USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A MIOCHOL-E DMF submitted to regulatory agencies in the US is known as a USDMF. MIOCHOL-E USDMF includes data on MIOCHOL-E's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The MIOCHOL-E USDMF is kept confidential to protect the manufacturer’s intellectual property.
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