01 1AstraZeneca
01 1TOCAINIDE HCL. INJECTION
01 1United Kingdom
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5629
Submission : 1984-12-14
Status : Inactive
Type : II
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A (+)-2-Amino-N-(2,6-dimethylphenyl)propanamide monohydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of (+)-2-Amino-N-(2,6-dimethylphenyl)propanamide monohydrochloride, including repackagers and relabelers. The FDA regulates (+)-2-Amino-N-(2,6-dimethylphenyl)propanamide monohydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. (+)-2-Amino-N-(2,6-dimethylphenyl)propanamide monohydrochloride 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 (+)-2-Amino-N-(2,6-dimethylphenyl)propanamide monohydrochloride supplier is an individual or a company that provides (+)-2-Amino-N-(2,6-dimethylphenyl)propanamide monohydrochloride active pharmaceutical ingredient (API) or (+)-2-Amino-N-(2,6-dimethylphenyl)propanamide monohydrochloride finished formulations upon request. The (+)-2-Amino-N-(2,6-dimethylphenyl)propanamide monohydrochloride suppliers may include (+)-2-Amino-N-(2,6-dimethylphenyl)propanamide monohydrochloride API manufacturers, exporters, distributors and traders.
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A (+)-2-Amino-N-(2,6-dimethylphenyl)propanamide monohydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of (+)-2-Amino-N-(2,6-dimethylphenyl)propanamide monohydrochloride active pharmaceutical ingredient (API) in detail. Different forms of (+)-2-Amino-N-(2,6-dimethylphenyl)propanamide monohydrochloride DMFs exist exist since differing nations have different regulations, such as (+)-2-Amino-N-(2,6-dimethylphenyl)propanamide monohydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A (+)-2-Amino-N-(2,6-dimethylphenyl)propanamide monohydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. (+)-2-Amino-N-(2,6-dimethylphenyl)propanamide monohydrochloride USDMF includes data on (+)-2-Amino-N-(2,6-dimethylphenyl)propanamide monohydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The (+)-2-Amino-N-(2,6-dimethylphenyl)propanamide monohydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
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We have 1 companies offering (+)-2-Amino-N-(2,6-dimethylphenyl)propanamide monohydrochloride
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