01 1Shodhana Laboratories
01 1CYANODIOL HEMI DPTTA SALT
01 1India
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32563
Submission : 2018-02-21
Status : Active
Type : II
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A (2S,3S)-2,3-bis[(4-methylbenzoyl)oxy]butanedioic acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of (2S,3S)-2,3-bis[(4-methylbenzoyl)oxy]butanedioic acid, including repackagers and relabelers. The FDA regulates (2S,3S)-2,3-bis[(4-methylbenzoyl)oxy]butanedioic acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. (2S,3S)-2,3-bis[(4-methylbenzoyl)oxy]butanedioic acid 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 (2S,3S)-2,3-bis[(4-methylbenzoyl)oxy]butanedioic acid supplier is an individual or a company that provides (2S,3S)-2,3-bis[(4-methylbenzoyl)oxy]butanedioic acid active pharmaceutical ingredient (API) or (2S,3S)-2,3-bis[(4-methylbenzoyl)oxy]butanedioic acid finished formulations upon request. The (2S,3S)-2,3-bis[(4-methylbenzoyl)oxy]butanedioic acid suppliers may include (2S,3S)-2,3-bis[(4-methylbenzoyl)oxy]butanedioic acid API manufacturers, exporters, distributors and traders.
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A (2S,3S)-2,3-bis[(4-methylbenzoyl)oxy]butanedioic acid DMF (Drug Master File) is a document detailing the whole manufacturing process of (2S,3S)-2,3-bis[(4-methylbenzoyl)oxy]butanedioic acid active pharmaceutical ingredient (API) in detail. Different forms of (2S,3S)-2,3-bis[(4-methylbenzoyl)oxy]butanedioic acid DMFs exist exist since differing nations have different regulations, such as (2S,3S)-2,3-bis[(4-methylbenzoyl)oxy]butanedioic acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A (2S,3S)-2,3-bis[(4-methylbenzoyl)oxy]butanedioic acid DMF submitted to regulatory agencies in the US is known as a USDMF. (2S,3S)-2,3-bis[(4-methylbenzoyl)oxy]butanedioic acid USDMF includes data on (2S,3S)-2,3-bis[(4-methylbenzoyl)oxy]butanedioic acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The (2S,3S)-2,3-bis[(4-methylbenzoyl)oxy]butanedioic acid USDMF is kept confidential to protect the manufacturer’s intellectual property.
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We have 1 companies offering (2S,3S)-2,3-bis[(4-methylbenzoyl)oxy]butanedioic acid
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