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