01 1Nira Life Sciences
01 1CLONIXIN-LYSINATE
01 1India
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 42122
Submission : 2025-06-20
Status : Active
Type : II
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A Dorixina manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dorixina, including repackagers and relabelers. The FDA regulates Dorixina manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dorixina 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 Dorixina manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Dorixina supplier is an individual or a company that provides Dorixina active pharmaceutical ingredient (API) or Dorixina finished formulations upon request. The Dorixina suppliers may include Dorixina API manufacturers, exporters, distributors and traders.
click here to find a list of Dorixina suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Dorixina DMF (Drug Master File) is a document detailing the whole manufacturing process of Dorixina active pharmaceutical ingredient (API) in detail. Different forms of Dorixina DMFs exist exist since differing nations have different regulations, such as Dorixina USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dorixina DMF submitted to regulatory agencies in the US is known as a USDMF. Dorixina USDMF includes data on Dorixina's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dorixina USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dorixina suppliers with USDMF on PharmaCompass.
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