01 1DEVATS INDIA
01 1NIMORAZOLE
01 1India
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24814
Submission : 2011-03-30
Status : Active
Type : II
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A Naxogin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Naxogin, including repackagers and relabelers. The FDA regulates Naxogin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Naxogin 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 Naxogin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Naxogin supplier is an individual or a company that provides Naxogin active pharmaceutical ingredient (API) or Naxogin finished formulations upon request. The Naxogin suppliers may include Naxogin API manufacturers, exporters, distributors and traders.
click here to find a list of Naxogin suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Naxogin DMF (Drug Master File) is a document detailing the whole manufacturing process of Naxogin active pharmaceutical ingredient (API) in detail. Different forms of Naxogin DMFs exist exist since differing nations have different regulations, such as Naxogin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Naxogin DMF submitted to regulatory agencies in the US is known as a USDMF. Naxogin USDMF includes data on Naxogin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Naxogin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Naxogin suppliers with USDMF on PharmaCompass.
