01 1C-Squared Pharma
01 1BENOXINATE HYDROCHLORIDE
01 1Ireland
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40430
Submission : 2025-03-07
Status : Active
Type : II
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A Novesin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Novesin, including repackagers and relabelers. The FDA regulates Novesin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Novesin 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 Novesin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Novesin supplier is an individual or a company that provides Novesin active pharmaceutical ingredient (API) or Novesin finished formulations upon request. The Novesin suppliers may include Novesin API manufacturers, exporters, distributors and traders.
click here to find a list of Novesin suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Novesin DMF (Drug Master File) is a document detailing the whole manufacturing process of Novesin active pharmaceutical ingredient (API) in detail. Different forms of Novesin DMFs exist exist since differing nations have different regulations, such as Novesin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Novesin DMF submitted to regulatory agencies in the US is known as a USDMF. Novesin USDMF includes data on Novesin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Novesin USDMF is kept confidential to protect the manufacturer’s intellectual property.
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