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