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01 1POLYHEXAMETHYLENE BIGUANIDE
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01 1Active
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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38861
Submission : 2023-10-27
Status : Active
Type : II
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PharmaCompass offers a list of Polyhexanide 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 Polyhexanide manufacturer or Polyhexanide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Polyhexanide manufacturer or Polyhexanide supplier.
A Polyhexanide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Polyhexanide, including repackagers and relabelers. The FDA regulates Polyhexanide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Polyhexanide 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 Polyhexanide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Polyhexanide supplier is an individual or a company that provides Polyhexanide active pharmaceutical ingredient (API) or Polyhexanide finished formulations upon request. The Polyhexanide suppliers may include Polyhexanide API manufacturers, exporters, distributors and traders.
click here to find a list of Polyhexanide suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Polyhexanide DMF (Drug Master File) is a document detailing the whole manufacturing process of Polyhexanide active pharmaceutical ingredient (API) in detail. Different forms of Polyhexanide DMFs exist exist since differing nations have different regulations, such as Polyhexanide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Polyhexanide DMF submitted to regulatory agencies in the US is known as a USDMF. Polyhexanide USDMF includes data on Polyhexanide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Polyhexanide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Polyhexanide suppliers with USDMF on PharmaCompass.
