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