01 1Kyowa Pharma Chemical Co Ltd
01 1SYNTHETIC ALUMINUM SILICATE
01 1Japan
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15628
Submission : 2001-09-10
Status : Active
Type : IV
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A Bentone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bentone, including repackagers and relabelers. The FDA regulates Bentone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bentone 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 Bentone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Bentone supplier is an individual or a company that provides Bentone active pharmaceutical ingredient (API) or Bentone finished formulations upon request. The Bentone suppliers may include Bentone API manufacturers, exporters, distributors and traders.
click here to find a list of Bentone suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Bentone DMF (Drug Master File) is a document detailing the whole manufacturing process of Bentone active pharmaceutical ingredient (API) in detail. Different forms of Bentone DMFs exist exist since differing nations have different regulations, such as Bentone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bentone DMF submitted to regulatory agencies in the US is known as a USDMF. Bentone USDMF includes data on Bentone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bentone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bentone suppliers with USDMF on PharmaCompass.
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