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