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