01 1Shiratori Pharmaceutical
01 1EMEDASTINE DIFUMARATE
01 1Japan
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11759
Submission : 1995-11-29
Status : Active
Type : II
A Emedastine Fumarate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Emedastine Fumarate, including repackagers and relabelers. The FDA regulates Emedastine Fumarate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Emedastine Fumarate 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 Emedastine Fumarate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Emedastine Fumarate supplier is an individual or a company that provides Emedastine Fumarate active pharmaceutical ingredient (API) or Emedastine Fumarate finished formulations upon request. The Emedastine Fumarate suppliers may include Emedastine Fumarate API manufacturers, exporters, distributors and traders.
click here to find a list of Emedastine Fumarate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Emedastine Fumarate DMF (Drug Master File) is a document detailing the whole manufacturing process of Emedastine Fumarate active pharmaceutical ingredient (API) in detail. Different forms of Emedastine Fumarate DMFs exist exist since differing nations have different regulations, such as Emedastine Fumarate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Emedastine Fumarate DMF submitted to regulatory agencies in the US is known as a USDMF. Emedastine Fumarate USDMF includes data on Emedastine Fumarate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Emedastine Fumarate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Emedastine Fumarate suppliers with USDMF on PharmaCompass.
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