01 1Chemspec-API
01 1CHLORAL HYDRATE
01 1U.S.A
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28017
Submission : 2015-07-15
Status : Active
Type : II
A Chloral Hydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Chloral Hydrate, including repackagers and relabelers. The FDA regulates Chloral Hydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Chloral Hydrate 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 Chloral Hydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Chloral Hydrate supplier is an individual or a company that provides Chloral Hydrate active pharmaceutical ingredient (API) or Chloral Hydrate finished formulations upon request. The Chloral Hydrate suppliers may include Chloral Hydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Chloral Hydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Chloral Hydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Chloral Hydrate active pharmaceutical ingredient (API) in detail. Different forms of Chloral Hydrate DMFs exist exist since differing nations have different regulations, such as Chloral Hydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Chloral Hydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Chloral Hydrate USDMF includes data on Chloral Hydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Chloral Hydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Chloral Hydrate suppliers with USDMF on PharmaCompass.
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