01 1Irvine Scientific Sales Company
01 1HEPES BUFFER SOLUTION 1M-LIQUID
01 1U.S.A
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28064
Submission : 2014-02-26
Status : Active
Type : II
A Hepes API manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hepes API, including repackagers and relabelers. The FDA regulates Hepes API manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hepes API API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Hepes API supplier is an individual or a company that provides Hepes API active pharmaceutical ingredient (API) or Hepes API finished formulations upon request. The Hepes API suppliers may include Hepes API API manufacturers, exporters, distributors and traders.
click here to find a list of Hepes API suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Hepes API DMF (Drug Master File) is a document detailing the whole manufacturing process of Hepes API active pharmaceutical ingredient (API) in detail. Different forms of Hepes API DMFs exist exist since differing nations have different regulations, such as Hepes API USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Hepes API DMF submitted to regulatory agencies in the US is known as a USDMF. Hepes API USDMF includes data on Hepes API's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Hepes API USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Hepes API suppliers with USDMF on PharmaCompass.
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