01 1Irvine Scientific Sales Company
01 1U.S.A
01 1Active
01 1Blank
01 1Blank
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.
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