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01 1Amphastar Pharmaceuticals
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01 1U.S.A
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01 1Active
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33258
Submission : 2018-11-21
Status : Active
Type : IV
NDC Package Code : 52221-120
Start Marketing Date : 2017-06-07
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (500g/500g)
Marketing Category : BULK INGREDIENT
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A Sodium taurocholate hydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sodium taurocholate hydrate, including repackagers and relabelers. The FDA regulates Sodium taurocholate hydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sodium taurocholate 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.
A Sodium taurocholate hydrate supplier is an individual or a company that provides Sodium taurocholate hydrate active pharmaceutical ingredient (API) or Sodium taurocholate hydrate finished formulations upon request. The Sodium taurocholate hydrate suppliers may include Sodium taurocholate hydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Sodium taurocholate hydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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