01 1AlzChem AG
01 1CREATINE MONOHYDRATE
01 1Germany
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16538
Submission : 2003-04-02
Status : Inactive
Type : II
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PharmaCompass offers a list of Creatine Monohydrate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Creatine Monohydrate manufacturer or Creatine Monohydrate supplier for your needs.
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A Creatine Monohydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Creatine Monohydrate, including repackagers and relabelers. The FDA regulates Creatine Monohydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Creatine Monohydrate 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 Creatine Monohydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Creatine Monohydrate supplier is an individual or a company that provides Creatine Monohydrate active pharmaceutical ingredient (API) or Creatine Monohydrate finished formulations upon request. The Creatine Monohydrate suppliers may include Creatine Monohydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Creatine Monohydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Creatine Monohydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Creatine Monohydrate active pharmaceutical ingredient (API) in detail. Different forms of Creatine Monohydrate DMFs exist exist since differing nations have different regulations, such as Creatine Monohydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Creatine Monohydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Creatine Monohydrate USDMF includes data on Creatine Monohydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Creatine Monohydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Creatine Monohydrate suppliers with USDMF on PharmaCompass.
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