01 1Jost Chemical
01 1CALCIUM SUCCINATE, MONOHYDRATE USP
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25131
Submission : 2011-07-05
Status : Inactive
Type : II
A Calcium Succinate Monohydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Calcium Succinate Monohydrate, including repackagers and relabelers. The FDA regulates Calcium Succinate Monohydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Calcium Succinate 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 Calcium Succinate Monohydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Calcium Succinate Monohydrate supplier is an individual or a company that provides Calcium Succinate Monohydrate active pharmaceutical ingredient (API) or Calcium Succinate Monohydrate finished formulations upon request. The Calcium Succinate Monohydrate suppliers may include Calcium Succinate Monohydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Calcium Succinate Monohydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Calcium Succinate Monohydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Calcium Succinate Monohydrate active pharmaceutical ingredient (API) in detail. Different forms of Calcium Succinate Monohydrate DMFs exist exist since differing nations have different regulations, such as Calcium Succinate Monohydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Calcium Succinate Monohydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Calcium Succinate Monohydrate USDMF includes data on Calcium Succinate Monohydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Calcium Succinate Monohydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Calcium Succinate Monohydrate suppliers with USDMF on PharmaCompass.
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