01 1Emcure Pharmaceuticals
01 1SODIUM CARBONATE MONOHYDRATE USP-NF
01 1India
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31491
Submission : 2017-04-24
Status : Active
Type : II
A Sodium Carbonate Monohydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sodium Carbonate Monohydrate, including repackagers and relabelers. The FDA regulates Sodium Carbonate Monohydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sodium Carbonate 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 Sodium Carbonate Monohydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sodium Carbonate Monohydrate supplier is an individual or a company that provides Sodium Carbonate Monohydrate active pharmaceutical ingredient (API) or Sodium Carbonate Monohydrate finished formulations upon request. The Sodium Carbonate Monohydrate suppliers may include Sodium Carbonate Monohydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Sodium Carbonate Monohydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sodium Carbonate Monohydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Sodium Carbonate Monohydrate active pharmaceutical ingredient (API) in detail. Different forms of Sodium Carbonate Monohydrate DMFs exist exist since differing nations have different regulations, such as Sodium Carbonate Monohydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sodium Carbonate Monohydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Sodium Carbonate Monohydrate USDMF includes data on Sodium Carbonate Monohydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sodium Carbonate Monohydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sodium Carbonate Monohydrate suppliers with USDMF on PharmaCompass.
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