Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
01 1Pfanstiehl
02 1Roquette
01 1SODIUM GLUCONATE
02 1SODIUM GLUCONATE, USP (S-108)
01 1France
02 1U.S.A
01 2Active
01 1Complete
02 1Blank
Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
GDUFA
DMF Review : Complete
Rev. Date : 2021-09-14
Pay. Date : 2021-09-09
DMF Number : 9147
Submission : 1991-05-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34499
Submission : 2020-01-15
Status : Active
Type : II
A Sodium Gluconate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sodium Gluconate, including repackagers and relabelers. The FDA regulates Sodium Gluconate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sodium Gluconate 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 Gluconate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sodium Gluconate supplier is an individual or a company that provides Sodium Gluconate active pharmaceutical ingredient (API) or Sodium Gluconate finished formulations upon request. The Sodium Gluconate suppliers may include Sodium Gluconate API manufacturers, exporters, distributors and traders.
click here to find a list of Sodium Gluconate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sodium Gluconate DMF (Drug Master File) is a document detailing the whole manufacturing process of Sodium Gluconate active pharmaceutical ingredient (API) in detail. Different forms of Sodium Gluconate DMFs exist exist since differing nations have different regulations, such as Sodium Gluconate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sodium Gluconate DMF submitted to regulatory agencies in the US is known as a USDMF. Sodium Gluconate USDMF includes data on Sodium Gluconate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sodium Gluconate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sodium Gluconate suppliers with USDMF on PharmaCompass.
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