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 potassium 2,3,4,5,6-pentahydroxyhexanoate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of potassium 2,3,4,5,6-pentahydroxyhexanoate, including repackagers and relabelers. The FDA regulates potassium 2,3,4,5,6-pentahydroxyhexanoate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. potassium 2,3,4,5,6-pentahydroxyhexanoate 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 potassium 2,3,4,5,6-pentahydroxyhexanoate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A potassium 2,3,4,5,6-pentahydroxyhexanoate supplier is an individual or a company that provides potassium 2,3,4,5,6-pentahydroxyhexanoate active pharmaceutical ingredient (API) or potassium 2,3,4,5,6-pentahydroxyhexanoate finished formulations upon request. The potassium 2,3,4,5,6-pentahydroxyhexanoate suppliers may include potassium 2,3,4,5,6-pentahydroxyhexanoate API manufacturers, exporters, distributors and traders.
click here to find a list of potassium 2,3,4,5,6-pentahydroxyhexanoate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A potassium 2,3,4,5,6-pentahydroxyhexanoate DMF (Drug Master File) is a document detailing the whole manufacturing process of potassium 2,3,4,5,6-pentahydroxyhexanoate active pharmaceutical ingredient (API) in detail. Different forms of potassium 2,3,4,5,6-pentahydroxyhexanoate DMFs exist exist since differing nations have different regulations, such as potassium 2,3,4,5,6-pentahydroxyhexanoate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A potassium 2,3,4,5,6-pentahydroxyhexanoate DMF submitted to regulatory agencies in the US is known as a USDMF. potassium 2,3,4,5,6-pentahydroxyhexanoate USDMF includes data on potassium 2,3,4,5,6-pentahydroxyhexanoate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The potassium 2,3,4,5,6-pentahydroxyhexanoate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of potassium 2,3,4,5,6-pentahydroxyhexanoate suppliers with USDMF on PharmaCompass.
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