01 1BIOSYN ARZNEIMITTEL GMBH
02 1TaiRx
01 2SODIUM SELENITE PENTAHYDRATE
01 1Germany
02 1Taiwan
01 2Active
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27544
Submission : 2013-09-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36408
Submission : 2021-10-28
Status : Active
Type : II
A Sodium Selenite manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sodium Selenite, including repackagers and relabelers. The FDA regulates Sodium Selenite manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sodium Selenite 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 Selenite manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sodium Selenite supplier is an individual or a company that provides Sodium Selenite active pharmaceutical ingredient (API) or Sodium Selenite finished formulations upon request. The Sodium Selenite suppliers may include Sodium Selenite API manufacturers, exporters, distributors and traders.
click here to find a list of Sodium Selenite suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sodium Selenite DMF (Drug Master File) is a document detailing the whole manufacturing process of Sodium Selenite active pharmaceutical ingredient (API) in detail. Different forms of Sodium Selenite DMFs exist exist since differing nations have different regulations, such as Sodium Selenite USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sodium Selenite DMF submitted to regulatory agencies in the US is known as a USDMF. Sodium Selenite USDMF includes data on Sodium Selenite's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sodium Selenite USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sodium Selenite suppliers with USDMF on PharmaCompass.
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