Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
01 1Pfanstiehl
01 1SUCCINIC ACID, HIGH PURITY, LOW ENDOTOXIN, LOW METALS, NF, EP, BP, JPE, CHP (S-142)
01 1U.S.A
01 1Active
01 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 : N/A
Rev. Date :
Pay. Date :
DMF Number : 41241
Submission : 2025-01-28
Status : Active
Type : IV
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A Wormwood manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Wormwood, including repackagers and relabelers. The FDA regulates Wormwood manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Wormwood API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Wormwood DMF (Drug Master File) is a document detailing the whole manufacturing process of Wormwood active pharmaceutical ingredient (API) in detail. Different forms of Wormwood DMFs exist exist since differing nations have different regulations, such as Wormwood USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Wormwood DMF submitted to regulatory agencies in the US is known as a USDMF. Wormwood USDMF includes data on Wormwood's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Wormwood USDMF is kept confidential to protect the manufacturer’s intellectual property.
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