Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
01 1Pfanstiehl
02 1Anmol Chemicals
01 1SUCCINIC ACID BP/EP/USP
02 1SUCCINIC ACID, HIGH PURITY, LOW ENDOTOXIN, LOW METALS, NF, EP, BP, JPE, CHP (S-142)
01 1India
02 1U.S.A
01 2Active
01 2Blank
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
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39462
Submission : 2024-02-06
Status : Active
Type : IV
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A Butanedioic Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Butanedioic Acid, including repackagers and relabelers. The FDA regulates Butanedioic Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Butanedioic Acid 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 Butanedioic Acid supplier is an individual or a company that provides Butanedioic Acid active pharmaceutical ingredient (API) or Butanedioic Acid finished formulations upon request. The Butanedioic Acid suppliers may include Butanedioic Acid API manufacturers, exporters, distributors and traders.
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A Butanedioic Acid DMF (Drug Master File) is a document detailing the whole manufacturing process of Butanedioic Acid active pharmaceutical ingredient (API) in detail. Different forms of Butanedioic Acid DMFs exist exist since differing nations have different regulations, such as Butanedioic Acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Butanedioic Acid DMF submitted to regulatory agencies in the US is known as a USDMF. Butanedioic Acid USDMF includes data on Butanedioic Acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Butanedioic Acid USDMF is kept confidential to protect the manufacturer’s intellectual property.
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