Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
01 1Pfanstiehl
02 1ANGUS Chemical Company
03 1Abbott Laboratories
04 1BioSpectra
05 1F. Hoffmann-La Roche
06 1SIGMA TAU
07 1Takara Bio
08 1The Mosaic Company
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 : 42613
Submission : 2025-09-22
Status :
Type : II
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A CAS-77-86-1 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of CAS-77-86-1, including repackagers and relabelers. The FDA regulates CAS-77-86-1 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. CAS-77-86-1 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 CAS-77-86-1 supplier is an individual or a company that provides CAS-77-86-1 active pharmaceutical ingredient (API) or CAS-77-86-1 finished formulations upon request. The CAS-77-86-1 suppliers may include CAS-77-86-1 API manufacturers, exporters, distributors and traders.
click here to find a list of CAS-77-86-1 suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A CAS-77-86-1 DMF (Drug Master File) is a document detailing the whole manufacturing process of CAS-77-86-1 active pharmaceutical ingredient (API) in detail. Different forms of CAS-77-86-1 DMFs exist exist since differing nations have different regulations, such as CAS-77-86-1 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A CAS-77-86-1 DMF submitted to regulatory agencies in the US is known as a USDMF. CAS-77-86-1 USDMF includes data on CAS-77-86-1's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The CAS-77-86-1 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of CAS-77-86-1 suppliers with USDMF on PharmaCompass.
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