Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
01 1Pfanstiehl
02 1Chattem Chemicals, Inc
03 1Corbion
04 1INOLEX CHEMICAL CO
01 3AMMONIUM LACTATE
02 1AMMONIUM LACTATE, PURASAL NH 70
01 1Netherlands
02 3U.S.A
01 3Active
02 1Inactive
01 1Complete
02 3Blank
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 : 12612
Submission : 1997-08-05
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-08-15
Pay. Date : 2023-07-12
DMF Number : 13843
Submission : 1998-11-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11075
Submission : 1994-09-13
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5130
Submission : 1983-09-30
Status : Active
Type : II
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A Kerasal AL manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Kerasal AL, including repackagers and relabelers. The FDA regulates Kerasal AL manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Kerasal AL 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 Kerasal AL supplier is an individual or a company that provides Kerasal AL active pharmaceutical ingredient (API) or Kerasal AL finished formulations upon request. The Kerasal AL suppliers may include Kerasal AL API manufacturers, exporters, distributors and traders.
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A Kerasal AL DMF (Drug Master File) is a document detailing the whole manufacturing process of Kerasal AL active pharmaceutical ingredient (API) in detail. Different forms of Kerasal AL DMFs exist exist since differing nations have different regulations, such as Kerasal AL USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Kerasal AL DMF submitted to regulatory agencies in the US is known as a USDMF. Kerasal AL USDMF includes data on Kerasal AL's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Kerasal AL USDMF is kept confidential to protect the manufacturer’s intellectual property.
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