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 Amlactin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Amlactin, including repackagers and relabelers. The FDA regulates Amlactin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Amlactin 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 Amlactin supplier is an individual or a company that provides Amlactin active pharmaceutical ingredient (API) or Amlactin finished formulations upon request. The Amlactin suppliers may include Amlactin API manufacturers, exporters, distributors and traders.
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A Amlactin DMF (Drug Master File) is a document detailing the whole manufacturing process of Amlactin active pharmaceutical ingredient (API) in detail. Different forms of Amlactin DMFs exist exist since differing nations have different regulations, such as Amlactin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Amlactin DMF submitted to regulatory agencies in the US is known as a USDMF. Amlactin USDMF includes data on Amlactin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Amlactin USDMF is kept confidential to protect the manufacturer’s intellectual property.
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