Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
01 1Seqens
02 1Pfanstiehl
03 1Chattem Chemicals, Inc
04 1Corbion
05 1INOLEX CHEMICAL CO
01 4AMMONIUM LACTATE
02 1AMMONIUM LACTATE, PURASAL NH 70
01 1France
02 1Netherlands
03 3U.S.A
01 4Active
02 1Inactive
01 2Complete
02 3Blank
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
GDUFA
DMF Review : Complete
Rev. Date : 2023-11-02
Pay. Date : 2023-10-30
DMF Number : 12003
Submission : 1996-06-17
Status : Active
Type : II
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
A Ammonium Lactate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ammonium Lactate, including repackagers and relabelers. The FDA regulates Ammonium Lactate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ammonium Lactate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Ammonium Lactate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ammonium Lactate supplier is an individual or a company that provides Ammonium Lactate active pharmaceutical ingredient (API) or Ammonium Lactate finished formulations upon request. The Ammonium Lactate suppliers may include Ammonium Lactate API manufacturers, exporters, distributors and traders.
click here to find a list of Ammonium Lactate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ammonium Lactate DMF (Drug Master File) is a document detailing the whole manufacturing process of Ammonium Lactate active pharmaceutical ingredient (API) in detail. Different forms of Ammonium Lactate DMFs exist exist since differing nations have different regulations, such as Ammonium Lactate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ammonium Lactate DMF submitted to regulatory agencies in the US is known as a USDMF. Ammonium Lactate USDMF includes data on Ammonium Lactate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ammonium Lactate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ammonium Lactate suppliers with USDMF on PharmaCompass.
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