Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
01 1Sanofi
02 1Biosynth AG
03 1Flamma SpA
04 1Helsinn Advanced Synthesis
05 1Regis Technologies
06 1SIGMA TAU
07 1Swati Spentose
01 4MELATONIN
02 1MELATONIN AND A STABILITY INDICATION ASSAY METHOD FOR MELATONIN
03 1MELATONIN USP
04 1N-[2-(5-METHOXYINDOL-3-YL)ETHYL] ACETAMIDE (MELATONIN)
01 1France
02 1India
03 1Italy
04 2Switzerland
05 2U.S.A
01 2Active
02 5Inactive
01 7Blank
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12055
Submission : 1996-07-19
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11014
Submission : 1994-07-28
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22610
Submission : 2009-03-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11575
Submission : 1995-07-04
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7869
Submission : 1989-01-05
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4353
Submission : 1981-11-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34979
Submission : 2020-08-08
Status : Active
Type : II
A Melatonin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Melatonin, including repackagers and relabelers. The FDA regulates Melatonin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Melatonin 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 Melatonin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Melatonin supplier is an individual or a company that provides Melatonin active pharmaceutical ingredient (API) or Melatonin finished formulations upon request. The Melatonin suppliers may include Melatonin API manufacturers, exporters, distributors and traders.
click here to find a list of Melatonin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Melatonin DMF (Drug Master File) is a document detailing the whole manufacturing process of Melatonin active pharmaceutical ingredient (API) in detail. Different forms of Melatonin DMFs exist exist since differing nations have different regulations, such as Melatonin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Melatonin DMF submitted to regulatory agencies in the US is known as a USDMF. Melatonin USDMF includes data on Melatonin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Melatonin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Melatonin suppliers with USDMF on PharmaCompass.
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