01 1ChemPacific Corp
02 1Franco-Indian Pharmaceuticals Private Limited
03 1Solara Active Pharma Sciences
04 1Therakos
05 1Wanbury Limited
06 2Blank
01 3METHOXSALEN
02 1METHOXSALEN DRUG SUBSTANCE
03 2METHOXSALEN USP
04 1UVADEX (METHOXSALEN), STERILE SOLUTION, NUTLEY, NJ
01 3India
02 1U.S.A
03 1United Kingdom
04 2Blank
01 2Active
02 5Inactive
01 1Complete
02 6Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19350
Submission : 2006-04-12
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3564
Submission : 1979-04-30
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-07-02
Pay. Date : 2020-06-26
DMF Number : 21862
Submission : 2008-08-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8390
Submission : 1990-01-19
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20038
Submission : 2006-12-11
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4792
Submission : 1983-01-21
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2934
Submission : 1977-04-28
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
A Methoxsalen manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Methoxsalen, including repackagers and relabelers. The FDA regulates Methoxsalen manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Methoxsalen 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 Methoxsalen manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Methoxsalen supplier is an individual or a company that provides Methoxsalen active pharmaceutical ingredient (API) or Methoxsalen finished formulations upon request. The Methoxsalen suppliers may include Methoxsalen API manufacturers, exporters, distributors and traders.
click here to find a list of Methoxsalen suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Methoxsalen DMF (Drug Master File) is a document detailing the whole manufacturing process of Methoxsalen active pharmaceutical ingredient (API) in detail. Different forms of Methoxsalen DMFs exist exist since differing nations have different regulations, such as Methoxsalen USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Methoxsalen DMF submitted to regulatory agencies in the US is known as a USDMF. Methoxsalen USDMF includes data on Methoxsalen's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Methoxsalen USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Methoxsalen suppliers with USDMF on PharmaCompass.
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