ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
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02 1Cilag AG
03 1Divis Laboratories
04 1Fuan Pharmaceutical
05 1GLAND PHARMA LIMITED
06 1Recordati
07 1Shanghai Ziyuan Pharmaceutical
08 1Sun Pharmaceutical Industries Limited
09 1Trifarma
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01 2FOSPHENYTOIN SODIUM
02 1FOSPHENYTOIN SODIUM API
03 1FOSPHENYTOIN SODIUM DRUG SUBSTANCE (ACTIVE PHARMACEUTICAL INGREDIENT)
04 5FOSPHENYTOIN SODIUM USP
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02 3India
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ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Complete
Rev. Date : 2023-05-03
Pay. Date : 2023-03-30
DMF Number : 37565
Submission : 2023-03-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18954
Submission : 2005-11-14
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18806
Submission : 2005-09-25
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-02-09
Pay. Date : 2020-03-05
DMF Number : 32816
Submission : 2018-08-08
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-06-09
Pay. Date : 2019-04-24
DMF Number : 33756
Submission : 2019-04-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16899
Submission : 2003-10-08
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-06-16
Pay. Date : 2017-05-23
DMF Number : 17333
Submission : 2004-04-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19455
Submission : 2006-05-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20970
Submission : 2007-10-24
Status : Inactive
Type : II
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PharmaCompass offers a list of Fosphenytoin Sodium API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Fosphenytoin Sodium manufacturer or Fosphenytoin Sodium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Fosphenytoin Sodium manufacturer or Fosphenytoin Sodium supplier.
PharmaCompass also assists you with knowing the Fosphenytoin Sodium API Price utilized in the formulation of products. Fosphenytoin Sodium API Price is not always fixed or binding as the Fosphenytoin Sodium Price is obtained through a variety of data sources. The Fosphenytoin Sodium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Fosphenytoin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fosphenytoin, including repackagers and relabelers. The FDA regulates Fosphenytoin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fosphenytoin 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 Fosphenytoin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fosphenytoin supplier is an individual or a company that provides Fosphenytoin active pharmaceutical ingredient (API) or Fosphenytoin finished formulations upon request. The Fosphenytoin suppliers may include Fosphenytoin API manufacturers, exporters, distributors and traders.
click here to find a list of Fosphenytoin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fosphenytoin DMF (Drug Master File) is a document detailing the whole manufacturing process of Fosphenytoin active pharmaceutical ingredient (API) in detail. Different forms of Fosphenytoin DMFs exist exist since differing nations have different regulations, such as Fosphenytoin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fosphenytoin DMF submitted to regulatory agencies in the US is known as a USDMF. Fosphenytoin USDMF includes data on Fosphenytoin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fosphenytoin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fosphenytoin suppliers with USDMF on PharmaCompass.
We have 9 companies offering Fosphenytoin
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