01 1Eli Lilly
02 1Fermenta Biotech Limited
03 1Macleods Pharmaceuticals Limited
04 1Solara Active Pharma Sciences
05 3Blank
01 6CYCLOSERINE
02 1CYCLOSERINE USP
01 3India
02 1U.S.A
03 3Blank
01 2Active
02 5Inactive
01 1Complete
02 6Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13686
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13571
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-12-15
Pay. Date : 2016-09-21
DMF Number : 30598
Submission : 2016-08-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21720
Submission : 2008-06-20
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13416
Submission : 1998-09-01
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 : 13317
Submission : 1998-09-01
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 : 13660
Submission : 1998-09-01
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
A Cycloserine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cycloserine, including repackagers and relabelers. The FDA regulates Cycloserine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cycloserine 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 Cycloserine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cycloserine supplier is an individual or a company that provides Cycloserine active pharmaceutical ingredient (API) or Cycloserine finished formulations upon request. The Cycloserine suppliers may include Cycloserine API manufacturers, exporters, distributors and traders.
click here to find a list of Cycloserine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cycloserine DMF (Drug Master File) is a document detailing the whole manufacturing process of Cycloserine active pharmaceutical ingredient (API) in detail. Different forms of Cycloserine DMFs exist exist since differing nations have different regulations, such as Cycloserine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cycloserine DMF submitted to regulatory agencies in the US is known as a USDMF. Cycloserine USDMF includes data on Cycloserine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cycloserine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cycloserine suppliers with USDMF on PharmaCompass.
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