01 1Eli Lilly
02 1Fermenta Biotech Limited
03 1Green Stone Swiss Co ., Ltd
04 1Macleods Pharmaceuticals Limited
05 1ST Pharma
06 1Saurav Chemicals
07 1Solara Active Pharma Sciences
08 3Blank
01 1China
02 4India
03 1South Korea
04 1U.S.A
05 3Blank
01 2Active
02 5Inactive
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01 1WC-0127
02 1WC-0171
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21720
Submission : 2008-06-20
Status : Active
Type : II
Date of Issue : 2022-09-30
Valid Till : 2025-08-04
Written Confirmation Number : WC-0127
Address of the Firm :
NDC Package Code : 72643-027
Start Marketing Date : 2021-11-09
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-12-15
Pay. Date : 2016-09-21
DMF Number : 30598
Submission : 2016-08-03
Status : Active
Type : II
NDC Package Code : 33342-600
Start Marketing Date : 2023-08-10
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (0.5kg/.5kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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
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
Registrant Name : Estifarm Co., Ltd.
Registration Date : 2022-10-14
Registration Number : 20221014-209-J-1379
Manufacturer Name : Estifarm Co., Ltd.
Manufacturer Address : 231, Hyeop-ro, Siheung-si, Gyeonggi-do
Date of Issue : 2019-08-13
Valid Till : 2022-08-12
Written Confirmation Number : WC-0171
Address of the Firm :
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.
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