Comhony Biotech manufactures fermentation & semi-synthetic APIs which aim at dermatology, anti-biotics; mitochondria & memory health.
01 2Comhony Biotech
02 1Biosintez
03 1Ercros
04 1Hanways Chempharm
05 1JOYANG LABORATORIES
06 5Leo Pharma
07 1Unipex
08 1WORLD JIANGSU INDUSTRY CO LTD
01 5China
02 5Denmark
03 1France
04 1Russia
05 1Spain
01 4Active
02 2Inactive
03 7Blank
01 7Valid
02 3Withdrawn by Holder
03 3Blank
01 1218MF10952
02 12Blank
01 13Blank
Comhony Biotech manufactures fermentation & semi-synthetic APIs which aim at dermatology, anti-biotics; mitochondria & memory health.
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33777
Submission : 2019-04-19
Status : Active
Type : II
Certificate Number : CEP 2022-369 - Rev 01
Issue Date : 2024-11-04
Type : Chemical
Substance Number : 848
Status : Valid
Comhony Biotech manufactures fermentation & semi-synthetic APIs which aim at dermatology, anti-biotics; mitochondria & memory health.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37497
Submission : 2022-09-06
Status : Active
Type : II
Certificate Number : R0-CEP 2019-284 - Rev 01
Issue Date : 2021-10-27
Type : Chemical
Substance Number : 848
Status : Withdrawn by Holder
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20405
Submission : 2007-03-29
Status : Active
Type : II
Certificate Number : R1-CEP 2006-120 - Rev 02
Issue Date : 2022-02-18
Type : Chemical
Substance Number : 848
Status : Valid
NDC Package Code : 12836-0314
Start Marketing Date : 2009-01-12
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2019-04-22
Registration Number : 20190422-209-J-87
Manufacturer Name : Ercros SA
Manufacturer Address : Paseo del Deleite s/n, Aranjuez 28300 Madrid Spain
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36285
Submission : 2021-10-08
Status : Active
Type : II
Certificate Number : CEP 2021-307 - Rev 01
Issue Date : 2024-07-11
Type : Chemical
Substance Number : 848
Status : Valid
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2024-10-31
Registration Number : 20241031-209-J-1707
Manufacturer Name : Joyang Laboratories
Manufacturer Address : No. 9 Haidu North Road, Sheyang Economic Development zone, Yancheng, Jiangsu, 224300 China
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8527
Submission : 1990-04-16
Status : Inactive
Type : II
Certificate Number : R0-CEP 2021-042 - Rev 00
Issue Date : 2021-06-04
Type : Chemical
Substance Number : 848
Status : Valid
Registration Number : 218MF10952
Registrant's Address : Industryparken 55, DK-2750 Ballerup
Initial Date of Registration : 2006-11-24
Latest Date of Registration : --
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21243
Submission : 2008-01-08
Status : Inactive
Type : II
Certificate Number : R1-CEP 2009-309 - Rev 00
Issue Date : 2016-07-29
Type : Chemical
Substance Number : 848
Status : Valid
Certificate Number : R1-CEP 2008-207 - Rev 00
Issue Date : 2015-05-07
Type : Chemical
Substance Number : 848
Status : Withdrawn by Holder
Certificate Number : R0-CEP 2021-041 - Rev 01
Issue Date : 2022-01-19
Type : Chemical
Substance Number : 848
Status : Valid
Certificate Number : R1-CEP 2009-317 - Rev 02
Issue Date : 2022-01-19
Type : Chemical
Substance Number : 848
Status : Valid
Certificate Number : R0-CEP 2009-380 - Rev 00
Issue Date : 2011-11-14
Type : Chemical
Substance Number : 848
Status : Withdrawn by Holder
A Sodium Fusidate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sodium Fusidate, including repackagers and relabelers. The FDA regulates Sodium Fusidate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sodium Fusidate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Sodium Fusidate supplier is an individual or a company that provides Sodium Fusidate active pharmaceutical ingredient (API) or Sodium Fusidate finished formulations upon request. The Sodium Fusidate suppliers may include Sodium Fusidate API manufacturers, exporters, distributors and traders.
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