Curia - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.

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01 1218MF10153
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01 120200714-210-J-587
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01 114593-851
02 117223-0003
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Curia - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-11-18
Pay. Date : 2013-10-25
DMF Number : 20760
Submission : 2007-08-07
Status : Active
Type : II
NDC Package Code : 55486-1607
Start Marketing Date : 2015-03-23
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
| Available Reg Filing : ASMF |
Lundbeck CDM has decades of experience in development and production services related to APIs and custom manufacturing services.
NDC Package Code : 45562-1124
Start Marketing Date : 2005-12-14
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : DRUG FOR FURTHER PROCESSING
Curia - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.
NDC Package Code : 55486-1582
Start Marketing Date : 2012-06-03
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
| Available Reg Filing : ASMF |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 42426
Submission : 2025-08-15
Status : Active
Type : II

GDUFA
DMF Review : Reviewed
Rev. Date : 2013-07-12
Pay. Date : 2013-03-26
DMF Number : 25400
Submission : 2011-10-27
Status : Active
Type : II

GDUFA
DMF Review : Reviewed
Rev. Date : 2014-12-15
Pay. Date : 2014-11-28
DMF Number : 28030
Submission : 2014-05-15
Status : Active
Type : II

GDUFA
DMF Review : Reviewed
Rev. Date : 2021-10-01
Pay. Date : 2021-04-14
DMF Number : 35491
Submission : 2020-12-26
Status : Active
Type : II
Registration Number : 305MF10140
Registrant's Address : Building C25-C28, No. 218 Xinghu Road, Suzhou Industrial Park, Suzhou, Jiangsu, China 215123
Initial Date of Registration : 2023-12-22
Latest Date of Registration :
NDC Package Code : 62227-015
Start Marketing Date : 2018-01-30
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (2kg/2kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Otran Korea Co., Ltd.
Registration Date : 2025-04-30
Registration Number : 20250430-210-J-1853
Manufacturer Name : BrightGene Pharmaceutical Co.,Ltd.
Manufacturer Address : Building C25-C28, No.218 Xinghu Road, Suzhou Industrial Park, Suzhou, Jiangsu 215123, China

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31131
Submission : 2016-12-05
Status : Active
Type : II
NDC Package Code : 17223-0003
Start Marketing Date : 2014-07-16
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7801
Submission : 1988-12-08
Status : Inactive
Type : II
Registrant Name : Tanabe Pharma Korea Co., Ltd.
Registration Date : 2022-01-21
Registration Number : 20220121-210-J-1219
Manufacturer Name : Mitsubishi Tanabe Pharma Factory Ltd., Onoda Plant
Manufacturer Address : 7473-2, Ooaza Onoda, SanyoOnoda,Yamaguchi, 756-0054, Japan

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22935
Submission : 2009-07-10
Status : Inactive
Type : II

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PharmaCompass offers a list of Argatroban API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Argatroban manufacturer or Argatroban supplier for your needs.
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A Acova manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Acova, including repackagers and relabelers. The FDA regulates Acova manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Acova 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 Acova manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Acova supplier is an individual or a company that provides Acova active pharmaceutical ingredient (API) or Acova finished formulations upon request. The Acova suppliers may include Acova API manufacturers, exporters, distributors and traders.
click here to find a list of Acova suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
We have 21 companies offering Acova
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