Capital Farma, a leading European pharmaceutical company focusing on the development & distribution of niche APIs & Pharma Services.
01 1Capital Farma
02 1Metrochem API Private Limited
03 1Cohance Lifesciences
04 1HRV Global Life Sciences
05 1Nortec Quimica
06 1TAPI Technology & API Services
07 2Ajinomoto Company
08 1Aurobindo Pharma Limited
09 1Credo Life Sciences
10 1Estechpharma
11 1Indena
12 2Johnson & Johnson Innovative Medicine
13 1Jubilant Generics
14 1Jubilant Pharmova
15 1Nanjing Bold Chemical
16 1Pellets Pharma Limited
17 1RANBAXY LABORATORIES LIMITED
18 2Sanochemia Pharmazeutika GmbH
19 3ScinoPharm Taiwan, Ltd
20 1Teva Pharmaceutical Industries
21 1Wuhan Shiji Pharmaceutical
22 1ZHEJIANG YIXIN PHARMACEUTICAL CO LTD
23 2Blank
01 2Austria
02 1Brazil
03 3China
04 9India
05 2Israel
06 1Italy
07 2Japan
08 1South Korea
09 1Spain
10 3Taiwan
11 2U.S.A
12 2Blank
01 7Active
02 8Inactive
03 14Blank
01 7Valid
02 1Withdrawn by Holder
03 21Blank
01 1230MF10065
02 1231MF10027
03 1231MF10054
04 1306MF10088
05 25Blank
01 1WC-0023
02 1WC-0092
03 27Blank
Capital Farma, a leading European pharmaceutical company focusing on the development & distribution of niche APIs & Pharma Services.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-12-05
Pay. Date : 2012-11-08
DMF Number : 18112
Submission : 2005-02-23
Status : Active
Type : II
Certificate Number : R1-CEP 2011-053 - Rev 02
Issue Date : 2020-02-20
Type : Chemical
Substance Number : 2366
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21934
Submission : 2008-09-02
Status : Active
Type : II
Certificate Number : CEP 2009-316 - Rev 03
Issue Date : 2024-10-30
Type : Chemical
Substance Number : 2366
Status : Valid
Registration Number : 306MF10088
Registrant's Address : Plot No. 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, INDIA.
Initial Date of Registration : 2024-07-03
Latest Date of Registration : --
Date of Issue : 2019-06-26
Valid Till : 2022-06-25
Written Confirmation Number : WC-0023
Address of the Firm :
NDC Package Code : 65862-487
Start Marketing Date : 2024-01-11
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Sungwoo Chemical Co., Ltd.
Registration Date : 2023-03-15
Registration Number : 20211015-209-J-1014(1)
Manufacturer Name : Aurobindo Pharma Limited (Unit-XI)
Manufacturer Address : Unit-XI, Survey No, 1/22, 2/1 to 5,6 to 18, 61 to 69, Pydibhimavaram Village, Ranasthalam Mandal, Srikakulam Dist., Andhra Pradesh, India
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-08-24
Pay. Date : 2015-08-17
DMF Number : 17863
Submission : 2004-12-01
Status : Active
Type : II
Certificate Number : CEP 2011-011 - Rev 02
Issue Date : 2024-10-21
Type : Chemical
Substance Number : 2366
Status : Valid
Registration Number : 230MF10065
Registrant's Address : No. 1, Nan-Ke 8th Road, Shan-Hua, Tainan 741014, Taiwan
Initial Date of Registration : 2018-05-15
Latest Date of Registration : --
NDC Package Code : 65129-1113
Start Marketing Date : 2004-04-29
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Hyundai Pharmaceutical Co., Ltd.
Registration Date : 2021-10-12
Registration Number : 20211012-209-J-1119
Manufacturer Name : ScinoPharm Taiwan, Ltd.
Manufacturer Address : No. 1, Nan-Ke 8th Road, Shan-Hua, Tainan 74144, Taiwan
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27564
Submission : 2013-12-30
Status : Active
Type : II
NDC Package Code : 65129-1113
Start Marketing Date : 2004-04-29
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Hyundai Pharmaceutical Co., Ltd.
Registration Date : 2021-10-12
Registration Number : 20211012-209-J-1119
Manufacturer Name : ScinoPharm Taiwan, Ltd.
Manufacturer Address : No. 1, Nan-Ke 8th Road, Shan-Hua, Tainan 74144, Taiwan
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17972
Submission : 2005-01-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26643
Submission : 2012-11-26
Status : Active
Type : II
Certificate Number : CEP 2023-389 - Rev 00
Issue Date : 2024-06-19
Type : Chemical
Substance Number : 2366
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21989
Submission : 2008-11-26
Status : Active
Type : II
Certificate Number : R1-CEP 2011-123 - Rev 02
Issue Date : 2022-08-12
Type : Chemical
Substance Number : 2366
Status : Valid
Registration Number : 231MF10054
Registrant's Address : 1A, Sector 16A, Noida 201 301, Uttar Pradesh, India
Initial Date of Registration : 2019-02-21
Latest Date of Registration : --
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14425
Submission : 1999-09-29
Status : Inactive
Type : II
Certificate Number : R1-CEP 2012-248 - Rev 01
Issue Date : 2021-11-19
Type : Chemical
Substance Number : 2366
Status : Valid
NDC Package Code : 12578-890
Start Marketing Date : 2001-11-15
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Korea Janssen Co., Ltd.
Registration Date : 2021-06-10
Registration Number : 20210610-209-J-538
Manufacturer Name : Janssen Pharmaceutica NV
Manufacturer Address : Jassen Pharmaceuticalaan 3, Geel, 2440, Belgium
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15384
Submission : 2001-05-08
Status : Inactive
Type : II
NDC Package Code : 12578-890
Start Marketing Date : 2001-11-15
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Korea Janssen Co., Ltd.
Registration Date : 2021-06-10
Registration Number : 20210610-209-J-538
Manufacturer Name : Janssen Pharmaceutica NV
Manufacturer Address : Jassen Pharmaceuticalaan 3, Geel, 2440, Belgium
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18114
Submission : 2005-02-22
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18045
Submission : 2005-01-28
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18152
Submission : 2005-03-03
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17967
Submission : 2005-01-03
Status : Inactive
Type : II
Date of Issue : 2022-09-01
Valid Till : 2024-11-04
Written Confirmation Number : WC-0092
Address of the Firm :
NDC Package Code : 65372-1138
Start Marketing Date : 2008-11-28
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Certificate Number : R1-CEP 2011-288 - Rev 01
Issue Date : 2020-11-19
Type : Chemical
Substance Number : 2366
Status : Valid
Registration Number : 231MF10027
Registrant's Address : Ostravska 305/29, Komarov, 747 70 Opava, Czech Republic
Initial Date of Registration : 2019-02-05
Latest Date of Registration : --
NDC Package Code : 47848-023
Start Marketing Date : 2022-01-26
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (100kg/100kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2021-05-10
Registration Number : 20210510-209-J-776
Manufacturer Name : Teva Czech Industries sro
Manufacturer Address : Ostravska 305/29, Komarov 747 70 Opava, Czech Republic.
NDC Package Code : 65129-1113
Start Marketing Date : 2004-04-29
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Hyundai Pharmaceutical Co., Ltd.
Registration Date : 2021-10-12
Registration Number : 20211012-209-J-1119
Manufacturer Name : ScinoPharm Taiwan, Ltd.
Manufacturer Address : No. 1, Nan-Ke 8th Road, Shan-Hua, Tainan 74144, Taiwan
Certificate Number : R1-CEP 2012-328 - Rev 00
Issue Date : 2019-03-07
Type : Chemical
Substance Number : 2366
Status : Withdrawn by Holder
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 : 19134
Submission : 2006-01-22
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 : 21088
Submission : 2007-11-15
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
A Galantamine Hydrobromide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Galantamine Hydrobromide, including repackagers and relabelers. The FDA regulates Galantamine Hydrobromide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Galantamine Hydrobromide 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 Galantamine Hydrobromide supplier is an individual or a company that provides Galantamine Hydrobromide active pharmaceutical ingredient (API) or Galantamine Hydrobromide finished formulations upon request. The Galantamine Hydrobromide suppliers may include Galantamine Hydrobromide API manufacturers, exporters, distributors and traders.
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