LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
01 1LGM Pharma
02 2Bachem AG
03 1Fermion Oy
04 1Egis Pharmaceuticals PLC
05 2TAPI Technology & API Services
06 1Abbott Laboratories
07 1American Chemical Products
08 1Bajaj Healthcare
09 1DAITO CORP
10 1Daito Pharmaceutical
11 1Divis Laboratories
12 1Esteve Quimica
13 1Euroasia Trans Continental
14 1Everest Organics
15 1Glochem Industries
16 1Guangzhou Tosun Pharmaceutical
17 1Hetero Drugs
18 1Juzen Chemical Corporation
19 1Kraemer & Martin Pharma Handels GmbH DE 47804 Krefeld
20 1Maithri Drugs
21 1Nippon Kayaku
22 1Nishchem International Pvt. Ltd
23 1Otto Brandes
24 1Qingdao Qingmei Biotech
25 1R L Fine Chem
26 1Sato Yakuhin Kogyo Co., Ltd
27 1Shandong Xinhua Pharmaceutical
28 1Shodhana Laboratories Pvt. Ltd
29 1Sicor Societa Italiana Corticosteroidi Srl
30 1Smruthi Organics
31 1Solara Active Pharma Sciences
32 1Teva Pharmaceutical Industries
33 1Zhejiang Wild Wind Pharmaceutical Co
34 2Zhejiang Yongtai Technology
35 2Zhejiang chiral Medicine Chemicals Co
01 8China
02 1Finland
03 2Germany
04 1Hungary
05 12India
06 3Israel
07 1Italy
08 5Japan
09 1Spain
10 2Switzerland
11 3U.S.A
01 13Active
02 7Inactive
03 19Blank
01 1Expired
02 14Valid
03 1Withdrawn by EDQM Failure to CEP procedure
04 1Withdrawn by Holder
05 22Blank
01 1219MF10152
02 1220MF10226
03 1222MF10146
04 1222MF10178
05 1225MF10125
06 1226MF10233
07 1227MF10095
08 1227MF10242
09 31Blank
01 1WC-0030
02 38Blank
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-07-11
Pay. Date : 2013-06-17
DMF Number : 9231
Submission : 1991-07-11
Status : Active
Type : II
Certificate Number : R1-CEP 2000-012 - Rev 08
Issue Date : 2019-12-16
Type : Chemical
Substance Number : 755
Status : Valid
Registration Number : 222MF10146
Registrant's Address : Route du simplon 22, CH-1895 Vionnaz-Switzerland
Initial Date of Registration : 2010-04-22
Latest Date of Registration : --
NDC Package Code : 51504-0001
Start Marketing Date : 1991-07-11
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2021-03-03
Registration Number : 20210303-211-J-655
Manufacturer Name : Bachem SA
Manufacturer Address : Succursale of Vionnaz, Route du Simplon 22, 1895 Vionnaz, Switzerland
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-11-20
Pay. Date : 2013-05-10
DMF Number : 26416
Submission : 2012-09-14
Status : Active
Type : II
Certificate Number : CEP 2011-275 - Rev 02
Issue Date : 2024-09-25
Type : Chemical
Substance Number : 755
Status : Valid
NDC Package Code : 12780-4420
Start Marketing Date : 2011-06-28
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Alvogen Korea Co., Ltd.
Registration Date : 2022-01-10
Registration Number : 20220110-211-J-1205
Manufacturer Name : Fermion Oy, Hanko plant
Manufacturer Address : Orioninkatu 2, Hanko, FI-10900, Finland
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Registration Number : 220MF10226
Registrant's Address : H-1106 BUDAPEST KERESZTURI UT 30-38 HUNGARY
Initial Date of Registration : 2008-11-10
Latest Date of Registration : --
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 : 2012-11-29
Pay. Date : 2012-11-13
DMF Number : 8296
Submission : 1989-11-14
Status : Active
Type : II
Certificate Number : R1-CEP 2002-052 - Rev 08
Issue Date : 2022-11-23
Type : Chemical
Substance Number : 755
Status : Valid
NDC Package Code : 15894-0040
Start Marketing Date : 2023-02-23
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Available Reg Filing : CA, ASMF |
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
Certificate Number : R0-CEP 2020-364 - Rev 00
Issue Date : 2021-06-22
Type : Chemical
Substance Number : 755
Status : Valid
NDC Package Code : 51504-0001
Start Marketing Date : 1991-07-11
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2021-03-03
Registration Number : 20210303-211-J-655
Manufacturer Name : Bachem SA
Manufacturer Address : Succursale of Vionnaz, Route du Simplon 22, 1895 Vionnaz, Switzerland
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 : 2012-11-29
Pay. Date : 2012-11-13
DMF Number : 8656
Submission : 1990-07-11
Status : Active
Type : II
Certificate Number : R1-CEP 2001-352 - Rev 08
Issue Date : 2023-07-31
Type : Chemical
Substance Number : 755
Status : Valid
NDC Package Code : 15894-0040
Start Marketing Date : 2023-02-23
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Available Reg Filing : CA, ASMF |
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-02-01
Pay. Date : 2023-12-05
DMF Number : 37758
Submission : 2023-11-17
Status : Active
Type : II
Certificate Number : CEP 2024-003 - Rev 00
Issue Date : 2024-03-19
Type : Chemical
Substance Number : 755
Status : Valid
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-05-21
Pay. Date : 2012-12-12
DMF Number : 19899
Submission : 2006-10-16
Status : Active
Type : II
Certificate Number : R1-CEP 2007-067 - Rev 06
Issue Date : 2023-08-30
Type : Chemical
Substance Number : 755
Status : Valid
NDC Package Code : 67628-2001
Start Marketing Date : 2013-08-09
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2023-05-11
Registration Number : 20230511-211-J-1484
Manufacturer Name : Zhejiang Chiral Medicine Chemicals Co., Ltd@(주)국전약품
Manufacturer Address : Nanyang Economy Development Zone, Xiaoshan, Hangzhou, Zhejiang Province, China@8 Balan Industrial Complex Road, Hyangnam-eup, Hwaseong-si, Gyeonggi-do
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22424
Submission : 2008-12-10
Status : Active
Type : II
Certificate Number : R1-CEP 2009-073 - Rev 01
Issue Date : 2018-04-19
Type : Chemical
Substance Number : 755
Status : Valid
Registration Number : 226MF10233
Registrant's Address : Beijing Industrial Zone, Geshan Town, Dongyang, Zhejiang Province, China
Initial Date of Registration : 2014-12-08
Latest Date of Registration : --
Registrant Name : Masung LS Co., Ltd.
Registration Date : 2023-11-23
Registration Number : 20231123-211-J-1574
Manufacturer Name : Zhejiang Wild Wind Pharmaceutical Co., Ltd
Manufacturer Address : Beijiang Industrial Zone, Geshan Town, Dongyang City, Zhejiang Province, China
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-06-19
Pay. Date : 2012-12-31
DMF Number : 26734
Submission : 2013-01-07
Status : Active
Type : II
Certificate Number : R1-CEP 2014-126 - Rev 01
Issue Date : 2023-08-30
Type : Chemical
Substance Number : 755
Status : Valid
NDC Package Code : 67628-2001
Start Marketing Date : 2013-08-09
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2023-05-11
Registration Number : 20230511-211-J-1484
Manufacturer Name : Zhejiang Chiral Medicine Chemicals Co., Ltd@(주)국전약품
Manufacturer Address : Nanyang Economy Development Zone, Xiaoshan, Hangzhou, Zhejiang Province, China@8 Balan Industrial Complex Road, Hyangnam-eup, Hwaseong-si, Gyeonggi-do
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-09-27
Pay. Date : 2022-08-03
DMF Number : 37354
Submission : 2022-08-19
Status : Active
Type : II
Certificate Number : CEP 2022-358 - Rev 00
Issue Date : 2023-09-18
Type : Chemical
Substance Number : 755
Status : Valid
NDC Package Code : 65977-0131
Start Marketing Date : 1982-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-11-23
Pay. Date : 2012-12-06
DMF Number : 17846
Submission : 2004-11-20
Status : Active
Type : II
Certificate Number : R1-CEP 2005-057 - Rev 05
Issue Date : 2021-11-22
Type : Chemical
Substance Number : 755
Status : Valid
Registration Number : 225MF10125
Registrant's Address : 1-72/23(P)/DIVIS/303, Divi Towers, Cyber Hills, Gachibowli, Hyderabad-500 032, Telangana, India.
Initial Date of Registration : 2013-07-02
Latest Date of Registration : --
Date of Issue : 2019-06-17
Valid Till : 2022-06-16
Written Confirmation Number : WC-0030
Address of the Firm :
NDC Package Code : 62331-014
Start Marketing Date : 2004-03-29
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2020-03-12
Registration Number : 20180816-211-J-254(2)
Manufacturer Name : Divi's Laboratories Limited
Manufacturer Address : Chippada Village Annavaram Post Bheemunipatnam Mandal Visakhapatnam District - 531 162 Andhra Pradesh, India
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35521
Submission : 2020-12-31
Status : Active
Type : II
Certificate Number : R0-CEP 2020-143 - Rev 00
Issue Date : 2021-06-11
Type : Chemical
Substance Number : 755
Status : Valid
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-04-20
Pay. Date : 2017-12-04
DMF Number : 27430
Submission : 2013-07-23
Status : Active
Type : II
Certificate Number : R1-CEP 2016-052 - Rev 00
Issue Date : 2022-04-20
Type : Chemical
Substance Number : 755
Status : Valid
Registration Number : 227MF10242
Registrant's Address : No. 14, Dongyi Road, Zhangdian Zibo, Shandong, P. R. China
Initial Date of Registration : 2015-10-07
Latest Date of Registration : --
NDC Package Code : 58624-0621
Start Marketing Date : 1984-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-03-10
Pay. Date : 2013-12-06
DMF Number : 25563
Submission : 2011-12-07
Status : Active
Type : II
Certificate Number : R0-CEP 2010-338 - Rev 02
Issue Date : 2015-05-06
Type : Chemical
Substance Number : 755
Status : Expired
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9061
Submission : 1991-04-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8127
Submission : 1989-07-05
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11246
Submission : 1994-12-08
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7063
Submission : 1987-06-22
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9433
Submission : 1991-11-27
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18245
Submission : 2005-04-05
Status : Inactive
Type : II
Certificate Number : R0-CEP 2006-138 - Rev 01
Issue Date : 2009-11-26
Type : Chemical
Substance Number : 755
Status : Withdrawn by EDQM F...
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7361
Submission : 1988-02-29
Status : Inactive
Type : II
Certificate Number : R0-CEP 2006-066 - Rev 00
Issue Date : 2007-06-21
Type : Chemical
Substance Number : 755
Status : Withdrawn by Holder
Certificate Number : CEP 2024-034 - Rev 00
Issue Date : 2024-03-25
Type : Chemical
Substance Number : 755
Status : Valid
A Carbidopa manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Carbidopa, including repackagers and relabelers. The FDA regulates Carbidopa manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Carbidopa 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 Carbidopa supplier is an individual or a company that provides Carbidopa active pharmaceutical ingredient (API) or Carbidopa finished formulations upon request. The Carbidopa suppliers may include Carbidopa API manufacturers, exporters, distributors and traders.
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