Fishfa Biogenics: Renowned Manufacturer, & Exporter of Tacrolimus & Mupirocin API.
01 1Fishfa Biogenics
02 1ChemWerth Inc
03 1AbbVie Inc
04 1Shanghai Minbiotech
05 4TAPI Technology & API Services
06 1Actavis Inc
07 1Apotex Fermentation Inc.
08 1Apotex Pharmachem
09 1CKD Bio Corporation
10 2Catalent Pharma Solutions
11 1Concord Biotech
12 2Curia
13 1Fujian Kerui Pharmaceutical Co Ltd
14 1GALENA AS
15 1Guangzhou Topwork Chemical
16 1Guangzhou Tosun Pharmaceutical
17 1Hangzhou Longshine Bio-Tech
18 1Hangzhou Zhongmei Huadong Pharmaceutical
19 1JOYANG LABORATORIES
20 2North China Pharmaceutical Co., Ltd.
21 1North China Pharmaceutical Huasheng Co Ltd
22 1Novartis Pharmaceuticals Corporation
23 1Ruibang Laboratories
24 1Sandoz B2B
25 1TAISHAN CITY CHEMICAL PHARMACEUTICAL CO., LTD. CN 529 200
26 1Tecoland Corporation
27 1Teva Pharmaceutical Industries
28 1Unipex
29 2Zhejiang Ruibang Laboratories
01 2Canada
02 14China
03 1Czech Republic
04 1France
05 2India
06 1Ireland
07 5Israel
08 1South Korea
09 2Switzerland
10 7U.S.A
01 14Active
02 9Inactive
03 13Blank
01 8Valid
02 1Withdrawn by EDQM Failure to CEP procedure
03 2Withdrawn by Holder
04 25Blank
01 1217MF11017
02 1218MF10617
03 1220MF10190
04 1222MF10083
05 1226MF10056
06 1302MF10130
07 1305MF10032
08 1305MF10106
09 1305MF10110
10 27Blank
01 1WC-0111
02 35Blank
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13800
Submission : 1998-09-01
Status : Active
Type : II
Certificate Number : R1-CEP 1998-093 - Rev 07
Issue Date : 2020-10-09
Type : Chemical and TSE
Substance Number : 994
Status : Valid
NDC Package Code : 0074-5503
Start Marketing Date : 2010-05-24
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : AbbVie Korea Inc.
Registration Date : 2005-08-31
Registration Number : 20050831-18-C-100-05
Manufacturer Name : AbbVie Inc.
Manufacturer Address : 1401 Sheridan Road, North Chicago, IL, 60064-4000, USA
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
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 : 2012-11-07
DMF Number : 12932
Submission : 1998-04-02
Status : Active
Type : II
Certificate Number : R1-CEP 2002-152 - Rev 06
Issue Date : 2023-06-21
Type : Chemical
Substance Number : 994
Status : Valid
Registration Number : 305MF10110
Registrant's Address : Ostravska 305/29, Komarov, 747 70 Opava, Czech Republic
Initial Date of Registration : 2023-09-20
Latest Date of Registration : --
Available Reg Filing : ASMF, CA |
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13799
Submission : 1998-09-01
Status : Active
Type : II
Certificate Number : R1-CEP 1997-045 - Rev 05
Issue Date : 2017-11-02
Type : Chemical
Substance Number : 994
Status : Withdrawn by Holder
Registration Number : 305MF10106
Registrant's Address : Ostravska 305/29, Komarov, 747 70 Opava, Czech Republic
Initial Date of Registration : 2023-09-06
Latest Date of Registration : --
Available Reg Filing : ASMF, CA |
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 : 2015-12-18
Pay. Date : 2015-07-22
DMF Number : 29557
Submission : 2015-07-30
Status : Active
Type : II
Registration Number : 220MF10190
Registrant's Address : Ostravska 305/29, Komarov, 747 70 Opava, Czech Republic
Initial Date of Registration : 2008-08-18
Latest Date of Registration : --
Available Reg Filing : ASMF, CA |
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34642
Submission : 2020-03-11
Status : Active
Type : II
Available Reg Filing : ASMF, CA |
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-04-23
Pay. Date : 2015-01-07
DMF Number : 28512
Submission : 2014-12-03
Status : Active
Type : II
Certificate Number : R0-CEP 2020-144 - Rev 00
Issue Date : 2023-04-20
Type : Chemical and TSE
Substance Number : 994
Status : Valid
NDC Package Code : 66507-0001
Start Marketing Date : 2014-02-27
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-09-05
Pay. Date : 2013-04-08
DMF Number : 23962
Submission : 2010-07-08
Status : Active
Type : II
Certificate Number : R1-CEP 2010-214 - Rev 03
Issue Date : 2022-10-17
Type : Chemical
Substance Number : 994
Status : Valid
Registration Number : 226MF10056
Registrant's Address : 1482-1486, Trasad Road, Dholka, Dist. Ahmedabad-382225, Gujarat, INDIA
Initial Date of Registration : 2014-03-06
Latest Date of Registration : --
Date of Issue : 2019-09-23
Valid Till : 2022-07-02
Written Confirmation Number : WC-0111
Address of the Firm :
NDC Package Code : 68254-0008
Start Marketing Date : 2010-02-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1mg/mg)
Marketing Category : BULK INGREDIENT
Registrant Name : Novartis Korea Ltd.
Registration Date : 2024-07-30
Registration Number : 20120806-18-C-299-06(2)
Manufacturer Name : CONCORD BIOTECH LIMITED
Manufacturer Address : 1482-1486, Trasad Road, Dholka, District - Ahmedabad Pin Code - 387810, India
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-11-11
Pay. Date : 2014-05-08
DMF Number : 13929
Submission : 1999-01-04
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12214
Submission : 1996-10-25
Status : Active
Type : II
Certificate Number : R1-CEP 2007-251 - Rev 02
Issue Date : 2021-08-26
Type : Chemical
Substance Number : 994
Status : Valid
NDC Package Code : 52972-0027
Start Marketing Date : 1996-11-19
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Chong Kun Dang Bio Co., Ltd.
Registration Date : 2019-07-02
Registration Number : 20190702-18-C-381-08
Manufacturer Name : Chong Kun Dang Bio Co., Ltd. @ Chong Kun Dang Bio Co., Ltd.
Manufacturer Address : 226, 101ho, 2-1dong, 3-1dong, 4dong, Sandan 3-gil, Sapgyo-eup, Yesan-gun, Chungcheongnam-do @ 292 Sinwon-ro, Danwon-gu, Ansan-si, Gyeonggi-do.
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-03-03
Pay. Date : 2014-02-19
DMF Number : 18932
Submission : 2005-09-06
Status : Active
Type : II
Certificate Number : CEP 2003-105 - Rev 03
Issue Date : 2024-06-19
Type : Chemical and TSE
Substance Number : 994
Status : Valid
Registration Number : 217MF11017
Registrant's Address : Xiangfu Bridge, No. 866 Morganshan Road, Hangzhou, Zhejiang, People's Republic of China 310011
Initial Date of Registration : 2005-11-21
Latest Date of Registration : --
NDC Package Code : 65897-1008
Start Marketing Date : 2013-01-24
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33946
Submission : 2019-06-15
Status : Active
Type : II
Registration Number : 305MF10032
Registrant's Address : No. 8 Yangzi Road, Shijiazhuang, Economic & Technical Development Zone, Hebei 052160, China
Initial Date of Registration : 2023-03-07
Latest Date of Registration : --
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-01-16
Pay. Date : 2013-12-02
DMF Number : 12949
Submission : 1998-04-13
Status : Active
Type : II
Certificate Number : R1-CEP 1999-034 - Rev 06
Issue Date : 2021-08-30
Type : Chemical
Substance Number : 994
Status : Valid
Registration Number : 218MF10617
Registrant's Address : Via del Vecchio Politecnico n. 9, 20121 Milano (MI) - Italy
Initial Date of Registration : 2006-07-03
Latest Date of Registration : --
NDC Package Code : 55486-1567
Start Marketing Date : 2012-06-03
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : AbbVie Korea Inc.
Registration Date : 2015-06-18
Registration Number : 20150618-18-C-338-07
Manufacturer Name : Curia Italy Srl
Manufacturer Address : Via Volturno, 41/43 - 20089 ROZZANO (MI), Italy
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-07-14
Pay. Date : 2021-11-03
DMF Number : 36385
Submission : 2021-10-14
Status : Active
Type : II
NDC Package Code : 55486-1567
Start Marketing Date : 2012-06-03
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : AbbVie Korea Inc.
Registration Date : 2015-06-18
Registration Number : 20150618-18-C-338-07
Manufacturer Name : Curia Italy Srl
Manufacturer Address : Via Volturno, 41/43 - 20089 ROZZANO (MI), Italy
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-01-16
Pay. Date : 2013-12-12
DMF Number : 13789
Submission : 1998-09-01
Status : Active
Type : II
NDC Package Code : 59573-0001
Start Marketing Date : 2017-12-28
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31465
Submission : 2018-03-05
Status : Inactive
Type : II
NDC Package Code : 66507-0001
Start Marketing Date : 2014-02-27
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18279
Submission : 2005-04-13
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18987
Submission : 2005-11-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13858
Submission : 1998-11-23
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10281
Submission : 1993-06-08
Status : Inactive
Type : II
Certificate Number : CEP 2021-399 - Rev 00
Issue Date : 2024-02-20
Type : Chemical
Substance Number : 994
Status : Valid
NDC Package Code : 55500-0009
Start Marketing Date : 2019-06-28
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14315
Submission : 1998-07-01
Status : Inactive
Type : II
NDC Package Code : 55500-0009
Start Marketing Date : 2019-06-28
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15328
Submission : 2001-03-14
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11971
Submission : 1996-05-13
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11618
Submission : 1995-08-07
Status : Inactive
Type : II
Certificate Number : R0-CEP 2015-367 - Rev 00
Issue Date : 2017-11-27
Type : Chemical
Substance Number : 994
Status : Withdrawn by Holder
Certificate Number : R0-CEP 2006-223 - Rev 01
Issue Date : 2010-04-23
Type : Chemical
Substance Number : 994
Status : Withdrawn by EDQM F...
A Cyclosporine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cyclosporine, including repackagers and relabelers. The FDA regulates Cyclosporine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cyclosporine 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 Cyclosporine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cyclosporine supplier is an individual or a company that provides Cyclosporine active pharmaceutical ingredient (API) or Cyclosporine finished formulations upon request. The Cyclosporine suppliers may include Cyclosporine API manufacturers, exporters, distributors and traders.
click here to find a list of Cyclosporine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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