Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
01 3Chunghwa Chemical Synthesis & Biotech
02 1Fishfa Biogenics
03 1ChemWerth Inc
04 1LGM Pharma
05 1Metrochem API Private Limited
06 1Symbiotec Pharmalab
07 1DKSH
08 1Jai Radhe Sales
09 1HRV Global Life Sciences
10 1Octavius Pharma Pvt. Ltd
11 1Shanghai Minbiotech
12 1Farmhispania
13 1TAPI Technology & API Services
14 1Beijing Mesochem Technology
15 1ACS DOBFAR SPA
16 1Apotex Fermentation Inc.
17 1Astellas Pharma
18 1Bills Biotech
19 4Biocon
20 1BrightGene Bio-Medical Technology Co.,Ltd
21 1CKD Bio Corporation
22 1Cerata Pharmaceuticals
23 1Ceres F&D
24 2Concord Biotech
25 1Guangzhou Topwork Chemical
26 1Guangzhou Tosun Pharmaceutical
27 1Hangzhou Huadong Medicine Group Kangrun Pharmaceutical
28 1Hangzhou Zhongmei Huadong Pharmaceutical
29 1Hanways Chempharm
30 1Hubei Vanz Pharm
31 1JOYANG LABORATORIES
32 2Lek Pharmaceuticals
33 2Lunan Pharmaceutical
34 1Murli Krishna Pharma
35 1North China Pharmaceutical Co., Ltd.
36 1North China Pharmaceutical Huasheng Co Ltd
37 1Synthland
38 1Tecoland Corporation
39 1Teva Pharmaceutical Industries
40 1Viruj Pharmaceuticals Pvt Ltd
41 1Wuxi Fortune Pharmaceutical Co., Ltd
42 1Yacht Bio-Technology
43 2Zhejiang Hisun Pharmaceutical
44 1Zim Laboratories
45 1Blank
01 1Canada
02 19China
03 17India
04 2Israel
05 1Italy
06 1Japan
07 2Slovenia
08 2South Korea
09 1Spain
10 1Switzerland
11 3Taiwan
12 3U.S.A
13 1Blank
01 23Active
02 6Inactive
03 25Blank
01 11Valid
02 43Blank
01 1217MF11288
02 1222MF10197
03 1222MF10265
04 1224MF10125
05 1302MF10106
06 1306MF10114
07 48Blank
01 1WC-0109A
02 1WC-0111
03 1WC-0489
04 1WC-0529n
05 50Blank
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-04-01
Pay. Date : 2016-03-09
DMF Number : 18985
Submission : 2005-11-28
Status : Active
Type : II
Certificate Number : CEP 2018-241 - Rev 02
Issue Date : 2024-12-20
Type : Chemical
Substance Number : 2244
Status : Valid
Registration Number : 224MF10125
Registrant's Address : No. 1, Tung-Hsing St. , Shu-Lin, New Taipei City 23850, Taiwan
Initial Date of Registration : 2012-07-13
Latest Date of Registration : --
NDC Package Code : 52076-6222
Start Marketing Date : 2017-05-23
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Hwail Pharmaceutical Co., Ltd.
Registration Date : 2014-04-17
Registration Number : 20140417-204-I-289-08
Manufacturer Name : Chunghwa Chemical Synthesis & Biotech Co., Ltd. Shanjia Plant
Manufacturer Address : No.1, Tung-Hsing st., Shu-Lin, New Taipei City, Taiwan
Available Reg Filing : ASMF |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39667
Submission : 2024-03-19
Status : Active
Type : II
Date of Issue : 2022-06-13
Valid Till : 2025-06-12
Written Confirmation Number : WC-0529n
Address of the Firm :
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35852
Submission : 2021-04-23
Status : Active
Type : II
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 : 2014-10-20
Pay. Date : 2014-08-22
DMF Number : 28524
Submission : 2014-08-24
Status : Active
Type : II
Registration Number : 222MF10265
Registrant's Address : Ostravska 305/29, Komarov, 747 70 Opava, Czech Republic
Initial Date of Registration : 2010-12-08
Latest Date of Registration : --
Available Reg Filing : ASMF |
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23213
Submission : 2009-10-26
Status : Active
Type : II
Certificate Number : CEP 2023-345 - Rev 00
Issue Date : 2024-03-28
Type : Chemical
Substance Number : 2244
Status : Valid
NDC Package Code : 52076-6222
Start Marketing Date : 2017-05-23
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Hwail Pharmaceutical Co., Ltd.
Registration Date : 2014-04-17
Registration Number : 20140417-204-I-289-08
Manufacturer Name : Chunghwa Chemical Synthesis & Biotech Co., Ltd. Shanjia Plant
Manufacturer Address : No.1, Tung-Hsing st., Shu-Lin, New Taipei City, Taiwan
Available Reg Filing : ASMF |
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38310
Submission : 2023-04-26
Status : Active
Type : II
NDC Package Code : 52076-6222
Start Marketing Date : 2017-05-23
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Hwail Pharmaceutical Co., Ltd.
Registration Date : 2014-04-17
Registration Number : 20140417-204-I-289-08
Manufacturer Name : Chunghwa Chemical Synthesis & Biotech Co., Ltd. Shanjia Plant
Manufacturer Address : No.1, Tung-Hsing st., Shu-Lin, New Taipei City, Taiwan
Available Reg Filing : ASMF |
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-08-28
Pay. Date : 2013-08-16
DMF Number : 18908
Submission : 2005-10-24
Status : Active
Type : II
Certificate Number : R0-CEP 2018-216 - Rev 00
Issue Date : 2020-06-02
Type : Chemical
Substance Number : 2244
Status : Valid
Registration Number : 222MF10197
Registrant's Address : 1482-1486, Trasad Road, Dholka, Dist. Ahmedabad-382225, Gujarat, INDIA
Initial Date of Registration : 2010-07-13
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 : 68254-0002
Start Marketing Date : 2007-02-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Hanmi Pharmaceutical Co., Ltd.
Registration Date : 2012-05-25
Registration Number : 20120302-204-I-23-01(2)
Manufacturer Name : CONCORD BIOTECH LIMITED
Manufacturer Address : 1482-1486, Trasad Road, Dholka, District - Ahmedabad,382225
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-02-21
Pay. Date : 2016-12-29
DMF Number : 31225
Submission : 2016-12-03
Status : Active
Type : II
NDC Package Code : 65897-1010
Start Marketing Date : 2017-01-23
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 : 27626
Submission : 2013-09-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16833
Submission : 2003-09-12
Status : Active
Type : II
Registration Number : 217MF11288
Registrant's Address : 2-5-1 Nihonbashi Honcho, Chuo-ku, Tokyo
Initial Date of Registration : 2005-12-22
Latest Date of Registration : --
Registrant Name : Astellas Pharma Korea Co., Ltd.
Registration Date : 2012-08-07
Registration Number : 20120807-204-I-74-02
Manufacturer Name : Astellas Pharma Inc. Toyama Technology Center
Manufacturer Address : 2-178 Kojin-machi, Toyama city, Toyama 930-0809, Japan
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39816
Submission : 2024-06-25
Status : Active
Type : II
Certificate Number : CEP 2023-051 - Rev 00
Issue Date : 2024-09-26
Type : Chemical
Substance Number : 2244
Status : Valid
NDC Package Code : 65050-0321
Start Marketing Date : 2021-01-12
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38985
Submission : 2023-11-17
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-04-02
Pay. Date : 2021-03-19
DMF Number : 34270
Submission : 2020-03-25
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-05-28
Pay. Date : 2015-05-05
DMF Number : 19979
Submission : 2006-11-20
Status : Active
Type : II
Certificate Number : R0-CEP 2021-204 - Rev 01
Issue Date : 2023-08-07
Type : Chemical
Substance Number : 2244
Status : Valid
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-02-24
Pay. Date : 2020-12-03
DMF Number : 34063
Submission : 2020-08-06
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-10-01
Pay. Date : 2013-06-27
DMF Number : 27202
Submission : 2013-06-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34630
Submission : 2020-03-03
Status : Inactive
Type : II
Certificate Number : CEP 2021-210 - Rev 01
Issue Date : 2024-07-22
Type : Chemical and TSE
Substance Number : 2244
Status : Valid
NDC Package Code : 52928-006
Start Marketing Date : 2021-11-15
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Masung LS Co., Ltd.
Registration Date : 2023-11-15
Registration Number : 20231115-204-I-664-11
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 : 20390
Submission : 2007-03-26
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37982
Submission : 2023-02-05
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19072
Submission : 2005-12-22
Status : Inactive
Type : II
Certificate Number : CEP 2018-284 - Rev 02
Issue Date : 2024-10-28
Type : Chemical
Substance Number : 2244
Status : Valid
A Tacrolimus manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tacrolimus, including repackagers and relabelers. The FDA regulates Tacrolimus manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tacrolimus 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 Tacrolimus manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tacrolimus supplier is an individual or a company that provides Tacrolimus active pharmaceutical ingredient (API) or Tacrolimus finished formulations upon request. The Tacrolimus suppliers may include Tacrolimus API manufacturers, exporters, distributors and traders.
click here to find a list of Tacrolimus suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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