Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
01 1Chunghwa Chemical Synthesis & Biotech
02 1TAPI Technology & API Services
03 1Apotex Pharmachem
04 2Biocon
05 1Chongqing DaXin Pharmaceutical
06 1Concord Biotech
07 1DEAFARMA
08 2Daiichi Sankyo
09 2Guangdong Blue Treasure Pharmaceutical Co. Ltd.
10 1Kyowa Hakko Bio
11 2Lek Pharmaceuticals
12 1Livzon Group Fuzhou Fuxing Pharmaceutical Co., Ltd.
13 1Livzon New North River Pharmaceutical
14 1RANBAXY LABORATORIES LIMITED
15 1Teva Pharmaceutical Industries
16 2Tianwei Biotech Group
17 1Tocopharm Co. Limited
18 1Vitalpharms
19 3Zhejiang Hisun Pharmaceutical
01 1Canada
02 12China
03 4India
04 2Israel
05 1Italy
06 3Japan
07 2Slovenia
08 1Taiwan
01 7Active
02 9Inactive
03 10Blank
01 1Expired
02 8Valid
03 3Withdrawn by Holder
04 14Blank
01 1218MF10474
02 1218MF10727
03 1219MF10113
04 1219MF10201
05 1223MF10038
06 1223MF10039
07 1229MF10176
08 1231MF10011
09 1306MF10030
10 17Blank
01 1WC-0100N1
02 1WC-0109A
03 1WC-0111
04 23Blank
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 : 14235
Submission : 1999-06-24
Status : Active
Type : II
Certificate Number : R1-CEP 2004-168 - Rev 01
Issue Date : 2021-03-04
Type : Chemical and TSE
Substance Number : 2059
Status : Valid
Registration Number : 218MF10474
Registrant's Address : No. 1, Tung-Hsing St. , Shu-Lin, New Taipei City 23850, Taiwan
Initial Date of Registration : 2006-04-27
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 : 2012-12-24
Pay. Date : 2012-11-13
DMF Number : 14729
Submission : 2000-02-25
Status : Active
Type : II
Registration Number : 218MF10727
Registrant's Address : 13 Pallagi u(´)t, Debrecen, 4042-Hungary
Initial Date of Registration : 2006-09-06
Latest Date of Registration : --
Available Reg Filing : ASMF |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20727
Submission : 2007-08-16
Status : Active
Type : II
Certificate Number : R1-CEP 2010-018 - Rev 01
Issue Date : 2017-10-31
Type : Chemical
Substance Number : 2059
Status : Valid
Date of Issue : 2019-09-23
Valid Till : 2022-07-02
Written Confirmation Number : WC-0111
Address of the Firm :
NDC Package Code : 68254-0004
Start Marketing Date : 2008-11-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-07-07
Pay. Date : 2014-05-06
DMF Number : 27615
Submission : 2013-10-21
Status : Active
Type : II
NDC Package Code : 58623-0123
Start Marketing Date : 2018-05-04
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2022-06-07
Registration Number : 20220607-70-B-464-09
Manufacturer Name : Zhejiang Hisun Pharmaceutical Co., Ltd.
Manufacturer Address : No.56, Binhai Road, Jiaojiang District, Taizhou City, Zhejiang Province, China
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17023
Submission : 2003-12-11
Status : Active
Type : II
Certificate Number : R1-CEP 2003-101 - Rev 04
Issue Date : 2019-11-05
Type : Chemical
Substance Number : 2059
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16048
Submission : 2002-07-12
Status : Active
Type : II
Certificate Number : CEP 2004-085 - Rev 06
Issue Date : 2024-12-02
Type : Chemical
Substance Number : 2059
Status : Valid
Registration Number : 223MF10038
Registrant's Address : 20th KM Hosur Road, Electronics City, Bengaluru-560 100, Karnataka, India.
Initial Date of Registration : 2011-03-10
Latest Date of Registration : --
Date of Issue : 2022-05-06
Valid Till : 2025-07-02
Written Confirmation Number : WC-0100N1
Address of the Firm :
NDC Package Code : 65727-003
Start Marketing Date : 2005-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2020-02-06
Registration Number : 20151015-70-B-379-08(1)
Manufacturer Name : Biocon Limited
Manufacturer Address : Plot No. 2,3,4 & 5, Phase-IV, Bommasandra Jigani Link Road, Bommasandra Post Bengaluru-560 099, India
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-03-03
Pay. Date : 2014-02-21
DMF Number : 17447
Submission : 2004-06-03
Status : Active
Type : II
Certificate Number : R1-CEP 2002-177 - Rev 02
Issue Date : 2013-06-13
Type : Chemical
Substance Number : 2059
Status : Valid
Registration Number : 223MF10039
Registrant's Address : 20th K. M. Hosur Road, Electronics City-560100, Bangalore, India
Initial Date of Registration : 2011-03-10
Latest Date of Registration : --
Date of Issue : 2022-04-13
Valid Till : 2025-07-02
Written Confirmation Number : WC-0109A
Address of the Firm :
NDC Package Code : 65727-003
Start Marketing Date : 2005-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2020-02-06
Registration Number : 20151015-70-B-379-08(1)
Manufacturer Name : Biocon Limited
Manufacturer Address : Plot No. 2,3,4 & 5, Phase-IV, Bommasandra Jigani Link Road, Bommasandra Post Bengaluru-560 099, India
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16309
Submission : 2002-12-13
Status : Inactive
Type : II
Certificate Number : R1-CEP 2002-009 - Rev 02
Issue Date : 2021-03-17
Type : Chemical
Substance Number : 2059
Status : Valid
NDC Package Code : 58623-0123
Start Marketing Date : 2018-05-04
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2022-06-07
Registration Number : 20220607-70-B-464-09
Manufacturer Name : Zhejiang Hisun Pharmaceutical Co., Ltd.
Manufacturer Address : No.56, Binhai Road, Jiaojiang District, Taizhou City, Zhejiang Province, China
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18709
Submission : 2005-08-24
Status : Inactive
Type : II
NDC Package Code : 58623-0123
Start Marketing Date : 2018-05-04
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2022-06-07
Registration Number : 20220607-70-B-464-09
Manufacturer Name : Zhejiang Hisun Pharmaceutical Co., Ltd.
Manufacturer Address : No.56, Binhai Road, Jiaojiang District, Taizhou City, Zhejiang Province, China
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16031
Submission : 2002-06-26
Status : Inactive
Type : II
Certificate Number : R1-CEP 2003-230 - Rev 00
Issue Date : 2009-12-14
Type : Chemical
Substance Number : 2059
Status : Withdrawn by Holder
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16975
Submission : 2003-11-20
Status : Inactive
Type : II
Certificate Number : R0-CEP 2005-016 - Rev 02
Issue Date : 2009-11-19
Type : Chemical
Substance Number : 2059
Status : Expired
Registration Number : 219MF10201
Registrant's Address : 1-6-1 Otemachi, Chiyoda-ku, Tokyo
Initial Date of Registration : 2007-06-13
Latest Date of Registration : --
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5968
Submission : 1985-08-29
Status : Inactive
Type : II
Certificate Number : R1-CEP 2003-122 - Rev 05
Issue Date : 2016-06-14
Type : Chemical
Substance Number : 2059
Status : Valid
Registrant Name : HKINNOEN Co., Ltd.
Registration Date : 2005-08-31
Registration Number : 20050831-70-B-192-07
Manufacturer Name : Daiichi Sankyo Chemical Pharma Co., Ltd.
Manufacturer Address : 389-4 Izumimachi Shimokawa, Aza-ohtsurugi, Iwaki, Fukushima 971-8183, Japan
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7568
Submission : 1988-07-11
Status : Inactive
Type : II
Registrant Name : HKINNOEN Co., Ltd.
Registration Date : 2005-08-31
Registration Number : 20050831-70-B-192-07
Manufacturer Name : Daiichi Sankyo Chemical Pharma Co., Ltd.
Manufacturer Address : 389-4 Izumimachi Shimokawa, Aza-ohtsurugi, Iwaki, Fukushima 971-8183, Japan
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18580
Submission : 2005-08-11
Status : Inactive
Type : II
Certificate Number : R1-CEP 2006-167 - Rev 00
Issue Date : 2013-08-21
Type : Chemical
Substance Number : 2059
Status : Withdrawn by Holder
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15922
Submission : 2002-04-03
Status : Inactive
Type : II
Certificate Number : R1-CEP 2003-025 - Rev 00
Issue Date : 2009-04-14
Type : Chemical
Substance Number : 2059
Status : Withdrawn by Holder
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16204
Submission : 2002-10-22
Status : Inactive
Type : II
Registration Number : 229MF10176
Registrant's Address : No. 4258 Jindu Road, Shanghai, China
Initial Date of Registration : 2017-09-07
Latest Date of Registration : --
Registration Number : 306MF10030
Registrant's Address : No. 44, Renmin One Road, Qingyuan, Guangdong Province, P. R. China
Initial Date of Registration : 2024-02-21
Latest Date of Registration : --
Registrant Name : Youngjin Pharmaceutical Co., Ltd.
Registration Date : 2014-07-04
Registration Number : 20140704-70-B-364-07
Manufacturer Name : Guangdong Blue Treasure Pharmaceuticals Co., Ltd.
Manufacturer Address : Renmin One Road, Qingyuan, Guangdong Province, China
Registration Number : 231MF10011
Registrant's Address : No. 44, Renmin One Road, Qingyuan, Guangdong Province, P. R. China
Initial Date of Registration : 2019-01-10
Latest Date of Registration : --
Registrant Name : Youngjin Pharmaceutical Co., Ltd.
Registration Date : 2014-07-04
Registration Number : 20140704-70-B-364-07
Manufacturer Name : Guangdong Blue Treasure Pharmaceuticals Co., Ltd.
Manufacturer Address : Renmin One Road, Qingyuan, Guangdong Province, China
Certificate Number : R1-CEP 2003-073 - Rev 03
Issue Date : 2022-02-25
Type : Chemical
Substance Number : 2059
Status : Valid
NDC Package Code : 51846-1022
Start Marketing Date : 2020-04-30
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (100kg/100kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Saehan Pharmaceutical Co., Ltd.
Registration Date : 2024-11-21
Registration Number : 20050831-70-B-191-06(A)
Manufacturer Name : Teva Pharmaceutical Works Private Limited Company
Manufacturer Address : Pallagi ut 13 Debrecen 4042, Hungary
Registration Number : 219MF10113
Registrant's Address : No. 4258 Jindu Road, Shanghai, China
Initial Date of Registration : 2007-03-23
Latest Date of Registration : --
A Pravastatin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pravastatin, including repackagers and relabelers. The FDA regulates Pravastatin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pravastatin 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 Pravastatin supplier is an individual or a company that provides Pravastatin active pharmaceutical ingredient (API) or Pravastatin finished formulations upon request. The Pravastatin suppliers may include Pravastatin API manufacturers, exporters, distributors and traders.
click here to find a list of Pravastatin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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