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List of all Manufacturers, Suppliers & Exporters of Dutasteride API listed on PharmaCompass with details of regulatory filings

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01 Hubei Gedian Humanwell Pharmaceutical (2)

02 Jai Radhe Sales (1)

03 Metrochem API Private Limited (1)

04 Gonane Pharma (1)

05 Dr. Reddy's Laboratories (1)

06 DKSH (1)

07 LGM Pharma (1)

08 HRV Global Life Sciences (1)

09 Aspen Biopharma Labs (1)

10 Aspire Lifesciences Pvt Ltd (2)

11 Aurobindo Pharma Limited (1)

12 Catalent Pharma Solutions (2)

13 Chongqing Huapont Pharmaceutical (1)

14 Cipla (1)

15 Credo Life Sciences (1)

16 Gador SA (1)

17 Guangzhou Tosun Pharmaceutical (1)

18 Hetero Drugs (2)

19 Ind Swift Laboratories Limited (1)

20 MSN Laboratories (2)

21 Maharshi Pharma Chem (1)

22 NEWEDGE Overseas (1)

23 PHF SA (1)

24 Pellets Pharma Limited (1)

25 Pellsys Pharma (1)

26 Reliance Life Sciences Private Limited (1)

27 Rumit Group of Companies (1)

28 Sakar Healthcare (1)

29 Sichuan Gowell Pharmaceutical (1)

30 Spansules Pharma (1)

31 Sterling Chemical Malta (1)

32 Sterling Spa (2)

33 Stermone Chemicals (1)

34 Swati Spentose (1)

35 Titan Laboratories (1)

36 Unimax Group (1)

37 Zhejiang Xianju Junye Pharmaceutical Co. LTD (1)

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01 Argentina (1)

02 China (6)

03 India (28)

04 Italy (2)

05 Malta (1)

06 Switzerland (2)

07 U.S.A (3)

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01 Active (9)

02 Inactive (8)

03 Blank (26)

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01 Valid (5)

02 Withdrawn by Holder (2)

03 Blank (36)

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01 229MF10186 (1)

02 230MF10024 (1)

03 230MF10161 (1)

04 231MF10024 (1)

05 231MF10062 (1)

06 302MF10123 (1)

07 Blank (37)

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01 WC-0017 (1)

02 WC-0021n (1)

03 WC-0034 (1)

04 WC-0041 (1)

05 WC-0142A4-5 (1)

06 WC-0419 (1)

07 Blank (37)

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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
26803
R0-CEP 2020-298 - Rev 01
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
DUTASTERIDE
Dutasteride, Non-micronised and mic...
Issue/Submission Date
2013-01-09
2021-07-05
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
Status
 
Filing Details
Issue/Submission Date
Jai Radhe Sales

Swiss Biotech Day

Not Confirmed

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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
Status
 
Filing Details
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

Found WC

Application Number
26475
Indian CDSCO WC-0034
Status
Active
Fees Paid
Reviewed
 
Valid
2025-06-16
Filing Details
DUTASTERIDE (PROCESS-II) USP
Dutasteride (IH)
Issue/Submission Date
2012-10-03
2022-06-15
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
Status
 
Filing Details
Issue/Submission Date
HRV Global Life Sciences Company Banner

Swiss Biotech Day

Not Confirmed

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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
27763
Status
Active
Fees Paid
N/A
 
Filing Details
DUTASTERIDE ACID
Issue/Submission Date
2013-12-16
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USDMF

Found USDMF

CEP/COS

Found CEP/COS

Japanese DMF

Found JDMF

Written Confirmation

Found WC

Application Number
23533
R1-CEP 2014-019 - Rev 00
230MF10024
Indian CDSCO WC-0021n
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-14
Filing Details
DUTASTERIDE USP [ROUTE CODE - "DT"]
Dutasteride
Dutasteride at Plot No: C-24, Sanat...
Dutasteride IH/USP/EP
Issue/Submission Date
2010-02-16
2020-08-31
2018-02-14
2022-06-17
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
33063
R1-CEP 2015-252 - Rev 00
Status
Active
Fees Paid
N/A
Withdrawn by Holder
 
Filing Details
DUTASTERIDE USP
Dutasteride, Route "DJ"
Issue/Submission Date
2018-08-06
2021-01-15
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USDMF

Found USDMF

CEP/COS

Found CEP/COS

Japanese DMF

Found JDMF

Written Confirmation

Found WC

Application Number
29577
CEP 2014-306 - Rev 01
231MF10062
Indian CDSCO WC-0017
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-06-10
Filing Details
DUTASTERIDE USP
Dutasteride
Dutasteride at Plot No. 2, Maitrivi...
Dutasteride (Ph.Eur.)
Issue/Submission Date
2015-07-31
2023-11-16
2019-03-04
2022-06-06
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USDMF

Found USDMF

CEP/COS

Found CEP/COS

Japanese DMF

Found JDMF

Written Confirmation

Found WC

Application Number
27774
R1-CEP 2016-126 - Rev 00
231MF10024
Indian CDSCO WC-0041
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-08-08
Filing Details
DUTASTERIDE
Dutasteride
Dutasteride "K" at 7-2-A2,Hetero Co...
Dutasteride (IH/USP/Ph. Eur)
Issue/Submission Date
2013-12-11
2022-07-26
2019-02-05
2022-09-16
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USDMF

Found USDMF

CEP/COS

Found CEP/COS

Japanese DMF

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Written Confirmation

Close WC

Application Number
20918
CEP 2015-258 - Rev 01
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
DUTASTERIDE
Dutasteride, Form I
Issue/Submission Date
2007-10-08
2024-02-06
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
30143
Status
Active
Fees Paid
N/A
 
Filing Details
DUTASTERIDE FORM I
Issue/Submission Date
2015-12-23
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
24880
Status
Inactive
Fees Paid
N/A
 
Filing Details
DUTASTERIDE
Issue/Submission Date
2011-07-29
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
14643
Status
Inactive
Fees Paid
N/A
 
Filing Details
DUTASTERIDE SOFT GELATIN CAPSULES ....
Issue/Submission Date
1999-12-22
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USDMF

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CEP/COS

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Application Number
24304
Status
Inactive
Fees Paid
N/A
 
Filing Details
DUTASTERIDE 0.5 MG SOFT GELATIN CAP...
Issue/Submission Date
2010-10-19
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

Caution WC

Application Number
20180
R0-CEP 2015-050 - Rev 00
Indian CDSCO WC-0142A4-5
Status
Inactive
Fees Paid
N/A
Withdrawn by Holder
 
Expired
2022-08-04
Filing Details
DUTASTERIDE
Dutasteride
Dutasteride IH
Issue/Submission Date
2009-05-06
2017-06-15
2022-03-11
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
23494
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
DUTASTERIDE
Issue/Submission Date
2010-04-30
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USDMF

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Application Number
27011
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
DUTASTERIDE, NON-STERILE, BULK DRUG...
Issue/Submission Date
2013-03-26
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USDMF

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CEP/COS

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Written Confirmation

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Application Number
27788
Status
Inactive
Fees Paid
N/A
 
Filing Details
DUTASTERIDE USP
Issue/Submission Date
2014-06-13
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USDMF

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Application Number
23810
Status
Inactive
Fees Paid
N/A
 
Filing Details
DUTASTERIDE
Issue/Submission Date
2010-05-18
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USDMF

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USDMF

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USDMF

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Application Number
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

Caution WC

Application Number
230MF10161
Indian CDSCO WC-0419
Status
 
Expired
2021-06-10
Filing Details
Dutasteride at 114 Marine Chambers,...
Dutasteride EP/IP
Issue/Submission Date
2018-12-03
2018-06-11
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USDMF

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CEP/COS

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USDMF

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Written Confirmation

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Application Number
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USDMF

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Looking for 164656-23-9 / Dutasteride API manufacturers, exporters & distributors?

Dutasteride manufacturers, exporters & distributors 1

64

PharmaCompass offers a list of Dutasteride API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Dutasteride manufacturer or Dutasteride supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Dutasteride manufacturer or Dutasteride supplier.

PharmaCompass also assists you with knowing the Dutasteride API Price utilized in the formulation of products. Dutasteride API Price is not always fixed or binding as the Dutasteride Price is obtained through a variety of data sources. The Dutasteride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Dutasteride

Synonyms

164656-23-9, Avodart, Avolve, Gg-745, Gi 198745, Gi-198745

Cas Number

164656-23-9

Unique Ingredient Identifier (UNII)

O0J6XJN02I

About Dutasteride

A 5-ALPHA-REDUCTASE INHIBITOR that is reported to inhibit both type-1 and type2 isoforms of the enzyme and is used to treat BENIGN PROSTATIC HYPERPLASIA.

Dutasteride Manufacturers

A Dutasteride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dutasteride, including repackagers and relabelers. The FDA regulates Dutasteride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dutasteride 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 Dutasteride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Dutasteride Suppliers

A Dutasteride supplier is an individual or a company that provides Dutasteride active pharmaceutical ingredient (API) or Dutasteride finished formulations upon request. The Dutasteride suppliers may include Dutasteride API manufacturers, exporters, distributors and traders.

click here to find a list of Dutasteride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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