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List of Drug Master Files (DMF) of Dutasteride Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Hubei Gedian Humanwell Pharmaceutical (2)

02 Dr. Reddy's Laboratories (1)

03 Aurobindo Pharma Limited (1)

04 Catalent Pharma Solutions (2)

05 Cipla (1)

06 Gador SA (1)

07 Hetero Drugs (1)

08 Ind Swift Laboratories Limited (1)

09 MSN Laboratories (2)

10 PHF SA (1)

11 Reliance Life Sciences Private Limited (1)

12 Sterling Spa (2)

13 Zhejiang Xianju Junye Pharmaceutical Co. LTD (1)

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01 DUTASTERIDE (7)

02 DUTASTERIDE (PROCESS-II) USP (1)

03 DUTASTERIDE 0.5 MG SOFT GELATIN CAPSULES (1)

04 DUTASTERIDE ACID (1)

05 DUTASTERIDE FORM I (1)

06 DUTASTERIDE SOFT GELATIN CAPSULES .5MG (1)

07 DUTASTERIDE USP (3)

08 DUTASTERIDE USP [ROUTE CODE - "DT"] (1)

09 DUTASTERIDE, NON-STERILE, BULK DRUG SUBSTANCE (1)

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01 Argentina (1)

02 China (3)

03 India (8)

04 Italy (2)

05 Switzerland (1)

06 U.S.A (2)

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01 Active (9)

02 Inactive (8)

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01 Complete (6)

02 Blank (11)

URL Supplier Web Content
29577
Active
2015-07-31
Complete
2015-12-04
2015-07-28
II
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URL Supplier Web Content
14643
Inactive
1999-12-22
N/A
II
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URL Supplier Web Content
27774
Active
2013-12-11
Complete
2014-04-04
2013-12-10
II
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URL Supplier Web Content
23533
Active
2010-02-16
Complete
2013-01-09
2012-12-06
II
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URL Supplier Web Content
33063
Active
2018-08-06
N/A
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URL Supplier Web Content
20918
Active
2007-10-08
Complete
2015-05-07
2015-04-30
II
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URL Supplier Web Content
30143
Active
2015-12-23
N/A
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Looking for 164656-23-9 / Dutasteride API manufacturers, exporters & distributors?

Dutasteride manufacturers, exporters & distributors 1

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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.

Dutasteride USDMF

A Dutasteride DMF (Drug Master File) is a document detailing the whole manufacturing process of Dutasteride active pharmaceutical ingredient (API) in detail. Different forms of Dutasteride DMFs exist exist since differing nations have different regulations, such as Dutasteride USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Dutasteride DMF submitted to regulatory agencies in the US is known as a USDMF. Dutasteride USDMF includes data on Dutasteride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dutasteride USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Dutasteride suppliers with USDMF on PharmaCompass.

Dutasteride Manufacturers | Traders | Suppliers

Dutasteride Manufacturers, Traders, Suppliers 1
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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