Inabata Inabata


Find Dutasteride manufacturers, exporters & distributors on PharmaCompass

API Suppliers

API Suppliers

US DMFs Filed

US DMFs Filed

CEP/COS Certifications

CEP/COS Certifications

JDMFs Filed

JDMFs Filed



Listed Suppliers

Listed Suppliers



USA (Orange Book)

USA (Orange Book)







South Africa

South Africa

Uploaded Dossiers

Uploaded Dossiers


U.S. Medicaid

Annual Reports


USFDA Orange Book Patents


USFDA Exclusivities



Blog #PharmaFlow







Other Listed Suppliers

left grey arrow
right gray arrow
  • CAPSULE;ORAL - 0.5MG;0.4MG

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

Dutasteride manufacturers, exporters & distributors 1


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



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

Cas Number


Unique Ingredient Identifier (UNII)


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 JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Dutasteride Drug Master File in Japan (Dutasteride JDMF) empowers Dutasteride API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Dutasteride JDMF during the approval evaluation for pharmaceutical products. At the time of Dutasteride JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

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

Dutasteride KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Dutasteride Drug Master File in Korea (Dutasteride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Dutasteride. The MFDS reviews the Dutasteride KDMF as part of the drug registration process and uses the information provided in the Dutasteride KDMF to evaluate the safety and efficacy of the drug.

After submitting a Dutasteride KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Dutasteride API can apply through the Korea Drug Master File (KDMF).

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

Dutasteride CEP

A Dutasteride CEP of the European Pharmacopoeia monograph is often referred to as a Dutasteride Certificate of Suitability (COS). The purpose of a Dutasteride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Dutasteride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Dutasteride to their clients by showing that a Dutasteride CEP has been issued for it. The manufacturer submits a Dutasteride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Dutasteride CEP holder for the record. Additionally, the data presented in the Dutasteride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Dutasteride DMF.

A Dutasteride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Dutasteride CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of Dutasteride suppliers with CEP (COS) on PharmaCompass.

Dutasteride WC

A Dutasteride written confirmation (Dutasteride WC) is an official document issued by a regulatory agency to a Dutasteride manufacturer, verifying that the manufacturing facility of a Dutasteride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Dutasteride APIs or Dutasteride finished pharmaceutical products to another nation, regulatory agencies frequently require a Dutasteride WC (written confirmation) as part of the regulatory process.

click here to find a list of Dutasteride suppliers with Written Confirmation (WC) on PharmaCompass.

Dutasteride NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Dutasteride as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Dutasteride API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Dutasteride as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Dutasteride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Dutasteride NDC to their finished compounded human drug products, they may choose to do so.

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

Dutasteride GMP

Dutasteride Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

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

Dutasteride CoA

A Dutasteride CoA (Certificate of Analysis) is a formal document that attests to Dutasteride's compliance with Dutasteride specifications and serves as a tool for batch-level quality control.

Dutasteride CoA mostly includes findings from lab analyses of a specific batch. For each Dutasteride CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Dutasteride may be tested according to a variety of international standards, such as European Pharmacopoeia (Dutasteride EP), Dutasteride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dutasteride USP).

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.
Ask Us for Pharmaceutical Supplier and Partner
Ask Us, Find A Supplier / Partner
No Commissions, No Strings Attached, Get Connected for FREE

What are you looking for?

How can we help you?

The request can't be empty

Please read our Privacy Policy carefully

You must agree to the privacy policy

The name can't be empty
The company can't be empty.
The email can't be empty Please enter a valid email.
The mobile can't be empty
Post Enquiry