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Looking for 13311-84-7 / Flutamide API manufacturers, exporters & distributors?

Flutamide manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Flutamide 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 Flutamide manufacturer or Flutamide supplier for your needs.

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

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

API | Excipient name

Flutamide

Synonyms

13311-84-7, Eulexin, Niftolide, Niftholide, Sch 13521, 2-methyl-n-[4-nitro-3-(trifluoromethyl)phenyl]propanamide

Cas Number

13311-84-7

Unique Ingredient Identifier (UNII)

76W6J0943E

About Flutamide

An antiandrogen with about the same potency as cyproterone in rodent and canine species.

Flutamide Manufacturers

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

Flutamide Suppliers

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

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

Flutamide USDMF

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

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

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

Flutamide 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 Flutamide Drug Master File in Japan (Flutamide JDMF) empowers Flutamide 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 Flutamide JDMF during the approval evaluation for pharmaceutical products. At the time of Flutamide 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 Flutamide suppliers with JDMF on PharmaCompass.

Flutamide CEP

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

A Flutamide CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Flutamide 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 Flutamide suppliers with CEP (COS) on PharmaCompass.

Flutamide WC

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

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

Flutamide 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 Flutamide as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Flutamide 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 Flutamide 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 Flutamide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Flutamide NDC to their finished compounded human drug products, they may choose to do so.

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

Flutamide GMP

Flutamide 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 Flutamide 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 Flutamide GMP manufacturer or Flutamide GMP API supplier for your needs.

Flutamide CoA

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

Flutamide CoA mostly includes findings from lab analyses of a specific batch. For each Flutamide 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.

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