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  • OINTMENT;TOPICAL - 0.005% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • SPRAY, METERED;NASAL - 0.05MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • SPRAY, METERED;NASAL - 0.137MG/SPRAY;0.05MG/SPRAY
  • SPRAY, METERED;NASAL - 0.05MG/SPRAY
  • POWDER;INHALATION - 0.05MG/INH
  • POWDER;INHALATION - 0.1MG/INH
  • POWDER;INHALATION - 0.25MG/INH
  • POWDER;INHALATION - 0.03MG/INH
  • POWDER;INHALATION - 0.055MG/INH
  • POWDER;INHALATION - 0.113MG/INH
  • POWDER;INHALATION - 0.232MG/INH
  • POWDER;INHALATION - 0.055MG/INH;EQ 0.014MG BASE/INH
  • POWDER;INHALATION - 0.113MG/INH;EQ 0.014MG BASE/INH
  • POWDER;INHALATION - 0.232MG/INH;EQ 0.014MG BASE/INH
  • POWDER;INHALATION - 0.1MG/INH;EQ 0.05MG BASE/INH
  • POWDER;INHALATION - 0.25MG/INH;EQ 0.05MG BASE/INH
  • POWDER;INHALATION - 0.5MG/INH;EQ 0.05MG BASE/INH
  • LOTION;TOPICAL - 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • AEROSOL, METERED;INHALATION - 0.044MG/INH
  • AEROSOL, METERED;INHALATION - 0.11MG/INH
  • AEROSOL, METERED;INHALATION - 0.22MG/INH

Looking for 80474-14-2 / Fluticasone Propionate API manufacturers, exporters & distributors?

Fluticasone Propionate manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Fluticasone Propionate

Synonyms

80474-14-2, Flovent, Cutivate, Flixotide, Flonase, Flixonase

Cas Number

80474-14-2

Unique Ingredient Identifier (UNII)

O2GMZ0LF5W

About Fluticasone Propionate

A STEROID with GLUCOCORTICOID RECEPTOR activity that is used to manage the symptoms of ASTHMA; ALLERGIC RHINITIS, and ATOPIC DERMATITIS.

Fluticasone Manufacturers

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

Fluticasone Suppliers

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

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

Fluticasone USDMF

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

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

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

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

Fluticasone KDMF

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

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

After submitting a Fluticasone 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 Fluticasone API can apply through the Korea Drug Master File (KDMF).

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

Fluticasone CEP

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

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

Fluticasone WC

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

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

Fluticasone 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 Fluticasone as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Fluticasone GMP

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

Fluticasone CoA

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

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

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