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  • OINTMENT;TOPICAL - 0.1%
  • CREAM;TOPICAL - 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • LOTION;TOPICAL - 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • AEROSOL, METERED;INHALATION - 0.05MG/INH
  • AEROSOL, METERED;INHALATION - 0.10MG/INH
  • AEROSOL, METERED;INHALATION - 0.20MG/INH
  • SPRAY, METERED;NASAL - 0.05MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • POWDER;INHALATION - 0.11MG/INH
  • POWDER;INHALATION - 0.22MG/INH
  • AEROSOL, METERED;INHALATION - 0.005MG/INH;0.05MG/INH
  • AEROSOL, METERED;INHALATION - 0.005MG/INH;0.1MG/INH
  • AEROSOL, METERED;INHALATION - 0.005MG/INH;0.2MG/INH

Looking for 83919-23-7 / Mometasone Furoate API manufacturers, exporters & distributors?

Mometasone Furoate manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Mometasone Furoate

Synonyms

83919-23-7, Asmanex, Nasonex, Elocon, Monovo, Sch 32088

Cas Number

83919-23-7

Unique Ingredient Identifier (UNII)

04201GDN4R

About Mometasone Furoate

A pregnadienediol derivative ANTI-ALLERGIC AGENT and ANTI-INFLAMMATORY AGENT that is used in the management of ASTHMA and ALLERGIC RHINITIS. It is also used as a topical treatment for skin disorders.

Mometasone Manufacturers

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

Mometasone Suppliers

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

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

Mometasone USDMF

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

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

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

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

Mometasone KDMF

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

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

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

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

Mometasone CEP

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

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

Mometasone WC

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

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

Mometasone 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 Mometasone as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Mometasone GMP

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

Mometasone CoA

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

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

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