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  • SPRAY, METERED;NASAL - EQ 0.042MG DIPROP/SPRAY
  • AEROSOL, METERED;NASAL - 0.04MG/ACTUATION
  • AEROSOL, METERED;NASAL - 0.08MG/ACTUATION
  • AEROSOL, METERED;INHALATION - 0.04MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • AEROSOL, METERED;INHALATION - 0.08MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Looking for 5534-09-8 / Beclomethasone Dipropionate API manufacturers, exporters & distributors?

Beclomethasone Dipropionate manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Beclomethasone Dipropionate

Synonyms

Beclometasone dipropionate, 5534-09-8, Beclovent, Beconase, Vancenase, Sanasthmax

Cas Number

5534-09-8

Unique Ingredient Identifier (UNII)

5B307S63B2

About Beclomethasone Dipropionate

An anti-inflammatory, synthetic glucocorticoid. It is used topically as an anti-inflammatory agent and in aerosol form for the treatment of ASTHMA.

Beclomethasone Manufacturers

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

Beclomethasone Suppliers

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

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

Beclomethasone USDMF

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

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

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

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

Beclomethasone KDMF

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

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

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

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

Beclomethasone CEP

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

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

Beclomethasone WC

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

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

Beclomethasone 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 Beclomethasone as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Beclomethasone GMP

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

Beclomethasone CoA

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

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

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