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PharmaCompass offers a list of Betamethasone 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 Betamethasone Dipropionate manufacturer or Betamethasone Dipropionate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Betamethasone Dipropionate manufacturer or Betamethasone Dipropionate supplier.
PharmaCompass also assists you with knowing the Betamethasone Dipropionate API Price utilized in the formulation of products. Betamethasone Dipropionate API Price is not always fixed or binding as the Betamethasone Dipropionate Price is obtained through a variety of data sources. The Betamethasone Dipropionate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Betamethasone Dipropionate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Betamethasone Dipropionate, including repackagers and relabelers. The FDA regulates Betamethasone Dipropionate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Betamethasone Dipropionate 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 Betamethasone Dipropionate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Betamethasone Dipropionate supplier is an individual or a company that provides Betamethasone Dipropionate active pharmaceutical ingredient (API) or Betamethasone Dipropionate finished formulations upon request. The Betamethasone Dipropionate suppliers may include Betamethasone Dipropionate API manufacturers, exporters, distributors and traders.
click here to find a list of Betamethasone Dipropionate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Betamethasone Dipropionate DMF (Drug Master File) is a document detailing the whole manufacturing process of Betamethasone Dipropionate active pharmaceutical ingredient (API) in detail. Different forms of Betamethasone Dipropionate DMFs exist exist since differing nations have different regulations, such as Betamethasone Dipropionate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Betamethasone Dipropionate DMF submitted to regulatory agencies in the US is known as a USDMF. Betamethasone Dipropionate USDMF includes data on Betamethasone Dipropionate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Betamethasone Dipropionate USDMF is kept confidential to protect the manufacturer’s intellectual property.
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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 Betamethasone Dipropionate Drug Master File in Japan (Betamethasone Dipropionate JDMF) empowers Betamethasone Dipropionate 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 Betamethasone Dipropionate JDMF during the approval evaluation for pharmaceutical products. At the time of Betamethasone Dipropionate JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Betamethasone Dipropionate Drug Master File in Korea (Betamethasone Dipropionate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Betamethasone Dipropionate. The MFDS reviews the Betamethasone Dipropionate KDMF as part of the drug registration process and uses the information provided in the Betamethasone Dipropionate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Betamethasone Dipropionate 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 Betamethasone Dipropionate API can apply through the Korea Drug Master File (KDMF).
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A Betamethasone Dipropionate CEP of the European Pharmacopoeia monograph is often referred to as a Betamethasone Dipropionate Certificate of Suitability (COS). The purpose of a Betamethasone Dipropionate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Betamethasone Dipropionate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Betamethasone Dipropionate to their clients by showing that a Betamethasone Dipropionate CEP has been issued for it. The manufacturer submits a Betamethasone Dipropionate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Betamethasone Dipropionate CEP holder for the record. Additionally, the data presented in the Betamethasone Dipropionate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Betamethasone Dipropionate DMF.
A Betamethasone Dipropionate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Betamethasone Dipropionate CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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A Betamethasone Dipropionate written confirmation (Betamethasone Dipropionate WC) is an official document issued by a regulatory agency to a Betamethasone Dipropionate manufacturer, verifying that the manufacturing facility of a Betamethasone Dipropionate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Betamethasone Dipropionate APIs or Betamethasone Dipropionate finished pharmaceutical products to another nation, regulatory agencies frequently require a Betamethasone Dipropionate WC (written confirmation) as part of the regulatory process.
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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 Betamethasone Dipropionate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Betamethasone Dipropionate API and other APIs are published in this directory by the FDA.
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 Betamethasone Dipropionate 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.
The NDC directory also contains data on finished compounded human drug products that contain Betamethasone Dipropionate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Betamethasone Dipropionate NDC to their finished compounded human drug products, they may choose to do so.
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Betamethasone Dipropionate 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 Betamethasone Dipropionate 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 Betamethasone Dipropionate GMP manufacturer or Betamethasone Dipropionate GMP API supplier for your needs.
A Betamethasone Dipropionate CoA (Certificate of Analysis) is a formal document that attests to Betamethasone Dipropionate's compliance with Betamethasone Dipropionate specifications and serves as a tool for batch-level quality control.
Betamethasone Dipropionate CoA mostly includes findings from lab analyses of a specific batch. For each Betamethasone Dipropionate 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.
Betamethasone Dipropionate may be tested according to a variety of international standards, such as European Pharmacopoeia (Betamethasone Dipropionate EP), Betamethasone Dipropionate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Betamethasone Dipropionate USP).
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