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