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