X
API Suppliers
US DMFs Filed
CEP/COS Certifications
0
JDMFs Filed
0
Other Certificates
Other Suppliers
USA (Orange Book)
Europe
Canada
Australia
0
South Africa
Uploaded Dossiers
U.S. Medicaid
Annual Reports
0
41
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 Myrbetriq manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Myrbetriq, including repackagers and relabelers. The FDA regulates Myrbetriq manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Myrbetriq 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 Myrbetriq manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Myrbetriq supplier is an individual or a company that provides Myrbetriq active pharmaceutical ingredient (API) or Myrbetriq finished formulations upon request. The Myrbetriq suppliers may include Myrbetriq API manufacturers, exporters, distributors and traders.
click here to find a list of Myrbetriq suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Myrbetriq DMF (Drug Master File) is a document detailing the whole manufacturing process of Myrbetriq active pharmaceutical ingredient (API) in detail. Different forms of Myrbetriq DMFs exist exist since differing nations have different regulations, such as Myrbetriq USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Myrbetriq DMF submitted to regulatory agencies in the US is known as a USDMF. Myrbetriq USDMF includes data on Myrbetriq's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Myrbetriq USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Myrbetriq suppliers with USDMF 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 Myrbetriq Drug Master File in Korea (Myrbetriq KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Myrbetriq. The MFDS reviews the Myrbetriq KDMF as part of the drug registration process and uses the information provided in the Myrbetriq KDMF to evaluate the safety and efficacy of the drug.
After submitting a Myrbetriq 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 Myrbetriq API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Myrbetriq suppliers with KDMF on PharmaCompass.
A Myrbetriq written confirmation (Myrbetriq WC) is an official document issued by a regulatory agency to a Myrbetriq manufacturer, verifying that the manufacturing facility of a Myrbetriq active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Myrbetriq APIs or Myrbetriq finished pharmaceutical products to another nation, regulatory agencies frequently require a Myrbetriq WC (written confirmation) as part of the regulatory process.
click here to find a list of Myrbetriq 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 Myrbetriq as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Myrbetriq 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 Myrbetriq 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 Myrbetriq and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Myrbetriq NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Myrbetriq suppliers with NDC on PharmaCompass.
Myrbetriq 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 Myrbetriq 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 Myrbetriq GMP manufacturer or Myrbetriq GMP API supplier for your needs.
A Myrbetriq CoA (Certificate of Analysis) is a formal document that attests to Myrbetriq's compliance with Myrbetriq specifications and serves as a tool for batch-level quality control.
Myrbetriq CoA mostly includes findings from lab analyses of a specific batch. For each Myrbetriq 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.
Myrbetriq may be tested according to a variety of international standards, such as European Pharmacopoeia (Myrbetriq EP), Myrbetriq JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Myrbetriq USP).
Market Place
