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