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API SUPPLIERS
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USDMF
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FDF Dossiers
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DOSAGE - TABLET;ORAL - 10MG
USFDA APPLICATION NUMBER - 88440
DOSAGE - TABLET;ORAL - 25MG
USFDA APPLICATION NUMBER - 88441
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Bethanechol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bethanechol, including repackagers and relabelers. The FDA regulates Bethanechol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bethanechol 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 Bethanechol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bethanechol supplier is an individual or a company that provides Bethanechol active pharmaceutical ingredient (API) or Bethanechol finished formulations upon request. The Bethanechol suppliers may include Bethanechol API manufacturers, exporters, distributors and traders.
click here to find a list of Bethanechol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bethanechol DMF (Drug Master File) is a document detailing the whole manufacturing process of Bethanechol active pharmaceutical ingredient (API) in detail. Different forms of Bethanechol DMFs exist exist since differing nations have different regulations, such as Bethanechol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bethanechol DMF submitted to regulatory agencies in the US is known as a USDMF. Bethanechol USDMF includes data on Bethanechol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bethanechol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bethanechol 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 Bethanechol Drug Master File in Japan (Bethanechol JDMF) empowers Bethanechol 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 Bethanechol JDMF during the approval evaluation for pharmaceutical products. At the time of Bethanechol 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 Bethanechol 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 Bethanechol Drug Master File in Korea (Bethanechol KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Bethanechol. The MFDS reviews the Bethanechol KDMF as part of the drug registration process and uses the information provided in the Bethanechol KDMF to evaluate the safety and efficacy of the drug.
After submitting a Bethanechol 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 Bethanechol API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Bethanechol suppliers with KDMF on PharmaCompass.
A Bethanechol written confirmation (Bethanechol WC) is an official document issued by a regulatory agency to a Bethanechol manufacturer, verifying that the manufacturing facility of a Bethanechol active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Bethanechol APIs or Bethanechol finished pharmaceutical products to another nation, regulatory agencies frequently require a Bethanechol WC (written confirmation) as part of the regulatory process.
click here to find a list of Bethanechol 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 Bethanechol as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Bethanechol 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 Bethanechol 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 Bethanechol and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Bethanechol NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Bethanechol suppliers with NDC on PharmaCompass.
Bethanechol 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 Bethanechol 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 Bethanechol GMP manufacturer or Bethanechol GMP API supplier for your needs.
A Bethanechol CoA (Certificate of Analysis) is a formal document that attests to Bethanechol's compliance with Bethanechol specifications and serves as a tool for batch-level quality control.
Bethanechol CoA mostly includes findings from lab analyses of a specific batch. For each Bethanechol 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.
Bethanechol may be tested according to a variety of international standards, such as European Pharmacopoeia (Bethanechol EP), Bethanechol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Bethanechol USP).
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