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