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API SUPPLIERS
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USDMF
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DOSAGE - FOR SOLUTION;ORAL - 12GM/PACKET;3.5G...DOSAGE - FOR SOLUTION;ORAL - 12GM/PACKET;3.5GM/PACKET;10MG/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 202535
DOSAGE - SOLUTION;ORAL - 12GM/BOT;3.5GM/BOT;1...DOSAGE - SOLUTION;ORAL - 12GM/BOT;3.5GM/BOT;10MG/BOT
USFDA APPLICATION NUMBER - 209589
Related Excipient Companies
Rochem International Inc
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharm-RX Chemical
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PharmaCompass offers a list of Sodium Picosulfate 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 Sodium Picosulfate manufacturer or Sodium Picosulfate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sodium Picosulfate manufacturer or Sodium Picosulfate supplier.
PharmaCompass also assists you with knowing the Sodium Picosulfate API Price utilized in the formulation of products. Sodium Picosulfate API Price is not always fixed or binding as the Sodium Picosulfate Price is obtained through a variety of data sources. The Sodium Picosulfate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Guttalax manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Guttalax, including repackagers and relabelers. The FDA regulates Guttalax manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Guttalax 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 Guttalax manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Guttalax supplier is an individual or a company that provides Guttalax active pharmaceutical ingredient (API) or Guttalax finished formulations upon request. The Guttalax suppliers may include Guttalax API manufacturers, exporters, distributors and traders.
click here to find a list of Guttalax suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Guttalax DMF (Drug Master File) is a document detailing the whole manufacturing process of Guttalax active pharmaceutical ingredient (API) in detail. Different forms of Guttalax DMFs exist exist since differing nations have different regulations, such as Guttalax USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Guttalax DMF submitted to regulatory agencies in the US is known as a USDMF. Guttalax USDMF includes data on Guttalax's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Guttalax USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Guttalax 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 Guttalax Drug Master File in Japan (Guttalax JDMF) empowers Guttalax 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 Guttalax JDMF during the approval evaluation for pharmaceutical products. At the time of Guttalax 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 Guttalax suppliers with JDMF on PharmaCompass.
A Guttalax CEP of the European Pharmacopoeia monograph is often referred to as a Guttalax Certificate of Suitability (COS). The purpose of a Guttalax CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Guttalax EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Guttalax to their clients by showing that a Guttalax CEP has been issued for it. The manufacturer submits a Guttalax CEP (COS) as part of the market authorization procedure, and it takes on the role of a Guttalax CEP holder for the record. Additionally, the data presented in the Guttalax CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Guttalax DMF.
A Guttalax CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Guttalax 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 Guttalax suppliers with CEP (COS) on PharmaCompass.
A Guttalax written confirmation (Guttalax WC) is an official document issued by a regulatory agency to a Guttalax manufacturer, verifying that the manufacturing facility of a Guttalax active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Guttalax APIs or Guttalax finished pharmaceutical products to another nation, regulatory agencies frequently require a Guttalax WC (written confirmation) as part of the regulatory process.
click here to find a list of Guttalax 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 Guttalax as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Guttalax 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 Guttalax 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 Guttalax and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Guttalax NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Guttalax suppliers with NDC on PharmaCompass.
Guttalax 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 Guttalax 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 Guttalax GMP manufacturer or Guttalax GMP API supplier for your needs.
A Guttalax CoA (Certificate of Analysis) is a formal document that attests to Guttalax's compliance with Guttalax specifications and serves as a tool for batch-level quality control.
Guttalax CoA mostly includes findings from lab analyses of a specific batch. For each Guttalax 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.
Guttalax may be tested according to a variety of international standards, such as European Pharmacopoeia (Guttalax EP), Guttalax JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Guttalax USP).
