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- 12GM/PACKET;3.5GM/PACKET;10MG/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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