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- 12GM/PACKET;3.5GM/PACKET;10MG/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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