Synopsis
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CEP/COS
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EU WC
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KDMF
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VMF
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FDF
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Europe
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Canada
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Australia
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South Africa
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Listed Dossiers
DRUG PRODUCT COMPOSITIONS0
EDQM
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USP
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JP
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Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
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News #PharmaBuzz
US Medicaid
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Annual Reports
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Finished Drug Prices
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API SUPPLIERS
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USDMF
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - POWDER;ORAL - EQ 16.8GM BASE/PACKET
USFDA APPLICATION NUMBER - 205739
DOSAGE - POWDER;ORAL - EQ 1GM BASE/PACKET
USFDA APPLICATION NUMBER - 205739
DOSAGE - POWDER;ORAL - EQ 25.2GM BASE/PACKET
USFDA APPLICATION NUMBER - 205739
DOSAGE - POWDER;ORAL - EQ 8.4GM BASE/PACKET
USFDA APPLICATION NUMBER - 205739
Market Place
ABOUT THIS PAGE
A Patiromer Sorbitex Calcium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Patiromer Sorbitex Calcium, including repackagers and relabelers. The FDA regulates Patiromer Sorbitex Calcium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Patiromer Sorbitex Calcium 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 Patiromer Sorbitex Calcium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Patiromer Sorbitex Calcium supplier is an individual or a company that provides Patiromer Sorbitex Calcium active pharmaceutical ingredient (API) or Patiromer Sorbitex Calcium finished formulations upon request. The Patiromer Sorbitex Calcium suppliers may include Patiromer Sorbitex Calcium API manufacturers, exporters, distributors and traders.
click here to find a list of Patiromer Sorbitex Calcium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Patiromer Sorbitex Calcium DMF (Drug Master File) is a document detailing the whole manufacturing process of Patiromer Sorbitex Calcium active pharmaceutical ingredient (API) in detail. Different forms of Patiromer Sorbitex Calcium DMFs exist exist since differing nations have different regulations, such as Patiromer Sorbitex Calcium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Patiromer Sorbitex Calcium DMF submitted to regulatory agencies in the US is known as a USDMF. Patiromer Sorbitex Calcium USDMF includes data on Patiromer Sorbitex Calcium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Patiromer Sorbitex Calcium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Patiromer Sorbitex Calcium 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 Patiromer Sorbitex Calcium Drug Master File in Japan (Patiromer Sorbitex Calcium JDMF) empowers Patiromer Sorbitex Calcium 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 Patiromer Sorbitex Calcium JDMF during the approval evaluation for pharmaceutical products. At the time of Patiromer Sorbitex Calcium 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 Patiromer Sorbitex Calcium suppliers with JDMF 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 Patiromer Sorbitex Calcium as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Patiromer Sorbitex Calcium 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 Patiromer Sorbitex Calcium 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 Patiromer Sorbitex Calcium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Patiromer Sorbitex Calcium NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Patiromer Sorbitex Calcium suppliers with NDC on PharmaCompass.
Patiromer Sorbitex Calcium 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 Patiromer Sorbitex Calcium 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 Patiromer Sorbitex Calcium GMP manufacturer or Patiromer Sorbitex Calcium GMP API supplier for your needs.
A Patiromer Sorbitex Calcium CoA (Certificate of Analysis) is a formal document that attests to Patiromer Sorbitex Calcium's compliance with Patiromer Sorbitex Calcium specifications and serves as a tool for batch-level quality control.
Patiromer Sorbitex Calcium CoA mostly includes findings from lab analyses of a specific batch. For each Patiromer Sorbitex Calcium 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.
Patiromer Sorbitex Calcium may be tested according to a variety of international standards, such as European Pharmacopoeia (Patiromer Sorbitex Calcium EP), Patiromer Sorbitex Calcium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Patiromer Sorbitex Calcium USP).
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