Synopsis
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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EDQM
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USP
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JP
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Others
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Australia
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South Africa
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Listed Dossiers
US Medicaid
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Annual Reports
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Regulatory FDF Prices
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FDF
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Data Compilation #PharmaFlow
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| Molecular Weight | 901.1 g/mol |
|---|---|
| Molecular Formula | C50H62CaF2O10 |
| Hydrogen Bond Donor Count | 6 |
| Hydrogen Bond Acceptor Count | 12 |
| Rotatable Bond Count | 16 |
| Exact Mass | 900.3936953 g/mol |
| Monoisotopic Mass | 900.3936953 g/mol |
| Topological Polar Surface Area | 202 A^2 |
| Heavy Atom Count | 63 |
| Formal Charge | 0 |
| Complexity | 556 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 4 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 8 |

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PharmaCompass offers a list of Patiromer Sorbitex Calcium 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 Patiromer Sorbitex Calcium manufacturer or Patiromer Sorbitex Calcium supplier for your needs.
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A Calcium, hydrolyzed divinylbenzene-Me 2-fluoro-2-propenoate-1,7-octadiene polymer sorbitol complexes manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Calcium, hydrolyzed divinylbenzene-Me 2-fluoro-2-propenoate-1,7-octadiene polymer sorbitol complexes, including repackagers and relabelers. The FDA regulates Calcium, hydrolyzed divinylbenzene-Me 2-fluoro-2-propenoate-1,7-octadiene polymer sorbitol complexes manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Calcium, hydrolyzed divinylbenzene-Me 2-fluoro-2-propenoate-1,7-octadiene polymer sorbitol complexes API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Calcium, hydrolyzed divinylbenzene-Me 2-fluoro-2-propenoate-1,7-octadiene polymer sorbitol complexes supplier is an individual or a company that provides Calcium, hydrolyzed divinylbenzene-Me 2-fluoro-2-propenoate-1,7-octadiene polymer sorbitol complexes active pharmaceutical ingredient (API) or Calcium, hydrolyzed divinylbenzene-Me 2-fluoro-2-propenoate-1,7-octadiene polymer sorbitol complexes finished formulations upon request. The Calcium, hydrolyzed divinylbenzene-Me 2-fluoro-2-propenoate-1,7-octadiene polymer sorbitol complexes suppliers may include Calcium, hydrolyzed divinylbenzene-Me 2-fluoro-2-propenoate-1,7-octadiene polymer sorbitol complexes API manufacturers, exporters, distributors and traders.
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A Calcium, hydrolyzed divinylbenzene-Me 2-fluoro-2-propenoate-1,7-octadiene polymer sorbitol complexes DMF (Drug Master File) is a document detailing the whole manufacturing process of Calcium, hydrolyzed divinylbenzene-Me 2-fluoro-2-propenoate-1,7-octadiene polymer sorbitol complexes active pharmaceutical ingredient (API) in detail. Different forms of Calcium, hydrolyzed divinylbenzene-Me 2-fluoro-2-propenoate-1,7-octadiene polymer sorbitol complexes DMFs exist exist since differing nations have different regulations, such as Calcium, hydrolyzed divinylbenzene-Me 2-fluoro-2-propenoate-1,7-octadiene polymer sorbitol complexes USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Calcium, hydrolyzed divinylbenzene-Me 2-fluoro-2-propenoate-1,7-octadiene polymer sorbitol complexes DMF submitted to regulatory agencies in the US is known as a USDMF. Calcium, hydrolyzed divinylbenzene-Me 2-fluoro-2-propenoate-1,7-octadiene polymer sorbitol complexes USDMF includes data on Calcium, hydrolyzed divinylbenzene-Me 2-fluoro-2-propenoate-1,7-octadiene polymer sorbitol complexes's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Calcium, hydrolyzed divinylbenzene-Me 2-fluoro-2-propenoate-1,7-octadiene polymer sorbitol complexes USDMF is kept confidential to protect the manufacturer’s intellectual property.
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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 Calcium, hydrolyzed divinylbenzene-Me 2-fluoro-2-propenoate-1,7-octadiene polymer sorbitol complexes Drug Master File in Japan (Calcium, hydrolyzed divinylbenzene-Me 2-fluoro-2-propenoate-1,7-octadiene polymer sorbitol complexes JDMF) empowers Calcium, hydrolyzed divinylbenzene-Me 2-fluoro-2-propenoate-1,7-octadiene polymer sorbitol complexes 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 Calcium, hydrolyzed divinylbenzene-Me 2-fluoro-2-propenoate-1,7-octadiene polymer sorbitol complexes JDMF during the approval evaluation for pharmaceutical products. At the time of Calcium, hydrolyzed divinylbenzene-Me 2-fluoro-2-propenoate-1,7-octadiene polymer sorbitol complexes JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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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 Calcium, hydrolyzed divinylbenzene-Me 2-fluoro-2-propenoate-1,7-octadiene polymer sorbitol complexes as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Calcium, hydrolyzed divinylbenzene-Me 2-fluoro-2-propenoate-1,7-octadiene polymer sorbitol complexes 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 Calcium, hydrolyzed divinylbenzene-Me 2-fluoro-2-propenoate-1,7-octadiene polymer sorbitol complexes 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 Calcium, hydrolyzed divinylbenzene-Me 2-fluoro-2-propenoate-1,7-octadiene polymer sorbitol complexes and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Calcium, hydrolyzed divinylbenzene-Me 2-fluoro-2-propenoate-1,7-octadiene polymer sorbitol complexes NDC to their finished compounded human drug products, they may choose to do so.
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Calcium, hydrolyzed divinylbenzene-Me 2-fluoro-2-propenoate-1,7-octadiene polymer sorbitol complexes 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 Calcium, hydrolyzed divinylbenzene-Me 2-fluoro-2-propenoate-1,7-octadiene polymer sorbitol complexes 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 Calcium, hydrolyzed divinylbenzene-Me 2-fluoro-2-propenoate-1,7-octadiene polymer sorbitol complexes GMP manufacturer or Calcium, hydrolyzed divinylbenzene-Me 2-fluoro-2-propenoate-1,7-octadiene polymer sorbitol complexes GMP API supplier for your needs.
A Calcium, hydrolyzed divinylbenzene-Me 2-fluoro-2-propenoate-1,7-octadiene polymer sorbitol complexes CoA (Certificate of Analysis) is a formal document that attests to Calcium, hydrolyzed divinylbenzene-Me 2-fluoro-2-propenoate-1,7-octadiene polymer sorbitol complexes's compliance with Calcium, hydrolyzed divinylbenzene-Me 2-fluoro-2-propenoate-1,7-octadiene polymer sorbitol complexes specifications and serves as a tool for batch-level quality control.
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Calcium, hydrolyzed divinylbenzene-Me 2-fluoro-2-propenoate-1,7-octadiene polymer sorbitol complexes may be tested according to a variety of international standards, such as European Pharmacopoeia (Calcium, hydrolyzed divinylbenzene-Me 2-fluoro-2-propenoate-1,7-octadiene polymer sorbitol complexes EP), Calcium, hydrolyzed divinylbenzene-Me 2-fluoro-2-propenoate-1,7-octadiene polymer sorbitol complexes JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Calcium, hydrolyzed divinylbenzene-Me 2-fluoro-2-propenoate-1,7-octadiene polymer sorbitol complexes USP).