Find Patiromer Sorbitex Calcium manufacturers, exporters & distributors on PharmaCompass

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Synopsis

Synopsis

ACTIVE PHARMA INGREDIENTS

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CEP/COS

CEP/COS Certifications

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EU WC

EU WC

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KDMF

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VMF

NDC API

0INTERMEDIATES

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EDQM

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USP

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JP

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FINISHED DOSAGE FORMULATIONS

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Australia

Australia

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South Africa

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API REF. PRICE (USD/KG)

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Chemistry

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Also known as:
Molecular Formula
C50H62CaF2O10
Molecular Weight
901.1  g/mol
InChI Key
KDDZXVQCHUXALQ-NIQIMLPHSA-L

Patiromer Sorbitex Calcium
1 2D Structure

Patiromer Sorbitex Calcium

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
calcium;1,2-bis(ethenyl)benzene;1,3-bis(ethenyl)benzene;1,4-bis(ethenyl)benzene;2-fluoroprop-2-enoate;(2R,3R,4R,5S)-hexane-1,2,3,4,5,6-hexol;octa-1,7-diene
2.1.2 InChI
InChI=1S/3C10H10.C8H14.C6H14O6.2C3H3FO2.Ca/c1-3-9-5-7-10(4-2)8-6-9;1-3-9-6-5-7-10(4-2)8-9;1-3-9-7-5-6-8-10(9)4-2;1-3-5-7-8-6-4-2;7-1-3(9)5(11)6(12)4(10)2-8;2*1-2(4)3(5)6;/h3*3-8H,1-2H2;3-4H,1-2,5-8H2;3-12H,1-2H2;2*1H2,(H,5,6);/q;;;;;;;+2/p-2/t;;;;3-,4+,5-,6-;;;/m....1.../s1
2.1.3 InChI Key
KDDZXVQCHUXALQ-NIQIMLPHSA-L
2.1.4 Canonical SMILES
C=CCCCCC=C.C=CC1=CC=C(C=C1)C=C.C=CC1=CC(=CC=C1)C=C.C=CC1=CC=CC=C1C=C.C=C(C(=O)[O-])F.C=C(C(=O)[O-])F.C(C(C(C(C(CO)O)O)O)O)O.[Ca+2]
2.1.5 Isomeric SMILES
C=CCCCCC=C.C=CC1=CC=C(C=C1)C=C.C=CC1=CC(=CC=C1)C=C.C=CC1=CC=CC=C1C=C.C=C(C(=O)[O-])F.C=C(C(=O)[O-])F.C([C@H]([C@H]([C@@H]([C@H](CO)O)O)O)O)O.[Ca+2]
2.2 Create Date
2015-01-24
3 Chemical and Physical Properties
Molecular Weight 901.1 g/mol
Molecular Formula C50H62CaF2O10
Hydrogen Bond Donor Count6
Hydrogen Bond Acceptor Count12
Rotatable Bond Count16
Exact Mass900.3936953 g/mol
Monoisotopic Mass900.3936953 g/mol
Topological Polar Surface Area202 A^2
Heavy Atom Count63
Formal Charge0
Complexity556
Isotope Atom Count0
Defined Atom Stereocenter Count4
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count8
4 Drug and Medication Information
4.1 Drug Information
1 of 1  
Drug NameVELTASSA
Active IngredientPATIROMER SORBITEX CALCIUM
CompanyRELYPSA INC (Application Number: N205739. Patents: 7556799, 8147873, 8216560, 8282913, 8287847, 8337824, 8475780, 8778324, 8889115, 9492476, 9925212)

API Reference Price

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20-Oct-2023
20-Oct-2023
KGS
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DRUG PRODUCT COMPOSITIONS

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DOSAGE - POWDER;ORAL - EQ 16.8GM BASE/PACKET

USFDA APPLICATION NUMBER - 205739

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DOSAGE - POWDER;ORAL - EQ 1GM BASE/PACKET

USFDA APPLICATION NUMBER - 205739

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DOSAGE - POWDER;ORAL - EQ 25.2GM BASE/PACKET

USFDA APPLICATION NUMBER - 205739

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DOSAGE - POWDER;ORAL - EQ 8.4GM BASE/PACKET

USFDA APPLICATION NUMBER - 205739

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ABOUT THIS PAGE

Looking for / Patiromer Sorbitex Calcium API manufacturers, exporters & distributors?

Patiromer Sorbitex Calcium manufacturers, exporters & distributors 1

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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.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Patiromer Sorbitex Calcium manufacturer or Patiromer Sorbitex Calcium supplier.

PharmaCompass also assists you with knowing the Patiromer Sorbitex Calcium API Price utilized in the formulation of products. Patiromer Sorbitex Calcium API Price is not always fixed or binding as the Patiromer Sorbitex Calcium Price is obtained through a variety of data sources. The Patiromer Sorbitex Calcium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Patiromer Sorbitex Calcium

Calcium, hydrolyzed divinylbenzene-Me 2-fluoro-2-propenoate-1,7-octadiene polymer sorbitol complexes Manufacturers

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.

click here to find a list of Calcium, hydrolyzed divinylbenzene-Me 2-fluoro-2-propenoate-1,7-octadiene polymer sorbitol complexes manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Calcium, hydrolyzed divinylbenzene-Me 2-fluoro-2-propenoate-1,7-octadiene polymer sorbitol complexes Suppliers

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.

click here to find a list of Calcium, hydrolyzed divinylbenzene-Me 2-fluoro-2-propenoate-1,7-octadiene polymer sorbitol complexes suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Calcium, hydrolyzed divinylbenzene-Me 2-fluoro-2-propenoate-1,7-octadiene polymer sorbitol complexes USDMF

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.

click here to find a list of Calcium, hydrolyzed divinylbenzene-Me 2-fluoro-2-propenoate-1,7-octadiene polymer sorbitol complexes suppliers with USDMF on PharmaCompass.

Calcium, hydrolyzed divinylbenzene-Me 2-fluoro-2-propenoate-1,7-octadiene polymer sorbitol complexes JDMF

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.

click here to find a list of Calcium, hydrolyzed divinylbenzene-Me 2-fluoro-2-propenoate-1,7-octadiene polymer sorbitol complexes suppliers with JDMF on PharmaCompass.

Calcium, hydrolyzed divinylbenzene-Me 2-fluoro-2-propenoate-1,7-octadiene polymer sorbitol complexes NDC

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).

Finished drug products

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.

Unfinished drugs

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.

Compounded drug products

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.

click here to find a list of Calcium, hydrolyzed divinylbenzene-Me 2-fluoro-2-propenoate-1,7-octadiene polymer sorbitol complexes suppliers with NDC on PharmaCompass.

Calcium, hydrolyzed divinylbenzene-Me 2-fluoro-2-propenoate-1,7-octadiene polymer sorbitol complexes GMP

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.

Calcium, hydrolyzed divinylbenzene-Me 2-fluoro-2-propenoate-1,7-octadiene polymer sorbitol complexes CoA

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.

Calcium, hydrolyzed divinylbenzene-Me 2-fluoro-2-propenoate-1,7-octadiene polymer sorbitol complexes CoA mostly includes findings from lab analyses of a specific batch. For each Calcium, hydrolyzed divinylbenzene-Me 2-fluoro-2-propenoate-1,7-octadiene polymer sorbitol complexes 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.

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).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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