Find Ferumoxytol 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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JDMF

JDMFs Filed

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EU WC

EU WC

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KDMF

KDMF

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NDC API

NDC API

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VMF

NDC API

API REF. PRICE (USD/KG)

MARKET PLACE

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FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

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Europe

Europe

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Canada

Canada

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Australia

Australia

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South Africa

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EDQM

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USP

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GLOBAL SALES INFORMATION

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0RELATED EXCIPIENT COMPANIES

0EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: Bcp30643
Molecular Formula
Fe3H2O4
Molecular Weight
233.55  g/mol
InChI Key
UCNNJGDEJXIUCC-UHFFFAOYSA-L

Ferumoxytol
1 2D Structure

Ferumoxytol

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
hydroxy(oxo)iron;iron
2.1.2 InChI
InChI=1S/3Fe.2H2O.2O/h;;;2*1H2;;/q;2*+1;;;;/p-2
2.1.3 InChI Key
UCNNJGDEJXIUCC-UHFFFAOYSA-L
2.1.4 Canonical SMILES
O[Fe]=O.O[Fe]=O.[Fe]
2.2 Synonyms
2.2.1 Depositor-Supplied Synonyms

1. Bcp30643

2.3 Create Date
2011-02-18
3 Chemical and Physical Properties
Molecular Weight 233.55 g/mol
Molecular Formula Fe3H2O4
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count4
Rotatable Bond Count0
Exact Mass233.800115 g/mol
Monoisotopic Mass233.800115 g/mol
Topological Polar Surface Area74.6 Ų
Heavy Atom Count7
Formal Charge0
Complexity10.3
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count3
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NameFeraheme
PubMed HealthParenteral Mineral/Trace Mineral Combination (Injection)
Drug ClassesAnticonvulsant, Laxative, Hyperosmotic, Nutritive Agent, Parenteral Mineral-Trace Mineral, Renal-Urologic Agent
Drug LabelFeraheme, an iron replacement product, is a non-stoichiometric magnetite (superparamagnetic iron oxide) coated with polyglucose sorbitol carboxymethylether. The overall colloidal particle size is 17-31 nm in diameter. The chemical formula of Feraheme...
Active IngredientFerumoxytol
Dosage FormSolution
RouteIntravenous
Strengtheq 510mg iron/17ml (eq 30mg iron/ml)
Market StatusPrescription
CompanyAmag Pharms

2 of 2  
Drug NameFeraheme
PubMed HealthParenteral Mineral/Trace Mineral Combination (Injection)
Drug ClassesAnticonvulsant, Laxative, Hyperosmotic, Nutritive Agent, Parenteral Mineral-Trace Mineral, Renal-Urologic Agent
Drug LabelFeraheme, an iron replacement product, is a non-stoichiometric magnetite (superparamagnetic iron oxide) coated with polyglucose sorbitol carboxymethylether. The overall colloidal particle size is 17-31 nm in diameter. The chemical formula of Feraheme...
Active IngredientFerumoxytol
Dosage FormSolution
RouteIntravenous
Strengtheq 510mg iron/17ml (eq 30mg iron/ml)
Market StatusPrescription
CompanyAmag Pharms

API SUPPLIERS

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USDMF

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01

Apicore Llc

India

USDMF

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BIO CEO & Investor
Not Confirmed

01

Apicore Llc

India
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BIO CEO & Investor
Not Confirmed

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 39032

Submission : 2023-10-24

Status : Active

Type : II

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02

Lek Pharmaceuticals Dd

Slovenia

USDMF

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BIO CEO & Investor
Not Confirmed

02

BIO CEO & Investor
Not Confirmed

GDUFA

DMF Review : Complete

Rev. Date : 2014-02-12

Pay. Date : 2013-11-21

DMF Number : 27718

Submission : 2013-11-26

Status : Active

Type : II

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03

BIO CEO & Investor
Not Confirmed

03

BIO CEO & Investor
Not Confirmed

GDUFA

DMF Review : Complete

Rev. Date : 2023-01-25

Pay. Date : 2022-12-15

DMF Number : 37265

Submission : 2022-07-18

Status : Active

Type : II

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API Reference Price

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[{"dataSource":"API Export","activeIngredients":"FERUMOXYTOL","year":"2021","qtr":"Q2","strtotime":1618511400,"product":"FERUMOXYTOL BATCH NO RD-503-014-065","address":"PLOT 121 GIDC MAKARPURA INDL.ESTATEMAKARPURA","city":"VADODARA","supplier":"VIATRIS","supplierCountry":"INDIA","foreign_port":"BUCARAMANGA","customer":"TEVA PHARMACEUTICAL INDUSTRIES","customerCountry":"ISRAEL","quantity":"0.02","actualQuantity":"20","unit":"GMS","unitRateFc":"27.9","totalValueFC":"540","currency":"USD","unitRateINR":2010.1500000000001,"date":"16-Apr-2021","totalValueINR":"40203","totalValueInUsd":"540","indian_port":"BOMBAY AIR","hs_no":"29420090","bill_no":"1150642","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ISRAEL","selfForZScoreResived":"Pharma Grade","supplierPort":"BOMBAY AIR","supplierAddress":"PLOT 121 GIDC MAKARPURA INDL.ESTATEMAKARPURA, VADODARA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2021","qtr":"Q3","strtotime":1630953000,"product":"FERUMOXYTOL","address":"PLOT 121 GIDC MAKARPURA INDL.ESTATEMAKARPURA","city":"VADODARA","supplier":"VIATRIS","supplierCountry":"INDIA","foreign_port":"TEL AVIV YAFO","customer":"TEVA PHARMACEUTICAL INDUSTRIES","customerCountry":"ISRAEL","quantity":"0.30","actualQuantity":"300","unit":"GMS","unitRateFc":"30","totalValueFC":"8836.8","currency":"USD","unitRateINR":2166.6666666666665,"date":"07-Sep-2021","totalValueINR":"650000","totalValueInUsd":"8836.8","indian_port":"AHMEDABAD AIR","hs_no":"29420090","bill_no":"4407594","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ISRAEL","selfForZScoreResived":"Pharma Grade","supplierPort":"AHMEDABAD AIR","supplierAddress":"PLOT 121 GIDC MAKARPURA INDL.ESTATEMAKARPURA, VADODARA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1652898600,"product":"BULK DRUG FERUMOXYTOL","address":"BLOCK NO.252-253, VILLAGE DHOBIKUV A,PADRA JAMBUSAR HIGHWAY TAL PADRA","city":"VADODARA,GUJARAT","supplier":"VIATRIS","supplierCountry":"INDIA","foreign_port":"TEL AVIV YAFO","customer":"TEVA PHARMACEUTICAL INDUSTRIES","customerCountry":"ISRAEL","quantity":"0.75","actualQuantity":"750","unit":"GMS","unitRateFc":"30","totalValueFC":"21931.6","currency":"USD","unitRateINR":2260,"date":"19-May-2022","totalValueINR":"1695000","totalValueInUsd":"21931.6","indian_port":"AHMEDABAD AIR","hs_no":"29420090","bill_no":"1485601","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ISRAEL","selfForZScoreResived":"Pharma Grade","supplierPort":"AHMEDABAD AIR","supplierAddress":"BLOCK NO.252-253, VILLAGE DHOBIKUV A,PADRA JAMBUSAR HIGHWAY TAL PADRA, VADODARA,GUJARAT","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1669746600,"product":"BULK DRUG-FERUMOXYTOL","address":"BLOCK NO.252-253, VILLAGE DHOBIKUV A,PADRA JAMBUSAR HIGHWAY TAL PADRA","city":"VADODARA,GUJARAT","supplier":"VIATRIS","supplierCountry":"INDIA","foreign_port":"NEW YORK","customer":"RK PHARMA INC","customerCountry":"UNITED STATES","quantity":"7.85","actualQuantity":"7.845","unit":"KGS","unitRateFc":"12000","totalValueFC":"93318.8","currency":"USD","unitRateINR":970809.43275971955,"date":"30-Nov-2022","totalValueINR":"7616000","totalValueInUsd":"93318.8","indian_port":"BOMBAY AIR","hs_no":"29420090","bill_no":"5833637","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"BOMBAY AIR","supplierAddress":"BLOCK NO.252-253, VILLAGE DHOBIKUV A,PADRA JAMBUSAR HIGHWAY TAL PADRA, VADODARA,GUJARAT","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1673029800,"product":"FERUMOXYTOL (BULK DRUG), BATCH NO:FRMX\/2","address":"BLOCK NO.252-253, VILLAGE DHOBIKUV A,PADRA JAMBUSAR HIGHWAY TAL PADRA","city":"VADODARA,GUJARAT","supplier":"VIATRIS","supplierCountry":"INDIA","foreign_port":"NEW YORK - JOHN F. K","customer":"RK PHARMA","customerCountry":"UNITED STATES","quantity":"15.00","actualQuantity":"15","unit":"KGS","unitRateFc":"12000","totalValueFC":"180419.5","currency":"USD","unitRateINR":983400,"date":"07-Jan-2023","totalValueINR":"14751000","totalValueInUsd":"180419.5","indian_port":"AHMEDABAD AIR","hs_no":"29420090","bill_no":"6770892","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"AHMEDABAD AIR","supplierAddress":"BLOCK NO.252-253, VILLAGE DHOBIKUV A,PADRA JAMBUSAR HIGHWAY TAL PADRA, VADODARA,GUJARAT","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1682533800,"product":"FERUMOXYTOL","address":"BLOCK NO.252-253, VILLAGE DHOBIKUV A,PADRA JAMBUSAR HIGHWAY TAL PADRA","city":"VADODARA,GUJARAT","supplier":"VIATRIS","supplierCountry":"INDIA","foreign_port":"TEL AVIV YAFO","customer":"TEVA PHARMACEUTICAL INDUSTRIES","customerCountry":"ISRAEL","quantity":"0.31","actualQuantity":"0.31","unit":"KGS","unitRateFc":"30000","totalValueFC":"9236.9","currency":"USD","unitRateINR":2441935.4838709678,"date":"27-Apr-2023","totalValueINR":"757000","totalValueInUsd":"9236.9","indian_port":"BOMBAY AIR","hs_no":"29420090","bill_no":"9592757","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ISRAEL","selfForZScoreResived":"Pharma Grade","supplierPort":"BOMBAY AIR","supplierAddress":"BLOCK NO.252-253, VILLAGE DHOBIKUV A,PADRA JAMBUSAR HIGHWAY TAL PADRA, VADODARA,GUJARAT","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1696876200,"product":"PHARMACEUTICAL RAW MATERIAL: FERUMOXYTOL","address":"PLOT 121 GIDC MAKARPURA INDL.ESTATE","city":"VADODARA","supplier":"VIATRIS","supplierCountry":"INDIA","foreign_port":"DHAKA","customer":"MERCANTILE BANK LIMITED","customerCountry":"BANGLADESH","quantity":"1.50","actualQuantity":"1.5","unit":"KGS","unitRateFc":"30000","totalValueFC":"43566.4","currency":"USD","unitRateINR":2417333.3333333335,"date":"10-Oct-2023","totalValueINR":"3626000","totalValueInUsd":"43566.4","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"4520862","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BANGLADESH","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"PLOT 121 GIDC MAKARPURA INDL.ESTATE, VADODARA","customerAddress":""}]
16-Apr-2021
10-Oct-2023
KGS
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Average Price (USD/KGS)

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Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country Total Quantity
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FDF Dossiers

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01

Pharmathen SA

Greece
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BIO CEO & Investor
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  • fda
  • EDQM
  • WHO-GMP

Virtual BoothPharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

Flag Greece
Digital Content Digital Content

Regulatory Info : USA

Registration Country : Greece

Ferumoxytol

Brand Name :

Dosage Form : Injection For Intravenous Use

Dosage Strength : 30MG/ML

Packaging :

Approval Date :

Application Number :

Regulatory Info : USA

Registration Country : Greece

Pharmathen

02

Covis Pharma

Luxembourg
BIO CEO & Investor
Not Confirmed
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Covis Pharma

Luxembourg
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FERUMOXYTOL

Brand Name : FERAHEME

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : EQ 510MG IRON/17ML (EQ 30MG IRON/ML)

Packaging :

Approval Date : 2009-06-30

Application Number : 22180

Regulatory Info : RX

Registration Country : USA

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03

Sandoz B2B

Switzerland
BIO CEO & Investor
Not Confirmed
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Sandoz B2B

Switzerland
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BIO CEO & Investor
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FERUMOXYTOL

Brand Name : FERUMOXYTOL

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : EQ 510MG IRON/17ML (EQ 30MG IRON/ML)

Packaging :

Approval Date : 2021-01-15

Application Number : 206604

Regulatory Info : RX

Registration Country : USA

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FDA Orange Book

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COVIS

Luxembourg
BIO CEO & Investor
Not Confirmed
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COVIS

Luxembourg
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BIO CEO & Investor
Not Confirmed

FERUMOXYTOL

Brand Name : FERAHEME

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : EQ 510MG IRON/17ML (EQ 30MG IRON/ML)

Approval Date : 2009-06-30

Application Number : 22180

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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02

SANDOZ

Switzerland
BIO CEO & Investor
Not Confirmed
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SANDOZ

Switzerland
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BIO CEO & Investor
Not Confirmed

FERUMOXYTOL

Brand Name : FERUMOXYTOL

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : EQ 510MG IRON/17ML (EQ 30MG IRON/ML)

Approval Date : 2021-01-15

Application Number : 206604

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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Digital Content read-more

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NEWS #PharmaBuzz

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https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206604

FDA
20 Jan 2021

http://twofourinsight.com/analyzing-data-earliest-market-entry-subsequent-anda-filers/

TWOFOUR INSIGHT
12 Feb 2016

http://ir.amagpharma.com/phoenix.zhtml?c=61596&p=irol-newsArticle&id=2002105

Press Release AMAG PHARMACEUTICALS
29 Dec 2014

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ABOUT THIS PAGE

Feraheme Manufacturers

A Feraheme manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Feraheme, including repackagers and relabelers. The FDA regulates Feraheme manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Feraheme 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 Feraheme manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Feraheme Suppliers

A Feraheme supplier is an individual or a company that provides Feraheme active pharmaceutical ingredient (API) or Feraheme finished formulations upon request. The Feraheme suppliers may include Feraheme API manufacturers, exporters, distributors and traders.

click here to find a list of Feraheme suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Feraheme USDMF

A Feraheme DMF (Drug Master File) is a document detailing the whole manufacturing process of Feraheme active pharmaceutical ingredient (API) in detail. Different forms of Feraheme DMFs exist exist since differing nations have different regulations, such as Feraheme USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Feraheme DMF submitted to regulatory agencies in the US is known as a USDMF. Feraheme USDMF includes data on Feraheme's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Feraheme USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Feraheme suppliers with USDMF on PharmaCompass.

Feraheme GMP

Feraheme 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 Feraheme 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 Feraheme GMP manufacturer or Feraheme GMP API supplier for your needs.

Feraheme CoA

A Feraheme CoA (Certificate of Analysis) is a formal document that attests to Feraheme's compliance with Feraheme specifications and serves as a tool for batch-level quality control.

Feraheme CoA mostly includes findings from lab analyses of a specific batch. For each Feraheme 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.

Feraheme may be tested according to a variety of international standards, such as European Pharmacopoeia (Feraheme EP), Feraheme JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Feraheme 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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