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Chemistry

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Also known as: Vyndaqel, 951395-08-7, Fx-1006a, Fx1006a, Fx 1006a, Zu7cf08a1a
Molecular Formula
C21H24Cl2N2O8
Molecular Weight
503.3  g/mol
InChI Key
DQJDBUPLRMRBAB-WZTVWXICSA-N
FDA UNII
ZU7CF08A1A

Tafamidis Meglumine
Tafamidis Meglumine is a soft gelatin capsule formulation containing the meglumine salt form of tafamidis, a small molecule and pharmacological chaperone with potential disease-modifying activity. Tafamidis binds to and stabilizes wild-type and variant (V122I) transthyretin (TTR), thereby preventing tetramer dissociation into monomers; this prevents misfolding of the TTR protein and inhibits the formation of TTR amyloid fibrils and the subsequent deposition of these insoluble protein clusters in peripheral nerve tissues and organs. TTR is a 127 amino acid transport protein for thyroxine and retinol and is secreted by the liver.
1 2D Structure

Tafamidis Meglumine

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
2-(3,5-dichlorophenyl)-1,3-benzoxazole-6-carboxylic acid;(2R,3R,4R,5S)-6-(methylamino)hexane-1,2,3,4,5-pentol
2.1.2 InChI
InChI=1S/C14H7Cl2NO3.C7H17NO5/c15-9-3-8(4-10(16)6-9)13-17-11-2-1-7(14(18)19)5-12(11)20-13;1-8-2-4(10)6(12)7(13)5(11)3-9/h1-6H,(H,18,19);4-13H,2-3H2,1H3/t;4-,5+,6+,7+/m.0/s1
2.1.3 InChI Key
DQJDBUPLRMRBAB-WZTVWXICSA-N
2.1.4 Canonical SMILES
CNCC(C(C(C(CO)O)O)O)O.C1=CC2=C(C=C1C(=O)O)OC(=N2)C3=CC(=CC(=C3)Cl)Cl
2.1.5 Isomeric SMILES
CNC[C@@H]([C@H]([C@@H]([C@@H](CO)O)O)O)O.C1=CC2=C(C=C1C(=O)O)OC(=N2)C3=CC(=CC(=C3)Cl)Cl
2.2 Other Identifiers
2.2.1 UNII
ZU7CF08A1A
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Fx 1006a

2. Fx-1006a

3. Fx1006a

4. Tafamidis

5. Vyndamax

6. Vyndaqel

2.3.2 Depositor-Supplied Synonyms

1. Vyndaqel

2. 951395-08-7

3. Fx-1006a

4. Fx1006a

5. Fx 1006a

6. Zu7cf08a1a

7. Chebi:79345

8. 951395-08-7 (meglumine)

9. (2r,3r,4r,5s)-6-(methylamino)hexane-1,2,3,4,5-pentaol 2-(3,5-dichlorophenyl)benzo[d]oxazole-6-carboxylate

10. (2r,3r,4r,5s)-6-(methylamino)hexane-1,2,3,4,5-pentaol 2-(3,5-dichlorophenyl)benzo[d]oxazole-6-carboxylic Acid

11. Unii-zu7cf08a1a

12. Tafamidis Meglumine [usan]

13. Tafamidis Meglumine [usan:inn]

14. Vyndaqel (tn)

15. Chembl2105675

16. Schembl14783506

17. Tafamidis Meglumine [mi]

18. Tafamidis Meglumine (jan/usan)

19. Dtxsid50915094

20. Tafamidis Meglumine [jan]

21. Ex-a3550

22. Hy-14852a

23. Mfcd28502032

24. Tafamidis Meglumine [who-dd]

25. Akos037649321

26. At18247

27. D-glucitol, 1-deoxy-1-(methylamino)-, 2-(3,5-dichlorophenyl)-6-benzoxazolecarboxylate

28. Tafamidis Meglumine [orange Book]

29. Bs-18043

30. Cs-0045567

31. Pf-06291826

32. D09674

33. Q27148396

34. 1-deoxy-1-(methylazaniumyl)-d-glucitol 2-(3,5-dichlorophenyl)-1,3-benzoxazole-6-carboxylate

35. 2-(3,5-dichlorophenyl)-1,3-benzoxazole-6-carboxylic Acid--1-deoxy-1-(methylamino)-d-glucitol (1/1)

36. 2-(3,5-dichlorophenyl)-1,3-benzoxazole-6-carboxylic Acid--1-deoxy-1-(methylamino)hexitol (1/1)

37. 2-(3,5-dichlorophenyl)-1,3-benzoxazole-6-carboxylic Acid;(2r,3r,4r,5s)-6-(methylamino)hexane-1,2,3,4,5-pentol

38. D-glucitol, 1-deoxy-1-(methylamino)-, 2-(3,5-dichlorophenyl)-6-benzoxazolecarboxylate (1:1)

39. D-gluco-2,3,4,5,6-pentahydroxy-n-methylhexan-1-aminium 2-(3,5-dichlorophenyl)benzoxazole-6-carboxylate

2.4 Create Date
2008-10-20
3 Chemical and Physical Properties
Molecular Weight 503.3 g/mol
Molecular Formula C21H24Cl2N2O8
Hydrogen Bond Donor Count7
Hydrogen Bond Acceptor Count10
Rotatable Bond Count8
Exact Mass502.0909711 g/mol
Monoisotopic Mass502.0909711 g/mol
Topological Polar Surface Area177 Ų
Heavy Atom Count33
Formal Charge0
Complexity506
Isotope Atom Count0
Defined Atom Stereocenter Count4
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Indication

Investigated for use/treatment in amyloidosis.


Neuropathic heredofamilial amyloidosis


5 Pharmacology and Biochemistry
5.1 Mechanism of Action

Fx-1006A is a first-in-class, disease-modifying compound that is designed to inhibit the formation of amyloid deposits by preventing the misfolding and deposition of the transthyretin protein (TTR), which is associated with amyloidosis.


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03-Mar-2021
08-Jul-2024
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Tafamidis Meglumine

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Dosage Strength : 20MG

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DMF filings hit all-time high in Q3 2024; China tops list with 58% increase in Type II submissions
Drug Master Files, or DMFs, are confidential documents that play a crucial role in the pharmaceutical industry. These files, submitted to the US Food and Drug Administration (FDA), contain detailed information about ingredients, manufacturing processes, and packaging of medicines. They help the FDA oversee drug quality. Of the four types, Type II DMFs involve active pharmaceutical ingredients (APIs) for both branded and generic drugs. The third quarter (Q3) of 2024 saw Type II DMF submissions set a new record. A total of 309 Type II DMFs were submitted to the FDA during this period, a substantial 24.6 percent increase over Q3 2023 (with 248 submissions). The second quarter of 2024 too saw a remarkable increase, with 237 Type II DMFs being submitted compared to 178 in Q2 2023. View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) China witnesses steep rise in DMF submissions, beats India with maximum filings In Q3 2024, China filed 153 DMFs submissions, marking a substantial 57.7 percent increase from the 97 submissions filed in Q3 2023. India maintained its strong position but fell to the number two spot with 110 DMFs, representing a modest 3.8 percent increase from 106 in Q3 2023. The US, which came a distant third, saw a slight decline in DMF submissions, with 13 filed in Q3 2024, as compared to 18 in Q3 2023. For several years, India had a lead in Type II DMFs. Since 2020, which marked the start of the pandemic, we have noticed a gradual increase in DMFs filed by China. This year, China has surpassed India considerably in the first three quarters. During the first nine months of 2024, China submitted 372, while India filed 286 DMFs. If this lead is maintained in Q4, DMFs from China will surpass that of India in 2024.  Amongst European countries, Spain led with seven DMFs, followed by Italy at four, and Germany and the Netherlands at three each. Among other nations, Japan contributed six while Israel submitted four DMFs. In company-wise tally, China’s Jiangsu East-Mab Biomedical Technology topped the list with an impressive 14 DMFs. On its heels were Indian companies — MSN at 13 DMFs, and Vamsi Labs and Hetero Drugs at nine DMFs each. China’s Porton Pharma and Wuxi AppTec filed five, while Shanghai Keze Yongxin Biotechnology, and Qingdao Glycogene Pharmaceutical contributed four submissions each. India's Maithri Drugs also submitted four. Japanese company Santeja filed five. Overall, Asia accounted for nearly 90 percent, with China contributing a dominant 49.5 percent of all DMF submissions. India was at 35.6 percent, the US at 4.2 percent, while Europe contributed 6.5 percent.  View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) Diabetes, obesity, cancer, women’s health drugs emerge as hot molecules in Q3 2024 In terms of molecules, semaglutide (used for the treatment of type 2 diabetes and weight management) and relugolix (to treat prostate cancer and uterine fibroids) saw six DMF filings each in Q3 2024, indicating significant industry interest in these compounds. Following closely behind were semaglutide’s competitor tirzepatide and overactive bladder therapy vibegron, garnering four DMFs each. Finerenone (a non-steroidal drug for chronic kidney disease associated with type 2 diabetes) and voclosporin (an immunosuppressant for lupus nephritis) saw three DMFs each.  The last quarter also witnessed the introduction of 14 molecules with first-time DMFs. Among them were acetoxy empagliflozin, cabozantinib fumarate, tivozanib hydrochloride monohydrate, diosmetin, trilaciclib, clenbuterol hydrochloride, fenoterol hydrobromide, tapinarof and fezolinetant. Fezolinetant, with a DMF from Spain’s Moehs Iberica, is the active ingredient in Astellas’ Veozah, which is the first non-hormonal treatment for menopausal symptoms approved by the FDA. Tapinarof, filed by India’s Maithri Drugs, is used in Vtama, a novel steroid-free psoriasis cream. Other compounds that made their DMF debut include berotralstat, calcium phosphoryl choline chloride, phloroglucinol dihydrate, belumosudil mesylate and trimethylphloroglucinol. During Q2 2024, there were 19 drugs that saw DMF submissions for the first time, including molecules like triptorelin, sorafenib, pralsetinib, trilaciclib dihydrochloride, resmetirom (hepatology) and teneligliptin hydrochloride hydrate (metabolic disorders).  View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available)    GDUFA fee for FY 2025: The FDA’s Generic Drug User Fee Amendments (GDUFA) is a law designed to speed access to safe and effective generic drugs to the public and reduce costs to the industry. The fiscal year 2025 fee rates were published on July 31, 2024. The FDA has revised fees under GDUFA III for all categories. While there is a slight increase in the DMF fee from US$ 94,682 in 2024 to US$ 95,084 in 2025, the ANDA fee has witnessed a significant jump — from US$ 252,453 in 2024 to US$ 321,920 in 2025. FY 2024 and FY 2025 User Fee Rates Generic drug fee category Fees rates for FY 2024 Fees rates for FY 2025 Applications: Abbreviated New Drug Application (ANDA) US$ 2,52,453   US$ 3,21,920   Drug Master File (DMF) US$ 94,682 US$ 95,084 Facilities: Active Pharmaceutical Ingredient (API)—Domestic US$ 40,464 US$ 41,580 API—Foreign US$ 55,464 US$ 56,580 Finished Dosage Form (FDF)—Domestic US$ 2,20,427   US$ 2,31,952 FDF—Foreign US$ 2,35,427   US$ 2,46,952 Contract Manufacturing Organization (CMO)—Domestic US$ 52,902 US$ 55,668 CMO—Foreign US$ 67,902 US$ 70,668 GDUFA Program: Large size operation generic drug applicant US$ 17,29,629   US$ 18,91,664 Medium size operation generic drug applicant US$ 6,91,852   US$ 7,56,666 Small business generic drug applicant US$ 1,72,963   US$ 1,89,166 Our view The highlight of the last few quarters has been the sharp rise in Type II DMF filings from China. The submission of a DMF is not required by law or any FDA regulation. FDA’s DMF guideline offers guidance on acceptable approaches to meeting regulatory requirements. Moreover, DMFs establish trust in APIs from lesser-known companies. With a growing emphasis on compliance and quality assurance, it appears that Chinese drug companies are eager to demonstrate their commitment to high standards and build trust in the US market. And that’s good news for the pharmaceutical industry.   

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https://www.pharmacompass.com/radio-compass-blog/dmf-filings-hit-all-time-high-in-q3-2024-china-tops-list-with-58-increase-in-type-ii-submissions

#PharmaFlow by PHARMACOMPASS
24 Oct 2024

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US Medicaid Prescriptions

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Company :

Tafamidis Meglumine

Drug Cost (USD) : 109,330,317

Year : 2022

Prescribers : 604

Prescriptions : 4705

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Company :

Tafamidis Meglumine

Drug Cost (USD) : 126,772,500

Year : 2021

Prescribers : 759

Prescriptions : 5797

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Company :

Tafamidis Meglumine

Drug Cost (USD) : 199,634,904

Year : 2020

Prescribers : 1337

Prescriptions : 9304

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Company :

Tafamidis Meglumine

Drug Cost (USD) : 130,157,322

Year : 2019

Prescribers : 1621

Prescriptions : 6211

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Company :

Tafamidis Meglumine

Drug Cost (USD) : 0

Year : 2018

Prescribers :

Prescriptions : 0

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Company :

Tafamidis Meglumine

Drug Cost (USD) : 0

Year : 2017

Prescribers :

Prescriptions : 0

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Company :

Tafamidis Meglumine

Drug Cost (USD) : 0

Year : 2016

Prescribers :

Prescriptions : 0

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Company :

Tafamidis Meglumine

Drug Cost (USD) : 0

Year : 2015

Prescribers :

Prescriptions : 0

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Finished Drug Prices

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Brand Name : Vyndaqel

U.S.A
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Brand Name : Vyndaqel

U.S.A
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Tafamidis Meglumine

Dosage Form : Tafamidis 20Mg 30 Joined' Oral U...

Dosage Strength : 30 cps 20 mg

Price Per Pack (Euro) : 20,630.16

Published in :

Country : U.S.A

RX/OTC/DISCN : Class H

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Annual Reports

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Brand Name : Vyndaqel/Vyndamax

Tafamidis Meglumine

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Brand Name : Vyndaqel/Vyndamax

U.S.A
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Tafamidis Meglumine

Main Therapeutic Indication : Rare Disorders

Currency : USD

2019 Revenue in Millions : 473

2018 Revenue in Millions : 148

Growth (%) : 220

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Brand Name : Vyndaqel/Vyndamax

Tafamidis Meglumine

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Brand Name : Vyndaqel/Vyndamax

U.S.A
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Tafamidis Meglumine

Main Therapeutic Indication : Rare Disorders

Currency : USD

2020 Revenue in Millions : 1,288

2019 Revenue in Millions : 473

Growth (%) : 172

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Brand Name : Vyndaqel/Vyndamax

Tafamidis Meglumine

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Brand Name : Vyndaqel/Vyndamax

U.S.A
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Tafamidis Meglumine

Main Therapeutic Indication : Rare Disorders

Currency : USD

2021 Revenue in Millions : 2,015

2020 Revenue in Millions : 1,288

Growth (%) : 56

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Brand Name : Vyndaqel/Vyndamax

Tafamidis Meglumine

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Brand Name : Vyndaqel/Vyndamax

U.S.A
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Tafamidis Meglumine

Main Therapeutic Indication : Rare Diseases

Currency : USD

2022 Revenue in Millions : 2,447

2021 Revenue in Millions : 2,015

Growth (%) : 21

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Brand Name : Vyndaqel/Vyndamax

Tafamidis Meglumine

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Brand Name : Vyndaqel/Vyndamax

U.S.A
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Tafamidis Meglumine

Main Therapeutic Indication : Rare Diseases

Currency : USD

2023 Revenue in Millions : 3,321

2022 Revenue in Millions : 2,447

Growth (%) : 36

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ABOUT THIS PAGE

Tafamidis Meglumine Manufacturers

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

Tafamidis Meglumine Suppliers

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

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

Tafamidis Meglumine USDMF

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

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

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

Tafamidis Meglumine WC

A Tafamidis Meglumine written confirmation (Tafamidis Meglumine WC) is an official document issued by a regulatory agency to a Tafamidis Meglumine manufacturer, verifying that the manufacturing facility of a Tafamidis Meglumine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Tafamidis Meglumine APIs or Tafamidis Meglumine finished pharmaceutical products to another nation, regulatory agencies frequently require a Tafamidis Meglumine WC (written confirmation) as part of the regulatory process.

click here to find a list of Tafamidis Meglumine suppliers with Written Confirmation (WC) on PharmaCompass.

Tafamidis Meglumine 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 Tafamidis Meglumine as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Tafamidis Meglumine 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 Tafamidis Meglumine 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 Tafamidis Meglumine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Tafamidis Meglumine NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Tafamidis Meglumine suppliers with NDC on PharmaCompass.

Tafamidis Meglumine GMP

Tafamidis Meglumine 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 Tafamidis Meglumine 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 Tafamidis Meglumine GMP manufacturer or Tafamidis Meglumine GMP API supplier for your needs.

Tafamidis Meglumine CoA

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

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

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