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Synopsis

ACTIVE PHARMA INGREDIENTS

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USDMF

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CEP/COS

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Chemistry

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Also known as: Ag10 hydrochloride, Ag-10 hydrochloride, Alxn2060 hydrochloride, Acoramidis (hydrochloride), Alxn-2060 hydrochloride, Vy9c88c2nv
Molecular Formula
C15H18ClFN2O3
Molecular Weight
328.76  g/mol
InChI Key
MGFZEARHINUOMX-UHFFFAOYSA-N
FDA UNII
VY9C88C2NV

Acoramidis Hydrochloride
1 2D Structure

Acoramidis Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
3-[3-(3,5-dimethyl-1H-pyrazol-4-yl)propoxy]-4-fluorobenzoic acid;hydrochloride
2.1.2 InChI
InChI=1S/C15H17FN2O3.ClH/c1-9-12(10(2)18-17-9)4-3-7-21-14-8-11(15(19)20)5-6-13(14)16;/h5-6,8H,3-4,7H2,1-2H3,(H,17,18)(H,19,20);1H
2.1.3 InChI Key
MGFZEARHINUOMX-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CC1=C(C(=NN1)C)CCCOC2=C(C=CC(=C2)C(=O)O)F.Cl
2.2 Other Identifiers
2.2.1 UNII
VY9C88C2NV
2.3 Synonyms
2.3.1 Depositor-Supplied Synonyms

1. Ag10 Hydrochloride

2. Ag-10 Hydrochloride

3. Alxn2060 Hydrochloride

4. Acoramidis (hydrochloride)

5. Alxn-2060 Hydrochloride

6. Vy9c88c2nv

7. Acoramidis Hydrochloride [usan]

8. 2242751-53-5

9. Benzoic Acid, 3-(3-(3,5-dimethyl-1h-pyrazol-4-yl)propoxy)-4-fluoro-, Hydrochloride (1:1)

10. Unii-vy9c88c2nv

11. Chembl4650226

12. Schembl20475239

13. Acoramidis Hydrochloride [jan]

14. Hy-109165a

15. Cs-0143619

16. 3-(3-(3-5-dimethyl-1h-pyrazol-4-yl)propoxy)-4-fluorobenzoic Acid Hydrochloride

2.4 Create Date
2018-12-15
3 Chemical and Physical Properties
Molecular Weight 328.76 g/mol
Molecular Formula C15H18ClFN2O3
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count5
Rotatable Bond Count6
Exact Mass328.0989983 g/mol
Monoisotopic Mass328.0989983 g/mol
Topological Polar Surface Area75.2 Ų
Heavy Atom Count22
Formal Charge0
Complexity356
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2

API SUPPLIERS

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Metrochem API Private Limited

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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HRV Global Life Sciences

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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  • WHO-GMP

Virtual BoothHRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

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HRV Global Life Sciences

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Cambrex Corporation

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Cambrex Corporation

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Cambrex Corporation

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

AGGSpend
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Cambrex Corporation

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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NDC API

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ACORAMIDIS HYDROCHLORIDE

NDC Package Code : 59116-5910

Start Marketing Date : 2021-12-30

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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ACORAMIDIS HYDROCHLORIDE

NDC Package Code : 59116-5911

Start Marketing Date : 2021-12-30

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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Listed Suppliers

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  • fda
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Virtual BoothMetrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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Digital Content Digital Content

Acoramidis

About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...

Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product groups and has been approved by ISO 9001-2015, USFDA, WHO GMP, Cofepris & Japanese authorities. Metrochem’s in-depth industry knowledge, & hi-tech & advanced infrastructure, helps it provide quality products to its customers. Note: None of the products will be supplied to the countries where this could conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer
Metrochem

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Virtual BoothHRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

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Acoramidis

About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...

HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It offers services such as sourcing, manufacturing & supply, helping partners enter new markets worldwide. Its strong partnerships with major players in the pharma and food additive industries help HRV Global effectively promote projects and products. HRV Global represents over 30 large Indian drugmakers, primarily targeting Europe, the US & the Middle East markets. Headquartered in India, HRV Global has offices in the US, Switzerland, Dubai, Lithuania & Turkey.
HRV Global Life Sciences
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API Reference Price

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10-Jan-2022
10-Jan-2022
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Drugs in Development

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Details:

Beyonttra (acoramidis hydrochloride) is an orally administered near-complete stabilizer of TTR for the treatment of transthyretin amyloidosis in adult patients with cardiomyopathy.


Lead Product(s): Acoramidis Hydrochloride

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Beyonttra

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: HealthCare Royalty

Deal Size: $300.0 million Upfront Cash: $300.0 million

Deal Type: Agreement June 30, 2025

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AGGSpend
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Details : Beyonttra (acoramidis hydrochloride) is an orally administered near-complete stabilizer of TTR for the treatment of transthyretin amyloidosis in adult patients with cardiomyopathy.

Product Name : Beyonttra

Product Type : Other Small Molecule

Upfront Cash : $300.0 million

June 30, 2025

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Details:

Attruby (acoramidis) is a transthyretin stabilizer being investigated for the treatment of younger patients with cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM).


Lead Product(s): Acoramidis Hydrochloride

Therapeutic Area: Genetic Disease Brand Name: Attruby

Study Phase: Phase IIIProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable May 13, 2025

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AGGSpend
Not Confirmed
AGGSpend
Not Confirmed

Details : Attruby (acoramidis) is a transthyretin stabilizer being investigated for the treatment of younger patients with cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM).

Product Name : Attruby

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

May 13, 2025

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Details:

Beyonttra is an orally administered stabilizer of transthyretin (TTR) indicated for the treatment of wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy.


Lead Product(s): Acoramidis Hydrochloride

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Beyonttra

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable April 28, 2025

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AGGSpend
Not Confirmed
AGGSpend
Not Confirmed

Details : Beyonttra is an orally administered stabilizer of transthyretin (TTR) indicated for the treatment of wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy.

Product Name : Beyonttra

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

April 28, 2025

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Details:

Beyonttra (acoramidis) is a next-generation, orally-administered, highly potent, small molecule stabiliser of transthyretin. It is approved for the treatment of Transthyretin Amyloid Cardiomyopathy.


Lead Product(s): Acoramidis Hydrochloride

Therapeutic Area: Genetic Disease Brand Name: Beyonttra

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable March 27, 2025

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AGGSpend
Not Confirmed
AGGSpend
Not Confirmed

Details : Beyonttra (acoramidis) is a next-generation, orally-administered, highly potent, small molecule stabiliser of transthyretin. It is approved for the treatment of Transthyretin Amyloid Cardiomyopathy.

Product Name : Beyonttra

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

March 27, 2025

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FDF Dossiers

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ACORAMIDIS HYDROCHLORIDE

Brand Name : ATTRUBY

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 356MG BASE

Packaging :

Approval Date : 2024-11-22

Application Number : 216540

Regulatory Info : RX

Registration Country : USA

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FDA Orange Book

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ACORAMIDIS HYDROCHLORIDE

Brand Name : ATTRUBY

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 356MG BASE

Approval Date : 2024-11-22

Application Number : 216540

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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DATA COMPILATION #PharmaFlow

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NEWS #PharmaBuzz

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https://www.globenewswire.com/news-release/2025/05/20/3084731/0/en/Acoramidis-Reduced-Incidence-of-Atrial-Fibrillation-Events-in-Patients-with-ATTR-CM.html

GLOBENEWSWIRE
20 May 2025

https://www.globenewswire.com/news-release/2025/05/19/3084268/0/en/Early-and-Sustained-Increase-in-Serum-TTR-Levels-by-Acoramidis-Independently-Predicted-Improved-Survival-in-the-ATTRibute-CM-Study.html

GLOBENEWSWIRE
19 May 2025

https://www.globenewswire.com/news-release/2025/05/13/3079989/0/en/First-Participant-Dosed-with-Acoramidis-in-ACT-EARLY-the-First-Ever-ATTR-Primary-Prevention-Study.html

GLOBENEWSWIRE
13 May 2025

https://www.globenewswire.com/news-release/2025/04/28/3068975/0/en/BEYONTTRA-acoramidis-the-First-Near-complete-TTR-Stabilizer-90-Approved-by-the-UK-Medicines-and-Healthcare-Products-Regulatory-Agency-to-Treat-ATTR-CM.html

GLOBENEWSWIRE
28 Apr 2025

https://www.globenewswire.com/news-release/2023/08/27/2732246/0/en/BridgeBio-presents-detailed-positive-results-from-Phase-3-ATTRibute-CM-study-of-acoramidis-for-patients-with-transthyretin-amyloid-cardiomyopathy-ATTR-CM-at-European-Society-of-Car.html

GLOBENEWSWIRE
27 Aug 2023

https://www.fiercebiotech.com/biotech/bridgebio-heart-disease-drug-vindicated-phase-3-victory-plots-fda-submission-23

Max Bayer FIERCE BIOTECH
17 Jul 2023

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Patents & EXCLUSIVITIES

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US Patents

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ACORAMIDIS HYDROCHLORIDE

US Patent Number : 8877795

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 216540

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2031-05-05

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ACORAMIDIS HYDROCHLORIDE

US Patent Number : 11058668

Drug Substance Claim :

Drug Product Claim :

Application Number : 216540

Patent Use Code : U-4046

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2039-03-22

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ACORAMIDIS HYDROCHLORIDE

US Patent Number : 10513497

Drug Substance Claim : Y

Drug Product Claim :

Application Number : 216540

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2038-02-16

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ACORAMIDIS HYDROCHLORIDE

US Patent Number : 10842777

Drug Substance Claim :

Drug Product Claim :

Application Number : 216540

Patent Use Code : U-4046

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2031-05-05

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ACORAMIDIS HYDROCHLORIDE

US Patent Number : 11260047

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 216540

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2039-08-16

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ACORAMIDIS HYDROCHLORIDE

US Patent Number : 11919865

Drug Substance Claim :

Drug Product Claim :

Application Number : 216540

Patent Use Code : U-4046

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2038-02-16

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ACORAMIDIS HYDROCHLORIDE

US Patent Number : 12070449

Drug Substance Claim :

Drug Product Claim :

Application Number : 216540

Patent Use Code : U-4046

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2039-03-22

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ACORAMIDIS HYDROCHLORIDE

US Patent Number : 10398681

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 216540

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2031-05-05

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ACORAMIDIS HYDROCHLORIDE

US Patent Number : 9169214

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 216540

Patent Use Code : U-4046

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2031-05-05

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ACORAMIDIS HYDROCHLORIDE

US Patent Number : 9642838

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 216540

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2031-05-05

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US Exclusivities

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ACORAMIDIS HYDROCHLORIDE

Exclusivity Code : ODE-506

Exclusivity Expiration Date : 2031-11-22

Application Number : 216540

Product Number : 1

Exclusivity Details :

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ABOUT THIS PAGE

Looking for 2242751-53-5 / Acoramidis Hydrochloride API manufacturers, exporters & distributors?

Acoramidis Hydrochloride manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Acoramidis Hydrochloride 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 Acoramidis Hydrochloride manufacturer or Acoramidis Hydrochloride supplier for your needs.

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

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

API | Excipient name

Acoramidis Hydrochloride

Synonyms

Ag10 hydrochloride, Ag-10 hydrochloride, Alxn2060 hydrochloride, Acoramidis (hydrochloride), Alxn-2060 hydrochloride, Vy9c88c2nv

Cas Number

2242751-53-5

Unique Ingredient Identifier (UNII)

VY9C88C2NV

Acoramidis Hydrochloride Manufacturers

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

Acoramidis Hydrochloride Suppliers

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

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

Acoramidis Hydrochloride 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 Acoramidis Hydrochloride as an active pharmaceutical ingredient (API).

Finished drug products

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

click here to find a list of Acoramidis Hydrochloride suppliers with NDC on PharmaCompass.

Acoramidis Hydrochloride GMP

Acoramidis Hydrochloride 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 Acoramidis Hydrochloride 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 Acoramidis Hydrochloride GMP manufacturer or Acoramidis Hydrochloride GMP API supplier for your needs.

Acoramidis Hydrochloride CoA

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

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

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