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ACTIVE PHARMA INGREDIENTS

2 NDC API

2 NDC API

DEVELOPMENTS

16 Drugs in Development

16 Drugs in Development

FINISHED DOSAGE FORMULATIONS

1 FDF Dossiers, 1 FDA Orange Book

1 FDF Dossiers
1 FDA Orange Book

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 3 NEWS #PharmaBuzz

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1 DATA COMPILATION #PharmaFlow
3 NEWS #PharmaBuzz

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 0

MARKET PLACE

API

FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

Annual Reports (USD Million)

Finished Drug Prices

0RELATED EXCIPIENT COMPANIES

0EXCIPIENTS BY APPLICATIONS

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

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 Formula	C₁₅H₁₈ClFN₂O₃
Molecular Weight	328.76 g/mol
Hydrogen Bond Donor Count	3
Hydrogen Bond Acceptor Count	5
Rotatable Bond Count	6
Exact Mass	328.0989983 g/mol
Monoisotopic Mass	328.0989983 g/mol
Topological Polar Surface Area	75.2 Å²
Heavy Atom Count	22
Formal Charge	0
Complexity	356
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

NDC API

01

Cambrex Charles City, Inc

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

02

Cambrex Charles City, Inc

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Drugs in Development

01 BridgeBio Pharma

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

02 BridgeBio Pharma

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

03 BridgeBio Pharma

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

04 BridgeBio Pharma

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

05 BridgeBio Pharma

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

06 BridgeBio Pharma

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

07 BridgeBio Pharma

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

08 BridgeBio Pharma

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

09 BridgeBio Pharma

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

10 BridgeBio Pharma

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

Only 10 entries up to this point, click to access all

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

FDF Dossiers

01

BridgeBio Pharma

U.S.A

Duphat

Not Confirmed

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

FDA Orange Book

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Digital Content

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DATA COMPILATION #PharmaFlow

FDA approvals slump 19% in H1 2024; NASH, COPD, PAH get new treatment options

The first half of 2024 saw a significant slowdown in approvals of new drugs and biologics by the US Food and Drug Administration (FDA) compared to the same period last year.FDA’s Center for Drug Evaluation and Research (CDER) approved 21 drugs in H1 2024, reflecting a 19 percent decrease from the 26 approvals granted in H1 2023. Of them, 81 percent (17) were first-in-class drugs (therapies that use a new and unique mechanism of action), while small molecules made up for 67 percent (14) of the total drugs approved.Similarly, the Center for Biologics Evaluation and Research (CBER) granted approvals to only eight biologics, as compared to 10 in H1 2023.Health Canada also saw a drop in drug approvals as only 10 drugs were okayed in H1 2024, as opposed to 13 approvals in H1 2023.The European Medicines Agency (EMA) saw a marginal rise in drug authorizations at 15 for H1 2024 as compared to 14 approvals in H1 2023. Interestingly, the EMA also saw a surge in pending decisions (applications under review) — from two in H1 2023 to 14 in H1 2024.View New Drug Approvals in H1 2024 with Estimated Sales (Free Excel Available)Merck, Madrigal, Verona bag approvals for breakthrough meds; Lilly’s donanemab okayedThe first half saw some closely watched drugs win regulatory approvals. FDA approved a breakthrough therapy from Merck — Winrevair (sotatercept) — that treats adults with hypertension caused by the constriction of arteries in the lungs, known as pulmonary arterial hypertension (PAH).Merck had acquired Winrevair through its US$ 11.5 billion acquisition of Acceleron Pharma in 2021. The therapy is set to generate nearly US$ 3 billion in global peak sales by 2028. Another breakthrough therapy approved in H1 2024 is Madrigal’s Rezdiffra (resmetirom), the first FDA-approved treatment for adults with the common fatty liver disease — nonalcoholic steatohepatitis (NASH). Rezdiffra is expected to touch sales of US$ 2.1 billion by 2028.The agency also approved the first maintenance treatment for chronic obstructive pulmonary disease (COPD) in over 20 years — Verona’s Ohtuvayre. The drug has a novel mechanism of action and is the first inhaled maintenance treatment for COPD. Approved in June by the FDA, Ohtuvayre is forecast to bring in global sales of US$ 1.5 billion by 2030.The approval of Eli Lilly’s donanemab was surprisingly delayed, and finally came through on July 2 after an FDA advisory committee voted unanimously in favor of its benefits outweighing its risks. To be sold as Kinsula, the Alzheimer's drug is estimated to bring in US$ 2.2 billion in sales by 2028.Across the pond, EMA approved Novo Nordisk’s weekly insulin injection Awiqli (insulin icodec). The replacement insulin in Awiqli acts in the same way as the body’s own insulin and helps glucose enter cells from the blood. Meanwhile, FDA rejected this once-a-week insulin earlier this month and has requested information related to the manufacturing process.View New Drug Approvals in H1 2024 with Estimated Sales (Free Excel Available) ImmunityBio, Geron, Day One win approvals for their oncology drugsIn what marks the first approval for ImmunityBio, FDA greenlit Anktiva (nogapendekin alfa inbakicept-pmln) as part of a combination therapy to treat a type of bladder cancer. Anktiva is a next-generation immunotherapy that creates long-term immunity by activating the so-called natural killer (NK) cells and T-cells. It will compete with Merck’s Keytruda. Anktiva’s yearly sales by 2030 are expected to be around US$ 1.7 billion.BeiGene’s PD-1 blocker Tevimbra (tislelizumab) got the go-ahead from the FDA as the treatment for adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor. Tevimbra’s 2028 global sales are forecast to bring in US$ 1.6 billion.FDA signed off on Geron’s Rytelo (imetelstat) for treating transfusion-dependent anemia in patients with low- to intermediate-risk myelodysplastic syndromes (MDS), a group of blood cancers. This was Geron’s maiden approval and Rytelo is expected to bring in US$ 1.3 billion by 2030.Day One Biopharmaceuticals’ Ojemda (tovorafenib) was granted FDA’s accelerated approval to treat certain types of pediatric brain cancer. This is the first FDA approval of a systemic therapy for treating what is the most common form of childhood brain tumor, including fusions. Ojemda is forecast to bring in US$ 1 billion in sales by 2030.FDA granted accelerated approval to Amgen’s Imdelltra (tarlatamab-dlle) for adults in advanced stages of small cell lung cancer (SCLC) that has proven to be hard to treat or has worsened despite platinum-based chemotherapy. Imdelltra is expected to bring in annual sales of US$ 975 million by 2030.View New Drug Approvals in H1 2024 with Estimated Sales (Free Excel Available) Infectious disease drugs from Basilea, Merck, rare disease med from Ipsen bag approvalsAfter oncology, infections and infectious diseases, and rare diseases were the two therapeutic areas that saw the second and third most approvals, respectively. FDA approved Basilea Pharmaceutica’s Zevtera (ceftobiprole medocaril sodium for injection), an antibiotic for bacterial infections including multidrug-resistant strains.The US agency also approved Merck’s next-generation vaccine designed to protect adults from pneumococcus bacteria that causes serious illnesses and pneumonia. The jab, known as Capvaxive, helped produce an immune response against all 21 variations (serotypes) of the bacteria that it targeted. These 21 strains account for about 85 percent of invasive pneumococcal disease cases in adults aged 65 and above. FDA also approved Moderna’s mRESVIA, a messenger RNA-based (mRNA) respiratory syncytial virus (RSV) vaccine, to protect adults aged 60 years and older from lower respiratory tract disease caused by the syncytial virus. This is the first non-Covid mRNA vaccine to be approved in the US.The agency granted accelerated approval to Ipsen’s Iqirvo (elafibranor) to treat primary biliary cholangitis (PBC), a rare liver disease. This is the first new medicine approved in nearly a decade for the treatment of PBC. Orchard Therapeutics’ Lenmeldy secured FDA approval to become the first gene therapy in the US for a rare pediatric disorder, known as metachromatic leukodystrophy (MLD). The debilitating hereditary disease affects the brain and the nervous system and causes loss of cognitive and motor functions and early death.View New Drug Approvals in H1 2024 with Estimated Sales (Free Excel Available) Our viewThe increased momentum of drug approvals witnessed after the pandemic appears to have slowed down, but what’s encouraging is the increase in first-in-class therapies, cancer drugs and promising new treatment options for a range of conditions such as PAH, NASH, and COPD.The second half has already kicked off with the approval of Lilly’s donanemab. And there are several pathbreaking drugs likely to be approved soon, such as Karuna Therapeutics’ schizophrenia drug KarXT and BridgeBio’s heart drug acoramidis. There is every possibility that new drug approvals will spring back up in H2 2024.

Impressions: 2086

NEWS #PharmaBuzz

BridgeBio presents detailed +ve results from Ph3 ATTRibute-CM study acoramidis

27 Aug 2023

// GLOBENEWSWIRE

BridgeBio heart disease med vindicated with phase 3 victory

17 Jul 2023

// Max Bayer FIERCE BIOTECH

BridgeBio shares crash as their lead PhIII drug fails

28 Dec 2021

// John Carroll ENDPTS

ABOUT THIS PAGE

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.

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.

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.

Find Acoramidis Hydrochloride manufacturers, exporters & distributors on PharmaCompass

ACCESS ALL DATA

Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

2 NDC API

DEVELOPMENTS

16 Drugs in Development

FINISHED DOSAGE FORMULATIONS

1 FDF Dossiers

1 FDA Orange Book

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow

3 NEWS #PharmaBuzz

ACTIVE PHARMA INGREDIENTS

API REF. PRICE (USD/KG)

$ 0

MARKET PLACE

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

PATENTS & EXCLUSIVITIES

DIGITAL CONTENT

GLOBAL SALES INFORMATION

0RELATED EXCIPIENT COMPANIES

0EXCIPIENTS BY APPLICATIONS

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01

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03

04

05

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09

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Acoramidis Hydrochloride Manufacturers

Acoramidis Hydrochloride Suppliers

Acoramidis Hydrochloride NDC

Finished drug products

Unfinished drugs

Compounded drug products

Acoramidis Hydrochloride GMP

Acoramidis Hydrochloride CoA

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