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    Also known as: Asundexian [inn], 2064121-65-7, La585um8de, 4-[[(2s)-2-[4-[5-chloro-2-[4-(trifluoromethyl)triazol-1-yl]phenyl]-5-methoxy-2-oxopyridin-1-yl]butanoyl]amino]-2-fluorobenzamide, Unii-la585um8de, Schembl20360602
    Molecular Formula
    C26H21ClF4N6O4
    Molecular Weight
    592.9  g/mol
    InChI Key
    XYWIPYBIIRTJMM-IBGZPJMESA-N
    FDA UNII
    LA585UM8DE
    Asundexian
    1 2D Structure

    Asundexian

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    4-[[(2S)-2-[4-[5-chloro-2-[4-(trifluoromethyl)triazol-1-yl]phenyl]-5-methoxy-2-oxopyridin-1-yl]butanoyl]amino]-2-fluorobenzamide
    2.1.2 InChI
    InChI=1S/C26H21ClF4N6O4/c1-3-19(25(40)33-14-5-6-15(24(32)39)18(28)9-14)36-11-21(41-2)17(10-23(36)38)16-8-13(27)4-7-20(16)37-12-22(34-35-37)26(29,30)31/h4-12,19H,3H2,1-2H3,(H2,32,39)(H,33,40)/t19-/m0/s1
    2.1.3 InChI Key
    XYWIPYBIIRTJMM-IBGZPJMESA-N
    2.1.4 Canonical SMILES
    CCC(C(=O)NC1=CC(=C(C=C1)C(=O)N)F)N2C=C(C(=CC2=O)C3=C(C=CC(=C3)Cl)N4C=C(N=N4)C(F)(F)F)OC
    2.1.5 Isomeric SMILES
    CC[C@@H](C(=O)NC1=CC(=C(C=C1)C(=O)N)F)N2C=C(C(=CC2=O)C3=C(C=CC(=C3)Cl)N4C=C(N=N4)C(F)(F)F)OC
    2.2 Other Identifiers
    2.2.1 UNII
    LA585UM8DE
    2.3 Synonyms
    2.3.1 Depositor-Supplied Synonyms

    1. Asundexian [inn]

    2. 2064121-65-7

    3. La585um8de

    4. 4-[[(2s)-2-[4-[5-chloro-2-[4-(trifluoromethyl)triazol-1-yl]phenyl]-5-methoxy-2-oxopyridin-1-yl]butanoyl]amino]-2-fluorobenzamide

    5. Unii-la585um8de

    6. Schembl20360602

    7. Gtpl11710

    8. Bdbm413842

    9. Glxc-25353

    10. Ex-a6019

    11. Us10421742, Example 235

    12. Bay2433334

    13. Bay 2433334

    14. Bay-2433334

    15. Example 235 [wo2017005725a1]

    16. Hy-137431

    17. Cs-0138630

    18. 1(2h)-pyridineacetamide, N-(4-(aminocarbonyl)-3-fluorophenyl)-4-(5-chloro-2-(4-(trifluoromethyl)-1h-1,2,3-triazol-1-yl)phenyl)-.alpha.-ethyl-5-methoxy-2-oxo-, (.alpha.s)-

    19. 1(2h)-pyridineacetamide, N-(4-(aminocarbonyl)-3-fluorophenyl)-4-(5-chloro-2-(4-(trifluoromethyl)-1h-1,2,3-triazol-1-yl)phenyl)-alpha-ethyl-5-methoxy-2-oxo-, (alphas)-

    20. 4-({(2s)-2-[4-{5-chloro-2-[4-(trifluoromethyl)-1h-1,2,3-triazol-1-yl]phenyl}-5-methoxy-2-oxopyridin-1(2h)-yl]butanoyl}amino)-2-fluorobenzamide (enantiomer 2)

    2.4 Create Date
    2018-12-15
    3 Chemical and Physical Properties
    Molecular Weight 592.9 g/mol
    Molecular Formula C26H21ClF4N6O4
    XLogP33
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count10
    Rotatable Bond Count8
    Exact Mass592.1248935 g/mol
    Monoisotopic Mass592.1248935 g/mol
    Topological Polar Surface Area132 Ų
    Heavy Atom Count41
    Formal Charge0
    Complexity1080
    Isotope Atom Count0
    Defined Atom Stereocenter Count1
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1

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    Pfizer’s buyout of Seagen, drugmakers suing US govt, obesity drugs make it to top 10 Phispers of 2023

    Pfizer’s buyout of Seagen, drugmakers suing US govt, obesity drugs make it to top 10 Phispers of 2023

    Every week, PharmaCompass compiles important developments in the world of pharmaceuticals and brings a compilation to you in the form of Phispers. Of the hundreds of stories we carried in 2023, here are the top 10 stories, including some trends and updates.I. Pfizer buys Seagen for US$ 43 billion to bolster its oncology portfolioIn March, Pfizer said it is acquiring cancer treatment specialist Seagen for US$ 43 billion. Seagen is a pioneer in antibody-drug conjugates (ADCs), or drugs that work like “guided missiles” to destroy cancer cells while sparing healthy cells. Another important deal in the field of ADCs took place in December when AbbVie picked up ImmunoGen for US$ 10.1 billion, giving it access to Elahere (mirvetuximab soravtansine-gynx), an ADC approved for platinum-resistant ovarian cancer. Elahere is expected to achieve blockbuster status by 2030. II. Merck, BMS, trade bodies, sue US government over IRA negotiationsIn June, Merck filed a lawsuit against the US government seeking to block Medicare from negotiating lower prescription drug prices under the Inflation Reduction Act (IRA). Days later, the US Chamber of Commerce, one of the most influential trade groups in the US, filed a separate lawsuit, arguing that the negotiations violated drugmakers’ constitutional rights and granted excessive control over prices to the government. They were joined by Bristol Myers Squibb (BMS) and lobby group PhRMA. Drugmakers and the Biden administration appeared to be at each other’s throats. In December, the White House identified 48 drugs whose prices spiked faster than inflation in Q4. These drugs may be subject to rebates starting January 2024. Biden Administration also announced it is setting a new “march-in” policy that allows the government to seize medicine patents held by drugmakers for therapies whose development was taxpayer-funded, if it believes they are not “reasonably available and affordable.”III. US, UK approve Lilly’s Mounjaro for weight management; to be sold as ZepboundIn November, drug regulators in the US and the United Kingdom approved Eli Lilly's Mounjaro (tirzepatide) for weight management, to be sold under the brand name Zepbound. The drug will pose strong competition to Novo Nordisk’s Wegovy in a market that's expected to reach US$ 100 billion by the end of the decade.IV. Novo, Lilly plan capacity expansions for weight loss drugsBoth Novo Nordisk and Eli Lilly announced expanding their manufacturing capacities in order to capitalize on the burgeoning market for weight loss drugs. Novo is investing over DKK 42 billion (US$ 6 billion) in Kalundborg (Denmark), US$ 2.3 billion to expand its site in Chartres (France) and over € 2 billion (US$ 2.18 billion) in Dublin (Ireland) to boost production of its blockbuster diabetes and weight-loss drugs, including Ozempic and Wegovy (both semaglutide). Similarly, Eli Lilly had announced a US$ 2.5 billion manufacturing facility in Germany in November to address the demand for its new obesity and diabetes therapies.V. FDA finds violations at Global Pharma’s eye drops plant in India; issues Form 483In April, FDA found several violations in manufacturing processes and sterilization methods used by India-based Global Pharma for its EzriCare Artificial Tears Eye Drop, which has been linked to 68 cases of eye infection in the US, including eight cases of vision loss and three deaths.VI. ‘Intas India staff tore documents, threw acid to destroy evidence’, notes FDAIn January, FDA issued a Form 483 with 11 observations to Intas Pharma’s drug manufacturing facility in Ahmedabad (Gujarat, India). A team of three FDA drug regulators conducted an inspection of the manufacturing facility from November 22 to December 2, 2022. The 36-page report issued by the FDA has alleged that employees at the facility had destroyed documents related to manufacturing practices by tearing them into pieces and disposing them inside the quality control lab and scrap areas. Acid was used to destroy evidence, notes FDA.VII. GSK overtakes Pfizer in bagging first FDA approval for RSV vaccineIn May, FDA approved GSK’s respiratory syncytial virus (RSV) vaccine for people aged 60 and above. Arexvy is the first RSV vaccine to be approved in the US for the common condition that can be fatal for the elderly. Later that month, Pfizer’s RSV vaccine Abrysvo also got approved. In July, Sanofi-AstraZeneca’s RSV antibody therapy, Beyfortus (nirsevimab-alip), received approval from the FDA. It is a long-acting treatment that can be given once per season. The approval is specifically developed for newborns and infants.VIII. UK authorizes gene therapy Casgevy for blood disorders, US follows suit In November, Britain’s Medicines and Healthcare products Regulatory Agency was first off the block in authorizing CRISPR Therapeutics and Vertex Pharmaceuticals’ Casgevy, a therapy that seeks to cure two blood disorders — sickle-cell disease (SCD) and β-thalassemia. The therapy is based on gene editing technology that had won its scientists the Nobel Prize in Chemistry in 2020.Less than a month later, FDA not only approved Casgevy (exagamglogene autotemcel) for SCD, but also approved bluebird bio’s Lyfgenia (lovotibeglogene autotemcel) for the treatment of SCD in patients aged 12 and older who have a history of vaso-occlusive events (when tissues become deprived of oxygen).IX. Leqembi becomes first med to bag full approval to treat Alzheimer’sEisai and Biogen’s Alzheimer’s drug Leqembi (lecanemab) had won FDA’s accelerated approval in January. It treats patients who are in the earliest stages of the neurodegenerative disease. In July, it became the first treatment to receive full FDA approval to treat the condition.X. Bayer’s experimental anticoagulant fails late-stage trialOne of the biggest disappointments from clinical trials came when a major late-stage trial for Bayer’s experimental anticoagulant asundexian had to be discontinued due to its inadequate effectiveness. Bayer had expectations in excess of € 5 billion (US$ 5.5 billion) from this drug.  
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    Pipeline Prospector November 2025: Kimberly-Clark to buy Kenvue for US$ 48.7 bn; FDA approves Novartis’ gene therapy

    Pipeline Prospector November 2025: Kimberly-Clark to buy Kenvue for US$ 48.7 bn; FDA approves Novartis’ gene therapy

    November saw several big ticket acquisitions across the consumer health and biopharma space, including the US$ 48.7 billion acquisition of Johnson & Johnson’s consumer health unit Kenvue by Kimberly-Clark and Pfizer’s up to US$ 10 billion acquisition of obesity-focused biotech Metsera. Additionally, the trend of companies announcing capacity expansions continued unabated.The month saw several key drug approvals by the US Food and Drug Administration (FDA), including Kura Oncology-Kyowa Kirin’s Komzifti (ziftomenib) for treating adults with relapsed or refractory acute myeloid leukemia (AML) with an NPM1 mutation.The indices rose substantially during the month. The Nasdaq Biotechnology Index (NBI) rose 8.85 percent, from 5,344.91 at the end of October to 5,818.03 by November-end. The SPDR S&P Biotech ETF (XBI) gained 10.97 percent from 110.98 to 123.16. The S&P Biotechnology Select Industry Index (SPSIBI) also advanced 9.08 percent — from 8,789.93 to 9,588.09. Access the Pipeline Prospector Dashboard for November 2025 Newsmakers (Free Excel)Pfizer clinches up to US$ 10 bn deal for Metsera; Merck to buy Cidara for US$ 9.2 bnPfizer inked an agreement worth up to US$ 10 billion to acquire obesity-focused biotech Metsera. The deal ended a competitive bidding process between Pfizer and Novo Nordisk. Pfizer had filed lawsuits, alleging that Metsera breached an earlier merger agreement. Metsera accepted Pfizer’s revised offer after raising concerns about potential antitrust risks associated with Novo’s competing bid. In early November, Kimberly-Clark announced the acquisition of Johnson & Johnson’s consumer health unit — Kenvue — in a cash-and-stock deal valued at US$ 48.7 billion. The merger will create a consumer health company with expected annual revenue of about US$ 32 billion and a portfolio of highly-valued brands, including Tylenol (paracetamol), Neutrogena, Aveeno, and Listerine.Merck announced the acquisition of Cidara Therapeutics in a deal valued at US$ 9.2 billion. The acquisition gives Merck access to an experimental influenza antiviral designed to provide season-long protection with a single dose. Its stock rose 22 percent in November.Johnson & Johnson is buying Halda Therapeutics for US$ 3.05 billion in cash. Halda, a Connecticut-based biotech, adds early-stage cancer programs to J&J’s pipeline, including a lead candidate in prostate cancer.Like Pfizer and Novo Nordisk, Lundbeck and Alkermes were also embroiled in a bidding war for Avadel Pharmaceuticals. Lundbeck later withdrew from the race, clearing the way for Alkermes, which eventually agreed to acquire Avadel for US$ 2.37 billion.Drugmakers continued to announce plans to expand capacities. Eli Lilly (whose stock rose 22 percent in November) announced plans to invest US$ 3 billion to build an oral medicines manufacturing site in the Netherlands to support its experimental GLP-1 pill, orforglipron. It will also invest more than US$ 1.2 billion to expand its facility in Puerto Rico.AstraZeneca said it will invest US$ 2 billion to expand its manufacturing capacity in Maryland (US). And Novartis said it will set up a flagship manufacturing hub in North Carolina, post a trade agreement that lowers US tariff rates on Swiss imports. Access the Pipeline Prospector Dashboard for November 2025 Newsmakers (Free Excel) FDA approves Komzifti for leukemia; Bayer’s Hyrnuo wins accelerated approval for lung cancerFDA approved Komzifti (ziftomenib), a once-daily pill from Kura Oncology and Japan’s Kyowa Kirin, for adults with relapsed or refractory acute myeloid leukemia (AML) with an NPM1 mutation.The agency also expanded the approval of Epkinly (epcoritamab), developed by AbbVie and Genmab, for use as a second-line treatment of relapsed or refractory follicular lymphoma.The agency also granted accelerated approval to Bayer’s Hyrnuo (sevabertinib) for people with non-squamous non-small cell lung cancer (NSCLC) that has recurred or spread and carries a specific HER2 mutation.Moreover, FDA approved UCB’s Kygevvi (doxecitine and doxribtimine), the first treatment for thymidine kinase 2 deficiency (TK2d), a rare inherited mitochondrial disorder that leads to progressive muscle weakness and respiratory complications.Further, FDA approved Redemplo (plozasiran sodium), Arrowhead Pharmaceuticals’ first marketed drug for adults with familial chylomicronemia syndrome (FCS), a rare genetic disorder that causes extremely high levels of triglycerides in the blood that can cause acute pancreatitis. During the month, Arrowhead’s stock price went up by 31 percent.FDA also granted accelerated approval to Otsuka’s Voyxact (sibeprenlimab-szsi) to help reduce excess urinary protein in adults with IgA nephropathy, a chronic kidney disease.Separately, FDA approved Novartis’ gene-replacement therapy Itvisma (onasemnogene abeparvovec-brve) for patients aged two years and older with spinal muscular atrophy (SMA) caused by an SMN1 mutation. Itvisma uses the same active ingredient as Zolgensma and is the first approved gene therapy for a broader SMA population.Other than these, the regulator approved the Padcev (enfortumab vedotin) and Keytruda (pembrolizumab) regimen for people with muscle-invasive bladder cancer who cannot receive cisplatin-based chemotherapy. The combination is the first and only approved regimen that can be used before and after surgery. Access the Pipeline Prospector Dashboard for November 2025 Newsmakers (Free Excel) Bayer’s asundexian shows benefit in strokes; Novo’s Rybelsus fails Alzheimer’s trialsThe month saw several trial wins. For instance, Bayer reported positive phase 3 results for asundexian, an experimental blood thinner that lowered the risk of repeated strokes without increasing major bleeding. In another phase 3 trial, Amgen’s Repatha (evolocumab) reduced major cardiovascular events in adults without prior heart attack or stroke when added to statins or other therapies.Cogent Biosciences (stock up 146 percent in November) reported strong phase 3 results for bezuclastinib in combination with sunitinib in patients with gastrointestinal stromal tumor (GIST) whose disease had progressed after earlier treatment.In trial failures, Novo Nordisk’s oral semaglutide pill, Rybelsus, failed to slow Alzheimer’s disease progression in two large phase 3 trials. The studies showed no benefit over placebo in more than 3,800 people with early-stage disease.The agency also paused two phase 3 studies of Intellia’s gene-editing therapy nexiguran ziclumeran after a patient developed severe liver problems. The share price of the company fell by 33 percent over the month.November wasn’t a good month for Sarepta (its stock was down 13 percent). The company said its late-stage trial of casimersen and golodirsen for Duchenne muscular dystrophy did not meet its main goal. Moreover, FDA added a boxed warning to Sarepta’s gene therapy Elevidys (delandistrogene moxeparvovec-rokl) following the deaths of two non-ambulatory children from acute liver failure. Access the Pipeline Prospector Dashboard for November 2025 Newsmakers (Free Excel) Our viewAfter a few difficult years marked by stock-market volatility and disruptions in global supply chains, the pharmaceutical sector is finally showing signs of sustained growth and stability. The uptick in big-ticket M&A activity is a clear indicator of the industry’s confidence. These are all huge positives as we move closer to 2026. Access the Pipeline Prospector Dashboard for November 2025 Newsmakers (Free Excel) 

    Impressions: 2019

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    https://www.pharmacompass.com/pipeline-prospector-blog/pipeline-prospector-november-2025-kimberly-clark-to-buy-kenvue-for-us-48-7-bn-fda-approves-novartis-gene-therapy

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    Looking for 2064121-65-7 / Asundexian API manufacturers, exporters & distributors?

    Asundexian manufacturers, exporters & distributors 1

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

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

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

    API | Excipient name

    Asundexian

    Synonyms

    Asundexian [inn], 2064121-65-7, La585um8de, 4-[[(2s)-2-[4-[5-chloro-2-[4-(trifluoromethyl)triazol-1-yl]phenyl]-5-methoxy-2-oxopyridin-1-yl]butanoyl]amino]-2-fluorobenzamide, Unii-la585um8de, Schembl20360602

    Cas Number

    2064121-65-7

    Unique Ingredient Identifier (UNII)

    LA585UM8DE

    Asundexian Manufacturers

    A Asundexian manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Asundexian, including repackagers and relabelers. The FDA regulates Asundexian manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Asundexian API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

    Asundexian Suppliers

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

    Asundexian GMP

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

    Asundexian CoA

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

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

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