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    Chemistry

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    Also known as: 850649-62-6, Nesina, Syr 322, Syr-322, Alogliptin (benzoate), (r)-2-((6-(3-aminopiperidin-1-yl)-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2h)-yl)methyl)benzonitrile benzoate
    Molecular Formula
    C25H27N5O4
    Molecular Weight
    461.5  g/mol
    InChI Key
    KEJICOXJTRHYAK-XFULWGLBSA-N
    FDA UNII
    EEN99869SC
    Alogliptin Benzoate
    Alogliptin Benzoate is the benzoate salt form of alogliptin, a selective, orally bioavailable, pyrimidinedione-based inhibitor of dipeptidyl peptidase 4 (DPP-4), with hypoglycemic activity. In addition to its effect on glucose levels, alogliptin may inhibit inflammatory responses by preventing the toll-like receptor 4 (TLR-4)-mediated formation of proinflammatory cytokines.
    1 2D Structure

    Alogliptin Benzoate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    2-[[6-[(3R)-3-aminopiperidin-1-yl]-3-methyl-2,4-dioxopyrimidin-1-yl]methyl]benzonitrile;benzoic acid
    2.1.2 InChI
    InChI=1S/C18H21N5O2.C7H6O2/c1-21-17(24)9-16(22-8-4-7-15(20)12-22)23(18(21)25)11-14-6-3-2-5-13(14)10-19;8-7(9)6-4-2-1-3-5-6/h2-3,5-6,9,15H,4,7-8,11-12,20H2,1H3;1-5H,(H,8,9)/t15-;/m1./s1
    2.1.3 InChI Key
    KEJICOXJTRHYAK-XFULWGLBSA-N
    2.1.4 Canonical SMILES
    CN1C(=O)C=C(N(C1=O)CC2=CC=CC=C2C#N)N3CCCC(C3)N.C1=CC=C(C=C1)C(=O)O
    2.1.5 Isomeric SMILES
    CN1C(=O)C=C(N(C1=O)CC2=CC=CC=C2C#N)N3CCC[C@H](C3)N.C1=CC=C(C=C1)C(=O)O
    2.2 Other Identifiers
    2.2.1 UNII
    EEN99869SC
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 2-((6-((3r)-3-aminopiperidin-1-yl)-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2h)-yl)methyl) Benzonitrile

    2. Alogliptin

    3. Nesina

    4. Syr 322

    5. Syr-322

    6. Syr322

    2.3.2 Depositor-Supplied Synonyms

    1. 850649-62-6

    2. Nesina

    3. Syr 322

    4. Syr-322

    5. Alogliptin (benzoate)

    6. (r)-2-((6-(3-aminopiperidin-1-yl)-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2h)-yl)methyl)benzonitrile Benzoate

    7. 850649-62-6 (benzoate)

    8. Alogliptin (as Benzoate)

    9. Een99869sc

    10. Chebi:72324

    11. 2-((6-((3r)-3-amino-1-piperidinyl)-3,4-dihydro-3-methyl-2,4-dioxo-1(2h)- Pyrimidinyl)methyl)benzonitrile Monobenzoate

    12. 2-[[6-[(3r)-3-aminopiperidin-1-yl]-3-methyl-2,4-dioxopyrimidin-1-yl]methyl]benzonitrile;benzoic Acid

    13. 6-((3r)-3-aminopiperidin-1-yl)-1-(2-cyanobenzyl)-3-methylpyrimidin-2,4(1h,3h)-dione Monobenzoate

    14. Benzonitrile, 2-((6-((3r)-3-amino-1-piperidinyl)-3,4-dihydro-3-methyl-2,4-dioxo-1(2h)-pyrimidinyl)methyl)-, Monobenzoate

    15. Alogliptin, Benzoate

    16. Alogliptin Benzoate [usan]

    17. Unii-een99869sc

    18. Mfcd09833195

    19. Alogliptin Benzoate [usan:jan]

    20. Vipidia (tn)

    21. Nesina (tn)

    22. Alogliptin Monobenzoate

    23. Alogliptin(syr-322)

    24. Schembl476231

    25. Chembl227529

    26. Alogliptin Benzoate [mi]

    27. Alogliptin Benzoate (jan/usan)

    28. Alogliptin Benzoate [jan]

    29. Dtxsid20582095

    30. Alogliptin Benzoate [vandf]

    31. Alogliptin Benzoate [mart.]

    32. Bcp08885

    33. Hy-a0023

    34. Ac-021

    35. Alogliptin Benzoate [who-dd]

    36. Akos015917686

    37. Cs-0761

    38. Alogliptin Benzoate [orange Book]

    39. 2-[[6-[(3r)-3-amino-1-piperidinyl]-3,4-dihydro-3-methyl-2,4-dioxo-1(2h)-pyrimidinyl]methyl]benzonitrile Benzoate

    40. As-14073

    41. Oseni Component Alogliptin Benzoate

    42. Kazano Component Alogliptin Benzoate

    43. Alogliptin Pound Syr-322 Pound(c)benzoate

    44. Alogliptin Benzoate Component Of Oseni

    45. Am20090704

    46. Alogliptin Benzoate Component Of Kazano

    47. D06553

    48. Q27888443

    49. Syr 322 Benzoate; Syr-322 Benzoate; Syr322 Benzoate

    50. (3r)-1-[3-(2-cyanobenzyl)-1-methyl-2,6-dioxo-1,2,3,6-tetrahydropyrimidin-4-yl]piperidin-3-aminium Benzoate

    51. 2-((6-((3r)-3-aminopiperidin-1-yl)-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2h)-yl)methyl)benzonitrile Monobenzoate

    52. 2-({6-[(3r)-3-aminopiperidin-1-yl]-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2h)-yl}methyl)benzonitrile Benzoate

    53. Benzoic Acid--2-({6-[(3r)-3-aminopiperidin-1-yl]-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2h)-yl}methyl)benzonitrile (1/1)

    54. Benzonitrile, 2-[[6-[(3r)-3-amino-1-piperidinyl]-3,4-dihydro-3-methyl-2,4-dioxo-1(2h)-pyrimidinyl]methyl]-, Benzoate (1:1)

    2.4 Create Date
    2007-06-18
    3 Chemical and Physical Properties
    Molecular Weight 461.5 g/mol
    Molecular Formula C25H27N5O4
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count7
    Rotatable Bond Count4
    Exact Mass461.20630436 g/mol
    Monoisotopic Mass461.20630436 g/mol
    Topological Polar Surface Area131 Ų
    Heavy Atom Count34
    Formal Charge0
    Complexity726
    Isotope Atom Count0
    Defined Atom Stereocenter Count1
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NameNesina
    PubMed HealthAlogliptin (By mouth)
    Drug ClassesAntidiabetic
    Drug LabelNESINA tablets contain the active ingredient alogliptin, which is a selective, orally bioavailable inhibitor of the enzymatic activity of dipeptidyl peptidase-4 (DPP-4).Chemically, alogliptin is prepared as a benzoate salt, which is identified as 2-(...
    Active IngredientAlogliptin benzoate
    Dosage FormTablet
    RouteOral
    Strengtheq 12.5mg base; eq 6.25mg base; eq 25mg base
    Market StatusPrescription
    CompanyTakeda Pharms Usa

    2 of 2  
    Drug NameNesina
    PubMed HealthAlogliptin (By mouth)
    Drug ClassesAntidiabetic
    Drug LabelNESINA tablets contain the active ingredient alogliptin, which is a selective, orally bioavailable inhibitor of the enzymatic activity of dipeptidyl peptidase-4 (DPP-4).Chemically, alogliptin is prepared as a benzoate salt, which is identified as 2-(...
    Active IngredientAlogliptin benzoate
    Dosage FormTablet
    RouteOral
    Strengtheq 12.5mg base; eq 6.25mg base; eq 25mg base
    Market StatusPrescription
    CompanyTakeda Pharms Usa

    4.2 Drug Indication

    Vipidia is indicated in adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control in combination with other glucose lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see sections 4. 4, 4. 5 and 5. 1 for available data on different combinations).

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Dipeptidyl-Peptidase IV Inhibitors

    Compounds that suppress the degradation of INCRETINS by blocking the action of DIPEPTIDYL-PEPTIDASE IV. This helps to correct the defective INSULIN and GLUCAGON secretion characteristic of TYPE 2 DIABETES MELLITUS by stimulating insulin secretion and suppressing glucagon release. (See all compounds classified as Dipeptidyl-Peptidase IV Inhibitors.)

    Hypoglycemic Agents

    Substances which lower blood glucose levels. (See all compounds classified as Hypoglycemic Agents.)

    Incretins

    Peptides which stimulate INSULIN release from the PANCREATIC BETA CELLS following oral nutrient ingestion, or postprandially. (See all compounds classified as Incretins.)

    5.2 ATC Code

    A10BH04

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    25-Jan-2021
    20-Dec-2024
    KGS
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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET;ORAL - EQ 12.5MG BASE;1GM

    USFDA APPLICATION NUMBER - 203414

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    DOSAGE - TABLET;ORAL - EQ 12.5MG BASE;500MG

    USFDA APPLICATION NUMBER - 203414

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    DOSAGE - TABLET;ORAL - EQ 12.5MG BASE

    USFDA APPLICATION NUMBER - 22271

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    DOSAGE - TABLET;ORAL - EQ 25MG BASE

    USFDA APPLICATION NUMBER - 22271

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    DOSAGE - TABLET;ORAL - EQ 6.25MG BASE

    USFDA APPLICATION NUMBER - 22271

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    ABOUT THIS PAGE

    Alogliptin Benzoate Manufacturers

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

    Alogliptin Benzoate Suppliers

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

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

    Alogliptin Benzoate USDMF

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

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

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

    Alogliptin Benzoate JDMF

    The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

    The Alogliptin Benzoate Drug Master File in Japan (Alogliptin Benzoate JDMF) empowers Alogliptin Benzoate API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

    PMDA reviews the Alogliptin Benzoate JDMF during the approval evaluation for pharmaceutical products. At the time of Alogliptin Benzoate JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

    click here to find a list of Alogliptin Benzoate suppliers with JDMF on PharmaCompass.

    Alogliptin Benzoate KDMF

    In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

    Pharmaceutical companies submit a Alogliptin Benzoate Drug Master File in Korea (Alogliptin Benzoate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Alogliptin Benzoate. The MFDS reviews the Alogliptin Benzoate KDMF as part of the drug registration process and uses the information provided in the Alogliptin Benzoate KDMF to evaluate the safety and efficacy of the drug.

    After submitting a Alogliptin Benzoate KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Alogliptin Benzoate API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Alogliptin Benzoate suppliers with KDMF on PharmaCompass.

    Alogliptin Benzoate WC

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

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

    Alogliptin Benzoate 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 Alogliptin Benzoate as an active pharmaceutical ingredient (API).

    Finished drug products

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

    click here to find a list of Alogliptin Benzoate suppliers with NDC on PharmaCompass.

    Alogliptin Benzoate GMP

    Alogliptin Benzoate 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 Alogliptin Benzoate 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 Alogliptin Benzoate GMP manufacturer or Alogliptin Benzoate GMP API supplier for your needs.

    Alogliptin Benzoate CoA

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

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

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