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    Chemistry

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    Also known as: 138786-67-1, Pantoloc, Protonix, Pantecta, Zurcal, Pantoprazole sodium salt
    Molecular Formula
    C16H14F2N3NaO4S
    Molecular Weight
    405.4  g/mol
    InChI Key
    YNWDKZIIWCEDEE-UHFFFAOYSA-N
    Pantoprazole Sodium
    2-pyridinylmethylsulfinylbenzimidazole proton pump inhibitor that is used in the treatment of GASTROESOPHAGEAL REFLUX and PEPTIC ULCER.
    1 2D Structure

    Pantoprazole Sodium

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    sodium;5-(difluoromethoxy)-2-[(3,4-dimethoxypyridin-2-yl)methylsulfinyl]benzimidazol-1-ide
    2.1.2 InChI
    InChI=1S/C16H14F2N3O4S.Na/c1-23-13-5-6-19-12(14(13)24-2)8-26(22)16-20-10-4-3-9(25-15(17)18)7-11(10)21-16;/h3-7,15H,8H2,1-2H3;/q-1;+1
    2.1.3 InChI Key
    YNWDKZIIWCEDEE-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    COC1=C(C(=NC=C1)CS(=O)C2=NC3=C([N-]2)C=CC(=C3)OC(F)F)OC.[Na+]
    2.2 Synonyms
    2.2.1 MeSH Synonyms

    1. By 1023

    2. By-1023

    3. By1023

    4. Pantoprazole

    5. Protonix

    6. Sk And F 96022

    7. Sk And F-96022

    8. Sk And F96022

    9. Skf 96022

    10. Skf-96022

    11. Skf96022

    2.2.2 Depositor-Supplied Synonyms

    1. 138786-67-1

    2. Pantoloc

    3. Protonix

    4. Pantecta

    5. Zurcal

    6. Pantoprazole Sodium Salt

    7. Skf96022 Sodium

    8. By-1023 Sodium

    9. Chebi:50270

    10. Sodium;5-(difluoromethoxy)-2-[(3,4-dimethoxypyridin-2-yl)methylsulfinyl]benzimidazol-1-ide

    11. Pantozol Control

    12. 5-(difluoromethoxy)-2-(((3,4-dimethoxy-2-pyridinyl)methyl) Sulfinyl)-1h-benzimidazole Sodium

    13. Dsstox_cid_24215

    14. Dsstox_rid_80123

    15. Dsstox_gsid_44215

    16. Sodium 5-(difluoromethoxy)-2-(((3,4-dimethoxypyridin-2-yl)methyl)sulfinyl)benzo[d]imidazol-1-ide

    17. Sodium 5-(difluoromethoxy)-2-((3,4-dimethoxypyridin-2-yl)methylsulfinyl)benzo[d]imidazol-1-ide

    18. Cas-138786-67-1

    19. Anagastra

    20. Inipomp

    21. Pantorc

    22. Peptazol

    23. Ulcotenal

    24. Citrel

    25. Apton

    26. Rifun

    27. Pantoprazole Sodium;

    28. By1023 (sodium)

    29. Pantoprazole Sodium,(s)

    30. Skf96022 (sodium)

    31. Schembl3543

    32. Mls001424073

    33. Pantoprazole Sodium Monohydrate

    34. Chembl1200408

    35. Dtxsid7044215

    36. Dz-2352a

    37. Hms2051l19

    38. Hms3393l19

    39. Hms3715d12

    40. Act02633

    41. Tox21_112996

    42. Tox21_302362

    43. Mfcd01658543

    44. S4538

    45. Akos015994677

    46. Ccg-100980

    47. Ks-1093

    48. Nc00230

    49. S86p671

    50. Sb17369

    51. By-1023/sk&f-96022

    52. Ncgc00255835-01

    53. Smr000469592

    54. Ft-0602602

    55. Ft-0673508

    56. A807440

    57. B-8610-23/sk&f-96022-z

    58. J-516336

    59. B-8510-29

    60. Q27122012

    61. Sodium 5-(difluoromethoxy)-2-[(3,4-dimethoxypyridin-2-yl)methylsulfinyl] Benzimidazol-1-ide

    62. 5-(difluoromethoxy)-2-(((3,4-dimethoxypyridin-2-yl)methyl)sulfinyl)-1h-benzo[d]imidazole, Sodium Salt

    63. 5-(difluoromethoxy)-2-[(3,4-dimethoxy-2-pyridyl)methylsulfinyl]benzimidazol-1-ide; Sodium;pantoprazole Sodium

    64. Sodium 5-(difluoromethoxy)-2-(((3,4-dimethoxy-2-pyridinyl)methyl)sulfinyl)-1h-benzimidazole

    65. Sodium 5-(difluoromethoxy)-2-{[(3,4-dimethoxypyridin-2-yl)methyl]sulfinyl}benzimidazol-1-ide

    2.2.3 Other Synonyms

    1. Pantozol

    2. S-pantoprazole

    3. Pantoprazole

    2.3 Create Date
    2007-02-09
    3 Chemical and Physical Properties
    Molecular Weight 405.4 g/mol
    Molecular Formula C16H14F2N3NaO4S
    Hydrogen Bond Donor Count0
    Hydrogen Bond Acceptor Count10
    Rotatable Bond Count7
    Exact Mass405.05707772 g/mol
    Monoisotopic Mass405.05707772 g/mol
    Topological Polar Surface Area90.8 Ų
    Heavy Atom Count27
    Formal Charge0
    Complexity497
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count1
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 4  
    Drug NamePantoprazole sodium
    Drug LabelThe active ingredient in pantoprazole sodium delayed-release tablets USP is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole sesquihydrate, a compound that inhibits gastric acid...
    Active IngredientPantoprazole sodium
    Dosage FormInjectable; Tablet, delayed release
    Routeinjection; Iv (infusion); Oral
    Strengtheq 20mg base; eq 40mg base/vial; eq 40mg base; 40mg
    Market StatusTentative Approval; Prescription
    CompanyWockhardt; Mylan Pharms; Hetero Labs Ltd V; Teva Parenteral; Teva; Apotex; Aurobindo Pharma; Torrent Pharms; Sun Pharma Global; Perrigo R And D; Actavis Elizabeth; Macleods Pharms; Jubilant Generics; Kudco Ireland; Ranbaxy Labs; Dr Reddys Labs; Akorn

    2 of 4  
    Drug NameProtonix iv
    Active IngredientPantoprazole sodium
    Dosage FormInjectable
    RouteIv (infusion)
    Strengtheq 40mg base/vial
    Market StatusPrescription
    CompanyWyeth Pharms

    3 of 4  
    Drug NamePantoprazole sodium
    Drug LabelThe active ingredient in pantoprazole sodium delayed-release tablets USP is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole sesquihydrate, a compound that inhibits gastric acid...
    Active IngredientPantoprazole sodium
    Dosage FormInjectable; Tablet, delayed release
    Routeinjection; Iv (infusion); Oral
    Strengtheq 20mg base; eq 40mg base/vial; eq 40mg base; 40mg
    Market StatusTentative Approval; Prescription
    CompanyWockhardt; Mylan Pharms; Hetero Labs Ltd V; Teva Parenteral; Teva; Apotex; Aurobindo Pharma; Torrent Pharms; Sun Pharma Global; Perrigo R And D; Actavis Elizabeth; Macleods Pharms; Jubilant Generics; Kudco Ireland; Ranbaxy Labs; Dr Reddys Labs; Akorn

    4 of 4  
    Drug NameProtonix iv
    Active IngredientPantoprazole sodium
    Dosage FormInjectable
    RouteIv (infusion)
    Strengtheq 40mg base/vial
    Market StatusPrescription
    CompanyWyeth Pharms

    4.2 Drug Indication

    Short-term treatment of reflux symptoms (e. g. heartburn, acid regurgitation) in adults.

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Anti-Ulcer Agents

    Various agents with different action mechanisms used to treat or ameliorate PEPTIC ULCER or irritation of the gastrointestinal tract. This has included ANTIBIOTICS to treat HELICOBACTER INFECTIONS; HISTAMINE H2 ANTAGONISTS to reduce GASTRIC ACID secretion; and ANTACIDS for symptomatic relief. (See all compounds classified as Anti-Ulcer Agents.)

    Proton Pump Inhibitors

    Compounds that inhibit H(+)-K(+)-EXCHANGING ATPASE. They are used as ANTI-ULCER AGENTS and sometimes in place of HISTAMINE H2 ANTAGONISTS for GASTROESOPHAGEAL REFLUX. (See all compounds classified as Proton Pump Inhibitors.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Proton Pump Inhibitors [MoA]; Proton Pump Inhibitor [EPC]
    5.3 ATC Code

    A02BC02

    API Reference Price

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COLONY,","city":"VISAKHAPATNAM,ANDHRA PRADESH","supplier":"GL PHARMA","supplierCountry":"INDIA","foreign_port":"N\/A","customer":"ASSURGEN PHARMA","customerCountry":"INDIA","quantity":"99.00","actualQuantity":"99","unit":"KGS","unitRateFc":"100","totalValueFC":"12068.1","currency":"EUR","unitRateINR":"9194.4","date":"20-Dec-2021","totalValueINR":"910247.59","totalValueInUsd":"12068.1","indian_port":"HYDERABAD AIR","hs_no":"29339990","bill_no":"6763719","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"","customerAddress":"02-35-73\/8, PLOT NO. 74,,SECTOR 10 , MVP COLONY,"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1645813800,"product":"RE IMPORT PANTOPRAZOLE SODIUM SESQUIHYDRATE PH EUR (SB NO 5956479 DT 31\/07\/2019 EXPORT INV NO RPL3719E102\/31\/07\/2019","address":"425\/3 RT D NO 7-1-621\/328, S.R.NAGAR Contact No: 919177739734","city":"HYDERABAD","supplier":"ALFRED E TIEFENBACHER GMBH","supplierCountry":"INDIA","foreign_port":"NA","customer":"RAKSHIT PHARMACEUTICALS LIMITED","customerCountry":"INDIA","quantity":"2170.00","actualQuantity":"2170","unit":"KGS","unitRateFc":"107","totalValueFC":"269185.5","currency":"EUR","unitRateINR":"9298.3","date":"26-Feb-2022","totalValueINR":"20177311","totalValueInUsd":"269185.5","indian_port":"MADRAS SEA","hs_no":"29331999","bill_no":"7661437","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"425\/3 RT D NO 7-1-621\/328, S.R.NAGAR Contact No: 919177739734"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1649701800,"product":"PANTOPRAZOLE SODIUM SESQUIHYDRATE PH.EUR (RE-IMP VIDE SB.NO4337714 DT:07.08.2020)","address":"H NO 8-3-680 OPP VISHAL TOWERS,LIC COLONY 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","supplierCountry":"INDIA","foreign_port":"NA","customer":"HETERO DRUGS","customerCountry":"INDIA","quantity":"293.61","actualQuantity":"293.61","unit":"KGS","unitRateFc":"209","totalValueFC":"63172.2","currency":"USD","unitRateINR":"17119.4","date":"11-Aug-2022","totalValueINR":"5026434.06","totalValueInUsd":"63172.2","indian_port":"HYDERABAD AIR","hs_no":"29339990","bill_no":"9965959","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"7-2-A2, HETERO CORPORATE, INDUSTRIAL ESTATE, SANATHNAGAR, Con"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1660156200,"product":"PANTOPRAZOLE SODIUM SESQUIHYDRATE USP (BATCH NO.: PN21070094)","address":"7-2-A2, HETERO CORPORATE, INDUSTRIAL ESTATE, SANATHNAGAR, Con","city":"HYDERABAD","supplier":"VARTIA PHARMA PTE. ","supplierCountry":"INDIA","foreign_port":"NA","customer":"HETERO DRUGS","customerCountry":"INDIA","quantity":"303.75","actualQuantity":"303.75","unit":"KGS","unitRateFc":"209","totalValueFC":"65353.9","currency":"USD","unitRateINR":"17119.4","date":"11-Aug-2022","totalValueINR":"5200025.02","totalValueInUsd":"65353.9","indian_port":"HYDERABAD AIR","hs_no":"29339990","bill_no":"9965959","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"7-2-A2, HETERO CORPORATE, INDUSTRIAL ESTATE, SANATHNAGAR, Con"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1680287400,"product":"(RE-IMPORT) PANTOPRAZOLE SODIUM SESQUIHYDRATE PH EUR (BATCHNO: PN22030105 & PN22030106)(SB NO:9225367, 26.03.22)","address":"7-2-A2, HETERO CORPORATE, INDUSTRIAL ESTATE, SANATHNAGAR, Con","city":"HYDERABAD","supplier":"SANDOZ AG, LICHTSTRASSE 35, 4056 BASEL, SWITZERLAN","supplierCountry":"INDIA","foreign_port":"NA","customer":"HETERO DRUGS","customerCountry":"INDIA","quantity":"605.39","actualQuantity":"605.386","unit":"KGS","unitRateFc":"145","totalValueFC":"92061","currency":"USD","unitRateINR":"12462.7","date":"01-Apr-2023","totalValueINR":"7544743.61","totalValueInUsd":"92061","indian_port":"HYDERABAD AIR","hs_no":"29339990","bill_no":"5327320","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"7-2-A2, HETERO CORPORATE, INDUSTRIAL ESTATE, SANATHNAGAR, Con"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1712514600,"product":"PANTOPRAZOLE SODIUM SESQUIHYDRATE PH.EUR(B.NO:PN23100260)(EXP. VIDE SB NO:5918298\/09-12-23,INV NO:SI3623123580\/29-11-23)","address":"7-2-A2, HETERO CORPORATE,","city":"HYDERABAD-A.P.","supplier":"BALKANPHARMA -DUPNITSA AD","supplierCountry":"INDIA","foreign_port":"SOFIA","customer":"HETERO DRUGS","customerCountry":"INDIA","quantity":"199.92","actualQuantity":"199.918","unit":"KGS","unitRateFc":"145","totalValueFC":"30605.1","currency":"USD","unitRateINR":"12784","date":"08-Apr-2024","totalValueINR":"2555751.37","totalValueInUsd":"30605.1","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"2928200","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"SOFIA","supplierAddress":"3SAMOKOVSKO SHOSSE STR359701 \/58175 FAX :359701\/58554BULGARIA BG","customerAddress":"7-2-A2, HETERO CORPORATE,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1714761000,"product":"PANTOPRAZOLE SODIUM SESQUIHYDRATE PH.EUR, PN21080182,PN21080192,PN21080193(EXP VIDE SB NO:5336212\/16-10-21\/SI3621122086)","address":"7-2-A2, HETERO CORPORATE,","city":"HYDERABAD-A.P.","supplier":"ACINO PHARMA","supplierCountry":"INDIA","foreign_port":"BASLE","customer":"HETERO DRUGS","customerCountry":"INDIA","quantity":"677.40","actualQuantity":"677.4","unit":"KGS","unitRateFc":"170","totalValueFC":"119620.5","currency":"USD","unitRateINR":"14719.3","date":"04-May-2024","totalValueINR":"9970866.42","totalValueInUsd":"119620.5","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"3329930","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"BASLE","supplierAddress":"BIRSWEG 2CG-4253 MIESBERGSDNF CH","customerAddress":"7-2-A2, HETERO CORPORATE,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1722018600,"product":"PANTOPRAZOLE SODIUM SESQUI HYDRATE PH.EU(VIDE RE IMPORT SB NO: 8244480 DT:12.03.2024)","address":"MSN HOUSE, PLOT NO. C-24,","city":"HYDERABAD. AP","supplier":"TEVA PHARMACEUTICAL INDUSTRIES","supplierCountry":"INDIA","foreign_port":"BARCELONA","customer":"MSN LABORATORIES","customerCountry":"INDIA","quantity":"484.10","actualQuantity":"484.1","unit":"KGS","unitRateFc":"120","totalValueFC":"62038.1","currency":"USD","unitRateINR":"10712.3","date":"27-Jul-2024","totalValueINR":"5185831.98","totalValueInUsd":"62038.1","indian_port":"Hyderabad Air","hs_no":"29333990","bill_no":"4724068","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"C\/ ANABEL SEGURA-11 B-EDIFICIO ALBATROS, ALCOBENDAS(MADRID)-28108 SPAIN Spain","customerAddress":"MSN HOUSE, PLOT NO. C-24,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1735842600,"product":"PANTOPRAZOLE SODIUM SESQUIHYDRATE","address":"PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD\/ANDHRA PRADESH","supplier":"ALL PHARMA (SHANGHAI) TRADING CO. LTD","supplierCountry":"CHINA","foreign_port":"NANJING","customer":"AUROBINDO PHARMA LIMITED","customerCountry":"INDIA","quantity":"185.14","actualQuantity":"185.142","unit":"KGS","unitRateFc":"259","totalValueFC":"48158","currency":"USD","unitRateINR":"22429.4","date":"03-Jan-2025","totalValueINR":"4152623.98","totalValueInUsd":"48158","indian_port":"SEZ\/Mahaboobnagar","hs_no":"29339990","bill_no":"7592113","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NANJING","supplierAddress":"Room 1401,BuildingA,No.319 Xianxia Room 1401,BuildingA,No.319 Xianxia SDNF China","customerAddress":"PLOT NO.2, MAITRIVIHAR,"}]
    04-Jan-2021
    30-Apr-2025
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    DOSAGE - POWDER;INTRAVENOUS - EQ 40MG BASE/VI...DOSAGE - POWDER;INTRAVENOUS - EQ 40MG BASE/VIAL

    USFDA APPLICATION NUMBER - 209463

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    DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 20...DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 20MG BASE

    USFDA APPLICATION NUMBER - 20987

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    DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 40...DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 40MG BASE

    USFDA APPLICATION NUMBER - 20987

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    DOSAGE - INJECTABLE;INTRAVENOUS - EQ 40MG BAS...DOSAGE - INJECTABLE;INTRAVENOUS - EQ 40MG BASE/VIAL

    USFDA APPLICATION NUMBER - 20988

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    ABOUT THIS PAGE

    Looking for 138786-67-1 / Pantoprazole Sodium API manufacturers, exporters & distributors?

    Pantoprazole Sodium manufacturers, exporters & distributors 1

    12

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

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

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

    API | Excipient name

    Pantoprazole Sodium

    Synonyms

    138786-67-1, Pantoloc, Protonix, Pantecta, Zurcal, Pantoprazole sodium salt

    Cas Number

    138786-67-1

    About Pantoprazole Sodium

    2-pyridinylmethylsulfinylbenzimidazole proton pump inhibitor that is used in the treatment of GASTROESOPHAGEAL REFLUX and PEPTIC ULCER.

    Pantoloc Manufacturers

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

    Pantoloc Suppliers

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

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

    Pantoloc USDMF

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

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

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

    Pantoloc KDMF

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

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

    After submitting a Pantoloc 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 Pantoloc API can apply through the Korea Drug Master File (KDMF).

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

    Pantoloc CEP

    A Pantoloc CEP of the European Pharmacopoeia monograph is often referred to as a Pantoloc Certificate of Suitability (COS). The purpose of a Pantoloc CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Pantoloc EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Pantoloc to their clients by showing that a Pantoloc CEP has been issued for it. The manufacturer submits a Pantoloc CEP (COS) as part of the market authorization procedure, and it takes on the role of a Pantoloc CEP holder for the record. Additionally, the data presented in the Pantoloc CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Pantoloc DMF.

    A Pantoloc CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Pantoloc CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

    click here to find a list of Pantoloc suppliers with CEP (COS) on PharmaCompass.

    Pantoloc WC

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

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

    Pantoloc 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 Pantoloc as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Pantoloc GMP

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

    Pantoloc CoA

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

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

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