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    Also known as: 119302-91-9, Zemuron, Esmeron, Rocuronium (bromide), Org 9426, Org-9426
    Molecular Formula
    C32H53BrN2O4
    Molecular Weight
    609.7  g/mol
    InChI Key
    OYTJKRAYGYRUJK-FMCCZJBLSA-M
    FDA UNII
    I65MW4OFHZ
    Rocuronium Bromide
    An androstanol non-depolarizing neuromuscular blocking agent. It has a mono-quaternary structure and is a weaker nicotinic antagonist than PANCURONIUM.
    1 2D Structure

    Rocuronium Bromide

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    [(2S,3S,5S,8R,9S,10S,13S,14S,16S,17R)-3-hydroxy-10,13-dimethyl-2-morpholin-4-yl-16-(1-prop-2-enylpyrrolidin-1-ium-1-yl)-2,3,4,5,6,7,8,9,11,12,14,15,16,17-tetradecahydro-1H-cyclopenta[a]phenanthren-17-yl] acetate;bromide
    2.1.2 InChI
    InChI=1S/C32H53N2O4.BrH/c1-5-14-34(15-6-7-16-34)28-20-26-24-9-8-23-19-29(36)27(33-12-17-37-18-13-33)21-32(23,4)25(24)10-11-31(26,3)30(28)38-22(2)35;/h5,23-30,36H,1,6-21H2,2-4H3;1H/q+1;/p-1/t23-,24+,25-,26-,27-,28-,29-,30-,31-,32-;/m0./s1
    2.1.3 InChI Key
    OYTJKRAYGYRUJK-FMCCZJBLSA-M
    2.1.4 Canonical SMILES
    CC(=O)OC1C(CC2C1(CCC3C2CCC4C3(CC(C(C4)O)N5CCOCC5)C)C)[N+]6(CCCC6)CC=C.[Br-]
    2.1.5 Isomeric SMILES
    CC(=O)O[C@H]1[C@H](C[C@@H]2[C@@]1(CC[C@H]3[C@H]2CC[C@@H]4[C@@]3(C[C@@H]([C@H](C4)O)N5CCOCC5)C)C)[N+]6(CCCC6)CC=C.[Br-]
    2.2 Other Identifiers
    2.2.1 UNII
    I65MW4OFHZ
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 1-(17-(acetoyl)-3-hydroxy-2-(4-morpholinyl)androstan-16-yl)-1-(2-propenyl)pyrrolidinium

    2. Androstane-3,17-diol, 2-(4-morpholinyl)-16-(1-(2-propen-1-yl)-1-pyrrolidiniumyl)-, 17-acetate, (2beta,3alpha,5alpha,16beta,17beta)-

    3. Esmeron

    4. Esmerone

    5. Org 9426

    6. Org-9426

    7. Org9426

    8. Pyrrolidinium, 1-((2beta,3alpha,5alpha,16beta,17beta)-17-(acetyloxy)-3-hydroxy-2-(4-morpholinyl)androstan-16-yl)-1-(2-propenyl)-, Bromide

    9. Rocuronium

    10. Zemuron

    2.3.2 Depositor-Supplied Synonyms

    1. 119302-91-9

    2. Zemuron

    3. Esmeron

    4. Rocuronium (bromide)

    5. Org 9426

    6. Org-9426

    7. Chebi:8885

    8. I65mw4ofhz

    9. 1-allyl-1-(3alpha,17beta-dihydroxy-2beta-morpholino-5alpha-androstan-16beta-yl)pyrrolidinium Bromide, 17-acetate

    10. [(2s,3s,5s,8r,9s,10s,13s,14s,16s,17r)-3-hydroxy-10,13-dimethyl-2-morpholin-4-yl-16-(1-prop-2-enylpyrrolidin-1-ium-1-yl)-2,3,4,5,6,7,8,9,11,12,14,15,16,17-tetradecahydro-1h-cyclopenta[a]phenanthren-17-yl] Acetate;bromide

    11. Pyrrolidinium, 1-[(2beta,3alpha,5alpha,16beta,17beta)-17-(acetyloxy)-3-hydroxy-2-(4-morpholinyl)androstan-16-yl]-1-(2-propenyl)-, Bromide

    12. Rocuronium Hydrobromide

    13. 1-[17b-(acetyloxy)-3a-hydroxy-2b-(4-morpholinyl)-5a-androstan-16b-yl]-1-(2-propenyl)pyrrolidinium Bromide

    14. Pyrrolidinium, 1-((2beta,3alpha,5alpha,16beta,17beta)-17-(acetyloxy)-3-hydroxy-2-(4-morpholinyl)androstan-16-yl)-1-(2-propenyl)-, Bromide

    15. Ncgc00167433-01

    16. Unii-i65mw4ofhz

    17. Org9426

    18. Eslax

    19. Rocuroniumbromide

    20. Zemuron (tn)

    21. Mfcd00867768

    22. Rocuronium Bromide [usan:usp:inn:ban]

    23. Rocuronium Bromide - Ep

    24. Dsstox_cid_3566

    25. Org 9426 (bromide)

    26. Dsstox_rid_77083

    27. Dsstox_gsid_23566

    28. Schembl41320

    29. (+)-rocuronium Bromide

    30. Rocuronium Bromide [mi]

    31. Chembl1200648

    32. Dtxsid7023566

    33. Rocuronium Bromide [inn]

    34. Rocuronium Bromide [jan]

    35. Rocuronium Bromide [usan]

    36. Hms3884o13

    37. Rocuronium Bromide [vandf]

    38. Rocuronium Bromide [mart.]

    39. Rocuronium Bromide (jan/usp/inn)

    40. Rocuronium Bromide [usp-rs]

    41. Rocuronium Bromide [who-dd]

    42. Tox21_112437

    43. Bdbm50248153

    44. S1397

    45. Akos025149635

    46. Ac-2004

    47. Ccg-270222

    48. Cs-1467

    49. Rocuronium Bromide [orange Book]

    50. Rocuronium Bromide [ep Monograph]

    51. 1-((2s,3s,5s,8r,9s,10s,13s,14s,16s,17r)-17-acetoxy-3-hydroxy-10,13-dimethyl-2-morpholinohexadecahydro-1h-cyclopenta[a]phenanthren-16-yl)-1-allylpyrrolidin-1-ium Bromide

    52. 111ge014

    53. As-13323

    54. Br177300

    55. Hy-17440

    56. Rocuronium Bromide [usp Monograph]

    57. Bcp0726000028

    58. Cas-119302-91-9

    59. R0099

    60. D00765

    61. Q-101010

    62. Q27108171

    63. Rocuronium Bromide, >=98% (perchloric Acid Titration)

    64. Rocuronium Bromide, European Pharmacopoeia (ep) Reference Standard

    65. Rocuronium Bromide, United States Pharmacopeia (usp) Reference Standard

    66. Rocuronium For Peak Identification, European Pharmacopoeia (ep) Reference Standard

    67. (2beta,3alpha,5alpha,16beta,17beta)-17-(acetyloxy)-3-hydroxy-2-morpholin-4-yl-16-(1-prop-2-en-1-ylpyrrolidinium-1-yl)androstane Bromide

    68. 1-((2s,3s,8r,9s,10s,13s,14s,16s,17r)-17-acetoxy-3-hydroxy-10,13-dimethyl-2-morpholinohexadecahydro-1h-cyclopenta[a]phenanthren-16-yl)-1-allylpyrrolidinium Bromide

    69. 1-[(2beta,3alpha,5alpha,16beta,17beta)-17-acetyloxy-3-hydroxy-2-(4-morpholinyl)-androstan-16-yl]-1(2-propenyl)pyrrolidinium Bromide

    70. 1-[17beta-acetyloxy-3alpha-hydroxy-2beta-(4-morpholinyl)-5alpha-androstan-16beta-yl]-1-(2-propenyl)pyrrolidinium Bromide

    71. 1-allyl-1-(3.alpha.,17.beta.-dihydroxy-2.beta.-morpholino-5.alpha.-androstan-16.beta.-yl)pyrrolidinium Bromide, 17-acetate

    72. 17beta-(acetyloxy)-3alpha-hydroxy-2beta-(morpholin-4-yl)-16beta-[1-(prop-2-en-1-yl)pyrrolidinium-1-yl]-5alpha-androstane

    73. 17beta-acetoxy-16beta-(1-allylpyrrolidinium-1-yl)-3alpha-hydroxy-2beta-(morpholin-4-yl)-5alphaandrostane

    74. Pyrrolidinium, 1-((2.beta.,3.alpha.,5.alpha.,16.beta.,17.beta.)-17-(acetyloxy)-3-hydroxy-2-(4-morpholinyl)androstan-16-yl)-1-(2-propenyl)-, Bromide

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 609.7 g/mol
    Molecular Formula C32H53BrN2O4
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count6
    Rotatable Bond Count6
    Exact Mass608.31887 g/mol
    Monoisotopic Mass608.31887 g/mol
    Topological Polar Surface Area59 Ų
    Heavy Atom Count39
    Formal Charge0
    Complexity898
    Isotope Atom Count0
    Defined Atom Stereocenter Count10
    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 4  
    Drug NameRocuronium bromide
    PubMed HealthRocuronium (Injection)
    Drug ClassesMusculoskeletal Agent
    Drug LabelRocuronium bromide injection is a nondepolarizing neuromuscular blocking agent with a rapid to intermediate onset depending on dose and intermediate duration. Rocuronium bromide USP is chemically designated as 1-[17-(acetyloxy)-3-hydroxy-2-(4-m...
    Active IngredientRocuronium bromide
    Dosage FormInjectable
    RouteInjection
    Strength50mg/5ml (10mg/ml); 100mg/10ml (10mg/ml)
    Market StatusPrescription
    CompanySagent Strides; Hospira; Sandoz; Teva Pharms; Fresenius Kabi Usa; Tamarang; Mylan Institutional

    2 of 4  
    Drug NameZemuron
    Drug LabelZEMURON (rocuronium bromide) injection is a nondepolarizing neuromuscular blocking agent with a rapid to intermediate onset depending on dose and intermediate duration. Rocuronium bromide is chemically designated as 1-[17-(acetyloxy)-3-hydroxy-2...
    Active IngredientRocuronium bromide
    Dosage FormInjectable
    RouteInjection
    Strength50mg/5ml (10mg/ml); 100mg/10ml (10mg/ml)
    Market StatusPrescription
    CompanyOrganon Usa

    3 of 4  
    Drug NameRocuronium bromide
    PubMed HealthRocuronium (Injection)
    Drug ClassesMusculoskeletal Agent
    Drug LabelRocuronium bromide injection is a nondepolarizing neuromuscular blocking agent with a rapid to intermediate onset depending on dose and intermediate duration. Rocuronium bromide USP is chemically designated as 1-[17-(acetyloxy)-3-hydroxy-2-(4-m...
    Active IngredientRocuronium bromide
    Dosage FormInjectable
    RouteInjection
    Strength50mg/5ml (10mg/ml); 100mg/10ml (10mg/ml)
    Market StatusPrescription
    CompanySagent Strides; Hospira; Sandoz; Teva Pharms; Fresenius Kabi Usa; Tamarang; Mylan Institutional

    4 of 4  
    Drug NameZemuron
    Drug LabelZEMURON (rocuronium bromide) injection is a nondepolarizing neuromuscular blocking agent with a rapid to intermediate onset depending on dose and intermediate duration. Rocuronium bromide is chemically designated as 1-[17-(acetyloxy)-3-hydroxy-2...
    Active IngredientRocuronium bromide
    Dosage FormInjectable
    RouteInjection
    Strength50mg/5ml (10mg/ml); 100mg/10ml (10mg/ml)
    Market StatusPrescription
    CompanyOrganon Usa

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Neuromuscular Nondepolarizing Agents

    Drugs that interrupt transmission at the skeletal neuromuscular junction without causing depolarization of the motor end plate. They prevent acetylcholine from triggering muscle contraction and are used as muscle relaxants during electroshock treatments, in convulsive states, and as anesthesia adjuvants. (See all compounds classified as Neuromuscular Nondepolarizing Agents.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Nondepolarizing Neuromuscular Blocker [EPC]; Neuromuscular Nondepolarizing Blockade [PE]
    5.3 ATC Code

    M - Musculo-skeletal system

    M03 - Muscle relaxants

    M03A - Muscle relaxants, peripherally acting agents

    M03AC - Other quaternary ammonium compounds

    M03AC09 - Rocuronium bromide

    API Reference Price

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10 - 08160 MONTMELOSDNF ES","customerAddress":"1\/5, SANTOSH COMPLEX, ARMUGAM"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1717093800,"product":"ROCURONIUM BROMIDE","address":"NARBAVI NO3 LAKSHMANAN STREET,,T.N","city":"CHENNAI,TAMIL NADU","supplier":"FARMHISPANIA","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"CAPLIN STERILES LIMITED","customerCountry":"INDIA","quantity":"1.22","actualQuantity":"1.222","unit":"KGS","unitRateFc":"8500","totalValueFC":"11526.7","currency":"EUR","unitRateINR":"786250","date":"31-May-2024","totalValueINR":"960797.5","totalValueInUsd":"11526.7","indian_port":"Madras Air","hs_no":"29349990","bill_no":"3754350","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"PASSEIG RIU BESOS ,9 - 10 - 08160 MONTMELO ,ESPANA ES","customerAddress":"NARBAVI NO3 LAKSHMANAN STREET,,T.N"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1719772200,"product":"TOXIC SOLID, ORGANIC, N. 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10 - 08160 M ONTMELO ESPANA ESPANA, , Spain SDNF Spain","customerAddress":"HETERO HOUSE,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1728585000,"product":"ROCURONIUM BROMIDE USP","address":"HETERO HOUSE,","city":"HYDERABAD, AP.","supplier":"TAPI TECHNOLOGY & API SERVICES","supplierCountry":"MEXICO","foreign_port":"MEXICO CITY","customer":"ASPIRO PHARMA","customerCountry":"INDIA","quantity":"1.50","actualQuantity":"1.5","unit":"KGS","unitRateFc":"12500","totalValueFC":"18933.7","currency":"USD","unitRateINR":"1060625","date":"11-Oct-2024","totalValueINR":"1590937.5","totalValueInUsd":"18933.7","indian_port":"Hyderabad Air","hs_no":"29349990","bill_no":"6071047","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"MEXICO","selfForZScoreResived":"Pharma Grade","supplierPort":"MEXICO CITY","supplierAddress":"PIET HEIN BUILDING, PIET HEINKADE 1 07 1019 GM AMSTERDAM NETHERLANDS Am sterdam, , Netherlands Netherlands","customerAddress":"HETERO HOUSE,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729794600,"product":"ROCURONIUM BROMIDE","address":"NARBAVI NO3 LAKSHMANAN STREET,,T.N","city":"CHENNAI,TAMIL NADU","supplier":"CURIA","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"CAPLIN STERILES LIMITED","customerCountry":"INDIA","quantity":"0.56","actualQuantity":"0.556","unit":"KGS","unitRateFc":"10000","totalValueFC":"5621.1","currency":"USD","unitRateINR":"849500","date":"25-Oct-2024","totalValueINR":"472322","totalValueInUsd":"5621.1","indian_port":"Madras Air","hs_no":"29339990","bill_no":"6321244","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"SEDE LEGALE VIA DEL VECCHIO POLITEC NICO 9, 20121 MILANO SDNF IT","customerAddress":"NARBAVI NO3 LAKSHMANAN STREET,,T.N"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729794600,"product":"ROCURONIUM BROMIDE","address":"NARBAVI NO3 LAKSHMANAN STREET,,T.N","city":"CHENNAI,TAMIL NADU","supplier":"CURIA","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"CAPLIN STERILES LIMITED","customerCountry":"INDIA","quantity":"4.77","actualQuantity":"4.767","unit":"KGS","unitRateFc":"10000","totalValueFC":"48193.9","currency":"USD","unitRateINR":"849500","date":"25-Oct-2024","totalValueINR":"4049566.5","totalValueInUsd":"48193.9","indian_port":"Madras Air","hs_no":"29339990","bill_no":"6321244","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - 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    11-Jan-2021
    04-Dec-2024
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    DOSAGE - INJECTABLE;INJECTION - 100MG/10ML (1...DOSAGE - INJECTABLE;INJECTION - 100MG/10ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 20214

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    DOSAGE - INJECTABLE;INJECTION - 10MG/ML (10MG...DOSAGE - INJECTABLE;INJECTION - 10MG/ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 20214

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    DOSAGE - INJECTABLE;INJECTION - 50MG/5ML (10M...DOSAGE - INJECTABLE;INJECTION - 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 20214

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    ABOUT THIS PAGE

    Rocuronium Bromide Manufacturers

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

    Rocuronium Bromide Suppliers

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

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

    Rocuronium Bromide USDMF

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

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

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

    Rocuronium Bromide 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 Rocuronium Bromide Drug Master File in Japan (Rocuronium Bromide JDMF) empowers Rocuronium Bromide 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 Rocuronium Bromide JDMF during the approval evaluation for pharmaceutical products. At the time of Rocuronium Bromide 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 Rocuronium Bromide suppliers with JDMF on PharmaCompass.

    Rocuronium Bromide KDMF

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

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

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

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

    Rocuronium Bromide CEP

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

    A Rocuronium Bromide CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Rocuronium Bromide 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 Rocuronium Bromide suppliers with CEP (COS) on PharmaCompass.

    Rocuronium Bromide WC

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

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

    Rocuronium Bromide 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 Rocuronium Bromide as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Rocuronium Bromide GMP

    Rocuronium Bromide 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 Rocuronium Bromide 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 Rocuronium Bromide GMP manufacturer or Rocuronium Bromide GMP API supplier for your needs.

    Rocuronium Bromide CoA

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

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

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