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Chemistry

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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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MALPENSA","customer":"CAPLIN STERILES LTD","customerCountry":"INDIA","quantity":"9.56","actualQuantity":"9.56","unit":"KGS","unitRateFc":"10000","totalValueFC":"96650.6","currency":"USD","unitRateINR":"849500","date":"25-Oct-2024","totalValueINR":"8121220","totalValueInUsd":"96650.6","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 ITALY SRL AKA AMRI ITALY SRL","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"CAPLIN STERILES LTD","customerCountry":"INDIA","quantity":"10.05","actualQuantity":"10.05","unit":"KGS","unitRateFc":"10000","totalValueFC":"101604.5","currency":"USD","unitRateINR":"849500","date":"25-Oct-2024","totalValueINR":"8537475","totalValueInUsd":"101604.5","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":1732645800,"product":"31028, ROCURONIUM BROMIDE BATCH NO-3102800872(FOR R&D)TL NO-TL\/BDZ\/23\/000269","address":"B-310, SOM DATT CHAMBERS, 1,","city":"NEW DELHI","supplier":"FARMHISANIASA","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"FRESENIUS KABI ONCOLOGY LTD","customerCountry":"INDIA","quantity":"0.38","actualQuantity":"0.375","unit":"KGS","unitRateFc":"16000","totalValueFC":"7858.8","currency":"EURO","unitRateINR":"1768496","date":"27-Nov-2024","totalValueINR":"663185.99","totalValueInUsd":"7858.8","indian_port":"Delhi Air","hs_no":"29420090","bill_no":"6906392","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"PASSEIG RIU BESOS ,9-10-08160 MONTM ELO,ESPANA SDNF SPAIN","customerAddress":"B-310, SOM DATT CHAMBERS, 1,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1734719400,"product":"ROCURONIUM BROMIDE (LIST 4 SR. 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03-Jan-2022
15-May-2025
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DRUG PRODUCT COMPOSITIONS

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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

Looking for 119302-91-9 / Rocuronium Bromide API manufacturers, exporters & distributors?

Rocuronium Bromide manufacturers, exporters & distributors 1

12

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

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

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

API | Excipient name

Rocuronium Bromide

Synonyms

119302-91-9, Zemuron, Esmeron, Rocuronium (bromide), Org 9426, Org-9426

Cas Number

119302-91-9

Unique Ingredient Identifier (UNII)

I65MW4OFHZ

About Rocuronium Bromide

An androstanol non-depolarizing neuromuscular blocking agent. It has a mono-quaternary structure and is a weaker nicotinic antagonist than PANCURONIUM.

DSSTox_CID_3566 Manufacturers

A DSSTox_CID_3566 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of DSSTox_CID_3566, including repackagers and relabelers. The FDA regulates DSSTox_CID_3566 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. DSSTox_CID_3566 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 DSSTox_CID_3566 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

DSSTox_CID_3566 Suppliers

A DSSTox_CID_3566 supplier is an individual or a company that provides DSSTox_CID_3566 active pharmaceutical ingredient (API) or DSSTox_CID_3566 finished formulations upon request. The DSSTox_CID_3566 suppliers may include DSSTox_CID_3566 API manufacturers, exporters, distributors and traders.

click here to find a list of DSSTox_CID_3566 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

DSSTox_CID_3566 USDMF

A DSSTox_CID_3566 DMF (Drug Master File) is a document detailing the whole manufacturing process of DSSTox_CID_3566 active pharmaceutical ingredient (API) in detail. Different forms of DSSTox_CID_3566 DMFs exist exist since differing nations have different regulations, such as DSSTox_CID_3566 USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A DSSTox_CID_3566 DMF submitted to regulatory agencies in the US is known as a USDMF. DSSTox_CID_3566 USDMF includes data on DSSTox_CID_3566's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The DSSTox_CID_3566 USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of DSSTox_CID_3566 suppliers with USDMF on PharmaCompass.

DSSTox_CID_3566 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 DSSTox_CID_3566 Drug Master File in Japan (DSSTox_CID_3566 JDMF) empowers DSSTox_CID_3566 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 DSSTox_CID_3566 JDMF during the approval evaluation for pharmaceutical products. At the time of DSSTox_CID_3566 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 DSSTox_CID_3566 suppliers with JDMF on PharmaCompass.

DSSTox_CID_3566 KDMF

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

Pharmaceutical companies submit a DSSTox_CID_3566 Drug Master File in Korea (DSSTox_CID_3566 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of DSSTox_CID_3566. The MFDS reviews the DSSTox_CID_3566 KDMF as part of the drug registration process and uses the information provided in the DSSTox_CID_3566 KDMF to evaluate the safety and efficacy of the drug.

After submitting a DSSTox_CID_3566 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 DSSTox_CID_3566 API can apply through the Korea Drug Master File (KDMF).

click here to find a list of DSSTox_CID_3566 suppliers with KDMF on PharmaCompass.

DSSTox_CID_3566 CEP

A DSSTox_CID_3566 CEP of the European Pharmacopoeia monograph is often referred to as a DSSTox_CID_3566 Certificate of Suitability (COS). The purpose of a DSSTox_CID_3566 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of DSSTox_CID_3566 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of DSSTox_CID_3566 to their clients by showing that a DSSTox_CID_3566 CEP has been issued for it. The manufacturer submits a DSSTox_CID_3566 CEP (COS) as part of the market authorization procedure, and it takes on the role of a DSSTox_CID_3566 CEP holder for the record. Additionally, the data presented in the DSSTox_CID_3566 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the DSSTox_CID_3566 DMF.

A DSSTox_CID_3566 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. DSSTox_CID_3566 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 DSSTox_CID_3566 suppliers with CEP (COS) on PharmaCompass.

DSSTox_CID_3566 WC

A DSSTox_CID_3566 written confirmation (DSSTox_CID_3566 WC) is an official document issued by a regulatory agency to a DSSTox_CID_3566 manufacturer, verifying that the manufacturing facility of a DSSTox_CID_3566 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting DSSTox_CID_3566 APIs or DSSTox_CID_3566 finished pharmaceutical products to another nation, regulatory agencies frequently require a DSSTox_CID_3566 WC (written confirmation) as part of the regulatory process.

click here to find a list of DSSTox_CID_3566 suppliers with Written Confirmation (WC) on PharmaCompass.

DSSTox_CID_3566 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 DSSTox_CID_3566 as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for DSSTox_CID_3566 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 DSSTox_CID_3566 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 DSSTox_CID_3566 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a DSSTox_CID_3566 NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of DSSTox_CID_3566 suppliers with NDC on PharmaCompass.

DSSTox_CID_3566 GMP

DSSTox_CID_3566 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 DSSTox_CID_3566 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 DSSTox_CID_3566 GMP manufacturer or DSSTox_CID_3566 GMP API supplier for your needs.

DSSTox_CID_3566 CoA

A DSSTox_CID_3566 CoA (Certificate of Analysis) is a formal document that attests to DSSTox_CID_3566's compliance with DSSTox_CID_3566 specifications and serves as a tool for batch-level quality control.

DSSTox_CID_3566 CoA mostly includes findings from lab analyses of a specific batch. For each DSSTox_CID_3566 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.

DSSTox_CID_3566 may be tested according to a variety of international standards, such as European Pharmacopoeia (DSSTox_CID_3566 EP), DSSTox_CID_3566 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (DSSTox_CID_3566 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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