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Chemistry

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Also known as: Alvesco, Omnaris, 126544-47-6, Zetonna, Rpr251526, Rpr-251526
Molecular Formula
C32H44O7
Molecular Weight
540.7  g/mol
InChI Key
LUKZNWIVRBCLON-GXOBDPJESA-N
FDA UNII
S59502J185

Ciclesonide
Ciclesonide is a nonhalogenated, synthetic, inhaled corticosteroid (ICS) with anti-inflammatory and potential antiviral activities. Upon administration by oral inhalation into the lungs, ciclesonide (CIC) is converted by local esterases to its active metabolite desisobutyryl-ciclesonide (des-CIC), which binds to intracellular glucocorticoid receptors (GRs). The ligand-bound GRs regulate gene expressions, which lead to inhibitory activities against multiple cell types, such as mast cells, eosinophils, basophils, lymphocytes, macrophages and neutrophils, and various mediators associated with inflammation, such as histamine, eicosanoids, leukotrienes and cytokines. In addition, ciclesonide may suppress the replication of human coronavirus by targeting viral nonstructural protein 15 (NSP15).
1 2D Structure

Ciclesonide

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
[2-[(1S,2S,4R,6R,8S,9S,11S,12S,13R)-6-cyclohexyl-11-hydroxy-9,13-dimethyl-16-oxo-5,7-dioxapentacyclo[10.8.0.02,9.04,8.013,18]icosa-14,17-dien-8-yl]-2-oxoethyl] 2-methylpropanoate
2.1.2 InChI
InChI=1S/C32H44O7/c1-18(2)28(36)37-17-25(35)32-26(38-29(39-32)19-8-6-5-7-9-19)15-23-22-11-10-20-14-21(33)12-13-30(20,3)27(22)24(34)16-31(23,32)4/h12-14,18-19,22-24,26-27,29,34H,5-11,15-17H2,1-4H3/t22-,23-,24-,26+,27+,29+,30-,31-,32+/m0/s1
2.1.3 InChI Key
LUKZNWIVRBCLON-GXOBDPJESA-N
2.1.4 Canonical SMILES
CC(C)C(=O)OCC(=O)C12C(CC3C1(CC(C4C3CCC5=CC(=O)C=CC45C)O)C)OC(O2)C6CCCCC6
2.1.5 Isomeric SMILES
CC(C)C(=O)OCC(=O)[C@@]12[C@@H](C[C@@H]3[C@@]1(C[C@@H]([C@H]4[C@H]3CCC5=CC(=O)C=C[C@]45C)O)C)O[C@H](O2)C6CCCCC6
2.2 Other Identifiers
2.2.1 UNII
S59502J185
2.3 Synonyms
2.3.1 MeSH Synonyms

1. (r)-11beta,16alpha,17,21-tetrahydroxypregna-1,4-diene-3,20-dione Cyclic 16,17-acetal With Cyclohexanecarboxaldehyde, 21-isobutyrate

2. Alvesco

3. Omnaris

2.3.2 Depositor-Supplied Synonyms

1. Alvesco

2. Omnaris

3. 126544-47-6

4. Zetonna

5. Rpr251526

6. Rpr-251526

7. Ciclesonide [inn]

8. 141845-82-1

9. Bi54903

10. S59502j185

11. [2-[(1s,2s,4r,6r,8s,9s,11s,12s,13r)-6-cyclohexyl-11-hydroxy-9,13-dimethyl-16-oxo-5,7-dioxapentacyclo[10.8.0.02,9.04,8.013,18]icosa-14,17-dien-8-yl]-2-oxoethyl] 2-methylpropanoate

12. [2-[(1s,2s,4r,8s,9s,11s,12s,13r)-6-cyclohexyl-11-hydroxy-9,13-dimethyl-16-oxo-5,7-dioxapentacyclo[10.8.0.02,9.04,8.013,18]icosa-14,17-dien-8-yl]-2-oxoethyl] 2-methylpropanoate

13. Osonase

14. Osonide

15. Omnair

16. Rpr 251526

17. Alvesco Hfa

18. Omnaris Hfa

19. Alvesco (tn)

20. Omnaris (tn)

21. Ciclesonide [usan:inn]

22. Btr-15k

23. Ciclesonide (jan/usan/inn)

24. Btr-15

25. Tbn-15

26. (r)-11beta,16alpha,17,21-tetrahydroxypregna-1,4-diene-3,20-dione Cyclic 16,17-acetal With Cyclohexanecarboxaldehyde, 21-isobutyrate

27. Unii-s59502j185

28. Ncgc00167484-01

29. (11?,16?)-16,17-[[(r)-cyclohexylmethylene]bis(oxy)]-11-hydroxy-21-(2-methyl-1-oxopropoxy)-pregna-1,4-diene-3,20-dione

30. Alvesco 80

31. Zetonna (tn)

32. Alvesco, Ciclesonide

33. Byk-20426

34. Alvesco 160

35. By-9010

36. Ks-1165

37. Ac1miwnr

38. Ciclesonide [mi]

39. Ciclesonide [jan]

40. Ciclesonide [usan]

41. Ciclesonide [vandf]

42. Schembl3688

43. Ciclesonide [mart.]

44. Dsstox_cid_26659

45. Dsstox_rid_81802

46. Dsstox_gsid_46659

47. Ciclesonide [who-dd]

48. B-9207-015

49. Gtpl7469

50. El-87-6

51. Chembl2040682

52. Dtxsid9046659

53. Chebi:31397

54. Ciclesonide, >=98% (hplc)

55. Ciclesonide [orange Book]

56. Ciclesonide [ep Monograph]

57. Hms3714n07

58. Ex-a4195

59. Hy-b0625

60. Zinc3915154

61. Tox21_112486

62. Bdbm50247997

63. S4646

64. Akos015994702

65. Ac-1330

66. Ccg-269962

67. Db01410

68. Ncgc00167972-01

69. Pregna-1,4-diene-3,20-dione, 16,17-(((r)-cyclohexylmethylene)bis(oxy))-11-hydroxy-21-(2-methyl-1-oxopropoxy)-, (11beta,16alpha)-

70. Pregna-1,4-diene-3,20-dione, 16,17-((cyclohexylmethylene)bis(oxy))-11-hydroxy-21-(2-methyl-1-oxopropoxy)-, (11beta,16alpha(r))-

71. Ciclesonide 100 Microg/ml In Acetonitrile

72. C3701

73. Cas-141845-82-1

74. C72110

75. D01703

76. 544c476

77. A899067

78. Sr-01000942227

79. Q5119448

80. Sr-01000942227-1

81. Ciclesonide, European Pharmacopoeia (ep) Reference Standard

82. (11?,16?)-16,17-[[(r)-cyclohexylmethylene]bis(oxy)]-11-hydroxy-21-(2-methyl-1-oxopropoxy)pregna-1,4-diene-3,20-dione

83. 2-((6ar,6bs,7s,8as,8bs,10r,11ar,12as,12bs)-10-cyclohexyl-7-hydroxy-6a,8a-dimethyl-4-oxo-1,2,4,6a,6b,7,8,8a,11a,12,12a,12b-dodecahydro-8bh-naphtho[2',1':4,5]indeno[1,2-d][1,3]dioxol-8b-yl)-2-oxoethyl Isobutyrate

84. 2h-naphth (2',1':4,5) Indeno (1,2-d) (1,3) Dioxole, Pregna-1,4-diene-3,20-dione Deriv.

85. Pregna-1,4-diene-3,20-dione, 16,17-(((r)-cyclohexylmethylene)bis(oxy))-11-hydroxy-21-(2-methyl-1-oxopropoxy)-, (11.beta.,16.alpha.)

2.3.3 Other Synonyms

1. Desisobutyrylciclesonide

2. Desisobuytyryl Ciclesonide

3. Desisobutyryl Ciclesonide

2.4 Create Date
2006-07-28
3 Chemical and Physical Properties
Molecular Weight 540.7 g/mol
Molecular Formula C32H44O7
XLogP35.3
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count7
Rotatable Bond Count6
Exact Mass540.30870374 g/mol
Monoisotopic Mass540.30870374 g/mol
Topological Polar Surface Area99.1 Ų
Heavy Atom Count39
Formal Charge0
Complexity1100
Isotope Atom Count0
Defined Atom Stereocenter Count9
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 6  
Drug NameAlvesco
PubMed HealthCiclesonide
Drug ClassesAnti-Inflammatory, Endocrine-Metabolic Agent
Drug LabelThe active component of ALVESCO 80 mcg Inhalation Aerosol, and ALVESCO 160 mcg Inhalation Aerosol is ciclesonide, a non-halogenated glucocorticoid having the chemical name pregna-1,4-diene-3,20-dione, 16,17-[[(R)-cyclohexylmethylene]bis(oxy)]-11-hydr...
Active IngredientCiclesonide
Dosage FormAerosol, metered
RouteInhalation
Strength0.08mg/inh; 0.16mg/inh
Market StatusPrescription
CompanyTakeda Gmbh

2 of 6  
Drug NameOmnaris
PubMed HealthCiclesonide
Drug ClassesAnti-Inflammatory, Endocrine-Metabolic Agent
Drug LabelThe active component of OMNARIS Nasal Spray is ciclesonide, a non-halogenated glucocorticoid having the chemical name pregna -1,4-diene-3,20-dione, 16,17-[[R-cyclohexylmethylene]bis(oxy)]-11-hydroxy-21-(2-methyl-1-oxopropoxy)-,(11,16)-. Ciclesoni...
Active IngredientCiclesonide
Dosage FormSpray, metered; Spray
Routenasal; Nasal
Strength50mcg; 0.05mg/inh
Market StatusPrescription
CompanyNycomed Us; Takeda Gmbh

3 of 6  
Drug NameZetonna
PubMed HealthCiclesonide
Drug ClassesAnti-Inflammatory, Endocrine-Metabolic Agent
Drug LabelThe active component of ZETONNA Nasal Aerosol is ciclesonide, a non-halogenated glucocorticoid having the chemical name pregna -1,4-diene-3,20-dione, 16,17-[[R-cyclohexylmethylene]bis(oxy)]-11-hydroxy-21-(2-methyl-1-oxopropoxy)-,(11,16)-. Cicleso...
Active IngredientCiclesonide
Dosage FormAerosol, metered
RouteNasal
Strength0.037mg/inh
Market StatusPrescription
CompanyTakeda Gmbh

4 of 6  
Drug NameAlvesco
PubMed HealthCiclesonide
Drug ClassesAnti-Inflammatory, Endocrine-Metabolic Agent
Drug LabelThe active component of ALVESCO 80 mcg Inhalation Aerosol, and ALVESCO 160 mcg Inhalation Aerosol is ciclesonide, a non-halogenated glucocorticoid having the chemical name pregna-1,4-diene-3,20-dione, 16,17-[[(R)-cyclohexylmethylene]bis(oxy)]-11-hydr...
Active IngredientCiclesonide
Dosage FormAerosol, metered
RouteInhalation
Strength0.08mg/inh; 0.16mg/inh
Market StatusPrescription
CompanyTakeda Gmbh

5 of 6  
Drug NameOmnaris
PubMed HealthCiclesonide
Drug ClassesAnti-Inflammatory, Endocrine-Metabolic Agent
Drug LabelThe active component of OMNARIS Nasal Spray is ciclesonide, a non-halogenated glucocorticoid having the chemical name pregna -1,4-diene-3,20-dione, 16,17-[[R-cyclohexylmethylene]bis(oxy)]-11-hydroxy-21-(2-methyl-1-oxopropoxy)-,(11,16)-. Ciclesoni...
Active IngredientCiclesonide
Dosage FormSpray, metered; Spray
Routenasal; Nasal
Strength50mcg; 0.05mg/inh
Market StatusPrescription
CompanyNycomed Us; Takeda Gmbh

6 of 6  
Drug NameZetonna
PubMed HealthCiclesonide
Drug ClassesAnti-Inflammatory, Endocrine-Metabolic Agent
Drug LabelThe active component of ZETONNA Nasal Aerosol is ciclesonide, a non-halogenated glucocorticoid having the chemical name pregna -1,4-diene-3,20-dione, 16,17-[[R-cyclohexylmethylene]bis(oxy)]-11-hydroxy-21-(2-methyl-1-oxopropoxy)-,(11,16)-. Cicleso...
Active IngredientCiclesonide
Dosage FormAerosol, metered
RouteNasal
Strength0.037mg/inh
Market StatusPrescription
CompanyTakeda Gmbh

4.2 Drug Indication

For the treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis in adults and adolescents 12 years of age and older.


For the alleviation of clinical signs of severe equine asthma (formerly known as Recurrent Airway Obstruction (RAO), Summer Pasture Associated Recurrent Airway Obstruction (SPA-RAO)).


5 Pharmacology and Biochemistry
5.1 Pharmacology

Ciclesonide is a pro-drug that is enzymatically hydrolyzed to a pharmacologically active metabolite, C21-desisobutyryl-ciclesonide (des-ciclesonide or RM1) following intranasal application. Des-ciclesonide has anti-inflammatory activity with affinity for the glucocorticoid receptor that is 120 times higher than the parent compound. The precise mechanism through which ciclesonide affects allergic rhinitis symptoms is not known. Corticosteroids have been shown to have a wide range of effects on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines) involved in allergic inflammation.


5.2 MeSH Pharmacological Classification

Anti-Allergic Agents

Agents that are used to treat allergic reactions. Most of these drugs act by preventing the release of inflammatory mediators or inhibiting the actions of released mediators on their target cells. (From AMA Drug Evaluations Annual, 1994, p475) (See all compounds classified as Anti-Allergic Agents.)


Glucocorticoids

A group of CORTICOSTEROIDS that affect carbohydrate metabolism (GLUCONEOGENESIS, liver glycogen deposition, elevation of BLOOD SUGAR), inhibit ADRENOCORTICOTROPIC HORMONE secretion, and possess pronounced anti-inflammatory activity. They also play a role in fat and protein metabolism, maintenance of arterial blood pressure, alteration of the connective tissue response to injury, reduction in the number of circulating lymphocytes, and functioning of the central nervous system. (See all compounds classified as Glucocorticoids.)


5.3 ATC Code

QR03BA08


R - Respiratory system

R01 - Nasal preparations

R01A - Decongestants and other nasal preparations for topical use

R01AD - Corticosteroids

R01AD13 - Ciclesonide


R - Respiratory system

R03 - Drugs for obstructive airway diseases

R03B - Other drugs for obstructive airway diseases, inhalants

R03BA - Glucocorticoids

R03BA08 - Ciclesonide


5.4 Absorption, Distribution and Excretion

Absorption

Ciclesonide and des-ciclesonide have negligible oral bioavailability (both less than 1%) due to low gastrointestinal absorption and high first-pass metabolism. The intranasal administration of ciclesonide at recommended doses results in negligible serum concentrations of ciclesonide.


Clearance

152 L/hr [Following IV administration of 800 mcg of ciclesonide]


5.5 Metabolism/Metabolites

Des-ciclesonide undergoes metabolism in the liver to additional metabolites mainly by the cytochrome P450 (CYP) 3A4 isozyme and to a lesser extent by CYP 2D6.


5.6 Mechanism of Action

Glucocorticoids such as ciclesonide can inhibit leukocyte infiltration at the site of inflammation, interfere with mediators of inflammatory response, and suppress humoral immune responses. The antiinflammatory actions of glucocorticoids are thought to involve phospholipase A2 inhibitory proteins, lipocortins, which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes. Ciclesonide reduces inflammatory reaction by limiting the capillary dilatation and permeability of the vascular structures. These compounds restrict the accumulation of polymorphonuclear leukocytes and macrophages and reduce the release of vasoactive kinins. Recent research suggests that corticosteroids may inhibit the release of arachidonic acid from phospholipids, thereby reducing the formation of prostaglandins. Ciclesonide is a glucocorticoid receptor agonist. On binding, the corticoreceptor-ligand complex translocates itself into the cell nucleus, where it binds to many glucocorticoid response elements (GRE) in the promoter region of the target genes. The DNA bound receptor then interacts with basic transcription factors, causing an increase or decrease in expression of specific target genes, including suppression of IL2 (interleukin 2) expression.


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MAHARASHTRA","supplier":"STERLING SPA","supplierCountry":"ITALY","foreign_port":"ROME","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.06","actualQuantity":"0.06","unit":"KGS","unitRateFc":"30000","totalValueFC":"1812","currency":"USD","unitRateINR":"2514000","date":"22-Dec-2023","totalValueINR":"150840","totalValueInUsd":"1812","indian_port":"Delhi Air","hs_no":"29372900","bill_no":"9354212","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Micronized","supplierPort":"ROME","supplierAddress":"VIA DELLA CARBONERIA, 30 SOLOMEO 06073 CORCIANO PERUGIA -SDNF ITALY","customerAddress":"B\/2 MAHALAXMI CHAMBERS"}]
25-Jun-2021
21-Nov-2024
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DOSAGE - AEROSOL, METERED;NASAL - 0.037MG/INH

USFDA APPLICATION NUMBER - 202129

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DOSAGE - AEROSOL, METERED;INHALATION - 0.08MG...DOSAGE - AEROSOL, METERED;INHALATION - 0.08MG/INH

USFDA APPLICATION NUMBER - 21658

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DOSAGE - AEROSOL, METERED;INHALATION - 0.16MG...DOSAGE - AEROSOL, METERED;INHALATION - 0.16MG/INH

USFDA APPLICATION NUMBER - 21658

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DOSAGE - SPRAY, METERED;NASAL - 0.05MG/SPRAY

USFDA APPLICATION NUMBER - 22004

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ABOUT THIS PAGE

Looking for 126544-47-6 / Ciclesonide API manufacturers, exporters & distributors?

Ciclesonide manufacturers, exporters & distributors 1

18

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

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

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

API | Excipient name

Ciclesonide

Synonyms

Alvesco, Omnaris, 126544-47-6, Zetonna, Rpr251526, Rpr-251526

Cas Number

126544-47-6

Unique Ingredient Identifier (UNII)

S59502J185

About Ciclesonide

Ciclesonide is a nonhalogenated, synthetic, inhaled corticosteroid (ICS) with anti-inflammatory and potential antiviral activities. Upon administration by oral inhalation into the lungs, ciclesonide (CIC) is converted by local esterases to its active metabolite desisobutyryl-ciclesonide (des-CIC), which binds to intracellular glucocorticoid receptors (GRs). The ligand-bound GRs regulate gene expressions, which lead to inhibitory activities against multiple cell types, such as mast cells, eosinophils, basophils, lymphocytes, macrophages and neutrophils, and various mediators associated with inflammation, such as histamine, eicosanoids, leukotrienes and cytokines. In addition, ciclesonide may suppress the replication of human coronavirus by targeting viral nonstructural protein 15 (NSP15).

Omnaris HFA Manufacturers

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

Omnaris HFA Suppliers

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

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

Omnaris HFA USDMF

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

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

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

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

Omnaris HFA KDMF

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

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

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

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

Omnaris HFA CEP

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

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

Omnaris HFA WC

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

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

Omnaris HFA 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 Omnaris HFA as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Omnaris HFA GMP

Omnaris HFA 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 Omnaris HFA 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 Omnaris HFA GMP manufacturer or Omnaris HFA GMP API supplier for your needs.

Omnaris HFA CoA

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

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

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