Find Fentanyl Citrate manufacturers, exporters & distributors on PharmaCompass

Fentanyl Citrate

Synopsis, Chemistry

APIs // Active Pharmaceutical Ingredients

33 API Suppliers, 14 USDMF, 12 CEP/COS, 3 JDMF, 4 EU WC, 4 KDMF, 16 NDC API, 17 Listed Suppliers

PRICE INFORMATION

API Reference Price, API Exports, API Imports, FDF Exports

DOSSIERs // Finished Dosage Formulations

186 Dossiers, 77 FDA Orange Book, 68 Europe, 14 Canada, 3 South Africa, 24 Listed Dossiers

DRUG PRODUCT COMPOSITION

TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.2MG BASE, TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.4MG BASE, TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.6MG BASE, TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.8MG BASE, TROCHE/LOZENGE;TRANSMUCOSAL - EQ 1.2MG BASE, TROCHE/LOZENGE;TRANSMUCOSAL - EQ 1.6MG BASE, TABLET;BUCCAL, SUBLINGUAL - EQ 0.1MG BASE, TABLET;BUCCAL, SUBLINGUAL - EQ 0.2MG BASE, TABLET;BUCCAL, SUBLINGUAL - EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;BUCCAL, SUBLINGUAL - EQ 0.4MG BASE, TABLET;BUCCAL, SUBLINGUAL - EQ 0.6MG BASE, TABLET;BUCCAL, SUBLINGUAL - EQ 0.8MG BASE, TABLET;SUBLINGUAL - EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 0.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 0.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 0.8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SPRAY, METERED;NASAL - EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SPRAY, METERED;NASAL - EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SPRAY, METERED;NASAL - EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.2MG BASE
TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.4MG BASE
TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.6MG BASE
TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.8MG BASE
TROCHE/LOZENGE;TRANSMUCOSAL - EQ 1.2MG BASE
TROCHE/LOZENGE;TRANSMUCOSAL - EQ 1.6MG BASE
TABLET;BUCCAL, SUBLINGUAL - EQ 0.1MG BASE
TABLET;BUCCAL, SUBLINGUAL - EQ 0.2MG BASE
TABLET;BUCCAL, SUBLINGUAL - EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;BUCCAL, SUBLINGUAL - EQ 0.4MG BASE
TABLET;BUCCAL, SUBLINGUAL - EQ 0.6MG BASE
TABLET;BUCCAL, SUBLINGUAL - EQ 0.8MG BASE
TABLET;SUBLINGUAL - EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;SUBLINGUAL - EQ 0.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;SUBLINGUAL - EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;SUBLINGUAL - EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;SUBLINGUAL - EQ 0.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;SUBLINGUAL - EQ 0.8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SPRAY, METERED;NASAL - EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SPRAY, METERED;NASAL - EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SPRAY, METERED;NASAL - EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

Suppliers, 18 Roquette, 17 SPI Pharma, 17 Kerry, 11 Microlex e.U, 10 Corel Pharma Chem, 10 Sigachi Industries, 10 Gangwal Healthcare, 8 Seppic, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 6 Actylis, 6 Lonza Capsugel, 5 Ingredion Pharma Solutions, 5 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 4 DFE Pharma, 4 Prachin Chemical, 4 Vasa Pharmachem, 4 BASF, 3 Kima Chemical, 2 DKSH, 2 Pfanstiehl, 2 The Dow Chemical Company, 2 Pharmatrans-Sanaq, 2 Rochem International Inc, 1 Finar, 1 Huzhou Sunflower Pharmaceutical, 1 Alcedo Pharmachem, 1 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 1 Jai Radhe Sales, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 1 Qualicaps, 1 Boai NKY Pharmaceuticals Ltd

EXCIPIENTS BY APPLICATIONS

57 Fillers, Diluents & Binders, 43 Coating Systems & Additives, 30 Direct Compression, 28 Disintegrants & Superdisintegrants, 23 Controlled & Modified Release, 18 Taste Masking, 17 Thickeners and Stabilizers, 16 Granulation, 15 Chewable & Orodispersible Aids, 12 Co-Processed Excipients, 11 Lubricants & Glidants, 10 Film Formers & Plasticizers, 7 Parenteral, 5 Empty Capsules, 5 API Stability Enhancers, 4 Vegetarian Capsules, 4 Solubilizers, 3 Rheology Modifiers, 2 Coloring Agents, 2 Emulsifying Agents, 2 Topical

GLOBAL SALES INFORMATION

42 US Medicaid Prescriptions, 12 Finished Drug Prices

MARKET PLACE

11 APIs, 5 DOSSIERS // FDF

PATENTS

36 US Patents, 17 Health Canada Patents

ANALYTICAL SOLUTION(s)

2 EDQM Standards, 1 USP Standards, 3 Other Ref. Standards

DIGITAL CONTENT

35 News

35 News

API SUPPLIERS

API Suppliers

US DMFs Filed

CEP/COS Certifications

JDMFs Filed

Other Certificates

Other Suppliers

API REF. PRICE (USD / KG)

64,860

API Market Place

INTERMEDIATES

DOSSIERS // FDF

USA (Orange Book)

Europe

Canada

Australia

South Africa

Uploaded Dossiers

GLOBAL SALES (USD Million)

U.S. Medicaid

228.00

Annual Reports

FDF Market Place

EXCIPIENTS

180

PATENTS & EXCLUSIVITIES

USFDA Orange Book Patents

USFDA Exclusivities

DIGITAL CONTENT

Blog #PharmaFlow

News

REF STANDARD

EDQM

USP

Other Listed Suppliers

SERVICES

Also known as: 990-73-8, Leptanal, Phentanyl citrate, Actiq, Fentanyl dihydrogen citrate, Abstral

Molecular Formula

C₂₈H₃₆N₂O₈

Molecular Weight

528.6 g/mol

InChI Key

IVLVTNPOHDFFCJ-UHFFFAOYSA-N

FDA UNII

MUN5LYG46H

A potent narcotic analgesic, abuse of which leads to habituation or addiction. It is primarily a mu-opioid agonist. Fentanyl is also used as an adjunct to general anesthetics, and as an anesthetic for induction and maintenance. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1078)

1 2D Structure

Fentanyl Citrate

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

2-hydroxypropane-1,2,3-tricarboxylic acid;N-phenyl-N-[1-(2-phenylethyl)piperidin-4-yl]propanamide

2.1.2 InChI

InChI=1S/C22H28N2O.C6H8O7/c1-2-22(25)24(20-11-7-4-8-12-20)21-14-17-23(18-15-21)16-13-19-9-5-3-6-10-19;7-3(8)1-6(13,5(11)12)2-4(9)10/h3-12,21H,2,13-18H2,1H3;13H,1-2H2,(H,7,8)(H,9,10)(H,11,12)

2.1.3 InChI Key

IVLVTNPOHDFFCJ-UHFFFAOYSA-N

2.1.4 Canonical SMILES

CCC(=O)N(C1CCN(CC1)CCC2=CC=CC=C2)C3=CC=CC=C3.C(C(=O)O)C(CC(=O)O)(C(=O)O)O

2.2 Other Identifiers

2.2.1 UNII

MUN5LYG46H

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Duragesic

2. Durogesic

3. Fentanest

4. Fentanyl

5. Fentora

6. Phentanyl

7. R 4263

8. R-4263

9. R4263

10. Sublimaze

11. Transmucosal Oral Fentanyl Citrate

2.3.2 Depositor-Supplied Synonyms

1. 990-73-8

2. Leptanal

3. Phentanyl Citrate

4. Actiq

5. Fentanyl Dihydrogen Citrate

6. Abstral

7. Fentanyl Citrate Salt

8. Lazanda

9. Onsolis

10. Mcn-jr-4263-49

11. Instanyl

12. Fentanyl Buccal

13. Fentanyl Citrate Cii

14. Mun5lyg46h

15. Oralet

16. N-(1-phenethyl-4-piperidyl)propionanilide Citrate

17. N-(1-phenethyl-4-piperidyl)propionanilide Citrate (1:1)

18. N-(1-phenethyl-4-piperidyl)propionanilide Dihydrogen Citrate

19. Chebi:31602

20. Fentaz

21. N-(1-phenethyl-4-piperidinyl)propionanilide Dihydrogen Citrate

22. R-4263

23. Kw-2246

24. Propanamide, N-phenyl-n-(1-(2-phenylethyl)-4-piperidinyl)-, 2-hydroxy-1,2,3-propanetricarboxylate (1:1)

25. N-(1-phenethylpiperidin-4-yl)-n-phenylpropionamide Citrate

26. Rapinyl

27. 2-hydroxypropane-1,2,3-tricarboxylic Acid;n-phenyl-n-[1-(2-phenylethyl)piperidin-4-yl]propanamide

28. Mcn-jr 4263

29. Sublimaze Preservative Free

30. Einecs 213-588-0

31. Unii-mun5lyg46h

32. Fentanyl Citrate Preservative Free

33. R 5240

34. Fentanyl Monocitrate

35. Abstral (tn)

36. Fentora (tn)

37. Lazanda (tn)

38. Oralet (tn)

39. Fentanyl Citrate [usan:usp:ban:jan]

40. Propionanilide, N-(1-phenethyl-4-piperidyl)-, Citrate (1:1)

41. Chembl688

42. Schembl40733

43. Fentanyl Citrate [mi]

44. Fentanyl Citrate [jan]

45. Fentanyl Citrate (jp17/usp)

46. Fentanyl Citrate [usan]

47. Fentanyl Citrate [vandf]

48. Dtxsid80243933

49. Fentanyl Citrate [mart.]

50. Fentanyl Citrate [who-dd]

51. Fentanyl Citrate [ema Epar]

52. Fentanyl Citrate [green Book]

53. Akos024457504

54. Fentanyl Citrate [orange Book]

55. Fentanyl Citrate Cii [usp-rs]

56. Fentanyl Citrate [ep Monograph]

57. Fentanyl Citrate [usp Monograph]

58. Innovar Component Fentanyl Citrate

59. B5403

60. Fentanyl Citrate Component Of Innovar

61. D01399

62. 990f738

63. Q27104201

64. N-phenyl-n-[1-(2-phenylethyl)-4-piperidyl]propanamide Citrate

65. Fentanyl Citrate, European Pharmacopoeia (ep) Reference Standard

66. N-phenyl-n-[1-(2-phenylethyl)-4-piperidinyl]propanamide Citrate

67. Fentanyl Citrate, United States Pharmacopeia (usp) Reference Standard

68. Fentanyl Citrate Salt Solution, Drug Standard, 100 Mug/ml In Methanol: Tert-butanol (3:2)

69. N-(1-phenethylpiperidin-4-yl)-n-phenylpropionamide 2-hydroxypropane-1,2,3-tricarboxylate

70. N-phenyl-n-[1-(2-phenylethyl)piperidin-4-yl]propanamide 2-hydroxypropane-1,2,3-tricarboxylate

2.4 Create Date

2005-06-24

3 Chemical and Physical Properties

Molecular Formula	C₂₈H₃₆N₂O₈
Molecular Weight	528.6 g/mol
Hydrogen Bond Donor Count	4
Hydrogen Bond Acceptor Count	9
Rotatable Bond Count	11
Exact Mass	528.24716611 g/mol
Monoisotopic Mass	528.24716611 g/mol
Topological Polar Surface Area	156 Å²
Heavy Atom Count	38
Formal Charge	0
Complexity	618
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Drug Information

1 of 8
Drug Name	Abstral
PubMed Health	Fentanyl
Drug Classes	Analgesic, Anesthetic Adjunct
Drug Label	ABSTRAL (fentanyl) sublingual tablet is a solid formulation of fentanyl citrate, a potent opioid analgesic intended for oral sublingual administration. ABSTRAL is formulated as a white tablet available in six strengths, distinguishable by the shape o...
Active Ingredient	Fentanyl citrate
Dosage Form	Tablet
Route	Sublingual
Strength	eq 0.1mg base; eq 0.8mg base; eq 0.3mg base; eq 0.6mg base; eq 0.4mg base; eq 0.2mg base
Market Status	Prescription
Company	Galena Biopharma

2 of 8
Drug Name	Fentanyl citrate
Drug Label	Oral transmucosal fentanyl citrate is a solid formulation of fentanyl citrate, a potent opioid analgesic, intended for oral transmucosal administration. Oral transmucosal fentanyl citrate is formulated as a white to off-white solid drug matrix on a h...
Active Ingredient	Fentanyl citrate
Dosage Form	Injectable; Troche/lozenge
Route	Transmucosal; Injection
Strength	eq 0.05mg base/ml; eq 0.8mg base; eq 1.6mg base; eq 0.6mg base; eq 1.2mg base; eq 0.4mg base; eq 0.2mg base
Market Status	Prescription
Company	Hospira; Mallinckrodt; Par Pharm

3 of 8
Drug Name	Fentanyl citrate preservative free
Active Ingredient	Fentanyl citrate
Dosage Form	Injectable
Route	Injection
Strength	eq 0.05mg base/ml
Market Status	Prescription
Company	Hospira; Hikma Maple

4 of 8
Drug Name	Sublimaze preservative free
Active Ingredient	Fentanyl citrate
Dosage Form	Injectable
Route	Injection
Strength	eq 0.05mg base/ml
Market Status	Prescription
Company	Akorn

5 of 8
Drug Name	Abstral
PubMed Health	Fentanyl
Drug Classes	Analgesic, Anesthetic Adjunct
Drug Label	ABSTRAL (fentanyl) sublingual tablet is a solid formulation of fentanyl citrate, a potent opioid analgesic intended for oral sublingual administration. ABSTRAL is formulated as a white tablet available in six strengths, distinguishable by the shape o...
Active Ingredient	Fentanyl citrate
Dosage Form	Tablet
Route	Sublingual
Strength	eq 0.1mg base; eq 0.8mg base; eq 0.3mg base; eq 0.6mg base; eq 0.4mg base; eq 0.2mg base
Market Status	Prescription
Company	Galena Biopharma

6 of 8
Drug Name	Fentanyl citrate
Drug Label	Oral transmucosal fentanyl citrate is a solid formulation of fentanyl citrate, a potent opioid analgesic, intended for oral transmucosal administration. Oral transmucosal fentanyl citrate is formulated as a white to off-white solid drug matrix on a h...
Active Ingredient	Fentanyl citrate
Dosage Form	Injectable; Troche/lozenge
Route	Transmucosal; Injection
Strength	eq 0.05mg base/ml; eq 0.8mg base; eq 1.6mg base; eq 0.6mg base; eq 1.2mg base; eq 0.4mg base; eq 0.2mg base
Market Status	Prescription
Company	Hospira; Mallinckrodt; Par Pharm

7 of 8
Drug Name	Fentanyl citrate preservative free
Active Ingredient	Fentanyl citrate
Dosage Form	Injectable
Route	Injection
Strength	eq 0.05mg base/ml
Market Status	Prescription
Company	Hospira; Hikma Maple

8 of 8
Drug Name	Sublimaze preservative free
Active Ingredient	Fentanyl citrate
Dosage Form	Injectable
Route	Injection
Strength	eq 0.05mg base/ml
Market Status	Prescription
Company	Akorn

4.2 Drug Indication

Instanyl is indicated for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain. Breakthrough pain is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain.

Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.

Treatment of acute pain, Prevention of acute pain

Acute pain

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Analgesics, Opioid

Compounds with activity like OPIATE ALKALOIDS, acting at OPIOID RECEPTORS. Properties include induction of ANALGESIA or NARCOSIS. (See all compounds classified as Analgesics, Opioid.)

Anesthetics, Intravenous

Ultrashort-acting anesthetics that are used for induction. Loss of consciousness is rapid and induction is pleasant, but there is no muscle relaxation and reflexes frequently are not reduced adequately. Repeated administration results in accumulation and prolongs the recovery time. Since these agents have little if any analgesic activity, they are seldom used alone except in brief minor procedures. (From AMA Drug Evaluations Annual, 1994, p174) (See all compounds classified as Anesthetics, Intravenous.)

Narcotics

Agents that induce NARCOSIS. Narcotics include agents that cause somnolence or induced sleep (STUPOR); natural or synthetic derivatives of OPIUM or MORPHINE or any substance that has such effects. They are potent inducers of ANALGESIA and OPIOID-RELATED DISORDERS. (See all compounds classified as Narcotics.)

Adjuvants, Anesthesia

Agents that are administered in association with anesthetics to increase effectiveness, improve delivery, or decrease required dosage. (See all compounds classified as Adjuvants, Anesthesia.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Opioid Agonist [EPC]; Full Opioid Agonists [MoA]

5.3 ATC Code

N02AB03