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Chemistry

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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

Fentanyl Citrate
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 Weight 528.6 g/mol
Molecular Formula C28H36N2O8
Hydrogen Bond Donor Count4
Hydrogen Bond Acceptor Count9
Rotatable Bond Count11
Exact Mass528.24716611 g/mol
Monoisotopic Mass528.24716611 g/mol
Topological Polar Surface Area156 Ų
Heavy Atom Count38
Formal Charge0
Complexity618
Isotope Atom Count0
Defined Atom Stereocenter Count0
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 8  
Drug NameAbstral
PubMed HealthFentanyl
Drug ClassesAnalgesic, Anesthetic Adjunct
Drug LabelABSTRAL (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 IngredientFentanyl citrate
Dosage FormTablet
RouteSublingual
Strengtheq 0.1mg base; eq 0.8mg base; eq 0.3mg base; eq 0.6mg base; eq 0.4mg base; eq 0.2mg base
Market StatusPrescription
CompanyGalena Biopharma

2 of 8  
Drug NameFentanyl citrate
Drug LabelOral 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 IngredientFentanyl citrate
Dosage FormInjectable; Troche/lozenge
RouteTransmucosal; Injection
Strengtheq 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 StatusPrescription
CompanyHospira; Mallinckrodt; Par Pharm

3 of 8  
Drug NameFentanyl citrate preservative free
Active IngredientFentanyl citrate
Dosage FormInjectable
RouteInjection
Strengtheq 0.05mg base/ml
Market StatusPrescription
CompanyHospira; Hikma Maple

4 of 8  
Drug NameSublimaze preservative free
Active IngredientFentanyl citrate
Dosage FormInjectable
RouteInjection
Strengtheq 0.05mg base/ml
Market StatusPrescription
CompanyAkorn

5 of 8  
Drug NameAbstral
PubMed HealthFentanyl
Drug ClassesAnalgesic, Anesthetic Adjunct
Drug LabelABSTRAL (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 IngredientFentanyl citrate
Dosage FormTablet
RouteSublingual
Strengtheq 0.1mg base; eq 0.8mg base; eq 0.3mg base; eq 0.6mg base; eq 0.4mg base; eq 0.2mg base
Market StatusPrescription
CompanyGalena Biopharma

6 of 8  
Drug NameFentanyl citrate
Drug LabelOral 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 IngredientFentanyl citrate
Dosage FormInjectable; Troche/lozenge
RouteTransmucosal; Injection
Strengtheq 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 StatusPrescription
CompanyHospira; Mallinckrodt; Par Pharm

7 of 8  
Drug NameFentanyl citrate preservative free
Active IngredientFentanyl citrate
Dosage FormInjectable
RouteInjection
Strengtheq 0.05mg base/ml
Market StatusPrescription
CompanyHospira; Hikma Maple

8 of 8  
Drug NameSublimaze preservative free
Active IngredientFentanyl citrate
Dosage FormInjectable
RouteInjection
Strengtheq 0.05mg base/ml
Market StatusPrescription
CompanyAkorn

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


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Fentanyl Citrate

Registration Number : 306MF10148

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Registration Number : 226MF10217

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Fentanyl Citrate FP

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Registration Number : 218MF10580

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Initial Date of Registration : 2006-06-22

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Fentanyl Citrate EP/BP/USP

Date of Issue : 2025-02-11

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Date of Issue : 2022-08-08

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Aspen API is the cooperative entity formed by Aspen Oss in the Netherlands and Fine Chemicals Corporation in South Africa. With quality, compliance, and teamwork at its core, Aspen API works tirelessly to deliver top-quality APIs to clients worldwide. Aspen API has a portfolio of over 58 high-quality APIs, including high potency, oncology, peptides, narcotics, analgesics, botanical extractions, and biochemicals. Aspen API places a strong emphasis on sustainability. It employs eco-friendly technologies and solvents in its chemical processes, ensuring responsible and environmentally conscious manufacturing.
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About the Company : Veranova is a global leader in the development and manufacturing of specialist and complex APIs for pharma and biotech customers. We have over 50 years of experience navigating the...

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Fentanyl Citrate

About the Company : Malladi Drugs & Pharmaceuticals Ltd was founded in 1980 by microbiologist Mr. M L N Sastry. Within a few years, Malladi established itself as a leader in manufacturing ephedrine an...

Malladi Drugs & Pharmaceuticals Ltd was founded in 1980 by microbiologist Mr. M L N Sastry. Within a few years, Malladi established itself as a leader in manufacturing ephedrine and pseudoephedrine salts. Today, it is the leading manufacturer of APIs in the cough and cold segment. It also has a dominant presence in several therapeutic segments like antihistamines, anti-convulsants, anti-depressants and anxiolytics (CNS). Malladi exports its products to around 60 countries and over 85% of its revenue is generated from exports. Its manufacturing facilities have been approved by the FDA, EDQM, KFDA, TGA and various other regulatory agencies.
Malladi

04

Rusan Pharma

India
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothRusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.

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Fentanyl Citrate

About the Company : Rusan Pharma is a fully integrated global pharmaceutical company specializing in the treatment of addiction & pain management. We manufacture & market a wide range of APIs & formul...

Rusan Pharma is a fully integrated global pharmaceutical company specializing in the treatment of addiction & pain management. We manufacture & market a wide range of APIs & formulations, in the area of controlled substances. Our facilities are GMP-approved by Health Canada, EU, TGA, ANVISA, PIC/S, WHO, Russia & SAHPRA. We have CEP approval for various APIs such as Buprenorphine, Fentanyl, Naltrexone, Methadone, Bisoprolol & we also manufacture Naloxone, Nalbuphine, Nalmefene, Apomorphine, Efflornithine & Sodium Oxybate. We also develop & manufacture various transdermal patches & long-acting formulations such as depot injections & Implants.
Rusan Pharma

05

Arevipharma

Germany
ACS Fall 2025
Not Confirmed
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Arevipharma

Germany
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ACS Fall 2025
Not Confirmed

Fentanyl Citrate

About the Company : Arevipharma GmbH is a modern manufacturer of active pharmaceutical ingredients and intermediates with more than 140 years of expertise. Our customers are generic and research-based...

Arevipharma GmbH is a modern manufacturer of active pharmaceutical ingredients and intermediates with more than 140 years of expertise. Our customers are generic and research-based pharmaceutical companies on five continents. Our business partners recognise us as a competent, reliable and efficient company that is distinguished by individual service and an innovative character. The company’s 140 year history is based on the knowledge, skills, commitment and loyalty of its employees. Arevipharma also feels committed to its owners and investors. Due to the consistent expansion of new technologies,
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06

ACS Fall 2025
Not Confirmed
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ACS Fall 2025
Not Confirmed

Fentanyl Citrate

About the Company : Hasti Aria Shimi (H.A.S.) is established in 2010 as an R&D center of GPI. This company states (determined) R&D activities for developing API and technical know-how to other subsidi...

Hasti Aria Shimi (H.A.S.) is established in 2010 as an R&D center of GPI. This company states (determined) R&D activities for developing API and technical know-how to other subsidiary companies equipped with knowledgeable specialists and state-of-the-art facilities. To attain it’s determined goals, HAS benefits from technical units such as R&D department, Pharmaceutical Engineering Department, Market Research Department, Kilo Lab Unit and Mini Plant.
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07

Kimyagaran

Iran
ACS Fall 2025
Not Confirmed
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Kimyagaran

Iran
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ACS Fall 2025
Not Confirmed

Fentanyl Citrate

About the Company : Established in 1995, Kimyagaran Emrooz Chemical Industries Co. is recognized as one of the major leading production enterprises in the ethoxylation and propoxylation industry for m...

Established in 1995, Kimyagaran Emrooz Chemical Industries Co. is recognized as one of the major leading production enterprises in the ethoxylation and propoxylation industry for manufacturing a wide variety of chemicals and pharmaceuticals in the Middle East. The company started out its journey by producing pharmaceutical polyethylene glycols (PEGs). It is currently the leading manufacturer of a wide variety of ethoxylated and propoxylated products that are consumed in 17 different industrial branches. The firm places a lot of emphasis on focuses a lot on research and development. The company currently boasts of over 3,000 customers.
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08

Maiden Group

India
ACS Fall 2025
Not Confirmed
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Maiden Group

India
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ACS Fall 2025
Not Confirmed

Fentanyl Citrate

About the Company : We are Maiden, a rapidly growing Indian pharma company committed to developing, manufacturing and marketing diverse portfolio of products. Our core strength lies in development, up...

We are Maiden, a rapidly growing Indian pharma company committed to developing, manufacturing and marketing diverse portfolio of products. Our core strength lies in development, up scaling and manufacturing differentiated formulations. Various national and multi-national pharmaceutical companies across geographies rely on our expertises to deliver world class quality products. Maiden complies with various National / International regulatory norms and standards. We strive hard to make a difference in people lives, through our innovative healthcare solutions.
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09

ACS Fall 2025
Not Confirmed
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ACS Fall 2025
Not Confirmed

Fentanyl Citrate

About the Company : Founded in 1950, we were one of the first API manufacturing companies in Northern Europe. The company combines over 65 years of experience in chemical synthesis manufacturing with ...

Founded in 1950, we were one of the first API manufacturing companies in Northern Europe. The company combines over 65 years of experience in chemical synthesis manufacturing with continuous technical innovation. Northern Synthesis is one of the oldest API manufacturing companies in Northern Europe with an internationally approved quality system, experienced personnel and a bespoke product distribution system. Our API products comply with pharmacopoeia requirements of Monograph of EP; BP and USP. The whole manufacturing process of the API is compliant with the official written procedures and quality control requirements.
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10

OmnisMed Pharmaceuticals

United Kingdom
ACS Fall 2025
Not Confirmed
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OmnisMed Pharmaceuticals

United Kingdom
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ACS Fall 2025
Not Confirmed

Fentanyl Citrate

About the Company : OmnisMed Pharmaceuticals believes that good healthcare must be accessible to everyone; That is the core of our philosophy. We are experts in providing a wide range of high-quality ...

OmnisMed Pharmaceuticals believes that good healthcare must be accessible to everyone; That is the core of our philosophy. We are experts in providing a wide range of high-quality pharmaceutical products, highly tested and approved controlled drugs, and fully certifiable medical devices. All our suppliers hold several GMPs and certifications which are readily accepted by developed and developing markets. The high daily manufacturing capacity of our facilities and our distribution network allows us to quickly fulfill large orders and ensure our manufacturing process is cost-effective.
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API Reference Price

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04-May-2022
02-May-2025
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DRUG PRODUCT COMPOSITIONS

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DOSAGE - TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.2...DOSAGE - TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.2MG BASE

USFDA APPLICATION NUMBER - 20747

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DOSAGE - TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.4...DOSAGE - TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.4MG BASE

USFDA APPLICATION NUMBER - 20747

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DOSAGE - TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.6...DOSAGE - TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.6MG BASE

USFDA APPLICATION NUMBER - 20747

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DOSAGE - TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.8...DOSAGE - TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.8MG BASE

USFDA APPLICATION NUMBER - 20747

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DOSAGE - TROCHE/LOZENGE;TRANSMUCOSAL - EQ 1.2...DOSAGE - TROCHE/LOZENGE;TRANSMUCOSAL - EQ 1.2MG BASE

USFDA APPLICATION NUMBER - 20747

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DOSAGE - TROCHE/LOZENGE;TRANSMUCOSAL - EQ 1.6...DOSAGE - TROCHE/LOZENGE;TRANSMUCOSAL - EQ 1.6MG BASE

USFDA APPLICATION NUMBER - 20747

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DOSAGE - TABLET;BUCCAL, SUBLINGUAL - EQ 0.1MG...DOSAGE - TABLET;BUCCAL, SUBLINGUAL - EQ 0.1MG BASE

USFDA APPLICATION NUMBER - 21947

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DOSAGE - TABLET;BUCCAL, SUBLINGUAL - EQ 0.2MG...DOSAGE - TABLET;BUCCAL, SUBLINGUAL - EQ 0.2MG BASE

USFDA APPLICATION NUMBER - 21947

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DOSAGE - TABLET;BUCCAL, SUBLINGUAL - EQ 0.3MG...DOSAGE - TABLET;BUCCAL, SUBLINGUAL - EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 21947

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DOSAGE - TABLET;BUCCAL, SUBLINGUAL - EQ 0.4MG...DOSAGE - TABLET;BUCCAL, SUBLINGUAL - EQ 0.4MG BASE

USFDA APPLICATION NUMBER - 21947

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DOSAGE - TABLET;BUCCAL, SUBLINGUAL - EQ 0.6MG...DOSAGE - TABLET;BUCCAL, SUBLINGUAL - EQ 0.6MG BASE

USFDA APPLICATION NUMBER - 21947

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DOSAGE - TABLET;BUCCAL, SUBLINGUAL - EQ 0.8MG...DOSAGE - TABLET;BUCCAL, SUBLINGUAL - EQ 0.8MG BASE

USFDA APPLICATION NUMBER - 21947

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DOSAGE - TABLET;SUBLINGUAL - EQ 0.1MG BASE **...DOSAGE - TABLET;SUBLINGUAL - EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 22510

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DOSAGE - TABLET;SUBLINGUAL - EQ 0.2MG BASE **...DOSAGE - TABLET;SUBLINGUAL - EQ 0.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 22510

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DOSAGE - TABLET;SUBLINGUAL - EQ 0.3MG BASE **...DOSAGE - TABLET;SUBLINGUAL - EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 22510

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DOSAGE - TABLET;SUBLINGUAL - EQ 0.4MG BASE **...DOSAGE - TABLET;SUBLINGUAL - EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 22510

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DOSAGE - TABLET;SUBLINGUAL - EQ 0.6MG BASE **...DOSAGE - TABLET;SUBLINGUAL - EQ 0.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 22510

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DOSAGE - TABLET;SUBLINGUAL - EQ 0.8MG BASE **...DOSAGE - TABLET;SUBLINGUAL - EQ 0.8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 22510

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DOSAGE - SPRAY, METERED;NASAL - EQ 0.1MG BASE...DOSAGE - SPRAY, METERED;NASAL - EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 22569

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DOSAGE - SPRAY, METERED;NASAL - EQ 0.3MG BASE...DOSAGE - SPRAY, METERED;NASAL - EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 22569

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DOSAGE - SPRAY, METERED;NASAL - EQ 0.4MG BASE...DOSAGE - SPRAY, METERED;NASAL - EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 22569

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ABOUT THIS PAGE

Looking for 990-73-8 / Fentanyl Citrate API manufacturers, exporters & distributors?

Fentanyl Citrate manufacturers, exporters & distributors 1

12

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

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

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

API | Excipient name

Fentanyl Citrate

Synonyms

990-73-8, Leptanal, Phentanyl citrate, Actiq, Fentanyl dihydrogen citrate, Abstral

Cas Number

990-73-8

Unique Ingredient Identifier (UNII)

MUN5LYG46H

About Fentanyl Citrate

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)

Leptanol Manufacturers

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

Leptanol Suppliers

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

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

Leptanol USDMF

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

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

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

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

Leptanol KDMF

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

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

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

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

Leptanol CEP

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

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

Leptanol WC

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

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

Leptanol 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 Leptanol as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Leptanol GMP

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

Leptanol CoA

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

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

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