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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
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
Molecular Weight | 528.6 g/mol |
---|---|
Molecular Formula | C28H36N2O8 |
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 Ų |
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 |
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 |
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
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.)
N02AB03
Certificate Number : R1-CEP 2013-071 - Rev 00
Issue Date : 2019-09-04
Type : Chemical
Substance Number : 1103
Status : Valid
Available Reg Filing : ASMF |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5038
Submission : 1983-08-15
Status : Active
Type : II
Certificate Number : R1-CEP 2005-104 - Rev 04
Issue Date : 2023-08-30
Type : Chemical
Substance Number : 1103
Status : Valid
NDC Package Code : 49812-0001
Start Marketing Date : 1985-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Baeksu Pharmaceutical Co., Ltd.
Registration Date : 2021-06-22
Registration Number : 20210622-210-J-918
Manufacturer Name : Macfarlan Smith Limited
Manufacturer Address : 10 Wheatfield Road, Edinburgh, EH11 2QA, United Kingdom
Available Reg Filing : ROW |
Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
Certificate Number : R1-CEP 2016-023 - Rev 00
Issue Date : 2022-05-30
Type : Chemical
Substance Number : 1103
Status : Valid
Date of Issue : 2025-02-11
Valid Till : 2027-06-09
Written Confirmation Number : WC-0278
Address of the Firm :
Certificate Number : R1-CEP 2000-303 - Rev 04
Issue Date : 2014-10-13
Type : Chemical
Substance Number : 1103
Status : Valid
Registrant Name : Samung Industrial Co., Ltd.
Registration Date : 2021-06-22
Registration Number : 20210622-210-J-918(A)
Manufacturer Name : Macfarlan Smith Limited
Manufacturer Address : 10 Wheatfield Road, Edinburgh, EH11 2QA, United Kingdom
Available Reg Filing : ROW |
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-02-12
Pay. Date : 2012-11-27
DMF Number : 10128
Submission : 1993-03-15
Status : Active
Type : II
Registration Number : 218MF10580
Registrant's Address : 385 Marshall Ave, Webster Groves, Missouri 63119, United States
Initial Date of Registration : 2006-06-22
Latest Date of Registration :
NDC Package Code : 0406-1205
Start Marketing Date : 2013-04-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20774
Submission : 2007-07-18
Status : Inactive
Type : II
Certificate Number : CEP 2007-208 - Rev 03
Issue Date : 2023-11-03
Type : Chemical
Substance Number : 1103
Status : Valid
Registrant Name : Samung Industrial Co., Ltd.
Registration Date : 2022-02-15
Registration Number : 20220215-210-J-1232
Manufacturer Name : Yichang Humanwell Pharmaceutical Co., Ltd.
Manufacturer Address : No.19, Dalian Road, Yichang Development Zone, Hubei, China
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4751
Submission : 1983-01-04
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19081
Submission : 2006-01-03
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7051
Submission : 1987-07-02
Status : Inactive
Type : II
Certificate Number : CEP 2009-097 - Rev 02
Issue Date : 2024-01-30
Type : Chemical
Substance Number : 1103
Status : Valid
Registration Number : 229MF10161
Registrant's Address : 385 Marshall Ave, Webster Groves, Missouri 63119, United States
Initial Date of Registration : 2017-08-17
Latest Date of Registration :
NDC Package Code : 0406-1333
Start Marketing Date : 2013-11-20
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Certificate Number : R1-CEP 2013-071 - Rev 00
Status : Valid
Issue Date : 2019-09-04
Type : Chemical
Substance Number : 1103
Certificate Number : R1-CEP 2005-104 - Rev 04
Status : Valid
Issue Date : 2023-08-30
Type : Chemical
Substance Number : 1103
Certificate Number : R1-CEP 2000-303 - Rev 04
Status : Valid
Issue Date : 2014-10-13
Type : Chemical
Substance Number : 1103
Certificate Number : R1-CEP 2016-023 - Rev 00
Status : Valid
Issue Date : 2022-05-30
Type : Chemical
Substance Number : 1103
Certificate Number : CEP 2007-340 - Rev 02
Status : Valid
Issue Date : 2024-04-19
Type : Chemical
Substance Number : 1103
Certificate Number : R1-CEP 2006-288 - Rev 01
Status : Valid
Issue Date : 2019-09-24
Type : Chemical
Substance Number : 1103
Certificate Number : R1-CEP 1998-045 - Rev 06
Status : Valid
Issue Date : 2019-06-17
Type : Chemical
Substance Number : 1103
Certificate Number : R1-CEP 2005-068 - Rev 01
Status : Valid
Issue Date : 2013-01-15
Type : Chemical
Substance Number : 1103
Certificate Number : CEP 2009-097 - Rev 02
Status : Valid
Issue Date : 2024-01-30
Type : Chemical
Substance Number : 1103
Certificate Number : CEP 2007-208 - Rev 03
Status : Valid
Issue Date : 2023-11-03
Type : Chemical
Substance Number : 1103
Registration Number : 306MF10148
Registrant's Address : Meissner Strasse 35 D-01445 Radebeul, Germany
Initial Date of Registration : 2024-11-20
Latest Date of Registration : 2024-11-20
Registration Number : 226MF10217
Registrant's Address : Pol. Ind. Colo(´)n II Venus, 72 08228 Terrassa (Barcelona)-Spain
Initial Date of Registration : 2014-11-17
Latest Date of Registration : 2022-06-01
Registration Number : 229MF10161
Registrant's Address : 385 Marshall Ave, Webster Groves, Missouri 63119, United States
Initial Date of Registration : 2017-08-17
Latest Date of Registration : 2017-08-17
Registration Number : 218MF10580
Registrant's Address : 385 Marshall Ave, Webster Groves, Missouri 63119, United States
Initial Date of Registration : 2006-06-22
Latest Date of Registration : 2006-06-22
Date of Issue : 2025-02-11
Valid Till : 2027-06-09
Written Confirmation Number : WC-0278
Address of the Firm : Plot No.6406, 6407 & 6411, GIDC Estate, Ankleshwar-393002, Dist- Bharuch
Date of Issue : 2022-08-08
Valid Till : 2024-07-08
Written Confirmation Number : WC-0174
Address of the Firm : Plot No. 6,7,8,20 & 24, MIDC Industrial Area, Post Kulgaon, Badlapur, Dist. Than...
About the Company : 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...
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...
Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
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...
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...
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...
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...
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...
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...
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 ...
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 ...
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Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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DRUG PRODUCT COMPOSITIONS
Related Excipient Companies
Dosage Form : Tablet
Grade : Oral
Application : Taste Masking
Excipient Details : Mannitol is used as a filler, bulking agent and taste masking agent in ODT formulations such as tablets.
Dosage Form : Cream / Lotion / Ointment
Grade : Oral, Topical
Application : Thickeners and Stabilizers
Excipient Details : Pectin is used as a thickening and stabilizing agent in the production of pharmaceutical suspensions and creams.
Dosage Form : Tablet
Grade : Oral
Application : Fillers, Diluents & Binders
Excipient Details : Microlose (Lactose Monohydrate & Microcrystalline Cellulose) is used as a diluent in oral dosage forms such as tablets.
Pharmacopoeia Ref : DMF, EXCiPAT, KOSHER, HALAL, W...
Technical Specs : Lactose Monohydrate – 40%, Microcrystalline cellulose – 60%
Ingredient(s) : Lactose Monohydrate
Dosage Form : Tablet
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Excipient Details : ProBlend (SMCC) is a co-processed excipient consists of microcrystalline cellulose & colloidal silicon dioxide, used as a diluent & binder in OSDs.
Pharmacopoeia Ref : USP-NF, DMF, EXCiPAT, KOSHER, ...
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Ingredient(s) : Silicified Microcrystalline Cellulose
Dosage Form : Capsule
Grade : Oral
Application : Disintegrants & Superdisintegrants
Excipient Details : Sallyso (Croscarmellose Sodium) is a cross-linked polymer of carboxymethylcellulose sodium, used as a superdisintegrant in tablets and capsules.
Pharmacopoeia Ref : USP-NF, BP, IP, EP, DMF, EXCiP...
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Excipients by Applications
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ABOUT THIS PAGE
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.
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.
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.
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.
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.
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.
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.
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.
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).
The FDA updates the NDC directory daily. The NDC numbers for Leptanol API and other APIs are published in this directory by the FDA.
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.
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 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.
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).