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1. 3-((1r,2r)-3-(dimethylamino)-1-ethyl-2-methylpropyl)phenol
2. Nucynta
3. Tapentadol
1. 175591-09-0
2. Tapentadol Hcl
3. Nucynta
4. Palexia
5. Tapentadol (hydrochloride)
6. Nucynta Er
7. Bn-200 Hydrochloride
8. Cg5503 Hydrochloride
9. Cg-5503 Hydrochloride
10. 3-((2r,3r)-1-(dimethylamino)-2-methylpentan-3-yl)phenol Hydrochloride
11. 71204kii53
12. 175591-09-0 (hcl)
13. Tapentadol Hydrochloride (jan)
14. Tapentadol Hydrochloride [jan]
15. 3-[(1r,2r)-3-(dimethylamino)-1-ethyl-2-methylpropyl]phenol Hydrochloride
16. Palexia Retard
17. 3-((1r,2r)-3-(dimethylamino)-1-ethyl-2-methylpropyl)phenol Hydrochloride
18. Unii-71204kii53
19. Palexia Sr
20. Phenol, 3-[(1r,2r)-3-(dimethylamino)-1-ethyl-2-methylpropyl]-, Hydrochloride (1:1)
21. Phenol, 3-((1r,2r)-3-(dimethylamino)-1-ethyl-2-methylpropyl)-, Hydrochloride (1:1)
22. Nucynta (tn)
23. Schembl238138
24. Jns-024 Er
25. Chembl1201777
26. Dtxsid00938677
27. Amy25232
28. Hy-70042a
29. Mfcd00944992
30. Tapentadol Hydrochloride [mi]
31. Akos016842888
32. Cs-0879
33. Tapentadol Hydrochloride [mart.]
34. Tapentadol Hydrochloride [vandf]
35. Tapentadol Hydrochloride [who-dd]
36. Ac-32018
37. Tapentadol Hydrochloride [orange Book]
38. D10199
39. Tapentadol Hydrochloride [ep Monograph]
40. 591t238
41. Tapentadol Hydrochloride (1.0 Mg/ml In Methanol)
42. R-331333
43. Q27265914
44. 3-((1r,2r)-3-(dimethylamino)-1-ethyl-2-methylpropyl) Phenol Hydrochloride
45. 3-((1r,2r)-3-(dimethylamino)-1-ethyl-2-methylpropyl)-phenol Hydrochloride
46. 3-[(2r,3r)-1-(dimethylamino)-2-methylpentan-3-yl]phenol;hydrochloride
47. 3-[1-(dimethylamino)-2-methylpentan-3-yl]phenol--hydrogen Chloride (1/1)
48. (-)-(1r,2r)-3-(3-dimethylamino-1-ethyl-2-methyl-propyl)-phenol Hydrochloride
49. (-)-(1r,2r)-3-(3-dimethylamino-1-ethyl-2-methylpropyl)-phenol Hydrochloride
50. 3-[(1r,2r)-3-(dimethylamino)-1-ethyl-2-methylpropyl]phenol Monohydrochloride
51. Phenol, 3-((1r,2r)-3-(dimethylamino)-1-ethyl-2-methylpropyl)-, Hydrochloride
52. Phenol, 3-(3-(dimethylamino)-1-ethyl-2-methylpropyl)-, Hydrochloride, (r-(r*,r*))-
53. Tapentadol Hydrochloride Solution, 1.0 Mg/ml In Methanol (as Free Base), Ampule Of 1 Ml, Certified Reference Material
Molecular Weight | 257.80 g/mol |
---|---|
Molecular Formula | C14H24ClNO |
Hydrogen Bond Donor Count | 2 |
Hydrogen Bond Acceptor Count | 2 |
Rotatable Bond Count | 5 |
Exact Mass | 257.1546421 g/mol |
Monoisotopic Mass | 257.1546421 g/mol |
Topological Polar Surface Area | 23.5 Ų |
Heavy Atom Count | 17 |
Formal Charge | 0 |
Complexity | 193 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 2 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
1 of 4 | |
---|---|
Drug Name | Nucynta |
PubMed Health | Tapentadol (By mouth) |
Drug Classes | Analgesic |
Drug Label | NUCYNTA ER (tapentadol) is a mu-opioid receptor agonist, supplied in extended-release film-coated tablets for oral administration, containing 58.24, 116.48, 174.72, 232.96, and 291.20 mg of tapentadol hydrochloride in each tablet strength, correspo... |
Active Ingredient | Tapentadol hydrochloride |
Dosage Form | Tablet; Solution |
Route | Oral |
Strength | eq 100mg base; eq 50mg base; eq 75mg base; eq 20mg base/ml |
Market Status | Prescription |
Company | Janssen Pharms |
2 of 4 | |
---|---|
Drug Name | Nucynta er |
Drug Label | NUCYNTA ER (tapentadol) is a mu-opioid receptor agonist, supplied in extended-release film-coated tablets for oral administration, containing 58.24, 116.48, 174.72, 232.96, and 291.20 mg of tapentadol hydrochloride in each tablet strength, correspo... |
Active Ingredient | Tapentadol hydrochloride |
Dosage Form | Tablet, extended release |
Route | Oral |
Strength | eq 100mg base; eq 50mg base; eq 250mg base; eq 150mg base; eq 200mg base |
Market Status | Prescription |
Company | Janssen Pharms |
3 of 4 | |
---|---|
Drug Name | Nucynta |
PubMed Health | Tapentadol (By mouth) |
Drug Classes | Analgesic |
Drug Label | NUCYNTA ER (tapentadol) is a mu-opioid receptor agonist, supplied in extended-release film-coated tablets for oral administration, containing 58.24, 116.48, 174.72, 232.96, and 291.20 mg of tapentadol hydrochloride in each tablet strength, correspo... |
Active Ingredient | Tapentadol hydrochloride |
Dosage Form | Tablet; Solution |
Route | Oral |
Strength | eq 100mg base; eq 50mg base; eq 75mg base; eq 20mg base/ml |
Market Status | Prescription |
Company | Janssen Pharms |
4 of 4 | |
---|---|
Drug Name | Nucynta er |
Drug Label | NUCYNTA ER (tapentadol) is a mu-opioid receptor agonist, supplied in extended-release film-coated tablets for oral administration, containing 58.24, 116.48, 174.72, 232.96, and 291.20 mg of tapentadol hydrochloride in each tablet strength, correspo... |
Active Ingredient | Tapentadol hydrochloride |
Dosage Form | Tablet, extended release |
Route | Oral |
Strength | eq 100mg base; eq 50mg base; eq 250mg base; eq 150mg base; eq 200mg base |
Market Status | Prescription |
Company | Janssen Pharms |
Treatment of acute pain
Treatment of acute pain
Treatment of acute pain
Treatment of chronic pain
Treatment of chronic pain
Treatment of acute pain
Treatment of chronic pain
Adrenergic Uptake Inhibitors
Drugs that block the transport of adrenergic transmitters into axon terminals or into storage vesicles within terminals. The tricyclic antidepressants (ANTIDEPRESSIVE AGENTS, TRICYCLIC) and amphetamines are among the therapeutically important drugs that may act via inhibition of adrenergic transport. Many of these drugs also block transport of serotonin. (See all compounds classified as Adrenergic Uptake Inhibitors.)
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.)
Certificate Number : CEP 2023-142 - Rev 00
Issue Date : 2024-10-31
Type : Chemical
Substance Number : 3035
Status : Valid
Date of Issue : 2024-01-15
Valid Till : 2027-01-15
Written Confirmation Number : WC-0575
Address of the Firm :
Available Reg Filing : ASMF |
Certificate Number : R0-CEP 2021-290 - Rev 00
Issue Date : 2022-11-24
Type : Chemical
Substance Number : 3035
Status : Valid
Date of Issue : 2022-08-11
Valid Till : 2025-06-26
Written Confirmation Number : WC-0054
Address of the Firm :
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-08-05
Pay. Date : 2020-07-30
DMF Number : 21084
Submission : 2008-01-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28541
Submission : 2014-09-25
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-03-13
Pay. Date : 2012-11-02
DMF Number : 26490
Submission : 2012-09-27
Status : Active
Type : II
NDC Package Code : 17180-9780
Start Marketing Date : 2012-06-26
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-03-01
Pay. Date : 2012-11-08
DMF Number : 26519
Submission : 2012-10-23
Status : Active
Type : II
Date of Issue : 2022-07-23
Valid Till : 2025-09-05
Written Confirmation Number : WC-0370n
Address of the Firm :
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
GDUFA
DMF Review : Complete
Rev. Date : 2020-08-05
Pay. Date : 2020-07-30
DMF Number : 21084
Submission : 2008-01-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-03-01
Pay. Date : 2012-11-08
DMF Number : 26519
Submission : 2012-10-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-08-18
Pay. Date : 2017-03-30
DMF Number : 31435
Submission : 2017-03-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28541
Submission : 2014-09-25
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-03-13
Pay. Date : 2012-11-02
DMF Number : 26490
Submission : 2012-09-27
Status : Active
Type : II
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
---|
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Details:
Through the agreement, Collegium will exclusively manufacture and supply Hikma with all authorized generic products for sale, including Nucynta-Generic (tapentadol HCl).
Lead Product(s): Tapentadol
Therapeutic Area: Neurology Brand Name: Nucynta-Generic
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Hikma Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement April 29, 2024
Lead Product(s) : Tapentadol
Therapeutic Area : Neurology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Hikma Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Agreement
Collegium Announces Authorized Generic Agreement with Hikma for Nucynta® and Nucynta® ER
Details : Through the agreement, Collegium will exclusively manufacture and supply Hikma with all authorized generic products for sale, including Nucynta-Generic (tapentadol HCl).
Brand Name : Nucynta-Generic
Molecule Type : Small molecule
Upfront Cash : Undisclosed
April 29, 2024
Details:
Assertio Therapeutics has entered into a definitive agreement with Collegium Pharmaceutical, Inc. under which Collegium will acquire the NUCYNTA® franchise of products from the Company.
Lead Product(s): Tapentadol
Therapeutic Area: Neurology Brand Name: Undisclosed
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Collegium Pharmaceutical
Deal Size: $375.0 million Upfront Cash: $375.0 million
Deal Type: Agreement February 06, 2020
Lead Product(s) : Tapentadol
Therapeutic Area : Neurology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Collegium Pharmaceutical
Deal Size : $375.0 million
Deal Type : Agreement
Assertio Announces Sale of NUCYNTA® Franchise to Collegium
Details : Assertio Therapeutics has entered into a definitive agreement with Collegium Pharmaceutical, Inc. under which Collegium will acquire the NUCYNTA® franchise of products from the Company.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : $375.0 million
February 06, 2020
Regulatory Info : EU Dossier Readiness-Q1 2020
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Dossier Readiness-Q1 2020
Registration Country : Germany
Regulatory Info : EU Dossier Readiness-Q3 2019
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 75MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Dossier Readiness-Q3 2019
Registration Country : Germany
Regulatory Info : EU Dossier Readiness-Q3 2019
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 100MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Dossier Readiness-Q3 2019
Registration Country : Germany
Regulatory Info : Status- Early Development
Registration Country : Germany
Brand Name :
Dosage Form : XR Tablet
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Status- Early Development
Registration Country : Germany
Regulatory Info : Status- Early Development
Registration Country : Germany
Brand Name :
Dosage Form : XR Tablet
Dosage Strength : 100MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Status- Early Development
Registration Country : Germany
Regulatory Info : Status- Early Development
Registration Country : Germany
Brand Name :
Dosage Form : XR Tablet
Dosage Strength : 150MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Status- Early Development
Registration Country : Germany
Regulatory Info : Status- Early Development
Registration Country : Germany
Brand Name :
Dosage Form : XR Tablet
Dosage Strength : 200MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Status- Early Development
Registration Country : Germany
Regulatory Info : Status- Early Development
Registration Country : Germany
Brand Name :
Dosage Form : XR Tablet
Dosage Strength : 250MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Status- Early Development
Registration Country : Germany
Regulatory Info : Status- Early Development
Registration Country : Germany
Brand Name :
Dosage Form : Solution
Dosage Strength : 4MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info : Status- Early Development
Registration Country : Germany
Regulatory Info : Status- Early Development
Registration Country : Germany
Brand Name :
Dosage Form : Solution
Dosage Strength : 20MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info : Status- Early Development
Registration Country : Germany
Regulatory Info : EU Dossier Readiness-Q1 2020
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Dossier Readiness-Q1 2020
Registration Country : Germany
Packaging :
Regulatory Info : EU Dossier Readiness-Q1 2020
Dosage : Film Coated Tablet
Dosage Strength : 50MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Germany
Regulatory Info : EU Dossier Readiness-Q3 2019
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 75MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Dossier Readiness-Q3 2019
Registration Country : Germany
Packaging :
Regulatory Info : EU Dossier Readiness-Q3 2019
Dosage : Film Coated Tablet
Dosage Strength : 75MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Germany
Regulatory Info : EU Dossier Readiness-Q3 2019
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 100MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Dossier Readiness-Q3 2019
Registration Country : Germany
Packaging :
Regulatory Info : EU Dossier Readiness-Q3 2019
Dosage : Film Coated Tablet
Dosage Strength : 100MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Germany
Regulatory Info : Status- Early Development
Registration Country : Germany
Brand Name :
Dosage Form : XR Tablet
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Status- Early Development
Registration Country : Germany
Packaging :
Regulatory Info : Status- Early Development
Dosage : XR Tablet
Dosage Strength : 50MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Germany
Regulatory Info : Status- Early Development
Registration Country : Germany
Brand Name :
Dosage Form : XR Tablet
Dosage Strength : 100MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Status- Early Development
Registration Country : Germany
Packaging :
Regulatory Info : Status- Early Development
Dosage : XR Tablet
Dosage Strength : 100MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Germany
Regulatory Info : Status- Early Development
Registration Country : Germany
Brand Name :
Dosage Form : XR Tablet
Dosage Strength : 150MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Status- Early Development
Registration Country : Germany
Packaging :
Regulatory Info : Status- Early Development
Dosage : XR Tablet
Dosage Strength : 150MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Germany
Regulatory Info : Status- Early Development
Registration Country : Germany
Brand Name :
Dosage Form : XR Tablet
Dosage Strength : 200MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Status- Early Development
Registration Country : Germany
Packaging :
Regulatory Info : Status- Early Development
Dosage : XR Tablet
Dosage Strength : 200MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Germany
Regulatory Info : Status- Early Development
Registration Country : Germany
Brand Name :
Dosage Form : XR Tablet
Dosage Strength : 250MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Status- Early Development
Registration Country : Germany
Packaging :
Regulatory Info : Status- Early Development
Dosage : XR Tablet
Dosage Strength : 250MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Germany
Regulatory Info : Status- Early Development
Registration Country : Germany
Brand Name :
Dosage Form : Solution
Dosage Strength : 4MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info : Status- Early Development
Registration Country : Germany
Packaging :
Regulatory Info : Status- Early Development
Dosage : Solution
Dosage Strength : 4MG/ML
Brand Name :
Approval Date :
Application Number :
Registration Country : Germany
Regulatory Info : Status- Early Development
Registration Country : Germany
Brand Name :
Dosage Form : Solution
Dosage Strength : 20MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info : Status- Early Development
Registration Country : Germany
Packaging :
Regulatory Info : Status- Early Development
Dosage : Solution
Dosage Strength : 20MG/ML
Brand Name :
Approval Date :
Application Number :
Registration Country : Germany
DRUG PRODUCT COMPOSITIONS
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Global Sales Information
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Patents & EXCLUSIVITIES
Patent Expiration Date : 2025-06-27
US Patent Number : 7994364
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 22304
Patent Use Code : U-931
Delist Requested :
Patent Use Description : RELIEF OF MODERATE TO ...
Patent Expiration Date : 2025-06-27
Patent Expiration Date : 2029-03-22
US Patent Number : 8536130*PED
Drug Substance Claim :
Drug Product Claim :
Application Number : 200533
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2029-03-22
Patent Expiration Date : 2025-06-27
US Patent Number : 7994364
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 200533
Patent Use Code : U-1178
Delist Requested :
Patent Use Description : RELIEF OF MODERATE TO ...
Patent Expiration Date : 2025-06-27
Patent Expiration Date : 2025-12-27
US Patent Number : 7994364*PED
Drug Substance Claim :
Drug Product Claim :
Application Number : 22304
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2025-12-27
Patent Expiration Date : 2028-09-22
US Patent Number : 8536130
Drug Substance Claim :
Drug Product Claim :
Application Number : 200533
Patent Use Code : U-1276
Delist Requested :
Patent Use Description : MANAGEMENT OF NEUROPAT...
Patent Expiration Date : 2028-09-22
Patent Expiration Date : 2028-04-21
US Patent Number : 11344512
Drug Substance Claim :
Drug Product Claim :
Application Number : 200533
Patent Use Code : U-3392
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2028-04-21
Patent Expiration Date : 2025-06-27
US Patent Number : 7994364
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 22304
Patent Use Code : U-931
Delist Requested :
Patent Use Description : RELIEF OF MODERATE TO ...
Patent Expiration Date : 2025-06-27
Patent Expiration Date : 2029-03-22
US Patent Number : 8536130*PED
Drug Substance Claim :
Drug Product Claim :
Application Number : 200533
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2029-03-22
Patent Expiration Date : 2028-09-22
US Patent Number : 8536130
Drug Substance Claim :
Drug Product Claim :
Application Number : 200533
Patent Use Code : U-1276
Delist Requested :
Patent Use Description : MANAGEMENT OF NEUROPAT...
Patent Expiration Date : 2028-09-22
Patent Expiration Date : 2025-12-27
US Patent Number : 7994364*PED
Drug Substance Claim :
Drug Product Claim :
Application Number : 200533
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2025-12-27
ABOUT THIS PAGE
A Tapentadol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tapentadol, including repackagers and relabelers. The FDA regulates Tapentadol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tapentadol 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 Tapentadol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tapentadol supplier is an individual or a company that provides Tapentadol active pharmaceutical ingredient (API) or Tapentadol finished formulations upon request. The Tapentadol suppliers may include Tapentadol API manufacturers, exporters, distributors and traders.
click here to find a list of Tapentadol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tapentadol DMF (Drug Master File) is a document detailing the whole manufacturing process of Tapentadol active pharmaceutical ingredient (API) in detail. Different forms of Tapentadol DMFs exist exist since differing nations have different regulations, such as Tapentadol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tapentadol DMF submitted to regulatory agencies in the US is known as a USDMF. Tapentadol USDMF includes data on Tapentadol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tapentadol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tapentadol suppliers with USDMF 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 Tapentadol Drug Master File in Korea (Tapentadol KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Tapentadol. The MFDS reviews the Tapentadol KDMF as part of the drug registration process and uses the information provided in the Tapentadol KDMF to evaluate the safety and efficacy of the drug.
After submitting a Tapentadol 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 Tapentadol API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Tapentadol suppliers with KDMF on PharmaCompass.
A Tapentadol CEP of the European Pharmacopoeia monograph is often referred to as a Tapentadol Certificate of Suitability (COS). The purpose of a Tapentadol CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Tapentadol EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Tapentadol to their clients by showing that a Tapentadol CEP has been issued for it. The manufacturer submits a Tapentadol CEP (COS) as part of the market authorization procedure, and it takes on the role of a Tapentadol CEP holder for the record. Additionally, the data presented in the Tapentadol CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Tapentadol DMF.
A Tapentadol CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Tapentadol 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 Tapentadol suppliers with CEP (COS) on PharmaCompass.
A Tapentadol written confirmation (Tapentadol WC) is an official document issued by a regulatory agency to a Tapentadol manufacturer, verifying that the manufacturing facility of a Tapentadol active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Tapentadol APIs or Tapentadol finished pharmaceutical products to another nation, regulatory agencies frequently require a Tapentadol WC (written confirmation) as part of the regulatory process.
click here to find a list of Tapentadol 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 Tapentadol as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Tapentadol 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 Tapentadol 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 Tapentadol and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Tapentadol NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Tapentadol suppliers with NDC on PharmaCompass.
Tapentadol 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 Tapentadol 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 Tapentadol GMP manufacturer or Tapentadol GMP API supplier for your needs.
A Tapentadol CoA (Certificate of Analysis) is a formal document that attests to Tapentadol's compliance with Tapentadol specifications and serves as a tool for batch-level quality control.
Tapentadol CoA mostly includes findings from lab analyses of a specific batch. For each Tapentadol 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.
Tapentadol may be tested according to a variety of international standards, such as European Pharmacopoeia (Tapentadol EP), Tapentadol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tapentadol USP).
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