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1. Adolonta
2. Amadol
3. Biodalgic
4. Biokanol
5. Contramal
6. Jutadol
7. K 315
8. K-315
9. K315
10. Mtw Tramadol
11. Mtw-tramadol
12. Mtwtramadol
13. Nobligan
14. Prontofort
15. Ranitidin 1a Pharma
16. Takadol
17. Theradol
18. Tiral
19. Topalgic
20. Tradol
21. Tradol Puren
22. Tradol-puren
23. Tradolpuren
24. Tradonal
25. Tralgiol
26. Trama 1a Pharma
27. Trama Abz
28. Trama Dorsch
29. Trama Kd
30. Trama-dorsch
31. Tramabeta
32. Tramadin
33. Tramadoc
34. Tramadol
35. Tramadol 1a
36. Tramadol Acis
37. Tramadol Al
38. Tramadol Asta Medica
39. Tramadol Basics
40. Tramadol Bayvit
41. Tramadol Bexal
42. Tramadol Cinfa
43. Tramadol Dolgit
44. Tramadol Edigen
45. Tramadol Hameln
46. Tramadol Heumann
47. Tramadol Kern
48. Tramadol Lichtenstein
49. Tramadol Lindo
50. Tramadol Mabo
51. Tramadol Normon
52. Tramadol Pb
53. Tramadol Ratiopharm
54. Tramadol Stada
55. Tramadol-dolgit
56. Tramadol-hameln
57. Tramadol-ratiopharm
58. Tramadoldolgit
59. Tramadolhameln
60. Tramadolor
61. Tramadolratiopharm
62. Tramadorsch
63. Tramadura
64. Tramagetic
65. Tramagit
66. Tramake
67. Tramal
68. Tramex
69. Tramundin
70. Trasedal
71. Ultram
72. Xymel 50
73. Zamudol
74. Zumalgic
75. Zydol
76. Zytram
1. 36282-47-0
2. Contramal
3. (+)-tramadol Hydrochloride
4. Tradonal
5. 148229-78-1
6. Cis-tramadol Hydrochloride
7. Tramadol Hcl
8. Amadol
9. Zydol
10. Conzip
11. 22204-88-2
12. Tramal
13. Zydol Hydrochloride
14. Crispin
15. Ryzolt
16. Cg-315e
17. 9n7r477wck
18. 194602-08-9
19. Bellatram
20. Omnidol
21. Zumatran
22. Chebi:75733
23. Radol
24. Tadol
25. (1r,2r)-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexan-1-ol;hydrochloride
26. Melanate
27. Poltram
28. Tramadex
29. Tramagetic
30. Tramazac
31. U-26225a
32. Dolana
33. Mabron
34. Trabar
35. Tramed
36. Tramol
37. Tridol
38. U-26,225a
39. Tradol-puren
40. (1r,2r)-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol Hydrochloride
41. Cyclohexanol, 2-((dimethylamino)methyl)-1-(3-methoxyphenyl)-, Hydrochloride, (1r,2r)-rel-
42. Zamudol
43. Zertane
44. Tramadolhydrochloride
45. Adolanta
46. Cemadol
47. Synapryn
48. Tridural
49. Rybix
50. Viotra
51. Tramal Retard
52. Ira-tramadol
53. Ultram Er
54. Cyclohexanol, 2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)-,hydrochloride, (1r,2r)-rel-
55. Rybix Odt
56. Cg 315
57. Smr000449308
58. Tramadol Hydrochloride Civ
59. Tramadol Related Compound A
60. Zydol Xl 150
61. Einecs 252-950-2
62. Unii-9n7r477wck
63. Tramundin
64. Cg-315
65. Nih-10969
66. Nsc-759105
67. (1r,2r)-2-((dimethylamino)methyl)-1-(3-methoxyphenyl)cyclohexanol Hydrochloride
68. (1r,2r)-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexan-1-ol Hydrochloride
69. Nih 10969
70. Ultram (tn)
71. Qdolo
72. Tramadole Hydrochloride
73. Tramadol/hcl
74. Tramadol Hydrochloride [usan:usp:jan]
75. (+-)-cis-2-((dimethylamino)methyl)-1-(m-methoxyphenyl)cyclohexanol Hydrochloride
76. Cyclohexanol, 2-((dimethylamino)methyl)-1-(3-methoxyphenyl)-, Hydrochloride, Cis-
77. Schembl41748
78. (r,r)-tramadol Hydrochloride
79. 53611-16-8
80. Mls000758218
81. Mls001424208
82. Chembl1200336
83. Dtxsid7023691
84. Hy-b0582a
85. Tramadol Hydrochloride, Ep Grade
86. Dtxsid60933340
87. (1rs,2sr)-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol Hydrochloride
88. Tramadol Hydrochloride [mi]
89. 3,3,4,4-terephthaloydiphthalicacid
90. Tramadol Hydrochloride (jp17/usp)
91. Tramadol Hydrochloride [jan]
92. Ac-796
93. Mfcd00798507
94. Tramadol Hydrochloride [hsdb]
95. Tramadol Hydrochloride [usan]
96. Tramadol Hydrochloride [vandf]
97. (+)-(1r,2r)-tramadol Hydrochloride
98. Akos015907739
99. Tramadol Hydrochloride [mart.]
100. Ccg-101135
101. Ks-1124
102. Nc00385
103. Nsc 759105
104. Tramadol Hydrochloride [who-dd]
105. (+-)-cis-2-((dimethylamino)methyl)-1-(3-methoxyphenyl)cyclohexanol Hydrochloride
106. Bt162445
107. Tramadol Hydrochloride [orange Book]
108. Tramadol Hydrochloride Civ [usp-rs]
109. Tramadol Hydrochloride, >=99.0% (hplc)
110. Tramadol Hydrochloride [ep Monograph]
111. Tramadol Hydrochloride [usp Monograph]
112. D01355
113. Tramadol Hydrochloride, >=98% (hplc), Solid
114. Ultracet Component Tramadol Hydrochloride
115. 204t882
116. Sr-01000759320
117. Tramadol Hydrochloride Component Of Ultracet
118. Q-201847
119. Sr-01000759320-5
120. Q27145507
121. Tramadol Hydrochloride 1.0 Mg/ml In Methanol (as Free Base)
122. (+)-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol Hydrochloride
123. Tramadol Hydrochloride, British Pharmacopoeia (bp) Reference Standard
124. Tramadol Hydrochloride, European Pharmacopoeia (ep) Reference Standard
125. Tramadol Hydrochloride, United States Pharmacopeia (usp) Reference Standard
126. (+/-)-cis-2-((dimethylamino)methyl)-1-(m-methoxyphenyl)cyclohexanol Hydrochloride
127. (1r,2r)-2-(dimethylaminomethyl)-1-(3-methoxyphenyl)-cyclohexanol Hydrochloride
128. [(1r,2r)-2-hydroxy-2-(3-methoxyphenyl)cyclohexyl]-n,n-dimethylmethanaminium Chloride
129. 2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexan-1-ol--hydrogen Chloride (1/1)
130. Cyclohexanol, 2-((dimethylamino)methyl)-1-(3-methoxyphenyl)-, Hydrochloride, Cis-(+-)-
131. Cis-tramadol Hydrochloride Solution, 1.0 Mg/ml In Methanol (as Free Base), Ampule Of 1 Ml, Certified Reference Material
132. Cyclohexanol, 2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)-, (1r,2r)-, Hydrochloride (1:1)
| Molecular Weight | 299.83 g/mol |
|---|---|
| Molecular Formula | C16H26ClNO2 |
| Hydrogen Bond Donor Count | 2 |
| Hydrogen Bond Acceptor Count | 3 |
| Rotatable Bond Count | 4 |
| Exact Mass | 299.1652068 g/mol |
| Monoisotopic Mass | 299.1652068 g/mol |
| Topological Polar Surface Area | 32.7 Ų |
| Heavy Atom Count | 20 |
| Formal Charge | 0 |
| Complexity | 282 |
| 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 6 | |
|---|---|
| Drug Name | Conzip |
| PubMed Health | Tramadol (By mouth) |
| Drug Classes | Analgesic |
| Drug Label | ConZip (tramadol hydrochloride) capsules is a centrally acting synthetic analgesic in an extended-release oral formulation. The chemical name for tramadol hydrochloride is ()cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochl... |
| Active Ingredient | Tramadol hydrochloride |
| Dosage Form | Capsule, extended release |
| Route | Oral |
| Strength | 300mg; 200mg; 100mg; 150mg |
| Market Status | Prescription |
| Company | Cipher Pharms |
| 2 of 6 | |
|---|---|
| Drug Name | Tramadol hydrochloride |
| PubMed Health | Tramadol (By mouth) |
| Drug Classes | Analgesic |
| Drug Label | Tramadol hydrochloride is a centrally acting synthetic analgesic in an extended-release formulation. The chemical name is ()cis-2-[(dimethylamino) methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is: Figure 1The molecu... |
| Active Ingredient | Tramadol hydrochloride |
| Dosage Form | Tablet, extended release; Tablet |
| Route | Oral |
| Strength | 200mg; 300mg; 100mg; 50mg |
| Market Status | Prescription |
| Company | Anchen Pharms; Amneal Pharms; Mylan Pharms; Teva; Apotex; Accord Hlthcare; Aurobindo Pharma; Cspc Ouyi Pharm; Sun Pharm Inds; Lupin; Mallinckrodt; Allied Pharma; Northstar Hlthcare; Sun Pharma Global; Par Pharm; Actavis Elizabeth; Ipca Labs; Mutual Pharm; |
| 3 of 6 | |
|---|---|
| Drug Name | Ultram er |
| Drug Label | ULTRAMER (tramadol hydrochloride) is a centrally acting synthetic analgesic in an extended-release formulation. The chemical name is (cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is:Figure 1The... |
| Active Ingredient | Tramadol hydrochloride |
| Dosage Form | Tablet, extended release |
| Route | Oral |
| Strength | 200mg; 300mg; 100mg |
| Market Status | Prescription |
| Company | Valeant Intl |
| 4 of 6 | |
|---|---|
| Drug Name | Conzip |
| PubMed Health | Tramadol (By mouth) |
| Drug Classes | Analgesic |
| Drug Label | ConZip (tramadol hydrochloride) capsules is a centrally acting synthetic analgesic in an extended-release oral formulation. The chemical name for tramadol hydrochloride is ()cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochl... |
| Active Ingredient | Tramadol hydrochloride |
| Dosage Form | Capsule, extended release |
| Route | Oral |
| Strength | 300mg; 200mg; 100mg; 150mg |
| Market Status | Prescription |
| Company | Cipher Pharms |
| 5 of 6 | |
|---|---|
| Drug Name | Tramadol hydrochloride |
| PubMed Health | Tramadol (By mouth) |
| Drug Classes | Analgesic |
| Drug Label | Tramadol hydrochloride is a centrally acting synthetic analgesic in an extended-release formulation. The chemical name is ()cis-2-[(dimethylamino) methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is: Figure 1The molecu... |
| Active Ingredient | Tramadol hydrochloride |
| Dosage Form | Tablet, extended release; Tablet |
| Route | Oral |
| Strength | 200mg; 300mg; 100mg; 50mg |
| Market Status | Prescription |
| Company | Anchen Pharms; Amneal Pharms; Mylan Pharms; Teva; Apotex; Accord Hlthcare; Aurobindo Pharma; Cspc Ouyi Pharm; Sun Pharm Inds; Lupin; Mallinckrodt; Allied Pharma; Northstar Hlthcare; Sun Pharma Global; Par Pharm; Actavis Elizabeth; Ipca Labs; Mutual Pharm; |
| 6 of 6 | |
|---|---|
| Drug Name | Ultram er |
| Drug Label | ULTRAMER (tramadol hydrochloride) is a centrally acting synthetic analgesic in an extended-release formulation. The chemical name is (cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is:Figure 1The... |
| Active Ingredient | Tramadol hydrochloride |
| Dosage Form | Tablet, extended release |
| Route | Oral |
| Strength | 200mg; 300mg; 100mg |
| Market Status | Prescription |
| Company | Valeant Intl |
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.)
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.)
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Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
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GDUFA
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DMF Number : 39533
Submission : 2024-02-29
Status : Active
Type : II
Date of Issue : 2022-06-29
Valid Till : 2025-07-02
Written Confirmation Number : WC-0218
Address of the Firm :
NDC Package Code : 61281-8500
Start Marketing Date : 2014-03-18
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : IMCD Korea Co., Ltd.
Registration Date : 2024-07-17
Registration Number : 20141203-161-I-436-13(10)
Manufacturer Name : Supriya Lifescience Ltd
Manufacturer Address : A-5/2, Lote Parshuram Industrial Area, MIDC, Tal-Khed, Dist.-Ratnagiri, 415722, Maharashtra State, India
| Available Reg Filing : ASMF |
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
IKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
Certificate Number : CEP 2003-146 - Rev 09
Issue Date : 2023-10-31
Type : Chemical
Substance Number : 1681
Status : Valid
NDC Package Code : 58175-0364
Start Marketing Date : 2001-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Sanil Pharma Co., Ltd.
Registration Date : 2017-10-30
Registration Number : 20120803-161-I-28-02(10)
Manufacturer Name : Wavelength Enterprises Ltd.
Manufacturer Address : Neot Hovav Eco-Industrial Park, POB 3593, Be'er Sheva 8413502, Israel
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USDMF
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
GDUFA
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Rev. Date :
Pay. Date :
DMF Number : 39533
Submission : 2024-02-29
Status : Active
Type : II
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-30
Pay. Date : 2013-01-08
DMF Number : 11959
Submission : 1996-05-06
Status : Active
Type : II
With Virupaksha, you get a quality product with on-time delivery.
GDUFA
DMF Review : Complete
Rev. Date : 2018-08-01
Pay. Date : 2018-02-20
DMF Number : 30504
Submission : 2016-04-22
Status : Active
Type : II
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DMF Number : 12830
Submission : 1998-01-23
Status : Inactive
Type : II
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DMF Number : 9811
Submission : 1992-08-05
Status : Inactive
Type : II
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Rev. Date :
Pay. Date :
DMF Number : 11605
Submission : 1995-07-28
Status : Inactive
Type : II
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DMF Number : 12494
Submission : 1997-04-30
Status : Inactive
Type : IV
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DMF Number : 12404
Submission : 1997-02-28
Status : Inactive
Type : II
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DMF Number : 11526
Submission : 1995-05-19
Status : Inactive
Type : II
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Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
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Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
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Tramadol Hydrochloride; Paracetamol
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DOSAGE - TABLET;ORAL - 100MG **Federal Regist...DOSAGE - TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20281
DOSAGE - TABLET;ORAL - 50MG **Federal Registe...DOSAGE - TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20281
DOSAGE - TABLET;ORAL - 325MG;37.5MG
USFDA APPLICATION NUMBER - 21123
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 100M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21692
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 200M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21692
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 300M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21692
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 100M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21745
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 200M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21745
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 300M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21745
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 100...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 100MG
USFDA APPLICATION NUMBER - 22370
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 150...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 150MG
USFDA APPLICATION NUMBER - 22370
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 200...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 200MG
USFDA APPLICATION NUMBER - 22370
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 300...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 300MG
USFDA APPLICATION NUMBER - 22370
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ABOUT THIS PAGE
A Tramadol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tramadol, including repackagers and relabelers. The FDA regulates Tramadol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tramadol 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 Tramadol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tramadol supplier is an individual or a company that provides Tramadol active pharmaceutical ingredient (API) or Tramadol finished formulations upon request. The Tramadol suppliers may include Tramadol API manufacturers, exporters, distributors and traders.
click here to find a list of Tramadol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tramadol DMF (Drug Master File) is a document detailing the whole manufacturing process of Tramadol active pharmaceutical ingredient (API) in detail. Different forms of Tramadol DMFs exist exist since differing nations have different regulations, such as Tramadol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tramadol DMF submitted to regulatory agencies in the US is known as a USDMF. Tramadol USDMF includes data on Tramadol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tramadol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tramadol 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 Tramadol Drug Master File in Japan (Tramadol JDMF) empowers Tramadol 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 Tramadol JDMF during the approval evaluation for pharmaceutical products. At the time of Tramadol 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 Tramadol 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 Tramadol Drug Master File in Korea (Tramadol KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Tramadol. The MFDS reviews the Tramadol KDMF as part of the drug registration process and uses the information provided in the Tramadol KDMF to evaluate the safety and efficacy of the drug.
After submitting a Tramadol 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 Tramadol API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Tramadol suppliers with KDMF on PharmaCompass.
A Tramadol CEP of the European Pharmacopoeia monograph is often referred to as a Tramadol Certificate of Suitability (COS). The purpose of a Tramadol CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Tramadol EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Tramadol to their clients by showing that a Tramadol CEP has been issued for it. The manufacturer submits a Tramadol CEP (COS) as part of the market authorization procedure, and it takes on the role of a Tramadol CEP holder for the record. Additionally, the data presented in the Tramadol CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Tramadol DMF.
A Tramadol CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Tramadol 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 Tramadol suppliers with CEP (COS) on PharmaCompass.
A Tramadol written confirmation (Tramadol WC) is an official document issued by a regulatory agency to a Tramadol manufacturer, verifying that the manufacturing facility of a Tramadol active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Tramadol APIs or Tramadol finished pharmaceutical products to another nation, regulatory agencies frequently require a Tramadol WC (written confirmation) as part of the regulatory process.
click here to find a list of Tramadol 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 Tramadol as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Tramadol 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 Tramadol 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 Tramadol and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Tramadol NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Tramadol suppliers with NDC on PharmaCompass.
Tramadol 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 Tramadol 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 Tramadol GMP manufacturer or Tramadol GMP API supplier for your needs.
A Tramadol CoA (Certificate of Analysis) is a formal document that attests to Tramadol's compliance with Tramadol specifications and serves as a tool for batch-level quality control.
Tramadol CoA mostly includes findings from lab analyses of a specific batch. For each Tramadol 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.
Tramadol may be tested according to a variety of international standards, such as European Pharmacopoeia (Tramadol EP), Tramadol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tramadol USP).
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