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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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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
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 : Hi-Pharm Co., Ltd.
Registration Date : 2025-02-21
Registration Number : 20141203-161-I-436-13(11)
Manufacturer Name : Supriya Lifescience Ltd.
Manufacturer Address : A-5/2, Lote Parshuram Industrial Area, MIDC Tal-Khed, Dist- Ratnagiri Ratnagiri 415722, Maharashtra State, India
| Available Reg Filing : ASMF |
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GDUFA
DMF Review : Reviewed
Rev. Date : 2018-08-01
Pay. Date : 2018-02-20
DMF Number : 30504
Submission : 2016-04-22
Status : Active
Type : II
Certificate Number : R1-CEP 2015-203 - Rev 02
Issue Date : 2023-07-25
Type : Chemical
Substance Number : 1681
Status : Valid
Date of Issue : 2024-01-15
Valid Till : 2027-01-15
Written Confirmation Number : WC-0575
Address of the Firm :
NDC Package Code : 51686-0009
Start Marketing Date : 2004-06-19
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
Registrant Name : Hanyoung Farm Co., Ltd.
Registration Date : 2025-01-09
Registration Number : 20130516-161-I-55-11(9)
Manufacturer Name : Virupaksha Organics Limited
Manufacturer Address : Sy. No. 10, Gaddapotharma Village, Jinnaram Mandal, Sangareddy District-502319, Telangana State, India
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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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PharmaCompass offers a list of Tramadol Hydrochloride 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 Tramadol Hydrochloride manufacturer or Tramadol Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Tramadol Hydrochloride manufacturer or Tramadol Hydrochloride supplier.
PharmaCompass also assists you with knowing the Tramadol Hydrochloride API Price utilized in the formulation of products. Tramadol Hydrochloride API Price is not always fixed or binding as the Tramadol Hydrochloride Price is obtained through a variety of data sources. The Tramadol Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Zamudol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Zamudol, including repackagers and relabelers. The FDA regulates Zamudol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Zamudol 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 Zamudol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Zamudol supplier is an individual or a company that provides Zamudol active pharmaceutical ingredient (API) or Zamudol finished formulations upon request. The Zamudol suppliers may include Zamudol API manufacturers, exporters, distributors and traders.
click here to find a list of Zamudol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Zamudol DMF (Drug Master File) is a document detailing the whole manufacturing process of Zamudol active pharmaceutical ingredient (API) in detail. Different forms of Zamudol DMFs exist exist since differing nations have different regulations, such as Zamudol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Zamudol DMF submitted to regulatory agencies in the US is known as a USDMF. Zamudol USDMF includes data on Zamudol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Zamudol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Zamudol 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 Zamudol Drug Master File in Japan (Zamudol JDMF) empowers Zamudol 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 Zamudol JDMF during the approval evaluation for pharmaceutical products. At the time of Zamudol 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 Zamudol 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 Zamudol Drug Master File in Korea (Zamudol KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Zamudol. The MFDS reviews the Zamudol KDMF as part of the drug registration process and uses the information provided in the Zamudol KDMF to evaluate the safety and efficacy of the drug.
After submitting a Zamudol 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 Zamudol API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Zamudol suppliers with KDMF on PharmaCompass.
A Zamudol CEP of the European Pharmacopoeia monograph is often referred to as a Zamudol Certificate of Suitability (COS). The purpose of a Zamudol CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Zamudol EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Zamudol to their clients by showing that a Zamudol CEP has been issued for it. The manufacturer submits a Zamudol CEP (COS) as part of the market authorization procedure, and it takes on the role of a Zamudol CEP holder for the record. Additionally, the data presented in the Zamudol CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Zamudol DMF.
A Zamudol CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Zamudol 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 Zamudol suppliers with CEP (COS) on PharmaCompass.
A Zamudol written confirmation (Zamudol WC) is an official document issued by a regulatory agency to a Zamudol manufacturer, verifying that the manufacturing facility of a Zamudol active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Zamudol APIs or Zamudol finished pharmaceutical products to another nation, regulatory agencies frequently require a Zamudol WC (written confirmation) as part of the regulatory process.
click here to find a list of Zamudol 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 Zamudol as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Zamudol 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 Zamudol 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 Zamudol and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Zamudol NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Zamudol suppliers with NDC on PharmaCompass.
Zamudol 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 Zamudol 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 Zamudol GMP manufacturer or Zamudol GMP API supplier for your needs.
A Zamudol CoA (Certificate of Analysis) is a formal document that attests to Zamudol's compliance with Zamudol specifications and serves as a tool for batch-level quality control.
Zamudol CoA mostly includes findings from lab analyses of a specific batch. For each Zamudol 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.
Zamudol may be tested according to a variety of international standards, such as European Pharmacopoeia (Zamudol EP), Zamudol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Zamudol USP).
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