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JDMF
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Australia
DRUG PRODUCT COMPOSITIONS0
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1. Aleve
2. Anaprox
3. Methoxypropiocin
4. Naprosin
5. Naprosyn
6. Naproxen
7. Naproxenate, Sodium
8. Proxen
9. Sodium Naproxenate
10. Sodium, Naproxen
11. Synflex
1. 26159-34-2
2. Naprelan
3. Anaprox
4. Naproxen Sodium Salt
5. Miranax
6. (-)-naproxen Sodium
7. Aleve
8. Naproxen (sodium)
9. Naprium
10. Naprux
11. Proxen
12. Sodium (s)-2-(6-methoxynaphthalen-2-yl)propanoate
13. Bayh6689
14. Apo-napro-na
15. (s)-naproxen Sodium Salt
16. Sodium Naproxen
17. Rs-3650
18. Naproxen Sodium Anhydrous
19. Mls000069555
20. 9tn87s3a3c
21. Chebi:7477
22. (-)-sodium (s)-6-methoxy-alpha-methyl-2-naphthaleneacetate
23. 2-naphthaleneacetic Acid, 6-methoxy-alpha-methyl-, Sodium Salt, (s)-
24. Bay117031
25. Sodium;(2s)-2-(6-methoxynaphthalen-2-yl)propanoate
26. Bay-117031
27. Ncgc00017097-01
28. Anapran
29. Anaprotab
30. Aprowell
31. Floginex
32. Flogogin
33. Floneks
34. Floxalin
35. Gibinap
36. Gibixen
37. Karoksen
38. Leniartril
39. Monarit
40. Naprodil
41. Naprodol
42. Naprovite
43. Natrioxen
44. Pactens
45. Primeral
46. Smr000058746
47. Sodimax
48. Synflex
49. Flogen
50. Kapnax
51. Opraks
52. Tandax
53. (s)-6-methoxy-alpha-methyl-2-naphthaleneacetic Acid Sodium Salt
54. Aprol
55. Nixal
56. Cas-26159-34-2
57. Causalon Pro
58. Naproxen Natrium
59. Naprux Gesic
60. Axer Alfa
61. Dsstox_cid_25576
62. Dsstox_rid_80973
63. Dsstox_gsid_45576
64. Sodium (2s)-2-(6-methoxy-2-naphthyl)propanoate
65. A-nox
66. Anaprox Ds
67. Naproxensodium
68. Sunprox
69. Flanax
70. Naproxen Sodium [usan]
71. Einecs 247-486-2
72. Mfcd00058507
73. Unm-0000306098
74. Rs 3650
75. Topcare All Day Pain Relief
76. Unii-9tn87s3a3c
77. Naproxen Sodium [usan:usp]
78. Bay H6689
79. Naproxen (aleve)
80. Sodium (-)-2-(6-methoxy-2-naphthyl)propionate
81. Anaprox (tn)
82. Naproxen Sodium,(s)
83. Naproxen Sodium (usp)
84. L-(-)-6-methoxy-alpha-methyl-2-naphthaleneacetic Acid Sodium Salt
85. Opera_id_1200
86. Lopac-m-1275
87. Schembl7361
88. Mls001076076
89. Mls001424214
90. Naproxen Sodium [vandf]
91. Chembl1200806
92. Dtxsid7045576
93. Naproxen Sodium [mart.]
94. Naproxen Sodium [usp-rs]
95. Naproxen Sodium [who-dd]
96. Naproxen Sodium Salt [mi]
97. Hms1570o04
98. Hms2052g05
99. Hms2230d08
100. Hms3262o06
101. Hms3269j19
102. Hms3413p03
103. Hms3884g04
104. Tox21_110774
105. Tox21_500792
106. Hy-15030a
107. Naproxen Sodium, 98.0-102.0%
108. Naproxen Sodium [ep Impurity]
109. Naproxen Sodium [orange Book]
110. 2-naphthaleneacetic Acid, 6-methoxy-.alpha.-methyl-, Sodium Salt, (s)-
111. Akos015895696
112. Akos015994759
113. Naproxen Sodium [ep Monograph]
114. Naproxen Sodium [usp Impurity]
115. Tox21_110774_1
116. Bcp9000977
117. Ccg-101082
118. Ks-5141
119. Lp00792
120. Naproxen Sodium [usp Monograph]
121. 2-naphthaleneacetic Acid, 6-methoxy-alpha-methyl-, Sodium Salt, L-(-)-
122. Aleve-d Component Naproxen Sodium
123. Ncgc00016166-01
124. Ncgc00016759-04
125. Ncgc00017097-02
126. Ncgc00094127-01
127. Ncgc00261477-01
128. Treximet Component Naproxen Sodium
129. Bcp0726000300
130. Naproxen Sodium Component Of Aleve-d
131. Eu-0100792
132. M3406
133. Naproxen Sodium Component Of Treximet
134. S1626
135. Sw197105-3
136. 59n342
137. Bim-0050769.0001
138. D00970
139. M 1275
140. Sodium (s)-2-(6-methoxy-2-naphthyl)propionate
141. A818221
142. Naproxen Sodium, Meets Usp Testing Specifications
143. Sodium(s)-2-(6-methoxynaphthalen-2-yl)propanoate
144. W-107195
145. Q27107504
146. (2s)-2-(6-methoxy(2-naphthyl))propanoic Acid Sodium Salt
147. (2s)-2-(6-methoxy-2-naphthyl)propanoic Acid Sodium Salt
148. (s)-6-methoxy-alpha-methyl-2-naphthaleneacetic Acid Sodium
149. Naproxen Sodium, United States Pharmacopeia (usp) Reference Standard
150. 2-naphthaleneacetic Acid, 6-methoxy-.alpha.-methyl-, Sodium Salt, (.alpha.s)- (1:1)
151. Naproxen Sodium, Pharmaceutical Secondary Standard; Certified Reference Material
| Molecular Weight | 252.24 g/mol |
|---|---|
| Molecular Formula | C14H13NaO3 |
| Hydrogen Bond Donor Count | 0 |
| Hydrogen Bond Acceptor Count | 3 |
| Rotatable Bond Count | 3 |
| Exact Mass | 252.07623855 g/mol |
| Monoisotopic Mass | 252.07623855 g/mol |
| Topological Polar Surface Area | 49.4 Ų |
| Heavy Atom Count | 18 |
| Formal Charge | 0 |
| Complexity | 282 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 1 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
| 1 of 12 | |
|---|---|
| Drug Name | Aleve |
| Active Ingredient | Naproxen sodium |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | eq 200mg base |
| Market Status | Over the Counter |
| Company | Bayer |
| 2 of 12 | |
|---|---|
| Drug Name | Anaprox |
| Drug Label | Naproxen is a proprionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs.The chemical names for naproxen and naproxen sodium are (S)-6-methoxy--methyl-2-naphthaleneacetic acid and (S)-6-methoxy--methyl... |
| Active Ingredient | Naproxen sodium |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | eq 250mg base |
| Market Status | Prescription |
| Company | Hoffmann La Roche |
| 3 of 12 | |
|---|---|
| Drug Name | Anaprox ds |
| Drug Label | Naproxen is a proprionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs.The chemical names for naproxen and naproxen sodium are (S)-6-methoxy--methyl-2-naphthaleneacetic acid and (S)-6-methoxy--methyl... |
| Active Ingredient | Naproxen sodium |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | eq 500mg base |
| Market Status | Prescription |
| Company | Hoffmann La Roche |
| 4 of 12 | |
|---|---|
| Drug Name | Naprelan |
| Drug Label | NAPRELAN* Tablets contain naproxen sodium, a member of the arylacetic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). NAPRELAN Tablets use the proprietary IPDAS** (Intestinal Protective Drug Absorption System) technology. It is a r... |
| Active Ingredient | Naproxen sodium |
| Dosage Form | Tablet, extended release |
| Route | Oral |
| Strength | eq 750mg base; eq 500mg base; eq 375mg base |
| Market Status | Prescription |
| Company | Almatica Pharma |
| 5 of 12 | |
|---|---|
| Drug Name | Naprosyn |
| Drug Label | Naproxen is a proprionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs.The chemical names for naproxen and naproxen sodium are (S)-6-methoxy--methyl-2-naphthaleneacetic acid and (S)-6-methoxy--methyl... |
| Active Ingredient | Naproxen |
| Dosage Form | Tablet; Suspension |
| Route | Oral |
| Strength | 250mg; 375mg; 500mg; 25mg/ml |
| Market Status | Prescription |
| Company | Roche Palo |
| 6 of 12 | |
|---|---|
| Drug Name | Naproxen sodium |
| Drug Label | NAPRELAN* Tablets contain naproxen sodium, a member of the arylacetic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). NAPRELAN Tablets use the proprietary IPDAS** (Intestinal Protective Drug Absorption System) technology. It is a r... |
| Active Ingredient | Naproxen sodium |
| Dosage Form | Tablet, extended release; Tablet; Capsule |
| Route | Oral |
| Strength | eq 500mg base; eq 250mg base; eq 200mg base; eq 375mg base |
| Market Status | Over the Counter; Prescription |
| Company | Marksans Pharma; Actavis Labs Fl; Teva; Aurobindo Pharma; Banner Pharmacaps; Granules India; Hikma; Amneal Pharms Ny; Glenmark Generics; Perrigo; Contract Pharmacal; Ranbaxy Labs; Dr Reddys Labs |
| 7 of 12 | |
|---|---|
| Drug Name | Aleve |
| Active Ingredient | Naproxen sodium |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | eq 200mg base |
| Market Status | Over the Counter |
| Company | Bayer |
| 8 of 12 | |
|---|---|
| Drug Name | Anaprox |
| Drug Label | Naproxen is a proprionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs.The chemical names for naproxen and naproxen sodium are (S)-6-methoxy--methyl-2-naphthaleneacetic acid and (S)-6-methoxy--methyl... |
| Active Ingredient | Naproxen sodium |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | eq 250mg base |
| Market Status | Prescription |
| Company | Hoffmann La Roche |
| 9 of 12 | |
|---|---|
| Drug Name | Anaprox ds |
| Drug Label | Naproxen is a proprionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs.The chemical names for naproxen and naproxen sodium are (S)-6-methoxy--methyl-2-naphthaleneacetic acid and (S)-6-methoxy--methyl... |
| Active Ingredient | Naproxen sodium |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | eq 500mg base |
| Market Status | Prescription |
| Company | Hoffmann La Roche |
| 10 of 12 | |
|---|---|
| Drug Name | Naprelan |
| Drug Label | NAPRELAN* Tablets contain naproxen sodium, a member of the arylacetic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). NAPRELAN Tablets use the proprietary IPDAS** (Intestinal Protective Drug Absorption System) technology. It is a r... |
| Active Ingredient | Naproxen sodium |
| Dosage Form | Tablet, extended release |
| Route | Oral |
| Strength | eq 750mg base; eq 500mg base; eq 375mg base |
| Market Status | Prescription |
| Company | Almatica Pharma |
| 11 of 12 | |
|---|---|
| Drug Name | Naprosyn |
| Drug Label | Naproxen is a proprionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs.The chemical names for naproxen and naproxen sodium are (S)-6-methoxy--methyl-2-naphthaleneacetic acid and (S)-6-methoxy--methyl... |
| Active Ingredient | Naproxen |
| Dosage Form | Tablet; Suspension |
| Route | Oral |
| Strength | 250mg; 375mg; 500mg; 25mg/ml |
| Market Status | Prescription |
| Company | Roche Palo |
| 12 of 12 | |
|---|---|
| Drug Name | Naproxen sodium |
| Drug Label | NAPRELAN* Tablets contain naproxen sodium, a member of the arylacetic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). NAPRELAN Tablets use the proprietary IPDAS** (Intestinal Protective Drug Absorption System) technology. It is a r... |
| Active Ingredient | Naproxen sodium |
| Dosage Form | Tablet, extended release; Tablet; Capsule |
| Route | Oral |
| Strength | eq 500mg base; eq 250mg base; eq 200mg base; eq 375mg base |
| Market Status | Over the Counter; Prescription |
| Company | Marksans Pharma; Actavis Labs Fl; Teva; Aurobindo Pharma; Banner Pharmacaps; Granules India; Hikma; Amneal Pharms Ny; Glenmark Generics; Perrigo; Contract Pharmacal; Ranbaxy Labs; Dr Reddys Labs |
Anti-Inflammatory Agents, Non-Steroidal
Anti-inflammatory agents that are non-steroidal in nature. In addition to anti-inflammatory actions, they have analgesic, antipyretic, and platelet-inhibitory actions. They act by blocking the synthesis of prostaglandins by inhibiting cyclooxygenase, which converts arachidonic acid to cyclic endoperoxides, precursors of prostaglandins. Inhibition of prostaglandin synthesis accounts for their analgesic, antipyretic, and platelet-inhibitory actions; other mechanisms may contribute to their anti-inflammatory effects. (See all compounds classified as Anti-Inflammatory Agents, Non-Steroidal.)
Cyclooxygenase Inhibitors
Compounds or agents that combine with cyclooxygenase (PROSTAGLANDIN-ENDOPEROXIDE SYNTHASES) and thereby prevent its substrate-enzyme combination with arachidonic acid and the formation of eicosanoids, prostaglandins, and thromboxanes. (See all compounds classified as Cyclooxygenase Inhibitors.)
Gout Suppressants
Agents that increase uric acid excretion by the kidney (URICOSURIC AGENTS), decrease uric acid production (antihyperuricemics), or alleviate the pain and inflammation of acute attacks of gout. (See all compounds classified as Gout Suppressants.)
API SUPPLIERS
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-03-26
Pay. Date : 2015-03-19
DMF Number : 3208
Submission : 1978-05-25
Status : Active
Type : II
Certificate Number : R1-CEP 2008-110 - Rev 01
Issue Date : 2015-06-10
Type : Chemical
Substance Number : 1702
Status : Valid
NDC Package Code : 30007-815
Start Marketing Date : 2012-02-06
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : SK Chemical Co., Ltd.
Registration Date : 2022-01-12
Registration Number : 20140318-143-I-360-09(3)
Manufacturer Name : Industrialas Quimicas Falcon de Mexico, SA De CV
Manufacturer Address : Km. 4.5, Carretera Federal Cuernavaca-Cuautla Col. CIVAC CP 62578 Mpio. Jiutepec, Morelos, Mexico
| Available Reg Filing : BR, RU |
Pharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-01-30
Pay. Date : 2013-01-16
DMF Number : 12342
Submission : 1997-01-28
Status : Active
Type : II
Certificate Number : R1-CEP 2008-068 - Rev 03
Issue Date : 2019-06-21
Type : Chemical
Substance Number : 1702
Status : Valid
NDC Package Code : 55111-004
Start Marketing Date : 1997-01-28
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Hiple Co., Ltd.
Registration Date : 2019-12-31
Registration Number : 20140318-143-I-360-09(2)
Manufacturer Name : Industrialas Quimicas Falcon de Mexico, SA De CV
Manufacturer Address : Km. 4.5, Carretera Federal Cuernavaca-Cuautla Col. CIVAC CP 62578 Mpio. Jiutepec, Morelos, Mexico
| Available Reg Filing : BR, RU |
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Registrant Name : Pami Future Co., Ltd.
Registration Date : 2019-04-22
Registration Number : 20140318-143-I-360-09(1)
Manufacturer Name : Industrialas Quimicas Falcon de Mexico, SA De CV
Manufacturer Address : Km. 4.5, Carretera Federal Cuernavaca-Cuautla Col. CIVAC CP 62578 Mpio. Jiutepec, Morelos, Mexico
| Available Reg Filing : BR, RU |
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Registrant Name : Pami Future Co., Ltd.
Registration Date : 2014-03-18
Registration Number : 20140318-143-I-360-09
Manufacturer Name : Industrialas Quimicas Falcon de Mexico, SA De CV
Manufacturer Address : Km. 4.5, Carretera Federal Cuernavaca-Cuautla Col. CIVAC CP 62578 Mpio. Jiutepec, Morelos, Mexico
| Available Reg Filing : BR, RU |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37526
Submission : 2022-12-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14185
Submission : 1999-06-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12559
Submission : 1997-06-25
Status : Inactive
Type : II
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Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
About the Company : Established in 1994, Rochem is a distributor of pharmaceutical, food, nutritional and animal health ingredients to some of the largest companies in the world. It sources high-quali...
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfoli...
Pharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.
About the Company : Pharm-Rx has earned an outstanding reputation since its establishment in 1991, serving as a reputable importer and distributor of active ingredients to the pharmaceutical, nutritio...
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...
About the Company : Divi's Laboratories Limited is a leading independent contract manufacturer of Active Pharmaceutical Ingredients and registered intermediates. We custom / exclusively manufacture fo...
About the Company : Guangzhou Tosun Pharmaceutical was founded in 1999, which mainly focuses on importation & exportation of Active Pharmaceutical Ingrediants, Chemical Raw Materials, Intermediate, Ex...
About the Company : Hy-Gro Chemicals Pharmtek Pvt. Ltd. (Hy-Gro) is a fast growing pharmaceutical company engaged in the manufacture of Active Pharmaceutical Ingredients (APIs), Advanced Intermediates...
About the Company : Nhwa is specialized in manufacturing APIs and dosages in the field of Central Nervous System. With 40 years of experience and excellent reputation, Nhwa has become the leader of ma...
About the Company : Public health is always an imperative that implies immense responsibility, not a mere re-adjustable option. As a company operating under world’s second largest industry of Pharma...
About the Company : Solara Active Pharma Sciences is a young, dynamic, entrepreneurial and customer oriented API manufacturer. We have a legacy of over three decades and trace our origins to the API e...
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Drugs in Development
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DOSAGE - TABLET;ORAL - EQ 250MG BASE **Federa...DOSAGE - TABLET;ORAL - EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 18164
DOSAGE - TABLET;ORAL - EQ 500MG BASE
USFDA APPLICATION NUMBER - 18164
DOSAGE - TABLET;ORAL - 220MG
USFDA APPLICATION NUMBER - 20204
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 3...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 375MG BASE
USFDA APPLICATION NUMBER - 20353
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 5...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 500MG BASE
USFDA APPLICATION NUMBER - 20353
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 7...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 750MG BASE
USFDA APPLICATION NUMBER - 20353
DOSAGE - CAPSULE;ORAL - EQ 200MG BASE
USFDA APPLICATION NUMBER - 21920
DOSAGE - TABLET;ORAL - 500MG;EQ 85MG BASE
USFDA APPLICATION NUMBER - 21926
DOSAGE - TABLET;ORAL - 60MG;EQ 10MG BASE
USFDA APPLICATION NUMBER - 21926
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PharmaCompass offers a list of Naproxen Sodium 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 Naproxen Sodium manufacturer or Naproxen Sodium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Naproxen Sodium manufacturer or Naproxen Sodium supplier.
PharmaCompass also assists you with knowing the Naproxen Sodium API Price utilized in the formulation of products. Naproxen Sodium API Price is not always fixed or binding as the Naproxen Sodium Price is obtained through a variety of data sources. The Naproxen Sodium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A MNPA manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of MNPA, including repackagers and relabelers. The FDA regulates MNPA manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. MNPA 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 MNPA manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A MNPA supplier is an individual or a company that provides MNPA active pharmaceutical ingredient (API) or MNPA finished formulations upon request. The MNPA suppliers may include MNPA API manufacturers, exporters, distributors and traders.
click here to find a list of MNPA suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A MNPA DMF (Drug Master File) is a document detailing the whole manufacturing process of MNPA active pharmaceutical ingredient (API) in detail. Different forms of MNPA DMFs exist exist since differing nations have different regulations, such as MNPA USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A MNPA DMF submitted to regulatory agencies in the US is known as a USDMF. MNPA USDMF includes data on MNPA's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The MNPA USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of MNPA 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 MNPA Drug Master File in Korea (MNPA KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of MNPA. The MFDS reviews the MNPA KDMF as part of the drug registration process and uses the information provided in the MNPA KDMF to evaluate the safety and efficacy of the drug.
After submitting a MNPA 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 MNPA API can apply through the Korea Drug Master File (KDMF).
click here to find a list of MNPA suppliers with KDMF on PharmaCompass.
A MNPA CEP of the European Pharmacopoeia monograph is often referred to as a MNPA Certificate of Suitability (COS). The purpose of a MNPA CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of MNPA EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of MNPA to their clients by showing that a MNPA CEP has been issued for it. The manufacturer submits a MNPA CEP (COS) as part of the market authorization procedure, and it takes on the role of a MNPA CEP holder for the record. Additionally, the data presented in the MNPA CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the MNPA DMF.
A MNPA CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. MNPA 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 MNPA suppliers with CEP (COS) on PharmaCompass.
A MNPA written confirmation (MNPA WC) is an official document issued by a regulatory agency to a MNPA manufacturer, verifying that the manufacturing facility of a MNPA active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting MNPA APIs or MNPA finished pharmaceutical products to another nation, regulatory agencies frequently require a MNPA WC (written confirmation) as part of the regulatory process.
click here to find a list of MNPA 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 MNPA as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for MNPA 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 MNPA 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 MNPA and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a MNPA NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of MNPA suppliers with NDC on PharmaCompass.
MNPA 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 MNPA 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 MNPA GMP manufacturer or MNPA GMP API supplier for your needs.
A MNPA CoA (Certificate of Analysis) is a formal document that attests to MNPA's compliance with MNPA specifications and serves as a tool for batch-level quality control.
MNPA CoA mostly includes findings from lab analyses of a specific batch. For each MNPA 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.
MNPA may be tested according to a variety of international standards, such as European Pharmacopoeia (MNPA EP), MNPA JP (Japanese Pharmacopeia) and the US Pharmacopoeia (MNPA USP).
