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31 API Suppliers, 22 USDMF, 8 CEP/COS, 5 EU WC, 34 KDMF, 11 NDC API, 9 Listed Suppliers, $ API Reference Price

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22 USDMF
8 CEP/COS
5 EU WC
34 KDMF
11 NDC API
9 Listed Suppliers
$ API Reference Price

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152 FDF Dossiers
85 FDA Orange Book
11 Europe
18 Canada
4 South Africa
34 Listed Dossiers

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TABLET;ORAL - EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 500MG BASE, TABLET;ORAL - 220MG, TABLET, EXTENDED RELEASE;ORAL - EQ 375MG BASE, TABLET, EXTENDED RELEASE;ORAL - EQ 500MG BASE, TABLET, EXTENDED RELEASE;ORAL - EQ 750MG BASE, CAPSULE;ORAL - EQ 200MG BASE, TABLET;ORAL - 500MG;EQ 85MG BASE, TABLET;ORAL - 60MG;EQ 10MG BASE

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TABLET;ORAL - EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 500MG BASE
TABLET;ORAL - 220MG
TABLET, EXTENDED RELEASE;ORAL - EQ 375MG BASE
TABLET, EXTENDED RELEASE;ORAL - EQ 500MG BASE
TABLET, EXTENDED RELEASE;ORAL - EQ 750MG BASE
CAPSULE;ORAL - EQ 200MG BASE
TABLET;ORAL - 500MG;EQ 85MG BASE
TABLET;ORAL - 60MG;EQ 10MG BASE

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33 Kerry
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1 Nanjing Bold Chemical
2 Nomisma Healthcare
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4 Prachin Chemical
1 Qianhao Chemical (Hebei) Co., Ltd
2 Qualicaps
38 Roquette
13 Seppic
7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
1 Shanghai Welltone Material Technology Co., Ltd
2 Shijiazhuang Huaxu Pharmaceutical
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3 The Dow Chemical Company
3 Ulanqab Kema New Material
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1 Zhejiang Huakang Pharmaceutical

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Synopsis

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Chemistry

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Also known as: 26159-34-2, Naprelan, Anaprox, Naproxen sodium salt, Miranax, (-)-naproxen sodium

Molecular Formula

C₁₄H₁₃NaO₃

Molecular Weight

252.24 g/mol

InChI Key

CDBRNDSHEYLDJV-FVGYRXGTSA-M

FDA UNII

9TN87S3A3C

An anti-inflammatory agent with analgesic and antipyretic properties. Both the acid and its sodium salt are used in the treatment of rheumatoid arthritis and other rheumatic or musculoskeletal disorders, dysmenorrhea, and acute gout.

1 2D Structure

Naproxen Sodium

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

sodium;(2S)-2-(6-methoxynaphthalen-2-yl)propanoate

2.1.2 InChI

InChI=1S/C14H14O3.Na/c1-9(14(15)16)10-3-4-12-8-13(17-2)6-5-11(12)7-10;/h3-9H,1-2H3,(H,15,16);/q;+1/p-1/t9-;/m0./s1

2.1.3 InChI Key

CDBRNDSHEYLDJV-FVGYRXGTSA-M

2.1.4 Canonical SMILES

CC(C1=CC2=C(C=C1)C=C(C=C2)OC)C(=O)[O-].[Na+]

2.1.5 Isomeric SMILES

C[C@@H](C1=CC2=C(C=C1)C=C(C=C2)OC)C(=O)[O-].[Na+]

2.2 Other Identifiers

2.2.1 UNII

9TN87S3A3C

2.3 Synonyms

2.3.1 MeSH Synonyms

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

2.3.2 Depositor-Supplied Synonyms

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

2.4 Create Date

2008-02-05

3 Chemical and Physical Properties

Molecular Formula	C₁₄H₁₃NaO₃
Molecular Weight	252.24 g/mol
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 Å²
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

4 Drug and Medication Information

4.1 Drug Information

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

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

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.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Cyclooxygenase Inhibitors [MoA]; Histamine H1 Receptor Antagonists [MoA]; Histamine-1 Receptor Antagonist [EPC]; Nonsteroidal Anti-inflammatory Drug [EPC]; Anti-Inflammatory Agents, Non-Steroidal [CS]

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CIVAC C.P.62578 JIUT EPEC, MORELOS, Cuautla Morelos, , M Mexico","customerAddress":"H.NO. 8-2-337, BESIDE TV9 OFFICE,,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731868200,"product":"NAPROXEN SODIUM USP","address":"NARBAVI, NO.3,LAKSHMANAN STREET,","city":"CHENNAI\/TAMILNADU","supplier":"DIVIS LABORATORIES LIMITED-SEZ UNIT","supplierCountry":"INDIA","foreign_port":"DLL SEZ","customer":"CAPLIN POINT LABORATORIES LIMITED","customerCountry":"INDIA","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"34.1","totalValueFC":"3442.4","currency":"USD","unitRateINR":"2905","date":"18-Nov-2024","totalValueINR":"290500","totalValueInUsd":"3442.4","indian_port":"Vizag-DLL SEZ","hs_no":"29189990","bill_no":"6726385","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"DLL SEZ","supplierAddress":"CHIPPADA VILLAGE ANNAVARAM POST BHEEMUNIPATNAM MANDAL VISAKHAPATNAM SDNF India","customerAddress":"NARBAVI, NO.3,LAKSHMANAN STREET,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732300200,"product":"NAPROXEN SODIUM BP\/USP","address":"202, SAI PLAZA, SANT NAGAR","city":"NEW DELHI","supplier":"DIVIS LABORATORIES LIMITED-SEZ UNIT","supplierCountry":"INDIA","foreign_port":"DLL SEZ","customer":"PRETTY PETALS PRIVATE ","customerCountry":"INDIA","quantity":"5000.00","actualQuantity":"5000","unit":"KGS","unitRateFc":"26.9","totalValueFC":"136275","currency":"USD","unitRateINR":"2300","date":"23-Nov-2024","totalValueINR":"11500000","totalValueInUsd":"136275","indian_port":"Vizag-DLL SEZ","hs_no":"29189990","bill_no":"6834792","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"DLL SEZ","supplierAddress":"CHIPPADA VILLAGE ANNAVARAM POST BHEEMUNIPATNAM MANDAL VISAKHAPATNAM SDNF India","customerAddress":"202, SAI PLAZA, SANT NAGAR"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732473000,"product":"NAPROXEN SODIUM USP (LOT NO:ANRA00245B) (AS PER INVOICE)","address":"H.NO. 8-2-337,BESIDE TV9 OFFICE","city":"HYDERABAD ANDHRA PRADESH","supplier":"INDUSTRIAS QUIMICAS FALCON ","supplierCountry":"MEXICO","foreign_port":"MANZANILLO","customer":"DR. REDDY\\'S LABORATORIES","customerCountry":"INDIA","quantity":"2000.00","actualQuantity":"2000","unit":"KGS","unitRateFc":"32","totalValueFC":"64729.4","currency":"USD","unitRateINR":"2731.2","date":"25-Nov-2024","totalValueINR":"5462400","totalValueInUsd":"64729.4","indian_port":"Hyderabad ICD","hs_no":"29189990","bill_no":"6862654","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"MEXICO","selfForZScoreResived":"Pharma Grade","supplierPort":"MANZANILLO","supplierAddress":"CARRETERA FEDERAL CUERNAVACA-CUAUTL A KM. 4.5 COL. CIVAC C.P.62578 JIUT EPEC, MORELOS, Cuautla Morelos, , M Mexico","customerAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732473000,"product":"NAPROXEN SODIUM USP (LOT NO:ANRA00201B) (AS PER INVOICE)","address":"H.NO. 8-2-337, BESIDE TV9 OFFICE,,","city":"HYDERABAD,TELANGANA","supplier":"INDUSTRIAS QUIMICAS FALCON ","supplierCountry":"MEXICO","foreign_port":"MANZANILLO","customer":"DR. REDDY\\'S LABORATORIES","customerCountry":"INDIA","quantity":"1916.50","actualQuantity":"1916.5","unit":"KGS","unitRateFc":"32","totalValueFC":"62027","currency":"USD","unitRateINR":"2731.2","date":"25-Nov-2024","totalValueINR":"5234344.8","totalValueInUsd":"62027","indian_port":"Hyderabad ICD","hs_no":"29189990","bill_no":"6862654","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"MEXICO","selfForZScoreResived":"Pharma Grade","supplierPort":"MANZANILLO","supplierAddress":"CARRETERA FEDERAL CUERNAVACA-CUAUTL A KM. 4.5 COL. CIVAC C.P.62578 JIUT EPEC, MORELOS, Cuautla Morelos, , M Mexico","customerAddress":"H.NO. 8-2-337, BESIDE TV9 OFFICE,,"}]

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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Adamed Sp. z.o.o.

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Adamed Sp. z.o.o.

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Adamed Sp. z.o.o.

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World Medicine Ilac San ve tic LTD STl

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World Medicine Ilac San ve tic LTD STl

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06

Meda OTC AB,

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07

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Duphat

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APOTEX INC

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02

ARALEZ PHARMACEUTICALS CANADA INC

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ATNAHS PHARMA UK LIMITED

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04

BAYER INC

Germany

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05

BAYER INC

Germany

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06

BAYER INC

Germany

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07

Pharmascience Inc.

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08

PHARMASCIENCE INC

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09

PRO DOC LIMITEE

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TEVA CANADA LIMITED

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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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ABOUT THIS PAGE

Naproxen Sodium Manufacturers

A Naproxen Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Naproxen Sodium, including repackagers and relabelers. The FDA regulates Naproxen Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Naproxen Sodium 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 Naproxen Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Naproxen Sodium Suppliers

A Naproxen Sodium supplier is an individual or a company that provides Naproxen Sodium active pharmaceutical ingredient (API) or Naproxen Sodium finished formulations upon request. The Naproxen Sodium suppliers may include Naproxen Sodium API manufacturers, exporters, distributors and traders.

click here to find a list of Naproxen Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Naproxen Sodium USDMF

A Naproxen Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Naproxen Sodium active pharmaceutical ingredient (API) in detail. Different forms of Naproxen Sodium DMFs exist exist since differing nations have different regulations, such as Naproxen Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Naproxen Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Naproxen Sodium USDMF includes data on Naproxen Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Naproxen Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Naproxen Sodium suppliers with USDMF on PharmaCompass.

Naproxen Sodium KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Naproxen Sodium Drug Master File in Korea (Naproxen Sodium KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Naproxen Sodium. The MFDS reviews the Naproxen Sodium KDMF as part of the drug registration process and uses the information provided in the Naproxen Sodium KDMF to evaluate the safety and efficacy of the drug.

After submitting a Naproxen Sodium 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 Naproxen Sodium API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Naproxen Sodium suppliers with KDMF on PharmaCompass.

Naproxen Sodium CEP

A Naproxen Sodium CEP of the European Pharmacopoeia monograph is often referred to as a Naproxen Sodium Certificate of Suitability (COS). The purpose of a Naproxen Sodium CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Naproxen Sodium EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Naproxen Sodium to their clients by showing that a Naproxen Sodium CEP has been issued for it. The manufacturer submits a Naproxen Sodium CEP (COS) as part of the market authorization procedure, and it takes on the role of a Naproxen Sodium CEP holder for the record. Additionally, the data presented in the Naproxen Sodium CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Naproxen Sodium DMF.

A Naproxen Sodium CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Naproxen Sodium 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 Naproxen Sodium suppliers with CEP (COS) on PharmaCompass.

Naproxen Sodium WC

A Naproxen Sodium written confirmation (Naproxen Sodium WC) is an official document issued by a regulatory agency to a Naproxen Sodium manufacturer, verifying that the manufacturing facility of a Naproxen Sodium active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Naproxen Sodium APIs or Naproxen Sodium finished pharmaceutical products to another nation, regulatory agencies frequently require a Naproxen Sodium WC (written confirmation) as part of the regulatory process.

click here to find a list of Naproxen Sodium suppliers with Written Confirmation (WC) on PharmaCompass.

Naproxen Sodium NDC

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 Naproxen Sodium as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Naproxen Sodium API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 Naproxen Sodium 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Naproxen Sodium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Naproxen Sodium NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Naproxen Sodium suppliers with NDC on PharmaCompass.

Naproxen Sodium GMP

Naproxen Sodium 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 Naproxen Sodium 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 Naproxen Sodium GMP manufacturer or Naproxen Sodium GMP API supplier for your needs.

Naproxen Sodium CoA

A Naproxen Sodium CoA (Certificate of Analysis) is a formal document that attests to Naproxen Sodium's compliance with Naproxen Sodium specifications and serves as a tool for batch-level quality control.

Naproxen Sodium CoA mostly includes findings from lab analyses of a specific batch. For each Naproxen Sodium 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.

Naproxen Sodium may be tested according to a variety of international standards, such as European Pharmacopoeia (Naproxen Sodium EP), Naproxen Sodium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Naproxen Sodium USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

31 API Suppliers

22 USDMF

8 CEP/COS

5 EU WC

34 KDMF

11 NDC API

9 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

6 Drugs in Development

FINISHED DOSAGE FORMULATIONS

152 FDF Dossiers

85 FDA Orange Book

11 Europe

18 Canada

4 South Africa

34 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - EQ 500MG BASE

TABLET;ORAL - 220MG

TABLET, EXTENDED RELEASE;ORAL - EQ 375MG BASE

TABLET, EXTENDED RELEASE;ORAL - EQ 500MG BASE

TABLET, EXTENDED RELEASE;ORAL - EQ 750MG BASE

CAPSULE;ORAL - EQ 200MG BASE

TABLET;ORAL - 500MG;EQ 85MG BASE

TABLET;ORAL - 60MG;EQ 10MG BASE

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TABLET;ORAL - EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons