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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

Naproxen Sodium
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 Weight 252.24 g/mol
Molecular Formula C14H13NaO3
Hydrogen Bond Donor Count0
Hydrogen Bond Acceptor Count3
Rotatable Bond Count3
Exact Mass252.07623855 g/mol
Monoisotopic Mass252.07623855 g/mol
Topological Polar Surface Area49.4 Ų
Heavy Atom Count18
Formal Charge0
Complexity282
Isotope Atom Count0
Defined Atom Stereocenter Count1
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 12  
Drug NameAleve
Active IngredientNaproxen sodium
Dosage FormTablet
RouteOral
Strengtheq 200mg base
Market StatusOver the Counter
CompanyBayer

2 of 12  
Drug NameAnaprox
Drug LabelNaproxen 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 IngredientNaproxen sodium
Dosage FormTablet
RouteOral
Strengtheq 250mg base
Market StatusPrescription
CompanyHoffmann La Roche

3 of 12  
Drug NameAnaprox ds
Drug LabelNaproxen 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 IngredientNaproxen sodium
Dosage FormTablet
RouteOral
Strengtheq 500mg base
Market StatusPrescription
CompanyHoffmann La Roche

4 of 12  
Drug NameNaprelan
Drug LabelNAPRELAN* 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 IngredientNaproxen sodium
Dosage FormTablet, extended release
RouteOral
Strengtheq 750mg base; eq 500mg base; eq 375mg base
Market StatusPrescription
CompanyAlmatica Pharma

5 of 12  
Drug NameNaprosyn
Drug LabelNaproxen 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 IngredientNaproxen
Dosage FormTablet; Suspension
RouteOral
Strength250mg; 375mg; 500mg; 25mg/ml
Market StatusPrescription
CompanyRoche Palo

6 of 12  
Drug NameNaproxen sodium
Drug LabelNAPRELAN* 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 IngredientNaproxen sodium
Dosage FormTablet, extended release; Tablet; Capsule
RouteOral
Strengtheq 500mg base; eq 250mg base; eq 200mg base; eq 375mg base
Market StatusOver the Counter; Prescription
CompanyMarksans 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 NameAleve
Active IngredientNaproxen sodium
Dosage FormTablet
RouteOral
Strengtheq 200mg base
Market StatusOver the Counter
CompanyBayer

8 of 12  
Drug NameAnaprox
Drug LabelNaproxen 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 IngredientNaproxen sodium
Dosage FormTablet
RouteOral
Strengtheq 250mg base
Market StatusPrescription
CompanyHoffmann La Roche

9 of 12  
Drug NameAnaprox ds
Drug LabelNaproxen 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 IngredientNaproxen sodium
Dosage FormTablet
RouteOral
Strengtheq 500mg base
Market StatusPrescription
CompanyHoffmann La Roche

10 of 12  
Drug NameNaprelan
Drug LabelNAPRELAN* 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 IngredientNaproxen sodium
Dosage FormTablet, extended release
RouteOral
Strengtheq 750mg base; eq 500mg base; eq 375mg base
Market StatusPrescription
CompanyAlmatica Pharma

11 of 12  
Drug NameNaprosyn
Drug LabelNaproxen 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 IngredientNaproxen
Dosage FormTablet; Suspension
RouteOral
Strength250mg; 375mg; 500mg; 25mg/ml
Market StatusPrescription
CompanyRoche Palo

12 of 12  
Drug NameNaproxen sodium
Drug LabelNAPRELAN* 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 IngredientNaproxen sodium
Dosage FormTablet, extended release; Tablet; Capsule
RouteOral
Strengtheq 500mg base; eq 250mg base; eq 200mg base; eq 375mg base
Market StatusOver the Counter; Prescription
CompanyMarksans 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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29-Jan-2021
30-Apr-2025
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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

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DOSAGE - TABLET;ORAL - EQ 500MG BASE

USFDA APPLICATION NUMBER - 18164

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DOSAGE - TABLET;ORAL - 220MG

USFDA APPLICATION NUMBER - 20204

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 3...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 375MG BASE

USFDA APPLICATION NUMBER - 20353

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 5...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 500MG BASE

USFDA APPLICATION NUMBER - 20353

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 7...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 750MG BASE

USFDA APPLICATION NUMBER - 20353

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DOSAGE - CAPSULE;ORAL - EQ 200MG BASE

USFDA APPLICATION NUMBER - 21920

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DOSAGE - TABLET;ORAL - 500MG;EQ 85MG BASE

USFDA APPLICATION NUMBER - 21926

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DOSAGE - TABLET;ORAL - 60MG;EQ 10MG BASE

USFDA APPLICATION NUMBER - 21926

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ABOUT THIS PAGE

Looking for 26159-34-2 / Naproxen Sodium API manufacturers, exporters & distributors?

Naproxen Sodium manufacturers, exporters & distributors 1

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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.

API | Excipient name

Naproxen Sodium

Synonyms

26159-34-2, Naprelan, Anaprox, Naproxen sodium salt, Miranax, (-)-naproxen sodium

Cas Number

26159-34-2

Unique Ingredient Identifier (UNII)

9TN87S3A3C

About Naproxen Sodium

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.

Anaprox, Miranax, Naprelan, Naposin, Antalgin, Feminax Ultra, Naproxen Sodium Manufacturers

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

Anaprox, Miranax, Naprelan, Naposin, Antalgin, Feminax Ultra, Naproxen Sodium Suppliers

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

click here to find a list of Anaprox, Miranax, Naprelan, Naposin, Antalgin, Feminax Ultra, Naproxen Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Anaprox, Miranax, Naprelan, Naposin, Antalgin, Feminax Ultra, Naproxen Sodium USDMF

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

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

click here to find a list of Anaprox, Miranax, Naprelan, Naposin, Antalgin, Feminax Ultra, Naproxen Sodium suppliers with USDMF on PharmaCompass.

Anaprox, Miranax, Naprelan, Naposin, Antalgin, Feminax Ultra, 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 Anaprox, Miranax, Naprelan, Naposin, Antalgin, Feminax Ultra, Naproxen Sodium Drug Master File in Korea (Anaprox, Miranax, Naprelan, Naposin, Antalgin, Feminax Ultra, Naproxen Sodium KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Anaprox, Miranax, Naprelan, Naposin, Antalgin, Feminax Ultra, Naproxen Sodium. The MFDS reviews the Anaprox, Miranax, Naprelan, Naposin, Antalgin, Feminax Ultra, Naproxen Sodium KDMF as part of the drug registration process and uses the information provided in the Anaprox, Miranax, Naprelan, Naposin, Antalgin, Feminax Ultra, Naproxen Sodium KDMF to evaluate the safety and efficacy of the drug.

After submitting a Anaprox, Miranax, Naprelan, Naposin, Antalgin, Feminax Ultra, 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 Anaprox, Miranax, Naprelan, Naposin, Antalgin, Feminax Ultra, Naproxen Sodium API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Anaprox, Miranax, Naprelan, Naposin, Antalgin, Feminax Ultra, Naproxen Sodium suppliers with KDMF on PharmaCompass.

Anaprox, Miranax, Naprelan, Naposin, Antalgin, Feminax Ultra, Naproxen Sodium CEP

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

A Anaprox, Miranax, Naprelan, Naposin, Antalgin, Feminax Ultra, Naproxen Sodium CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Anaprox, Miranax, Naprelan, Naposin, Antalgin, Feminax Ultra, 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 Anaprox, Miranax, Naprelan, Naposin, Antalgin, Feminax Ultra, Naproxen Sodium suppliers with CEP (COS) on PharmaCompass.

Anaprox, Miranax, Naprelan, Naposin, Antalgin, Feminax Ultra, Naproxen Sodium WC

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

click here to find a list of Anaprox, Miranax, Naprelan, Naposin, Antalgin, Feminax Ultra, Naproxen Sodium suppliers with Written Confirmation (WC) on PharmaCompass.

Anaprox, Miranax, Naprelan, Naposin, Antalgin, Feminax Ultra, 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 Anaprox, Miranax, Naprelan, Naposin, Antalgin, Feminax Ultra, Naproxen Sodium as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Anaprox, Miranax, Naprelan, Naposin, Antalgin, Feminax Ultra, 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 Anaprox, Miranax, Naprelan, Naposin, Antalgin, Feminax Ultra, 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 Anaprox, Miranax, Naprelan, Naposin, Antalgin, Feminax Ultra, Naproxen Sodium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Anaprox, Miranax, Naprelan, Naposin, Antalgin, Feminax Ultra, Naproxen Sodium NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Anaprox, Miranax, Naprelan, Naposin, Antalgin, Feminax Ultra, Naproxen Sodium suppliers with NDC on PharmaCompass.

Anaprox, Miranax, Naprelan, Naposin, Antalgin, Feminax Ultra, Naproxen Sodium GMP

Anaprox, Miranax, Naprelan, Naposin, Antalgin, Feminax Ultra, 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 Anaprox, Miranax, Naprelan, Naposin, Antalgin, Feminax Ultra, 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 Anaprox, Miranax, Naprelan, Naposin, Antalgin, Feminax Ultra, Naproxen Sodium GMP manufacturer or Anaprox, Miranax, Naprelan, Naposin, Antalgin, Feminax Ultra, Naproxen Sodium GMP API supplier for your needs.

Anaprox, Miranax, Naprelan, Naposin, Antalgin, Feminax Ultra, Naproxen Sodium CoA

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

Anaprox, Miranax, Naprelan, Naposin, Antalgin, Feminax Ultra, Naproxen Sodium CoA mostly includes findings from lab analyses of a specific batch. For each Anaprox, Miranax, Naprelan, Naposin, Antalgin, Feminax Ultra, 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.

Anaprox, Miranax, Naprelan, Naposin, Antalgin, Feminax Ultra, Naproxen Sodium may be tested according to a variety of international standards, such as European Pharmacopoeia (Anaprox, Miranax, Naprelan, Naposin, Antalgin, Feminax Ultra, Naproxen Sodium EP), Anaprox, Miranax, Naprelan, Naposin, Antalgin, Feminax Ultra, Naproxen Sodium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Anaprox, Miranax, Naprelan, Naposin, Antalgin, Feminax Ultra, 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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