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Chemistry

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Also known as: 41340-25-4, Etodolic acid, Lodine, Ultradol, Lodine xl, Ay-24236
Molecular Formula
C17H21NO3
Molecular Weight
287.35  g/mol
InChI Key
NNYBQONXHNTVIJ-UHFFFAOYSA-N
FDA UNII
2M36281008

Etodolac
A non-steroidal anti-inflammatory agent and cyclooxygenase-2 (COX-2) inhibitor with potent analgesic and anti-arthritic properties. It has been shown to be effective in the treatment of OSTEOARTHRITIS; RHEUMATOID ARTHRITIS; ANKYLOSING SPONDYLITIS; and in the alleviation of postoperative pain (PAIN, POSTOPERATIVE).
Etodolac is a Nonsteroidal Anti-inflammatory Drug. The mechanism of action of etodolac is as a Cyclooxygenase Inhibitor.
1 2D Structure

Etodolac

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
2-(1,8-diethyl-4,9-dihydro-3H-pyrano[3,4-b]indol-1-yl)acetic acid
2.1.2 InChI
InChI=1S/C17H21NO3/c1-3-11-6-5-7-12-13-8-9-21-17(4-2,10-14(19)20)16(13)18-15(11)12/h5-7,18H,3-4,8-10H2,1-2H3,(H,19,20)
2.1.3 InChI Key
NNYBQONXHNTVIJ-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CCC1=C2C(=CC=C1)C3=C(N2)C(OCC3)(CC)CC(=O)O
2.2 Other Identifiers
2.2.1 UNII
2M36281008
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Ay 24,236

2. Ay 24236

3. Ay-24,236

4. Ay-24236

5. Etodolac, (+-)-isomer

6. Etodolac, (-)-isomer

7. Etodolac, (s)-isomer

8. Etodolac, Monosodium Salt

9. Etodolac, Monosodium Salt, (+-) Isomer

10. Etodolac, Monosodium Salt, (s)-isomer

11. Etodolic Acid

12. Lodine

13. Ramodar

14. Ultradol

2.3.2 Depositor-Supplied Synonyms

1. 41340-25-4

2. Etodolic Acid

3. Lodine

4. Ultradol

5. Lodine Xl

6. Ay-24236

7. Edolan

8. Ramodar

9. Ay-24,236

10. Etodolaco

11. Etodolacum

12. Tedolan

13. Zedolac

14. Rac-etodolac

15. Ay 24236

16. Eccoxolac

17. Flancox

18. Napilac

19. 2-(1,8-diethyl-1,3,4,9-tetrahydropyrano[3,4-b]indol-1-yl)acetic Acid

20. Lodin Xl

21. 1,8-diethyl-1,3,4,9-tetrahydropyrano(3,4-b)indole-1-acetic Acid

22. Pyrano[3,4-b]indole-1-acetic Acid, 1,8-diethyl-1,3,4,9-tetrahydro-

23. (rs)-etodolic Acid

24. 1,3,4,9-tetrahydro-1,8-diethylpyrano(3,4-b)indole-1-acetic Acid

25. 1,8-diethyl-1,3,4,9-tetrahydropyrano[3,4-b]indole-1-acetic Acid

26. 2-(1,8-diethyl-4,9-dihydro-3h-pyrano[3,4-b]indol-1-yl)acetic Acid

27. Chembl622

28. Nsc-282126

29. (1,8-diethyl-1,3,4,9-tetrahydropyrano[3,4-b]indol-1-yl)acetic Acid

30. Pyrano(3,4-b)indole-1-acetic Acid, 1,8-diethyl-1,3,4,9-tetrahydro-

31. Mls000028474

32. Chebi:4909

33. Rak-591

34. 2-{1,8-diethyl-1h,3h,4h,9h-pyrano[3,4-b]indol-1-yl}acetic Acid

35. (1,8-diethyl-1,3,4,9-tetrahydro-pyrano[3,4-b]indol-1-yl)-acetic Acid

36. Nih-9918

37. Nsc282126

38. Smr000058443

39. Ay-24-236

40. Dsstox_cid_615

41. (+-)-1,8-diethyl-1,3,4,9-tetrahydropyrano(3,4-b)indole-1-acetic Acid

42. (rs)-2-(1,8-diethyl-4,9-dihydro-3h-pyrano[3,4-b]indol-1-yl)acetic Acid

43. Etodolacum [inn-latin]

44. Dsstox_rid_75691

45. Dsstox_gsid_20615

46. Etodolaco [inn-spanish]

47. 2m36281008

48. Hypen

49. 1,8-diethyl-1,3,4,9-tetrahydro-pyrano[3,4-b]indole-1-acetic Acid

50. 1,8-diethyl-1,3,4,9-tetrahydropyrano[3,4-b]indol-1-ylacetic Acid

51. (+/-)-1,8-diethyl-1,3,4,9-tetrahydropyrano(3,4-b)indole-1-acetic Acid

52. Ccris 3923

53. Sr-01000000100

54. Nsc 282126

55. Etogesic

56. Osteluc

57. Etodolac O

58. Etodlic Acid

59. Lodine Sr

60. Etodolac [usan:usp:inn:ban]

61. Etodolac- Bio-x

62. Ncgc00016849-01

63. Etodolac,(s)

64. Prestwick_209

65. Cas-41340-25-4

66. Lodine (tn)

67. Mfcd00133313

68. Unii-2m36281008

69. Etodolac Assay Standard

70. Spectrum_001244

71. Etodolac [usan]

72. Etodolac [inn]

73. Etodolac [jan]

74. Etodolac [mi]

75. Etodolac [vandf]

76. Opera_id_1774

77. Prestwick0_000231

78. Prestwick1_000231

79. Prestwick2_000231

80. Prestwick3_000231

81. Spectrum2_001387

82. Spectrum3_001429

83. Spectrum4_000410

84. Spectrum5_001347

85. Etodolac [mart.]

86. Etodolac [usp-rs]

87. Etodolac [who-dd]

88. Schembl3903

89. Lopac0_000479

90. (+/-)-etodolac

91. Bspbio_000301

92. Bspbio_003138

93. Kbiogr_000680

94. Kbioss_001724

95. Mls001077315

96. Mls006011566

97. Divk1c_000147

98. Etodolac [green Book]

99. Spectrum1501005

100. Etodolac (jp17/usp/inn)

101. Spbio_001374

102. Spbio_002222

103. Etodolac [orange Book]

104. Bpbio1_000333

105. Gtpl7185

106. Etodolac [ep Monograph]

107. Etodolac For Peak Identification

108. Dtxsid9020615

109. Etodolac [usp Monograph]

110. Hms500h09

111. Kbio1_000147

112. Kbio2_001724

113. Kbio2_004292

114. Kbio2_006860

115. Kbio3_002358

116. Ninds_000147

117. Hms1568p03

118. Hms1921b09

119. Hms2092o20

120. Hms2095p03

121. Hms2231d04

122. Hms3259p10

123. Hms3261o20

124. Hms3374g09

125. Hms3712p03

126. Pharmakon1600-01501005

127. Bcp28411

128. Tox21_110644

129. Tox21_202218

130. Tox21_500479

131. Bdbm50016799

132. Ccg-39005

133. Nsc757821

134. Pyrano(3,4-b)indole-1-acetic Acid, 1,3,4,9-tetrahydro-1,8-diethyl-

135. Akos015838610

136. Pyrano(3,4-b)indole-1-acetic Acid, 1,8-diethyl-1,3,4,9-tetrahydro-(+-)-

137. Tox21_110644_1

138. Ac-4231

139. Cs-0832

140. Db00749

141. Lp00479

142. Nc00718

143. Nsc-757821

144. Sdccgsbi-0050463.p004

145. Etodolac 100 Microg/ml In Acetonitrile

146. Idi1_000147

147. Ncgc00015399-03

148. Ncgc00015399-04

149. Ncgc00015399-05

150. Ncgc00015399-06

151. Ncgc00015399-07

152. Ncgc00015399-08

153. Ncgc00015399-09

154. Ncgc00015399-11

155. Ncgc00015399-12

156. Ncgc00015399-13

157. Ncgc00015399-15

158. Ncgc00015399-16

159. Ncgc00015399-26

160. Ncgc00089769-02

161. Ncgc00089769-03

162. Ncgc00089769-04

163. Ncgc00089769-05

164. Ncgc00089769-06

165. Ncgc00089769-07

166. Ncgc00259767-01

167. Ncgc00261164-01

168. Br164431

169. Hy-76251

170. Sbi-0050463.p003

171. Ab00052194

172. E0858

173. Eu-0100479

174. Ft-0607046

175. Ft-0668424

176. Ft-0668425

177. C06991

178. D00315

179. E 0516

180. Pyrano[3, 1,8-diethyl-1,3,4,9-tetrahydro-

181. Ab00052194_17

182. 340e254

183. Q-201099

184. Q2465218

185. Sr-01000000100-2

186. Sr-01000000100-4

187. Sr-01000000100-7

188. Brd-a74667430-001-05-3

189. Brd-a74667430-001-15-2

190. 1,3,4,9-tetrahydropyrano[3,4-b]indole-1-acetic Acid

191. Etodolac, European Pharmacopoeia (ep) Reference Standard

192. F2173-0681

193. Z1820178466

194. Etodolac, United States Pharmacopeia (usp) Reference Standard

195. 1,8-diethyl-1,3,4,9-tetrahydropyranol[3,4-b]indole-1-acetic Acid

196. 1,8-diethyl-1,3,4,9-tetrahydropyrano(3,4-b)indol-1-acetic Acid

197. 2-(1,8-diethyl-4,9-dihydro-3h-pyrano[3,4-b]indol-1-yl)acetic Acid.

198. Pyrano(3,4,b)indole-1-acetic Acid, 1,3,4,9-tetrahydro-1,8-diethyl-

199. Ay 24,236; Ay 24236;ay-24,236; Ay-24236; Ay24,236; Ay24236

200. Etodolac For Peak Identification, European Pharmacopoeia (ep) Reference Standard

201. Pyrano(3,4-b)indole-1-acetic Acid, 1,8-diethyl-1,3,4,9-tetrahydro-(+/-)-

2.4 Create Date
2005-03-25
3 Chemical and Physical Properties
Molecular Weight 287.35 g/mol
Molecular Formula C17H21NO3
XLogP32.8
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count3
Rotatable Bond Count4
Exact Mass287.15214353 g/mol
Monoisotopic Mass287.15214353 g/mol
Topological Polar Surface Area62.3 Ų
Heavy Atom Count21
Formal Charge0
Complexity400
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count1
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NameEtodolac
PubMed HealthEtodolac (By mouth)
Drug ClassesAnalgesic, Antirheumatic, Central Nervous System Agent, Musculoskeletal Agent
Drug LabelEtodolac capsules and tablets, USP are members of the pyranocarboxylic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each tablet and capsule contains etodolac for oral administration. Etodolac is a racemic mixture of [+]S and [-]R-enan...
Active IngredientEtodolac
Dosage FormTablet, extended release; Tablet; Capsule
RouteOral
Strength300mg; 200mg; 600mg; 500mg; 400mg
Market StatusPrescription
CompanyAni Pharms; Teva; Apotex; Taro; Taro Pharm Inds; Zydus Pharms Usa; Sandoz; Mylan

2 of 2  
Drug NameEtodolac
PubMed HealthEtodolac (By mouth)
Drug ClassesAnalgesic, Antirheumatic, Central Nervous System Agent, Musculoskeletal Agent
Drug LabelEtodolac capsules and tablets, USP are members of the pyranocarboxylic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each tablet and capsule contains etodolac for oral administration. Etodolac is a racemic mixture of [+]S and [-]R-enan...
Active IngredientEtodolac
Dosage FormTablet, extended release; Tablet; Capsule
RouteOral
Strength300mg; 200mg; 600mg; 500mg; 400mg
Market StatusPrescription
CompanyAni Pharms; Teva; Apotex; Taro; Taro Pharm Inds; Zydus Pharms Usa; Sandoz; Mylan

4.2 Drug Indication

For acute and long-term management of signs and symptoms of osteoarthritis and rheumatoid arthritis, as well as for the management of pain.


FDA Label


5 Pharmacology and Biochemistry
5.1 Pharmacology

Etodolac is an anti-inflammatory agent with analgesic and antipyretic properties. It is used to treat osteoarthritis, rheumatoid arthritis and control acute pain. The therapeutic effects of etodolac are achieved via inhibition of the synthesis of prostaglandins involved in fever, pain, swelling and inflammation. Etodolac is administered as a racemate. As with other NSAIDs, the S-form has been shown to be active while the R-form is inactive. Both enantiomers are stable and there is no evidence of R- to S- conversion _in vivo_.


5.2 MeSH Pharmacological Classification

Cyclooxygenase 2 Inhibitors

A subclass of cyclooxygenase inhibitors with specificity for CYCLOOXYGENASE-2. (See all compounds classified as Cyclooxygenase 2 Inhibitors.)


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.)


5.3 FDA Pharmacological Classification
5.3.1 Active Moiety
ETODOLAC
5.3.2 FDA UNII
2M36281008
5.3.3 Pharmacological Classes
Cyclooxygenase Inhibitors [MoA]; Nonsteroidal Anti-inflammatory Drug [EPC]; Anti-Inflammatory Agents, Non-Steroidal [CS]
5.4 ATC Code

M - Musculo-skeletal system

M01 - Antiinflammatory and antirheumatic products

M01A - Antiinflammatory and antirheumatic products, non-steroids

M01AB - Acetic acid derivatives and related substances

M01AB08 - Etodolac


5.5 Absorption, Distribution and Excretion

Absorption

Based on mass balance studies, the systemic bioavailability of etodolac from either the tablet or capsule formulation is at least 80%.


Route of Elimination

It is not known whether etodolac is excreted in human milk; however, based on its physical-chemical properties, excretion into breast milk is expected. Etodolac is extensively metabolized in the liver. The hydroxylated-etodolac metabolites undergo further glucuronidation followed by renal excretion and partial elimination in the feces (16% of dose). Approximately 1% of a etodolac dose is excreted unchanged in the urine with 72% of the dose excreted into urine as parent drug plus metabolite.


Volume of Distribution

390 mL/kg


Clearance

Oral cl=49.1 mL/h/kg [Normal healthy adults]

Oral cl=49.4 mL/h/kg [Healthy males (18-65 years)]

Oral cl=35.7 mL/h/kg [Healthy females (27-65 years)]

Oral cl=45.7 mL/h/kg [Eldery (>65 years)]

Oral cl=58.3 mL/h/kg [Renal impairement (46-73 years)]

Oral cl=42.0 mL/h/kg [Hepatic impairement (34-60 years)]


5.6 Metabolism/Metabolites

Etodolac is extensively metabolized in the liver. Renal elimination of etodolac and its metabolites is the primary route of excretion (72%). Metabolites found in urine (with percents of the administered dose) are: unchanged etodolac (1%), etodolac glucuronide (13%), hydroxylated metabolites (6-, 7-, and 8-OH; 5%), hydroxylated metabolite glucuronides (20%), and unidentified metabolites (33%). Fecal excretion accounts for 16% of its elimination.


Etodolac has known human metabolites that include (2S,3S,4S,5R)-6-[2-(1,8-Diethyl-4,9-dihydro-3H-pyrano[3,4-b]indol-1-yl)acetyl]oxy-3,4,5-trihydroxyoxane-2-carboxylic acid.

S73 | METXBIODB | Metabolite Reaction Database from BioTransformer | DOI:10.5281/zenodo.4056560


5.7 Biological Half-Life

Terminal t1/2, 7.3 ± 4.0 hours. Distribution t1/2, 0.71 ± 0.50 hours


5.8 Mechanism of Action

Similar to other NSAIDs, the anti-inflammatory effects of etodolac result from inhibition of the enzyme cycooxygenase (COX). This decreases the synthesis of peripheral prostaglandins involved in mediating inflammation. Etodolac binds to the upper portion of the COX enzyme active site and prevents its substrate, arachidonic acid, from entering the active site. Etodolac was previously thought to be a non-selective COX inhibitor, but it is now known to be 5 50 times more selective for COX-2 than COX-1. Antipyresis may occur by central action on the hypothalamus, resulting in peripheral dilation, increased cutaneous blood flow, and subsequent heat loss.


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CO","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"AMNEAL PHARMACEUTICALS","customerCountry":"INDIA","quantity":"1400.00","actualQuantity":"1400","unit":"KGS","unitRateFc":"120","totalValueFC":"168325.4","currency":"USD","unitRateINR":"9930","date":"08-Feb-2023","totalValueINR":"13902000","totalValueInUsd":"168325.4","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29349990","bill_no":"1000557","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"N\/A","customerAddress":"882\/1-871, NEAR KANKAVATI ,VILLAGE-"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1678213800,"product":"ETODOLAC USP","address":"PLOT NO.2, MAITRIVIHAR BEHIND MAITRIVANAM, AMEERPET","city":"HYDERABAD","supplier":"ZHEJIANG CHIRAL MEDICINE CHEMICALS CO","supplierCountry":"CHINA","foreign_port":"NA","customer":"AUROBINDO PHARMA LIMITED","customerCountry":"INDIA","quantity":"4.00","actualQuantity":"4","unit":"KGS","unitRateFc":"200","totalValueFC":"812.2","currency":"USD","unitRateINR":"16700","date":"08-Mar-2023","totalValueINR":"66800","totalValueInUsd":"812.2","indian_port":"HYDERABAD AIR","hs_no":"29349990","bill_no":"4955388","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"PLOT NO.2, MAITRIVIHAR BEHIND MAITRIVANAM, AMEERPET"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1713551400,"product":"(RAW MATERIAL FOR PHARMACEUTICAL MEDICINE) ETODOLAC USP EDA5 EMB BATCH NO EDA9AYJ19A & EDA9AYJ20A & EDA9AYJ21A & EDA9AY","address":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H","city":"AHMEDABAD,GUJARAT","supplier":"ALIDAC HEALTHCARE MYANMAR ","supplierCountry":"INDIA","foreign_port":"YANGON","customer":"ZYDUS LIFESCIENCES","customerCountry":"INDIA","quantity":"684.20","actualQuantity":"684.2","unit":"KGS","unitRateFc":"142.5","totalValueFC":"100118.7","currency":"USD","unitRateINR":"12219.6","date":"20-Apr-2024","totalValueINR":"8360639.59","totalValueInUsd":"100118.7","indian_port":"JNPT","hs_no":"29339990","bill_no":"3108265","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"YANGON","supplierAddress":"PLOT NO.B-19,ZONE A,THILAWA SPECIALECONOMIC ZONE,THANLYIN TOWNSHIP Yangon - 11291-11293, , Myanmar Myanmar","customerAddress":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H"}]
19-Jan-2021
29-Mar-2025
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ABOUT THIS PAGE

Looking for 41340-25-4 / Etodolac API manufacturers, exporters & distributors?

Etodolac manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Etodolac 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 Etodolac manufacturer or Etodolac supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Etodolac manufacturer or Etodolac supplier.

PharmaCompass also assists you with knowing the Etodolac API Price utilized in the formulation of products. Etodolac API Price is not always fixed or binding as the Etodolac Price is obtained through a variety of data sources. The Etodolac Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Etodolac

Synonyms

41340-25-4, Etodolic acid, Lodine, Ultradol, Lodine xl, Ay-24236

Cas Number

41340-25-4

Unique Ingredient Identifier (UNII)

2M36281008

About Etodolac

A non-steroidal anti-inflammatory agent and cyclooxygenase-2 (COX-2) inhibitor with potent analgesic and anti-arthritic properties. It has been shown to be effective in the treatment of OSTEOARTHRITIS; RHEUMATOID ARTHRITIS; ANKYLOSING SPONDYLITIS; and in the alleviation of postoperative pain (PAIN, POSTOPERATIVE).

Lodine SR Manufacturers

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

Lodine SR Suppliers

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

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

Lodine SR USDMF

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

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

click here to find a list of Lodine SR suppliers with USDMF on PharmaCompass.

Lodine SR JDMF

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 Lodine SR Drug Master File in Japan (Lodine SR JDMF) empowers Lodine SR 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 Lodine SR JDMF during the approval evaluation for pharmaceutical products. At the time of Lodine SR 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 Lodine SR suppliers with JDMF on PharmaCompass.

Lodine SR KDMF

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

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

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

click here to find a list of Lodine SR suppliers with KDMF on PharmaCompass.

Lodine SR CEP

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

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

Lodine SR WC

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

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

Lodine SR 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 Lodine SR as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Lodine SR 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 Lodine SR 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 Lodine SR and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Lodine SR NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Lodine SR suppliers with NDC on PharmaCompass.

Lodine SR GMP

Lodine SR 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 Lodine SR 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 Lodine SR GMP manufacturer or Lodine SR GMP API supplier for your needs.

Lodine SR CoA

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

Lodine SR CoA mostly includes findings from lab analyses of a specific batch. For each Lodine SR 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.

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