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1. (+)-2-ethoxy-alpha-(((s)-alpha-isobutyl-o-piperidinobenzyl)carbamoyl)-p-toluic Acid
2. (+)-repaglinide
3. (-)-repaglinide
4. (s)-2-ethoxy-4-(2-((3-methyl-1-(2-(1-piperidinyl)-phenyl)butyl)amino)-2-oxoethyl)-benzoic Acid
5. 2-ethoxy-4-(2-(((1r)-3-methyl-1-(2-(1-piperidinyl)phenyl)butyl)amino)-2-oxoethyl)benzoic Acid
6. 2-ethoxy-4-(2-((3-methyl-1-(2-(1-piperidinyl)phenyl)butyl)amino)-2-oxoethyl)benzoic Acid
7. 2-ethoxy-n-(alpha-(2-methyl-1-propyl)-2-piperidinobenzyl)-4-carbamoylmethylbenzoic Acid
8. Ag-ee 388
9. Ag-ee 388 Zw
10. Ag-ee 623 Zw
11. Ag-ee 624zw
12. Ag-ee-623-zw
13. Ag-ee-623zw
14. Ag-ee-624zw
15. Agee-623zw
16. Gluconorm
17. Novonorm
18. Prandin
19. Repa-glinide
20. Repaglinide Impurity E
21. Repaglinide Related Compound E
22. Repaglinide, (+-)-isomer
1. 135062-02-1
2. Prandin
3. Novonorm
4. Gluconorm
5. Ag-ee 623 Zw
6. Ag-ee 388 Zw
7. Repaglinidum [inn-latin]
8. Repaglinida [inn-spanish]
9. Agee-623zw
10. (s)-2-ethoxy-4-(2-((3-methyl-1-(2-(piperidin-1-yl)phenyl)butyl)amino)-2-oxoethyl)benzoic Acid
11. C27h36n2o4
12. Ag-ee 623zw
13. Ag-ee-623zw
14. Ag-ee-623-zw
15. 2-ethoxy-4-[2-[[(1s)-3-methyl-1-(2-piperidin-1-ylphenyl)butyl]amino]-2-oxoethyl]benzoic Acid
16. A10bx02
17. Nsc-759893
18. Chembl1272
19. (s)-(+)-2-ethoxy-4-[n-[1-(2-piperidinophenyl)-3-methyl-1-butyl]aminocarbonylmethyl]benzoic Acid
20. (s)-2-ethoxy-4-(2-(3-methyl-1-(2-(piperidin-1-yl)phenyl)butylamino)-2-oxoethyl)benzoic Acid
21. Chebi:8805
22. (-)-repaglinide
23. 668z8c33lu
24. 2-ethoxy-4-({[(1s)-3-methyl-1-[2-(piperidin-1-yl)phenyl]butyl]carbamoyl}methyl)benzoic Acid
25. 2-ethoxy-4-[2-({(1s)-3-methyl-1-[2-(piperidin-1-yl)phenyl]butyl}amino)-2-oxoethyl]benzoic Acid
26. Ncgc00016978-01
27. Repaglinida
28. Repaglinidum
29. Repaglinide [usan]
30. Cas-135062-02-1
31. Actulin
32. Surepost
33. Reglin
34. Mfcd00906179
35. 2-ethoxy-4-(2-{[(1s)-3-methyl-1-(2-piperidin-1-ylphenyl)butyl]amino}-2-oxoethyl)benzoic Acid
36. Smr000466305
37. Prandin (tn)
38. Repaglinide (jan/usp/inn)
39. Unii-668z8c33lu
40. Ag-ee-623 Zw
41. Ag-ee-388
42. Repaglinide,(s)
43. Smp-508
44. Surepost (tn)
45. (s)-2-ethoxy-4-[2-[[3-methyl-1-[2-(piperidin-1-yl)phenyl]butyl]amino]-2-oxoethyl]benzoic Acid
46. Bjx
47. Repaglinide [usan:usp:inn:ban]
48. Repaglinide- Bio-x
49. Nn-623
50. (+)-2-ethoxy-alpha-(((s)-alpha-isobutyl-o-piperidinobenzyl)carbamoyl)-p-toluic Acid
51. 2-ethoxy-4-[2-[[(1s)-3-methyl-1-[2-(1-piperidinyl)phenyl]butyl]amino]-2-oxoethyl]benzoic Acid
52. 111ge012
53. Repaglinide [mi]
54. Prestwick0_001046
55. Prestwick1_001046
56. Prestwick2_001046
57. Prestwick3_001046
58. Repaglinide [inn]
59. Repaglinide [jan]
60. Dsstox_cid_3552
61. Repaglinide [vandf]
62. (s)-2-ethoxy-4-(2-((methyl-1-(2-(1-piperidinyl)phenyl)butyl)amino)-2-oxoethyl)-benzoic Acid
63. Dsstox_rid_77078
64. Repaglinide [mart.]
65. Dsstox_gsid_23552
66. Schembl16137
67. Bspbio_000972
68. Repaglinide [usp-rs]
69. Repaglinide [who-dd]
70. Mls000759407
71. Mls001076684
72. Mls001424111
73. Mls006011560
74. Bidd:gt0338
75. Spbio_002906
76. Repaglinide [ema Epar]
77. Bpbio1_001070
78. Gtpl6841
79. Dtxsid3023552
80. Repaglinide [orange Book]
81. Repaglinide For System Suitability
82. Hms1571a14
83. Hms2051n08
84. Hms2094c07
85. Hms2098a14
86. Hms2231m21
87. Hms3414d09
88. Hms3678d09
89. Hms3715a14
90. Pharmakon1600-01506035
91. Repaglinide [ep Monograph]
92. Repaglinide [usp Monograph]
93. Bcp04250
94. Zinc3798537
95. Tox21_110721
96. Ac-726
97. Bdbm50153520
98. Nsc759893
99. S1426
100. Stk629501
101. Akos005561792
102. Repaglinide, >=98% (hplc), Solid
103. Bs-1010
104. Ccg-101013
105. Cs-0979
106. Db00912
107. Nc00263
108. Nsc 759893
109. Repaglinide 100 Microg/ml In Methanol
110. Ncgc00016978-02
111. Ncgc00016978-04
112. Ncgc00016978-05
113. Benzoic Acid, 2-ethoxy-4-(2-((3-methyl-1-(2-(1-piperidinyl)phenyl)butyl)amino)-2-oxoethyl)-, (s)-
114. Br164332
115. Hy-15209
116. Sbi-0206942.p001
117. Ab00514019
118. Am20090697
119. R0179
120. Sw197344-4
121. 62r021
122. C07670
123. D00594
124. F15001
125. Ab00514019-09
126. Ab00514019_10
127. Ab00514019_11
128. A806877
129. Sr-01000759404
130. Q-201663
131. Q2195995
132. Sr-01000759404-4
133. Brd-k82846253-001-03-0
134. Z1777729210
135. Repaglinide, European Pharmacopoeia (ep) Reference Standard
136. Repaglinide, United States Pharmacopeia (usp) Reference Standard
137. (s)-(+)-2-ethoxy-4-(2-oxo-2-[(alpha-isobutyl-2-piperidinobenzyl)amino]ethyl)-benzoic Acid
138. Repaglinide For System Suitability, European Pharmacopoeia (ep) Reference Standard
139. (+)-2-ethoxy-.alpha.-(((s)-.alpha.-isobutyl-o-piperidinobenzyl)carbamoyl)-p-toluic Acid
140. (2s)-2-[[(2s)-2-[[(2s,3s)-2-[[(2s)-4-amino-2-[[(2s,3s)-2-[[(2s)-2-[[2-[[(2s)-2-[[(2s)-1-[(2s)-2-[[(2s)-2-amino-5-guanidino-pentanoyl]amino]-4-carboxy-butanoyl]pyrrolidine-2-carbonyl]amino]propanoyl]amino]acetyl]amino]-4-methyl-pentanoyl]amino]-3-methyl-pe;(s)-2-ethoxy-4-[2-[[3-methyl-1-[2-(1-piperidyl)phenyl]butyl]amino]-2-oxoethyl]benzoic Acid
141. (s)-2-ethoxy-4-(2-((3-methyl-1-(2-(piperidin-1-yl)phenyl)butyl)amino)-2-oxoethyl)benzoicacid
142. (s)-2-ethoxy-4-(2-(methyl-1-(2-(1-piperidinyl)phenyl)butylamino)-2-oxoethyl)-benzoic Acid
143. (s)-2-ethoxy-4-[2-[[[(1s)-3-methyl-1-[2-(1-piperidinyl)phenyl]butyl]amino]-2-oxoethyl]benzoic Acid
144. (s)-2-ethoxy-4-[n-(1-(2-piperidino-phenyl)-3-methyl-1-butyl)-aminocarbonylmethyl]-benzoic Acid
145. 2-ethoxy-4-[2-[[(1s)-3-methyl-1-[2-(1-piperidinyl)phenyl]butyl]amino]-2-oxoethyl]benz Oic Acid
146. 2-ethoxy-4-{[(s)-3-methyl-1-(2-piperidin-1-yl-phenyl)-butylcarbamoyl]-methyl}-benzoic Acid
147. Benzoic Acid, 2-ethoxy-4-[2-[[(1s)-3-methyl-1-[2-(1-piperidinyl)phenyl]butyl]amino]-2-oxoethyl]-
| Molecular Weight | 452.6 g/mol |
|---|---|
| Molecular Formula | C27H36N2O4 |
| XLogP3 | 5.2 |
| Hydrogen Bond Donor Count | 2 |
| Hydrogen Bond Acceptor Count | 5 |
| Rotatable Bond Count | 10 |
| Exact Mass | 452.26750763 g/mol |
| Monoisotopic Mass | 452.26750763 g/mol |
| Topological Polar Surface Area | 78.9 Ų |
| Heavy Atom Count | 33 |
| Formal Charge | 0 |
| Complexity | 619 |
| 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 | 1 |
| 1 of 4 | |
|---|---|
| Drug Name | Prandin |
| PubMed Health | Repaglinide (By mouth) |
| Drug Label | PRANDIN(repaglinide) is an oral blood glucose-lowering drug of the meglitinide clab used in the management of type 2 diabetes mellitus (also known as non-insulin dependent diabetes mellitus or NIDDM). Repaglinide, S(+)2-ethoxy-4(2((3-methyl-1-(2-(1-... |
| Active Ingredient | Repaglinide |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | 0.5mg; 1mg; 2mg |
| Market Status | Prescription |
| Company | Novo Nordisk |
| 2 of 4 | |
|---|---|
| Drug Name | Repaglinide |
| PubMed Health | Repaglinide (By mouth) |
| Drug Label | PRANDIN(repaglinide) is an oral blood glucose-lowering drug of the meglitinide clab used in the management of type 2 diabetes mellitus (also known as non-insulin dependent diabetes mellitus or NIDDM). Repaglinide, S(+)2-ethoxy-4(2((3-methyl-1-(2-(1-... |
| Active Ingredient | Repaglinide |
| Dosage Form | Tablet |
| Route | oral; Oral |
| Strength | 0.5mg; 1mg; 2mg |
| Market Status | Tentative Approval; Prescription |
| Company | Mylan Pharms; Aurobindo Pharma; Sun Pharm Inds; Actavis Totowa; Sandoz; Paddock |
| 3 of 4 | |
|---|---|
| Drug Name | Prandin |
| PubMed Health | Repaglinide (By mouth) |
| Drug Label | PRANDIN(repaglinide) is an oral blood glucose-lowering drug of the meglitinide clab used in the management of type 2 diabetes mellitus (also known as non-insulin dependent diabetes mellitus or NIDDM). Repaglinide, S(+)2-ethoxy-4(2((3-methyl-1-(2-(1-... |
| Active Ingredient | Repaglinide |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | 0.5mg; 1mg; 2mg |
| Market Status | Prescription |
| Company | Novo Nordisk |
| 4 of 4 | |
|---|---|
| Drug Name | Repaglinide |
| PubMed Health | Repaglinide (By mouth) |
| Drug Label | PRANDIN(repaglinide) is an oral blood glucose-lowering drug of the meglitinide clab used in the management of type 2 diabetes mellitus (also known as non-insulin dependent diabetes mellitus or NIDDM). Repaglinide, S(+)2-ethoxy-4(2((3-methyl-1-(2-(1-... |
| Active Ingredient | Repaglinide |
| Dosage Form | Tablet |
| Route | oral; Oral |
| Strength | 0.5mg; 1mg; 2mg |
| Market Status | Tentative Approval; Prescription |
| Company | Mylan Pharms; Aurobindo Pharma; Sun Pharm Inds; Actavis Totowa; Sandoz; Paddock |
As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
FDA Label
Repaglinide is indicated in patients with type-2 diabetes (non-insulin-dependent diabetes mellitus (NIDDM)) whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise.
Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals.
Repaglinide is indicated in patients with type-2 diabetes (non-insulin-dependent diabetes mellitus (NIDDM)) whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise. Repaglinide is also indicated in combination with metformin in type-2 diabetes patients who are not satisfactorily controlled on metformin alone.
Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals.
Repaglinide is indicated in patients with type-2 diabetes (non-insulin-dependent diabetes mellitus (NIDDM)) whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise.
Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals.
Repaglinide is indicated in patients with type-2 diabetes (non-insulin-dependent diabetes mellitus (NIDDM)) whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise. Repaglinide is also indicated in combination with metformin in type 2 diabetes patients who are not satisfactorily controlled on metformin alone.
Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals.
Repaglinide is indicated in patients with type-2 diabetes (non-insulin-dependent diabetes mellitus (NIDDM)) whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise. Repaglinide is also indicated in combination with metformin in type-2-diabetes patients who are not satisfactorily controlled on metformin alone.
Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals.
Repaglinide is indicated in patients with type-2 diabetes (non-insulin-dependent diabetes mellitus (NIDDM)) whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise. Repaglinide is also indicated in combination with metformin in type-2 diabetes patients who are not satisfactorily controlled on metformin alone.
Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals.
Insulin secretion by pancreatic β cells is partly controlled by cellular membrane potential. Membrane potential is regulated through an inverse relationship between the activity of cell membrane ATP-sensitive potassium channels (ABCC8) and extracellular glucose concentrations. Extracellular glucose enters the cell via GLUT2 (SLC2A2) transporters. Once inside the cell, glucose is metabolized to produce ATP. High concentrations of ATP inhibit ATP-sensitive potassium channels causing membrane depolarization. When extracellular glucose concentrations are low, ATP-sensitive potassium channels open causing membrane repolarization. High glucose concentrations cause ATP-sensitive potassium channels to close resulting in membrane depolarization and opening of L-type calcium channels. The influx of calcium ions stimulates calcium-dependent exocytosis of insulin granules. Repaglinide increases insulin release by inhibiting ATP-sensitive potassium channels in a glucose-dependent manner.
Hypoglycemic Agents
Substances which lower blood glucose levels. (See all compounds classified as Hypoglycemic Agents.)
A10BX02
A10BX02
A10BX02
A10BX02
A10BX02
A10BX02
A10BX02
S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355
A - Alimentary tract and metabolism
A10 - Drugs used in diabetes
A10B - Blood glucose lowering drugs, excl. insulins
A10BX - Other blood glucose lowering drugs, excl. insulins
A10BX02 - Repaglinide
Absorption
Rapidly and completely absorbed following oral administration. Peak plasma concentrations are observed within 1 hour (range 0.5-1.4 hours). The absolute bioavailability is approximately 56%. Maximal biological effect is observed within 3-3.5 hours and plasma insulin levels remain elevated for 4-6 hours. When a single 2 mg dose of repaglinide is given to healthy subjects, the area under the curve (AUC) is 18.0 - 18.7 (ng/mL/h)^3.
Route of Elimination
90% eliminated in feces (<2% as unchanged drug), 8% in urine (0.1% as unchanged drug)
Volume of Distribution
31 L following IV administration in healthy individuals
Clearance
33-38 L/hour following IV administration
Repaglinide is rapidly metabolized via oxidation and dealkylation by cytochrome P450 3A4 and 2C9 to form the major dicarboxylic acid derivative (M2). Further oxidation produces the aromatic amine derivative (M1). Glucuronidation of the carboxylic acid group of repaglinide yields an acyl glucuronide (M7). Several other unidentified metabolites have been detected. Repaglinide metabolites to not possess appreciable hypoglycemic activity.
Repaglinide has known human metabolites that include 2-Hydroxy-4-[2-[[3-methyl-1-(2-piperidin-1-ylphenyl)butyl]amino]-2-oxoethyl]benzoic acid, 2-ethoxy-4-[2-[[1-[2-(4-hydroxybutylamino)phenyl]-3-methylbutyl]amino]-2-oxoethyl]benzoic acid, 2-ethoxy-4-[2-[[3-hydroxy-3-methyl-1-(2-piperidin-1-ylphenyl)butyl]amino]-2-oxoethyl]benzoic acid, 3'-Hydroxy Repaglinide(Mixture of Diastereomers), and Repaglinide aromatic amine.
S73 | METXBIODB | Metabolite Reaction Database from BioTransformer | DOI:10.5281/zenodo.4056560
1 hour
Repaglinide activity is dependent on the presence functioning β cells and glucose. In contrast to sulfonylurea insulin secretatogogues, repaglinide has no effect on insulin release in the absence of glucose. Rather, it potentiates the effect of extracellular glucose on ATP-sensitive potassium channel and has little effect on insulin levels between meals and overnight. As such, repaglinide is more effective at reducing postprandial blood glucose levels than fasting blood glucose levels and requires a longer duration of therapy (approximately one month) before decreases in fasting blood glucose are observed. The insulinotropic effects of repaglinide are highest at intermediate glucose levels (3 to 10 mmol/L) and it does not increase insulin release already stimulated by high glucose concentrations (greater than 15 mmol/L). Repaglinide appears to be selective for pancreatic β cells and does not appear to affect skeletal or cardiac muscle or thyroid tissue.
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DOSAGE - TABLET;ORAL - 0.5MG **Federal Regist...DOSAGE - TABLET;ORAL - 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20741
DOSAGE - TABLET;ORAL - 1MG **Federal Register...DOSAGE - TABLET;ORAL - 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20741
DOSAGE - TABLET;ORAL - 2MG **Federal Register...DOSAGE - TABLET;ORAL - 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20741
DOSAGE - TABLET;ORAL - 500MG;1MG
USFDA APPLICATION NUMBER - 22386
DOSAGE - TABLET;ORAL - 500MG;2MG
USFDA APPLICATION NUMBER - 22386
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ABOUT THIS PAGE
A Repaglinide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Repaglinide, including repackagers and relabelers. The FDA regulates Repaglinide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Repaglinide 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 Repaglinide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Repaglinide supplier is an individual or a company that provides Repaglinide active pharmaceutical ingredient (API) or Repaglinide finished formulations upon request. The Repaglinide suppliers may include Repaglinide API manufacturers, exporters, distributors and traders.
click here to find a list of Repaglinide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Repaglinide DMF (Drug Master File) is a document detailing the whole manufacturing process of Repaglinide active pharmaceutical ingredient (API) in detail. Different forms of Repaglinide DMFs exist exist since differing nations have different regulations, such as Repaglinide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Repaglinide DMF submitted to regulatory agencies in the US is known as a USDMF. Repaglinide USDMF includes data on Repaglinide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Repaglinide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Repaglinide suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Repaglinide Drug Master File in Japan (Repaglinide JDMF) empowers Repaglinide 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 Repaglinide JDMF during the approval evaluation for pharmaceutical products. At the time of Repaglinide 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 Repaglinide suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Repaglinide Drug Master File in Korea (Repaglinide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Repaglinide. The MFDS reviews the Repaglinide KDMF as part of the drug registration process and uses the information provided in the Repaglinide KDMF to evaluate the safety and efficacy of the drug.
After submitting a Repaglinide 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 Repaglinide API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Repaglinide suppliers with KDMF on PharmaCompass.
A Repaglinide CEP of the European Pharmacopoeia monograph is often referred to as a Repaglinide Certificate of Suitability (COS). The purpose of a Repaglinide CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Repaglinide EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Repaglinide to their clients by showing that a Repaglinide CEP has been issued for it. The manufacturer submits a Repaglinide CEP (COS) as part of the market authorization procedure, and it takes on the role of a Repaglinide CEP holder for the record. Additionally, the data presented in the Repaglinide CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Repaglinide DMF.
A Repaglinide CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Repaglinide 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 Repaglinide suppliers with CEP (COS) on PharmaCompass.
A Repaglinide written confirmation (Repaglinide WC) is an official document issued by a regulatory agency to a Repaglinide manufacturer, verifying that the manufacturing facility of a Repaglinide active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Repaglinide APIs or Repaglinide finished pharmaceutical products to another nation, regulatory agencies frequently require a Repaglinide WC (written confirmation) as part of the regulatory process.
click here to find a list of Repaglinide 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 Repaglinide as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Repaglinide 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 Repaglinide 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 Repaglinide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Repaglinide NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Repaglinide suppliers with NDC on PharmaCompass.
Repaglinide 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 Repaglinide 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 Repaglinide GMP manufacturer or Repaglinide GMP API supplier for your needs.
A Repaglinide CoA (Certificate of Analysis) is a formal document that attests to Repaglinide's compliance with Repaglinide specifications and serves as a tool for batch-level quality control.
Repaglinide CoA mostly includes findings from lab analyses of a specific batch. For each Repaglinide 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.
Repaglinide may be tested according to a variety of international standards, such as European Pharmacopoeia (Repaglinide EP), Repaglinide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Repaglinide USP).
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