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Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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Synopsis

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Chemistry

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Also known as: 26807-65-8, Noranat, Veroxil, Tertensif, Lozol, Indaflex

Molecular Formula

C₁₆H₁₆ClN₃O₃S

Molecular Weight

365.8 g/mol

InChI Key

NDDAHWYSQHTHNT-UHFFFAOYSA-N

FDA UNII

F089I0511L

A benzamide-sulfonamide-indole derived DIURETIC that functions by inhibiting SODIUM CHLORIDE SYMPORTERS.

Indapamide is a Thiazide-like Diuretic. The physiologic effect of indapamide is by means of Increased Diuresis.

1 2D Structure

Indapamide

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

4-chloro-N-(2-methyl-2,3-dihydroindol-1-yl)-3-sulfamoylbenzamide

2.1.2 InChI

InChI=1S/C16H16ClN3O3S/c1-10-8-11-4-2-3-5-14(11)20(10)19-16(21)12-6-7-13(17)15(9-12)24(18,22)23/h2-7,9-10H,8H2,1H3,(H,19,21)(H2,18,22,23)

2.1.3 InChI Key

NDDAHWYSQHTHNT-UHFFFAOYSA-N

2.1.4 Canonical SMILES

CC1CC2=CC=CC=C2N1NC(=O)C3=CC(=C(C=C3)Cl)S(=O)(=O)N

2.2 Other Identifiers

2.2.1 UNII

F089I0511L

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Metindamide

2. S 1520

3. S-1520

4. S1520

5. Se 1520

6. Se-1520

7. Se1520

2.3.2 Depositor-Supplied Synonyms

1. 26807-65-8

2. Noranat

3. Veroxil

4. Tertensif

5. Lozol

6. Indaflex

7. Arifon

8. Fludex

9. Indamol

10. Bajaten

11. Ipamix

12. Tandix

13. Natrilix

14. Damide

15. Pressurai

16. Indapamida

17. Indapamidum

18. Natrix

19. Indapamidum [inn-latin]

20. Indapamida [inn-spanish]

21. Se-1520

22. Flupamid

23. Indamide

24. 1-(4-chloro-3-sulfamoylbenzamido)-2-methylindoline

25. Fludin

26. Lorvas

27. 4-chloro-n-(2-methyl-2,3-dihydroindol-1-yl)-3-sulfamoylbenzamide

28. S-1520

29. Benzamide, 3-(aminosulfonyl)-4-chloro-n-(2,3-dihydro-2-methyl-1h-indol-1-yl)-

30. 4-chloro-n-(2-methyl-1-indolinyl)-3-sulfamoylbenzamide

31. Indapamide (lozol)

32. Flubest

33. 4-chloro-n-(2-methyl-2,3-dihydro-1h-indol-1-yl)-3-sulfamoylbenzamide

34. Metindamide

35. Cormil

36. Nsc-757075

37. N-(4-chloro-3-sulfamoylbenzamido)-2-methylindoline

38. Mls000028554

39. Chebi:5893

40. 26807-65-8(free Base)

41. Kyd-041

42. Benzamide, 4-chloro-n-(2-methyl-1-indolinyl)-3-sulfamoyl-

43. F089i0511l

44. Ncgc00018172-03

45. Smr000058829

46. 4-chloro-n-(2-methylindolin-1-yl)-3-sulfamoylbenzamide

47. Dsstox_cid_24633

48. Dsstox_rid_80366

49. Dsstox_gsid_44633

50. Se 1520

51. Rhc 2555

52. Usv 2555

53. Natrix (tn)

54. Lozol (tn)

55. Sr-01000003079

56. Einecs 248-012-7

57. Mfcd00079375

58. Brn 1604026

59. Unii-f089i0511l

60. Hypen Sr

61. 3-(aminosulfonyl)-4-chloro-n-(2,3-dihydro-2-methyl-1h-indol-1-yl)benzamide

62. Indapamide [usan:usp:inn:ban:jan]

63. Spectrum_000917

64. Indapamide [mi]

65. Opera_id_110

66. Indapamide [inn]

67. Indapamide [jan]

68. Prestwick3_000220

69. Spectrum2_000980

70. Spectrum3_000467

71. Spectrum4_000017

72. Spectrum5_000866

73. Indapamide [usan]

74. S1520

75. Indapamide [vandf]

76. Chembl406

77. Indapamide (jp17/usp)

78. Indapamide [mart.]

79. Indapamide [usp-rs]

80. Indapamide [who-dd]

81. Schembl41303

82. Bspbio_000239

83. Bspbio_002174

84. Kbiogr_000393

85. Kbioss_001397

86. 5-20-06-00348 (beilstein Handbook Reference)

87. Mls001148152

88. Mls002222229

89. Mls006011900

90. Divk1c_000508

91. Spectrum1500349

92. Spbio_001019

93. Bpbio1_000263

94. Gtpl7203

95. Dtxsid7044633

96. Indapamide [ep Impurity]

97. Indapamide [orange Book]

98. Bdbm25901

99. Hms501j10

100. Kbio1_000508

101. Kbio2_001397

102. Kbio2_003965

103. Kbio2_006533

104. Kbio3_001394

105. Indapamide [ep Monograph]

106. Ninds_000508

107. Hms1920f19

108. Hms2090m16

109. Hms2091n07

110. Hms2095l21

111. Hms2231g13

112. Hms3259c14

113. Hms3369j20

114. Hms3655e06

115. Hms3712l21

116. Hms3748k05

117. Indapamide [usp Monograph]

118. Pharmakon1600-01500349

119. Indapamide 1.0 Mg/ml In Methanol

120. Amy31945

121. Bcp04140

122. Hy-b0259

123. Tox21_110775

124. Tox21_113182

125. Tox21_302687

126. Ccg-40198

127. Nsc757075

128. S1730

129. Stl257105

130. Stl455045

131. 3-(aminosulfonyl)-4-chloro-n-(2-methyl-2,3-dihydro-1h-indol-1-yl)benzamide

132. Akos015888148

133. Tox21_110775_1

134. Ab03037

135. Ac-2073

136. Db00808

137. Ks-5219

138. Nc00568

139. Nsc 757075

140. Benzamide, 3-(aminosulfonyl)-4-chloro-n-(2,3-dihydro-2-methyl-1h-indol-l-yl)-

141. Idi1_000508

142. Ncgc00018172-02

143. Ncgc00018172-04

144. Ncgc00018172-06

145. Ncgc00018172-08

146. Ncgc00018172-09

147. Ncgc00089727-02

148. Ncgc00089727-03

149. Ncgc00256884-01

150. Sbi-0051415.p003

151. Db-047020

152. Ab00052021

153. I0730

154. Sw198686-2

155. A23574

156. D00345

157. Ab00052021-14

158. Ab00052021-15

159. Ab00052021_16

160. Ab00052021_17

161. 807i658

162. Indapamide, Analytical Standard, For Drug Analysis

163. J-016554

164. Q1078392

165. Sr-01000003079-2

166. Sr-01000003079-3

167. Brd-a95869247-001-04-6

168. Brd-a95869247-001-14-5

169. Z2786158257

170. Indapamide, British Pharmacopoeia (bp) Reference Standard

171. Indapamide, European Pharmacopoeia (ep) Reference Standard

172. Indapamide, United States Pharmacopeia (usp) Reference Standard

173. 3-aminosulfonyl-4-chloro-n-(2,3-dihydro-2-methyl-1h-indol-1-yl)benzamide

174. 4-chloro-3-aminosulphonyl-n-(2,3-dihydro2-methyl-1h-indol-1-yl)benzamide

175. Indapamide, Pharmaceutical Secondary Standard; Certified Reference Material

176. 3-(aminosulphonyl)-4-chloro-n-(2-methyl-2,3-dihydro-1h-indol-1--yl)benzamide

177. 3-(aminosulphonyl)-4-chloro-n-(2-methyl-2,3-dihydro-1h-indol-1-yl)benzamide

178. 4-chloro-n-(2-methyl-2,3-dihydro-1h-indol-1-yl)-3-sulfamoylbenzenecarboximidic Acid

2.4 Create Date

2005-03-25

3 Chemical and Physical Properties

Molecular Formula	C₁₆H₁₆ClN₃O₃S
Molecular Weight	365.8 g/mol
XLogP3	2.9
Hydrogen Bond Donor Count	2
Hydrogen Bond Acceptor Count	5
Rotatable Bond Count	3
Exact Mass	365.0600902 g/mol
Monoisotopic Mass	365.0600902 g/mol
Topological Polar Surface Area	101 Å²
Heavy Atom Count	24
Formal Charge	0
Complexity	580
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	1
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	1

4 Drug and Medication Information

4.1 Drug Information

1 of 2
Drug Name	Indapamide
PubMed Health	Indapamide (By mouth)
Drug Classes	Cardiovascular Agent
Drug Label	Indapamide is an oral antihypertensive/diuretic. Its molecule contains both a polar sulfamoyl chlorobenzamide moiety and a lipid-soluble methylindoline moiety. It differs chemically from the thiazides in that it does not possess the thiazide ring sys...
Active Ingredient	Indapamide
Dosage Form	Tablet
Route	Oral
Strength	2.5mg; 1.25mg
Market Status	Prescription
Company	Mylan Pharms; Ivax Sub Teva Pharms; Actavis Elizabeth; Mylan

2 of 2
Drug Name	Indapamide
PubMed Health	Indapamide (By mouth)
Drug Classes	Cardiovascular Agent
Drug Label	Indapamide is an oral antihypertensive/diuretic. Its molecule contains both a polar sulfamoyl chlorobenzamide moiety and a lipid-soluble methylindoline moiety. It differs chemically from the thiazides in that it does not possess the thiazide ring sys...
Active Ingredient	Indapamide
Dosage Form	Tablet
Route	Oral
Strength	2.5mg; 1.25mg
Market Status	Prescription
Company	Mylan Pharms; Ivax Sub Teva Pharms; Actavis Elizabeth; Mylan

4.2 Drug Indication

Indapamide is a diuretic indicated for use as monotherapy or in combination with other blood pressure-lowering agents to treat hypertension. It may also be used to treat fluid and salt retention associated with congestive heart failure.

FDA Label

5 Pharmacology and Biochemistry

5.1 Pharmacology

Classified as a sulfonamide diuretic, indapamide is an effective antihypertensive agent and by extension, has shown efficacy in the prevention of target organ damage. Administration of indapamide produces water and electrolyte loss, with higher doses associated with increased diuresis. Severe and clinically significant electrolyte disturbances may occur with indapamide use - for example, hypokalemia resulting from renal potassium loss may lead to QTc prolongation. Further electrolyte imbalances may occur due to renal excretion of sodium, chloride, and magnesium. Other indapamide induced changes include increases in plasma renin and aldosterone, and reduced calcium excretion in the urine. In many studies investigating the effects of indapamide in both non-diabetic and diabetic hypertensive patients, glucose tolerance was not significantly altered. However, additional studies are necessary to assess the long term metabolic impacts of indapamide, since thiazide related impaired glucose tolerance can take several years to develop in non-diabetic patients.

5.2 MeSH Pharmacological Classification

Diuretics

Agents that promote the excretion of urine through their effects on kidney function. (See all compounds classified as Diuretics.)

Antihypertensive Agents

Drugs used in the treatment of acute or chronic vascular HYPERTENSION regardless of pharmacological mechanism. Among the antihypertensive agents are DIURETICS; (especially DIURETICS, THIAZIDE); ADRENERGIC BETA-ANTAGONISTS; ADRENERGIC ALPHA-ANTAGONISTS; ANGIOTENSIN-CONVERTING ENZYME INHIBITORS; CALCIUM CHANNEL BLOCKERS; GANGLIONIC BLOCKERS; and VASODILATOR AGENTS. (See all compounds classified as Antihypertensive Agents.)

Sodium Chloride Symporter Inhibitors

Agents that inhibit SODIUM CHLORIDE SYMPORTERS. They act as DIURETICS. Excess use is associated with HYPOKALEMIA. (See all compounds classified as Sodium Chloride Symporter Inhibitors.)

5.3 FDA Pharmacological Classification

5.3.1 Active Moiety

INDAPAMIDE

5.3.2 FDA UNII

F089I0511L

5.3.3 Pharmacological Classes

Thiazide-like Diuretic [EPC]; Increased Diuresis [PE]

5.4 ATC Code

C03BA11

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

C - Cardiovascular system

C03 - Diuretics

C03B - Low-ceiling diuretics, excl. thiazides

C03BA - Sulfonamides, plain

C03BA11 - Indapamide

5.5 Absorption, Distribution and Excretion

Absorption

The bioavailability of indapamide is virtually complete after an oral dose and is unaffected by food or antacids. Indapamide is highly lipid-soluble due to its indoline moiety - a characteristic that likely explains why indapamides renal clearance makes up less than 10% of its total systemic clearance. The Tmax occurs approximately 2.3 hours after oral administration. The Cmax and AUC_0-24 values are 263 ng/mL and 2.95 ug/hr/mL, respectively.

Route of Elimination

An estimated 60-70% of indapamide is eliminated in the urine, while 16-23% is eliminated in the feces.

Volume of Distribution

Some sources report an apparent volume of distribution of 25 L for indapamide, while others report a value of approximately 60 L.

Clearance

Indapamide's renal and hepatic clearance values are reported to be 1.71 mL/min and 20-23.4 mL/min, respectively.

5.6 Metabolism/Metabolites

As a result of extensive metabolism in the liver, the majority of indapamide excreted is metabolized, with only 7% remaining unchanged. In humans, as many as 19 distinct indapamide metabolites may be produced, although not all have been identified. There are several metabolic routes through which indapamide may be metabolized, and CYP3A4 is the main enzyme involved in the corresponding hydroxylation, carboxylation, and dehydrogenation reactions. Indapamide can undergo dehydrogenation to form M5, then oxidation to form M4, then further hydroxylation at the indole moiety to form M2. These reactions are facilitated by CYP3A4. Another route of metabolism occurs when indapamide is first hydroxylated to M1 by CYP3A4. M1 then undergoes dehydrogenation to form M3 and is further oxidized to form M2. Hydroxylation of indapamides indole moiety is thought to form the major metabolite (M1), which is less pharmacologically active compared to its parent compound according to animal studies. Indapamide may also undergo epoxidation via CYP3A4 to form a reactive epoxide intermediate. The unstable epoxide intermediate may then undergo dihydroxylation via microsomal epoxide hydrolase to form M6, or glutathione conjugation to form M7.

5.7 Biological Half-Life

Indapamide is characterized by biphasic elimination. In healthy subjects, indapamide's elimination half-life can range from 13.9 to 18 hours. The long half-life is conducive to once-daily dosing.

5.8 Mechanism of Action

Indapamide acts on the nephron, specifically at the proximal segment of the distal convoluted tubule where it inhibits the Na+/Cl- cotransporter, leading to reduced sodium reabsorption. As a result, sodium and water are retained in the lumen of the nephron for urinary excretion. The effects that follow include reduced plasma volume, reduced venous return, lower cardiac output, and ultimately decreased blood pressure. Interestingly, it is likely that thiazide-like diuretics such as indapamide have additional blood pressure lowering mechanisms that are unrelated to diuresis. This is exemplified by the observation that the antihypertensive effects of thiazides are sustained 4-6 weeks after initiation of therapy, despite recovering plasma and extracellular fluid volumes. Some studies have suggested that indapamide may decrease responsiveness to pressor agents while others have suggested it can decrease peripheral resistance. Although it is clear that diuresis contributes to the antihypertensive effects of indapamide, further studies are needed to investigate the medications ability to decrease peripheral vascular resistance and relax vascular smooth muscle.

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SPA","supplierCountry":"ITALY","foreign_port":"MILAN","customer":"ZYDUS LIFESCIENCES","customerCountry":"INDIA","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"1100","totalValueFC":"12120.1","currency":"EUR","unitRateINR":"100925","date":"23-Nov-2023","totalValueINR":"1009250","totalValueInUsd":"12120.1","indian_port":"Bombay Air","hs_no":"29359090","bill_no":"8901296","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN","supplierAddress":"15067 NOVI LIGURE VIA DE AMBROSIIS2 AMBROSIIS, ItalySDNF Italy","customerAddress":"\\\"A\\\"BLOCK,SHIV SAGAR ESTATE,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1700677800,"product":"INDAPAMIDE (FOR PHARMACEUTICALS USE ONLY)","address":"TORRENT HOUSE,","city":"AHMEDABAD. GUJARAT","supplier":"BIOINDUSTRIA L.I.M. SPA","supplierCountry":"ITALY","foreign_port":"MILAN","customer":"TORRENT PHARMACEUTICALS LIMITED","customerCountry":"INDIA","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"1030","totalValueFC":"113488.1","currency":"EUR","unitRateINR":"94502.5","date":"23-Nov-2023","totalValueINR":"9450250","totalValueInUsd":"113488.1","indian_port":"Bombay Air","hs_no":"29359090","bill_no":"8894451","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN","supplierAddress":"15067, NOVI LIGURE AL VIA DE AMBROSIIS 2-4-6 ITALY-15067SDNF ITALY","customerAddress":"TORRENT HOUSE,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1706466600,"product":"INDAPAMIDE","address":"564\/A\/22, ROAD NO.92","city":"HYDERABAD,ANDHRA PRADESH","supplier":"RECIPHARM AB","supplierCountry":"ITALY","foreign_port":"MILAN","customer":"VIATRIS","customerCountry":"INDIA","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"1850","totalValueFC":"20545.2","currency":"EUR","unitRateINR":"170755","date":"29-Jan-2024","totalValueINR":"1707550","totalValueInUsd":"20545.2","indian_port":"Hyderabad Air","hs_no":"29359090","bill_no":"9876848","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN","supplierAddress":"STRADA STATALE DEI GIOVI 131 20037PADERNO DUGNANO MILANOSDNF Italy","customerAddress":"564\/A\/22, ROAD NO.92"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1707417000,"product":"INDAPAMIDE (FOR PHARMACEUTICALS USE ONLY)","address":"TORRENT HOUSE,","city":"AHMEDABAD. GUJARAT","supplier":"BIOINDUSTRIA L.I.M. SPA","supplierCountry":"ITALY","foreign_port":"MILAN","customer":"TORRENT PHARMACEUTICALS LIMITED","customerCountry":"INDIA","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"1030","totalValueFC":"113522","currency":"EUR","unitRateINR":"94193.5","date":"09-Feb-2024","totalValueINR":"9419350","totalValueInUsd":"113522","indian_port":"Bombay Air","hs_no":"29359090","bill_no":"2062699","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN","supplierAddress":"15067, NOVI LIGURE AL VIA DE AMBROSIIS 2-4-6 ITALY-15067SDNF ITALY","customerAddress":"TORRENT HOUSE,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1710181800,"product":"INDAPAMIDE EP\/CEP (BATCH 2C04-20231203)","address":"206, DEVAVRATA,","city":"NAVI MUMBAI, MAHARASHTRA.","supplier":"SUPERHEALTH PHARMACEUTICAL CO.,LIMITED","supplierCountry":"CHINA","foreign_port":"HONG KONG","customer":"STRIDES PHARMA SCIENCE","customerCountry":"INDIA","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"610","totalValueFC":"15381.2","currency":"USD","unitRateINR":"51087.5","date":"12-Mar-2024","totalValueINR":"1277187.5","totalValueInUsd":"15381.2","indian_port":"Bangalore Air","hs_no":"29359090","bill_no":"2542120","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"HONG KONG","supplierAddress":"ROOM 1116,NO.111,CHANGJIANG ROAD XUANWU DISTRICT210018 NANJING CITY CHINA","customerAddress":"206, DEVAVRATA,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1712860200,"product":"CHEMICAL : INDAPAMIDE (FOR PHARMACEUTICALS USE ONLY)","address":"TORRENT HOUSE,","city":"AHMEDABAD. GUJARAT","supplier":"BIOINDUSTRIA L.I.M. SPA","supplierCountry":"ITALY","foreign_port":"MILAN","customer":"TORRENT PHARMACEUTICALS LIMITED","customerCountry":"INDIA","quantity":"1.70","actualQuantity":"1.7","unit":"KGS","unitRateFc":"1030","totalValueFC":"1930.1","currency":"EUR","unitRateINR":"94811.5","date":"12-Apr-2024","totalValueINR":"161179.55","totalValueInUsd":"1930.1","indian_port":"Ahmedabad Air","hs_no":"29359090","bill_no":"2984337","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN","supplierAddress":"15067 NOVI LIGURE (AL) VIA DE AMBROSIIS 2 ITALYSDNF ITALY","customerAddress":"TORRENT HOUSE,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1713292200,"product":"INDAPAMIDE BATCH NO-IN 2024\/00999","address":"UNICHEM BHAVAN, S. V. ROAD","city":"MUMBAI,MAHARASHTRA.","supplier":"BIOINDUSTRIA L.I.M. SPA","supplierCountry":"ITALY","foreign_port":"MILAN","customer":"UNICHEM LABORATORIES LIMITED","customerCountry":"INDIA","quantity":"75.00","actualQuantity":"75","unit":"KGS","unitRateFc":"1030","totalValueFC":"85152.6","currency":"EUR","unitRateINR":"94811.5","date":"17-Apr-2024","totalValueINR":"7110862.5","totalValueInUsd":"85152.6","indian_port":"Delhi Air","hs_no":"29359090","bill_no":"3065124","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN","supplierAddress":"MEDICINALI S.P.A.VIA DE AMBROSIS 2 15067 NOVI LIGUREITALY, ITALY","customerAddress":"UNICHEM BHAVAN, S. V. ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1715452200,"product":"INDAPAMIDE MICRONIZED BP\/EP","address":"PLOT NOI.1 FOURTS AVENUE","city":"CHENNAI","supplier":"BIOINDUSTRIA L.I.M. SPA","supplierCountry":"ITALY","foreign_port":"MILAN - LINATE","customer":"FOURRTS INDIA LABORATORIES PVT LTD","customerCountry":"INDIA","quantity":"9.00","actualQuantity":"9","unit":"KGS","unitRateFc":"1300","totalValueFC":"12773.2","currency":"EUR","unitRateINR":"118300","date":"12-May-2024","totalValueINR":"1064700","totalValueInUsd":"12773.2","indian_port":"Madras Air","hs_no":"29359090","bill_no":"3449925","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Micronized","supplierPort":"MILAN - LINATE","supplierAddress":"VIA DE AMBROSIS 215067 NOVI LIGURE ITSDNF IT","customerAddress":"PLOT NOI.1 FOURTS AVENUE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1715452200,"product":"INDAPAMIDE MICRONIZED BP\/EP","address":"PLOT NOI.1 FOURTS AVENUE","city":"CHENNAI","supplier":"BIOINDUSTRIA L.I.M. SPA","supplierCountry":"ITALY","foreign_port":"MILAN - LINATE","customer":"FOURRTS INDIA LABORATORIES PVT LTD","customerCountry":"INDIA","quantity":"28.00","actualQuantity":"28","unit":"KGS","unitRateFc":"1300","totalValueFC":"39738.9","currency":"EUR","unitRateINR":"118300","date":"12-May-2024","totalValueINR":"3312400","totalValueInUsd":"39738.9","indian_port":"Madras Air","hs_no":"29359090","bill_no":"3449925","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Micronized","supplierPort":"MILAN - LINATE","supplierAddress":"VIA DE AMBROSIS 215067 NOVI LIGURE ITSDNF IT","customerAddress":"PLOT NOI.1 FOURTS AVENUE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1717525800,"product":"INDAPAMIDE IP (BULK DRUG)","address":"SERDIA HOUSE ,OFF.DR.S.S.RAO ROAD,","city":"MUMBAI ,MAHARASHTRA","supplier":"SERVIER","supplierCountry":"FRANCE","foreign_port":"PARIS - CHARLES DE G","customer":"SERVIER","customerCountry":"INDIA","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"3187","totalValueFC":"35313.8","currency":"EUR","unitRateINR":"294797.5","date":"05-Jun-2024","totalValueINR":"2947975","totalValueInUsd":"35313.8","indian_port":"Bombay Air","hs_no":"29359090","bill_no":"3841656","productDescription":"API","marketType":"REGULATED MARKET","country":"FRANCE","selfForZScoreResived":"Pharma Grade","supplierPort":"PARIS - CHARLES DE G","supplierAddress":"50 RUE CARNOTSURESNESCEDEX FR","customerAddress":"SERDIA HOUSE ,OFF.DR.S.S.RAO ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1720204200,"product":"INDAPAMIDE IP (BULK DRUG)","address":"SERDIA HOUSE ,OFF.DR.S.S.RAO ROAD,","city":"MUMBAI ,MAHARASHTRA","supplier":"SERVIER","supplierCountry":"FRANCE","foreign_port":"PARIS - CHARLES DE G","customer":"SERVIER","customerCountry":"INDIA","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"3187","totalValueFC":"34980.7","currency":"EUR","unitRateINR":"292407.3","date":"06-Jul-2024","totalValueINR":"2924072.5","totalValueInUsd":"34980.7","indian_port":"Bombay Air","hs_no":"29359090","bill_no":"4367227","productDescription":"API","marketType":"REGULATED MARKET","country":"FRANCE","selfForZScoreResived":"Pharma Grade","supplierPort":"PARIS - CHARLES DE G","supplierAddress":"50 RUE CARNOTSURESNESCEDEX FR","customerAddress":"SERDIA HOUSE ,OFF.DR.S.S.RAO ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725301800,"product":"INDAPAMIDE EP(4 CHLORO-N-(2-METHYL-2.3-DIHYDROINDOL-1-YL)-3-SULFAMOYLBENZAMIDE","address":"UNICHEM BHAVAN, S. V. ROAD","city":"MUMBAI,MAHARASHTRA.","supplier":"BIOINDUSTRIA L.I.M. SPA","supplierCountry":"ITALY","foreign_port":"MILAN","customer":"UNICHEM LABORATORIES LIMITED","customerCountry":"INDIA","quantity":"75.00","actualQuantity":"75","unit":"KGS","unitRateFc":"1030","totalValueFC":"86513.2","currency":"EUR","unitRateINR":"96665.5","date":"03-Sep-2024","totalValueINR":"7249912.5","totalValueInUsd":"86513.2","indian_port":"Delhi Air","hs_no":"29359090","bill_no":"5406021","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN","supplierAddress":"MEDICINALI S.P.A. VIA DE AMBROSIS 2 15067 NOVI LIGURE ITALY, ITALY ITALY","customerAddress":"UNICHEM BHAVAN, S. V. ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1726165800,"product":"INDAPAMIDE MICRONIZED USP\/EP\/BP\/EUR.PH 7.0","address":"NO.49D, BOMMASANDRA INDUSTRIAL","city":"BANGALORE","supplier":"REFARMED CHEMICALS SA","supplierCountry":"SWITZERLAND","foreign_port":"ZURICH","customer":"ADCOCK INGRAM","customerCountry":"INDIA","quantity":"15.00","actualQuantity":"15","unit":"KGS","unitRateFc":"1030","totalValueFC":"17468.6","currency":"EUR","unitRateINR":"97592.5","date":"13-Sep-2024","totalValueINR":"1463887.5","totalValueInUsd":"17468.6","indian_port":"Bangalore Air","hs_no":"29420090","bill_no":"5577379","productDescription":"API","marketType":"REGULATED MARKET","country":"SWITZERLAND","selfForZScoreResived":"Micronized","supplierPort":"ZURICH","supplierAddress":"VIA GIOVANNI FERRI 15 6900 LUGANO SDNF SWITZERLAND","customerAddress":"NO.49D, BOMMASANDRA INDUSTRIAL"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1728066600,"product":"INDAPAMIDE IP (BULK DRUG)","address":"SERDIA HOUSE ,OFF.DR.S.S.RAO ROAD,","city":"MUMBAI ,MAHARASHTRA","supplier":"SERVIER","supplierCountry":"FRANCE","foreign_port":"PARIS - CHARLES DE G","customer":"SERVIER","customerCountry":"INDIA","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"3187","totalValueFC":"35747.6","currency":"EUR","unitRateINR":"300374.8","date":"05-Oct-2024","totalValueINR":"3003747.5","totalValueInUsd":"35747.6","indian_port":"Bombay Air","hs_no":"29359090","bill_no":"5980914","productDescription":"API","marketType":"REGULATED MARKET","country":"FRANCE","selfForZScoreResived":"Pharma Grade","supplierPort":"PARIS - CHARLES DE G","supplierAddress":"50 RUE CARNOT SURESNES CEDEX FR","customerAddress":"SERDIA HOUSE ,OFF.DR.S.S.RAO ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729621800,"product":"INDAPAMIDE MICRONIZED","address":"PIRAMAL ANANTA, PIRAMAL AGASTYA PARK","city":"KURLA, MUMBAI","supplier":"CHEMO","supplierCountry":"SPAIN","foreign_port":"MADRID","customer":"PIRAMAL PHARMA SOLUTIONS","customerCountry":"INDIA","quantity":"5.96","actualQuantity":"5.96","unit":"KGS","unitRateFc":"2600","totalValueFC":"15666.3","currency":"USD","unitRateINR":"220870","date":"23-Oct-2024","totalValueINR":"1316385.2","totalValueInUsd":"15666.3","indian_port":"Bombay Air","hs_no":"29359090","bill_no":"6291611","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Micronized","supplierPort":"MADRID","supplierAddress":"LUGANO BRANCH VIA.F.PELLI 17 , P.O. BOX 6901 LUGANO SWITZERLAND , , Swi tzerland Switzerland","customerAddress":"PIRAMAL ANANTA, PIRAMAL AGASTYA PARK"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729621800,"product":"INDAPAMIDE MICRONIZED","address":"PIRAMAL ANANTA, PIRAMAL AGASTYA PARK","city":"KURLA, MUMBAI","supplier":"CHEMO","supplierCountry":"SPAIN","foreign_port":"MADRID","customer":"PIRAMAL PHARMA SOLUTIONS","customerCountry":"INDIA","quantity":"7.57","actualQuantity":"7.57","unit":"KGS","unitRateFc":"2600","totalValueFC":"19898.3","currency":"USD","unitRateINR":"220870","date":"23-Oct-2024","totalValueINR":"1671985.9","totalValueInUsd":"19898.3","indian_port":"Bombay Air","hs_no":"29359090","bill_no":"6291611","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Micronized","supplierPort":"MADRID","supplierAddress":"LUGANO BRANCH VIA.F.PELLI 17 , P.O. BOX 6901 LUGANO SWITZERLAND , , Swi tzerland Switzerland","customerAddress":"PIRAMAL ANANTA, PIRAMAL AGASTYA PARK"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731349800,"product":"1000064,INDAPAMIDE LOT NO:INMR 2024\/10121 (PHARMACEUTICAL PRODUCTS)","address":"SITE NO.1,BOMMASANDRA INDL.AREA,IV","city":"ANEKAL TALUK,BANGALORE","supplier":"ACIC FINE CHEMICALS","supplierCountry":"CANADA","foreign_port":"TORONTO","customer":"APOTEX INC","customerCountry":"INDIA","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"1645","totalValueFC":"41520.6","currency":"USD","unitRateINR":"140154","date":"12-Nov-2024","totalValueINR":"3503850","totalValueInUsd":"41520.6","indian_port":"Bangalore Air","hs_no":"29339990","bill_no":"6631667","productDescription":"API","marketType":"REGULATED MARKET","country":"CANADA","selfForZScoreResived":"Pharma Grade","supplierPort":"TORONTO","supplierAddress":"D-17 CORPORATE PLACE BRANTFORD ONTARIO N3R 8A6 SDNF CA","customerAddress":"SITE NO.1,BOMMASANDRA INDL.AREA,IV"}]

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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Drugs in Development

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

INTERMEDIATES SUPPLIERS

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

FDF Dossiers

01

Sanofi

France

Biotech Showcase

Not Confirmed

Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Contact Supplier

France

Virtual Booth

Digital Content

Regulatory Info : DISCN

Registration Country : USA

INDAPAMIDE

Brand Name : LOZOL

Dosage Form : TABLET;ORAL

Dosage Strength : 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 1983-07-06

Application Number : 18538

Regulatory Info : DISCN

Registration Country : USA

Portfolio PDF

Product Web Link

02

Sanofi

France

Biotech Showcase

Not Confirmed

Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Contact Supplier

France

Virtual Booth

Digital Content

Regulatory Info : DISCN

Registration Country : USA

INDAPAMIDE

Brand Name : LOZOL

Dosage Form : TABLET;ORAL

Dosage Strength : 1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 1993-04-29

Application Number : 18538

Regulatory Info : DISCN

Registration Country : USA

Portfolio PDF

Product Web Link

03

Sanofi

France

Biotech Showcase

Not Confirmed

Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Contact Supplier

France

Virtual Booth

Digital Content

Regulatory Info :

Registration Country : Switzerland

Perindoprilum-tert-butylamine; Amlodipine; Indapamidum

Brand Name : Perindopril Amlodipin Indapamid Zentiva

Dosage Form : Tabl

Dosage Strength : 4/10/1.25mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Portfolio PDF

Product Web Link

04

Sanofi

France

Biotech Showcase

Not Confirmed

Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Contact Supplier

France

Virtual Booth

Digital Content

Regulatory Info :

Registration Country : Switzerland

Perindoprilum-tert-butylamine; Amlodipine; Indapamidum

Brand Name : Perindopril Amlodipin Indapamid Zentiva

Dosage Form : Tabl

Dosage Strength : 4/10/1.25mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Portfolio PDF

Product Web Link

05

Sanofi

France

Biotech Showcase

Not Confirmed

Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Contact Supplier

France

Virtual Booth

Digital Content

Regulatory Info :

Registration Country : Switzerland

Perindoprilum-tert-butylamine; Amlodipine; Indapamidum

Brand Name : Perindopril Amlodipin Indapamid Zentiva

Dosage Form : Tabl

Dosage Strength : 4/5/1.25mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Portfolio PDF

Product Web Link

06

Sanofi

France

Biotech Showcase

Not Confirmed

Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Contact Supplier

France

Virtual Booth

Digital Content

Regulatory Info :

Registration Country : Switzerland

Perindoprilum-tert-butylamine; Amlodipine; Indapamidum

Brand Name : Perindopril Amlodipin Indapamid Zentiva

Dosage Form : Tabl

Dosage Strength : 8/10/2.5mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Portfolio PDF

Product Web Link

07

Sanofi

France

Biotech Showcase

Not Confirmed

Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Contact Supplier

France

Virtual Booth

Digital Content

Regulatory Info :

Registration Country : Switzerland

Perindoprilum-tert-butylamine; Amlodipine; Indapamidum

Brand Name : Perindopril Amlodipin Indapamid Zentiva

Dosage Form : Tabl

Dosage Strength : 8/10/2.5mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Portfolio PDF

Product Web Link

08

Sanofi

France

Biotech Showcase

Not Confirmed

Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Contact Supplier

France

Virtual Booth

Digital Content

Regulatory Info :

Registration Country : Switzerland

Perindoprilum-tert-butylamine; Amlodipine; Indapamidum

Brand Name : Perindopril Amlodipin Indapamid Zentiva

Dosage Form : Tabl

Dosage Strength : 8/5/2.5mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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09

Sanofi

France

Biotech Showcase

Not Confirmed

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Regulatory Info :

Registration Country : Switzerland

Perindoprilum-tert-butylamine; Amlodipine; Indapamidum

Brand Name : Perindopril Amlodipin Indapamid Zentiva

Dosage Form : Tabl

Dosage Strength : 8/5/2.5mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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10

Sanofi

France

Biotech Showcase

Not Confirmed

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France

Virtual Booth

Digital Content

Regulatory Info :

Registration Country : Switzerland

Perindoprilum-tert-butylamine; Amlodipine; Indapamidum

Brand Name : Perindopril Amlodipine Indapamide Zentiva

Dosage Form : Tabl

Dosage Strength : 4/5/1.25mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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FDA Orange Book

01

SANOFI AVENTIS US

France

BIO Partnering at JPM

Not Confirmed

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France

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RLD : Yes

TE Code :

INDAPAMIDE

Brand Name : LOZOL

Dosage Form : TABLET;ORAL

Dosage Strength : 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1983-07-06

Application Number : 18538

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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02

SANOFI AVENTIS US

France

BIO Partnering at JPM

Not Confirmed

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France

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RLD : Yes

TE Code :

INDAPAMIDE

Brand Name : LOZOL

Dosage Form : TABLET;ORAL

Dosage Strength : 1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1993-04-29

Application Number : 18538

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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Product Web Link

03

WATSON LABS

Ireland

BIO Partnering at JPM

Not Confirmed

04

WATSON LABS

Ireland

BIO Partnering at JPM

Not Confirmed

05

ACTAVIS ELIZABETH

Ireland

BIO Partnering at JPM

Not Confirmed

06

ANI PHARMS

U.S.A

BIO Partnering at JPM

Not Confirmed

07

ANI PHARMS

U.S.A

BIO Partnering at JPM

Not Confirmed

08

ANI PHARMS

U.S.A

BIO Partnering at JPM

Not Confirmed

09

AUROBINDO PHARMA USA

India

BIO Partnering at JPM

Not Confirmed

10

AUROBINDO PHARMA USA

India

Biotech Showcase

Not Confirmed

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Europe

01

Helvepharm AG

France

Biotech Showcase

Not Confirmed

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France

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Regulatory Info :

Registration Country : Switzerland

Perindoprilum-tert-butylamine; Amlodipine; Indapamidum

Brand Name : Perindopril Amlodipin Indapamid Zentiva

Dosage Form : Tabl

Dosage Strength : 4/10/1.25mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Portfolio PDF

Product Web Link

02

Helvepharm AG

France

Biotech Showcase

Not Confirmed

Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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France

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Digital Content

Regulatory Info :

Registration Country : Switzerland

Perindoprilum-tert-butylamine; Amlodipine; Indapamidum

Brand Name : Perindopril Amlodipin Indapamid Zentiva

Dosage Form : Tabl

Dosage Strength : 4/10/1.25mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Portfolio PDF

Product Web Link

03

Helvepharm AG

France

Biotech Showcase

Not Confirmed

Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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France

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Digital Content

Regulatory Info :

Registration Country : Switzerland

Perindoprilum-tert-butylamine; Amlodipine; Indapamidum

Brand Name : Perindopril Amlodipin Indapamid Zentiva

Dosage Form : Tabl

Dosage Strength : 4/5/1.25mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Portfolio PDF

Product Web Link

04

Helvepharm AG

France

Biotech Showcase

Not Confirmed

Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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France

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Digital Content

Regulatory Info :

Registration Country : Switzerland

Perindoprilum-tert-butylamine; Amlodipine; Indapamidum

Brand Name : Perindopril Amlodipin Indapamid Zentiva

Dosage Form : Tabl

Dosage Strength : 8/10/2.5mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Portfolio PDF

Product Web Link

05

Helvepharm AG

France

Biotech Showcase

Not Confirmed

Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Contact Supplier

France

Virtual Booth

Digital Content

Regulatory Info :

Registration Country : Switzerland

Perindoprilum-tert-butylamine; Amlodipine; Indapamidum

Brand Name : Perindopril Amlodipin Indapamid Zentiva

Dosage Form : Tabl

Dosage Strength : 8/10/2.5mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Portfolio PDF

Product Web Link

06

Helvepharm AG

France

Biotech Showcase

Not Confirmed

Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Contact Supplier

France

Virtual Booth

Digital Content

Regulatory Info :

Registration Country : Switzerland

Perindoprilum-tert-butylamine; Amlodipine; Indapamidum

Brand Name : Perindopril Amlodipin Indapamid Zentiva

Dosage Form : Tabl

Dosage Strength : 8/5/2.5mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Portfolio PDF

Product Web Link

07

Helvepharm AG

France

Biotech Showcase

Not Confirmed

Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Contact Supplier

France

Virtual Booth

Digital Content

Regulatory Info :

Registration Country : Switzerland

Perindoprilum-tert-butylamine; Amlodipine; Indapamidum

Brand Name : Perindopril Amlodipin Indapamid Zentiva

Dosage Form : Tabl

Dosage Strength : 8/5/2.5mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Portfolio PDF

Product Web Link

08

Helvepharm AG

France

Biotech Showcase

Not Confirmed

Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Contact Supplier

France

Virtual Booth

Digital Content

Regulatory Info :

Registration Country : Switzerland

Perindoprilum-tert-butylamine; Amlodipine; Indapamidum

Brand Name : Perindopril Amlodipine Indapamide Zentiva

Dosage Form : Tabl

Dosage Strength : 4/5/1.25mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Portfolio PDF

Product Web Link

09

TOWA PHARMACEUTICAL SPA

Japan

Biotech Showcase

Not Confirmed

Towa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.

Contact Supplier

Japan

Virtual Booth

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Regulatory Info :

Registration Country : Italy

Indapamide

Brand Name : INDAPAMIDE THINK

Dosage Form : Coated Tablets

Dosage Strength : 2.5 mg

Packaging : 50 UNITS 2.5 MG - ORAL USE

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

Portfolio PDF

Product Web Link

10

LISAPHARMA SpA

Italy

Biotech Showcase

Not Confirmed

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Related Excipient Companies

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Excipients by Applications

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Fillers, Diluents & Binders

Coating Systems & Additives

Direct Compression

Controlled & Modified Release

Thickeners and Stabilizers

Granulation

Solubilizers

Lubricants & Glidants

Co-Processed Excipients

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Disintegrants & Superdisintegrants

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US Medicaid Prescriptions

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Finished Drug Prices

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APIs

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REF. STANDARDS & IMPURITIES

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EDQM

01

EDQM, Council of Europe

Methylnitrosoindoline

BIO Partnering at JPM

Not Confirmed

02

EDQM, Council of Europe

Indapamide impurity B

BIO Partnering at JPM

Not Confirmed

03

EDQM, Council of Europe

Indapamide

BIO Partnering at JPM

Not Confirmed

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USP

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Others

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ANALYTICAL

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BioAnalytical Methods

01

QUINTA-ANALYTICA s.r.o

Indapamide

BIO Partnering at JPM

Not Confirmed

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Analytical Methods

01

YMC

YMC CHIRAL ƒÀ-CD BR

BIO Partnering at JPM

Not Confirmed

ABOUT THIS PAGE

Indapamide Manufacturers

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

Indapamide Suppliers

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

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

Indapamide USDMF

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

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

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

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

Indapamide KDMF

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

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

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

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

Indapamide CEP

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

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

Indapamide WC

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

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

Indapamide 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 Indapamide as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Indapamide GMP

Indapamide 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 Indapamide 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 Indapamide GMP manufacturer or Indapamide GMP API supplier for your needs.

Indapamide CoA

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

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

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

26 API Suppliers

7 USDMF

10 CEP/COS

1 JDMF

5 EU WC

4 KDMF

6 NDC API

16 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

4 Drugs in Development

INTERMEDIATES

1 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

293 FDF Dossiers

20 FDA Orange Book

160 Europe

25 Canada

12 Australia

37 South Africa

39 Listed Dossiers

RELATED EXCIPIENT COMPANIES

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5 SPI Pharma

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3 DKSH

5 Faran Shimi Pharmaceutical

10 Gangwal Healthcare

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6 Actylis

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5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

15 BASF

10 Corel Pharma Chem

5 DFE Pharma

1 Finar

9 Gangwal Chemicals

5 Ideal Cures Pvt Ltd

2 Ingredion Pharma Solutions

35 Kerry

3 Kima Chemical

6 Lonza Capsugel

11 Microlex e.U

1 Nanjing Bold Chemical

2 Nomisma Healthcare

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2 Prachin Chemical

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1 Qualicaps

20 Roquette

13 Seppic

4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

10 Sigachi Industries

2 The Dow Chemical Company

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63 Fillers, Diluents & Binders

45 Coating Systems & Additives

29 Direct Compression

26 Controlled & Modified Release

21 Thickeners and Stabilizers

17 Granulation

17 Solubilizers

15 Lubricants & Glidants

15 Co-Processed Excipients

12 Taste Masking

11 Topical

10 Film Formers & Plasticizers

10 Disintegrants & Superdisintegrants

8 Parenteral

7 Emulsifying Agents