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26 API Suppliers, 16 USDMF, 12 CEP/COS, 9 JDMF, 3 EU WC, 9 KDMF, 5 NDC API, 9 Listed Suppliers, $ API Reference Price

26 API Suppliers
16 USDMF
12 CEP/COS
9 JDMF
3 EU WC
9 KDMF
5 NDC API
9 Listed Suppliers
$ API Reference Price

FINISHED DOSAGE FORMULATIONS

448 FDF Dossiers, 78 FDA Orange Book, 234 Europe, 51 Canada, 42 Australia, 27 South Africa, 16 Listed Dossiers

448 FDF Dossiers
78 FDA Orange Book
234 Europe
51 Canada
42 Australia
27 South Africa
16 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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TABLET;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem, 1 Rochem International Inc, 23 SPI Pharma, 3 DKSH, 7 Faran Shimi Pharmaceutical, 8 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 13 Gangwal Healthcare, 3 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 2 Aeon Procare, 2 Alcedo Pharmachem, 10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 21 BASF, 11 Corel Pharma Chem, 6 DFE Pharma, 10 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 37 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 17 Microlex e.U, 1 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 3 Novo Excipients, 4 Pharmatrans-Sanaq, 7 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 18 Roquette, 7 Seppic, 8 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 2 The Dow Chemical Company, 2 Ulanqab Kema New Material, 4 Vasa Pharmachem

relatedExcipients
1 Minakem
1 Rochem International Inc
23 SPI Pharma
3 DKSH
7 Faran Shimi Pharmaceutical
8 Boai NKY Pharmaceuticals Ltd
1 Chynops Pharma
13 Gangwal Healthcare
3 Nanjing Well Pharmaceutical
1 Pfanstiehl
1 ACG Worldwide
2 Aeon Procare
2 Alcedo Pharmachem
10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
21 BASF
11 Corel Pharma Chem
6 DFE Pharma
10 Gangwal Chemicals
5 Ideal Cures Pvt Ltd
4 Ingredion Pharma Solutions
37 Kerry
3 Kima Chemical
6 Lonza Capsugel
17 Microlex e.U
1 Nanjing Bold Chemical
1 NEWEDGE Overseas
3 Novo Excipients
4 Pharmatrans-Sanaq
7 Pluviaendo
4 Prachin Chemical
1 Qianhao Chemical (Hebei) Co., Ltd
1 Qualicaps
18 Roquette
7 Seppic
8 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
1 Shanghai Welltone Material Technology Co., Ltd
1 Shijiazhuang Huaxu Pharmaceutical
11 Sigachi Industries
2 The Dow Chemical Company
2 Ulanqab Kema New Material
4 Vasa Pharmachem

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89 Fillers, Diluents & Binders, 49 Direct Compression, 47 Coating Systems & Additives, 35 Disintegrants & Superdisintegrants, 30 Granulation, 28 Lubricants & Glidants, 25 Controlled & Modified Release, 23 Co-Processed Excipients, 20 Thickeners and Stabilizers, 20 Chewable & Orodispersible Aids, 17 Taste Masking, 14 Solubilizers, 10 API Stability Enhancers, 9 Parenteral, 9 Film Formers & Plasticizers, 6 Emulsifying Agents, 5 Empty Capsules, 4 Vegetarian Capsules, 4 Coloring Agents, 3 Topical, 3 Rheology Modifiers, 2 Surfactant & Foaming Agents

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GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 228 Finished Drug Prices, 1 Annual Reports

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1 US Medicaid Prescriptions
228 Finished Drug Prices
1 Annual Reports

MARKET PLACE

8 APIs, 2 FDF Dossiers

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8 APIs
2 FDF Dossiers

PATENTS & EXCLUSIVITIES

4 Health Canada Patents

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4 Health Canada Patents

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3 EDQM , 4 USP , 6 JP , 5 Others

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4 USP
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Synopsis

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API Suppliers

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JDMF

EU WC

KDMF

NDC API

VMF

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API REF. PRICE (USD/KG)

$ 619

MARKET PLACE

API

FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

448

FDF Dossiers

FDA Orange Book

234

Europe

Canada

Australia

South Africa

Listed Dossiers

0 DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

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GLOBAL SALES INFORMATION

US Medicaid (USD)

176,484,779

Annual Reports (USD Million)

106

Finished Drug Prices

272 RELATED EXCIPIENT COMPANIES

452EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 81131-70-6, Pravachol, Mevalotin, Selektine, Elisor, Pravaselect

Molecular Formula

C₂₃H₃₅NaO₇

Molecular Weight

446.5 g/mol

InChI Key

VWBQYTRBTXKKOG-IYNICTALSA-M

FDA UNII

3M8608UQ61

An antilipemic fungal metabolite isolated from cultures of Nocardia autotrophica. It acts as a competitive inhibitor of HMG CoA reductase (HYDROXYMETHYLGLUTARYL COA REDUCTASES).

1 2D Structure

Pravastatin

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

sodium;(3R,5R)-7-[(1S,2S,6S,8S,8aR)-6-hydroxy-2-methyl-8-[(2S)-2-methylbutanoyl]oxy-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]-3,5-dihydroxyheptanoate

2.1.2 InChI

InChI=1S/C23H36O7.Na/c1-4-13(2)23(29)30-20-11-17(25)9-15-6-5-14(3)19(22(15)20)8-7-16(24)10-18(26)12-21(27)28;/h5-6,9,13-14,16-20,22,24-26H,4,7-8,10-12H2,1-3H3,(H,27,28);/q;+1/p-1/t13-,14-,16+,17+,18+,19-,20-,22-;/m0./s1

2.1.3 InChI Key

VWBQYTRBTXKKOG-IYNICTALSA-M

2.1.4 Canonical SMILES

CCC(C)C(=O)OC1CC(C=C2C1C(C(C=C2)C)CCC(CC(CC(=O)[O-])O)O)O.[Na+]

2.1.5 Isomeric SMILES

CC[C@H](C)C(=O)O[C@H]1C[C@@H](C=C2[C@H]1[C@H]([C@H](C=C2)C)CC[C@H](C[C@H](CC(=O)[O-])O)O)O.[Na+]

2.2 Other Identifiers

2.2.1 UNII

3M8608UQ61

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Apo Pravastatin

2. Apo-pravastatin

3. Bristacol

4. Cs 514

5. Cs-514

6. Cs514

7. Elisor

8. Eptastatin

9. Lin Pravastatin

10. Lin-pravastatin

11. Lipemol

12. Liplat

13. Lipostat

14. Mevalotin

15. Nu Pravastatin

16. Nu-pravastatin

17. Prareduct

18. Pravachol

19. Pravacol

20. Pravasin

21. Pravastatin

22. Pravastatin Monosodium Salt, (6 Beta)-isomer

23. Pravastatin Sodium Salt

24. Pravastatin Tert Octylamine Salt

25. Pravastatin Tert-octylamine Salt

26. Pravastatin, (6 Beta)-isomer

27. Rms 431

28. Rms-431

29. Rms431

30. Selektine

31. Sodium Salt, Pravastatin

32. Sq 31,000

33. Sq 31000

34. Sq-31,000

35. Sq-31000

36. Sq31,000

37. Sq31000

38. Vasten

2.3.2 Depositor-Supplied Synonyms

1. 81131-70-6

2. Pravachol

3. Mevalotin

4. Selektine

5. Elisor

6. Pravaselect

7. Lipostat

8. Eptastatin Sodium

9. Cs-514

10. Pravastatin Sodium Salt

11. Pravastatin (sodium)

12. Dehypotin Protect

13. Sq-31000

14. Sq-31,000

15. Chebi:8361

16. Bristacol

17. Lipemol

18. Prareduct

19. Pravacol

20. Pravasin

21. 3m8608uq61

22. Nsc-759253

23. Sodium;(3r,5r)-7-[(1s,2s,6s,8s,8ar)-6-hydroxy-2-methyl-8-[(2s)-2-methylbutanoyl]oxy-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]-3,5-dihydroxyheptanoate

24. Aplactin

25. Lipidal

26. Liprevil

27. Pralidon

28. Pravasine

29. Sanaprav

30. Selipran

31. Vasen

32. Epastatin Sodium

33. Dsstox_cid_27525

34. Dsstox_rid_82395

35. Dsstox_gsid_47525

36. Liplat

37. Vasten

38. Pravastatin, Sodium Salt

39. (3r,5r)-3,5-dihydroxy-7-((1s,2s,6s,8s,8ar)-6-hydroxy-2-methyl-8-(((s)-2-methylbutanoyl)oxy)-1,2,6,7,8,8a-hexahydronaphthalen-1-yl)heptanoic Acid, Sodium Salt

40. Cas-81131-70-6

41. Pravastatin Natrium Mayrho Fer

42. Sq 31000

43. 3-beta-hydroxycompactin Sodium Salt

44. Drg-0319

45. Chembl690

46. Unii-3m8608uq61

47. Cres Pravastatin

48. Pravachol (tn)

49. Ncgc00095183-01

50. Pravastatin Sodium [usan:usp:jan]

51. Mfcd00887601

52. Pravastatinsodium,(s)

53. Cs-514 Sodium

54. Pravastatin Sodium- Bio-x

55. Schembl3013

56. Sodium (+)-(betar,deltar,1s,2s,6s,8s,8ar)-1,2,6,7,8,8a-hexahydro-beta,delta,6,8-tetrahydroxy-2-methyl-1-naphthaleneheptanoate, 8-((2s)-2-methylbutyrate)

57. Pravastatin Sodium [mi]

58. Dtxsid6047525

59. Pravastatin Sodium [jan]

60. Hy-b0165a

61. Pravastatin Sodium (jp17/usp)

62. Pravastatin Sodium [usan]

63. Hms2051p05

64. Hms3268l20

65. Hms3413e20

66. Pravastatin Sodium [vandf]

67. Hexahydronaphthalen-1-yl)heptanoate

68. Pravastatin Sodium [mart.]

69. Amy40517

70. Pravastatin Sodium [usp-rs]

71. Pravastatin Sodium [who-dd]

72. Tox21_111474

73. Tox21_300270

74. S3036

75. Akos015896504

76. Akos015964902

77. Ccg-100926

78. Cs-2003

79. Nc00176

80. Nsc 759253

81. Pravastatin Sodium [orange Book]

82. Ncgc00092370-01

83. Ncgc00254232-01

84. Pravastatin Sodium [ep Monograph]

85. 1-naphthaleneheptanoic Acid, 1,2,6,7,8,8a-hexahydro-2-methyl-8-(2-methyl-1-oxobutoxy)-beta,delta,6-trihydroxy-, Monosodium Salt, (1s-(1-alpha(beta-s*,delta-s*),2-alpha,6-alpha,8-beta(r*),8a-alpha))-

86. 1-naphthaleneheptanoic Acid, 1,2,6,7,8,8a-hexahydro-beta,delta,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, Monosodium Salt, (1s-(1alpha(betas*,deltas*),2alpha,6alpha,8beta(r*),8aalpha))-

87. Bp164292

88. Pravastatin Sodium [usp Monograph]

89. P1796

90. D00893

91. Pravigard Pac Component Pravastatin Sodium

92. Pravastatin Sodium Component Of Pravigard Pac

93. Q27108059

94. Pravastatin Sodium Salt Hydrate, >=98% (hplc), Powder

95. 2-methyl-8-((s)-2-methylbutanoyloxy)-1,2,6,7,8,8a-

96. Sodium (3r,5r)-3,5-dihydroxy-7-((1s,2s,6s,8s,8ar)-6-hydroxy-

97. (?r,?r,1s,2s,6s,8s,8ar)-1,2,6,7,8,8a-hexahydro-?,?,6-trihydroxy-2-methyl-8-[(2s)-2-methyl-1-oxobutoxy]-1-naphthaleneheptanoic Acid Monosodium Salt

98. (3r,5r)-3,5-dihydroxy-7-((1s,2s,6s,8s,8ar)-6-hydroxy-2-methyl-8-(((s)-2-methylbutanoyl)oxy)-1,2,6,7,8,8a-hexahydronaphthalen-1-yl)heptanoicacid,sodiumsalt

99. 1-naphthaleneheptanoic Acid, 1,2,6,7,8,8a-hexahydro-.beta.,d,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, Monosodium Salt, (1s-(1.alpha.(.beta.s*,ds*),2.alpha.,6.alpha.,8.beta.(r*),8a.alpha.))-

100. Sodium (+)-(.beta.r,dr,1s,2s,6s,8s,8ar)-1,2,6,7,8,8a-hexahydro-.beta.,d,6,8-tetrahydroxy-2-methyl-1-naphthaleneheptanoate, 8-((2s)-2-methylbutyrate)

101. Sodium (3r,5r)-3,5-dihydroxy-7-((1s,2s,6s,8s,8ar)-6-hydroxy-2-methyl-8-((s)-2-methylbutanoyloxy)-1,2,6,7,8,8a-hexahydronaphthalen-1-yl)heptanoate

102. Sodium (3r,5r)-3,5-dihydroxy-7-[(1s,2s,6s,8s,8ar)-6-hydroxy-2-methyl-8-{[(2s)-2-methylbutanoyl]oxy}-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]heptanoate

2.4 Create Date

2007-11-09

3 Chemical and Physical Properties

Molecular Formula	C₂₃H₃₅NaO₇
Molecular Weight	446.5 g/mol
Hydrogen Bond Donor Count	3
Hydrogen Bond Acceptor Count	7
Rotatable Bond Count	11
Exact Mass	446.22804773 g/mol
Monoisotopic Mass	446.22804773 g/mol
Topological Polar Surface Area	127 Å²
Heavy Atom Count	31
Formal Charge	0
Complexity	662
Isotope Atom Count	0
Defined Atom Stereocenter Count	8
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Drug Information

1 of 4
Drug Name	Pravachol
PubMed Health	Pravastatin (By mouth)
Drug Classes	Antihyperlipidemic
Drug Label	PRAVACHOL (pravastatin sodium) is one of a class of lipid-lowering compounds, the statins, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of HMG-CoA reductase, the enzyme catalyzing the early rate-limiting step in ch...
Active Ingredient	Pravastatin sodium
Dosage Form	Tablet
Route	Oral
Strength	10mg; 80mg; 40mg; 20mg
Market Status	Prescription
Company	Bristol Myers Squibb

2 of 4
Drug Name	Pravastatin sodium
Drug Label	Pravastatin sodium tablets are one of a class of lipid-lowering compounds, the HMG-CoA reductase inhibitors, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase,...
Active Ingredient	Pravastatin sodium
Dosage Form	Tablet
Route	oral; Oral
Strength	10mg; 80mg; 40mg; 20mg
Market Status	Tentative Approval; Prescription
Company	Mylan Pharms; Teva; Lupin Pharms; Apotex; Sandoz; Cipla; Watson Labs; Glenmark Generics; Teva Pharms; Pliva Hrvatska Doo; Zydus Pharms Usa; Dr Reddys Labs; Mylan

3 of 4
Drug Name	Pravachol
PubMed Health	Pravastatin (By mouth)
Drug Classes	Antihyperlipidemic
Drug Label	PRAVACHOL (pravastatin sodium) is one of a class of lipid-lowering compounds, the statins, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of HMG-CoA reductase, the enzyme catalyzing the early rate-limiting step in ch...
Active Ingredient	Pravastatin sodium
Dosage Form	Tablet
Route	Oral
Strength	10mg; 80mg; 40mg; 20mg
Market Status	Prescription
Company	Bristol Myers Squibb

4 of 4
Drug Name	Pravastatin sodium
Drug Label	Pravastatin sodium tablets are one of a class of lipid-lowering compounds, the HMG-CoA reductase inhibitors, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase,...
Active Ingredient	Pravastatin sodium
Dosage Form	Tablet
Route	oral; Oral
Strength	10mg; 80mg; 40mg; 20mg
Market Status	Tentative Approval; Prescription
Company	Mylan Pharms; Teva; Lupin Pharms; Apotex; Sandoz; Cipla; Watson Labs; Glenmark Generics; Teva Pharms; Pliva Hrvatska Doo; Zydus Pharms Usa; Dr Reddys Labs; Mylan

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Anticholesteremic Agents

Substances used to lower plasma cholesterol levels. (See all compounds classified as Anticholesteremic Agents.)

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Compounds that inhibit HYDROXYMETHYLGLUTARYL COA REDUCTASES. They have been shown to directly lower CHOLESTEROL synthesis. (See all compounds classified as Hydroxymethylglutaryl-CoA Reductase Inhibitors.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]; HMG-CoA Reductase Inhibitor [EPC]

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DMF Review : N/A

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DMF Number : 14235

Submission : 1999-06-24

Status : Active

Type : II

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Pravastatin Sodium

Certificate Number : R1-CEP 2004-168 - Rev 01

Status : Valid

Issue Date : 2021-03-04

Type : Chemical and TSE

Substance Number : 2059

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MAHARASHTRA","supplier":"TEVA PHARMACEUTICAL INDUSTRIES","supplierCountry":"HUNGARY","foreign_port":"BUDAPEST","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"762.00","actualQuantity":"762","unit":"KGS","unitRateFc":"524.9","totalValueFC":"401290","currency":"USD","unitRateINR":"42204.5","date":"27-Sep-2022","totalValueINR":"32159799","totalValueInUsd":"401290","indian_port":"Indore-EPZ\/SEZ","hs_no":"29181990","bill_no":"1006543","productDescription":"API","marketType":"REGULATED MARKET","country":"HUNGARY","selfForZScoreResived":"Micronized","supplierPort":"BUDAPEST","supplierAddress":"N\/A","customerAddress":"B\/2 MAHALAXMI CHAMBERS"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1664217000,"product":"PRAVASTATIN SODIUM USP (PRAVASTATIN SODIUM MICRONIZED) (BATCH NO.81100250222:-14 KGS)","address":"B\/2 MAHALAXMI CHAMBERS 22 BHULABHAI DESAI ROAD Contact No:","city":"MUMBAI","supplier":"TEVA API","supplierCountry":"HUNGARY","foreign_port":"NA","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"14.00","actualQuantity":"14","unit":"KGS","unitRateFc":"525","totalValueFC":"7373.7","currency":"USD","unitRateINR":"42210","date":"27-Sep-2022","totalValueINR":"590940","totalValueInUsd":"7373.7","indian_port":"BOMBAY AIR","hs_no":"29329990","bill_no":"2625571","productDescription":"API","marketType":"REGULATED MARKET","country":"HUNGARY","selfForZScoreResived":"Micronized","supplierPort":"NA","supplierAddress":"","customerAddress":"B\/2 MAHALAXMI CHAMBERS 22 BHULABHAI DESAI ROAD Contact No:"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1664217000,"product":"PRAVASTATIN SODIUM USP (PRAVASTATIN SODIUM MICRONIZED) (BATCH NO.81100250222:-186 KGS)","address":"B\/2 MAHALAXMI CHAMBERS 22 BHULABHAI DESAI ROAD Contact No:","city":"MUMBAI","supplier":"TEVA API","supplierCountry":"HUNGARY","foreign_port":"NA","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"186.00","actualQuantity":"186","unit":"KGS","unitRateFc":"525","totalValueFC":"97965.5","currency":"USD","unitRateINR":"42210","date":"27-Sep-2022","totalValueINR":"7851060","totalValueInUsd":"97965.5","indian_port":"BOMBAY AIR","hs_no":"29329990","bill_no":"2625571","productDescription":"API","marketType":"REGULATED MARKET","country":"HUNGARY","selfForZScoreResived":"Micronized","supplierPort":"NA","supplierAddress":"","customerAddress":"B\/2 MAHALAXMI CHAMBERS 22 BHULABHAI DESAI ROAD Contact No:"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1664217000,"product":"PRAVASTATIN SODIUM USP (PRAVASTATIN SODIUM MICRONIZED) (BATCH NO.81100250222:-48 KGS)","address":"B\/2 MAHALAXMI CHAMBERS 22 BHULABHAI DESAI ROAD Contact No:","city":"MUMBAI","supplier":"TEVA API","supplierCountry":"HUNGARY","foreign_port":"NA","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"48.00","actualQuantity":"48","unit":"KGS","unitRateFc":"525","totalValueFC":"25281.4","currency":"USD","unitRateINR":"42210","date":"27-Sep-2022","totalValueINR":"2026080","totalValueInUsd":"25281.4","indian_port":"BOMBAY AIR","hs_no":"29329990","bill_no":"2625571","productDescription":"API","marketType":"REGULATED MARKET","country":"HUNGARY","selfForZScoreResived":"Micronized","supplierPort":"NA","supplierAddress":"","customerAddress":"B\/2 MAHALAXMI CHAMBERS 22 BHULABHAI DESAI ROAD Contact No:"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1664217000,"product":"PRAVASTATIN SODIUM USP (PRAVASTATIN SODIUM MICRONIZED) (BATCH NO.81100250222:-53 KGS)","address":"B\/2 MAHALAXMI CHAMBERS 22 BHULABHAI DESAI ROAD Contact No:","city":"MUMBAI","supplier":"TEVA API","supplierCountry":"HUNGARY","foreign_port":"NA","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"53.00","actualQuantity":"53","unit":"KGS","unitRateFc":"525","totalValueFC":"27914.9","currency":"USD","unitRateINR":"42210","date":"27-Sep-2022","totalValueINR":"2237130","totalValueInUsd":"27914.9","indian_port":"BOMBAY AIR","hs_no":"29329990","bill_no":"2625571","productDescription":"API","marketType":"REGULATED MARKET","country":"HUNGARY","selfForZScoreResived":"Micronized","supplierPort":"NA","supplierAddress":"","customerAddress":"B\/2 MAHALAXMI CHAMBERS 22 BHULABHAI DESAI ROAD Contact No:"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1664303400,"product":"PRAVASTATIN SODIUM MICRONIZED","address":"B\/2 MAHALAXMI CHAMBERS","city":"MUMBAI. MAHARASHTRA","supplier":"TEVA PHARMACEUTICAL INDUSTRIES","supplierCountry":"HUNGARY","foreign_port":"BUDAPEST","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"388.00","actualQuantity":"388","unit":"KGS","unitRateFc":"525","totalValueFC":"204358.2","currency":"USD","unitRateINR":"42210","date":"28-Sep-2022","totalValueINR":"16377480","totalValueInUsd":"204358.2","indian_port":"Indore-EPZ\/SEZ","hs_no":"29181990","bill_no":"1006554","productDescription":"API","marketType":"REGULATED MARKET","country":"HUNGARY","selfForZScoreResived":"Micronized","supplierPort":"BUDAPEST","supplierAddress":"LIMITED COMPANY 13 PALLAGI STREET, H-4042 DEBRECEN Hungary","customerAddress":"B\/2 MAHALAXMI CHAMBERS"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1664389800,"product":"PRAVASTATIN SODIUM MICRONIZED","address":"B\/2 MAHALAXMI CHAMBERS","city":"MUMBAI. MAHARASHTRA","supplier":"TEVA PHARMACEUTICAL INDUSTRIES","supplierCountry":"HUNGARY","foreign_port":"BUDAPEST","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"700.00","actualQuantity":"700","unit":"KGS","unitRateFc":"525.1","totalValueFC":"368740.1","currency":"USD","unitRateINR":"42216","date":"29-Sep-2022","totalValueINR":"29551221","totalValueInUsd":"368740.1","indian_port":"Indore-EPZ\/SEZ","hs_no":"29181990","bill_no":"1006594","productDescription":"API","marketType":"REGULATED MARKET","country":"HUNGARY","selfForZScoreResived":"Micronized","supplierPort":"BUDAPEST","supplierAddress":"LIMITED COMPANY 13 PALLAGI STREET, H-4042 DEBRECEN Hungary","customerAddress":"B\/2 MAHALAXMI CHAMBERS"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1686594600,"product":"PRAVASTATIN SODIUM MICRONIZED","address":"B\/2 MAHALAXMI CHAMBERS","city":"MUMBAI. MAHARASHTRA","supplier":"XXVA XXARMXXEUTXXAL","supplierCountry":"HUNGARY","foreign_port":"BUDAPEST","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"750.00","actualQuantity":"750","unit":"KGS","unitRateFc":"450","totalValueFC":"342442.5","currency":"USD","unitRateINR":"37530","date":"13-Jun-2023","totalValueINR":"28147500","totalValueInUsd":"342442.5","indian_port":"Indore-EPZ\/SEZ","hs_no":"29181990","bill_no":"1003745","productDescription":"API","marketType":"REGULATED MARKET","country":"HUNGARY","selfForZScoreResived":"Micronized","supplierPort":"BUDAPEST","supplierAddress":"N\/A","customerAddress":"B\/2 MAHALAXMI CHAMBERS"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1696271400,"product":"PRAVASTATIN SODIUM MICRONIZED","address":"B\/2 MAHALAXMI CHAMBERS","city":"MUMBAI. MAHARASHTRA","supplier":"TEVA PHARMACEUTICAL INDUSTRIES","supplierCountry":"HUNGARY","foreign_port":"BUDAPEST","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"750.00","actualQuantity":"750","unit":"KGS","unitRateFc":"450","totalValueFC":"340828","currency":"USD","unitRateINR":"37822.5","date":"03-Oct-2023","totalValueINR":"28366875","totalValueInUsd":"340828","indian_port":"Indore-EPZ\/SEZ","hs_no":"29181990","bill_no":"1006519","productDescription":"API","marketType":"REGULATED MARKET","country":"HUNGARY","selfForZScoreResived":"Micronized","supplierPort":"BUDAPEST","supplierAddress":"N\/A","customerAddress":"B\/2 MAHALAXMI CHAMBERS"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725474600,"product":"PV202303094,PRAVASTATIN SODIUM (PHARMACEUTICAL PRODUCTS)","address":"SITE NO.1,BOMMASANDRA INDL.AREA,IV","city":"ANEKAL TALUK,BANGALORE","supplier":"GUANGDONG BLUE TREASURE PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"SHENZHEN","customer":"APOTEX INC","customerCountry":"INDIA","quantity":"119.00","actualQuantity":"119","unit":"KGS","unitRateFc":"450","totalValueFC":"54220.2","currency":"USD","unitRateINR":"38182.5","date":"05-Sep-2024","totalValueINR":"4543717.5","totalValueInUsd":"54220.2","indian_port":"Bangalore Air","hs_no":"29339990","bill_no":"5431387","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHENZHEN","supplierAddress":"RENMIN ONE ROAD QINGYUAN GUANGDONG CHINA SDNF CN CN","customerAddress":"SITE NO.1,BOMMASANDRA INDL.AREA,IV"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725474600,"product":"PV202303095,PRAVASTATIN SODIUM (PHARMACEUTICAL PRODUCTS)","address":"SITE NO.1,BOMMASANDRA INDL.AREA,IV","city":"ANEKAL TALUK,BANGALORE","supplier":"GUANGDONG BLUE TREASURE PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"SHENZHEN","customer":"APOTEX INC","customerCountry":"INDIA","quantity":"112.00","actualQuantity":"112","unit":"KGS","unitRateFc":"450","totalValueFC":"51030.8","currency":"USD","unitRateINR":"38182.5","date":"05-Sep-2024","totalValueINR":"4276440","totalValueInUsd":"51030.8","indian_port":"Bangalore Air","hs_no":"29339990","bill_no":"5431387","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHENZHEN","supplierAddress":"RENMIN ONE ROAD QINGYUAN GUANGDONG CHINA SDNF CN CN","customerAddress":"SITE NO.1,BOMMASANDRA INDL.AREA,IV"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725474600,"product":"PV202303099,PRAVASTATIN SODIUM (PHARMACEUTICAL PRODUCTS)","address":"SITE NO.1,BOMMASANDRA INDL.AREA,IV","city":"ANEKAL TALUK,BANGALORE","supplier":"GUANGDONG BLUE TREASURE PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"SHENZHEN","customer":"APOTEX INC","customerCountry":"INDIA","quantity":"112.00","actualQuantity":"112","unit":"KGS","unitRateFc":"450","totalValueFC":"51030.8","currency":"USD","unitRateINR":"38182.5","date":"05-Sep-2024","totalValueINR":"4276440","totalValueInUsd":"51030.8","indian_port":"Bangalore Air","hs_no":"29339990","bill_no":"5431387","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHENZHEN","supplierAddress":"RENMIN ONE ROAD QINGYUAN GUANGDONG CHINA SDNF CN CN","customerAddress":"SITE NO.1,BOMMASANDRA INDL.AREA,IV"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725474600,"product":"PV202304100,PRAVASTATIN SODIUM (PHARMACEUTICAL PRODUCTS)","address":"SITE NO.1,BOMMASANDRA INDL.AREA,IV","city":"ANEKAL TALUK,BANGALORE","supplier":"GUANGDONG BLUE TREASURE PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"SHENZHEN","customer":"APOTEX INC","customerCountry":"INDIA","quantity":"112.00","actualQuantity":"112","unit":"KGS","unitRateFc":"450","totalValueFC":"51030.8","currency":"USD","unitRateINR":"38182.5","date":"05-Sep-2024","totalValueINR":"4276440","totalValueInUsd":"51030.8","indian_port":"Bangalore Air","hs_no":"29339990","bill_no":"5431387","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHENZHEN","supplierAddress":"RENMIN ONE ROAD QINGYUAN GUANGDONG CHINA SDNF CN CN","customerAddress":"SITE NO.1,BOMMASANDRA INDL.AREA,IV"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725474600,"product":"PV202304104,PRAVASTATIN SODIUM (PHARMACEUTICAL PRODUCTS)","address":"SITE NO.1,BOMMASANDRA INDL.AREA,IV","city":"ANEKAL TALUK,BANGALORE","supplier":"GUANGDONG BLUE TREASURE PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"SHENZHEN","customer":"APOTEX INC","customerCountry":"INDIA","quantity":"84.00","actualQuantity":"84","unit":"KGS","unitRateFc":"450","totalValueFC":"38273.1","currency":"USD","unitRateINR":"38182.5","date":"05-Sep-2024","totalValueINR":"3207330","totalValueInUsd":"38273.1","indian_port":"Bangalore Air","hs_no":"29339990","bill_no":"5431387","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHENZHEN","supplierAddress":"RENMIN ONE ROAD QINGYUAN GUANGDONG CHINA SDNF CN CN","customerAddress":"SITE NO.1,BOMMASANDRA INDL.AREA,IV"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725474600,"product":"PV202305121,PRAVASTATIN SODIUM (PHARMACEUTICAL PRODUCTS)","address":"SITE NO.1,BOMMASANDRA INDL.AREA,IV","city":"ANEKAL TALUK,BANGALORE","supplier":"GUANGDONG BLUE TREASURE PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"SHENZHEN","customer":"APOTEX INC","customerCountry":"INDIA","quantity":"112.00","actualQuantity":"112","unit":"KGS","unitRateFc":"450","totalValueFC":"51030.8","currency":"USD","unitRateINR":"38182.5","date":"05-Sep-2024","totalValueINR":"4276440","totalValueInUsd":"51030.8","indian_port":"Bangalore Air","hs_no":"29339990","bill_no":"5431387","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHENZHEN","supplierAddress":"RENMIN ONE ROAD QINGYUAN GUANGDONG CHINA SDNF CN CN","customerAddress":"SITE NO.1,BOMMASANDRA INDL.AREA,IV"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725474600,"product":"PV202305123,PRAVASTATIN SODIUM (PHARMACEUTICAL PRODUCTS)","address":"SITE NO.1,BOMMASANDRA INDL.AREA,IV","city":"ANEKAL TALUK,BANGALORE","supplier":"GUANGDONG BLUE TREASURE PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"SHENZHEN","customer":"APOTEX INC","customerCountry":"INDIA","quantity":"112.00","actualQuantity":"112","unit":"KGS","unitRateFc":"450","totalValueFC":"51030.8","currency":"USD","unitRateINR":"38182.5","date":"05-Sep-2024","totalValueINR":"4276440","totalValueInUsd":"51030.8","indian_port":"Bangalore Air","hs_no":"29339990","bill_no":"5431387","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHENZHEN","supplierAddress":"RENMIN ONE ROAD QINGYUAN GUANGDONG CHINA SDNF CN CN","customerAddress":"SITE NO.1,BOMMASANDRA INDL.AREA,IV"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1727721000,"product":"PRAVASTATIN SODIUM MICRONIZED (BATCH NO.81100200524-27KGS\/81100200424-11KGS\/81100200524-4KGS)","address":"B\/2 MAHALAXMI CHAMBERS","city":"MUMBAI. MAHARASHTRA","supplier":"TEVA API","supplierCountry":"HUNGARY","foreign_port":"BUDAPEST,","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"42.00","actualQuantity":"42","unit":"KGS","unitRateFc":"540","totalValueFC":"22834.8","currency":"USD","unitRateINR":"45684","date":"01-Oct-2024","totalValueINR":"1918728","totalValueInUsd":"22834.8","indian_port":"Bombay Air","hs_no":"29329990","bill_no":"5902371","productDescription":"API","marketType":"REGULATED MARKET","country":"HUNGARY","selfForZScoreResived":"Micronized","supplierPort":"BUDAPEST,","supplierAddress":"PIET HEIN BUILDING, PIET HEINKADE 1 07 1019 GM AMSTERDAM THE NETHERLAND S Amsterdam, , Netherlands Netherlands","customerAddress":"B\/2 MAHALAXMI CHAMBERS"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729189800,"product":"PRAVASTATIN SODIUM MICRONIZED","address":"B\/2 MAHALAXMI CHAMBERS","city":"MUMBAI. MAHARASHTRA","supplier":"TEVA PHARMACEUTICAL INDUSTRIES","supplierCountry":"HUNGARY","foreign_port":"BUDAPEST","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"200.00","actualQuantity":"200","unit":"KGS","unitRateFc":"540","totalValueFC":"109186.9","currency":"USD","unitRateINR":"45873","date":"18-Oct-2024","totalValueINR":"9174600","totalValueInUsd":"109186.9","indian_port":"Indore-EPZ\/SEZ","hs_no":"29181990","bill_no":"1007426","productDescription":"API","marketType":"REGULATED MARKET","country":"HUNGARY","selfForZScoreResived":"Micronized","supplierPort":"BUDAPEST","supplierAddress":"13 PALLAGI ST, H-4042 Hungary","customerAddress":"B\/2 MAHALAXMI CHAMBERS"}]

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

Upgrade, download data, analyse, strategize, subscribe with us contact

FDF Dossiers

01

Sanofi

France

BIO Partnering at JPM

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

Pravastatin sodium

Brand Name : Pravastatin Zentiva

Dosage Form : Tabl

Dosage Strength : 20mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Portfolio PDF

Product Web Link

02

Sanofi

France

BIO Partnering at JPM

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

Pravastatin sodium

Brand Name : Pravastatin Zentiva

Dosage Form : Tabl

Dosage Strength : 20mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Portfolio PDF

Product Web Link

03

Sanofi

France

BIO Partnering at JPM

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

Pravastatin sodium

Brand Name : Pravastatin Zentiva

Dosage Form : Tabl

Dosage Strength : 40mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Portfolio PDF

Product Web Link

04

Sanofi

France

BIO Partnering at JPM

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

Pravastatin sodium

Brand Name : Pravastatin Zentiva

Dosage Form : Tabl

Dosage Strength : 40mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Portfolio PDF

Product Web Link

05

Aspen Pharmacare Holdings

South Africa

BIO Partnering at JPM

Not Confirmed

Contact Supplier

South Africa

Virtual Booth

Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Pravastatin

Brand Name : Aspen Pravastatin

Dosage Form : TAB

Dosage Strength : 10mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

06

Aspen Pharmacare Holdings

South Africa

BIO Partnering at JPM

Not Confirmed

Contact Supplier

South Africa

Virtual Booth

Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Pravastatin

Brand Name : Aspen Pravastatin

Dosage Form : TAB

Dosage Strength : 20mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

07

Aspen Pharmacare Holdings

South Africa

BIO Partnering at JPM

Not Confirmed

Contact Supplier

South Africa

Virtual Booth

Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Pravastatin

Brand Name : Aspen Pravastatin

Dosage Form : TAB

Dosage Strength : 40mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

08

Dr. Reddy's Laboratories

India

CPhI WW Frankfurt

Booth #9.1B48

DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Contact Supplier

India

Virtual Booth

Digital Content

Regulatory Info : RX

Registration Country : USA

PRAVASTATIN SODIUM

Brand Name : PRAVASTATIN SODIUM

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Packaging :

Approval Date : 2006-10-23

Application Number : 76714

Regulatory Info : RX

Registration Country : USA

Product Web Link

09

Dr. Reddy's Laboratories

India

CPhI WW Frankfurt

Booth #9.1B48

DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Contact Supplier

India

Virtual Booth

Digital Content

Regulatory Info : RX

Registration Country : USA

PRAVASTATIN SODIUM

Brand Name : PRAVASTATIN SODIUM

Dosage Form : TABLET;ORAL

Dosage Strength : 20MG

Packaging :

Approval Date : 2006-10-23

Application Number : 76714

Regulatory Info : RX

Registration Country : USA

Product Web Link

10

Dr. Reddy's Laboratories

India

CPhI WW Frankfurt

Booth #9.1B48

DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Contact Supplier

India

Virtual Booth

Digital Content

Regulatory Info : RX

Registration Country : USA

PRAVASTATIN SODIUM

Brand Name : PRAVASTATIN SODIUM

Dosage Form : TABLET;ORAL

Dosage Strength : 40MG

Packaging :

Approval Date : 2006-10-23

Application Number : 76714

Regulatory Info : RX

Registration Country : USA

Product Web Link

Only 10 entries up to this point, click to access all

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FDA Orange Book

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DOSAGE - TABLET;ORAL - 10MG **Federal Registe...DOSAGE - TABLET;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 19898

DOSAGE - TABLET;ORAL - 20MG **Federal Registe...DOSAGE - TABLET;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 19898

DOSAGE - TABLET;ORAL - 40MG **Federal Registe...DOSAGE - TABLET;ORAL - 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 19898

DOSAGE - TABLET;ORAL - 80MG **Federal Registe...DOSAGE - TABLET;ORAL - 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 19898

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ABOUT THIS PAGE

Pravastatin Manufacturers

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

Pravastatin Suppliers

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

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

Pravastatin USDMF

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

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

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

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

Pravastatin KDMF

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

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

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

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

Pravastatin CEP

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

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

Pravastatin WC

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

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

Pravastatin 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 Pravastatin as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Pravastatin GMP

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

Pravastatin CoA

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

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

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

Find Pravastatin manufacturers, exporters & distributors on PharmaCompass

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

26 API Suppliers

16 USDMF

12 CEP/COS

9 JDMF

3 EU WC

9 KDMF

5 NDC API

9 Listed Suppliers

$ API Reference Price

FINISHED DOSAGE FORMULATIONS

448 FDF Dossiers

78 FDA Orange Book

234 Europe

51 Canada

42 Australia

27 South Africa

16 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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EXCIPIENTS BY APPLICATIONS

89 Fillers, Diluents & Binders

49 Direct Compression

47 Coating Systems & Additives

35 Disintegrants & Superdisintegrants

30 Granulation

28 Lubricants & Glidants

25 Controlled & Modified Release

23 Co-Processed Excipients

20 Thickeners and Stabilizers

TABLET;ORAL - 10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons