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Nicardipine Hydrochloride

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

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ACTIVE PHARMA INGREDIENTS

30 API Suppliers, 14 USDMF, 1 JDMF, 2 EU WC, 2 KDMF, 7 NDC API, 18 Listed Suppliers, $ API Reference Price

30 API Suppliers
14 USDMF
1 JDMF
2 EU WC
2 KDMF
7 NDC API
18 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

4 Drugs in Development

4 Drugs in Development

INTERMEDIATES

2 Intermediates Suppliers

2 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

61 FDF Dossiers, 45 FDA Orange Book, 6 Europe, 10 Listed Dossiers

61 FDF Dossiers
45 FDA Orange Book
6 Europe
10 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INTRAVENOUS - 20MG/200ML (0.1MG/ML), INJECTABLE;INJECTION - 25MG/10ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INTRAVENOUS - 40MG/200ML (0.2MG/ML)

drugProductComposition
INJECTABLE;INTRAVENOUS - 20MG/200ML (0.1MG/ML)
INJECTABLE;INJECTION - 25MG/10ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
INJECTABLE;INTRAVENOUS - 40MG/200ML (0.2MG/ML)

RELATED EXCIPIENT COMPANIES

1 Evonik, 1 Rochem International Inc, 6 SPI Pharma, 8 DKSH, 3 Faran Shimi Pharmaceutical, 10 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 4 ACG Worldwide, 2 Actylis, 1 Alcedo Pharmachem, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 11 BASF, 3 Corel Pharma Chem, 2 DFE Pharma, 1 Finar, 6 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 2 Ingredion Pharma Solutions, 6 Kerry, 3 Lonza Capsugel, 7 Microlex e.U, 1 Pharmatrans-Sanaq, 3 Pluviaendo, 2 Prachin Chemical, 1 Qualicaps, 28 Roquette, 2 Seppic, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 8 Sigachi Industries, 2 Valens Pharmachem, 2 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

43 Fillers, Diluents & Binders, 27 Coating Systems & Additives, 23 Direct Compression, 17 Thickeners and Stabilizers, 15 Controlled & Modified Release, 14 Taste Masking, 13 Lubricants & Glidants, 13 Co-Processed Excipients, 12 Film Formers & Plasticizers, 11 Granulation, 9 Disintegrants & Superdisintegrants, 8 Empty Capsules, 7 Chewable & Orodispersible Aids, 7 Parenteral, 5 Solubilizers, 4 Topical, 4 Emulsifying Agents, 3 Coloring Agents, 1 API Stability Enhancers, 1 Surfactant & Foaming Agents, 1 Rheology Modifiers, 1 Soft Gelatin

DIGITAL CONTENT

3 DATA COMPILATION #PharmaFlow, 18 NEWS #PharmaBuzz

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3 DATA COMPILATION #PharmaFlow
18 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

7 Finished Drug Prices

globalSalesInformation
7 Finished Drug Prices

MARKET PLACE

17 APIs, 2 FDF Dossiers

marketPlace
17 APIs
2 FDF Dossiers

PATENTS & EXCLUSIVITIES

22 US Patents, 4 US Exclusivities, 5 Health Canada Patents

patents
22 US Patents
4 US Exclusivities
5 Health Canada Patents

REF. STANDARDS & IMPURITIES

1 EDQM , 1 USP , 4 Others

otherSolutions
1 EDQM
1 USP
4 Others

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 10,358

MARKET PLACE

API

FDF

2INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

4DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

Annual Reports (USD Million)

Finished Drug Prices

142 RELATED EXCIPIENT COMPANIES

239EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 54527-84-3, Nicardipine hcl, Cardene, Perdipine, Loxen, Nicodel

Molecular Formula

C₂₆H₃₀ClN₃O₆

Molecular Weight

516.0 g/mol

InChI Key

AIKVCUNQWYTVTO-UHFFFAOYSA-N

FDA UNII

K5BC5011K3

A potent calcium channel blockader with marked vasodilator action. It has antihypertensive properties and is effective in the treatment of angina and coronary spasms without showing cardiodepressant effects. It has also been used in the treatment of asthma and enhances the action of specific antineoplastic agents.

1 2D Structure

Nicardipine Hydrochloride

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

5-O-[2-[benzyl(methyl)amino]ethyl] 3-O-methyl 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate;hydrochloride

2.1.2 InChI

InChI=1S/C26H29N3O6.ClH/c1-17-22(25(30)34-4)24(20-11-8-12-21(15-20)29(32)33)23(18(2)27-17)26(31)35-14-13-28(3)16-19-9-6-5-7-10-19;/h5-12,15,24,27H,13-14,16H2,1-4H3;1H

2.1.3 InChI Key

AIKVCUNQWYTVTO-UHFFFAOYSA-N

2.1.4 Canonical SMILES

CC1=C(C(C(=C(N1)C)C(=O)OCCN(C)CC2=CC=CC=C2)C3=CC(=CC=C3)[N+](=O)[O-])C(=O)OC.Cl

2.2 Other Identifiers

2.2.1 UNII

K5BC5011K3

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Antagonil

2. Cardene

3. Cardene I.v.

4. Cardene Sr

5. Dagan

6. Flusemide

7. Hydrochloride, Nicardipine

8. La, Nicardipine

9. Lecibral

10. Lincil

11. Loxen

12. Lucenfal

13. Nicardipine

14. Nicardipine La

15. Nicardipino Ratiopharm

16. Nicardipino Seid

17. Perdipine

18. Ridene

19. Vasonase

20. Y 93

21. Y-93

22. Y93

2.3.2 Depositor-Supplied Synonyms

1. 54527-84-3

2. Nicardipine Hcl

3. Cardene

4. Perdipine

5. Loxen

6. Nicodel

7. Perdipina

8. Yc-93

9. Nicardipine (hydrochloride)

10. Dagan

11. Lecibral

12. Vasonase

13. Ridene

14. Yc-93 Hydrochloride

15. Nicardipinehydrochloride

16. Barizin

17. Cardepine

18. Dacarel

19. Lecibra

20. Lescodil

21. Nerdipina

22. Nicapress

23. Nicardal

24. Nicarpin

25. Nimicor

26. Rycarden

27. Vasodin

28. Nicant

29. Ranvil

30. Rydene

31. Rs-69216

32. Rs-69216-xx-07-0

33. Nsc-757855

34. Mls000069782

35. 2-(benzylmethylamino)ethyl Methyl 1,4-dihydro-2,6-dimethyl-4-(3-nitrophenyl)pyridine-3,5-dicarboxylatemonohydrochloride

36. Lincil

37. K5bc5011k3

38. Cardene Sr

39. 2-(benzylmethylamino)ethyl Methyl 1,4-dihydro-2,6-dimethyl-4-(m-nitrophenyl)-3,5-pyridinedicarboxylate Monohydrochloride

40. 3-{2-[benzyl(methyl)amino]ethyl} 5-methyl 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate Hydrochloride

41. Rs-69216xx07-0

42. Angioglebil

43. Bionicard

44. Nicardil

45. Smr000058487

46. Dafil

47. Cardene (tn)

48. 3,5-pyridinedicarboxylic Acid, 1,4-dihydro-2,6-dimethyl-4-(3-nitrophenyl)-, Methyl 2-(methyl(phenylmethyl)amino)ethyl Ester, Monohydrochloride

49. 3-(2-(benzyl(methyl)amino)ethyl) 5-methyl 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate Hydrochloride

50. 5-o-[2-[benzyl(methyl)amino]ethyl] 3-o-methyl 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate;hydrochloride

51. Yc 93

52. Sr-01000075333

53. Einecs 259-198-4

54. Nicardipine Hydrochloride [usan:jan]

55. Nerdipine

56. Unii-k5bc5011k3

57. Ccris 8508

58. 69441-18-5

59. 3,5-pyridinedicarboxylic Acid, 1,4-dihydro-2,6-dimethyl-4-(3-nitrophenyl)-, 3-methyl 5-(2-(methyl(phenylmethyl)amino)ethyl) Ester, Hydrochloride (1:1)

60. 3,5-pyridinedicarboxylic Acid, 1,4-dihydro-2,6-dimethyl-4-(3-nitrophenyl)-, 3-methyl 5-[2-[methyl(phenylmethyl)amino]ethyl] Ester, Hydrochloride (1:1)

61. Prestwick_590

62. Einecs 274-007-4

63. Mfcd00057327

64. Opera_id_357

65. Cardene In 4.8% Dextrose In Plastic Container

66. Cardene In 5.0% Dextrose In Plastic Container

67. Cas-54527-84-3

68. Dsstox_cid_26992

69. Dsstox_rid_82040

70. Dsstox_gsid_46992

71. Schembl41845

72. 1,4-dihydro-2,6-dimethyl-4-(3-nitrophenyl)methyl-2-[methyl(phenylmethyl)amino]-3,5-pyridinedicarboxylic Acid Ethyl Ester Hydrochloride

73. Mls001146898

74. Mls002153279

75. Mls002153794

76. Nicardipine Hydrochloride,(s)

77. Spectrum1501135

78. Chebi:7551

79. Cardene In 0.83% Sodium Chloride In Plastic Container

80. Cardene In 0.86% Sodium Chloride In Plastic Container

81. Chembl1200326

82. Chembl3199626

83. Dtxsid9046992

84. Hms1569m07

85. Hms1921h21

86. Pharmakon1600-01501135

87. Bcp05610

88. Tox21_301832

89. Tox21_500809

90. Ccg-39033

91. Hy-12515a

92. Nsc757855

93. S4181

94. Tn-901

95. Nicardipine Hydrochloride [mi]

96. Akos015994734

97. Bcp9000988

98. Cs-3684

99. Ks-1276

100. Lp00809

101. Nc00578

102. Nicardipine Hydrochloride [jan]

103. Nsc 757855

104. Rs-69216-xx-07-o

105. Nicardipine Hydrochloride (jp17/usan)

106. Nicardipine Hydrochloride [usan]

107. Ncgc00094142-01

108. Ncgc00094142-02

109. Ncgc00094142-03

110. Ncgc00094142-04

111. Ncgc00094142-05

112. Ncgc00256289-01

113. Ncgc00261494-01

114. Nicardipine Hydrochloride [mart.]

115. Nicardipine Hydrochloride [vandf]

116. 2-(benzyl(methyl)amino)ethyl Methyl 1,4-dihydro-2,6-dimethyl-4-(m-nitrophenyl)pyridine-3,5-dicarboxylate Hydrochloride

117. 3,5-pyridinedicarboxylic Acid, 1,4-dihydro-2,6-dimethyl-4-(m-nitrophenyl)-, 2-(benzylmethylamino)ethyl Methyl Ester, Monohydrochloride

118. Ac-36579

119. Nicardipine Hydrochloride [usp-rs]

120. Nicardipine Hydrochloride [who-dd]

121. Nicardipine Hydrochloride, Powder, >=98%

122. Db-052598

123. Eu-0100809

124. Ft-0630671

125. N0635

126. Sw196762-3

127. D00617

128. D91754

129. N 7510

130. Nicardipine Hydrochloride [ep Monograph]

131. Nicardipine Hydrochloride [orange Book]

132. Nicardipine Hydrochloride [usp Monograph]

133. 527n843

134. A830225

135. Sr-01000075333-1

136. Sr-01000075333-5

137. W-105615

138. Q27281986

139. 12-(7-nitrobenzofurazan-4-ylamino)dodecanoicacid

140. Nicardipine Hydrochloride, European Pharmacopoeia (ep) Reference Standard

141. Nicardipine For System Suitability, European Pharmacopoeia (ep) Reference Standard

142. Nicardipine Hydrochloride, United States Pharmacopeia (usp) Reference Standard

143. 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylic Acid 3-(2-(n-benzyl-n-methylamino))-ethyl Ester 5-methyl Ester Hydrochloride

144. 2-(n-benzyl-n-methylamino)ethyl Methyl 2,6-dimethyl-4-(m-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate Hydrochloride

145. 3,5-pyridinedicarboxylic Acid, 1,4-dihydro-2,6-dimethyl-4-(3-nitrophenyl)-,?methyl 2-[methyl(phenylmethyl)amino]ethyl Ester, Hydrochloride (1:1)

146. O5-[2-[benzyl(methyl)amino]ethyl] O3-methyl 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate Hydrochloride;nicardipine Hcl

2.4 Create Date

2005-06-24

3 Chemical and Physical Properties

Molecular Formula	C₂₆H₃₀ClN₃O₆
Molecular Weight	516.0 g/mol
Hydrogen Bond Donor Count	2
Hydrogen Bond Acceptor Count	8
Rotatable Bond Count	10
Exact Mass	515.1823134 g/mol
Monoisotopic Mass	515.1823134 g/mol
Topological Polar Surface Area	114 Å²
Heavy Atom Count	36
Formal Charge	0
Complexity	856
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	2

4 Drug and Medication Information

4.1 Drug Information

1 of 6
Drug Name	Cardene
Drug Label	Cardene (nicardipine HCI) is a calcium ion influx inhibitor (slow channel blocker or calcium channel blocker). Cardene I.V. for intravenous administration contains 2.5 mg/mL of nicardipine hydrochloride. Nicardipine hydrochloride is a dihydropy...
Active Ingredient	Nicardipine hydrochloride
Dosage Form	Injectable; Capsule
Route	Injection; Oral
Strength	25mg/10ml (2.5mg/ml); 30mg; 20mg
Market Status	Prescription
Company	Chiesi Usa

2 of 6
Drug Name	Cardene sr
Drug Label	CARDENE SR is a sustained release formulation of CARDENE. CARDENE SR capsules for oral administration each contain 30 mg, 45 mg or 60 mg of nicardipine hydrochloride. Nicardipine hydrochloride is a calcium ion influx inhibitor (slow channel block...
Active Ingredient	Nicardipine hydrochloride
Dosage Form	Capsule, extended release
Route	Oral
Strength	60mg; 30mg
Market Status	Prescription
Company	Chiesi Usa

3 of 6
Drug Name	Nicardipine hydrochloride
PubMed Health	Nicardipine
Drug Classes	Antianginal, Antihypertensive, Cardiovascular Agent
Drug Label	Nicardipine hydrochloride capsules for oral administration each contain 20 mg or 30 mg of nicardipine hydrochloride. Nicardipine hydrochloride is a calcium ion influx inhibitor (slow channel blocker or calcium channel blocker).Nicardipine hydrochlori...
Active Ingredient	Nicardipine hydrochloride
Dosage Form	Capsule; Injectable
Route	Injection; Oral
Strength	30mg; 25mg/10ml (2.5mg/ml); 20mg
Market Status	Prescription
Company	Exela Pharma Science; Wockhardt; Navinta; Bedford; Ani Pharms; Epic Pharma; Sun Pharma Global; Mylan Institutional; Luitpold; Mylan

4 of 6
Drug Name	Cardene
Drug Label	Cardene (nicardipine HCI) is a calcium ion influx inhibitor (slow channel blocker or calcium channel blocker). Cardene I.V. for intravenous administration contains 2.5 mg/mL of nicardipine hydrochloride. Nicardipine hydrochloride is a dihydropy...
Active Ingredient	Nicardipine hydrochloride
Dosage Form	Injectable; Capsule
Route	Injection; Oral
Strength	25mg/10ml (2.5mg/ml); 30mg; 20mg
Market Status	Prescription
Company	Chiesi Usa

5 of 6
Drug Name	Cardene sr
Drug Label	CARDENE SR is a sustained release formulation of CARDENE. CARDENE SR capsules for oral administration each contain 30 mg, 45 mg or 60 mg of nicardipine hydrochloride. Nicardipine hydrochloride is a calcium ion influx inhibitor (slow channel block...
Active Ingredient	Nicardipine hydrochloride
Dosage Form	Capsule, extended release
Route	Oral
Strength	60mg; 30mg
Market Status	Prescription
Company	Chiesi Usa

6 of 6
Drug Name	Nicardipine hydrochloride
PubMed Health	Nicardipine
Drug Classes	Antianginal, Antihypertensive, Cardiovascular Agent
Drug Label	Nicardipine hydrochloride capsules for oral administration each contain 20 mg or 30 mg of nicardipine hydrochloride. Nicardipine hydrochloride is a calcium ion influx inhibitor (slow channel blocker or calcium channel blocker).Nicardipine hydrochlori...
Active Ingredient	Nicardipine hydrochloride
Dosage Form	Capsule; Injectable
Route	Injection; Oral
Strength	30mg; 25mg/10ml (2.5mg/ml); 20mg
Market Status	Prescription
Company	Exela Pharma Science; Wockhardt; Navinta; Bedford; Ani Pharms; Epic Pharma; Sun Pharma Global; Mylan Institutional; Luitpold; Mylan

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

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.)

Calcium Channel Blockers

A class of drugs that act by selective inhibition of calcium influx through cellular membranes. (See all compounds classified as Calcium Channel Blockers.)

Vasodilator Agents

Drugs used to cause dilation of the blood vessels. (See all compounds classified as Vasodilator Agents.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Cytochrome P450 2C19 Inhibitors [MoA]; Cytochrome P450 2C8 Inhibitors [MoA]; Cytochrome P450 2D6 Inhibitors [MoA]; Cytochrome P450 3A4 Inhibitors [MoA]; Dihydropyridine Calcium Channel Blocker [EPC]; Dihydropyridines [CS]; Calcium Channel Antagonists [MoA]

API SUPPLIERS

01

ChemWerth Inc

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

VMX

Attending

ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

02

LGM Pharma

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Duphat

Not Confirmed

LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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Metrochem API Private Limited

India

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Duphat

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Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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India

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04

Octavius Pharma Pvt. Ltd

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

MAGHREB PHARMA

Stand #B09

Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.

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05

Sichuan Qingmu Pharmaceutical

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Duphat

Not Confirmed

06

Wockhardt

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Duphat

Not Confirmed

07

Sifavitor srl

Italy

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Duphat

Not Confirmed

08

Zhejiang Huahai Pharmaceutical

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Duphat

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09

MSN Laboratories

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Duphat

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10

Qilu Pharmaceutical

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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OFFICE: NO. 16\/2,","city":"BANGALORE, KARNATAKA","supplier":"OLON S.P.A","supplierCountry":"ITALY","foreign_port":"MILAN","customer":"SOMERSET THERAPEUTICS LIMITED","customerCountry":"INDIA","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"30000","totalValueFC":"303082.6","currency":"USD","unitRateINR":"2533500","date":"09-Jul-2024","totalValueINR":"25335000","totalValueInUsd":"303082.6","indian_port":"Bangalore Air","hs_no":"29333990","bill_no":"4412448","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN","supplierAddress":"DIREZIONE E UFFICI STR RIVOLTANA KM6\/7 20053 RODANO (MI) Milano, , Italy Italy","customerAddress":"REGD. OFFICE: NO. 16\/2,"}]

Number of Transactions

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Quantity (KGS) & Unit rate (USD/KGS) over time

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Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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DOSAGE - INJECTABLE;INTRAVENOUS - 20MG/200ML ...DOSAGE - INJECTABLE;INTRAVENOUS - 20MG/200ML (0.1MG/ML)

USFDA APPLICATION NUMBER - 19734

DOSAGE - INJECTABLE;INJECTION - 25MG/10ML (2....DOSAGE - INJECTABLE;INJECTION - 25MG/10ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 19734

DOSAGE - INJECTABLE;INTRAVENOUS - 40MG/200ML ...DOSAGE - INJECTABLE;INTRAVENOUS - 40MG/200ML (0.2MG/ML)

USFDA APPLICATION NUMBER - 19734

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ABOUT THIS PAGE

Nicardipine Hydrochloride Manufacturers

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

Nicardipine Hydrochloride Suppliers

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

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

Nicardipine Hydrochloride USDMF

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

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

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

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

Nicardipine Hydrochloride KDMF

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

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

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

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

Nicardipine Hydrochloride WC

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

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

Nicardipine Hydrochloride 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 Nicardipine Hydrochloride as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Nicardipine Hydrochloride GMP

Nicardipine Hydrochloride 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 Nicardipine Hydrochloride 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 Nicardipine Hydrochloride GMP manufacturer or Nicardipine Hydrochloride GMP API supplier for your needs.

Nicardipine Hydrochloride CoA

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

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

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

INJECTABLE;INTRAVENOUS - 20MG/200ML (0.1MG/ML)

INJECTABLE;INJECTION - 25MG/10ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INTRAVENOUS - 40MG/200ML (0.2MG/ML)

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7 Parenteral

5 Solubilizers

4 Topical

4 Emulsifying Agents

3 Coloring Agents

INJECTABLE;INJECTION - 25MG/10ML (2.5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons