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ACTIVE PHARMA INGREDIENTS

65 API Suppliers, 34 USDMF, 11 JDMF, 15 EU WC, 26 KDMF, 31 NDC API, 36 Listed Suppliers, $ API Reference Price

65 API Suppliers
34 USDMF
11 JDMF
15 EU WC
26 KDMF
31 NDC API
36 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

4 Drugs in Development

4 Drugs in Development

INTERMEDIATES

14 Intermediates Suppliers

14 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

480 FDF Dossiers, 125 FDA Orange Book, 244 Europe, 11 Canada, 14 Australia, 7 South Africa, 79 Listed Dossiers

480 FDF Dossiers
125 FDA Orange Book
244 Europe
11 Canada
14 Australia
7 South Africa
79 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 10MG, TABLET;ORAL - 5MG, CAPSULE, EXTENDED RELEASE;ORAL - 14MG, CAPSULE, EXTENDED RELEASE;ORAL - 21MG, CAPSULE, EXTENDED RELEASE;ORAL - 28MG, CAPSULE, EXTENDED RELEASE;ORAL - 7MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

drugProductComposition
TABLET;ORAL - 10MG
TABLET;ORAL - 5MG
CAPSULE, EXTENDED RELEASE;ORAL - 14MG
CAPSULE, EXTENDED RELEASE;ORAL - 21MG
CAPSULE, EXTENDED RELEASE;ORAL - 28MG
CAPSULE, EXTENDED RELEASE;ORAL - 7MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem, 2 Rochem International Inc, 8 SPI Pharma, 2 Seqens, 8 DKSH, 1 Pharm-RX Chemical, 7 Faran Shimi Pharmaceutical, 5 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 16 Gangwal Healthcare, 8 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 4 ACG Worldwide, 8 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Avesta Pharma, 26 BASF, 1 Bioplus Life Sciences, 2 Clariant, 11 Corel Pharma Chem, 7 DFE Pharma, 2 Finar, 9 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 37 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 12 Microlex e.U, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 3 Novo Excipients, 4 Pharmatrans-Sanaq, 8 Pluviaendo, 5 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 27 Roquette, 8 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 3 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem, 1 Vertellus, 1 Zhejiang Huakang Pharmaceutical

relatedExcipients
1 Minakem
2 Rochem International Inc
8 SPI Pharma
2 Seqens
8 DKSH
1 Pharm-RX Chemical
7 Faran Shimi Pharmaceutical
5 Boai NKY Pharmaceuticals Ltd
1 Chynops Pharma
16 Gangwal Healthcare
8 Nanjing Well Pharmaceutical
1 Pfanstiehl
4 ACG Worldwide
8 Actylis
1 Aeon Procare
1 Alcedo Pharmachem
10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
1 Avesta Pharma
26 BASF
1 Bioplus Life Sciences
2 Clariant
11 Corel Pharma Chem
7 DFE Pharma
2 Finar
9 Gangwal Chemicals
7 Ideal Cures Pvt Ltd
4 Ingredion Pharma Solutions
37 Kerry
4 Kima Chemical
6 Lonza Capsugel
12 Microlex e.U
1 NEWEDGE Overseas
2 Nomisma Healthcare
3 Novo Excipients
4 Pharmatrans-Sanaq
8 Pluviaendo
5 Prachin Chemical
1 Qianhao Chemical (Hebei) Co., Ltd
2 Qualicaps
27 Roquette
8 Seppic
6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
1 Shanghai Welltone Material Technology Co., Ltd
1 Shijiazhuang Huaxu Pharmaceutical
12 Sigachi Industries
3 The Dow Chemical Company
1 Ulanqab Kema New Material
1 Valens Pharmachem
4 Vasa Pharmachem
1 Vertellus
1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

87 Fillers, Diluents & Binders, 60 Coating Systems & Additives, 37 Direct Compression, 37 Controlled & Modified Release, 34 Disintegrants & Superdisintegrants, 29 Thickeners and Stabilizers, 26 Film Formers & Plasticizers, 26 Granulation, 25 Lubricants & Glidants, 19 Taste Masking, 19 Solubilizers, 19 Topical, 18 Co-Processed Excipients, 17 Parenteral, 10 Chewable & Orodispersible Aids, 9 Empty Capsules, 7 Emulsifying Agents, 6 API Stability Enhancers, 5 Coloring Agents, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 4 Rheology Modifiers, 1 Soft Gelatin

DIGITAL CONTENT

4 DATA COMPILATION #PharmaFlow, 85 NEWS #PharmaBuzz

media
4 DATA COMPILATION #PharmaFlow
85 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 174 Finished Drug Prices, 13 Annual Reports

globalSalesInformation
3 US Medicaid Prescriptions
174 Finished Drug Prices
13 Annual Reports

MARKET PLACE

14 APIs, 5 FDF Dossiers

marketPlace
14 APIs
5 FDF Dossiers

PATENTS & EXCLUSIVITIES

66 US Patents, 2 Health Canada Patents

patents
66 US Patents
2 Health Canada Patents

REF. STANDARDS & IMPURITIES

6 USP , 15 Others

otherSolutions
6 USP
15 Others

ANALYTICAL

1 BioAnalytical Methods

otherMethods
1 BioAnalytical Methods

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 548

MARKET PLACE

API

FDF

14INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

480

FDF Dossiers

125

FDA Orange Book

244

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)

232,145,315

Annual Reports (USD Million)

2,087

Finished Drug Prices

305 RELATED EXCIPIENT COMPANIES

503EXCIPIENTS BY APPLICATIONS

Chemistry

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Click the button for full data set

Also known as: 41100-52-1, Memantine hcl, Namenda, 3,5-dimethyl-1-adamantanamine hydrochloride, 3,5-dimethyladamantan-1-amine hydrochloride, Akatinol

Molecular Formula

C₁₂H₂₂ClN

Molecular Weight

215.76 g/mol

InChI Key

LDDHMLJTFXJGPI-UHFFFAOYSA-N

FDA UNII

JY0WD0UA60

AMANTADINE derivative that has some dopaminergic effects. It has been proposed as an antiparkinson agent.

1 2D Structure

Memantine Hydrochloride

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

3,5-dimethyladamantan-1-amine;hydrochloride

2.1.2 InChI

InChI=1S/C12H21N.ClH/c1-10-3-9-4-11(2,6-10)8-12(13,5-9)7-10;/h9H,3-8,13H2,1-2H3;1H

2.1.3 InChI Key

LDDHMLJTFXJGPI-UHFFFAOYSA-N

2.1.4 Canonical SMILES

CC12CC3CC(C1)(CC(C3)(C2)N)C.Cl

2.2 Other Identifiers

2.2.1 UNII

JY0WD0UA60

2.3 Synonyms

2.3.1 MeSH Synonyms

1. 1,3-dimethyl-5-aminoadamantane

2. 1-amino-3,5-dimethyladamantane

3. Axura

4. D 145

5. D-145

6. D145

7. Ebixa

8. Memantin

9. Memantine

10. Namenda

2.3.2 Depositor-Supplied Synonyms

1. 41100-52-1

2. Memantine Hcl

3. Namenda

4. 3,5-dimethyl-1-adamantanamine Hydrochloride

5. 3,5-dimethyladamantan-1-amine Hydrochloride

6. Akatinol

7. Axura

8. Namenda Xr

9. Memary

10. Ebixa

11. Memantine Mylan

12. 1-amino-3,5-dimethyladamantane Hydrochloride

13. Memantine Merz

14. Memantine.hcl

15. Memantine Accord

16. Memantine Lek

17. Memantine (hydrochloride)

18. Acrescent

19. Balaxur

20. Auxura

21. Unii-jy0wd0ua60

22. 3,5-dimethyladamantan-1-amine;hydrochloride

23. Jy0wd0ua60

24. Mfcd00214336

25. Memantine Ratiopharm

26. Memantine Hydrochloride [usan]

27. Chebi:64323

28. Sun-y7017

29. Nsc-102290

30. 3,5-dimethyladamantan-1-aminium Chloride

31. D-145

32. Mls001332605

33. 3,5-dimethyl-1-aminoadamantane Hydrochloride

34. (3,5-dimethyl-1-adamantyl)amine Hydrochloride

35. 3,5-dimethyltricyclo(3.3.1.1(3,7))decan-1-amine Hydrochloride

36. Fp-01

37. 1,3-dimethyl-5-adamantanamine Hcl

38. 3,5-dimethyltricyclo[3.3.1.13,7]decan-1-amine Hydrochloride

39. 41100-52-1 (hcl)

40. Tricyclo[3.3.1.13,7]decan-1-amine, 3,5-dimethyl-, Hydrochloride

41. D 145

42. Mantine

43. Ebixza

44. 3,5-dimethyl-tricyclo[3.3.1.13,7]decan-1-amine Hydrochloride

45. 3,5-dimethyltricyclo(3.3.1.13,7)decan-1-amine Hydrochloride

46. 3,5-dimethyltricyclo(3.3.1.1(sup 3,7))decan-1-amine Hydrochloride

47. Tricyclo(3.3.1.1(sup 3,7))decan-1-amine, 3,5-dimethyl-, Hydrochloride

48. 3,5-dimethyl-1-adamantylamine

49. 3,5-dimethyl-1-aminoadamantane

50. Smr000875213

51. Sr-01000075458

52. Sun Y7017

53. Einecs 255-219-6

54. Namenda (tn)

55. Memary (tn)

56. Marixino

57. Nsc 102290

58. D-145 (hydrochloride)

59. Schembl3053

60. C12h21n.hcl

61. Chembl1699

62. Mls001332606

63. Spectrum1501121

64. Hy-b0365a

65. Dtxsid90961439

66. Memantine Hydrochloride (namenda)

67. N06dx01

68. Nmi-131

69. Hms1571c17

70. Hms1921h03

71. Pharmakon1600-01501121

72. Memantine Hydrochloride (jan/usp)

73. Memantine Hydrochloride [mi]

74. Tox21_500861

75. Ac-559

76. Ccg-39018

77. Memantine Hydrochloride [jan]

78. Mrz-2/145

79. Nsc102290

80. Nsc757843

81. S2043

82. Akos015889460

83. Bcp9000253

84. Lp00861

85. Memantine Hydrochloride [mart.]

86. Nc00680

87. Memantine Hydrochloride [usp-rs]

88. Memantine Hydrochloride [who-dd]

89. Ncgc00094186-01

90. Ncgc00094186-02

91. Ncgc00094186-03

92. Ncgc00261546-01

93. As-13331

94. Bm164662

95. Memantine Hydrochloride [ema Epar]

96. Sy057917

97. 3,5-dimethyladamantan-1-aminehydrochloride

98. Am20070534

99. D3608

100. Eu-0100861

101. Ft-0650723

102. M-145

103. Memantine Hydrochloride [orange Book]

104. Sw060653-4

105. 1-amino-3,5-dimethyl-adamantane Hydrochloride

106. 3,5-dimethyladamantan-1-amine Hy-drochloride

107. 3,5-dimethyladamantan-1-amine;hydrochloride.

108. D04905

109. M 9292

110. Memantine Hydrochloride [usp Monograph]

111. Namzaric Component Memantine Hydrochloride

112. Memantine Hydrochloride Component Of Namzaric

113. Sr-01000075458-1

114. Sr-01000075458-3

115. Sr-01000075458-8

116. Q27133218

117. Z1551429722

118. Tricyclo(3.3.1.1(3,7))decan-1-amine, 3,5-dimethyl-, Hydrochloride

119. Tricyclo[3.3.1.13,7]decan-1-amine, 3,5-dimethyl-, Hydrochloride (1:1) (ca Index Name)

120. 1-amino-3,5-dimethyladamantane . Hcl 3,5-dimethyl-1-aminoadamantane . Hcl Memantine . Hydrochloride

2.4 Create Date

2005-07-19

3 Chemical and Physical Properties

Molecular Formula	C₁₂H₂₂ClN
Molecular Weight	215.76 g/mol
Hydrogen Bond Donor Count	2
Hydrogen Bond Acceptor Count	1
Rotatable Bond Count	0
Exact Mass	215.1440774 g/mol
Monoisotopic Mass	215.1440774 g/mol
Topological Polar Surface Area	26 Å²
Heavy Atom Count	14
Formal Charge	0
Complexity	240
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	2
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	Memantine hydrochloride
PubMed Health	Memantine (By mouth)
Drug Classes	Central Nervous System Agent
Drug Label	Namenda (memantine hydrochloride) is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula: The molecular formula is C12H21N...
Active Ingredient	Memantine hydrochloride
Dosage Form	Tablet
Route	oral; Oral
Strength	5mg; 10mg
Market Status	Tentative Approval
Company	Amneal Pharms; Alembic; Upsher Smith; Mylan Pharma; Unichem Pharms (usa); Apotex; Lupin Pharms; Aurobindo Pharma; Torrent Pharms; Macleods Pharms; Jubilant Life

2 of 6
Drug Name	Namenda
PubMed Health	Memantine (By mouth)
Drug Classes	Central Nervous System Agent
Drug Label	Namenda (memantine hydrochloride) is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula: The molecular formula is C12H21N...
Active Ingredient	Memantine hydrochloride
Dosage Form	Tablet; Solution
Route	Oral
Strength	2mg/ml; 5mg; 10mg
Market Status	Prescription
Company	Forest Labs

3 of 6
Drug Name	Namenda xr
Drug Label	NAMENDA XR is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula: The molecular formula is C12H21NHCl and the molecular wei...
Active Ingredient	Memantine hydrochloride
Dosage Form	Capsule, extended release
Route	Oral
Strength	7mg; 14mg; 21mg; 28mg
Market Status	Prescription
Company	Forest Labs

4 of 6
Drug Name	Memantine hydrochloride
PubMed Health	Memantine (By mouth)
Drug Classes	Central Nervous System Agent
Drug Label	Namenda (memantine hydrochloride) is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula: The molecular formula is C12H21N...
Active Ingredient	Memantine hydrochloride
Dosage Form	Tablet
Route	oral; Oral
Strength	5mg; 10mg
Market Status	Tentative Approval
Company	Amneal Pharms; Alembic; Upsher Smith; Mylan Pharma; Unichem Pharms (usa); Apotex; Lupin Pharms; Aurobindo Pharma; Torrent Pharms; Macleods Pharms; Jubilant Life

5 of 6
Drug Name	Namenda
PubMed Health	Memantine (By mouth)
Drug Classes	Central Nervous System Agent
Drug Label	Namenda (memantine hydrochloride) is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula: The molecular formula is C12H21N...
Active Ingredient	Memantine hydrochloride
Dosage Form	Tablet; Solution
Route	Oral
Strength	2mg/ml; 5mg; 10mg
Market Status	Prescription
Company	Forest Labs

6 of 6
Drug Name	Namenda xr
Drug Label	NAMENDA XR is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula: The molecular formula is C12H21NHCl and the molecular wei...
Active Ingredient	Memantine hydrochloride
Dosage Form	Capsule, extended release
Route	Oral
Strength	7mg; 14mg; 21mg; 28mg
Market Status	Prescription
Company	Forest Labs

4.2 Drug Indication

Treatment of patients with moderate to severe Alzheimer's disease.

Treatment of patients with moderate to severe Alzheimers disease.

Treatment of patients with moderate to severe Alzheimer's disease.

Treatment of patients with moderate to severe Alzheimers disease

Treatment of patients with moderate to severe Alzheimers disease.

Treatment of Alzheimers disease

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Antiparkinson Agents

Agents used in the treatment of Parkinson's disease. The most commonly used drugs act on the dopaminergic system in the striatum and basal ganglia or are centrally acting muscarinic antagonists. (See all compounds classified as Antiparkinson Agents.)

Dopamine Agents

Any drugs that are used for their effects on dopamine receptors, on the life cycle of dopamine, or on the survival of dopaminergic neurons. (See all compounds classified as Dopamine Agents.)

Excitatory Amino Acid Antagonists

Drugs that bind to but do not activate excitatory amino acid receptors, thereby blocking the actions of agonists. (See all compounds classified as Excitatory Amino Acid Antagonists.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

NMDA Receptor Antagonists [MoA]; N-methyl-D-aspartate Receptor Antagonist [EPC]

5.3 ATC Code

N06DX01

N06D

N06DA52

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API Reference Price

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VAISHNODE"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1695321000,"product":"MEMANTINE HYDROCHLORIDE, U.S.P.","address":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H","city":"AHMEDABAD,GUJARAT","supplier":"AMSA SPA","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"ZYDUS LIFESCIENCES LIMITED","customerCountry":"INDIA","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"650","totalValueFC":"17628.5","currency":"EUR","unitRateINR":"58532.5","date":"22-Sep-2023","totalValueINR":"1463312.5","totalValueInUsd":"17628.5","indian_port":"Bombay Air","hs_no":"29213090","bill_no":"7961136","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"VIALE DEL GHISALLO 20-20151 MILANOMILAN, ItalySDNF Italy","customerAddress":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1696012200,"product":"MEMANTINE HYDROCHLORIDE USP","address":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H","city":"AHMEDABAD,GUJARAT","supplier":"AMSA SPA","supplierCountry":"ITALY","foreign_port":"SEGRATE AIRPRT MILAN","customer":"ZYDUS LIFESCIENCES LIMITED","customerCountry":"INDIA","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"650","totalValueFC":"17628.5","currency":"EUR","unitRateINR":"58532.5","date":"30-Sep-2023","totalValueINR":"1463312.5","totalValueInUsd":"17628.5","indian_port":"Bombay Air","hs_no":"29213090","bill_no":"8098771","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"SEGRATE AIRPRT MILAN","supplierAddress":"VIALE DEL GHISALLO 20-20151 MILANOMILAN, ItalySDNF Italy","customerAddress":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1706466600,"product":"MEMANTINE HYDROCHLORIDE","address":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H","city":"AHMEDABAD,GUJARAT","supplier":"AMSA SPA","supplierCountry":"ITALY","foreign_port":"SEGRATE AIRPRT MILAN","customer":"ZYDUS LIFESCIENCES LIMITED","customerCountry":"INDIA","quantity":"9.27","actualQuantity":"9.27","unit":"KGS","unitRateFc":"650","totalValueFC":"6691.6","currency":"EUR","unitRateINR":"59995","date":"29-Jan-2024","totalValueINR":"556153.65","totalValueInUsd":"6691.6","indian_port":"Bombay Air","hs_no":"29213090","bill_no":"9885106","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"SEGRATE AIRPRT MILAN","supplierAddress":"VIALE DEL GHISALLO 20-20151 MILANOMILAN, , ItalySDNF Italy","customerAddress":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1709922600,"product":"MEMANTINE HYDROCHLORIDE","address":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H","city":"AHMEDABAD,GUJARAT","supplier":"AMSA SPA","supplierCountry":"ITALY","foreign_port":"SEGRATE AIRPRT MILAN","customer":"ZYDUS LIFESCIENCES LIMITED","customerCountry":"INDIA","quantity":"33.31","actualQuantity":"33.31","unit":"KGS","unitRateFc":"650","totalValueFC":"23962.8","currency":"EUR","unitRateINR":"59735","date":"09-Mar-2024","totalValueINR":"1989772.85","totalValueInUsd":"23962.8","indian_port":"Bombay Air","hs_no":"29213090","bill_no":"2499114","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"SEGRATE AIRPRT MILAN","supplierAddress":"VIALE DEL GHISALLO 20-20151 MILANOMILAN, , ItalySDNF Italy","customerAddress":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1709922600,"product":"MEMANTINE HYDROCHLORIDE","address":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H","city":"AHMEDABAD,GUJARAT","supplier":"AMSA SPA","supplierCountry":"ITALY","foreign_port":"SEGRATE AIRPRT MILAN","customer":"ZYDUS LIFESCIENCES LIMITED","customerCountry":"INDIA","quantity":"109.42","actualQuantity":"109.42","unit":"KGS","unitRateFc":"650","totalValueFC":"78715.5","currency":"EUR","unitRateINR":"59735","date":"09-Mar-2024","totalValueINR":"6536203.7","totalValueInUsd":"78715.5","indian_port":"Bombay Air","hs_no":"29213090","bill_no":"2499114","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"SEGRATE AIRPRT MILAN","supplierAddress":"VIALE DEL GHISALLO 20-20151 MILANOMILAN, , ItalySDNF Italy","customerAddress":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1712255400,"product":"MEMANTINE","address":"BIOCON SEZ, BIOCON PARK,PLOT NO.2 3","city":"","supplier":"COMBI BLOCKS INC","supplierCountry":"CHINA","foreign_port":"SAN DIEGO","customer":"SYNGENE INTERNATIONAL LIMITED","customerCountry":"INDIA","quantity":"0.09","actualQuantity":"87","unit":"GMS","unitRateFc":"18.6","totalValueFC":"1636.8","currency":"USD","unitRateINR":"1571.1","date":"05-Apr-2024","totalValueINR":"136687","totalValueInUsd":"1636.8","indian_port":"Biocon-SEZ","hs_no":"29420090","bill_no":"1004243","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SAN DIEGO","supplierAddress":"N\/A","customerAddress":"BIOCON SEZ, BIOCON PARK,PLOT NO.2 3"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1724265000,"product":"MEMANTINE HCL IH","address":"HETERO CORPORATE, NO. 7-2-A2,,INDU","city":"HYDERABAD,TELANGANA","supplier":"HETERO DRUGS LTD UNIT IX","supplierCountry":"INDIA","foreign_port":"HIPL SEZ","customer":"HETERO DRUGS","customerCountry":"INDIA","quantity":"32.00","actualQuantity":"32","unit":"KGS","unitRateFc":"471.4","totalValueFC":"15260.2","currency":"USD","unitRateINR":"40000","date":"22-Aug-2024","totalValueINR":"1280000","totalValueInUsd":"15260.2","indian_port":"Vizag-HIPL SEZ","hs_no":"29213090","bill_no":"5179937","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"HIPL SEZ","supplierAddress":"PLOT NO 1 HETERO INFRASTRUCTURE SEZ N.NARASAPURAM (V), NAKKAPALLY SDNF India","customerAddress":"HETERO CORPORATE, NO. 7-2-A2,,INDU"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725820200,"product":"MEMANTINE HYDROCHLORIDE USP","address":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR","city":"AHMEDABAD\/GUJRAT","supplier":"AMSA SPA","supplierCountry":"ITALY","foreign_port":"SEGRATE AIRPRT MILAN","customer":"ZYDUS LIFESCIENCES LIMITED","customerCountry":"INDIA","quantity":"56.00","actualQuantity":"56","unit":"KGS","unitRateFc":"625","totalValueFC":"39572.8","currency":"EUR","unitRateINR":"59218.8","date":"09-Sep-2024","totalValueINR":"3316250","totalValueInUsd":"39572.8","indian_port":"Bombay Air","hs_no":"29213090","bill_no":"5504333","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"SEGRATE AIRPRT MILAN","supplierAddress":"VIALE DEL GHISALLO 20-20151 MILANO MILAN, , Italy SDNF Italy Italy","customerAddress":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1727289000,"product":"MEMANTINE HYDROCHLORIDE USP","address":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H","city":"AHMEDABAD,GUJARAT","supplier":"AMSA SPA","supplierCountry":"ITALY","foreign_port":"SEGRATE AIRPRT MILAN","customer":"ZYDUS LIFESCIENCES LIMITED","customerCountry":"INDIA","quantity":"175.00","actualQuantity":"175","unit":"KGS","unitRateFc":"625","totalValueFC":"123599.8","currency":"EUR","unitRateINR":"59187.5","date":"26-Sep-2024","totalValueINR":"10357812.5","totalValueInUsd":"123599.8","indian_port":"Bombay Air","hs_no":"29213090","bill_no":"5811849","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"SEGRATE AIRPRT MILAN","supplierAddress":"VIALE DEL GHISALLO 20-20151 MILANO MILAN, , Italy SDNF Italy","customerAddress":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732818600,"product":"MEMANTINE HYDROCHLORIDE USP","address":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H","city":"AHMEDABAD,GUJARAT","supplier":"AMSA SPA","supplierCountry":"ITALY","foreign_port":"SIEGEN","customer":"ZYDUS LIFESCIENCES LIMITED","customerCountry":"INDIA","quantity":"43.20","actualQuantity":"43.2","unit":"KGS","unitRateFc":"625","totalValueFC":"29051.5","currency":"EUR","unitRateINR":"56750","date":"29-Nov-2024","totalValueINR":"2451600","totalValueInUsd":"29051.5","indian_port":"Bombay Air","hs_no":"29213090","bill_no":"6951825","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"SIEGEN","supplierAddress":"VIALE DEL GHISALLO 20-20151 MILANO MILAN, Italy SDNF Italy","customerAddress":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H"}]

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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DOSAGE - TABLET;ORAL - 10MG

USFDA APPLICATION NUMBER - 21487

DOSAGE - TABLET;ORAL - 5MG

USFDA APPLICATION NUMBER - 21487

DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 14M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 14MG

USFDA APPLICATION NUMBER - 22525

DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 21M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 21MG

USFDA APPLICATION NUMBER - 22525

DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 28M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 28MG

USFDA APPLICATION NUMBER - 22525

DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 7MG...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 7MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 22525

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ABOUT THIS PAGE

Memantine Hydrochloride Manufacturers

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

Memantine Hydrochloride Suppliers

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

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

Memantine Hydrochloride USDMF

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

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

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

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

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

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

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

Memantine Hydrochloride WC

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

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

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

Finished drug products

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

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

Memantine Hydrochloride GMP

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

Memantine Hydrochloride CoA

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

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

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

Find Memantine Hydrochloride manufacturers, exporters & distributors on PharmaCompass

Memantine Hydrochloride

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

65 API Suppliers

34 USDMF

11 JDMF

15 EU WC

26 KDMF

31 NDC API

36 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

4 Drugs in Development

INTERMEDIATES

14 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

480 FDF Dossiers

125 FDA Orange Book

244 Europe

11 Canada

14 Australia

7 South Africa

79 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 10MG

TABLET;ORAL - 5MG

CAPSULE, EXTENDED RELEASE;ORAL - 14MG

CAPSULE, EXTENDED RELEASE;ORAL - 21MG

CAPSULE, EXTENDED RELEASE;ORAL - 28MG

CAPSULE, EXTENDED RELEASE;ORAL - 7MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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CAPSULE, EXTENDED RELEASE;ORAL - 7MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons