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ACTIVE PHARMA INGREDIENTS

23 API Suppliers, 16 USDMF, 6 CEP/COS, 3 JDMF, 2 KDMF, 13 NDC API, 10 Listed Suppliers, $ API Reference Price

23 API Suppliers
16 USDMF
6 CEP/COS
3 JDMF
2 KDMF
13 NDC API
10 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

46 Drugs in Development

46 Drugs in Development

INTERMEDIATES

2 Intermediates Suppliers

2 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

175 FDF Dossiers, 137 FDA Orange Book, 3 Europe, 7 Canada, 2 Australia, 6 South Africa, 20 Listed Dossiers

175 FDF Dossiers
137 FDA Orange Book
3 Europe
7 Canada
2 Australia
6 South Africa
20 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - EQ 100MG BASE/VIAL, CAPSULE;ORAL - EQ 100MG BASE, CAPSULE;ORAL - EQ 50MG BASE, CAPSULE;ORAL - EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, POWDER, EXTENDED RELEASE;DENTAL - EQ 1MG BASE, TABLET, EXTENDED RELEASE;ORAL - EQ 105MG BASE, TABLET, EXTENDED RELEASE;ORAL - EQ 115MG BASE, TABLET, EXTENDED RELEASE;ORAL - EQ 135MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - EQ 55MG BASE, TABLET, EXTENDED RELEASE;ORAL - EQ 65MG BASE, TABLET, EXTENDED RELEASE;ORAL - EQ 80MG BASE, TABLET, EXTENDED RELEASE;ORAL - EQ 90MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

drugProductComposition
INJECTABLE;INJECTION - EQ 100MG BASE/VIAL
CAPSULE;ORAL - EQ 100MG BASE
CAPSULE;ORAL - EQ 50MG BASE
CAPSULE;ORAL - EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
POWDER, EXTENDED RELEASE;DENTAL - EQ 1MG BASE
TABLET, EXTENDED RELEASE;ORAL - EQ 105MG BASE
TABLET, EXTENDED RELEASE;ORAL - EQ 115MG BASE
TABLET, EXTENDED RELEASE;ORAL - EQ 135MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - EQ 55MG BASE
TABLET, EXTENDED RELEASE;ORAL - EQ 65MG BASE
TABLET, EXTENDED RELEASE;ORAL - EQ 80MG BASE
TABLET, EXTENDED RELEASE;ORAL - EQ 90MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem, 5 SPI Pharma, 2 Seqens, 8 DKSH, 2 Jai Radhe Sales, 4 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 13 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 4 ACG Worldwide, 5 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 27 BASF, 1 Clariant, 10 Corel Pharma Chem, 6 DFE Pharma, 2 Finar, 10 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 35 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 14 Microlex e.U, 1 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 2 Novo Excipients, 4 Pharmatrans-Sanaq, 5 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 19 Roquette, 14 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 11 Sigachi Industries, 2 The Dow Chemical Company, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem, 1 Vertellus

relatedExcipients
1 Minakem
5 SPI Pharma
2 Seqens
8 DKSH
2 Jai Radhe Sales
4 Boai NKY Pharmaceuticals Ltd
1 Chynops Pharma
13 Gangwal Healthcare
7 Nanjing Well Pharmaceutical
4 ACG Worldwide
5 Actylis
1 Aeon Procare
1 Alcedo Pharmachem
8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
27 BASF
1 Clariant
10 Corel Pharma Chem
6 DFE Pharma
2 Finar
10 Gangwal Chemicals
5 Ideal Cures Pvt Ltd
3 Ingredion Pharma Solutions
35 Kerry
3 Kima Chemical
6 Lonza Capsugel
14 Microlex e.U
1 Nanjing Bold Chemical
1 NEWEDGE Overseas
2 Nomisma Healthcare
2 Novo Excipients
4 Pharmatrans-Sanaq
5 Pluviaendo
4 Prachin Chemical
1 Qianhao Chemical (Hebei) Co., Ltd
2 Qualicaps
19 Roquette
14 Seppic
5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
1 Shanghai Welltone Material Technology Co., Ltd
11 Sigachi Industries
2 The Dow Chemical Company
2 Ulanqab Kema New Material
1 Valens Pharmachem
3 Vasa Pharmachem
1 Vertellus

EXCIPIENTS BY APPLICATIONS

78 Fillers, Diluents & Binders, 52 Coating Systems & Additives, 36 Direct Compression, 30 Controlled & Modified Release, 29 Thickeners and Stabilizers, 28 Lubricants & Glidants, 25 Solubilizers, 24 Disintegrants & Superdisintegrants, 23 Granulation, 20 Film Formers & Plasticizers, 18 Co-Processed Excipients, 18 Topical, 13 Parenteral, 10 Taste Masking, 9 Empty Capsules, 8 Emulsifying Agents, 8 Chewable & Orodispersible Aids, 6 API Stability Enhancers, 5 Surfactant & Foaming Agents, 5 Coloring Agents, 4 Vegetarian Capsules, 4 Rheology Modifiers

DIGITAL CONTENT

4 DATA COMPILATION #PharmaFlow, 69 NEWS #PharmaBuzz

media
4 DATA COMPILATION #PharmaFlow
69 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

6 US Medicaid Prescriptions, 21 Finished Drug Prices, 1 Annual Reports

globalSalesInformation
6 US Medicaid Prescriptions
21 Finished Drug Prices
1 Annual Reports

MARKET PLACE

33 APIs, 2 FDF Dossiers

marketPlace
33 APIs
2 FDF Dossiers

PATENTS & EXCLUSIVITIES

82 US Patents, 3 Health Canada Patents

patents
82 US Patents
3 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM , 1 USP , 2 Others

otherSolutions
2 EDQM
1 USP
2 Others

ANALYTICAL

1 BioAnalytical Methods

otherMethods
1 BioAnalytical Methods

Suanfarma Minocycline Hydrochloride

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 1,136

MARKET PLACE

API

FDF

2INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

175

FDF Dossiers

137

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

46DRUGS 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)

20,272,156

Annual Reports (USD Million)

Finished Drug Prices

265 RELATED EXCIPIENT COMPANIES

453EXCIPIENTS BY APPLICATIONS

Chemistry

Click the arrow to open the dropdown

Click the button for full data set

Also known as: 13614-98-7, Minocycline hcl, Arestin, Solodyn, Minomycin, Minocin

Molecular Formula

C₂₃H₂₈ClN₃O₇

Molecular Weight

493.9 g/mol

InChI Key

WTJXVDPDEQKTCV-VQAITOIOSA-N

FDA UNII

0020414E5U

A TETRACYCLINE analog, having a 7-dimethylamino and lacking the 5 methyl and hydroxyl groups, which is effective against tetracycline-resistant STAPHYLOCOCCUS infections.

1 2D Structure

Minocycline Hydrochloride

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

(4S,4aS,5aR,12aR)-4,7-bis(dimethylamino)-1,10,11,12a-tetrahydroxy-3,12-dioxo-4a,5,5a,6-tetrahydro-4H-tetracene-2-carboxamide;hydrochloride

2.1.2 InChI

InChI=1S/C23H27N3O7.ClH/c1-25(2)12-5-6-13(27)15-10(12)7-9-8-11-17(26(3)4)19(29)16(22(24)32)21(31)23(11,33)20(30)14(9)18(15)28;/h5-6,9,11,17,27-28,31,33H,7-8H2,1-4H3,(H2,24,32);1H/t9-,11-,17-,23-;/m0./s1

2.1.3 InChI Key

WTJXVDPDEQKTCV-VQAITOIOSA-N

2.1.4 Canonical SMILES

CN(C)C1C2CC3CC4=C(C=CC(=C4C(=C3C(=O)C2(C(=C(C1=O)C(=O)N)O)O)O)O)N(C)C.Cl

2.1.5 Isomeric SMILES

CN(C)[C@H]1[C@@H]2C[C@@H]3CC4=C(C=CC(=C4C(=C3C(=O)[C@@]2(C(=C(C1=O)C(=O)N)O)O)O)O)N(C)C.Cl

2.2 Other Identifiers

2.2.1 UNII

0020414E5U

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Akamin

2. Akne Puren

3. Akne-puren

4. Aknemin

5. Aknin Mino

6. Aknin-mino

7. Aknosan

8. Apo Minocycline

9. Apo-minocycline

10. Arestin

11. Blemix

12. Cyclomin

13. Cyclops

14. Dentomycin

15. Dynacin

16. Hydrochloride, Minocycline

17. Icht Oral

18. Icht-oral

19. Klinomycin

20. Lederderm

21. Mestacine

22. Minakne

23. Mino Wolff

24. Mino-wolff

25. Minocin

26. Minocin Mr

27. Minoclir

28. Minocycline

29. Minocycline Monohydrochloride

30. Minocycline, (4r-(4 Alpha,4a Beta,5a Beta,12a Beta))-isomer

31. Minolis

32. Minomycin

33. Minoplus

34. Minotab

35. Minox 50

36. Monohydrochloride, Minocycline

37. Mynocine

2.3.2 Depositor-Supplied Synonyms

1. 13614-98-7

2. Minocycline Hcl

3. Arestin

4. Solodyn

5. Minomycin

6. Minocin

7. Dynacin

8. Periocline

9. Ximino

10. Minocycline (hydrochloride)

11. Vectrin

12. Minomax

13. (4s,4as,5ar,12as)-4,7-bis(dimethylamino)-3,10,12,12a-tetrahydroxy-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide Hydrochloride

14. Mynocine Hydrochloride

15. Minocycline (as Hydrochloride)

16. Minocycline, Hydrochloride

17. 4,7-bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide Monohydrochloride

18. 0020414e5u

19. Tri-mino

20. Nsc-141993

21. Dsstox_cid_24545

22. Dsstox_rid_80306

23. Dsstox_gsid_44545

24. (4s,4as,5ar,12ar)-4,7-bis(dimethylamino)-1,10,11,12a-tetrahydroxy-3,12-dioxo-4a,5,5a,6-tetrahydro-4h-tetracene-2-carboxamide;hydrochloride

25. [4s-(4alpha,4aalpha,5aalpha,12aalpha)]-4,7-bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxonaphthacene-2-carboxamide Monohydrochloride

26. Lederderm

27. Mynocine

28. Acnez

29. Minomycin Chloride

30. Chebi:50697

31. (4s-(4alpha,4aalpha,5aalpha,12aalpha))-4,7-bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxonaphthacene-2-carboxamide Monohydrochloride

32. [4s-(4?,4a?,5a?,12a?)]-4,7-bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a,tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide

33. 2-naphthacenecarboxamide, 4,7-bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-, Hydrochloride (1:2), (4s,4as,5ar,12as)-

34. Einecs 237-099-7

35. Minocycline Hydrochloride (internal Use)

36. C23h27n3o7.hcl

37. Minocycline, Hcl

38. Unii-0020414e5u

39. Ncgc00096006-01

40. Prestwick_626

41. Arestin (tn)

42. Dynacin (tn)

43. Minocin (tn)

44. Solodyn (tn)

45. Minocycline Hydrochloride [usp:jan]

46. 7-dimethylamino-6-demethyl-6-deoxytetracycline, Hcl

47. Mfcd00083669

48. Minocyclinhydrochlorid

49. Amzeeq

50. Minolira

51. Zilxi

52. Minomycin Hydrochloride

53. Schembl2537

54. Cas-13614-98-7

55. 2-naphthacenecarboxamide, 4,7-bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-, Monohydrochloride, (4s-(4alpha,4aalpha,5aalpha,12aalpha))-

56. Mls002548863

57. Spectrum1500414

58. Fxfm-244

59. Chembl1200881

60. Chembl4576719

61. Dtxsid8044545

62. Hms1568p12

63. Pharmakon1600-01500414

64. Bcp06597

65. Tox21_111250

66. Tox21_113183

67. Tox21_301590

68. Ccg-40107

69. Nsc757120

70. S4226

71. Minocycline Hydrochloride [mi]

72. Minocycline Hydrochloride, Crystalline

73. Akos015951312

74. Minocycline Hydrochloride (jp17/usp)

75. Tox21_111250_1

76. Cs-1256

77. Minocycline Hydrochloride [jan]

78. Nc00460

79. Nsc-757120

80. Minocycline Hydrochloride [mart.]

81. Minocycline Hydrochloride [vandf]

82. Ncgc00178854-03

83. Ncgc00255988-01

84. Ac-22362

85. As-75306

86. Hy-17412

87. Minocycline Hydrochloride [usp-rs]

88. Minocycline Hydrochloride [who-dd]

89. Smr001906766

90. M2288

91. D00850

92. Minocycline Hydrochloride [orange Book]

93. Minocycline Hydrochloride [usp Monograph]

94. 614m987

95. Sr-01000075625

96. Q-201407

97. Sr-01000075625-1

98. Q27104777

99. Minocycline Hydrochloride, Antibiotic For Culture Media Use Only

100. Minocycline Hydrochloride, European Pharmacopoeia (ep) Reference Standard

101. Minocycline Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material

102. Minocycline Hydrochloride, United States Pharmacopeia (usp) Reference Standard

103. (4s,12as,4as,5ar)-4,7-bis(dimethylamino)-3,10,12,12a-tetrahydroxy-1,11-dioxo-4,5,6,12a,4a,5a-hexahydronaphthacene-2-carboxamide Hydrochloride

104. (4s,4as,5ar,12as)-4,7-bis(dimethylamino)-3,10,12,12a-tetrahydroxy-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamidehydrochloride

105. 2-naphthacenecarboxamide, 4,7-bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-, Monohydrochloride, (4s-(4.alpha.,4a.alpha.,5a.alpha.,12a.alpha.))-

2.4 Create Date

2011-12-26

3 Chemical and Physical Properties

Molecular Formula	C₂₃H₂₈ClN₃O₇
Molecular Weight	493.9 g/mol
Hydrogen Bond Donor Count	6
Hydrogen Bond Acceptor Count	9
Rotatable Bond Count	3
Exact Mass	493.1615779 g/mol
Monoisotopic Mass	493.1615779 g/mol
Topological Polar Surface Area	165 Å²
Heavy Atom Count	34
Formal Charge	0
Complexity	971
Isotope Atom Count	0
Defined Atom Stereocenter Count	4
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 10
Drug Name	Arestin
PubMed Health	Minocycline
Drug Classes	Amebicide, Intestinal, Antiacne, Antiacne Antibacterial, Antibiotic, Antiprotozoal, Tetracycline
Drug Label	ARESTIN (minocycline hydrochloride) Microspheres is a subgingival sustained-release product containing the antibiotic minocycline hydrochloride incorporated into a bioresorbable polymer, Poly (glycolide-co-dl-lactide) or PGLA, for professional subg...
Active Ingredient	Minocycline hydrochloride
Dosage Form	Powder, extended release
Route	Dental
Strength	eq 1mg base
Market Status	Prescription
Company	Orapharma

2 of 10
Drug Name	Dynacin
Drug Label	Minocycline hydrochloride, is a semisynthetic derivative of tetracycline, 4,7-Bis(dimethylamino)1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1, 11-dioxo-2naphthacenecarboxamide monohydrochloride. Its structural formula is:C23H27N3O7...
Active Ingredient	Minocycline hydrochloride
Dosage Form	Capsule
Route	Oral
Strength	eq 100mg base; eq 75mg base
Market Status	Prescription
Company	Cnty Line Pharms

3 of 10
Drug Name	Minocin
PubMed Health	Minocycline, Regular Release (By mouth)
Drug Classes	Amebicide, Intestinal, Antiacne, Antibiotic, Antiprotozoal
Drug Label	MINOCIN minocycline hydrochloride, is a semisynthetic derivative of tetracycline, 4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride.Its structural formula is:C23H27N...
Active Ingredient	Minocycline hydrochloride
Dosage Form	Capsule; Injectable
Route	Injection; Oral
Strength	eq 100mg base; eq 50mg base; eq 100mg base/vial
Market Status	Prescription
Company	Rempex Pharms; Precision Dermat

4 of 10
Drug Name	Minocycline hydrochloride
Drug Label	To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride capsules and other antibacterial drugs, minocycline hydrochloride capsules should be used only to treat or prevent infections that are pr...
Active Ingredient	Minocycline hydrochloride
Dosage Form	Tablet, extended release; Tablet; Capsule
Route	oral; Oral
Strength	65mg; 115mg; eq 100mg base; eq 50mg base; eq 105mg base; eq 65mg base; eq 115mg base; eq 75mg base; eq 90mg base; eq 80mg base; 55mg; eq 45mg base; eq 55mg base; eq 135mg base
Market Status	Tentative Approval; Prescription
Company	Mylan Pharms; Ranbaxy; Teva; Mylan Labs; Sun Pharm Inds; Aurobindo Pharma; Lupin; Barr Labs; Sandoz; Par Pharm; Watson Labs; Ranbaxy Labs; Dr Reddys Labs; Impax Labs

5 of 10
Drug Name	Solodyn
PubMed Health	Minocycline
Drug Classes	Amebicide, Intestinal, Antiacne, Antiacne Antibacterial, Antibiotic, Antiprotozoal, Tetracycline
Drug Label	Minocycline hydrochloride, a semi synthetic derivative of tetracycline, is [4S-(4,4a,5a,12a)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide mono hydrochloride. The structura...
Active Ingredient	Minocycline hydrochloride
Dosage Form	Tablet, extended release
Route	Oral
Strength	eq 105mg base; eq 65mg base; eq 115mg base; eq 80mg base; eq 55mg base
Market Status	Prescription
Company	Medicis

6 of 10
Drug Name	Arestin
PubMed Health	Minocycline
Drug Classes	Amebicide, Intestinal, Antiacne, Antiacne Antibacterial, Antibiotic, Antiprotozoal, Tetracycline
Drug Label	ARESTIN (minocycline hydrochloride) Microspheres is a subgingival sustained-release product containing the antibiotic minocycline hydrochloride incorporated into a bioresorbable polymer, Poly (glycolide-co-dl-lactide) or PGLA, for professional subg...
Active Ingredient	Minocycline hydrochloride
Dosage Form	Powder, extended release
Route	Dental
Strength	eq 1mg base
Market Status	Prescription
Company	Orapharma

7 of 10
Drug Name	Dynacin
Drug Label	Minocycline hydrochloride, is a semisynthetic derivative of tetracycline, 4,7-Bis(dimethylamino)1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1, 11-dioxo-2naphthacenecarboxamide monohydrochloride. Its structural formula is:C23H27N3O7...
Active Ingredient	Minocycline hydrochloride
Dosage Form	Capsule
Route	Oral
Strength	eq 100mg base; eq 75mg base
Market Status	Prescription
Company	Cnty Line Pharms

8 of 10
Drug Name	Minocin
PubMed Health	Minocycline, Regular Release (By mouth)
Drug Classes	Amebicide, Intestinal, Antiacne, Antibiotic, Antiprotozoal
Drug Label	MINOCIN minocycline hydrochloride, is a semisynthetic derivative of tetracycline, 4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride.Its structural formula is:C23H27N...
Active Ingredient	Minocycline hydrochloride
Dosage Form	Capsule; Injectable
Route	Injection; Oral
Strength	eq 100mg base; eq 50mg base; eq 100mg base/vial
Market Status	Prescription
Company	Rempex Pharms; Precision Dermat

9 of 10
Drug Name	Minocycline hydrochloride
Drug Label	To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride capsules and other antibacterial drugs, minocycline hydrochloride capsules should be used only to treat or prevent infections that are pr...
Active Ingredient	Minocycline hydrochloride
Dosage Form	Tablet, extended release; Tablet; Capsule
Route	oral; Oral
Strength	65mg; 115mg; eq 100mg base; eq 50mg base; eq 105mg base; eq 65mg base; eq 115mg base; eq 75mg base; eq 90mg base; eq 80mg base; 55mg; eq 45mg base; eq 55mg base; eq 135mg base
Market Status	Tentative Approval; Prescription
Company	Mylan Pharms; Ranbaxy; Teva; Mylan Labs; Sun Pharm Inds; Aurobindo Pharma; Lupin; Barr Labs; Sandoz; Par Pharm; Watson Labs; Ranbaxy Labs; Dr Reddys Labs; Impax Labs

10 of 10
Drug Name	Solodyn
PubMed Health	Minocycline
Drug Classes	Amebicide, Intestinal, Antiacne, Antiacne Antibacterial, Antibiotic, Antiprotozoal, Tetracycline
Drug Label	Minocycline hydrochloride, a semi synthetic derivative of tetracycline, is [4S-(4,4a,5a,12a)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide mono hydrochloride. The structura...
Active Ingredient	Minocycline hydrochloride
Dosage Form	Tablet, extended release
Route	Oral
Strength	eq 105mg base; eq 65mg base; eq 115mg base; eq 80mg base; eq 55mg base
Market Status	Prescription
Company	Medicis

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Anti-Bacterial Agents

Substances that inhibit the growth or reproduction of BACTERIA. (See all compounds classified as Anti-Bacterial Agents.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Tetracyclines [CS]; Tetracycline-class Drug [EPC]

API SUPPLIERS

01

Suanfarma

Spain

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

CPhI Worldwide, Milan

Booth #1B34

SuanFarma is present in all origins: Natural, Chemical & Biotechnological.

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Pfizer Inc

U.S.A

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

26th North American ISSX

Not Confirmed

03

Pfizer Inc

U.S.A

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

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04

Kyowa Hakko Bio

Japan

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05

Kyowa Hakko Bio

Japan

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

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06

UQUIFA

Spain

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

26th North American ISSX

Not Confirmed

07

Nippon Kayaku

Japan

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

26th North American ISSX

Not Confirmed

Not Confirmed

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

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USDMF

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CEP/COS

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JDMF

01

CIPAN-Companhia Industrial Produtor...

Spain

CPhI Worldwide, Milan

Booth #1B34

SuanFarma is present in all origins: Natural, Chemical & Biotechnological.

Contact Supplier

Spain

Virtual Booth

Digital Content

Minocycline hydrochloride

Registration Number : 304MF10123

Registrant's Address : Rua da Estacao, 1 e 1A, 2600-726 Castanheira do Ribatejo, Portugal

Initial Date of Registration : 2022-08-17

Latest Date of Registration : 2022-08-17

02

Curia Italy S. rl

U.S.A

26th North American ISSX

Not Confirmed

03

HOVIONE FARMACIENCIA SA

Portugal

26th North American ISSX

Not Confirmed

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KDMF

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NDC API

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Listed Suppliers

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API Reference Price

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Number of Transactions

Total Quantity (KGS)

Total Value (USD)

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

API Imports and Exports

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

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Drugs in Development

01 Citius Pharmaceuticals

U.S.A

26th North American ISSX

Not Confirmed

02 Journey Medical Corporation

U.S.A

26th North American ISSX

Not Confirmed

03 Journey Medical Corporation

Shenzhen Haorui

China

26th North American ISSX

Not Confirmed

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

FDF Dossiers

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

FDA Orange Book

01

STRIDES PHARMA

India

CPhI Worldwide, Milan

Booth #5C33

Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

Contact Supplier

India

Virtual Booth

Digital Content

RLD : No

TE Code : AB

MINOCYCLINE HYDROCHLORIDE

Brand Name : MINOCYCLINE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 50MG BASE

Approval Date : 2003-04-16

Application Number : 65131

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

02

STRIDES PHARMA

India

CPhI Worldwide, Milan

Booth #5C33

Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

Contact Supplier

India

Virtual Booth

Digital Content

RLD : No

TE Code : AB

MINOCYCLINE HYDROCHLORIDE

Brand Name : MINOCYCLINE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 75MG BASE

Approval Date : 2003-04-16

Application Number : 65131

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

03

STRIDES PHARMA

India

CPhI Worldwide, Milan

Booth #5C33

Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

Contact Supplier

India

Virtual Booth

Digital Content

RLD : No

TE Code : AB

MINOCYCLINE HYDROCHLORIDE

Brand Name : MINOCYCLINE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 100MG BASE

Approval Date : 2003-04-16

Application Number : 65131

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

04

ALKEM LABS LTD

India

26th North American ISSX

Not Confirmed

05

BAUSCH

Canada

26th North American ISSX

Not Confirmed

06

SIDMAK LABS INDIA

India

26th North American ISSX

Not Confirmed

07

SUN PHARM INDUSTRIES

India

India

26th North American ISSX

Not Confirmed

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Listed Dossiers

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - INJECTABLE;INJECTION - EQ 100MG BASE...DOSAGE - INJECTABLE;INJECTION - EQ 100MG BASE/VIAL

USFDA APPLICATION NUMBER - 50444

DOSAGE - CAPSULE;ORAL - EQ 100MG BASE

USFDA APPLICATION NUMBER - 50649

DOSAGE - CAPSULE;ORAL - EQ 50MG BASE

USFDA APPLICATION NUMBER - 50649

DOSAGE - CAPSULE;ORAL - EQ 75MG BASE **Federa...DOSAGE - CAPSULE;ORAL - EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 50649

DOSAGE - POWDER, EXTENDED RELEASE;DENTAL - EQ...DOSAGE - POWDER, EXTENDED RELEASE;DENTAL - EQ 1MG BASE

USFDA APPLICATION NUMBER - 50781

DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 1...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 105MG BASE