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    Chemistry

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    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
    Minocycline Hydrochloride
    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 Weight 493.9 g/mol
    Molecular Formula C23H28ClN3O7
    Hydrogen Bond Donor Count6
    Hydrogen Bond Acceptor Count9
    Rotatable Bond Count3
    Exact Mass493.1615779 g/mol
    Monoisotopic Mass493.1615779 g/mol
    Topological Polar Surface Area165 Ų
    Heavy Atom Count34
    Formal Charge0
    Complexity971
    Isotope Atom Count0
    Defined Atom Stereocenter Count4
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 10  
    Drug NameArestin
    PubMed HealthMinocycline
    Drug ClassesAmebicide, Intestinal, Antiacne, Antiacne Antibacterial, Antibiotic, Antiprotozoal, Tetracycline
    Drug LabelARESTIN (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 IngredientMinocycline hydrochloride
    Dosage FormPowder, extended release
    RouteDental
    Strengtheq 1mg base
    Market StatusPrescription
    CompanyOrapharma

    2 of 10  
    Drug NameDynacin
    Drug LabelMinocycline 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 IngredientMinocycline hydrochloride
    Dosage FormCapsule
    RouteOral
    Strengtheq 100mg base; eq 75mg base
    Market StatusPrescription
    CompanyCnty Line Pharms

    3 of 10  
    Drug NameMinocin
    PubMed HealthMinocycline, Regular Release (By mouth)
    Drug ClassesAmebicide, Intestinal, Antiacne, Antibiotic, Antiprotozoal
    Drug LabelMINOCIN 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 IngredientMinocycline hydrochloride
    Dosage FormCapsule; Injectable
    RouteInjection; Oral
    Strengtheq 100mg base; eq 50mg base; eq 100mg base/vial
    Market StatusPrescription
    CompanyRempex Pharms; Precision Dermat

    4 of 10  
    Drug NameMinocycline hydrochloride
    Drug LabelTo 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 IngredientMinocycline hydrochloride
    Dosage FormTablet, extended release; Tablet; Capsule
    Routeoral; Oral
    Strength65mg; 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 StatusTentative Approval; Prescription
    CompanyMylan 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 NameSolodyn
    PubMed HealthMinocycline
    Drug ClassesAmebicide, Intestinal, Antiacne, Antiacne Antibacterial, Antibiotic, Antiprotozoal, Tetracycline
    Drug LabelMinocycline 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 IngredientMinocycline hydrochloride
    Dosage FormTablet, extended release
    RouteOral
    Strengtheq 105mg base; eq 65mg base; eq 115mg base; eq 80mg base; eq 55mg base
    Market StatusPrescription
    CompanyMedicis

    6 of 10  
    Drug NameArestin
    PubMed HealthMinocycline
    Drug ClassesAmebicide, Intestinal, Antiacne, Antiacne Antibacterial, Antibiotic, Antiprotozoal, Tetracycline
    Drug LabelARESTIN (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 IngredientMinocycline hydrochloride
    Dosage FormPowder, extended release
    RouteDental
    Strengtheq 1mg base
    Market StatusPrescription
    CompanyOrapharma

    7 of 10  
    Drug NameDynacin
    Drug LabelMinocycline 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 IngredientMinocycline hydrochloride
    Dosage FormCapsule
    RouteOral
    Strengtheq 100mg base; eq 75mg base
    Market StatusPrescription
    CompanyCnty Line Pharms

    8 of 10  
    Drug NameMinocin
    PubMed HealthMinocycline, Regular Release (By mouth)
    Drug ClassesAmebicide, Intestinal, Antiacne, Antibiotic, Antiprotozoal
    Drug LabelMINOCIN 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 IngredientMinocycline hydrochloride
    Dosage FormCapsule; Injectable
    RouteInjection; Oral
    Strengtheq 100mg base; eq 50mg base; eq 100mg base/vial
    Market StatusPrescription
    CompanyRempex Pharms; Precision Dermat

    9 of 10  
    Drug NameMinocycline hydrochloride
    Drug LabelTo 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 IngredientMinocycline hydrochloride
    Dosage FormTablet, extended release; Tablet; Capsule
    Routeoral; Oral
    Strength65mg; 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 StatusTentative Approval; Prescription
    CompanyMylan 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 NameSolodyn
    PubMed HealthMinocycline
    Drug ClassesAmebicide, Intestinal, Antiacne, Antiacne Antibacterial, Antibiotic, Antiprotozoal, Tetracycline
    Drug LabelMinocycline 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 IngredientMinocycline hydrochloride
    Dosage FormTablet, extended release
    RouteOral
    Strengtheq 105mg base; eq 65mg base; eq 115mg base; eq 80mg base; eq 55mg base
    Market StatusPrescription
    CompanyMedicis

    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]

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ROAD,","city":"MUMBAI,MAHARASHTRA","supplier":"HANGZHOU PROSERRE CHEMICAL CO LTD","supplierCountry":"CHINA","foreign_port":"HANGCHOW (HANGZHOU)","customer":"LUPIN LTD","customerCountry":"INDIA","quantity":"12.15","actualQuantity":"12.15","unit":"KGS","unitRateFc":"1500","totalValueFC":"18473.8","currency":"USD","unitRateINR":"131700","date":"20-Mar-2025","totalValueINR":"1600155","totalValueInUsd":"18473.8","indian_port":"Bombay Air","hs_no":"29413090","bill_no":"8989064","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"HANGCHOW (HANGZHOU)","supplierAddress":"ROOM NO 2002 , SUNON CENTRAL MANSIO N NO 200 SHIMIN ROAD , JIANGGAN DIS TRICT , HANGZHOU ZHEJIANG CHINA Han China","customerAddress":"159, C.S.T. ROAD,"}]
    12-Jan-2021
    20-Mar-2025
    KGS
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    DOSAGE - INJECTABLE;INJECTION - EQ 100MG BASE...DOSAGE - INJECTABLE;INJECTION - EQ 100MG BASE/VIAL

    USFDA APPLICATION NUMBER - 50444

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    DOSAGE - CAPSULE;ORAL - EQ 100MG BASE

    USFDA APPLICATION NUMBER - 50649

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    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

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

    USFDA APPLICATION NUMBER - 50781

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

    USFDA APPLICATION NUMBER - 50808

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 1...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 115MG BASE

    USFDA APPLICATION NUMBER - 50808

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 1...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 135MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 50808

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 4...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 50808

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 5...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 55MG BASE

    USFDA APPLICATION NUMBER - 50808

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 6...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 65MG BASE

    USFDA APPLICATION NUMBER - 50808

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 8...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 80MG BASE

    USFDA APPLICATION NUMBER - 50808

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 9...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 90MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 50808

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    PharmaCompass offers a list of Minocycline Hydrochloride API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Minocycline Hydrochloride manufacturer or Minocycline Hydrochloride supplier for your needs.

    Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Minocycline Hydrochloride manufacturer or Minocycline Hydrochloride supplier.

    PharmaCompass also assists you with knowing the Minocycline Hydrochloride API Price utilized in the formulation of products. Minocycline Hydrochloride API Price is not always fixed or binding as the Minocycline Hydrochloride Price is obtained through a variety of data sources. The Minocycline Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

    API | Excipient name

    Minocycline Hydrochloride

    Synonyms

    13614-98-7, Minocycline hcl, Arestin, Solodyn, Minomycin, Minocin

    Cas Number

    13614-98-7

    Unique Ingredient Identifier (UNII)

    0020414E5U

    About Minocycline Hydrochloride

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

    Minocycline HCl Manufacturers

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

    Minocycline HCl Suppliers

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

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

    Minocycline HCl USDMF

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

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

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

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

    Minocycline HCl KDMF

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

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

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

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

    Minocycline HCl CEP

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

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

    Minocycline HCl 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 Minocycline HCl as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Minocycline HCl GMP

    Minocycline HCl 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 Minocycline HCl 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 Minocycline HCl GMP manufacturer or Minocycline HCl GMP API supplier for your needs.

    Minocycline HCl CoA

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

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

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