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    Chemistry

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    Also known as: Doxycycline hyclate, 24390-14-5, Atridox, Periostat, Vibra-tabs, Doxyprex
    Molecular Formula
    C46H58Cl2N4O18
    Molecular Weight
    1025.9  g/mol
    InChI Key
    UHHHTIKWXBRCLT-VDBOFHIQSA-N
    FDA UNII
    19XTS3T51U
    Doxycycline Hyclate
    A synthetic tetracycline derivative with similar antimicrobial activity.
    1 2D Structure

    Doxycycline Hyclate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (4S,4aR,5S,5aR,6R,12aR)-4-(dimethylamino)-1,5,10,11,12a-pentahydroxy-6-methyl-3,12-dioxo-4a,5,5a,6-tetrahydro-4H-tetracene-2-carboxamide;ethanol;hydrate;dihydrochloride
    2.1.2 InChI
    InChI=1S/2C22H24N2O8.C2H6O.2ClH.H2O/c2*1-7-8-5-4-6-9(25)11(8)16(26)12-10(7)17(27)14-15(24(2)3)18(28)13(21(23)31)20(30)22(14,32)19(12)29;1-2-3;;;/h2*4-7,10,14-15,17,25-27,30,32H,1-3H3,(H2,23,31);3H,2H2,1H3;2*1H;1H2/t2*7-,10+,14+,15-,17-,22-;;;;/m00..../s1
    2.1.3 InChI Key
    UHHHTIKWXBRCLT-VDBOFHIQSA-N
    2.1.4 Canonical SMILES
    CCO.CC1C2C(C3C(C(=O)C(=C(C3(C(=O)C2=C(C4=C1C=CC=C4O)O)O)O)C(=O)N)N(C)C)O.CC1C2C(C3C(C(=O)C(=C(C3(C(=O)C2=C(C4=C1C=CC=C4O)O)O)O)C(=O)N)N(C)C)O.O.Cl.Cl
    2.1.5 Isomeric SMILES
    CCO.C[C@@H]1[C@H]2[C@@H]([C@H]3[C@@H](C(=O)C(=C([C@]3(C(=O)C2=C(C4=C1C=CC=C4O)O)O)O)C(=O)N)N(C)C)O.C[C@@H]1[C@H]2[C@@H]([C@H]3[C@@H](C(=O)C(=C([C@]3(C(=O)C2=C(C4=C1C=CC=C4O)O)O)O)C(=O)N)N(C)C)O.O.Cl.Cl
    2.2 Other Identifiers
    2.2.1 UNII
    19XTS3T51U
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 2-naphthacenecarboxamide, 4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-, (4s-(4alpha,4aalpha,5alpha,5aalpha,6alpha,12aalpha))-

    2. Alpha 6 Deoxyoxytetracycline

    3. Alpha-6-deoxyoxytetracycline

    4. Atridox

    5. Bmy 28689

    6. Bmy-28689

    7. Bmy28689

    8. Bu 3839t

    9. Bu-3839t

    10. Bu3839t

    11. Doxycycline

    12. Doxycycline Calcium

    13. Doxycycline Calcium Salt (1:2)

    14. Doxycycline Chinoin

    15. Doxycycline Hemiethanolate

    16. Doxycycline Hyclate

    17. Doxycycline Monohydrate

    18. Doxycycline Monohydrochloride, 6 Epimer

    19. Doxycycline Monohydrochloride, 6-epimer

    20. Doxycycline Monohydrochloride, Dihydrate

    21. Doxycycline Phosphate (1:1)

    22. Doxycycline-chinoin

    23. Hydramycin

    24. Oracea

    25. Periostat

    26. Vibra Tabs

    27. Vibra-tabs

    28. Vibramycin

    29. Vibramycin Novum

    30. Vibravenos

    2.3.2 Depositor-Supplied Synonyms

    1. Doxycycline Hyclate

    2. 24390-14-5

    3. Atridox

    4. Periostat

    5. Vibra-tabs

    6. Doxyprex

    7. Monodoks

    8. Tetraclean

    9. Doxy-lemmon

    10. Doxychel Hyclate

    11. Vibramycin

    12. Acticlate

    13. Mespafin

    14. Tetradox

    15. Doxy

    16. Doxycycline Hydrochloride Hemiethanolate Hemihydrate

    17. Retens

    18. Doxicrisol

    19. Vibraveineuse

    20. Vibravenos

    21. Azudoxat

    22. Clinofug

    23. Diocimex

    24. Duradoxal

    25. Granudoxy

    26. Ronaxan

    27. Zadorin

    28. Spanor

    29. Unacil

    30. Acticlate Cap

    31. 19xts3t51u

    32. Nsc-741421

    33. 4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide Monohydrochloride, Compound With Ethyl Alcohol (2:1), Monohydrate

    34. Vivox

    35. 6-deoxy-5-hydroxytetracycline Hydrochloride Hemihydrate

    36. (4s,4ar,5s,5ar,6r,12ar)-4-(dimethylamino)-1,5,10,11,12a-pentahydroxy-6-methyl-3,12-dioxo-4a,5,5a,6-tetrahydro-4h-tetracene-2-carboxamide;ethanol;hydrate;dihydrochloride

    37. Dentista

    38. Doxteric

    39. Doxy 100

    40. 10592-13-9

    41. Mfcd07357237

    42. Doxy 200

    43. Doxycycline Hyclate (internal Use)

    44. Unii-19xts3t51u

    45. Doryx Mpc

    46. Doxycycline Hyclate [usan:usp]

    47. Doxycyclini Hyclas

    48. Periostat (tn)

    49. (4s,4ar,5s,5ar,6r,12as)-4-(dimethylamino)-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-4a,5,5a,6-tetrahydro-4h-tetracene-2-carboxamide;ethanol;hydrate;dihydrochloride

    50. Vibra-tabs (tn)

    51. Lymepak (tn)

    52. Doxylar

    53. Lymepak

    54. Doryx (tn)

    55. Wc 2031

    56. 2-naphthacenecarboxamide, 4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-, Hydrochloride, (4s,4ar,5s,5ar,6r,12as)-, Compd. With Ethanol, Hydrate (2:2:1:1)

    57. Doxycycline Hyclate (usp)

    58. Chembl3989740

    59. Doxycycline Hyclate [vandf]

    60. (4s,4ar,5s,5ar,6r,12as)-4-(dimethylamino)-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide Compound With Ethanol (2:1) Dihydrochloride Hydrate

    61. Amy32700

    62. Doxycycline Hyclate [usp-rs]

    63. Doxycycline Hyclate [who-dd]

    64. Doxycycline Hyclate [who-ip]

    65. S4163

    66. Wc2031

    67. Akos025402170

    68. Ac-6017

    69. Ccg-270611

    70. Ds-9077

    71. Nsc 741421

    72. Doxycycline Hyclate [green Book]

    73. Doxycycline Hyclate [ep Impurity]

    74. Doxycycline Hyclate [orange Book]

    75. 2-naphthacenecarboxamide, 4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-, Monohydrochloride, Compd. With Ethanol (2:1), Monohydrate, (4s-(4alpha,4aalpha,5alpha,5aalpha,6alpha,12aalpha))-

    76. 2-naphthacenecarboxamide, 4beta-(dimeethylamino)-1,4,4abeta,5,5abeta,6,11,12a-octahydro-3,5beta,10,12,12abeta-pentahydroxy-6beta-methyl-1,11-dioxo-, Monohydrochloride, Compd. With Ethyl Alcohol (2:1), Monohydrate

    77. Bd166236

    78. Doxycycline Hyclate [ep Monograph]

    79. Doxycycline Hydrochloride Hydrate (jp17)

    80. Doxycyclini Hyclas [who-ip Latin]

    81. Ethanol, Compd. With (4s,4ar,5s,5ar,6r,12as)-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide Monohydrochloride (1:2), Monohydrate

    82. Doxycycline Hyclate [usp Monograph]

    83. Doxycycline, Hyclate - Cas 24390-14-5

    84. Sw219440-1

    85. Sw219440-2

    86. D02129

    87. Doxycycline Hydrochloride Hydrate [jan]

    88. Doxycycline Hyclate 100 Microg/ml In Acetonitrile

    89. Q27116248

    90. Z2791720087

    91. Doxycycline Hydrochloride Hemiethanolate Hemihydrate [mi]

    92. Doxycycline Hyclate Is Known As A Broad-spectrum Tetracycline Antibiotic.

    93. (4s,4ar,5s,5ar,6r,12as)-4-(dimethylamino)-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide - Ethanol (2:1) Dihydrochloride Hydrate

    94. Bis((4s,4ar,5s,5ar,6r,12as)-4-(dimethylamino)-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide) Ethanol Hydrate Dihydrochloride

    2.4 Create Date
    2011-12-26
    3 Chemical and Physical Properties
    Molecular Weight 1025.9 g/mol
    Molecular Formula C46H58Cl2N4O18
    Hydrogen Bond Donor Count16
    Hydrogen Bond Acceptor Count20
    Rotatable Bond Count4
    Exact Mass1024.3123164 g/mol
    Monoisotopic Mass1024.3123164 g/mol
    Topological Polar Surface Area385 Ų
    Heavy Atom Count70
    Formal Charge0
    Complexity958
    Isotope Atom Count0
    Defined Atom Stereocenter Count12
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count6
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 10  
    Drug NameAtridox
    Drug LabelDORYX Capsules contain specially coated pellets of doxycycline hyclate, a broad-spectrum antibiotic synthetically derived from oxytetracycline, in a delayed-release formulation for oral administration.The structural formula for doxycycline hyclate is...
    Active IngredientDoxycycline hyclate
    Dosage FormSystem, extended release
    RoutePeriodontal
    Strength50mg
    Market StatusPrescription
    CompanyTolmar

    2 of 10  
    Drug NameDoryx
    Active IngredientDoxycycline hyclate
    Dosage FormTablet, delayed release
    RouteOral
    Strengtheq 100mg base; eq 80mg base; eq 200mg base; eq 150mg base; eq 75mg base
    Market StatusPrescription
    CompanyMayne Pharma

    3 of 10  
    Drug NameDoxy 100
    PubMed HealthDoxycycline (Injection)
    Drug ClassesAntibiotic, Antimalarial, Antiprotozoal
    Drug LabelDoxycycline for Injection, USP is a sterile, lyophilized powder prepared from a solution of doxycycline hyclate, ascorbic acid and mannitol in Water for Injection. Doxycycline hyclate is a broad spectrum antibiotic derived from oxytetracycline. It is...
    Active IngredientDoxycycline hyclate
    Dosage FormInjectable
    RouteInjection
    Strengtheq 100mg base/vial
    Market StatusPrescription
    CompanyFresenius Kabi Usa

    4 of 10  
    Drug NameDoxy 200
    PubMed HealthDoxycycline (Subgingival)
    Drug ClassesAntibacterial
    Drug LabelDoxycycline hyclate is a broad-spectrum antibiotic synthetically derived from oxytetracycline. The structural formula is as follows:with a molecular formula of C22H24N2O8H2O and a molecular weight of 462.46. The chemical designation for doxycycline i...
    Active IngredientDoxycycline hyclate
    Dosage FormInjectable
    RouteInjection
    Strengtheq 200mg base/vial
    Market StatusPrescription
    CompanyFresenius Kabi Usa

    5 of 10  
    Drug NameDoxycycline hyclate
    Active IngredientDoxycycline hyclate
    Dosage FormTablet; Capsule, delayed release; Capsule; Tablet, delayed release
    RouteOral
    Strengtheq 100mg base; eq 50mg base; eq 150mg base; eq 20mg base; eq 75mg base
    Market StatusPrescription
    CompanyCorepharma; Mutual Pharma; Vintage Pharms; Hikma Intl Pharms; Mylan Pharms; Blu Caribe; Ivax Sub Teva Pharms; Actavis Elizabeth; Larken Labs; Lannett; Mutual Pharm; Actavis Labs Fl; Medicis; Chartwell Life Sci; Mylan; Impax Labs; Heritage Pharms

    6 of 10  
    Drug NameDoryx
    Active IngredientDoxycycline hyclate
    Dosage FormTablet, delayed release
    RouteOral
    Strengtheq 100mg base; eq 80mg base; eq 200mg base; eq 150mg base; eq 75mg base
    Market StatusPrescription
    CompanyMayne Pharma

    7 of 10  
    Drug NameDoxy 100
    PubMed HealthDoxycycline (Injection)
    Drug ClassesAntibiotic, Antimalarial, Antiprotozoal
    Drug LabelDoxycycline for Injection, USP is a sterile, lyophilized powder prepared from a solution of doxycycline hyclate, ascorbic acid and mannitol in Water for Injection. Doxycycline hyclate is a broad spectrum antibiotic derived from oxytetracycline. It is...
    Active IngredientDoxycycline hyclate
    Dosage FormInjectable
    RouteInjection
    Strengtheq 100mg base/vial
    Market StatusPrescription
    CompanyFresenius Kabi Usa

    8 of 10  
    Drug NameDoxy 200
    PubMed HealthDoxycycline (Subgingival)
    Drug ClassesAntibacterial
    Drug LabelDoxycycline hyclate is a broad-spectrum antibiotic synthetically derived from oxytetracycline. The structural formula is as follows:with a molecular formula of C22H24N2O8H2O and a molecular weight of 462.46. The chemical designation for doxycycline i...
    Active IngredientDoxycycline hyclate
    Dosage FormInjectable
    RouteInjection
    Strengtheq 200mg base/vial
    Market StatusPrescription
    CompanyFresenius Kabi Usa

    9 of 10  
    Drug NameDoxycycline hyclate
    Active IngredientDoxycycline hyclate
    Dosage FormTablet; Capsule, delayed release; Capsule; Tablet, delayed release
    RouteOral
    Strengtheq 100mg base; eq 50mg base; eq 150mg base; eq 20mg base; eq 75mg base
    Market StatusPrescription
    CompanyCorepharma; Mutual Pharma; Vintage Pharms; Hikma Intl Pharms; Mylan Pharms; Blu Caribe; Ivax Sub Teva Pharms; Actavis Elizabeth; Larken Labs; Lannett; Mutual Pharm; Actavis Labs Fl; Medicis; Chartwell Life Sci; Mylan; Impax Labs; Heritage Pharms

    10 of 10  
    Drug NameAtridox
    Drug LabelDORYX Capsules contain specially coated pellets of doxycycline hyclate, a broad-spectrum antibiotic synthetically derived from oxytetracycline, in a delayed-release formulation for oral administration.The structural formula for doxycycline hyclate is...
    Active IngredientDoxycycline hyclate
    Dosage FormSystem, extended release
    RoutePeriodontal
    Strength50mg
    Market StatusPrescription
    CompanyTolmar

    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.)

    Antimalarials

    Agents used in the treatment of malaria. They are usually classified on the basis of their action against plasmodia at different stages in their life cycle in the human. (From AMA, Drug Evaluations Annual, 1992, p1585) (See all compounds classified as Antimalarials.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Tetracyclines [CS]; Tetracycline-class Drug [EPC]

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    Doxycycline Hyclate manufacturers, exporters & distributors 1

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    PharmaCompass offers a list of Doxycycline Hyclate 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 Doxycycline Hyclate manufacturer or Doxycycline Hyclate supplier for your needs.

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

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

    API | Excipient name

    Doxycycline Hyclate

    Synonyms

    24390-14-5, Atridox, Periostat, Vibra-tabs, Doxyprex, Monodoks

    Cas Number

    24390-14-5

    Unique Ingredient Identifier (UNII)

    19XTS3T51U

    About Doxycycline Hyclate

    A synthetic tetracycline derivative with similar antimicrobial activity.

    Doxycycline hyclate [USP] Manufacturers

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

    Doxycycline hyclate [USP] Suppliers

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

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

    Doxycycline hyclate [USP] USDMF

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

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

    click here to find a list of Doxycycline hyclate [USP] suppliers with USDMF on PharmaCompass.

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

    Doxycycline hyclate [USP] KDMF

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

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

    After submitting a Doxycycline hyclate [USP] 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 Doxycycline hyclate [USP] API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Doxycycline hyclate [USP] suppliers with KDMF on PharmaCompass.

    Doxycycline hyclate [USP] CEP

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

    A Doxycycline hyclate [USP] CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Doxycycline hyclate [USP] 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 Doxycycline hyclate [USP] suppliers with CEP (COS) on PharmaCompass.

    Doxycycline hyclate [USP] WC

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

    click here to find a list of Doxycycline hyclate [USP] suppliers with Written Confirmation (WC) on PharmaCompass.

    Doxycycline hyclate [USP] 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 Doxycycline hyclate [USP] as an active pharmaceutical ingredient (API).

    Finished drug products

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

    click here to find a list of Doxycycline hyclate [USP] suppliers with NDC on PharmaCompass.

    Doxycycline hyclate [USP] GMP

    Doxycycline hyclate [USP] 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 Doxycycline hyclate [USP] 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 Doxycycline hyclate [USP] GMP manufacturer or Doxycycline hyclate [USP] GMP API supplier for your needs.

    Doxycycline hyclate [USP] CoA

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

    Doxycycline hyclate [USP] CoA mostly includes findings from lab analyses of a specific batch. For each Doxycycline hyclate [USP] 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.

    Doxycycline hyclate [USP] may be tested according to a variety of international standards, such as European Pharmacopoeia (Doxycycline hyclate [USP] EP), Doxycycline hyclate [USP] JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Doxycycline hyclate [USP] 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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