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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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04-Jan-2021
29-Mar-2025
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DOSAGE - TABLET;ORAL - EQ 150MG BASE

USFDA APPLICATION NUMBER - 205931

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DOSAGE - TABLET;ORAL - EQ 75MG BASE

USFDA APPLICATION NUMBER - 205931

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DOSAGE - TABLET;ORAL - EQ 100MG BASE

USFDA APPLICATION NUMBER - 209844

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DOSAGE - CAPSULE;ORAL - EQ 100MG BASE

USFDA APPLICATION NUMBER - 50007

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DOSAGE - CAPSULE;ORAL - EQ 50MG BASE **Federa...DOSAGE - CAPSULE;ORAL - EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 50007

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DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - EQ 1...DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - EQ 100MG BASE

USFDA APPLICATION NUMBER - 50582

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DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - EQ 7...DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - EQ 75MG BASE

USFDA APPLICATION NUMBER - 50582

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DOSAGE - SYSTEM, EXTENDED RELEASE;PERIODONTAL...DOSAGE - SYSTEM, EXTENDED RELEASE;PERIODONTAL - 50MG

USFDA APPLICATION NUMBER - 50751

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DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 10...DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 50795

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DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 12...DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 120MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 50795

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DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 15...DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 50795

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DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 20...DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 200MG BASE

USFDA APPLICATION NUMBER - 50795

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DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 50...DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 50795

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DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 60...DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 60MG BASE

USFDA APPLICATION NUMBER - 50795

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

USFDA APPLICATION NUMBER - 50795

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

USFDA APPLICATION NUMBER - 50795

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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 20 mg twice daily Manufacturers

A doxycycline hyclate 20 mg twice daily manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of doxycycline hyclate 20 mg twice daily, including repackagers and relabelers. The FDA regulates doxycycline hyclate 20 mg twice daily manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. doxycycline hyclate 20 mg twice daily 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 20 mg twice daily manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

doxycycline hyclate 20 mg twice daily Suppliers

A doxycycline hyclate 20 mg twice daily supplier is an individual or a company that provides doxycycline hyclate 20 mg twice daily active pharmaceutical ingredient (API) or doxycycline hyclate 20 mg twice daily finished formulations upon request. The doxycycline hyclate 20 mg twice daily suppliers may include doxycycline hyclate 20 mg twice daily API manufacturers, exporters, distributors and traders.

click here to find a list of doxycycline hyclate 20 mg twice daily suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

doxycycline hyclate 20 mg twice daily USDMF

A doxycycline hyclate 20 mg twice daily DMF (Drug Master File) is a document detailing the whole manufacturing process of doxycycline hyclate 20 mg twice daily active pharmaceutical ingredient (API) in detail. Different forms of doxycycline hyclate 20 mg twice daily DMFs exist exist since differing nations have different regulations, such as doxycycline hyclate 20 mg twice daily USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A doxycycline hyclate 20 mg twice daily DMF submitted to regulatory agencies in the US is known as a USDMF. doxycycline hyclate 20 mg twice daily USDMF includes data on doxycycline hyclate 20 mg twice daily's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The doxycycline hyclate 20 mg twice daily USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of doxycycline hyclate 20 mg twice daily suppliers with USDMF on PharmaCompass.

doxycycline hyclate 20 mg twice daily 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 20 mg twice daily Drug Master File in Japan (doxycycline hyclate 20 mg twice daily JDMF) empowers doxycycline hyclate 20 mg twice daily 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 20 mg twice daily JDMF during the approval evaluation for pharmaceutical products. At the time of doxycycline hyclate 20 mg twice daily 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 20 mg twice daily suppliers with JDMF on PharmaCompass.

doxycycline hyclate 20 mg twice daily 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 20 mg twice daily Drug Master File in Korea (doxycycline hyclate 20 mg twice daily KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of doxycycline hyclate 20 mg twice daily. The MFDS reviews the doxycycline hyclate 20 mg twice daily KDMF as part of the drug registration process and uses the information provided in the doxycycline hyclate 20 mg twice daily KDMF to evaluate the safety and efficacy of the drug.

After submitting a doxycycline hyclate 20 mg twice daily 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 20 mg twice daily API can apply through the Korea Drug Master File (KDMF).

click here to find a list of doxycycline hyclate 20 mg twice daily suppliers with KDMF on PharmaCompass.

doxycycline hyclate 20 mg twice daily CEP

A doxycycline hyclate 20 mg twice daily CEP of the European Pharmacopoeia monograph is often referred to as a doxycycline hyclate 20 mg twice daily Certificate of Suitability (COS). The purpose of a doxycycline hyclate 20 mg twice daily CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of doxycycline hyclate 20 mg twice daily EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of doxycycline hyclate 20 mg twice daily to their clients by showing that a doxycycline hyclate 20 mg twice daily CEP has been issued for it. The manufacturer submits a doxycycline hyclate 20 mg twice daily CEP (COS) as part of the market authorization procedure, and it takes on the role of a doxycycline hyclate 20 mg twice daily CEP holder for the record. Additionally, the data presented in the doxycycline hyclate 20 mg twice daily CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the doxycycline hyclate 20 mg twice daily DMF.

A doxycycline hyclate 20 mg twice daily CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. doxycycline hyclate 20 mg twice daily 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 20 mg twice daily suppliers with CEP (COS) on PharmaCompass.

doxycycline hyclate 20 mg twice daily WC

A doxycycline hyclate 20 mg twice daily written confirmation (doxycycline hyclate 20 mg twice daily WC) is an official document issued by a regulatory agency to a doxycycline hyclate 20 mg twice daily manufacturer, verifying that the manufacturing facility of a doxycycline hyclate 20 mg twice daily active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting doxycycline hyclate 20 mg twice daily APIs or doxycycline hyclate 20 mg twice daily finished pharmaceutical products to another nation, regulatory agencies frequently require a doxycycline hyclate 20 mg twice daily WC (written confirmation) as part of the regulatory process.

click here to find a list of doxycycline hyclate 20 mg twice daily suppliers with Written Confirmation (WC) on PharmaCompass.

doxycycline hyclate 20 mg twice daily 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 20 mg twice daily as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for doxycycline hyclate 20 mg twice daily 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 20 mg twice daily 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 20 mg twice daily and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a doxycycline hyclate 20 mg twice daily NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of doxycycline hyclate 20 mg twice daily suppliers with NDC on PharmaCompass.

doxycycline hyclate 20 mg twice daily GMP

doxycycline hyclate 20 mg twice daily 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 20 mg twice daily 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 20 mg twice daily GMP manufacturer or doxycycline hyclate 20 mg twice daily GMP API supplier for your needs.

doxycycline hyclate 20 mg twice daily CoA

A doxycycline hyclate 20 mg twice daily CoA (Certificate of Analysis) is a formal document that attests to doxycycline hyclate 20 mg twice daily's compliance with doxycycline hyclate 20 mg twice daily specifications and serves as a tool for batch-level quality control.

doxycycline hyclate 20 mg twice daily CoA mostly includes findings from lab analyses of a specific batch. For each doxycycline hyclate 20 mg twice daily 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 20 mg twice daily may be tested according to a variety of international standards, such as European Pharmacopoeia (doxycycline hyclate 20 mg twice daily EP), doxycycline hyclate 20 mg twice daily JP (Japanese Pharmacopeia) and the US Pharmacopoeia (doxycycline hyclate 20 mg twice daily 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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