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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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ENTERPRISES","customerCountry":"INDIA","quantity":"3000.00","actualQuantity":"3000","unit":"KGS","unitRateFc":"44.5","totalValueFC":"134422.5","currency":"USD","unitRateINR":"4067.1","date":"06-Feb-2026","totalValueINR":"12201372","totalValueInUsd":"134422.5","indian_port":"JNPT","hs_no":"29413010","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"30 F, EXCELLENCE CENTER, 1258 HAIDE 3RD ROAD, HAIZHU COMMUNITY, YUEHAI STREET, NANSHAN DISTRICT SHENZHEN CN","customerAddress":"AGARWAL B2B CENTRE, 604 KANCHPADA"},{"dataSource":"API Import","activeIngredients":"","year":"2026","qtr":"Q1","strtotime":1771180200,"product":"DOXYCYCLINE HYCLATE IP","address":"13,VITHALDAS ROAD,BULAKHIDAS","city":"MUMBAI,MAHARASHTRA","supplier":"Z TO ORDER AND NA.","supplierCountry":"CHINA","foreign_port":"SHANGHAI PT","customer":"MEDI PHARMA DRUG HOUSE","customerCountry":"INDIA","quantity":"1925.00","actualQuantity":"1925","unit":"KGS","unitRateFc":"44.7","totalValueFC":"86579.1","currency":"USD","unitRateINR":"4082.4","date":"16-Feb-2026","totalValueINR":"7858680.64","totalValueInUsd":"86579.1","indian_port":"JNPT SEZ\/MUMBAI","hs_no":"29413010","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI PT","supplierAddress":"SINOBRIGHT IMPORT & EXPORT CO.,LTD 30 F,EXCELLENCE CEN.1258 HAIDE 3RD RD,HAIZHU COM.YUEHAI ST NANSHAN DI CHINA","customerAddress":"13,VITHALDAS ROAD,BULAKHIDAS"},{"dataSource":"API Import","activeIngredients":"","year":"2026","qtr":"Q1","strtotime":1771439400,"product":"DOXYCYCLINE HYCLATE IP","address":"42,MAHANT ROAD,3,VILE PARLE","city":"MUMBAI,MAHARASHTRA","supplier":"SINOBRIGHT PHARMA IMPORT & EXPORT CO., LTD.","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"PRATISTHA PHARMA","customerCountry":"INDIA","quantity":"1000.00","actualQuantity":"1000","unit":"KGS","unitRateFc":"41","totalValueFC":"41281.6","currency":"USD","unitRateINR":"3747.1","date":"19-Feb-2026","totalValueINR":"3747080.53","totalValueInUsd":"41281.6","indian_port":"JNPT","hs_no":"29413010","bill_no":"33","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"30F, EXCELLENCE CENTRE, 1258 HAIDE 3RD ROAD, HAIZHU COMMUNITY, YUEHAI STREET, NANSHAN DISTRICT,SHENZHEN, CHINA","customerAddress":"42,MAHANT ROAD,3,VILE PARLE"},{"dataSource":"API Import","activeIngredients":"","year":"2026","qtr":"Q1","strtotime":1771612200,"product":"DOXYCYCLINE HYCLATE IP2024","address":"A 407,ANJANI COMPLEX, OPP GURUNANAK","city":"CHAKALA, ANDHERI EAST, MUMBAI","supplier":"BRILLIANT PHARMACEUTICAL LIMITED..","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"IMEX OVERSEAS","customerCountry":"INDIA","quantity":"1500.00","actualQuantity":"1500","unit":"KGS","unitRateFc":"47","totalValueFC":"71378.6","currency":"USD","unitRateINR":"4319.3","date":"21-Feb-2026","totalValueINR":"6478950","totalValueInUsd":"71378.6","indian_port":"JNPT","hs_no":"29413010","bill_no":"3","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"UNIT 02, 25\/F, WAI WAH COMMERCIAL C ENTRE NO.6 WILMER STREET, SAI YING PUN, HONG KONG, CHINA HONGKONG, HON CHINA","customerAddress":"A 407,ANJANI COMPLEX, OPP GURUNANAK"},{"dataSource":"API Import","activeIngredients":"","year":"2026","qtr":"Q1","strtotime":1771612200,"product":"DOXYCYCLINE HYCLATE USP","address":"H.NO. 8-2-337,BESIDE TV9 OFFICE","city":"HYDERABAD ANDHRA PRADESH","supplier":"HOVIONE HOLDING ASIA LTD","supplierCountry":"MACAU","foreign_port":"MACAO","customer":"DR REDDY'S LABORATORIES","customerCountry":"INDIA","quantity":"20.00","actualQuantity":"20","unit":"KGS","unitRateFc":"3066","totalValueFC":"62084.2","currency":"USD","unitRateINR":"281765.4","date":"21-Feb-2026","totalValueINR":"5635308","totalValueInUsd":"62084.2","indian_port":"Hyderabad Air","hs_no":"29413010","bill_no":"43623","productDescription":"API","marketType":"","country":"MACAU ISLANDS","selfForZScoreResived":"Pharma Grade","supplierPort":"MACAO","supplierAddress":"QUEEN ROAD EAST, WAN CHAI, HONG KON G OFFICE 1006 SPACES, HONG KONG SDNF Hong Kong","customerAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE"},{"dataSource":"API Import","activeIngredients":"","year":"2026","qtr":"Q1","strtotime":1772217000,"product":"DOXYCYCLINE HYCLATE IP DOXYCYCLINE HYCLATE IP","address":"13,VITHALDAS ROAD,BULAKHIDAS","city":"MUMBAI,MAHARASHTRA","supplier":"Z TO ORDER AND NA.","supplierCountry":"CHINA","foreign_port":"SHANGHAI PT","customer":"MEDI PHARMA DRUG HOUSE","customerCountry":"INDIA","quantity":"3000.00","actualQuantity":"3000","unit":"KGS","unitRateFc":"43.7","totalValueFC":"132703.4","currency":"USD","unitRateINR":"4015.1","date":"28-Feb-2026","totalValueINR":"12045333","totalValueInUsd":"132703.4","indian_port":"JNPT SEZ\/MUMBAI","hs_no":"29413010","bill_no":"3926","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI PT","supplierAddress":"SINOBRIGHT PHARMA IMPORT & EXPORT C 30 F,EXCELLENCE CEN.1258 HAIDE 3RD RD,HAIZHU COM.YUEHAI ST NANSHAN DIS CHINA","customerAddress":"13,VITHALDAS ROAD,BULAKHIDAS"}]
01-Jan-2022
28-Feb-2026
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DRUG PRODUCT COMPOSITIONS

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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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DATA COMPILATION #PharmaFlow

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DMF filings rise 4.5% in Q3 2025; China holds lead, India records 20% growth in submissions
The third quarter (Q3) of 2025 witnessed a steady rise in Drug Master File (DMF) submissions to the US Food and Drug Administration (FDA). DMFs are used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug productsA total of 323 Type II DMFs were submitted during this period, as opposed to 309 submissions in Q3 2024, marking an increase of 4.53 percent. This is the second highest number since 2018. In Q1 2025, 339 Type II filings were recorded.Across all DMF types (II, III, IV, and V), 479 DMFs were filed in Q3 2025, compared to 394 in Q3 2024, representing a 21.57 percent increase. Out of the 323 Type II DMFs submitted in Q3 2025, 40 had completed their review by the end of Q3, reflecting a processing lag between submission and review completion. View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available)China maintains its lead while India posts double-digit growth in DMF submissions China and India continued to dominate DMF submissions in Q3 2025. China retained the top spot with 153 Type II DMFs, matching its submission count from Q3 2024. India recorded 131 DMFs, marking a 20.18 percent increase over 109 filings during the corresponding period last year.The United States stood a distant third with 17 filings, compared to 13 in Q3 2024. Among European nations, Italy recorded eight DMFs, doubling its 2024 tally. The Netherlands filed four, up from three. Spain submitted only one DMF, as against seven submitted in Q3 2024. Taiwan made three filings, up from one submitted in Q3 2024. Together, India, China and Taiwan accounted for about 88.9 percent of all Type II DMFs filed during the quarter. View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available) China’s Suzhou Ryway Biotech tops corporate tally; India’s Hetero, Biophore followChina’s Suzhou Ryway Biotech led the company-wise tally with 12 DMF submissions in Q3 2025. The company had not filed any DMFs in Q3 2024.India’s Hetero Group followed with nine DMFs, maintaining the same number of filings as Q3 2024. Biophore India Pharmaceuticals ranked third with six DMFs, doubling its count from three last year.Other notable contributors include Sai Sreyas Pharmaceuticals (India) and Shanghai Haoyuan Chemexpress (China), with five DMFs each. Companies such as SNJ Group, Lunan Pharmaceutical, Allsino Pharmaceutical, Shankus Pharma, Jiangxi Xinganjiang Pharmaceutical, Sunpure Extracts, Lee Pharma, Umedica Laboratories, Linhai Tianyu Pharmaceutical and Maithri Drugs filed four DMFs each. View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available) Olaparib, semaglutide lead molecular filings; Dr. Reddy’s files DMF for edoxaban & tucatinibDr. Reddy’s Laboratories also featured among key DMF filers in Q3 2025, submitting two DMFs — for edoxaban tosylate monohydrate and tucatinib copovidone. Edoxaban tosylate monohydrate (marketed as Savaysa by Daiichi Sankyo) is a prescription anticoagulant used to reduce the risk of stroke and to treat deep vein thrombosis and pulmonary embolism. Patent exclusivity for Savaysa extends until October 2026 in the United States, with no generic currently available.In terms of molecules, the highest number of DMFs were filed for olaparib, semaglutide, ruxolitinib phosphate, ferric carboxymaltose, and vismodegib, with three DMFs each in Q3 2025.Olaparib, sold by AstraZeneca under the brand name Lynparza, saw DMFs being filed by BDR Lifesciences and Intas Pharmaceuticals from India, and by ScinoPharm Taiwan during the quarter.Semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist developed by Novo Nordisk, continued to draw strong interest from API manufacturers. DMFs for semaglutide were filed by three Chinese companies: Yangzhou Aurisco Pharmaceutical, Zhejiang Peptites Biotech, and Fujian Genohope Biotech.Ruxolitinib phosphate, marketed by Incyte as Jakafi, saw three DMFs. Three Indian companies — Alembic Pharmaceuticals, Valary Labs, and Devi Pharmatech — filed DMFs for this API in Q3 2025. Other molecules that received multiple DMF submissions include ferric carboxymaltose (used to treat iron-deficiency anemia) and vismodegib (an oral therapy for basal-cell carcinoma). View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available) First-time DMF filings span 17 companies; India leads with nine first-time DMFs The quarter saw first-time DMF filings from 17 companies. India took a lead here with nine first-time DMF filings, followed by China (six), and the US (two).The DMF filings in this quarter included inclisiran sodium (filed by Aurisco Pharmaceutical of China), pacritinib citrate (by TAPI Nl B.V. of the Netherlands), and vosoritide (by Apicore LLC of the US).Out of the 19 first-time DMFs filed in Q3 2025, four completed their Generic Drug User Fee Amendments (GDUFA) review process during the quarter. View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available) GDUFA fee for FY 2026: The FDA Generic Drug User Fee Amendments (GDUFA) is a law designed to speed access to safe and effective generic drugs to the public and reduce costs to the industry.Fee rates for fiscal year 2026 were published on July 30, 2025. FDA has revised fees under GDUFA III across all categories. While there is a slight increase in the DMF fee from US$ 95,084 in 2025 to US$ 102,584 in 2026, the ANDA fee has seen a sharp rise: from US$ 321,920 in 2025 to US$ 358,247 in 2026.FY 2025 and FY 2026 User Fee Rates Generic drug fee category Fees rates for FY 2025 Fees rates for FY 2026 Applications:     Abbreviated New Drug Application (ANDA) US$ 3,21,920 US$ 3,58,247 Drug Master File (DMF) US$ 95,084 US$ 1,02,584 Facilities:     Active Pharmaceutical Ingredient (API)—Domestic US$ 41,580 US$ 43,549 API—Foreign US$ 56,580 US$ 58,549 Finished Dosage Form (FDF)—Domestic US$ 2,31,952 US$ 2,38,943 FDF—Foreign US$ 2,46,952 US$ 2,53,943 Contract Manufacturing Organization (CMO)—Domestic US$ 55,668 US$ 57,346 CMO—Foreign US$ 70,668 US$ 72,346 GDUFA Program:     Large size operation generic drug applicant US$ 18,91,664 US$ 19,18,377 Medium size operation generic drug applicant US$ 7,56,666 US$ 7,67,351 Small business generic drug applicant US$ 1,89,166 US$ 1,91,838 Our viewFor several years prior to the pandemic, India had a lead in Type II DMF submissions. In recent years, China has surpassed India in DMF filings. But Q3 2025 numbers indicate that Indian drugmakers are fast catching up. Since DMFs establish trust in APIs from across the world, we feel this healthy competition between drugmakers from the two countries is good for the global pharmaceutical industry. 

Impressions: 3650

https://www.pharmacompass.com/radio-compass-blog/dmf-filings-rise-4-5-in-q3-2025-china-holds-lead-india-records-20-growth-in-submissions

#PharmaFlow by PHARMACOMPASS
13 Nov 2025

NEWS #PharmaBuzz

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ABOUT THIS PAGE

Looking for 24390-14-5 / Doxycycline Hyclate API manufacturers, exporters & distributors?

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.

Vivox Manufacturers

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

Vivox Suppliers

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

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

Vivox USDMF

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

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

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

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

Vivox KDMF

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

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

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

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

Vivox CEP

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

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

Vivox WC

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

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

Vivox 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 Vivox as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Vivox GMP

Vivox 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 Vivox 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 Vivox GMP manufacturer or Vivox GMP API supplier for your needs.

Vivox CoA

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

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

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