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Synopsis

Chemistry

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Also known as: Fujimycin, 104987-11-3, Prograf, Tsukubaenolide, Protopic, Fk506
Molecular Formula
C44H69NO12
Molecular Weight
804.0  g/mol
InChI Key
QJJXYPPXXYFBGM-LFZNUXCKSA-N
FDA UNII
Y5L2157C4J

Tacrolimus
A macrolide isolated from the culture broth of a strain of Streptomyces tsukubaensis that has strong immunosuppressive activity in vivo and prevents the activation of T-lymphocytes in response to antigenic or mitogenic stimulation in vitro.
Tacrolimus anhydrous is a Calcineurin Inhibitor Immunosuppressant. The mechanism of action of tacrolimus anhydrous is as a Calcineurin Inhibitor.
1 2D Structure

Tacrolimus

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(1R,9S,12S,13R,14S,17R,18E,21S,23S,24R,25S,27R)-1,14-dihydroxy-12-[(E)-1-[(1R,3R,4R)-4-hydroxy-3-methoxycyclohexyl]prop-1-en-2-yl]-23,25-dimethoxy-13,19,21,27-tetramethyl-17-prop-2-enyl-11,28-dioxa-4-azatricyclo[22.3.1.04,9]octacos-18-ene-2,3,10,16-tetrone
2.1.2 InChI
InChI=1S/C44H69NO12/c1-10-13-31-19-25(2)18-26(3)20-37(54-8)40-38(55-9)22-28(5)44(52,57-40)41(49)42(50)45-17-12-11-14-32(45)43(51)56-39(29(6)34(47)24-35(31)48)27(4)21-30-15-16-33(46)36(23-30)53-7/h10,19,21,26,28-34,36-40,46-47,52H,1,11-18,20,22-24H2,2-9H3/b25-19+,27-21+/t26-,28+,29+,30-,31+,32-,33+,34-,36+,37-,38-,39+,40+,44+/m0/s1
2.1.3 InChI Key
QJJXYPPXXYFBGM-LFZNUXCKSA-N
2.1.4 Canonical SMILES
CC1CC(C2C(CC(C(O2)(C(=O)C(=O)N3CCCCC3C(=O)OC(C(C(CC(=O)C(C=C(C1)C)CC=C)O)C)C(=CC4CCC(C(C4)OC)O)C)O)C)OC)OC
2.1.5 Isomeric SMILES
C[C@@H]1C[C@@H]([C@@H]2[C@H](C[C@H]([C@@](O2)(C(=O)C(=O)N3CCCC[C@H]3C(=O)O[C@@H]([C@@H]([C@H](CC(=O)[C@@H](/C=C(/C1)\C)CC=C)O)C)/C(=C/[C@@H]4CC[C@H]([C@@H](C4)OC)O)/C)O)C)OC)OC
2.2 Other Identifiers
2.2.1 UNII
Y5L2157C4J
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Anhydrous Tacrolimus

2. Anhydrous, Tacrolimus

3. Fk 506

4. Fk-506

5. Fk506

6. Fr 900506

7. Fr-900506

8. Fr900506

9. Prograf

10. Prograft

11. Tacrolimus Anhydrous

12. Tacrolimus, Anhydrous

2.3.2 Depositor-Supplied Synonyms

1. Fujimycin

2. 104987-11-3

3. Prograf

4. Tsukubaenolide

5. Protopic

6. Fk506

7. Tacrolimus Anhydrous

8. Anhydrous Tacrolimus

9. Modigraf

10. Fk-506

11. Protopy

12. Lcp-tacro

13. Advagraf

14. Tacrolimus (fk506)

15. Fk 506

16. Fr-900506

17. Tacrolimus, Anhydrous

18. 8-deethyl-8-[but-3-enyl]-ascomycin

19. Tacrolimus (inn)

20. Fr900506

21. Astagraf Xl

22. Envarsus Xr

23. (-)-fk 506

24. Prograf (tn)

25. Tacrolimus [usan]

26. Chembl269732

27. Chebi:61049

28. Y5l2157c4j

29. Nsc-758659

30. K506

31. Ncgc00163470-03

32. Prograft

33. Tacrolimus [inn]

34. Avagraf

35. Envarsus

36. Graceptor

37. (3s,4r,5s,8r,9e,12s,14s,15r,16s,18r,19r,26as)-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[(1e)-2-[(1r,3r,4r)-4-hydroxy-3-methoxycyclohexyl]-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propen-1-yl)-15,19-epoxy-3h-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4h,23h)tetrone

38. Fk-506 (tacrolimus)

39. Tacrolimus (anhydrous)

40. Sr-05000001879

41. Tacrolimus [usan:inn]

42. Hecoria

43. Talymus

44. Unii-y5l2157c4j

45. Ccris 7124

46. Mfcd00869853

47. Hsdb 8195

48. L 679934

49. Prograph

50. Tacro

51. Envarsus-xr

52. Tacrolimus [mi]

53. Schembl3088

54. Tacrolimus [mart.]

55. Dsstox_cid_26354

56. Dsstox_rid_81557

57. Tacrolimus [who-dd]

58. Dsstox_gsid_46354

59. Bspbio_001279

60. Chembl66247

61. L-679934

62. Gtpl6784

63. Dtxsid5046354

64. Chebi:93221

65. Hms503o21

66. Hms1792o21

67. Hms1990o21

68. Hms2093m19

69. Hms3403o21

70. Pharmakon1600-01503968

71. Ex-a1677

72. Tox21_112056

73. Bdbm50030448

74. Bdbm50079777

75. Lmpk04000003

76. Nsc758659

77. S5003

78. Akos005145901

79. Zinc169289411

80. Ac-1182

81. Am81227

82. Ccg-270494

83. Cs-1507

84. Db00864

85. Idi1_001040

86. Ncgc00163470-01

87. Ncgc00163470-02

88. Ncgc00163470-04

89. Ncgc00163470-05

90. Ncgc00163470-06

91. Ncgc00163470-07

92. Ncgc00163470-27

93. (3s,4r,5s,8r,9e,12s,14s,15r,16s,18r,19r,26as)-5,19-dihydroxy-3-{(1e)-1-[(1r,3r,4r)-4-hydroxy-3-methoxycyclohexyl]prop-1-en-2-yl}-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(prop-2-en-1-yl)-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-3h-15,19-epoxypyrido[2,1-c][1,4]oxazacyclotricosine-1,7,20,21(4h,23h)-tetrone

94. Hy-13756

95. Sbi-0052894.p002

96. Cas-104987-11-3

97. M2258

98. C01375

99. D08556

100. Ab01209746-01

101. Ab01209746_03

102. 581t933

103. Q411648

104. Q-201775

105. Sr-05000001879-1

106. Sr-05000001879-2

107. Sr-05000001879-5

108. Brd-k35452788-001-02-1

109. Brd-k69608737-001-03-7

110. Brd-k69608737-001-10-2

111. [(e)-2-[(1r,3r,4r)-4-hydroxy-3-methoxycyclohexyl]-1-methylethenyl]-14,16-

112. 15,19-epoxy-3h-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(23h)-tetrone,

113. (1r,9s,12s,13r,14s,17r,18e,21s,23s,24r,25s,27r)-1,14-dihydroxy-12-[(e)-1-[(1r,3r,4r)-4-hydroxy-3-methoxycyclohexyl]prop-1-en-2-yl]-23,25-dimethoxy-13,19,21,27-tetramethyl-17-prop-2-enyl-11,28-dioxa-4-azatricyclo[22.3.1.04,9]octacos-18-ene-2,3,10,16-tetrone

114. (3s,4r,5s,8r,9e,12s,14s,15r,16s,18r,19r,26as)-5,19-dihydroxy-3-{(e)-2-[(1r,3r,4r)-4-hydroxy-3-methoxycyclohexyl]-1-methylethenyl}-14,16-dimethoxy-4,10,12,18-tetramethyl-8-prop-2-en-1-yl-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-3h-15,19-epoxypyrido[2,1-c][1,4]oxazacyclotricosine-1,7,20,21(4h,23h)-tetrone

115. (3s,4r,5s,8r,9e,12s,14s,15r,16s,18r,19r,26as)-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[(1e)-2-[(1r,3r,4r)-4-hydroxy-3-methoxycyclohexyl]-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propen-1-yl)-15,19

116. (e)-(1r,9s,12s,13r,14r,21s,23s,24r,25s,27r)-17-allyl-1,14-dihydroxy-12-[(e)-2-((3r,4r)-4-hydroxy-3-methoxy-cyclohexyl)-1-methyl-vinyl]-23,25-dimethoxy-13,19,21,27-tetramethyl-11,28-dioxa-4-aza-tricyclo[22.3.1.0*4,9*]octacos-18-ene-2,3,10,16-tetraone

117. 15,19-epoxy-3h-pyrido(2,1-c)(1,4)oxaazacyclotricosine-1,7,20,21(4h,23h)-tetrone, 5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-((1e)-2-((1r,3r,4r)-4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl)-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propen-1-yl)-, (3s,4r,5s,8r,9e,12s,14s,15r,16s,18r,19r,26as)-

118. 15,19-epoxy-3h-pyrido(2,1-c)(1,4)oxaazacyclotricosine-1,7,20,21(4h,23h)-tetrone, 5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-(2-(4-hydroxy-3-methoxycyclohexyl)-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-, (3s-(3r*(e(1s*,3s*,4s*)),4s*,5r*,8s*,9e,12r*,14r*,15s*,16r*,18s*,19s*,26ar*))-

119. 15,19-epoxy-3h-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4h,23h)-tetrone, 5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[(1e)-2-[(1r,3r,4r)-4-hydroxy-3-methoxycyc

120. 15,19-epoxy-3h-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4h,23h)-tetrone, 5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[(e)-2-[(1r,3r,4r)-4-hydroxy-3-methoxycycl Ohexyl]-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propen-1-yl)-, (3s,4r,5s,8r,9e,12s,14s,15r,16s,18r,19r,26as)-

121. 4,5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-heptadecahydro-5,19-dihydroxy-3-

122. Dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-,(3s,4r,5s,8r,12s,14s,15r,16s,18r,19r,26as)-

123. Lohexyl]-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propen-1-yl)-, (3s,4r,5s,8r,9e,12s,14s,15r,16s,18r,19r,26as)-

124. Tacrolimus Solution, 1.0 Mg/ml In Acetonitrile, Ampule Of 1 Ml, Certified Reference Material

2.4 Create Date
2005-06-08
3 Chemical and Physical Properties
Molecular Weight 804.0 g/mol
Molecular Formula C44H69NO12
XLogP32.7
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count12
Rotatable Bond Count7
Exact Mass803.48197664 g/mol
Monoisotopic Mass803.48197664 g/mol
Topological Polar Surface Area178 Ų
Heavy Atom Count57
Formal Charge0
Complexity1480
Isotope Atom Count0
Defined Atom Stereocenter Count14
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count2
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 8  
Drug NameAstagraf xl
PubMed HealthTacrolimus
Drug ClassesAntipsoriatic, Immune Suppressant
Drug LabelASTAGRAF XL is available for oral administration as hard gelatin capsules (tacrolimus extended-release capsules) containing the equivalent of 0.5 mg, 1 mg or 5 mg of anhydrous tacrolimus USP. Inactive ingredients include ethylcellulose NF, hypromello...
Active IngredientTacrolimus
Dosage FormCapsule, extended release
RouteOral
Strengtheq 5mg base; eq 0.5mg base; eq 1mg base
Market StatusPrescription
CompanyAstellas

2 of 8  
Drug NamePrograf
PubMed HealthTacrolimus
Drug ClassesAntipsoriatic, Immune Suppressant
Drug LabelPrograf is available for oral administration as capsules (tacrolimus capsules USP) containing the equivalent of 0.5 mg, 1 mg or 5 mg of anhydrous tacrolimus USP. Inactive ingredients include lactose monohydrate NF, hypromellose USP, croscarmellose so...
Active IngredientTacrolimus
Dosage FormCapsule; Injectable
RouteInjection; Oral
Strengtheq 0.5mg base; eq 5mg base; eq 1mg base; eq 5mg base/ml
Market StatusPrescription
CompanyAstellas

3 of 8  
Drug NameProtopic
PubMed HealthTacrolimus (On the skin)
Drug ClassesAntipsoriatic
Drug LabelPROTOPIC (tacrolimus) Ointment contains tacrolimus, a macrolide immunosuppressant produced by Streptomyces tsukubaensis. It is for topical dermatologic use only. Chemically, tacrolimus is designated as [3S-[3R*[E(1S*,3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R...
Active IngredientTacrolimus
Dosage FormOintment
RouteTopical
Strength0.1%; 0.03%
Market StatusPrescription
CompanyAstellas

4 of 8  
Drug NameTacrolimus
PubMed HealthTacrolimus
Drug ClassesAntipsoriatic, Immune Suppressant
Drug LabelPrograf is available for oral administration as capsules (tacrolimus capsules USP) containing the equivalent of 0.5 mg, 1 mg or 5 mg of anhydrous tacrolimus USP. Inactive ingredients include lactose monohydrate NF, hypromellose USP, croscarmellose so...
Active IngredientTacrolimus
Dosage FormOintment; Capsule
RouteOral; Topical
Strengtheq 5mg base; eq 0.5mg base; 0.1%; eq 1mg base; 0.03%
Market StatusPrescription
CompanyPanacea Biotec; Accord Hlthcare; Sandoz; Strides Pharma; Fougera Pharms; Dr Reddys Labs; Mylan

5 of 8  
Drug NameAstagraf xl
PubMed HealthTacrolimus
Drug ClassesAntipsoriatic, Immune Suppressant
Drug LabelASTAGRAF XL is available for oral administration as hard gelatin capsules (tacrolimus extended-release capsules) containing the equivalent of 0.5 mg, 1 mg or 5 mg of anhydrous tacrolimus USP. Inactive ingredients include ethylcellulose NF, hypromello...
Active IngredientTacrolimus
Dosage FormCapsule, extended release
RouteOral
Strengtheq 5mg base; eq 0.5mg base; eq 1mg base
Market StatusPrescription
CompanyAstellas

6 of 8  
Drug NamePrograf
PubMed HealthTacrolimus
Drug ClassesAntipsoriatic, Immune Suppressant
Drug LabelPrograf is available for oral administration as capsules (tacrolimus capsules USP) containing the equivalent of 0.5 mg, 1 mg or 5 mg of anhydrous tacrolimus USP. Inactive ingredients include lactose monohydrate NF, hypromellose USP, croscarmellose so...
Active IngredientTacrolimus
Dosage FormCapsule; Injectable
RouteInjection; Oral
Strengtheq 0.5mg base; eq 5mg base; eq 1mg base; eq 5mg base/ml
Market StatusPrescription
CompanyAstellas

7 of 8  
Drug NameProtopic
PubMed HealthTacrolimus (On the skin)
Drug ClassesAntipsoriatic
Drug LabelPROTOPIC (tacrolimus) Ointment contains tacrolimus, a macrolide immunosuppressant produced by Streptomyces tsukubaensis. It is for topical dermatologic use only. Chemically, tacrolimus is designated as [3S-[3R*[E(1S*,3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R...
Active IngredientTacrolimus
Dosage FormOintment
RouteTopical
Strength0.1%; 0.03%
Market StatusPrescription
CompanyAstellas

8 of 8  
Drug NameTacrolimus
PubMed HealthTacrolimus
Drug ClassesAntipsoriatic, Immune Suppressant
Drug LabelPrograf is available for oral administration as capsules (tacrolimus capsules USP) containing the equivalent of 0.5 mg, 1 mg or 5 mg of anhydrous tacrolimus USP. Inactive ingredients include lactose monohydrate NF, hypromellose USP, croscarmellose so...
Active IngredientTacrolimus
Dosage FormOintment; Capsule
RouteOral; Topical
Strengtheq 5mg base; eq 0.5mg base; 0.1%; eq 1mg base; 0.03%
Market StatusPrescription
CompanyPanacea Biotec; Accord Hlthcare; Sandoz; Strides Pharma; Fougera Pharms; Dr Reddys Labs; Mylan

4.2 Therapeutic Uses

Immunosuppressive Agents

National Library of Medicine's Medical Subject Headings. Tacrolimus. Online file (MeSH, 2014). Available from, as of April 30 2014: https://www.nlm.nih.gov/mesh/2014/mesh_browser/MBrowser.html


Prograf is indicated for the prophylaxis of organ rejection in patients receiving allogeneic kidney transplants. It is recommended that Prograf be used concomitantly with azathioprine or mycophenolate mofetil (MMF) and adrenal corticosteroids. /Included in US product label/

NIH; DailyMed. Current Medication Information for Prograf (Tacrolimus) Capsule, Gelatin Coated; Prograf (Tacrolimus) Injection, Solution (Revised: September 2013). Available from, as of June 17, 2014: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=7f667de1-9dfa-4bd6-8ba0-15ee2d78873b


Prograf is indicated for the prophylaxis of organ rejection in patients receiving allogeneic liver transplants. It is recommended that Prograf be used concomitantly with adrenal corticosteroids. Therapeutic drug monitoring is recommended for all patients receiving Prograf. /Included in US product label/

NIH; DailyMed. Current Medication Information for Prograf (Tacrolimus) Capsule, Gelatin Coated; Prograf (Tacrolimus) Injection, Solution (Revised: September 2013). Available from, as of June 17, 2014: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=7f667de1-9dfa-4bd6-8ba0-15ee2d78873b


Prograf is indicated for the prophylaxis of organ rejection in patients receiving allogeneic heart transplants. It is recommended that Prograf be used concomitantly with azathioprine or mycophenolate mofetil (MMF) and adrenal corticosteroids. /Included in US product label/

NIH; DailyMed. Current Medication Information for Prograf (Tacrolimus) Capsule, Gelatin Coated; Prograf (Tacrolimus) Injection, Solution (Revised: September 2013). Available from, as of June 17, 2014: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=7f667de1-9dfa-4bd6-8ba0-15ee2d78873b


For more Therapeutic Uses (Complete) data for Tacrolimus (13 total), please visit the HSDB record page.


4.3 Drug Warning

/BOXED WARNING/ MALIGNANCIES AND SERIOUS INFECTIONS. Increased risk of development of lymphoma and other malignancies, particularly of the skin, due to immunosuppression. Increased susceptibility to bacterial, viral, fungal, and protozoal infections, including opportunistic infections. Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe Prograf. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient.

NIH; DailyMed. Current Medication Information for Prograf (Tacrolimus) Capsule, Gelatin Coated; Prograf (Tacrolimus) Injection, Solution (Revised: September 2013). Available from, as of June 17, 2014: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=7f667de1-9dfa-4bd6-8ba0-15ee2d78873b


/BOXED WARNING/ WARNING: Long-term Safety of Topical Calcineurin Inhibitors Has Not Been Established Although a causal relationship has not been established, rare cases of malignancy (e.g., skin and lymphoma) have been reported in patients treated with topical calcineurin inhibitors, including Protopic Ointment. Therefore: Continuous long-term use of topical calcineurin inhibitors, including Protopic Ointment, in any age group should be avoided, and application limited to areas of involvement with atopic dermatitis; Protopic Ointment is not indicated for use in children less than 2 years of age; Only 0.03% Protopic Ointment is indicated for use in children 2-15 years of age.

NIH; DailyMed. DailyMed. Current Medication Information for Protopic (Tacrolimus) Ointment (Revised: May 2012). Available from, as of June 17, 2014: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=8c2e5036-5f1b-4e71-bf87-5faef295fa96


Topical tacrolimus therapy should be avoided for malignant or premalignant skin conditions (e.g., cutaneous T-cell lymphoma (CTCL)), which may appear clinically similar to dermatitis.

American Society of Health-System Pharmacists 2014; Drug Information 2014. Bethesda, MD. 2014


Because of a potential increased risk for skin cancer, patients /using topical tacrolimus/ should be advised to limit exposure to sunlight or other UV light by wearing protective clothing and using a broad-spectrum sunscreen with a high protection factor.

American Society of Health-System Pharmacists 2014; Drug Information 2014. Bethesda, MD. 2014


For more Drug Warnings (Complete) data for Tacrolimus (42 total), please visit the HSDB record page.


4.4 Drug Indication

For use after allogenic organ transplant to reduce the activity of the patient's immune system and so the risk of organ rejection. It was given FDA approval in 1994 for use in liver transplantation. Since then, this indication has expanded to kidney, heart, small bowel, pancreas, lung, trachea, skin, cornea, and limb transplants. It has also been used in a topical preparation in the treatment of severe atopic dermatitis.


FDA Label


Prophylaxis of transplant rejection in adult kidney or liver allograft recipients.

Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients.


Prophylaxis of transplant rejection in adult kidney or liver allograft recipients. Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients.


Prophylaxis of transplant rejection in adult and paediatric, kidney, liver or heart allograft recipients.

Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult and paediatric patients.


Prophylaxis of transplant rejection in adult kidney or liver allograft recipients.

Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients.


* Flare treatment:

Adults and adolescents (16 years of age and above)

Treatment of moderate to severe atopic dermatitis in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids.

Children (two years of age and above)

Treatment of moderate to severe atopic dermatitis in children (two years of age and above) who failed to respond adequately to conventional therapies such as topical corticosteroids.

* Maintenance treatment:

Maintenance treatment of moderate to severe atopic dermatitis for the prevention of flares and the prolongation of flare-free intervals in patients experiencing a high frequency of disease exacerbations (i. e. occurring four or more times per year) who have had an initial response to a maximum of six weeks treatment of twice daily tacrolimus ointment (lesions cleared, almost cleared or mildly affected).


Treatment of moderate to severe atopic dermatitis in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids. Treatment of moderate to severe atopic dermatitis in children (2 years of age and above) who failed to respond adequately to conventional therapies such as topical corticosteroids.

Maintenance treatment of moderate to severe atopic dermatitis for the prevention of flares and the prolongation of flare-free intervals in patients experiencing a high frequency of disease exacerbations (i. e. occurring 4 or more times per year) who have had an initial response to a maximum of 6 weeks treatment of twice daily tacrolimus ointment (lesions cleared, almost cleared or mildly affected).


Prevention of solid organ transplant rejection, Treatment of solid organ transplant rejection


5 Pharmacology and Biochemistry
5.1 Pharmacology

Tacrolimus acts by reducing peptidyl-prolyl isomerase activity by binding to the immunophilin FKBP-12 (FK506 binding protein) creating a new complex. This inhibits both T-lymphocyte signal transduction and IL-2 transcription. Tacrolimus has similar activity to cyclosporine but rates of rejection are lower with tacrolimus. Tacrolimus has also been shown to be effective in the topical treatment of eczema, particularly atopic eczema. It suppresses inflammation in a similar way to steroids, but is not as powerful. An important dermatological advantage of tacrolimus is that it can be used directly on the face; topical steroids cannot be used on the face, as they thin the skin dramatically there. On other parts of the body, topical steroid are generally a better treatment.


5.2 MeSH Pharmacological Classification

Calcineurin Inhibitors

Compounds that inhibit or block the PHOSPHATASE activity of CALCINEURIN. (See all compounds classified as Calcineurin Inhibitors.)


Immunosuppressive Agents

Agents that suppress immune function by one of several mechanisms of action. Classical cytotoxic immunosuppressants act by inhibiting DNA synthesis. Others may act through activation of T-CELLS or by inhibiting the activation of HELPER CELLS. While immunosuppression has been brought about in the past primarily to prevent rejection of transplanted organs, new applications involving mediation of the effects of INTERLEUKINS and other CYTOKINES are emerging. (See all compounds classified as Immunosuppressive Agents.)


5.3 FDA Pharmacological Classification
5.3.1 Active Moiety
TACROLIMUS ANHYDROUS
5.3.2 FDA UNII
Y5L2157C4J
5.3.3 Pharmacological Classes
Calcineurin Inhibitors [MoA]; Calcineurin Inhibitor Immunosuppressant [EPC]
5.4 ATC Code

L04AD02


L04AD02


L04AD02


L04AD02


D11AH01


D11AX14


L04AD02

S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355


D - Dermatologicals

D11 - Other dermatological preparations

D11A - Other dermatological preparations

D11AH - Agents for dermatitis, excluding corticosteroids

D11AH01 - Tacrolimus


L - Antineoplastic and immunomodulating agents

L04 - Immunosuppressants

L04A - Immunosuppressants

L04AD - Calcineurin inhibitors

L04AD02 - Tacrolimus


5.5 Absorption, Distribution and Excretion

Absorption

Absorption of tacrolimus from the gastrointestinal tract after oral administration is incomplete and variable. The absolute bioavailability in adult kidney transplant patients is 1710%; in adults liver transplant patients is 226%; in healthy subjects is 185%. The absolute bioavailability in pediatric liver transplant patients was 3124%. Tacrolimus maximum blood concentrations (Cmax) and area under the curve (AUC) appeared to increase in a dose-proportional fashion in 18 fasted healthy volunteers receiving a single oral dose of 3, 7, and 10 mg. When given without food, the rate and extent of absorption were the greatest. The time of the meal also affected bioavailability. When given immediately after a meal, mean Cmax was reduced 71%, and mean AUC was reduced 39%, relative to the fasted condition. When administered 1.5 hours following the meal, mean Cmax was reduced 63%, and mean AUC was reduced 39%, relative to the fasted condition.


Route of Elimination

In man, less than 1% of the dose administered is excreted unchanged in urine. When administered IV, fecal elimination accounted for 92.630.7%, urinary elimination accounted for 2.31.1%.


Volume of Distribution

2.6 2.1 L/kg [pediatric liver transplant patients]

1.07 0.20 L/kg [patients with renal impairment, 0.02 mg/kg/4 hr dose, IV]

3.1 1.6 L/kg [Mild Hepatic Impairment, 0.02 mg/kg/4 hr dose, IV]

3.7 4.7 L/kg [Mild Hepatic Impairment, 7.7 mg dose, PO]

3.9 1.0 L/kg [Severe hepatic impairment, 0.02 mg/kg/4 hr dose, IV]

3.1 3.4 L/kg [Severe hepatic impairment, 8 mg dose, PO]


Clearance

0.040 L/hr/kg [healthy subjects, IV]

0.172 0.088 L/hr/kg [healthy subjects, oral]

0.083 L/hr/kg [adult kidney transplant patients, IV]

0.053 L/hr/kg [adult liver transplant patients, IV]

0.051 L/hr/kg [adult heart transplant patients, IV]

0.138 0.071 L/hr/kg [pediatric liver transplant patients]

0.12 0.04 (range 0.06-0.17) L/hr/kg [pediatric kidney transplant patients]

0.038 0.014 L/hr/kg [patients with renal impairment, 0.02 mg/kg/4 hr dose, IV]

0.042 0.02 L/hr/kg [Mild Hepatic Impairment, 0.02 mg/kg/4 hr dose, IV]

0.034 0.019 L/hr/kg [Mild Hepatic Impairment, 7.7 mg dose, PO]

0.017 0.013 L/hr/kg [Severe hepatic impairment, 0.02 mg/kg/4 hr dose, IV]

0.016 0.011 L/hr/kg [Severe hepatic impairment, 8 mg dose, PO]


The aim of this study was to assess tacrolimus levels in breast milk and neonatal exposure during breastfeeding. An observational cohort study was performed in two tertiary referral high-risk obstetric medicine clinics. Fourteen women taking tacrolimus during pregnancy and lactation, and their 15 infants, 11 of whom were exclusively breast-fed, were assessed. Tacrolimus levels were analyzed by liquid chromatography-tandem mass spectrometry. Samples from mothers and cord blood were collected at delivery and from mothers, infants, and breast milk postnatally where possible. All infants with serial sampling had a decline in tacrolimus level, which was approximately 15% per day (ratio of geometric mean concentrations 0.85; 95% confidence interval, 0.82-0.88; P<0.001). Breast-fed infants did not have higher tacrolimus levels compared with bottle-fed infants (median 1.3 ug/L [range, 0.0-4.0] versus 1.0 ug/L (range, 0.0-2.3), respectively; P=0.91). Maximum estimated absorption from breast milk is 0.23% of maternal dose (weight-adjusted). Ingestion of tacrolimus by infants via breast milk is negligible. Breastfeeding does not appear to slow the decline of infant tacrolimus levels from higher levels present at birth.

PMID:23349333 Full text: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3613954 Bramham K et al; Clin J Am Soc Nephrol 8 (4): 563-7 (2013)


Maternal and umbilical cord (venous and arterial) samples were obtained at delivery from eight solid organ allograft recipients to measure tacrolimus and metabolite bound and unbound concentrations in blood and plasma. Tacrolimus pharmacokinetics in breast milk were assessed in one subject. Mean (+ or - SD) tacrolimus concentrations at the time of delivery in umbilical cord venous blood (6.6 + or - 1.8 ng ml(-1)) were 71 + or - 18% (range 45-99%) of maternal concentrations (9.0 + or - 3.4 ng ml(-1)). The mean umbilical cord venous plasma (0.09 + or - 0.04 ng ml(-1)) and unbound drug concentrations (0.003 + or - 0.001 ng ml(-1)) were approximately one fifth of the respective maternal concentrations. Arterial umbilical cord blood concentrations of tacrolimus were 100 + or - 12% of umbilical venous concentrations. In addition, infant exposure to tacrolimus through the breast milk was less than 0.3% of the mother's weight-adjusted dose. Differences between maternal and umbilical cord tacrolimus concentrations may be explained in part by placental P-gp function, greater red blood cell partitioning and higher haematocrit levels in venous cord blood.

PMID:23528073 Full text: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3845323 Zheng S et al; Br J Clin Pharmacol 76 (6): 988-96 (2013)


Ten colostrum samples were obtained from six women in the immediate postpartum period (0-3 days) with a mean drug concentration of 0.79 ng/mL (range 0.3-1.9 ng/mL). The median milk:maternal plasma ratio was 0.5.

Briggs, G.G., Freeman, R.K., Yaffee, S.J.; Drugs in Pregancy and Lactation Nineth Edition. Wolters Kluwer/Lippincott Williams & Wilkins, Philadelphia, PA. 2011, p. 1385


The plasma protein binding of tacrolimus is approximately 99% and is independent of concentration over a range of 5-50 ng/mL. Tacrolimus is bound mainly to albumin and alpha-1-acid glycoprotein, and has a high level of association with erythrocytes. The distribution of tacrolimus between whole blood and plasma depends on several factors, such as hematocrit, temperature at the time of plasma separation, drug concentration, and plasma protein concentration. In a US study, the ratio of whole blood concentration to plasma concentration averaged 35 (range 12 to 67). There was no evidence based on blood concentrations that tacrolimus accumulates systemically upon intermittent topical application for periods of up to 1 year. As with other topical calcineurin inhibitors, it is not known whether tacrolimus is distributed into the lymphatic system.

NIH; DailyMed. DailyMed. Current Medication Information for Protopic (Tacrolimus) Ointment (Revised: May 2012). Available from, as of June 17, 2014: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=8c2e5036-5f1b-4e71-bf87-5faef295fa96


For more Absorption, Distribution and Excretion (Complete) data for Tacrolimus (9 total), please visit the HSDB record page.


5.6 Metabolism/Metabolites

The metabolism of tacrolimus is predominantly mediated by CYP3A4 and secondarily by CYP3A5. Tacrolimus is metabolized into 8 metabolites: 13-demethyl tacrolimus, 31-demethyl tacrolimus, 15-demethyl tacrolimus, 12-hydroxy tacrolimus, 15,31-didemethyl tacrolimus, 13,31-didemethyl tacrolimus, 13,15-didemethyl tacrolimus, and a final metabolite involving O-demethylation and the formation of a fused ring. The major metabolite identified in incubations with human liver microsomes is 13-demethyl tacrolimus. In in vitro studies, a 31-demethyl metabolite has been reported to have the same activity as tacrolimus.


Tacrolimus is extensively metabolized by the mixed-function oxidase system, primarily the cytochrome P-450 system (CYP3A). A metabolic pathway leading to the formation of 8 possible metabolites has been proposed. Demethylation and hydroxylation were identified as the primary mechanisms of biotransformation in vitro. The major metabolite identified in incubations with human liver microsomes is 13-demethyl tacrolimus. In in vitro studies, a 31-demethyl metabolite has been reported to have the same activity as tacrolimus.

NIH; DailyMed. Current Medication Information for Prograf (Tacrolimus) Capsule, Gelatin Coated; Prograf (Tacrolimus) Injection, Solution (Revised: September 2013). Available from, as of June 17, 2014: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=7f667de1-9dfa-4bd6-8ba0-15ee2d78873b


Fk_506 has known human metabolites that include 13-O-Desmethyltacrolimus and 15-O-Desmethyltacrolimus.

S73 | METXBIODB | Metabolite Reaction Database from BioTransformer | DOI:10.5281/zenodo.4056560


5.7 Biological Half-Life

The elimination half life in adult healthy volunteers, kidney transplant patients, liver transplants patients, and heart transplant patients are approximately 35, 19, 12, 24 hours, respectively. The elimination half life in pediatric liver transplant patients was 11.53.8 hours, in pediatric kidney transplant patients was 10.25.0 (range 3.4-25) hours.


In a mass balance study of IV administered radiolabeled tacrolimus to 6 healthy volunteers, ... the elimination half-life based on radioactivity was 48.1+ or - 15.9 hours whereas it was 43.5 + or- 11.6 hours based on tacrolimus concentrations. ... When administered PO, the elimination half-life based on radioactivity was 31.9 + or- 10.5 hours whereas it was 48.4 + or - 12.3 hours based on tacrolimus concentrations ... .

NIH; DailyMed. Current Medication Information for Prograf (Tacrolimus) Capsule, Gelatin Coated; Prograf (Tacrolimus) Injection, Solution (Revised: September 2013). Available from, as of June 17, 2014: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=7f667de1-9dfa-4bd6-8ba0-15ee2d78873b


... A case of tacrolimus toxicity in a non-transplant patient /is presented/. ... /The/ patient's tacrolimus dose was 2.1 mg/kg/day for 4 days (therapeutic 0.03 to 0.05 mg/kg/day). Her tacrolimus elimination half-life was 16.5 hours, compared to a mean half-life in healthy volunteers of 34.2 +/- 7.7 hours. ...

PMID:18608277 O'Connor AD et al; Clin Toxicol (Phila) 46 (9): 838-40 (2008)


5.8 Mechanism of Action

The mechanism of action of tacrolimus in atopic dermatitis is not known. While the following have been observed, the clinical significance of these observations in atopic dermatitis is not known. It has been demonstrated that tacrolimus inhibits T-lymphocyte activation by first binding to an intracellular protein, FKBP-12. A complex of tacrolimus-FKBP-12, calcium, calmodulin, and calcineurin is then formed and the phosphatase activity of calcineurin is inhibited. This prevents the dephosphorylation and translocation of nuclear factor of activated T-cells (NF-AT), a nuclear component thought to initiate gene transcription for the formation of lymphokines. Tacrolimus also inhibits the transcription for genes which encode IL-3, IL-4, IL-5, GM-CSF, and TNF-, all of which are involved in the early stages of T-cell activation. Additionally, tacrolimus has been shown to inhibit the release of pre-formed mediators from skin mast cells and basophils, and to downregulate the expression of FceRI on Langerhans cells.


Tacrolimus is a macrolide immunosuppressant produced by Streptomyces tsukubaensis. Tacrolimus is commercially available for topical use as a 0.03 or 0.1% ointment. The exact mechanism(s) of action of tacrolimus in the treatment of atopic dermatitis has not been elucidated but appears to involve inhibition of the activation of T cells. Tacrolimus also has been shown to inhibit release of mediators from skin mast cells and basophils and to downregulate the expression of high-affinity receptors for immunoglobulin E (IgE) on Langerhans cells. Although tacrolimus is not genotoxic and does not interact directly with DNA, the drug may impair local immunosurveillance.

American Society of Health-System Pharmacists 2014; Drug Information 2014. Bethesda, MD. 2014


Tacrolimus inhibits T-lymphocyte activation, although the exact mechanism of action is not known. Experimental evidence suggests that tacrolimus binds to an intracellular protein, FKBP-12. A complex of tacrolimus-FKBP-12, calcium, calmodulin, and calcineurin is then formed and the phosphatase activity of calcineurin inhibited. This effect may prevent the dephosphorylation and translocation of nuclear factor of activated T-cells (NF-AT), a nuclear component thought to initiate gene transcription for the formation of lymphokines (such as interleukin-2, gamma interferon). The net result is the inhibition of T-lymphocyte activation (i.e., immunosuppression).

NIH; DailyMed. Current Medication Information for Prograf (Tacrolimus) Capsule, Gelatin Coated; Prograf (Tacrolimus) Injection, Solution (Revised: September 2013). Available from, as of June 17, 2014: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=7f667de1-9dfa-4bd6-8ba0-15ee2d78873b


The mechanism of action of tacrolimus in atopic dermatitis is not known. While the following have been observed, the clinical significance of these observations in atopic dermatitis is not known. It has been demonstrated that tacrolimus inhibits T-lymphocyte activation by first binding to an intracellular protein, FKBP-12. A complex of tacrolimus-FKBP-12, calcium, calmodulin, and calcineurin is then formed and the phosphatase activity of calcineurin is inhibited. This effect has been shown to prevent the dephosphorylation and translocation of nuclear factor of activated T-cells (NF-AT), a nuclear component thought to initiate gene transcription for the formation of lymphokines (such as interleukin-2, gamma interferon). Tacrolimus also inhibits the transcription for genes which encode IL-3, IL-4, IL-5, GM-CSF, and TNF-a, all of which are involved in the early stages of T-cell activation. Additionally, tacrolimus has been shown to inhibit the release of pre-formed mediators from skin mast cells and basophils, and to down regulate the expression of FceRI on Langerhans cells.

NIH; DailyMed. DailyMed. Current Medication Information for Protopic (Tacrolimus) Ointment (Revised: May 2012). Available from, as of June 17, 2014: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=8c2e5036-5f1b-4e71-bf87-5faef295fa96


Tacrolimus, formerly known as FK506, is a macrolide antibiotic with immunosuppressive properties. Although structurally unrelated to cyclosporin A (CsA), its mode of action is similar. It exerts its effects principally through impairment of gene expression in target cells. Tacrolimus bonds to an immunophilin, FK506 binding protein (FKBP). This complex inhibits calcineurin phosphatase. The drug inhibits calcium-dependent events, such as interleukin-2 gene transcription, nitric oxide synthase activation, cell degranulation, and apoptosis. Tacrolimus also potentiates the actions of glucocorticoids and progesterone by binding to FKBPs contained within the hormone receptor complex, preventing degradation. The agent may enhance expression of the transforming growth factor beta-1 gene in a fashion analogous to that demonstrated for CsA. T cell proliferation in response to ligation of the T cell receptor is inhibited by tacrolimus. Type 1 T helper cells appear to be preferentially suppressed compared with type 2 T helper cells. T cell-mediated cytotoxicity is impaired. B cell growth and antibody production are affected indirectly by the suppression of T cell-derived growth factors necessary for these functions. Antigen presentation appears to be spared. ...

PMID:8588225 Thomson AW et al; Ther Drug Monit 17 (6): 584-91 (1995)


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Status : Valid

Issue Date : 2024-07-22

Type : Chemical and TSE

Substance Number : 2244

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Certificate Number : R0-CEP 2021-204 - Rev 01

Status : Valid

Issue Date : 2023-08-07

Type : Chemical

Substance Number : 2244

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Certificate Number : R0-CEP 2021-180 - Rev 01

Status : Valid

Issue Date : 2023-06-19

Type : Chemical

Substance Number : 2244

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Certificate Number : CEP 2023-051 - Rev 00

Status : Valid

Issue Date : 2024-09-26

Type : Chemical

Substance Number : 2244

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EU WC

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  • fda
  • EDQM
  • WHO-GMP

Virtual BoothFishfa Biogenics: Renowned Manufacturer, & Exporter of Tacrolimus & Mupirocin API.

Flag India
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Tacrolimus Monohydrate EP

Date of Issue : 2022-06-13

Valid Till : 2025-06-12

Written Confirmation Number : WC-0529n

Address of the Firm : Survey no 43/2/2, 47/2, 50/1/2, 50/2, Kuvadwa Wankaner Hihgway, Rampara(Surya), ...

Fishfa Biogenics

02

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Tacrolimus Monohydrate EP

Date of Issue : 2023-11-15

Valid Till : 2026-11-14

Written Confirmation Number : WC-0489

Address of the Firm : Plot No. P-1, Biotech Park, G.I.D.C, Manjusar TA: Savli, Dist. Vadodara, Gujarat...

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Biocon

India
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Biocon

India
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Tacrolimus USP/IH

Date of Issue : 2025-09-24

Valid Till : 2028-07-02

Written Confirmation Number : WC-0109

Address of the Firm : 20th KM, Hosur Road, Electronics City, Bengaluru ? 560 100

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Biocon

India
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Biocon

India
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Tacrolimus Monohydrate EP

Date of Issue : 2025-09-24

Valid Till : 2028-07-02

Written Confirmation Number : WC-0109

Address of the Firm : 20th KM, Hosur Road, Electronics City, Bengaluru ? 560 100

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Tacrolimus Monohydrate IH/USP/EP/JP

Date of Issue : 2025-11-04

Valid Till : 2028-07-02

Written Confirmation Number : WC-0111

Address of the Firm : Survay No. 1482-1486, Trasad Road, Dholka, Dist:- Ahmedabad-382225, Gujarat Stat...

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Tacrolimus Premix 20%, Tacrolimus Premix IH Manufacturing & Packing 18. Tacrolimus Premix 20% Bulk IH

Date of Issue : 2025-11-04

Valid Till : 2028-07-02

Written Confirmation Number : WC-0111

Address of the Firm : Survay No. 1482-1486, Trasad Road, Dholka, Dist:- Ahmedabad-382225, Gujarat Stat...

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Tacrolimus Monohydrate EP

Date of Issue : 2023-09-18

Valid Till : 2026-09-17

Written Confirmation Number : WC-0568

Address of the Firm : Unit-lll, Plot No. 84 and 668, Ranasar and Malawada, Limbasi Sojitra Road, Near ...

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Tacrolimus IP/USP/EP/JP

Date of Issue : 2023-09-18

Valid Till : 2026-09-17

Written Confirmation Number : WC-0568

Address of the Firm : Unit-lll, Plot No. 84 and 668, Ranasar and Malawada, Limbasi Sojitra Road, Near ...

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Listed Suppliers

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Virtual BoothChunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.

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Tacrolimus

About the Company : Chunghwa Chemical Synthesis & Biotech Co. Ltd. (CCSB) offers cost-effective APIs with speed, supported by a skilled team. As the first Southeast Asian company to receive FDA approv...

Chunghwa Chemical Synthesis & Biotech Co. Ltd. (CCSB) offers cost-effective APIs with speed, supported by a skilled team. As the first Southeast Asian company to receive FDA approval for synthetic and biotech APIs, CCSB has commercialized Statin, Immunosuppressant, Muscle Relaxant, and ACE Inhibitor APIs with complete DMF or COS. It partners with leading drug companies to develop and produce specialty APIs using advanced fermentation and synthesis technologies in Taiwan. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
CCSB Company Banner

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothFishfa Biogenics: Renowned Manufacturer, & Exporter of Tacrolimus & Mupirocin API.

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Tacrolimus

About the Company : Fishfa Biogenics, a division of Fishfa Rubbers Ltd., manufactures and supplies biological APIs. The company operates GLP labs and WHO-GMP-certified facilities, specializing in ferm...

Fishfa Biogenics, a division of Fishfa Rubbers Ltd., manufactures and supplies biological APIs. The company operates GLP labs and WHO-GMP-certified facilities, specializing in fermentation-based production, process development, and manufacturing. Its site includes microbial drug substance production, quality testing, and technical, regulatory, and IP support. Fishfa exports APIs such as Mupirocin and Tacrolimus to markets in Europe, Asia, the Middle East, South America, Russia, New Zealand, and the UK. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
Fishfa Biogenics

03

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  • WHO-GMP

Virtual BoothChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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Tacrolimus

About the Company : ChemWerth, established in 1982, is a US-headquartered full-service generic API company. It supplies cGMP-quality APIs to regulated markets worldwide, with exclusive partnerships fo...

ChemWerth, established in 1982, is a US-headquartered full-service generic API company. It supplies cGMP-quality APIs to regulated markets worldwide, with exclusive partnerships for product development, compliance, and secure logistics. ChemWerth accesses over 500 APIs and 30 manufacturing facilities across the US, Europe, India, and China, acts as a regulatory agent for 25+ FDA-approved facilities, sells 100+ products, and operates in 38 countries. In 2020, it filed its 500th DMF with the FDA . Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
Chemwerth Compnay Banner

04

LGM Pharma

U.S.A
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothLGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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Tacrolimus

About the Company : LGM Pharma is a global leader in sourcing APIs, including hard-to-find drug substances, for pharmaceutical and biotech industries. LGM also operates as a full-service drug product ...

LGM Pharma is a global leader in sourcing APIs, including hard-to-find drug substances, for pharmaceutical and biotech industries. LGM also operates as a full-service drug product CDMO, offering formulation, analytical method development and testing, regulatory support, and commercial manufacturing. Supported by a network of over 220 accredited cGMP manufacturing partners and more than 100,000 sq. ft. of FDA-inspected cGMP manufacturing and warehouse space, LGM delivers secure, end-to-end solutions across multiple dosage forms. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
LGM Pharma CB

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMetrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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Tacrolimus

About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...

Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product groups and has been approved by ISO 9001-2015, USFDA, WHO GMP, Cofepris & Japanese authorities. Metrochem’s in-depth industry knowledge, & hi-tech & advanced infrastructure, helps it provide quality products to its customers. Note: None of the products will be supplied to the countries where this could conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer
Metrochem

06

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

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Tacrolimus

About the Company : Symbiotec, based in Indore, India, is a leading API manufacturer specializing in cortico-steroids and steroid-hormone APIs since 1995. Focused on R&D, sustainability, and innovatio...

Symbiotec, based in Indore, India, is a leading API manufacturer specializing in cortico-steroids and steroid-hormone APIs since 1995. Focused on R&D, sustainability, and innovation, it operates a state-of-the-art facility inaugurated in 2004. Certified by WHO-GMP, ISO, US FDA, and EU GMP, Symbiotec is a trusted provider known for quality, adaptability, efficiency, and competitive pricing in global healthcare. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
Symbiotec Pharmalab

07

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothJai Radhe Sales is your partner for all your sourcing needs.

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Tacrolimus

About the Company : Jai Radhe Sales, founded in 1999, is a global distributor specializing in high-quality pharmaceutical ingredients from India. It offers complete sourcing solutions, technical and r...

Jai Radhe Sales, founded in 1999, is a global distributor specializing in high-quality pharmaceutical ingredients from India. It offers complete sourcing solutions, technical and regulatory support, and strives for global standards. Known for quality and affordability, it has established a niche through innovative methods and exports to nearly every continent. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
Jai Radhe Sales

08

HRV Pharma

India
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothHRV Pharma - Market Expansion Leader in Pharmaceuticals.

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Tacrolimus

About the Company : HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing...

HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing, manufacturing, and supply services to support partners entering new markets worldwide. HRV Pharma works closely with major pharma and food additive companies and represents over 30 Indian drugmakers, primarily serving Europe, the US, and the Middle East. Headquartered in India, it operates offices in the US, Switzerland, Dubai, Lithuania, and Turkey. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
HRV Global Life Sciences

09

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothShanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.

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Tacrolimus Monohydrate

About the Company : Shanghai Minbiotech is specializing in the R&D and production of advanced pharmaceutical intermediates and biological APIs. There are more than 1000 square meters of R&D centers in...

Shanghai Minbiotech is specializing in the R&D and production of advanced pharmaceutical intermediates and biological APIs. There are more than 1000 square meters of R&D centers in Nantong, Jiangsu and Jinan, Shandong, with more than 13,000㎡ of production sites. While supplying products to customers, the company also provides services such as technology development, technology transfer and technology exchange, aiming to provide customers with comprehensive supply and solutions in the biomedical industry. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
Shanghai Minbiotech CB

10

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothTenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.

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Tacrolimus

About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...

Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opportunities grew, it was felt that the proprietorship firm had outlived its usefulness and that it needed a corporate structure. So, Tenatra Exports Private Limited was incorporated in 2002. Since then, the company has come a long way, gaining valuable experience and knowledge in the fields of chemicals and pharmaceuticals in India. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
Tenatra
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Drugs in Development

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Details:

Amlitelimab is a Antibody drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Dermatitis, Atopic.


Lead Product(s): Amlitelimab,Corticosteroid,Tacrolimus

Therapeutic Area: Dermatology Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Antibody, Unconjugated

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable February 05, 2024

Sanofi Company Banner

01

Sanofi

France
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Lead Product(s) : Amlitelimab,Corticosteroid,Tacrolimus

Therapeutic Area : Dermatology

Highest Development Status : Phase III

Partner/Sponsor/Collaborator : Undisclosed

Deal Size : Inapplicable

Deal Type : Inapplicable

Details : Amlitelimab is a Antibody drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Dermatitis, Atopic.

Product Name : Undisclosed

Product Type : Antibody, Unconjugated

Upfront Cash : Inapplicable

February 05, 2024

Sanofi Company Banner

Details:

SAR445088 is a Antibody drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Graft Rejection.


Lead Product(s): SAR445088,Antithymocyte Globulin,Tacrolimus,Mycophenolic Acid

Therapeutic Area: Immunology Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Antibody, Unconjugated

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable December 14, 2021

Sanofi Company Banner

02

Sanofi

France
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Lead Product(s) : SAR445088,Antithymocyte Globulin,Tacrolimus,Mycophenolic Acid

Therapeutic Area : Immunology

Highest Development Status : Phase II

Partner/Sponsor/Collaborator : Undisclosed

Deal Size : Inapplicable

Deal Type : Inapplicable

Details : SAR445088 is a Antibody drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Graft Rejection.

Product Name : Undisclosed

Product Type : Antibody, Unconjugated

Upfront Cash : Inapplicable

December 14, 2021

Sanofi Company Banner

Details:

Tacrolimus is a Antibiotic drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Kidney Failure, Chronic.


Lead Product(s): Tacrolimus,Methylprednisolone,Mycophenolate Mofetil,Mycophenolate Sodium,Prednisone

Therapeutic Area: Nephrology Brand Name: Undisclosed

Study Phase: Phase IVProduct Type: Antibiotic

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable April 04, 2017

Sanofi Company Banner

03

Sanofi

France
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Lead Product(s) : Tacrolimus,Methylprednisolone,Mycophenolate Mofetil,Mycophenolate Sodium,Prednisone

Therapeutic Area : Nephrology

Highest Development Status : Phase IV

Partner/Sponsor/Collaborator : Undisclosed

Deal Size : Inapplicable

Deal Type : Inapplicable

Details : Tacrolimus is a Antibiotic drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Kidney Failure, Chronic.

Product Name : Undisclosed

Product Type : Antibiotic

Upfront Cash : Inapplicable

April 04, 2017

Sanofi Company Banner

Details:

Sarilumab is a Antibody drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Arthritis, Rheumatoid.


Lead Product(s): Sarilumab,Sulfasalazine,Leflunomide,Bucillamine,Tacrolimus,Mizoribine

Therapeutic Area: Immunology Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Antibody, Unconjugated

Sponsor: Regeneron Pharmaceuticals

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable February 26, 2015

Sanofi Company Banner

04

Sanofi

France
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Lead Product(s) : Sarilumab, Sulfasalazine, Leflunomide, Bucillamine, Tacrolimus

Therapeutic Area : Immunology

Highest Development Status : Phase III

Partner/Sponsor/Collaborator : Regeneron Pharmaceuticals

Deal Size : Inapplicable

Deal Type : Inapplicable

Details : Sarilumab is a Antibody drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Arthritis, Rheumatoid.

Product Name : Undisclosed

Product Type : Antibody, Unconjugated

Upfront Cash : Inapplicable

February 26, 2015

Sanofi Company Banner

Details:

Tacrolimus is a Antibiotic drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.


Lead Product(s): Tacrolimus,Inapplicable

Therapeutic Area: Undisclosed Brand Name: Undisclosed

Study Phase: Phase IProduct Type: Antibiotic

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable May 27, 2010

Dr Reddy Company Banner

05

Lead Product(s) : Tacrolimus,Inapplicable

Therapeutic Area : Undisclosed

Highest Development Status : Phase I

Partner/Sponsor/Collaborator : Undisclosed

Deal Size : Inapplicable

Deal Type : Inapplicable

Details : Tacrolimus is a Antibiotic drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.

Product Name : Undisclosed

Product Type : Antibiotic

Upfront Cash : Inapplicable

May 27, 2010

Dr Reddy Company Banner

Details:

Tacrolimus is a Antibiotic drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.


Lead Product(s): Tacrolimus,Inapplicable

Therapeutic Area: Undisclosed Brand Name: Undisclosed

Study Phase: Phase IProduct Type: Antibiotic

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable May 27, 2010

Dr Reddy Company Banner

06

Lead Product(s) : Tacrolimus,Inapplicable

Therapeutic Area : Undisclosed

Highest Development Status : Phase I

Partner/Sponsor/Collaborator : Undisclosed

Deal Size : Inapplicable

Deal Type : Inapplicable

Details : Tacrolimus is a Antibiotic drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.

Product Name : Undisclosed

Product Type : Antibiotic

Upfront Cash : Inapplicable

May 27, 2010

Dr Reddy Company Banner

Details:

The top selling brands are Pangraf (tacrolimus), Alphadol (alfacalcidol), Cilamin (penicillamine) & Livoluk Fibre (lactulose in combination with ispaghula) were ranked number 1, whereas Glizid (Gliclazide + Metformin), Mycept (Mycophenolate Mofetil) were among the top 5.


Lead Product(s): Tacrolimus,Inapplicable

Therapeutic Area: Dermatology Brand Name: Pangraf

Study Phase: Approved FDFProduct Type: Antibiotic

Sponsor: Panacea Biotec Limited

Deal Size: $251.1 million Upfront Cash: Undisclosed

Deal Type: Agreement February 01, 2022

Company Banner

07

Lead Product(s) : Tacrolimus,Inapplicable

Therapeutic Area : Dermatology

Highest Development Status : Approved FDF

Partner/Sponsor/Collaborator : Panacea Biotec Limited

Deal Size : $251.1 million

Deal Type : Agreement

Details : The top selling brands are Pangraf (tacrolimus), Alphadol (alfacalcidol), Cilamin (penicillamine) & Livoluk Fibre (lactulose in combination with ispaghula) were ranked number 1, whereas Glizid (Gliclazide + Metformin), Mycept (Mycophenolate Mofetil) were...

Product Name : Pangraf

Product Type : Antibiotic

Upfront Cash : Undisclosed

February 01, 2022

Company Banner
  • Development Update

Details:

Dopacell is a cell & gene therapy drug, which is currently being evaluated in Phase I clinical studies for the treatment of parkinson disease.


Lead Product(s): Dopacell,Basiliximab,Tacrolimus,Prednisolone

Therapeutic Area: Neurology Brand Name: Undisclosed

Study Phase: Phase IProduct Type: Cell & Gene Therapy

Sponsor: Royan AtiTech Pharmed | Shiraz University of Medical Sciences | Iran University of Medical Sciences

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable May 07, 2026

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Royan Institute

Country
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Royan Institute

Country
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Not Confirmed

Lead Product(s) : Dopacell,Basiliximab,Tacrolimus,Prednisolone

Therapeutic Area : Neurology

Highest Development Status : Phase I

Partner/Sponsor/Collaborator : Royan AtiTech Pharmed | Shiraz University of Medical Sciences | Iran University of Medical Sciences

Deal Size : Inapplicable

Deal Type : Inapplicable

Details : Dopacell is a cell & gene therapy drug, which is currently being evaluated in Phase I clinical studies for the treatment of parkinson disease.

Product Name : Undisclosed

Product Type : Cell & Gene Therapy

Upfront Cash : Inapplicable

May 07, 2026

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  • Development Update

Details:

Azacitidine is a cytotoxic drug drug, which is currently being evaluated in Phase I clinical studies for the treatment of leukemia, myeloid, acute.


Lead Product(s): Azacitidine,Cyclophosphamide,Mycophenolate Mofetil,Ruxolitinib Phosphate,Tacrolimus

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IProduct Type: Cytotoxic Drug

Sponsor: Incyte Corporation

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable April 23, 2026

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09

OHSU Knight Cancer Institute

Country
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Not Confirmed

OHSU Knight Cancer Institute

Country
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Not Confirmed

Details : Azacitidine is a cytotoxic drug drug, which is currently being evaluated in Phase I clinical studies for the treatment of leukemia, myeloid, acute.

Product Name : Undisclosed

Product Type : Cytotoxic Drug

Upfront Cash : Inapplicable

April 23, 2026

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Details:

Prograf-Generic (Tacrolimus) is a antibiotic drug, which is currently being evaluated in Approved FDF clinical studies for the treatment of graft rejection.


Lead Product(s): Tacrolimus,Inapplicable

Therapeutic Area: Immunology Brand Name: Prograf-Generic

Study Phase: Approved FDFProduct Type: Antibiotic

Sponsor: CNX Therapeutics

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Acquisition April 02, 2026

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10

Pharmanovia

United Kingdom
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Not Confirmed

Pharmanovia

United Kingdom
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PEGS Boston Summit
Not Confirmed

Details : Prograf-Generic (Tacrolimus) is a antibiotic drug, which is currently being evaluated in Approved FDF clinical studies for the treatment of graft rejection.

Product Name : Prograf-Generic

Product Type : Antibiotic

Upfront Cash : Undisclosed

April 02, 2026

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INTERMEDIATE SUPPLIERS

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01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothTogether we can improve the quality of life

CAS Number : 333-27-7

End Use API : Tacrolimus

About The Company : Shamrock Pharmachemi Pvt Ltd. is a globally recognized API leader with 26+ years in human and veterinary pharmaceuticals. Operating in 40+ countries, it owns tw...

Company Banner

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothPanvo Organics: Advancing quality APIs and formulations with Halal, Kosher, US FDA, and WHO-approved manufacturing excellence.

CAS Number : 24057-28-1

End Use API : Tacrolimus

About The Company : Panvo Organics Pvt. Ltd., established in 2006, is a WHO-GMP certified manufacturer of Active Pharmaceutical Ingredients, novel formulations, and sustainable agr...

Panvo Company Banner

03

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CAS Number : CAS-24057-28-1-

End Use API : Tacrolimus

About The Company : In 2011 we entered the fine chemical market of Noble Metal Catalyst ,Organic Phosphine Ligands and OLED intermediates.With the joint efforts of our senior exper...

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04

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CAS Number : CAS-24057-28-1

End Use API : Tacrolimus

About The Company : In 2011 we entered the fine chemical market of Noble Metal Catalyst ,Organic Phosphine Ligands and OLED intermediates.With the joint efforts of our senior exper...

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05

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CAS Number : CAS-24057-28-1

End Use API : Tacrolimus

About The Company : Jubilant Ingrevia, a global integrated Life Science products and Innovative Solutions provider serving, Pharmaceutical, Nutrition, Agrochemical, Consumer and In...

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06

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CAS Number : 24057-28-1

End Use API : Tacrolimus

About The Company : Sigmak Lifesciences is a leading contract manufacturer, merchant exporter, & distributor of pharmaceutical APIs & Fine Chemicals. We excel in Contract Manufactu...

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CAS Number : CAS-24057-28-1

End Use API : Tacrolimus

About The Company : With decades of experience in production and selling high-quality chemicals, Zhengzhou Alfa Chemical supplies organic chemicals, catalysts and auxiliary, pharma...

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 0...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 0.75MG BASE

USFDA APPLICATION NUMBER - 206406

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

USFDA APPLICATION NUMBER - 206406

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 4...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 4MG BASE

USFDA APPLICATION NUMBER - 206406

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DOSAGE - CAPSULE;ORAL - EQ 0.5MG BASE

USFDA APPLICATION NUMBER - 50708

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DOSAGE - CAPSULE;ORAL - EQ 1MG BASE

USFDA APPLICATION NUMBER - 50708

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DOSAGE - CAPSULE;ORAL - EQ 5MG BASE

USFDA APPLICATION NUMBER - 50708

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Looking for 104987-11-3 / Tacrolimus API manufacturers, exporters & distributors?

Tacrolimus manufacturers, exporters & distributors 1

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

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

API | Excipient name

Tacrolimus

Synonyms

Fujimycin, 104987-11-3, Prograf, Tsukubaenolide, Protopic, Fk506

Cas Number

104987-11-3

Unique Ingredient Identifier (UNII)

Y5L2157C4J

About Tacrolimus

A macrolide isolated from the culture broth of a strain of Streptomyces tsukubaensis that has strong immunosuppressive activity in vivo and prevents the activation of T-lymphocytes in response to antigenic or mitogenic stimulation in vitro.

Tacrolimus Hydrate Manufacturers

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

Tacrolimus Hydrate Suppliers

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

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

Tacrolimus Hydrate USDMF

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

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

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

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

Tacrolimus Hydrate KDMF

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

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

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

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

Tacrolimus Hydrate CEP

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

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

Tacrolimus Hydrate WC

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

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

Tacrolimus Hydrate 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 Tacrolimus Hydrate as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Tacrolimus Hydrate GMP

Tacrolimus Hydrate 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 Tacrolimus Hydrate GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Tacrolimus Hydrate GMP manufacturer or Tacrolimus Hydrate GMP API supplier for your needs.

Tacrolimus Hydrate CoA

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

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

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