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1. 1-(2'-hydroxypropyl)-2-methyl-5- Nitroimidazole
2. 14,539 Rp
3. Minovag
4. Sabima
5. Secnidal
6. Secnol
7. Solosec
1. 3366-95-8
2. Secnidazol
3. Flagentyl
4. Secnidazolum
5. 1-(2-methyl-5-nitro-1h-imidazol-1-yl)propan-2-ol
6. Secnidazolum [inn-latin]
7. Solosec
8. Rp 14539
9. Secnidal
10. 1-(2-methyl-5-nitroimidazol-1-yl)propan-2-ol
11. Pm 185184
12. Pm-185184
13. Sym-1219
14. Secnidazole Anhydrous
15. Rp-14539
16. Secnidazole (flagentyl)
17. Ornidazole Metabolite M4
18. 1-(2-methyl-5-nitro-1-imidazolyl)-2-propanol
19. Nsc-759812
20. Mls000559043
21. 1-(2-methyl-5-nitro-imidazol-1-yl)-propan-2-ol
22. R3459k699k
23. Ncgc00095158-01
24. Smr000149359
25. Rp-14539;pm-185184
26. Dsstox_cid_25934
27. Dsstox_rid_81233
28. Dsstox_gsid_45934
29. Secnidazol [inn-spanish]
30. Cas-3366-95-8
31. Sr-01000685111
32. Einecs 222-134-0
33. Alpha,2-dimethyl-5-nitro-1h-imidazole-1-ethanol
34. Sindose
35. Secnil
36. Unii-r3459k699k
37. 1-(2-hydroxypropyl)-2-methyl-5-nitroimidazol
38. Secnidal (tn)
39. Secnidazole-[d6]
40. Secnidazole [usan:inn:ban:dcf]
41. Sym 1219
42. Solosec (tn)
43. Secnidazole [mi]
44. Opera_id_1811
45. Spectrum2_000033
46. Spectrum3_001956
47. Secnidazole [inn]
48. Alpha,2-dimethyl-5-nitroimidazole-1-ethanol
49. Secnidazole (usan/inn)
50. Secnidazole [usan]
51. 1-(2-methyl-5-nitroimidazol-1-yl)-2-propanol
52. Imidazole-1-ethanol, Alpha,2-dimethyl-5-nitro-
53. Secnidazole [mart.]
54. Bspbio_003556
55. Secnidazole [who-dd]
56. Mls000759496
57. Mls001201813
58. Mls001424126
59. Mls006011434
60. Schembl363924
61. Spectrum1505304
62. Spbio_000125
63. 1h-imidazole-1-ethanol, .alpha.,2-dimethyl-5-nitro-
64. Chembl498847
65. Dtxsid3045934
66. Chebi:94433
67. Kbio3_002874
68. Secnidazole [orange Book]
69. Chebi:140628
70. Hms1922b12
71. Hms2051c20
72. Hms2090n15
73. Hms2231g11
74. Hms3369n08
75. Hms3393c20
76. Hms3656g14
77. Hms3714i05
78. Pharmakon1600-01505304
79. Bcp12459
80. Hy-b1118
81. Tox21_111457
82. Bbl010784
83. Bdbm50349330
84. Ccg-39993
85. Mfcd00864656
86. Nsc759812
87. Stk590474
88. Akos005512552
89. Akos025149490
90. Tox21_111457_1
91. Ccg-100896
92. Cs-4641
93. Db12834
94. Ks-1191
95. Nc00146
96. Nsc 759812
97. Sb19197
98. Secnidazole 100 Microg/ml In Methanol
99. Ncgc00095158-02
100. Ncgc00095158-03
101. Ncgc00095158-04
102. Ncgc00095158-05
103. Ncgc00095158-08
104. Ac-12065
105. Sbi-0207037.p001
106. Secnidazole 100 Microg/ml In Acetonitrile
107. Db-000688
108. Ft-0601624
109. S2537
110. Sw197526-3
111. D07353
112. 1-(2- Hydroxypropyl)-2-methyl-5-nitroimidazole
113. 1h-imidazole-1-ethanol, A,2-dimethyl-5-nitro-
114. Ab00456738-13
115. Ab00456738-15
116. Ab00456738_16
117. Ab00456738_17
118. 366s958
119. A821901
120. J-019291
121. Q4413249
122. Sr-01000685111-4
123. Sr-01000685111-6
124. Sr-01000685111-7
125. .alpha.,2-dimethyl-5-nitroimidazole-1-ethanol
126. Brd-a70083328-001-02-9
127. Brd-a70083328-001-12-8
128. 1-(2-methyl-5-nitro-1h-imidazol-1-yl) Propan-2- Ol
129. 1-(2-methyl-5-nitro-imidazol-1-yl)propan-2-ol;secnidazole
| Molecular Weight | 185.18 g/mol |
|---|---|
| Molecular Formula | C7H11N3O3 |
| XLogP3 | 0.2 |
| Hydrogen Bond Donor Count | 1 |
| Hydrogen Bond Acceptor Count | 4 |
| Rotatable Bond Count | 2 |
| Exact Mass | 185.08004122 g/mol |
| Monoisotopic Mass | 185.08004122 g/mol |
| Topological Polar Surface Area | 83.9 Ų |
| Heavy Atom Count | 13 |
| Formal Charge | 0 |
| Complexity | 194 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 1 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
Secnidazole is indicated for the treatment of trichomoniasis in adults and bacterial vaginosis in adult women.
FDA Label
Secnidazole is a nitroimidazole antimicrobial drug that displays selectivity against many anaerobic Gram-positive and Gram-negative bacteria and protozoa. In vitro studies demonstrates the effectiveness of the drug against *Bacteroides fragilis*, *Trichomonas vaginalis*, *Entamoeba histolytica* and *Giardia lamblia*. There is no significant bacterial or protozoal resistance reported from secnidazole treatment.
Antiprotozoal Agents
Substances that are destructive to protozoans. (See all compounds classified as Antiprotozoal Agents.)
P01AB07
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
P - Antiparasitic products, insecticides and repellents
P01 - Antiprotozoals
P01A - Agents against amoebiasis and other protozoal diseases
P01AB - Nitroimidazole derivatives
P01AB07 - Secnidazole
Absorption
Secnidazole is rapidly and completely absorbed after oral administration. Following a single oral dose of 2 g in healthy adult female subjects, the mean (SD) secnidazole peak plasma concentration (Cmax) of 45.4 (7.64) mcg/mL and mean (SD) systemic exposure (AUC0-inf) of 1331.6 (230.16) mcg x hr/mL was reached. Median (range) time to peak concentration (Tmax) was 4.0 (3.0-4.0) hours.
Route of Elimination
The predominant route of elimination is renal elimination. Following a single oral dose of 2g secnidazole, approximately 15% of the drug is excreted as unchanged compoung in the urine.
Volume of Distribution
The apparent volume of distribution of secnidazole is approximately 42-49 L.
Clearance
The total body clearance of secnidazole is approximately 25 mL/min. The renal clearance of secnidazole is approximately 3.9 mL/min.
According to *in vitro* studies, secnidazole is metabolized via oxidation by human hepatic CYP450 enzyme system with 1% conversion to metabolites.
The plasma elimination half-life for secnidazole is approximately 17 hours.
Secnidazole enters the bacterial cell as a prodrug without an antimicrobial activity. The drug is converted to an active form via reduction of nitro groups to radical anions by bacterial enzymes. The radical anions are thought to interfere with bacterial DNA synthesis of susceptible isolates.
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19450
Submission : 2006-05-16
Status : Active
Type : II
NDC Package Code : 14799-2008
Start Marketing Date : 2010-08-16
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27383
Submission : 2013-08-01
Status : Active
Type : II
NDC Package Code : 49964-0047
Start Marketing Date : 2016-11-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 71052-367
Start Marketing Date : 2020-09-18
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (5000g/5000g)
Marketing Category : BULK INGREDIENT
NDC Package Code : 73212-110
Start Marketing Date : 2024-07-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
NDC Package Code : 49574-526
Start Marketing Date : 2019-05-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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Drugs in Development
Details:
Solosec (Secnidazole) is a Antibiotic drug candidate, which is currently being evaluated in Approved FDF clinical studies for the treatment of Vaginosis, Bacterial.
Lead Product(s): Secnidazole
Therapeutic Area: Infections and Infectious Diseases Brand Name: Solosec
Study Phase: Approved FDFProduct Type: Antibiotic
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 01, 2025
Lead Product(s) : Secnidazole
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Evofem's SOLOSEC Submitted for Marketing Approval in United Arab Emirates
Details : Solosec (Secnidazole) is a Antibiotic drug candidate, which is currently being evaluated in Approved FDF clinical studies for the treatment of Vaginosis, Bacterial.
Product Name : Solosec
Product Type : Antibiotic
Upfront Cash : Inapplicable
October 01, 2025
Details:
The agreement grants Pharma 1 to Solosec (secnidazole) oral granules, Evofem's FDA-approved single-dose oral treatment for two common sexual health conditions.
Lead Product(s): Secnidazole,Inapplicable
Therapeutic Area: Infections and Infectious Diseases Brand Name: Solosec
Study Phase: Approved FDFProduct Type: Antibiotic
Sponsor: Pharma 1 Drug Store
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement May 21, 2025
Lead Product(s) : Secnidazole,Inapplicable
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Pharma 1 Drug Store
Deal Size : Undisclosed
Deal Type : Agreement
Evofem Signs SOLOSEC License Agreement for Middle East with Pharma 1
Details : The agreement grants Pharma 1 to Solosec (secnidazole) oral granules, Evofem's FDA-approved single-dose oral treatment for two common sexual health conditions.
Product Name : Solosec
Product Type : Antibiotic
Upfront Cash : Undisclosed
May 21, 2025
Details:
Lupin divested its U.S. Commercial Women's Health Specialty Business to Evofem, which includes Solosec (secnidazole) oral granules, which is indicated for the treatment of bacterial vaginosis.
Lead Product(s): Secnidazole,Inapplicable
Therapeutic Area: Infections and Infectious Diseases Brand Name: Solosec
Study Phase: Approved FDFProduct Type: Antibiotic
Sponsor: Evofem Biosciences
Deal Size: $84.0 million Upfront Cash: Undisclosed
Deal Type: Divestment July 15, 2024
Lead Product(s) : Secnidazole,Inapplicable
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Evofem Biosciences
Deal Size : $84.0 million
Deal Type : Divestment
Lupin divests women’s health specialty business in US to Evofem for $84 million
Details : Lupin divested its U.S. Commercial Women's Health Specialty Business to Evofem, which includes Solosec (secnidazole) oral granules, which is indicated for the treatment of bacterial vaginosis.
Product Name : Solosec
Product Type : Antibiotic
Upfront Cash : Undisclosed
July 15, 2024
Details:
SOLOSEC (secnidazole) 2 g oral granules is the first, single-dose oral approved to treat both bacterial vaginosis, common vaginal infection, in female patients 12 years of age and older and trichomoniasis, sexually transmitted infection, in patients 12 years of age and older.
Lead Product(s): Secnidazole,Inapplicable
Therapeutic Area: Infections and Infectious Diseases Brand Name: Solosec
Study Phase: Approved FDFProduct Type: Antibiotic
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 17, 2022
Lead Product(s) : Secnidazole,Inapplicable
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Lupin Announces FDA Approval of Supplemental New Drug Application for SOLOSEC® (secnidazole) in A...
Details : SOLOSEC (secnidazole) 2 g oral granules is the first, single-dose oral approved to treat both bacterial vaginosis, common vaginal infection, in female patients 12 years of age and older and trichomoniasis, sexually transmitted infection, in patients 12 y...
Product Name : Solosec
Product Type : Antibiotic
Upfront Cash : Inapplicable
February 17, 2022
Details:
This partnership will expand the reach of SOLOSEC®, allowing more Healthcare Providers to be aware of the benefits of SOLOSEC®, and increase access for adult women suffering with bacterial vaginosis and adults with trichomoniasis.
Lead Product(s): Secnidazole,Inapplicable
Therapeutic Area: Infections and Infectious Diseases Brand Name: Solosec
Study Phase: Approved FDFProduct Type: Antibiotic
Sponsor: Lupin Ltd
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement January 27, 2022
Lead Product(s) : Secnidazole,Inapplicable
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Lupin Ltd
Deal Size : Undisclosed
Deal Type : Agreement
Lupin Signs Promotional Agreement with Exeltis on SOLOSEC® (secnidazole) Expanding Access for Adu...
Details : This partnership will expand the reach of SOLOSEC®, allowing more Healthcare Providers to be aware of the benefits of SOLOSEC®, and increase access for adult women suffering with bacterial vaginosis and adults with trichomoniasis.
Product Name : Solosec
Product Type : Antibiotic
Upfront Cash : Undisclosed
January 27, 2022
Details:
Solosec is used for treatment of vaginal infection among women of childbearing age — became Lupin’s asset after it acquired Symbiomix Therapeutics.
Lead Product(s): Secnidazole,Inapplicable
Therapeutic Area: Infections and Infectious Diseases Brand Name: Solosec
Study Phase: Approved FDFProduct Type: Antibiotic
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 28, 2021
Lead Product(s) : Secnidazole,Inapplicable
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Lupin Says Trying to Find Marketing Partner, or Open to Possible Sale of Specialty Drug Solosec
Details : Solosec is used for treatment of vaginal infection among women of childbearing age — became Lupin’s asset after it acquired Symbiomix Therapeutics.
Product Name : Solosec
Product Type : Antibiotic
Upfront Cash : Inapplicable
October 28, 2021
Details:
Secnidazole is a Antibiotic drug candidate, which is currently being evaluated in phase II/ phase III clinical studies for the treatment of Vaginosis, Bacterial.
Lead Product(s): Secnidazole,Inapplicable
Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed
Study Phase: Phase II/ Phase IIIProduct Type: Antibiotic
Sponsor: Lupin Ltd
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 05, 2021
Lead Product(s) : Secnidazole,Inapplicable
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II/ Phase III
Partner/Sponsor/Collaborator : Lupin Ltd
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Secnidazole is a Antibiotic drug candidate, which is currently being evaluated in phase II/ phase III clinical studies for the treatment of Vaginosis, Bacterial.
Product Name : Undisclosed
Product Type : Antibiotic
Upfront Cash : Inapplicable
September 05, 2021
Details:
The Solosec® sNDA is based, in part, on trial results that showed a clinically and statistically significant response rate, or microbiological cure, in patients treated with Solosec® as compared to placebo.
Lead Product(s): Secnidazole,Inapplicable
Therapeutic Area: Infections and Infectious Diseases Brand Name: Solosec
Study Phase: Phase IIIProduct Type: Antibiotic
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 16, 2020
Lead Product(s) : Secnidazole,Inapplicable
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Lupin Announces FDA Filing Acceptance of Supplemental New Drug Application for Solosec® for the T...
Details : The Solosec® sNDA is based, in part, on trial results that showed a clinically and statistically significant response rate, or microbiological cure, in patients treated with Solosec® as compared to placebo.
Product Name : Solosec
Product Type : Antibiotic
Upfront Cash : Inapplicable
November 16, 2020
Details:
Single-dose treatment with Solosec® resulted in a highly statistically significant response rate, or microbiological cure, in 92-95% of patients versus 1.5-1.7% in placebo.
Lead Product(s): Secnidazole,Inapplicable
Therapeutic Area: Infections and Infectious Diseases Brand Name: Solosec
Study Phase: Phase IIIProduct Type: Antibiotic
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 14, 2020
Lead Product(s) : Secnidazole,Inapplicable
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Lupin Presents Phase 3 Data for Solosec® (secnidazole) Demonstrating Significant Response Rate in...
Details : Single-dose treatment with Solosec® resulted in a highly statistically significant response rate, or microbiological cure, in 92-95% of patients versus 1.5-1.7% in placebo.
Product Name : Solosec
Product Type : Antibiotic
Upfront Cash : Inapplicable
August 14, 2020
Details:
The promotional arrangement includes detailing and demonstration of Ceek's products, alongside Lupin's women's health flagship product, Solosec 2g oral granules, indicated for the treatment of bacterial vaginosis. Solosec is a 5-nitroimidazole antimicrobial agent.
Lead Product(s): Secnidazole,Inapplicable
Therapeutic Area: Infections and Infectious Diseases Brand Name: Solosec
Study Phase: Approved FDFProduct Type: Antibiotic
Sponsor: Lupin Ltd
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement June 09, 2020
Lead Product(s) : Secnidazole,Inapplicable
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Lupin Ltd
Deal Size : Undisclosed
Deal Type : Agreement
Details : The promotional arrangement includes detailing and demonstration of Ceek's products, alongside Lupin's women's health flagship product, Solosec 2g oral granules, indicated for the treatment of bacterial vaginosis. Solosec is a 5-nitroimidazole antimicrob...
Product Name : Solosec
Product Type : Antibiotic
Upfront Cash : Undisclosed
June 09, 2020
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Athena Pharmaceutiques is a Partner of Choice for Drug Delivery & Life Cycle Management.
Regulatory Info :
Registration Country : France
Brand Name : Secnidazole
Dosage Form : Taste Masked Pellets Sachet
Dosage Strength : 2G
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : France
Regulatory Info : RX
Registration Country : USA
Brand Name : SOLOSEC
Dosage Form : GRANULE;ORAL
Dosage Strength : 2GM/PACKET
Packaging :
Approval Date : 2017-09-15
Application Number : 209363
Regulatory Info : RX
Registration Country : USA
Regulatory Info : Generic
Registration Country : India
Brand Name : SAMITOL
Dosage Form : TABLET
Dosage Strength : 500MG
Packaging : PVC/PVDC Blister
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Coated IR Pellets
Dosage Strength : 50%/W/W
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info : Generic ACTD Dossier- Available
Registration Country : India
Brand Name :
Dosage Form : Tablet
Dosage Strength : 1000MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Generic ACTD Dossier- Available
Registration Country : India
Regulatory Info : Generic
Registration Country : Turkey
Brand Name :
Dosage Form : FILM COATED TABLET
Dosage Strength : 500MG
Packaging : 2 Or 4 Tablets
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : Turkey
Regulatory Info : Generic
Registration Country : Turkey
Brand Name :
Dosage Form : FILM COATED TABLET
Dosage Strength : 1000MG
Packaging : 2 Or 4 Tablets
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : Turkey
Regulatory Info :
Registration Country : Turkey
Brand Name : SECNIDOX
Dosage Form : FILM COATED TABLET
Dosage Strength : 500MG
Packaging : 2 OR 4 TABLETS
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Turkey
Regulatory Info :
Registration Country : Turkey
Brand Name : SECNIDOX
Dosage Form : FILM COATED TABLET
Dosage Strength : 1000MG
Packaging : 2 OR 4 TABLETS
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Turkey
Regulatory Info :
Registration Country : Kenya
Brand Name : SEZOL DS
Dosage Form : Tablet
Dosage Strength : 1G
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Kenya
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Patents & EXCLUSIVITIES
US Patents
Patent Expiration Date : 2035-09-04
US Patent Number : 11602522
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 209363
Patent Use Code : U-3302
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2035-09-04
Patent Expiration Date : 2035-09-16
US Patent Number : 11684607
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 209363
Patent Use Code : U-2583
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2035-09-16
Patent Expiration Date : 2035-09-04
US Patent Number : 11020377
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 209363
Patent Use Code : U-3302
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2035-09-04
Patent Expiration Date : 2035-09-04
US Patent Number : 10849884
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 209363
Patent Use Code : U-3169
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2035-09-04
Patent Expiration Date : 2035-09-16
US Patent Number : 11684607
Drug Substance Claim :
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Patent Use Code : U-3169
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2035-09-16
Patent Expiration Date : 2035-09-04
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Drug Substance Claim :
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Delist Requested :
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Drug Substance Claim :
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Delist Requested :
Patent Use Description :
Patent Expiration Date : 2035-09-04
Patent Expiration Date : 2035-09-16
US Patent Number : 11684607
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 209363
Patent Use Code : U-3270
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2035-09-16
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Drug Substance Claim :
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Delist Requested :
Patent Use Description :
Patent Expiration Date : 2035-09-04
Patent Expiration Date : 2035-09-04
US Patent Number : 11020377
Drug Substance Claim :
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Application Number : 209363
Patent Use Code : U-3169
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2035-09-04
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]US Exclusivities
Exclusivity Code : NCE
Exclusivity Expiration Date : 2022-09-15
Application Number : 209363
Product Number : 1
Exclusivity Details :
Exclusivity Code : NPP
Exclusivity Expiration Date : 2025-01-26
Application Number : 209363
Product Number : 1
Exclusivity Details :
Exclusivity Code : GAIN
Exclusivity Expiration Date : 2027-09-15
Application Number : 209363
Product Number : 1
Exclusivity Details :
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
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PharmaCompass offers a list of Secnidazole 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 Secnidazole manufacturer or Secnidazole supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Secnidazole manufacturer or Secnidazole supplier.
PharmaCompass also assists you with knowing the Secnidazole API Price utilized in the formulation of products. Secnidazole API Price is not always fixed or binding as the Secnidazole Price is obtained through a variety of data sources. The Secnidazole Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Secnol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Secnol, including repackagers and relabelers. The FDA regulates Secnol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Secnol 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 Secnol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Secnol supplier is an individual or a company that provides Secnol active pharmaceutical ingredient (API) or Secnol finished formulations upon request. The Secnol suppliers may include Secnol API manufacturers, exporters, distributors and traders.
click here to find a list of Secnol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Secnol DMF (Drug Master File) is a document detailing the whole manufacturing process of Secnol active pharmaceutical ingredient (API) in detail. Different forms of Secnol DMFs exist exist since differing nations have different regulations, such as Secnol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Secnol DMF submitted to regulatory agencies in the US is known as a USDMF. Secnol USDMF includes data on Secnol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Secnol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Secnol suppliers with USDMF on PharmaCompass.
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 Secnol as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Secnol API and other APIs are published in this directory by the FDA.
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 Secnol 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.
The NDC directory also contains data on finished compounded human drug products that contain Secnol and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Secnol NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Secnol suppliers with NDC on PharmaCompass.
Secnol 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 Secnol 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 Secnol GMP manufacturer or Secnol GMP API supplier for your needs.
A Secnol CoA (Certificate of Analysis) is a formal document that attests to Secnol's compliance with Secnol specifications and serves as a tool for batch-level quality control.
Secnol CoA mostly includes findings from lab analyses of a specific batch. For each Secnol 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.
Secnol may be tested according to a variety of international standards, such as European Pharmacopoeia (Secnol EP), Secnol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Secnol USP).
