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1. Brl 14151
2. Brl-14151
3. Brl14151
4. Clavulanate
5. Clavulanate, Potassium
6. Clavulanate, Sodium
7. Clavulanic Acid
8. Clavulanic Acid, Monopotassium Salt
9. Clavulanic Acid, Monosodium Salt
10. Mm 14151
11. Mm-14151
12. Mm14151
13. Potassium Clavulanate
14. Potassium, Clavulanate
15. Sodium Clavulanate
1. Potassium Clavulanate
2. 61177-45-5
3. Clavulanic Acid Potassium Salt
4. Brl 14151k
5. Clavulanate (potassium)
6. Q42omw3at8
7. Chebi:85264
8. Brl-14151k
9. Potassium (2r,3z,5r)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylate
10. Potassium (z)-(2r,5r)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo(3.2.0)heptane-2-carboxylate
11. Potassium;(2r,3z,5r)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylate
12. Amonate
13. Potassium (2r,5r,z)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylate
14. Clavulansaeure Kaliumsalz
15. Einecs 262-640-9
16. Unii-q42omw3at8
17. Potassium Clavlanate
18. Clavulanate Potassium [usan:usp:jan]
19. Chembl1003
20. Schembl203411
21. Clavulanic Acid Potassium
22. Hy-a0256a
23. Dtxsid60210067
24. Hms3715b13
25. Clavulanate Potassium (jp17/usp)
26. Potassium Clavulanate [jan]
27. Bcp13548
28. Clavulanate Potassium [usan]
29. Clavulanate Potassium [vandf]
30. Potassium Clavulanate [mart.]
31. Potassium Clavulanate Cellulose(1:1)
32. Akos015961326
33. Clavulanate Potassium [who-dd]
34. Ccg-221126
35. 4-oxa-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid, 3-(2-hydroxyethylidene)-7-oxo-, Monopotassium Salt, (2r-(2alpha,3z,5alpha))-
36. Ac-13551
37. Bp-30181
38. Clavulanate Potassium [green Book]
39. Potassium (2r-(2alpha,3z,5alpha))-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo(3.2.0)heptane-2-carboxylate
40. Clavulanate Potassium [orange Book]
41. Potassium Clavulanate [ep Monograph]
42. Clavulanate Potassium [usp Monograph]
43. Cs-0019771
44. Augmentin Component Clavulanate Potassium
45. C-6660
46. Clavulox Component Clavulanate Potassium
47. D02370
48. D84066
49. Timentin Component Clavulanate Potassium
50. A833076
51. Clavulanate Potassium Component Of Augmentin
52. Clavulanate Potassium Component Of Clavulox
53. Clavulanate Potassium Component Of Timentin
54. Clavulanic Acid (as Clavulanate Potassium)
55. Clavulanic Acid Potassium 100 Microg/ml In Water
56. W-105420
57. Clavulanate Potassium+microcrystalline Cellulose(1:1)
58. Potassium Clavulanate (40%) : Silicon Dioxide Mixture
59. Q27158444
60. Potassium Clavulanate (50%) : Microcrystalline Cellulose
61. Clavulanate Potassium Salt, Antibiotic For Culture Media Use Only
62. Potassium Clavulanate - 1:1 Mixture With Cellulose, Antibiotic For Culture Media Use Only
63. (2r,5r)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2beta-carboxylic Acid Potassium Salt
64. 4-oxa-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid, 3-(2-hydroxyethylidene)-7-oxo-, Monopotassium Salt, (2r-(2.alpha.,3z,5.alpha.))-
65. Potassium (2r,3z,5r)-3-(2-oxidanylethylidene)-7-oxidanylidene-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylate
66. Potassium (2r,5r,z)- 3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylate
67. Potassium(2r,5r,z)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylate
| Molecular Weight | 237.25 g/mol |
|---|---|
| Molecular Formula | C8H8KNO5 |
| Hydrogen Bond Donor Count | 1 |
| Hydrogen Bond Acceptor Count | 5 |
| Rotatable Bond Count | 2 |
| Exact Mass | 237.00395384 g/mol |
| Monoisotopic Mass | 237.00395384 g/mol |
| Topological Polar Surface Area | 89.9 Ų |
| Heavy Atom Count | 15 |
| Formal Charge | 0 |
| Complexity | 329 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 2 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 1 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
beta-Lactamase Inhibitors
Endogenous substances and drugs that inhibit or block the activity of BETA-LACTAMASES. (See all compounds classified as beta-Lactamase Inhibitors.)
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Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
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Manufacturer Name : Shandong New Time Pharmaceutical Co.,Ltd.
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NDC Package Code : 55657-105
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NDC Package Code : 48866-9981
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Registrant Name : Yuhan Corporation
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Registration Number : 20081031-113-F-10-03(4)
Manufacturer Name : lek pharmaceuticals dd
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DMF Number : 14436
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DMF Number : 4349
Submission : 1981-12-02
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Potassium Clavulanate, Diluted, With Silica, Col...
Certificate Number : R1-CEP 2005-180 - Rev 03
Status : Valid
Issue Date : 2017-01-18
Type : Chemical and TSE
Substance Number : 1653
Potassium Clavulanate, Diluted, With Silica, Col...
Certificate Number : R1-CEP 2006-018 - Rev 02
Status : Valid
Issue Date : 2014-12-08
Type : Chemical
Substance Number : 1653
Potassium Clavulanate, Sterile
Certificate Number : R1-CEP 1999-113 - Rev 04
Status : Valid
Issue Date : 2014-02-26
Type : Chemical
Substance Number : 1140
Potassium Clavulanate, Diluted, Silica, Colloida...
Certificate Number : R0-CEP 2006-068 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2010-02-02
Type : Chemical
Substance Number : 1653
Potassium Clavulanate, Diluted, With Microcrysta...
Certificate Number : R0-CEP 2004-234 - Rev 01
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Type : Chemical
Substance Number : 1653
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Manufacturer Name : lek pharmaceuticals dd
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Registrant Name : Lee Sung International Co., Ltd.
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Registration Number : 20220425-113-F-96-26
Manufacturer Name : Lek farmacevtska družba dd,...
Manufacturer Address : Trimlini 2D, Lendava, 9220, Slovenia
Registrant Name : Hwail Pharmaceutical Co., Ltd.
Registration Date : 2018-01-16
Registration Number : 20120615-113-F-69-16(1)
Manufacturer Name : Shandong New Time Pharmaceut...
Manufacturer Address : No.1, North Outer Ring Road, Feixian County, Shandong Province, China
Registrant Name : Hwail Pharmaceutical Co., Ltd.
Registration Date : 2017-10-25
Registration Number : 20120615-113-F-68-17(4)
Manufacturer Name : Shandong New Time Pharmaceut...
Manufacturer Address : No.1, North Outer Ring Road, Feixian County, Shandong Province, China
Registrant Name : Boryeong Co., Ltd.
Registration Date : 2017-07-27
Registration Number : 20120615-113-F-68-17(3)
Manufacturer Name : Shandong New Time Pharmaceut...
Manufacturer Address : No.1, North Outer Ring Road, Feixian County, Shandong Province, China
Registrant Name : Hwail Pharmaceutical Co., Ltd.
Registration Date : 2017-10-25
Registration Number : 20120615-113-F-67-18(4)
Manufacturer Name : Shandong New Time Pharmaceut...
Manufacturer Address : No.1, North Outer Ring Road, Feixian County, Shandong Province, China
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NDC Package Code : 52972-0034
Start Marketing Date : 2005-06-10
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (0.5kg/kg)
Marketing Category : DRUG FOR FURTHER PROCESSING
NDC Package Code : 52972-0033
Start Marketing Date : 2005-06-10
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (0.5kg/kg)
Marketing Category : DRUG FOR FURTHER PROCESSING
NDC Package Code : 39390-0044
Start Marketing Date : 2018-11-23
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NDC Package Code : 39390-0046
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Marketing Category : BULK INGREDIENT
NDC Package Code : 39390-0043
Start Marketing Date : 2018-11-23
End Marketing Date : 2028-01-13
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 39390-0045
Start Marketing Date : 2024-02-12
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 42677-104
Start Marketing Date : 2007-02-18
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (0.5kg/kg)
Marketing Category : DRUG FOR FURTHER PROCESSING
NDC Package Code : 55657-105
Start Marketing Date : 2006-02-27
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/2kg)
Marketing Category : DRUG FOR FURTHER PROCESSING
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Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
About the Company : Established in 1994, Rochem is a distributor of pharmaceutical, food, nutritional and animal health ingredients to some of the largest companies in the world. It sources high-quali...
Capital Farma, a leading European pharmaceutical company focusing on the development & distribution of niche APIs & Pharma Services.
About the Company : Capital Farma offers a comprehensive range of pharmaceutical solutions. Our API offering includes active ingredients sourced exclusively from top European manufacturers, ensuring t...
About the Company : Darou Pakhsh Pharma Chem (DPPC Co.) as one of the qualified and leading producers of active pharmaceutical ingredients in the Iranian pharmaceutical industry started production sin...
About the Company : Fuan Pharmaceutical (Group) Co., Ltd. was established on February 25, 2004. The company is located in Chongqing Changshou Economic and Technological Development Zone, covering an a...
About the Company : Founded in the year 1981. GCCPL has grown from a small enterprise to a large corporation serving some of the top pharmaceutical & cosmetic companies across the world. Our focus on ...
About the Company : HENGDIAN GROUP was established in 1975, till now it has become a transnational,conglomerate group and been one of the largest private-owned enterprises in China. The Pharmaceutical...
About the Company : Lunan Pharmaceutical Group is an integrated pharmaceutical group setting production, scientific research and sale of traditional Chinese medicines, chemicals, biological products i...
About the Company : Otto Brandes Gmbh was founded in 1923 and is an independent distributor of high quality Pharmaceutical Active Ingredients and excipients for the pharmaceutical industry. We regard ...
About the Company : Sandoz B2B provides access to an extensive portfolio of high-quality products and services, covering more than 20 therapeutic areas. Delivering unique added value to our partners w...
CLAVULANATE POTASSIUM WITH MICROCRYSTALLINE CELLUL
About the Company : 1. We are listed on Hong Kong Union Stock Exchange. Vertically integrated management for our six Production Bases: Finished Product Plant, HK; Bulk Medicine Plant, Zhuhai; Finished...
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Drugs in Development
Details:
LP-001 (amoxicillin/clavulanate) oral suspension is currently being investigated as an effective antimicrobial for the treatment of children with acute otitis media in 3-12 moth age pediatric.
Lead Product(s): Amoxicillin Trihydrate,Clavulanic Acid
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 14, 2024
Lead Product(s) : Amoxicillin Trihydrate,Clavulanic Acid
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Kaizen Bioscience Preparing Lead Asset for NDA Submission in 2025
Details : LP-001 (amoxicillin/clavulanate) oral suspension is currently being investigated as an effective antimicrobial for the treatment of children with acute otitis media in 3-12 moth age pediatric.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
November 14, 2024
Details:
Lu AF28996 is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Lead Product(s): Lu AF28996,Aspirin,Mefenamic Acid,Amoxicillin Trihydrate,Clavulanic Acid
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 26, 2024
Lead Product(s) : Lu AF28996,Aspirin,Mefenamic Acid,Amoxicillin Trihydrate,Clavulanic Acid
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
A Trial Investigating Lu AF28996 in Healthy Adult Participants
Details : Lu AF28996 is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
February 26, 2024
Details:
Amoxicillin is a Antibiotic drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Bronchitis.
Lead Product(s): Amoxicillin Trihydrate,Clavulanic Acid
Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Antibiotic
Sponsor: Oslo University Hospital | Haukeland University Hospital | Alesund Hospital | Akershus University Hospital | Trondheim University Hospital | University Hospital of North Norway
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 01, 2023
Lead Product(s) : Amoxicillin Trihydrate,Clavulanic Acid
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Oslo University Hospital | Haukeland University Hospital | Alesund Hospital | Akershus University Hospital | Trondheim University Hospital | University Hospital of North Norway
Deal Size : Inapplicable
Deal Type : Inapplicable
Antibiotics, Microbiology and Immunology in Children With Chronic Wet Cough - the AMIC Study
Details : Amoxicillin is a Antibiotic drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Bronchitis.
Product Name : Undisclosed
Product Type : Antibiotic
Upfront Cash : Inapplicable
September 01, 2023
Details:
Bacillus Subtilis is a Probiotic drug candidate, which is currently being evaluated in clinical studies for the treatment of Respiratory Tract Infections.
Lead Product(s): Bacillus Subtilis,Bacillus Clausii,Amoxicillin Trihydrate,Clavulanic Acid,Acetylcysteine,Xylometazoline
Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed
Study Phase: UndisclosedProduct Type: Probiotic
Sponsor: Thai Binh University of Medicine and Pharmacy
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 07, 2023
Lead Product(s) : Bacillus Subtilis,Bacillus Clausii,Amoxicillin Trihydrate,Clavulanic Acid,Acetylcysteine,Xylometazoline
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Undisclosed
Partner/Sponsor/Collaborator : Thai Binh University of Medicine and Pharmacy
Deal Size : Inapplicable
Deal Type : Inapplicable
LiveSpo Navax® Supports the Treatment of Acute Rhinosinusitis and Otitis Media
Details : Bacillus Subtilis is a Probiotic drug candidate, which is currently being evaluated in clinical studies for the treatment of Respiratory Tract Infections.
Product Name : Undisclosed
Product Type : Probiotic
Upfront Cash : Inapplicable
April 07, 2023
Details:
Cephalexin is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Tuberculosis, Pulmonary.
Lead Product(s): Cephalexin,Amoxicillin Trihydrate,Clavulanic Acid
Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Centre Of Research Excellence in Tuberculosis Control
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 23, 2022
Lead Product(s) : Cephalexin,Amoxicillin Trihydrate,Clavulanic Acid
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Centre Of Research Excellence in Tuberculosis Control
Deal Size : Inapplicable
Deal Type : Inapplicable
The BLAST- 1 Trial - Cephalexin+Amoxicillin-clavulanate for Tuberculosis
Details : Cephalexin is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Tuberculosis, Pulmonary.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
December 23, 2022
Details:
Amoxicillin is a Antibiotic drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Bacterial Infections.
Lead Product(s): Amoxicillin Trihydrate,Clavulanic Acid
Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Antibiotic
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 18, 2022
Lead Product(s) : Amoxicillin Trihydrate,Clavulanic Acid
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
A Pharmacokinetic Study of LP-001 in Children With a Bacterial Infection
Details : Amoxicillin is a Antibiotic drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Bacterial Infections.
Product Name : Undisclosed
Product Type : Antibiotic
Upfront Cash : Inapplicable
October 18, 2022
Details:
Amoxicillin is a Antibiotic drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Bacterial Infections.
Lead Product(s): Amoxicillin Trihydrate,Clavulanic Acid
Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Antibiotic
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 22, 2022
Lead Product(s) : Amoxicillin Trihydrate,Clavulanic Acid
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
A Pharmacokinetics and Safety Study of Augmentin ES-600 in Children With CAP and ABRS
Details : Amoxicillin is a Antibiotic drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Bacterial Infections.
Product Name : Undisclosed
Product Type : Antibiotic
Upfront Cash : Inapplicable
April 22, 2022
Details:
Rifampicin is a Antibiotic drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Buruli Ulcer.
Lead Product(s): Rifampicin,Clarithromycin,Amoxicillin Trihydrate,Clavulanic Acid
Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Antibiotic
Sponsor: Universidad de Zaragoza | Fondation Raoul Follereau | Université d'Abomey-Calavi | Instituto de Salud Carlos III | Fundación Anesvad | Tres Cantos Open Lab Foundation | GSK
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 27, 2021
Lead Product(s) : Rifampicin,Clarithromycin,Amoxicillin Trihydrate,Clavulanic Acid
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Universidad de Zaragoza | Fondation Raoul Follereau | Université d'Abomey-Calavi | Instituto de Salud Carlos III | Fundación Anesvad | Tres Cantos Open Lab Foundation | GSK
Deal Size : Inapplicable
Deal Type : Inapplicable
Beta-Lactam Containing Regimen for the Shortening of Buruli Ulcer Disease Therapy
Details : Rifampicin is a Antibiotic drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Buruli Ulcer.
Product Name : Undisclosed
Product Type : Antibiotic
Upfront Cash : Inapplicable
December 27, 2021
Details:
Ceftriaxone is a Antibiotic drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Pneumonia, Aspiration.
Lead Product(s): Ceftriaxone,Amoxicillin Trihydrate,Clavulanic Acid,Cefepime,Vancomycin Hydrochloride,Levofloxacin
Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Antibiotic
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 15, 2021
Lead Product(s) : Ceftriaxone,Amoxicillin Trihydrate,Clavulanic Acid,Cefepime,Vancomycin Hydrochloride,Levofloxacin
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Early Antibiotics After Aspiration in ICU Patients
Details : Ceftriaxone is a Antibiotic drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Pneumonia, Aspiration.
Product Name : Undisclosed
Product Type : Antibiotic
Upfront Cash : Inapplicable
October 15, 2021
Details:
Amoxicillin is a Antibiotic drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Otitis Media.
Lead Product(s): Amoxicillin Trihydrate,Clavulanic Acid
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Antibiotic
Sponsor: IQVIA
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 23, 2020
Lead Product(s) : Amoxicillin Trihydrate,Clavulanic Acid
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : IQVIA
Deal Size : Inapplicable
Deal Type : Inapplicable
Study to Evaluate the Safety and Clinical Efficacy of Augmentin® Extra Strength-600 in Children...
Details : Amoxicillin is a Antibiotic drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Otitis Media.
Product Name : Undisclosed
Product Type : Antibiotic
Upfront Cash : Inapplicable
October 23, 2020
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DOSAGE - FOR SUSPENSION;ORAL - 400MG/5ML;EQ 5...DOSAGE - FOR SUSPENSION;ORAL - 400MG/5ML;EQ 57MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50725
DOSAGE - FOR SUSPENSION;ORAL - 600MG/5ML;EQ 4...DOSAGE - FOR SUSPENSION;ORAL - 600MG/5ML;EQ 42.9MG BASE/5ML
USFDA APPLICATION NUMBER - 50755
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1GM;...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 62.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50785
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PharmaCompass offers a list of Clavulanic Acid 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 Clavulanic Acid manufacturer or Clavulanic Acid supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Clavulanic Acid manufacturer or Clavulanic Acid supplier.
PharmaCompass also assists you with knowing the Clavulanic Acid API Price utilized in the formulation of products. Clavulanic Acid API Price is not always fixed or binding as the Clavulanic Acid Price is obtained through a variety of data sources. The Clavulanic Acid Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Clavulanate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Clavulanate, including repackagers and relabelers. The FDA regulates Clavulanate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Clavulanate 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 Clavulanate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Clavulanate supplier is an individual or a company that provides Clavulanate active pharmaceutical ingredient (API) or Clavulanate finished formulations upon request. The Clavulanate suppliers may include Clavulanate API manufacturers, exporters, distributors and traders.
click here to find a list of Clavulanate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Clavulanate DMF (Drug Master File) is a document detailing the whole manufacturing process of Clavulanate active pharmaceutical ingredient (API) in detail. Different forms of Clavulanate DMFs exist exist since differing nations have different regulations, such as Clavulanate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Clavulanate DMF submitted to regulatory agencies in the US is known as a USDMF. Clavulanate USDMF includes data on Clavulanate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Clavulanate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Clavulanate suppliers with USDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Clavulanate Drug Master File in Korea (Clavulanate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Clavulanate. The MFDS reviews the Clavulanate KDMF as part of the drug registration process and uses the information provided in the Clavulanate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Clavulanate 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 Clavulanate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Clavulanate suppliers with KDMF on PharmaCompass.
A Clavulanate CEP of the European Pharmacopoeia monograph is often referred to as a Clavulanate Certificate of Suitability (COS). The purpose of a Clavulanate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Clavulanate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Clavulanate to their clients by showing that a Clavulanate CEP has been issued for it. The manufacturer submits a Clavulanate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Clavulanate CEP holder for the record. Additionally, the data presented in the Clavulanate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Clavulanate DMF.
A Clavulanate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Clavulanate 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 Clavulanate suppliers with CEP (COS) 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 Clavulanate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Clavulanate 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 Clavulanate 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 Clavulanate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Clavulanate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Clavulanate suppliers with NDC on PharmaCompass.
Clavulanate 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 Clavulanate 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 Clavulanate GMP manufacturer or Clavulanate GMP API supplier for your needs.
A Clavulanate CoA (Certificate of Analysis) is a formal document that attests to Clavulanate's compliance with Clavulanate specifications and serves as a tool for batch-level quality control.
Clavulanate CoA mostly includes findings from lab analyses of a specific batch. For each Clavulanate 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.
Clavulanate may be tested according to a variety of international standards, such as European Pharmacopoeia (Clavulanate EP), Clavulanate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Clavulanate USP).
