Synopsis
Synopsis
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VMF
DRUG PRODUCT COMPOSITIONS
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US Patents
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Stock Recap #PipelineProspector
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1. Rifomycin S
2. Rifampicin S
Molecular Weight | 822.9 g/mol |
---|---|
Molecular Formula | C43H58N4O12 |
XLogP3 | 4 |
Hydrogen Bond Donor Count | 6 |
Hydrogen Bond Acceptor Count | 15 |
Rotatable Bond Count | 5 |
Exact Mass | 822.40512330 g/mol |
Monoisotopic Mass | 822.40512330 g/mol |
Topological Polar Surface Area | 217 A^2 |
Heavy Atom Count | 59 |
Formal Charge | 0 |
Complexity | 1750 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 9 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 4 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
1 of 6 | |
---|---|
Drug Name | Rifadin |
PubMed Health | Rifampin (Injection) |
Drug Classes | Antitubercular |
Drug Label | RIFADIN (rifampin capsules USP) for oral administration contain 150 mg or 300 mg rifampin per capsule. The 150 mg and 300 mg capsules also contain, as inactive ingredients: corn starch, D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin |
Active Ingredient | Rifampin |
Dosage Form | Capsule; Injectable |
Route | Injection; Oral |
Strength | 150mg; 300mg; 600mg/vial |
Market Status | Prescription |
Company | Sanofi Aventis Us |
2 of 6 | |
---|---|
Drug Name | Rifampin |
Active Ingredient | Rifampin |
Dosage Form | Capsule; Injectable |
Route | Injection; Oral |
Strength | 150mg; 300mg; 600mg/vial |
Market Status | Prescription |
Company | Bedford; Lupin Pharms; Sandoz; Emcure Pharms; Fresenius Kabi Usa; Versapharm; Lannett; Agila Speclts |
3 of 6 | |
---|---|
Drug Name | Rimactane |
PubMed Health | Rifampin |
Drug Classes | Antitubercular |
Drug Label | Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight i... |
Active Ingredient | Rifampin |
Dosage Form | Capsule |
Route | Oral |
Strength | 300mg |
Market Status | Prescription |
Company | Prosam Labs |
4 of 6 | |
---|---|
Drug Name | Rifadin |
PubMed Health | Rifampin (Injection) |
Drug Classes | Antitubercular |
Drug Label | RIFADIN (rifampin capsules USP) for oral administration contain 150 mg or 300 mg rifampin per capsule. The 150 mg and 300 mg capsules also contain, as inactive ingredients: corn starch, D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin |
Active Ingredient | Rifampin |
Dosage Form | Capsule; Injectable |
Route | Injection; Oral |
Strength | 150mg; 300mg; 600mg/vial |
Market Status | Prescription |
Company | Sanofi Aventis Us |
5 of 6 | |
---|---|
Drug Name | Rifampin |
Active Ingredient | Rifampin |
Dosage Form | Capsule; Injectable |
Route | Injection; Oral |
Strength | 150mg; 300mg; 600mg/vial |
Market Status | Prescription |
Company | Bedford; Lupin Pharms; Sandoz; Emcure Pharms; Fresenius Kabi Usa; Versapharm; Lannett; Agila Speclts |
6 of 6 | |
---|---|
Drug Name | Rimactane |
PubMed Health | Rifampin |
Drug Classes | Antitubercular |
Drug Label | Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight i... |
Active Ingredient | Rifampin |
Dosage Form | Capsule |
Route | Oral |
Strength | 300mg |
Market Status | Prescription |
Company | Prosam Labs |
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-02-12
Pay. Date : 2013-01-22
DMF Number : 13383
Submission : 1998-09-01
Status : Active
Type : II
Registration Number : 218MF10388
Registrant's Address : Via Angelo Titi, 22/26, Zona ex punto franco, 72100 Brindisi, Italy
Initial Date of Registration : 2006-03-20
Latest Date of Registration :
NDC Package Code : 82297-101
Start Marketing Date : 1973-04-09
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Available Reg Filing : ASMF |
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Certificate Number : R0-CEP 2000-337 - Rev 03
Issue Date : 2005-02-18
Type : TSE
Substance Number : 52
Status : Withdrawn by Holder
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38768
Submission : 2023-09-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13214
Submission : 1998-04-30
Status : Active
Type : II
Date of Issue : 2022-09-30
Valid Till : 2025-09-10
Written Confirmation Number : WC-0201
Address of the Firm :
NDC Package Code : 57297-444
Start Marketing Date : 1998-04-30
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Masung LS Co., Ltd.
Registration Date : 2009-10-27
Registration Number : 20091027-103-F-48-03
Manufacturer Name : Lupin Limited,
Manufacturer Address : India, T-142, MIDC, Tarapur, Via Boisar, Maharashtra 401 506
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-10-04
Pay. Date : 2013-09-26
DMF Number : 13663
Submission : 1998-09-01
Status : Active
Type : II
NDC Package Code : 52972-0026
Start Marketing Date : 1998-11-16
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Chong Kun Dang Bio Co., Ltd.
Registration Date : 2009-01-30
Registration Number : 20090130-103-F-36-01
Manufacturer Name : Chong Kun Dang Bio Co., Ltd._x000D_
Manufacturer Address : 454,486 Biblock 16 Complex, Moknae-dong, Danwon-gu, Ansan-si, Gyeonggi-do (425-100) (368-3 Chungjeong-ro 3-ga, Seodaemun-gu, Seoul (120-756))
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13796
Submission : 1998-09-01
Status : Active
Type : II
Certificate Number : CEP 2009-275 - Rev 05
Issue Date : 2024-05-27
Type : Chemical
Substance Number : 52
Status : Valid
Date of Issue : 2022-09-16
Valid Till : 2025-09-08
Written Confirmation Number : WC-0197
Address of the Firm :
NDC Package Code : 73005-0006
Start Marketing Date : 2022-07-19
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-05-13
Pay. Date : 2022-03-29
DMF Number : 36879
Submission : 2022-04-04
Status : Active
Type : II
Date of Issue : 2022-09-16
Valid Till : 2025-09-08
Written Confirmation Number : WC-0197
Address of the Firm :
NDC Package Code : 17337-0031
Start Marketing Date : 2012-12-27
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13717
Submission : 1998-09-01
Status : Inactive
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13398
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13644
Submission : 1998-09-01
Status : Inactive
Type : II
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Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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Details:
Isoniazid is a Small Molecule drug candidate drug candidate, which is currently being evaluated in Phase III clinical studies for the treatment of Tuberculosis.
Lead Product(s): Isoniazid,Rifampicin,Pyrazinamide,Ethambutol
Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: National University of Medical Sciences, Pakistan | Aurum Institute | Biomedical Research and Training Institute, Zimbabwe | Foundation for Innovative New Diagnostics, Switzerland | KTH Royal Institute of Technology | London School of Hygiene & Tropical M
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 09, 2025
Lead Product(s) : Isoniazid,Rifampicin,Pyrazinamide,Ethambutol
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : National University of Medical Sciences, Pakistan | Aurum Institute | Biomedical Research and Training Institute, Zimbabwe | Foundation for Innovative New Diagnostics, Switzerland | KTH Royal Institute of Technology | London School of Hygiene & Tropical M
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Isoniazid is a Small Molecule drug candidate drug candidate, which is currently being evaluated in Phase III clinical studies for the treatment of Tuberculosis.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
September 09, 2025
Details:
HSK31858 is a Other Small Molecule drug candidate, which is currently being evaluated in Phase I clinical studies for the treatment of unspecified medical condition.
Lead Product(s): HSK31858,Rifampicin
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 21, 2025
Lead Product(s) : HSK31858,Rifampicin
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Effect of Rifampicin on PK of HSK31858 in Healthy Subjects
Details : HSK31858 is a Other Small Molecule drug candidate, which is currently being evaluated in Phase I clinical studies for the treatment of unspecified medical condition.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
August 21, 2025
Details:
Rifampicin is a Antibiotic drug candidate, which is currently being evaluated in Phase III clinical studies for the treatment of Tuberculosis, Pulmonary.
Lead Product(s): Rifampicin,Inapplicable
Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Antibiotic
Sponsor: St George's, University of London | McMaster University
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 12, 2025
Lead Product(s) : Rifampicin,Inapplicable
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : St George's, University of London | McMaster University
Deal Size : Inapplicable
Deal Type : Inapplicable
Shorter Rifampicin-Based Treatment in Less Severe Tuberculosis
Details : Rifampicin is a Antibiotic drug candidate, which is currently being evaluated in Phase III clinical studies for the treatment of Tuberculosis, Pulmonary.
Product Name : Undisclosed
Product Type : Antibiotic
Upfront Cash : Inapplicable
August 12, 2025
Details:
Contezolid is a Other Small Molecule drug candidate, which is currently being evaluated in Phase IV clinical studies for the treatment of Mycobacterium Avium Complex Pulmonary Disease.
Lead Product(s): Contezolid,Azithromycin,Rifampicin,Ethambutol
Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Miscellaneous
Sponsor: Beijing Chest Hospital, Capital Medical University | Jiangxi Provincial Chest Hospital | Bin Cao
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 24, 2025
Lead Product(s) : Contezolid,Azithromycin,Rifampicin,Ethambutol
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Beijing Chest Hospital, Capital Medical University | Jiangxi Provincial Chest Hospital | Bin Cao
Deal Size : Inapplicable
Deal Type : Inapplicable
Short-term Bactericidal Effect of Contezolid in MAC-PD
Details : Contezolid is a Other Small Molecule drug candidate, which is currently being evaluated in Phase IV clinical studies for the treatment of Mycobacterium Avium Complex Pulmonary Disease.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
July 24, 2025
Details:
RESP30TB 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): RESP30TB,Rifampicin,Isoniazid,Pyrazinamide,Ethambutol
Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 18, 2025
Lead Product(s) : RESP30TB,Rifampicin,Isoniazid,Pyrazinamide,Ethambutol
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Phase II Trial of RESP30TB Safety, Tolerability, & Early Bactericidal Activity
Details : RESP30TB 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
July 18, 2025
Details:
Rifampicin is a Antibiotic drug candidate, which is currently being evaluated in Phase I clinical studies for the treatment of Obesity.
Lead Product(s): Rifampicin,VCT220,Itraconazole
Therapeutic Area: Nutrition and Weight Loss Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Antibiotic
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 09, 2025
Lead Product(s) : Rifampicin,VCT220,Itraconazole
Therapeutic Area : Nutrition and Weight Loss
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
VCT220 PK with Rifampin Or Itraconazole In Healthy Volunteers
Details : Rifampicin is a Antibiotic drug candidate, which is currently being evaluated in Phase I clinical studies for the treatment of Obesity.
Product Name : Undisclosed
Product Type : Antibiotic
Upfront Cash : Inapplicable
July 09, 2025
Details:
INCB161734 is a drug candidate, which is currently being evaluated in Phase I clinical studies for the treatment of unspecified medical condition.
Lead Product(s): INCB161734,Itraconazole,Rifampicin,Esomeprazole Magnesium,Famotidine
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Undisclosed
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 12, 2025
Lead Product(s) : INCB161734,Itraconazole,Rifampicin,Esomeprazole Magnesium,Famotidine
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
INCB161734 PK Study with Itraconazole, Rifampin, Acid-Reducing Agents In Healthy Adults
Details : INCB161734 is a drug candidate, which is currently being evaluated in Phase I clinical studies for the treatment of unspecified medical condition.
Product Name : Undisclosed
Product Type : Undisclosed
Upfront Cash : Inapplicable
June 12, 2025
Details:
HRS-5041 is a drug candidate, which is currently being evaluated in Phase I clinical studies for the treatment of Prostatic Neoplasms.
Lead Product(s): HRS-5041,Rifampicin
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Undisclosed
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 11, 2025
Lead Product(s) : HRS-5041,Rifampicin
Therapeutic Area : Oncology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Effect of Rifampicin on Pharmacokinetics of Oral HRS-5041 in Healthy Subjects
Details : HRS-5041 is a drug candidate, which is currently being evaluated in Phase I clinical studies for the treatment of Prostatic Neoplasms.
Product Name : Undisclosed
Product Type : Undisclosed
Upfront Cash : Inapplicable
June 11, 2025
Details:
Azvudine is a Other Small Molecule drug candidate, which is currently being evaluated in Phase I clinical studies for the treatment of unspecified medical condition.
Lead Product(s): Azvudine,Rifampicin
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 03, 2025
Lead Product(s) : Azvudine,Rifampicin
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Interaction of Azvudine Tablets (FNC) & Rifampicin Capsules (RIF)
Details : Azvudine is a Other Small Molecule drug candidate, which is currently being evaluated in Phase I clinical studies for the treatment of unspecified medical condition.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
June 03, 2025
Details:
TNP-2092 is a Antibiotic drug candidate, which is currently being evaluated in phase I/ phase II clinical studies for the treatment of Prosthesis-Related Infections.
Lead Product(s): TNP-2092,Vancomycin HCl,Rifampicin,Levofloxacin
Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed
Study Phase: Phase I/ Phase IIProduct Type: Antibiotic
Sponsor: First Affiliated Hospital of Xinjiang Medical University
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 21, 2025
Lead Product(s) : TNP-2092,Vancomycin HCl,Rifampicin,Levofloxacin
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase I/ Phase II
Partner/Sponsor/Collaborator : First Affiliated Hospital of Xinjiang Medical University
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : TNP-2092 is a Antibiotic drug candidate, which is currently being evaluated in phase I/ phase II clinical studies for the treatment of Prosthesis-Related Infections.
Product Name : Undisclosed
Product Type : Antibiotic
Upfront Cash : Inapplicable
March 21, 2025
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : DISCN
Registration Country : USA
Brand Name : RIFADIN
Dosage Form : CAPSULE;ORAL
Dosage Strength : 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 1982-01-01
Application Number : 50420
Regulatory Info : DISCN
Registration Country : USA
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : DISCN
Registration Country : USA
Brand Name : RIFADIN
Dosage Form : CAPSULE;ORAL
Dosage Strength : 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 1982-01-01
Application Number : 50420
Regulatory Info : DISCN
Registration Country : USA
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : RX
Registration Country : USA
Brand Name : RIFADIN
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 600MG/VIAL
Packaging :
Approval Date : 1989-05-25
Application Number : 50627
Regulatory Info : RX
Registration Country : USA
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : DISCN
Registration Country : USA
ISONIAZID; PYRAZINAMIDE; RIFAMPIN
Brand Name : RIFATER
Dosage Form : TABLET;ORAL
Dosage Strength : 50MG;300MG;120MG
Packaging :
Approval Date : 1994-05-31
Application Number : 50705
Regulatory Info : DISCN
Registration Country : USA
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : DISCN
Registration Country : USA
Brand Name : RIFAMATE
Dosage Form : CAPSULE;ORAL
Dosage Strength : 150MG;300MG
Packaging :
Approval Date : 1982-01-01
Application Number : 61884
Regulatory Info : DISCN
Registration Country : USA
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Italy
Isoniazid; Pyrazinamide; Rifampin
Brand Name : Rifater
Dosage Form : Isoniazid+Pyrazinamide+Rifampicin 50+300+120Mg 40 Combined Oral Use
Dosage Strength : 40 cpr riv 50 mg + 300mg + 120 mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Italy
Brand Name : Rifadin
Dosage Form : Rifampicin 2% 60Ml Oral Use
Dosage Strength : 1 bottle 60 ml 20 mg/ml syrup
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Italy
Brand Name : Rifadin
Dosage Form : Rifampicin 300Mg 8 Joined' Oral Use
Dosage Strength : 8 cps 300 mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Italy
Brand Name : Rifadin
Dosage Form : Rifampicin 450Mg 8 Joined' Oral Use
Dosage Strength : 8 cpr riv 450 mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Italy
Brand Name : Rifadin
Dosage Form : Rifampicin 600Mg 1 Unit Parenteral Use
Dosage Strength : 1 ampoule EV 600 mg + 1 ampoule solv 10 ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
RLD : Yes
TE Code :
Brand Name : RIFADIN
Dosage Form : CAPSULE;ORAL
Dosage Strength : 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1982-01-01
Application Number : 50420
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
RLD : Yes
TE Code :
Brand Name : RIFADIN
Dosage Form : CAPSULE;ORAL
Dosage Strength : 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1982-01-01
Application Number : 50420
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
RLD : Yes
TE Code : AP
Brand Name : RIFADIN
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 600MG/VIAL
Approval Date : 1989-05-25
Application Number : 50627
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AP
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
RLD : Yes
TE Code :
ISONIAZID; PYRAZINAMIDE; RIFAMPIN
Brand Name : RIFATER
Dosage Form : TABLET;ORAL
Dosage Strength : 50MG;300MG;120MG
Approval Date : 1994-05-31
Application Number : 50705
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
RLD : No
TE Code :
Brand Name : RIFAMATE
Dosage Form : CAPSULE;ORAL
Dosage Strength : 150MG;300MG
Approval Date : 1982-01-01
Application Number : 61884
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code : AB
Brand Name : RIFAMPIN
Dosage Form : CAPSULE;ORAL
Dosage Strength : 300MG
Approval Date : 2008-03-28
Application Number : 65390
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : RIFAMPIN
Dosage Form : CAPSULE;ORAL
Dosage Strength : 300MG
Approval Date : 1997-05-28
Application Number : 64150
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AP
Brand Name : RIFAMPIN
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 600MG/VIAL
Approval Date : 2010-09-21
Application Number : 65502
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code : AB
Brand Name : RIMACTANE
Dosage Form : CAPSULE;ORAL
Dosage Strength : 300MG
Approval Date : 1982-01-01
Application Number : 50429
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : RIFAMPIN
Dosage Form : CAPSULE;ORAL
Dosage Strength : 150MG
Approval Date : 2013-08-21
Application Number : 90034
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Italy
Isoniazid; Pyrazinamide; Rifampin
Brand Name : Rifater
Dosage Form : Isoniazid+Pyrazinamide+Rifampicin 50+300+120Mg 40 Combined Oral Use
Dosage Strength : 40 cpr riv 50 mg + 300mg + 120 mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Italy
Brand Name : Rifadin
Dosage Form : Rifampicin 2% 60Ml Oral Use
Dosage Strength : 1 bottle 60 ml 20 mg/ml syrup
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Italy
Brand Name : Rifadin
Dosage Form : Rifampicin 450Mg 8 Joined' Oral Use
Dosage Strength : 8 cpr riv 450 mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Italy
Brand Name : Rifadin
Dosage Form : Rifampicin 600Mg 1 Unit Parenteral Use
Dosage Strength : 1 ampoule EV 600 mg + 1 ampoule solv 10 ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Italy
Brand Name : Rifinah
Dosage Form : Rifampicin+Isoniazid+150300 Mg 24 Units Of Oral Use
Dosage Strength : 24 cpr riv 300 mg + 150 mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Rifadin
Dosage Form : Solution For Infusion
Dosage Strength : 600mg
Packaging :
Approval Date : 05/02/1982
Application Number : 19820205000098
Regulatory Info : Approved
Registration Country : Sweden
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Rifinah
Dosage Form : Coated Tablet
Dosage Strength :
Packaging :
Approval Date : 18/09/1975
Application Number : 38931
Regulatory Info : Allowed
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Authorized
Registration Country : Spain
Isoniazide; Pyrazinamide; Rifampicin
Brand Name : Rifater Coated Tablets
Dosage Form : Film Coated Tablet
Dosage Strength :
Packaging :
Approval Date : 1989-04-01
Application Number : 58299
Regulatory Info : Authorized
Registration Country : Spain
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Rifinah
Dosage Form : Film Coated Tablet
Dosage Strength : 300MG; 150 MG
Packaging :
Approval Date : 1978-09-01
Application Number : 54213
Regulatory Info : Authorized
Registration Country : Spain
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Rifaldin
Dosage Form : Oral Suspension
Dosage Strength : 20MG
Packaging :
Approval Date : 1968-06-01
Application Number : 46028
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : ROFACT
Dosage Form : CAPSULE
Dosage Strength : 300MG
Packaging : 100
Approval Date :
Application Number : 343617
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : ROFACT
Dosage Form : CAPSULE
Dosage Strength : 150MG
Packaging : 100
Approval Date :
Application Number : 393444
Regulatory Info : Prescription
Registration Country : Canada
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PharmaCompass offers a list of Rifampicin 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 Rifampicin manufacturer or Rifampicin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Rifampicin manufacturer or Rifampicin supplier.
PharmaCompass also assists you with knowing the Rifampicin API Price utilized in the formulation of products. Rifampicin API Price is not always fixed or binding as the Rifampicin Price is obtained through a variety of data sources. The Rifampicin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Rifampin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rifampin, including repackagers and relabelers. The FDA regulates Rifampin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rifampin 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 Rifampin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Rifampin supplier is an individual or a company that provides Rifampin active pharmaceutical ingredient (API) or Rifampin finished formulations upon request. The Rifampin suppliers may include Rifampin API manufacturers, exporters, distributors and traders.
click here to find a list of Rifampin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Rifampin DMF (Drug Master File) is a document detailing the whole manufacturing process of Rifampin active pharmaceutical ingredient (API) in detail. Different forms of Rifampin DMFs exist exist since differing nations have different regulations, such as Rifampin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Rifampin DMF submitted to regulatory agencies in the US is known as a USDMF. Rifampin USDMF includes data on Rifampin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Rifampin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Rifampin suppliers with USDMF on PharmaCompass.
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 Rifampin Drug Master File in Japan (Rifampin JDMF) empowers Rifampin 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 Rifampin JDMF during the approval evaluation for pharmaceutical products. At the time of Rifampin 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 Rifampin suppliers with JDMF 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 Rifampin Drug Master File in Korea (Rifampin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Rifampin. The MFDS reviews the Rifampin KDMF as part of the drug registration process and uses the information provided in the Rifampin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Rifampin 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 Rifampin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Rifampin suppliers with KDMF on PharmaCompass.
A Rifampin CEP of the European Pharmacopoeia monograph is often referred to as a Rifampin Certificate of Suitability (COS). The purpose of a Rifampin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Rifampin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Rifampin to their clients by showing that a Rifampin CEP has been issued for it. The manufacturer submits a Rifampin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Rifampin CEP holder for the record. Additionally, the data presented in the Rifampin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Rifampin DMF.
A Rifampin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Rifampin 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 Rifampin suppliers with CEP (COS) on PharmaCompass.
A Rifampin written confirmation (Rifampin WC) is an official document issued by a regulatory agency to a Rifampin manufacturer, verifying that the manufacturing facility of a Rifampin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Rifampin APIs or Rifampin finished pharmaceutical products to another nation, regulatory agencies frequently require a Rifampin WC (written confirmation) as part of the regulatory process.
click here to find a list of Rifampin suppliers with Written Confirmation (WC) 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 Rifampin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Rifampin 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 Rifampin 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 Rifampin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Rifampin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Rifampin suppliers with NDC on PharmaCompass.
Rifampin 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 Rifampin 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 Rifampin GMP manufacturer or Rifampin GMP API supplier for your needs.
A Rifampin CoA (Certificate of Analysis) is a formal document that attests to Rifampin's compliance with Rifampin specifications and serves as a tool for batch-level quality control.
Rifampin CoA mostly includes findings from lab analyses of a specific batch. For each Rifampin 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.
Rifampin may be tested according to a variety of international standards, such as European Pharmacopoeia (Rifampin EP), Rifampin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Rifampin USP).