Synopsis
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VMF
DRUG PRODUCT COMPOSITIONS
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US Patents
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US Exclusivities
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Health Canada Patents
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Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
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 : 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 : 2019-09-09
Valid Till : 2022-09-08
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
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 : 38768
Submission : 2023-09-29
Status : Active
Type : II
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 : 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
Certificate Number : R0-CEP 2004-295 - Rev 00
Issue Date : 2008-12-16
Type : Chemical
Substance Number : 52
Status : Withdrawn by EDQM F...
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Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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Details:
EluPro is designed to prevent post-operative complications, such as infections, in patients with cardiac implantable electronic devices (CIEDs) like pacemakers and defibrillators.
Lead Product(s): Rifampicin,Minocycline Hydrochloride
Therapeutic Area: Infections and Infectious Diseases Brand Name: EluPro
Study Phase: Approved FDFProduct Type: Antibiotic
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 14, 2025
Lead Product(s) : Rifampicin,Minocycline Hydrochloride
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Elutia Announces Full Launch of EluPro™ Following Strong Initial Demand
Details : EluPro is designed to prevent post-operative complications, such as infections, in patients with cardiac implantable electronic devices (CIEDs) like pacemakers and defibrillators.
Product Name : EluPro
Product Type : Antibiotic
Upfront Cash : Inapplicable
January 14, 2025
Details:
The agreement aims to provide access to Elutia’s innovative EluPro Antibiotic Eluting BioEnvelope, embedded with rifampin and minocycline, to S3P’s extensive network of 993 acute care facilities.
Lead Product(s): Rifampicin,Minocycline Hydrochloride
Therapeutic Area: Infections and Infectious Diseases Brand Name: EluPro
Study Phase: Approved FDFProduct Type: Antibiotic
Sponsor: Vizient
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement January 06, 2025
Lead Product(s) : Rifampicin,Minocycline Hydrochloride
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Vizient
Deal Size : Undisclosed
Deal Type : Agreement
Elutia Announces EluPro™ GPO Agreement with Southern Strategic Sourcing Partners
Details : The agreement aims to provide access to Elutia’s innovative EluPro Antibiotic Eluting BioEnvelope, embedded with rifampin and minocycline, to S3P’s extensive network of 993 acute care facilities.
Product Name : EluPro
Product Type : Antibiotic
Upfront Cash : Undisclosed
January 06, 2025
Details:
EluPro is designed to prevent post-operative complications, such as infections, in patients with cardiac implantable electronic devices (CIEDs) like pacemakers and defibrillators.
Lead Product(s): Rifampicin,Minocycline Hydrochloride
Therapeutic Area: Infections and Infectious Diseases Brand Name: EluPro
Study Phase: Approved FDFProduct Type: Antibiotic
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 05, 2024
Lead Product(s) : Rifampicin,Minocycline Hydrochloride
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Elutia Implants First EluPro™, a Drug-Eluting BioEnvelope for Cardiac Use
Details : EluPro is designed to prevent post-operative complications, such as infections, in patients with cardiac implantable electronic devices (CIEDs) like pacemakers and defibrillators.
Product Name : EluPro
Product Type : Antibiotic
Upfront Cash : Inapplicable
September 05, 2024
Details:
The net proceeds will support the Company’s advancement of its drug-eluting biomatrix product EluPro (rifampin), the world’s first antibiotic-eluting BioEnvelope for Post-surgical Infections.
Lead Product(s): Rifampicin,Minocycline Hydrochloride
Therapeutic Area: Infections and Infectious Diseases Brand Name: EluPro
Study Phase: Approved FDFProduct Type: Antibiotic
Sponsor: Lake Street Capital Markets
Deal Size: $15.7 million Upfront Cash: Undisclosed
Deal Type: Private Placement August 01, 2024
Lead Product(s) : Rifampicin,Minocycline Hydrochloride
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Lake Street Capital Markets
Deal Size : $15.7 million
Deal Type : Private Placement
Elutia Announces Full Exercise of Warrants Generating $15.7 Million in Gross Proceeds
Details : The net proceeds will support the Company’s advancement of its drug-eluting biomatrix product EluPro (rifampin), the world’s first antibiotic-eluting BioEnvelope for Post-surgical Infections.
Product Name : EluPro
Product Type : Antibiotic
Upfront Cash : Undisclosed
August 01, 2024
Details:
EluPro is designed to prevent post-operative complications, such as infections, in patients with cardiac implantable electronic devices (CIEDs) like pacemakers and defibrillators.
Lead Product(s): Rifampicin,Minocycline Hydrochloride
Therapeutic Area: Infections and Infectious Diseases Brand Name: EluPro
Study Phase: Approved FDFProduct Type: Antibiotic
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 17, 2024
Lead Product(s) : Rifampicin,Minocycline Hydrochloride
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Elutia Wins FDA Clearance for EluPro™, an Antibiotic-Eluting BioEnvelope
Details : EluPro is designed to prevent post-operative complications, such as infections, in patients with cardiac implantable electronic devices (CIEDs) like pacemakers and defibrillators.
Product Name : EluPro
Product Type : Antibiotic
Upfront Cash : Inapplicable
June 17, 2024
Details:
CanGaroo RM featuring an advanced biomatrix and the drugs rifampin and minocycline for extended antibiotic protection is under evaluation for post-surgical infections.
Lead Product(s): Rifampicin,Minocycline Hydrochloride
Therapeutic Area: Infections and Infectious Diseases Brand Name: CanGaroo RM
Study Phase: Approved FDFProduct Type: Antibiotic
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 18, 2023
Lead Product(s) : Rifampicin,Minocycline Hydrochloride
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Elutia Submits CanGarooRM® Antibiotic-Eluting Biomatrix for FDA Clearance
Details : CanGaroo RM featuring an advanced biomatrix and the drugs rifampin and minocycline for extended antibiotic protection is under evaluation for post-surgical infections.
Product Name : CanGaroo RM
Product Type : Antibiotic
Upfront Cash : Inapplicable
December 18, 2023
Details:
The net proceeds will support the Company’s advancement of its drug-eluting biomatrix products, including CanGaroo featuring an advanced biomatrix and the drugs rifampin and minocycline for extended antibiotic protection.
Lead Product(s): Rifampicin,Minocycline Hydrochloride
Therapeutic Area: Infections and Infectious Diseases Brand Name: CanGaroo
Study Phase: PreclinicalProduct Type: Antibiotic
Sponsor: HighCape Capital
Deal Size: $26.2 million Upfront Cash: Undisclosed
Deal Type: Private Placement September 19, 2023
Lead Product(s) : Rifampicin,Minocycline Hydrochloride
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Preclinical
Partner/Sponsor/Collaborator : HighCape Capital
Deal Size : $26.2 million
Deal Type : Private Placement
Elutia Announces Private Placement for Proceeds up to $26 Million
Details : The net proceeds will support the Company’s advancement of its drug-eluting biomatrix products, including CanGaroo featuring an advanced biomatrix and the drugs rifampin and minocycline for extended antibiotic protection.
Product Name : CanGaroo
Product Type : Antibiotic
Upfront Cash : Undisclosed
September 19, 2023
Details:
Through the divestment, Elutia sells its Orthobiologics business unit to Berkeley Biologics, including Company’s lead drug-eluting product, CanGaroo featuring an advanced biomatrix and the drugs rifampin and minocycline for extended antibiotic protection.
Lead Product(s): Rifampicin,Minocycline Hydrochloride
Therapeutic Area: Infections and Infectious Diseases Brand Name: CanGaroo
Study Phase: PreclinicalProduct Type: Antibiotic
Sponsor: Berkeley Biologics
Deal Size: $35.0 million Upfront Cash: $35.0 million
Deal Type: Divestment September 18, 2023
Lead Product(s) : Rifampicin,Minocycline Hydrochloride
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Preclinical
Partner/Sponsor/Collaborator : Berkeley Biologics
Deal Size : $35.0 million
Deal Type : Divestment
Elutia Announces Sale of Orthobiologics Business Unit for Cash Proceeds of up to $35 Million
Details : Through the divestment, Elutia sells its Orthobiologics business unit to Berkeley Biologics, including Company’s lead drug-eluting product, CanGaroo featuring an advanced biomatrix and the drugs rifampin and minocycline for extended antibiotic protecti...
Product Name : CanGaroo
Product Type : Antibiotic
Upfront Cash : $35.0 million
September 18, 2023
Details:
Through the divestment, Elutia sells its Orthobiologics business unit to Berkeley Biologics, including Company’s lead drug-eluting product, CanGaroo featuring an advanced biomatrix and the drugs rifampin and minocycline for extended antibiotic protection.
Lead Product(s): Rifampicin,Minocycline Hydrochloride
Therapeutic Area: Infections and Infectious Diseases Brand Name: CanGaroo
Study Phase: PreclinicalProduct Type: Antibiotic
Sponsor: Berkeley Biologics
Deal Size: $35.0 million Upfront Cash: $35.0 million
Deal Type: Divestment September 11, 2023
Lead Product(s) : Rifampicin,Minocycline Hydrochloride
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Preclinical
Partner/Sponsor/Collaborator : Berkeley Biologics
Deal Size : $35.0 million
Deal Type : Divestment
Details : Through the divestment, Elutia sells its Orthobiologics business unit to Berkeley Biologics, including Company’s lead drug-eluting product, CanGaroo featuring an advanced biomatrix and the drugs rifampin and minocycline for extended antibiotic protecti...
Product Name : CanGaroo
Product Type : Antibiotic
Upfront Cash : $35.0 million
September 11, 2023
Details:
Citius intends to use the net proceeds for pre-clinical and clinical development of its product candidates, including Mino-Wrap, a malleable, bio-absorbable film impregnated with minocycline and rifampin used in patients that elect to undergo reconstructive breast surgery.
Lead Product(s): Minocycline Hydrochloride,Rifampicin
Therapeutic Area: Infections and Infectious Diseases Brand Name: Mino-Wrap
Study Phase: PreclinicalProduct Type: Other Small Molecule
Sponsor: H.C. Wainwright & Co
Deal Size: $15.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering April 05, 2023
Lead Product(s) : Minocycline Hydrochloride,Rifampicin
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Preclinical
Partner/Sponsor/Collaborator : H.C. Wainwright & Co
Deal Size : $15.0 million
Deal Type : Public Offering
Citius Pharmaceuticals Announces $15 Million Registered Direct Offering
Details : Citius intends to use the net proceeds for pre-clinical and clinical development of its product candidates, including Mino-Wrap, a malleable, bio-absorbable film impregnated with minocycline and rifampin used in patients that elect to undergo reconstruct...
Product Name : Mino-Wrap
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
April 05, 2023
CAS Number : 75-64-9
End Use API : Rifampicin
About The Company : Capital Farma offers a comprehensive range of pharmaceutical solutions. Our API offering includes active ingredients sourced exclusively from top European manuf...
1-Amino-1-cyclopentylpiperazine
CAS Number : 61379-64-4
End Use API : Rifampicin
About The Company : Established in 2003 with small pilot plant and came in to commercial production in 2013 in the name of Allchem Laboratories, it is an independent privately owne...
CAS Number : 6928-85-4
End Use API : Rifampicin
About The Company : Huvepharma® Italia is a fast-growing global pharmaceutical company duly organized for developing, manufacturing and marketing advanced intermediates and active...
CAS Number : 6928-85-4
End Use API : Rifampicin
About The Company : SLN Pharmachem was setup in 1997 with an objective to provide technology based products (Intermediates) for Pharmaceutical, Cosmetic and Fine Chemical Industry....
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
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 :
TE Code :
Brand Name : RIFADIN
Dosage Form : CAPSULE;ORAL
Dosage Strength : 150MG
Approval Date :
Application Number : 50420
RX/OTC/DISCN :
RLD :
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 : Generic
Registration Country : South Africa
Brand Name : Rifinah-300
Dosage Form : TAB
Dosage Strength : 300mg
Packaging : 56X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Rimtib Tablets
Dosage Form : TAB
Dosage Strength : 150mg
Packaging : 112X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Afaris Paed 75/50
Dosage Form : TAB
Dosage Strength : 75mg
Packaging : 84X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Rifabact
Dosage Form : TAB
Dosage Strength : 150mg
Packaging : 84X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Rimactazid 150/75
Dosage Form : TAB
Dosage Strength : 150mg
Packaging : 56X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Rimstar 4-Fdc
Dosage Form : TAB
Dosage Strength : 150mg
Packaging : 80X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Rimstar 4-Fdc
Dosage Form : TAB
Dosage Strength : 150mg
Packaging : 84X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Rimactane 150
Dosage Form : CAP
Dosage Strength : 150mg
Packaging : 100X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Rimactazid Paed 60/60
Dosage Form : TAB
Dosage Strength : 60mg
Packaging : 56X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Rimcure Paed 3-Fdc
Dosage Form : TAB
Dosage Strength : 60mg
Packaging : 500X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.
Regulatory Info : Dossier Availability: Q4 2026
Registration Country : Poland
Brand Name :
Dosage Form : Hard Capsule
Dosage Strength : 150MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Dossier Availability: Q4 2026
Registration Country : Poland
Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.
Packaging :
Regulatory Info : Dossier Availability: Q4 2026
Dosage : Hard Capsule
Dosage Strength : 150MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Poland
Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.
Regulatory Info : Dossier Availability: Q4 2026
Registration Country : Poland
Brand Name :
Dosage Form : Hard Capsule
Dosage Strength : 300MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Dossier Availability: Q4 2026
Registration Country : Poland
Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.
Packaging :
Regulatory Info : Dossier Availability: Q4 2026
Dosage : Hard Capsule
Dosage Strength : 300MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Poland
Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.
Regulatory Info : Dossier Availability: Q4 2026
Registration Country : Poland
Brand Name :
Dosage Form : Hard Capsule
Dosage Strength : 150MG; 100MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Dossier Availability: Q4 2026
Registration Country : Poland
Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.
Packaging :
Regulatory Info : Dossier Availability: Q4 2026
Dosage : Hard Capsule
Dosage Strength : 150MG; 100MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Poland
Regulatory Info :
Registration Country : Romania
Brand Name : SINERDOL®
Dosage Form : capsules
Dosage Strength : 300MG
Packaging : Box x 10 capsules Box x 1000 capsules
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Romania
Packaging : Box x 10 capsules Box x 1000 capsules
Regulatory Info :
Dosage : capsules
Dosage Strength : 300MG
Brand Name : SINERDOL®
Approval Date :
Application Number :
Registration Country : Romania
Regulatory Info :
Registration Country : China
Brand Name :
Dosage Form : Injection
Dosage Strength : 450MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : China
Packaging :
Regulatory Info :
Dosage : Injection
Dosage Strength : 450MG
Brand Name :
Approval Date :
Application Number :
Registration Country : China
Regulatory Info :
Registration Country : Hungary
Brand Name : Rifamed
Dosage Form : Film Coated Tablet
Dosage Strength : 300MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Hungary
Packaging :
Regulatory Info :
Dosage : Film Coated Tablet
Dosage Strength : 300MG
Brand Name : Rifamed
Approval Date :
Application Number :
Registration Country : Hungary
Regulatory Info :
Registration Country : Hungary
Brand Name : Rifamed
Dosage Form : Film Coated Tablet
Dosage Strength : 150MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Hungary
Packaging :
Regulatory Info :
Dosage : Film Coated Tablet
Dosage Strength : 150MG
Brand Name : Rifamed
Approval Date :
Application Number :
Registration Country : Hungary
Regulatory Info :
Registration Country : Hungary
Brand Name : Rifazid
Dosage Form : Film Coated Tablet
Dosage Strength : 300; 150MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Hungary
Packaging :
Regulatory Info :
Dosage : Film Coated Tablet
Dosage Strength : 300; 150MG
Brand Name : Rifazid
Approval Date :
Application Number :
Registration Country : Hungary
Regulatory Info :
Registration Country : China
Brand Name :
Dosage Form : Powder for Injection
Dosage Strength : 0.45g
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : China
Packaging :
Regulatory Info :
Dosage : Powder for Injection
Dosage Strength : 0.45g
Brand Name :
Approval Date :
Application Number :
Registration Country : China
Regulatory Info : Generic
Registration Country : Zimbabwe
Brand Name : Rifacure
Dosage Form : CAPSULE
Dosage Strength : 150MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : Zimbabwe
Packaging :
Regulatory Info : Generic
Dosage : CAPSULE
Dosage Strength : 150MG
Brand Name : Rifacure
Approval Date :
Application Number :
Registration Country : Zimbabwe
Related Excipient Companies
Dosage Form : Capsule
Grade : Not Available
Application : Solubilizers
Excipient Details : Solubilizing matrix, crystallization inhibitor & stabilizer in injectables and ophthalmic products
Dosage Form : Capsule
Grade : Not Available
Application : Solubilizers
Excipient Details : Solubilizing matrix, crystallization inhibitor & stabilizer in injectables and ophthalmic products
Pharmacopoeia Ref : Ph. Eur., USP: Povidone; JPE: ...
Technical Specs : Not Available
Ingredient(s) : Povidone
Dosage Form : Tablet
Grade : Not Available
Application : Controlled & Modified Release
Excipient Details : Solubilization, dispersion, crystallization inhibition, instant release matrices & spray drying
Dosage Form : Tablet
Grade : Not Available
Application : Solubilizers
Excipient Details : Solubilization, dispersion, crystallization inhibition, instant release matrices & spray drying
Pharmacopoeia Ref : Ph. Eur., USP, JP: Povidone
Technical Specs : Not Available
Ingredient(s) : Povidone
Dosage Form : Tablet
Grade : Not Available
Application : Fillers, Diluents & Binders
Excipient Details : Binder for peroxide sensitive drugs in solid oral dosage forms. Drug solubilizer with low peroxide in transdermal patches.
Pharmacopoeia Ref : Ph. Eur., USP, JP: Povidone
Technical Specs : Not Available
Ingredient(s) : Povidone
Dosage Form : Capsule
Grade : Not Available
Application : Fillers, Diluents & Binders
Excipient Details : Tablet binding, thickener, stabilizers of suspensions, reduces sedimentation, crystallization inhibition.
Pharmacopoeia Ref : Ph. Eur., USP, JP: Povidone
Technical Specs : Not Available
Ingredient(s) : Povidone
Dosage Form : Tablet
Grade : Not Available
Application : Granulation
Excipient Details : For non-erodible matrices using direct compression, Controlled release matrix. Matrix former in transdermal patches and topical films.
Pharmacopoeia Ref : Ph. Eur., USP-NF, JP-JPE: 80 %...
Technical Specs : Not Available
Ingredient(s) : Povidone
Dosage Form : Tablet
Grade : Not Available
Application : Granulation
Excipient Details : Wetting agent, reduces disintegration time, Ionic solubilizer, high HLB anionic emulsifier for semi-solids and foams.
Pharmacopoeia Ref : Ph. Eur.: Sodium Laurilsulfate...
Technical Specs : Not Available
Ingredient(s) : Sodium Lauryl Sulfate
Dosage Form : Tablet
Grade : Not Available
Application : Film Formers & Plasticizers
Excipient Details : Liquid plasticizer with high ADI, hydrophilic solvent & humectant in emulsions, skin penetration enhancer in topical formulaitons.
Pharmacopoeia Ref : Ph. Eur., JP, FCC, USP
Technical Specs : Not Available
Ingredient(s) : Propylene Glycol
Dosage Form : Tablet
Grade : Not Available
Application : Direct Compression
Excipient Details : Ready-to-use direct compression solution for tablets.
Excipients by Applications
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
98
PharmaCompass offers a list of Rifampin 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 Rifampin manufacturer or Rifampin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Rifampin manufacturer or Rifampin supplier.
PharmaCompass also assists you with knowing the Rifampin API Price utilized in the formulation of products. Rifampin API Price is not always fixed or binding as the Rifampin Price is obtained through a variety of data sources. The Rifampin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Rifa manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rifa, including repackagers and relabelers. The FDA regulates Rifa manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rifa 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 Rifa manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Rifa supplier is an individual or a company that provides Rifa active pharmaceutical ingredient (API) or Rifa finished formulations upon request. The Rifa suppliers may include Rifa API manufacturers, exporters, distributors and traders.
click here to find a list of Rifa suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Rifa DMF (Drug Master File) is a document detailing the whole manufacturing process of Rifa active pharmaceutical ingredient (API) in detail. Different forms of Rifa DMFs exist exist since differing nations have different regulations, such as Rifa USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Rifa DMF submitted to regulatory agencies in the US is known as a USDMF. Rifa USDMF includes data on Rifa's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Rifa USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Rifa 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 Rifa Drug Master File in Japan (Rifa JDMF) empowers Rifa 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 Rifa JDMF during the approval evaluation for pharmaceutical products. At the time of Rifa 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 Rifa 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 Rifa Drug Master File in Korea (Rifa KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Rifa. The MFDS reviews the Rifa KDMF as part of the drug registration process and uses the information provided in the Rifa KDMF to evaluate the safety and efficacy of the drug.
After submitting a Rifa 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 Rifa API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Rifa suppliers with KDMF on PharmaCompass.
A Rifa CEP of the European Pharmacopoeia monograph is often referred to as a Rifa Certificate of Suitability (COS). The purpose of a Rifa CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Rifa EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Rifa to their clients by showing that a Rifa CEP has been issued for it. The manufacturer submits a Rifa CEP (COS) as part of the market authorization procedure, and it takes on the role of a Rifa CEP holder for the record. Additionally, the data presented in the Rifa CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Rifa DMF.
A Rifa CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Rifa 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 Rifa suppliers with CEP (COS) on PharmaCompass.
A Rifa written confirmation (Rifa WC) is an official document issued by a regulatory agency to a Rifa manufacturer, verifying that the manufacturing facility of a Rifa active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Rifa APIs or Rifa finished pharmaceutical products to another nation, regulatory agencies frequently require a Rifa WC (written confirmation) as part of the regulatory process.
click here to find a list of Rifa 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 Rifa as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Rifa 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 Rifa 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 Rifa and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Rifa NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Rifa suppliers with NDC on PharmaCompass.
Rifa 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 Rifa 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 Rifa GMP manufacturer or Rifa GMP API supplier for your needs.
A Rifa CoA (Certificate of Analysis) is a formal document that attests to Rifa's compliance with Rifa specifications and serves as a tool for batch-level quality control.
Rifa CoA mostly includes findings from lab analyses of a specific batch. For each Rifa 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.
Rifa may be tested according to a variety of international standards, such as European Pharmacopoeia (Rifa EP), Rifa JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Rifa USP).