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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 |

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API Imports and Exports
| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
|---|
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Details:
Sotagliflozin is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Diabetes Mellitus.
Lead Product(s): Sotagliflozin,Rifampicin
Therapeutic Area: Endocrinology Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 24, 2017
Lead Product(s) : Sotagliflozin,Rifampicin
Therapeutic Area : Endocrinology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Effect of Rifampicin on the Pharmacokinetics and Pharmacodynamics of Sotagliflozin
Details : Sotagliflozin is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Diabetes Mellitus.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
February 24, 2017
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Details:
Venetoclax is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Lymphoma, Non-Hodgkin.
Lead Product(s): Venetoclax,Rifampicin
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Genentech
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 25, 2013
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Lead Product(s) : Venetoclax,Rifampicin
Therapeutic Area : Oncology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Genentech
Deal Size : Inapplicable
Deal Type : Inapplicable
A Study to Assess the Effect of Rifampin on the Metabolism of ABT-199
Details : Venetoclax is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Lymphoma, Non-Hodgkin.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
October 25, 2013
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Details:
Navitoclax is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Leukemia, Lymphoid.
Lead Product(s): Navitoclax,Rifampicin
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 12, 2010
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Lead Product(s) : Navitoclax,Rifampicin
Therapeutic Area : Oncology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
A Study to Assess the Effect of Rifampin on the Metabolism of Navitoclax
Details : Navitoclax is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Leukemia, Lymphoid.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
May 12, 2010
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Details:
BMS-986365 is a PROTACs drug candidate, which is currently being evaluated in Phase I clinical studies for the treatment of undefined medical condition.
Lead Product(s): BMS-986365,Itraconazole,Rifampicin
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IProduct Type: PROTACs
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 21, 2025

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Lead Product(s) : BMS-986365,Itraconazole,Rifampicin
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : BMS-986365 is a PROTACs drug candidate, which is currently being evaluated in Phase I clinical studies for the treatment of undefined medical condition.
Product Name : Undisclosed
Product Type : PROTACs
Upfront Cash : Inapplicable
November 21, 2025

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Details:
Contezolid is a 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,Ethambutol,Rifampicin
Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Miscellaneous
Sponsor: Bin Cao | Shanghai Pulmonary Hospital | Beijing Chest Hospital | Anhui Chest Hospital | Jiangxi Chest Hospital | Guangzhou Chest Hospital.
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 09, 2025

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Lead Product(s) : Contezolid,Azithromycin,Ethambutol,Rifampicin
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Bin Cao | Shanghai Pulmonary Hospital | Beijing Chest Hospital | Anhui Chest Hospital | Jiangxi Chest Hospital | Guangzhou Chest Hospital.
Deal Size : Inapplicable
Deal Type : Inapplicable
Short-term Antibiotic Therapy in Mycobacterium Avium Complex Pulmonary Disease
Details : Contezolid is a 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
October 09, 2025

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Details:
Elutia will leverage its proven drug-eluting biologics platform with a more concentrated focus on advancing NXT-41x, a biomatrix that directly addresses the root causes of reconstruction infections.
Lead Product(s): Rifampicin,Minocycline Hydrochloride
Therapeutic Area: Infections and Infectious Diseases Brand Name: EluPro
Study Phase: Approved FDFProduct Type: Antibiotic
Sponsor: Boston Scientific
Deal Size: $88.0 million Upfront Cash: $88.0 million
Deal Type: Divestment October 01, 2025

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Lead Product(s) : Rifampicin,Minocycline Hydrochloride
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Boston Scientific
Deal Size : $88.0 million
Deal Type : Divestment
Elutia Announces Closing of BioEnvelope Business Sale to Boston Scientific
Details : Elutia will leverage its proven drug-eluting biologics platform with a more concentrated focus on advancing NXT-41x, a biomatrix that directly addresses the root causes of reconstruction infections.
Product Name : EluPro
Product Type : Antibiotic
Upfront Cash : $88.0 million
October 01, 2025

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

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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

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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

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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

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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

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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

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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

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Global Sales Information
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
RX/OTC/DISCN : Class A
Isoniazid; Pyrazinamide; Rifampicin
Dosage Form : Isoniazid+Pyrazinamide+Rifampici...
Dosage Strength : 40 cpr riv 50 mg + 300mg + 120 mg
Price Per Pack (Euro) : 10.57
Published in :
Country : Italy
RX/OTC/DISCN : Class A
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
RX/OTC/DISCN : Class A
Dosage Form : Rifampicin 2% 60Ml Oral Use
Dosage Strength : 1 bottle 60 ml 20 mg/ml syrup
Price Per Pack (Euro) : 2.8
Published in :
Country : Italy
RX/OTC/DISCN : Class A
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
RX/OTC/DISCN : Class A
Dosage Form : Rifampicin 300Mg 8 Joined' Oral ...
Dosage Strength : 8 cps 300 mg
Price Per Pack (Euro) : 3.72
Published in :
Country : Italy
RX/OTC/DISCN : Class A
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
RX/OTC/DISCN : Class A
Dosage Form : Rifampicin 450Mg 8 Joined' Oral ...
Dosage Strength : 8 cpr riv 450 mg
Price Per Pack (Euro) : 4.86
Published in :
Country : Italy
RX/OTC/DISCN : Class A
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
RX/OTC/DISCN : Class A
Dosage Form : Rifampicin 600Mg 1 Unit Parenter...
Dosage Strength : 1 ampoule EV 600 mg + 1 ampoule solv 10 ml
Price Per Pack (Euro) : 9.28
Published in :
Country : Italy
RX/OTC/DISCN : Class A
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
RX/OTC/DISCN : Class A
Dosage Form : Rifampicin+Isoniazid+150300 Mg 2...
Dosage Strength : 24 cpr riv 300 mg + 150 mg
Price Per Pack (Euro) : 9.48
Published in :
Country : Italy
RX/OTC/DISCN : Class A
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 150 mg/75 mg/400 mg
Price Per Pack (Euro) : 49.302
Published in :
Country : Norway
RX/OTC/DISCN :

Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 150 mg/75 mg/400 mg/275 mg
Price Per Pack (Euro) : 73.106
Published in :
Country : Norway
RX/OTC/DISCN :

Dosage Form : Capsule, hard
Dosage Strength : 150 mg
Price Per Pack (Euro) : 56.694
Published in :
Country : Norway
RX/OTC/DISCN :

Dosage Form : Capsule, hard
Dosage Strength : 150 mg
Price Per Pack (Euro) : 56.694
Published in :
Country : Norway
RX/OTC/DISCN :

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REF. STANDARDS & IMPURITIES
CAS Number : 13983-13-6
Quantity Per Vial : 100 mg
Sale Unit : 1
Order Code : R0800000
Batch No : 4
Price (€) : 79
Storage : +5°C ± 3°C

CAS Number : 13292-46-1
Quantity Per Vial : 100 mg
Sale Unit : 1
Order Code : R0700000
Batch No : 2
Price (€) : 79
Storage : +5°C ± 3°C

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Sigma-Aldrich empowers scientific discovery with top-quality solutions to accelerate research, innovation, and better health worldwide.
CAS Number : 13292-46-1
Quantity Per Vial :
Sale Unit :
Price : $310.00
Details :
Monograph : PHR1806-500MG
Storage : +2°C to +8°C
Code/Batch No :
Sigma-Aldrich empowers scientific discovery with top-quality solutions to accelerate research, innovation, and better health worldwide.
CAS Number : 14897-39-3
Quantity Per Vial :
Sale Unit :
Price : $159.00
Details :
Monograph : PHR1664-500MG
Storage : -10°C to -25°C
Code/Batch No :
CAS Number :
Quantity Per Vial :
Sale Unit :
Price : $310.00
Details :
Monograph : PHR1806-500MG
Storage : +2?C to +8?C
Code/Batch No :

CAS Number : 17555-51-0
Quantity Per Vial :
Sale Unit :
Price :
Details : In stock
Monograph :
Storage :
Code/Batch No : R0012.10

Rifampin Quinone (25 mg) (1,4-dideoxy-1,4- di...
CAS Number : 13983-13-6
Quantity Per Vial : 25
Sale Unit : mg
Price : $775.00
Details : Material Origin- Chemical Synthesis; USMCA- N...
Monograph :
Storage :
Code/Batch No : Catalog #1604202 / R109W 0

CAS Number : 13292-46-1
Quantity Per Vial : 300
Sale Unit : mg
Price : $245.00
Details : Material Origin- Fermentation- Chemical Synth...
Monograph :
Storage :
Code/Batch No : Catalog #1604009 / R124W 0

CAS Number : 125833-03-6
Quantity Per Vial : 25
Sale Unit : mg
Price : $630.00
Details : Material Origin- Fermentation- Chemical Synth...
Monograph :
Storage :
Code/Batch No : Catalog #1604199 / F120C0

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
96
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 Rifampicin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rifampicin, including repackagers and relabelers. The FDA regulates Rifampicin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rifampicin 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 Rifampicin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Rifampicin supplier is an individual or a company that provides Rifampicin active pharmaceutical ingredient (API) or Rifampicin finished formulations upon request. The Rifampicin suppliers may include Rifampicin API manufacturers, exporters, distributors and traders.
click here to find a list of Rifampicin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Rifampicin DMF (Drug Master File) is a document detailing the whole manufacturing process of Rifampicin active pharmaceutical ingredient (API) in detail. Different forms of Rifampicin DMFs exist exist since differing nations have different regulations, such as Rifampicin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Rifampicin DMF submitted to regulatory agencies in the US is known as a USDMF. Rifampicin USDMF includes data on Rifampicin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Rifampicin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Rifampicin 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 Rifampicin Drug Master File in Japan (Rifampicin JDMF) empowers Rifampicin 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 Rifampicin JDMF during the approval evaluation for pharmaceutical products. At the time of Rifampicin 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 Rifampicin 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 Rifampicin Drug Master File in Korea (Rifampicin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Rifampicin. The MFDS reviews the Rifampicin KDMF as part of the drug registration process and uses the information provided in the Rifampicin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Rifampicin 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 Rifampicin API can apply through the Korea Drug Master File (KDMF).
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A Rifampicin CEP of the European Pharmacopoeia monograph is often referred to as a Rifampicin Certificate of Suitability (COS). The purpose of a Rifampicin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Rifampicin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Rifampicin to their clients by showing that a Rifampicin CEP has been issued for it. The manufacturer submits a Rifampicin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Rifampicin CEP holder for the record. Additionally, the data presented in the Rifampicin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Rifampicin DMF.
A Rifampicin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Rifampicin 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 Rifampicin suppliers with CEP (COS) on PharmaCompass.
A Rifampicin written confirmation (Rifampicin WC) is an official document issued by a regulatory agency to a Rifampicin manufacturer, verifying that the manufacturing facility of a Rifampicin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Rifampicin APIs or Rifampicin finished pharmaceutical products to another nation, regulatory agencies frequently require a Rifampicin WC (written confirmation) as part of the regulatory process.
click here to find a list of Rifampicin 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 Rifampicin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Rifampicin 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 Rifampicin 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 Rifampicin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Rifampicin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Rifampicin suppliers with NDC on PharmaCompass.
Rifampicin 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 Rifampicin 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 Rifampicin GMP manufacturer or Rifampicin GMP API supplier for your needs.
A Rifampicin CoA (Certificate of Analysis) is a formal document that attests to Rifampicin's compliance with Rifampicin specifications and serves as a tool for batch-level quality control.
Rifampicin CoA mostly includes findings from lab analyses of a specific batch. For each Rifampicin 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.
Rifampicin may be tested according to a variety of international standards, such as European Pharmacopoeia (Rifampicin EP), Rifampicin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Rifampicin USP).