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API SUPPLIERS
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
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NDC
ASMF
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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USDMF
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-12
Pay. Date : 2013-01-22
DMF Number : 13383
Submission : 1998-09-01
Status :
Type : II
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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Sweden
Brand Name : Rifadin
Dosage Form : ORAL SUSPENSION
Dosage Strength : 20 MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Sweden
Brand Name : Rifadin
Dosage Form : PULVER OCH VÄTSKA TILL INFUSIONSVÄTSKA
Dosage Strength : 600 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
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.
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 :
Registration Country : Switzerland
Brand Name : Rifinah 150
Dosage Form : Drag
Dosage Strength : 150/100
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Rifampicinum; Isoniazidum; Pyrazinamidum
Brand Name : Rifater
Dosage Form : Drag
Dosage Strength : 50mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Australia
Brand Name : Rifadin
Dosage Form : oral
Dosage Strength : 100 mg/5 mL
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
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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
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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.
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.
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
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Rochem International Inc
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Dosage Form : Capsule
Grade : Topical, Oral
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Dosage Form : Cream / Lotion / Ointment
Grade : Topical, Oral
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ABOUT THIS PAGE
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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 Rifinah manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rifinah, including repackagers and relabelers. The FDA regulates Rifinah manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rifinah 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 Rifinah manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Rifinah supplier is an individual or a company that provides Rifinah active pharmaceutical ingredient (API) or Rifinah finished formulations upon request. The Rifinah suppliers may include Rifinah API manufacturers, exporters, distributors and traders.
click here to find a list of Rifinah suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Rifinah DMF (Drug Master File) is a document detailing the whole manufacturing process of Rifinah active pharmaceutical ingredient (API) in detail. Different forms of Rifinah DMFs exist exist since differing nations have different regulations, such as Rifinah USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Rifinah DMF submitted to regulatory agencies in the US is known as a USDMF. Rifinah USDMF includes data on Rifinah's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Rifinah USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Rifinah 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 Rifinah Drug Master File in Japan (Rifinah JDMF) empowers Rifinah 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 Rifinah JDMF during the approval evaluation for pharmaceutical products. At the time of Rifinah 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 Rifinah 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 Rifinah Drug Master File in Korea (Rifinah KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Rifinah. The MFDS reviews the Rifinah KDMF as part of the drug registration process and uses the information provided in the Rifinah KDMF to evaluate the safety and efficacy of the drug.
After submitting a Rifinah 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 Rifinah API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Rifinah suppliers with KDMF on PharmaCompass.
A Rifinah CEP of the European Pharmacopoeia monograph is often referred to as a Rifinah Certificate of Suitability (COS). The purpose of a Rifinah CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Rifinah EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Rifinah to their clients by showing that a Rifinah CEP has been issued for it. The manufacturer submits a Rifinah CEP (COS) as part of the market authorization procedure, and it takes on the role of a Rifinah CEP holder for the record. Additionally, the data presented in the Rifinah CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Rifinah DMF.
A Rifinah CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Rifinah 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 Rifinah suppliers with CEP (COS) on PharmaCompass.
A Rifinah written confirmation (Rifinah WC) is an official document issued by a regulatory agency to a Rifinah manufacturer, verifying that the manufacturing facility of a Rifinah active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Rifinah APIs or Rifinah finished pharmaceutical products to another nation, regulatory agencies frequently require a Rifinah WC (written confirmation) as part of the regulatory process.
click here to find a list of Rifinah 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 Rifinah as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Rifinah 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 Rifinah 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 Rifinah and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Rifinah NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Rifinah suppliers with NDC on PharmaCompass.
Rifinah 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 Rifinah 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 Rifinah GMP manufacturer or Rifinah GMP API supplier for your needs.
A Rifinah CoA (Certificate of Analysis) is a formal document that attests to Rifinah's compliance with Rifinah specifications and serves as a tool for batch-level quality control.
Rifinah CoA mostly includes findings from lab analyses of a specific batch. For each Rifinah 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.
Rifinah may be tested according to a variety of international standards, such as European Pharmacopoeia (Rifinah EP), Rifinah JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Rifinah USP).
