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API SUPPLIERS
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USDMF
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Towa International works to research, develop, manufacture, and market, generic and value-added medicines to patients around the world.
Regulatory Info :
Registration Country : Italy
Brand Name : CEFTRIAXONE THINKS
Dosage Form : Powder And Solvent For Injection
Dosage Strength : 1 g/3.5 ml
Packaging : 1 UNIT 1000 MG - PARENTERAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
Parenteral
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REF. STANDARDS & IMPURITIES
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ABOUT THIS PAGE
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PharmaCompass offers a list of Ceftriaxone API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Ceftriaxone manufacturer or Ceftriaxone supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ceftriaxone manufacturer or Ceftriaxone supplier.
A Terbac manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Terbac, including repackagers and relabelers. The FDA regulates Terbac manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Terbac 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 Terbac manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Terbac supplier is an individual or a company that provides Terbac active pharmaceutical ingredient (API) or Terbac finished formulations upon request. The Terbac suppliers may include Terbac API manufacturers, exporters, distributors and traders.
click here to find a list of Terbac suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Terbac DMF (Drug Master File) is a document detailing the whole manufacturing process of Terbac active pharmaceutical ingredient (API) in detail. Different forms of Terbac DMFs exist exist since differing nations have different regulations, such as Terbac USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Terbac DMF submitted to regulatory agencies in the US is known as a USDMF. Terbac USDMF includes data on Terbac's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Terbac USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Terbac 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 Terbac Drug Master File in Japan (Terbac JDMF) empowers Terbac 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 Terbac JDMF during the approval evaluation for pharmaceutical products. At the time of Terbac 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 Terbac 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 Terbac Drug Master File in Korea (Terbac KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Terbac. The MFDS reviews the Terbac KDMF as part of the drug registration process and uses the information provided in the Terbac KDMF to evaluate the safety and efficacy of the drug.
After submitting a Terbac 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 Terbac API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Terbac suppliers with KDMF on PharmaCompass.
A Terbac CEP of the European Pharmacopoeia monograph is often referred to as a Terbac Certificate of Suitability (COS). The purpose of a Terbac CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Terbac EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Terbac to their clients by showing that a Terbac CEP has been issued for it. The manufacturer submits a Terbac CEP (COS) as part of the market authorization procedure, and it takes on the role of a Terbac CEP holder for the record. Additionally, the data presented in the Terbac CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Terbac DMF.
A Terbac CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Terbac 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 Terbac suppliers with CEP (COS) on PharmaCompass.
A Terbac written confirmation (Terbac WC) is an official document issued by a regulatory agency to a Terbac manufacturer, verifying that the manufacturing facility of a Terbac active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Terbac APIs or Terbac finished pharmaceutical products to another nation, regulatory agencies frequently require a Terbac WC (written confirmation) as part of the regulatory process.
click here to find a list of Terbac 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 Terbac as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Terbac 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 Terbac 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 Terbac and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Terbac NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Terbac suppliers with NDC on PharmaCompass.
Terbac 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 Terbac GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Terbac GMP manufacturer or Terbac GMP API supplier for your needs.
A Terbac CoA (Certificate of Analysis) is a formal document that attests to Terbac's compliance with Terbac specifications and serves as a tool for batch-level quality control.
Terbac CoA mostly includes findings from lab analyses of a specific batch. For each Terbac 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.
Terbac may be tested according to a variety of international standards, such as European Pharmacopoeia (Terbac EP), Terbac JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Terbac USP).
