Synopsis
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JDMF
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EU WC
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VMF
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Canada
DRUG PRODUCT COMPOSITIONS0
Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
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USDMF
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DOSAGE - TABLET;ORAL - 250MG;EQ 125MG BASE **...DOSAGE - TABLET;ORAL - 250MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50564
DOSAGE - TABLET;ORAL - 500MG;EQ 125MG BASE **...DOSAGE - TABLET;ORAL - 500MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50564
DOSAGE - FOR SUSPENSION;ORAL - 125MG/5ML;EQ 3...DOSAGE - FOR SUSPENSION;ORAL - 125MG/5ML;EQ 31.25MG BASE/5ML
USFDA APPLICATION NUMBER - 50575
DOSAGE - FOR SUSPENSION;ORAL - 250MG/5ML;EQ 6...DOSAGE - FOR SUSPENSION;ORAL - 250MG/5ML;EQ 62.5MG BASE/5ML
USFDA APPLICATION NUMBER - 50575
DOSAGE - TABLET;ORAL - 875MG;EQ 125MG BASE
USFDA APPLICATION NUMBER - 50720
DOSAGE - FOR SUSPENSION;ORAL - 200MG/5ML;EQ 2...DOSAGE - FOR SUSPENSION;ORAL - 200MG/5ML;EQ 28.5MG BASE/5ML
USFDA APPLICATION NUMBER - 50725
DOSAGE - FOR SUSPENSION;ORAL - 400MG/5ML;EQ 5...DOSAGE - FOR SUSPENSION;ORAL - 400MG/5ML;EQ 57MG BASE/5ML
USFDA APPLICATION NUMBER - 50725
DOSAGE - FOR SUSPENSION;ORAL - 600MG/5ML;EQ 4...DOSAGE - FOR SUSPENSION;ORAL - 600MG/5ML;EQ 42.9MG BASE/5ML
USFDA APPLICATION NUMBER - 50755
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1GM;...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 62.5MG BASE
USFDA APPLICATION NUMBER - 50785
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Coating Systems & Additives
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Clavulanic Acid 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 Clavulanic Acid manufacturer or Clavulanic Acid supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Clavulanic Acid manufacturer or Clavulanic Acid supplier.
PharmaCompass also assists you with knowing the Clavulanic Acid API Price utilized in the formulation of products. Clavulanic Acid API Price is not always fixed or binding as the Clavulanic Acid Price is obtained through a variety of data sources. The Clavulanic Acid Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A TIMENTIN manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of TIMENTIN, including repackagers and relabelers. The FDA regulates TIMENTIN manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. TIMENTIN 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 TIMENTIN manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A TIMENTIN supplier is an individual or a company that provides TIMENTIN active pharmaceutical ingredient (API) or TIMENTIN finished formulations upon request. The TIMENTIN suppliers may include TIMENTIN API manufacturers, exporters, distributors and traders.
click here to find a list of TIMENTIN suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A TIMENTIN DMF (Drug Master File) is a document detailing the whole manufacturing process of TIMENTIN active pharmaceutical ingredient (API) in detail. Different forms of TIMENTIN DMFs exist exist since differing nations have different regulations, such as TIMENTIN USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A TIMENTIN DMF submitted to regulatory agencies in the US is known as a USDMF. TIMENTIN USDMF includes data on TIMENTIN's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The TIMENTIN USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of TIMENTIN suppliers with USDMF 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 TIMENTIN Drug Master File in Korea (TIMENTIN KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of TIMENTIN. The MFDS reviews the TIMENTIN KDMF as part of the drug registration process and uses the information provided in the TIMENTIN KDMF to evaluate the safety and efficacy of the drug.
After submitting a TIMENTIN 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 TIMENTIN API can apply through the Korea Drug Master File (KDMF).
click here to find a list of TIMENTIN suppliers with KDMF on PharmaCompass.
A TIMENTIN CEP of the European Pharmacopoeia monograph is often referred to as a TIMENTIN Certificate of Suitability (COS). The purpose of a TIMENTIN CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of TIMENTIN EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of TIMENTIN to their clients by showing that a TIMENTIN CEP has been issued for it. The manufacturer submits a TIMENTIN CEP (COS) as part of the market authorization procedure, and it takes on the role of a TIMENTIN CEP holder for the record. Additionally, the data presented in the TIMENTIN CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the TIMENTIN DMF.
A TIMENTIN CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. TIMENTIN 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 TIMENTIN suppliers with CEP (COS) 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 TIMENTIN as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for TIMENTIN 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 TIMENTIN 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 TIMENTIN and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a TIMENTIN NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of TIMENTIN suppliers with NDC on PharmaCompass.
TIMENTIN 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 TIMENTIN 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 TIMENTIN GMP manufacturer or TIMENTIN GMP API supplier for your needs.
A TIMENTIN CoA (Certificate of Analysis) is a formal document that attests to TIMENTIN's compliance with TIMENTIN specifications and serves as a tool for batch-level quality control.
TIMENTIN CoA mostly includes findings from lab analyses of a specific batch. For each TIMENTIN 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.
TIMENTIN may be tested according to a variety of international standards, such as European Pharmacopoeia (TIMENTIN EP), TIMENTIN JP (Japanese Pharmacopeia) and the US Pharmacopoeia (TIMENTIN USP).
