Synopsis
DRUG PRODUCT COMPOSITIONS0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Australia
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
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**...DOSAGE - TABLET;ORAL - 250MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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**...DOSAGE - TABLET;ORAL - 500MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 - TABLET;ORAL - 500MG **Federal Regist...DOSAGE - TABLET;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50754
DOSAGE - TABLET;ORAL - 875MG **Federal Regist...DOSAGE - TABLET;ORAL - 875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50754
DOSAGE - FOR SUSPENSION;ORAL - 600MG/5ML;EQ 4...DOSAGE - FOR SUSPENSION;ORAL - 600MG/5ML;EQ 42.9MG BASE/5ML
USFDA APPLICATION NUMBER - 50755
DOSAGE - CAPSULE, TABLET, CAPSULE, DELAYED RE...DOSAGE - CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL - 500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50757
DOSAGE - FOR SUSPENSION;ORAL - 200MG/5ML **Fe...DOSAGE - FOR SUSPENSION;ORAL - 200MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50760
DOSAGE - FOR SUSPENSION;ORAL - 400MG/5ML
USFDA APPLICATION NUMBER - 50760
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1GM;...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 62.5MG BASE
USFDA APPLICATION NUMBER - 50785
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 775M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 775MG
USFDA APPLICATION NUMBER - 50813
DOSAGE - CAPSULE, TABLET, CAPSULE, DELAYED RE...DOSAGE - CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL - 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50824
Related Excipient Companies
Rochem International Inc
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]SPI Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharm-RX Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kirsch Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Dr. Paul Lohmann GmbH & Co. KGaA
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ACG Worldwide
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Actylis
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CD Formulation
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Corel Pharma Chem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DFE Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Esteem Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Finar
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ideal Cures
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ingredion Pharma Solutions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kerry
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Keval Exports
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kima Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Lonza Capsugel
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Microlex e.U
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Neelkanth MineChem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nitika Pharmaceutical Specialities
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nomisma Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Novo Excipients
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharmatrans-Sanaq
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pluviaendo
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Prachin Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qianhao Chemical (Hebei) Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qualicaps
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Roquette
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Seppic
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Sigachi Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Silverline Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]The Dow Chemical Company
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Coating Systems & Additives
Fillers, Diluents & Binders
Thickeners and Stabilizers
Controlled & Modified Release
Disintegrants & Superdisintegrants
Lubricants & Glidants
Direct Compression
Granulation
Topical
Co-Processed Excipients
Film Formers & Plasticizers
API Stability Enhancers
Solubilizers
Empty Capsules
Taste Masking
Emulsifying Agents
Chewable & Orodispersible Aids
Vegetarian Capsules
Rheology Modifiers
Coloring Agents
Parenteral
Digital Content
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
US Patents
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]REF. STANDARDS & IMPURITIES
USP
ANALYTICAL
Analytical Methods
ABOUT THIS PAGE
66
PharmaCompass offers a list of Amoxicillin Trihydrate 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 Amoxicillin Trihydrate manufacturer or Amoxicillin Trihydrate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Amoxicillin Trihydrate manufacturer or Amoxicillin Trihydrate supplier.
PharmaCompass also assists you with knowing the Amoxicillin Trihydrate API Price utilized in the formulation of products. Amoxicillin Trihydrate API Price is not always fixed or binding as the Amoxicillin Trihydrate Price is obtained through a variety of data sources. The Amoxicillin Trihydrate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Trimox manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Trimox, including repackagers and relabelers. The FDA regulates Trimox manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Trimox 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 Trimox manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Trimox supplier is an individual or a company that provides Trimox active pharmaceutical ingredient (API) or Trimox finished formulations upon request. The Trimox suppliers may include Trimox API manufacturers, exporters, distributors and traders.
click here to find a list of Trimox suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Trimox DMF (Drug Master File) is a document detailing the whole manufacturing process of Trimox active pharmaceutical ingredient (API) in detail. Different forms of Trimox DMFs exist exist since differing nations have different regulations, such as Trimox USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Trimox DMF submitted to regulatory agencies in the US is known as a USDMF. Trimox USDMF includes data on Trimox's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Trimox USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Trimox 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 Trimox Drug Master File in Japan (Trimox JDMF) empowers Trimox 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 Trimox JDMF during the approval evaluation for pharmaceutical products. At the time of Trimox 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 Trimox 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 Trimox Drug Master File in Korea (Trimox KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Trimox. The MFDS reviews the Trimox KDMF as part of the drug registration process and uses the information provided in the Trimox KDMF to evaluate the safety and efficacy of the drug.
After submitting a Trimox 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 Trimox API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Trimox suppliers with KDMF on PharmaCompass.
A Trimox CEP of the European Pharmacopoeia monograph is often referred to as a Trimox Certificate of Suitability (COS). The purpose of a Trimox CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Trimox EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Trimox to their clients by showing that a Trimox CEP has been issued for it. The manufacturer submits a Trimox CEP (COS) as part of the market authorization procedure, and it takes on the role of a Trimox CEP holder for the record. Additionally, the data presented in the Trimox CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Trimox DMF.
A Trimox CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Trimox 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 Trimox suppliers with CEP (COS) on PharmaCompass.
A Trimox written confirmation (Trimox WC) is an official document issued by a regulatory agency to a Trimox manufacturer, verifying that the manufacturing facility of a Trimox active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Trimox APIs or Trimox finished pharmaceutical products to another nation, regulatory agencies frequently require a Trimox WC (written confirmation) as part of the regulatory process.
click here to find a list of Trimox 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 Trimox as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Trimox 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 Trimox 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 Trimox and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Trimox NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Trimox suppliers with NDC on PharmaCompass.
Trimox 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 Trimox 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 Trimox GMP manufacturer or Trimox GMP API supplier for your needs.
A Trimox CoA (Certificate of Analysis) is a formal document that attests to Trimox's compliance with Trimox specifications and serves as a tool for batch-level quality control.
Trimox CoA mostly includes findings from lab analyses of a specific batch. For each Trimox 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.
Trimox may be tested according to a variety of international standards, such as European Pharmacopoeia (Trimox EP), Trimox JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Trimox USP).
