Synopsis
DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
Bioquim: An European GMP-certified company manufacturing bulk APIs, specializing in sterile lyophilization and chemical synthesis.
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USDMF
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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing APIs, including hard-to-find drug substances, for pharmaceutical and biotech industries. LGM also operates as a full-service drug product ...
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing...
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...
Bioquim: An European GMP-certified company manufacturing bulk APIs, specializing in sterile lyophilization and chemical synthesis.
About the Company : Bioquim is a European company specializing in bulk oral and sterile APIs for the pharmaceutical industry. With over 40 years of experience, the company supplies corticosteroids, pe...
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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**...DOSAGE - TABLET;ORAL - 250MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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**...DOSAGE - TABLET;ORAL - 500MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 - 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
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ABOUT THIS PAGE
53
PharmaCompass offers a list of Amoxicillin Trihydrate 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 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.
A Amoxicillin Trihydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Amoxicillin Trihydrate, including repackagers and relabelers. The FDA regulates Amoxicillin Trihydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Amoxicillin Trihydrate 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 Amoxicillin Trihydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Amoxicillin Trihydrate supplier is an individual or a company that provides Amoxicillin Trihydrate active pharmaceutical ingredient (API) or Amoxicillin Trihydrate finished formulations upon request. The Amoxicillin Trihydrate suppliers may include Amoxicillin Trihydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Amoxicillin Trihydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Amoxicillin Trihydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Amoxicillin Trihydrate active pharmaceutical ingredient (API) in detail. Different forms of Amoxicillin Trihydrate DMFs exist exist since differing nations have different regulations, such as Amoxicillin Trihydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Amoxicillin Trihydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Amoxicillin Trihydrate USDMF includes data on Amoxicillin Trihydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Amoxicillin Trihydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Amoxicillin Trihydrate 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 Amoxicillin Trihydrate Drug Master File in Japan (Amoxicillin Trihydrate JDMF) empowers Amoxicillin Trihydrate 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 Amoxicillin Trihydrate JDMF during the approval evaluation for pharmaceutical products. At the time of Amoxicillin Trihydrate 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 Amoxicillin Trihydrate 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 Amoxicillin Trihydrate Drug Master File in Korea (Amoxicillin Trihydrate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Amoxicillin Trihydrate. The MFDS reviews the Amoxicillin Trihydrate KDMF as part of the drug registration process and uses the information provided in the Amoxicillin Trihydrate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Amoxicillin Trihydrate 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 Amoxicillin Trihydrate API can apply through the Korea Drug Master File (KDMF).
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A Amoxicillin Trihydrate CEP of the European Pharmacopoeia monograph is often referred to as a Amoxicillin Trihydrate Certificate of Suitability (COS). The purpose of a Amoxicillin Trihydrate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Amoxicillin Trihydrate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Amoxicillin Trihydrate to their clients by showing that a Amoxicillin Trihydrate CEP has been issued for it. The manufacturer submits a Amoxicillin Trihydrate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Amoxicillin Trihydrate CEP holder for the record. Additionally, the data presented in the Amoxicillin Trihydrate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Amoxicillin Trihydrate DMF.
A Amoxicillin Trihydrate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Amoxicillin Trihydrate 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 Amoxicillin Trihydrate suppliers with CEP (COS) on PharmaCompass.
A Amoxicillin Trihydrate written confirmation (Amoxicillin Trihydrate WC) is an official document issued by a regulatory agency to a Amoxicillin Trihydrate manufacturer, verifying that the manufacturing facility of a Amoxicillin Trihydrate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Amoxicillin Trihydrate APIs or Amoxicillin Trihydrate finished pharmaceutical products to another nation, regulatory agencies frequently require a Amoxicillin Trihydrate WC (written confirmation) as part of the regulatory process.
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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 Amoxicillin Trihydrate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Amoxicillin Trihydrate 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 Amoxicillin Trihydrate 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 Amoxicillin Trihydrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Amoxicillin Trihydrate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Amoxicillin Trihydrate suppliers with NDC on PharmaCompass.
Amoxicillin Trihydrate 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 Amoxicillin Trihydrate GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Amoxicillin Trihydrate GMP manufacturer or Amoxicillin Trihydrate GMP API supplier for your needs.
A Amoxicillin Trihydrate CoA (Certificate of Analysis) is a formal document that attests to Amoxicillin Trihydrate's compliance with Amoxicillin Trihydrate specifications and serves as a tool for batch-level quality control.
Amoxicillin Trihydrate CoA mostly includes findings from lab analyses of a specific batch. For each Amoxicillin Trihydrate 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.
Amoxicillin Trihydrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Amoxicillin Trihydrate EP), Amoxicillin Trihydrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Amoxicillin Trihydrate USP).
