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Sumar Biotech work together to Innovate & Manufacture Semi-synthetic, Synthetic & Fermentation API.
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Bioquim: An European GMP-certified company manufacturing bulk APIs, specializing in sterile lyophilization and chemical synthesis.
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Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
GDUFA
DMF Review : Complete
Rev. Date : 2024-11-21
Pay. Date : 2024-10-18
DMF Number : 40335
Submission : 2024-09-27
Status :
Type : II
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Sumar Biotech work together to Innovate & Manufacture Semi-synthetic, Synthetic & Fermentation API.
About the Company : Sumar Biotech LLP, registered in January 2018, is a startup approved by the Gujarat State Biotechnology Mission. It was founded by emerging entrepreneurs and a team of young yet ex...
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
About the Company : Octavius Pharma is a global leader in Directly Compressible Granules with over 45 years of expertise in formulation development, manufacturing, and commercialization. Our portfolio...
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 & sterile APIs for the pharmaceutical industry. With over 40 years of experience, we offer high-quality corticosteroids, pep...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
About the Company : Honour is a leading global CDMO and a trusted manufacturer of specialty chemicals and ingredients. With seven world-class facilities built to meet global safety and quality standar...
Together we can improve the quality of life
About the Company : Shamrock Pharmachemi Pvt Ltd. is a globally recognized API leader with over 26 years of expertise in human and veterinary pharmaceuticals. Operating in 40+ countries, we own two st...
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PharmaCompass offers a list of Fosfomycin Trometamol 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 Fosfomycin Trometamol manufacturer or Fosfomycin Trometamol supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Fosfomycin Trometamol manufacturer or Fosfomycin Trometamol supplier.
PharmaCompass also assists you with knowing the Fosfomycin Trometamol API Price utilized in the formulation of products. Fosfomycin Trometamol API Price is not always fixed or binding as the Fosfomycin Trometamol Price is obtained through a variety of data sources. The Fosfomycin Trometamol Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Fosfomycin Tromethamine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fosfomycin Tromethamine, including repackagers and relabelers. The FDA regulates Fosfomycin Tromethamine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fosfomycin Tromethamine 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 Fosfomycin Tromethamine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fosfomycin Tromethamine supplier is an individual or a company that provides Fosfomycin Tromethamine active pharmaceutical ingredient (API) or Fosfomycin Tromethamine finished formulations upon request. The Fosfomycin Tromethamine suppliers may include Fosfomycin Tromethamine API manufacturers, exporters, distributors and traders.
click here to find a list of Fosfomycin Tromethamine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fosfomycin Tromethamine DMF (Drug Master File) is a document detailing the whole manufacturing process of Fosfomycin Tromethamine active pharmaceutical ingredient (API) in detail. Different forms of Fosfomycin Tromethamine DMFs exist exist since differing nations have different regulations, such as Fosfomycin Tromethamine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fosfomycin Tromethamine DMF submitted to regulatory agencies in the US is known as a USDMF. Fosfomycin Tromethamine USDMF includes data on Fosfomycin Tromethamine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fosfomycin Tromethamine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fosfomycin Tromethamine 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 Fosfomycin Tromethamine Drug Master File in Japan (Fosfomycin Tromethamine JDMF) empowers Fosfomycin Tromethamine 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 Fosfomycin Tromethamine JDMF during the approval evaluation for pharmaceutical products. At the time of Fosfomycin Tromethamine 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 Fosfomycin Tromethamine 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 Fosfomycin Tromethamine Drug Master File in Korea (Fosfomycin Tromethamine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Fosfomycin Tromethamine. The MFDS reviews the Fosfomycin Tromethamine KDMF as part of the drug registration process and uses the information provided in the Fosfomycin Tromethamine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Fosfomycin Tromethamine 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 Fosfomycin Tromethamine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Fosfomycin Tromethamine suppliers with KDMF on PharmaCompass.
A Fosfomycin Tromethamine CEP of the European Pharmacopoeia monograph is often referred to as a Fosfomycin Tromethamine Certificate of Suitability (COS). The purpose of a Fosfomycin Tromethamine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Fosfomycin Tromethamine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Fosfomycin Tromethamine to their clients by showing that a Fosfomycin Tromethamine CEP has been issued for it. The manufacturer submits a Fosfomycin Tromethamine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Fosfomycin Tromethamine CEP holder for the record. Additionally, the data presented in the Fosfomycin Tromethamine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Fosfomycin Tromethamine DMF.
A Fosfomycin Tromethamine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Fosfomycin Tromethamine 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 Fosfomycin Tromethamine suppliers with CEP (COS) on PharmaCompass.
A Fosfomycin Tromethamine written confirmation (Fosfomycin Tromethamine WC) is an official document issued by a regulatory agency to a Fosfomycin Tromethamine manufacturer, verifying that the manufacturing facility of a Fosfomycin Tromethamine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Fosfomycin Tromethamine APIs or Fosfomycin Tromethamine finished pharmaceutical products to another nation, regulatory agencies frequently require a Fosfomycin Tromethamine WC (written confirmation) as part of the regulatory process.
click here to find a list of Fosfomycin Tromethamine 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 Fosfomycin Tromethamine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Fosfomycin Tromethamine 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 Fosfomycin Tromethamine 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 Fosfomycin Tromethamine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Fosfomycin Tromethamine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Fosfomycin Tromethamine suppliers with NDC on PharmaCompass.
Fosfomycin Tromethamine 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 Fosfomycin Tromethamine 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 Fosfomycin Tromethamine GMP manufacturer or Fosfomycin Tromethamine GMP API supplier for your needs.
A Fosfomycin Tromethamine CoA (Certificate of Analysis) is a formal document that attests to Fosfomycin Tromethamine's compliance with Fosfomycin Tromethamine specifications and serves as a tool for batch-level quality control.
Fosfomycin Tromethamine CoA mostly includes findings from lab analyses of a specific batch. For each Fosfomycin Tromethamine 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.
Fosfomycin Tromethamine may be tested according to a variety of international standards, such as European Pharmacopoeia (Fosfomycin Tromethamine EP), Fosfomycin Tromethamine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Fosfomycin Tromethamine USP).
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