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API SUPPLIERS
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.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Emay Pharmaceuticals is a GMP-certified API manufacturing company.
Bioquim: An European GMP-certified company manufacturing bulk APIs, specializing in sterile lyophilization and chemical synthesis.
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
Together we can improve the quality of life
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
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USDMF
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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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 Monuril manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Monuril, including repackagers and relabelers. The FDA regulates Monuril manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Monuril 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 Monuril manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Monuril supplier is an individual or a company that provides Monuril active pharmaceutical ingredient (API) or Monuril finished formulations upon request. The Monuril suppliers may include Monuril API manufacturers, exporters, distributors and traders.
click here to find a list of Monuril suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Monuril DMF (Drug Master File) is a document detailing the whole manufacturing process of Monuril active pharmaceutical ingredient (API) in detail. Different forms of Monuril DMFs exist exist since differing nations have different regulations, such as Monuril USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Monuril DMF submitted to regulatory agencies in the US is known as a USDMF. Monuril USDMF includes data on Monuril's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Monuril USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Monuril 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 Monuril Drug Master File in Japan (Monuril JDMF) empowers Monuril 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 Monuril JDMF during the approval evaluation for pharmaceutical products. At the time of Monuril 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 Monuril 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 Monuril Drug Master File in Korea (Monuril KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Monuril. The MFDS reviews the Monuril KDMF as part of the drug registration process and uses the information provided in the Monuril KDMF to evaluate the safety and efficacy of the drug.
After submitting a Monuril 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 Monuril API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Monuril suppliers with KDMF on PharmaCompass.
A Monuril CEP of the European Pharmacopoeia monograph is often referred to as a Monuril Certificate of Suitability (COS). The purpose of a Monuril CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Monuril EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Monuril to their clients by showing that a Monuril CEP has been issued for it. The manufacturer submits a Monuril CEP (COS) as part of the market authorization procedure, and it takes on the role of a Monuril CEP holder for the record. Additionally, the data presented in the Monuril CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Monuril DMF.
A Monuril CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Monuril 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 Monuril 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 Monuril as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Monuril 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 Monuril 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 Monuril and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Monuril NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Monuril suppliers with NDC on PharmaCompass.
Monuril 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 Monuril 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 Monuril GMP manufacturer or Monuril GMP API supplier for your needs.
A Monuril CoA (Certificate of Analysis) is a formal document that attests to Monuril's compliance with Monuril specifications and serves as a tool for batch-level quality control.
Monuril CoA mostly includes findings from lab analyses of a specific batch. For each Monuril 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.
Monuril may be tested according to a variety of international standards, such as European Pharmacopoeia (Monuril EP), Monuril JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Monuril USP).
