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API SUPPLIERS
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USDMF
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DOSAGE - FOR SUSPENSION;ORAL - EQ 10MG BASE/M...DOSAGE - FOR SUSPENSION;ORAL - EQ 10MG BASE/ML
USFDA APPLICATION NUMBER - 203109
DOSAGE - TABLET;ORAL - EQ 100MG BASE
USFDA APPLICATION NUMBER - 20895
DOSAGE - TABLET;ORAL - EQ 25MG BASE
USFDA APPLICATION NUMBER - 20895
DOSAGE - TABLET;ORAL - EQ 50MG BASE
USFDA APPLICATION NUMBER - 20895
DOSAGE - TABLET;ORAL - EQ 20MG BASE
USFDA APPLICATION NUMBER - 21845
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ANALYTICAL
ABOUT THIS PAGE
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PharmaCompass offers a list of Sildenafil Citrate 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 Sildenafil Citrate manufacturer or Sildenafil Citrate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sildenafil Citrate manufacturer or Sildenafil Citrate supplier.
A Duromist manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Duromist, including repackagers and relabelers. The FDA regulates Duromist manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Duromist 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 Duromist manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Duromist supplier is an individual or a company that provides Duromist active pharmaceutical ingredient (API) or Duromist finished formulations upon request. The Duromist suppliers may include Duromist API manufacturers, exporters, distributors and traders.
click here to find a list of Duromist suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Duromist DMF (Drug Master File) is a document detailing the whole manufacturing process of Duromist active pharmaceutical ingredient (API) in detail. Different forms of Duromist DMFs exist exist since differing nations have different regulations, such as Duromist USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Duromist DMF submitted to regulatory agencies in the US is known as a USDMF. Duromist USDMF includes data on Duromist's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Duromist USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Duromist 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 Duromist Drug Master File in Japan (Duromist JDMF) empowers Duromist 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 Duromist JDMF during the approval evaluation for pharmaceutical products. At the time of Duromist 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 Duromist 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 Duromist Drug Master File in Korea (Duromist KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Duromist. The MFDS reviews the Duromist KDMF as part of the drug registration process and uses the information provided in the Duromist KDMF to evaluate the safety and efficacy of the drug.
After submitting a Duromist 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 Duromist API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Duromist suppliers with KDMF on PharmaCompass.
A Duromist CEP of the European Pharmacopoeia monograph is often referred to as a Duromist Certificate of Suitability (COS). The purpose of a Duromist CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Duromist EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Duromist to their clients by showing that a Duromist CEP has been issued for it. The manufacturer submits a Duromist CEP (COS) as part of the market authorization procedure, and it takes on the role of a Duromist CEP holder for the record. Additionally, the data presented in the Duromist CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Duromist DMF.
A Duromist CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Duromist 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 Duromist suppliers with CEP (COS) on PharmaCompass.
A Duromist written confirmation (Duromist WC) is an official document issued by a regulatory agency to a Duromist manufacturer, verifying that the manufacturing facility of a Duromist active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Duromist APIs or Duromist finished pharmaceutical products to another nation, regulatory agencies frequently require a Duromist WC (written confirmation) as part of the regulatory process.
click here to find a list of Duromist 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 Duromist as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Duromist 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 Duromist 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 Duromist and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Duromist NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Duromist suppliers with NDC on PharmaCompass.
Duromist 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 Duromist GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Duromist GMP manufacturer or Duromist GMP API supplier for your needs.
A Duromist CoA (Certificate of Analysis) is a formal document that attests to Duromist's compliance with Duromist specifications and serves as a tool for batch-level quality control.
Duromist CoA mostly includes findings from lab analyses of a specific batch. For each Duromist 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.
Duromist may be tested according to a variety of international standards, such as European Pharmacopoeia (Duromist EP), Duromist JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Duromist USP).
