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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
47
PharmaCompass offers a list of Sildenafil Citrate 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 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.
PharmaCompass also assists you with knowing the Sildenafil Citrate API Price utilized in the formulation of products. Sildenafil Citrate API Price is not always fixed or binding as the Sildenafil Citrate Price is obtained through a variety of data sources. The Sildenafil Citrate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Viagra, Sildenafil citrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Viagra, Sildenafil citrate, including repackagers and relabelers. The FDA regulates Viagra, Sildenafil citrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Viagra, Sildenafil citrate 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 Viagra, Sildenafil citrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Viagra, Sildenafil citrate supplier is an individual or a company that provides Viagra, Sildenafil citrate active pharmaceutical ingredient (API) or Viagra, Sildenafil citrate finished formulations upon request. The Viagra, Sildenafil citrate suppliers may include Viagra, Sildenafil citrate API manufacturers, exporters, distributors and traders.
click here to find a list of Viagra, Sildenafil citrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Viagra, Sildenafil citrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Viagra, Sildenafil citrate active pharmaceutical ingredient (API) in detail. Different forms of Viagra, Sildenafil citrate DMFs exist exist since differing nations have different regulations, such as Viagra, Sildenafil citrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Viagra, Sildenafil citrate DMF submitted to regulatory agencies in the US is known as a USDMF. Viagra, Sildenafil citrate USDMF includes data on Viagra, Sildenafil citrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Viagra, Sildenafil citrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Viagra, Sildenafil citrate 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 Viagra, Sildenafil citrate Drug Master File in Japan (Viagra, Sildenafil citrate JDMF) empowers Viagra, Sildenafil citrate 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 Viagra, Sildenafil citrate JDMF during the approval evaluation for pharmaceutical products. At the time of Viagra, Sildenafil citrate 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 Viagra, Sildenafil citrate 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 Viagra, Sildenafil citrate Drug Master File in Korea (Viagra, Sildenafil citrate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Viagra, Sildenafil citrate. The MFDS reviews the Viagra, Sildenafil citrate KDMF as part of the drug registration process and uses the information provided in the Viagra, Sildenafil citrate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Viagra, Sildenafil citrate 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 Viagra, Sildenafil citrate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Viagra, Sildenafil citrate suppliers with KDMF on PharmaCompass.
A Viagra, Sildenafil citrate CEP of the European Pharmacopoeia monograph is often referred to as a Viagra, Sildenafil citrate Certificate of Suitability (COS). The purpose of a Viagra, Sildenafil citrate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Viagra, Sildenafil citrate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Viagra, Sildenafil citrate to their clients by showing that a Viagra, Sildenafil citrate CEP has been issued for it. The manufacturer submits a Viagra, Sildenafil citrate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Viagra, Sildenafil citrate CEP holder for the record. Additionally, the data presented in the Viagra, Sildenafil citrate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Viagra, Sildenafil citrate DMF.
A Viagra, Sildenafil citrate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Viagra, Sildenafil citrate 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 Viagra, Sildenafil citrate suppliers with CEP (COS) on PharmaCompass.
A Viagra, Sildenafil citrate written confirmation (Viagra, Sildenafil citrate WC) is an official document issued by a regulatory agency to a Viagra, Sildenafil citrate manufacturer, verifying that the manufacturing facility of a Viagra, Sildenafil citrate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Viagra, Sildenafil citrate APIs or Viagra, Sildenafil citrate finished pharmaceutical products to another nation, regulatory agencies frequently require a Viagra, Sildenafil citrate WC (written confirmation) as part of the regulatory process.
click here to find a list of Viagra, Sildenafil citrate 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 Viagra, Sildenafil citrate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Viagra, Sildenafil citrate 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 Viagra, Sildenafil citrate 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 Viagra, Sildenafil citrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Viagra, Sildenafil citrate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Viagra, Sildenafil citrate suppliers with NDC on PharmaCompass.
Viagra, Sildenafil citrate 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 Viagra, Sildenafil citrate 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 Viagra, Sildenafil citrate GMP manufacturer or Viagra, Sildenafil citrate GMP API supplier for your needs.
A Viagra, Sildenafil citrate CoA (Certificate of Analysis) is a formal document that attests to Viagra, Sildenafil citrate's compliance with Viagra, Sildenafil citrate specifications and serves as a tool for batch-level quality control.
Viagra, Sildenafil citrate CoA mostly includes findings from lab analyses of a specific batch. For each Viagra, Sildenafil citrate 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.
Viagra, Sildenafil citrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Viagra, Sildenafil citrate EP), Viagra, Sildenafil citrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Viagra, Sildenafil citrate USP).
