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