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VMF
DRUG PRODUCT COMPOSITIONS0
Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
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USDMF
European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.
GDUFA
DMF Review : Complete
Rev. Date : 2016-08-11
Pay. Date : 2016-06-13
DMF Number : 23930
Submission : 2010-06-29
Status :
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2017-12-29
Pay. Date : 2017-12-11
DMF Number : 17778
Submission : 2004-10-25
Status :
Type : II
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] JDMF
European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.
Registration Number : 225MF10011
Registrant's Address : 19 Pellinska Str. 83-200 Starogard Gdanski POLAND
Initial Date of Registration : 2013-01-30
Latest Date of Registration : 2020-12-23
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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 Wan Ai Ke manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Wan Ai Ke, including repackagers and relabelers. The FDA regulates Wan Ai Ke manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Wan Ai Ke 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 Wan Ai Ke manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Wan Ai Ke supplier is an individual or a company that provides Wan Ai Ke active pharmaceutical ingredient (API) or Wan Ai Ke finished formulations upon request. The Wan Ai Ke suppliers may include Wan Ai Ke API manufacturers, exporters, distributors and traders.
click here to find a list of Wan Ai Ke suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Wan Ai Ke DMF (Drug Master File) is a document detailing the whole manufacturing process of Wan Ai Ke active pharmaceutical ingredient (API) in detail. Different forms of Wan Ai Ke DMFs exist exist since differing nations have different regulations, such as Wan Ai Ke USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Wan Ai Ke DMF submitted to regulatory agencies in the US is known as a USDMF. Wan Ai Ke USDMF includes data on Wan Ai Ke's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Wan Ai Ke USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Wan Ai Ke 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 Wan Ai Ke Drug Master File in Japan (Wan Ai Ke JDMF) empowers Wan Ai Ke 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 Wan Ai Ke JDMF during the approval evaluation for pharmaceutical products. At the time of Wan Ai Ke 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 Wan Ai Ke 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 Wan Ai Ke Drug Master File in Korea (Wan Ai Ke KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Wan Ai Ke. The MFDS reviews the Wan Ai Ke KDMF as part of the drug registration process and uses the information provided in the Wan Ai Ke KDMF to evaluate the safety and efficacy of the drug.
After submitting a Wan Ai Ke 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 Wan Ai Ke API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Wan Ai Ke suppliers with KDMF on PharmaCompass.
A Wan Ai Ke CEP of the European Pharmacopoeia monograph is often referred to as a Wan Ai Ke Certificate of Suitability (COS). The purpose of a Wan Ai Ke CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Wan Ai Ke EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Wan Ai Ke to their clients by showing that a Wan Ai Ke CEP has been issued for it. The manufacturer submits a Wan Ai Ke CEP (COS) as part of the market authorization procedure, and it takes on the role of a Wan Ai Ke CEP holder for the record. Additionally, the data presented in the Wan Ai Ke CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Wan Ai Ke DMF.
A Wan Ai Ke CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Wan Ai Ke 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 Wan Ai Ke suppliers with CEP (COS) on PharmaCompass.
A Wan Ai Ke written confirmation (Wan Ai Ke WC) is an official document issued by a regulatory agency to a Wan Ai Ke manufacturer, verifying that the manufacturing facility of a Wan Ai Ke active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Wan Ai Ke APIs or Wan Ai Ke finished pharmaceutical products to another nation, regulatory agencies frequently require a Wan Ai Ke WC (written confirmation) as part of the regulatory process.
click here to find a list of Wan Ai Ke 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 Wan Ai Ke as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Wan Ai Ke 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 Wan Ai Ke 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 Wan Ai Ke and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Wan Ai Ke NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Wan Ai Ke suppliers with NDC on PharmaCompass.
Wan Ai Ke 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 Wan Ai Ke GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Wan Ai Ke GMP manufacturer or Wan Ai Ke GMP API supplier for your needs.
A Wan Ai Ke CoA (Certificate of Analysis) is a formal document that attests to Wan Ai Ke's compliance with Wan Ai Ke specifications and serves as a tool for batch-level quality control.
Wan Ai Ke CoA mostly includes findings from lab analyses of a specific batch. For each Wan Ai Ke 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.
Wan Ai Ke may be tested according to a variety of international standards, such as European Pharmacopoeia (Wan Ai Ke EP), Wan Ai Ke JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Wan Ai Ke USP).
