Synopsis
0
VMF
DRUG PRODUCT COMPOSITIONS0
Stock Recap #PipelineProspector
API SUPPLIERS
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USDMF
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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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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
Lead Product(s) : Sildenafil Citrate,Inapplicable
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Granules India Limited Received ANDA Approval for Sildenafil for Oral Suspension
Details : Sildenafil is an inhibitor of cyclic GMP specific PDE type 5, the predominant enzyme metabolizing cyclic GMP in the corpus cavernosum. It is indicated for pulmonary arterial hypertension in adults.
Product Name : Revatio-Generic
Product Type : Miscellaneous
Upfront Cash : Inapplicable
December 03, 2023
Lead Product(s) : Riociguat,Sildenafil Citrate
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Adempas (Riociguat) is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Hypertension, Pulmonary.
Product Name : Adempas
Product Type : Miscellaneous
Upfront Cash : Inapplicable
August 11, 2010
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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
28
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 Sildenafil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sildenafil, including repackagers and relabelers. The FDA regulates Sildenafil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sildenafil 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 Sildenafil manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Sildenafil supplier is an individual or a company that provides Sildenafil active pharmaceutical ingredient (API) or Sildenafil finished formulations upon request. The Sildenafil suppliers may include Sildenafil API manufacturers, exporters, distributors and traders.
click here to find a list of Sildenafil suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Sildenafil DMF (Drug Master File) is a document detailing the whole manufacturing process of Sildenafil active pharmaceutical ingredient (API) in detail. Different forms of Sildenafil DMFs exist exist since differing nations have different regulations, such as Sildenafil USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sildenafil DMF submitted to regulatory agencies in the US is known as a USDMF. Sildenafil USDMF includes data on Sildenafil's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sildenafil USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sildenafil 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 Sildenafil Drug Master File in Japan (Sildenafil JDMF) empowers Sildenafil 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 Sildenafil JDMF during the approval evaluation for pharmaceutical products. At the time of Sildenafil 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 Sildenafil 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 Sildenafil Drug Master File in Korea (Sildenafil KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Sildenafil. The MFDS reviews the Sildenafil KDMF as part of the drug registration process and uses the information provided in the Sildenafil KDMF to evaluate the safety and efficacy of the drug.
After submitting a Sildenafil 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 Sildenafil API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Sildenafil suppliers with KDMF on PharmaCompass.
A Sildenafil CEP of the European Pharmacopoeia monograph is often referred to as a Sildenafil Certificate of Suitability (COS). The purpose of a Sildenafil CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Sildenafil EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Sildenafil to their clients by showing that a Sildenafil CEP has been issued for it. The manufacturer submits a Sildenafil CEP (COS) as part of the market authorization procedure, and it takes on the role of a Sildenafil CEP holder for the record. Additionally, the data presented in the Sildenafil CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Sildenafil DMF.
A Sildenafil CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Sildenafil 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 Sildenafil suppliers with CEP (COS) on PharmaCompass.
A Sildenafil written confirmation (Sildenafil WC) is an official document issued by a regulatory agency to a Sildenafil manufacturer, verifying that the manufacturing facility of a Sildenafil active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Sildenafil APIs or Sildenafil finished pharmaceutical products to another nation, regulatory agencies frequently require a Sildenafil WC (written confirmation) as part of the regulatory process.
click here to find a list of Sildenafil 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 Sildenafil as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Sildenafil 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 Sildenafil 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 Sildenafil and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sildenafil NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Sildenafil suppliers with NDC on PharmaCompass.
Sildenafil 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 Sildenafil GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Sildenafil GMP manufacturer or Sildenafil GMP API supplier for your needs.
A Sildenafil CoA (Certificate of Analysis) is a formal document that attests to Sildenafil's compliance with Sildenafil specifications and serves as a tool for batch-level quality control.
Sildenafil CoA mostly includes findings from lab analyses of a specific batch. For each Sildenafil 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.
Sildenafil may be tested according to a variety of international standards, such as European Pharmacopoeia (Sildenafil EP), Sildenafil JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sildenafil USP).
