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| Molecular Weight | 666.7 g/mol |
|---|---|
| Molecular Formula | C28H38N6O11S |
| Hydrogen Bond Donor Count | 5 |
| Hydrogen Bond Acceptor Count | 14 |
| Rotatable Bond Count | 12 |
| Exact Mass | 666.23192722 g/mol |
| Monoisotopic Mass | 666.23192722 g/mol |
| Topological Polar Surface Area | 250 A^2 |
| Heavy Atom Count | 46 |
| Formal Charge | 0 |
| Complexity | 1070 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
| 1 of 8 | |
|---|---|
| Drug Name | Revatio |
| PubMed Health | Sildenafil |
| Drug Classes | Antihypertensive, Peripheral Vasodilator, Erectile Dysfunction Agent, Vasodilator |
| Drug Label | REVATIO, phosphodiesterase-5 (PDE-5) inhibitor, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type-5 (PDE-5). Sildenafil is also marketed as VIAGRA for erectile dysfunct... |
| Active Ingredient | Sildenafil citrate |
| Dosage Form | Tablet; Solution; For suspension |
| Route | Oral; Intravenous |
| Strength | eq 20mg base; eq 10mg base/ml; eq 10mg base/12.5ml (eq 0.8mg base/ml) |
| Market Status | Prescription |
| Company | Pfizer |
| 2 of 8 | |
|---|---|
| Drug Name | Sildenafil citrate |
| Drug Label | VIAGRA, an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).Sildenafil citrate is designated chemically as 1-[[3-(6,7-d... |
| Active Ingredient | Sildenafil citrate |
| Dosage Form | Tablet |
| Route | oral |
| Strength | 25mg; 100mg; 50mg |
| Market Status | Tentative Approval |
| Company | Macleods Pharma |
| 3 of 8 | |
|---|---|
| Drug Name | Sildenafil citrate |
| PubMed Health | Sildenafil |
| Drug Classes | Antihypertensive, Peripheral Vasodilator, Erectile Dysfunction Agent, Vasodilator |
| Drug Label | VIAGRA, an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).Sildenafil citrate is designated chemically as 1-[[3-(6,7-d... |
| Active Ingredient | Sildenafil citrate |
| Dosage Form | Tablet |
| Route | oral; Oral |
| Strength | eq 100mg base; 25mg; eq 50mg base; eq 20mg base; 100mg; 50mg; eq 25mg base |
| Market Status | Tentative Approval; Prescription |
| Company | Amneal Pharms; Mylan Pharms; Hetero Labs Ltd V; Mylan Pharma; Actavis Pharma; Apotex; Torrent Pharms; Watson Labs; Actavis Grp Ptc; Teva Pharms; Macleods Pharms; Dr Reddys Labs |
| 4 of 8 | |
|---|---|
| Drug Name | Viagra |
| Drug Label | VIAGRA, an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).Sildenafil citrate is designated chemically as 1-[[3-(6,7-d... |
| Active Ingredient | Sildenafil citrate |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | eq 100mg base; eq 50mg base; eq 25mg base |
| Market Status | Prescription |
| Company | Pfizer Ireland |
| 5 of 8 | |
|---|---|
| Drug Name | Revatio |
| PubMed Health | Sildenafil |
| Drug Classes | Antihypertensive, Peripheral Vasodilator, Erectile Dysfunction Agent, Vasodilator |
| Drug Label | REVATIO, phosphodiesterase-5 (PDE-5) inhibitor, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type-5 (PDE-5). Sildenafil is also marketed as VIAGRA for erectile dysfunct... |
| Active Ingredient | Sildenafil citrate |
| Dosage Form | Tablet; Solution; For suspension |
| Route | Oral; Intravenous |
| Strength | eq 20mg base; eq 10mg base/ml; eq 10mg base/12.5ml (eq 0.8mg base/ml) |
| Market Status | Prescription |
| Company | Pfizer |
| 6 of 8 | |
|---|---|
| Drug Name | Sildenafil citrate |
| Drug Label | VIAGRA, an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).Sildenafil citrate is designated chemically as 1-[[3-(6,7-d... |
| Active Ingredient | Sildenafil citrate |
| Dosage Form | Tablet |
| Route | oral |
| Strength | 25mg; 100mg; 50mg |
| Market Status | Tentative Approval |
| Company | Macleods Pharma |
| 7 of 8 | |
|---|---|
| Drug Name | Sildenafil citrate |
| PubMed Health | Sildenafil |
| Drug Classes | Antihypertensive, Peripheral Vasodilator, Erectile Dysfunction Agent, Vasodilator |
| Drug Label | VIAGRA, an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).Sildenafil citrate is designated chemically as 1-[[3-(6,7-d... |
| Active Ingredient | Sildenafil citrate |
| Dosage Form | Tablet |
| Route | oral; Oral |
| Strength | eq 100mg base; 25mg; eq 50mg base; eq 20mg base; 100mg; 50mg; eq 25mg base |
| Market Status | Tentative Approval; Prescription |
| Company | Amneal Pharms; Mylan Pharms; Hetero Labs Ltd V; Mylan Pharma; Actavis Pharma; Apotex; Torrent Pharms; Watson Labs; Actavis Grp Ptc; Teva Pharms; Macleods Pharms; Dr Reddys Labs |
| 8 of 8 | |
|---|---|
| Drug Name | Viagra |
| Drug Label | VIAGRA, an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).Sildenafil citrate is designated chemically as 1-[[3-(6,7-d... |
| Active Ingredient | Sildenafil citrate |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | eq 100mg base; eq 50mg base; eq 25mg base |
| Market Status | Prescription |
| Company | Pfizer Ireland |
API SUPPLIERS
Atman Pharma Private Limited: A One Stop Solution Provider to All Your API Needs.
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-08-11
Pay. Date : 2016-06-13
DMF Number : 23930
Submission : 2010-06-29
Status : Active
Type : II
Certificate Number : CEP 2013-073 - Rev 04
Issue Date : 2024-11-19
Type : Chemical
Substance Number : 2270
Status : Valid
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 :
NDC Package Code : 12658-0585
Start Marketing Date : 1998-03-27
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (15kg/15kg)
Marketing Category : BULK INGREDIENT
| Available Reg Filing : ASMF, CN, CA |
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Date of Issue : 2022-06-17
Valid Till : 2025-07-07
Written Confirmation Number : WC-0067
Address of the Firm :
Jai Radhe Sales is your partner for all your sourcing needs.
Century has been an API manufacturer for over 40 years & is the partner of choice for multipurpose custom manufacturing projects.
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Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
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USFDA APPLICATION NUMBER - 203109
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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, 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 acetildenafil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of acetildenafil, including repackagers and relabelers. The FDA regulates acetildenafil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. acetildenafil 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 acetildenafil manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A acetildenafil supplier is an individual or a company that provides acetildenafil active pharmaceutical ingredient (API) or acetildenafil finished formulations upon request. The acetildenafil suppliers may include acetildenafil API manufacturers, exporters, distributors and traders.
click here to find a list of acetildenafil suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A acetildenafil DMF (Drug Master File) is a document detailing the whole manufacturing process of acetildenafil active pharmaceutical ingredient (API) in detail. Different forms of acetildenafil DMFs exist exist since differing nations have different regulations, such as acetildenafil USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A acetildenafil DMF submitted to regulatory agencies in the US is known as a USDMF. acetildenafil USDMF includes data on acetildenafil's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The acetildenafil USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of acetildenafil 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 acetildenafil Drug Master File in Japan (acetildenafil JDMF) empowers acetildenafil 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 acetildenafil JDMF during the approval evaluation for pharmaceutical products. At the time of acetildenafil 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 acetildenafil 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 acetildenafil Drug Master File in Korea (acetildenafil KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of acetildenafil. The MFDS reviews the acetildenafil KDMF as part of the drug registration process and uses the information provided in the acetildenafil KDMF to evaluate the safety and efficacy of the drug.
After submitting a acetildenafil 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 acetildenafil API can apply through the Korea Drug Master File (KDMF).
click here to find a list of acetildenafil suppliers with KDMF on PharmaCompass.
A acetildenafil CEP of the European Pharmacopoeia monograph is often referred to as a acetildenafil Certificate of Suitability (COS). The purpose of a acetildenafil CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of acetildenafil EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of acetildenafil to their clients by showing that a acetildenafil CEP has been issued for it. The manufacturer submits a acetildenafil CEP (COS) as part of the market authorization procedure, and it takes on the role of a acetildenafil CEP holder for the record. Additionally, the data presented in the acetildenafil CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the acetildenafil DMF.
A acetildenafil CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. acetildenafil 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 acetildenafil suppliers with CEP (COS) on PharmaCompass.
A acetildenafil written confirmation (acetildenafil WC) is an official document issued by a regulatory agency to a acetildenafil manufacturer, verifying that the manufacturing facility of a acetildenafil active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting acetildenafil APIs or acetildenafil finished pharmaceutical products to another nation, regulatory agencies frequently require a acetildenafil WC (written confirmation) as part of the regulatory process.
click here to find a list of acetildenafil 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 acetildenafil as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for acetildenafil 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 acetildenafil 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 acetildenafil and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a acetildenafil NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of acetildenafil suppliers with NDC on PharmaCompass.
acetildenafil 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 acetildenafil 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 acetildenafil GMP manufacturer or acetildenafil GMP API supplier for your needs.
A acetildenafil CoA (Certificate of Analysis) is a formal document that attests to acetildenafil's compliance with acetildenafil specifications and serves as a tool for batch-level quality control.
acetildenafil CoA mostly includes findings from lab analyses of a specific batch. For each acetildenafil 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.
acetildenafil may be tested according to a variety of international standards, such as European Pharmacopoeia (acetildenafil EP), acetildenafil JP (Japanese Pharmacopeia) and the US Pharmacopoeia (acetildenafil USP).
