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VMF
DRUG PRODUCT COMPOSITIONS0
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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
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
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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 : 12658-0483
Start Marketing Date : 1998-03-27
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
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.
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 Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
NDC Package Code : 61281-1500
Start Marketing Date : 2014-04-10
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
Zeon Pharma is a manufacturer and supplier of APIs & Intermediates.
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USFDA APPLICATION NUMBER - 203109
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USFDA APPLICATION NUMBER - 21845
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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 GHL-901 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of GHL-901, including repackagers and relabelers. The FDA regulates GHL-901 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. GHL-901 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 GHL-901 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A GHL-901 supplier is an individual or a company that provides GHL-901 active pharmaceutical ingredient (API) or GHL-901 finished formulations upon request. The GHL-901 suppliers may include GHL-901 API manufacturers, exporters, distributors and traders.
click here to find a list of GHL-901 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A GHL-901 DMF (Drug Master File) is a document detailing the whole manufacturing process of GHL-901 active pharmaceutical ingredient (API) in detail. Different forms of GHL-901 DMFs exist exist since differing nations have different regulations, such as GHL-901 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A GHL-901 DMF submitted to regulatory agencies in the US is known as a USDMF. GHL-901 USDMF includes data on GHL-901's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The GHL-901 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of GHL-901 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 GHL-901 Drug Master File in Japan (GHL-901 JDMF) empowers GHL-901 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 GHL-901 JDMF during the approval evaluation for pharmaceutical products. At the time of GHL-901 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 GHL-901 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 GHL-901 Drug Master File in Korea (GHL-901 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of GHL-901. The MFDS reviews the GHL-901 KDMF as part of the drug registration process and uses the information provided in the GHL-901 KDMF to evaluate the safety and efficacy of the drug.
After submitting a GHL-901 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 GHL-901 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of GHL-901 suppliers with KDMF on PharmaCompass.
A GHL-901 CEP of the European Pharmacopoeia monograph is often referred to as a GHL-901 Certificate of Suitability (COS). The purpose of a GHL-901 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of GHL-901 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of GHL-901 to their clients by showing that a GHL-901 CEP has been issued for it. The manufacturer submits a GHL-901 CEP (COS) as part of the market authorization procedure, and it takes on the role of a GHL-901 CEP holder for the record. Additionally, the data presented in the GHL-901 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the GHL-901 DMF.
A GHL-901 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. GHL-901 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 GHL-901 suppliers with CEP (COS) on PharmaCompass.
A GHL-901 written confirmation (GHL-901 WC) is an official document issued by a regulatory agency to a GHL-901 manufacturer, verifying that the manufacturing facility of a GHL-901 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting GHL-901 APIs or GHL-901 finished pharmaceutical products to another nation, regulatory agencies frequently require a GHL-901 WC (written confirmation) as part of the regulatory process.
click here to find a list of GHL-901 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 GHL-901 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for GHL-901 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 GHL-901 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 GHL-901 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a GHL-901 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of GHL-901 suppliers with NDC on PharmaCompass.
GHL-901 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 GHL-901 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 GHL-901 GMP manufacturer or GHL-901 GMP API supplier for your needs.
A GHL-901 CoA (Certificate of Analysis) is a formal document that attests to GHL-901's compliance with GHL-901 specifications and serves as a tool for batch-level quality control.
GHL-901 CoA mostly includes findings from lab analyses of a specific batch. For each GHL-901 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.
GHL-901 may be tested according to a variety of international standards, such as European Pharmacopoeia (GHL-901 EP), GHL-901 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (GHL-901 USP).
