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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
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USDMF
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Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
Sildenafil Citrate, Process B, Standard, Milled ...
Certificate Number : CEP 2013-073 - Rev 04
Status : Valid
Issue Date : 2024-11-19
Type : Chemical
Substance Number : 2270
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
Certificate Number : R1-CEP 2013-072 - Rev 02
Status : Valid
Issue Date : 2022-03-14
Type : Chemical
Substance Number : 2270
Certificate Number : R1-CEP 2014-223 - Rev 01
Status : Valid
Issue Date : 2021-02-04
Type : Chemical
Substance Number : 2270
Certificate Number : R1-CEP 2013-291 - Rev 00
Status : Valid
Issue Date : 2019-12-16
Type : Chemical
Substance Number : 2270
Certificate Number : R1-CEP 2013-002 - Rev 00
Status : Valid
Issue Date : 2019-01-22
Type : Chemical
Substance Number : 2270
Certificate Number : R0-CEP 2015-357 - Rev 00
Status : Expired
Issue Date : 2017-03-16
Type : Chemical
Substance Number : 2270
Certificate Number : R1-CEP 2013-100 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2020-04-09
Type : Chemical
Substance Number : 2270
Certificate Number : R1-CEP 2013-219 - Rev 01
Status : Valid
Issue Date : 2021-12-13
Type : Chemical
Substance Number : 2270
Certificate Number : R0-CEP 2014-283 - Rev 00
Status : Expired
Issue Date : 2016-02-15
Type : Chemical
Substance Number : 2270
Certificate Number : R1-CEP 2014-246 - Rev 00
Status : Valid
Issue Date : 2021-01-18
Type : Chemical
Substance Number : 2270
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API Imports and Exports
| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
|---|
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Drugs in Development
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Regulatory Info :
Registration Country : Sweden
Brand Name : Sildenafil Orion
Dosage Form : FILM COATED PILL
Dosage Strength : 25 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Sildenafil Orion
Dosage Form : FILM COATED PILL
Dosage Strength : 50 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Sildenafil Orion
Dosage Form : FILM COATED PILL
Dosage Strength : 100 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Norway
Brand Name : Orisild
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 20 mg
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info :
Registration Country : Italy
Brand Name : SILDENAFIL DR. REDDY'S
Dosage Form : Film-Coated Tablet
Dosage Strength : 20mg
Packaging : 90 UNITS 20 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info : Generic
Registration Country : Turkey
Brand Name : Vigaroo
Dosage Form : Film Coated Tablet
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : Turkey
Regulatory Info : Generic
Registration Country : United Kingdom
Brand Name :
Dosage Form : TABLET
Dosage Strength : 25MG
Packaging :
Approval Date :
Application Number : 202255
Regulatory Info : Generic
Registration Country : United Kingdom
Regulatory Info :
Registration Country : Sweden
Brand Name : OLVION
Dosage Form : FILM COATED PILL
Dosage Strength : 50 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Norway
Brand Name : Viagra
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 25 mg
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Revatio
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 20 mg
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
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Athena Pharmaceutiques is a Partner of Choice for Drug Delivery & Life Cycle Management.
Regulatory Info :
Registration Country : France
Brand Name :
Dosage Form : Oro-Dispersible Tablet
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : France
Athena Pharmaceutiques is a Partner of Choice for Drug Delivery & Life Cycle Management.
Packaging :
Regulatory Info :
Dosage : Oro-Dispersible Tablet
Dosage Strength : 50MG
Brand Name :
Approval Date :
Application Number :
Registration Country : France
Athena Pharmaceutiques is a Partner of Choice for Drug Delivery & Life Cycle Management.
Regulatory Info :
Registration Country : France
Brand Name :
Dosage Form : Oro-Dispersible Tablet
Dosage Strength : 100MG
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Application Number :
Regulatory Info :
Registration Country : France
Athena Pharmaceutiques is a Partner of Choice for Drug Delivery & Life Cycle Management.
Packaging :
Regulatory Info :
Dosage : Oro-Dispersible Tablet
Dosage Strength : 100MG
Brand Name :
Approval Date :
Application Number :
Registration Country : France
Athena Pharmaceutiques is a Partner of Choice for Drug Delivery & Life Cycle Management.
Regulatory Info :
Registration Country : France
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 20MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : France
Athena Pharmaceutiques is a Partner of Choice for Drug Delivery & Life Cycle Management.
Packaging :
Regulatory Info :
Dosage : Film Coated Tablet
Dosage Strength : 20MG
Brand Name :
Approval Date :
Application Number :
Registration Country : France
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Tablet
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Packaging :
Regulatory Info :
Dosage : Tablet
Dosage Strength : 50MG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Tablet
Dosage Strength : 100MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Packaging :
Regulatory Info :
Dosage : Tablet
Dosage Strength : 100MG
Brand Name :
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Application Number :
Registration Country : India
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Sildenafil Citrate; Dapoxetine Hydrochloride
Brand Name :
Dosage Form : Tablet
Dosage Strength : 50MG; 30MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Packaging :
Regulatory Info :
Sildenafil Citrate; Dapoxetine Hydrochloride
Dosage : Tablet
Dosage Strength : 50MG; 30MG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info : DMF Available|FDF Compliance-U...
Registration Country : India
Brand Name :
Dosage Form : DC Granules
Dosage Strength : 25MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : DMF Available|FDF Compliance-U...
Registration Country : India
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Packaging :
Regulatory Info : DMF Available|FDF Compliance-U...
Dosage : DC Granules
Dosage Strength : 25MG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info : DMF Available|FDF Compliance-U...
Registration Country : India
Brand Name :
Dosage Form : DC Granules
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : DMF Available|FDF Compliance-U...
Registration Country : India
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Packaging :
Regulatory Info : DMF Available|FDF Compliance-U...
Dosage : DC Granules
Dosage Strength : 50MG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info : DMF Available|FDF Compliance-U...
Registration Country : India
Brand Name :
Dosage Form : DC Granules
Dosage Strength : 100MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : DMF Available|FDF Compliance-U...
Registration Country : India
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Packaging :
Regulatory Info : DMF Available|FDF Compliance-U...
Dosage : DC Granules
Dosage Strength : 100MG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info : DMF Available|FDF Compliance-I...
Registration Country : India
Sildenafil Citrate; Dapoxetine Hydrochloride
Brand Name :
Dosage Form : DC Granules
Dosage Strength : 50MG; 30MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : DMF Available|FDF Compliance-I...
Registration Country : India
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Packaging :
Regulatory Info : DMF Available|FDF Compliance-I...
Sildenafil Citrate; Dapoxetine Hydrochloride
Dosage : DC Granules
Dosage Strength : 50MG; 30MG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
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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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ABOUT THIS PAGE
A Sildenafil Citrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sildenafil Citrate, including repackagers and relabelers. The FDA regulates Sildenafil Citrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sildenafil Citrate 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 Citrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sildenafil Citrate supplier is an individual or a company that provides Sildenafil Citrate active pharmaceutical ingredient (API) or Sildenafil Citrate finished formulations upon request. The Sildenafil Citrate suppliers may include Sildenafil Citrate API manufacturers, exporters, distributors and traders.
click here to find a list of Sildenafil Citrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sildenafil Citrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Sildenafil Citrate active pharmaceutical ingredient (API) in detail. Different forms of Sildenafil Citrate DMFs exist exist since differing nations have different regulations, such as Sildenafil Citrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sildenafil Citrate DMF submitted to regulatory agencies in the US is known as a USDMF. Sildenafil Citrate USDMF includes data on Sildenafil Citrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sildenafil Citrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sildenafil Citrate 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 Citrate Drug Master File in Japan (Sildenafil Citrate JDMF) empowers Sildenafil Citrate 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 Citrate JDMF during the approval evaluation for pharmaceutical products. At the time of Sildenafil Citrate 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 Citrate 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 Citrate Drug Master File in Korea (Sildenafil Citrate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Sildenafil Citrate. The MFDS reviews the Sildenafil Citrate KDMF as part of the drug registration process and uses the information provided in the Sildenafil Citrate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Sildenafil Citrate 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 Citrate API can apply through the Korea Drug Master File (KDMF).
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A Sildenafil Citrate CEP of the European Pharmacopoeia monograph is often referred to as a Sildenafil Citrate Certificate of Suitability (COS). The purpose of a Sildenafil Citrate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Sildenafil Citrate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Sildenafil Citrate to their clients by showing that a Sildenafil Citrate CEP has been issued for it. The manufacturer submits a Sildenafil Citrate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Sildenafil Citrate CEP holder for the record. Additionally, the data presented in the Sildenafil Citrate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Sildenafil Citrate DMF.
A Sildenafil Citrate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Sildenafil Citrate 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 Citrate suppliers with CEP (COS) on PharmaCompass.
A Sildenafil Citrate written confirmation (Sildenafil Citrate WC) is an official document issued by a regulatory agency to a Sildenafil Citrate manufacturer, verifying that the manufacturing facility of a Sildenafil Citrate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Sildenafil Citrate APIs or Sildenafil Citrate finished pharmaceutical products to another nation, regulatory agencies frequently require a Sildenafil Citrate WC (written confirmation) as part of the regulatory process.
click here to find a list of Sildenafil Citrate 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 Citrate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Sildenafil Citrate 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 Citrate 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 Citrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sildenafil Citrate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Sildenafil Citrate suppliers with NDC on PharmaCompass.
Sildenafil Citrate 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 Citrate 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 Sildenafil Citrate GMP manufacturer or Sildenafil Citrate GMP API supplier for your needs.
A Sildenafil Citrate CoA (Certificate of Analysis) is a formal document that attests to Sildenafil Citrate's compliance with Sildenafil Citrate specifications and serves as a tool for batch-level quality control.
Sildenafil Citrate CoA mostly includes findings from lab analyses of a specific batch. For each Sildenafil Citrate 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 Citrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Sildenafil Citrate EP), Sildenafil Citrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sildenafil Citrate USP).
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