Synopsis
Synopsis
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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
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USDMF
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GDUFA
DMF Review : Complete
Rev. Date : 2016-08-11
Pay. Date : 2016-06-13
DMF Number : 23930
Submission : 2010-06-29
Status : Active
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 : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-04-23
Pay. Date : 2013-04-09
DMF Number : 21154
Submission : 2007-12-13
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-11-25
Pay. Date : 2013-11-18
DMF Number : 21619
Submission : 2008-05-15
Status : Active
Type : II
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DMF Number : 23067
Submission : 2009-08-21
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-08-04
Pay. Date : 2017-07-07
DMF Number : 23509
Submission : 2010-02-02
Status : Active
Type : II
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DMF Number : 22599
Submission : 2009-03-06
Status : Inactive
Type : II
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DMF Number : 21250
Submission : 2008-01-22
Status : Inactive
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DMF Number : 22142
Submission : 2008-10-31
Status : Active
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DMF Number : 19097
Submission : 2006-01-10
Status : Active
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Average Price (USD/KGS) |
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Drugs in Development
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.
Lead Product(s): Sildenafil Citrate,Inapplicable
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Revatio-Generic
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 03, 2023
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
Details:
ASP-001.1 is a drug candidate, which is currently being evaluated in Phase I clinical studies for the treatment of Erectile Dysfunction.
Lead Product(s): ASP-001.1,ASP-001,Sildenafil Citrate,Tadalafil
Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Undisclosed
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 12, 2025
Lead Product(s) : ASP-001.1,ASP-001,Sildenafil Citrate,Tadalafil
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Hezkue®, Hezkue Turbo®, and Commercial Sildenafil Products in Fed Healthy Male Subject
Details : ASP-001.1 is a drug candidate, which is currently being evaluated in Phase I clinical studies for the treatment of Erectile Dysfunction.
Product Name : Undisclosed
Product Type : Undisclosed
Upfront Cash : Inapplicable
August 12, 2025
Details:
TOP-N53 is a drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Scleroderma, Systemic.
Lead Product(s): TOP-N53,Sildenafil Citrate
Therapeutic Area: Immunology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Undisclosed
Sponsor: Bioskin
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 01, 2025
Lead Product(s) : TOP-N53,Sildenafil Citrate
Therapeutic Area : Immunology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Bioskin
Deal Size : Inapplicable
Deal Type : Inapplicable
Safety and Tolerability of TOP-N53 Applied on Digital Ulcers in Patients With Systemic Sclerosis
Details : TOP-N53 is a drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Scleroderma, Systemic.
Product Name : Undisclosed
Product Type : Undisclosed
Upfront Cash : Inapplicable
May 01, 2025
Details:
Sildenafil is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Erectile Dysfunction.
Lead Product(s): Sildenafil Citrate,Inapplicable
Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Miscellaneous
Sponsor: Antoni van Leeuwenhoek Hospital | Viatris | Memidis Pharma
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 13, 2025
Lead Product(s) : Sildenafil Citrate,Inapplicable
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Antoni van Leeuwenhoek Hospital | Viatris | Memidis Pharma
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Sildenafil is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Erectile Dysfunction.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
March 13, 2025
Details:
ASP-001 is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Erectile Dysfunction.
Lead Product(s): ASP-001,Sildenafil Citrate
Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 20, 2025
Lead Product(s) : ASP-001,Sildenafil Citrate
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Study to Compare the Effects of Viagra® Vs Hezkue® in Healthy Fasted Male Participants.
Details : ASP-001 is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Erectile Dysfunction.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
January 20, 2025
Details:
The proceeds will fund the Phase 3 program for Sildenafil Cream, a potential first-in-category treatment for female sexual arousal disorder using the same active ingredient as in Viagra.
Lead Product(s): Sildenafil Citrate,Inapplicable
Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Lincoln Park Capital Fund
Deal Size: $15.0 million Upfront Cash: Undisclosed
Deal Type: Agreement October 21, 2024
Lead Product(s) : Sildenafil Citrate,Inapplicable
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Lincoln Park Capital Fund
Deal Size : $15.0 million
Deal Type : Agreement
Daré Signs $15M Stock Purchase Agreement with Lincoln Park Capital
Details : The proceeds will fund the Phase 3 program for Sildenafil Cream, a potential first-in-category treatment for female sexual arousal disorder using the same active ingredient as in Viagra.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Undisclosed
October 21, 2024
Details:
Collagenase Clostridium Histolyticum is a Enzyme drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Penile Induration.
Lead Product(s): Collagenase Clostridium Histolyticum,Sildenafil Citrate
Therapeutic Area: Dermatology Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Enzyme
Sponsor: Endo Pharm
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 18, 2024
Lead Product(s) : Collagenase Clostridium Histolyticum,Sildenafil Citrate
Therapeutic Area : Dermatology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Endo Pharm
Deal Size : Inapplicable
Deal Type : Inapplicable
Delayed Dose Collagenase Clostridium Histolyticum (CCH) Protocol for Men With Peyronie's Disease
Details : Collagenase Clostridium Histolyticum is a Enzyme drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Penile Induration.
Product Name : Undisclosed
Product Type : Enzyme
Upfront Cash : Inapplicable
October 18, 2024
Details:
ASP-001 (sildenafil citrate oral spray) is a PDE-5 inhibitor, administered via a spray pump, which is being investigated for the treatment of erectile dysfunction.
Lead Product(s): Sildenafil Citrate,Inapplicable
Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 30, 2024
Lead Product(s) : Sildenafil Citrate,Inapplicable
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Aspargo Labs Data Shows ASP-001 Oral Spray Absorbs Faster than Viagra® Tablets
Details : ASP-001 (sildenafil citrate oral spray) is a PDE-5 inhibitor, administered via a spray pump, which is being investigated for the treatment of erectile dysfunction.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
July 30, 2024
Details:
Sildenafil is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Asphyxia Neonatorum.
Lead Product(s): Sildenafil Citrate,Inapplicable
Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: University Teaching Hospital, Lusaka, Zambia | Egerton University | Cameroon Baptist Convention Health
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 22, 2024
Lead Product(s) : Sildenafil Citrate,Inapplicable
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : University Teaching Hospital, Lusaka, Zambia | Egerton University | Cameroon Baptist Convention Health
Deal Size : Inapplicable
Deal Type : Inapplicable
Intrapartum Sildenafil in Laboring Mothers
Details : Sildenafil is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Asphyxia Neonatorum.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
April 22, 2024
Details:
Treprostinil Sodium is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Pulmonary Arterial Hypertension.
Lead Product(s): Treprostinil Sodium,Tadalafil,Sildenafil Citrate,Ambrisentan,Bosentan Hydrate,Macitentan
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Miscellaneous
Sponsor: ANOVA CRO | PharmaLex | Aixial s.r.o. | GCP-Service International
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 19, 2024
Lead Product(s) : Treprostinil Sodium,Tadalafil,Sildenafil Citrate,Ambrisentan,Bosentan Hydrate,Macitentan
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : ANOVA CRO | PharmaLex | Aixial s.r.o. | GCP-Service International
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Treprostinil Sodium is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Pulmonary Arterial Hypertension.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
March 19, 2024
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Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
RLD : No
TE Code :
Brand Name : SILDENAFIL CITRATE
Dosage Form : FOR SUSPENSION;ORAL
Dosage Strength : EQ 10MG BASE/ML
Approval Date : 2023-12-01
Application Number : 214556
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD :
TE Code :
Brand Name : SILDENAFIL CITRATE
Dosage Form : TABLET; ORAL
Dosage Strength : 50MG
Approval Date :
Application Number : 200165
RX/OTC/DISCN :
RLD :
TE Code :
RLD : No
TE Code :
Brand Name : SILDENAFIL CITRATE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 25MG BASE
Approval Date : 2020-11-25
Application Number : 202506
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code : AB
Brand Name : SILDENAFIL CITRATE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 50MG BASE
Approval Date : 2018-10-12
Application Number : 206401
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD :
TE Code :
Brand Name : SILDENAFIL CITRATE
Dosage Form : TABLET; ORAL
Dosage Strength : 100MG
Approval Date :
Application Number : 91378
RX/OTC/DISCN :
RLD :
TE Code :
RLD : No
TE Code : AP
Brand Name : SILDENAFIL CITRATE
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)
Approval Date : 2015-04-01
Application Number : 203988
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code : AB
Brand Name : SILDENAFIL CITRATE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 100MG BASE
Approval Date : 2019-03-22
Application Number : 212051
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : SILDENAFIL CITRATE
Dosage Form : FOR SUSPENSION;ORAL
Dosage Strength : EQ 10MG BASE/ML
Approval Date : 2021-04-29
Application Number : 213814
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : SILDENAFIL CITRATE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 20MG BASE
Approval Date : 2025-03-06
Application Number : 202954
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : SILDENAFIL CITRATE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 100MG BASE
Approval Date : 2023-08-29
Application Number : 216383
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
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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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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nitika Pharmaceutical Specialities
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nomisma Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Novo Excipients
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharmatrans-Sanaq
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pluviaendo
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Prachin Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qianhao Chemical (Hebei) Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qualicaps
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Roquette
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Seppic
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shijiazhuang Huaxu Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Sigachi Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Silverline Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]The Dow Chemical Company
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Vasa Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Zhejiang Huakang Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Excipients by Applications
Coating Systems & Additives
Fillers, Diluents & Binders
Controlled & Modified Release
Lubricants & Glidants
Thickeners and Stabilizers
Granulation
Direct Compression
Film Formers & Plasticizers
Disintegrants & Superdisintegrants
Topical
Parenteral
Taste Masking
Co-Processed Excipients
Rheology Modifiers
Chewable & Orodispersible Aids
Solubilizers
API Stability Enhancers
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Dosage Form : Cream / Lotion / Ointment, Suspension
Grade : Topical
Category : API Stability Enhancers, Thickeners and Stabilizers
Application : API Stability Enhancers, Thickeners and Stabilizers
Excipient Details : Xanthan gum, a polysaccharide widely used in many industries as a food additive, thickening agent and stabilizer in topical formulations.
Pharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.
Dosage Form : Cream / Lotion / Ointment, Capsule, Gel, Tablet
Grade : Oral, Topical
Category : API Stability Enhancers, Thickeners and Stabilizers
Application : API Stability Enhancers, Thickeners and Stabilizers
Excipient Details : Xanthan gum is widely used in oral dosage forms as a suspending and thickening agent. It is also used in topical formulations as a stabilizer.
Application : API Stability Enhancers, Thickeners and Stabilizers
Excipient Details : Adsorbent, Moisture Protection, Stabilization of API
Pharmacopoeia Ref : USP-NF, JP, EP
Technical Specs : Also Available as FUJISIL-F
Ingredient(s) : Silicon Dioxide
Grade : Not Available
Category : API Stability Enhancers, Coating Systems & Additives, Controlled & Modified Release, Direct Compression, Granulation, Rheology Modifiers, Vegetarian Capsules
Application : API Stability Enhancers, Coating Systems & Additives, Controlled & Modified Release, Direct Compression, Granulation, Rheology Modifiers, Vegetarian Capsules
Excipient Details : Controlled Release, Direct Compression,Wet Granulation,Tablet Coating, Liquid Solutions and Suspensions
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Hydroxypropyl Methyl Cellulose
Dosage Form : Suspension, Tablet
Grade : Not Available
Category : Controlled & Modified Release, Rheology Modifiers, Thickeners and Stabilizers
Application : Controlled & Modified Release, Rheology Modifiers, Thickeners and Stabilizers
Excipient Details : Xanthan gum occurs as a cream- or white-colored, odorless, fine powder which is used as gelling, stabilizing, sustained-release & suspending agent.
Application : API Stability Enhancers, Coating Systems & Additives
Excipient Details : Instacoat EMB is an excellent moisture barrier which reduces degradation of moisture sensitive APIs.
Dosage Form : Capsule
Grade : Oral and Inhalation
Category : API Stability Enhancers, Vegetarian Capsules
Application : API Stability Enhancers, Vegetarian Capsules
Pharmacopoeia Ref : Certified Vegan, Non-GMO, Vege...
Technical Specs : "Water content – less than 9%, can be customized; Size # 00el -...
Ingredient(s) : Hydroxypropyl Methyl Cellulose
Dosage Form : Capsule
Grade : Oral
Category : API Stability Enhancers, Taste Masking, Vegetarian Capsules
Application : API Stability Enhancers, Taste Masking, Vegetarian Capsules
Pharmacopoeia Ref : Certified Vegan, Non-GMO, Vege...
Technical Specs : Size # 0-1
Ingredient(s) : Hydroxypropyl Methyl Cellulose
Empty Capsules
Emulsifying Agents
Vegetarian Capsules
Coloring Agents
Soft Gelatin
Surfactant & Foaming Agents
Digital Content
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
Patents & EXCLUSIVITIES
US Patents
Patent Expiration Date : 2038-12-24
US Patent Number : 12005062
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 214952
Patent Use Code : U-3582
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2038-12-24
Patent Expiration Date : 2038-12-24
US Patent Number : 11337979
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 214952
Patent Use Code : U-3582
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2038-12-24
Patent Expiration Date : 2038-12-24
US Patent Number : 11464778
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 214952
Patent Use Code : U-3582
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2038-12-24
Patent Expiration Date : 2038-12-24
US Patent Number : 12186321
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 214952
Patent Use Code : U-3582
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2038-12-24
Patent Expiration Date : 2038-12-24
US Patent Number : 11759468
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 214952
Patent Use Code : U-3582
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2038-12-24
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]REF. STANDARDS & IMPURITIES
ANALYTICAL
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 Patrex manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Patrex, including repackagers and relabelers. The FDA regulates Patrex manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Patrex 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 Patrex manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Patrex supplier is an individual or a company that provides Patrex active pharmaceutical ingredient (API) or Patrex finished formulations upon request. The Patrex suppliers may include Patrex API manufacturers, exporters, distributors and traders.
click here to find a list of Patrex suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Patrex DMF (Drug Master File) is a document detailing the whole manufacturing process of Patrex active pharmaceutical ingredient (API) in detail. Different forms of Patrex DMFs exist exist since differing nations have different regulations, such as Patrex USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Patrex DMF submitted to regulatory agencies in the US is known as a USDMF. Patrex USDMF includes data on Patrex's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Patrex USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Patrex 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 Patrex Drug Master File in Japan (Patrex JDMF) empowers Patrex 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 Patrex JDMF during the approval evaluation for pharmaceutical products. At the time of Patrex 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 Patrex 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 Patrex Drug Master File in Korea (Patrex KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Patrex. The MFDS reviews the Patrex KDMF as part of the drug registration process and uses the information provided in the Patrex KDMF to evaluate the safety and efficacy of the drug.
After submitting a Patrex 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 Patrex API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Patrex suppliers with KDMF on PharmaCompass.
A Patrex CEP of the European Pharmacopoeia monograph is often referred to as a Patrex Certificate of Suitability (COS). The purpose of a Patrex CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Patrex EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Patrex to their clients by showing that a Patrex CEP has been issued for it. The manufacturer submits a Patrex CEP (COS) as part of the market authorization procedure, and it takes on the role of a Patrex CEP holder for the record. Additionally, the data presented in the Patrex CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Patrex DMF.
A Patrex CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Patrex 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 Patrex suppliers with CEP (COS) on PharmaCompass.
A Patrex written confirmation (Patrex WC) is an official document issued by a regulatory agency to a Patrex manufacturer, verifying that the manufacturing facility of a Patrex active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Patrex APIs or Patrex finished pharmaceutical products to another nation, regulatory agencies frequently require a Patrex WC (written confirmation) as part of the regulatory process.
click here to find a list of Patrex 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 Patrex as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Patrex 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 Patrex 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 Patrex and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Patrex NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Patrex suppliers with NDC on PharmaCompass.
Patrex 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 Patrex 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 Patrex GMP manufacturer or Patrex GMP API supplier for your needs.
A Patrex CoA (Certificate of Analysis) is a formal document that attests to Patrex's compliance with Patrex specifications and serves as a tool for batch-level quality control.
Patrex CoA mostly includes findings from lab analyses of a specific batch. For each Patrex 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.
Patrex may be tested according to a variety of international standards, such as European Pharmacopoeia (Patrex EP), Patrex JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Patrex USP).
