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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.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
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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USDMF
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
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
GDUFA
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DMF Number : 22599
Submission : 2009-03-06
Status : Inactive
Type : II
GDUFA
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DMF Number : 21250
Submission : 2008-01-22
Status : Inactive
Type : II
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DMF Number : 22142
Submission : 2008-10-31
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DMF Number : 19097
Submission : 2006-01-10
Status : Active
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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 2016-336 - Rev 00
Status : Valid
Issue Date : 2023-05-11
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 : 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
Certificate Number : R1-CEP 2014-361 - Rev 01
Status : Valid
Issue Date : 2023-01-10
Type : Chemical
Substance Number : 2270
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] JDMF
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
Registration Number : 225MF10011
Registrant's Address : 19 Pellinska Str. 83-200 Starogard Gdanski POLAND
Initial Date of Registration : 2013-01-30
Latest Date of Registration : 2020-12-23
Registration Number : 225MF10131
Registrant's Address : 1-10-11 Nihonbashi Horidomecho, Chuo-ku, Tokyo
Initial Date of Registration : 2013-07-16
Latest Date of Registration : 2013-07-16
Registration Number : 225MF10095
Registrant's Address : 1-10-11 Nihonbashi Horidomecho, Chuo-ku, Tokyo
Initial Date of Registration : 2013-05-08
Latest Date of Registration : 2013-05-08
Registration Number : 225MF10016
Registrant's Address : 1410 Takada, Kashiwa City, Chiba Prefecture
Initial Date of Registration : 2013-02-05
Latest Date of Registration : 2014-10-27
Registration Number : 224MF10197
Registrant's Address : Plot No. 564/A/22, Road No. 92, Jubilee Hills, Hyderabad-500096, Telangana, India
Initial Date of Registration : 2012-09-11
Latest Date of Registration : 2019-07-05
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
Date of Issue : 2022-06-07
Valid Till : 2025-06-25
Written Confirmation Number : WC-0023
Address of the Firm : Survey no. 52,53,58,59,61 to 78,127&128, Pydibhimanvaram Village &Sy.No. 1,2,4t0...
Sildenafil Citrate IH/USP/Ph.Eur.
Date of Issue : 2022-09-01
Valid Till : 2025-07-02
Written Confirmation Number : WC-0074Amended
Address of the Firm : 294, GIDC Estate Ankleshwar, Bharuch-393002, Gujarat India
Sildenafil Citrate IH/USP/Ph.Eur
Date of Issue : 2022-04-07
Valid Till : 2025-03-07
Written Confirmation Number : WC-0040n
Address of the Firm : Sy. No. 213, 214 & 255, Bonthapally Village, Gummadidala Mandai, Sangareddy Dist...
Date of Issue : 2022-09-07
Valid Till : 2025-07-02
Written Confirmation Number : WC-0079
Address of the Firm : Plot No. - 2209, G.I.D.C., Sarigam - 396 155, Dist - Valsad, Gujarat, India
Date of Issue : 2023-04-06
Valid Till : 2026-05-19
Written Confirmation Number : WC-0281
Address of the Firm : Sy.No.224/A, Bibinagar (V&M), Yadadri Bhuvanagiri (Dist), Telangana State, Pinco...
Date of Issue : 2021-12-16
Valid Till : 2024-03-12
Written Confirmation Number : WC-0304
Address of the Firm : Plot No. 68/A, Jawaharlal Nehru Pharma City, Parawada (M), Visakhapatnam Distric...
Sildenafil Citrate IP/USP/Ph.Eur./BP
Date of Issue : 2022-09-07
Valid Till : 2025-09-09
Written Confirmation Number : WC-0181n
Address of the Firm : Unit-I , Sy. No. 180/2, Kazipalli (V), Jinnaram (M), Sangareddy District, Telang...
Sildenafil Citrate USP/Ph.Eur./IP
Date of Issue : 2022-06-29
Valid Till : 2025-02-07
Written Confirmation Number : WC-0071n
Address of the Firm : Unit-II, Plot No. 24 & 24 B and 36 & 37, S. V. Co-Operative Industrial Estate, B...
Date of Issue : 2022-07-15
Valid Till : 2025-06-26
Written Confirmation Number : WC-0016
Address of the Firm : (Unit-9) Plot No.5, Road No. 12, Jawaharlal Nehru Pharma City, Tadi Village, Par...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
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
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
NDC Package Code : 62512-0038
Start Marketing Date : 2007-06-03
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 38779-2950
Start Marketing Date : 2017-03-22
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
NDC Package Code : 82393-303
Start Marketing Date : 2023-06-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 67835-5042
Start Marketing Date : 2011-06-15
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 49452-7528
Start Marketing Date : 2016-12-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
NDC Package Code : 65015-861
Start Marketing Date : 2018-07-11
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 10695-017
Start Marketing Date : 2016-07-14
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
NDC Package Code : 84241-111
Start Marketing Date : 2024-11-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
About the Company : Polpharma API, part of a leading Polish pharmaceutical group, has over 70 years of experience in process development and cGMP manufacturing. We offer end-to-end solutions, from API...
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
About the Company : Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-appro...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete ...
Century has been an API manufacturer for over 40 years & is the partner of choice for multipurpose custom manufacturing projects.
About the Company : Century Pharmaceuticals, established in 1982, has 40 years of experience in manufacturing APIs. It has been supplying APIs produced in-house to several major pharma companies in In...
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
About the Company : Octavius Pharma is a global leader in Directly Compressible Granules with over 45 years of expertise in formulation development, manufacturing, and commercialization. Our portfolio...
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...
Zeon Pharma is a manufacturer and supplier of APIs & Intermediates.
About the Company : Zeon Pharma Industries India Pvt ltd is an ISO & GMP certified manufacturer of Bulk drugs & Intermediate and also supplies our associate manufacturing plant API / Semi finish form...
Delivering Quality APIs, Drug Intermediates, and Specialty Chemicals to Over 50 Countries Across the Globe.
About the Company : Zeal MediPharma is a globally recognized Star One Export House, serving customers in over 50 countries for more than two decades. We specialize in sourcing and exporting high-quali...
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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
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Revatio-Generic
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 12, 2023
Lead Product(s) : Sildenafil Citrate
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
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 : Other Small Molecule
Upfront Cash : Inapplicable
March 12, 2023
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
Therapeutic Area: Psychiatry/Psychology Brand Name: SST-6007
Study Phase: Phase IIProduct Type: Other Small Molecule
Sponsor: Lincoln Park Capital Fund
Deal Size: $15.0 million Upfront Cash: Undisclosed
Deal Type: Agreement October 21, 2024
Lead Product(s) : Sildenafil Citrate
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 : SST-6007
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
October 21, 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
Therapeutic Area: Psychiatry/Psychology Brand Name: ASP-001
Study Phase: Phase IProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 30, 2024
Lead Product(s) : Sildenafil Citrate
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Inapplicable
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 : ASP-001
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
July 30, 2024
Details:
SST-6007 (Sildenafil Citrate) is a topical PDE-5 inhibitor. It is being evaluated in phase 2 clinical trials in women with female sexual arousal disorder.
Lead Product(s): Sildenafil Citrate
Therapeutic Area: Psychiatry/Psychology Brand Name: SST-6007
Study Phase: Phase IIProduct Type: Other Small Molecule
Sponsor: Strategic Science & Technologies
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 31, 2024
Lead Product(s) : Sildenafil Citrate
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Strategic Science & Technologies
Deal Size : Inapplicable
Deal Type : Inapplicable
Dare Bioscience Reports Positive Phase 2 Meeting on Sildenafil for Female SAD
Details : SST-6007 (Sildenafil Citrate) is a topical PDE-5 inhibitor. It is being evaluated in phase 2 clinical trials in women with female sexual arousal disorder.
Product Name : SST-6007
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
January 31, 2024
Details:
The net proceeds will support the development of Dare’s late-stage candidates, including SST-6007, a first-in-class topical sildenafil product candidate in development as an over-the-counter treatment for Female Sexual Arousal Disorder.
Lead Product(s): Sildenafil Citrate
Therapeutic Area: Psychiatry/Psychology Brand Name: SST-6007
Study Phase: Phase IIProduct Type: Other Small Molecule
Sponsor: Undisclosed
Deal Size: $12.0 million Upfront Cash: Undisclosed
Deal Type: Financing December 26, 2023
Lead Product(s) : Sildenafil Citrate
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : $12.0 million
Deal Type : Financing
Daré Bioscience Secures $12 million in Royalty-backed Investment Structure
Details : The net proceeds will support the development of Dare’s late-stage candidates, including SST-6007, a first-in-class topical sildenafil product candidate in development as an over-the-counter treatment for Female Sexual Arousal Disorder.
Product Name : SST-6007
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
December 26, 2023
Details:
SST-6007 (sildenafil citrate) cream is applied locally to the vaginal tissue prior to sexual activity to facilitate vasodilation and increase blood flow directly to the genital tissue to improve the physical arousal responsein womens with FSAD.
Lead Product(s): Sildenafil Citrate
Therapeutic Area: Psychiatry/Psychology Brand Name: SST-6007
Study Phase: Phase IIProduct Type: Other Small Molecule
Sponsor: Strategic Science & Technologies
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 07, 2023
Lead Product(s) : Sildenafil Citrate
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Strategic Science & Technologies
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : SST-6007 (sildenafil citrate) cream is applied locally to the vaginal tissue prior to sexual activity to facilitate vasodilation and increase blood flow directly to the genital tissue to improve the physical arousal responsein womens with FSAD.
Product Name : SST-6007
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
November 07, 2023
Details:
Sildenafil oral suspension is an oral liquid suspension of sildenafil citrate administered via a metered-dose pump that dispenses 12.5 mg of sildenafil per actuation act as phosphodiesterase-5 inhibitor, which being investigated for the treatment of erectile dysfunction.
Lead Product(s): Sildenafil Citrate
Therapeutic Area: Psychiatry/Psychology Brand Name: ASP-001
Study Phase: Phase IProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 19, 2023
Lead Product(s) : Sildenafil Citrate
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Sildenafil oral suspension is an oral liquid suspension of sildenafil citrate administered via a metered-dose pump that dispenses 12.5 mg of sildenafil per actuation act as phosphodiesterase-5 inhibitor, which being investigated for the treatment of erec...
Product Name : ASP-001
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 19, 2023
Details:
Lybrido is a novel combination tablet, consisting of a testosterone coating for sublingual administration and an inner-core component containing the PDE-5 inhibitor, sildenafil. It increases central sexual motivation and physiological sexual responses.
Lead Product(s): Sildenafil Citrate
Therapeutic Area: Psychiatry/Psychology Brand Name: Lybrido
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 05, 2023
Lead Product(s) : Sildenafil Citrate
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Lybrido is a novel combination tablet, consisting of a testosterone coating for sublingual administration and an inner-core component containing the PDE-5 inhibitor, sildenafil. It increases central sexual motivation and physiological sexual responses.
Product Name : Lybrido
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 05, 2023
Details:
Daré intends to use the proceeds for the development of SST-6007 (sildenafil citrate), a proprietary cream formulation that is specifically designed to locally increase blood flow to the vulvar-vaginal tissue in women, for Female Sexual Arousal Disorder (FSAD).
Lead Product(s): Sildenafil Citrate
Therapeutic Area: Psychiatry/Psychology Brand Name: SST-6007
Study Phase: Phase IIProduct Type: Other Small Molecule
Sponsor: Undisclosed
Deal Size: $7.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering August 30, 2023
Lead Product(s) : Sildenafil Citrate
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : $7.0 million
Deal Type : Public Offering
Daré Bioscience Announces $7.0 Million Registered Direct Offering Priced at-the-Market under Nasd...
Details : Daré intends to use the proceeds for the development of SST-6007 (sildenafil citrate), a proprietary cream formulation that is specifically designed to locally increase blood flow to the vulvar-vaginal tissue in women, for Female Sexual Arousal Disorder...
Product Name : SST-6007
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
August 30, 2023
Details:
Mango (sildenafil citrate) mango-flavored, rapid dissolve tablet is a Phosphodiesterase-5 inhibitor, which is being indicated for the treatment of erectile dysfunction.
Lead Product(s): Sildenafil Citrate,L-Arginine,Oxytocin
Therapeutic Area: Psychiatry/Psychology Brand Name: Mango
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 16, 2023
Lead Product(s) : Sildenafil Citrate,L-Arginine,Oxytocin
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Mango (sildenafil citrate) mango-flavored, rapid dissolve tablet is a Phosphodiesterase-5 inhibitor, which is being indicated for the treatment of erectile dysfunction.
Product Name : Mango
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
August 16, 2023
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
Suanfarma, at the Core of a Better Life.
CAS Number : 530-62-1
End Use API : Sildenafil Citrate
About The Company : Suanfarma founded in 1993, is a B2B life science partner committed to health advancement by developing, manufacturing, & distributing high-quality APIs for the ...
Zeon Pharma is a manufacturer and supplier of APIs & Intermediates.
1-methyl-4-nitro-3-n-propylpyrazole-5-carboxamide
CAS Number : 139756-01-7
End Use API : Sildenafil Citrate
About The Company : Zeon Pharma Industries India Pvt ltd is an ISO & GMP certified manufacturer of Bulk drugs & Intermediate and also supplies our associate manufacturing plant API...
Zeon Pharma is a manufacturer and supplier of APIs & Intermediates.
4-Amino-1-Methyl-3-Propyl Pyrazole-5-Carboxamide
CAS Number : 139756-02-8
End Use API : Sildenafil Citrate
About The Company : Zeon Pharma Industries India Pvt ltd is an ISO & GMP certified manufacturer of Bulk drugs & Intermediate and also supplies our associate manufacturing plant API...
Zeon Pharma is a manufacturer and supplier of APIs & Intermediates.
1-(3-(4,7-Dihydro-1methyl-7-oxo-3-propyl-1H-pyrazo...
CAS Number : 139756-22-2
End Use API : Sildenafil Citrate
About The Company : Zeon Pharma Industries India Pvt ltd is an ISO & GMP certified manufacturer of Bulk drugs & Intermediate and also supplies our associate manufacturing plant API...
Zeon Pharma is a manufacturer and supplier of APIs & Intermediates.
1-methyl-3-n-propylpyrazole-5-carboxylic acid
CAS Number : 139755-99-0
End Use API : Sildenafil Citrate
About The Company : Zeon Pharma Industries India Pvt ltd is an ISO & GMP certified manufacturer of Bulk drugs & Intermediate and also supplies our associate manufacturing plant API...
Zeon Pharma is a manufacturer and supplier of APIs & Intermediates.
1-methyl-4-nitro-3-n-propylpyrazole-5-carboxylic a...
CAS Number : 139756-00-6
End Use API : Sildenafil Citrate
About The Company : Zeon Pharma Industries India Pvt ltd is an ISO & GMP certified manufacturer of Bulk drugs & Intermediate and also supplies our associate manufacturing plant API...
Zeon Pharma is a manufacturer and supplier of APIs & Intermediates.
4-2-Ethoxy-5-(4-Methyl Piperazine-1-yl) Sulfonyl B...
CAS Number : 200575-15-1
End Use API : Sildenafil Citrate
About The Company : Zeon Pharma Industries India Pvt ltd is an ISO & GMP certified manufacturer of Bulk drugs & Intermediate and also supplies our associate manufacturing plant API...
N, N-Carbonyldiimidazole (CDI)
CAS Number : 530-62-1
End Use API : Sildenafil Citrate
About The Company : Scimplify is a science-first company specializing in end-to-end development and manufacturing of specialty chemicals. We support the entire product life cycle, ...
CAS Number : 530-62-1
End Use API : Sildenafil Citrate
About The Company : Shamrock Medicaments Ltd, formerly known as Doctor Lifeline Remedies India Ltd, has an intriguing evolution. Established within the robust Shamrock Group in 200...
4-Nitro-1-methyl-3n-propyl pyrazole-5- carboxamide
CAS Number : 139756-01-7
End Use API : Sildenafil Citrate
About The Company : Smilax Laboratories Limited is a research-driven, vertically integrated pharmaceutical company manufacturing Active Pharmaceutical Ingredients, API Intermediate...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
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 : 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 : Generic
Registration Country : United Kingdom
Brand Name :
Dosage Form : TABLET
Dosage Strength : 100MG
Packaging :
Approval Date :
Application Number : 202255
Regulatory Info : Generic
Registration Country : United Kingdom
Regulatory Info : Generic US CTD
Registration Country : United Kingdom
Brand Name :
Dosage Form : TABLET
Dosage Strength : 25MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Generic US CTD
Registration Country : United Kingdom
Regulatory Info :
Registration Country : Sweden
Brand Name : Revatio
Dosage Form : PULVER TILL ORAL SUSPENSION
Dosage Strength : 10 MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Italy
Brand Name : Viagra
Dosage Form :
Dosage Strength : 8 Cpr 50 Mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Australia
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]South Africa
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Dossiers
Athena Pharmaceutiques is a Partner of Choice for Drug Delivery & Life Cycle Management.
Regulatory Info :
Registration Country : France
Brand Name : Sildenafil
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 : Sildenafil
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 : Sildenafil
Dosage Form : Oro-Dispersible Tablet
Dosage Strength : 100MG
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 : 100MG
Brand Name : Sildenafil
Approval Date :
Application Number :
Registration Country : France
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Brand Name : Sildenafil Citrate
Dosage Form : DC Granules
Dosage Strength : 25MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Packaging :
Regulatory Info :
Dosage : DC Granules
Dosage Strength : 25MG
Brand Name : Sildenafil Citrate
Approval Date :
Application Number :
Registration Country : India
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Brand Name : Sildenafil Citrate
Dosage Form : DC Granules
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Packaging :
Regulatory Info :
Dosage : DC Granules
Dosage Strength : 50MG
Brand Name : Sildenafil Citrate
Approval Date :
Application Number :
Registration Country : India
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Brand Name : Sildenafil Citrate
Dosage Form : DC Granules
Dosage Strength : 100MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Packaging :
Regulatory Info :
Dosage : DC Granules
Dosage Strength : 100MG
Brand Name : Sildenafil Citrate
Approval Date :
Application Number :
Registration Country : India
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Brand Name : Sildenafil Citrate
Dosage Form : Tablet
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Octavius Pharma 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 : Sildenafil Citrate
Approval Date :
Application Number :
Registration Country : India
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Brand Name : Sildenafil Citrate
Dosage Form : Tablet
Dosage Strength : 100MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Octavius Pharma 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 : Sildenafil Citrate
Approval Date :
Application Number :
Registration Country : India
Octavius Pharma 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 : Sildenafil Citrate; Da...
Dosage Form : DC Granules
Dosage Strength : 50MG; 30MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Packaging :
Regulatory Info :
Sildenafil Citrate; Dapoxetine Hydrochloride
Dosage : DC Granules
Dosage Strength : 50MG; 30MG
Brand Name : Sildenafil Citrate; Da...
Approval Date :
Application Number :
Registration Country : India
Octavius Pharma 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 : Sildenafil Citrate; Da...
Dosage Form : DC Granules
Dosage Strength : 100MG; 60MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Packaging :
Regulatory Info :
Sildenafil Citrate; Dapoxetine Hydrochloride
Dosage : DC Granules
Dosage Strength : 100MG; 60MG
Brand Name : Sildenafil Citrate; Da...
Approval Date :
Application Number :
Registration Country : India
Octavius Pharma 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 : Sildenafil Citrate; Da...
Dosage Form : Tablet
Dosage Strength : 50MG; 30MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Octavius Pharma 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 : Sildenafil Citrate; Da...
Approval Date :
Application Number :
Registration Country : India
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
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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DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Tablet
Grade : Oral
Application : Emulsifying Agents
Excipient Details : HDK N20 Pharma is used as a pharmaceutical emulsifying agent in tablets, capsules, syrups, and solutions.
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Suspension
Grade : Oral, Topical
Application : Rheology Modifiers
Excipient Details : HPMC 60HD4000 is used as thickener and viscosity modifier in oral solid, liquid and topical dosage forms.
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Suspension
Grade : Oral
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Tablet
Grade : Oral
Brand Name : Titanium dioxide PRETIOX ...
Application : Coloring Agents
Excipient Details : Titanium dioxide Pretiox AV01FG is used as a coloring and coating agent in oral solid dosage forms such as capsules, tablets, granules, and pellets.
Pharmacopoeia Ref : Fami-QS, Kosher, Halal, OHSAS ...
Technical Specs : Ti 59.95% and O 40.05%
Ingredient(s) : Titanium Dioxide
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Tablet
Grade : Oral
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Suspension
Grade : Topical, Oral
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Suspension
Grade : Topical, Oral
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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 citro; sildenafil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of citro; sildenafil, including repackagers and relabelers. The FDA regulates citro; sildenafil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. citro; sildenafil API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of citro; sildenafil manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A citro; sildenafil supplier is an individual or a company that provides citro; sildenafil active pharmaceutical ingredient (API) or citro; sildenafil finished formulations upon request. The citro; sildenafil suppliers may include citro; sildenafil API manufacturers, exporters, distributors and traders.
click here to find a list of citro; sildenafil suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A citro; sildenafil DMF (Drug Master File) is a document detailing the whole manufacturing process of citro; sildenafil active pharmaceutical ingredient (API) in detail. Different forms of citro; sildenafil DMFs exist exist since differing nations have different regulations, such as citro; sildenafil USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A citro; sildenafil DMF submitted to regulatory agencies in the US is known as a USDMF. citro; sildenafil USDMF includes data on citro; sildenafil's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The citro; sildenafil USDMF is kept confidential to protect the manufacturer’s intellectual property.
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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 citro; sildenafil Drug Master File in Japan (citro; sildenafil JDMF) empowers citro; sildenafil API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the citro; sildenafil JDMF during the approval evaluation for pharmaceutical products. At the time of citro; sildenafil JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of citro; sildenafil suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a citro; sildenafil Drug Master File in Korea (citro; sildenafil KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of citro; sildenafil. The MFDS reviews the citro; sildenafil KDMF as part of the drug registration process and uses the information provided in the citro; sildenafil KDMF to evaluate the safety and efficacy of the drug.
After submitting a citro; sildenafil KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their citro; sildenafil API can apply through the Korea Drug Master File (KDMF).
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A citro; sildenafil CEP of the European Pharmacopoeia monograph is often referred to as a citro; sildenafil Certificate of Suitability (COS). The purpose of a citro; sildenafil CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of citro; sildenafil EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of citro; sildenafil to their clients by showing that a citro; sildenafil CEP has been issued for it. The manufacturer submits a citro; sildenafil CEP (COS) as part of the market authorization procedure, and it takes on the role of a citro; sildenafil CEP holder for the record. Additionally, the data presented in the citro; sildenafil CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the citro; sildenafil DMF.
A citro; sildenafil CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. citro; sildenafil CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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A citro; sildenafil written confirmation (citro; sildenafil WC) is an official document issued by a regulatory agency to a citro; sildenafil manufacturer, verifying that the manufacturing facility of a citro; sildenafil active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting citro; sildenafil APIs or citro; sildenafil finished pharmaceutical products to another nation, regulatory agencies frequently require a citro; sildenafil WC (written confirmation) as part of the regulatory process.
click here to find a list of citro; sildenafil suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing citro; sildenafil as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for citro; sildenafil API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture citro; sildenafil as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain citro; sildenafil and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a citro; sildenafil NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of citro; sildenafil suppliers with NDC on PharmaCompass.
citro; sildenafil Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of citro; sildenafil 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 citro; sildenafil GMP manufacturer or citro; sildenafil GMP API supplier for your needs.
A citro; sildenafil CoA (Certificate of Analysis) is a formal document that attests to citro; sildenafil's compliance with citro; sildenafil specifications and serves as a tool for batch-level quality control.
citro; sildenafil CoA mostly includes findings from lab analyses of a specific batch. For each citro; sildenafil CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
citro; sildenafil may be tested according to a variety of international standards, such as European Pharmacopoeia (citro; sildenafil EP), citro; sildenafil JP (Japanese Pharmacopeia) and the US Pharmacopoeia (citro; sildenafil USP).
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