Synopsis
Synopsis
0
VMF
DRUG PRODUCT COMPOSITIONS0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
| 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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API Imports and Exports
| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
|---|
Upgrade, download data, analyse, strategize, subscribe with us 
Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATES SUPPLIERS
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 : Turkey
Brand Name : Vigaroo
Dosage Form : Film Coated Tablet
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : Turkey
Regulatory Info : Generic
Registration Country : United Kingdom
Brand Name :
Dosage Form : TABLET
Dosage Strength : 25MG
Packaging :
Approval Date :
Application Number : 202255
Regulatory Info : Generic
Registration Country : United Kingdom
Regulatory Info :
Registration Country : Sweden
Brand Name : OLVION
Dosage Form : FILM COATED PILL
Dosage Strength : 50 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Norway
Brand Name : Viagra
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 25 mg
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Revatio
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 20 mg
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
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 :
Dosage Form : Oro-Dispersible Tablet
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : France
Athena Pharmaceutiques is a Partner of Choice for Drug Delivery & Life Cycle Management.
Packaging :
Regulatory Info :
Dosage : Oro-Dispersible Tablet
Dosage Strength : 50MG
Brand Name :
Approval Date :
Application Number :
Registration Country : France
Athena Pharmaceutiques is a Partner of Choice for Drug Delivery & Life Cycle Management.
Regulatory Info :
Registration Country : France
Brand Name :
Dosage Form : Oro-Dispersible Tablet
Dosage Strength : 100MG
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 :
Approval Date :
Application Number :
Registration Country : France
Athena Pharmaceutiques is a Partner of Choice for Drug Delivery & Life Cycle Management.
Regulatory Info :
Registration Country : France
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 20MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : France
Athena Pharmaceutiques is a Partner of Choice for Drug Delivery & Life Cycle Management.
Packaging :
Regulatory Info :
Dosage : Film Coated Tablet
Dosage Strength : 20MG
Brand Name :
Approval Date :
Application Number :
Registration Country : France
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Tablet
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Packaging :
Regulatory Info :
Dosage : Tablet
Dosage Strength : 50MG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Tablet
Dosage Strength : 100MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Packaging :
Regulatory Info :
Dosage : Tablet
Dosage Strength : 100MG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Sildenafil Citrate; Dapoxetine Hydrochloride
Brand Name :
Dosage Form : Tablet
Dosage Strength : 50MG; 30MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Packaging :
Regulatory Info :
Sildenafil Citrate; Dapoxetine Hydrochloride
Dosage : Tablet
Dosage Strength : 50MG; 30MG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info : DMF Available|FDF Compliance-U...
Registration Country : India
Brand Name :
Dosage Form : DC Granules
Dosage Strength : 25MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : DMF Available|FDF Compliance-U...
Registration Country : India
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Packaging :
Regulatory Info : DMF Available|FDF Compliance-U...
Dosage : DC Granules
Dosage Strength : 25MG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info : DMF Available|FDF Compliance-U...
Registration Country : India
Brand Name :
Dosage Form : DC Granules
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : DMF Available|FDF Compliance-U...
Registration Country : India
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Packaging :
Regulatory Info : DMF Available|FDF Compliance-U...
Dosage : DC Granules
Dosage Strength : 50MG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info : DMF Available|FDF Compliance-U...
Registration Country : India
Brand Name :
Dosage Form : DC Granules
Dosage Strength : 100MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : DMF Available|FDF Compliance-U...
Registration Country : India
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Packaging :
Regulatory Info : DMF Available|FDF Compliance-U...
Dosage : DC Granules
Dosage Strength : 100MG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info : DMF Available|FDF Compliance-I...
Registration Country : India
Sildenafil Citrate; Dapoxetine Hydrochloride
Brand Name :
Dosage Form : DC Granules
Dosage Strength : 50MG; 30MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : DMF Available|FDF Compliance-I...
Registration Country : India
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Packaging :
Regulatory Info : DMF Available|FDF Compliance-I...
Sildenafil Citrate; Dapoxetine Hydrochloride
Dosage : DC Granules
Dosage Strength : 50MG; 30MG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
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
Related Excipient Companies
Minakem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Rochem International Inc
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]SPI Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Seqens
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharm-RX Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Faran Shimi Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Chynops Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Well Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ACG Worldwide
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Actylis
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Aeon Procare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Alcedo Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Avesta Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Bioplus Life Sciences
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Clariant
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Corel Pharma Chem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DFE Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Finar
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ideal Cures Pvt Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ingredion Pharma Solutions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kerry
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kima Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Lonza Capsugel
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Microlex e.U
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NEWEDGE Overseas
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]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
Fillers, Diluents & Binders
Coating Systems & Additives
Controlled & Modified Release
Direct Compression
Thickeners and Stabilizers
Lubricants & Glidants
Disintegrants & Superdisintegrants
Film Formers & Plasticizers
Granulation
Co-Processed Excipients
Topical
Parenteral
Taste Masking
Solubilizers
Chewable & Orodispersible Aids
API Stability Enhancers
Empty Capsules
Emulsifying Agents
Rheology Modifiers
Vegetarian Capsules
Coloring Agents
Surfactant & Foaming Agents
Soft Gelatin
Digital Content
DATA COMPILATION #PharmaFlow
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]REF. STANDARDS & IMPURITIES
USP
ANALYTICAL
ABOUT THIS PAGE
A Sildenafil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sildenafil, including repackagers and relabelers. The FDA regulates Sildenafil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 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 Sildenafil manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sildenafil supplier is an individual or a company that provides Sildenafil active pharmaceutical ingredient (API) or Sildenafil finished formulations upon request. The Sildenafil suppliers may include Sildenafil API manufacturers, exporters, distributors and traders.
click here to find a list of Sildenafil suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sildenafil DMF (Drug Master File) is a document detailing the whole manufacturing process of Sildenafil active pharmaceutical ingredient (API) in detail. Different forms of Sildenafil DMFs exist exist since differing nations have different regulations, such as Sildenafil USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sildenafil DMF submitted to regulatory agencies in the US is known as a USDMF. Sildenafil USDMF includes data on Sildenafil's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sildenafil USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sildenafil suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Sildenafil Drug Master File in Japan (Sildenafil JDMF) empowers 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 Sildenafil JDMF during the approval evaluation for pharmaceutical products. At the time of 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 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 Sildenafil Drug Master File in Korea (Sildenafil KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Sildenafil. The MFDS reviews the Sildenafil KDMF as part of the drug registration process and uses the information provided in the Sildenafil KDMF to evaluate the safety and efficacy of the drug.
After submitting a 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 Sildenafil API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Sildenafil suppliers with KDMF on PharmaCompass.
A Sildenafil CEP of the European Pharmacopoeia monograph is often referred to as a Sildenafil Certificate of Suitability (COS). The purpose of a Sildenafil CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Sildenafil EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Sildenafil to their clients by showing that a Sildenafil CEP has been issued for it. The manufacturer submits a Sildenafil CEP (COS) as part of the market authorization procedure, and it takes on the role of a Sildenafil CEP holder for the record. Additionally, the data presented in the Sildenafil CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Sildenafil DMF.
A Sildenafil CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Sildenafil CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Sildenafil suppliers with CEP (COS) on PharmaCompass.
A Sildenafil written confirmation (Sildenafil WC) is an official document issued by a regulatory agency to a Sildenafil manufacturer, verifying that the manufacturing facility of a Sildenafil active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Sildenafil APIs or Sildenafil finished pharmaceutical products to another nation, regulatory agencies frequently require a Sildenafil WC (written confirmation) as part of the regulatory process.
click here to find a list of 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 Sildenafil as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for 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 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 Sildenafil and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sildenafil NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Sildenafil suppliers with NDC on PharmaCompass.
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 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 Sildenafil GMP manufacturer or Sildenafil GMP API supplier for your needs.
A Sildenafil CoA (Certificate of Analysis) is a formal document that attests to Sildenafil's compliance with Sildenafil specifications and serves as a tool for batch-level quality control.
Sildenafil CoA mostly includes findings from lab analyses of a specific batch. For each 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.
Sildenafil may be tested according to a variety of international standards, such as European Pharmacopoeia (Sildenafil EP), Sildenafil JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sildenafil USP).
LOOKING FOR A SUPPLIER?
