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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
Willow Birch Pharma delivers trusted, high-quality APIs nationwide with unmatched service, compliance, and competitive value.
NDC Package Code : 10695-329
Start Marketing Date : 2026-01-08
End Marketing Date : 2027-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
Century has been an API manufacturer for over 40 years & is the partner of choice for multipurpose custom manufacturing projects.
Date of Issue : 2025-10-07
Valid Till : 2028-10-06
Written Confirmation Number : WC-0293
Address of the Firm :
European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.
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 |
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.
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
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
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Willow Birch Pharma delivers trusted, high-quality APIs nationwide with unmatched service, compliance, and competitive value.
About the Company : Willow Birch Pharma, Inc. is a premier supplier of bulk APIs to North American Compounding Pharmacies, sourcing from FDA registered and GMP manufacturers. With licenses in all 50 s...
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 manufacturing APIs for major pharma companies in India and abroad. Its products are made in compliance with...
European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.
About the Company : Polpharma API, a division of a leading Polish pharmaceutical group, has over 75 years of expertise in process development and cGMP manufacturing. Based at an FDA-approved site in C...
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
About the Company : Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&...
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 pharmaceutical and biotech industries. LGM also operates as a full-service CDMO, offering formulat...
Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales, founded in 1999, is a global distributor specializing in high-quality pharmaceutical ingredients from India. It offers complete sourcing solutions, technical and r...
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing...
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 experience in formulation development, manufacturing, and commercialization. Its portfoli...
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 9001:2015, cGMP, and WHO-GMP certified company with a dedicated manufacturing facility for Bulk Drugs (APIs), phytochemicals, herba...
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| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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Drugs in Development
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 is a B2B life sciences company focused on developing, manufacturing, and distributing high-quality ingredients for the pharmaceutical industry in an i...
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 9001:2015, cGMP, and WHO-GMP certified company with a dedicated manufacturing facility for Bulk Drugs (APIs), p...
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 9001:2015, cGMP, and WHO-GMP certified company with a dedicated manufacturing facility for Bulk Drugs (APIs), p...
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 9001:2015, cGMP, and WHO-GMP certified company with a dedicated manufacturing facility for Bulk Drugs (APIs), p...
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 9001:2015, cGMP, and WHO-GMP certified company with a dedicated manufacturing facility for Bulk Drugs (APIs), p...
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 9001:2015, cGMP, and WHO-GMP certified company with a dedicated manufacturing facility for Bulk Drugs (APIs), p...
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 9001:2015, cGMP, and WHO-GMP certified company with a dedicated manufacturing facility for Bulk Drugs (APIs), p...
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...
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Regulatory Info : Prescription
Registration Country : Denmark
Brand Name : Sildenafil \"Orion\"
Dosage Form : Film Coated Tablet
Dosage Strength : 100mg
Packaging :
Approval Date : 09-11-2017
Application Number : 28105884316
Regulatory Info : Prescription
Registration Country : Denmark
Regulatory Info : Prescription
Registration Country : Denmark
Brand Name : Sildenafil \"Orion\"
Dosage Form : Film Coated Tablet
Dosage Strength : 25mg
Packaging :
Approval Date : 09-11-2017
Application Number : 28105884116
Regulatory Info : Prescription
Registration Country : Denmark
Regulatory Info : Prescription
Registration Country : Denmark
Brand Name : Sildenafil \"Orion\"
Dosage Form : Film Coated Tablet
Dosage Strength : 50mg
Packaging :
Approval Date : 09-11-2017
Application Number : 28105884216
Regulatory Info : Prescription
Registration Country : Denmark
Regulatory Info : Deregistered
Registration Country : Sweden
Brand Name : Sildenafil Orion
Dosage Form : Film Coated Tablet
Dosage Strength : 25mg
Packaging :
Approval Date : 09-04-2010
Application Number : 2.01E+13
Regulatory Info : Deregistered
Registration Country : Sweden
Regulatory Info : Deregistered
Registration Country : Sweden
Brand Name : Sildenafil Orion
Dosage Form : Film Coated Tablet
Dosage Strength : 50mg
Packaging :
Approval Date : 09-04-2010
Application Number : 2.01E+13
Regulatory Info : Deregistered
Registration Country : Sweden
Regulatory Info : Deregistered
Registration Country : Sweden
Brand Name : Sildenafil Orion
Dosage Form : Film Coated Tablet
Dosage Strength : 100mg
Packaging :
Approval Date : 09-04-2010
Application Number : 2.01E+13
Regulatory Info : Deregistered
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Orisild
Dosage Form : Film Coated Tablet
Dosage Strength : 20mg
Packaging :
Approval Date : 23-09-2016
Application Number : 2.02E+13
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Sildenafil Orion
Dosage Form : Film Coated Tablet
Dosage Strength : 25mg
Packaging :
Approval Date : 05-12-2017
Application Number : 2.02E+13
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Sildenafil Orion
Dosage Form : Film Coated Tablet
Dosage Strength : 50mg
Packaging :
Approval Date : 05-12-2017
Application Number : 2.02E+13
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Sildenafil Orion
Dosage Form : Film Coated Tablet
Dosage Strength : 100mg
Packaging :
Approval Date : 05-12-2017
Application Number : 2.02E+13
Regulatory Info : Approved
Registration Country : Sweden
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DOSAGE - FOR SUSPENSION;ORAL - EQ 10MG BASE/M...DOSAGE - FOR SUSPENSION;ORAL - EQ 10MG BASE/ML
USFDA APPLICATION NUMBER - 203109
DOSAGE - TABLET;ORAL - EQ 100MG BASE
USFDA APPLICATION NUMBER - 20895
DOSAGE - TABLET;ORAL - EQ 25MG BASE
USFDA APPLICATION NUMBER - 20895
DOSAGE - TABLET;ORAL - EQ 50MG BASE
USFDA APPLICATION NUMBER - 20895
DOSAGE - TABLET;ORAL - EQ 20MG BASE
USFDA APPLICATION NUMBER - 21845
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ABOUT THIS PAGE
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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 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.
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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 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.
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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).
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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.
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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.
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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.
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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).
