Synopsis
Synopsis
0
CEP/COS
0
JDMF
0
VMF
0
EDQM
0
USP
0
JP
0
Others
DRUG PRODUCT COMPOSITIONS
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
1. 5fe2o3.9h2o
2. Ferric Hydroxide Oxide
3. Ferric Hydroxide Oxide (feooh)
4. Ferric Oxy-hydroxide
5. Ferric Oxyhydroxide (feo2h)
6. Ferrihydrite
7. Iron Hydroxide Oxide (fe(oh)o)
8. Iron Hydroxide Oxide (feo(oh))
9. Iron(iii) Oxyhydroxide
1. Iron Hydroxide Oxide
2. Iron(3+);oxygen(2-);hydroxide
3. Iron Hydroxide Oxide Nanoparticles / Nanopowder
4. Iron Oxide Hydroxide
5. Iron Hydroxide Nanorods
6. Ferric Oxy-hydroxide
7. Ferric Hydroxide [mi]
8. Dtxsid3042057
9. Ferric Oxyhydroxide (feo2h)
10. Ferric Hydroxide Oxide (feooh)
11. Db14695
12. Iron Hydroxide Oxide (feo(oh))
13. Iron Oxide Hydroxide, Aqueous Nanoparticle Dispersion, <5 Nm (dls), 20% Solids By Weight, Ph ~3, 99.5% Trace Metals Basis
1. Feojectin
2. Ferplex Ss
3. Ferrivenin
4. Iviron
5. Proferrin
6. Sucrofer
7. Iron Sugar
8. Saccharated Iron
9. Venoferrum
10. Fesin
11. Ferrum Vitis
12. Hippiron
13. Ferum Hausmann
Molecular Weight | 88.85 g/mol |
---|---|
Molecular Formula | FeHO2 |
Hydrogen Bond Donor Count | 1 |
Hydrogen Bond Acceptor Count | 2 |
Rotatable Bond Count | 0 |
Exact Mass | 88.932590 g/mol |
Monoisotopic Mass | 88.932590 g/mol |
Topological Polar Surface Area | 2 Ų |
Heavy Atom Count | 3 |
Formal Charge | 0 |
Complexity | 0 |
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 | 3 |
1 of 2 | |
---|---|
Drug Name | Velphoro |
PubMed Health | Sucroferric Oxyhydroxide (By mouth) |
Drug Classes | Phosphate Binder |
Active Ingredient | Sucroferric oxyhydroxide |
Dosage Form | Tablet, chewable |
Route | Oral |
Strength | 500mg |
Market Status | Prescription |
Company | Vifor Fresenius |
2 of 2 | |
---|---|
Drug Name | Velphoro |
PubMed Health | Sucroferric Oxyhydroxide (By mouth) |
Drug Classes | Phosphate Binder |
Active Ingredient | Sucroferric oxyhydroxide |
Dosage Form | Tablet, chewable |
Route | Oral |
Strength | 500mg |
Market Status | Prescription |
Company | Vifor Fresenius |
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-08-04
Pay. Date : 2016-07-14
DMF Number : 28865
Submission : 2016-07-07
Status : Active
Type : II
Date of Issue : 2022-07-28
Valid Till : 2025-11-30
Written Confirmation Number : WC-0390
Address of the Firm :
Available Reg Filing : BR |
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33643
Submission : 2019-03-30
Status : Active
Type : II
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Date of Issue : 2022-05-27
Valid Till : 2025-05-20
Written Confirmation Number : WC-0001A2
Address of the Firm :
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34957
Submission : 2020-06-30
Status : Active
Type : II
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-11-10
Pay. Date : 2023-09-28
DMF Number : 38610
Submission : 2023-07-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31315
Submission : 2017-01-03
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-04-26
Pay. Date : 2019-02-19
DMF Number : 33020
Submission : 2018-08-09
Status : Active
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2016-08-04
Pay. Date : 2016-07-14
DMF Number : 28865
Submission : 2016-07-07
Status : Active
Type : II
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2023-11-10
Pay. Date : 2023-09-28
DMF Number : 38610
Submission : 2023-07-31
Status : Active
Type : II
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34957
Submission : 2020-06-30
Status : Active
Type : II
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33643
Submission : 2019-03-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18261
Submission : 2005-04-11
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18015
Submission : 2005-01-12
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-31
Pay. Date : 2013-01-09
DMF Number : 18390
Submission : 2005-05-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-03-17
Pay. Date : 2022-03-14
DMF Number : 19544
Submission : 2006-06-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13245
Submission : 1998-09-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-08-20
Pay. Date : 2014-06-03
DMF Number : 27958
Submission : 2014-05-30
Status : Active
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfoli...
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
About the Company : Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediates and biological 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...
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, ...
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 ...
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
About the Company : Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...
About the Company : Emcure Pharmaceuticals Ltd. is a fast-growing fully integrated Indian pharmaceutical company with a global presence engaged in developing, manufacturing, and marketing a broad rang...
About the Company : Krufren Pharma serves as a reliable partner in research and development (R&D) and manufacturing, dedicated to translating your concepts into impactful solutions and maintaining a c...
About the Company : Laxmidas Dahyabhai & Co. (LDCO) was established in the year 1928. Appointed as a distributor for few Ayurvedic companies to cater to South Mumbai, today we are a distributor for mo...
API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
---|
Upgrade, download data, analyse, strategize, subscribe with us
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
RLD : No
TE Code :
Brand Name : IRON DEXTRAN
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 50MG IRON/ML
Approval Date : 1982-01-01
Application Number : 10787
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
RLD : Yes
TE Code : AB
Brand Name : FERRLECIT
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)
Approval Date : 1999-02-18
Application Number : 20955
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB
RLD : Yes
TE Code : BP
Brand Name : INFED
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 100MG IRON/2ML (EQ 50MG IRON/ML)
Approval Date : 1982-01-01
Application Number : 17441
RX/OTC/DISCN : RX
RLD : Yes
TE Code : BP
RLD : Yes
TE Code :
Brand Name : VENOFER
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : EQ 100MG IRON/5ML (EQ 20MG IRON/ML)
Approval Date : 2000-11-06
Application Number : 21135
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : VENOFER
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML)
Approval Date : 2005-03-20
Application Number : 21135
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : No
TE Code :
Brand Name : VENOFER
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : EQ 75MG IRON/3.75ML (EQ 20MG IRON/ML)
Approval Date : 2005-03-29
Application Number : 21135
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : Yes
TE Code :
Brand Name : VENOFER
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : EQ 200MG IRON/10ML (EQ 20MG IRON/ML)
Approval Date : 2007-02-09
Application Number : 21135
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : No
TE Code :
Brand Name : DEXFERRUM
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 50MG IRON/ML
Approval Date : 1996-02-23
Application Number : 40024
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : Yes
TE Code :
Brand Name : VELPHORO
Dosage Form : TABLET, CHEWABLE;ORAL
Dosage Strength : EQ 500MG IRON
Approval Date : 2013-11-27
Application Number : 205109
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : No
TE Code : AB
Brand Name : SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)
Approval Date : 2011-03-31
Application Number : 78215
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : Lead Market Dossiers- Filed
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 100MG/5ML
Packaging :
Approval Date :
Application Number :
Regulatory Info : Lead Market Dossiers- Filed
Registration Country : India
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Packaging :
Regulatory Info : Lead Market Dossiers- Filed
Dosage : Injection
Dosage Strength : 100MG/5ML
Brand Name :
Approval Date :
Application Number :
Registration Country : India
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : Lead Market Dossiers- Filed
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 200MG/10ML
Packaging :
Approval Date :
Application Number :
Regulatory Info : Lead Market Dossiers- Filed
Registration Country : India
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Packaging :
Regulatory Info : Lead Market Dossiers- Filed
Dosage : Injection
Dosage Strength : 200MG/10ML
Brand Name :
Approval Date :
Application Number :
Registration Country : India
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : Lead Market Dossiers- Filed
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 50MG/2.5ML
Packaging :
Approval Date :
Application Number :
Regulatory Info : Lead Market Dossiers- Filed
Registration Country : India
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Packaging :
Regulatory Info : Lead Market Dossiers- Filed
Dosage : Injection
Dosage Strength : 50MG/2.5ML
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Tablet
Dosage Strength : 500MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
Packaging :
Regulatory Info :
Dosage : Tablet
Dosage Strength : 500MG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info : USA
Registration Country : Greece
Brand Name :
Dosage Form : Injection For Intraven...
Dosage Strength : 50MG/2.5ML
Packaging :
Approval Date :
Application Number :
Regulatory Info : USA
Registration Country : Greece
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Packaging :
Regulatory Info : USA
Dosage : Injection For Intraven...
Dosage Strength : 50MG/2.5ML
Brand Name :
Approval Date :
Application Number :
Registration Country : Greece
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info : USA
Registration Country : Greece
Brand Name :
Dosage Form : Injection For Intraven...
Dosage Strength : 100MG/5ML
Packaging :
Approval Date :
Application Number :
Regulatory Info : USA
Registration Country : Greece
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Packaging :
Regulatory Info : USA
Dosage : Injection For Intraven...
Dosage Strength : 100MG/5ML
Brand Name :
Approval Date :
Application Number :
Registration Country : Greece
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info : USA
Registration Country : Greece
Brand Name :
Dosage Form : Injection For Intraven...
Dosage Strength : 200MG/10ML
Packaging :
Approval Date :
Application Number :
Regulatory Info : USA
Registration Country : Greece
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Packaging :
Regulatory Info : USA
Dosage : Injection For Intraven...
Dosage Strength : 200MG/10ML
Brand Name :
Approval Date :
Application Number :
Registration Country : Greece
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 5ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Dosage : Injection
Dosage Strength : 5ML
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 100MG/5ML
Packaging : Ampoule
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging : Ampoule
Regulatory Info :
Dosage : Injection
Dosage Strength : 100MG/5ML
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 50MG/2.5ML
Packaging : Ampoule
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging : Ampoule
Regulatory Info :
Dosage : Injection
Dosage Strength : 50MG/2.5ML
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Related Excipient Companies
Dosage Form : Capsule
Grade : Oral
Application : Fillers, Diluents & Binders
Excipient Details : It is used as an adhesive agent.
Pharmacopoeia Ref : Not Available
Technical Specs : Also Available as AnyCoat®-C AN3, AN4, AN5, AN6, AN15, AN50, BN4
Ingredient(s) : Hydroxypropyl Methyl Cellulose
Dosage Form : Tablet
Grade : Oral
Application : Fillers, Diluents & Binders
Excipient Details : It is used as a filler in formulation.
Pharmacopoeia Ref : Not Available
Technical Specs : Also Available as Comprecel M102, M102CG, M103, M105, M124, M113, M200, M224, M301, M302
Ingredient(s) : Microcrystalline Cellulose
Dosage Form : Capsule
Grade : Not Available
Application : Disintegrants & Superdisintegrants
Excipient Details : It is used as a disintegrating agent.
Pharmacopoeia Ref : Not Available
Technical Specs : Also Available as Disolcel® GF
Ingredient(s) : Croscarmellose Sodium
Dosage Form : Tablet
Grade : Oral
Application : Lubricants & Glidants
Excipient Details : It is used as a lubricant.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Magnesium Stearate
Dosage Form : Capsule
Grade : Oral
Application : Fillers, Diluents & Binders
Excipient Details : It is used as a filler in formulation.
Dosage Form : Injectable / Parenteral
Grade : Not Available
Application : Parenteral
Excipient Details : Fructose injection is supplements of the energy and fluid, fructose easier forms glycogen than glucose
Pharmacopoeia Ref : CP/BP/ EP/ USP/IP
Technical Specs : Pharma Grade/Food Grade
Ingredient(s) : Fructose
Excipients by Applications
Global Sales Information
Market Place
Patents & EXCLUSIVITIES
ABOUT THIS PAGE
38
PharmaCompass offers a list of Sucroferric Oxyhydroxide 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 Sucroferric Oxyhydroxide manufacturer or Sucroferric Oxyhydroxide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sucroferric Oxyhydroxide manufacturer or Sucroferric Oxyhydroxide supplier.
PharmaCompass also assists you with knowing the Sucroferric Oxyhydroxide API Price utilized in the formulation of products. Sucroferric Oxyhydroxide API Price is not always fixed or binding as the Sucroferric Oxyhydroxide Price is obtained through a variety of data sources. The Sucroferric Oxyhydroxide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Velphoro manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Velphoro, including repackagers and relabelers. The FDA regulates Velphoro manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Velphoro 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 Velphoro manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Velphoro supplier is an individual or a company that provides Velphoro active pharmaceutical ingredient (API) or Velphoro finished formulations upon request. The Velphoro suppliers may include Velphoro API manufacturers, exporters, distributors and traders.
click here to find a list of Velphoro suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Velphoro DMF (Drug Master File) is a document detailing the whole manufacturing process of Velphoro active pharmaceutical ingredient (API) in detail. Different forms of Velphoro DMFs exist exist since differing nations have different regulations, such as Velphoro USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Velphoro DMF submitted to regulatory agencies in the US is known as a USDMF. Velphoro USDMF includes data on Velphoro's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Velphoro USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Velphoro suppliers with USDMF 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 Velphoro Drug Master File in Korea (Velphoro KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Velphoro. The MFDS reviews the Velphoro KDMF as part of the drug registration process and uses the information provided in the Velphoro KDMF to evaluate the safety and efficacy of the drug.
After submitting a Velphoro 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 Velphoro API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Velphoro suppliers with KDMF on PharmaCompass.
A Velphoro written confirmation (Velphoro WC) is an official document issued by a regulatory agency to a Velphoro manufacturer, verifying that the manufacturing facility of a Velphoro active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Velphoro APIs or Velphoro finished pharmaceutical products to another nation, regulatory agencies frequently require a Velphoro WC (written confirmation) as part of the regulatory process.
click here to find a list of Velphoro 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 Velphoro as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Velphoro 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 Velphoro 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 Velphoro and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Velphoro NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Velphoro suppliers with NDC on PharmaCompass.
Velphoro 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 Velphoro 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 Velphoro GMP manufacturer or Velphoro GMP API supplier for your needs.
A Velphoro CoA (Certificate of Analysis) is a formal document that attests to Velphoro's compliance with Velphoro specifications and serves as a tool for batch-level quality control.
Velphoro CoA mostly includes findings from lab analyses of a specific batch. For each Velphoro 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.
Velphoro may be tested according to a variety of international standards, such as European Pharmacopoeia (Velphoro EP), Velphoro JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Velphoro USP).