Synopsis
Synopsis
0
VMF
DRUG PRODUCT COMPOSITIONS0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
| Molecular Weight | 136.11 g/mol |
|---|---|
| Molecular Formula | C5H4N4O |
| XLogP3 | -0.5 |
| Hydrogen Bond Donor Count | 2 |
| Hydrogen Bond Acceptor Count | 2 |
| Rotatable Bond Count | 0 |
| Exact Mass | 136.03851076 g/mol |
| Monoisotopic Mass | 136.03851076 g/mol |
| Topological Polar Surface Area | 65.8 A^2 |
| Heavy Atom Count | 10 |
| Formal Charge | 0 |
| Complexity | 275 |
| 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 | 1 |
| 1 of 10 | |
|---|---|
| Drug Name | Allopurinol |
| PubMed Health | Allopurinol |
| Drug Classes | Antigout, Urinary Stone Agent |
| Drug Label | Allopurinol is known chemically as 1,5-Dihydro-4H-pyrazolo[3,4-d ]pyrimidin-4-one. It is a xanthine oxidase inhibitor which is administered orally. Its solubility in water at 37C is 80 mg/dL and is greater in an alkaline solution. Allopurinol Table... |
| Active Ingredient | Allopurinol |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | 300mg; 100mg |
| Market Status | Prescription |
| Company | Watson Labs; Vintage Pharms; Ipca Labs; Mutual Pharm; Apotex; Accord Hlthcare; Sun Pharm Inds; Northstar Hlthcare; Mylan |
| 2 of 10 | |
|---|---|
| Drug Name | Allopurinol sodium |
| PubMed Health | Allopurinol (Injection) |
| Drug Classes | Antigout, Urinary Stone Agent |
| Drug Label | ALOPRIM (allopurinol sodium) for Injection is the brand name for allopurinol, a xanthine oxidase inhibitor. ALOPRIM (allopurinol sodium) for Injection is a sterile solution for intravenous infusion only. It is available in vials as the sterile lyophi... |
| Active Ingredient | Allopurinol sodium |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | eq 500mg base/vial |
| Market Status | Prescription |
| Company | Eurohlth Intl |
| 3 of 10 | |
|---|---|
| Drug Name | Aloprim |
| PubMed Health | Allopurinol |
| Drug Classes | Antigout, Urinary Stone Agent |
| Drug Label | ZYLOPRIM (allopurinol) has the following structural formula:ZYLOPRIM is known chemically as 1,5-dihydro-4H-pyrazolo [3,4-d]pyrimidin-4-one. It is a xanthine oxidase inhibitor which is administered orally. Each scored white tablet contains 100 mg allo... |
| Active Ingredient | Allopurinol sodium |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | eq 500mg base/vial |
| Market Status | Prescription |
| Company | Mylan Institutional |
| 4 of 10 | |
|---|---|
| Drug Name | Lopurin |
| Active Ingredient | Allopurinol |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | 300mg; 100mg |
| Market Status | Prescription |
| Company | Dr Reddys La |
| 5 of 10 | |
|---|---|
| Drug Name | Zyloprim |
| Active Ingredient | Allopurinol |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | 300mg; 100mg |
| Market Status | Prescription |
| Company | Prometheus Labs |
| 6 of 10 | |
|---|---|
| Drug Name | Allopurinol |
| PubMed Health | Allopurinol |
| Drug Classes | Antigout, Urinary Stone Agent |
| Drug Label | Allopurinol is known chemically as 1,5-Dihydro-4H-pyrazolo[3,4-d ]pyrimidin-4-one. It is a xanthine oxidase inhibitor which is administered orally. Its solubility in water at 37C is 80 mg/dL and is greater in an alkaline solution. Allopurinol Table... |
| Active Ingredient | Allopurinol |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | 300mg; 100mg |
| Market Status | Prescription |
| Company | Watson Labs; Vintage Pharms; Ipca Labs; Mutual Pharm; Apotex; Accord Hlthcare; Sun Pharm Inds; Northstar Hlthcare; Mylan |
| 7 of 10 | |
|---|---|
| Drug Name | Allopurinol sodium |
| PubMed Health | Allopurinol (Injection) |
| Drug Classes | Antigout, Urinary Stone Agent |
| Drug Label | ALOPRIM (allopurinol sodium) for Injection is the brand name for allopurinol, a xanthine oxidase inhibitor. ALOPRIM (allopurinol sodium) for Injection is a sterile solution for intravenous infusion only. It is available in vials as the sterile lyophi... |
| Active Ingredient | Allopurinol sodium |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | eq 500mg base/vial |
| Market Status | Prescription |
| Company | Eurohlth Intl |
| 8 of 10 | |
|---|---|
| Drug Name | Aloprim |
| PubMed Health | Allopurinol |
| Drug Classes | Antigout, Urinary Stone Agent |
| Drug Label | ZYLOPRIM (allopurinol) has the following structural formula:ZYLOPRIM is known chemically as 1,5-dihydro-4H-pyrazolo [3,4-d]pyrimidin-4-one. It is a xanthine oxidase inhibitor which is administered orally. Each scored white tablet contains 100 mg allo... |
| Active Ingredient | Allopurinol sodium |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | eq 500mg base/vial |
| Market Status | Prescription |
| Company | Mylan Institutional |
| 9 of 10 | |
|---|---|
| Drug Name | Lopurin |
| Active Ingredient | Allopurinol |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | 300mg; 100mg |
| Market Status | Prescription |
| Company | Dr Reddys La |
| 10 of 10 | |
|---|---|
| Drug Name | Zyloprim |
| Active Ingredient | Allopurinol |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | 300mg; 100mg |
| Market Status | Prescription |
| Company | Prometheus Labs |
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/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 
Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Allopurinol Zentiva
Dosage Form : Tabl
Dosage Strength : 100mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Allopurinol Zentiva
Dosage Form : Tabl
Dosage Strength : 300mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Allopurinol Zentiva
Dosage Form : Tabl
Dosage Strength : 300mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Aspen API. More than just an API™
Regulatory Info :
Registration Country : Sweden
Brand Name : Zyloric
Dosage Form : TABLET
Dosage Strength : 100 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Aspen API. More than just an API™
Regulatory Info :
Registration Country : Sweden
Brand Name : Zyloric
Dosage Form : TABLET
Dosage Strength : 300 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Aspen API. More than just an API™
Regulatory Info :
Registration Country : Norway
Brand Name : Zyloric
Dosage Form : Antic-calc Tablet
Dosage Strength : 100 mg
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Aspen API. More than just an API™
Regulatory Info :
Registration Country : Norway
Brand Name : Zyloric
Dosage Form : Antic-calc Tablet
Dosage Strength : 100 mg
Packaging : Box
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Aspen API. More than just an API™
Regulatory Info :
Registration Country : Norway
Brand Name : Zyloric
Dosage Form : Antic-calc Tablet
Dosage Strength : 300 mg
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Aspen API. More than just an API™
Regulatory Info :
Registration Country : Norway
Brand Name : Zyloric
Dosage Form : Antic-calc Tablet
Dosage Strength : 300 mg
Packaging : Box
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Switzerland
Brand Name : Zyloric 300
Dosage Form : Tabl
Dosage Strength : 300mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
RLD : No
TE Code : AB
Brand Name : LOPURIN
Dosage Form : TABLET;ORAL
Dosage Strength : 100MG
Approval Date : 1987-04-02
Application Number : 71586
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
RLD : No
TE Code : AB
Brand Name : LOPURIN
Dosage Form : TABLET;ORAL
Dosage Strength : 300MG
Approval Date : 1987-04-02
Application Number : 71587
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : ALLOPURINOL
Dosage Form : TABLET;ORAL
Dosage Strength : 100MG
Approval Date : 2013-05-06
Application Number : 203154
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : ALLOPURINOL
Dosage Form : TABLET;ORAL
Dosage Strength : 300MG
Approval Date : 2013-05-06
Application Number : 203154
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code :
Brand Name : ALLOPURINOL
Dosage Form : TABLET;ORAL
Dosage Strength : 100MG
Approval Date : 1985-12-31
Application Number : 70268
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code : AB
Brand Name : ALLOPURINOL
Dosage Form : TABLET;ORAL
Dosage Strength : 100MG
Approval Date : 2025-04-14
Application Number : 215091
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : Yes
TE Code : AB
Brand Name : ZYLOPRIM
Dosage Form : TABLET;ORAL
Dosage Strength : 100MG
Approval Date : 1982-01-01
Application Number : 16084
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB
RLD : No
TE Code : AB
Brand Name : ALLOPURINOL
Dosage Form : TABLET;ORAL
Dosage Strength : 200MG
Approval Date : 2024-06-17
Application Number : 214443
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code :
Brand Name : ALLOPURINOL
Dosage Form : TABLET;ORAL
Dosage Strength : 100MG
Approval Date : 1985-12-10
Application Number : 70150
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : ALLOPURINOL
Dosage Form : TABLET;ORAL
Dosage Strength : 300MG
Approval Date : 1986-04-14
Application Number : 70580
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
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]DRUG PRODUCT COMPOSITIONS
DOSAGE - TABLET;ORAL - 100MG
USFDA APPLICATION NUMBER - 16084
DOSAGE - TABLET;ORAL - 200MG
USFDA APPLICATION NUMBER - 16084
DOSAGE - TABLET;ORAL - 300MG
USFDA APPLICATION NUMBER - 16084
DOSAGE - TABLET;ORAL - 200MG;200MG
USFDA APPLICATION NUMBER - 209203
DOSAGE - TABLET;ORAL - 300MG;200MG
USFDA APPLICATION NUMBER - 209203
Related Excipient Companies
SPI Pharma
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]Boai NKY Pharmaceuticals Ltd
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]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]Ashland
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]Gangwal Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ideal Cures
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]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]Shanghai Welltone Material Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Sigachi Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Silverline Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]The Dow Chemical Company
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ulanqab Kema New Material
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
Disintegrants & Superdisintegrants
Direct Compression
Granulation
Controlled & Modified Release
Thickeners and Stabilizers
Co-Processed Excipients
Lubricants & Glidants
Solubilizers
Film Formers & Plasticizers
Taste Masking
Chewable & Orodispersible Aids
API Stability Enhancers
Rheology Modifiers
Empty Capsules
Vegetarian Capsules
Coloring Agents
Emulsifying Agents
Topical
Parenteral
Surfactant & Foaming Agents
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
Patent Expiration Date : 2025-08-25
US Patent Number : 8003681
Drug Substance Claim : Y
Drug Product Claim :
Application Number : 209203
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2025-08-25
Patent Expiration Date : 2025-08-25
US Patent Number : 8003681
Drug Substance Claim : Y
Drug Product Claim :
Application Number : 209203
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2025-08-25
Patent Expiration Date : 2029-04-29
US Patent Number : 8546437
Drug Substance Claim :
Drug Product Claim :
Application Number : 209203
Patent Use Code : U-2104
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2029-04-29
Patent Expiration Date : 2031-08-01
US Patent Number : 9216179
Drug Substance Claim :
Drug Product Claim :
Application Number : 209203
Patent Use Code : U-2104
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2031-08-01
Patent Expiration Date : 2028-11-26
US Patent Number : 10183012
Drug Substance Claim :
Drug Product Claim :
Application Number : 209203
Patent Use Code : U-2104
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2028-11-26
Patent Expiration Date : 2028-11-26
US Patent Number : 8283369
Drug Substance Claim :
Drug Product Claim :
Application Number : 209203
Patent Use Code : U-2104
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2028-11-26
Patent Expiration Date : 2029-08-17
US Patent Number : 8084483
Drug Substance Claim :
Drug Product Claim :
Application Number : 209203
Patent Use Code : U-2104
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2029-08-17
Patent Expiration Date : 2029-12-22
US Patent Number : 8357713
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 209203
Patent Use Code : U-2104
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2029-12-22
Patent Expiration Date : 2029-08-17
US Patent Number : 8084483
Drug Substance Claim :
Drug Product Claim :
Application Number : 209203
Patent Use Code : U-2104
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2029-08-17
Patent Expiration Date : 2028-11-26
US Patent Number : 8283369
Drug Substance Claim :
Drug Product Claim :
Application Number : 209203
Patent Use Code : U-2104
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2028-11-26
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]REF. STANDARDS & IMPURITIES
ANALYTICAL
Analytical Methods
ABOUT THIS PAGE
10
PharmaCompass offers a list of Allopurinol 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 Allopurinol manufacturer or Allopurinol supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Allopurinol manufacturer or Allopurinol supplier.
PharmaCompass also assists you with knowing the Allopurinol API Price utilized in the formulation of products. Allopurinol API Price is not always fixed or binding as the Allopurinol Price is obtained through a variety of data sources. The Allopurinol Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Hexal Brand of Allopurinol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hexal Brand of Allopurinol, including repackagers and relabelers. The FDA regulates Hexal Brand of Allopurinol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hexal Brand of Allopurinol 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 Hexal Brand of Allopurinol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Hexal Brand of Allopurinol supplier is an individual or a company that provides Hexal Brand of Allopurinol active pharmaceutical ingredient (API) or Hexal Brand of Allopurinol finished formulations upon request. The Hexal Brand of Allopurinol suppliers may include Hexal Brand of Allopurinol API manufacturers, exporters, distributors and traders.
click here to find a list of Hexal Brand of Allopurinol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Hexal Brand of Allopurinol DMF (Drug Master File) is a document detailing the whole manufacturing process of Hexal Brand of Allopurinol active pharmaceutical ingredient (API) in detail. Different forms of Hexal Brand of Allopurinol DMFs exist exist since differing nations have different regulations, such as Hexal Brand of Allopurinol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Hexal Brand of Allopurinol DMF submitted to regulatory agencies in the US is known as a USDMF. Hexal Brand of Allopurinol USDMF includes data on Hexal Brand of Allopurinol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Hexal Brand of Allopurinol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Hexal Brand of Allopurinol 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 Hexal Brand of Allopurinol Drug Master File in Japan (Hexal Brand of Allopurinol JDMF) empowers Hexal Brand of Allopurinol 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 Hexal Brand of Allopurinol JDMF during the approval evaluation for pharmaceutical products. At the time of Hexal Brand of Allopurinol 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 Hexal Brand of Allopurinol 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 Hexal Brand of Allopurinol Drug Master File in Korea (Hexal Brand of Allopurinol KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Hexal Brand of Allopurinol. The MFDS reviews the Hexal Brand of Allopurinol KDMF as part of the drug registration process and uses the information provided in the Hexal Brand of Allopurinol KDMF to evaluate the safety and efficacy of the drug.
After submitting a Hexal Brand of Allopurinol 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 Hexal Brand of Allopurinol API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Hexal Brand of Allopurinol suppliers with KDMF on PharmaCompass.
A Hexal Brand of Allopurinol CEP of the European Pharmacopoeia monograph is often referred to as a Hexal Brand of Allopurinol Certificate of Suitability (COS). The purpose of a Hexal Brand of Allopurinol CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Hexal Brand of Allopurinol EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Hexal Brand of Allopurinol to their clients by showing that a Hexal Brand of Allopurinol CEP has been issued for it. The manufacturer submits a Hexal Brand of Allopurinol CEP (COS) as part of the market authorization procedure, and it takes on the role of a Hexal Brand of Allopurinol CEP holder for the record. Additionally, the data presented in the Hexal Brand of Allopurinol CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Hexal Brand of Allopurinol DMF.
A Hexal Brand of Allopurinol CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Hexal Brand of Allopurinol 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 Hexal Brand of Allopurinol suppliers with CEP (COS) on PharmaCompass.
A Hexal Brand of Allopurinol written confirmation (Hexal Brand of Allopurinol WC) is an official document issued by a regulatory agency to a Hexal Brand of Allopurinol manufacturer, verifying that the manufacturing facility of a Hexal Brand of Allopurinol active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Hexal Brand of Allopurinol APIs or Hexal Brand of Allopurinol finished pharmaceutical products to another nation, regulatory agencies frequently require a Hexal Brand of Allopurinol WC (written confirmation) as part of the regulatory process.
click here to find a list of Hexal Brand of Allopurinol 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 Hexal Brand of Allopurinol as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Hexal Brand of Allopurinol 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 Hexal Brand of Allopurinol 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 Hexal Brand of Allopurinol and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Hexal Brand of Allopurinol NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Hexal Brand of Allopurinol suppliers with NDC on PharmaCompass.
Hexal Brand of Allopurinol 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 Hexal Brand of Allopurinol 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 Hexal Brand of Allopurinol GMP manufacturer or Hexal Brand of Allopurinol GMP API supplier for your needs.
A Hexal Brand of Allopurinol CoA (Certificate of Analysis) is a formal document that attests to Hexal Brand of Allopurinol's compliance with Hexal Brand of Allopurinol specifications and serves as a tool for batch-level quality control.
Hexal Brand of Allopurinol CoA mostly includes findings from lab analyses of a specific batch. For each Hexal Brand of Allopurinol 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.
Hexal Brand of Allopurinol may be tested according to a variety of international standards, such as European Pharmacopoeia (Hexal Brand of Allopurinol EP), Hexal Brand of Allopurinol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Hexal Brand of Allopurinol USP).
