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| 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
IOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37104
Submission : 2023-01-20
Status : Active
Type : II
Certificate Number : CEP 2023-029 - Rev 00
Issue Date : 2024-06-10
Type : Chemical
Substance Number : 576
Status : Valid
NDC Package Code : 49716-328
Start Marketing Date : 2023-10-15
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Jai Radhe Sales is your partner for all your sourcing needs.
JPN Pharma offers excellence in API manufacturing through precision, innovation & quality, delivering solutions to the pharma industry
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Certificate Number : CEP 2014-364 - Rev 01
Issue Date : 2023-11-27
Type : Chemical
Substance Number : 576
Status : Valid
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
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.
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 39568
Submission : 2024-03-05
Status : Active
Type : II
Date of Issue : 2025-09-02
Valid Till : 2028-07-02
Written Confirmation Number : WC-0218
Address of the Firm :
NDC Package Code : 61281-9750
Start Marketing Date : 2023-07-31
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
| Available Reg Filing : ASMF |
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
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USDMF
IOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37104
Submission : 2023-01-20
Status : Active
Type : II
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39568
Submission : 2024-03-05
Status : Active
Type : II
GDUFA
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Rev. Date :
Pay. Date :
DMF Number : 4307
Submission : 1981-10-19
Status : Inactive
Type : II
GDUFA
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Rev. Date :
Pay. Date :
DMF Number : 4950
Submission : 1983-02-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5235
Submission : 1984-01-25
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2870
Submission : 1977-02-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2506
Submission : 1975-08-13
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2534
Submission : 1975-10-13
Status : Inactive
Type : II
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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3583
Submission : 1979-07-22
Status : Inactive
Type : II
Portfolio PDF
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
IOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.
IOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.
Certificate Number : CEP 2023-029 - Rev 00
Status : Valid
Issue Date : 2024-06-10
Type : Chemical
Substance Number : 576
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Allopurinol, Synthetic Route B
Certificate Number : CEP 2014-364 - Rev 01
Status : Valid
Issue Date : 2023-11-27
Type : Chemical
Substance Number : 576
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Certificate Number : R1-CEP 1996-032 - Rev 05
Status : Valid
Issue Date : 2019-08-09
Type : Chemical
Substance Number : 576
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Certificate Number : CEP 1998-118 - Rev 08
Status : Valid
Issue Date : 2025-07-11
Type : Chemical
Substance Number : 576
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Allopurinol, Allopurinol P-process
Certificate Number : CEP 2014-117 - Rev 03
Status : Valid
Issue Date : 2025-06-30
Type : Chemical
Substance Number : 576
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Certificate Number : CEP 1999-007 - Rev 08
Status : Valid
Issue Date : 2025-04-01
Type : Chemical
Substance Number : 576
Certificate Number : R0-CEP 2007-189 - Rev 00
Status : Expired
Issue Date : 2010-06-30
Type : Chemical
Substance Number : 576
Certificate Number : R0-CEP 2003-213 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2004-10-13
Type : Chemical
Substance Number : 576
Certificate Number : R0-CEP 2004-189 - Rev 02
Status : Withdrawn by EDQM Failure to CEP pro...
Issue Date : 2008-09-26
Type : Chemical
Substance Number : 576
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] JDMF
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Registration Number : 231MF10077
Registrant's Address : H-1106 BUDAPEST KERESZTURI UT 30-38 HUNGARY
Initial Date of Registration : 2019-03-29
Latest Date of Registration : 2019-03-29
Registration Number : 230MF10119
Registrant's Address : No. 2066 Tangkou Road, Economy and Technology Development Zone, Hefei, Anhui Province...
Initial Date of Registration : 2018-08-22
Latest Date of Registration : 2018-08-22
Japanese Pharmacopoeia Allopurinol (for manufacturing purposes only)
Registration Number : 221MF10235
Registrant's Address : 326 Yokamachi, Toyama City, Toyama Prefecture
Initial Date of Registration : 2009-10-29
Latest Date of Registration : 2018-11-05
Registration Number : 231MF10078
Registrant's Address : 107-A, Vinay Bhavya Complex, 159-A, C. S. T Road, Kalina, Santa Cruz (East), Mumbai-4...
Initial Date of Registration : 2019-03-29
Latest Date of Registration : 2025-01-28
Registration Number : 225MF10144
Registrant's Address : 'Indoco House', 166 CST Road, Kalina, Santacruz (E) Mumbai-400 098 India
Initial Date of Registration : 2013-07-25
Latest Date of Registration : 2021-03-17
Registration Number : 218MF10260
Registrant's Address : Piazzale Luigi Cadorna, 4-20123 MILANO, Italy
Initial Date of Registration : 2006-02-17
Latest Date of Registration : 2006-02-17
Registration Number : 301MF10064
Registrant's Address : Piazzale Luigi Cadorna, 4-20123 MILANO, Italy
Initial Date of Registration : 2019-09-17
Latest Date of Registration : 2020-09-17
Registration Number : 217MF10578
Registrant's Address : Plot No. 14, 99 and 100, IDA, Pashamylaram Phase-II, Patancheru, Sangareddy District ...
Initial Date of Registration : 2005-09-14
Latest Date of Registration : 2009-07-30
Registration Number : 221MF10137
Registrant's Address : No. 35, Donghai Fifth Avenue, Linhaiyuan District, Zhejiang Chemical Raw Materials Ba...
Initial Date of Registration : 2009-07-09
Latest Date of Registration : 2009-07-09
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Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Date of Issue : 2025-09-02
Valid Till : 2028-07-02
Written Confirmation Number : WC-0218
Address of the Firm : A-5/2, Late Parshuram Industrial Area, MIDC, Tal-Khed, Dist. Ratnagiri-415 722, ...
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Date of Issue : 2025-09-02
Valid Till : 2028-07-02
Written Confirmation Number : WC-0218
Address of the Firm : A-5/2, Late Parshuram Industrial Area, MIDC, Tal-Khed, Dist. Ratnagiri-415 722, ...
Date of Issue : 2023-04-18
Valid Till : 2026-01-03
Written Confirmation Number : WC-0086
Address of the Firm : E-17/3, 17/4 & E18 Boisar, MIDCTarapur, Tal.District-Palghar, 401506, Maharashtr...
Date of Issue : 2025-05-19
Valid Till : 2028-10-07
Written Confirmation Number : WC-0428
Address of the Firm : Plot No. 23 E, Survey No. 24P & 25P, AP SEZ Denotified Area, Lalamkoduru (V), Ra...
Date of Issue : 2025-10-16
Valid Till : 2028-07-21
Written Confirmation Number : WC-0044
Address of the Firm : Plot No. A-100, A-100/1, A-100/2 & D-1, M.I.D.C Ind. Area, Shendra, Aurangabad-4...
Date of Issue : 2022-08-06
Valid Till : 2025-07-21
Written Confirmation Number : WC-0045nA2
Address of the Firm : Plot No. E-7, E-8, E-9, MIDC Industrial Area, Chikalthana, Aurangabad-431006
Date of Issue : 2025-09-19
Valid Till : 2028-07-03
Written Confirmation Number : WC-0040
Address of the Firm : Unit-l, Sy. No. 213, 214 & 255, Bonthapally (Village),Gummadidala (Mandal), Sang...
Date of Issue : 2025-09-08
Valid Till : 2025-08-15
Written Confirmation Number : WC-0151
Address of the Firm : A-26, A-27, A-28/1, A-28/2, MIDC IND Area, Patalganga, Village Kaire, Tal. Khala...
Date of Issue : 2025-06-19
Valid Till : 2028-07-02
Written Confirmation Number : WC-0091
Address of the Firm : P.O. Sejavta, District -Ratlam, (M.P.)-457001, India
Date of Issue : 2025-08-01
Valid Till : 2028-07-02
Written Confirmation Number : WC-0103
Address of the Firm : H-4, MIDC, Waluj, CHH. Sambhajinagar -431136, Taluka: Gangapur, District: Aurang...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]KDMF
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Registrant Name : Masung LS Co., Ltd.
Registration Date : 2021-01-25
Registration Number : 20210125-209-J-511
Manufacturer Name : EGIS Pharmaceuticals Plc.
Manufacturer Address : Kereszturi ut 30-38., Budapest, 1106, Hungary
Registrant Name : Samil Pharmaceutical Co., Ltd.
Registration Date : 2021-04-20
Registration Number : 20210420-209-J-559
Manufacturer Name : Harman Finochem Limited
Manufacturer Address : A-100, A-100/1, A-100/2 & D-1, MIDC Industrial Area, Shendra, Aurangabad -431 007, Ma...
Registrant Name : Pharmapia Co., Ltd.
Registration Date : 2021-12-02
Registration Number : 20211202-209-J-1166
Manufacturer Name : SMS Lifesciences India Limit...
Manufacturer Address : Unit-I, Sy No. 180/2, Kazipalli (V), Jinnaram (M), Sangareddy District, Telangana - 5...
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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
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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 Aloral manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Aloral, including repackagers and relabelers. The FDA regulates Aloral manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Aloral 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 Aloral manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Aloral supplier is an individual or a company that provides Aloral active pharmaceutical ingredient (API) or Aloral finished formulations upon request. The Aloral suppliers may include Aloral API manufacturers, exporters, distributors and traders.
click here to find a list of Aloral suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Aloral DMF (Drug Master File) is a document detailing the whole manufacturing process of Aloral active pharmaceutical ingredient (API) in detail. Different forms of Aloral DMFs exist exist since differing nations have different regulations, such as Aloral USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Aloral DMF submitted to regulatory agencies in the US is known as a USDMF. Aloral USDMF includes data on Aloral's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Aloral USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Aloral 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 Aloral Drug Master File in Japan (Aloral JDMF) empowers Aloral 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 Aloral JDMF during the approval evaluation for pharmaceutical products. At the time of Aloral 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 Aloral 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 Aloral Drug Master File in Korea (Aloral KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Aloral. The MFDS reviews the Aloral KDMF as part of the drug registration process and uses the information provided in the Aloral KDMF to evaluate the safety and efficacy of the drug.
After submitting a Aloral 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 Aloral API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Aloral suppliers with KDMF on PharmaCompass.
A Aloral CEP of the European Pharmacopoeia monograph is often referred to as a Aloral Certificate of Suitability (COS). The purpose of a Aloral CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Aloral EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Aloral to their clients by showing that a Aloral CEP has been issued for it. The manufacturer submits a Aloral CEP (COS) as part of the market authorization procedure, and it takes on the role of a Aloral CEP holder for the record. Additionally, the data presented in the Aloral CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Aloral DMF.
A Aloral CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Aloral 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 Aloral suppliers with CEP (COS) on PharmaCompass.
A Aloral written confirmation (Aloral WC) is an official document issued by a regulatory agency to a Aloral manufacturer, verifying that the manufacturing facility of a Aloral active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Aloral APIs or Aloral finished pharmaceutical products to another nation, regulatory agencies frequently require a Aloral WC (written confirmation) as part of the regulatory process.
click here to find a list of Aloral 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 Aloral as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Aloral 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 Aloral 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 Aloral and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Aloral NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Aloral suppliers with NDC on PharmaCompass.
Aloral 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 Aloral 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 Aloral GMP manufacturer or Aloral GMP API supplier for your needs.
A Aloral CoA (Certificate of Analysis) is a formal document that attests to Aloral's compliance with Aloral specifications and serves as a tool for batch-level quality control.
Aloral CoA mostly includes findings from lab analyses of a specific batch. For each Aloral 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.
Aloral may be tested according to a variety of international standards, such as European Pharmacopoeia (Aloral EP), Aloral JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Aloral USP).
