Synopsis
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VMF
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Molecular Weight | 534.4 g/mol |
---|---|
Molecular Formula | C23H21F7N4O3 |
XLogP3 | 4.2 |
Hydrogen Bond Donor Count | 2 |
Hydrogen Bond Acceptor Count | 11 |
Rotatable Bond Count | 6 |
Exact Mass | 534.15018768 g/mol |
Monoisotopic Mass | 534.15018768 g/mol |
Topological Polar Surface Area | 75.2 A^2 |
Heavy Atom Count | 37 |
Formal Charge | 0 |
Complexity | 810 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 3 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
1 of 4 | |
---|---|
Drug Name | Aprepitant |
PubMed Health | Aprepitant (By mouth) |
Drug Classes | Antiemetic |
Drug Label | EMEND (aprepitant) is a substance P/neurokinin 1 (NK1) receptor antagonist, chemically described as 5-[[(2R,3S)-2-[(1R)-1-[3,5-bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)-4-morpholinyl]methyl]-1,2-dihydro-3H-1,2,4-triazol-3-one. Its empiric... |
Active Ingredient | Aprepitant |
Dosage Form | Capsule |
Route | Oral |
Strength | 125mg; 80mg; 40mg |
Market Status | Prescription |
Company | Sandoz |
2 of 4 | |
---|---|
Drug Name | Emend |
PubMed Health | Aprepitant (By mouth) |
Drug Classes | Antiemetic |
Drug Label | EMEND (aprepitant) is a substance P/neurokinin 1 (NK1) receptor antagonist, chemically described as 5-[[(2R,3S)-2-[(1R)-1-[3,5-bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)-4-morpholinyl]methyl]-1,2-dihydro-3H-1,2,4-triazol-3-one. Its empiric... |
Active Ingredient | Aprepitant; Fosaprepitant dimeglumine |
Dosage Form | Capsule; Powder |
Route | Intravenous; Oral |
Strength | eq 150mg base/vial; 125mg; 80mg; 40mg |
Market Status | Prescription |
Company | Merck; Merck And |
3 of 4 | |
---|---|
Drug Name | Aprepitant |
PubMed Health | Aprepitant (By mouth) |
Drug Classes | Antiemetic |
Drug Label | EMEND (aprepitant) is a substance P/neurokinin 1 (NK1) receptor antagonist, chemically described as 5-[[(2R,3S)-2-[(1R)-1-[3,5-bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)-4-morpholinyl]methyl]-1,2-dihydro-3H-1,2,4-triazol-3-one. Its empiric... |
Active Ingredient | Aprepitant |
Dosage Form | Capsule |
Route | Oral |
Strength | 125mg; 80mg; 40mg |
Market Status | Prescription |
Company | Sandoz |
4 of 4 | |
---|---|
Drug Name | Emend |
PubMed Health | Aprepitant (By mouth) |
Drug Classes | Antiemetic |
Drug Label | EMEND (aprepitant) is a substance P/neurokinin 1 (NK1) receptor antagonist, chemically described as 5-[[(2R,3S)-2-[(1R)-1-[3,5-bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)-4-morpholinyl]methyl]-1,2-dihydro-3H-1,2,4-triazol-3-one. Its empiric... |
Active Ingredient | Aprepitant; Fosaprepitant dimeglumine |
Dosage Form | Capsule; Powder |
Route | Intravenous; Oral |
Strength | eq 150mg base/vial; 125mg; 80mg; 40mg |
Market Status | Prescription |
Company | Merck; Merck And |
GDUFA
DMF Review : Complete
Rev. Date : 2022-05-31
Pay. Date : 2022-05-16
DMF Number : 35497
Submission : 2022-04-26
Status : Active
Type : II
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
GDUFA
DMF Review : Complete
Rev. Date : 2018-03-20
Pay. Date : 2017-11-15
DMF Number : 32203
Submission : 2017-12-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20381
Submission : 2007-03-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-04-23
Pay. Date : 2014-01-14
DMF Number : 27610
Submission : 2014-01-10
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-24
Pay. Date : 2013-10-01
DMF Number : 25572
Submission : 2011-12-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26852
Submission : 2013-03-15
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-11-12
Pay. Date : 2020-09-29
DMF Number : 27214
Submission : 2013-06-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-07-15
Pay. Date : 2019-07-10
DMF Number : 24835
Submission : 2011-04-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26065
Submission : 2012-05-11
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25715
Submission : 2012-01-17
Status : Inactive
Type : II
Aprepitant, Micronised And Non Micronised
Certificate Number : CEP 2022-247 - Rev 00
Status : Valid
Issue Date : 2024-10-29
Type : Chemical
Substance Number : 2757
Certificate Number : CEP 2022-365 - Rev 01
Status : Valid
Issue Date : 2025-04-03
Type : Chemical
Substance Number : 2757
Certificate Number : CEP 2017-196 - Rev 03
Status : Valid
Issue Date : 2025-03-06
Type : Chemical
Substance Number : 2757
Certificate Number : CEP 2017-051 - Rev 01
Status : Valid
Issue Date : 2023-12-06
Type : Chemical
Substance Number : 2757
Certificate Number : CEP 2021-434 - Rev 01
Status : Valid
Issue Date : 2023-10-24
Type : Chemical
Substance Number : 2757
Certificate Number : CEP 2017-041 - Rev 03
Status : Valid
Issue Date : 2023-10-13
Type : Chemical
Substance Number : 2757
Certificate Number : CEP 2017-192 - Rev 03
Status : Valid
Issue Date : 2024-05-02
Type : Chemical
Substance Number : 2757
Certificate Number : CEP 2021-323 - Rev 00
Status : Valid
Issue Date : 2024-01-22
Type : Chemical
Substance Number : 2757
Certificate Number : CEP 2022-033 - Rev 00
Status : Valid
Issue Date : 2025-01-15
Type : Chemical
Substance Number : 2757
Certificate Number : CEP 2019-025 - Rev 02
Status : Valid
Issue Date : 2025-02-10
Type : Chemical
Substance Number : 2757
Registration Number : 304MF10161
Registrant's Address : 811, Summit Business Park, Off Andheri Kurla Road, Andheri East, Mumbai 400093
Initial Date of Registration : 2022-12-23
Latest Date of Registration : 2022-12-23
Registration Number : 228MF10004
Registrant's Address : Route du Simplon 1,36,CH-1902 Evionnaz,Switzerland
Initial Date of Registration : 2016-01-08
Latest Date of Registration : 2016-01-08
Registration Number : 305MF10125
Registrant's Address : 2nd Floor, Admin Block 27, Vandalooor kelambakkam Road, Keelakottaiyur Village, Melak...
Initial Date of Registration : 2023-11-29
Latest Date of Registration : 2023-11-29
Registration Number : 230MF10074
Registrant's Address : No. 18 Qinghua Road, Sanchang, Haimen, Jiangsu, China
Initial Date of Registration : 2018-07-03
Latest Date of Registration : 2021-02-19
Date of Issue : 2022-07-06
Valid Till : 2025-06-25
Written Confirmation Number : WC-0057n
Address of the Firm : Plot No. 3109, GIDC, Industrial Estate Ankleshwar, Distt- Bharuch - 393002, Guja...
Date of Issue : 2022-04-07
Valid Till : 2025-03-07
Written Confirmation Number : WC-0040n
Address of the Firm : Sy. No. 213, 214 & 255, Bonthapally Village, Gummadidala Mandai, Sangareddy Dist...
Date of Issue : 2025-02-14
Valid Till : 2027-11-04
Written Confirmation Number : WC-0092
Address of the Firm : Plot No. 18, 56, 57, 58, KIADB Industrial Area, Nanjangud, 571 302, Dist: Mysore...
Date of Issue : 2022-10-14
Valid Till : 2025-07-02
Written Confirmation Number : WC-0214
Address of the Firm : Gut No. 546,571,519 and 520, Village Kumbhavali, Boisar, Tal & Dist- Palghar, Pi...
Date of Issue : 2022-07-11
Valid Till : 2025-08-15
Written Confirmation Number : WC-0022
Address of the Firm : Plot No. 182 to 186, 192-A and 193 to 197 & 212/A,B,C,D Phase-ll, IDA, Pashamyla...
Date of Issue : 2022-09-16
Valid Till : 2025-09-08
Written Confirmation Number : WC-0197
Address of the Firm : Plot No. L-1, L-21 to L-28 & L-44, Additional Phase MIDC, Mahad, Taluka: Mahad, ...
Date of Issue : 2022-11-02
Valid Till : 2025-07-02
Written Confirmation Number : WC-0182
Address of the Firm : Sy.No.239&240,Dothigudem Village,Pochampally MandalYadadri-Bhuvanagiri,Dist.-508...
Date of Issue : 2022-06-29
Valid Till : 2025-02-07
Written Confirmation Number : WC-0123
Address of the Firm : Sy. Nos. 7-70, 70/1 & 70/2, Digwal Village, Kohir Mandai, Sangareddy District, T...
Date of Issue : 2022-06-29
Valid Till : 2025-02-07
Written Confirmation Number : WC-0123
Address of the Firm : Sy. Nos. 7-70, 70/1 & 70/2, Digwal Village, Kohir Mandai, Sangareddy District, T...
Registrant Name : M-Peak Korea Co., Ltd.
Registration Date : 2019-07-18
Registration Number : No. 6580-19-ND(3)
Manufacturer Name : Glenmark Life Sciences LTD.
Manufacturer Address : Plot No 3109, GIDC Industrial Estate, Ankleshwar City: Ankleshwar-393 002, Dist: Bhar...
Registrant Name : Daewoong Bio Co., Ltd.
Registration Date : 2017-12-08
Registration Number : No. 6580-19-ND(1)
Manufacturer Name : Glenmark Life Sciences Limit...
Manufacturer Address : Plot No. 3109, GIDC, Industrial Estate, Ankleshwar, City : Ankleshwar - 393 002, Dist...
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2018-11-09
Registration Number : No. 6580-19-ND(2)
Manufacturer Name : Glenmark Life Sciences Limit...
Manufacturer Address : Plot No. 3109, GIDC, Industrial Estate, Ankleshwar, City : Ankleshwar - 393 002, Dist...
Registrant Name : M-Peak Korea Co., Ltd.
Registration Date : 2015-12-23
Registration Number : No. 6580-19-ND
Manufacturer Name : Alivus Life Sciences Limited
Manufacturer Address : Plot No. 3109, GIDC, Industrial Estate, Ankleshwar, City : Ankleshwar - 393 002, Dist...
Registrant Name : Wonpung Pharmaceutical Co., Ltd.
Registration Date : 2012-04-27
Registration Number : No. 3838-1-ND
Manufacturer Name : Hetero Drugs Limited
Manufacturer Address : Sy.No.213,214&255, Bonthapally Village, Gummadidala Mandal, Sangareddy District, Tela...
Registrant Name : Hwail Pharmaceutical Co., Ltd.
Registration Date : 2016-06-17
Registration Number : No. 3838-1-ND(1)
Manufacturer Name : Hetero Drugs Limited
Manufacturer Address : Sy.No.213,214&255, Bonthapally Village, Gummadidala Mandal, Sangareddy District, Tela...
Registrant Name : Korea MSD Co., Ltd.
Registration Date : 2005-07-28
Registration Number : No. 906-4-ND
Manufacturer Name : MSD International GmbH (Puer...
Manufacturer Address : Road #2, Kilometer 56.7, Barceloneta, PR 00617
Registrant Name : Ace Pharma Co., Ltd.
Registration Date : 2020-11-19
Registration Number : Su105-1-ND
Manufacturer Name : Optimus Drugs Private Limite...
Manufacturer Address : Sy. No. 239 & 240, Dothigudem Village, Pochampally Mandal, Yadadri-Bhuvanagiri Distri...
Registrant Name : Korea MSD Co., Ltd.
Registration Date : 2016-01-14
Registration Number : Su3281-16-ND
Manufacturer Name : Siegfried Evionnaz SA
Manufacturer Address : Route du Simplon 1, 36, 1902, Evionnaz, Switzerland_x000D_
NDC Package Code : 64567-0021
Start Marketing Date : 2021-01-14
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 66039-880
Start Marketing Date : 2014-01-10
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 65977-0024
Start Marketing Date : 2006-06-30
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 65372-1169
Start Marketing Date : 2012-12-12
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 50370-0022
Start Marketing Date : 2010-04-12
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 50370-0048
Start Marketing Date : 2015-01-15
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 59285-015
Start Marketing Date : 2017-10-12
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 65085-0043
Start Marketing Date : 2018-11-21
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (20kg/20kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 72643-020
Start Marketing Date : 2020-02-20
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 13612-0024
Start Marketing Date : 2021-10-26
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
About the Company : Inke S.A., is focused since 1980 in the development and manufacture of the highest quality Active Pharmaceutical Ingredients (APIs) with complex synthesis processes for diverse the...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
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Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
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Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
About the Company : Pharmathen, established in 1969, has emerged as a leading in-house development partner in Europe. It specializes in the development, registration, manufacturing & life-cycle manage...
About the Company : Beijing Mesochem Technology Co. Ltd., which is located in the national economic and technological development area of Yizhuang, China, manufactures pharmaceutical chemicals, fine c...
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About the Company : Mehta API Pvt Ltd engaged in manufacturing and marketing of APIs & Advance Drug Intermediates.... Globally. Mehta Api has been inordinately proud of its achievements since its ince...
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API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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Regulatory Info :
Registration Country : Sweden
Brand Name : EMEND
Dosage Form : HARD CAPSULES
Dosage Strength : 125 MG + 80 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : EMEND
Dosage Form : HARD CAPSULES
Dosage Strength : 80 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : EMEND
Dosage Form : HARD CAPSULES
Dosage Strength : 40 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : EMEND
Dosage Form : HARD CAPSULES
Dosage Strength : 125 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : EMEND
Dosage Form : POWDER FOR ORAL SUSPENSION
Dosage Strength : 125 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : EMEND
Dosage Form : HARD CAPSULES
Dosage Strength : 165 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Italy
Brand Name : Emend
Dosage Form : Aprepitant 125Mg 1 Unit + 80 Mg 2 Units' Oral Use
Dosage Strength : 1 cps 125 mg + 2 cps 80 mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Norway
Brand Name : Emend
Dosage Form :
Dosage Strength :
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Emend
Dosage Form : Capsule, hard
Dosage Strength : 125 mg
Packaging : Blister, endose
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Emend
Dosage Form : Capsule, hard
Dosage Strength : 80 mg
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
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ABOUT THIS PAGE
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PharmaCompass offers a list of Aprepitant 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 Aprepitant manufacturer or Aprepitant supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Aprepitant manufacturer or Aprepitant supplier.
PharmaCompass also assists you with knowing the Aprepitant API Price utilized in the formulation of products. Aprepitant API Price is not always fixed or binding as the Aprepitant Price is obtained through a variety of data sources. The Aprepitant Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Aprepitant manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Aprepitant, including repackagers and relabelers. The FDA regulates Aprepitant manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Aprepitant 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 Aprepitant manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Aprepitant supplier is an individual or a company that provides Aprepitant active pharmaceutical ingredient (API) or Aprepitant finished formulations upon request. The Aprepitant suppliers may include Aprepitant API manufacturers, exporters, distributors and traders.
click here to find a list of Aprepitant suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Aprepitant DMF (Drug Master File) is a document detailing the whole manufacturing process of Aprepitant active pharmaceutical ingredient (API) in detail. Different forms of Aprepitant DMFs exist exist since differing nations have different regulations, such as Aprepitant USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Aprepitant DMF submitted to regulatory agencies in the US is known as a USDMF. Aprepitant USDMF includes data on Aprepitant's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Aprepitant USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Aprepitant 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 Aprepitant Drug Master File in Japan (Aprepitant JDMF) empowers Aprepitant 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 Aprepitant JDMF during the approval evaluation for pharmaceutical products. At the time of Aprepitant 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 Aprepitant 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 Aprepitant Drug Master File in Korea (Aprepitant KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Aprepitant. The MFDS reviews the Aprepitant KDMF as part of the drug registration process and uses the information provided in the Aprepitant KDMF to evaluate the safety and efficacy of the drug.
After submitting a Aprepitant 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 Aprepitant API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Aprepitant suppliers with KDMF on PharmaCompass.
A Aprepitant CEP of the European Pharmacopoeia monograph is often referred to as a Aprepitant Certificate of Suitability (COS). The purpose of a Aprepitant CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Aprepitant EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Aprepitant to their clients by showing that a Aprepitant CEP has been issued for it. The manufacturer submits a Aprepitant CEP (COS) as part of the market authorization procedure, and it takes on the role of a Aprepitant CEP holder for the record. Additionally, the data presented in the Aprepitant CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Aprepitant DMF.
A Aprepitant CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Aprepitant 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 Aprepitant suppliers with CEP (COS) on PharmaCompass.
A Aprepitant written confirmation (Aprepitant WC) is an official document issued by a regulatory agency to a Aprepitant manufacturer, verifying that the manufacturing facility of a Aprepitant active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Aprepitant APIs or Aprepitant finished pharmaceutical products to another nation, regulatory agencies frequently require a Aprepitant WC (written confirmation) as part of the regulatory process.
click here to find a list of Aprepitant 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 Aprepitant as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Aprepitant 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 Aprepitant 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 Aprepitant and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Aprepitant NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Aprepitant suppliers with NDC on PharmaCompass.
Aprepitant 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 Aprepitant 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 Aprepitant GMP manufacturer or Aprepitant GMP API supplier for your needs.
A Aprepitant CoA (Certificate of Analysis) is a formal document that attests to Aprepitant's compliance with Aprepitant specifications and serves as a tool for batch-level quality control.
Aprepitant CoA mostly includes findings from lab analyses of a specific batch. For each Aprepitant 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.
Aprepitant may be tested according to a variety of international standards, such as European Pharmacopoeia (Aprepitant EP), Aprepitant JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Aprepitant USP).