Synopsis
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Molecular Weight | 534.4 g/mol |
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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 | |
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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 | |
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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 |
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API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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Details:
Quotient has prior experience of working with the Nuformix NXP-001 co-crystal and previously developed a capsule and a powder for oral suspension formulation of Aprepitant, evaluating its performance in a relative bioavailability study versus EMEND.
Lead Product(s): Aprepitant
Therapeutic Area: Gastroenterology Brand Name: NXP-001
Study Phase: Phase IProduct Type: Other Small Molecule
Sponsor: Oxilio
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement July 02, 2022
Lead Product(s) : Aprepitant
Therapeutic Area : Gastroenterology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Oxilio
Deal Size : Undisclosed
Deal Type : Agreement
Details : Quotient has prior experience of working with the Nuformix NXP-001 co-crystal and previously developed a capsule and a powder for oral suspension formulation of Aprepitant, evaluating its performance in a relative bioavailability study versus EMEND.
Product Name : NXP-001
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
July 02, 2022
Details:
HT-001 (aprepitant) is a proprietary, non-steroidal topical formulation, which is being evaluated for the treatment of pruritus associated skin toxicities.
Lead Product(s): Aprepitant
Therapeutic Area: Dermatology Brand Name: HT-001
Study Phase: Phase IIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 15, 2025
Lead Product(s) : Aprepitant
Therapeutic Area : Dermatology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Hoth Therapeutics Announces Positive Initial Data in Phase 2a Clinical Trial
Details : HT-001 (aprepitant) is a proprietary, non-steroidal topical formulation, which is being evaluated for the treatment of pruritus associated skin toxicities.
Product Name : HT-001
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
April 15, 2025
Details:
HT-001 (aprepitant) is an investigational topical therapeutic product. which is being evaluated for the treatment of rash and skin disorders associated with EGFR inhibitor therapy.
Lead Product(s): Aprepitant
Therapeutic Area: Dermatology Brand Name: HT-001
Study Phase: Phase IIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 10, 2025
Lead Product(s) : Aprepitant
Therapeutic Area : Dermatology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Hoth Plans Expanded Access Application for HT-001 in Cancer Patients
Details : HT-001 (aprepitant) is an investigational topical therapeutic product. which is being evaluated for the treatment of rash and skin disorders associated with EGFR inhibitor therapy.
Product Name : HT-001
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
March 10, 2025
Details:
HT-001 (aprepitant) is an investigational topical therapeutic product. which is being evaluated for the treatment of rash and skin disorders associated with EGFR inhibitor therapy.
Lead Product(s): Aprepitant
Therapeutic Area: Dermatology Brand Name: HT-001
Study Phase: Phase IIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 07, 2025
Lead Product(s) : Aprepitant
Therapeutic Area : Dermatology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Hoth Therapeutics Achieves Breakthrough in Phase 2a Cancer Treatment Trial
Details : HT-001 (aprepitant) is an investigational topical therapeutic product. which is being evaluated for the treatment of rash and skin disorders associated with EGFR inhibitor therapy.
Product Name : HT-001
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
January 07, 2025
Details:
Under the collaboration, PlusVitech will use Nanoform's state-of-the-art nanomedicine technology to repurpose the anti-nausea medicine aprepitant as a treatment for non-small cell lung cancer.
Lead Product(s): Aprepitant
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Other Small Molecule
Sponsor: PlusVitech
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration September 04, 2024
Lead Product(s) : Aprepitant
Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : PlusVitech
Deal Size : Undisclosed
Deal Type : Collaboration
Nanoform and PlusVitech Partner to Repurpose Aprepitant as a Treatment for Lung Cancer
Details : Under the collaboration, PlusVitech will use Nanoform's state-of-the-art nanomedicine technology to repurpose the anti-nausea medicine aprepitant as a treatment for non-small cell lung cancer.
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
September 04, 2024
Details:
HT-001 (aprepitant) is an investigational topical therapeutic product. which is being evaluated for the treatment of rash and skin disorders associated with EGFR inhibitor therapy.
Lead Product(s): Aprepitant
Therapeutic Area: Dermatology Brand Name: HT-001
Study Phase: Phase IIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 09, 2024
Lead Product(s) : Aprepitant
Therapeutic Area : Dermatology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Hoth Therapeutics Reports Positive Data on HT-001 for EGFRI-Associated Skin Toxicities
Details : HT-001 (aprepitant) is an investigational topical therapeutic product. which is being evaluated for the treatment of rash and skin disorders associated with EGFR inhibitor therapy.
Product Name : HT-001
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
May 09, 2024
Details:
HT-001 (aprepitant) is an investigational topical therapeutic product, being evaluated for the treatment of rash and skin disorders associated with EGFR inhibitor therapy.
Lead Product(s): Aprepitant
Therapeutic Area: Dermatology Brand Name: HT-001
Study Phase: Phase IIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 09, 2024
Lead Product(s) : Aprepitant
Therapeutic Area : Dermatology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Hoth Therapeutics Announces Expansion of Clinical Sites for HT-001 Phase 2a Trial
Details : HT-001 (aprepitant) is an investigational topical therapeutic product, being evaluated for the treatment of rash and skin disorders associated with EGFR inhibitor therapy.
Product Name : HT-001
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
May 09, 2024
Details:
HT-001 (aprepitant) is a Neurokinin 1 receptor inhibitor. It is being evaluated in phase 2 clinical trials for the treatment of skin toxicities associated with EGFR Inhibitors.
Lead Product(s): Aprepitant
Therapeutic Area: Dermatology Brand Name: HT-001
Study Phase: Phase IIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 18, 2024
Lead Product(s) : Aprepitant
Therapeutic Area : Dermatology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Hoth Therapeutics Receives FDA Approval to Expand HT-001 Trial for Severely Ill Patients
Details : HT-001 (aprepitant) is a Neurokinin 1 receptor inhibitor. It is being evaluated in phase 2 clinical trials for the treatment of skin toxicities associated with EGFR Inhibitors.
Product Name : HT-001
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
January 18, 2024
Details:
HT-001 (aprepitant) is an investigational topical therapeutic product. Currently it is being evaluated in phase 2 clinical trials for the treatment of rash and skin disorders associated with EGFR inhibitor therapy.
Lead Product(s): Aprepitant
Therapeutic Area: Dermatology Brand Name: HT-001
Study Phase: Phase IIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 27, 2023
Lead Product(s) : Aprepitant
Therapeutic Area : Dermatology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : HT-001 (aprepitant) is an investigational topical therapeutic product. Currently it is being evaluated in phase 2 clinical trials for the treatment of rash and skin disorders associated with EGFR inhibitor therapy.
Product Name : HT-001
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
December 27, 2023
Details:
The collaboration aims at activation of Washington University School of Medicine as the first clinical site in the CLEER-001 Phase 2a clinical trial of HT-001 (aprepitant) for the treatment for rash and skin disorders associated with EGFR inhibitor therapy.
Lead Product(s): Aprepitant
Therapeutic Area: Dermatology Brand Name: HT-001
Study Phase: Phase IIProduct Type: Other Small Molecule
Sponsor: Washington University School of Medicine
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration August 03, 2023
Lead Product(s) : Aprepitant
Therapeutic Area : Dermatology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Washington University School of Medicine
Deal Size : Undisclosed
Deal Type : Collaboration
Details : The collaboration aims at activation of Washington University School of Medicine as the first clinical site in the CLEER-001 Phase 2a clinical trial of HT-001 (aprepitant) for the treatment for rash and skin disorders associated with EGFR inhibitor thera...
Product Name : HT-001
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
August 03, 2023
Ethypharm is an international Pharma company with European roots manufacturing and commercializing essential drugs all over the world.
Regulatory Info :
Registration Country : France
Brand Name :
Dosage Form : Capsule
Dosage Strength : 80MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : France
Ethypharm is an international Pharma company with European roots manufacturing and commercializing essential drugs all over the world.
Regulatory Info :
Registration Country : France
Brand Name :
Dosage Form : Capsule
Dosage Strength : 125MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : France
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Brand Name : Aprepitant
Dosage Form : Pellets/Micro pellets for capsules
Dosage Strength : 40%
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info : EU Approved
Registration Country : Greece
Brand Name :
Dosage Form : Hard Capsule
Dosage Strength : 40MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Approved
Registration Country : Greece
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info : EU Approved
Registration Country : Greece
Brand Name :
Dosage Form : Hard Capsule
Dosage Strength : 80MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Approved
Registration Country : Greece
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info : EU Approved
Registration Country : Greece
Brand Name :
Dosage Form : Hard Capsule
Dosage Strength : 125MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Approved
Registration Country : Greece
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info : EU Approved
Registration Country : Greece
Brand Name :
Dosage Form : Hard Capsule
Dosage Strength : 165MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Approved
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 : Injectable Emulsion, For Intravenous Use
Dosage Strength : 130MG
Packaging : Single Dose Vial
Approval Date :
Application Number :
Regulatory Info : USA
Registration Country : Greece
Regulatory Info :
Registration Country : Australia
Brand Name : Aprepitant APOTEX
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
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
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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-Supplied by Selleck Chemicals manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Aprepitant-Supplied by Selleck Chemicals, including repackagers and relabelers. The FDA regulates Aprepitant-Supplied by Selleck Chemicals manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Aprepitant-Supplied by Selleck Chemicals 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-Supplied by Selleck Chemicals manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Aprepitant-Supplied by Selleck Chemicals supplier is an individual or a company that provides Aprepitant-Supplied by Selleck Chemicals active pharmaceutical ingredient (API) or Aprepitant-Supplied by Selleck Chemicals finished formulations upon request. The Aprepitant-Supplied by Selleck Chemicals suppliers may include Aprepitant-Supplied by Selleck Chemicals API manufacturers, exporters, distributors and traders.
click here to find a list of Aprepitant-Supplied by Selleck Chemicals suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Aprepitant-Supplied by Selleck Chemicals DMF (Drug Master File) is a document detailing the whole manufacturing process of Aprepitant-Supplied by Selleck Chemicals active pharmaceutical ingredient (API) in detail. Different forms of Aprepitant-Supplied by Selleck Chemicals DMFs exist exist since differing nations have different regulations, such as Aprepitant-Supplied by Selleck Chemicals USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Aprepitant-Supplied by Selleck Chemicals DMF submitted to regulatory agencies in the US is known as a USDMF. Aprepitant-Supplied by Selleck Chemicals USDMF includes data on Aprepitant-Supplied by Selleck Chemicals's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Aprepitant-Supplied by Selleck Chemicals USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Aprepitant-Supplied by Selleck Chemicals 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-Supplied by Selleck Chemicals Drug Master File in Japan (Aprepitant-Supplied by Selleck Chemicals JDMF) empowers Aprepitant-Supplied by Selleck Chemicals 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-Supplied by Selleck Chemicals JDMF during the approval evaluation for pharmaceutical products. At the time of Aprepitant-Supplied by Selleck Chemicals 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-Supplied by Selleck Chemicals 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-Supplied by Selleck Chemicals Drug Master File in Korea (Aprepitant-Supplied by Selleck Chemicals KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Aprepitant-Supplied by Selleck Chemicals. The MFDS reviews the Aprepitant-Supplied by Selleck Chemicals KDMF as part of the drug registration process and uses the information provided in the Aprepitant-Supplied by Selleck Chemicals KDMF to evaluate the safety and efficacy of the drug.
After submitting a Aprepitant-Supplied by Selleck Chemicals 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-Supplied by Selleck Chemicals API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Aprepitant-Supplied by Selleck Chemicals suppliers with KDMF on PharmaCompass.
A Aprepitant-Supplied by Selleck Chemicals CEP of the European Pharmacopoeia monograph is often referred to as a Aprepitant-Supplied by Selleck Chemicals Certificate of Suitability (COS). The purpose of a Aprepitant-Supplied by Selleck Chemicals CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Aprepitant-Supplied by Selleck Chemicals EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Aprepitant-Supplied by Selleck Chemicals to their clients by showing that a Aprepitant-Supplied by Selleck Chemicals CEP has been issued for it. The manufacturer submits a Aprepitant-Supplied by Selleck Chemicals CEP (COS) as part of the market authorization procedure, and it takes on the role of a Aprepitant-Supplied by Selleck Chemicals CEP holder for the record. Additionally, the data presented in the Aprepitant-Supplied by Selleck Chemicals CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Aprepitant-Supplied by Selleck Chemicals DMF.
A Aprepitant-Supplied by Selleck Chemicals CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Aprepitant-Supplied by Selleck Chemicals 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-Supplied by Selleck Chemicals suppliers with CEP (COS) on PharmaCompass.
A Aprepitant-Supplied by Selleck Chemicals written confirmation (Aprepitant-Supplied by Selleck Chemicals WC) is an official document issued by a regulatory agency to a Aprepitant-Supplied by Selleck Chemicals manufacturer, verifying that the manufacturing facility of a Aprepitant-Supplied by Selleck Chemicals active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Aprepitant-Supplied by Selleck Chemicals APIs or Aprepitant-Supplied by Selleck Chemicals finished pharmaceutical products to another nation, regulatory agencies frequently require a Aprepitant-Supplied by Selleck Chemicals WC (written confirmation) as part of the regulatory process.
click here to find a list of Aprepitant-Supplied by Selleck Chemicals 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-Supplied by Selleck Chemicals as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Aprepitant-Supplied by Selleck Chemicals 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-Supplied by Selleck Chemicals 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-Supplied by Selleck Chemicals and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Aprepitant-Supplied by Selleck Chemicals NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Aprepitant-Supplied by Selleck Chemicals suppliers with NDC on PharmaCompass.
Aprepitant-Supplied by Selleck Chemicals 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-Supplied by Selleck Chemicals 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-Supplied by Selleck Chemicals GMP manufacturer or Aprepitant-Supplied by Selleck Chemicals GMP API supplier for your needs.
A Aprepitant-Supplied by Selleck Chemicals CoA (Certificate of Analysis) is a formal document that attests to Aprepitant-Supplied by Selleck Chemicals's compliance with Aprepitant-Supplied by Selleck Chemicals specifications and serves as a tool for batch-level quality control.
Aprepitant-Supplied by Selleck Chemicals CoA mostly includes findings from lab analyses of a specific batch. For each Aprepitant-Supplied by Selleck Chemicals 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-Supplied by Selleck Chemicals may be tested according to a variety of international standards, such as European Pharmacopoeia (Aprepitant-Supplied by Selleck Chemicals EP), Aprepitant-Supplied by Selleck Chemicals JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Aprepitant-Supplied by Selleck Chemicals USP).