Synopsis
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VMF
DRUG PRODUCT COMPOSITIONS0
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| Molecular Weight | 326.8 g/mol |
|---|---|
| Molecular Formula | C18H19ClN4 |
| XLogP3 | 3.2 |
| Hydrogen Bond Donor Count | 1 |
| Hydrogen Bond Acceptor Count | 4 |
| Rotatable Bond Count | 1 |
| Exact Mass | 326.1298243 g/mol |
| Monoisotopic Mass | 326.1298243 g/mol |
| Topological Polar Surface Area | 30.9 A^2 |
| Heavy Atom Count | 23 |
| Formal Charge | 0 |
| Complexity | 584 |
| 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 6 | |
|---|---|
| Drug Name | Clozapine |
| PubMed Health | Clozapine (By mouth) |
| Drug Classes | Antipsychotic |
| Drug Label | VERSACLOZ, an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo[b,e][1,4]diazepine.The structural formula is: VERSACLOZ is available as a free-flowing yellow suspension. Each mL c... |
| Active Ingredient | Clozapine |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | 200mg; 100mg; 25mg; 50mg; 12.5mg |
| Market Status | Prescription |
| Company | Ivax Sub Teva Pharms; Sun Pharm Inds; Mylan |
| 2 of 6 | |
|---|---|
| Drug Name | Clozaril |
| PubMed Health | Clozapine (By mouth) |
| Drug Classes | Antipsychotic |
| Drug Label | CLOZARIL (clozapine), an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo [b,e] [1,4] diazepine.The structural formula isCLOZARIL is available in pale yellow tablets of 25mg... |
| Active Ingredient | Clozapine |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | 100mg; 25mg |
| Market Status | Prescription |
| Company | Novartis |
| 3 of 6 | |
|---|---|
| Drug Name | Fazaclo odt |
| Active Ingredient | Clozapine |
| Dosage Form | Tablet, orally disintegrating |
| Route | Oral |
| Strength | 200mg; 100mg; 25mg; 150mg; 12.5mg |
| Market Status | Prescription |
| Company | Jazz Pharms Iii |
| 4 of 6 | |
|---|---|
| Drug Name | Clozapine |
| PubMed Health | Clozapine (By mouth) |
| Drug Classes | Antipsychotic |
| Drug Label | VERSACLOZ, an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo[b,e][1,4]diazepine.The structural formula is: VERSACLOZ is available as a free-flowing yellow suspension. Each mL c... |
| Active Ingredient | Clozapine |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | 200mg; 100mg; 25mg; 50mg; 12.5mg |
| Market Status | Prescription |
| Company | Ivax Sub Teva Pharms; Sun Pharm Inds; Mylan |
| 5 of 6 | |
|---|---|
| Drug Name | Clozaril |
| PubMed Health | Clozapine (By mouth) |
| Drug Classes | Antipsychotic |
| Drug Label | CLOZARIL (clozapine), an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo [b,e] [1,4] diazepine.The structural formula isCLOZARIL is available in pale yellow tablets of 25mg... |
| Active Ingredient | Clozapine |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | 100mg; 25mg |
| Market Status | Prescription |
| Company | Novartis |
| 6 of 6 | |
|---|---|
| Drug Name | Fazaclo odt |
| Active Ingredient | Clozapine |
| Dosage Form | Tablet, orally disintegrating |
| Route | Oral |
| Strength | 200mg; 100mg; 25mg; 150mg; 12.5mg |
| Market Status | Prescription |
| Company | Jazz Pharms Iii |
API SUPPLIERS
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USDMF
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Drugs in Development
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DOSAGE - TABLET;ORAL - 100MG
USFDA APPLICATION NUMBER - 19758
DOSAGE - TABLET;ORAL - 200MG
USFDA APPLICATION NUMBER - 19758
DOSAGE - TABLET;ORAL - 25MG
USFDA APPLICATION NUMBER - 19758
DOSAGE - TABLET;ORAL - 50MG
USFDA APPLICATION NUMBER - 19758
DOSAGE - SUSPENSION;ORAL - 50MG/ML
USFDA APPLICATION NUMBER - 203479
DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL -...DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21590
DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL -...DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21590
DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL -...DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21590
DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL -...DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21590
DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL -...DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21590
DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL -...DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21590
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ABOUT THIS PAGE
51
PharmaCompass offers a list of Clozapine 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 Clozapine manufacturer or Clozapine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Clozapine manufacturer or Clozapine supplier.
PharmaCompass also assists you with knowing the Clozapine API Price utilized in the formulation of products. Clozapine API Price is not always fixed or binding as the Clozapine Price is obtained through a variety of data sources. The Clozapine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A LP00276 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of LP00276, including repackagers and relabelers. The FDA regulates LP00276 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. LP00276 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 LP00276 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A LP00276 supplier is an individual or a company that provides LP00276 active pharmaceutical ingredient (API) or LP00276 finished formulations upon request. The LP00276 suppliers may include LP00276 API manufacturers, exporters, distributors and traders.
click here to find a list of LP00276 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A LP00276 DMF (Drug Master File) is a document detailing the whole manufacturing process of LP00276 active pharmaceutical ingredient (API) in detail. Different forms of LP00276 DMFs exist exist since differing nations have different regulations, such as LP00276 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A LP00276 DMF submitted to regulatory agencies in the US is known as a USDMF. LP00276 USDMF includes data on LP00276's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The LP00276 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of LP00276 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 LP00276 Drug Master File in Japan (LP00276 JDMF) empowers LP00276 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 LP00276 JDMF during the approval evaluation for pharmaceutical products. At the time of LP00276 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 LP00276 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 LP00276 Drug Master File in Korea (LP00276 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of LP00276. The MFDS reviews the LP00276 KDMF as part of the drug registration process and uses the information provided in the LP00276 KDMF to evaluate the safety and efficacy of the drug.
After submitting a LP00276 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 LP00276 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of LP00276 suppliers with KDMF on PharmaCompass.
A LP00276 CEP of the European Pharmacopoeia monograph is often referred to as a LP00276 Certificate of Suitability (COS). The purpose of a LP00276 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of LP00276 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of LP00276 to their clients by showing that a LP00276 CEP has been issued for it. The manufacturer submits a LP00276 CEP (COS) as part of the market authorization procedure, and it takes on the role of a LP00276 CEP holder for the record. Additionally, the data presented in the LP00276 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the LP00276 DMF.
A LP00276 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. LP00276 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 LP00276 suppliers with CEP (COS) on PharmaCompass.
A LP00276 written confirmation (LP00276 WC) is an official document issued by a regulatory agency to a LP00276 manufacturer, verifying that the manufacturing facility of a LP00276 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting LP00276 APIs or LP00276 finished pharmaceutical products to another nation, regulatory agencies frequently require a LP00276 WC (written confirmation) as part of the regulatory process.
click here to find a list of LP00276 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 LP00276 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for LP00276 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 LP00276 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 LP00276 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a LP00276 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of LP00276 suppliers with NDC on PharmaCompass.
LP00276 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 LP00276 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 LP00276 GMP manufacturer or LP00276 GMP API supplier for your needs.
A LP00276 CoA (Certificate of Analysis) is a formal document that attests to LP00276's compliance with LP00276 specifications and serves as a tool for batch-level quality control.
LP00276 CoA mostly includes findings from lab analyses of a specific batch. For each LP00276 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.
LP00276 may be tested according to a variety of international standards, such as European Pharmacopoeia (LP00276 EP), LP00276 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (LP00276 USP).
