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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 |
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-01-29
Pay. Date : 2018-12-07
DMF Number : 31999
Submission : 2017-08-24
Status : Active
Type : II
Certificate Number : R0-CEP 2018-192 - Rev 01
Issue Date : 2021-02-12
Type : Chemical
Substance Number : 1191
Status : Withdrawn by Holder
NDC Package Code : 76072-1010
Start Marketing Date : 2017-06-05
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37540
Submission : 2023-02-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39913
Submission : 2024-05-28
Status : Active
Type : II
Date of Issue : 2022-01-07
Valid Till : 2025-07-21
Written Confirmation Number : WC-0373
Address of the Firm :
NDC Package Code : 67835-0028
Start Marketing Date : 2021-09-17
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-01-26
Pay. Date : 2022-12-12
DMF Number : 36645
Submission : 2021-12-23
Status : Active
Type : II
Certificate Number : CEP 2023-444 - Rev 00
Issue Date : 2024-03-28
Type : Chemical
Substance Number : 1191
Status : Valid
Date of Issue : 2022-09-12
Valid Till : 2025-08-12
Written Confirmation Number : WC-0542
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-08-29
Pay. Date : 2013-09-25
DMF Number : 25182
Submission : 2011-08-03
Status : Active
Type : II
Certificate Number : R1-CEP 2012-006 - Rev 00
Issue Date : 2018-04-12
Type : Chemical
Substance Number : 1191
Status : Valid
NDC Package Code : 64374-004
Start Marketing Date : 2016-07-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11195
Submission : 1994-11-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36869
Submission : 2022-03-23
Status : Active
Type : II
Certificate Number : CEP 2022-328 - Rev 00
Issue Date : 2024-12-13
Type : Chemical
Substance Number : 1191
Status : Valid
Date of Issue : 2022-06-17
Valid Till : 2025-07-07
Written Confirmation Number : WC-0104
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19822
Submission : 2006-10-02
Status : Active
Type : II
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2019-01-29
Pay. Date : 2018-12-07
DMF Number : 31999
Submission : 2017-08-24
Status : Active
Type : II
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37540
Submission : 2023-02-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10862
Submission : 1994-04-05
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-04
Pay. Date : 2013-09-30
DMF Number : 11692
Submission : 1995-10-03
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-01-29
Pay. Date : 2015-01-26
DMF Number : 10534
Submission : 1993-10-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11098
Submission : 1994-09-26
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11195
Submission : 1994-11-16
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-08-29
Pay. Date : 2013-09-25
DMF Number : 25182
Submission : 2011-08-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19822
Submission : 2006-10-02
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12873
Submission : 1998-02-22
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Certificate Number : R0-CEP 2018-192 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2021-02-12
Type : Chemical
Substance Number : 1191
Certificate Number : R1-CEP 2006-205 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2015-11-05
Type : Chemical
Substance Number : 1191
Certificate Number : CEP 2021-110 - Rev 01
Status : Valid
Issue Date : 2025-01-20
Type : Chemical
Substance Number : 1191
Certificate Number : CEP 2023-444 - Rev 00
Status : Valid
Issue Date : 2024-03-28
Type : Chemical
Substance Number : 1191
Certificate Number : R1-CEP 2005-128 - Rev 03
Status : Valid
Issue Date : 2022-05-31
Type : Chemical
Substance Number : 1191
Certificate Number : CEP 2022-328 - Rev 00
Status : Valid
Issue Date : 2024-12-13
Type : Chemical
Substance Number : 1191
Certificate Number : R1-CEP 2008-151 - Rev 00
Status : Valid
Issue Date : 2015-07-13
Type : Chemical
Substance Number : 1191
Certificate Number : R1-CEP 2012-006 - Rev 00
Status : Valid
Issue Date : 2018-04-12
Type : Chemical
Substance Number : 1191
Certificate Number : CEP 2008-234 - Rev 02
Status : Valid
Issue Date : 2024-07-25
Type : Chemical
Substance Number : 1191
Certificate Number : R1-CEP 2010-087 - Rev 01
Status : Valid
Issue Date : 2019-04-23
Type : Chemical
Substance Number : 1191
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
About the Company : Mankind Pharma, came into existence in 1986. In 1991, the company was formed into a legal corporation. However, it actively started working as a fully integrated pharmaceutical com...
About the Company : Aurore Life Sciences is a pure-play API manufacturer with a diverse portfolio of capabilities in delivering efficiencies to generic players globally. Founded in 2017 by a team with...
About the Company : As an EU-GMP certified global company and an established hallmark for pharmaceutical standards, Global Calcium has stood the test of time since its inception in 1979 as Calcium Ind...
About the Company : JIN DUN Medical Research Institute is affiliated to Shanghai JIN DUN Industrial Co., Ltd., headquartered in Shanghai, adjacent to Hongqiao High-speed Railway Station and Hongqiao I...
About the Company : Medichem is an indepently-owned company based in Barcelona. Founded in 1972 and with more than 45 years, Medichem has been engaged in the process development and manufacture of Act...
About the Company : Medilux Laboratories has been providing quality back-end support to the pharmaceutical industry since our inception in 1988. Our resources are dedicated to promoting better health ...
About the Company : Smilax Laboratories Limited is a research-driven, vertically integrated pharmaceutical company manufacturing Active Pharmaceutical Ingredients, API Intermediates and NDDS/Pellets f...
About the Company : SMS Pharmaceuticals Ltd. is a global player in API manufacturing having a strong research and manufacturing team supported by state of the art facilities. What started off as a sin...
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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:
Tanner to distribute Versacloz in areas outside of the U.S where the product is not yet registered. Versacloz is indicated for the treatment of severely ill patients with schizophrenia who fail to respond to standard antipsychotic treatment.
Lead Product(s): Clozapine
Therapeutic Area: Psychiatry/Psychology Brand Name: Versacloz
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Tasmanian Alkaloids Pty Ltd
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement June 22, 2020
Lead Product(s) : Clozapine
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Tasmanian Alkaloids Pty Ltd
Deal Size : Undisclosed
Deal Type : Agreement
Tanner Pharma Group Signs Versacloz Distribution Agreement with Tasman Pharma Inc.
Details : Tanner to distribute Versacloz in areas outside of the U.S where the product is not yet registered. Versacloz is indicated for the treatment of severely ill patients with schizophrenia who fail to respond to standard antipsychotic treatment.
Product Name : Versacloz
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
June 22, 2020
DRUG PRODUCT COMPOSITIONS
Related Excipient Companies
Dosage Form : Tablet
Grade : Oral
Dosage Form : Cream / Lotion / Ointment
Grade : Topical, Parenteral
Excipients by Applications
Global Sales Information
Market Place
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Patents & EXCLUSIVITIES
Patent Expiration Date : 2028-05-01
US Patent Number : 8057811
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 203479
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2028-05-01
REF. STANDARDS & IMPURITIES
ANALYTICAL
ABOUT THIS PAGE
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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 Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex, including repackagers and relabelers. The FDA regulates Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex supplier is an individual or a company that provides Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex active pharmaceutical ingredient (API) or Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex finished formulations upon request. The Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex suppliers may include Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex API manufacturers, exporters, distributors and traders.
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A Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex DMF (Drug Master File) is a document detailing the whole manufacturing process of Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex active pharmaceutical ingredient (API) in detail. Different forms of Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex DMFs exist exist since differing nations have different regulations, such as Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex DMF submitted to regulatory agencies in the US is known as a USDMF. Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex USDMF includes data on Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex USDMF is kept confidential to protect the manufacturer’s intellectual property.
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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 Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex Drug Master File in Japan (Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex JDMF) empowers Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex 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 Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex JDMF during the approval evaluation for pharmaceutical products. At the time of Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex Drug Master File in Korea (Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex. The MFDS reviews the Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex KDMF as part of the drug registration process and uses the information provided in the Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex KDMF to evaluate the safety and efficacy of the drug.
After submitting a Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex 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 Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex API can apply through the Korea Drug Master File (KDMF).
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A Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex CEP of the European Pharmacopoeia monograph is often referred to as a Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex Certificate of Suitability (COS). The purpose of a Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex to their clients by showing that a Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex CEP has been issued for it. The manufacturer submits a Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex CEP (COS) as part of the market authorization procedure, and it takes on the role of a Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex CEP holder for the record. Additionally, the data presented in the Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex DMF.
A Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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A Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex written confirmation (Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex WC) is an official document issued by a regulatory agency to a Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex manufacturer, verifying that the manufacturing facility of a Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex APIs or Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex finished pharmaceutical products to another nation, regulatory agencies frequently require a Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex WC (written confirmation) as part of the regulatory process.
click here to find a list of Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex 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 Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex 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 Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex 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 Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex suppliers with NDC on PharmaCompass.
Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex 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 Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex 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 Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex GMP manufacturer or Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex GMP API supplier for your needs.
A Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex CoA (Certificate of Analysis) is a formal document that attests to Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex's compliance with Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex specifications and serves as a tool for batch-level quality control.
Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex CoA mostly includes findings from lab analyses of a specific batch. For each Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex 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.
Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex may be tested according to a variety of international standards, such as European Pharmacopoeia (Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex EP), Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Clozapine, Clozaril, Azaleptin, Leponex, Fazaclo, Froidir, Denzapine, Zaponex USP).