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VMF
DRUG PRODUCT COMPOSITIONS0
Data Compilation #PharmaFlow
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API SUPPLIERS
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USDMF
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 :
Type : II
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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, ...
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Pharma 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...
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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- TABLET, ORALLY DISINTEGRATING;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- TABLET, ORALLY DISINTEGRATING;ORAL - 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- TABLET, ORALLY DISINTEGRATING;ORAL - 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
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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(tautomer) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of clozapine(tautomer), including repackagers and relabelers. The FDA regulates clozapine(tautomer) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. clozapine(tautomer) 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 clozapine(tautomer) manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A clozapine(tautomer) supplier is an individual or a company that provides clozapine(tautomer) active pharmaceutical ingredient (API) or clozapine(tautomer) finished formulations upon request. The clozapine(tautomer) suppliers may include clozapine(tautomer) API manufacturers, exporters, distributors and traders.
click here to find a list of clozapine(tautomer) suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A clozapine(tautomer) DMF (Drug Master File) is a document detailing the whole manufacturing process of clozapine(tautomer) active pharmaceutical ingredient (API) in detail. Different forms of clozapine(tautomer) DMFs exist exist since differing nations have different regulations, such as clozapine(tautomer) USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A clozapine(tautomer) DMF submitted to regulatory agencies in the US is known as a USDMF. clozapine(tautomer) USDMF includes data on clozapine(tautomer)'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The clozapine(tautomer) USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of clozapine(tautomer) 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 clozapine(tautomer) Drug Master File in Japan (clozapine(tautomer) JDMF) empowers clozapine(tautomer) 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(tautomer) JDMF during the approval evaluation for pharmaceutical products. At the time of clozapine(tautomer) 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 clozapine(tautomer) 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 clozapine(tautomer) Drug Master File in Korea (clozapine(tautomer) KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of clozapine(tautomer). The MFDS reviews the clozapine(tautomer) KDMF as part of the drug registration process and uses the information provided in the clozapine(tautomer) KDMF to evaluate the safety and efficacy of the drug.
After submitting a clozapine(tautomer) 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(tautomer) API can apply through the Korea Drug Master File (KDMF).
click here to find a list of clozapine(tautomer) suppliers with KDMF on PharmaCompass.
A clozapine(tautomer) CEP of the European Pharmacopoeia monograph is often referred to as a clozapine(tautomer) Certificate of Suitability (COS). The purpose of a clozapine(tautomer) CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of clozapine(tautomer) EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of clozapine(tautomer) to their clients by showing that a clozapine(tautomer) CEP has been issued for it. The manufacturer submits a clozapine(tautomer) CEP (COS) as part of the market authorization procedure, and it takes on the role of a clozapine(tautomer) CEP holder for the record. Additionally, the data presented in the clozapine(tautomer) CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the clozapine(tautomer) DMF.
A clozapine(tautomer) CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. clozapine(tautomer) 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 clozapine(tautomer) suppliers with CEP (COS) on PharmaCompass.
A clozapine(tautomer) written confirmation (clozapine(tautomer) WC) is an official document issued by a regulatory agency to a clozapine(tautomer) manufacturer, verifying that the manufacturing facility of a clozapine(tautomer) active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting clozapine(tautomer) APIs or clozapine(tautomer) finished pharmaceutical products to another nation, regulatory agencies frequently require a clozapine(tautomer) WC (written confirmation) as part of the regulatory process.
click here to find a list of clozapine(tautomer) 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(tautomer) as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for clozapine(tautomer) 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(tautomer) 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(tautomer) and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a clozapine(tautomer) NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of clozapine(tautomer) suppliers with NDC on PharmaCompass.
clozapine(tautomer) 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(tautomer) 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(tautomer) GMP manufacturer or clozapine(tautomer) GMP API supplier for your needs.
A clozapine(tautomer) CoA (Certificate of Analysis) is a formal document that attests to clozapine(tautomer)'s compliance with clozapine(tautomer) specifications and serves as a tool for batch-level quality control.
clozapine(tautomer) CoA mostly includes findings from lab analyses of a specific batch. For each clozapine(tautomer) 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(tautomer) may be tested according to a variety of international standards, such as European Pharmacopoeia (clozapine(tautomer) EP), clozapine(tautomer) JP (Japanese Pharmacopeia) and the US Pharmacopoeia (clozapine(tautomer) USP).
