Synopsis
0
VMF
DRUG PRODUCT COMPOSITIONS0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
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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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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
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- TABLET, ORALLY DISINTEGRATING;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- TABLET, ORALLY DISINTEGRATING;ORAL - 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- TABLET, ORALLY DISINTEGRATING;ORAL - 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- TABLET, ORALLY DISINTEGRATING;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- TABLET, ORALLY DISINTEGRATING;ORAL - 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
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EUROAPI
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Taste Masking
Direct Compression
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Disintegrants & Superdisintegrants
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NEWS #PharmaBuzz
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REF. STANDARDS & IMPURITIES
ANALYTICAL
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 Cloment manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cloment, including repackagers and relabelers. The FDA regulates Cloment manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cloment 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 Cloment manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cloment supplier is an individual or a company that provides Cloment active pharmaceutical ingredient (API) or Cloment finished formulations upon request. The Cloment suppliers may include Cloment API manufacturers, exporters, distributors and traders.
click here to find a list of Cloment suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cloment DMF (Drug Master File) is a document detailing the whole manufacturing process of Cloment active pharmaceutical ingredient (API) in detail. Different forms of Cloment DMFs exist exist since differing nations have different regulations, such as Cloment USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cloment DMF submitted to regulatory agencies in the US is known as a USDMF. Cloment USDMF includes data on Cloment's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cloment USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cloment 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 Cloment Drug Master File in Japan (Cloment JDMF) empowers Cloment 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 Cloment JDMF during the approval evaluation for pharmaceutical products. At the time of Cloment 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 Cloment 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 Cloment Drug Master File in Korea (Cloment KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Cloment. The MFDS reviews the Cloment KDMF as part of the drug registration process and uses the information provided in the Cloment KDMF to evaluate the safety and efficacy of the drug.
After submitting a Cloment 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 Cloment API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Cloment suppliers with KDMF on PharmaCompass.
A Cloment CEP of the European Pharmacopoeia monograph is often referred to as a Cloment Certificate of Suitability (COS). The purpose of a Cloment CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Cloment EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Cloment to their clients by showing that a Cloment CEP has been issued for it. The manufacturer submits a Cloment CEP (COS) as part of the market authorization procedure, and it takes on the role of a Cloment CEP holder for the record. Additionally, the data presented in the Cloment CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Cloment DMF.
A Cloment CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Cloment 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 Cloment suppliers with CEP (COS) on PharmaCompass.
A Cloment written confirmation (Cloment WC) is an official document issued by a regulatory agency to a Cloment manufacturer, verifying that the manufacturing facility of a Cloment active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Cloment APIs or Cloment finished pharmaceutical products to another nation, regulatory agencies frequently require a Cloment WC (written confirmation) as part of the regulatory process.
click here to find a list of Cloment 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 Cloment as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Cloment 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 Cloment 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 Cloment and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cloment NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Cloment suppliers with NDC on PharmaCompass.
Cloment 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 Cloment 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 Cloment GMP manufacturer or Cloment GMP API supplier for your needs.
A Cloment CoA (Certificate of Analysis) is a formal document that attests to Cloment's compliance with Cloment specifications and serves as a tool for batch-level quality control.
Cloment CoA mostly includes findings from lab analyses of a specific batch. For each Cloment 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.
Cloment may be tested according to a variety of international standards, such as European Pharmacopoeia (Cloment EP), Cloment JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cloment USP).
