Synopsis
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VMF
DRUG PRODUCT COMPOSITIONS0
Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
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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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- TABLET, ORALLY DISINTEGRATING;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- TABLET, ORALLY DISINTEGRATING;ORAL - 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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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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 CID2818 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of CID2818, including repackagers and relabelers. The FDA regulates CID2818 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. CID2818 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 CID2818 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A CID2818 supplier is an individual or a company that provides CID2818 active pharmaceutical ingredient (API) or CID2818 finished formulations upon request. The CID2818 suppliers may include CID2818 API manufacturers, exporters, distributors and traders.
click here to find a list of CID2818 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A CID2818 DMF (Drug Master File) is a document detailing the whole manufacturing process of CID2818 active pharmaceutical ingredient (API) in detail. Different forms of CID2818 DMFs exist exist since differing nations have different regulations, such as CID2818 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A CID2818 DMF submitted to regulatory agencies in the US is known as a USDMF. CID2818 USDMF includes data on CID2818's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The CID2818 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of CID2818 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 CID2818 Drug Master File in Japan (CID2818 JDMF) empowers CID2818 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 CID2818 JDMF during the approval evaluation for pharmaceutical products. At the time of CID2818 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 CID2818 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 CID2818 Drug Master File in Korea (CID2818 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of CID2818. The MFDS reviews the CID2818 KDMF as part of the drug registration process and uses the information provided in the CID2818 KDMF to evaluate the safety and efficacy of the drug.
After submitting a CID2818 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 CID2818 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of CID2818 suppliers with KDMF on PharmaCompass.
A CID2818 CEP of the European Pharmacopoeia monograph is often referred to as a CID2818 Certificate of Suitability (COS). The purpose of a CID2818 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of CID2818 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of CID2818 to their clients by showing that a CID2818 CEP has been issued for it. The manufacturer submits a CID2818 CEP (COS) as part of the market authorization procedure, and it takes on the role of a CID2818 CEP holder for the record. Additionally, the data presented in the CID2818 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the CID2818 DMF.
A CID2818 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. CID2818 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 CID2818 suppliers with CEP (COS) on PharmaCompass.
A CID2818 written confirmation (CID2818 WC) is an official document issued by a regulatory agency to a CID2818 manufacturer, verifying that the manufacturing facility of a CID2818 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting CID2818 APIs or CID2818 finished pharmaceutical products to another nation, regulatory agencies frequently require a CID2818 WC (written confirmation) as part of the regulatory process.
click here to find a list of CID2818 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 CID2818 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for CID2818 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 CID2818 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 CID2818 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a CID2818 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of CID2818 suppliers with NDC on PharmaCompass.
CID2818 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 CID2818 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 CID2818 GMP manufacturer or CID2818 GMP API supplier for your needs.
A CID2818 CoA (Certificate of Analysis) is a formal document that attests to CID2818's compliance with CID2818 specifications and serves as a tool for batch-level quality control.
CID2818 CoA mostly includes findings from lab analyses of a specific batch. For each CID2818 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.
CID2818 may be tested according to a variety of international standards, such as European Pharmacopoeia (CID2818 EP), CID2818 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (CID2818 USP).
