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- TABLET, ORALLY DISINTEGRATING;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- TABLET, ORALLY DISINTEGRATING;ORAL - 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- TABLET, ORALLY DISINTEGRATING;ORAL - 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- TABLET, ORALLY DISINTEGRATING;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- TABLET, ORALLY DISINTEGRATING;ORAL - 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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