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KDMF
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Australia
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Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
Click Us!
NDC
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
CEP/COS
NDC
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
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USDMF
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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 - 0.5MG
USFDA APPLICATION NUMBER - 17794
DOSAGE - TABLET;ORAL - 1MG
USFDA APPLICATION NUMBER - 17794
DOSAGE - TABLET;ORAL - 2MG
USFDA APPLICATION NUMBER - 17794
DOSAGE - INJECTABLE;INJECTION - 2MG/ML
USFDA APPLICATION NUMBER - 18140
DOSAGE - INJECTABLE;INJECTION - 4MG/ML
USFDA APPLICATION NUMBER - 18140
Related Excipient Companies
Minakem
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REF. STANDARDS & IMPURITIES
ANALYTICAL
ABOUT THIS PAGE
42
PharmaCompass offers a list of Lorazepam 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 Lorazepam manufacturer or Lorazepam supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Lorazepam manufacturer or Lorazepam supplier.
PharmaCompass also assists you with knowing the Lorazepam API Price utilized in the formulation of products. Lorazepam API Price is not always fixed or binding as the Lorazepam Price is obtained through a variety of data sources. The Lorazepam Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Tavor manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tavor, including repackagers and relabelers. The FDA regulates Tavor manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tavor 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 Tavor manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tavor supplier is an individual or a company that provides Tavor active pharmaceutical ingredient (API) or Tavor finished formulations upon request. The Tavor suppliers may include Tavor API manufacturers, exporters, distributors and traders.
click here to find a list of Tavor suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tavor DMF (Drug Master File) is a document detailing the whole manufacturing process of Tavor active pharmaceutical ingredient (API) in detail. Different forms of Tavor DMFs exist exist since differing nations have different regulations, such as Tavor USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tavor DMF submitted to regulatory agencies in the US is known as a USDMF. Tavor USDMF includes data on Tavor's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tavor USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tavor 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 Tavor Drug Master File in Japan (Tavor JDMF) empowers Tavor 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 Tavor JDMF during the approval evaluation for pharmaceutical products. At the time of Tavor 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 Tavor suppliers with JDMF on PharmaCompass.
A Tavor CEP of the European Pharmacopoeia monograph is often referred to as a Tavor Certificate of Suitability (COS). The purpose of a Tavor CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Tavor EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Tavor to their clients by showing that a Tavor CEP has been issued for it. The manufacturer submits a Tavor CEP (COS) as part of the market authorization procedure, and it takes on the role of a Tavor CEP holder for the record. Additionally, the data presented in the Tavor CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Tavor DMF.
A Tavor CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Tavor 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 Tavor suppliers with CEP (COS) on PharmaCompass.
A Tavor written confirmation (Tavor WC) is an official document issued by a regulatory agency to a Tavor manufacturer, verifying that the manufacturing facility of a Tavor active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Tavor APIs or Tavor finished pharmaceutical products to another nation, regulatory agencies frequently require a Tavor WC (written confirmation) as part of the regulatory process.
click here to find a list of Tavor 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 Tavor as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Tavor 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 Tavor 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 Tavor and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Tavor NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Tavor suppliers with NDC on PharmaCompass.
Tavor 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 Tavor 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 Tavor GMP manufacturer or Tavor GMP API supplier for your needs.
A Tavor CoA (Certificate of Analysis) is a formal document that attests to Tavor's compliance with Tavor specifications and serves as a tool for batch-level quality control.
Tavor CoA mostly includes findings from lab analyses of a specific batch. For each Tavor 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.
Tavor may be tested according to a variety of international standards, such as European Pharmacopoeia (Tavor EP), Tavor JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tavor USP).
