Synopsis
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KDMF
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VMF
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Australia
DRUG PRODUCT COMPOSITIONS0
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.
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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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Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
About the Company : Malladi Drugs & Pharmaceuticals Ltd was founded in 1980 by microbiologist Mr. M L N Sastry. Within a few years, Malladi established itself as a leader in manufacturing ephedrine an...
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, ...
Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
About the Company : Evonik is one of the world leaders in specialty chemicals.
The company is active in >100 countries around the world & generated sales of €15.3 billion & an operating profit ...
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
About the Company : Established in 2012, Nuray Chemicals Pvt Ltd is an API manufacturer for highly regulated markets. Its manufacturing facility with state-of-the-art R&D is located near Chennai in th...
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...
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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
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REF. STANDARDS & IMPURITIES
USP
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 Lorazepam manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lorazepam, including repackagers and relabelers. The FDA regulates Lorazepam manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lorazepam 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 Lorazepam manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lorazepam supplier is an individual or a company that provides Lorazepam active pharmaceutical ingredient (API) or Lorazepam finished formulations upon request. The Lorazepam suppliers may include Lorazepam API manufacturers, exporters, distributors and traders.
click here to find a list of Lorazepam suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lorazepam DMF (Drug Master File) is a document detailing the whole manufacturing process of Lorazepam active pharmaceutical ingredient (API) in detail. Different forms of Lorazepam DMFs exist exist since differing nations have different regulations, such as Lorazepam USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lorazepam DMF submitted to regulatory agencies in the US is known as a USDMF. Lorazepam USDMF includes data on Lorazepam's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lorazepam USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lorazepam 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 Lorazepam Drug Master File in Japan (Lorazepam JDMF) empowers Lorazepam 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 Lorazepam JDMF during the approval evaluation for pharmaceutical products. At the time of Lorazepam 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 Lorazepam suppliers with JDMF on PharmaCompass.
A Lorazepam CEP of the European Pharmacopoeia monograph is often referred to as a Lorazepam Certificate of Suitability (COS). The purpose of a Lorazepam CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Lorazepam EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Lorazepam to their clients by showing that a Lorazepam CEP has been issued for it. The manufacturer submits a Lorazepam CEP (COS) as part of the market authorization procedure, and it takes on the role of a Lorazepam CEP holder for the record. Additionally, the data presented in the Lorazepam CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Lorazepam DMF.
A Lorazepam CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Lorazepam 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 Lorazepam suppliers with CEP (COS) on PharmaCompass.
A Lorazepam written confirmation (Lorazepam WC) is an official document issued by a regulatory agency to a Lorazepam manufacturer, verifying that the manufacturing facility of a Lorazepam active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Lorazepam APIs or Lorazepam finished pharmaceutical products to another nation, regulatory agencies frequently require a Lorazepam WC (written confirmation) as part of the regulatory process.
click here to find a list of Lorazepam 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 Lorazepam as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Lorazepam 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 Lorazepam 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 Lorazepam and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Lorazepam NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Lorazepam suppliers with NDC on PharmaCompass.
Lorazepam 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 Lorazepam 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 Lorazepam GMP manufacturer or Lorazepam GMP API supplier for your needs.
A Lorazepam CoA (Certificate of Analysis) is a formal document that attests to Lorazepam's compliance with Lorazepam specifications and serves as a tool for batch-level quality control.
Lorazepam CoA mostly includes findings from lab analyses of a specific batch. For each Lorazepam 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.
Lorazepam may be tested according to a variety of international standards, such as European Pharmacopoeia (Lorazepam EP), Lorazepam JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Lorazepam USP).
