Synopsis
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CEP/COS
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KDMF
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VMF
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EDQM
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USP
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JP
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Others
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Europe
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Canada
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Australia
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South Africa
DRUG PRODUCT COMPOSITIONS
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Data Compilation #PharmaFlow
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Weekly News Recap #Phispers
API SUPPLIERS
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
Together we can improve the quality of life
Maithri Drugs: Delivering Trusted, High-Quality APIs to 35+ Countries with Innovation, Compliance, and Excellence.
EU-WC
CN, BR
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USDMF
Maithri Drugs: Dedicated to your API needs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32935
Submission : 2018-07-06
Status :
Type : II
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Maithri Drugs: Dedicated to your API needs.
Date of Issue : 2024-02-12
Valid Till : 2027-02-11
Written Confirmation Number : WC-0407
Address of the Firm : Sy. No. 205, 222 to 226, IDA Bonthapally, Bonthapally (Village), Gummadidala (Ma...
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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, ...
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...
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...
Together we can improve the quality of life
About the Company : Shamrock Pharmachemi Pvt Ltd. is a globally recognized API leader with over 26 years of expertise in human and veterinary pharmaceuticals. Operating in 40+ countries, we own two st...
Maithri Drugs: Dedicated to your API needs.
About the Company : Maithri Drugs Pvt. Ltd. is a trusted global partner in Active Pharmaceutical Ingredients (APIs), supplying to pharmaceutical leaders in 60+ countries. With APIs spanning antivirals...
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Nanjing Well Pharmaceutical
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Solubilizers
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ABOUT THIS PAGE
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PharmaCompass offers a list of Luliconazole 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 Luliconazole manufacturer or Luliconazole supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Luliconazole manufacturer or Luliconazole supplier.
PharmaCompass also assists you with knowing the Luliconazole API Price utilized in the formulation of products. Luliconazole API Price is not always fixed or binding as the Luliconazole Price is obtained through a variety of data sources. The Luliconazole Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Luliconazole manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Luliconazole, including repackagers and relabelers. The FDA regulates Luliconazole manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Luliconazole 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 Luliconazole manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Luliconazole supplier is an individual or a company that provides Luliconazole active pharmaceutical ingredient (API) or Luliconazole finished formulations upon request. The Luliconazole suppliers may include Luliconazole API manufacturers, exporters, distributors and traders.
click here to find a list of Luliconazole suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Luliconazole DMF (Drug Master File) is a document detailing the whole manufacturing process of Luliconazole active pharmaceutical ingredient (API) in detail. Different forms of Luliconazole DMFs exist exist since differing nations have different regulations, such as Luliconazole USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Luliconazole DMF submitted to regulatory agencies in the US is known as a USDMF. Luliconazole USDMF includes data on Luliconazole's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Luliconazole USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Luliconazole 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 Luliconazole Drug Master File in Japan (Luliconazole JDMF) empowers Luliconazole 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 Luliconazole JDMF during the approval evaluation for pharmaceutical products. At the time of Luliconazole 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 Luliconazole suppliers with JDMF on PharmaCompass.
A Luliconazole written confirmation (Luliconazole WC) is an official document issued by a regulatory agency to a Luliconazole manufacturer, verifying that the manufacturing facility of a Luliconazole active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Luliconazole APIs or Luliconazole finished pharmaceutical products to another nation, regulatory agencies frequently require a Luliconazole WC (written confirmation) as part of the regulatory process.
click here to find a list of Luliconazole 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 Luliconazole as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Luliconazole 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 Luliconazole 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 Luliconazole and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Luliconazole NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Luliconazole suppliers with NDC on PharmaCompass.
Luliconazole 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 Luliconazole 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 Luliconazole GMP manufacturer or Luliconazole GMP API supplier for your needs.
A Luliconazole CoA (Certificate of Analysis) is a formal document that attests to Luliconazole's compliance with Luliconazole specifications and serves as a tool for batch-level quality control.
Luliconazole CoA mostly includes findings from lab analyses of a specific batch. For each Luliconazole 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.
Luliconazole may be tested according to a variety of international standards, such as European Pharmacopoeia (Luliconazole EP), Luliconazole JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Luliconazole USP).
