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