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DOSAGE - SOLUTION;INTRAVENOUS - EQ 175MG BASE...DOSAGE - SOLUTION;INTRAVENOUS - EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20140
DOSAGE - SOLUTION;INTRAVENOUS - EQ 250MG BASE...DOSAGE - SOLUTION;INTRAVENOUS - EQ 250MG BASE/25ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20140
DOSAGE - POWDER;INTRAVENOUS - EQ 50MG BASE/VI...DOSAGE - POWDER;INTRAVENOUS - EQ 50MG BASE/VIAL
USFDA APPLICATION NUMBER - 20140
DOSAGE - POWDER;INTRAVENOUS - EQ 175MG BASE/V...DOSAGE - POWDER;INTRAVENOUS - EQ 175MG BASE/VIAL
USFDA APPLICATION NUMBER - 208723
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ABOUT THIS PAGE
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PharmaCompass offers a list of Levoleucovorin Calcium 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 Levoleucovorin Calcium manufacturer or Levoleucovorin Calcium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Levoleucovorin Calcium manufacturer or Levoleucovorin Calcium supplier.
PharmaCompass also assists you with knowing the Levoleucovorin Calcium API Price utilized in the formulation of products. Levoleucovorin Calcium API Price is not always fixed or binding as the Levoleucovorin Calcium Price is obtained through a variety of data sources. The Levoleucovorin Calcium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Calcium Levofolinate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Calcium Levofolinate, including repackagers and relabelers. The FDA regulates Calcium Levofolinate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Calcium Levofolinate 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 Calcium Levofolinate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Calcium Levofolinate supplier is an individual or a company that provides Calcium Levofolinate active pharmaceutical ingredient (API) or Calcium Levofolinate finished formulations upon request. The Calcium Levofolinate suppliers may include Calcium Levofolinate API manufacturers, exporters, distributors and traders.
click here to find a list of Calcium Levofolinate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Calcium Levofolinate DMF (Drug Master File) is a document detailing the whole manufacturing process of Calcium Levofolinate active pharmaceutical ingredient (API) in detail. Different forms of Calcium Levofolinate DMFs exist exist since differing nations have different regulations, such as Calcium Levofolinate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Calcium Levofolinate DMF submitted to regulatory agencies in the US is known as a USDMF. Calcium Levofolinate USDMF includes data on Calcium Levofolinate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Calcium Levofolinate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Calcium Levofolinate 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 Calcium Levofolinate Drug Master File in Japan (Calcium Levofolinate JDMF) empowers Calcium Levofolinate 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 Calcium Levofolinate JDMF during the approval evaluation for pharmaceutical products. At the time of Calcium Levofolinate 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 Calcium Levofolinate 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 Calcium Levofolinate Drug Master File in Korea (Calcium Levofolinate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Calcium Levofolinate. The MFDS reviews the Calcium Levofolinate KDMF as part of the drug registration process and uses the information provided in the Calcium Levofolinate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Calcium Levofolinate 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 Calcium Levofolinate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Calcium Levofolinate suppliers with KDMF on PharmaCompass.
A Calcium Levofolinate CEP of the European Pharmacopoeia monograph is often referred to as a Calcium Levofolinate Certificate of Suitability (COS). The purpose of a Calcium Levofolinate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Calcium Levofolinate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Calcium Levofolinate to their clients by showing that a Calcium Levofolinate CEP has been issued for it. The manufacturer submits a Calcium Levofolinate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Calcium Levofolinate CEP holder for the record. Additionally, the data presented in the Calcium Levofolinate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Calcium Levofolinate DMF.
A Calcium Levofolinate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Calcium Levofolinate 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 Calcium Levofolinate suppliers with CEP (COS) 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 Calcium Levofolinate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Calcium Levofolinate 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 Calcium Levofolinate 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 Calcium Levofolinate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Calcium Levofolinate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Calcium Levofolinate suppliers with NDC on PharmaCompass.
Calcium Levofolinate 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 Calcium Levofolinate 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 Calcium Levofolinate GMP manufacturer or Calcium Levofolinate GMP API supplier for your needs.
A Calcium Levofolinate CoA (Certificate of Analysis) is a formal document that attests to Calcium Levofolinate's compliance with Calcium Levofolinate specifications and serves as a tool for batch-level quality control.
Calcium Levofolinate CoA mostly includes findings from lab analyses of a specific batch. For each Calcium Levofolinate 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.
Calcium Levofolinate may be tested according to a variety of international standards, such as European Pharmacopoeia (Calcium Levofolinate EP), Calcium Levofolinate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Calcium Levofolinate USP).
