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- EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- EQ 250MG BASE/25ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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