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- EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- EQ 250MG BASE/25ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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