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Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
About the Company : Established in 1994, Rochem is a distributor of pharmaceutical, food, nutritional and animal health ingredients to some of the largest companies in the world. It sources high-quali...
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API Imports and Exports
Drugs in Development
Lead Product(s) : Aflibercept,Calcium Folinate,Irinotecan Hydrochloride,Fluorouracil
Therapeutic Area : Oncology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Regeneron Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Aflibercept is a Protein drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Neoplasms.
Product Name : Undisclosed
Product Type : Protein
Upfront Cash : Inapplicable
August 29, 2013
Lead Product(s) : Sarilumab,Prednisone,Methotrexate,Calcium Folinate
Therapeutic Area : Ophthalmology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Phase II Study to Analyze Sarilumab in Non-Infectious Uveitis
Details : Sarilumab is a Antibody drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Uveitis.
Product Name : Undisclosed
Product Type : Antibody, Unconjugated
Upfront Cash : Inapplicable
July 16, 2013
Lead Product(s) : Aflibercept,Irinotecan Hydrochloride,Fluorouracil,Calcium Folinate
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Regeneron Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Aflibercept is a Protein drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Colorectal Neoplasms.
Product Name : Undisclosed
Product Type : Protein
Upfront Cash : Inapplicable
August 22, 2012
Lead Product(s) : Aflibercept,Calcium Folinate,Fluorouracil,Irinotecan Hydrochloride
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Regeneron Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Aflibercept is a Protein drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Colorectal Neoplasms.
Product Name : Undisclosed
Product Type : Protein
Upfront Cash : Inapplicable
April 05, 2012
Lead Product(s) : Sarilumab,Methotrexate,Calcium Folinate
Therapeutic Area : Immunology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Regeneron Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Sarilumab is a Antibody drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Arthritis, Rheumatoid.
Product Name : Undisclosed
Product Type : Antibody, Unconjugated
Upfront Cash : Inapplicable
October 08, 2010
Lead Product(s) : Calcium Folinate,Oxaliplatin,Fluorouracil
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Randomized Study With Oxaliplatin in 2nd Line Pancreatic Cancer
Details : Leucovorin is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Pancreatic Neoplasms.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
May 12, 2010
Lead Product(s) : Telisotuzumab Adizutecan,Fluorouracil,Oxaliplatin,Calcium Folinate,Bevacizumab
Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Telisotuzumab Adizutecan is a Antibody-drug Conjugate drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Colorectal Neoplasms.
Product Name : Undisclosed
Product Type : Antibody-drug Conjugate
Upfront Cash : Inapplicable
February 11, 2025
Lead Product(s) : ABBV-400,Budigalimab,Fluorouracil,Calcium Folinate
Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : ABBV-400 is a drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Gastroesophageal Junction Neoplasms.
Product Name : Undisclosed
Product Type : Undisclosed
Upfront Cash : Inapplicable
October 04, 2024
Lead Product(s) : ABBV-400,Bevacizumab,Calcium Folinate,Fluorouracil
Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : ABBV-400 is a drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Colorectal Neoplasms.
Product Name : Undisclosed
Product Type : Undisclosed
Upfront Cash : Inapplicable
October 30, 2023
Lead Product(s) : ABBV-927,Budiglimab,Fluorouracil,Calcium Folinate,Irinotecan Hydrochloride,Oxaliplatin
Therapeutic Area : Oncology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : ABBV-927 is a Antibody drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Pancreatic Neoplasms.
Product Name : Undisclosed
Product Type : Antibody, Unconjugated
Upfront Cash : Inapplicable
March 19, 2021
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Calcium Folinate 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 Calcium Folinate manufacturer or Calcium Folinate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Calcium Folinate manufacturer or Calcium Folinate supplier.
PharmaCompass also assists you with knowing the Calcium Folinate API Price utilized in the formulation of products. Calcium Folinate API Price is not always fixed or binding as the Calcium Folinate Price is obtained through a variety of data sources. The Calcium Folinate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Leucovorin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Leucovorin, including repackagers and relabelers. The FDA regulates Leucovorin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Leucovorin 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 Leucovorin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Leucovorin supplier is an individual or a company that provides Leucovorin active pharmaceutical ingredient (API) or Leucovorin finished formulations upon request. The Leucovorin suppliers may include Leucovorin API manufacturers, exporters, distributors and traders.
click here to find a list of Leucovorin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Leucovorin DMF (Drug Master File) is a document detailing the whole manufacturing process of Leucovorin active pharmaceutical ingredient (API) in detail. Different forms of Leucovorin DMFs exist exist since differing nations have different regulations, such as Leucovorin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Leucovorin DMF submitted to regulatory agencies in the US is known as a USDMF. Leucovorin USDMF includes data on Leucovorin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Leucovorin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Leucovorin 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 Leucovorin Drug Master File in Japan (Leucovorin JDMF) empowers Leucovorin 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 Leucovorin JDMF during the approval evaluation for pharmaceutical products. At the time of Leucovorin 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 Leucovorin 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 Leucovorin Drug Master File in Korea (Leucovorin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Leucovorin. The MFDS reviews the Leucovorin KDMF as part of the drug registration process and uses the information provided in the Leucovorin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Leucovorin 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 Leucovorin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Leucovorin suppliers with KDMF on PharmaCompass.
A Leucovorin CEP of the European Pharmacopoeia monograph is often referred to as a Leucovorin Certificate of Suitability (COS). The purpose of a Leucovorin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Leucovorin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Leucovorin to their clients by showing that a Leucovorin CEP has been issued for it. The manufacturer submits a Leucovorin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Leucovorin CEP holder for the record. Additionally, the data presented in the Leucovorin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Leucovorin DMF.
A Leucovorin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Leucovorin 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 Leucovorin suppliers with CEP (COS) on PharmaCompass.
A Leucovorin written confirmation (Leucovorin WC) is an official document issued by a regulatory agency to a Leucovorin manufacturer, verifying that the manufacturing facility of a Leucovorin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Leucovorin APIs or Leucovorin finished pharmaceutical products to another nation, regulatory agencies frequently require a Leucovorin WC (written confirmation) as part of the regulatory process.
click here to find a list of Leucovorin 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 Leucovorin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Leucovorin 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 Leucovorin 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 Leucovorin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Leucovorin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Leucovorin suppliers with NDC on PharmaCompass.
Leucovorin 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 Leucovorin 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 Leucovorin GMP manufacturer or Leucovorin GMP API supplier for your needs.
A Leucovorin CoA (Certificate of Analysis) is a formal document that attests to Leucovorin's compliance with Leucovorin specifications and serves as a tool for batch-level quality control.
Leucovorin CoA mostly includes findings from lab analyses of a specific batch. For each Leucovorin 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.
Leucovorin may be tested according to a variety of international standards, such as European Pharmacopoeia (Leucovorin EP), Leucovorin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Leucovorin USP).
