Synopsis
0
NDC API
0
VMF
0
FDA Orange Book
0
Canada
DRUG PRODUCT COMPOSITIONS
0
US Patents
0
US Exclusivities
0
Health Canada Patents
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Panvo Organics: Advancing quality APIs and formulations with Halal, Kosher, US FDA, and WHO-approved manufacturing excellence.
Willow Birch Pharma delivers trusted, high-quality APIs nationwide with unmatched service, compliance, and competitive value.
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] Drugs in Development
Lead Product(s) : Aflibercept,Fluorouracil,Calcium Folinate,Irinotecan Hydrochloride
Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : CR-CSSS Champlain-Charles-Le Moyne
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Aflibercept is a Protein drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Colorectal Neoplasms.
Product Name : Undisclosed
Product Type : Protein
Upfront Cash : Inapplicable
January 24, 2014
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,Oxaliplatin,Calcium Folinate,Fluorouracil
Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : John Hays
Deal Size : Inapplicable
Deal Type : Inapplicable
Aflibercept and FOLFOX6 Treatment for Previously Untreated Stage IV Colorectal Cancer
Details : Aflibercept is a Protein drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Colonic Neoplasms.
Product Name : Undisclosed
Product Type : Protein
Upfront Cash : Inapplicable
July 27, 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,Calcium Folinate,Oxaliplatin
Therapeutic Area : Oncology
Highest Development Status : Phase II/ Phase III
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/ Phase III clinical studies for the treatment of Carcinoma, Pancreatic Ductal.
Product Name : Undisclosed
Product Type : Antibody-drug Conjugate
Upfront Cash : Inapplicable
March 24, 2026
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Australia
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]South Africa
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Dossiers
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Tablet
Dosage Strength : 5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Ethypharm is an international Pharma company with European roots manufacturing and commercializing essential drugs all over the world.
Regulatory Info :
Registration Country : France
Brand Name :
Dosage Form : Vial
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : France
Ethypharm is an international Pharma company with European roots manufacturing and commercializing essential drugs all over the world.
Regulatory Info :
Registration Country : France
Brand Name :
Dosage Form : Vial
Dosage Strength : 350MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : France
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 100MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 200MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 350MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 100MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 200MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
EUROAPI
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Rochem International Inc
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]SPI Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Boai NKY Pharmaceuticals Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Well Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pfanstiehl
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kirsch Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Dr. Paul Lohmann GmbH & Co. KGaA
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ACG Worldwide
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Actylis
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Aeon Procare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ashland
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Cassava Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CD Formulation
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Corel Pharma Chem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DFE Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Esteem Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Finar
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ideal Cures
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ingredion Pharma Solutions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kerry
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Keval Exports
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kima Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Lonza Capsugel
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Microlex e.U
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Neelkanth MineChem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nitika Pharmaceutical Specialities
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nomisma Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Novo Excipients
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharmatrans-Sanaq
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pluviaendo
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Prachin Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qianhao Chemical (Hebei) Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qualicaps
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Roquette
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Seppic
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Sigachi Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Silverline Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]The Dow Chemical Company
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Fillers, Diluents & Binders
Coating Systems & Additives
Thickeners and Stabilizers
Controlled & Modified Release
Granulation
Direct Compression
Disintegrants & Superdisintegrants
Parenteral
Lubricants & Glidants
Topical
Co-Processed Excipients
Solubilizers
Film Formers & Plasticizers
Taste Masking
Empty Capsules
API Stability Enhancers
Chewable & Orodispersible Aids
Emulsifying Agents
Vegetarian Capsules
Rheology Modifiers
Coloring Agents
Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
APIs
Reply
16 Apr 2026
Reply
04 Oct 2025
Reply
03 May 2025
Reply
31 Jan 2025
Reply
23 Jan 2025
Reply
09 Sep 2024
Reply
03 Sep 2024
Reply
26 Jan 2024
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
41
PharmaCompass offers a list of Calcium Folinate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, 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.
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, and COA 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, and COA 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.
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, 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).
Comment (2)
